Risk for complications with LAA ligation device may be higher than previously reported

Despite observing high rates of acute closure, researchers reported that the rate of major procedural complications with a transcatheter left atrial appendage ligation device in a cohort of patients treated for stroke prevention in atrial fibrillation was 10%, a rate higher than previously documented in earlier research.

Matthew J. Price, MD, with Scripps Clinic, La Jolla, California, and colleagues conducted the retrospective, multicenter study to investigate transcatheter left atrial appendage ligation (LAA; Lariat, SentreHeart) as an alternative to oral anticoagulation to prevent stroke in the setting of AF. The analysis included 154 patients treated at eight sites in the United States.

The primary endpoint was procedural success and no major complication at discharge. Procedural success was defined as device success, which the researchers noted was suture deployment and <5 mm leak by post-procedure transesophageal echocardiography. Major complications included death, MI, stroke, Bleeding Academic Research Consortium bleeding type 3 or greater, or cardiac surgery. Operators determined patient management after discharge.

Matthew J. Price

The median CHADS2 score was 3 (interquartile range [IQR], 2-4).

The researchers reported a 94% device success rate and an 86% procedural success rate. The major complication rate was 9.7%, with major bleeding occurring in 9.1% of the cohort. Bleeding was driven by the need for transfusion in 4.5% of patients. The rate of significant pericardial effusion was 10.4%.

Follow-up data at 112 days (IQR, 50-270 days) were available for 134 patients. At this point, 2.9% experienced death, MI or stroke.

A 4.8% rate of thrombi and a 20% rate of residual leak occurred in 63 patients with acute closure and available transesophageal echocardiography follow-up data.

“In this initial multicenter experience of LAA ligation with the Lariat device, the rate of acute closure was high, but procedural success was limited by bleeding,” Price and colleagues concluded. “A prospective randomized trial is required to adequately define clinical efficacy, optimal post-procedure medical therapy, and the effect of operator experience on procedural safety.”

In an accompanying editorial, Nikolaos Dagres, MD, of the University of Athens and Attikon University Hospital in Athens, Greece, and Sascha Rolf, MD, and Gerhard Hindricks, MD, of the University of Leipzig, Germany, wrote that the study “is a systematic and honest depiction of outcomes after a novel treatment method for which only limited information is available,” they wrote. “The current paper draws a considerably different picture than previously published single-center studies, which reported significantly lower complication rates.”

The retrospective design is a limitation, as is the uncertainty about which patients underwent the procedure because of LAA thrombus or because they were not considered candidates based on CT scan results, according to the editorialists. They added that imaging follow-up data were lacking.

“Patient selection is a major consideration with this type of procedure,” Dagres and colleagues wrote. “Obviously, given the very good results of anticoagulation therapy with regard to stroke prevention in AF patients and the rising variety of available drugs with the addition of [novel oral anticoagulants], the target population consists of patients who are not suitable for long-term anticoagulation. But how do we define lack of suitability for long-term anticoagulation therapy?”

The editorialists suggested “relatively lenient patient selection” for this procedure, but added that the results of the current study may not support this approach.

“The high complication rate in the present series is apparently related to the complexity of the procedure, which requires both a pericardial and a trans-septal access,” they wrote. “As with most invasive techniques, improved procedural outcomes are anticipated with increasing operators’ experience. Given the limited experience with the Lariat device, reflected in the low median number of included patients per site (n=19), which notably comprised the entire Lariat experience at each site, this may be an important factor resulting in a significant reduction of complications in the future.”

They noted, however, that this is just speculation. “Even if a patient is considered to be a candidate for LAA occlusion, why should this new technique be administered instead of the established occlusion with a permanent device or by means of minimally invasive surgery?” they wrote.

Dagres and colleagues ultimately agreed with the study researchers that this approach should be used selectively in patients with substantial risk for bleeding and thromboembolism. “At present, the Lariat technique for LAA occlusion is certainly not ready for primetime,” they wrote. “Further randomized controlled trials are definitely needed to assess the benefit-to-risk profile of the procedure.”

For more information:

Price MJ. J Am Coll Cardiol. 2014;64:565-572.

Dagres N. J Am Coll Cardiol. 2014;64:573-575.

Disclosure: The researchers report financial disclosures with Asahi Intecc, AtriCure, Biosense Webster, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Hansen Medical, Janssen Pharmaceuticals, Medtronic, Sanofi Aventis, SentreHeart, St. Jude Medical and W.L. Gore. The editorialists report financial disclosures with Biosense Webster, Biotronik, Boston Scientific and St. Jude Medical.