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

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

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.

Clinical trial registration: Clinicaltrials.gov Identifier: NCT02447081.https://ichgcp.net/clinical-trials-registry/NCT02447081.

Keywords: AF, atrial fibrillation; CV, cardiovascular; DAPT, dual antiplatelet therapy; DRT, device-related thrombus; Gender difference; LAAO, left atrial appendage occlusion; Left atrial appendage occlusion; Mortality; PCI, percutaneous coronary intervention; SAPT, single antiplatelet therapy; Stroke; TAVI, transcatheter aortic valve implantation; TEE, transesophageal echocardiography; TIA, transient ischemic attack.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

© 2021 The Authors.

Figures

Fig. 1
Fig. 1
The antithrombotic medication regimen prescribed over 2 years post-LAAO was comparable between males and females. The majority of patients were discharged on DAPT and transitioned to SAPT at the 1–3 month follow-up visit. At 2 years, >80% of each gender were on SAPT or no antithrombotic medications.
Fig. 2
Fig. 2
Clinical outcomes were reported through a 2 year post-LAAO visit and adjudicated by an independent clinical events committee. The primary outcome, a composite of ischemic stroke, systemic embolism, or cardiovascular mortality was similar between genders (A). The rates of cardiovascular mortality (B) and all-cause mortality (C) were also no different between genders over 2 years post-LAAO.
Fig. 3
Fig. 3
The observed annualized ischemic stroke rate was similar between males and females (2.2 vs 2.1%/year). Due to higher baseline CHA2DS2-VASc score, and thus increased predicted rate of ischemic stroke, females exhibited greater absolute and relative reductions in ischemic stroke risk, as compared to the predicted rate.

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Source: PubMed

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