Sex-Specific Outcomes of Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve: Insights From the PARTNER II S3 High-Risk and Intermediate-Risk Cohorts

Molly Szerlip, Sarah Gualano, Elizabeth Holper, John J. Squiers, Jonathon M. White, Darshan Doshi, Mathew R. Williams, Rebecca T. Hahn, John G. Webb, Lars G. Svensson, Ajay J. Kirtane, David J. Cohen, Pamela S. Douglas, Maria C. Alu, Aaron Crowley, E. Murat Tuzcu, Raj R. Makkar, Howard C. Herrmann, Vasilis Babaliaros, Vinod H. ThouraniMartin B. Leon, Susheel K. Kodali, Michael J. Mack

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

Objectives The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. Background A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. Methods The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. Results Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts. Conclusions The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

Original languageEnglish (US)
Pages (from-to)13-20
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume11
Issue number1
DOIs
StatePublished - Jan 8 2018

Keywords

  • TAVR
  • aortic stenosis
  • sex differences

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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