Health Policy Advisory Committee on
Technology
Technology Brief
Sutureless aortic valve replacement in patients with severe
aortic valve stenosis
August 2012
© State of Queensland (Queensland Health) 2012
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This brief was prepared byMs. Robyn Lambert and Ms. Stefanie Gurgacz from the Australian Safety
and Efficacy Register for New Interventional Procedures – Surgical (ASERNIP-S).
TECHNOLOGY BRIEF
Register ID
WP121
Name of technology
Sutureless aortic valve replacement
Purpose and target group
Patients with severe degenerative aortic valve
stenosis who require aortic valve replacement
Stage of development in Australia

Yet to emerge

Established

Experimental

Established but changed indication
or modification of technique

Investigational

Should be taken out of use

Nearly established
Australian Therapeutic Goods Administration approval

Yes

No

Not applicable
ARTG number
International utilisation
Country
Level of use
Trials underway or
completed
Austria

Belgium

Canada

France

Germany

Netherlands

New Zealand

Poland

Russia

Switzerland

UK

Sutureless Aortic Valve Replacement: August 2012
Limited use
Widely diffused
1
Impact summary
Sutureless aortic valve replacement (AVR) devices have been developed by various
manufacturers for the treatment of symptomatic aortic stenosis. There is a high risk of
sudden death in patients with severe aortic stenosis if the diseased valve is not
replaced. Sutureless AVR is performed under general anaesthesia by a cardiovascular
surgeon using a full or partial sternotomy and requires cardiopulmonary bypass (CPB).
The valves require minimal sutures to remain in situ and reduce CPB and aortic crossclamp time as compared to traditional AVR, thus providing a treatment option for
patients at a high operative risk. The results of studies included within this technology
brief demonstrate low rates of adverse events. Although there is currently little
comparative evidence to support the use of sutureless AVR devices, such devices have
recently been employed in both Canada and New Zealand.
Background
Aortic stenosis is the progressive narrowing of the native aortic valve opening resulting
in the obstruction of blood outflow. Left ventricular hypertrophy and congestive heart
failure may result due to the increase in pressure within the left ventricle and
subsequent increase in cardiac workload.1 Aortic stenosis has a long latency period
followed by rapid disease progression, and within two years of developing symptoms,
approximately 50 per cent of patients succumb to the disease.
Traditional therapy for the treatment of symptomatic aortic stenosis consists of open
aortic valve implantation under general anaesthesia, requiring cardiopulmonary bypass
(surgical AVR). Patients with severe aortic stenosis may, however, be deemed high-risk
or contraindicated for open surgical implantation due to numerous comorbidities.
Consequently, minimally invasive percutaneous options for the treatment of aortic
stenosis have been developed, including percutaneous transcatheter aortic valve
implantation (TAVI) and sutureless implantable valves.
Sutureless implantable valves are an alternative to traditional AVR and TAVI. These
bioprostheses are mounted on self-expandable nitinol frames which are implanted
following resection of the diseased tissue. The procedure is similar to open AVR as
sternotomy and CPB are still required; however, the sternotomy may be partial or full
and CPB and aortic cross-clamp time may be reduced. Sutureless devices eliminate the
need for many sutures as the valve is maintained in situ by the outward radial force of
the frame.2
The devices summarised in Table 1 are sutureless aortic valves with a CE Mark of
approval, or that have recently been used in clinical trials.
Sutureless Aortic Valve Replacement: August 2012
2
Table 1
Sutureless aortic valves
Device name
Manufacturer
Description
Approval / diffusion status
& relevant clinical trials
ATS 3f Enable®
(now 3f® Aortic
Bioprosthesis)
Medtronic,
Minneapolis, USA
Uses three equine pericardial
leaflets shaped in the form of
a tube attached to a self2
expanding nitinol frame.
CE Mark approval
NCT01116024
Indicated for the replacement
of diseased, damaged, or
malfunctioning native or
3
prosthetic aortic valves.
Perceval S™
Sorin, Italy
Consists of a trileaflet bovine
pericardial valve mounted on
2
an expandable metal frame.
Indicated for medium to high
risk AVR patients for whom
cross-clamp time reduction is
4
critical.
CE Mark approval
NCT01368666
NCT00860730
INTUITY Valve
System™
Edwards
Lifesciences,
Irvine, California,
USA
Consists of a trileaflet bovine
pericardial valve with a
balloon expandable, cloth5
covered stent frame.
CE Mark approval
Arbor Trilogy™
Aortic Valve
System
Arbor Surgical
Technologies,
Irvine, California,
USA
Consists of a trilobal bovine
pericardial valve on a nitinol
6
frame.
Placed in 32 patients as part
of a multi-centre trial.
NCT01445171
Clinical need and burden of disease
Aortic stenosis is the most common type of heart valve disease. In Western populations,
approximately three per cent of people over 75 have severe aortic stenosis and 25 per
cent over 65 have aortic sclerosis. In 2007-2008, 8,073 AVR or replacement procedures
were performed on hospitalised patients in Australia, with an age-standardised rate of
47 per 100,000 for males and 27 per 100,000 for females.7In 2009-2010, there were
7,439 principle diagnoses of aortic stenosis within Australian public hospitals. 8 Table 2
summarises claims for Medicare Benefits Schedule (MBS) items related to AVR; 71 per
cent of claims were for patients aged 65 and older.
In New Zealand, the prevalence of aortic stenosis is approximately one to two per cent
in people aged 65 and over and four per cent in those over 85. From 2008-2011, 3,042
AVR procedures were performed in New Zealand.9 Population projections in 2011
estimated the number of New Zealanders with aortic stenosis to be 10,000, of whom
5,000 were expected to be AVR candidates.9
Sutureless Aortic Valve Replacement: August 2012
3
Table 2
MBS claims for AVR
10
MBS item
number
Descriptor
Claims
Claims for patients
aged 65 and over (%
of total)
38488
Valve replacement with bioprosthesis or mechanical
prosthesis.
2,469
1,905 (77)
38489
Valve replacement with allograft (subcoronary or
cylindrical implant) or unstentedxenograft.
57
6 (10.5)
38556
Repair or replacement of the ascending thoracic aorta
with AVR or repair, and implantation of coronary
arteries.
228
86 (38)
38562
Repair or replacement of the aortic arch and
ascending thoracic aorta, with AVR or repair, without
implantation of coronary arteries.
50
41 (82)
38565
Repair or replacement of the aortic arch and
ascending thoracic aorta, with AVR or repair, and
implantation of coronary arteries.
75
27 (36)
2,879
2,065 (72)
Total
AVR: aortic valve replacement; MBS: Medicare Benefits Schedule
Diffusion of technology in Australia
There is no published evidence to suggest that sutureless AVR surgery is being
performed in Australia.
Comparators
Comparators to sutureless AVR include open AVR and percutaneous replacement
procedures are described in Table 3. Open surgical AVR is the current treatment
standard and the most effective surgical treatment option for patients with
symptomatic aortic stenosis.11
Sutureless Aortic Valve Replacement: August 2012
4
Table 3
Alternative treatment options for aortic stenosis
Comparator
Description
Benefits / risks
Traditional open
AVR (gold
standard)
Full sternotomy and extracorporeal
circulation are required. The surgeon
separates the sternum to expose the
aortic valve. The native valve is
removed and replaced with a
mechanical or biological prosthesis,
11
attached via sutures.
Excellent symptom relief and long-term
survival. However, many patients are poor
surgical candidates due to age,
comorbidities and previous cardiac surgery.
Full sternotomy results in extended hospital
stay, postoperative pain and prolonged
12
recovery.
TAVI
The device is introduced into the aortic
valve using a transfemoral approach.
Once in position, the balloon system is
inflated then deflated and the catheter
13
removed, leaving the valve in place.
Avoids complications associated with open
surgery, and reduces postoperative hospital
stay and recovery period.May be
contraindicated in patients with peripheral
vascular disease. Associated with a high
incidence of major vascular complications
14
and bleeding.
AVR= aortic valve replacement; TAVI =:transcatheter aortic valve implantation
Safety and effectiveness
Martens et al 2
Study description
This prospective, multi-centre case series (level IV evidence) aimed to assess the safety
and effectiveness of the ATS 3f Enable® sutureless bioprosthesis in patients undergoing
AVR with or without concomitant procedures. A total of 140 patients across 10 sites
were enrolled between March 2007 and December 2009 (prior to CE approval in 2010).
Indications for surgery included degenerative native aortic valve disease (n=113; 81%),
rheumatic heart disease (n=24; 17%), abnormality related to prior endocarditis (n=1;
1%) and other aortic valve pathology (n=2; 1%).There were a number of exclusion
criteria such as active endocarditis or other systemic infections and life expectancy ≤ 24
months. Mid-term results are reported, with a total accumulated follow-up of 122
patient-years.
Almost two thirds of patients were female (n=87; 62%), mean age was 76.1 ± standard
deviation of 5.7 years. A complete physical examination, routine chemistry panel and
transthoracic echocardiogram (TTE) were performed at the time of hospital discharge, 36 months post implantation, 11-14 months post implantation, and annually thereafter.
No pre-operative values relating to mean and peak gradient and left ventricular cardiac
output were provided. Pre-operative comorbidities were common, the most prevalent
being systemic hypertension (n=120; 86%), coronary artery disease (n=77; 55%),
hyperlipidaemia (n=64; 46%) and diabetes mellitus (n=43; 31%).
Sutureless Aortic Valve Replacement: August 2012
5
Safety
Adverse events were divided into ‘early’ (less than 30 days postoperatively) and ‘late’
(more than 30 days postoperatively). Late adverse events were expressed as the
number of events according to the total length of follow-up in patient-years.
Five of 140 patients (4%) died within 30 days of surgery; two were classified as valverelated. One of these patients died of multi-organ failure and one of biventricular heart
failure. Early non-fatal adverse events consisted of a single case of cerebrovascular
accident (1%), major paravalvular leak (PVL) prompting valve explantation in three
patients (2%), and minor PVL not requiring surgical intervention in a further three
patients (2%).
In the late postoperative period there were thirteen deaths, two of which were valverelated (2% per patient-year) and resulted in sudden cardiac death. The causes of the
remaining eleven deaths were not reported. Late adverse events consisted of major PVL
in one patient (1% per patient-year) prompting valve explantation, and endocarditis in
three patients (3% per patient-year).
Effectiveness
Valve implantation was achieved using one suture in 119/140 (86%) patients, whereas
three patients (2%) required two or more. Seventeen patients (12%) did not require
sutures. No valve migration or tilting was noted post-implantation. Concomitant
procedures were performed in 42 patients (30%), and consisted primarily of coronary
artery bypass grafting (n=26; 19%), subvalvular myectomy (n=6; 4%) and left atrial
appendage closure (n=5; 4%). Complete median sternotomy was required in 112
patients (80%), with the less invasive partial upper sternotomy performed on 28
patients (20%).
Mean aortic cross-clamp and CPB times were approximately 60 and 85 minutes,
respectively (two centres reported mean cross-clamp and CPB times as low as 37 and 55
minutes for their stand-alone procedures; n = 34). Cumulative freedom from valverelated mortality and total mortality at one year, were 97 per cent and 85 per cent,
respectively.
The value of all haemodynamic parameters gradually decreased over time following
hospital discharge (Table 4). The severity of cardiac disease was assessed both before
and after surgery using the New York Heart Association (NYHA) functional capacity scale.
Results demonstrate significant improvement post-surgery compared to baseline
(p<0.0001). Prior to surgery, 62 per cent of patients were NYHA class III or IV, dropping
to one per cent at 11-14 months after surgery. Subsequently, the proportion of patients
Sutureless Aortic Valve Replacement: August 2012
6
classified as NYHA class I or II increased from 33 per cent pre-operatively to 99 per cent
at 11-14 months postoperatively (p<0.001). The authors commented that early
haemodynamic data were comparable to those obtained with conventional stented
valves.
Table 4
Haemodynamic parameters as measured using transthoracic
2
echocardiography
Parameter (mean ± SD)
Discharge
3-6 months
11-14 months
Mean gradient (mm Hg)
10.24 ± 4.2
9.04 ± 3.56
8.62 ± 3.16
20.34 ± 8.15
18.21 ± 6.89
16.44 ± 6.0
Effective orifice area (cm )
1.75 ± 0.45
1.69 ± 0.52
1.67 ± 0.44
Indexed effective orifice area
2
2
(cm /m )
0.98 ± 0.26
0.92 ± 0.28
0.92 ± 0.24
Left ventricular cardiac output (L/min)
5.20 ± 1.16
4.57 ± 1.11
4.48 ± 1.0
Left ventricular cardiac index (L/min
2
m)
2.92 ± 0.65
2.51 ± 0.66
2.47 ± 0.6
Peak gradient (mm Hg)
2
SD: standard deviation
Folliguet et al 15
Study description
This case series (level IV evidence) was a prospective, multi-centre study assessing the
safety and effectiveness of the Perceval S™ sutureless bioprosthesis in patients
undergoing AVR. A total of 211 patients aged > 65 years were enrolled between January
2007 and September 2011. Three patients were excluded from the analysis after
receiving a larger annulus (>25 mm) during the procedure, resulting in a final cohort of
208 patients. The indication for surgery was degenerative native aortic valve disease in
all cases.
Mean patient age was 79 ± 5.3 years, and 141 of included patients (68%) were female.
In contrast to Martens et al 2, patients were only eligible for inclusion if they were of
NYHA class III (90%) or IV (10%).
In this mid-term analysis, mean follow-up was 10 ± 20 months, producing a cumulative
total of 156 patient-years. Haemodynamic parameters were assessed using
echocardiography before surgery, at discharge and during follow-up.
Safety
Adverse events were stratified as either early (less than 30 days postoperatively) or late
(more than 30 days postoperatively). For the late postoperative period, adverse events
were calculated as the number of events per 100 patient-years of patient exposure.
Sutureless Aortic Valve Replacement: August 2012
7
There were no intra-procedural deaths. Five patients (2%) died during the hospital stay;
however, none were considered to be valve-related. Twenty patients died during followup but it was not specified how many deaths were valve-related.
Nine patients (4%) experienced peri-operative PVL, seven of which were subsequently
treated with a Perceval S™ bioprosthesis and two with a stented bioprosthesis. A further
nine patients (4%) experienced postoperative PVL which required reoperation; seven
occurred between postoperative days 2-13, one occurred on day 163 and one on day
576. Minor PVL was observed in five patients (2%), the incidence of which was not
separated into early and late cases.
There were nine early (4%) and four late (2%) instances of bleeding, all of which
required transfusions. During follow-up, 10cases of thromboembolism occurred,
consisting of strokes (n=2; 1%), transient ischemic attack (n=1; 0.5%), limb embolism
(n=3; 1%), pulmonary embolism (n=2; 1%) and retinal embolism (n=1; 0.5%).
Pericardial effusion requiring drainage occurred in four patients (n=2%), sepsis requiring
antibiotics in 18 patients (8%), and heart failure requiring inotropic drugs in five patients
(2%). Endocarditis was diagnosed in three patients (1%), two of whom required surgery.
Pacemaker insertion for atrioventricular block was necessary in 16 patients (7%). There
was no valve tipping or migrating, structural prosthetic deterioration, valve thrombosis,
or significant transvalvular aortic regurgitation during the study period.
Effectiveness
Implantation was successful in 199 of 208(96%) patients. Forty-four patients (21%)
received concomitant coronary revascularisation, while48 patients (23%) received
concomitant coronary artery bypass graft (CABG) surgery. The majority of patients
(163/208; 78%) required median sternotomy with the remainder (45/208; 22%)
undergoing less invasive mini-sternotomy. Mean cross-clamp and CPB times were 33.5 ±
13.8 minutes and 54.5 ± 24.2 minutes, respectively. Cumulative freedom from valverelated mortality was 87, 82, 82 and 70 per cent at 1-year, 2-years, 3-years and 4-years,
respectively.
A decrease in aortic pressure gradient and increase in orifice area were observed via TTE
at all follow-up time points (Table 5).
Sutureless Aortic Valve Replacement: August 2012
8
Table 5 Haemodynamic parameters as measured using transthoracic echocardiography
Parameter
Pre-operative
Discharge
3-6 months
1-4 years
Mean gradient (mm Hg)
48.6 ± 18.6
10.4 ± 4.3
8.9 ± 3.2
8.7 ± 3.7
76 ± 29
21.3 ± 8.6
19.6 ± 6.7
18.8 ± 7.6
Effective orifice area (cm )
0.7 ± 0.2
1.4 ± 0.4
1.5 ± 0.4
1.5 ± 0.3
Indexed effective orifice area
2
2
(cm /m )
0.42 ± 0.14
0.85 ± 0.23
0.89 ± 0.24
0.91 ± 0.22
Peak gradient (mm Hg)
2
15
All data reported as mean ± standard deviation.
Prior to implantation, all patients were NYHA class III or IV. In contrast, only 18 per cent
were NYHA class III or IV at the 1-year and 2-year follow-up visits (p<0.0001).
Breitenbachet al6
Study description
This multi-centre pilot study (level IV evidence) assessed the safety and effectiveness of
AVR using the Trilogy™ system. Thirty-two patients were enrolled between November
2006 and November 2008. Mean patient age was 71.7 ± 6.5 years, and 18 of the 32
patients were female (56%). All patients were followed up at 4-6 months, 11-14 months,
and annually thereafter. Sixteen of 32 patients (50%) were NYHA class III or IV prior to
surgery. No information was provided regarding surgical indication, baseline disease
severity or baseline echocardiography.
Safety
There were no intraoperative deaths. One patient died of lung cancer during the followup period and there was an additional death unrelated to the AVR (cause of death not
provided). A second patient developed endocarditis 22 months postoperatively due to a
1.5 cm vegetation at the non-coronary cusp with an abscess below the SecuRing
component of the Trilogy™ system. Reoperation was performed using an aortic
homograft and the patient had an uneventful post-operative course.
Effectiveness
Mean CPB and cross-clamp times were 111 ± 42 minutes and 70 ± 23 minutes,
respectively. Valve implantation was successful in 30 out of 32 patients (94%); however,
explantation of the valve was required in two patients (6%) due to the inability of the
SecuRing to effectively seal the valve crown. This resulted in severe leakage between
the gasket and crown in one of the two patients (3%), and device failure in the other
patient (3%); both patients were converted to conventional AVR. Concomitant CABG
surgery was performed in six patients (19%). Reductions in mean and peak gradient, and
Sutureless Aortic Valve Replacement: August 2012
9
left ventricular outflow diameter, were observed during follow-up (Table 6). During this
same period, effective orifice area increased; however, no measure of statistical
significance was provided.
At baseline, 16 out of 32 (50%) patients were NYHA class III or IV; whereas, at discharge,
only 3 out of 29 (10%) patients were NYHA class III. At 11-14 months, only one of 27
patients (4%)was NYHA class III, with the majority (22/27; 82%) being NYHA class I.
Table 6
Haemodynamic parameters as measured using transthoracic
6
echocardiography
Time interval
Valve
diameter (n)
Mean
gradient (mm
Hg)
Peak gradient
(mm Hg)
Effective
orifice area
2
(cm )
LVOT
diameter (cm)
Discharge
21 mm
(n=10)
10 ± 3 (7-14)
21 ± 8 12-33)
10 ± 4 (5-22)
19 ± 6 (9-35)
1.8 ± 0.3 (1.51.9)
1.8 ± 0.2 (1.61.9)
2.0 ± 0.3 (1.52.6)
1.9 ± 0.1 (1.81.9)
1.9 ± 0.2 (1.72.1)
1.7 ± 0.1 (1.61.7)
2.0 ± 0.3 (1.52.4)
1.8 ± 0.1 (1.61.8)
1.9 ± 0.3 (1.62)
1.7 ± 0.1 (1.71.8)
2.1 ± 0.3 (1.62.6)
1.8 ± 0.1 (1.82.0)
23 mm
(n=19)
3-6 months
21 mm
(n=10)
11 ± 6 (4-24)
21 ± 8 (8-35)
8 ± 4 (4-16)
15 ± 7 (7-31)
23 mm
(n=19)
11-14 months
21 mm (n=8)
10 ± 4 (6-13)
17 ± 6 (9-25)
23 mm
(n=19)
9 ± 4 (5-18)
16 ± 6 (9-30)
Data are reported as mean ± standard deviation. Data ranges are reported in parentheses. LVOT: left ventricular outflow
tract
Cost impact
In New Zealand, a National Health Committee technology note reported that the price
of one device was approximately NZD $16,000 in 2008.9Pricing information has been
requested from the manufacturers of both the Perceval S™ (Sorin Group, Italy) and 3f
Enable® (Medtronic, USA) devices; however, no response has been received.
During the 2010-2011 fiscal year, the average cost of heart valve replacement surgery in
Australia was $47,012, including both hospital and medical service related charges.16
TAVI procedures have been reported to cost €43,600 (approximately $56,200 Australian
dollars, 2012).17 Table 7 provides claims data for MBS 38488 (heart valve replacement).
Sutureless Aortic Valve Replacement: August 2012
10
Table 7
MBS benefits for heart valve replacement
10
MBS item number
Descriptor
Cost
Total benefits paid
2010-11
38488
Valve replacement with
bioprosthesis or mechanical
prosthesis.
Fee: $1,874.00 Benefit:
75% = $1,405.50
$2,249,124
Ethical, cultural or religious considerations
No ethical, cultural or religious considerations were identified.
Other issues
In 2008, Medtronic and Arbor Surgical Technologies Inc. signed an exclusive global
licencing agreement under which the Trilogy™ sutureless AVR device would be
manufactured, marketed and distributed by Medtronic.18 Subsequent to this statement,
Medtronic signed an agreement to acquire ATS Medical (29 April 2010), thereby
inheriting the 3f Enable® platform.19 No evidence is available to suggest that the
Trilogy™ sutureless AVR device is being manufactured or used at this time.
Several clinical trials have been identified involving sutureless AVR devices, namely the
3f Enable®, Perceval S™ and Edwards INTUITY™ (Table 8); however, study completion
dates, where reported, are two years or greater.
On 1 May 2012, the Montreal Heart Institute (MHI) performed minimally-invasive
sutureless AVR (5 cm incisions) on two patients using the Perceval S™ device and both
surgeries were successful. As a result, the MHI is planning on performing 30 similar
procedures in the coming year on elderly patients at high surgical risk.20Several
procedures using sutureless AVR devices have been performed in New Zealand.9
Sutureless Aortic Valve Replacement: August 2012
11
Table 8
Registered clinical trials
Study
Study population
Status and description
Surgical Treatment of Aortic
Stenosis With a Next
Generation Surgical Aortic
Valve (TRITON), using the
Edwards INTUITY™ valve.
Estimated enrolment: 350
Currently recruiting
Endpoint classification: safety
study
This is a two-phase, nonrandomised, prospective,
single arm, multi-centre clinical
investigation. Each subject in
Phase 1 and Phase 2 has
consented for a period of
fiveyears. All subjects will be
assessed for clinical follow-up
at the following intervals:
Discharge, onemonth, three
months, one year and annually
thereafter until five years of
follow-up is achieved per
subject.
NCT01445171
Intervention model: single
group assignment
Masking: open label
Primary purpose: treatment
Study completion date: NR
ATS 3f Enable® Aortic
Bioprosthesis, Model 6000
NCT01116024
(Potentially the study for which
Martens et al (2011) presented
mid-term results)
Estimated enrolment: 173
Active – not recruiting
Allocation: non-randomised
This is a prospective, nonrandomised, multi-centre study
designed to evaluate the
safety and effectiveness of the
ATS 3f Enable® Aortic
Bioprosthesis in patients
undergoing isolated AVR with
or without concomitant
procedures.
Endpoint classification:
Safety/efficacy study
Intervention model: Single
group assignment
Masking: open label
Primary purpose: treatment
Study completion date: August
2014
Safety and Effectiveness Study
of Perceval S™ Valve for
Extended CE Mark
(CAVALIER)
NCT01368666
Estimated enrolment: 300
Currently recruiting
Allocation: non-randomised
The primary objective is to
assess the safety and
effectiveness of the Perceval
S™ valve 12 months after
implantation when used to
replace a diseased or
dysfunctional aortic valve or
aortic valve prosthesis.
Endpoint classification:
safety/efficacy study
Intervention model: single
group assignment
Masking: open label
Primary purpose: treatment
PERCEVAL Pivotal Trial
First updated: March 11, 2009
NCT00860730
No changes have been posted
since.
Study completion date:
September 2017
Status unknown
Source: Clinical Trials Database (US) accessed May 2012.
Sutureless Aortic Valve Replacement: August 2012
12
Summary of findings
The evidence included in this technology brief indicates that the sutureless AVR devices
assessed appear to be safe, with a small proportion of patients experiencing
paravalvular leaks and thromboembolic events. Although a higher rate of adverse
events was observed in the Perceval S™ study, the variation in inclusion criteria and
differences in patient baseline characteristics may have contributed (ATS 3f Enable® and
Trilogy™ trials included NYHA class I and II patients, whereas Perceval S™ did not). All
three devices demonstrated continuing reductions in mean and peak gradient over
time. The Perceval S™ and Trilogy™ valves both produced minor increases in effective
orifice area during follow-up, whereas the ATS 3f Enable® valve produced a slight
decrease.
Although results are promising, no comparative studies are available (or planned) that
compare sutureless AVR devices with alternative AVR techniques; however, such a study
may be confounded by differences in baseline patient characteristics due to the slightly
different indication for each procedure. Even so, the use of sutureless AVR devices is
becoming more widespread, as highlighted by their recent use in Canada.
HealthPACT assessment:
Although there are no comparative data, and completion dates for ongoing studies are
distant, the diffusion of this technology may progress in the near future. As such,
HealthPACT recommended that the technology be monitored for 24 months.
Number of studies included
All evidence included for assessment in this Technology Brief has been assessed
according to the revised NHMRC levels of evidence. A document summarising these
levels may be accessed via the HealthPACT web site.
Total number of studies:
Total number of level IV studies:
3
3
References
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Search criteria to be used (MeSH terms)
Sutureless AVR, Perceval, “3f Enable”, aortic valve replacement
Sutureless Aortic Valve Replacement: August 2012
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