EXPEDITED REVIEW
Treatment of Calcific Aortic Stenosis With the Percutaneous Heart Valve
Mid-Term Follow-Up From the Initial Feasibility Studies: The French Experience
Alain Cribier, MD, FACC*,*,
Helene Eltchaninoff, MD*,
Christophe Tron, MD*,
Fabrice Bauer, MD*,
Carla Agatiello, MD*,
Deborah Nercolini, MD*,
Sydney Tapiero, MD*,
Pierre-Yves Litzler, MD ,
Jean-Paul Bessou, MD and
Vasilis Babaliaros, MD*
* Department of Cardiology
Department of Cardiac Surgery, Charles Nicolle Hospital, Rouen, France
Manuscript received December 20, 2005;
revised manuscript received January 19, 2006,
accepted January 24, 2006.
* Reprint requests and correspondence: Dr. Alain Cribier, Service de Cardiologie, Hopital Charles Nicolle, 1 rue de Germont, 76 031 Rouen Cedex, France (Email: Alain.Cribier{at}chu-rouen.fr).
OBJECTIVES: The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position.
BACKGROUND: We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS).
METHODS: Thirty-six patients (aortic valve area 0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially.
RESULTS: Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 ± 0.11 cm2 to 1.70 ± 0.10 cm2, p < 0.0001) and transvalvular gradient (37 ± 13 mm Hg to 9 ± 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 ± 18% to 53 ± 14%, p = 0.02) was most pronounced in patients with ejection fraction <50% (35 ± 10% to 50 ± 16%, p < 0.0001). Thirty-day major adverse events after successful implantation were 26% (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related.
CONCLUSIONS: Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future.
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J. Rodes-Cabau, J. G. Webb, A. Cheung, J. Ye, E. Dumont, C. M. Feindel, M. Osten, M. K. Natarajan, J. L. Velianou, G. Martucci, et al.
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K. A. Horvath, D. Mazilu, M. Guttman, A. Zetts, T. Hunt, and M. Li
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M. Z. Khawaja, P. Haworth, A. Ghuran, L. Lee, A. de Belder, N. Hutchinson, U. Trivedi, J.-C. Laborde, and D. Hildick-Smith
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J. G. Webb and F. Nietlispach
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A. N. Azadani, N. Jaussaud, P. B. Matthews, L. Ge, T. S. Guy, T. A.M. Chuter, and E. E. Tseng
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A. N. Azadani, N. Jaussaud, P. B. Matthews, L. Ge, T. S. Guy, T. A.M. Chuter, and E. E. Tseng
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A. A. Klein, S. T. Webb, S. Tsui, C. Sudarshan, L. Shapiro, and C. Densem
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M. Thielmann, D. Wendt, H. Eggebrecht, P. Kahlert, P. Massoudy, M. Kamler, R. Erbel, H. Jakob, and S. Sack
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A. Zierer, G. Wimmer-Greinecker, S. Martens, A. Moritz, and M. Doss
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S. Bleiziffer, H. Ruge, D. Mazzitelli, A. Hutter, A. Opitz, R. Bauernschmitt, and R. Lange
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H. A. Dwyer, P. B. Matthews, A. Azadani, L. Ge, T. S. Guy, and E. E. Tseng
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F. De Robertis, A. Asgar, S. Davies, N. Delahunty, A. Kelleher, R. Trimlett, M. Mullen, and N. Moat
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T. Z. Naqvi
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L. F Tops, V. Delgado, F. van der Kley, and J. J Bax
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J.-B. Masson, J. Kovac, G. Schuler, J. Ye, A. Cheung, S. Kapadia, M. E. Tuzcu, S. Kodali, M. B. Leon, and J. G. Webb
Transcatheter Aortic Valve Implantation: Review of the Nature, Management, and Avoidance of Procedural Complications
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D. Detaint, L. Lepage, D. Himbert, E. Brochet, D. Messika-Zeitoun, B. Iung, and A. Vahanian
Determinants of Significant Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation: Impact of Device and Annulus Discongruence
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C. Fraccaro, M. Napodano, G. Tarantini, V. Gasparetto, G. Gerosa, R. Bianco, R. Bonato, D. Pittarello, G. Isabella, S. Iliceto, et al.
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T. Grebel and J. Schumm
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S. Salizzoni, P. Bajona, K. J. Zehr, W. D. Anderson, S. Vandenberghe, and G. Speziali
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D. R. Holmes Jr, R. Nishimura, R. Fountain, and Z. G. Turi
Iatrogenic Pericardial Effusion and Tamponade in the Percutaneous Intracardiac Intervention Era
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H. A. Dwyer, P. B. Matthews, A. Azadani, N. Jaussaud, L. Ge, T. S. Guy, and E. E. Tseng
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D. Himbert, F. Descoutures, N. Al-Attar, B. Iung, G. Ducrocq, D. Detaint, E. Brochet, D. Messika-Zeitoun, F. Francis, H. Ibrahim, et al.
Results of Transfemoral or Transapical Aortic Valve Implantation Following a Uniform Assessment in High-Risk Patients With Aortic Stenosis
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R. Zegdi, P. Achouh, D. Blanchard, A. Lafont, and J.-N. Fabiani
Percutaneous aortic valve implantation: What does oversizing mean?
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F. Aregger, P. Wenaweser, G. J. Hellige, A. Kadner, T. Carrel, S. Windecker, and F. J. Frey
Risk of acute kidney injury in patients with severe aortic valve stenosis undergoing transcatheter valve replacement
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N. Al-Attar, D. Himbert, F. Descoutures, B. Iung, R. Raffoul, D. Messika-Zeitoun, E. Brochet, F. Francis, H. Ibrahim, A. Vahanian, et al.
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S. R. Kapadia, S. S. Goel, L. Svensson, E. Roselli, R. M. Savage, L. Wallace, S. Sola, P. Schoenhagen, M. H. Shishehbor, R. Christofferson, et al.
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A. Zajarias and A. G. Cribier
Outcomes and Safety of Percutaneous Aortic Valve Replacement
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M.-A. Clavel, J. G. Webb, P. Pibarot, L. Altwegg, E. Dumont, C. Thompson, R. De Larochelliere, D. Doyle, J.-B. Masson, S. Bergeron, et al.
Comparison of the Hemodynamic Performance of Percutaneous and Surgical Bioprostheses for the Treatment of Severe Aortic Stenosis
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F. T. Billings IV, S. K. Kodali, and J. S. Shanewise
Transcatheter Aortic Valve Implantation: Anesthetic Considerations
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