EXPEDITED REVIEW
Percutaneous Aortic Valve Replacement for Severe Aortic Stenosis in High-Risk Patients Using the Second- and Current Third-Generation Self-Expanding CoreValve ProsthesisDevice Success and 30-Day Clinical Outcome
Eberhard Grube, MD, FACC*,1,*,
Gerhard Schuler, MD, FACC ,
Lutz Buellesfeld, MD*,
Ulrich Gerckens, MD*,
Axel Linke, MD ,
Peter Wenaweser, MD*,
Barthel Sauren, MD*,
Friedrich-Wilhelm Mohr, MD ,
Thomas Walther, MD ,
Bernfried Zickmann, MD*,
Stein Iversen, MD*,
Thomas Felderhoff, MD*,
Raymond Cartier, MD and
Raoul Bonan, MD, FACC ,1
* HELIOS Heart Center Siegburg, Siegburg, Germany
Heart Center Leipzig, Leipzig, Germany
Institut de Cardiologie de Montreal, Montreal, Canada.
Manuscript received February 20, 2007;
revised manuscript received April 10, 2007,
accepted April 16, 2007.
* Reprint requests and correspondence: Dr. Eberhard Grube, Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. (Email: GrubeE{at}aol.com).
Objectives: We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California).
Background: Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis.
Methods: Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age 80 years with a logistic EuroSCORE 20% (21-F group) or age 75 years with a logistic EuroSCORE 15% (18-F group); or 3) age 65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support.
Results: A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 ± 0.19 cm2 (21-F) and 0.54 ± 0.15 cm2 (18-F), a mean age of 81.3 ± 5.2 years (21-F) and 83.4 ± 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 ± 13.5% (21-F) and 19.1 ± 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%.
Conclusions: Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.
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Abbreviations and Acronyms
| | AS = aortic stenosis | | F = French | | MACCE = major adverse cardiovascular and cerebral event | | MI = myocardial infarction |
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F. Descoutures, D. Himbert, L. Lepage, B. Iung, D. Detaint, D. Tchetche, E. Brochet, Y. Castier, J.-P. Depoix, P. Nataf, et al.
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M. J. Antunes
Percutaneous aortic valve implantation. The demise of classical aortic valve replacement?
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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.
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N. Piazza, Y. Onuma, E. Jesserun, P. P. Kint, A.-M. Maugenest, R. H. Anderson, P. P. T. de Jaegere, and P. W. Serruys
Early and Persistent Intraventricular Conduction Abnormalities and Requirements for Pacemaking After Percutaneous Replacement of the Aortic Valve
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D. Wendt, M. Thielmann, T. Buck, R.-A. Janosi, T. Bossert, N. Pizanis, M. Kamler, and H. Jakob
First clinical experience and 1-year follow-up with the sutureless 3F-Enable aortic valve prosthesis
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J. Grunenfelder, A. Plass, H. Alkadhi, and M. Genoni
Evaluation of biological aortic valve prostheses by dual source computer tomography and anatomic measurements for potential transapical valve-in-valve procedure
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J. G. Webb
Percutaneous Aortic Valve Replacement Will Become a Common Treatment for Aortic Valve Disease
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T. Walther, J. Kempfert, M. A. Borger, J. Fassl, V. Falk, J. Blumenstein, M. Dehdashtian, G. Schuler, and F. W. Mohr
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B. Murtuza, J. R. Pepper, R. DeL Stanbridge, C. Jones, C. Rao, A. Darzi, and T. Athanasiou
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A. N. DeMaria, J. J. Bax, O. Ben-Yehuda, P. Clopton, G. K. Feld, G. S. Ginsburg, B. H. Greenberg, J. D. Knoke, W. Y.W. Lew, J. A.C. Lima, et al.
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R. Zegdi, G. Sleilaty, A. Lafont, and J.-N. Fabiani
Percutaneous Aortic Valve Replacement With the CoreValve Prosthesis
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E. Grube, U. Gerckens, P. Wenaweser, and L. Buellesfeld
Reply
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W. J. Stewart
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Promising Initial Results with CoreValve Percutaneous Aortic Valve Placement
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