Subscribe to RSS
DOI: 10.1055/s-0032-1322621
Indication and Structures and Management of Transcatheter Aortic Valve Implantation: A Review of the Literature
Publication History
19 March 2012
03 April 2012
Publication Date:
28 August 2012 (online)
Abstract
Background Transcatheter aortic valve implantation (TAVI) is a new treatment option for patients with severe symptomatic aortic stenosis. Despite a lack of scientific evidence for a benefit of the procedure compared with surgical valve replacement or repair as the current gold standard and pending questions about safety and long-term results, a continuous and remarkable increase of its application in Germany can be observed.
Methods In a systematic research, publications suitable for the deduction of criteria for indication and structural and process standards were identified.
Results No appropriate studies exist to define scientifically sound criteria for indication and structural and process standards for TAVI. Two randomized controlled trials give hints for potential patient selection criteria. However, several interdisciplinary position statements of the most relevant scientific societies in Europe and North America provide recommendations for indication criteria and minimum structural and process requirements. TAVI should be used only in patients with contraindications for open surgery or highest perioperative risk. Multidisciplinary heart teams comprising at least one cardiac surgeon and one cardiologist are mandatory for patient selection and performance of TAVI. Structural equipment to carry out immediate open heart surgery is mandatory. Most recommendations require performing TAVI only in hospitals with a cardiac surgery unit. Participation in a registry is recommended.
Conclusion Currently, TAVI should be restricted to patients with severe symptomatic aortic valve stenosis and contraindications against open heart surgery or maximum perioperative risk. The surgical risk should be assessed by a multidisciplinary team. The procedure should be performed by interdisciplinary heart teams in hospitals with a cardiac surgery unit.
-
References
- 1 Cribier A, Eltchaninoff H, Bash A , et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002; 106 (24) 3006-3008
- 2 Coeytaux RR, Williams Jr JW, Gray RN, Wang A. Percutaneous heart valve replacement for aortic stenosis: state of the evidence. Ann Intern Med 2010; 153 (5) 314-324
- 3 Vahanian A, Baumgartner H, Bax J , et al; Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology; ESC Committee for Practice Guidelines. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur Heart J 2007; 28 (2) 230-268
- 4 Holmes Jr DR, Mack MJ ; Writing Committee. Transcatheter valve therapy: a professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. Ann Thorac Surg 2011; 92 (1) 380-389
- 5 Smith CR, Leon MB, Mack MJ , et al; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364 (23) 2187-2198
- 6 Federal Statistical Office. TAVI. Data provided on specific request from October 19, 2011.
- 7 AQUA-Institute. National Results for 2009. Aortic valve surgery, isolated, transcatheter. 2010. Available at: http://www.sqg.de/downloads/Bundesauswertungen/2009/bu_Gesamt_HCHAb_2009.pdf . Accessed February 19, 2012
- 8 AQUA-Institute. National Results for 2010. Aortic valve surgery, isolated, transcatheter. 2011 . Available at: http://www.sqg.de/downloads/Bundesauswertungen/2010/bu_Gesamt_HCH-AORT-KATH_2010.pdf . Accessed February 19, 2012
- 9 Cavallo A, Cerbo M, Jefferson T, Lo Scalzo A, Migliore A, Ratti M. TransApical Transcatheter Aortic Valve Implantation. Rome: Agenzia nazionale per i servizi sanitari regionali; 2009. . Available at: http://www.salute.gov.it/imgs/C_17_pagineAree_1394_listaFile_itemName_3_file.pdf . Accessed February 19, 2012
- 10 CCOHTA/Canadian Coordinating Office for Health Technology Assessment. Percutaneous heart valve replacement. Emerging technology list. 2005. http://www.cadth.ca/media/pdf/390_No28_heartvalve_replacement_e.pdf . Accessed February 19, 2012
- 11 HAS/Haute Autorité de Santé. Évaluation des bioprothèses valvulaires aortiques implantées par voie rétrograde transfémorale et transapicale. 2008. Available at: http://www.has-sante.fr/portail/upload/docs/application/pdf/rapport_valves_2008.pdf . Accessed February 19, 2012
- 12 Health Technology Inquiry Service. Percutaneous heart valve replacement for valvular heart disease: a review of the clinical effectiveness, cost-effectiveness, and guidelines. Ottawa, Canada: Canadian Agency for Drugs and Technologies in Health; 2010. . Available at: http://www.cadth.ca/media/pdf/l0149_percutaneous_heart_valves_htis-2.pdf . Accessed February 19, 2012
- 13 Federaal Kenniscentrum voor de Gezondheidszorg. Percutaneous Heart Valve Implantation in Congenital and Degenerative Valve Disease. A Rapid Health Technology Assessment. KCE reports 95C. Brüssel, Belgium; 2008. Available at: http://kce.fgov.be/sites/default/files/page_documents/d20081027381.pdf . Accessed February 19, 2012
- 14 McGregor M, Esfandiari S. Transcatheter Aortic Valve Implantation (TAVI) at the MUHC: a Health Technology Assessment. Montreal, Canada: McGill University Health Centre; 2009. . Available at: http://www.mcgill.ca/files/tau/TAVI_REPORT.pdf . Accessed February 19, 2012
- 15 Williams JW, Coeytaux R, Wang A, Glower DD. Percutaneous Heart Valve Replacement. Rockville, MD: Agency for Healthcare Research and Quality, 2010. Technical Brief No. 2. Prepared by Duke Evidence-based Practice Center under Contract No. 290–02–0025. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/66/492/TechBrief_PercutaneousHeart_final.pdf . Accessed February 19, 2012
- 16 Zamora L. Percutaneous Aortic Valve Replacement. Horizon Scanning Technology. Prioritising Summary. Canberra, Australia: Department of Health, Australian Government. 2007. Updated August 2009. Available at: http://www.health.gov.au/internet/horizon/publishing.nsf/Content/A21BB57C2AA8FA71CA2575AD0080F3DF/$File/PS%20Update%20Percutaneous%20aortic%20valve%20replacement.pdf . Accessed February 19, 2012
- 17 Figulla L, Neumann A, Figulla HR, Kahlert P, Erbel R, Neumann T. Transcatheter aortic valve implantation: evidence on safety and efficacy compared with medical therapy. A systematic review of current literature. Clin Res Cardiol 2011; 100 (4) 265-276
- 18 Van Brabandt H, Neyt M. Safety of percutaneous aortic valve insertion. A systematic review. BMC Cardiovasc Disord 2009; 9: 45
- 19 Wild C, Langley T, Gartlehner G. Minimal-invasiver perkutaner Aortenklappenersatz. Vienna, Austria: Ludwig Boltzmann Institut für Health Technology Assessment; 2008. Decision Support Document Nr. 18. ISSN online 1998–0469. Available at: http://eprints.hta.lbg.ac.at/766/1/DSD_18.pdf . Accessed February 19, 2012
- 20 Yan TD, Cao C, Martens-Nielsen J , et al. Transcatheter aortic valve implantation for high-risk patients with severe aortic stenosis: a systematic review. J Thorac Cardiovasc Surg 2010; 139 (6) 1519-1528
- 21 Leon MB, Smith CR, Mack M , et al. PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363 (17) 1597-1607
- 22 British Cardiovascular Intervention Society (BCIS), Society of Cardiothoracic Surgeons (SCTS). Transcatheter Aortic Valve Implantation (TAVI). A position statement of the British Cardiovascular Intervention Society (BCIS) and the Society of Cardiothoracic Surgeons (SCTS). March 2009. Available at: http://www.bcis.org.uk/resources/documents/BCIS%20SCTS%20position%20statement.pdf . Accessed February 19, 2012
- 23 Figulla HR, Cremer J, Walther T , et al. Positionspapier zur kathetergeführten Aortenklappenintervention. Kardiologe 2009; 3: 199-206
- 24 NICE National Institute for Clinical Excellence. Transcatheter aortic valve implantation for aortic stenosis. 2008. http://www.nice.org.uk/nicemedia/live/11914/41020/41020.pdf . Accessed February 19, 2012
- 25 Rosengart TK, Feldman T, Borger MA , et al; American Heart Association Council on Cardiovascular Surgery and Anesthesia; American Heart Association Council on Clinical Cardiology; Functional Genomics and Translational Biology Interdisciplinary Working Group; Quality of Care and Outcomes Research Interdisciplinary Working Group. Percutaneous and minimally invasive valve procedures: a scientific statement from the American Heart Association Council on Cardiovascular Surgery and Anesthesia, Council on Clinical Cardiology, Functional Genomics and Translational Biology Interdisciplinary Working Group, and Quality of Care and Outcomes. Research Interdisciplinary Working Group. Circulation 2008; 117 (13) 1750-1767
- 26 Santoro G, Vitali E, Tamburino C , et al; Italian Federation of Cardiology; Italian Society for Cardiac Surgery. Impianto transcatetere di protesi valvolare aortica in pazienti con stenosi valvolare severa sintomatica. Documento di Consenso Federazione Italiana di Cardiologia (FIC) - Società Italiana di Chirurgia Cardiaca (SICCH). G Ital Cardiol (Rome) 2010; 11 (1) 45-53
- 27 Vahanian A, Alfieri O, Al-Attar N , et al; European Association of Cardio-Thoracic Surgery; European Society of Cardiology; European Association of Percutaneous Cardiovascular Interventions. 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 2008; 29 (11) 1463-1470
- 28 Wisser W, Gabriel H, Mächler H , et al. Positionspapier der OKG und ÖGTHC zu katheterunterstützten Herzklappeninterventionen. 2010 . Available at: http://www.atcardio.at/fileadmin/content_atcardio/img/newsletter/Positionspapier-%C3%96KG%2B%C3%96GTHC-2010.pdf . Accessed February 19, 2012
- 29 Institute for Quality and Efficiency in Health Care. Allgemeine Methoden 4.0. 2011. Available at: http://www.iqwig.de/download/IQWiG_Methoden_Version_4_0.pdf . Accessed February 20, 2012
- 30 Oxford Centre for Evidence-based Medicine. Levels of evidence. 2009. Available at: http://www.cebm.net/index.aspx?o=1025 . Accessed February 20, 2012
- 31 Gliklich RE, Dreyer NA , eds. Registries for Evaluating Patient Outcomes: A User's Guide. 2nd ed. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. d/b/a Outcome] under Contract No. HHSA29020050035I TO3). AHRQ Publication No.10–EHC049. Rockville, MD: Agency for Healthcare Research and Quality; 2010. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/74/531/Registries%202nd%20ed%20final%20to%20Eisenberg%209-15-10.pdf . Accessed February 20, 2012
- 32 German Aortic Valve Registry. Studienprotokoll. 2010 http://www.aortenklappenregister.de/images/pdf/studienprotokoll_aoklreg.pdf . Accessed February 20, 2012
- 33 Miller C. Surgeons caution against overenthusiasm for TAVI in light of PARTNER A stroke data. 2010 http://desertcardiology.com/2011/05/surgeons-caution-against-overenthusiasm-for-tavi-in-light-of-partner-a-stroke-data/ . Accessed February 20, 2012
- 34 GKV-Spitzenverband. Innovationszentren in der GKV-Versorgung. 2011. http://www.gkv-spitzenverband.de/upload/innovation_RZ_16234.pdf . Accessed February 20, 2012
- 35 Döbler K, Boukamp K, Mayer ED. Indikationsstellung, Strukturen und Prozesse für die kathetergestützte Aortenklappenimplantation. Z Herz-Thorax-Gefäßchir 2012; 26: 86-93