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TransApical Transcatheter Aortic Valve Implantation

Source agency:

Agenas (COTE)

Date of Submission:

07/10/2009

Date of Printing:

05/02/2012

Disclaimer:

This report is work in progress and should not be used for external distribution without permission from the originating agency. Users should be aware that reports are based on information available at the time of research and often on a limited literature search.

Technology, Company & Licensing

Technology name:

Edwards Sapien (TM)

Technology - description:

The surgical procedure consists of the insertion of a prosthetic valve which functionally replaces the damaged aortic valve, using fluoroscopic or ecographically-guided percutaneous procedures. The prosthetic valve (which is made from bovine pericardium) comprises of a metallic frame that is mounted within a delivery system that allows the release and positioning of the valve without sutures and without requiring open heart surgery. Today this procedure can be performed using two different approaches: transfemoral (TF) or transapical (TA). The TF-TAVI is performed through the femoral artery. The TA-TAVI (the object of this report) is performed by carrying out a mini-thoracotomy, delivering the valve through the cardiac apex [Walter, 2009].

Company or developer:

Edwards Lifesciences LLC

Reason for database entry:

Transapical transcatheter aortic valve implantation (TA-TAVI) can be considered an emerging technology in Italy and worldwide. TA-TAVI could have a positive impact, when used in the appropriate population.

Technology - stage in early warning process:

Assessment complete

Technology - stage of development:

Nearly established

Licensing, reimbursement and other approval:

The Edwards Sapien gained the CE mark in December 2007. At the time of writing (April 2009)the device has not yet gained FDA approval. The procedure is not reimbursed.

Technology - type(s):

Device

Technology - use(s):

Therapeutic

Patient Indication & Setting

Patient indications:

The procedure TA-TAVI is indicated in patients suffering from severe aortic stenosis with a high risk of death during a conventional surgical procedure. These patients are generally elderly and without treatment have a high risk of death. Their existing co-morbidities influence the risk/benefit ratio of a surgical intervention to replace the aortic valve (cardiopulmonary by-pass, CPB).

Disease description and associated mortality and morbidity:

Calcific aortic stenosis is a common condition in western countries, especially among the elderly. Approximately 50,000 valve replacement procedures are performed annually in Europe and the USA. The prevalence of clinically relevant stenosis is approximately 20% in the age range 65-75, 35% in the age range 75-85 and 48% in patients over 85 [Carabello, 2009]. Without treatment, severe aortic stenosis evolves progressively towards a marked
symptomatology and complete disability with a mean survival rate of 50% and 20% at 2 and 5 years respectively [Carabello, 1997, 2002; Lester, 1998].
To prevent irreversible damage to the cardiac muscle, the calcific aortic stenosis requires surgical intervention, replacing the damaged valve with a prosthetic mechanical or biological valve. Depending on the health of the patient (e.g. age and co-morbidities), in some cases a surgical intervention could entail high risk. The condition of the patient can be classified according to the NYHA (New York Heart Association) classes. NYHA is a functional classification system linking the patient’s symptoms and his quality of life to normal life activities [www.americanheart.org/].
Operative risk is generally assessed by using two main risk models:
- EuroSCORE: the European System for Cardiac Operative Risk Evaluation calculates the predictive operative mortality of patients that undergo cardiac surgery. For high-risk patients, the more accurate logistic EuroSCORE is used. This model can consider also particular combinations of the risk factors [www.euroscore.org/].
- STS score: it is a risk model developed by the Society of Thoracic Surgeons based on
clinical and demographic data in an adult population and used to predict operative
mortality and morbidity after cardiac surgery. The model is based on clinical and
epidemiological data of a given population who have received cardiac surgery [www.sts.org/].
Although these indicators have been validated for several surgical procedures, they may not be suitable for innovative procedures and emerging technologies such as the TAVI [Osswald 2009; Brown 2008].

Number of Patients:

At the 31st of March 2009 104 Ta-TAVI procedures have been performed in Italy.

Technology - specialities(s):

Cardiovascular disease & vascular surgery

Technology - setting(s):

General hospital and ambulatory care

Setting - further information:

The procedure is generally performed in a hospital, in a cardiac operating theatre or a hybrid operating room (sterilised and equipped with specific instrumentations needed for the procedure).

Impact

Alternative and/or complementary technology:

Substitution technology

Current Technology:

In principle, the main comparators are:
- Pharmacological treatment;
- Percutaneous aortic balloon valvuloplasty;
- Surgical aortic valve replacement;
- Transfemoral transcatheter aortic valve implantation (TF-TAVI).
However, a proper comparator cannot be identified since comparative studies are not yet available. At present, the technology is available to high-risk patients but no published studies have demonstrated that TA-TAVI has better outcomes than conventional surgery. To address this issue, in April 2007 a multi-center randomised trial was started: the Placement of AoRtic TraNscathetER Valve Trial (PARTNER trial, NCT00530894). The study aims to enroll 1040 patients across USA, Canada and Germany. Patients will be allocated to two arms: Arm A with
conventional surgery versus percutaneous and transapical treatment; Arm B with percutaneous versus pharmacological treatment [www.clinicaltrial.gov].

Health Impact:

The technology could potentially allow treatment for high-risk patients that currently do not receive any definitive treatment (e.g., pharmacological therapy) thereby increasing life expectancy.
Potential benefits could be the mortality reduction or increased survival.

Diffusion:

The Edwards Sapien valve with Ascendra delivery system has been on the Italian
market since January 2008. Italy is the fourth most important market after Germany, France and the UK. The centres that use this technology are distributed in 8 Regions: Campania, EmiIia-Romagna, Friuli Venezia Giulia, Lombardia, Piemonte, Puglia, Toscana, Veneto.

Cost, infrastructure and economic consequences:

The cost of the Edwards Sapien valve with Ascendra delivery system kit, is € 28.000 (+VAT at 4%). The management and costs of personnel training (cardiosurgeon,
interventional cardiologist, anaesthetist, operating room assistant, ecographers) is currently borne by the manufacturer.
The procedure must be performed in the appropriate settings that allow a multidisciplinary approach and patient safety (such as a surgical or hybrid operating suite). A cardiology room
with a haemodinamics laboratory and cardiosurgery suite are required [Vahanian, 2008].
The procedure must be performed by a multidisciplinary staff (cardiac surgeon, interventional cardiologist, anaesthetist, operating room assistant, ecographist), previously trained in the centres designated by the Manufacturer (these are in Germany and France). In particular, the
first operator must be experienced in balloon valvuloplasty, catheterising procedures, biologic valve implantation procedures and must be trained to use the valve-delivery system. The training course and a minimum of 24 cases to treat per year, are indispensable for issuing of the
kits by the manufacturer. These conditions are recommended by the BCIS and SCTS
[http://www.improvement.nhs.uk/heart/] and are related to the learning curve observed in the use of the system [Walther, 2008].

Ethical, social, legal, political and cultural impact:

 

Evidence & Policy

Clinical evidence and safety:

Initial searches were run on the CRD (DARE & HTA) and EuroScan databases to identify
English language Horizon Scanning reports and rapid Health Technology Assessment reports on TA-TAVI.
Three reports on Horizon Scanning and rapid Health Technology Assessment were identified.
The reports were produced in Australia [ANZHSN, 2007, update 2008], Belgium [KCE, 2008] and UK [NICE, 2008] during 2007-2008. Another report (written in French) was identified by the manufacturer [HAS, 2007].
The EMBASE, Medline, and Cochrane Library databases were searched, starting from the 1st January 2008. We did not search again for the original studies already assessed in the retrieved HTA reports and simply reported their extraction of data in our table of evidence (table 1). Table 1 reports an example of some of the variables of interest. Type of studies consisted of 2 case-series, the first was a multi-center study carried out across different countries [Walther, 2007, 2008], and one a feasibility study [Svensson, 2008]. This is the only study assessing the use of the equine pericardium valve, the others report the use of bovine pericardium. Five studies were retrieved from other reports (and included in the Table 1): four studies were case-series [Zierer, 2008; Spargias, 2008; Ye, 2008; Walther, 2009], and one study was referred to a prospective register [Rodés-Cabau, 2008]. The number of patients in the studies ranged from 4 to 59 ([Spargias, 2008] and [Walther, 2007] respectively). Three out of eight studies reported
outcomes at 12 months of follow-up [Walther, 2008; Ye, 2008; Walther, 2009].

Economic evaluation:

 

Ongoing research:

As TA -TAVI is an emerging technology, we analysed “grey literature” (such as registers and abstracts of presentations at meetings) documents, notwithstanding that this kind of literature may be considered less authoritative than peer reviewed published literature.
A European register (SOURCE) (started in November 2007) is operating in 12 countries (including Italy) and is managed by the Manufacturer. By October 2008 SOURCE had registered 309 TA-TAVI procedures; 30-days survival was 88.4%. In addition, improvements in NYHA class at 6 months (27 out of the 65 patients treated) were reported in the multicentric study PARTNER EU.

Ongoing or planned HTA:

 

Web link:

http://www.agenas.it/cote.html

References and sources:

1. Australia and New Zealand Horizon Scanning Network (ANZHSN), Zamora L. Hirizon scanning technology prioritising summary. Percutaneous aotic valve replacement. Canberra:Australian
Government; 2007. (2008 update).

2. Brown ML, Schaff HV, Sarano ME et al. Is the European System for Cardiac Operative Risk Evaluation model valid for estimating the operative risk of patients considered for percutaneous aortic valve replacement? J Thorac Cardiovasc Surg 2008;136:566-571

3. Carabello BA, Crawford FA. Valvular Heart Disease. N Engl J Med 1997; 337(1):32.

4. Carabello BA. Aortic stenosis. N Engl J Med 2002; 346(9):677-682.

5. Carabello BA, Paulus WJ. Aortic stenosis. The Lancet 2009;373:956-966

6. Chiam PTL, Ruiz CE. Percutaneous transcatheter aortic valve implantation: Evolution of the technology. Am Heart J 2009;157:229-42

7. Haute Autorité de Santé (HAS). Commission d’evaluation des produits et prestations, avis de la commission:EDWARS SAPIEN 9000TFX, valve aortique péricardique bovine à implantation transfémorale. 2007 (decembre)

8. KCE, Implantation percutanée des valvules cardiaques dans le cas de maladies valvulaires congénitales et dégénératives: A rapid Health Technology Assessment. Dicembre 2008.

9. Lester SJ. The natural history and rate of progression of aortic stenosis. Chest 1998;113(4): 1109-1114.

10. National Institute for Health and Clinical Excellence. Transcatheter aortic valve implantation for aortic stenosis. Giugno 2008.

11. Osswald BR, Gegouskov V, Badowski-Zyla D, et al. Overestimation of aortic valve replacement risk by EuroSCORE: implications for percutaneous valve replacement, European Heart Journal 2009 30(1):74-80.

12. Rodes-Cabau J, Dumont E, De LaRochelliere R, et al. Feasibility and Initial Results of Percutaneous Aortic Valve Implantation Including Selection of the Transfemoral or Transapical
Approach in Patients With Severe Aortic Stenosis, American Journal of Cardiology,
2008;102(9):1240-1246.

13. Spargias K, Manginas A, Pavlides G, et al. Transcatheter aortic valve implantation: first Greek experience. Hellenic J Cardiol, 2008;49(6):397-407.

14. Svensson LG, Dewey T, Kapadia S, et al. United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex. Ann Thorac Surg. 2008;86(1):46-54.

15. Vahanian A, Alfieri O, Al-Attar N et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European
Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur. Heart J. First
published online 12 May 2008;

16. Walther T, Simon P, Dewey T, et al. Transapical minimally invasive aortic valve implantation: multicenter experience. Circulation. 2007;116(11 Suppl):I240-5.

17. Walther T, Falk V, Kempfert J, Borger et al. Transapical minimally invasive aortic valve implantation; the initial 50 patients. Eur J Cardiothorac Surg. 2008;33(6):983-8.

18. Walther T, Dewey T, Borger MA et al. Transapical Aortic Valve Implantation: Step by Step Ann Thorac Surg 2009;87:276-283.

19. Walther T, Falk V, Borger M.A, et al. Transapical aortic implantation in patiets requiring redo surgery. European Journal of Cardio-thoracic Surgery, in press.

20. Ye J., Cheung A, Lichtenstein SV et al. Transapical transcatheter aortic valve implantation: 1-year outcome in 26 patients ,Journal of Thoracic and Cardiovascular Surgery, 2009;137(1):167-173.

21. Zierer A, Wimmer-Greinecker G, Martens S, et al, The transapical approach for aortic valve implantation, Journal of Thoracic and Cardiovascular Surgery, 2008;136(4):948-953.

Notes:

This report is based on information available when the searches were made and does not
contain data on subsequent developments or improvements of the evaluated technology. The
observations made on effectiveness, safety or cost-effectiveness of the technology evaluated in the report are to be considered temporary.