METHODS: We report six consecutive elderly patients with chronic atrial fibrillation and significant ASD who underwent LAA and fenestrated ASD closure from January 1, 2014 until December 31, 2019. All periprocedural and long-term (>1 year) outcomes were reported.
RESULTS: Six patients (male: 33.3%; mean age: 66.8 ± 3.3 years) were included. Mean CHADS2 , CHA2 DS2 -VASc , and HAS-BLED scores were 2.33 ± 0.82, 3.83 ± 0.75, and 1.83 ± 0.75. Four patients underwent simultaneous procedure, while two patients underwent a staged procedure. Procedural success was achieved in all patients. Total occlusion was achieved during LAA occlusion without device embolization prior to ASD closure. Patients who underwent simultaneous procedure had a shorter total hospital stay and lower total hospital stay. During a follow-up period of 32.8 ± 19.4 months, both the devices were well seated. No device-related thrombosis or erosion reported. All patients remained in atrial fibrillation. No patients experienced any thromboembolic stroke or transient ischemic attack.
CONCLUSIONS: LAA and ASD closure is feasible and can be safely performed in the same seating in elderly patients with a significant ASD.
Methods and results: Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 139 subjects at 10 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful Watchman implantation was achieved in 100% of patients. The overall 30-day serious adverse event (SAE) rate was 8.7%, with the device and/or procedure-related SAE rate of 1.4%. One pericardial effusion required percutaneous drainage, but there were no strokes, device embolization, or deaths at 30 days. The 30-day bleeding SAE rate was 2.9% with 55% of patients prescribed NOAC and 38% taking warfarin post-procedure.
Conclusion: The outcomes from these international, multicentre registries support the feasibility and safety of performing combined procedures of ablation and Watchman LAAC for patients with non-valvular AF and high stroke risk. Further data are needed on long-term outcomes for the hybrid technique on all-cause stroke and mortality.
Methods: Data were collected from consecutive patients across 9 centres. Major endpoints included procedural success, safety and long-term outcomes including occurrence of bleeding, stroke/transient ischaemic attack/systemic embolism and all-cause mortality.
Results: Subjects (n = 201) had a mean age of 70.8 ± 9.4 years, high stroke risk (CHA2DS2-VASc: 3.9 ± 1.7), elevated bleeding risk (HAS-BLED: 2.1 ± 1.2) with 53% patients from Asian countries. Successful implantation occurred in 98.5% of patients; 7-day device/procedure-related SAE rate was 3.0%. After 2 years of follow-up, the rates of ischaemic stroke/TIA/SE and major bleeding were 1.9 and 2.2 per 100-PY, respectively, representing relative reductions of 77% and 49% versus expected rates per risk scores. The relative risk reductions versus expected rates were more pronounced in Asians vs. Non-Asians (89% vs 62%; 77% vs 14%). Other significant findings included larger mean LAA ostium diameter for Asians vs. Non-Asians (23.4 ± 4.1 mm vs. 21.2 ± 3.2 mm, p atrial appendage closure with WATCHMAN has demonstrated low peri-procedural risk, and long-term efficacy for stroke and bleeding prevention in a primarily Asian cohort.