LAA occlusion beneficial in patients with contraindications to oral anticoagulants
In a real-world patient population consisting largely of patients with contraindications to oral anticoagulants, left atrial appendage occlusion appears to be safe and yields favorable rates of implant success and procedural outcomes, researchers reported in a recent study.
In the voluntary, multicenter, retrospective registry, researchers evaluated 371 patients (mean age, 73 years; 89% men) who underwent left atrial appendage (LAA) occlusion at eight centers in the United Kingdom between July 2009 and November 2014.
The researchers collected the following information on each patient: baseline demographics, risk scores for thromboembolic and bleeding events, clinical indication for LAA occlusion, procedural details, periprocedural and postprocedural antithrombotic regimen, procedure success, and procedure-related and postprocedural adverse events during follow-up. Patient information was reviewed about 2 months after the procedure, 6 months after, and annually thereafter. Telephone follow-ups were conducted annually.
The outcomes of interest were overall procedure success rate, implant success rate, acute major adverse events and acute minor adverse events.
Implantation results
Procedure success was achieved in 92.5% of cases. In 13 cases, implantation was not attempted, and 15 implantations failed, leaving 343 successful implantations. In 63% of cases, a Watchman device (Boston Scientific) was implanted; in 34.7% of cases, an Amplatzer cardiac plug (St. Jude Medical) was used; in 1.7% of cases, a Lariat device (SentreHeart) was implanted; and in 0.6% of cases, a WaveCrest device (Coherex Medical) was used.
According to the researchers, 13 acute adverse events occurred (3.5% of procedures) and one patient died (0.25%). There were two cases of transient ischemic attack/stroke, both of which occurred after the implant of an Amplatzer cardiac plug device, yielding a 0.54% acute thromboembolic event rate. Iliofemoral vascular complications necessitating treatment led to two cases of major pericardial effusion and five cases of major bleeding. Minor bleeds also occurred, leading to a 2.2% overall acute bleeding event rate.
The 343 patients successfully implanted with an LAA occlusion device were followed for 24.7 months.
Learning curve
There was an improvement in procedure success (from 89.2% to 95.7%; P = .018) and a decrease in acute major complications (from 6.5% to 0.5%; P = .001) between procedures performed in the first and the second half of the study’s recruitment interval, according to the findings.
When compared with the predicted annual risk based on CHADS2 score, a 90.1% annual RR reduction was seen in ischemic stroke during follow-up of 24.7 months, whereas an 87.2% RR reduction was observed in thromboembolic events compared with predicted annual risk based on CHA2DS2-VASC scores, and a 92.9% RR reduction was seen in major bleeding vs. the predicted annual risk based on HAS-BLED scores.
“In this retrospective study of LAA [occlusion] using mainly the Watchman and [Amplatzer cardiac plug] devices in a United Kingdom population consisting predominantly of patients with contraindications to [oral anticoagulants], procedure-related adverse events were low and decreased further with experience,” the researchers wrote. “This may support the paradigm that in patients with [atrial fibrillation] and high risk of thromboembolic stroke, LAA [occlusion] has a major impact on reducing stroke and systemic embolism without exposing patients to an increased risk of severe bleeding.” – by Jennifer Byrne
Disclosure: Some researchers report financial ties with Boston Scientific and St. Jude Medical. Please see the full study for a list of the researchers’ relevant financial disclosures.