Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis

Abstract

Aims: Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV).

Methods and results: Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm(2).

Conclusions: The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation.

Trial registration: ClinicalTrials.gov #NCT01314313.

Keywords: TAVI; TAVR; Transcatheter aortic valve replacement.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Figures

Figure 1

The SAPIEN 3 transcatheter heart valve. The SAPIEN 3 is a balloon-expandable transcatheter heart valve that consists of bovine pericardial leaflets sutured to a cobalt chromium frame with a polyethylene terephthalate skirt covering the inflow potion of the frame (A). The valve is available in 20, 23, 26, and 29 mm sizes and is compatible with a 14- or 16-Fr transfemoral delivery system (B). The valve is deployed in an intra-annular position via balloon inflation (C and D).

Figure 2

Symptom status by New York Heart Association functional class. Symptom status according to New York Heart Association class is shown at baseline and at 30 days among patients in both HR/inoperable and intermediate risk cohorts.

Figure 3

Change in effective orifice area and mean gradient stratified by transcatheter heart valve size. The effective orifice area (A) and mean aortic valve gradient (B) stratified by valve size are shown at baseline and 30-day follow-up.