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J Am Coll Cardiol, 2007; 50:69-76, doi:10.1016/j.jacc.2007.04.047 (Published online 5 June 2007).
© 2007 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

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

Eberhard Grube, MD, FACC*,1,*, Gerhard Schuler, MD, FACC{dagger}, Lutz Buellesfeld, MD*, Ulrich Gerckens, MD*, Axel Linke, MD{dagger}, Peter Wenaweser, MD*, Barthel Sauren, MD*, Friedrich-Wilhelm Mohr, MD{dagger}, Thomas Walther, MD{dagger}, Bernfried Zickmann, MD*, Stein Iversen, MD*, Thomas Felderhoff, MD*, Raymond Cartier, MD{ddagger} and Raoul Bonan, MD, FACC{ddagger},1

* HELIOS Heart Center Siegburg, Siegburg, Germany
{dagger} Heart Center Leipzig, Leipzig, Germany
{ddagger} 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.

Abbreviations and Acronyms
  AS = aortic stenosis
  F = French
  MACCE = major adverse cardiovascular and cerebral event
  MI = myocardial infarction




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J Am Coll Cardiol IntvHome page
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
J. Am. Coll. Cardiol. Intv., June 1, 2008; 1(3): 310 - 316.
[Abstract] [Full Text] [PDF]


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Eur. J. Cardiothorac. Surg.Home page
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
Eur. J. Cardiothorac. Surg., April 1, 2008; 33(4): 542 - 547.
[Abstract] [Full Text] [PDF]


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ICVTSHome page
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
Interactive CardioVascular and Thoracic Surgery, April 1, 2008; 7(2): 195 - 200.
[Abstract] [Full Text] [PDF]


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J Am Coll Cardiol IntvHome page
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]


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Ann. Thorac. Surg.Home page
T. Walther, J. Kempfert, M. A. Borger, J. Fassl, V. Falk, J. Blumenstein, M. Dehdashtian, G. Schuler, and F. W. Mohr
Human Minimally Invasive Off-Pump Valve-in-a-Valve Implantation
Ann. Thorac. Surg., March 1, 2008; 85(3): 1072 - 1073.
[Abstract] [Full Text] [PDF]


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Ann. Thorac. Surg.Home page
B. Murtuza, J. R. Pepper, R. DeL Stanbridge, C. Jones, C. Rao, A. Darzi, and T. Athanasiou
Minimal Access Aortic Valve Replacement: Is It Worth It?
Ann. Thorac. Surg., March 1, 2008; 85(3): 1121 - 1131.
[Abstract] [Full Text] [PDF]


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J Am Coll CardiolHome page
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.
Highlights of the year in JACC 2007.
J. Am. Coll. Cardiol., January 29, 2008; 51(4): 490 - 512.
[Full Text] [PDF]


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J Am Coll CardiolHome page
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]


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J Am Coll CardiolHome page
E. Grube, U. Gerckens, P. Wenaweser, and L. Buellesfeld
Reply
J. Am. Coll. Cardiol., January 15, 2008; 51(2): 170 - 171.
[Full Text] [PDF]


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J Am Coll Cardiol ImgHome page
W. J. Stewart
Imaging the future of transcatheter aortic valve replacement.
J. Am. Coll. Cardiol. Img., January 1, 2008; 1(1): 25 - 28.
[Full Text] [PDF]


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Journal Watch CardiologyHome page
Promising Initial Results with CoreValve Percutaneous Aortic Valve Placement
Journal Watch Cardiology, July 25, 2007; 2007(725): 3 - 3.
[Full Text]



 
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