Surgical strategies for a failed Watchman device (2020)

Central MessageSurgical extraction or exclusion of a failed Watchman device is a feasible alternative in patients who are not candidates for medical management.See Commentaries on pages 165 and 167. Surgical extraction or exclusion of a failed Watchman device is a feasible alternative in patients who are not candidates for medical management. See Commentaries on pages 165 and 167. Transcatheter closure of the left atrial appendage (LAA) using a Watchman device (Boston Scientific, Plymouth, Minn) is an approved alternative to oral anticoagulation to reduce the risk of stroke in patients with atrial fibrillation that are considered at high risk for bleeding complications.1Reddy V.Y. Doshi S.K. Kar S. Gibson D.N. Price M.J. Huber K. et al.PREVAIL and PROTECT AF Investigators5-year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials.J Am Coll Cardiol. 2017; 70: 2964-2975Crossref PubMed Scopus (503) Google Scholar Device malposition and/or incomplete LAA seal are known inherent modes of device failure. These events may be underreported, because most of these nonfatal complications can be managed by continued antithrombotic therapy. These scenarios may exacerbate thrombus formation, however, with the reported incidence of device-related thrombus as high as 3.9%.2Lempereur M. Aminian A. Freixa X. Gafoor S. Kefer J. Tzikas A. et al.Device-associated thrombus formation after left atrial appendage occlusion: a systematic review of events reported with the Watchman, the Amplatzer cardiac plug, and the Amulet.Catheter Cardiovasc Interv. 2017; 90: E111-E121Crossref PubMed Scopus (82) Google Scholar The PREVAIL trial, a landmark Watchman device study, failed to demonstrate that LAA occlusion was noninferior to warfarin at preventing adverse events at 18 months.1Reddy V.Y. Doshi S.K. Kar S. Gibson D.N. Price M.J. Huber K. et al.PREVAIL and PROTECT AF Investigators5-year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials.J Am Coll Cardiol. 2017; 70: 2964-2975Crossref PubMed Scopus (503) Google Scholar Although another landmark trial, the PROTECT-AF trial, demonstrated noninferiority of Watchman LAA occlusion versus warfarin alone, its substudy revealed that a peri-device flow rate at 12 months as high as 32%.3Viles-Gonzalez J.F. Kar S. Douglas P. Dukkipati S. Feldman T. Horton R. et al.The clinical impact of incomplete left atrial appendage closure with the Watchman device in patients with atrial fibrillation: a PROTECT AF (Percutaneous closure of the left atrial appendage versus Warfarin therapy for prevention of stroke in patients with atrial fibrillation) substudy.J Am Coll Cardiol. 2012; 59: 923-929Crossref PubMed Scopus (394) Google Scholar Moreover, none of those studies reported the number of patients requiring a surgical intervention and associated outcomes. Surgical device removal or exclusion is rarely considered except in situations with devastating device-related complications. There are limited data regarding the optimal approach and the feasibility of surgical device explant. We present a case series of Watchman device failures and discuss strategies for extraction or alternative approaches to LAA occlusion. We evaluated 5 cases of Watchman failure necessitating surgical intervention. Essential clinical data are summarized in Tables 1 and 2. Written informed consent for publication was obtained from each patient. All patients had a failed transcatheter radiofrequency ablation procedure and underwent Watchman implantation. The mean patient age was 74.4 years and 2 patients were male. The mean CHA2DS2-VASc score was 7.6. Of note, all developed bleeding complications, including 3 gastrointestinal (60%) 1 retroperitoneal (20%), and 1 hemorrhagic stroke (20%) while being maintained on oral anticoagulation in the presence of device failure. Modes of failure were peri-device leak in 3 patients (60%) device dislodgement in 1 patient (20%), and peri-device thrombus formation refractory to medical therapy in 1 patient (20%) (Figure 1).Table 1Relevant clinical characteristics at index Watchman implantationCharacteristicPatient 1Patient 2Patient 3Patient 4Patient 5Age (y)/sex77/female68/male78/male74/female75/femaleCHA2DS2-VASc score86996Previous radiofrequency ablation procedureYesYesYesYesYesYear of Watchman device implant20172018201720192016Device size (mm)33242424UnknownIndex Watchman device placement procedureInitial attempt with suboptimal compression/ residual flow; fully retrieved; second attempt successfulUneventfulInitial attempt with 27 mm with suboptimal positioning; second attempt successfulUneventfulUnknownAntithrombotic regimen before surgeryWarfarinAspirin + rivaroxabanWarfarinDual antiplatelet therapyWarfarinPreceding strokeNoNoYesNoNo Open table in a new tab Table 2Relevant clinical characteristics at Watchman explantation/exclusionCharacteristicPatient 1Patient 2Patient 3Patient 4Patient 5Clinical indication for Watchman explant or exclusionPeri-device leak and multiple thrombi formation refractory to medical therapy in the setting of multiple gastrointestinal bleeding episodesDevice dislodgement in the setting of gastrointestinal bleedingPeri-device leak in the setting of hemorrhagic strokeIntraoperatively incidentally detected peri-device leak in the setting of severe mitral regurgitationPeri-device leak in the setting of severe mitral regurgitationEchocardiographic findingsLarge thrombi attached to the device as well as the left atrial wallClosure device protruding into the left atrium with partial dehiscencePeri-device leakPeri-device leakPeri-device leakProcedure for the Watchman device and left atrial appendageExplantation with clipExplantation with primary closureThoracoscopic exclusion with clipExplantation with clipDevice left in situ due to severe incorporation; bovine pericardial patch exclusionWatchman age (y)32124Other concurrent proceduresFull biatrial Maze + aortic valve replacementFull biatrial MazeLeft atrial MazeFull biatrial Maze + mitral replacementFull biatrial Maze + mitral replacementPostexplant/exclusion echocardiographic findings of the left atrial appendageNo flow or residual stumpNo flow or residual stumpNo flow or residual stumpNo flow or residual stumpNo flow or residual stumpCurrent antithrombotic agent regimenNoneAspirinAspirinAspirin + rivaroxabanWarfarinLatest follow-upDoing well at 3 moDoing well at 3 moDoing well at 2 yDoing well at 3 moDoing well at 6 mo Open table in a new tab Watchman device removal/exclusion was the primary indication in 3 cases: case 1, a nonresponder to anticoagulation with multiple thrombi in the setting of peri-device leak; case 2, device dislodgement and anticoagulation intolerance due to gastrointestinal bleeding; and case 3, a peri-device leak with hemorrhagic stroke. It was the secondary indication in cases 4 and 5, with severe mitral regurgitation and peri-device leak, one of which was an incidental intraoperative finding. Three devices (60%) were explanted (Figure 2; Video 1), with subsequent LAA closure either using an AtriClip (AtriCure, Mason, Ohio) or performing primary endocardial suture closure with a running double layer of polypropylene. In case 3, the Watchman device was excluded through a thoracoscopic approach with a 45-mm Pro-V AtriClip (AtriCure) (Video 1).4Romano M.A. Minimally invasive thoracoscopic exclusion of the left atrial appendage following Watchman device with an AtriCure ProV LAA exclusion device.Innovations. 2019; 14: 509-511Crossref PubMed Scopus (0) Google Scholar In case 5, the device was excluded with bovine pericardium owing to severe endothelialization and the inability to be explanted. Overall, 3 of 4 (75%) attempted device extractions were successful without major LAA damage. All patients underwent a concurrent Maze procedure with or without valve replacement. Anticoagulation therapy was discontinued immediately postoperatively or within 6 months for cases 1 to 3.Figure 2A, Preoperative echocardiography showing a malpositioned Watchman device in a 68-year-old man (case 2). B, Intraoperative photographs of the Watchman explant procedure. Approximately 50% of the device was protruding into the left atrium without associated thrombus. Although the device was completely endothelialized, it was successfully extracted without major injury to the left atrial appendage tissue. The orifice of the left atrial appendage was then closed with a running 4-0 Prolene suture in 2 layers. C, The explanted Watchman device was completely intact on removal.View Large Image Figure ViewerDownload (PPT) We have described a series of Watchman device-related complications requiring surgical intervention. The first point to consider is when to treat a failed device. Intolerance of anticoagulation, such as bleeding in the presence of a peri-device leak or residual stump, warrants intervention. This scenario may exacerbate additional thromboembolic risk in addition to atrial fibrillation, given the presence of a thrombogenic foreign body in the LAA. It is likely that only a small subset of these patients are referred to surgery; most patients are managed by continued antithrombotic therapy, which, ironically, contradicts the original concept of the Watchman device. The second point to consider is how to treat a failed device. We strongly advocate device removal when technically possible. O'Hara and colleagues5O'Hara C. O'Hara G.E. Jacques F. Champagne J. Lemyre M. Charbonneau L. et al.Run with the hare and hunt with the hounds: Watchman device surgical resection in the setting of recurrent device related thrombi in a patient with bleeding diathesis.JACC Cardiovasc Interv. 2016; 9: e223-e225Crossref PubMed Scopus (3) Google Scholar presented the first reported surgical Watchman extraction due to recurrent device-related thrombus in which the LAA was resected with the device. In contrast, in our series, 3 different surgical strategies—Watchman explant, thoracoscopic Watchman exclusion with external clipping, and bovine pericardial patch exclusion—were used based on the need for other simultaneous procedures. A thoracoscopic approach is used in patients who are not undergoing reoperation, do not require a concomitant procedure, have no atrial thrombus present, and have no protrusion of the device (ie, must have a neck on which to place a clip). Despite late-stage extraction with complete endothelialization, most devices can be safely removed, providing high-risk patients with an alternative treatment to lifelong anticoagulation. eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiJkYjY0NDQ0ODg0NGIyZWRhZjBhZThhYzRlNmE2MDcyOCIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4Njc1NjI1fQ.swmrhIWZsqOw7kB1JeTMMd0rfs1OYuRQwDR0uiDAR-Y7h3AS0U2sAxRO4hw9YgLxbOWcQX5h3SqJ2DerLqw5q15YFjjsAtYgQ8mQG4M3p9bQTUVXOy2SapJwBiaij7G7pEr3uudSBSXZOPXR0Q_crD_biR-nZrh6LKVUs_m7n4FgxXNZD9YIzlL_cpPMeNBSYJYcDpxh92DTwT8nVKzL8KTUwwGVD72wTB0YFKnMP02Ed9zimw4aQlZMM23hSEaj-YF6anxYEFjT8rB5ABAjU7L2Ufn-bBgv1KEhJEdxVJ4S-6iJTVL0zKtB0OvrSKjoszxQgClyfyZ0bnx5p4o1dg Download .mp4 (36.15 MB) Help with .mp4 files Video 1Demonstration of various complications associated with Watchman device and surgical strategies. Video available at: https://www.jtcvs.org/article/S2666-2507(20)30400-4/fulltext. Commentary: Modern problems require modern solutions: Fixing the failed WATCHMANJTCVS TechniquesVol. 4PreviewThe development of less-invasive, nonsurgical alternatives to treat cardiovascular disease has long been a focus of cardiologists and a desire of patients. Efforts along these lines have created a variety of competing procedures, including coronary artery bypass grafting/percutaneous coronary intervention, surgical aortic valve replacement/transcatheter aortic valve replacement, and maze/catheter ablation. In each case, the advent of a percutaneous approach has created the need for surgeons to develop new strategies to employ when the percutaneous interventions fail. Full-Text PDF Open AccessCommentary: Watch out for WATCHMAN device failuresJTCVS TechniquesVol. 4PreviewIn this edition of JTCVS Techniques, Palmer and colleagues1 present a series of 5 patients with failed WATCHMAN (Boston Scientific, Plymouth, Minn) devices requiring surgical intervention. WATCHMAN device failure is often treated with anticoagulation to prevent thrombotic complications of a malpositioned device and to reduce the stroke risk associated with the patient's atrial fibrillation. Full-Text PDF Open Access