Next-generation LAA closure device safe in real-world population
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A next-generation left atrial appendage closure device conferred low rates of adverse events and peri-device leak in a real-world cohort at 45 days, according to results of the SURPASS study.
Samir R. Kapadia, MD, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, presented data from patients with atrial fibrillation treated with the left atrial appendage (LAA) closure device (Watchman FLX, Boston Scientific) for stroke prevention at the Cardiovascular Research Technologies meeting.
The SURPASS study included 16,048 patients (mean age, 76 years; 40% women; mean CHA2DS2-VASc score, 4.8; mean HAS-BLED score, 2.4) from the American College of Cardiology’s National Cardiovascular Data Registry LAAO Registry for whom data were available at discharge, of whom 14,107 had data available at 45 days.
“Almost 2,000 devices are used every month since commercialization,” Kapadia told Healio. “The question is, when we go from 400 patients (from the pivotal PINNACLE FLX trial) to 16,000, do we have similar outcomes in terms of low complication rates and a good success rate? This was the first time we had such a large data set for this particular device.”
The key safety endpoint of all-cause death, stroke, systemic embolism or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention occurred at the later of 7 days or hospital discharge occurred in 0.37% (95% CI, 0.29-0.48) of patients, Kapadia said, noting 21 patients died, 19 had an ischemic stroke and 20 had an event requiring reintervention.
At discharge, rates of adverse events were as follows: death, 0.07%; stroke, 0.09%; ischemic stroke, 0.08%; systemic embolism, 0%; major bleeding, 0.98%; major vascular complications, 0.12%; MI, 0.01%; device-related thrombus, 0.05%; and device embolization, 0.01%, according to the researchers.
At 45 days, Kapadia said, rates of adverse events were as follows: death, 0.91%; stroke, 0.38%; ischemic stroke, 0.28%; systemic embolism, 0.01%; device-related thrombus, 0.23%; device embolization, 0.03%; and major bleeding, 3.55%.
After the procedure, 95.3% of patients had no leak and 99.1% had a leak of less than 3 mm, whereas at 45 days, 82% had no leak and 95.4% had a leak of less than 3 mm, Kapadia said during the presentation.
Pericardial effusion requiring surgical or percutaneous intervention occurred in 0.32% of patients at discharge and 0.51% of patients at 45 days, he said.
“The device is extremely safe and can be used by people who are trained to do this procedure,” Kapadia told Healio.
The data were similar to those from the pivotal PINNACLE FLX study, he said.
The key message, Kapadia told Healio, is that “if you are looking for an alternative to blood thinners in patients with nonvalvular atrial fibrillation, this procedure with this device is a safe and effective alternative.”
Future research may pertain to ways to prevent device-related thrombus, long-term consequences of pericardial effusion and when/whether to stop anticoagulation in patients treated with the device, Kapadia said in an interview.
“We have a large number of patients and the ability to answer some mechanistic and subgroup questions,” he said. “We are thankful to all of the institutions for providing these invaluable data to make the therapy more effective and to better understand its limitations and strengths.”
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Kapadia SR, et al. Late Breaking Trials: Session II – Structural Session. Presented at: Cardiovascular Research Technologies; Feb. 26-March 1, 2022; Washington, D.C.
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