Circulation. 2002;106:3006-3008
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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(Circulation. 2002;106:3006.)
© 2002 American Heart Association, Inc.
Special Report |
Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis
First Human Case Description
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.).
Correspondence to Pr Alain Cribier, Service de Cardiologie, Hôpital Charles Nicolle, 1 rue de Germont, 76 000, Rouen, France. E-mail Alain.Cribier{at}chu-rouen.fr
Abstract
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.
Key Words: stenosis, aortic • valves, prosthetic • prosthesis • catheterization
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C. H. Huber, L. H. Cohn, and L. K. von Segesser Direct-Access Valve Replacement: A Novel Approach for Off-Pump Valve Implantation Using Valved Stents J. Am. Coll. Cardiol., July 19, 2005; 46(2): 366 - 370. [Abstract] [Full Text] [PDF]
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T. A. Vassiliades Jr, P. C. Block, L. H. Cohn, D. H. Adams, J. S. Borer, T. Feldman, D. R. Holmes, W. K. Laskey, B. W. Lytle, M. J. Mack, et al. 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) Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) J. Am. Coll. Cardiol., May 3, 2005; 45(9): 1554 - 1560. [Full Text] [PDF]
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American College of Cardiology Foundation (ACCF) a, T. A. Vassiliades Jr, P. C. Block, L. H. Cohn, D. H. Adams, J. S. Borer, T. Feldman, D. R. Holmes, W. K. Laskey, B. W. Lytle, et al. 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) J. Thorac. Cardiovasc. Surg., May 1, 2005; 129(5): 970 - 976. [Full Text] [PDF]
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B. Lytle and M. Mack The Future of Cardiac Surgery: The Times, They Are a Changin' Ann. Thorac. Surg., May 1, 2005; 79(5): 1470 - 1472. [Full Text] [PDF]
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T. A. Vassiliades Jr, P. C. Block, L. H. Cohn, D. H. Adams, J. S. Borer, T. Feldman, D. R. Holmes, W. K. Laskey, B. W. Lytle, M. J. Mack, et al. 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., May 1, 2005; 79(5): 1812 - 1818. [Full Text] [PDF]
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M. Pawelec-Wojtalik, L. K. von Segesser, M. Liang, and D. Bukowska Closure of left ventricle perforation with the use of muscular VSD occluder Eur. J. Cardiothorac. Surg., April 1, 2005; 27(4): 714 - 716. [Abstract] [Full Text] [PDF]
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Y. Boudjemline, S. Schievano, C. Bonnet, L. Coats, G. Agnoletti, S. Khambadkone, D. Bonnet, J. Deanfield, D. Sidi, and P. Bonhoeffer Off-pump replacement of the pulmonary valve in large right ventricular outflow tracts: A hybrid approach J. Thorac. Cardiovasc. Surg., April 1, 2005; 129(4): 831 - 837. [Abstract] [Full Text] [PDF]
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J. E. Sousa, M. A. Costa, E. M. Tuzcu, J. S. Yadav, and S. Ellis New Frontiers in Interventional Cardiology Circulation, February 8, 2005; 111(5): 671 - 681. [Full Text] [PDF]
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T. Kuehne, S. Yilmaz, C. Meinus, P. Moore, M. Saeed, O. Weber, C. B. Higgins, T. Blank, E. Elsaesser, B. Schnackenburg, et al. Magnetic resonance imaging-guided transcatheter implantation of a prosthetic valve in aortic valve position:: Feasibility study in swine J. Am. Coll. Cardiol., December 7, 2004; 44(11): 2247 - 2249. [Full Text] [PDF]
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G. Lutter, R. Ardehali, J. Cremer, and P. Bonhoeffer Percutaneous Valve Replacement: Current State and Future Prospects Ann. Thorac. Surg., December 1, 2004; 78(6): 2199 - 2206. [Abstract] [Full Text] [PDF]
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L. K. von Segesser, B. Marty, P. Tozzi, and P. Ruchat Impact of endoluminal stenting for aortic surgery Eur. J. Cardiothorac. Surg., December 1, 2004; 26(Suppl_1): S14 - S18. [Abstract] [Full Text] [PDF]
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L. K. von Segesser Direct percutaneous valve replacement: the next step? Eur. J. Cardiothorac. Surg., November 1, 2004; 26(5): 873 - 874. [Full Text] [PDF]
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M. Pawelec-Wojtalik, P. Antosik, G. Wasiatycz, and M. Wojtalik Use of muscular VSD Amplatzer occluder for closing right ventricular free wall perforation after hybrid procedure Eur. J. Cardiothorac. Surg., November 1, 2004; 26(5): 1044 - 1046. [Abstract] [Full Text] [PDF]
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M Ferrari, H R Figulla, M Schlosser, I Tenner, I Frerichs, C Damm, V Guyenot, G S Werner, and G Hellige Transarterial aortic valve replacement with a self expanding stent in pigs Heart, November 1, 2004; 90(11): 1326 - 1331. [Abstract] [Full Text] [PDF]
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I. F. Palacios Percutaneous valve replacement and repair: Fiction or reality? J. Am. Coll. Cardiol., October 19, 2004; 44(8): 1662 - 1663. [Full Text] [PDF]
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R. D. Fish Percutaneous Heart Valve Replacement: Enthusiasm Tempered Circulation, October 5, 2004; 110(14): 1876 - 1878. [Full Text] [PDF]
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F. Bauer, H. Eltchaninoff, C. Tron, P.-F. Lesault, C. Agatiello, D. Nercolini, G. Derumeaux, and A. Cribier Acute Improvement in Global and Regional Left Ventricular Systolic Function After Percutaneous Heart Valve Implantation in Patients With Symptomatic Aortic Stenosis Circulation, September 14, 2004; 110(11): 1473 - 1476. [Abstract] [Full Text] [PDF]
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C. H. Huber, P. Tozzi, A. F. Corno, B. Marty, P. Ruchat, P. Gersbach, M. Nasratulla, and L. K. von Segesser Do valved stents compromise coronary flow? Eur. J. Cardiothorac. Surg., May 1, 2004; 25(5): 754 - 759. [Abstract] [Full Text] [PDF]
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A. Vahanian and I. F. Palacios Percutaneous Approaches to Valvular Disease Circulation, April 6, 2004; 109(13): 1572 - 1579. [Full Text] [PDF]
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Y. Boudjemline, G. Agnoletti, D. Bonnet, D. Sidi, and P. Bonhoeffer Percutaneous pulmonary valve replacement in a large right ventricular outflow tract: An experimental study J. Am. Coll. Cardiol., March 17, 2004; 43(6): 1082 - 1087. [Abstract] [Full Text] [PDF]
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