One-Year Clinical Outcomes with SAPIEN 3 Transcatheter Aortic Valve Replacement in High Risk and Inoperable Patients with Severe Aortic Stenosis
Circulation Journal News Brief
Embargoed until 3 p.m. CT / 4 p.m. ET Tuesday, July 12, 2016
DALLAS, July 12, 2016 —Overall one-year survival was over 85 percent for high-risk or inoperable patients who underwent aortic valve replacement with the SAPIEN 3 trans-catheter aortic valve replacement system, according to a study published in the July 12 issue of the American Heart Association journal Circulation. This survival rate is strikingly higher compared to patient outcomes reported in studies that used older trans-catheter aortic valve replacements (TAVR) systems.
Between 30 days and one year, there was no increase in the low rate of moderate leaking around the prosthetic valve, which had been observed in earlier studies, and patients experienced a marked improvement in the quality of life.
This study suggests that the SAPIEN 3 system might be the preferred therapy for high-risk and inoperable patients with aortic stenosis. The authors also conclude that the system should receive additional evaluation to see if it would be appropriate for lower-risk patients.
Limitations: This study is a prospective registry of the Partner II trial of transcatheter aortic valve replacement (TAVR) for high risk (HR) and inoperable (INOP) patients, and was not a randomized comparison to other devices or patient populations. Therefore, such comparisons should be considered exploratory.
Funding Sources: The PARTNER Trial was funded by Edwards Lifesciences and the protocol was designed collaboratively by the sponsor and the trial executive committee. The sponsor was involved in data collection and management, but was not involved in the design and conduct of this substudy, the analysis and interpretation of the data, or the preparation, review, and approval of the manuscript.
Study author: Howard C. Herrmann, M.D., John Bryfogle professor of Cardiovascular Medicine and Surgery at the Perelman School of Medicine of the University of Pennsylvania and System Director for Interventional Cardiology and Director of the Cardiac Catheterization Laboratories, Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania.
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