Hemodynamic trends in patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve replacement (TAVR) showed excellent durability without significant structural valve deterioration at five-years, according to the results of the PARTNER I FIVE-YEAR ECHO Trial presented Nov. 1 at TCT 2016.

In the largest to-date longitudinal analysis of echocardiographic hemodynamic parameters systematically assessed by a core laboratory, Pamela S. Douglas, MD, MACC, et al., evaluated the patient population of all successful TAVR procedures (n=2,482; 282 patients at five-years) from the PARTNER IA, IB and continued access trials using the first generation SAPIEN THV device. Echocardiograms were performed at intervals of seven days, 30 days, six months, and one, two, three, four and five years post implant and then analyzed by a single core laboratory for mean aortic gradient, valve area and Doppler velocity index.

The results of the trial showed that the mean aortic gradients remained stable over the mid-term, with no indication of late structural deterioration. The modeled trend of mean aortic gradient decreased in the first few months post-implant, and then increased non-significantly over follow up (12.1 vs. 9.2 at three months vs. 10.3 mmHg at five years).

According to Douglas, “severely abnormal hemodynamics in individual patients, which might be suggestive of valve thrombosis or stenosis, were rare. Together, the results suggest that the low five-year survival observed in this cohort is not due to adverse hemodynamics.”

While the results of the trial are encouraging, no data on aortic valve regurgitation were provided. This remains a concern for TAVR procedures in the five to 10 year post-implant period.

Keywords: Transcatheter Cardiovascular Therapeutics, Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Valve Diseases, Hemodynamics, Transcatheter Aortic Valve Replacement, Constriction, Pathologic, Echocardiography, Echocardiography, Doppler, Follow-Up Studies, Thrombosis

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