A1 Refereed original research article in a scientific journal

Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer™ Amulet™ Observational Study




AuthorsDe Caterina Alberto Ranieri, Nielsen-Kudsk Jens Erik, Schmidt Boris, Mazzone Patrizio, Fischer Sven, Lund Juha, Montorfano Matteo, Gage Ryan, Lam Simon Cheung Chi, Berti Sergio

PublisherElsevier

Publication year2021

JournalInternational journal of cardiology : heart & vasculature

Journal name in sourceIJC HEART & VASCULATURE

Journal acronymIJC HEART VASC

Article numberARTN 100848

Volume35

Number of pages7

DOIhttps://doi.org/10.1016/j.ijcha.2021.100848

Self-archived copy’s web addresshttps://research.utu.fi/converis/portal/detail/Publication/66923569


Abstract

Background: Percutaneous LAAO represents an alternative for stroke prevention in patients not tolerating anticoagulation. While women are at higher risk of complications during percutaneous coronary or valvular interventions, the impact of gender on LAAO outcomes is not well characterized. The current study assessed potential gender-related differences in procedural and long-term outcomes following left atrial appendage occlusion (LAAO).

Methods: 1088 AF patients were enrolled in the prospective, multicenter, Amplatzer™ Amulet™ Observational Study and followed for 2 years with scheduled adverse event assessments. The prespecified primary outcome was ischemic stroke, systemic embolism or cardiovascular (CV) death at 2 years. We also compared the rate of procedural success, device-related thrombus (DRT) and major bleeding between genders.

Results: 702 men and 386 women underwent LAAO. Implant successwas high, and similar between men and women (98.9 vs 99.5%, p = 0.58). Similarly, no difference was observed in the primary outcome (12.0 vs 12.5%, p = 0.82). Compared to the CHA2DS2-VASc predicted rate, we observed a numerically greater absolute risk reduction of ischemic stroke in women (from 7.6 to 2.1%/year) than men (from 6.2 to 2.2%/year). DRT through 2 years was similar between groups (1.6%, p = 0.96). We found no significant gender difference in terms of periprocedural or long-term (7.1 vs 7.6%/year) major bleeding.

Conclusions: In this large group of patients undergoing LAAO using the Amplatzer™ Amulet™ device we found no significant gender difference in terms of procedural or long-term clinical outcomes. Similarly to oral anticoagulation, device-based LAA occlusion renders AF-related stroke risk similar in women and men.


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