The third generation SAPIEN 3 transcatheter heart valve is associated with low rates of early and 1-year complications and 1-year mortality in high risk and inoperable patients with severe aortic stenosis, according to recent data published in Circulation Cardiovascular Quality and Outcomes.

In the initial PARTNER trial of transcatheter aortic valve replacement (TAVR), mortality at 1 year was 24% in high risk patients and 31% in inoperable patients who underwent TAVR.

Due to recent a recent report that the SAPIEN 3 had low rates of adverse events at 30 days, Howard C. Herrmann, MD, of the Perelman School of Medicine at the University of Pennsylvania, and colleagues sought to examine the longer term outcomes with the device.


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A total of 583 patients (mean age: 83 years; 42% female) who were considered either high risk (65%) or inoperable (35%) were included in the study. Patients were treated with TAVR by either the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites between October 2013 and September 2014. An independent clinical events committee analyzed the major clinical events at 1 year and the echocardiographic results were analyzed by a core laboratory.

After 1 year of follow-up, the all cause survival rate was 85.6% among all patients, 87.3% among high-risk patients, and 82.3% among inoperable patients. In addition, the survival rate among patients who received TAVR by transfemoral access was 87.7% and 74.7% among patients who received TAVR by transapical/transaortic access (P log rank=.0006).

Researchers noted that there was no severe paravalvular leak, but moderate paravalvular leak, which occurred in 2.7% patients, was associated with an increase in 1-year mortality. Mild leaks had no significant impact. Other predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke.

The proportion of patients in the New York Heart Association class III and IV  decreased from 90% at the start of the study to 13% at 30 days (P<.0001) and to 8% at 1 year. The 6 minute walking distance also improved, from 134 ± 116 m at baseline to 179 ± 132 m at 1 year (P<.0001).

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“The combination of new design features of SAPIEN 3, procedural improvements, operator experience and improved patient selection have all contributed to a low rate of important adverse events (including stroke) and a high rate of 1-year survival in high-risk and inoperable patients with severe aortic stenosis,” the authors concluded.  

“These excellent 1-year follow-up data with SAPIEN 3 support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis as well as further evaluation of this device in lower risk patients.”

Disclosures: Several authors have received financial support from Edwards Lifescience, St. Jude Medical, Medtronic, and Boston Scientific, among other pharmaceutical/device companies.

Reference

Herrmann HC, Thourani VH, Kodali SK. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high risk inoperable patients with severe aortic stenosis. Circulation. 2016. doi: 10.1161/circulationaha.116.022797.