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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.

Publication ,  Journal Article
Szerlip, M; Gualano, S; Holper, E; Squiers, JJ; White, JM; Doshi, D; Williams, MR; Hahn, RT; Webb, JG; Svensson, LG; Kirtane, AJ; Cohen, DJ ...
Published in: JACC Cardiovasc Interv
January 8, 2018

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.

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Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

January 8, 2018

Volume

11

Issue

1

Start / End Page

13 / 20

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Transcatheter Aortic Valve Replacement
  • Time Factors
  • Sex Factors
  • Severity of Illness Index
  • Risk Factors
  • Risk Assessment
  • Postoperative Complications
  • Male
 

Citation

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Szerlip, M., Gualano, S., Holper, E., Squiers, J. J., White, J. M., Doshi, D., … Mack, M. J. (2018). 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. JACC Cardiovasc Interv, 11(1), 13–20. https://doi.org/10.1016/j.jcin.2017.09.035
Szerlip, Molly, Sarah Gualano, Elizabeth Holper, John J. Squiers, Jonathon M. White, Darshan Doshi, Mathew R. Williams, et al. “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.JACC Cardiovasc Interv 11, no. 1 (January 8, 2018): 13–20. https://doi.org/10.1016/j.jcin.2017.09.035.
Szerlip M, Gualano S, Holper E, Squiers JJ, White JM, Doshi D, et al. 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. JACC Cardiovasc Interv. 2018 Jan 8;11(1):13–20.
Szerlip, Molly, et al. “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.JACC Cardiovasc Interv, vol. 11, no. 1, Jan. 2018, pp. 13–20. Pubmed, doi:10.1016/j.jcin.2017.09.035.
Szerlip M, Gualano S, Holper E, Squiers JJ, White JM, Doshi D, Williams MR, Hahn RT, Webb JG, Svensson LG, Kirtane AJ, Cohen DJ, Douglas PS, Alu MC, Crowley A, Tuzcu EM, Makkar RR, Herrmann HC, Babaliaros V, Thourani VH, Leon MB, Kodali SK, Mack MJ. 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. JACC Cardiovasc Interv. 2018 Jan 8;11(1):13–20.
Journal cover image

Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

January 8, 2018

Volume

11

Issue

1

Start / End Page

13 / 20

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Transcatheter Aortic Valve Replacement
  • Time Factors
  • Sex Factors
  • Severity of Illness Index
  • Risk Factors
  • Risk Assessment
  • Postoperative Complications
  • Male