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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^_*,_*, 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

^_* HELIOS Heart Center Siegburg, Siegburg, Germany
Heart Center Leipzig, Leipzig, Germany
Institut de Cardiologie de Montreal, Montreal, Canada. Drs. Grube and Bonan are consultants to CoreValve

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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