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Positive results reported at 1 year with transapical TAVR
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Good functionality and outcomes were demonstrated at 1 year for patients who received transapical transcatheter aortic valve replacement, according to results from a multicenter trial.
In the European PREVAIL transapical study, researchers evaluated 1-year outcomes between September 2009 and August 2010 of 150 high-risk elderly patients (mean age, 81.6 years; 40.7% women) who underwent transapical TAVR using the second-generation Sapien XT valve and Ascendra-II delivery system (Edwards Lifesciences). Patients received either the 23-mm (n=36), 26-mm (n=57) or 29-mm (n=57) valve.
At 30 days, overall survival for all patients was 91.3%, and 77.9% at 1 year. Preserved left ventricular ejection fraction and low gradients also were found at 1 year using transthoracic echocardiography. Few patients had moderate aortic incompetence (7% at discharge; 4% at 1 year) and there was no increase in incompetence found over time. Walking distance increased significantly from 221 m after implant to 284 m at 1 year (P=.0004).
“Overall results of the PREVAIL TA trial are excellent, especially in view of the high-risk profiles of the patients treated,” the researchers wrote. “... Subgroup assessment indicated better survival in those patients who received a 29-mm Sapien XT in comparison with a 26-mm Sapien XT prosthesis. This may in part be related to some patient selection and waiting list issues: the larger (29-mm) prosthesis only became available 4 months after the initiation of this study.”
Disclosure: Walther reports no relevant financial disclosures.
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