A first US multicentre registry with the Lariat device (SentreHeart) for left atrial appendage ligation has shown 94% acute closure rate; however, procedural success has been limited with major bleeding.
The study, recently published in the Journal of the American College of Cardiology by Matthew Price (Scripps Clinic, La Jolla, USA) and others, sought to assess the early safety and efficacy of transcatheter ligation of the left atrial appendage-with the Lariat device-for stroke prevention in atrial fibrillation. To date, current data have been explored in a few small, single-centre studies, the authors write.
The Lariat device is FDA approved for the approximation of soft tissue and has been used for percutaneous left atrial appendage ligation in at least 2,000 patients in the USA, note Price et al. The left atrial appendage ligation with Lariat is performed by a combined transeptal and subxiphoid pericardial approach.
This retrospective study enrolled 154 patients with atrial fibrillation (72.1±9.4 average age, 38% female), thought to be unsuitable for long-term oral anticoagulation, at eight sites in the USA. The median CHADS2 score was three.
The primary endpoint was device success-defined as suture deployment and <5mm leak by post-procedure transesophageal echocardiography. Procedural success was defined as device success and no major complication at discharge (death, myocardial infarction, stroke, Bleeding Academic Consortium bleeding type 3 or greater, or cardiac surgery).
Price et al report that device success was achieved in 144 cases (94%). They also note that although procedural success was achieved in 132 patients (86%); there were 15 patients (10%) with at least one major periprocedural complication, 14 of those for major bleeding. Moreover, significant pericardial effusion occurred in 16 patients and pleural effusion in four patients. At a median follow-up of 112 days (134 patients were available) death, myocardial infarction, or stroke occurred in four patients. Sixty three patients with successful Lariat deployment had transesophageal echocardiography follow-up, of those there were three cases of thrombi and 13 with residual leak.
The authors suggest: “Given the incidence of procedural complications we observed and the lack of robust long-term efficacy data, it appears reasonable that if percutaneous left atrial appendage ligation is to be performed, it should be reserved for individuals at substantial thromboembolic and bleeding risk who are not candidates for prospective US FDA studies of left atrial appendage occlusion. Furthermore, whether a percutaneous approach to surgical ligation with the Lariat procedure provides any advantage over minimally invasive surgical ligation deserves exploration.”
Nikolaos Dagres (Second Cardiology Department, University of Athens, Attikon University Hospital, Athens, Greece) and others comment in an accompanying editorial that this study “draws a considerably different picture than previously published single-centre studies, which reported significantly lower complication rates [Barkus K et al, J Am Coll Cardiol 2013;62:108-18 and Stone D et al, Catheter Cardiovasc Interv 2013 Jun 13 (E-pub ahead of print)].”
They comment that the high complication rate in the present study is “apparently related to the complexity of the procedure, which requires both a pericardial and a transeptal access”, but note that “as with most invasive techniques, improved procedural outcomes are anticipated with increasing operators’ experience.”
Dagres et al conclude: “At present, the Lariat technique for left atrial appendage occlusion is certainly not ready for prime time. Further randomised controlled trials are definitely needed to assess the benefit-to-risk profile of the procedure.”