LAAO Registry Shows Higher Success Rates, Lower Adverse Outcomes Than Clinical Trials
Patients undergoing left atrial appendage occlusion (LAAO) experienced higher success rates and lower rates of in-hospital major adverse events, compared with those reported in randomized clinical trials, according to results from Featured Clinical Research presented March 29 during ACC.20/WCC and simultaneously published in the Journal of the American College of Cardiology.
James V. Freeman, MD, MPH, MS, FACC, et al., looked at data from the first three years of ACC’s LAAO Registry to evaluate the patient population receiving LAAO devices, hospitals performing the procedures and rates of in-hospital major adverse events. Study participants were stratified based on CHA2DS2-VASC and HAS-BLED scores. The researchers then compared device success and major in-hospital adverse events among patients who had successful, aborted or canceled procedures.
The researchers looked at a total of 38,158 procedures at 495 hospitals performed by 1,318 physicians between 2016 and 2018. The median age of patients was 76.1 years, and median CHA2DS2-VASC and HAS-BLED scores were 4.6 and 3, respectively. Most patients (69.3%) had a history of prior bleeding, while a history of prior stroke (27.3%) was common.
A device was deployed in 92.8% of all cases. Of those procedures, the device was successfully implanted in 98.3% of cases, substantially higher than in randomized trials. Patients who had a successful implant were more likely to be younger than those whose procedures were aborted or canceled. Patients whose procedure was aborted had higher rates of death (0.6% vs. 0.19%) and cardiac arrest (1.37% vs. 0.24%). The most common major in-hospital adverse events were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%). These were significantly more common among patients whose procedures were aborted.
According to the researchers, the first three years of data from the LAAO Registry show higher rates of device success and lower rates of in-hospital major adverse events compared with randomized trials. Going forward, the registry “will serve an important role in quality improvement for participating hospitals,” they write. “Data collection, site reporting and scientific inquiry will continue to iterate and evolve to address the questions and concerns of patients, hospitals, physicians, regulators and the scientific community,” they conclude.
In an accompanying editorial comment, Dhanunjaya Lakkireddy, MD, FACC, and Mohit K. Turagam, MD, write that the LAAO Registry is a “well-designed prospective database” that “will serve as a useful vehicle in refining patient selecting and tracking the safety and efficacy of LAAO devices for the next several decades.”
“Patients getting this procedure in the real world are generally older and sicker than the patients who were in clinical trials, and it is reassuring to see that the procedural safety profile looks good,” says Freeman. “We also did not see an increase in adverse events as the procedure was rolled out more widely in lower-volume hospitals. The findings were generally reassuring.”
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Pericardial Disease, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: ACC Annual Scientific Session, acc20, Atrial Fibrillation, Atrial Appendage, Pericardial Effusion, Stroke, Hemorrhage, Arrhythmias, Cardiac, Heart Failure, National Cardiovascular Data Registries
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