Health Policy Advisory Committee on
Technology
Technology Brief
Catheter ablation for atrial fibrillation
July 2014
© State of Queensland (Queensland Department of Health) 2014
This work is licensed under a Creative Commons Attribution Non-Commercial No Derivatives 3.0
Australia licence. In essence, you are free to copy and communicate the work in its current form for
non-commercial purposes, as long as you attribute the authors and abide by the licence terms. You
may not alter or adapt the work in any way.
To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/3.0/au/deed.en.
For further information, contact the HealthPACT Secretariat at:
HealthPACT Secretariat
c/o Clinical Access and Redesign Unit, Health Service and Clinical Innovation Division
Department of Health, Queensland
Level 2, 15 Butterfield St,
HERSTON QLD 4029
Postal Address: GPO Box 48, Brisbane QLD 4001
Email: HealthPACT@health.qld.gov.au
Telephone: +61 7 3646 9100
For permissions beyond the scope of this licence contact: Intellectual Property Officer, Department
of Health, GPO Box 48, Brisbane QLD 4001, email ip_officer@health.qld.gov.au, phone (07) 3328
9824.
Electronic copies can be obtained from: http://www.health.qld.gov.au/healthpact
DISCLAIMER: This Brief is published with the intention of providing information of interest. It is
based on information available at the time of research and cannot be expected to cover any
developments arising from subsequent improvements to health technologies. This Brief is based on
a limited literature search and is not a definitive statement on the safety, effectiveness or costeffectiveness of the health technology covered.
The State of Queensland acting through Queensland Health (“Queensland Health”) does not
guarantee the accuracy, currency or completeness of the information in this Brief. Information may
contain or summarise the views of others, and not necessarily reflect the views of Queensland
Health.
This Brief is not intended to be used as medical advice and it is not intended to be used to diagnose,
treat, cure or prevent any disease, nor should it be used for therapeutic purposes or as a substitute
for a health professional's advice. It must not be relied upon without verification from authoritative
sources. Queensland Health does not accept any liability, including for any injury, loss or damage,
incurred by use of or reliance on the information.
This Brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy
Advisory Committee on Technology (HealthPACT). The production of this Brief was overseen by
HealthPACT. HealthPACT comprises representatives from health departments in all States and
Territories, the Australian and New Zealand governments and MSAC. It is a sub-committee of the
Australian Health Ministers’ Advisory Council (AHMAC), reporting to AHMAC’s Hospitals Principal
Committee (HPC). AHMAC supports HealthPACT through funding.
This brief was prepared by Linda Mundy from the HealthPACT Secretariat.
Technology, Company and Licensing
Register ID
WP189
Technology name
Catheter ablation for atrial fibrillation
Patient indication
Patients with paroxysmal atrial fibrillation
Reason for assessment
This Brief was commissioned in response to horizon scanning activities that identified an
exponential growth in the rate of catheter ablation procedures for atrial fibrillation (AF)
being conducted in Australia and New Zealand. With an increase in the population
prevalence of atrial fibrillation, this trend has implications for health-care expenditure and
policy. In addition, recent literature has described uncertainty in the evidence base
describing the safety and long-term effectiveness of catheter ablation.
In September 2012, the National Health Committee (NHC) of New Zealand completed a
Technology Note on the use of catheter ablation for atrial fibrillation 1 (see Attachment 1).
The Technology Note highlights several issues: the increasing prevalence of AF, the
corresponding increase in the use of catheter ablation and the subsequent budgetary
impact on the public health system, and the potential need for service reorganisation,
assessing workforce and infrastructure capacity, in order to meet demand.
To avoid duplication of effort, this Technology Brief will only present the most recent
evidence around this topic, and as such will be an abbreviated version of a Brief.
Stage of development in Australia
Yet to emerge
Established
Experimental
Established but changed indication
or modification of technique
Should be taken out of use
Investigational
Nearly established
Licensing, reimbursement and other approval
Numerous catheters for the use of cardiac ablation and electrophysiological mapping are
registered on the ARTG. In addition, several mapping and navigation systems are registered
including Ensite™ NavX™ (St Jude Medical Inc, USA) and CARTO® (Biosense Webster Inc,
USA). In addition, robotic systems such as the Niobe® (Stereotaxis Inc, USA) and the Sensei®
(Hansen Medical, USA), which perform guidance, mapping and ablation remotely, have been
developed but as yet not registered on the ARTG.
Catheter ablation for atrial fibrillation: July 2014
1
Australian Therapeutic Goods Administration approval
Yes
ARTG number (s)
No
Not applicable
Technology type
Procedure
Technology use
Therapeutic
Patient Indication and Setting
Disease description and associated mortality and morbidity
See page three of the NHC’s Technology Note.1
A normal heart contracts 60 to 100 times per minute. Contraction of the atria is initiated by
electrical signals which emanate from the sinus node, situated at the top of the right atrium.
These electrical signals travel rapidly throughout the atria to ensure that all muscle fibres
contract in the appropriate sequence, pushing the blood into the ventricles. The atrioventricular node passes on these electrical signals, causing the ventricles to contract after
they have filled with blood from the atria. This normal, regular heart rhythm is referred to as
sinus rhythm (Figure 1).2
Figure 1
The normal heart and electrocardiogram (ECG) trace3
Abnormal electrical signals, originating from the pulmonary veins, cause the muscle fibres in
the atria to contract out of time, resulting in atrial fibrillation (AF) (Figure 2). These
abnormal signals may pass on to the ventricles, causing a rapid and irregular heartbeat.
Patients with AF may be aware of this irregular heartbeat and feel a “fluttering” of the
heart. Symptoms include an irregular pulse, fatigue, exercise intolerance, dizziness, fainting
Catheter ablation for atrial fibrillation: July 2014
2
and general weakness as the heart is not working efficiently. AF may occur as a one-off
episode, or may be paroxysmal or persistent.2
Figure 2
Heart and ECG trace demonstrating AF3
AF is the most common sustained cardiac rhythm disturbance, affecting approximately two
per cent of the population. The prevalence of AF increases with age with approximately five
per cent of individuals aged over 65 years affected. Haemodynamic impairment and
thromboembolic events related to AF result in significant morbidity, mortality, and cost.
The most common causes of AF include long-term high blood pressure and coronary heart
disease, valvular heart disease and, less commonly, hyperthyroidism.2
Atrial fibrillation may result in stroke, which is the most common cause of cerebrovascular
death. Stroke occurs when a blood vessel leading to the brain is blocked by a clot (ischaemic
stroke) or bleeds (haemorrhagic stroke). Although haemorrhagic strokes are less common
than ischaemic strokes they have a higher fatality rate. As well as causing death, stroke
results in high levels of disability in the community. An estimated 60,000 stroke events occur
in Australia every year and the majority of these (70%) are first-ever strokes.4 In people
aged over 65 years with untreated AF, the risk of experiencing a stroke is approximately one
in 20, which is five to six times higher than in those without AF. The risk of stroke increases
in individuals with AF and other co-morbidities, including diabetes and high blood pressure.2
In 2009, there were 8,300 deaths from stroke in Australia, accounting for six per cent of all
deaths and 18 per cent of deaths from cardiovascular disease. During the same period,
stroke was the second leading cause of death for females behind coronary heart disease
accounting for 6,706 or 9.8 per cent of all deaths. Stroke was the third leading cause of
death in males behind coronary heart disease and lung cancer, accounting for 4,514 or 6.2
per cent of all male deaths. Although more females died from stroke in 2009, the rate of
death per 100,000 population was higher for males than females (36.0 vs 33.9,
respectively).5
Catheter ablation for atrial fibrillation: July 2014
3
During 2009-10 there were 41,977 public hospital separations for cerebrovascular diseases
(I60 – I69). Of these, the greatest proportion was for cerebral infarction (I63) with 17,079
separations (ALOS 10.0 days) followed by stroke (I64, not specified as haemorrhage or
infarction) with 8,021 separations (ALOS 8.0 days).4
Number of patients
A recent Australian study by Kumar et al (2013) reported on the 10-year trend in the use of
catheter ablation for AF using data obtained from the AIHWa procedures database,
Medicare Benefits Schedule (MBS) item usage and from the Royal Melbourne Hospital
(RMH), a tertiary referral centre for electrophysiology and ablation of cardiac arrhythmias.6
All of these sources are problematic, highlighting the difficulty policy makers have in
accessing accurate usage data for many interventions conducted in Australia. The AIHW
data, whilst inclusive of procedures conducted in both public and private Australian
hospitals, has used a number of classifications over the years to describe ‘ablation of
arrhythmia’. For the purposes of this study data from the years 2000 to 2010 were collected
using the classification of ‘ablation of arrhythmia circuit or focus involving two atrial
chambers’, which was considered to most accurately represent the MBS item number for AF
ablation. Similarly, there is no specific MBS billing code for AF ablation alone, with the most
appropriate MBS item number for this indication considered to be ‘38290 – ablation of
arrhythmia circuits of foci, or isolation procedure involving both atrial chambers and
including curative procedures for atrial fibrillation’. However, MBS item number usage
statistics only reflect private hospital activity. The RMH data were used to validate the
trends observed in the AIHW and MBS data.
The AIHW data revealed that AF ablation constituted 28 per cent of all ablation procedures,
and that over the 10-year period the number of AF ablation increased from 0.003 to 0.04
procedures per 1,000 persons, representing a 30.9 per cent per year population-adjusted
increment (95%CI [21.1, 41.8] % per year, p< 0.001). This rate was significantly higher than
the increment rate for all cardiovascular procedures (3.8%, p= 0.002) and for percutaneous
coronary interventions (PCI) (5.1%, p=0.004) over the same period. This held true after a
sensitivity analysis was conducted to address possible errors in coding for the procedure.
This upward trend for AF ablation procedures was confirmed by the data obtained from the
MBS, where over the same 10-year time period, AF ablations increased from 0.01 to 0.07
procedures per 1,000 persons. This increase translated to a 23.2 per cent per year
population-adjusted increment (95%CI [18.9, 27.8] % per year, p< 0.001). Similarly, this rate
was significantly higher than the number of PCIs performed during the same time (5%,
p<0.001). Tertiary hospital data from the RMH confirmed this trend, with absolute numbers
a
AIHW = Australian Institute of Health and Welfare
Catheter ablation for atrial fibrillation: July 2014
4
of AF ablations increasing from 16 in 2001/02 to 200 in 2009/10, an increase of 39.8 per
cent per year.6
To confirm this trend, the number of procedures using the MBS item number 38290 were
obtained and plotted for the past 10 years (Figure 3), indicating a steady increase in item
usage over time.
Figure 3
The number of procedures using MBS item number 38290, 2003-2013
The authors concluded that with the given population prevalence of AF, that healthcare
expenditure for AF will rise exponentially, with concomitant implications for health policy,
especially in the areas of infrastructure, workforce and training of appropriate personnel,
and funding for catheter ablation for AF.6
In 2009-10 there were 51,381 public hospital separations for atrial fibrillation and flutter
(I48) with an average length of stay of 3-days. This represents an increase of five per cent
from the 48,869 separations recorded during 2008-09. The majority of these cases (76%)
occurred in patients aged 60 years and over.7
Speciality
Cardiovascular
Technology setting
Specialist or general hospital
Impact
Alternative and/or complementary technology
Additive and substitution: Technology can be used as a substitute in some cases, but may be
used in combination with current technologies in other instances.
Catheter ablation for atrial fibrillation: July 2014
5
Current technology
A number of options are available for the treatment of atrial fibrillation depending on the
severity of the symptoms, including medication, cardioversion or ablation procedures. Initial
treatment should be designed to control ventricular rate, especially in elderly patients. This
may later be supplemented by interventions to control rhythm, including medication or
ablation.8
Most patients diagnosed with AF will be prescribed an anticoagulant, often either aspirin or
warfarin, to prevent clot formation. Although warfarin is more effective than aspirin in
reducing the risk of stroke, it is associated with severe side effects including excessive
bleeding due to its mode of action blocking multiple active vitamin K-dependent coagulation
factors.2 It should be noted that several new oral anticoagulants are now on the market
(dabigatran, rivaroxaban and apixaban), which block the activity of only one single step in
the coagulation process, however these drugs may be associated with major bleeding
events that are equal to, or less than those experienced with warfarin.9 In addition, patients
may be prescribed medication which aims to slow the heart rate by increasing the time
taken for the ventricles to fill and contract (beta-blockers, digoxin and some calcium channel
blockers). Anti-arrhythmic drugs (AADs) may also be prescribed, including solatol, flecainide
and amiodarone, which aim to maintain a normal heart rhythm.2 Some AADs are
contraindicated in some patients due to their negative inotropic and pro-arrhythmic effects.
In addition, some AADs are associated with side effects including bradycardia,
photosensitivity, thyroid dysfunction and liver toxicity.19
Cardioversion, either electrical or pharmacological, aims to restore a normal heart beat after
a prolonged or severe episode of AF. During electrical cardioversion, the patient is sedated
or anaesthetised and an electrical “shock” is applied to the heart via external defibrillator
pads placed on the chest. The shock is synchronised to correspond to the R wave of the QRS
complex on the ECG. Ventricular fibrillation may be induced if the electrical shock is
delivered during the refractory period on the ECG. The same anti-arrhythmic drugs, as
described above, which may be given long-term to maintain patients with AF after electrical
cardioversion, may be prescribed to achieve pharmacological cardioversion. 2, 10
The treatment pathway for patients with or without structural heart disease, as outlined in
the 2010 European guidelines for the treatment of AF, is described in Figure 4.8
A number of new technologies are being developed to improve non-surgical techniques for
AF including: VytronUS, a low-intensity collimated ultrasound ablation system; focussed
ablation by cyclotron; radiosurgery; atrial rotor mapping; laser ablation and atrial rotor
mapping (personal correspondence Queensland Health).
Catheter ablation for atrial fibrillation: July 2014
6
Figure 4
Treatment pathway for patients with and without structural heart disease
HT = hypertension, LVH = left ventricular hypertrophy, CHF = congestive heart failure, CAD =
coronary heart disease, NYHA = New York Heart Association Functional Classification 8
Cost infrastructure and economic consequences
See page 18 onwards of the NHC’s Technology Note.
As an indication of the increase in costs to the health system for AF ablation procedures
over time, Figure 5 demonstrates the increase in benefits payable for MBS item number
38290, which attracts a fee of $2,671.95 and a 75 per cent benefit of $2,004. It should be
noted that this MBS item number underestimates the true cost of catheter ablation as it
does not include the cost of the device or diagnostic tests associated with the procedure.
The benefit paid in 2003-04 was $671,764, which increased steadily with the increasing
number of procedures performed to $4,779,610 in 2012-13, an increase of 611 per cent
over the 10-year period. The true cost to the public system of catheter ablation for AF is
difficult to ascertain due to the procedure being grouped under the same DRG as numerous
other catheter-based cardiac procedures.
Of note, are potential costs arising from patients with undiagnosed atrial fibrillation who
then experience a stroke. Patients with untreated atrial fibrillation have a risk of five per
cent each year to develop stroke. In Australia, the total financial costs of stroke were
estimated to be $5 billion in 2012, with health costs of $881 million, the majority of which
are borne by the Commonwealth ($376 million) and the States ($233 million). 18 The risk of
stroked in AF patients is greatly reduced with treatment.
Catheter ablation for atrial fibrillation: July 2014
7
Figure 5
The $ Benefit payable for MBS item number 38290 from July 2003 to June 2013.
Ethical, cultural or religious considerations
See pages 16 and 17 of the NHC’s Technology Note.
Evidence and Policy
In early 2013 the National Heart Foundation of Australia issued a consensus statement of
the use of catheter ablation for AF. Although these recommendations are designed for
healthcare providers, they are not viewed as clinical practice guidelines due to the limited
evidence on the use of catheter ablation for AF available at the time. Only one
recommendation could be graded according to the NHMRC levels of evidence. As such, the
consensus recommendations are largely based on the expert opinion of the members of the
National Heart Foundation’s working group.11
The recommendations state that the current evidence base supports the use of catheter
ablation as a means to improve the quality of life of patients with AF by relieving symptoms
of an irregular rhythm and a rapid ventricular rate including breathlessness, fatigue, lightheadedness and palpitations. However, there is currently a lack of evidence to support the
use of AF catheter ablation to decrease the risk of stroke and heart failure. The consensus
statement recommends that:
 Catheter ablation should only be carried out in symptomatic patients who are
refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic drug
(recommendation based on level I intervention evidence).
 Cessation of anticoagulant therapy is not considered a sole indication for catheter
ablation. Some asymptomatic AF patients may seek ablation as a means to cease
Catheter ablation for atrial fibrillation: July 2014
8
taking anticoagulation medication, however there is insufficient evidence to support
the cessation of medication over the long-term (consensus).
 Clinicians should consider the age of the patient presenting for the ablation
procedure, with improved results reported in younger patients (age not specified)
with paroxysmal AF with no significant structural heart disease or marked atrial
enlargement (consensus).
 Post-ablation patients should continue anticoagulation therapy for 1-3 months.
Discontinuation of anticoagulation therapy is not recommended for patients with a
CHADS2 scoreb ≥2.11
Safety and effectiveness
The NHC Technology Note reported on the results of eight RCTs, which indicated that 56-94
per cent of patients were free from AF at 12 months after catheter ablation, compared with
4-43 per cent of those treated with AADs alone. There was an 11-40% repeat procedure
rate. A Cochrane review of seven small RCTs reported that catheter ablation was more
effective at inhibiting the recurrence of AF (RR 0.27; 95% CI [0.18, 0.41]). However there was
significant heterogeneity between the studies with mixed paroxysmal, persistent and some
chronic AF patient populations of differing ages (I2 =72%, p=0.002). In terms of safety there
were no differences between catheter ablation and medical treatment in death, fatal and
non-fatal embolic complications.12
Since the NHC Technology Note was written, several studies have been published, the most
recent being the latest follow-up results from the RAAFT-2c randomised controlled trial
(RCT) (level II intervention evidence). This relatively small multicentre RCT randomised
treatment naïve patients with paroxysmal AF to receive either AAD (n=61) or catheter
ablation (CA, n=66) as a first-line treatment. There was no difference in the patient
characteristics between the two groups. The majority of patients were male (73.8 and
77.3%) with a mean age of 56.3 (± 9.3) and 54.3 (±11.7) years in the CA and AAD groups,
respectively. Each patient received a monitoring system to record episodes of symptomatic
AF, with adherence defined as the transmittance of at least 75 per cent of required
recordings. AADs were titrated or ablation was performed during a 3-month “blanking
period”.13
b
CHADS2 score is a clinical prediction rule for estimating the risk of stroke in patients with AF. Scores range
from 0 to 6, with points allocated according to the presence of symptoms: congestive heart failure =1;
hypertension = 1; age ≥ 75 years = 1; diabetes = 1 and prior stroke, thromboembolism or transient ischemic
attack = 2. Patients with a CHADS2 score of 2 have a 4.0% risk of stroke, with the risk increasing with an
increasing CHADS2 score (European Heart Rhythm Association, European Association for Cardio-Thoracic
Surgery et al. 2010)
c
RAAFT-2 = Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial
fibrillation
Catheter ablation for atrial fibrillation: July 2014
9
CA was performed in 63 of the 66 patients randomised to undergo the procedure. At 21
months follow-up, nine patients (13.6%) in the CA group had undergone a repeat procedure
and six (9.09%) had crossed over to the AAD arm. In addition, three patients from the AAD
arm crossed over to the CA arm. Results were reported on an intention-to-treat basis.
Overall, adequate transmittance of recordings were completed by 83 per cent of patients
with no difference between the CA (86.4%) and AAD (78.7%) arms.13
There were no reported deaths or strokes in either group. Six patients in the CA arm
experienced a serious adverse event (9.1%), including tamponade (n=4), severe pulmonary
vein stenosis ≥70% (n=1) and bradycardia leading to the insertion of a pacemaker (n=1). A
serious adverse event was reported in three patients in the AAD arm (4.9%), with two
patients experiencing syncope and one atrial flutter with 1:1 atrioventricular conduction.
Quality of life was measured by the EQ-5D tool, which measures health across five areas:
mobility, self-care, usual activities, pain or discomfort, and anxiety or depression, with a
worst score of zero and a score of one indicating excellent health. There was no difference
in median EQ-5D scores between the two groups at baseline (p>0.99) or at 12-months
follow-up (p=0.25). Although the EQ-5D score improved in both groups from baseline to 12months the change was only significant in the CA group (p= 0.03) and not the AAD group
(p = 0.22).
The primary and secondary effectiveness outcomes are summarised in Table 1. Although
there was a significant difference between the two groups in the rate of recurrent atrial
tachyarrhythmia as documented by patient transmitted data, it is unclear whether this
difference would be considered clinically significant. When only clinically identified events
were considered the difference between groups was abolished with 24 and 31 per cent of
patients in the CA and AAD arms, respectively, experiencing an event (HR 0.86, 95% CI [0.42,
1.72], p=0.66). In addition, it should be noted that recurrence was common in both groups
reported in almost 50 per cent of patients. This study is limited by its small size and the fact
that all patients were relatively young with little or no evidence of structural heart disease
as would be expected in a normal clinical population. Therefore caution should be advised
when considering catheter ablation as a first-line treatment option for AF.
Catheter ablation for atrial fibrillation: July 2014
10
Table 1 Primary and secondary outcomes of the RAAFT-2 trial13
CA arm
n (%)
AAD arm
n (%)
Hazard ratio
[95% CI]
p value
Recurrence of any atrial tachyarrhythmia
lasting longer than >30 seconds
36 (54.5%)
44 (72.1%)
0.56 [0.35, 0.90]
0.02
First recurrence of symptomatic AF, atrial
flutter and atrial tachycardia
31 (47%)
36 (59%)
0.56 [0.33, 0.95]
0.03
First recurrence of symptomatic AF
27 (41%)
35 (57%)
0.5 [0.3, 0.89]
0.02
First recurrence of symptomatic AF, atrial
flutter and atrial tachycardia not recorded
by monitor
16 (24%)
19 (31%)
0.86 [0.42, 1.72]
0.66
Total number of AF, atrial flutter and atrial
tachycardia (multiple recurrences, using a
recurrence event model)
213 (6.6%)
502 (14.7%)
0.33 [0.28, 0.4]
<0.001
CA = catheter ablation, AAD = Anti-arrhythmic drugs, AF = atrial fibrillation
These positive results contrast with those published in late 2012 by Nielsen et al who
conducted the larger MANTRA-PAFd RCT, which randomised treatment naïve patients with
paroxysmal AF to receive either AAD (n=148) or catheter ablation (n=146) as a first-line
treatment (level II intervention evidence). Similar to the RAAFT-s study the majority of
patients were relatively young (mean 55 ± 10 years) males (68-72%). There was no
difference in the baseline characteristics between the two groups. Clinical follow-up and 7day Holter monitoring was conducted at 3, 6, 12, 18 and 24-months, with Holter analysis
blinded with respect to randomisation. The primary outcome was the burden of AF as
defined by the percentage of time spent in AF on each Holter recording and the cumulative
burden of AF as defined as the percentage of time spent in AF during all Holter recordings.14
A total of 140 (96%) patients underwent a mean of 1.6 ± 0.7 ablation procedures. At 24months follow-up, 58 patients had undergone two, eight patients had three, and three
patients had four catheter ablation procedures. Reasons for repeat ablations were left atrial
arrhythmia (n=79 procedures), right atrial flutter (n=2), atrioventricular nodal re-entrant
tachycardia (n=1) and focal atrial tachycardia (n=1). In addition, 13 patients from the CA arm
had crossed over to the AAD arm. The majority of patients in the AAD arm received a class
IC AAD (n=131) with the remaining receiving a class III AAD. The mean number of AADs
prescribed to patients was 1.26 ± .046 (range 1-3). CA was performed in 54 (36%) patients
d
MANTRA-PAF = Medical antiarrhythmic treatment or radiofrequency ablation in paroxysmal atrial
fibrillation
Catheter ablation for atrial fibrillation: July 2014
11
from the AAD arm at a mean time of 8.7 ± 6.5 months post-randomisation. These patients
underwent a mean of 1.6 ± 0.7 ablations for left atrial arrhythmia (n=81 procedures) and
right atrial flutter (n=6).14
There was no difference in the number of serious adverse events with 25 and 22 reported in
the CA and AAD arms, respectively (p=0.45). Three patients in the CA and four patients in
the AAD group died during the study, with one death in the CA group considered to be a
procedure-related cerebral stroke. The other causes of death were not considered to be
related to the treatment. The more serious adverse events in each group are summarised in
Table 2. Quality of life at baseline, as measured by the SF-36, did not differ between the two
groups at baseline. Quality of life improved in both treatment groups, however there was a
greater improvement in the physical component of patients in the CA arm. 14
Table 2
Number of serious adverse events14
CA arm
AAD arm
Death
3
4
Atrial flutter with 1:1 atrioventricular conduction
0
2
Atrial flutter or atrial tachycardia
3
3
Perimyocarditis
1
0
Stroke
1
0
Transient ischaemic attack
1
1
Tamponade
3
0
Pericardial effusion without the need for pericardial puncture
0
1
Suspected perforation at transeptal puncture, no pericardial effusion
1
0
Pulmonary vein stenosis
1
0
Hospitalisation for heart failure
0
2
Holter recordings were available for analysis from 96 per cent of follow-up visits. There was
no reported difference in the cumulative AF burden, as assessed with 7-day Holter monitors
during the 24-month follow-up between the CA and AAD arms (90th percentile of
arrhythmia burden, 13% vs 19%, respectively, p=0.10). The AF burden was significantly
lower at each follow-up point in both treatment groups when compared to baseline
(p<0.001 for all comparisons). Although there was no difference between the two groups in
the burden of AF at 3, 6, 12 or 18-month follow-up, at 24-months the AF burden was
significantly lower in the CA group compared to patients in the AAD arm (90th percentile,
Catheter ablation for atrial fibrillation: July 2014
12
9% vs 18%, p=0.007). In addition, more patients in the CA group were free from any AF (85%
vs 71%, p=0.004) and from symptomatic AF (93% vs 84%, p=0.01) compared to the AAD arm
at 24-months.
Of interest is the report, commissioned by the Belgian Government, which analysed the
outcome of all patients who underwent a first catheter ablation for AF (level IV intervention
evidence). Data were obtained from a nationwide health insurers’ database, with all claims
of patients being retrieved between November 2007 and December 2008. During this time
1,030 patients underwent catheter ablation, however only 830 patients underwent the
procedure for the first time, the majority of whom were male (71.9%) with a mean age of 58
years. The majority of patients had paroxysmal AF (77%).15
Patient outcomes are summarised in Table 3. AAD usage was not considered during the of 3month post-ablation “blanking period”. Although patients were followed up for a mean
period of 30.2 months, AAD usage was only obtained for the 24-month period post-ablation.
At the end of follow-up a total of 214 patients (25.8%) underwent one or more repeat
ablations. Of these, 30 patients required two, one required three and another required four
repeat procedures. The average number of ablations per patient was 1.3 over the follow-up
period. In addition, at the end of follow-up, cardioversion was performed in 218 (26.3%)
patients, at a mean time of 220 days post-ablation (median 118 days). Using AAD use one
month after the blanking period as a measure of ablation failure, AF was estimated to recur
in 37.3 and 49.9 per cent of patients at 12 and 24-months, respectively (model 1 or 2 or 3c).
There was no relationship between the patient’s age, risk profile and the rate of AF
recurrence. Using pre and post-ablation prescription data it was estimated that up to 15.8
per cent of patients had undergone catheter ablation as a first-line AF treatment.15
These results were extracted from a full health technology assessment, which also intended
to conduct a cost-effectiveness analysis of catheter ablation for AF. However, this analysis
could not be conducted due to the lack of reported data on endpoints such as quality of life,
mortality and stroke. Costs from the healthcare payer perspective for catheter ablation in
this study were estimated to be €9,600 for the initial intervention, compared to €300 per
year for a combination of rate and rhythm control drugs.15
Catheter ablation for atrial fibrillation: July 2014
13
Table 3
Patient outcomes 12 and 24-months post-catheter ablation15
Model
Pre-ablation
n (%)
Follow-up
Follow-up
Follow-up
3-12 month, n
(%)
3-24 month, n
(%)
30.2 months, n (%)
Repeat ablation
1
134 (16.1%)
192 (23.1%)
214 (25.8%)
Electric cardioversion
2
94 (11.3%)
145 (17.5%)
218 (26.3%)
456 (54.9%)
504 (60.7%)
AAD use
At least 1 AAD
3a
At least 1 AAD with non-amiodarone*
3b
296 (35.7%)
386 (46.5%)
3c
211 (25.4%)
315 (38.0%)
1 or 2 or 3a
496 (59.8%)
547 (65.9%)
1 or 2 or 3b
378 (45.5%)
464 (55.9%)
1 or 2 or 3c
310 (37.3)
414 (49.9%)
At least 1 AAD with an AAD-free
window of 1 month beyond the blanking
period
Combinations
667 (80.4%)
AAD = Anti-arrhythmic drugs
* At least one AAD used beyond the blanking period, taking into account that for non-amiodarone AADs an AAD-free window of 1-month beyond the
blanking period is considered.
Another large European observational study captured 12-month follow-up catheter ablation
data from 72 centres in 10 European countries (level IV intervention evidence). Each centre
was required to recruit at least 20 consecutive patients undergoing their first CA procedure
for AF. A total of 1,391 patients from a mixed AF population underwent CA, with one patient
dying during the in-hospital phase. At 12-months, 1,300 (93.5%) patients were available for
follow-up (67% paroxysmal AF, 27.4% persistent AF, 4.5% permanent AF and 1.1%
undefined). The majority of patients were male (71.8%) with a median age at follow-up of
60 years (interquartile range 52-66 years). Most patients had preserved cardiac function
with only three and two per cent having dilated cardiomyopathy and chronic heart failure,
respectively. The most commonly used technology was radiofrequency ablation (80%)
followed by cryoablation (11%).16
A clinical visit at 12-month follow-up was only completed by 58.2 per cent of patients, with
the remaining patients being contacted by telephone regarding their symptoms, however
87.2 per cent of all patients had at least one ECG during the follow-up period. Success of CA
was defined as patient survival free from any AF, with or without AADs, after the 3-month
blanking period. Arrhythmia recurrence was defined as an ECG documented episode of AF
lasting at least 30 seconds.16
Although an overall success rate of CA was reported to be 72.6 per cent, this included
patients with or without the use of AADs at 12-months. In the absence of AADs, a successful
ablation procedure was reported in 40.3 per cent of all patients, with the highest rate of
Catheter ablation for atrial fibrillation: July 2014
14
43.7 per cent reported in patients with paroxysmal AF (Table 4). Overall 18.3 per cent of
patients in the success group required a second ablation procedure. In addition, 34.4 per
cent of patients considered to be a success still reported symptoms including palpitations,
dyspnoea and fatigue. Complete follow-up data were available for 1,281 patients, of whom
337 (26.3%) experienced a recurrence after the 3-month blanking period. Patients with nonparoxysmal AF had a higher probability of recurrence compared to those with paroxysmal
(43.6% vs 32.0%, p<0.0001). Asymptomatic recurrences occurred in 25.8 per cent of
patients.16
At 12-month follow-up, 65 per cent of all patients were taking an anticoagulant.
Interestingly, 24 per cent of those patients with a CHADS2 score >1 were not receiving
anticoagulation, however 48 per cent of those patients considered to be at low risk with a
CHADS2 score = 0 were still receiving anticoagulation therapy, indicating differences in
clinical practice from that recommended by guidelines.
A total of five deaths were reported, three of which were considered to be procedurerelated. The rate of adverse events was reported to be 2.5 per cent, of which 0.8 per cent
were considered to be major. More than one third were considered to be procedure related
(37.5%). A pacemaker was inserted in 13 patients, there were nine vascular and seven
cerebrovascular injuries, two phrenic nerve injuries and one case of pulmonary vein
stenosis. If post-CA atrial tachycardia/flutter was included as a complication, the rate of
adverse events increases to 26.5 per cent.16
The lower success rate when compared to other studies may be attributed to the mixed
patient population, different ablation techniques (differences not analysed), variation
between operators and variation in type and accuracy of follow-up.
Table 4
Success of catheter ablation by AF type16
Type of AF
Success without AADs
Success with AADs
Overall success
Paroxysmal (n=871)
381 (43.7%)
256 (29.4%)
647 (74.3%)
Persistent (n=265)
80 (30.2%)
99 (37.4%)
191 (72.1%)
Long-lasting persistent (n=90)
33 (36.7%)
18 (20.0%)
52 (57.8%)
Overall (n=1226)
494 (40.3%)
373 (30.4%)
890 (72.6%)
Catheter ablation for atrial fibrillation: July 2014
15
Economic evaluation
See page 14 onwards of the NHC’s Technology Note.
The most recent published systematic cost analysis was conducted by the Belgian
Government. This review identified five studies as described by the NHC Technology Note in
addition to two other papers. The conclusions of these studies are summarised in Table 5.
Eckard et al (2009) and Reynolds et al (2010) considered CA a cost-effective second-line
treatment for paroxysmal AF. This conclusion was based on assumptions that CA would
impact on mortality from stroke, however there is a lack of long-term follow-up data from
RCTs to support this assumption. CA is associated with high initial costs and patients may
need to undergo repeat procedures in addition to taking AADs post-procedure. The authors
therefore concluded that there was insufficient evidence to comment on the costeffectiveness of catheter ablation for the treatment of AF.17
Table 5
Conclusions of economic evaluations retrieved on the cost-effectiveness of catheter ablation17
Study
Conclusion
Chan et al (2006)
United States
In patients with AF, catheter ablation is unlikely to be cost-effective in patients at low risk for stroke.
In moderate-risk patients, catheter ablation may be cost-effective if sufficiently high efficacy rates in
restoring sinus rhythm translate into lower morbidity.
Ollendorf et al (2010)
United States
No explicit conclusion on the intervention’s cost -effectiveness is drawn.
There is only a high certainty of a small benefit for second-line ablation in paroxysmal AF patients. In
other populations and for first-line ablation there is a potential but unproven benefit.
Assasi et al (2010)
Canada
The primary economic evaluation using a five-year time horizon found the incremental cost per
QALY of AF ablation compared with AAD to be $59,194.
Eckard et al (2009)
Sweden
The radiofrequency ablation treatment strategy was associated with reduced cost and an
incremental gain in QALYs and was considered a cost-effective treatment strategy compared to the
AAD in a lifetime perspective.
Reynolds et al (2010)
United States
Catheter ablation with/without AAD for symptomatic, drug-refractory paroxysmal AF appears to be
reasonably cost-effective compared with AAD therapy alone from the perspective of the US
healthcare system. The ICER for catheter ablation versus AAD was $51,431 per QALY applying a 5year time horizon.
Rodgers et al (2008)
McKenna et al (2009)
United Kingdom
The overall conclusions regarding the cost-effectiveness of catheter ablation appear to require that
the QoL benefits are maintained for more than 5 years and/or that normal sinus rhythm has
prognostic value in preventing the risk of stroke. If neither of these is considered to be realistic then
the cost-effectiveness of catheter ablation remains highly uncertain.
A full cost-effectiveness analysis may reveal differences in rates of health services usage
before and after catheter ablation for AF. Ladapo et al (2012) examined patient records
from health insurance plans in the United States. The number of outpatient and emergency
department visits, in addition to number of hospitalised days, were compared in patients
(n=3,194, mean age 58.2 ± 10.6 years) with AF for 6-months prior to catheter ablation and
for 6-12-months post-ablation. There were significant reductions in the number of visits in
all categories (Table 6), however there was a great deal of variation both pre- and postablation as indicated by the large standard deviations. 20
Catheter ablation for atrial fibrillation: July 2014
16
Table 6
Outpatient, inpatient and hospitalisation usage pre- and post-catheter ablation for AF 20
Before ablation
6-months
Mean ± SD
Post-ablation
6-12 months
Mean ± SD
p-value
Number of outpatient office visits
11.25 ± 7.51
9.22 ± 7.82
<0.001
Number of outpatient hospital visits
4.74 ± 5.24
3.40 ± 5.32
<0.001
Number of emergency department visits
0.71 ± 1.28
0.34 ± .097
<0.001
Number of hospitalised days
1.59 ± 3.39
0.80 ± 2.77
<0.001
Utilisation by type
Percent of patients with utilisation by type
p-value
Outpatient office visits
98%
96%
0.001
Outpatient hospital visits
89%
69%
<0.001
Emergency department visits
38%
21%
<0.001
Hospitalisation
35%
18%
<0.001
SD = standard deviation
Ongoing research
As described in the NHC Technology Note, the largest RCT comparing catheter ablation to
AADs, the CABANAe trial, is still underway and recruiting patients. This RCT intends to recruit
2,200 patients with a mixed clinical diagnosis:

≥2 paroxysmal AF episodes lasting ≥1 hour in duration; or

electrocardiographic documentation of one persistent AF episode; or

electrocardiographic documentation of one longstanding persistent AF episode
(continuous AF of duration >1 year).
The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial
catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to
current state-of-the-art therapy with either rate control or rhythm control drugs for
decreasing the incidence of the composite endpoint of total mortality, disabling stroke,
e
CABANA = Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Catheter ablation for atrial fibrillation: July 2014
17
serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF
(NCT00911508).
Other issues
Other methods for the treatment of AF have been proposed, with several trials currently
recruiting patients. A German RCT (Interventional Strategies in Treatment of Atrial
Fibrillation: Percutaneous Closure of the Left Atrial Appendage Versus Catheter Ablation)
aims to compare the percutaneous closure of the left atrial appendage (LAA) combined with
a rate-control strategy to catheter ablation in the management of patients with persistent
AF. This proposal is based on the results of the PROTECT AF study, where percutaneous
closure of the LAA with a closure device provided an alternative strategy to oral
anticoagulation for stroke prophylaxis (NCT01363895).
A US and Russian RCT is currently recruiting 300 patients with paroxysmal AF and
hypertension to determine the role of renal sympathetic denervation in the prevention of
AF recurrence. Patients will be randomised to either AF catheter ablation or AF catheter
ablation plus renal sympathetic denervation (NCT01873352).
Summary of findings
The prevalence of AF in Australia and New Zealand has increased over time, with a
concomitant increase in the number of catheter ablation procedures being performed. Since
the publication of the NHC Technology Note, two high-quality studies have been published
describing the results of treatment naïve patients with paroxysmal AF randomised to either
catheter ablation or antiarrhythmic drugs as a first-line treatment. Results from these RCTs
were conflicting with one reporting a significantly lower rate of AF recurrence in CA treated
patients, whilst the other reported no difference in the cumulative burden of AF between
patients treated with CA and AADs. However, as the National Heart Foundation
recommends, based on level I intervention evidence, that catheter ablation should only be
carried out in symptomatic patients who are refractory or intolerant to at least one Class 1
or Class 3 antiarrhythmic drug, these results are not relevant to the Australian setting. The
remaining two studies included in this assessment were large observational studies, and can
therefore only inform a discussion around the safety, rather than the effectiveness of
catheter ablation. All studies did, however, report that catheter ablation is associated with a
number of potentially serious adverse events including stroke, tamponade and pulmonary
vein stenosis. All studies reported rates of repeat catheter ablation procedures ranging from
13.6 to 47 per cent of patients, with some patients undergoing more than one repeat
procedure, with each repeat procedure exposing the patient to the risk of experiencing a
serious adverse event. In addition, continued AAD use post-catheter ablation is common.
Long-term outcome data from large randomised controlled trials is lacking to inform a costeffectiveness analysis.
Catheter ablation for atrial fibrillation: July 2014
18
HealthPACT assessment
Based on the information gathered to inform this Technology Brief, combined with the
existing Technology Note from New Zealand, it is clear that the use of catheter ablation for
AF will increase over time. Although the evidence base is weak in terms of long-term
outcomes, such as the impact on mortality and reductions in the incidence of stroke, it
should be noted that the risk of stroke is markedly reduced in patients treated for atrial
fibrillation. There is also a lack of robust cost-effectiveness data on what appears to be an
established procedure. Long-term effectiveness data from the CABANA Trial is still many
years away from publication. HealthPACT noted that although catheter ablation was
considered a common procedure, it should be remembered that it is an invasive procedure
and as such is associated with risks. Australian jurisdictions and New Zealand should liaise
with their cardiac networks to ascertain the level of activity and to consider the role of
catheter ablation for atrial fibrillation with respect to appropriate patient selection and its
role in the clinical pathway. Therefore it is recommended that no further research on behalf
of HealthPACT is required.
Number of studies included
All evidence included for assessment in this Technology Brief has been assessed according
to the revised NHMRC levels of evidence. A document summarising these levels may be
accessed via the HealthPACT web site.
Total number of studies
Total number of Level IV intervention studies
Total number of Level II intervention studies
4
2
2
Search criteria to be used (MeSH terms)
Atrial Fibrillation/*drug therapy/prevention & control/*surgery
*Catheter Ablation/methods
Recurrence/prevention & control
References
1.
NHC (2012). NHC Technology Note for Catheter Ablation for the Treatment of Atrial
Fibrillation, National Health Committee, Wellington, New Zealand Available from:
http://nhc.health.govt.nz/committee-publications/catheter-ablation-treatmentatrial-fibrillation-technology-note.
2.
NHF (2008). Atrial fibrillation. [Internet]. National Heart Foundation of Australia.
Available from:
http://www.heartfoundation.org.au/SiteCollectionDocuments/A_CHD_AtrialFibrillati
on_INFC_20081211_FINAL.pdf [Accessed 11th August 2010].
3.
NZGG (2006). Atrial fibrillation. [Internet]. New Zealand Guidelines Group
Incorporated. Available from:
http://www.nzgg.org.nz/download/files/AtrialFIBRILLATIONWEB.pdf [Accessed 11th
August 2010].
Catheter ablation for atrial fibrillation: July 2014
19
4.
AIHW (2010). Australia’s health 2010, Australian Institute of Health and Welfare,
Canberra Available from: http://www.aihw.gov.au/publications/aus/ah10/ah10.pdf.
5.
AIHW (2012). Australia’s health 2012, Australian Institute of Health and Welfare,
Canberra Available from: http://www.aihw.gov.au/publicationdetail/?id=10737422172.
6.
Kumar, S, Walters, TE et al (2013). 'Ten-year trends in the use of catheter ablation for
treatment of atrial fibrillation vs. the use of coronary intervention for the treatment
of ischaemic heart disease in Australia'. Europace, 15 (12), 1702-9.
7.
Separation, patient day and average length of stay statistics by principal diagnosis in
ICD-10-AM, Australia, 1998-99 to 2009-10 [database on the Internet]. Australian
Institute of Health and Welfare. 2014 [Accessed 15th April]. Available from:
https://reporting.aihw.gov.au/Reports/openRVUrl.do.
8.
European Heart Rhythm Association, European Association for Cardio-Thoracic
Surgery et al (2010). 'Guidelines for the management of atrial fibrillation: the Task
Force for the Management of Atrial Fibrillation of the European Society of Cardiology
(ESC)'. Eur Heart J, 31 (19), 2369-429.
9.
Vergara, P & Della Bella, P (2014). 'Management of atrial fibrillation'. F1000Prime
Rep, 6, 22.
10.
Shea, JB & Maisel, WH (2002). Cardiology Patient Page - Cardioversion. [Internet].
American Heart Association. Available from:
http://circ.ahajournals.org/content/106/22/e176.full [Accessed 14th April 2014].
11.
Kalman, JM, Sanders, P et al (2013). 'National Heart Foundation of Australia
consensus statement on catheter ablation as a therapy for atrial fibrillation'. Med J
Aust, 198 (1), 27-8.
12.
Chen, HS, Wen, JM et al (2012). 'Catheter ablation for paroxysmal and persistent
atrial fibrillation'. The Cochrane database of systematic reviews, 4, Cd007101.
13.
Morillo, CA, Verma, A et al (2014). 'Radiofrequency ablation vs antiarrhythmic drugs
as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial'.
JAMA, 311 (7), 692-700.
14.
Cosedis Nielsen, J, Johannessen, A et al (2012). 'Radiofrequency ablation as initial
therapy in paroxysmal atrial fibrillation'. The New England journal of medicine, 367
(17), 1587-95.
15.
Van Brabandt, H, Neyt, M & Devos, C (2013). 'Effectiveness of catheter ablation of
atrial fibrillation in Belgian practice: a cohort analysis on administrative data'.
Europace, 15 (5), 663-8.
16.
Arbelo, E, Brugada, J et al (2014). 'The Atrial Fibrillation Ablation Pilot Study: an
European Survey on Methodology and * Results of Catheter Ablation for Atrial
Fibrillation: conducted by the European Heart Rhythm Association'. Eur Heart J.
17.
Neyt, M, Van Brabandt, H & Devos, C (2013). 'The cost-utility of catheter ablation of
atrial fibrillation: a systematic review and critical appraisal of economic evaluations'.
BMC Cardiovasc Disord, 13, 78.
18.
Deloitte Access Economics (2013). The economic impact of stroke in Australia,
National Stroke Foundation Available from:
Catheter ablation for atrial fibrillation: July 2014
20
http://strokefoundation.com.au/site/media/Final-Deloitte-Stroke-Report-14-Mar13.pdf.
19.
Bajpai, A, Savelieva, I & Camm, AJ (2008). 'Treatment of atrial fibrillation'. Br Med
Bull, 88 (1), 75-94.
20.
Ladapo, JA, David, G et al (2012). 'Healthcare utilization and expenditures in patients
with atrial fibrillation treated with catheter ablation'. J Cardiovasc Electrophysiol, 23
(1), 1-8.
Catheter ablation for atrial fibrillation: July 2014
21
Attachment 1
Technology Note
Catheter Ablation for the Treatment of Atrial Fibrillation
September 2012
Executive Summary
Catheter ablation is a minimally invasive procedure performed by Cardiac electrophysiology subspecialised Cardiologists for the treatment of many cardiac arrhythmias. It is a mature but
continually evolving technology with clear indications for use as first-line treatment in certain
defined population subgroups. Its role in the treatment of atrial fibrillation (AF) is less clear, but as
AF is the commonest adult arrhythmia the potential increase in demand is significant.
Atrial fibrillation affects 2.0% of the New Zealand population. It is more common in Maori, in whom
it occurs at a younger age. AF is associated with a 2-fold increase an overall mortality, as well as
increased risk of stroke, dementia, and heart failure. Standard treatment involves the use of
medications to control symptoms and reduce the rates of long-term complications.
Cardiac catheter ablation (CA) in atrial fibrillation avoids the complications and side effects of antiarrhythmic medication use. It offers possible long-term “cure” of AF, and is associated with
significantly improved rates of freedom from AF when compared with medication. The data on
long-term outcomes is less robust and there have to-date been no published randomised
controlled trials looking at its effect on rates of stroke, heart failure and mortality. Of concern has
been the 4-6% complication rate with serious adverse effects at 2-3%, but these rates reduce as
experience with the technology improves.
Cost-effectiveness analyses of CA in AF have had differing conclusions, from being cost-saving to
being cost-inefficient. Catheter ablation’s affordability is limited by significant capital expenditure
and the high up-front costs of procedures. Basic modelling in the New Zealand context suggests
that there may be a group of patients in whom catheter ablation is highly cost-effective.
New Zealand has a limited supply of cardiac electrophysiology services and there is the potential
for significantly increased future demand as the population ages, AF becomes more prevalent and
Atrial Fibrillation
1
the scope of EP grows. International data suggest New Zealand’s cardiac electrophysiology
services are growing significantly slower than Europe and North America. The sustainability of the
service requires extensive sector engagement, workforce analysis and retention, planned capital
investment and appropriate selection of the intervention population.
Purpose
The purpose of this report is to provide information to stakeholders, including clinicians, health
planners, funders and policy makers on the use of CA in AF, and as a basis for further discussion.
It includes:

Background on the nature and impact of AF

Explanation of the differing treatment strategies employed in its treatment

A summary the current literature on catheter ablation for AF

A description of its current and potential future use in New Zealand.
Catheter Ablation for Arrhythmia
Electrophysiology is a sub-speciality of Cardiology concerned with diseases causing abnormal
electrical conduction in the heart (arrhythmia). It is a complex and evolving area, with interventions
including, but not exclusively, catheter ablation, medical therapy, pacemaker and implantable
cardioverter-defibrillator insertion.
Catheter ablation involves the passing of a catheter through the blood vessels to the heart. There
the abnormal electrical signals are found, mapped and then destroyed or electrically isolated by
damaging (ablating) heart muscle. The technique has revolutionised the treatment of many
arrhythmias and offers a long term cure after a single procedure in some.1, 2 It has become the
standard of care for atrioventricular re-entrant tachycardia (AVRT), atrioventricular nodal re-entrant
tachycardia (AVNRT) and some types of atrial flutter.2
While it is undoubtedly efficacious and cost-effective in these patient groups,3, 4 its role in the
treatment of atrial fibrillation is more controversial. The technology is both expensive and evolving
with the potential for large increase in scope and demand on resources.
Atrial Fibrillation
Atrial fibrillation (AF) is the commonest sustained cardiac arrhythmia5, and has a large associated
societal, economic and health burden. A 2010 PricewaterhouseCoopers report estimated that the
annual cost of AF to Australia was AUS$1.25 billion.6 AF’s incidence rises with age and the
Atrial Fibrillation
2
prevalence of AF will grow as the population ages. AF, therefore, represents a potential future
epidemic7 and its cost-effective management an important challenge.
Background
Atrial fibrillation is characterised by loss of the normal electrical rhythm of the heart (sinus rhythm),
which is replaced by chaotic contraction of the atria (upper chambers of the heart) and results in an
irregular, often rapid, heartbeat. It is associated with an approximate 2-fold increase in cardiac and
overall mortality.8-10 The prevalence of atrial fibrillation based on international data is 0.4 – 2.8, 11
Atrial fibrillation may be asymptomatic (“silent AF”), but more frequently presents with palpitations,
dizziness, reduced exercise tolerance, breathlessness, collapse or chest discomfort. More
importantly, it is associated with an increased risk of cardioembolic complications (most notably
stroke), dementia, heart failure and death.12 The goals of treatment are the reduction of
symptomatic episodes (and hospitalisations), prevention of cardiac remodelling (including heart
failure), cardioembolic stroke and death.
Atrial fibrillation increases the risk of stroke between 2- and 7-fold.13 It is associated with increased
risk of post-stroke mortality, disability, longer hospital stays and lower rates of discharge home.
Between 1/5 and 1/6 of all strokes are due to AF.12, 14 AF also increases this risk of subsequent
heart failure.15
Atrial fibrillation is divided into the following diagnostic categories:

Paroxysmal AF – self-terminating, recurrent episodes of less than 7 days

Persistent AF – sustained episodes of between 7 days and 12 months

Permanent AF – sustained episodes of greater than 12 months where cardioversion
(restoration of sinus rhythm) has failed or been foregone

“Lone atrial fibrillation” – AF in the absence of any other structural heart disease, however
patients may have any of the above patterns
These categories are not mutually exclusive and up to 90% of paroxysmal episodes are
asymptomatic.16, 17 Estimates of the relative proportion of paroxysmal AF range from 25-62%,18, 19
with it representing a greater proportion of AF in younger people.20 Patients often move between
the different states, and many progress to permanent AF.21, 22
Secondary AF occurs in the setting of acute myocardial infarction, cardiac surgery, pericarditis,
myocarditis, hyperthyroidism, or acute pulmonary disease, and is considered a separate clinical
entity. Usually, treatment of the primary condition terminates the AF. 12
Atrial Fibrillation
3
The Cost of Atrial Fibrillation
The cost of AF has been examined in North America, Europe and Australia. The American,
French and UK analyses considered direct costs only, whereas an Australian report described both
direct and societal costs. None of the studies placed a monetary value on reduced quality of life.
The direct costs include inpatient hospital services, outpatient hospital services (including specialist
testing and specialist consultations), general practitioner consultations, pharmaceutical costs,
pharmaceutical adverse events, and laboratory tests. There are additional direct costs of care
relating to complications, such as stroke, heart failure, dementia and death, including disability
expenditure and residential aged care costs.
The 2010 Australian report by PricewaterhouseCoopers and commissioned by the Australian
National Stroke Foundation included non-financial costs due to lost productivity from absenteeism,
premature death and unpaid carer costs.6 Total direct health system costs were AUS$874 million,
with total costs of AUS$1.25 billion. The societal costs represented approximately 15% of the total
cost.
Information from the FRACTAL registry in the US showed the annual cost of AF treatment varied
from US$3,345 in patients with no documented recurrences, to US$10,312 with 3 or more
recurrences. More than half the costs were due to hospitalisation.23 The French study also showed
the main cost driver was hospital admission.24
A UK study estimated the annual cost of AF at £459 million (in year 2000 £s) but that figure is
almost certainly underestimated as the study neglected to include costs “related to stroke
rehabilitation, digoxin toxicity, and warfarin or aspirin related haemorrhage” and did not include “a
minimum of an additional £111 million also spent on admission to nursing homes”.7
Burden of AF in NZ
Current evidence on incidence and prevalence of AF in New Zealand is limited. Internationally,
prevalence rises from 0.5% in those less than 60 years of age, to >10% to those over 80 years of
age, as seen in Figure 1.11 This shows the annual incidence of AF is 0.23% and its prevalence is
2.0%.f The geographical distribution of AF prevalence is shown in Figure 2.
Age standardised data from 2001-02 suggested that Maori had almost twice the rate of AF as
compared with the total New Zealand population.25 This appears consistent with updated agestandardised NZ discharge data where the prevalence of AF in Maori is 2.3%. Additionally, it
f
Due to limitations in international administration data sets in ascertaining the true prevalence of disorders, the
prevalence rate was estimated by including any patient with a diagnosis of AF in the last 20 years and a current
prescription for one of 13 relevant cardiac medications, and those with a diagnosis of AF in the last five years
Atrial Fibrillation
4
affects Maori at a younger age, with prevalence in 40-60 year-olds 1.78 times the non-Maori
population of the same age. These results are not significantly changed when standardised for
deprivation level. Age-standardised data shows that Pacific people have a similar rate to that of
the general NZ population.
In 2010-11, approximately 2.3% of those patients diagnosed with AF were admitted with a stroke in
the following 12 months.
Figure 1.
Prevalence of Atrial Fibrillation in New Zealand
The figure shows the relationship between age and rising prevalence of AF. It shows the prevalence of AF is
consistently higher in Maori, whereas the prevalence in Pacific and European patients conforms closely.
Source: NHC executive analysis of national collections.
Atrial Fibrillation
5
Figure 2.
Geographical distribution of AF. The darker shades indicate higher crude prevalence.
AF prevalence
Source: NHC executive analysis of national collections.
Future Burden
The future burden of AF is difficult to predict but its incidence and prevalence increase significantly
with age. New Zealand, like many OECD countries, has an ageing population with low fertility and
mortality rates.
Using the most commonly used population prediction from Statistics NZ (medium fertility, medium
mortality and a net migration of 10,000 per annum) the number of New Zealanders aged 65 and
above is predicted to increase by 37% by 2022 and by 136% by 2061, when compared to 2012.
This age group will also represent a greater proportion of our population (14% in 2012, 17% in
2022 and 25% in 2061).26
If we assume that the proportion of the population affected by AF at each age remains the same,
then the prevalence of AF will rise to 2.4% in 2022 (~117,000 people) and 3.8% in 2061 (~216,000
people).
Atrial Fibrillation
6
Treatment
Treatment of AF is aimed at reducing symptoms, preventing cardiac remodelling and reducing the
risk of stroke, heart failure and death through one of two strategies:

Rate-control strategy – maintenance of heart rate with medication to within normal
physiological bounds with no attempt to restore sinus rhythm (SR)

Rhythm-control strategy – maintenance of sinus rhythm with either medication, catheter
ablation or, more rarely, surgery.
Stroke risk is lowered through anticoagulant (“blood-thinning”) medication depending on each
individual’s risk of stroke, regardless of treatment strategy. Multiple trials have demonstrated no
significant difference between rate- and rhythm-control strategies in rates of mortality and stroke.2730
Rate-control
In this strategy patients remain in atrial fibrillation with no attempt to restore sinus rhythm. The
heart rate is controlled with medication (usually β-adrenergic blockers, calcium-channel blockers
and/or digoxin) to reduce symptoms and increase exercise tolerance.
If the heart rate is difficult to control with medication alone then rarely some patients will require
pacemaker insertion to reduce symptoms and improve function.
Rhythm-control
In this strategy, once AF is identified normal electrical activity of the atria is restored either
medically or electrically. An attempt is then made to maintain sinus rhythm with anti-arrhythmic
drugs (AADs; primarily amiodarone, flecainide or sotalol). Once sinus rhythm is restored, its longterm maintenance is usually attempted with anti-arrhythmic medication (either taken regularly or at
the onset of symptoms). This strategy is variably effective and whilst 40-90% of people continue to
have paroxysmal AF, the frequency and intensity of their symptomatic episodes is reduced. One
study suggested that intermittent ECG monitoring for recurrence underestimates the burden of AF
by approximately 40%.16
Alternative strategies include catheter or surgical ablation (destruction of certain areas of the atria)
to prevent abnormal AF signalling. Surgical ablation is usually only undertaken in addition to
cardiac surgery being performed for another reason. If rhythm-control cannot be maintained then
patients will move to the rate-control strategy.
Anticoagulation
Anticoagulation is not mandated, but is based on each patient’s risk of stroke, independent of
treatment strategy. Stroke risk is commonly determined by a risk stratification index based on
Atrial Fibrillation
7
clinical risk factors (commonly CHADS2 or CHA2DS2VASc).31, 32 Aspirin, warfarin or no
anticoagulation may then be recommended.
Warfarin anticoagulation is more effective than aspirin but comes at the cost of an increased risk of
bleeding, including major haemorrhage and death. The most recent NZ guideline (2005)25
suggests discussion of aspirin use for patients at low-risk of stroke, discussion of aspirin or
warfarin for patients at intermediate risk, and warfarin administration for patients at high-risk.
Warfarin also has significant disadvantages in that it requires for frequent blood test monitoring,
multiple drug-drug and food-drug interactions and dosing individualised to response (i.e. different
doses for different patients).
Recently, a new class of antithrombotic agents has been trialled (direct thrombin inhibitors). These
medications appear as effective, with a similar rate of significant bleeding, no requirement for blood
tests, standard dosing schedules but are more expensive.33-35 In 2011, dabigatran was the first of
this class approved for use in New Zealand.
Rationale for more effective rhythm-control
There are physiological reasons to believe maintenance of co-ordinated atrial contraction is
beneficial. It allows more efficient filling of the ventricles, increased cardiac output and prevents
cardiac remodelling. The longer AF persists the more difficult restoration of sinus rhythm is made,
largely due to this remodelling.36, 37 Restoration of sinus rhythm may result in improved quality of
life, decreased stroke and heart failure risk and improved survival.38
Post-hoc analysis of trial data has shown that those patients in which sinus rhythm is maintained
may have a lower rate of stroke and mortality.39, 40 In the landmark AFFIRM trial a retrospective
analysis of patient outcomes found that those patients in SR (independent of treatment strategy)
had hazard ratios of 0.63 for stroke40 and 0.53 for mortality.41 The benefit of effective rhythmcontrol was possibly offset by the increased risk of mortality due to anti-arrhythmic medication itself
(HR 1.49). Maintaining sinus rhythm may also be beneficial in terms of quality of life, exercise
tolerance and prevention of heart failure.42, 43 Although retrospective data is strongly suggestive,
these hypotheses are yet to be proven in prospective trials.
These finding and inherent difficulties in monitoring for true AF recurrence, the poor efficacy of
AADs at maintaining SR and the increased mortality associated with AAD use have led physicians
to believe that alternative methods of rhythm-control would offer improved patient outcomes.
Atrial Fibrillation
8
Catheter Ablation in AF
Cox and colleagues have been credited with demonstrating the efficacy of surgical ablation in AF
(eventually developing the MAZE-III procedure).44 This led Cardiologists to attempt similar ablation
techniques non-surgically. In the late 1990s a major advance came with the discovery that
abnormal electrical signals originating in the pulmonary veins (and elsewhere) could “trigger” AF,
and that these could be obliterated with the use of catheter ablation.45, 46 Catheter ablation for AF
has subsequently become one of the most commonly performed ablation procedures around the
world.47
Catheter ablation (CA) is an elective, minimally invasive procedure most often performed under
sedation. A catheter is passed through the veins into the heart, with guidance of fluoroscopy and 3D mapping systems. A destructive energy source (alternating electrical current, cryothermal,
microwave, ultrasound or laser) is used to damage an area of atrial tissue, electrically isolating
these triggering signals and preventing activation of the normal muscle. Electrical isolation of the
pulmonary veins (PVs) is the cornerstone of the procedure, though there are many specific
techniques and patterns of ablation used.38 Each procedure may take many hours and requires
specialist staff, equipment and theatre facilities.
Radiofrequency ablation (RFCA) has been studied most extensively and uses alternating electrical
current to damage tissue. Cryoablation (using nitrous oxide to freeze tissue) is the most commonly
used alternative and recent studies suggest it has similar short term efficacy.48
Heart Rhythm UK has defined minimum standards for equipment and staff required to perform EP
studies and catheter ablation:49

Each physician should perform at least 50 cases each year as first operator.

Centres performing complex ablation should have at least 2 Cardiac electrophysiologists

Centres performing AF ablation should have surgical cover on site.

Cardiologists performing catheter ablation must audit their personal complications and share
these in an anonymised form.
Efficacy
In analysing the efficacy of CA in AF, there are significant challenges to interpretation of the data.
There are only a few randomised controlled trials (RCTs) comparing catheter ablation with the
alternative, anti-arrhythmic drug therapy. They are heterogeneous in design, inclusion and
exclusion criteria, ablation technique used and patient population (i.e. paroxysmal and/or persistent
AF). Most used freedom from AF at 12 months as their primary endpoint, and no published RCTs
have examined rates of stroke, heart failure and mortality. The CABANA trial which is currently
Atrial Fibrillation
9
underway seeks to answer some of these questions.50 This trial completed recruitment in February
2009 but final results are still some years away.
Most randomised trials have included a younger population (mean <60y) with few comorbidities
and predominantly paroxysmal AF. There are a number of non-randomised trials and registry data
that help clarify its role in a broader population but these data sources are less reliable.
Catheter ablation may have benefits in terms of reduction in: short- and long-term rates of
recurrent AF; hospital admissions; stroke and mortality; long-term sequelae, including heart failure;
avoidance of anticoagulation and improved quality of life.
1.
Freedom from AF at 12 months
There are at least 8 RCTs comparing RFA and AADs.51-58 All used freedom from AF at 12 months
as their primary endpoint.
After catheter ablation 56-94% of patients were free from AF at 12 months, compared with 4-43%
of those treated with AADs alone. There was an 11-40% repeat procedure rate. A Cochrane
review (2012) showed a 73% [CI 59-82%] reduction in relative risk of AF recurrence with RFCA
across seven of the studies.3 A recent meta-analysis of 63 randomised and non-randomised trials,
and the most recently completed worldwide survey of catheter ablation showed comparable
efficacy rates.59, 60
Generalising these results, RFCA has a 60-80% single procedure efficacy with an approximate 2040% chance of requiring repeat procedures. Clearly, RFCA is more efficacious than AADs at
maintaining sinus rhythm over the short-term.
2.
Long term freedom from AF
Although impressive success rates after ablation are seen in the first 12 months there have been
doubts raised about the rate at which AF recurs after this. Electrical reconnection of the PVs is
universally observed with late AF recurrence,38 highlighting the shortcomings of current technology
in creating permanent pulmonary vein isolation. Clearly, it is important to determine the durability
of responses for a procedure that has high up-front costs.
One RCT has reported 4-year follow-up data.61 At 4 years 91% in the RFCA group were free of AF
compared with 12% in the AAD group. 27% required repeat procedures. Non-randomised data
suggests lower success rates at 4-5 years, between 58-80%.62-64 Approximately 5-20% of patients
also required AADs to maintain SR.
The 2010 worldwide survey suggests an average of 1.3-1.4 procedures/patient are required to
achieve long-term success rates of approximately 80%.60
Atrial Fibrillation
10
3.
New Zealand perspective
A retrospective audit of catheter ablation in Christchurch was published in 2011.65 The mean age
of patients was 51 years. When compared with overseas results, it showed comparable efficacy at
12 months after a single procedure (74% for paroxysmal AF) and a comparable long-term repeat
procedure rate of 41.2%. This covered a period from 2001-2009 over which significant
technological advances have been made increasing efficacy and efficiency. The chance of being
AF-free at 5 years after all procedures was 95% for paroxysmal AF and 74% for persistent AF.
The complication rate was 6% (major complications 2.5%, no deaths).
4.
Reduction in hospitalisation
Reduction in symptomatic AF has been one of the key indications for CA in AF. Important cost
savings could be made by reducing hospital admissions due to symptomatic episodes. The quality
of evidence in this area is poor. When examined in RCTs little detail was reported as to the
reasons for readmission in both the AAD and RFCA groups.
However, both Wazni et al57 (9% v 54% 1-year readmission rate) and Pappone et al55 (24
admissions v 167 admissions) showed a significant drop in hospitalisations after RFCA, but neither
quantified the duration of admission or the associated costs. Stabile et al. showed no significant
difference in admission rates.56
5.
Stroke and Mortality
There are no randomised trials examining RFCA’s effect on the rates of stroke and mortality, but
the CABANA trial seeks to address this. Retrospective and registry data suggest RFCA is
associated with lower rates of mortality and stroke.66-72 In fact, one study suggests that the risk of
stroke returns to that of the general population following RFCA.66
Registry studies have shown a risk of stroke of 0.4-2.4% following RFCA compared with 2.8-7.4%
in matched medically treated cohorts.66-68, 70-72 Mortality is notoriously susceptible to selection bias
in non-randomised trials, but Hunter et al. demonstrated a 0.5% per year mortality rate versus
5.3% per year in a medically matched cohort.67
6.
Quality of Life
QoL has been examined in at least 3 RCTs, all of which showed an improvement in QOL with
RFCA.52, 57, 58 QOL scores were best in those in whom sinus rhythm was maintained and
approached the QOL scores of the general population.
7.
Avoidance of anticoagulation
One of the purported benefits of RFCA is the avoidance of anticoagulation, with its associated
drug, laboratory and morbidity costs. However, current guidelines suggest that anticoagulation
Atrial Fibrillation
11
should be continued regardless of the success of RFCA, in accordance with individual risk as
described above.14, 25, 38 This recommendation is based on the lack of Level A evidence showing a
reduction in risk of stroke following RFCA.
There are a number of trials that suggest there is a low risk of stroke in those who discontinue
anticoagulation after ablation.68, 69, 72, 73 If it was proven safe to stop anticoagulation this could
reduce on-going treatment costs following RFCA compared with standard practice.
8.
Heart failure
Co-morbid heart failure reduces the single procedure efficacy of RFCA, but reasonable efficacy
can be achieved with repeat procedures.38, 43 RFCA, when compared to AV node ablation and
dual chamber pacing, showed improved QOL, exercise capacity and LV function.
9.
Long-term sequelae
One consideration that is not clear in the literature but is potentially important is the prevention of
progression from paroxysmal AF to permanent AF and thereby the prevention of the long-term
sequelae, e.g. heart failure, premature admission to nursing homes and carer costs.
Efficacy in permanent/persistent (“non-paroxysmal”) AF
The have been no RCTs exclusively in this group of patients, but many non-randomised studies
have shown that RFCA is variably efficacious in this patient population.74 Success rates of 50-70%
in an optimal patient with persistent AF might be expected, compared with <40% in AF of 4 or
more years duration. Although the use of CA is expanding in this group of patients, its role is still
an area of significant debate. There is no real consensus on either the specific techniques and
patterns of ablation that should be used and the general role of RFCA.47
Limitations/Future Directions
The most significant limitation is the lack of randomised data regarding stroke, heart failure and
mortality between different treatment strategies. We also have little direct evidence of which
particular treatment strategy is the most efficacious in reducing hospitalisation and subsequent
healthcare resource utilisation.
The clinical opinion of CA in AF from international societies and European and American experts is
clear.47,76,77 It is seen as critical to the array of treatment options available for those with AF,
particularly paroxysmal AF.47, 75, 76 The exact ablation technique and the refining of energy
delivered to the muscle is an area of research, with the goal of achieving more permanent isolation
of the pulmonary veins and reducing the number of repeat procedures. Tools to shorten procedure
times, alternative and safer energy sources and even “remote/robotic” tools are being tested. 47
Atrial Fibrillation
12
Safety
Safety is a major concern for those undertaking RFCA in a young and otherwise relatively well
patient group. Although complications are infrequent, they can be significant and serious.
Complication rates are 4-6% and mortality is less than 0.1%.
RFCA for atrial fibrillation is one of the most complex interventional cardiac electrophysiology
procedures performed. The most important complications are: cardiac tamponade (~1.5%);
pulmonary vein stenosis (~1.3%); peri-procedural stroke/transient ischaemic attack (~1%);
vascular injury (0.5-2.0%); atrio-oesophageal fistula (0.1%).47, 60, 77 Dagres et al. found that
mortality of RFCA was similar to that of AADs after 1 year of treatment. 78
Complication rates are declining as the technique is refined. One centre of excellence has seen
complications fall from 11% in 2002 to 1.6% in 2010.47 Cryoablation has a similar safety profile but
notably there have been no documented cases of atrio-oesophageal fistula.79
Guidelines
International
A number of international guidelines and consensus statements have been published in this area.
The key guidelines and recommendations are listed below.
HRS/EHRA/ECAS Consensus statement on Catheter and Surgical ablation for Atrial

Fibrillation (2012)38
ACCF/AHA/ESC Guidelines for managing patients with atrial fibrillation (2006) and the

focused update (2011)35

ESC Guidelines for the management of atrial fibrillation (2010)14

Canadian Cardiovascular Society Atrial fibrillation guidelines 2010: Catheter ablation for atrial
fibrillation/atrial flutter.80
Key recommendations:

Class 1 (i.e. catheter ablation is recommended) –
Symptomatic AF and failed at least one anti-arrhythmic drug (“second-line”)

Class 2a (i.e. catheter ablation is reasonable) –
Symptomatic “non-paroxysmal” AF after at least one failed AAD
Prior to AAD in selected patients with paroxysmal AF (“first-line”)
Atrial Fibrillation
13
The final recommendation is a significant change compared to earlier guidelines, as it broadens
the potential population in whom EP is appropriate. As studies in this area mature, the trend has
been for widening indications for intervention.
New Zealand Guidelines
New Zealand’s most recent guideline on management of AF was published in 2005, and thus
lacked much of the current data available.25 At that time the recommendation was that catheter
ablation be limited to “highly-selected people with drug-refractory PAF [paroxysmal AF] and
structurally normal hearts”. This restriction was due to lack of randomised trial data and “limited
experience with this procedure” in New Zealand.
The New Zealand guidelines are far more restrictive than the more recently published international
guidelines. The implication of this difference is that if New Zealand were to follow international
guidelines the population for whom catheter ablation would be indicated would expand
significantly.
Cost-effectiveness
Studies
A number of studies have looked at cost-effectiveness of RFCA compared to anti-arrhythmic drug
(AAD) therapy. All have limitations, with differing methodology and contradictory findings.
Reynolds et al. (2009)81 found that over 5 years the absolute costs were US$26,584 and
US$19,898 of RFCA and AAD therapy respectively, which gave an ICERg of US$51,431/QALY.
Due to decreased health care costs in years following RFCA, the procedure became cost-neutral
at approximately 10 years. The high up-front costs of RFCA contributed significantly to the ICER in
the 5 year analysis. When compared to an earlier Canadian study82 the authors felt the “higher upfront costs of ablation in the United Sates” will have contributed to a longer timeline for cost
equalisation. Stroke and mortality risk were considered equal in both groups.
Chan et al. (2006)83 did assume a differing rate of stroke, and used multiple different scenarios to
determine cost-effectiveness. For a 55 year-old with a moderate risk of stroke RFCA had an ICER
of US$28,700/QALY, whereas for a 65 year-old patient with a low risk of stroke on aspirin the ICER
was US$98,900/QALY. In this study, stroke risk was assumed to reduce following RFCA. This
study shows that cost-effectiveness is sensitive both to reduction in stroke risk and selection of the
appropriate treatment population.
McKenna et al (2009)84 published the results of model using UK costs, which then on to be
published as a full Health Technology Assessment (HTA) analysis described below.
g
ICER (Incremental cost-effectiveness ratio) – the ratio of change in costs to incremental benefits of a therapeutic
intervention. This is usually expressed as a monetary amount per quality-adjusted life-years (QALYs) gained.
Atrial Fibrillation
14
HTA organisations
A number of HTA organisations have examined CA in AF. A CADTH review (2002)85 and Swedish
Council on Health Technology Assessment (2010)86 both found that there was insufficient evidence
to draw a conclusion on its cost-effectiveness.
Rodgers et al (2008)87 published the full HTA of the McKenna paper above, with a more detailed
explanation of the statistical and sensitivity analyses. They found that if QOL benefits are
maintained for the lifetime of patients, then RFCA has an ICER (Incremental Cost-Effectiveness
Ratio) of £7,768-£7910, but that if these benefits were only maintained for 5 years then the ICER
£20,831-£27,745. The UK National Institute for Clinical Excellence considers an ICER of £20,000£30,000 of only borderline cost-effectiveness.
The Ontario Medical Advisory secretariat published an HTA in 2006 that showed, even with
conservative estimates, RFCA with advanced mapping techniques became cost-neutral at 4.5
years compared with AADs.88 In contrast, Assasi et al. (2010)85 developed a similar model to that
of Rodgers et al., based on Canadian data and costs, and with a 5-year time horizon the ICER was
CA$59,194. The cost-effectiveness was highly sensitive to the time horizon used, with RFCA
becoming cost saving with a 20-year horizon.
An Institute for Clinical and Economic Review analysis (based at Massachusetts General
Hospital’s Institute for Technology Assessment (ITA) and an affiliate of Harvard Medical School) ,
showed the importance of targeting the correct patient population.89 For a 60 year old male patient
with paroxysmal AF the ICER was US$37,808, whereas a 75 year old male patient with persistent
AF, diabetes mellitus and hypertension the ICER was US$96,846.
In summary, these HTA assessments suggest that EP in AF is of variable cost-effectiveness, but
the results of the analyses are highly dependent on certain aspects. These models are most
sensitive to:

Patient population analysed

Utility decrements assigned to the AF state

Assumptions of duration of benefit post-RFCA

Cost of the procedure.
None have sought to define a patient population in which RFCA may be most cost-effective.
Limitations
The assessments described above show the complexity of this area. The UK and Canadian
models are comprehensive and suggest that RFCA is of borderline cost-effectiveness. However,
Atrial Fibrillation
15
without adequately analysing the reduced costs as a result of fewer symptomatic episodes of AF in
the years following ablation, these analyses will underestimate the benefit of RFCA.
The Canadian and United States analyses suggest that RFCA reaches a point of cost-neutrality 5
to 10 years after the procedure. The importance of higher procedural costs was demonstrated by
the US data which had the longer timeline to cost neutrality.
Despite the detail, these models are hindered by some important assumptions. They may have
underestimated RFCA benefit due to fewer hospitalisations after the procedure (a significant costburden). Equally, some the models may have overestimated the benefit by assuming a reduced
rate of stroke (currently unproven), and maintenance of QOL benefits linked to specific time
intervals rather than matched to sinus rhythm. If RFCA does not reduce stroke and mortality, and
the requirement for repeat procedures increases over longer timelines, then it may not be costeffective.
Other general limitations must be considered when examining these results from a New Zealand
perspective. Most of the information and analysis is from either North America or Britain which
have different patterns of care, costs, levels of experience, use of technology and levels of
remuneration. Although NZ clinical practice is similar to that of the UK its thresholds for costeffectiveness are not generalisable.
Societal and Ethical
Acceptability and Satisfaction
AF patients typically have low levels of knowledge about AF and there is a lack of consistency in
their knowledge, attitude and behaviours to more positively influence health and well-being.90
Satisfaction with current AF treatment is low in patients with AF, and physician satisfaction with
available AF drugs is driven by efficacy. Patient satisfaction, compliance, and functional ability
increase with perceived improved treatment efficacy. This was more recently confirmed in relation
to ablation therapy, stating that “persisting symptoms after the ablation procedure was a significant
predictor of patient satisfaction”. 91-93
It is likely, therefore, that catheter ablation will be more satisfactory than anti-arrhythmic drug
therapy to patients and doctors, as it is more efficacious and requires less on-going drug therapy.
Ethical considerations
The ethics of funding CA are complex. CA is a relatively new and evolving technology that has a
number of indisputable indications and is already embedded in our public health sector. It is
increasingly being seen as an integral part of the treatment spectrum of AF. The cost-effectiveness
is yet to be proven but despite this the recommended indications for its use in AF are widening.
Atrial Fibrillation
16
Further investment in a technology that has yet to be proven cost-effective sets a potentially
dangerous precedent, yet disinvestment in an established, efficacious and internationally
recommended procedure, that has yet to be proven insufficiently cost-effective, is potentially
unethical too. From a societal perspective the funding is likely to be a complex decision as wider
benefits, that have not be sufficiently examined in the literature to date, may influence this decision.
Defining an appropriate treatment group is also difficult. CA is a costly and limited resource in New
Zealand and its scarcity requires a degree of patient prioritisation. Equitable and transparent
access will be key considerations as currently intervention rates differ across ethnicities and
deprivation levels. The population for whom CA is both appropriate and cost-effective is likely to
represent only a tiny proportion of the total number of people with AF.
Catheter Ablation in New Zealand
Catheter ablation in New Zealand is still a small component within Cardiology services,
representing 5% of total Cardiac expenditure in 2011 (Case weight discharge data). There are 8-9
Cardiac electrophysiologists across the country. The services are well-established in Auckland,
Christchurch and Waikato. Although Capital and Coast DHB have EP facilities but they are
awaiting a Cardiac electrophysiologist to be cleared to work in order to reintroduce services.
The graph below (Figure 1) shows the prevalence of AF in the NZ population divided by age, and
the EP intervention rate in the population known to have AF. This shows AF prevalence increasing
with age, but contrastingly almost all EP is performed in those younger than 65. The median age
of intervention in 2011 for AF was 60.
It must be noted that these analyses are only estimations as there are significant limitations in
analysing local data. Assumptions and coding inaccuracies inherently introduce some imprecision
in the results. In order to produce more reliable and precise results relevant data collection would
need to be improved.
Atrial Fibrillation
17
Figure 3.
AF Prevalence and catheter ablation by age.
This figure shows that although AF prevalence increases with age interventions occur at younger ages. EP rates are
expressed as a percentage of the total AF population in each age band.
Source: NHC executive analysis of national collections.
Regulatory status
Devices used in EP procedures must be registered with the New Zealand WAND database. There
are nine suppliers of cardiac catheters, offering more than 50 different catheters, with prices
ranging from $800-$8,694, depending on complexity. Consumables can contribute up to 40% of
the procedural cost. There is currently no national procurement agreement for devices in this area.
Expenditure
Clinical coding limitations prevent a precise estimation of the activity and cost of CA for AF
nationally. Additionally, AF and atrial flutter are not reliably distinguishable in the data sets as they
are not coded separately. This is significant as the success of ablation and indications for it are
different between the two conditions despite being closely related.
Based on Case Weight Discharge (CWD) expenditure data, Cardiology expenditure increased by
NZ$22M (20%) between 2006 and 2011. In contrast, there has been only a 13% increase in CWD
expenditure for catheter ablation of AFL and AF since 2006, despite a 26% increase in total
cardiac electrophysiology procedure volumes. In 2011, cardiac electrophysiology represents only
5% of total Cardiac expenditure. Expenditure on CA for both AF and AFL in 2011, based on CWD,
was $4.9M comprising approximately 45% of the $10.8M cardiac electrophysiology costs, as
shown in Figure 4.
Atrial Fibrillation
18
Figure 4
Expenditure on cardiac electrophysiology by arrhythmia type. Spending on AF/AFlutter in 2011
was $4,920,179 out of a total of $10,847,781.
Source: NHC executive analysis of national collections.
EP represents only a small proportion of Cardiac expenditure at the present time and has shown a
lower than average growth in expenditure, suggesting there already exists an internal limitation on
increasing access.
Distribution by Region
Figure 5 below compares the prevalence of AF by DHB and the standardised intervention ratio for
AF catheter ablation by DHB. Although the prevalence varies to a small degree across the
country, EP intervention rates vary markedly and inconsistently with the prevalence. This
illustrates the inequalities of access across the country. Notably, access in the lower North Island
and upper South Island are disproportionately low compared with crude AF prevalence in these
regions, which may be driven by the lack of an Electrophysiology-trained Cardiologist in the region.
Atrial Fibrillation
19
Figure 5.
Inequity in access to EP services.
The maps show the contrast between regional distribution of AF (as seen earlier) and the EP intervention ratio across
New Zealand. The intervention ratio is the local regional intervention rate compared to the national average.
Crude AF
Prevalence
EP Intervention
Ratio
e
e
AF prevalence rates
1.0 - 1.5%
EP Intervention Ratio (c.f.
national average)
0.20 - 0.50
1.51 - 2.0%
0.51 - 1.00
2.01 - 2.5%
1.01 - 1.50
2.51 - 3.0%
1.51 - 1.85
Source: NHC executive analysis of national collections.
Inequalities of access also exist across ethnic groups, with Maori having lower rates of EP despite
having consistently higher prevalence of the disease. These data cannot account for other medical
factors (e.g. comorbidities) that may explain these differences.
Cost Analysis
Bearing in mind the significant limitations due to a lack of accurate New Zealand costing and
outcomes data (which would strengthen any further assessment in this area), an attempt to
understand the financial implications can be made. In addressing the funding of cardiac
electrophysiology, with a focus on AF, both the current model of care and future projections should
be considered.
In understanding the current delivery of care we are able to highlight ways in which current
resources might be more efficiently used, and by projecting future demand an estimation of the
potential future cost implications, and how these could be approached, can be made.
Atrial Fibrillation
20
This can be broadly summarised into three areas:

Assessing the current costs, cost-effectiveness and addressing mechanisms of cost-saving
in the current model of care.

Identifying those patients in whom EP has a the most significant clinical and financial benefit

Predicting the future demand and, by addressing the potential uncontrolled growth of the
service, avoid future cost.
The Current Environment
The financial impact of EP for AF has three aspects:

Direct costs to DHBs in Hospital and Emergency Department admissions, and outpatient
visits (which can be estimated with CWD data)

Wider health system costs including GP visits, medication, lab testing, nursing home
admission (which are much more difficult to ascertain accurately)

Societal and productivity costs due to absenteeism, “presenteeism” (reduced productivity
despite work attendance), carer costs and early retirement.
HTA assessments have sought to establish the cost effectiveness of RFCA as a whole. In these
analyses the cost-effectiveness is most sensitive to: patient population chosen; utility decrements
assigned to the AF state; assumptions of duration of benefit post-RFCA; and the cost of the
procedure. Although utility decrements and duration of benefits affect HTA results they cannot be
practically altered to improve cost efficiencies.
Therefore, obtaining optimal efficiency from EP resources can be approached in 2 ways:

Targeting the appropriate intervention population

Reducing the procedural costs.
Targeting the Population
A complete assessment of the ideal population is beyond the scope of this paper, but the analysis
below is illustrative of how targeting an appropriate population may affect EP service costeffectiveness.
The current indications for CA for AF target those people who are both highly symptomatic and
have failed drug therapy. This cohort is likely to have increased health expenditure in the years
preceding CA as a result of worsening control of their AF.
Figures 6 and 7 show the hospital expenditure for those patients who underwent an EP study, with
or without ablation, and who have a diagnosis of AF (differentiating this group from those who
actually underwent therapeutic catheter ablation for AF is not currently possible).
Atrial Fibrillation
21
By reducing the resource use in those patients, potential savings may be made. As seen in Figure
6, in the year prior to EP the hospital-related costs in some cohorts of AF patients increase
significantly (presumably as a result of increasing symptomatic episodes requiring hospitalisation).
Following EP, the hospital costs incurred reduce significantly. As an illustrative example of how
targeting the correct population can affect cost-effectiveness and affordability, we have divided the
EP population by the number of admissions each patient had in the year prior to admission (3 or
greater, 2, 1 or 0).
In 2005, those patients with ≥3 admissions in the year prior to CA cost the hospital system $19,500
in the year prior to CA. The expenditure in the year of CA is approximately $28,500, but then in the
years 2-5 the cost of their care reduces to $1,000-5,000 per annum. When a matched cohort of
patients (matched for age, deprivation quintile, gender and ethnicity) who did not undergo CA is
compared, the hospital costs are much higher in later years. The CA procedure becomes cost
neutral in year 4 following ablation (including 3.5% discounting), and by 5 years the patients are
actually $10,800 cheaper per patient to the hospital system than the matched cohort.
Figure 6.
Hospital expenditure for those patients with ≥3 and 2 admissions in the year prior to EP. Those
patients with 3 or more admissions have a higher subsequent expenditure than those with only
2 admissions.
Source: NHC executive analysis of national collections.
In contrast, those patients who have two admissions in the year prior to CA show less difference
hospital expenditure in the years following EP compared with a matched cohort. In these patients
their care becomes cost-neutral in year 7 following CA (by year 5 they are still $6,000 more
expensive). The same applies to those with one or no admissions (Figure 7). After CA their
hospital costs are significantly less than a matched cohort and their care becomes cost-neutral in
year 8 and year 10 respectively (if the difference in costs is extrapolated beyond year 5). There is
Atrial Fibrillation
22
a clear stepwise progression in cost recovery across these groups based on their admission
history prior to CA.
Figure 7.
Hospital expenditure for those patients with one or no admissions in the year prior to EP.
Although there is still a difference in hospital care costs between them and a matched cohort the difference is less than
the patients with 2 or 3+ admissions.
Source: NHC executive analysis of national collections.
In 2005, 5% of the total AF population had ≥3 admissions, and only 1% of these underwent CA.
This suggests there may be a large number who may be appropriate for CA but in whom it is not
performed. Of the 208 patients in 2005 who underwent ablation, only 23 had ≥3 admissions in the
year prior. If the patients with ≤2 admissions were replaced with a cohort with ≥3 admissions, and
we extrapolate the difference in hospital resource use, then this cohort costs the hospital system
approximately $3,000,000-$4,000,000 less (including 3.5% discounting) at 5 years.
By altering the group of patients in whom CA is performed, it is possible to reduce the overall costs
placed on hospitals by those patients with AF. If, for instance, the same number of procedures
was performed as has been in recent years (approximately 280), but that CA was only performed
on patients who had two or more admissions to hospital, i.e. those patients who had fewer than
two admissions and would now have had CA, would hypothetically be replaced by a group with two
or more admissions, a benefit could be expected in terms of reduced healthcare resource use.
This is demonstrated in two ways. Currently, patients who undergo CA have 2.7% fewer hospital
admissions than those who do not undergo CA. If the group was targeted as described above,
then CA would reduce admissions by 15% compared to the matched cohort. There would also be
an immediate saving to the health sector (i.e. from the year of CA) as resources are moved from
those who would otherwise use very few resources, to those who would use significantly more. In
Atrial Fibrillation
23
fact, by doing this modelling predicts that $1.4 million of resources could be saved or used for other
patients in the year of ablation (i.e year 0), and the cumulative reduction in resources use over 4
years would be $12.7 million (including 3.5% discounting).
While there is potential for error in the absolute costs, this clearly shows that there is potential to
stratify groups of patients in whom CA is not only highly efficacious, but also likely to save on
hospital expenditure in the subsequent years. This simple model does not include ED, outpatient
and primary care costs, but the HTA modelling described earlier have found these costs have been
consistently lower in CA groups compared to AAD-alone groups (due to lower drug and outpatient
care costs). This would further favour cost-effectiveness of CA.
Other factors that would improve success rates and cost-effectiveness include:
1.
Younger age – have a shorter duration of disease and more likely to be employed. By
reducing symptoms, not only are healthcare resources appropriately used, but longer life
expectancy and duration of benefit could reasonably be expected; and there would also be
greater productivity/societal benefits.
2.
Type of AF – success rates are higher in paroxysmal AF compared to persistent AF
3.
Duration of AF – higher success rates are seen with shorter durations of AF
4.
Fewer comorbidities – increase the single procedure efficacy
However, to consider performing this procedure only in a narrowly defined group of patients
ignores important clinical, quality of life and societal factors that cannot be incorporated in a simple
model. However, by using simple clinical measures (such as hospital admissions, type of AF,
comorbidities, number of failed AADs and age) in a priority scoring system, the NZ health sector
could offer this service appropriately, whilst improving cost-effectiveness.
Reducing the cost
Currently, there is no national procurement agreement for EP devices. If a national program could
reduce the cost of capital investment and consumables, cost-effectiveness would inevitably be
improved. With the limited information available at the current time on service organisation and
workforce capacity, this is an area which will require further investigation
Potential Societal/Productivity Considerations
The PricewaterhouseCoopers report suggests that 15% of the total costs of AF to Australia were
societal costs.6 The population in whom EP is performed in New Zealand is generally younger and
is more likely to be contributing to the economy. No study has considered these wider aspects but
it seems likely that with reduced symptoms, fewer hospitalisations, and improved quality of life that
the wider societal benefits would favour CA over AAD drug use. Increased economic productivity
Atrial Fibrillation
24
as a result of fewer absentee days, reduced carer requirements and reduced symptoms would
mean this societal benefit will make EP more attractive from a societal viewpoint.
Potential for growth
The potential growth in service demand is variable. Predictions are limited by the large potential
population in whom CA may be used. As one of the main drivers for CA is severity of symptoms,
which is not recorded in ICD coding, there is no reliable method for estimating the current size of
the potential intervention population in New Zealand.
In the UK, the number of ablations for AF rose by 316% between 2006 and 2011 (from 1,120 to
4,654).94, 95 The number of centres performing cardiac electrophysiology rose from 38 to 49 in the
same period. The main obstacles to guideline implantation were felt to be a lack of referrals and a
lack of centres.94 By contrast, New Zealand’s intervention rate for AF rose only 18.6% (by CWD
data from 278 to 338 procedures).
Below we consider a number of potential scenarios for demand expansion over the next 10 years:
Figure 7.
Potential growth in demand in catheter ablation for AF to 2022. Source: NHC executive
analysis of national collections.
Source: NHC executive analysis of national collections.
Atrial Fibrillation
25
Scenario 1: The absolute rate of intervention remains stable at 2011 levels across all age groups
(i.e. the minimum possible growth)
Scenario 2: The growth in intervention rates between 2006 and 2011 continues until 2022 but
remains constant (and interventions increase in proportion with each age group)
Scenario 3: A conservative estimate as absolute intervention rates double by 2022, (based on a
controlled rate of increase compared with the UK) i.e. if controlled by resource constraints.
Scenario 4: New evidence suggests EP reduces stroke risk and mortality and as indications widen
the intervention rates rise at the same rate as the UK rate between 2006 and 2011 (i.e.
approximately 2.3% of the AF population is treated with CA in 2022)
Scenario 5: New guidelines suggest EP should be used in the first line for paroxysmal AF in 40-65
year-olds (Assumption: paroxysmal AF represents 30% of AF in 40-65 year olds).18
Projected expenditure
Projecting the future need for EP in AF in New Zealand is difficult because as the technology
develops so its indications will likely increase, but costs will fall for existing interventions as new
technology evolves. There is a significant degree of speculation in each of the models.
An illustrative example:
If we assume that Scenario 2 is the base scenario and that intervention rates increase at a rate
consistent with the growth over the past 5 years, and compare this with Scenario 4. Estimating the
cost of each ablation procedure at $15,800 per patient (based on the median price of admission
from CWD data ) then the cost of performing CA on all the patients in Scenario 4 in 2011 NZ$
would be $42.5M, compared to the base case of $11.4M, i.e. an extra $31.2M in direct
expenditure. This excludes the capital costs of 3-6 extra theatres required and the extra Cardiac
Electrophysiologists performing the procedures.
If the intervention numbers were limited to Scenario 3 levels then the direct cost to the New
Zealand health system would be $14.8M, or alternatively $27.7M in avoided expenditure. However,
these examples need to be tempered by the earlier modelling which suggests there may be a
population in which a cautious expansion on the Cardiac electrophyisiology service would in fact
reduce overall healthcare costs.
Summary
The ubiquitous implementation of catheter ablation for atrial fibrillation is currently beyond the
workforce, infrastructural and financial capacity of New Zealand. However, the analysis above
shows that there is potential to target groups of patients in whom the personal and systemic
Atrial Fibrillation
26
benefits are greatest. If done judiciously, the improved outcomes might allow the redirection of
constrained resources in subsequent years, either to other services or to allow the health sector to
better plan for, and cope with, the inevitable increased demand for EP services.
The high up-front costs are strong determinants of affordability and cost-effectiveness and if a
stronger national approach is taken to capital and consumable costs it will allow for greater
efficiencies.
Non-commercial considerations
There are additional non-commercial considerations which impact any decision on the introduction
or expansion of health technologies. Workforce recruitment and retention is an important
consideration as most Cardiologists combine General Cardiology responsibilities with a subspeciality interest. There is the potential to lose New Zealand-trained and -experienced
Cardiologists overseas if overly severe restrictions are placed on their scope of practise.
Cardiac Electrophysiology is a growing sub-speciality,96 and is becoming popular with Cardiology
trainees, with 5-6 NZ trainees expressing an interest in EP.97 This compares to a current 1.8FTE
for EP at ADHB. The 2009 US national average of Cardiac Electrophysiologists is 7.8/1,000,000
population, with 8 states having <5.6/1,000,000.96 This compares with New Zealand’s current EP
specialist workforce of 2/1,000,000. This suggests that New Zealand is relatively under-resourced
in this area, even acknowledging the difference in practise between North America and New
Zealand.
Electrophysiology technology is constantly evolving with improving outcomes and falling
complication rates.47, 60, 96 Careful service configuration and wise investment could enable New
Zealand timely access to newer techniques and technologies that are definitely cost-effective
and/or cost-saving in this area.
Data quality
This report has highlighted the effect data limitations have on accurate analysis. Catheter ablation
is a procedure with significant up-front costs but which appears to deliver improved outcomes for
patients. In order to make interventions such as these more robust to cost-effectiveness and
outcomes scrutiny, a more complete record of the clinical and financial impacts would be a
significant asset.
There are local and international precedents in this area. In 2009, the Australian and New Zealand
Society for Vascular Surgery made participation in a bi-national audit a “necessary requirement for
ordinary members to maintain membership of the ANZSVS.”98
Atrial Fibrillation
27
A registry of cardiac electrophysiology intervention would aid timely and appropriate clinical and
financial data analysis to guide service development, adaptation and improvement, as well as
providing academic opportunities for those involved. A registry could include both clinical and
financial outcomes.
Conclusions
Cardiac Electrophysiology services are a crucial part of the New Zealand’s Cardiac services, but
they are also a finite resource with significant capital expenditure and procedural costs. Their
scarcity, on-going evolution and specialisation, and potential for growth in demand, with difficulties
in providing equitable access across the country make this an area that will require a strategic
planning and monitoring to ensure we provide an efficacious and cost-effective service for New
Zealanders.
Waiting list information is inadequate, national costs and outcomes difficult to assess and
appropriate national prioritisation of potential patients non-existent. Catheter ablation in AF
highlights the challenges ahead. Improving health outcomes and addressing inequalities will
require a concerted and co-ordinated effort that allows efficient use of resources, workforce
retention, recruitment of skilled staff, and on-going engagement with the sector.
International analyses of the cost-effectiveness of RFCA in AF have had variable results, but a
number of clinical guidelines recommended it in specific populations. Analysis of the New Zealand
data suggests that patients with AF who undergo EP ablation cost the NZ health system less in the
years after the procedure, and that there is a possibility that this procedure can be cost-neutral or
even cost-saving over time. Additionally, if CA in AF proves to reduce the long-term sequelae,
there may be potential cost savings beyond those considered in cost-effectiveness analyses.
There is also a tension between the payer perspective and the national-societal perspective. With
its high upfront and capital costs DHBs are likely to want to contain costs in this area; however,
from a societal perspective catheter ablation is likely to reduce societal costs based on
absenteeism and carer requirements. Careful implementation and patient selection may allow
synergism of societal and payer objectives.
The role of the NHC in this area is to initially highlight these issues to the sector and engage
experts in cardiac electrophysiology, structural organisation and development, and funding and
purchasing to develop a sensible and effective strategy for service development and monitoring.
Current limitations in outcomes and financial data collection limit stronger recommendations, and
further monitoring and analysis would allow more informed service design and planning.
Atrial Fibrillation
28
If this intervention proves not to be cost-effective then we must be prepared to steer resources to
practises that will provide better value for money, but if it proves to be cost-saving then a coordinated plan for workforce requirements, structure and development will be required.
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Scheinman, M, Calkins, H et al (2003). 'NASPE policy statement on catheter ablation'.
Pacing and clinical electrophysiology, 26 (3), 789-99.
Wood, AJJ & Morady, F (1999). 'Radio-frequency ablation as treatment for cardiac
arrhythmias'. New England Journal of Medicine, 340 (7), 534-44.
Chen, HS, JunMin, W et al (2008). 'Catheter ablation for paroxysmal and persistent atrial
fibrillation'. The Cochrane Library.
Weerasooriya, HR, Murdock, C et al (1994). 'The cost‐effectiveness of treatment of
supraventricular arrhythmias related to an accessory atrioventricular pathway: comparison
of catheter ablation, surgical division and medical treatment'. Australian and New Zealand
journal of medicine, 24 (2), 161-7.
Kannel, WB, Abbott, RD et al (1982). 'Epidemiologic Features of Chronic Atrial
Fibrillation'. New England Journal of Medicine, 306 (17), 1018-22.
PricewaterhouseCoopers (2010). The economic costs of atrial fibrillation in Australia.
Stewart, S, Murphy, N et al (2004). 'Cost of an emerging epidemic: an economic analysis of
atrial fibrillation in the UK'. Heart, 90 (3), 286-92.
Stewart, S, Hart, CL et al (2001). 'Population prevalence, incidence, and predictors of atrial
fibrillation in the Renfrew/Paisley study'. Heart, 86 (5), 516-21.
Noheria, A, Kumar, A et al (2008). 'Catheter ablation vs antiarrhythmic drug therapy for
atrial fibrillation: a systematic review'. Archives of Internal Medicine, 168 (6), 581-6.
Kirchhof, P, Auricchio, A et al (2007). 'Outcome parameters for trials in atrial fibrillation:
executive summary'. European Heart Journal, 28 (22), 2803-17.
Go, AS, Hylek, EM et al (2001). 'Prevalence of diagnosed atrial fibrillation in adults:
national implications for rhythm management and stroke prevention: the AnTicoagulation
and Risk Factors in Atrial Fibrillation (ATRIA) Study'. JAMA, 285 (18), 2370-5.
Fuster, V, Rydén, LE et al (2006). 'ACC/AHA/ESC 2006 Guidelines for the Management of
Patients With Atrial Fibrillation--Executive Summary: A Report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines and the
European Society of Cardiology Committee for Practice Guidelines (Writing Committee to
Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation)
Developed in Collaboration With the European Heart Rhythm Association and the Heart
Rhythm Society'. Journal of the American College of Cardiology, 48 (4), 854.
Wolf, PA, Mitchell, JB et al (1998). 'Impact of atrial fibrillation on mortality, stroke, and
medical costs'. Archives of Internal Medicine, 158 (3), 229.
Camm, AJ, Kirchhof, P et al (2010). 'Guidelines for the management of atrial fibrillation'.
Europace, 12 (10), 1360-420.
Wang, TJ, Larson, MG et al (2003). 'Temporal relations of atrial fibrillation and congestive
heart failure and their joint influence on mortality'. Circulation, 107 (23), 2920-5.
Israel, CW, Grönefeld, G et al (2004). 'Long-term risk of recurrent atrial fibrillation as
documented by an implantable monitoring device: implications for optimal patient care'.
Journal of the American College of Cardiology, 43 (1), 47-52.
Page, RL, Wilkinson, WE et al (1994). 'Asymptomatic arrhythmias in patients with
symptomatic paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia'.
Circulation, 89 (1), 224-7.
Atrial Fibrillation
29
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
Flaker, GC, Fletcher, KA et al (1995). 'Clinical and echocardiographic features of
intermittent atrial fibrillation that predict recurrent atrial fibrillation'. The American journal
of cardiology, 76 (5), 355-8.
Lip, GYH & Hee, FLLS (2001). 'Paroxysmal atrial fibrillation'. Qjm, 94 (12), 665-78.
Goudevenos, J, Vakalis, J et al (1999). 'An epidemiological study of symptomatic
paroxysmal atrial fibrillation in northwest Greece'. Europace, 1 (4), 226-33.
Al-Khatib, SM, Wilkinson, WE et al (2000). 'Observations on the transition from
intermittent to permanent atrial fibrillation'. American Heart Journal, 140 (1), 142-5.
Kerr, CR, Humphries, KH et al (2005). 'Progression to chronic atrial fibrillation after the
initial diagnosis of paroxysmal atrial fibrillation: results from the Canadian Registry of
Atrial Fibrillation'. American Heart Journal, 149 (3), 489-96.
Reynolds, MR, Essebag, V et al (2007). 'Healthcare resource utilization and costs associated
with recurrent episodes of atrial fibrillation: the FRACTAL registry'. Journal of
cardiovascular electrophysiology, 18 (6), 628-33.
Moeremans, K, Aliot, E et al (2000). 'Second line pharmacological management of
paroxysmal and persistent atrial fibrillation in France: a cost analysis'. Value in Health, 3
(6), 407-16.
The New Zealand Guidelines Group. The Management of People with Atrial Fibrillation
and Flutter2005: Available from: www.nzgg.org.nz [Accessed.
Statistics-NZ (2012). Projected Population of New Zealand, by Age and Sex, 2006 (base) 2061 Available from:
http://www.stats.govt.nz/tools_and_services/tools/TableBuilder/population-projectionstables.aspx
Carlsson, J, Miketic, S et al (2003). 'Randomized trial of rate-control versus rhythm-control
in persistent atrial fibrillation: the Strategies of Treatment of Atrial Fibrillation (STAF)
study'. Journal of the American College of Cardiology, 41 (10), 1690-6.
Roy, D, Talajic, M et al (2008). 'Rhythm Control versus Rate Control for Atrial Fibrillation
and Heart Failure'. New England Journal of Medicine, 358 (25), 2667-77.
Van Gelder, IC, Hagens, VE et al (2002). 'A Comparison of Rate Control and Rhythm
Control in Patients with Recurrent Persistent Atrial Fibrillation'. New England Journal of
Medicine, 347 (23), 1834-40.
Wyse, DG, Waldo, AL et al (2002). 'A comparison of rate control and rhythm control in
patients with atrial fibrillation'. New England Journal of Medicine, 347 (23), 1825-33.
Gage, BF, Waterman, AD et al (2001). 'Validation of clinical classification schemes for
predicting stroke'. JAMA: The Journal of the American Medical Association, 285 (22),
2864-70.
Lip, GYH, Nieuwlaat, R et al (2010). 'Refining Clinical Risk Stratification for Predicting
Stroke and Thromboembolism in Atrial Fibrillation Using a Novel Risk Factor-Based
Approach'. Chest, 137 (2), 263-72.
Connolly, SJ, Ezekowitz, MD et al (2009). 'Dabigatran versus warfarin in patients with atrial
fibrillation'. New England Journal of Medicine, 361 (12), 1139-51.
Swedish Council on Technology Assessment in Health Care (2011). Dabigatran to Prevent
Stroke in Patients With Atrial Fibrillation Available from:
http://www.sbu.se/upload/Publikationer/Content1/1/Dabigatran_Prevent_Stroke_Patients_
With_Atrial_Fibrillation_201104.pdf [Accessed
Wann, LS, Curtis, AB et al (2011). '2011 ACCF/AHA/HRS focused update on the
management of patients with atrial fibrillation (updating the 2006 guideline): a report of the
American College of Cardiology Foundation/American Heart Association Task Force on
Practice Guidelines'. Journal of the American College of Cardiology, 57 (2), 223.
Tieleman, R (2003). 'The pathophysiology of maintenance of atrial fibrillation'. Pacing and
clinical electrophysiology, 26 (7p2), 1569-71.
Atrial Fibrillation
30
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
Wijffels, MCEF, Kirchhof, CJHJ et al (1995). 'Atrial fibrillation begets atrial fibrillation: a
study in awake chronically instrumented goats'. Circulation, 92 (7), 1954-68.
Calkins, H, Kuck, KH et al (2012). '2012 HRS/EHRA/ECAS expert consensus statement on
catheter and surgical ablation of atrial fibrillation: recommendations for patient selection,
procedural techniques, patient management and follow-up, definitions, endpoints, and
research trial design'. Journal of Interventional Cardiac Electrophysiology, 1-87.
Pederson, O, Bagger, H et al (2001). 'for the Danish Investigations of Arrhythmia and
Morality ON Dofetilide Study Group,“Efficacy of dofetilide in the treatment of atrial
fibrillation-flutter in patients with reduced left ventricular function: A Danish Investigations
of Arrhythmia and Mortality ON Dofetilide (DIAMOND) substudy”'. Circulation, 104, 2926.
Sherman, DG, Kim, SG et al (2005). 'Occurrence and characteristics of stroke events in the
Atrial Fibrillation Follow-up Investigation of Sinus Rhythm Management (AFFIRM) study'.
Archives of Internal Medicine, 165 (10), 1185.
Corley, S, Epstein, A et al (2004). 'Relationships between sinus rhythm, treatment, and
survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management
(AFFIRM) Study'. Circulation, 109 (12), 1509.
Hsu, LF, Jaïs, P et al (2004). 'Catheter ablation for atrial fibrillation in congestive heart
failure'. New England Journal of Medicine, 351 (23), 2373-83.
Khan, MN, Jais, P et al (2008). 'Pulmonary-vein isolation for atrial fibrillation in patients
with heart failure'. New England Journal of Medicine, 359 (17), 1778-85.
Sundt, TM, Camillo, CJ & Cox, JL (1997). 'The maze procedure for cure of atrial
fibrillation'. Cardiology Clinics, 15 (4), 739.
Haissaguerre, M, Jais, P et al (1998). 'Spontaneous initiation of atrial fibrillation by ectopic
beats originating in the pulmonary veins'. New England Journal of Medicine, 339 (10), 65966.
Jais, P, Haissaguerre, M et al (1997). 'A focal source of atrial fibrillation treated by discrete
radiofrequency ablation'. Circulation, 95 (3), 572-6.
Calkins, H (2012). 'Catheter Ablation to Maintain Sinus Rhythm'. Circulation, 125 (11),
1439-45.
Packer, D, Irwin, J et al (2010). 'Cryoballoon ablation of pulmonary veins for paroxysmal
atrial fibrillation: first results of the North American Arctic Front STOP-AF pivotal trial'.
American College of Cardiology Annual Scientific Section, Atlanta, Ga, USA.
Heart Rhythm UK (2010). Standards for electrophysiological studies and catheter ablation,
Available from:
http://heartrhythmuk.org.uk/files/file/Docs/Guidelines/Heart%20Rhythm%20UK%20compe
tency%20standards%20for%20EP%20and%20ablation%20%20Sept%202010%20FINAL.pdf.
Cleland, JGF, Coletta, AP et al (2010). 'Clinical trials update from the American College of
Cardiology meeting 2010: DOSE, ASPIRE, CONNECT, STICH, STOP-AF, CABANA,
RACE II, EVEREST II, ACCORD, and NAVIGATOR'. European Journal of Heart
Failure, 12 (6), 623-9.
Forleo, GB, Mantica, M et al (2009). 'Catheter ablation of atrial fibrillation in patients with
diabetes mellitus type 2: results from a randomized study comparing pulmonary vein
isolation versus antiarrhythmic drug therapy'. Journal of cardiovascular electrophysiology,
20 (1), 22-8.
Jais, P, Cauchemez, B et al (2008). 'Catheter ablation versus antiarrhythmic drugs for atrial
fibrillation: the A4 study.[Erratum appears in Circulation. 2009 Sep 8;120(10):e83]'.
Circulation, 118 (24), 2498-505.
Krittayaphong, R, Raungrattanaamporn, O et al (2003). 'A randomized clinical trial of the
efficacy of radiofrequency catheter ablation and amiodarone in the treatment of
Atrial Fibrillation
31
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
symptomatic atrial fibrillation'. Journal of the Medical Association of Thailand, 86 Suppl 1,
S8-16.
Oral, H, Pappone, C et al (2006). 'Circumferential pulmonary-vein ablation for chronic atrial
fibrillation'. New England Journal of Medicine, 354 (9), 934-41.
Pappone, C, Augello, G et al (2006). 'A randomized trial of circumferential pulmonary vein
ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF
Study'. Journal of the American College of Cardiology, 48 (11), 2340-7.
Stabile, G, Bertaglia, E et al (2006). 'Catheter ablation treatment in patients with drugrefractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study
(Catheter Ablation For The Cure Of Atrial Fibrillation Study)'. European Heart Journal, 27
(2), 216-21.
Wazni, OM, Marrouche, NF et al (2005). 'Radiofrequency ablation vs antiarrhythmic drugs
as first-line treatment of symptomatic atrial fibrillation: a randomized trial'. JAMA, 293 (21),
2634-40.
Wilber, DJ, Pappone, C et al (2010). 'Comparison of antiarrhythmic drug therapy and
radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized
controlled trial'. JAMA, 303 (4), 333-40.
Calkins, H, Reynolds, MR et al (2009). 'Treatment of atrial fibrillation with antiarrhythmic
drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses'.
Circulation: Arrhythmia and Electrophysiology, 2 (4), 349-61.
Cappato, R, Calkins, H et al (2010). 'Updated Worldwide Survey on the Methods, Efficacy,
and Safety of Catheter Ablation for Human Atrial FibrillationCLINICAL PERSPECTIVE'.
Circulation: Arrhythmia and Electrophysiology, 3 (1), 32-8.
Pappone, C, Vicedomini, G et al (2011). 'Radiofrequency Catheter Ablation and
Antiarrhythmic Drug Therapy / Clinical Perspective'. Circulation: Arrhythmia and
Electrophysiology, 4 (6), 808-14.
Bertaglia, E, Tondo, C et al (2010). 'Does catheter ablation cure atrial fibrillation? Singleprocedure outcome of drug-refractory atrial fibrillation ablation: a 6-year multicentre
experience'. Europace, 12 (2), 181-7.
Ouyang, F, Tilz, R et al (2010). 'Long-Term Results of Catheter Ablation in Paroxysmal
Atrial FibrillationClinical Perspective'. Circulation, 122 (23), 2368-77.
Weerasooriya, R, Khairy, P et al (2011). 'Catheter Ablation for Atrial Fibrillation:: Are
Results Maintained at 5 Years of Follow-Up?'. Journal of the American College of
Cardiology, 57 (2), 160-6.
Daly, M, Melton, I & Crozier, I (2011). 'Pulmonary vein ablation for atrial fibrillation: the
Christchurch, New Zealand experience'. The New Zealand medical journal, 124 (1343), 39.
Bunch, TJ, Crandall, BG et al (2011). 'Patients Treated with Catheter Ablation for Atrial
Fibrillation Have Long‐Term Rates of Death, Stroke, and Dementia Similar to Patients
Without Atrial Fibrillation'. Journal of cardiovascular electrophysiology.
Hunter, RJ, McCready, J et al (2012). 'Maintenance of sinus rhythm with an ablation
strategy in patients with atrial fibrillation is associated with a lower risk of stroke and death'.
Heart, 98 (1), 48-53.
Nademanee, K, Schwab, MC et al (2008). 'Clinical outcomes of catheter substrate ablation
for high-risk patients with atrial fibrillation'. Journal of the American College of Cardiology,
51 (8), 843-9.
Oral, H, Chugh, A et al (2006). 'Risk of thromboembolic events after percutaneous left atrial
radiofrequency ablation of atrial fibrillation'. Circulation, 114 (8), 759-65.
Pappone, C, Rosanio, S et al (2003). 'Mortality, morbidity, and quality of life after
circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled
nonrandomized long-term study'. Journal of the American College of Cardiology, 42 (2),
185-97.
Atrial Fibrillation
32
71.
72.
73.
74.
75.
76.
77.
78.
79.
80.
81.
82.
83.
84.
85.
86.
87.
88.
Sonne, K, Patel, D et al (2009). 'Pulmonary vein antrum isolation, atrioventricular junction
ablation, and antiarrhythmic drugs combined with direct current cardioversion: survival
rates at 7 years follow-up'. Journal of Interventional Cardiac Electrophysiology, 26 (2),
121-6.
Themistoclakis, S, Corrado, A et al (2010). 'The risk of thromboembolism and need for oral
anticoagulation after successful atrial fibrillation ablation'. Journal of the American College
of Cardiology, 55 (8), 735-43.
Guiot, A, Jongnarangsin, K et al (2012). 'Anticoagulant therapy and risk of cerebrovascular
events after catheter ablation of atrial fibrillation in the elderly'. Journal of cardiovascular
electrophysiology.
Brooks, AG, Stiles, MK et al (2010). 'Outcomes of long-standing persistent atrial fibrillation
ablation: a systematic review'. Heart Rhythm, 7 (6), 835-46.
Pappone, C & Santinelli, V (2012). 'Atrial Fibrillation Ablation'. Revista Española de
CardiologÃa (English Edition).
Thomas, SP & Sanders, P (2012). 'Catheter Ablation for Atrial Fibrillation'. Heart, Lung and
Circulation.
Cappato, R, Calkins, H et al (2005). 'Worldwide survey on the methods, efficacy, and safety
of catheter ablation for human atrial fibrillation'. Circulation, 111 (9), 1100-5.
Dagres, N, Varounis, C et al (2009). 'Mortality after catheter ablation for atrial fibrillation
compared with antiarrhythmic drug therapy. A meta-analysis of randomized trials'.
American Heart Journal, 158 (1), 15-20.
Andrade, JG, Khairy, P et al (2011). 'Efficacy and safety of cryoballoon ablation for atrial
fibrillation: a systematic review of published studies'. Heart Rhythm, 8 (9), 1444-51.
Verma, A, Macle, L et al (2011). 'Canadian Cardiovascular Society Atrial Fibrillation
Guidelines 2010: catheter ablation for atrial fibrillation/atrial flutter'. Canadian Journal of
Cardiology, 27 (1), 60-6.
Reynolds, MR, Zimetbaum, P et al (2009). 'Cost-Effectiveness of Radiofrequency Catheter
Ablation Compared With Antiarrhythmic Drug Therapy for Paroxysmal Atrial
FibrillationCLINICAL PERSPECTIVE'. Circulation: Arrhythmia and Electrophysiology, 2
(4), 362-9.
Khaykin, Y, Wang, X et al (2009). 'Cost comparison of ablation versus antiarrhythmic drugs
as first-line therapy for atrial fibrillation: an economic evaluation of the RAAFT pilot study'.
Journal of cardiovascular electrophysiology, 20 (1), 7-12.
Chan, PS, Vijan, S et al (2006). 'Cost-effectiveness of radiofrequency catheter ablation for
atrial fibrillation'. Journal of the American College of Cardiology, 47 (12), 2513-20.
McKenna, C, Palmer, S et al (2009). 'Cost-effectiveness of radiofrequency catheter ablation
for the treatment of atrial fibrillation in the United Kingdom'. Heart, 95 (7), 542-9.
Assasi, N, Blackhouse, G et al (2010). Ablation procedures for rhythm control in patients
with atrial fibrillation: clinical and cost-effectiveness analyses (Structured abstract).
[Internet]. Canadian Agency for Drugs and Technologies in Health (CADTH). Available
from: http://cadth.ca/en/products/health-technology-assessment/publication/2663
Swedish Council on Health Technology Assessment. Catheter ablation for atrial fibrillation
(update) (Structured abstract). Stockholm: Swedish Council on Technology Assessment in
Health Care (SBU) [serial on the Internet]. 2010: Available from:
http://www.sbu.se/en/Published/Alert/Catheter-Ablation-for-Atrial-Fibrillation/
Rodgers, M, McKenna, C et al (2008). 'Curative catheter ablation in atrial fibrillation and
typical atrial flutter: systematic review and economic evaluation'. Health Technology
Assessment, 12 (34), iii-iv, xi-xiii, 1-198.
Medical Advisory Secretariat Ontario Ministry of Health Long-Term Care (2006). Ablation
for atrial fibrillation: an evidence-based analysis (Structured abstract). [Internet]. Medical
Advisory Secretariat, Ontario Ministry of Health and Long-Term Care (MAS). Available
Atrial Fibrillation
33
89.
90.
91.
92.
93.
94.
95.
96.
97.
98.
from:
http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_af_03010
6.pdf
Ollendorf, DA, Silverstein, MD et al (2010). Final appraisal document rhthym control and
stroke prevention strategies for patients with atrial fibrillation, Institute for clinical and
economic review (ICER) Available from: http://www.icer-review.org/index.php/CompletedAppraisals/a-fib-appraisal-1209.html.
Anderson, N, Fuller, R & Dudley, N (2007). '‘Rules of thumb’or reflective practice?
Understanding senior physicians’ decision-making about anti-thrombotic usage in atrial
fibrillation'. Qjm, 100 (5), 263.
Edvardsson, N, Westlund, A et al (2010). 'Pharmacological Rhythm and Rate Control
Treatment for Atrial Fibrillation: Patient and Physician Satisfaction'. The Patient: PatientCentered Outcomes Research, 3 (1), 33-43.
Lip, GYH, Kamath, S et al (2002). 'Ethnic Differences in Patient Perceptions of Atrial
Fibrillation and Anticoagulation Therapy'. Stroke, 33 (1), 238-42.
Wolber, T, On, CJ et al (2010). 'Patient satisfaction and clinical outcome following
outpatient radiofrequency catheter ablation of supraventricular tachycardia'. Swiss Medical
Weekly, 140 (3-4), 52-6.
Auricchio, A, Kuck, K-H et al (2012). 'The EHRA White Book 2012'. The current status of
cardiac electrophysiology in ESC member countries.
Brugada, J, Vardas, P & Wolpert, C (2008). 'The EHRA White Book 2008'. The current
status of cardiac electrophysiology in ESC member countries.
Deering, TF, Clair, WK et al (2010). 'A Heart Rhythm Society Electrophysiology
Workforce study: current survey analysis of physician workforce trends'. Heart Rhythm, 7
(9), 1346-55.
Doughty, R. Personal Communication. 2011.
Bourke, B (2009). Home page of the Australasian Vascular Audit. Available from:
http://www.anzsvs.org.au/national-audit/
Atrial Fibrillation
34
Attachment 1
National Health Committee (NHC) and Executive
5
10
15
The National Health Committee (NHC) is an independent statutory body which provides
advice to the New Zealand Minister of Health. It was reformed in 2011 to establish
evaluation systems that would provide the New Zealand people and health sector with
greater value for the money invested in health. The NHC Executive are the secretariat that
supports the Committee. The NHC Executive’s primary objective is to provide the
Committee with sufficient information for them to prioritise interventions and make
investment and disinvestment decisions. They do this through a variety of products
including Prioritising Summaries, Technology Notes, EpiNotes, CostNotes, Rapid Reviews,
and Health Technology Assessments which are chosen according to the nature of the
decision required and time-frame within which decisions need to be made.
Citation: National Health Committee.2012. NHC Technology Note for Catheter Ablation for
the Treatment of Atrial Fibrillation
Published in September 2012 by the National Health Committee
PO Box 5013, Wellington, New Zealand
20
This document is available on the National Health Committee’s website:
http://www.nhc.health.govt.nz/
Disclaimer
25
The information provided in this report is intended to provide general information to
clinicians, health and disability service providers and the public, and is not intended to
address specific circumstances of any particular individual or entity. All reasonable
measures have been taken to ensure the quality and accuracy of the information provided.
If you find any information that you believe may be inaccurate, please email to
NHC_Info@nhc.govt.nz.
30
The National Health Committee is an independent committee established by the Minister of
Health. The information in this report is the work of the National Health Committee and does
not necessarily represent the views of the Ministry of Health.
35
The National Health Committee make no warranty, express or implied, nor assumes any
legal liability or responsibility for the accuracy, correctness, completeness or use of any
information provided. Nothing contained in this report shall be relied on as a promise or
representation by the New Zealand government or the National Health Committee.
The contents of this report should not be construed as legal or professional advice and
specific advice from qualified professional people should be sought before undertaking any
action following information in this report.
40
Any reference to any specific commercial product, process, or service by trade name,
trademark, manufacture, or otherwise does not constitute an endorsement or
recommendation by the New Zealand government or the National Health Committee.
Atrial Fibrillation
1