Literature DB >> 29860075

Effect of SAPIEN 3 Transcatheter Valve Implantation on Health Status in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER S3i Trial.

Suzanne J Baron1, Vinod H Thourani2, Susheel Kodali2, Suzanne V Arnold2, Kaijun Wang2, Elizabeth A Magnuson2, Augusto D Pichard2, Vasilis Babaliaros2, Isaac George2, D Craig Miller2, E Murat Tuzcu2, Kevin Greason2, Howard C Herrmann2, Craig R Smith2, Martin B Leon2, David J Cohen2.   

Abstract

OBJECTIVES: The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).
BACKGROUND: In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation.
METHODS: Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups.
RESULTS: Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes.
CONCLUSIONS: Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.
Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  intermediate surgical risk; quality of life; transcatheter aortic valve replacement

Mesh:

Year:  2018        PMID: 29860075      PMCID: PMC6636916          DOI: 10.1016/j.jcin.2018.02.032

Source DB:  PubMed          Journal:  JACC Cardiovasc Interv        ISSN: 1936-8798            Impact factor:   11.195


  21 in total

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10.  Identifying heart failure patients at high risk for near-term cardiovascular events with serial health status assessments.

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