on November 25, 2002
Circulation. 2002
Published online before print November 25, 2002, doi: 10.1161/01.CIR.0000047200.36165.B8
Published online before print November 25, 2002, doi: 10.1161/01.CIR.0000047200.36165.B8
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Submitted on September 5, 2002
From the Department of Cardiology (A.C., H.E., C.T., F.B., G.D., F.A.), Charles Nicolle Hospital, University of Rouen, Rouen, France; the Centre d'Experimentation et de Recherche Appliquée (CERA) (N.B., F.L.), Institut Montsouris, Paris, France; the Cardiovascular Research Foundation (M.B.L.), Lenox Hill Hospital, New York, NY; and Percutaneous Valve Technologies, Fort Lee, NJ (A.B.). * To whom correspondence should be addressed. E-mail: Alain.Cribier{at}chu-rouen.fr.
Background—The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results. Methods and Results—With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation. Conclusions—Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.
Revised on October 18, 2002
Accepted on October 20, 2002
Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis. First Human Case Description
Alain Cribier MD*,
Key words: stenosis, aortic • valves, prosthetic • prosthesis • catheterization
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E. Grube, G. Schuler, L. Buellesfeld, U. Gerckens, A. Linke, P. Wenaweser, B. Sauren, F.-W. Mohr, T. Walther, B. Zickmann, et al. 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., July 3, 2007; 50(1): 69 - 76. [Abstract] [Full Text] [PDF]
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L. Coats and P. Bonhoeffer NEW PERCUTANEOUS TREATMENTS FOR VALVE DISEASE Heart, May 1, 2007; 93(5): 639 - 644. [Full Text] [PDF]
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F. di Marco and G. Gerosa Percutaneous aortic valve replacement: Which patients are suitable for it? A quest for a controlled use J. Thorac. Cardiovasc. Surg., February 1, 2007; 133(2): 294 - 298. [Full Text] [PDF]
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M. J. Antunes Off-pump aortic valve replacement with catheter-mounted valved stents.: Is the future already here? Eur. J. Cardiothorac. Surg., January 1, 2007; 31(1): 1 - 3. [Full Text] [PDF]
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T. Walther and F. W. Mohr Aortic valve surgery: time to be open-minded and to rethink Eur. J. Cardiothorac. Surg., January 1, 2007; 31(1): 4 - 6. [Full Text] [PDF]
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F. Beyersdorf Transapical transcatheter aortic valve implantation Eur. J. Cardiothorac. Surg., January 1, 2007; 31(1): 7 - 8. [Full Text] [PDF]
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T. Walther, V. Falk, M. A. Borger, T. Dewey, G. Wimmer-Greinecker, G. Schuler, M. Mack, and F. W. Mohr Minimally invasive transapical beating heart aortic valve implantation -- proof of concept Eur. J. Cardiothorac. Surg., January 1, 2007; 31(1): 9 - 15. [Abstract] [Full Text] [PDF]
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J. Ye, A. Cheung, S. V. Lichtenstein, S. Pasupati, R. G. Carere, C. R. Thompson, A. Sinhal, and J. G. Webb Six-month outcome of transapical transcatheter aortic valve implantation in the initial seven patients Eur. J. Cardiothorac. Surg., January 1, 2007; 31(1): 16 - 21. [Abstract] [Full Text] [PDF]
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Y. Lamarche, R. Cartier, A. Y. Denault, A. Basmadjian, C. Berry, J.-C. Laborde, and R. Bonan Implantation of the CoreValve Percutaneous Aortic Valve Ann. Thorac. Surg., January 1, 2007; 83(1): 284 - 287. [Abstract] [Full Text] [PDF]
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M. Handke, G. Heinrichs, U. Moser, F. Hirt, F. Margadant, F. Gattiker, C. Bode, and A. Geibel Transesophageal Real-Time Three-Dimensional Echocardiography: Methods and Initial In Vitro and Human In Vivo Studies J. Am. Coll. Cardiol., November 21, 2006; 48(10): 2070 - 2076. [Abstract] [Full Text] [PDF]
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E. Grube, J. C. Laborde, U. Gerckens, T. Felderhoff, B. Sauren, L. Buellesfeld, R. Mueller, M. Menichelli, T. Schmidt, B. Zickmann, et al. Percutaneous Implantation of the CoreValve Self-Expanding Valve Prosthesis in High-Risk Patients With Aortic Valve Disease: The Siegburg First-in-Man Study Circulation, October 10, 2006; 114(15): 1616 - 1624. [Abstract] [Full Text] [PDF]
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S. V. Lichtenstein, A. Cheung, J. Ye, C. R. Thompson, R. G. Carere, S. Pasupati, and J. G. Webb Transapical Transcatheter Aortic Valve Implantation in Humans: Initial Clinical Experience Circulation, August 8, 2006; 114(6): 591 - 596. [Abstract] [Full Text] [PDF]
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T. Attmann, R. Quaden, T. Jahnke, S. Muller-Hulsbeck, A. Boening, J. Cremer, and G. Lutter Percutaneous Pulmonary Valve Replacement: 3-Month Evaluation of Self-Expanding Valved Stents Ann. Thorac. Surg., August 1, 2006; 82(2): 708 - 713. [Abstract] [Full Text] [PDF]
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T. M. Dewey, T. Walther, M. Doss, D. Brown, W. H. Ryan, L. Svensson, T. Mihaljevic, R. Hambrecht, G. Schuler, G. Wimmer-Greinecker, et al. Transapical aortic valve implantation: an animal feasibility study. Ann. Thorac. Surg., July 1, 2006; 82(1): 110 - 116. [Abstract] [Full Text] [PDF]
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T. Walther, T. Dewey, G. Wimmer-Greinecker, M. Doss, R. Hambrecht, G. Schuler, F. W. Mohr, and M. Mack Transapical approach for sutureless stent-fixed aortic valve implantation: experimental results. Eur. J. Cardiothorac. Surg., May 1, 2006; 29(5): 703 - 708. [Abstract] [Full Text] [PDF]
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S. V. Lichtenstein Closed heart surgery: Back to the future J. Thorac. Cardiovasc. Surg., May 1, 2006; 131(5): 941 - 943. [Full Text] [PDF]
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J. Ye, A. Cheung, S. V. Lichtenstein, R. G. Carere, C. R. Thompson, S. Pasupati, and J. G. Webb Transapical aortic valve implantation in humans J. Thorac. Cardiovasc. Surg., May 1, 2006; 131(5): 1194 - 1196. [Full Text] [PDF]
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A. Cribier, H. Eltchaninoff, C. Tron, F. Bauer, C. Agatiello, D. Nercolini, S. Tapiero, P.-Y. Litzler, J.-P. Bessou, and V. Babaliaros 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., March 21, 2006; 47(6): 1214 - 1223. [Abstract] [Full Text] [PDF]
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C. H. Huber and L. K. von Segesser Direct Access Valve Replacement (DAVR) -- are we entering a new era in cardiac surgery? Eur. J. Cardiothorac. Surg., March 1, 2006; 29(3): 380 - 385. [Abstract] [Full Text] [PDF]
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T. Feldman Percutaneous Valve Repair and Replacement: Challenges Encountered, Challenges Met, Challenges Ahead Circulation, February 14, 2006; 113(6): 771 - 773. [Full Text] [PDF]
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J. G. Webb, M. Chandavimol, C. R. Thompson, D. R. Ricci, R. G. Carere, B. I. Munt, C. E. Buller, S. Pasupati, and S. Lichtenstein Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery Circulation, February 14, 2006; 113(6): 842 - 850. [Abstract] [Full Text] [PDF]
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D. G. Pennington The Impact of New Technology on Cardiothoracic Surgical Practice Ann. Thorac. Surg., January 1, 2006; 81(1): 10 - 18. [Full Text] [PDF]
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