EuroIntervention · 2020 · 14 citations · 14 references
MedicineCardiologySurgeryCardiothoracic SurgeryInterventional CardiologyPerioperative Outcomes ResearchCardiac CatheterizationLeft Atrial Appendage ClosurePatent Foramen OvalePatent Foramen Ovale ClosureStrokeThromboembolic OutcomesAtrial Septal PunctureMajor HemorrhagePercutaneous Left Atrial Appendage ClosurePrimary Efficacy EndpointsPropensity Score AdjustmentSafety Endpoint AnalysisSafety Endpoint AssessmentSurgical Left Atrial Appendage Closure
AIMS: The aim of this study was to compare the periprocedural and late clinical outcomes of left atrial appendage closure (LAAC) with AMPLATZER devices by access through transseptal puncture (TSP) versus a patent foramen ovale (PFO) or an atrial septal defect (ASD). METHODS AND RESULTS: Between 2009 and 2018, 578 consecutive patients underwent LAAC via TSP or PFO/ASD access in three centres. After a 3:1 propensity score matching, 246 (TSP) versus 91 (PFO/ASD) patients were compared using the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death and the primary safety endpoint of major periprocedural complications and major bleedings at follow-up. Mean age was 75.2±8.7 (TSP) vs 74.4±10.9 (PFO/ASD) years, CHA2DS2-VASc score 4.5±1.6 vs 4.3±1.4 and HAS-BLED score 3.3±1.0 vs 3.3±0.9. Device success (97.6% vs 97.8%, p=0.90) was similar. After 2.5±1.4 vs 2.6±1.6 years, clinical efficacy (46/603, 7.6% [TSP] vs 21/233, 9.0% [PFO/ASD], hazard ratio [HR] 1.2; 95% confidence interval [CI]: 0.69-0.85, p=0.54) and safety (24/603, 4.0% vs 11/233, 4.7%; HR 1.4; 95% CI: 0.52-3.6, p=0.49) did not differ. CONCLUSIONS: Use of a PFO/ASD access for LAAC with AMPLATZER devices offers similar periprocedural and late clinical outcomes to TSP. Simultaneous PFO/ASD closure for an additional protective benefit does not increase risk.
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Standardized Bleeding Definitions for Cardiovascular Clinical Trials
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5-Year Outcomes After Left Atrial Appendage Closure
Vivek Y. Reddy, Shephal K. Doshi, Saibal Kar et al. · Journal of the American College of Cardiology · 2017 · 991 citations · Full text