Technology Note
Sutureless Aortic Valve Replacement
May 2012
Summary
For the National Health Committee (NHC) to assess sutureless aortic valve replacement, longer
term outcome and cost-effectiveness information is required, as well as further work to ascertain its
feasibility within the New Zealand publicly funded health system. Current use of sutureless aortic
valve replacement within New Zealand should only be conducted under appropriate trial
conditions.
Next Steps
The Australasian Health Policy Advisory Committee on Technology (HealthPACT), of which the
NHC is a member, has contracted the Australian Safety and Efficacy Register of New
Interventional Procedures – Surgical (ASERNIP-S) to produce a technology brief on Sutureless
AVR which should be available later in 2012. HealthPACT is a joint initiative of all Australian
jurisdictions and New Zealand to oversee the early assessment and alert of new and emerging
technologies.
Introduction
This report is intended for the use of clinicians, health planners, funders and policy makers. It
provides background information on the different types of aortic valve replacement (standard
surgical, percutaneous and sutureless) and an overview of the current state of development of
sutureless aortic valve replacement. This includes its present use, the potential future application
of the technology, and its potential impact on the New Zealand health and disability care system.
This summary is a preliminary statement of the safety, effectiveness, cost-effectiveness, and
societal and ethical considerations associated with sutureless aortic valve replacement on the
basis of readily available information.
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Background
Aortic stenosis is a condition where the main outflow valve from the heart thickens and does not
open fully. Restricted blood flow strains the heart and eventually causes breathlessness, chest
pain, blackouts, and heart failure. Once they notice symptoms, from about 501 up to 802 percent
of patients with aortic stenosis will die within two years.
Aortic valve replacement (AVR) is used to treat patients with severe, symptomatic aortic stenosis3.
The current conventional intervention for AVR is open heart surgery via sternotomy using
extracorporeal circulation. However, only about 50 percent of patients with symptoms from their
aortic stenosis are suitable for open-heart surgery1. For the other 50 percent of patients, who
have medical conditions that make it too dangerous to perform open heart surgery, there has
historically been no ARV option available and they face disabling symptoms and frequent hospital
admissions.
Over the last decade there have been developments in the use of percutaneous AVR as an
alternative to surgical AVR, especially in high-risk patients. Percutaneous AVR involves the
implantation of a new valve inside the old one through a catheter inserted into an artery of the
thigh, which only requires a local anaesthetic and has a much shorter recovery time than open
heart surgery. It has been hypothesised that percutaneous technology would allow treatment of
high-risk patients with decreased mortality and morbidity compared to surgical AVR (the in-hospital
mortality rates of surgical AVR range from 3-8% for high risk patients)3. Current evidence,
however, shows that percutaneous methods still carry procedural risk, are not feasible in some
patient groups, and there is uncertainty around the longevity of outcomes3. Transcatheter Aortic
Valve Implantation (TAVI) is a particular percutaneous AVR procedure that has been trialled in
New Zealand and which is starting to diffuse.
Concurrent to the development of percutaneous AVR, there have also been developments in the
area of less invasive surgical AVR. Replacement valves have been developed that incorporate
sutureless fixation which can be delivered using less invasive partial upper sternotomy. While the
concept of sutureless valves has been around since the 1960s, recent developments reflect
current knowledge of aortic anatomy and function, new materials and bioengineering3. Sutureless
AVR is currently in trial phases internationally and has started to be performed in New Zealand.
Description of the technology and procedure
Sutureless valves are maintained in-situ by the radial force of their stent (although depending on
the model, a few sutures may be used to guide the descent of the prosthesis or tied to further
consolidate annular fixation). While still requiring cardiopulmonary bypass, the sternotomy may be
Sutureless Aortic Valve Replacement
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partial rather than full. Delivery is to an arrested heart and the diseased valve and annulus
calcifications are removed. The size of the annulus is measured and the appropriate valve then
implanted under direct visual control. 4
Sutureless AVR allows for rapid deployment, reducing cross clamp and total bypass time, and with
less invasive surgery compared with standard surgical AVR. Sutureless AVR provides surgical
precision of implantation and the removal of the native valve and calcifications compared with
percutaneous AVR.4
Intended purpose
Sutureless AVR provides a treatment option for patients at high-risk from standard surgical AVR,
eg, the elderly with severe comorbidities.3 It could also provide an alternative treatment option to
percutaneous AVR for some patients. Both sutureless and percutaneous AVR have the potential
to expand the patient base compared with the current standard surgical approaches, ie, to current
non-surgical candidates.
Stage of development
The use of sutureless AVR appears to still be in post market trial stages. At least three sutureless
valve devices are currently available3:

ATS 3f Enable valve™ model 6000, manufactured by Medtronic, Minneapolis, USA;

Perceval S™, manufactured by Sorin, Saluggia, Italy;

INTUITY Valve System™, manufactured by Edwards Lifesciences, Irvine, California, USA.
The Medtronic Enable device was developed by ATS Medical before it was acquired by Medtronic
Inc, which since 2009 has also acquired three other companies to build its cardiovascular division
(CoreValve Inc, Ventor Technologies and Invatec)*. Early feasibility studies and trials of the 3f
Enable device were conducted in 20055 and 20066. Following modifications to address
paravalvular leakage, a multicentre clinical trial was conducted between March 2007 and
December 2009 on 140 patients which concluded the device to be safe and of clinical utility7.
Enable received European conformity mark (CE) approval in 2010.
Trials of the Sorin Perceval device have been reported since 20078 and it received a CE mark in
early 2011 following pre-commercial clinical studies in 500 patients in 25 cardiac surgery centres
throughout Europe9.
*
While not directly related to sutureless devices, there has been on-going patent litigation between Medtronic and
Edwards Lifesciences over their competing TAVI systems.
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The Edwards Intuity device had a European feasibility study initiated in 2010 (TRITON) and
received a CE mark in 201210.
Another sutureless device, the Arbour Trilogy™ Aortic Valve System was reported in a study of 32
patients between 2006 and 200811. In 2008 Medtronic acquired a minor stake in Arbor Surgical
Technologies and announced an exclusive global licensing agreement under which Medtronic
manufacture, markets and distributes Arbour’s bovine pericardial tissue heart valve technologies
while Arbour retains its exclusive rights to the Trilogy system and sutureless implantation
technologies12.
Treatment
The following clinical trials using sutureless AVR are reported as being underway on the US
National Institutes of Health’s ClinicalTrials.gov website.

Safety and Effectiveness Study of Perceval S valve for Extended CE Mark (CAVALIER).
This is an interventional, non-randomised safety/efficacy study with single group assignment,
and in phases 2 & 3 of trial. Subjects are of age >65 years with aortic valve stenosis or stenoinsufficiency. Being conducted in 26 centres over eight European countries, some still
recruiting participants. Estimated primary outcome measure completion date is September
2012. Estimated study completion date is September 2017. Identifier NCT01368666, first
received June 2011 (but started February 2010).
There was also a Perceval Pivotal trial on a maximum of 150 patients in a minimum of eight
European centres with a reported study start date of January 2009 but no changes have been
posted since March 2009 (Identifier NCT00860730).

ATS 3f Enable Aortic Bioprosthesis, Model 6000. This is an interventional, non-randomised
safety/efficacy study with single group assignment. Subjects are 21+ years requiring isolated
aortic valve replacement with or without concomitant procedures such as coronary artery
bypass or another valve repair. Not recruiting participants. Estimated primary outcome
measure completion date is December 2010. Estimated study completion date is August 2014.
Identifier NCT01116024, first received April 2010 (but started May 2006).

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
(TRITON). This is an interventional safety study with single group assignment. Subjects are
18+ years with aortic valve stenosis or steno-insufficiency requiring a planned replacement.
Being conducted in seven centres over three European countries, all still recruiting participants.
Estimated primary outcome measure completion date is January 2015. Estimated study
completion date is April 2015. Identifier NCT01445171, first received August 2011 (but started
January 2010).
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Treatment Alternatives
For high-risk patients for standard surgical AVR, the current alternative in New Zealand is TAVI. In
high-risk operable patients, similar 1 year mortality rates for open heart surgery and TAVI have
been reported, although with higher rates of stroke after TAVI13. Longer term studies are required
to determine the longevity of TAVI outcomes. For current non-surgical candidates the treatment is
medical management.
Existing comparators
Currently there do not appear to be published studies comparing the different AVR interventions3,
eg, standard surgical vs percutaneous vs sutureless AVR.
Clinical Outcomes
Published trial reports suggest that sutureless AVR results in early significant clinical improvement
in patients, but longer term outcomes are not yet known.
Safety
Published trial reports suggest that sutureless AVR is a feasible intervention and relatively safe,
but not without the levels of risk associated with standard AVR.
Effectiveness
The need for a pacemaker following sutureless AVR is not different from standard surgical AVR, in
comparison to percutaneous AVR which has a higher pacemaker requirement3.
Clinical need and burden of disease
Aortic stenosis is the most common heart valve disease in western countries and prevalence
increases with age3. In New Zealand aortic stenosis is prevalent in approximately 1-2% in the
over-65 population and 4% in the over-85 population14 Assuming New Zealand prevalence rates
of 0.5%, 1%, 2%, 3%, 4% and 5% in the 65-69, 70-74, 75-79, 80-85, 85-90 and 90+ year-old ages
groups, respectively, and applying these to Statistics New Zealand 2011 population projections,
the numbers of New Zealand aortic stenosis patients would be around 10,000.
If there are around 10,000 potential aortic stenosis patients in New Zealand, it may be expected
that around 5,000 of these may be candidates for AVR. Current New Zealand annual volumes of
AVR are less than 1,000 (which may include patients requiring replacement of an existing artificial
valve).
While it is unclear what the proportion of current AVR patients would be classified as high risk
surgical candidates, this may be in the order of 10-20 percent (it has previously been estimated
that in New Zealand around 160-200 patients with severe symptomatic aortic stenosis may be
Sutureless Aortic Valve Replacement
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candidates for TAVI annually5). High-risk surgical candidates might be candidates for either
sutureless AVR or TAVI. It is also likely that both these types of interventions will increase the
potential range of patients to include current non-surgical candidates.
New Zealand Use
In the New Zealand publicly funded health system, AVRs are currently provided by the Auckland,
Waikato, Capital and Coast, Canterbury and Southern District Health Boards (DHBs). DHB annual
reported volumes to the National Minimum Dataset (NMDS) for the 2008 to 2011 calendar years
totalled 686, 793, 840 and 723, respectively. The following figure shows crude average annual
AVR intervention rates by the DHB of domicile of patients.
Average Annual Crude Rate per 100,000 Population
Publicly Funded Aortic Valve Replacements
2008-2011
35.0
30.0
25.0
20.0
15.0
10.0
5.0
0.0
Source: NMDS
* Now merged into Southern DHB
Patients DHB of Domicile
In the New Zealand private sector, reported private hospital data indicates that 85 and 67 AVRs
were performed in 2008 and 2009, respectively. The private hospitals these were reported from
were mainly St Georges Hospital, Wakefield Hospital, Mercy Hospital Auckland and Howick Baptist
Healthcare Ltd.
Percutaneous AVR started to be performed in New Zealand in 2008 (specifically TAVI, which was
piloted at Waikato DHB from 2008 to 2010) and in 2011 started to diffuse to other
New Zealand Cardiac centres. Publicly funded annual TAVI reported volumes for 2008 to 2011
were 18, 18, 14 and 33 respectively, the majority being performed in Waikato DHB but with small
numbers reported in 2011 in the Auckland, Canterbury and Southern DHBs. The following figure
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shows the number of publicly funded TAVIs performed by the DHB of domicile of patients for the
2008 to 2011 calendar years.
Total Number of Procedures 2008-2011
Total Publicly Funded TAVIs 2008-2011
50
45
40
35
30
25
20
15
10
5
0
Source: NMDS
* Now merged into Southern DHB
Patients DHB of Domicile
Use of sutureless AVR in New Zealand is difficult to quantify as it cannot be identified through
current national reporting coding systems. However, Sorin’s Perceval device was notified to
MedSafe’s WAND* database in 2011. Analysis of a reported free text field to national hospital
collections has identified two procedures conducted at Canterbury DHB in 2011 using the Perceval
device. These were provided to elderly patients, and one of these was an acute admission. It has
also been reported in the media15 that five sutureless AVR operations have been performed at
Waikato DHB.
The Edwards Intuity device has also been notified to MedSafe’s WAND database in 2012, and
Waikato DHB has recently been approached by Edwards Lifesciences to trial the Intuity device.
*
For medical devices to be legally supplied in New Zealand they must be notified to the Medsafe WAND database
(http://www.medsafe.govt.nz/regulatory/DevicesNew/3WAND.asp). Devices must be notified to the WAND database
within 30 calendar days of their use by the sponsor of the device. A sponsor is a person or organisation that imports
or exports a device or that manufactures or arranges the manufacture of a device in New Zealand. The notification of
medical devices to the WAND database does not constitute an approval process. However, it is mandatory so the
Director-General of Health has details about the medical devices supplied in this country.
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The Medtronic Enable device does not appear to have been notified to MedSafe for use in New
Zealand yet.
Auckland DHB’s Clinical Practice Committee is expecting an application for the use of a sutureless
device, although it is currently unclear which particular device this will be for.
Cost Analysis
Studies are needed to address the cost effectiveness of sutureless valves3.
Although formal published costs for the various devices have not been found, it has been reported
that the price of one device has reduced from an initial NZ$23,000 to around NZ$16,00014. This is
still many times the price of standard devices. Analysis would be required to ascertain whether this
would be covered within the existing publicly funded national pricing methodology for AVR.
In New Zealand the cost of getting a TAVI in the private sector is $50,000-60,000. In comparison,
open heart surgery costs on average $32,000, or $42,000 if there are complications2. Waikato
DHB information suggests that the costs of transarterial and transapical TAVI’s are $41,000 and
$49,000, respectively16.
Societal, Ethical, Cultural and Religious Considerations and other issues
Although no specific issues have been identified in the literature, an analysis of New Zealand data
would be required to identify any ethnic or socio-economic differences in both the prevalence of AS
and in the receipt of AVR interventions.
Because of the trial nature of sutureless AVR, it is expected that any interventions currently being
conducted would have appropriate ethical approval with informed patient consent and data being
reported to some trial register.
Clinical Guidelines
The National Cardiac Surgery Clinical Network has been working with DHBs to develop guidance
on patient selection and prioritisation of urgency in the use of TAVI. Similar work would be
required for sutureless AVRs before any diffusion.
Conclusions
There is insufficient evidence available at this time for the National Health Committee to assess
sutureless AVR. The longer-term benefits and cost effectiveness of sutureless AVR require
evaluation in comparison to conventional surgical and percutaneous methods.
Sutureless AVR has the potential to diffuse into the New Zealand public health system without
appropriate management, but its feasibility and sustainability requires further analysis, particularly
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from workforce and cost perspectives. Current use of sutureless AVR within New Zealand should
only be conducted under appropriate trial conditions.
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References
1.
Waikato Heart Trust (2008). Current Waikato Heart Trust Projects: TAVI 2008,
http://www.waikatohearttrust.org.nz/index.asp?pageID=2145865519.
2.
New Zealand Herald (2008). ‘Good as new’ a day after heart op, 21 August 2008,
http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10528192&pnum=0.
3.
Zannis, K., T. Folliguet, et al (2012). New sutureless aortic valve prosthesis: another tool in less
invasive aortic valve replacement. Current Opinion in Cardiology 27(2): 125-129 Mar.
4.
Al-Attar N. (2012). “Next Generation Surgical Aortic Biological Prostheses: “Sutureless Valves”. An
article from the e-journal of the ESC Council for Cardiology Practice.
http://www.escardio.org/communities/councils/ccp/e-journal/volume10/Pages/Next-generationsutureless-aortic-biological-prosthesis-sutureless-valves-Nawwar-Al-Attar.aspx.
5.
Wendt, D., M. Thielmann, et al. (2008). First clinical experience and 1-year follow-up with the
sutureless 3F-Enable aortic valve prosthesis. European Journal of Cardio-Thoracic Surgery 33(4):
542-547 Apr.
6.
Leyh, R., C. Yildirim, et al. (2006). "Early single-center experience with the 3F-enable aortic valve
bioprosthesis." Herz 31(5): 423-428 Aug.
7.
Martens, S., J. Sadowski, et al. (2011). Clinical experience with the ATS 3f Enable [REGISTERED]
Sutureless Bioprosthesis. European Journal of Cardio-Thoracic Surgery 40(3): 749-755 Sep.
8.
Shrestha, M., T. Folliguet, et al. (2009). "Sutureless Perceval S aortic valve replacement: a
multicenter, prospective pilot trial." Journal of Heart Valve Disease 18(6): 698-702 Nov.
9.
Sorin Group (2011). http://www.sorin.com/press-release/sorin-group-receives-ce-mark-approvalinnovative-self-anchoring-aortic-heart-valve-perceval-s.
10.
Edwards Lifesciences( 2012).
http://www.edwards.com/_layouts/Edwards.Moss.Web.WebApp/PrintNrForm.aspx?guid=b9d7acf
2-821c-46c2-8be9-f4b9541482b5&webUrl=http://www.edwards.com/NewsRoom.
11.
Breitenbach, I., G. Wimmer-Greinecker, et al. (2010). Sutureless aortic valve replacement with the
Trilogy Aortic Valve System: multicenter experience. Journal of Thoracic & Cardiovascular Surgery
140(4): 878-884 2010 Oct.
12.
Medtronic Inc. (2008).
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1201526995378&lang=en
_US
13.
British Medical Journal Open (2012). http://bmjopen.bmj.com/content/2/3/e001032.full
14.
National Service and Technology Review Advisory Committee (2008). NSTR recommendations for
the introduction of a TAVI programme for high-risk surgical patients with severe aortic stenosis,
April 2008.
15.
Waikato Times (2012). ‘Waikato surgeon makes heart history’, 28 April 2012.
16.
S Pasupati et al (2010). Early Experience with TAVI in Waikato Hospital, powerpoint presentation.
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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 reformed in 2011 to establish evaluation systems
that would provide the New Zealand people and health sector with greater value for the money
invested in health. The NHC Executive are the secretariat that supports the Committee. The
NHC Executive’s primary objective is to provide the Committee with sufficient information for
them to prioritise interventions and make investment and disinvestment decisions. They do this
through a variety of products including Prioritising Summaries, Technology Notes, EpiNotes,
CostNotes, Rapid Reviews, and Health Technology Assessments which are chosen according
to the nature of the decision required and time-frame within which decisions need to be made.
Citation: National Health Committee.2012. NHC Technology Note for Sutureless Aortic Valve
Replacement
Published in May 2012 by the National Health Committee
PO Box 5013, Wellington, New Zealand
This document is available on the National Health Committee’s website:
http://www.nhc.health.govt.nz/
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