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

Authors: Kodali, Susheel; Thourani, Vinod H.; White, Jonathon; Malaisrie, S. Chris; Lim, Scott; Greason, Kevin L.; Williams, Mathew; Guerrero, Mayra; Eisenhauer, Andrew C.; Kapadia, Samir R.; Kereiakes, Dean J.; Herrmann, Howard C.; Babaliaros, Vasilis; Szeto, Wilson Y.; Hahn, Rebecca T.; Pibarot, Philippe; Weissman, Neil J.; Leipsic, Jonathon; Blanke, Philipp; Whisenant, Brian K.; Suri, Rakesh M.; Makkar, Rajendra; Ayele, Girma M.; Svensson, Lars Gunnar; Webb, John G. (John Graydon); Mack, Michael J.; Smith, Craig R.; Leon, Martin B.
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 cm2. 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.
Document Type: Article de recherche
Issue Date: 31 March 2016
Open Access Date: Restricted access
Document version: VoR
Permalink: http://hdl.handle.net/20.500.11794/6528
This document was published in: European heart journal
Oxford University Press
Alternative version: 10.1093/eurheartj/ehw112
Collection:Articles publiés dans des revues avec comité de lecture

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