Sutureless Aortic Valve
Replacement –
Tier 3 Assessment
Sutureless Aortic Valve Replacement – Tier 3 Assessment
1
National Health Committee (NHC)
The National Health Committee (NHC) is an independent statutory body charged with prioritising new and
existing health technologies and making recommendations to the Minister of Health.
It was re-formed in 2011 to establish evaluation systems that would provide the New Zealand people and
the health sector with greater value for money invested in health.
The NHC executive is the secretariat that supports the committee. The NHC executive’s primary objective
is to provide the committee with sufficient information for it to make decisions regarding prioritisation and
reprioritisation of interventions and services. They do this through a range of evidence-based products
chosen according to the nature of the decision required and timeframe within which decisions need to be
made.
The New Zealand Government has asked that all new diagnostic and treatment (non-pharmaceutical)
services, and significant expansions of existing services, are to be referred to the NHC.
In August 2011 the NHC was appointed with new terms of reference and a mandate to establish the
capacity to assess new and existing health technologies. Its objectives (under Section 4.2 of its terms of
reference – www.nhc.health.govt.nz) include contributing to improved value for money and fiscal
sustainability in the health and disability sector by:
 providing timely advice and recommendations about relative cost-effectiveness based on the best
available evidence;
 providing advice and recommendations which influence the behaviour of decision-makers, including
clinicians and other health professionals;
 providing advice and recommendations which are reflected in resource allocation at national, regional
and local levels; and
 contributing to tangible reductions in the use of ineffective interventions and improved targeting to
those most likely to benefit.
In order to achieve its objectives under Section 4.2 and to achieve ‘value for money’, the NHC has
adopted a framework of four assessment domains – clinical safety and effectiveness; economic; societal
and ethical; and feasibility of adoption – in order that assessments cover the range of potential
considerations and that the recommendations made are reasonable.
It is intended that the research questions asked will fall across these domains to ensure that when the
committee comes to apply its decision-making criteria, it has a balanced range of information available to
it. When the NHC is setting those questions, they will have the decision-making criteria in mind.
The 11 decision-making criteria will assist in the determination of the NHC work programme and in the
appraisal and prioritisation of assessments.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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Executive summary
1. Aortic stenosis (AS) is a pathological narrowing of the aortic valve that obstructs blood flow out of
the heart. In adults, AS is most commonly caused by age-related calcification of the aortic valves,
although it can also be the result of a congenital heart defect or rheumatic heart disease.(1, 2)
Patients with asymptomatic AS mostly do not require treatment. For patients with severe
symptomatic AS, or severe AS with significant left ventricular dysfunction, aortic valve
replacement (AVR) is the standard of care.(2) In the absence of valve replacement, patients die on
average within two to three years of the emergence of symptoms.(3)
2. Sutureless AVR is a relatively new procedure which employs a bioprosthetic (tissue) valve
requiring no (or very few) sutures to stay in place. Sutureless valves stay in place using either a
self-expanding or balloon-expandable frame. By removing the need for sutures, operative and
cardiopulmonary bypass times may be reduced compared with conventional AVR. Reduced
operative time is particularly advantageous for patients requiring multiple procedures. Sutureless
AVR may be undertaken using conventional open heart surgery or minimally invasive techniques.
In New Zealand about 80 sutureless AVR procedures have been undertaken since 2011, all of
which have used open heart surgery.(4) Sutureless valves have now been approved for use in
Australia and Europe, but not yet in the United States outside clinical trials.
3. The current evidence base is limited. Randomised controlled trials with short follow-up time
suggest that sutureless AVR is safe with low incidence of complications and comparable mortality,
compared with conventional surgical AVR. This is supported by observational studies. Compared
with TAVI, sutureless AVR may have lower rates of paravalvular leak.
4. Current evidence suggests sutureless AVR may have similar cost-effectiveness to conventional
surgical AVR, with sutureless AVR having comparable outcomes and the possibility of lower
costs. The price differential between sutureless valves and conventional bioprosthetic valves is
small and declining. There is currently no evidence of additional procedural or downstream costs
associated with sutureless AVR compared with conventional surgical AVR, but there is some
evidence of potential savings from reduced hospital and ICU length of stay.(5-7) Sutureless AVR is
a substitute procedure for conventional surgical AVR in high-risk patients; as such it is not
expected to significantly expand the population pool receiving surgical AVR.
5. Given that the safety and efficacy of sutureless AVR seems comparable, varying access to
sutureless valves does not give cause for concern. However, this view may change as the
evidence for sutureless AVR evolves.
6. There may be between five and ten percent of AVR patients that could benefit from sutureless
AVR; potential beneficiaries of the procedure include patients with anatomical features that make
suturing difficult or risky such as a heavily calcified aortic annulus or a very small aortic root.
There are no workforce or infrastructure considerations identified that would impede the increase
Sutureless Aortic Valve Replacement – Tier 3 Assessment
3
use of sutureless AVR; although, like with all new treatments, appropriate training and oversight
would need to be put in place if the use of sutureless AVR increased.
7. Sutureless AVR should not replace conventional surgical AVR as the standard of care for severe
symptomatic AS. If clinicians would prefer to use sutureless valves, there seems to be sufficient
justification in them doing so; providing the sutureless valve is a similar price to conventional
bioprosthetic valves.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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Contents
Executive summary
3
1.
Introduction
6
2.
Background
7
3.
Clinical safety and effectiveness
12
4.
Economic
26
5.
Societal and ethical
31
6.
Feasibility of adoption
33
7.
Conclusion
35
Appendix 1: Methods
36
Appendix 2. Description of clinical trials of sutureless AVR
39
Appendix 3 Summary of clinical findings for sutureless AVR
45
8.
51
References
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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1. Introduction
The purpose of this report is to evaluate the latest evidence around sutureless aortic valve
replacement in order to assist the NHC in formulating recommendations regarding how the
diffusion of the technology into New Zealand clinical practice for treatment of aortic stenosis should
be best managed in terms of public funding and the target population.
The National Health Committee (NHC) prepared a brief Technology Note on sutureless aortic valve
replacement (AVR) in May 2012. At this time it was concluded that there was insufficient evidence
available for a full assessment to be made, and that sutureless AVR should be conducted only
under clinical trial conditions.
In March 2013, representatives from the Australian and New Zealand Society of Cardiac and
Thoracic Surgeons and the Waikato Cardiothoracic and Vascular Surgery Unit requested that the
NHC carry out further assessment of sutureless AVR. It was decided that further assessment of
sutureless AVR would be appropriate at this time, given that in the time since the previous NHC
report, additional clinical data had been published, NICE (National Institute for Health and Care
Excellence) had issued guidance,(8) and HealthPACT had assessed the procedure.(1, 9)
Our work on sutureless AVR has been developed in tandem with the NHC's transcatheter aortic
valve implantation (TAVI) assessment and fits within an overall assessment of the model of care
for aortic stenosis (AS). This paper reviews the evidence for sutureless AVR against the NHC's
four domains of assessment: clinical safety and effectiveness; societal and ethical; economic; and
feasibility of adoption.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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2. Background
Condition description
Aortic stenosis (AS) is a pathological narrowing of the aortic valve that obstructs blood flow out of
the heart. In adults, AS is most commonly caused by age-related calcification of the aortic valves,
although it can also be the result of a congenital heart defect or rheumatic heart disease.(1, 2). Agerelated calcification of the normal aortic valve typically presents in those aged ≥70 years. AS
usually presents as an asymptomatic disease and progresses slowly over many years. In the
absence of valve replacement, patients die on average within two to three years of emergence of
symptoms.(3)
Prevalence and incidence
In the absence of published data, the NHC used the New Zealand National Minimum Dataset
(NMDS)i to estimate the prevalence and incidence of hospital diagnosed AS. In 2012/13, the
prevalence of any hospital diagnoses of AS was 103 per 100,000 population or approximately
4,700 patients. Patients were recorded as having AS if they were still living in 20012/13 and had
received any hospital diagnosis of AS since 2005/06 but not an aortic valve replacement3. Detail
on our methodology is contained within National Health Committee Aortic Stenosis Overview Tier 2
(2015). Incidence was 36 cases per 100,000 population, counting any patient who received a new
hospital diagnosis of AS in 2012/13 not previously present.
Just over a third of all patients with a hospital diagnosis of AS in 2012/13 had AS recorded as a
primary diagnosis. A primary hospital diagnosis is assumed to represent a more severe and
symptomatic population as it is more likely to represent symptomatic admission rather than as a
secondary condition. The prevalence of a severe hospital diagnoses of AS is estimated at 38 per
100,000 population or approximately 1,703 patients. Of these patients, 23 were recorded as having
rheumatic AS. Incidence of AS was 19 cases per 100,000 population, ranging from one patient per
100,000 population for those aged under 50 to 145 per 100,000 population for those aged over 70.
There were 860 new cases of severe AS in 2012/13. As prevalence and incidence of AS are
greatest in older age groups, population ageing can be expected to increase the incidence of AS.
Mortality
In 2011 there were 295 deaths attributed to AS in New Zealand.(10) The age standardised mortality
rate was three per 100,000 population, with only four deaths recorded for Māori. Eighty-two
percent of all deaths occurred in patients aged over 80.
Current treatment
Patients with asymptomatic AS mostly do not require treatment. For patients with severe
symptomatic AS, or severe AS with significant left ventricular dysfunction, surgical aortic valve
replacement is the standard of care.(2) Surgical AVR can considerably improve patient survival and
quality of life. Long-term survival following surgical AVR is commonly reported as being close to
that observed in the general population of a similar age.(11) A single centre retrospective Swedish
study of 2,359 patients found a relative 15-year survival rate of 75% after surgical AVR compared
to that expected in the general Swedish population.(12) A systematic review of clinical studies found
health-related quality of life equivalent or superior for surgical AVR patients aged over 70
i
The NMDS records all publically funded inpatient events.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
7
compared with an age-matched general population. Follow-up time extended to five years in some
of the included studies. But significant heterogeneity among study designs, methods, and follow-up
times prohibited pooling of the results.(13)
AS mainly affects older people and for many patients, AVR will be futile due to frailty, significant
comorbidities, dementia or poor life expectancy. Where the risks from AVR outweigh the potential
benefits, patients are treated with palliative care. New Zealand and international studies estimate
that between a third and a half of all patients with severe symptomatic AS are considered ineligible
for surgical AVR.(14-16) For these patients, mortality rates are very high, with approximately half of
all patients dead within two years.(14)
Today there exist three major technologies for AVR: conventional surgical AVR, transcatheter
aortic valve implantation (TAVI), and sutureless AVR. Other treatment options, including
pharmaceutical treatment and balloon aortic valvuloplasty, have a very limited role in adults with
AS and are primarily used to control symptoms or as part of palliative care. Balloon aortic
valvuloplasty may occasionally be used as a bridge to surgical AVR or to test if AVR is likely to be
beneficial.
Conventional surgical AVR remains the primary avenue of treatment. Surgical care has traditionally
involved open heart surgery with a full sternotomy (separation of the sternum to allow access the
chest cavity) and requires the aortic valve to be sutured into place. TAVI is a potential alternative
treatment for patients who are at very high surgical risk or may otherwise be considered
inoperable.(17, 18) TAVI is a percutaneous intervention (delivered through a small incision in the skin)
that avoids major surgery and does not require cardiopulmonary bypass. TAVI requires specialised
catheterisation laboratory facilities and doesn’t allow the stenosed natural valve to be removed or
decalcification to be carried out. The role of this technology in the treatment of AS in New Zealand
is discussed in the NHC’s report: Transcatheter Aortic Valve Implantation: Assessment Report Tier
3 (2015).
Sutureless AVR is potentially less invasive than traditional open-heart surgical valve replacement
and, unlike TAVI, it allows the stenosed valve to be replaced and decalcification of the annulus to
be carried out. Sutureless valves allow the valves to stay in place without suturing by use of either
a self-expanding or balloon-expandable frame. By removing the need for sutures, operative and
cardiopulmonary bypass times may be reduced compared with conventional surgery. Sutureless
aortic valves may also facilitate minimally invasive procedures, through reducing operative time,
though comparative evidence is required to confirm this.(19) Internationally, sutureless AVR is often
undertaken using minimally invasive surgery.(19, 20) However, in New Zealand, sutureless AVR is
not currently undertaken using minimally invasive surgery.
Technology status
This report is limited to bioprosthetic sutureless aortic valves that have undergone clinical testing:
Perceval S (Sorin Group), 3f Enable (Medtronic) and Intuity (Edwards Lifesciences LLC). The
sutureless aortic valve Trilogy (Arbor) is not included because only one small clinical trial has been
reported,(21) and there is no evidence that the valve is being further developed. Bioprosthetic valves
are partly comprised of an animal heart valve or contain animal tissue. Sutureless mechanical
aortic valves (eg the Magovern-Cromie device) have been available since the 1960s,(22) but are no
longer widely in clinical use because of the technical difficulties of implantation and risk for
paravalvular leak and thromboembolic complications. These valves are not considered in this
report.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
8
The available sutureless aortic valves are described in Table 1. The bioprosthetic valves have
metallic frames that can be compressed to allow insertion through a smaller incision than
conventional surgery. Guiding sutures aid the correct positioning of the valve. When deployed (with
or without balloon expansion), the valve expands and anchors in the annulus.
Table 1. Overview of sutureless aortic valve devices(23-25)
Valve characteristics
Perceval S
3f Enable model 6000
Intuity
Appearance
Mounted on delivery system
Undeployed
Deployed
Deployed
Manufacturer
Sorin
(Saluggia, Italy)
Medtronic – devloped by ATS
Medical
(Minneapolis, USA)
Edwards Lifesciences
(California, USA)
Valve design
Trileaflet bovine pericardial valve
Three equal sections of
equine pericardial leaflets
interlocked in a tubular
structure. Polyester flange at
the inflow aspect.
Based on 3f Aortic
Bioprosthesis stentless valve
(model 1000).
Three independent, symmetrical
bovine pericardial
leaflets matched for thickness
and elasticity.
Based on Perimount valve.
Frame
Self-expanding nitinol frame with
two ring segments (outflow and
inflow rings)
Self-expanding Nitinol frame
Polyester cloth-covered
stainless steel frame with broad
sealing cuff
Positioning and deployment
Three guiding sutures aid correct
positioning, and are removed
after valve delivery
Valve is deployed with balloon
expansion
A single guiding suture aids
orientation, and is removed
after valve delivery
Thermal-controlled expansion
Three guiding sutures aid
correct positioning, and are
removed after valve delivery
Valve is deployed with balloon
expansion
Notification - NZ
NZ WAND database 2012
NZ WAND database 2012
NZ WAND database 2012
Registration - Europe
CE Mark Approval 2011
CE Mark Approval 2009
CE Mark Approval 2012
Registration – Australia
Austrlian Registry of Therapeutic
Goods (ARTG) number : 232485
(09/01/2015)
Avialable under TGA Special
Access Scheme
ARTG: 226932 (14/08/2014)
Registration – USA
Food and Drug Administration
(FDA) approval for
investigational use only 2013
FDA approval for
investigational use only was
pending.
FDA approval for investigational
use only 2012
Key trials
CAVALIER(26, 27)
Enable Multicentre European
Trial(28)
TRITON(29)
WAND = Web-Assisted Notification of Devices
Source: Shrestha 2013; Meuris 2010; Carrel 2013(23-25), Medsafe WAND database, ARTG database. Manufacturers
were contacted to confirm the regulatory status of their respective sutureless valves in January 2015.
There is currently no approval process for medical devices in New Zealand. For medical devices to
be legally supplied in New Zealand, however, they must be notified to Medsafe’s WAND database.
All three sutureless valves were notified on the database in 2012. All three sutureless valves have
Sutureless Aortic Valve Replacement – Tier 3 Assessment
9
been approved for use in Europe; where the CE (European Conformity) Mark indicates that the
product complies with the essential requirements of the relevant European health, safety and
environmental protection legislation and can be legally marketed. In Australia, the Intuity and
Perceval S valves have been approved for use by the Therapeutics Goods Administration, while
the 3f Enable valve is available only under a Special Access Scheme for clinical trials or by an
authorised prescriber. Medtronic announced the discontinuation of its Sutureless valve in May
2015, discussed below.(30) In the United States no sutureless valve has been approved for routine
use, but the Intuity and Perceval valves are approved for investigational purposes, meaning the
valves can be used in clinical trials.
Sorin Group advertises that more than 12,000 patients have received a Perceval S sutureless
valve replacement worldwide since 2007.ii
Use in New Zealand
Sutureless AVR, using conventional open heart surgery, have been undertaken in Waikato,
Canterbury and Auckland DHBs, and is provided privately in one institution (St George’s Hospital
Christchurch). Minimally invasive sutureless AVR has not been undertaken in New Zealand.
Canterbury and Waikato DHBs have, however, expressed interest in the minimally invasive
approach.
The current status of sutureless AVR is summarised in Table 2. Volumes remain very low, with just
19 publicly funded sutureless AVRs undertaken in 2013/14. Twelve of these operations were
funded by Canterbury DHB and five were funded by Auckland DHB. Canterbury DHB has been the
largest funder of sutureless AVR nationally with 66 operations between August 2011 and
September 2014.(31)
Sutureless valves have declined significantly in price over the past four years as a result of
competition. When the NHC first assessed sutureless AVR in 2012, the valve was nearly twice the
price it is today. A sutureless valve purchased by Auckland DHB is now roughly the same cost as a
regular tissue valve purchased by Canterbury DHB. However, whilst the Sorin Perceval S valve
and Medtronic 3f Enable model 6000 valve have become price competitive, the Edwards
Lifesciences Intuity valve is reportedly about twice the price of its competitors; with no head-tohead trials available to justify the premium.(32) However, Medtronic announced its intention to
discontinue production of the Medtronic 3f Enable valve in May 2015. There remains variation in
price of sutureless valves across the country, which indicates there could be savings. The savings
could be obtained from all the DHBs receiving the lowest cost, the lowest costs could be obtained
through DHB sharing pricing information or from national collective purchasing.
ii
Sorin Company marketing forwarded to National Health Committee, 20/08/2015, title: Sorin Cardiac Surgery Perceval
Sutureless Valve”.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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Table 2: Sutureless aortic valve status in New Zealand
DHB
Valve type
Volume
Cost per
(2013/14
valve
(2014)
Sutureless
5
$5,500
Auckland
Canterbury
Sutureless
Waikato
Surgical tissue
Surgical
mechanical
Sutureless
Capital and
coast
Southern
New Zealand
(2013/14)
14
$6,500
Change in cost
Minimally invasive sutureless AVR
Not currently used and would require
Clinical Practice Committee agreement
Sorin Valve:
$15,000(2011)
$9,900 (2012)
$6,500 (2014)
Price equivalent
to Medtronic
Valve
Not currently used but interest expressed
in the approach
$5,700
$4,800
2 (2012/13)
$18,000 (2011)
$9,900 (2013)
Do not use Sutureless and have no plans to use them
Expressed interest in minimally invasive
SU-AVR
No record of Sutureless use
Sutureless
19
Source: Information collected by NHC from DHBs, the NMDS, and valve manufacturers. It is difficult to get exact volumes
as there is currently no specific ICD-10 procedure code for sutureless AVR and the type of device is recorded only in free
text fields within the NMDS. Hence the NHC had DHBs confirm or amend records as a check.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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3. Clinical safety and effectiveness
Sutureless AVR was developed principally for high-risk surgical patients that may be under-served
by conventional AVR through enabling less invasive and more rapid surgery.(4) The current
evidence base is limited. Randomised controlled trials with short follow-up time suggest that
sutureless AVR is safe with low incidence of complications and comparable mortality, compared
with conventional AVR. This is supported by observational studies with a control group. Results of
observational studies without a control group are broadly reflective of comparative studies
regarding complications and mortality.
Whilst several hundred studies of sutureless AVR have been published, many are earlier reports of
the same studies, or subgroups of larger studies. More than 1,000 patients have been treated
within observational studies but nearly all these studies are small single arm observational trials.
There have been just two small randomised controlled clinical trials of a sutureless aortic valve.(33,
34)
Only four comparative studies have reported patient outcomes for 12 months or longer.(6, 35-37)
The methods for the literature search upon which this section is based is contained in Appendix 1.
In comparative studies of sutureless AVR to date, patients receiving a sutureless valve have most
often undergone minimally invasive surgery; whereas patients receiving a conventional valve have
most often undergone open heart surgery. This makes it difficult to distinguish the direct effect of
the sutureless valve from the effect of minimally invasive surgery.
Randomised controlled trials of sutureless AVR
Two randomised controlled trials (RCTs) have compared sutureless AVR with conventional AVR.
The results are limited to very short follow-up times, ie up to a month. Both studies report
comparable outcomes between treatment groups. The RCTs are further summarised below.
CADENCE-MIS randomised controlled trial
The CADENCE-MIS randomised controlled trial compared Edwards Lifesciences Intuity sutureless
valve performed with the minimally invasive technique (MIS-RDAVR, 46 patients analysed) with
conventional AVR performed with full sternotomy (FS AVR, 48 patients analysed). Baseline
characteristics were similar between groups, where patients had low preoperative risk; mean STS
scores were 1.6% and 1.7% in the sutureless and surgical AVR groups, respectively.(38)
Sutureless AVR was associated with reduced aortic cross-clamp times compared with
conventional AVR, 41.3 minutes compared with 54.0 minutes (p < 0.001). There were no
statistically significant or clinically significant differences in cardiopulmonary bypass time, operative
time or implanted valve size (Table 3).
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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Table 3: Procedural outcomes of CADENCE-MIS randomised controlled trial
Source Borger et al 2015
Early clinical outcomes were similar between the two groups. Early mortality was 4.3% (2 deaths)
for sutureless AVR, compared with 2.1% (1 death) for conventional AVR; this difference was not
statistically significant (p=0.5) (Table 4). The initial abstract for the study reported mortality on an
intention to treat basis, where the corresponding 30-day mortality rates were 6.1% vs 2.1%,
p=0.32, for sutureless AVR and conventional surgical AVR, respectively.(33) In the final analysis the
authors excluded three patients because of difficulty seating the valve from coronary anatomy; one
of these patients died.
Table 4 Early (<30 day) clinical outcomes of CADENCE-MIS randomised controlled trial
Source Borger et al 2015
The sutureless group had better postoperative hemodynamic function with sutureless AVR patients
having a significantly lower transvalvular gradient of 8.5 vs 10.3 mm Hg (p = 0.044). There was no
report of paravalvular leak in either arm and quality of life was relatively unchanged at three
months compared with baseline for both groups.
Small German RCT including sutureless AVR
A small randomised controlled trial of 54 elderly (>75 years) high surgical risk patients with
symptomatic AS and EuroSCORE >10 were randomly assigned to three treatment groups:
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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standard AVR using a Sorin flow bioprosthesis (n= 19), sutureless AVR using Medtronic 3f Enable
(Enable group, n= 18), and transapical aortic valve implantation using the Edwards Sapien valve
(TAVI group, n=17).(34) The groups were comparable regarding age, gender, EuroSCORE, and
transvalvular gradient. Few details are available on patient characteristics or methodology as only
an abstract was available.
Early outcomes were reported to be comparable between groups. The study reported CPB time
and aortic cross-clamp time were reduced by 15 minutes for sutureless AVR, compared with
conventional AVR. Mortality rates were not reported. There was no difference in ICU or hospital
length of stay between groups.
Observational studies of sutureless AVR with a control group
Four observational studies of sutureless AVR with a retrospective control group were identified that
reported clinical outcomes for 12 months or longer.(6, 35-37) Of these studies, three compared
propensity matched patient groups to reduce the risk of selection bias.(6, 35, 37) Propensity score
matching is a statistical technique that attempts to control for observed or unobserved confounding
factors, such as preoperative risk, that may affect the outcomes of a treatment. These four studies
inform the mortality and hospital length of stay sections below. Further comparative studies were
identified that have shorter follow-up times. Some of these studies compare sutureless AVR to
conventional AVR and are used to inform comparisons of cross-clamp time, cardiopulmonary
bypass time, haemodynamic outcomes, and complications.
The characteristics of the patients included in the comparative trials are shown in Table 11,
Appendix 2. Patients in the trials had severe AS; most reports did not clearly state whether patients
were symptomatic. Most patients had a moderate to high surgical risk based on log-EuroSCORE
(European System for Cardiac Operative Risk Evaluation). Two studies focused on patients with
low to moderate surgical risk (5, 35) (mean Logistic EuroSCORE <10). The average age of patients
was greater than 70 years in all studies, and greater than 80 years among sutureless AVR
recipients in two studies. A detailed summary of procedural outcomes from comparative studies is
contained in Appendix 3; the main findings are summarised below.
Mortality
Broadly comparative studies with follow-up of 12 months or more found no increased risk of death
from sutureless AVR in moderate to high-risk patients compared with conventional surgery at 30
days or up to 12 months (Table 5).
Comparative studies with shorter term follow-up are contained in Table 13, Appendix 3. These
studies report no statistically significant difference in 30-day mortality: for minimally invasive
sutureless AVR compared with minimally invasive AVR with a conventional valve (4% vs 6%
respectively);(5) and for sutureless AVR compared with TAVI (0% vs 1% respectively).(39) Across all
comparative studies the average 30-day, or within hospital, mortality rate is about 3% for
sutureless AVR. This is comparable with conventional surgical AVR. (40)
There is very limited longer-term data. Mortality rates at three years were similar for sutureless
AVR and standard surgical AVR in Shrestha et al (39% v.s 34% respectively).(36) The study
comprised patients in both arms with small aortic roots, an anatomical feature associated with high
operative risk. Mortality at 20 months was better for minimally invasive sutureless AVR compared
with minimally invasive conventional AVR in Gilanov et al, but the result was not statistically
significant (9% v.s 4% respectively, p = 0.33).(35) Compared with TAVI, Santarpino et al reported
significantly lower mortality at 19 months for sutureless (2.7% v.s 13.5%, p=0.015). (37) The
difference in mortality was attributed to paravalvular leak, where 25% of TAVI patients experienced
Sutureless Aortic Valve Replacement – Tier 3 Assessment
14
paravalvular leak but sutureless patients did not. When comparing survival in the absence of
paravalvular leak, no statistically significant difference in mortality was observed (2.7% vs 0%).
Hospital length of stay
Four comparative studies reported on hospital and intensive care (ICU) length of stay. Two of
these studies report statistically significant reductions in length of stay; none report increased
length of stay for sutureless AVR (Table 5). Pollari et al found a statistically significant reduction in
ICU and hospital length of stay for sutureless AVR compared with conventional AVR.(6) ICU length
of stay was reduced by 0.8 days (2.0 vs 2.8 days, p<0.001) and hospital length of stay was
reduced by 1.5 days (10.9 vs 12.4 days, p=0.001). Santarpino et al found a statistically significant
reduction in ICU length of stay of 0.9 days for patients undergoing sutureless AVR compared with
standard surgical AVR (1.9 vs. 2.8 days, p=0.002).(5) They also reported a small reduction in
hospital length of stay but the result was not statistically significant (10.5 vs. 10.9 days, p=0.3).
Gilmanov et al found no difference in hospital or ICU length of stay for sutureless AVR compared
with standard AVR. (35) Preoperative risk in both studies (Gilmanov et al and Santarpino et al) was
low to moderate (mean logistic EuroSCORE <10). Arguably there was less potential in these
studies for a length of stay reduction compared with studies with high risk patients, as lower risk
patients tend to have a lower length of stay.(41) Shrestha et al reported a 1.8 day reduction in
hospital length of stay for sutureless AVR compared with standard AVR, but the result was not
statistically significant.(36) It is possible that time in ICU and overall hospital stay will reduce once
clinicians are more confident with the outcomes of sutureless procedures; stakeholders have
reported that this is the case for TAVI in New Zealand.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
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Table 5: Primary outcomes from four observational studies with a control group with at least 12 months followup
Author
Gilmanov et al
(2014)(35)
Pollari et al
(2014)(6)
Santarpino et al
(2013)(37)
Shrestha et al
(2013)(36)
Device
(no.
patients)
Logistic
euroSCOR
E%
Perceval
S (n =
133)
5.46 (3.53–
8.17)
Standard
AVR
(n = 133)
5.83 (3.74–
8.77)
Perceval
S
(n = 82)
12.1 ± 4.9
Standard
AVR
(n = 82)
10.9 ± 4.2
Perceval
S
(n = 37)
18.1 ±1.9
TAVI
(n = 37)
20.6 ± 2.2
Perceval
S (n =
50)
20.4 ± 10.7
Standard
AVR
(n = 70)
16.7 ± 10.4
Propensity
matched
method
36 risk
factors
matched
14 risk
factors
matched
13 risk
factors
matched
No
matching
%
minimally
invasive
All-cause mortality (n; %)
Length of stay
(mean/ median
days)
In-hospital
or 30-day
1-year
ICU
Hospital
100%
1 (0.8%)
Median 10mo:
4%
1
6
0%
2 (1.5%)
5%
1
6
51%
2 (2.4%)
Median 13mo:
2.5%
2.0*
10.9*
40%
3 (3.7%)
3.8%
2.8
12.4
60%
0
Mean 19mo:
2.7%*
NR
NR
3 (8.1%)
Mean 19mo:
13.5%*
NR
NR
72%
0
5
(13%)
1.8
14.1
4.3%
3
(4.3%)
10
(16%)
2.0
15.9
* Significant to the 95% confidence level
Cross-clamp and cardiopulmonary bypass time
Sutureless AVR was reported to have lower cross-clamp times between 12 and 32 minutes.(5, 6, 35,
36)
Sutureless AVR was reported to have lower cardiopulmonary bypass times between 16 and 30
minutes.
Haemodynamic outcomes
Non-statistically significant differences were reported in haemodynamic outcomes, in four studies
that compared sutureless AVR and conventional AVR. Three of the four studies reported a
reduction in mean transvalvular gradient (5, 35, 39), the other study reported an increase(36)
Sutureless Aortic Valve Replacement – Tier 3 Assessment
16
Complications
Sutureless AVR was not associated with a higher rate of complications compared with
conventional surgical AVR in comparative trials, with the possible exception of paravalvular leak.
The severity of paravalvular leak was graded in a variety of ways in the comparative studies,
making it difficult to interpret the data. In D’Onofrio et al’s propensity matched study postoperative
aortic regurgitation (mild grade 1 or greater) was 19.4% in sutureless AVR compared with 1.8% in
conventional AVR (statistical significance not reported).(39) Shrestha et al’s non-propensity matched
study recorded mild (grade 1) perioperative paravalvular leak in 2.5% of conventional AVR patients
and 8.2% of sutureless patients, though the difference was not statistically significant.(36)
Santarpino et al’s propensity matched study reported no post-operative cases of paravalvular leak
in sutureless AVR compared with 13.5% (grade 1+) in TAVI patients (p=0.027). (37)
Regulatory warning for the 3f Enable aortic valve
Medsafe and the Australian Therapeutic Goods Administration released a warning for the 3f
Enable Aortic Bioprosthesis (model 6000) in late 2014, noting that there is the potential for the
valve to move after implantation, including partial or complete displacement or tilting from its
original implant location.(42, 43) The likelihood of this problem occurring is rare, with an occurrence
rate of less than 0.55% globally (as of 31 October 2014). Medtronic subsequently announced in
May 2015 the discontinuation of the 3f Enable Aortic Bioprosthesis due to lack of commercial
adoption, ceasing enrolment of all patients in all clinical studies. (30)
Meta analysis of observational studies
A recent meta analysis identified 12 studies that assessed AVR using a sutureless valve and
reporting mortality and complications.iii (19) The studies were predominantly single arm studies, also
included were studies comparing sutureless AVR to TAVI and one study comparing two different
sutureless valves. Pooled 30-day and 1-year mortality rates were 2.1%, and 4.9% respectively.(19)
The mean log EuroSCORE was 11.7 indicating moderate preoperative surgical risk. The total
patient population was 1,037 with a mean age of 77 years. The mortality rates were described by
the authors as low and acceptable, and similar to other recently reported rates for standard
surgical AVR.
The authors concluded that the evidence suggests sutureless AVR is a safe procedure associated
with shorter cross-clamp and cardiopulmonary bypass (CPB) duration, and comparable
complication rates to the conventional approach in the short-term.
Table 6 summarises key outcomes from the meta analysis. Mean postoperative paravalvular leak
rate was 3%, less than reported in earlier reports, suggesting a possible learning curve
improvement. The mean rate of stroke, with up to one year of follow-up, was 1.5%, comparable
with conventional surgical AVR (44). The mean rate of permanent pacemaker implantation was
5.6%, greater than for conventional AVR (around 3%).(19)
iii
Studies were included to January 2014 but excluded abstracts and conference presentations, case reports, editorials,
reviews and expert opinion papers were excluded.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
17
Table 6. Summary of outcomes from meta analysis
No. of trials
12
No. of patients
1,037
Outcomes (weighted mean - incidence of complication at latest available follow-up)
30-day mortality
2.1%
1-year mortality
4.9%
Paravalvular leak
3.0%
Stroke
1.5%
Permanent new pacemaker
5.6%
Valve degeneration/dislocation
0.4%
Renal failure
1.2%
Endocarditis
2.2%
Source: Phan et al.(19)
Included trials: Gilmanov et al. 2013(45); Kocher et al. 2013(29); Martens et al. 2011(28); Eichstaedt et al. 2013(46); :
Folliguet et al. 2012(27); Shrestha et al. 2013(36); D’Onofrio et al. 2012(47); Breitenbach et al. 2010(21); Flameng et al.
2011(48); Santarpino et al. 2014(37); Doss et al. 2005(49); Concistre et al. 2013(50)
The meta analysis found a mean CPB of 73 minutes and aortic cross-clamp time of 45 minutes.
These times were even shorter for isolated minimally invasive sutureless AVR procedures, with
CPB and cross-clamp time being 57 and 33 minutes respectively. The authors of the meta analysis
note that this data compares favourably with recent data for isolated conventional AVR with full
sternotomy from the STS database showing CPB and cross-clamp times of 106 and 78 minutes,
respectively.(19) This is suggestive of a halving of CPB and cross-clamp time with sutureless AVR
compared with standard full sternotomy.(19)
Efficacy in terms of haemodynamics was demonstrated in the sutureless AVR trials, with the mean
and peak transvalvular gradients (indication of aortic stenosis) decreasing from 11.1 and 19.6,
respectively, at discharge, to 9−10 and 17−18mmHg, respectively, at 6 and 12 months. Mean
effective orifice area (measure of valve quality) was maintained at 1.7−1.8 cm from discharge to 1
year. (19)
Facilitation of minimally invasive surgery
The authors conclude that sutureless AVR appears to facilitate minimally invasive surgery. This is
apparently due to the sutureless valve making minimally invasive surgery (which is technically
challenging) easier and reducing cross-clamp, CPB and operative duration.(51) Minimally invasive
aortic valve surgery involves smaller incisions allowing patients to recover more rapidly, and is
associated with reduced hospital and intensive care length of stay without elevated risk of death.(5256)
The Canadian Agency for Drugs and Technologies in Health note, however, that the use of
minimally approaches increases technical difficulty, leading to longer CPB and cross-clamp times,
potentially offsetting one of the main advantages of sutureless AVR over surgical AVR. (57) In
support, they cite a pooled analysis of 731 consecutive patients who underwent sutureless AVR
using the Perceval S valve in Europe between 2007 and 2012. (58) The study found that cross-
Sutureless Aortic Valve Replacement – Tier 3 Assessment
18
clamp and cardiopulmonary bypass times were greater using the minimally invasive sutureless
AVR compared with sutureless AVR with conventional full sternotomy. In isolated AVR, mean
cross-clamp and cardiopulmonary bypass times were 30.8 and 50.8 minutes in full sternotomy, and
37.6 and 64.4 minutes in the minimally invasive approach, respectively. What the study shows is
not that sutureless valves cannot simplify minimally invasive surgery, but that a comparative study
is needed to test the value of sutureless valves compared with conventional valves in minimally
invasive surgery.
Limitations
Reported statistical heterogeneity was moderate to high in the meta analysis of one-year mortality
(I2=59%), stroke (I2=43%), endocarditis (I2=58%), and paravalvular leak (I2=72%). This indicates
that the combined studies had significant underlying clinical diversity in their populations,
interventions, and outcomes and/or methodological diversity with variation in the intervention
effects being evaluated.(59) Studies included in the meta analyses mixed comparative and single
arm trials; mixed minimally invasive and conventional surgical sutureless AVR; and used different
sutureless valves. All studies included in the meta analysis were observational; ten were
prospective and two retrospective. Two studies included propensity matching. The number of
patients was more than 50 in only seven of the 12 studies, and follow-up was 12 months or more in
only five studies.
The strength of observational studies is in determining incidence, prevalence, and prognosis of a
condition. When studying the effect of an intervention, an association may be found between
intervention and effect because there actually is a causal link, or due to bias, confounding, or
chance. Study results are more reliable if the study is designed to minimise or eliminate the effects
of bias, confounding and chance. Observational studies ‘observe’ differences in outcomes, but do
not address bias, confounding, and chance. There can be more confidence in the findings of
studies designed to identify unbiased causal associations between exposure and outcome; that is,
they are more reliable. Randomised controlled trials (RCTs) are considered the best way of proving
causality. However, observational studies are frequently the best or only available evidence. When
this is the case they need to be evaluated for quality and their findings interpreted with caution.(60,
61)
New Zealand data
New Zealand data have been reported for the first 68 patients who underwent sutureless AVR
(91% with the Perceval sutureless valve) between 2011 and 2014 in Canterbury.(31) At the time of
writing, the results have not been published and limited information is available to report. Ninetyone percent of patients had a diagnosis of AS. The mean follow-up duration was four months
(range: 0-31months), and the median age was 78 years.
Thirty-day mortality was 6.1 percent, for a patient population with a predicated operative mortality
(logistic EuroSCORE) risk of 13.1 percent. Mean hospital stay was eight days (range: 4-45 days).
Mean aortic gradient improved from 45.4 mmHg to 12.3 mmHg postoperatively. Complications
included: neurological events in 9.0% of patients, including stroke in three patients, bleeding/
tamponade, acute renal failure, leg ischaemia, prolonged ICU stay, deep vein thrombosis, and
pneumonia in one patient each respectively. No patients developed a paravalvular leak. The study
did not address durability of performance.
The study compared isolated sutureless and isolated conventional AVR surgery, ie not including
concomitant procedures, for aortic cross-clamp time and cardiopulmonary bypass time. Baseline
Sutureless Aortic Valve Replacement – Tier 3 Assessment
19
characteristics have not yet been reported, making the comparison tenuous. Nevertheless, cross
clamp time and cardiopulmonary bypass time were lower in the sutureless group compared with
the conventional AVR group, at 55 vs 110 minutes and 38 vs 78 minutes for sutureless and
conventional surgery, respectively.
Observational studies without a control group
The observational studies without a control group include data for more than 1,000 patients in total.
However, it is likely that some patient groups have been reported more than once and have been
included in both comparative and non-comparative analyses (see Table 12 and Table 14,
Appendix 2). Observational studies without a control group have some value in demonstrating the
feasibility and safety of an intervention; but have limited value in demonstrating the marginal value
of a new intervention compared with standard care.
Mortality
The overall average early mortality rates (in-hospital or within 30 days) was 3% (Table 14,
Appendix 3,), with mean follow-up periods of eight months to one year, mortality rates were 5% to
13%.(26-29, 45, 46, 62, 63) A pooled analysis of 731 consecutive patients who underwent sutureless AVR
in 25 European centres using the Perceval S valve between 2007 and 2012, reported overall
survival rates at one and five years of 92.1 and 74.7%, respectively.(58) The mean age of patients
was 78.5 years, with moderate preoperative risk (mean logistic EuroSCORE 10.9%).
Complications
Consistent with the comparative studies discussed above, overall complications appear relatively
low. Folliguet et al (n=208) found a relatively high rate of paravalvular leak and bleeding
complications requiring blood transfusion in moderate to high risk patients at 8% and 6%
respectively.(27) Paravalvular leak was 3% or less in seven other studies.(26, 28, 29, 45, 46, 62, 63)
Gilmanov et al (n=137) found 5% of patients had bleeding complications requiring revision
surgery(45), and Eichstaedt et al (n=120) reported bleeding complications in 3% of patients(46);
bleeding complications were 2% or less in two further studies. (26, 29) In the aforementioned pooled
analysis of 731 Perceval S patient’s - major paravalvular leak occurred in 1.4% and 1% at early
and late follow-up, respectively.(58) There were no valve migrations, structural valve degeneration
or valve thrombosis in the follow-up to five years.
Sutureless AVR versus TAVI
Sutureless AVR has been positioned in what some researchers have termed the ‘grey zone’ –
essentially asserting sutureless AVR as an alternative to TAVI in moderate to high-risk but
operable patients. (37, 39, 47, 64, 65) TAVI is discussed in detail in our Tier 3 Assessment report on the
technology: Transcatheter Aortic Valve Implantation: Assessment Report Tier 3 2015. Briefly, in
one randomised controlled trial, TAVI demonstrated non-inferiority (regarding all-cause mortality) to
surgical AVR in high-risk patients with five years of follow-up;(66) in another RCT with two years of
follow-up TAVI was superior.(67) For sutureless AVR, just one small RCT has reported non-inferior
all-cause mortality compared with surgical AVR at 30 days in low-risk patients (discussed
above).(33) Although sutureless AVR is a surgical procedure, just with a modified bioprosthetic
valve, non-inferiority between TAVI and sutureless AVR cannot be inferred as the study
populations of the TAVI and sutureless RCTs are different. There has been no RCT for sutureless
AVR compared with surgical AVR in high-risk patients. No RCTs have compared TAVI with
sutureless AVR, and none are known to be in the pipeline. Accordingly, we discuss below the
observational data comparing TAVI with sutureless AVR. Overall, sutureless has similar clinical
Sutureless Aortic Valve Replacement – Tier 3 Assessment
20
outcomes to TAVI, but may be associated with lower rates of paravalvular leak, consistent with the
randomised controlled trials showing higher rates of paravalvular leak in TAVI compared with
conventional surgical AVR. (67-69)
Biancari et al propensity matched 144 pairs of TAVI and sutureless AVR patients using the
Perceval S prosthesis.(65) Matched patients had low to moderate preoperative risk with mean
EuroSCORE II < 5% in both groups. For matched pairs, in-hospital mortality was greater for TAVI
patients compared with sutureless AVR (6.9% vs 1.4%, p=0.035). Moderate or severe paravalvular
leak was evident in 14.8% of TAVI patients and 0.7% of sutureless AVR patients, p<0.001. TAVI
access was performed mostly using the transfemoral approach (97.7%), and using the Medtronic
CoreValve (72.6%). Fifty-four percent of sutureless AVR cases underwent minimally invasive
surgery. In the propensity matched groups 26.4% of sutureless patients underwent concomitant
coronary artery bypass surgery; while just one patient (0.7%) in the TAVI group underwent
concomitant percutaneous coronary intervention. Concomitant coronary artery bypass surgery is a
known operative mortality risk factor.(70) Hence in this observational study short-term survival
appears to be favourable in the sutureless group.
D’Onofrio et al (2013) undertook a propensity matched study comparing transapical TAVI with
sutureless AVR and conventional surgery. (39) Patients were matched across ten variables
including heart failure class (New York Heart Association Class ≥3) and preoperative risk (logistic
EuroSCORE). TAVI patients remained slightly older post-matching compared with open heart
surgery (conventional and sutureless) (mean 77.6 vs 73.5, p=0.003). All other baseline
characteristics were similar, with mean logistic EuroSCOREs of 18.3% and 20.2%, p=0.22, for
open heart surgery and TAVI, respectively. Post-matching baseline characteristics of the
sutureless group were not individually reported. Post-matching groups comprised 143 TAVI
patients, 31 sutureless AVR patients and 112 conventional surgical AVR patients. 30 day mortality
was lower for conventional AVR compared with TAVI (7% vs 1.8%, p=0.26), but no significant
difference in mortality was observed between sutureless and TAVI (1.8% vs 0%, p=0.21). Lower
rates of postoperative aortic regurgitation, pacemaker implantation, and renal replacement therapy
were observed in the sutureless group compared with the TAVI group, but did not reach statistical
significance. Postoperative aortic regurgitation (mild or greater) was 28.7%, 19.4% and 1.8% in the
TAVI, sutureless and conventional AVR groups, respectively. For TAVI versus conventional
surgical AVR the difference was significant, p<0.001.
In an earlier analysis D’Onofrio et al (2012) propensity matched 38 pairs of sutureless AVR and
TAVI patients, and reported hospital mortality of 5.3% and 0% in TAVI and sutureless groups,
respectively ( p=0.49). (47) Patients were moderate risk, with a mean logistic EuroSCORE of 14.8%
and 13.7 % in the TAVI and sutureless AVR groups, respectively (p=0.47). Again TAVI was
performed using the transapical approach.
Santarpino et al propensity matched 37 pairs of sutureless AVR and TAVI patients, reporting inhospital mortality of 0% and 8.1% in the sutureless and TAVI groups, respectively (p=0.24). (37)
Patients were moderate to high-risk with a mean logistic EuroSCORE of 18.1% and 20.6% in the
sutureless and TAVI groups, respectively (p=0.81). Pre-hospital discharge paravalvular leak (at
least mild) was higher in the TAVI group (13.5% vs 0%, p=0.027). Results are difficult to interpret
as the TAVI arm comprised a mix of approaches, (transapical and transfemoral) while some
sutureless patients also underwent concomitant heart surgery.
Muneretto et al compared TAVI (n=55), conventional surgery (n=55) and sutureless AVR (n=53) in
a prospective non-propensity matched observational study.(64) Baseline characteristics showed
patient groups had similar preoperative (moderate STS ≤6%) risk, but chronic obstructive
pulmonary disease was more frequent in TAVI patients (47%) compared with sutureless AVR
Sutureless Aortic Valve Replacement – Tier 3 Assessment
21
(15.1%) and surgical AVR (27.2%); while pulmonary hypertension was lower in the TAVI group
compared with the other groups. The study compared transfemoral TAVI with a mix of minimally
invasive or conventional surgery (using either standard or sutureless valves). Post -procedure
pacemaker implantation using the Medtronic CoreValve was high (25.5%) compared with
conventional surgery (1.8%) and sutureless AVR (2%). The TAVI result is consistent with high
rates of pacemaker implantation observed in randomised controlled trial for the Corevalve.(71)
Peripheral vascular complications were more frequent in the TAVI group (14.5% vs 0%, 0%), as
would be expected from a percutaneous procedure which enters through the groin rather than the
chest. All-cause mortality was similar between groups at 24 months, being 14.5%, 9.4% and
12.7% in the conventional AVR, sutureless AVR, and TAVI groups, respectively, p=0.46.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
22
Health technology assessments of sutureless AVR
HealthPACT has reviewed sutureless AVR in patients with severe AS in 2014. (9) They concluded
‘Short-term results are comparable to standard aortic valve replacement and benefits of using
these valves may include a shorter duration of surgery, however appropriate patient selection is
important. It would be prudent to await the results of a number of trials currently underway,
therefore HealthPACT recommends that this technology be monitored for further information in 24months’.
The National Institute for Health and Care Excellence (NICE) reviewed sutureless AVR in 2013,
finding evidence of limited quality supporting the efficacy of sutureless AVR for AS in the shortterm.(8) The evidence on safety was not considered to raise any major concerns apart from
paravalvular leak and central leaks. NICE supports sutureless AVR in high-risk surgical AVR
patients with special arrangements for clinical governance, consent and data collection. Clinicians
are to ensure patients understand the uncertainty around the intervention's safety and efficacy, and
communicate the alternative options to patients. Sutureless AVR was not supported for non-highrisk surgical patients outside the context of research.
The Canadian Agency for Drugs and Technologies in Health reviewed sutureless valves for the
treatment of aortic stenosis in 2015. They noted that:

Initial evidence suggested sutureless had comparable outcomes to surgical AVR, but
results in higher rates of paravalvular leakage and pacemaker implantation.

Sutureless AVR has lower rates of paravalvular leakage and pacemaker implantation than
TAVI.

There was potential savings due to lower procedure costs compared with surgical AVR,
citing a small McGill University study discussed below.

It is unclear which patients are the best candidates for sutureless valves, or if any
sutureless valve type was superior.(57)
Sutureless Aortic Valve Replacement – Tier 3 Assessment
23
Current and future trials
The Australian and New Zealand Clinical Trials Registry, and United States Institute of Health’s
clinical trial registry, ClinicalTrials.gov, were utilised to identify ongoing and planned trials relating
to sutureless AVR. Two small randomised trials are underway looking at the short-term efficacy of
minimally invasive surgery, with or without a sutureless valve, compared with conventional surgical
AVR. The trials are run by the same Swedish research team based in a single centre (Table 7).
The largest ongoing trial is the CAVALIER trial, with estimated enrolment of 658 patients. Its
primary completion date (final data for collection of primary outcome measure) was October 2014,
but the trial is ongoing with an estimated completion date of September 2018. The trial is for the
Sorin Perceval S valve as are the other two large single arm observational studies, all sponsored
by Sorin – the Perceval Pivotal Trial and the Perceval S Aortic Heart Valve Study – North North
America. Compared with TAVI, where there are more than 100 trials underway, including 24 RCTs,
there is relatively little ongoing research for the sutureless valve. Adding to this is Medtronic’s
recent exit from the market, stopping enrolment of new patients in all clinical studies, including:

3f Enable long-term follow-up study

3f Enable EASE post-market study.
Countering this, the International Valvular Surgery Study Group (IVSSG) was recently formulated
representing a global collaboration of 30 valvular surgeons from ten countries.iv The collaboration
aims to conduct sutureless research projects, with a particular aim to establish a multi-national
sutureless AVR registry to collect long-term outcomes data. New Zealand is not currently a
member of the collaboration, though two centres contribute from Australia. The IVSSG appears to
be actively looking for participants.
iv
http://suturelessprojects.com/
Sutureless Aortic Valve Replacement – Tier 3 Assessment
24
Table 7: Current and planned trials
Study
Primary end point
Comparator
Pilot Trial: Comparison of
Flow Patterns
Comparison of maximum and
minimum velocity, effective
orifice area, percentage of
turbulent flow, pressure drop
between 6 months and 4 years
after AVR
Regular valve
Perceval S Aortic Heart
Valve Study- North
America
All-cause mortality 12 months
Perceval Pivotal Trial
N
Primary
completion
date
Phase
Sponsor
Valve
Clinical trial
ID
20
July
2015
Medical
University of
Vienna
Edwards Intuity
valve
NCT02288871
NA
300
January
2016
Sorin Group
USA
PERCEVAL S
NCT01810679
Incidence of mortality and
morbidity at 3-6 months after
implant
NA
150
October
2009
2 and 3
Sorin Group
USA
PERCEVAL S
NCT00860730
CAVALIER
Incindence of Incidence of
mortality and morbidity at 12
months
NA
658
October
2014
2 and 3
Sorin Group
PERCEVAL S
NCT01368666
Surgical Trauma After
Partial Upper
Hemisternotomy Versus
Full Sternotomy Aortic
Valve Replacement (RCT)
Cardiac Function After
Minimally Invasive Aortic
Valve Implantation
(CMILE) (RCT)
Surgical Trauma up to 3 days
post operaively
Minimially
invasive AVR
vs
conventional
surgery AVR
Minimially
invasive AVR
vs
conventional
surgery AVR
20
December
2015
2
Karolinska
University
Hospital
NCT02272621
40
July
2015
2
Karolinska
University
Hospital
Mechanical and
bioprosthetic
(stented or
sutureless)
aortic valves
Mechanical and
bioprosthetic
(stented or
sutureless)
aortic valves
Cardiac function upto 40 days
post procedure
Sutureless Aortic Valve Replacement – Tier 3 Assessment
25
NCT01972555
4. Economic
Current evidence suggests sutureless AVR may have similar cost-effectiveness to conventional
AVR, with sutureless AVR having comparable outcomes and the possibility of lower procedural
costs. The methods for the economic literature search are contained in Appendix 1.
The cost of sutureless valve has been falling in recent years, which has led to the costs of
sutureless and conventional valves being similar (Figure 1). The Edwards Intuity valve may be an
exception to falling costs of sutureless valves, where a recent report from Germany suggests the
valve costs about twice that of the Sorin and Medtronic valves.(32) There are no head to head trials
of the Edwards Intuity valve with the Sorin or Medtronic valves to justify any price differential.v
Figure 1: Cost of a sutureless valve 2011 to 2014
Source: Cost of sutureless valve provided to NHC by the manufacturer. Cost of conventional bioprosthetic valve provided
by Auckland DHB for 2014
The evidence for reduced procedure and admission costs from sutureless AVR is mixed. One
study reported savings due to reduced hospital stay,(6) and there are indirect comparisons that
report reduced hospital stay and reduced operation time.(7, 19, 34, 72) Other studies report no
differences in length of stay.(35, 36) Costing studies that assume a reduction in hospital length of stay
and a reduction in hospital related costs, estimate sutureless AVR to cost 10% – 47% less than
conventional AVR.(6, 7, 72)
New Zealand cost data – cost of admission
The average cost of an admission with a sutureless AVR procedure in 2012/13 was $51,500
(range $43,000 to $73,000), with an average length of stay of 13 days (Table 8). Accounting for the
v
Edwards were contacted for cost and comparative head-to-head studies with competing valves. Cost information was
not provided. No head-to-head studies or RCTs have been undertaken using the valve.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
26
recent $3,500 price decline in two sutureless AVR valves, we estimate that the average cost of
sutureless AVR is now approximately $48,000. There were, however, just 12 records for sutureless
in 2012/13 for which cost information was available. 2012/13 data was used as it is the most recent
year for which data is available in the National Costing Collection and Pricing Programme.
Table 8: New Zealand cost data sutureless AVR 2012/13
Record
1
2
3
4
5
6
7
8
9
10
11
12
Average
Average
length of stay
(days)
11
16
8
8
6
6
36
16
14
13
11
6
13
Total CS-7 cost for
sutureless AVR
$72,678
$40,823
$65,278
$45,272
$41,568
$41,709
$73,399
$52,636
$45,535
$59,018
$41,318
$38,817
$51,504
Additional procedures
recorded
Reopening of the chest
CABG
CABG
CABG
CABG
Source: NHC analysis of NCCP data 2015, using cost schedule seven.
Four of the 12 identified sutureless AVR operations included concomitant coronary artery bypass
grafts (CABG) and one recorded a reopening of the chest. In our small dataset, the average cost of
sutureless AVR with concomitant CABG is $4,700 less than the total average cost of sutureless
AVR – probably due to the lower length of stay for these patients (9.5 days vs 13 days).
Incremental cost of sutureless AVR
National data collections do not record sufficient patient information to reliably estimate the
incremental cost of sutureless AVR compared with standard surgical AVR. In particular, there is no
record of surgical risk, where greater surgical risk is associated with greater cost. (73) In New
Zealand, sutureless AVR is being targeted at moderate to high-risk patients,(31) so we would expect
its average cost to be greater than the average cost of conventional bioprosthetic surgical AVR.
Our data, though limited to just 12 sutureless AVR records, shows a modest cost increase of
$2,000 with similar length of stay compared with conventional bioprosthetic surgical AVR (Table 9).
Sutureless Aortic Valve Replacement – Tier 3 Assessment
27
Table 9: Cost of sutureless AVR compared with conventional bioprosthetic AVR
Average cost
Average length of stay
(days)
Valve cost
Number of records
Sutureless All bioprosthetic valves
AVR
$48,000
$46,000
13
12
$6,500
12
$5,700
331
Source: NHC analysis of NCCP data accessed in 2015, using cost schedule seven.
International cost data
No cost-effectiveness evaluations of sutureless AVR have been identified, but three studies have
reported on cost. All three studies suggest cost savings for sutureless AVR compared with
conventional surgical AVR. Two studies report the costs associated with undertaking sutureless
AVR with the Perceval S valve (6, 72) while a Canadian health technology assessment included a
cost analysis of the 3f Enable valve.(7) One study is of reasonable quality as it is based on the
results of propensity matched study. The other two studies are of relatively low quality and are
based on indirect comparisons.
Cost-saving estimate from propensity matched study
Pollari et al (2014) undertook a propensity matched analysis of the short term outcomes of
sutureless valves; the study included 82 matched pairs(6) using the Perceval S valve. They
reported cost savings of approximately 25% using minimally invasive sutureless AVR, compared
with minimally invasive surgical AVR using a conventional valve. Savings were driven by a 1.5 day
reduction in hospital length of stay and a 0.8 day reduction in ICU length of stay. Patients were
moderate risk with a mean Logistic EuroSCORE of 12.1 in the sutureless arm and 10.9 in the
conventional surgical arm.
Further results of the study have been summarised in Table 4 and Table 13.
Simulation cost model based on indirect comparisons
Pradelli and Zaniolo (2012) examined the non-device costs associated with the procedure in four
European countries.(72) The study aimed to predict the costs and outcomes of AVR procedures
associated with Perceval S sutureless aortic valves compared to standard surgical AVR for
medium to high surgical risk patients. The researchers used probabilistic patient level simulation to
estimate the cost of sutureless AVR using conventional surgery (full sternotomy) and minimally
invasive surgery compared with standard surgical AVR. Simulations were conducted using cost
schedules from Italy, France, Germany and the United Kingdom. The methods used included a
number of indirect comparisons which leads to uncertainty in the results.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
28
An indirect comparison of health care utilisation was undertaken to estimate the differences
between sutureless AVR and conventional surgical AVR. The comparison was made by:

indirectly comparing cross-clamp time for sutureless AVR and conventional surgical AVR.

estimating cost outcomes by cross-clamp time based on three matched case-control
studies of conventional surgical AVR. Only direct health costs for the AVR surgery were
included – the cost of the operation, hospitalisation, and any complications.

applying costs for each of the outcomes based on country specific costs for each of the four
countries.
The cross-clamp time for sutureless AVR (Perceval S valve) was taken from the non-comparative
CAVALIER trial as reported by Folliguet et al (n = 208).(27) The cross-clamp time for conventional
AVR were taken from an adhoc study. Both sources included full sternotomy and minimally
invasive procedures.
Sutureless AVR done either as minimally invasive or conventional surgery were found to be costsaving compared with conventional surgical AVR. Perceval S was associated with fewer
complications and reduced costs in both approaches, with the minimally invasive approach
associated with the least complications and costs. The savings ranged from NZ $5,766 to NZ
$7,754 for conventional surgery (full sternotomy) and NZ $9,483 to NZ $13,139 for mini-invasive
sternotomyvi; these savings equate to a 19% to 47% reduction in costs.
Cost analysis from a Canadian university
McGill University Health Centre undertook a technology assessment of sutureless AVR, which was
published in 2013.(7) They noted that the 3f Enable valve had an additional cost of $3,750
Canadian dollars (NZ$4456); but potentially shorter operating room (OR) time, intensive care unit
(ICU) time, and hospital stay could result in lower procedure costs.
They speculated possible savings from sutureless AVR by assuming:

the minimally invasive technique employed with sutureless AVR would result in less
hospital costs than conventional surgery (full sternotomy) employed with conventional
surgical AVR;

hospital stay would be 1.5 days shorter, based on a doctors opinion;

operation time would be reduced by two hours, based on a doctor's opinion; and

ICU time would be reduced by 2.4 days, based on a comparison of 19 sutureless AVRs and
853 conventional surgical AVRs done at the university. This was supported somewhat by a
meta analysis of four studies reporting reduced ICU time of 0.57 days due to minimally
invasive surgery.
They reported an incremental cost of $1,665 (CAD$1,401) if savings in ICU time were excluded.
When reduced ICU time was included, the reported savings were $2,055 (CAD $1,728), ie 10%
less.
vi
All costs were in 2011 or 2012 values, and were in either Euros or Pounds. Costs were converted to New Zealand
dollars using the average exchange rate for 2012.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
29
Budget impact
There does not appear to be a material cost impact from sutureless AVR in New Zealand.
Procedure volumes remain low, and there is no evidence of a significant incremental cost over
conventional surgical AVR. In total we have identified less than 80 sutureless AVR procedures
undertaken since the first report in 2011, most of which have been undertaken in Christchurch.(31)
There is unlikely to be a significant cost impact on DHBs from increased use of sutureless AVR as
it is a substitute technology for conventional AVR, rather than a procedure for currently inoperable
patients. While international estimates suggest savings from sutureless AVR, they are of limited
quality and it is questionable if the estimated savings would eventuate in the New Zealand setting.
Clinical advice to the NHC's executive suggests that between five and ten percent of AVR patients
may benefit from sutureless AVR.vii In 2012/13, 511 patients with a primary diagnosis of aortic
stenosis underwent publicly funded aortic valve replacement (including TAVI and sutureless AVR).
Taking the higher end of this estimate suggests that about 50 patients per annum could possibly
benefit from sutureless AVR. Assuming an incremental cost/saving range of +$2,000 per
procedure to a 25% saving per procedure implies a budgetary impact of +$102,000 to a saving of
$586,500 per annum nationally.
vii
Email correspondence from a cardiac surgeon at Waikato DHB to the NHC executive dated 26/11/2014.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
30
5. Societal and ethical
Given that the safety and efficacy of sutureless AVR seems comparable, varying access to
sutureless valves does not give cause for concern. However, this view may change as the
evidence for sutureless AVR evolves. Sutureless has been suggested in patients with difficult
anatomies, including porcelain aorta or small aortic root; or where re-do surgery is required. These
are traditionally risky operations when using standard valve implantation. It is possible that
sutureless AVR may prove to have a comparative advantage compared with standard AVR in
these population subsets. Shrestha et al (discussed above) found similar mid-term mortality
between conventional AVR and sutureless AVR in a non-propensity matched single centre study of
patients with a small aortic root.(36) Data on other anatomical features appears limited to case
studies. Thus whilst sutureless AVR appears to have a similar safety and effectiveness profile to
conventional AVR in general, its potential comparative advantage in specific population subsets
requires further investigation. Any questions of inequality in access is premised upon clear
evidence of clinical advantage.
As with TAVI and any other implantable device, it is important that sutureless valves are
appropriately tracked for patient safety in the event of unforeseen issues with the valve. Registries
can be of significant benefit in tracking patients where there is a device recall for safety or any
other issue. The use of registries for tracking implantable devices is not yet systematic in New
Zealand. An example of the relevance of a registry is the recall of a hip implant in April 2012. The
NZ Joint Registry was set up in 1997 by the New Zealand Orthopaedic Association to keep track of
all implantsviii. When a faulty hip implant was recalled in April 2012, the distributor contacted all
surgeons who implanted the devices with the request to contact their patients. The distributor also
worked with the New Zealand Orthopaedic Association and the New Zealand Joint Registry to
ensure that patients were notified.ix
Regional variation
The majority of sutureless AVR procedures in New Zealand are done at one hospital (Christchurch
Hospital), creating regional disparities in access. Regional variance in access is to be expected
with very low procedure volumes. Diffusion rates can vary for a host of reasons, including divergent
clinical opinion about an interventions value; resource constraint (including scarce clinical
expertise); variation in underlying population need. With greater certainty around patient selection,
regional variation may become an issue to consider if sutureless AVR is introduced into business
as usual.
Ethnic inequality
There is historic evidence of ethnic inequality in the provision of cardiovascular interventions in
New Zealand.(74) Data from the mid-2000s show that while ischaemic heart disease mortality rates
were more than two times higher for Māori than non-Māori, cardiac revascularisation procedures
were provided at similar rates for the two groups. It is important to ensure equity of access to
health services, however, Māori have low incidence and prevalence of AS, and low associated
mortality (Table 10).
viii
ix
http://www.nzoa.org.nz/nz-joint-registry
http://www.medsafe.govt.nz/hot/media/2012/RecallHipImplantDevice.asp
Sutureless Aortic Valve Replacement – Tier 3 Assessment
31
Table 10 Māori/non-Māori prevalence, incidence and mortality for aortic stenosis – 2011
Māori
Non-Māori
Total
Agestandardised
prevalence per
100,000
49
63
62
Age
standardised
incidence per
100,000
7
12
12
Mortality
Age standardised
mortality per
100,000
4
291
295
1.3
3.1
3.0
Source: NHC analysis of NMDS and mortality records. Prevalence, Incidence and mortality are age standardised to the
WHO population. Incidence is for the 2012/13 financial year while mortality is for the 2011 calendar year, the most recent
year for which data was available at the time of analysis.
Rheumatic fever is a cause of AS, and Māori and Pacifica have high rates of rheumatic fever. This,
however, does not translate through to high rates of AS, as the disease mostly affects the mitral
valve, not the aortic valve. Incidence of rheumatic heart disease is respectively 20- and 40-times
higher for Māori and Pacific children than for non-Māori/non-Pacific children.(75) Pathological
evaluation of terminally ill patients with rheumatic heart disease indicates that mitral valve disease
is present in 90-95% of cases; with up to a quarter of these patients having aortic valve disease.(76)
Isolated aortic valve disease was reported in less than eight percent of cases. In 2012/13, less
than two percent of patients diagnosed in a New Zealand hospital with AS had rheumatic AS.
During this time, five patients with rheumatic heart disease underwent (publicly funded) AVR.x In
2011 there were two deaths from rheumatic AS, neither person was Māori.xi
Other issues
Though not specifically identified in the sutureless AVR literature, there is significant crossover with
the societal and ethical issues facing TAVI. These include the need to ensure informed consent,
and mitigate unnecessary harm through avoidance of futile interventions. These issues are
discussed in more depth in Transcatheter Aortic Valve Implantation: Assessment Report Tier 3
2015. Briefly, informed consent is a right enshrined in the Code of Health and Disability Services
Consumers’ Rights (right seven). No health or disability service can be provided to a consumer
without his or her informed consent.(77, 78) Corresponding rights include right five, the right to
effective communication, and right six, the right to be fully informed – implying that patients should
be fully informed of the potential harms and benefits of an intervention. This is particularly
important in the case of emerging technologies such as sutureless AVR where there is uncertainty
in mid and long-term outcomes.
An intervention may be considered medically futile if it fails to improve survival with an acceptable
quality of life, or in the case that there is no survival benefit, fails to improve quality of life. United
States and European professional guidelines note the need for clinicians to consider expected life
expectancy and patient quality of life post aortic valve replacement; where a life expectancy of less
than one year is considered a contraindication for intervention. (79, 80)
x
NHC analysis of national minimum dataset.
xi
MoH analysis of mortality records.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
32
6. Feasibility of adoption
There may be between five and ten percent of AVR patients that could benefit from sutureless
AVR. There are no workforce or infrastructure considerations identified that would impede the
increased use of sutureless AVR; although, like with all new treatments, appropriate training and
oversight would need to be put in place if the use of sutureless AVR increased. Sorin Group
informed the NHC that it funds training and support for the use of its Perceval sutureless valve.
This includes onsite clinical specialist support for surgical and nursing staff. Sorin Group informed
the NHC that the learning curve for the technology is short, with proficiency typically achieved after
five cases. They also noted that there were no additional capital requirements for sutureless AVR.
In the case of minimally invasive surgery, hemi-sternotomy (involving a smaller chest incision than
traditional full-sternotomy) can be performed with standard surgical equipment. Right anterior
mini-thoracotomy (entry through the rib cage) would require standard specialist minimally invasive
instruments used in minimally invasive cardiac surgery.
Patient selection
Outcomes for sutureless AVR and conventional surgical AVR are expected to be similar, based on
evidence to date. Given the lack of long-term safety and efficacy evidence for sutureless AVR,
sutureless AVR should not be adopted as the standard of care. However, there may be a small
subset of patients for whom sutureless AVR is beneficial. Concise selection criteria for sutureless
AVR have not been identified in literature. Clinical advice to the NHC's executive suggests that
between five and ten percent of AVR patients may benefit from sutureless AVR, equating to
roughly 25 to 50 patients per annum.xii Potential beneficiaries of the procedure include patients with
anatomical features that make suturing difficult or risky, such as a heavily calcified aortic annulus
or a very small aortic root.(36, 81) Conventional valves may not be suitable for some patients with
small aortic roots, resulting in a patient-prosthesis size mismatch. There are alternative surgical
techniques for addressing this issue, including the use of homografts. Sutureless AVR is proposed
as an additional option due to the large effective orifice of the valve.(36) Patients with an anticipated
prolonged bypass and cross-clamp time, including patients undergoing concomitant cardiac
surgery, may also benefit.(19) Two non-comparative feasibility studies have also looked at the role
of sutureless AVR in targeting patients with significant left ventricular hypertrophy in AS. (82, 83) While
the studies suggest that LV mass may be significantly reduced, well-designed comparative studies
are required to determine if sutureless AVR confers any advantage over conventional surgical
AVR. The learning curve for sutureless AVR is expected to be small as most surgeons are
acquainted with the valve insertion techniques required. xiii Figure 2 presents a draft patient
selection criteria for sutureless AVR. The criteria are presented purely to promote discussion.
xii
Email correspondence from a cardiac surgeon at Waikato DHB to the NHC executive dated 26/11/2014.
xiii
Email correspondence from a cardiac surgeon at Canterbury DHB to the NHC executive dated 04/11/2013
Sutureless Aortic Valve Replacement – Tier 3 Assessment
33
Figure 2: Draft patient selection criteria for sutureless AVR
Patient selection criteria
1. Severe symptomatic AS or equivalent indication for AVR, and
2. Anticipated good prognosis without severe impairment from any combination of
frailty, cognitive impairment and/or multiple significant comorbidities, and
3. Patient has been accepted by the cardiac surgical conference as suitable for
surgery, and one of the following
a. Patient has one or more of the following that make standard surgical AVR
unattractive:
i. Heavily calcified aortic annulus
ii. Previous AVR with a homograft
iii. Very small aortic root, or
b.
Patient for whom reduced aortic cross-clamp time would be extremely desirable to
improve perioperative survival, including high surgical risk patients undergoing
multiple valve replacements and/or concomitant coronary artery bypass grafting, or
c.
Patient has chest anatomy such that partial sternotomy is greatly preferred over full
sternotomy.
Source: Draft clinical criteria provided to NHC during clinical engagement
Workforce and infrastructure considerations
Sutureless AVR is currently being undertaken in three DHBs including, Auckland, Waikato, and
Canterbury. It has been estimated that surgeons need to undertake sutureless AVR on 10 to 20
patients to achieve a satisfactory level of experience.(5) The procedure does not involve a
significant learning curve,(31) and there is no additional workforce requirement suggested in the
literature. The findings of Pollari et al suggest that sutureless AVR may in fact require slightly less
medical labour, primarily due to reduced length of stay.(6) If patients were able to be discharged
from hospital earlier, this may allow waiting lists to be reduced.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
34
7. Conclusion
Sutureless AVR is a new valve procedure for patients with severe symptomatic AS. Evidence to
date suggests comparable outcomes with sutureless AVR and conventional surgical AVR.
However, evidence of long-term safety and efficacy is currently lacking.
Sutureless valves are now approved for use in Europe and Australia. There is unlikely to be a
significant cost impact on DHBs from sutureless AVR as it is a substitute technology for
conventional surgical AVR, rather than a procedure for currently inoperable patients. The cost of
sutureless valves is now close to the cost of conventional bioprosthetic valves. The admission
costs of sutureless AVR may be less than conventional surgical AVR.
No significant social or ethical issues have been identified. The main issue regarding the feasibility
of adoption involves identifying the patients who are most likely to benefit. The procedure is
associated with a small learning curve, where the training overhead is expected to be met by
industry. It is hypothesised that the technology may have a comparative advantage for patients
with anatomical features that make conventional surgery risky and in patients requiring a repeat
aortic valve replacement. Data is currently lacking here to establish a comparative advantage
relative to conventional AVR. If such an advantage were established, then equity of access would
become an issue the health system would need to address.
Sutureless AVR should not replace conventional surgical AVR as the standard of care for severe
symptomatic AS. If clinicians would prefer to use sutureless valves, there seems to be sufficient
justification in them doing so; particularly in a small number of high-risk patients.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
35
Appendix 1: Methods
A number of different methods were used to answer the research questions across the
NHC’s four domains: clinical safety and effectiveness; economic; feasibility of adoption,
and; societal and ethical.
Methods for clinical safety and effectiveness
The questions in the clinical safety and effectiveness domain were addressed primarily
by a systematic review of existing literature.
The following databases were searched up to end September 2014: MEDLINE,
Embase, CENTRAL (Cochrane Central Database of Controlled Trials), Cochrane
Database of Systematic Reviews, and DARE (Database of Abstracts of Reviews of
Effect). Further trials were identified by scanning the reference lists of relevant papers.
Additionally, international health technology assessment sites were searched for
relevant reports.
The search terms used were: ((sutureless OR suture-less OR stitchless OR stitch-less)
adj3 aortic adj3 valve).mp OR 3f-enable.mp OR ATS 3F.mp OR perceval s.mp OR
(perceval AND (sutureless OR suture-less OR stitchless OR stitch-less)).mp OR intuity
valve system.mp OR trilogy aortic valve system.mp.
The following inclusion and exclusion criteria were applied to the retrieved citations.
Clinical trials of AVR using a sutureless bioprosthetic device in adults were included;
trials in children and AVR using mechanical valves were excluded. To be included the
trial must report clinical outcomes of patients, including one or more of: haemodynamic
results; procedural outcomes (aortic clamp time, cardiopulmonary bypass time and/or
procedural success); mortality and/or safety. Pre-clinical studies and those that
reported solely on valve implantation technique were excluded.
Where a series of patients appeared to have been reported more than once, the most
recent and/or complete report was included. Case reports were excluded because of
the high risk of bias, ie there tends to be a bias towards publishing the most successful
or complex cases. Due to the lack of good quality evidence for sutureless aortic valves,
case series were included where it seemed likely that the outcomes of all patients
treated sequentially were reported, rather than only outcomes for selected patients
within the treated group being reported. The latter approach has a high risk of bias
because patients for whom results are reported may have different characteristics or
outcomes than those who for whom results are not reported.
Methods for economic evaluation
A literature search was conducted to identify cost and cost-effectiveness analyses of
sutureless AVR that could provide information relevant to inputs for economic
modelling. The same databases and search terms as described above, in combination
with a range of cost and economic terms, were used.
Volume estimates were obtained by searching free text fields in the National Minimum
Dataset and asking DHBs to confirm or amend our estimates from their records. There
is not yet a unique identifier for sutureless AVR in the NMDS. Costs for sutureless AVR
procedures were obtained from National Costing Collection and Pricing Protocol
Sutureless Aortic Valve Replacement – Tier 3 Assessment
36
(NCCP) data cube for all years for which data was available; more recent data than
2012/13 was not available because of reporting lags. Several New Zealand DHBs take
part in the NCCP, which aims to create an annual national price book for hospital
services. As a part of this, DHBs are asked to provide unit record estimates of
expenditure for each intervention across several cost schedules, which represent
different cost centres. Cost schedule seven was used to estimate cost as it is
considered more inclusive and reflective of cost than cost schedule two.
Sutureless AVR cost data 2013 financial year
Sutureless AVR events were identified using the information recorded in the free text
field of the NMDS. The events were then sent to the DHBs which performed the
procedures for confirmation and amendment where necessary. The information
supplied by the DHBs was used to ensure that the records used in the analysis were
correct and there was no duplication of records.
Cost data from the National Cost Collection Project (NCCP) was used to estimate the
costs of sutureless AVR events. Data collected in the NCCP project is sourced from
the costing systems employed by DHBs to allocate the cost of care across events
occurring in their hospitals. Costs are allocated on the basis of the length of stay in
hospital and the procedures included in the care of the patient. Costs were identified by
linking the unique patient identification code recorded in the verified NMDS data and
the NCCP data.
Cost data sutureless AVR compared to bioprosethetic valves 2013 financial year
Sutureless AVR events were identified using the information recorded in the free text
field of the NMDS. The events were then sent to the DHBs which performed the
procedures for confirmation and amendment where necessary. The information
supplied by the DHBs was used to ensure that the records used in the analysis were
correct and there was no duplication of records.
Bioprosethetic valve events were found by identifying records in the NMDS where the
implantation of a bioprosethetic valve was an element of the care provided during the
episode of care.
Cost data from the National Cost Collection Project (NCCP) was used to estimate the
cost of the TAVI and bioprosethetic valve events.
Data collected in the NCCP project is sourced from the costing systems employed by
DHBs to allocate the cost of care across events occurring in their hospitals. Costs are
allocated on the basis of the length of stay in hospital and the procedures included in
the care of the patient.
Costs for the TAVI and bioprosethetic valve events were identified by linking the
unique patient identification code recorded in the verified NMDS data and the NCCP
data.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
37
Māori/non-Māori prevalence, incidence and mortality for aortic stenosis – 2011
Mortality data for the 2012 calendar year was sourced from mortality statistic data sets
maintained by the Ministry of Health. Mortality events were selected where the cause
of death was coded as one of the following:
I350 Aortic (valve) stenosis
I352 Aortic (valve) stenosis with insufficiency
I060 Rheumatic aortic stenosis
I062 Rheumatic aortic stenosis with insufficiency
The data was aggregated into the following:
a)
b)
c)
d)
Ethnicity
Age group
Aortic stenosis
Rheumatic aortic stenosis.
Age group population data was obtained from the World Health Organisation (WHO)
website, aggregated and proportions calculated. Statistics New Zealand population
estimates for the 2012 calendar were aggregated using:
a) Ethnicity Māori and non-Māori
b) Age group.
The age adjusted rate was found by dividing the aggregated mortality data by the
Statistics New Zealand population estimates, which were then weighted by the
proportions derived from the WHO population statistics.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
38
Appendix 2. Description of clinical trials of sutureless AVR
Table 11: Patient characteristics and description of comparative trials of sutureless AVR; including comparisons with conventional AVR, TAVI and different
sutureless valves.
Comments
Log Euro
Mean/
Surgical
Author
Device
Patient group
SCORE
median
technique
(mean/
Age (y)
median%)
Concistre et al
(2013)(50)
Perceval S
(n = 97)
SSAS
Age >75y
3f Enable
(n = 32)
D’Onofrio et al
(2012)(47)
Perceval S
(n = 38)
Perceval S
(n = 31)
TAVI
(n = 143)
NR
Mini 65%
Concomitant or
redo procedures
35%
Reports initial experience with the technologies at the study centres;
choice of valve at physician discretion. Some or all patients in the
Perceval S group may be part of CAVALIER trial.
The authors declared no conflicts of interest; financial relationship
with Sorin for two of the authors disclosed in another paper (Pfeiffer
and Fischlein)
Design: retrospective. Baseline characteristics similar between
groups other than body surface area
13.7
81
Mini 29%
Plus CABG 32%
14.8
81
Transapical TAVI
Patients represent the entire experience with Perceval S at the study
centres
TAVI data from Italian Registry of Transapical Aortic Valve
Implantation, representing the majority of such procedures
undertaken in Italy
Decision re choice of technology made by cardiac surgeon based on
patient characteristics
Disclosure: No commercial support
Design: prospective, propensity-matched. Baseline patient
characteristics similar after propensity matching.
Excluded inoperable patients treated with TAVI
18.3a
74a
Mini 39%
20.2
78
Transapical TAVI
13.8
SSAS
Age >75y
TAVI
(n = 38)
D’Onofrio et al
(2013)(39)
11.4
SSAS
Age ≥75y for
Perceval S
Sutureless Aortic Valve Replacement – Tier 3 Assessment
Extension of above study
Perceval S and TAVI are drawn from the same patient groups as
above
Standard AVR from a consecutive series of patients, using the same
dataset and definitions as for the other groups
39
Author
Device
Log Euro
SCORE
(mean/
median%)
Mean/
median
Age (y)
Surgical
technique
Comments
18.3a
74a
Full sternotomy
Isolated AVR
The propensity matched cohort included 143 TAVI recipients and 143
surgical AVR recipients. Amongst the latter group, 31 underwent
sutureless AVR and 112 underwent standard surgical AVR.
The primary comparisons were: (1) TAVI vs Perceval S, and; (2)
TAVI vs standard AVR. Perceval S and standard AVR were not
directly compared.
Disclosure: No commercial support
Design: Prospective for Perceval S and TAVI; retrospective for
standard surgical AVR. Propensity-matched. TAVI group significantly
older than the surgical AVR group (Perceval S or Standard AVR)
Eligible for isolated
AVR by right
anterior
minithoracotomy
5.8
75
Mini all patients
Isolated AVR
5.5
74
Sutureless cohort is likely to include some patients from Gilmanov et
al noncomparative study(45)
Design: Retrospective, propensity matched. Baseline patient
characteristics similar after propensity matching.
Severe AS
Age >65y
12.1
76
10.9
75
Mini when
possible
Isolated AVR
Some patients in the Perceval S group part of CAVALIER multicentre
trial
Control group ineligible for Perceval S
The patient cohort is likely to include some patients also reported in
Santarpino et al. 2013(5) but the latter wasn’t propensity matched.
Disclosure: Financial relationship with Sorin disclosed by two of the
authors (Pfeiffer and Fischlein)
Design: Propensity matched. Baseline patient characteristics similar
after propensity matching.
9.9
78
Mini all patients
Isolated AVR
4.3
72
Some patients in the Perceval S group part of CAVALIER multicentre
trial
Control group ineligible for Perceval S
Disclosure: Financial relationship with Sorin disclosed by two of the
authors (Pfeiffer and Fischlein)
Design: Prospective. Significant differences between groups in age
Patient group
Standard
AVR
(n = 112)
Gilmanov et al
(2014)(35)
Sutureless
(n = 133)
Standard
AVR
(n = 133)
Pollari et al.(6)
Perceval S
(n = 82)
Standard
AVR
(n = 82)
Santarpino et al
(2013)(5)
Perceval S
(n = 50)
Standard
AVR
(n = 50)
SSAS Age ≥65y for
Perceval S
Sutureless Aortic Valve Replacement – Tier 3 Assessment
40
Author
Device
Patient group
Log Euro
SCORE
(mean/
median%)
Mean/
median
Age (y)
Surgical
technique
Comments
and surgical risk because the control group comprised patients for
whom sutureless AVR was not indicated.
Santarpino et al
(2013)(37)
Perceval S
(n = 37)
SSAS
Age ≥65y
TAVI
(n = 37)
Shrestha et al
(2013)(36)
Perceval S
(n = 50)
Age ≥75y
Small aortic roots
(<22mm)
Standard
AVR
(n = 70)
Doss et al
(2012)(84)
3f Enable
(n = 27)
Severe AS
TAVI
(n = 29)
Muneretto et al
(2014)(64)
Perceval S
(n=53)
CoreValve
TAVI (n=55)
Severe AS
18.1
81.5
Mini all
sutureless AVR
First enrolled Perceval S patients were part of the CAVALIER
multicentre trial; later patients received Perceval S under routine use
Disclosure: Financial relationship with Sorin disclosed by two of the
authors (Pfeiffer and Fischlein)
Design: retrospective. Propensity matched.
20.6
84.5
20.4
80
Mini 72%
Isolated AVR
16.7
77
Mini 4%
Isolated AVR
Perceval group may be part of Perceval Pivotal trial and/or
CAVALIER
Unclear whether control group were ineligible for Perceval S or were
treated prior to Perceval S being in use
Unclear whether data on control patients were collected prospectively
Disclosure: Institute received an unrestricted research grant from
Sorin to conduct the study
Design: Prospective. Baseline characteristics did not differ
significantly between groups other than a marginally higher surgical
risk in the Perceval S group (20.4 vs 16.7; p = 0.05)
13.7
78
Full sternotomy
and concomitant
procedures 37%
Partial
sternotomy for
isolated AVRs
35.3
85
Transapical TAVI
16
79
18.9%
ministernotomy
20.4
81
Transfemoral
Sutureless Aortic Valve Replacement – Tier 3 Assessment
Unclear how patients were selected for treatment group
3f Enable patients may be part of larger study as reported in Martens
et al. 2011(28)
Reports initial experience with the technologies at the study centre
No information provided regarding funding and conflicts of interest
Design: Prospective, nonrandomised cohorts. Surgical risk
significantly higher in the TAVI group
Design: Prospective, nonrandomised cohorts
41
Author
Device
Patient group
Standard
AVR ( 55)
Biancari et al
(2015)(65)
Perceval S
(n=142)
TAVI
(n=142)
Severe AS
Log Euro
SCORE
(mean/
median%)
Mean/
median
Age (y)
Surgical
technique
21.3
79
49.1%
ministernotomy
4.1 (ESII)
79.4
54% mini
3.6
79
98%
Transfemoral
Comments
Design: Retrospective propensity matched study. Sutureless AVR
with concomitant CABG in 26% of patients compared with Isolated
TAVI.
a Data for surgical AVR group as a whole (n= 143), including both sutureless and standard AVR.
AS = aortic stenosis; AVR = aortic valve replacement; CABG = coronary artery bypass grafting; NR = not reported; EuroSCORE = European System for Cardiac Operative
Risk Evaluation score; mini = minimally invasive; SSAS = severe, symptomatic AS or equivalent indication; TAVI = transcatheter aortic valve implantation
Sutureless Aortic Valve Replacement – Tier 3 Assessment
42
Table 12: Patient characteristics and description of non-comparative trials of sutureless AVR
Log
Mean/
Author
Device
No. pts Patient group
Comments
Euro
median
SCORE
age
(mean/
median
%)
Eichstaedt et al.
3f Enable
120
SSAS
20.7%
77y
Retrospective single centre experience
(46)
Disclosure: two authors have a financial relationship with Medtronic as proctors
Folliguet et al
(2012) (27)
Perceval S
208
AS or stenoinsufficiency
>5%
(mean
8.7%)
79y
Part of CAVALIER trial
No information provided regarding funding and conflicts of interest
Gilmanov et al
(2013)(45)
Perceval S
137
Eligible for
isolated AVR by
right anterior
minithoracotomy
10%
77y
Retrospective initial single centre experience
Update with 175 patients later presented at a conference(81)
No information provided regarding funding and conflicts of interest
Kocher et al
(2013)(29)
Intuity
152
AS or stenoinsufficiency
7.9%
76y
Part of TRITON trial
Disclosure: Edwards Lifesciences funded the study and managed collection and
monitoring of data
Martens et al
(2011)(28)
3f Enable
140
AS, stenoinsufficiency or
insufficiency
NR
76y
European Multicentre Enable trial
Disclosure: Financial support provided by ATS Medical
Mazine et al
(2013)(85)
Perceval S
123
SSAS
NR
79y
Sutureless Aortic Valve Replacement – Tier 3 Assessment
43
Author
Device
No. pts
Patient group
Log
Euro
SCORE
(mean/
median
%)
Mean/
median
age
Comments
Santarpino et al
(2012)(26)
Perceval S
83
Severe calcified
AS
10.7%
77y
Part of CAVALIER trial
No information provided regarding funding and conflicts of interest; financial relationship
with Sorin for two of the authors disclosed in another paper (Pfeiffer and Fischlein)
Shrestha et al
(2011)(62)
Perceval S
180
SSAS
13%
81y
Perceval Pivotal trial
Publication in Abstract form
No information provided regarding funding and conflicts of interest
Zannis et al
(2012)(63)
Perceval S
140
9.7%
79y
Single centre experience likely part of the Perceval Pivotal trial and/or CAVALIER, with at
least some patients included in other reports
Publication in Abstract form
No information provided regarding funding and conflicts of interest
AVR = aortic valve replacement; ; EuroSCORE = European System for Cardiac Operative Risk Evaluation score; SSAS = severe, symptomatic aortic stenosis
Sutureless Aortic Valve Replacement – Tier 3 Assessment
44
Appendix 3 Summary of clinical findings for sutureless AVR
Table 13: Summary of clinical findings from comparative trials of sutureless AVR
Device
Mean TV
Author
Complications
(no.
gradient
patients)
(mm Hg)
PV leak
Permanent
Stroke
pacemaker
(severity)
implant
Concistre et al
(2013) (50)
D’Onofrio et al
(2012)(47)
D’Onofrio et al
(2013)(39)
Gilmanov et al
(2014)(35)
All-cause mortality (n; %)
MI
Renal failure/
dialysis
Bleeding
complications
In-hospital or
30-day
1-year
Perceval
S
(n = 97)
9.1*
1%*
(moderate)
2 (6%)
2 (2%)
NR
RI: 3 (3%)
NR
2
(2.1%)
3
(3.2%)c
3f Enable
(n = 32)
11.2
16%
(moderate)
2 (6%)
1 (3%)
NR
RI: 1 (3%)
NR
1
(3.1%)
1
(3.1%)c
Perceval
S
(n = 38)
10.95
0a
(moderate AR
2+/3+)
2
(5.3%)
0
0
2 (5.3%)
1 major bleed
0
NR
TAVI
(n = 38)
10.25
8%
(moderate AR
2+/3+)
2
(5.3%)
0
0
1 (2.6%)
1 major bleed; 1
fatal bleed
(5.3%)
2
(5.3%)
NR
Perceval
S
(n = 31)
11.1
19.4%
(all at least mild;
AR ≥1+/3)
1
(3.2%)
0
0
1 (3.2%)
NR
0
NR
TAVI
(n = 143)
10.7
28.7%
(all at least mild;
AR ≥1+/3)
7
(4.9%)
4 (2.8%)
5
(3.5%)
7 (4.9%)
NR
10
(7%)†
NR
Standard
AVR
(n = 112)
16.5
1.8%
(all at least mild;
AR ≥1+/3)
1
(0.9%)
0
1
(0.9%)
0
NR
1
(0.9%)
NR
Sutureless
(n = 133)
11
NR
6 (4.5%)
2 (1.5%)
2 (1.5%)
1 (0.8%)
7% requiring
1 (0.8%)
Median
10mo:d
Sutureless Aortic Valve Replacement – Tier 3 Assessment
(2.6%)
45
Author
Device
(no.
patients)
Mean TV
gradient
(mm Hg)
Complications
PV leak
(severity)
All-cause mortality (n; %)
Permanent
pacemaker
implant
Stroke
MI
Renal failure/
dialysis
Bleeding
complications
In-hospital or
30-day
4%
reexploration
Pollari et al
(2014)(6)
Santarpino et al
(2013)(5)
Santarpino et al
(2013)(37)
Shrestha et al
(2013)(36)
1-year
Standard
AVR
(n = 133)
12
NR
3 (2%)
0
0
0
4% requiring
reexploration
2 (1.5%)
5%
Perceval
S
(n = 82)
NR
NR
5 (6%)
3 (4%)
(including
TIA)
NR
NR
2% requiring
reexploration
Mean blood tx
1.2U*
2 (2.4%)
Median
13mo:d
2.5%
Standard
AVR
(n = 82)
NR
NR
7 (8.5%)
6 (7%)
(including
TIA)
NR
NR
6% requiring
reexploration
Mean blood tx
2.5U
3 (3.7%)
3.8%
Perceval
S
(n = 50)
8.4
2%
(PV leak 1/4)
3 (6%)
NR
0
RI 2 (4%)
Mean blood tx
2
(4%)
NR
Standard
AVR
(n = 50)
10
4%
(PV leak 1/4)
4 (8%)
NR
1
(2%)
RI 3 (6%)
2.3U
3
(6%)
NR
Perceval
S
(n = 37)
13.3
0
(at least mild AR)
4 (10.8%)
2 (5.4%)
NR
0
NR
0
Mean 19mo:d
2.7%*
TAVI
(n = 37)
14.2
13.5%
(at least mild AR)
1 (2.7%)
2 (5.4%)
NR
2 (5.4%)
NR
3 (8.1%)
Mean 19mo:d
13.5%*
8%
(Minor; grade 1)
NR
NR
NR
NR
2 major bleedb
(4%)
0
5
(13%)
Perceval
S (n = 50)
15.9
Sutureless Aortic Valve Replacement – Tier 3 Assessment
1.1U*
46
Author
Doss et al
(2012)(84)
Device
(no.
patients)
Mean TV
gradient
(mm Hg)
Complications
PV leak
(severity)
Permanent
pacemaker
implant
Stroke
MI
Renal failure/
dialysis
Bleeding
complications
In-hospital or
30-day
1-year
Standard
AVR
(n = 70)
12.7
2%
(Minor: grade 1)
NR
NR
NR
NR
2 major bleedb
(2.9%)
3
(4.3%)
10
(16%)
3f Enable
(n = 27)
9
0
(Mod/major)
0
0
NR
NR
NR
3
(11%)
NR
17%
(Mod/major)
1 (3.5%)
0
NR
NR
NR
5
(17%)
NR
TAVI
(n = 29)
7
All-cause mortality (n; %)
a Significant difference for all paravalvular leak of at least mild severity (16% with Perceval S versus 45% with TAVI).
b Postoperative bleeding necessitating rethoracotomy.
c Mean follow-up 8 months.
d Based on Kaplan-Meier survival analysis
* Significant difference for sutureless AVR versus comparator (p < 0.05)
† Significant different for TAVI versus standard surgical AVR
AF = atrial fibrillation; AI = aortic insufficiency; AR = aortic regurgitation; AS = aortic stenosis; AVR = aortic valve replacement; CABG = coronary artery bypass grafting; MI = myocardial infarction; NR =
not reported; PV = paravalvular leak; RI = renal insufficiency; TAVI = transcatheter aortic valve implantation; TIA = transient ischaemic attack; TV = transvalvular; tx = transfusion.
Two late additions to this report: Biancari et al (2015)(65) and Muneretto et al (2014)(64) are discussed in the report but not summarised in the above table.
Table 14: Summary of clinical findings from non-comparative trials of sutureless AVR
Sutureless Aortic Valve Replacement – Tier 3 Assessment
47
Author
Folliguet et al
(2012) (27)
Gilmanov et al
(2013)(45)e
Device
ICU stay
(mean/
median
days)
Hospital
stay
(mean/
median
days)
Implant
successa
Complications
All-cause mortality
PV leak
(severity)
Permanent
pacemaker
implant
Stroke
Perceval S (n
= 208)
NR
NR
96%
8% (majorc)
NR
1%
Perceval S (n
= 137)
1.5
Renal
failure/
dialysis
Bleeding
complications
In-hospital
Follow-up
(period)
6% requiring tx
2.4%
9.6%
(other TE 4%)
7
100%
1.5%
4%
2%
(mild)
Santarpino
et al
(2012)(26)
Perceval S (n
= 83)
NR
Shrestha et
al (2011)(62)
Perceval S 9 n
= 180)
NR
Zannis et al
(2012)(63)
Perceval S (n
= 140)
NR
11
99%
1%
4%
(mean
10mo)
(mild
dysfunction
4%)
96%
2%
99%
Sutureless Aortic Valve Replacement – Tier 3 Assessment
3% (majord)
2.4%
1% fatal GI
bleed
7%
1%
NR
(>2+
mod/major)
NR
0
5%
1%
0.7%
noncardiac
(median
6mo)
1% major bleedb
2%
(major
3/4+)
NR
5% requiring
revision
NR
4.8%
(mean
8mo)
3%
11%
(30 day)
(median
1y)
4.3%
10%
(1y)
48
Author
Device
ICU stay
(mean/
median
days)
Hospital
stay
(mean/
median
days)
Implant
successa
Complications
Kocher et al
(2013)(29)
Intuity (n =
152)
NR
NR
96%
2%
Martens et al
(2011)(28)
3f Enable (n =
140)
NR
8%
All-cause mortality
1% major bleedb
(other TE 4%)
(mod/major
)
NR
100%
3%
NR
1%
NR
(major)
Eichstaedt et
al.(46)
3f Enable (n =
120)
NR
9
100%
2%
7%
(major;
≥grade 2)
3% major bleedb
1%
(other TE 1%)
2.1%
7.5%
(30-day)
(mean
10mo)
3.6%
12.9%
(30-day)
(≈1y)
6.7%
9%
(30-day)
(mean
9mo)
a Study valve successfully implanted and functioning.
b Reoperation required due to significant bleeding.
c 4% during implantation and affecting successful valve implantation; 4% necessitating reoperation.
d Necessitating reoperation.
e An update including 175 patients was later presented at a conference.(81) Outcomes were very similar. At a median follow-up of 10 months the noncardiac mortality rate was 1.7%.
ICU = intensive care unit; GI = gastrointestinal; TE = thromboembolism; tx = blood transfusion.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
49
Table 15: Summary of procedural outcomes from comparative trials of sutureless AVR
Author
Device (no.
patients)
ACC time
(mins)
CPB time
(mins)
Valve
implant
successb
ICU stay
(mean/median
days)
Hospital stay
(mean/median
days)
Concistre et al
(2013)(50)
Perceval S
(n = 97)
Isolated AVR
Isolated AVR
NR
NR
NR
36*
66*
3f Enable
(n = 32)
66
103
NR
NR
NR
Perceval S
(n = 38)
Isolated AVR
Isolated AVR
100%
NR
NR
44
69
TAVI
(n = 38)
NA
NA
97%
NR
NR
Sutureless
(n = 133)
56*
90*
NR
1
6
Standard AVR
(n = 133)
88
120
NR
1
6
Sutureless
(n = 82)
47*
71*
NR
2.0*
10.9*
Standard AVR
(n = 82)
59
92
NR
2.8
12.4
Perceval S
(n = 50)
Isolated AVR
Isolated AVR
98%
1.9*
10.5
40*
69*
Standard AVR
(n = 50)
66
105
100%
2.8
10.9
Perceval S
(n = 37)
39
69
95%
NR
NR
TAVI
(n = 37)
NA
NA
95%
NR
NR
Perceval S
(n = 50)
Isolated AVR
Isolated AVR
100%
1.8
14.1
30*
59*
Standard AVR
(n = 70)
50
75
NR
2.0
15.9
3f Enable
(n = 27)
Isolated AVR
Isolated AVR
93%
NR
NR
52
75
TAVI
(n = 29)
NA
NA
93%
NR
NR
D’Onofrio et al
(2012)(47)
Gilmanov et al
(2014) (35)
Pollari et al
(2014)(6)
Santarpino et al
(2013)(5)
Santarpino et al
(2013)(37)
Shrestha et al
(2013)(36)
Doss et al
(2012)(84)
a D’Onofrio et al. (2013) is not included because the paper didn’t report the outcomes of interest for this table.
b Study valve successfully implanted and functioning.
* Significant difference versus comparator (p < 0.05)
ACC = aortic cross-clamp; AVR = aortic valve replacement; CPB = cardiopulmonary bypass; ICU = intensive care unit; NA
= not applicable; NR = not reported; TAVI = transcatheter aortic valve implantation.
Sutureless Aortic Valve Replacement – Tier 3 Assessment
50
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National Health Committee (NHC) and Executive
The National Health Committee (NHC) is an independent statutory body which provides advice to the
New Zealand Minister of Health. It was re-formed in 2011 to establish evaluation systems that would
provide the New Zealand people and health sector with greater value for the money invested in
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recommendations regarding prioritisation and reprioritisation of interventions. They do this through a
range of evidence-based reports tailored to the nature of the decision required and timeframe within
which decisions need to be made.
Citation: National Health Committee. 2015. Sutureless Aortic Valve Replacement: Assessment
Report Tier 3. Wellington: National Health Committee
Published in October 2015 by the National Health Committee
PO Box 5013, Wellington, New Zealand
ISBN (to be confirmed for final version)
HP XXXX
This document is available on the National Health Committee’s website:
http://www.nhc.health.govt.nz/
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