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Updated: Jul 14, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
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Sex Differences in Long-Term Outcomes of Left Atrial Appendage Closure-Analysis from the LEADER Registry

Aviad Rotholz1,2, Hagai Itach2, Roi Ferman3

  • 1Cardiology Department, Beilinson Hospital, Rabin Medical Center, Ze'ev Jabotinsky St 39, Petah Tikva 4941492, Israel.

Journal of Clinical Medicine
|February 27, 2026
PubMed

Insights

Percutaneous left atrial appendage closure (LAAC) is a safe stroke prevention method for atrial fibrillation (AF) patients. This study found no significant sex differences in procedural or long-term outcomes for LAAC in AF patients.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Atrial Fibrillation Management

Background:

  • Percutaneous left atrial appendage closure (LAAC) offers an alternative to oral anticoagulation (OAC) for atrial fibrillation (AF) patients at high risk of bleeding.
  • Previous research suggested higher peri-procedural complication rates in women undergoing LAAC, but long-term outcome data remain inconsistent.

Purpose of the Study:

  • To investigate potential sex-based differences in peri-procedural and long-term clinical outcomes following LAAC.
  • To evaluate the efficacy and safety of LAAC as a stroke prevention strategy in a real-world AF patient population.

Main Methods:

  • Analysis of 407 consecutive AF patients who underwent LAAC between 2010 and 2023 across four Israeli medical centers (LEADER registry).
  • Comparison of baseline characteristics, procedural data, and clinical outcomes between male and female patients.
  • Primary endpoints included ischemic stroke/systemic embolism (efficacy) and a composite of mortality, complications, or major bleeding (safety) at 1 year.

Main Results:

  • No significant sex differences were observed in major peri-procedural complications (men 7.0% vs. women 4.9%, p=0.51).
  • At 1-year follow-up, efficacy endpoints (ischemic stroke/systemic embolism: 2.6%) and safety endpoints (composite: 19.2%, major bleeding: 8.9%, all-cause mortality: 9.3%) were comparable between sexes (all p>0.1).
  • Device implantation success rate exceeded 99% in both men and women.

Conclusions:

  • Contrary to some prior reports, this real-world multicenter study found no significant sex disparities in peri-procedural or 1-year outcomes after LAAC.
  • LAAC demonstrated comparable safety and efficacy in both men and women, supporting its role as a sex-independent stroke prevention strategy for AF patients.
  • These findings reinforce the value of LAAC for reducing stroke risk in high-bleeding-risk AF patients, regardless of sex.

Keywords:
LAACoutcomessex differences

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