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).
[en] AIMS: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. METHODS AND RESULTS: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. CONCLUSION: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Vahanian, Alec
Alfieri, Ottavio
Al-Attar, Nawwar
Antunes, Manuel
Bax, Jeroen
Cormier, Bertrand
Cribier, Alain
De Jaegere, Peter
Fournial, Gerard
Kappetein, Arie Pieter
Kovac, Jan
Ludgate, Susanne
Maisano, Francesco
Moat, Neil
Mohr, Friedrich
Nataf, Patrick
Pierard, Luc ; Université de Liège - ULiège > Département des sciences cliniques > Cardiologie - Pathologie spéciale et réhabilitation
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).
Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet 2006;368:1005-1011.
Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Bärwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on valvular disease. Eur Heart J 2003;24:1231-1243.
American College of Cardiology/American Heart Association Task Force on Practice Guidelines, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography Interventions, Society of Thoracic Surgeons; Bonow RO, Carabello BA, Kanu C, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 Guidelines for the Management of Patients with Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation 2006;114:e84-e231.
Vahanian A, Baumgartner H, Bax J, Butchart E, Dion R, Filippatos G, Flachskampf F, Hall R, Iung B, Kasprzak J, Nataf P, Tornos P, Torracca L, Wenink A. Task Force on the Management of Valvular Heart 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;28:230-268.
Kolh P, Kerzmann A, Honore C, Comte L, Limet R. Aortic valve surgery in octogenarians: predictive factors for operative and long term results. Eur J Cardiothorac Surg 2007;31:600-606.
Melby SJ, Zierer A, Kaiser YP, Guthrie TJ, Keune JD, Schuessler RB, Pasque MK, Lawton JS, Moazami N, Moon MJ, Damiano RJ Jr. Aortic valve replacement in octogenarians. Risk factors for early and late mortality. Ann Thorac Surg 2007;83:1651-1657.
Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, Gohlke-Bärwolf C, Boersma E, Ravaud P, Vahanian A. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 2005;26:2714-2720.
Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002;106:3006-3008.
Vassiliades TA Jr, Block PC, Cohn LH, Adams DH, Borer JS, Feldman T, Holmes DR, Laskey WK, Lytle BW, Mack MJ, Williams DO; Society of Thoracic Surgeons (STS), American Association for Thoracic Surgery (AATS), Society for Cardiovascular Angiography Interventions (SCAI), American College of Cardiology Foundation (ACCF), American Heart Association (AHA). The clinical development of percutaneous heart valve technology: a position statement of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI). Ann Thorac Surg 2005;79:1812-1818.
Rosengart TK, Feldman T, Borger MA, Vassiliades TA Jr, Gillinov AM, Hoercher KJ, Vahanian A, Bonow RO, O'Neill W. 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;117:1750-1767.
De Jaegere P, Van Dijk LC, Laborde JC, Sianos G, Orellana Ramos FJ, Lighart J, Kappetein AP, van der Ent M, Serruys PW. True percutaneous implantation of the CoreValve aortic valve prosthesis by the combined use of ultrasound guided vascular access, Prostar® XL and the TandemHeart®. EuroIntervention 2007;2:500-505.
Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol 2004;43:698-703.
Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, Tapiero S, Litzler PY, Bessou JP, Babaliaros V. Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol 2006;47:1214-1223.
Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation 2006;114:1616-1624.
Webb JG, Chandavimol M, Thompson CR, Ricci DR, Carere RG, Munt BI, Buller CE, Pasupati S, Lichtenstein S. Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation 2006;113:842-850.
Webb JG, Pasupati S, Humphries K, Thompson C, Altwegg L, Moss R, Sinhal A, Carere RG, Munt B, Ricci D, Ye J, Cheung A, Lichtenstein SV. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation 2007;116:755-763.
Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol 2007;50:69-76.
Lichtenstein SV, Cheung A, Ye J, Thompson CR, Carere RG, Pasupati S, Webb JG. Transapical transcatheter aortic valve implantation in humans: initial clinical experience. Circulation 2006;114:591-596.
Walther T, Simon P, Dewey T, Wimmer-Greinecker G, Falk V, Kasimir MT, Doss M, Borger MA, Schuler G, Glogar D, Fehske W, Wolner E, Mohr FW, Mack M. Transapical minimally invasive aortic valve implantation: multicenter experience. Circulation 2007;116(suppl.):I240-I245.
Ye J, Cheung A, Lichtenstein SV, Pasupati S, Carere RG, Thompson CR, Sinhal A, Webb JG. Six-month outcome of transapical transcatheter aortic valve implantation in the initial seven patients. Eur J Cardiothorac Surg 2007;31:16-21.
Edwards FH, Peterson ED, Coombs LP, DeLong ER, Jamieson WR, Shroyer ALW, Grover FL. Prediction of operative mortality after valve replacement surgery. J Am Coll Cardiol 2001;37:885-892.
Roques F, Nashef SA, Michel P; EuroSCORE study group. Risk factors for early mortality after valve surgery in Europe in the 1990s: lessons from the EuroSCORE pilot program. J Heart Valve Dis 2001;10:572-577.
STS National Database. STS US Cardiac Surgery Database: 1997 Aortic Valve Replacement Patients: Preoperative Risk Variables. Chicago: Society of Thoracic Surgeons; 2000. http://www.ctsnet.org/doc/3031 (10 May 2006).
Ambler G, Omar RZ, Royston P, Kinsman R, Keogh BE, Taylor KM. Generic, simple risk stratification model for heart valve surgery. Circulation 2005;112:224-231.
Dewey TM, Brown D, Ryan WH, Herbert MA, Prince SL, Mack MJ. Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement. J Thorac Cardiovasc Surg 2008;135:180-187.
Schelbert EB, Vaughan-Sarrazin MS, Welke KF, Rosenthal GE. Hospital volume and selection of valve type in older patients undergoing aortic valve replacement surgery in the United States. Circulation 2005;111:2178-2182.
Lee SJ, Lindquist K, Segal MR, Covinsky KE. Development and validation of a prognostic index for 4-year mortality in older adults. JAMA 2006;295:801-808. Erratum in JAMA;2006:295:1900.
Tops LF, Wood DA, Delgado V, Schuijf JD, Mayo JR, Pasupati S, Lamers FPL, van der Wall EE, Schalij MJ, Webb JG, Bax JJ. Noninvasive evaluation of the aortic root with multislice computed tomography: implications for transcatheter aortic valve replacement. J Am Coll Cardiol Imaging 2008; in press.
Moss RR, Ivens E, Pasupati S, Humphries K, Thompson CR, Munt B, Sinhal A, Webb JG. Role of echocardiography in percutaneous aortic valve implantation. J Am Coll Cardiol Imaging 2008;1:15-24.
Zegdi R, Ciobotaru V, Noghin M, Sleilaty G, Lafont A, Latrémouille C, Deloche A, Fabiani JN. Is it reasonable to treat all calcified stenotic aortic valves with a valved stent? Results form a human anatomic study in adults. J Am Coll Cardiol 2008;51:579-584.
Ludgate S. A user's guide to overcoming roadblocks: the European approval process. EuroIntervention 2006;1(Suppl. A):A79-A80.
Zuckerman BD. The FDA role in the development of percutaneous heart valve technology. EuroIntervention 2006;1(Suppl. A):A75-A78.
Grunkemeier GL, Jin R, Starr A. Prosthetic heart valves: objective performance criteria versus randomised clinical trial. Ann Thorac Surg 2006;82:776-780.
Descoutures F, Himbert D, Lepage L, Iung B, Détaint D, Tchetche D, Brochet E, Castier Y, Depoix JP, Nataf P, Vahanian A. Contemporary surgical or percutaneous management of severe aortic stenosis in the elderly. Eur Heart J 2008; epub ahead of print 6 March.