Long term follow-up from amplatzer cardiac plug European multicenter post market observational study

Purpose: The AMPLATZER® Cardiac Plug (ACP) is a percutaneous transcatheter device intended to prevent thrombus embolizations from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AF). The objective of this prospective, open-label study is to evaluate safety and performance of the ACP device in closure of the LAA and report the initial long-term follow-up results out to two years. Methods and results: We report safety results on a total of 40/161 (24.8%) patients who have been followed for two years post ACP implantation at ten investigative centers in Germany, Spain, United Kingdom, Ireland and the Czech Republic. Study follow-up included rigorous neurological and echocardiographic assessments at baseline, 1, 6, 12 months and 2 years post implant, as well as after a suspected stroke, TIA or systemic embolism. The study is being 100% monitored. An independent Data Monitoring Board is utilized and adjudicates seriousness and relatedness of all the safety events. In comparison to previously presented studies on ACP and other percutaneous LAA closure devices, this cohort was older and had a higher incidence of comorbidities. The majority of reconsented patients (50.9%) had a history of permanent AF, mean age was 70.48±12.54, mean CHA2DS2VASc score 3.27±1.55, and mean HAS-BLED score 2.857±1.15. Prior stroke or TIA was reported in 20.7% of reconsented patients. 100% of subjects with reported 2 year follow up TOE's reported closure of the LAA. Closure is defined as absence of flow or flow of < 3 mm jet into the LAA as assessed by transoesophageal echocardiography (TOE). From implant to six months, two ischemic strokes were adjudicated as unrelated to the device or procedure in a subject population of 204. With 40 subjects completing 6 months to 2 year follow-up, one new ischemic stroke occurred at 256 days post implant in a patient with a risk factor of prior ischemic stroke. Long term follow-up data revealed a total of 19 safety events occurring after the 6 month follow-up period in 9/40 (22.5%) patients. There have been no reported hemorrhagic strokes in any subjects post implant. There have been no reported thrombus on the device or device embolization after 6 months. Conclusion: The ACP device is a good alternative for high risk patients based on the reported excellent closure status. One out of five re-consented patients had a history of prior stroke/TIA and current long-term follow-up data revealed only one new stroke occurring after 6 months. The rate of safety events compares favorably with other LAA closure devices.