Krzysztof Bartus, Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul Hospital, Krakow, Poland, and others reported, in a study published ahead of print in the Journal of the American College of Cardiology (JACC), that left atrial appendage (LAA) closure for stroke prevention in patients with atrial fibrillation using a percutaneous ligation approach can be performed effectively and is associated with a low rate of complications.
Bartus et al reported that while surgical exclusion of the LAA for stroke prevention in patients with atrial fibrillation has been suggested as an alternative treatment option for patients who are intolerant of warfarin, the success rate of the procedure is variable. They added that the Watchman device (Boston Scientific) for LAA closure, according to data from the Watchman study, is non-inferior to warfarin but said: “concerns in regard to device embolization, tamponade, and periprocedural stroke have delayed its approval by the US Food and Drug Administration.”
The authors stated that a new percutaneous approach, using an epicardial suture, for the closure of the LAA has been shown to be feasible in humans. They wrote: “In this study, we report the efficacy and one-year clinical results of LAA closure via a percutaneous epicardial suture ligation approach.”
Patients were enrolled in the study if they had non-valvular atrial fibrillation, at least one risk factor for stroke, and were poor candidates or ineligible for warfarin therapy, and/or “warfarin failures”. The percutaneous suture ligation of the LAA was performed using a 15-mm compliant occlusion balloon catheter, 0.025-inch and 0.035-inch magnet-tipped guidewires, and a 12-F suture deliver device (Lariat, SentreHeart). Bartus et al wrote: “The procedure involves four basic steps: one, pericardial and transseptal access; two, placement of the endocardial magnet-tipped guidewire in the apex of the LAA with balloon identification of the LAA; three, connection of the epicardial and endocardial magnet-tipped guidewires for stabilisation of the LAA; and four, snare capture of the LAA with closure confirmation and release of the pre-tied suture for LAA ligation.”
Immediate LAA closure was achieved in 85 of the 89 patients who underwent the procedure and complete closure (defined as <1-mm jet by colour flow Doppler) was achieved in 96% of these patients. Furthermore, complete closure was observed in 95% of patients at one day, 30 days, and 90 days after the procedure (using TEE).
After one year, complete closure was observed in 98% of patients, including patients in whom a 2- to 3-mm colour Doppler leak was observed at the three-month follow-up point. The authors commented: “Thrombus formation was not detected at the site of the occlusion by TEE throughout the follow-up period. In one patient at the one-year follow-up TEE, there was a thrombus in the left atrium at a site distant from the occlusion site.” They added that this particular patient had stopped taking warfarin after the initial procedure and resumed taking the drug to resolve the thrombus.
Bartus et al commented: “The approach described in this study is superior to existing surgical methods that define successful closure as no communication of flow and a <1-cm non-trabeculated stump. Compared with percutaneous implants that consider closure success as <2- to 3-mm residual flow, the approach described in this study is 100% effective versus implant effectiveness of 86%.”
They added that as there will always be patients who have contraindications to anticoagulant therapy, the complete closure of the LAA could be used in such patients and said that complete closure may also allow “for safer anticoagulant strategies-such as apixaban, low-dose dabigatran, and/or aspirin, which are associated with lower bleeding rates than high-dose dabigatran or warfarin.”
Concluding, Bartus et al wrote: “Given the current data, percutaneous LAA ligation may be a complementary alternative to oral anticoagulation and the Watchman device for thromboembolic event risk reduction. However, no definitive statement can be made regarding stroke reduction without prospective studies.”