Temporal Changes and Clinical Implications of Delayed Peridevice Leak Following Left Atrial Appendage Closure

Response by Lakireddy et al to Letters Regarding Article, “Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial”

“…Furthermore, the real-world experience in postmarket studies is not reflective of the PINNACLE FLX data in terms of closure rate. 4…”

Left Atrial Appendage Occlusion, A Misnomer?

“…Conversely, leaks larger than 5 mm have been empirically treated with continued anticoagulation. More recently, Afzal et al 15 reviewed data on 1039 successful Watchman device procedures. Follow-up data were available in 108 patients who had peridevice leaks (PDLs) at 45 to 90 days following successful implantation with an average leak size of 3.2AE1.6 mm (median, 3 mm).…”

Amulet™ Shines and Protects; Pacing Battle Intensifies with “More Leads or No Leads”?

“…10 It has, however, been shown that a residual leak of even 3 mm or beyond confers an increased risk of embolic events, and more study is needed to determine if the Amulet™ does provide a better seal. 13 The increased rate of complete occlusion at the time of the procedure allowed more patients who received the Amulet™ occluder to be discharged off anticoagulation; however, at 9 months of follow-up, most patients from both groups were off anticoagulation. 12 While no differences in non-procedure-related major bleeding were reported, the higher rate of complete immediate closure might be of clinical importance in patients who require rapid de-escalation from full anticoagulation.…”