Circulation. 2006;114:1616-1624
Published online before print October 2, 2006, doi: 10.1161/CIRCULATIONAHA.106.639450
Published online before print October 2, 2006, doi: 10.1161/CIRCULATIONAHA.106.639450
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(Circulation. 2006;114:1616-1624.)
© 2006 American Heart Association, Inc.
Valvular Heart Disease |
Percutaneous Implantation of the CoreValve Self-Expanding Valve Prosthesis in High-Risk Patients With Aortic Valve Disease
The Siegburg First-in-Man Study
From the HELIOS Heart Center Siegburg, Departments of Cardiology (E.G., U.G., L.B., R.M., M.M., T.S.), Cardiac Surgery (T.F., S.I.), and Anesthesiology (B.S., B.Z.), Siegburg, Germany; Clinique Pasteur, Toulouse, France (J.C.L.); and Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.).
Correspondence to Eberhard Grube, MD, Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. E-mail GrubeE{at}aol.com
Received May 10, 2006; revision received August 11, 2006; accepted August 14, 2006.
Background— The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve).
Methods and Results— Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2±10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4±3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital.
Conclusions— Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.
CLINICAL PERSPECTIVE
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|
|
|
|
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|
|
|
|
|
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|
|
|
|
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|
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|
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|
|
|
|
|
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|
|
|
|
 |
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
 |
|
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|
|
|
|
 |
|
 I. M. SINGH, E. M. TUZCU, M. H. SHISHEHBOR, S. R. KAPADIA, and R. D. CHRISTOFFERSON Percutaneous treatment of aortic valve stenosis Cleveland Clinic Journal of Medicine, November 1, 2008; 75(11): 805 - 812. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
A. Vahanian, O. R. Alfieri, N. Al-Attar, M. J. Antunes, J. Bax, B. Cormier, A. Cribier, P. De Jaegere, G. Fournial, A. P. Kappetein, et al. 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. J. Cardiothorac. Surg., July 1, 2008; 34(1): 1 - 8. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. G. Svensson, T. Dewey, S. Kapadia, E. E. Roselli, A. Stewart, M. Williams, W. N. Anderson, D. Brown, M. Leon, B. Lytle, et al. United States Feasibility Study of Transcatheter Insertion of a Stented Aortic Valve by the Left Ventricular Apex Ann. Thorac. Surg., July 1, 2008; 86(1): 46 - 55. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Descoutures, D. Himbert, L. Lepage, B. Iung, D. Detaint, D. Tchetche, E. Brochet, Y. Castier, J.-P. Depoix, P. Nataf, et al. Contemporary surgical or percutaneous management of severe aortic stenosis in the elderly Eur. Heart J., June 1, 2008; 29(11): 1410 - 1417. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Vahanian, O. Alfieri, N. Al-Attar, M. Antunes, J. Bax, B. Cormier, A. Cribier, P. De Jaegere, G. Fournial, A. P. Kappetein, et al. 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., June 1, 2008; 29(11): 1463 - 1470. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. F. Tops, D. A. Wood, V. Delgado, J. D. Schuijf, J. R. Mayo, S. Pasupati, F. P.L. Lamers, E. E. van der Wall, M. J. Schalij, J. G. Webb, et al. Noninvasive evaluation of the aortic root with multislice computed tomography implications for transcatheter aortic valve replacement. J. Am. Coll. Cardiol. Img., May 1, 2008; 1(3): 321 - 330. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Quaden, T. Attmann, M. Schunke, D. Theisen-Kunde, J. Cremer, and G. Lutter Percutaneous aortic valve replacement: Endovascular resection of human aortic valves in situ. J. Thorac. Cardiovasc. Surg., May 1, 2008; 135(5): 1081 - 1086. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. G. Webb Percutaneous Aortic Valve Replacement Will Become a Common Treatment for Aortic Valve Disease J. Am. Coll. Cardiol. Intv., April 1, 2008; 1(2): 122 - 126. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. K. Rosengart, T. Feldman, M. A. Borger, T. A. Vassiliades Jr, A. M. Gillinov, K. J. Hoercher, A. Vahanian, R. O. Bonow, and W. O'Neill 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, April 1, 2008; 117(13): 1750 - 1767. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Zegdi, V. Ciobotaru, M. Noghin, G. Sleilaty, A. Lafont, C. Latremouille, A. Deloche, and J.-N. Fabiani Is it reasonable to treat all calcified stenotic aortic valves with a valved stent? Results from a human anatomic study in adults. J. Am. Coll. Cardiol., February 5, 2008; 51(5): 579 - 584. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Zegdi, G. Sleilaty, A. Lafont, and J.-N. Fabiani Percutaneous Aortic Valve Replacement With the CoreValve Prosthesis J. Am. Coll. Cardiol., January 15, 2008; 51(2): 170 - 170. [Full Text] [PDF]
|
|
|
|
|
|
E. A. Grossi, C. F. Schwartz, P.-J. Yu, U. P. Jorde, G. A. Crooke, J. B. Grau, G. H. Ribakove, F. G. Baumann, P. Ursumanno, A. T. Culliford, et al. High-Risk Aortic Valve Replacement: Are the Outcomes as Bad as Predicted? Ann. Thorac. Surg., January 1, 2008; 85(1): 102 - 107. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. J. Davidson and D. S. Baim Percutaneous Aortic Valve Interventions Card. Surg. Adult, January 1, 2008; 3(2008): 963 - 971. [Full Text]
|
|
|
|
|
|
T. Feldman and M. B. Leon Prospects for Percutaneous Valve Therapies Circulation, December 11, 2007; 116(24): 2866 - 2877. [Full Text] [PDF]
|
|
|
|
 |
|
 B. Qizilbash, P. Couture, and A. Denault Impact of Perioperative Transesophageal Echocardiography in Aortic Valve Replacement Seminars in Cardiothoracic and Vascular Anesthesia, December 1, 2007; 11(4): 288 - 300. [Abstract] [PDF]
|
|
|
|
|
|
S. H. Goldbarg, S. Elmariah, M. A. Miller, and V. Fuster Insights Into Degenerative Aortic Valve Disease J. Am. Coll. Cardiol., September 25, 2007; 50(13): 1205 - 1213. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. Walther, P. Simon, T. Dewey, G. Wimmer-Greinecker, V. Falk, M. T. Kasimir, M. Doss, M. A. Borger, G. Schuler, D. Glogar, et al. Transapical Minimally Invasive Aortic Valve Implantation: Multicenter Experience Circulation, September 11, 2007; 116(11_suppl): I-240 - I-245. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. R. Dixon, C. L. Grines, and W. W. O'Neill The Year in Interventional Cardiology J. Am. Coll. Cardiol., July 17, 2007; 50(3): 270 - 285. [Full Text] [PDF]
|
|
|
|
|
|
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|
|
|
|
|
|
T. Walther, V. Falk, T. Dewey, J. Kempfert, F. Emrich, B. Pfannmuller, P. Broske, M. A. Borger, G. Schuler, M. Mack, et al. Valve-in-a-Valve Concept for Transcatheter Minimally Invasive Repeat Xenograft Implantation J. Am. Coll. Cardiol., July 3, 2007; 50(1): 56 - 60. [Abstract] [Full Text] [PDF]
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|
|
|
|
|
|
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