Incomplete endothelialization of WatchmanTM Device: Predictors and Implications from Two Cases

Abstract

Background: Traditional surgical treatment for patients with atrial fibrillation (AF) is performed via sternotomy and on cardiopulmonary bypass. It is very effective in regard to rhythm control, but remains unpopular due to its invasiveness. Truly endoscopic AF treatments have decreased the threshold for electrophysiologists (and cardiologists) to refer, and the reluctance of patients to accept a standalone surgical approach. Practice guidelines from around the world have recognized this as an acceptable therapeutic approach. Current guidelines recommend the HeartTeam approach in treating these complex AF cases. In this study we report our experience with AF HeartTeam approach for surgical stand-alone AF ablation.Methods: The AF HeartTeam Program began in 2013, patients qualified for inclusion if either of the following was present: failed catheter ablation and/or medication, not suitable for catheter ablation, contraindication to anticoagulation, or patients preferring such an approach. All patients with a complex AF history were assessed by the AF HeartTeam, from which 42 patients were deemed suitable for a totally endoscopic AF procedure (epicardial ablation and LAA closure). Endpoints were intraoperative bidirectional block of the pulmonary veins and closure of left atrial appendage confirmed by transesophageal echocardiography (TEE). Post discharge rhythm follow-up was performed after 3 and 12, 24 and 36 months. Anticoagulation was discontinued 6 weeks after the procedure in patients after documented LAA closure.Results: In total 42 patients underwent the endoscopic procedure (Median CHA 2 DS 2 -VASC=3 (1-6), HAS-BLED=2 (1-6)) for paroxysmal (15/42) and non-paroxysmal AF (27/42) respectively. Bidirectional block was obtained in all patients and complete LAA closure was obtained in all but one Patient on TEE (41/42). In one patient the LAA was not addressed due to extensive adhesions. Two patients underwent median sternotomy because of bleeding during the endoscopic surgery early in the series. There were no deaths. Procedure duration was a median of 124min (Range 83-211) and duration of hospitalization was median of 5 days (Range 3-12). During 36 months follow-up survival free of mortality, thromboembolic events or strokes was 100%. Twelve month freedom from atrial arrhythmia off anti-arrhythmic medication was 93% and 89% for paroxysmal and non-paroxysmal patients respectively. 6/42 patients who had an AF recurrence during the follow-up underwent touch-up catheter ablation.Conclusions: Atrial fibrillation heart team approach provides excellent outcomes for patients with AF. This approach is beneficial for patients after failed catheter ablation or not candidates for such and offers a very effective mid-term outcome data. In addition to effective rhythm control the protective effect of epicardial LAA closure may play an important role in effectively reducing stroke. The creation of an AF HeartTeam as recommended by the guidelines insures unbiased therapies and provides access to this minimally invasive but ef...

Utility of transesophageal echocardiogram surveillance after watchman device placement

“…Although the risk of DRT was thought to be highest during early endothelization, there is increasing recognition of late-onset DRT with longer surveillance imaging which may be related to delayed or incomplete endothelization of the device. 10,11 We showed that with appropriate treatment of DRT detected at 45 days, there was complete resolution in those with follow-up, which highlights the importance of early surveillance imaging to guide appropriate therapy and prevent adverse events.…”

Pattern of Endothelialization in Left Atrial Appendage Occluder by Optic Coherence Tomography: A Pilot Study

“…However, there were surgical reports showing no or incomplete endothelization even after 1.5 years of LAAO implantation. 23 , 24 Although animal studies showed that endothelialization could be completed within 45 days, 25 whether this is also the case in humans remains unknown and we still need a good tool to evaluate device endothelialization.…”

Left Atrial Appendage Occlusion and Post-procedural Antithrombotic Management

“…In vivo gross evaluation of human device healing is sparsely described in autopsy reports and from surgically removed devices (Table 5). A total of ten patient cases have been reported, all displaying incomplete neo-endothelialization at eight months to three years follow-up [81][82][83][84][85][86][87]. Among these cases, only two were reported to be below 70 years of age at the time of evaluation, potentially explaining, in part, the discrepancy compared with healthy young study animals [82,85].…”

“…A total of ten patient cases have been reported, all displaying incomplete neo-endothelialization at eight months to three years follow-up [81][82][83][84][85][86][87]. Among these cases, only two were reported to be below 70 years of age at the time of evaluation, potentially explaining, in part, the discrepancy compared with healthy young study animals [82,85]. ACP, Amplatzer cardiac plug; AM, Amplatzer Amulet; ASA, acetylsalicylic acid; DAPT, dual antiplatelet therapy; DOAC, direct oral anticoagulation; VKA, vitamin K antagonist; WM (FLX), Watchman (flx); FLX Pro, Watchman FLX Pro.…”