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

Kodali, Susheel; Thourani, Vinod H; White, Jonathon; Malaisrie, S Chris; Lim, Scott; Greason, Kevin L; Williams, Mathew; Guerrero, Mayra; Eisenhauer, Andrew C; Kapadia, Samir; 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, Raj R; Ayele, Girma M; Svensson, Lars G; Webb, John G; Mack, Michael J; Smith, Craig R; Leon, Martin B.
Eur Heart J; 37(28): 2252-62, 2016 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-27190101

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.
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