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October 27, 2022
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LAAO device usage up, major adverse events down over time

Fact checked byRichard Smith
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From 2016 to 2019, percutaneous left atrial appendage occlusion procedures for stroke prevention rose and major adverse events associated with them fell, according to a real-world analysis published in HeartRhythm.

Mohak Gupta, MD, an internal medicine resident at Cleveland Clinic, and colleagues analyzed 61,090 patients (mean age, 76 years; 41% women) from the National Inpatient Sample who were hospitalized for percutaneous left atrial appendage occlusion (LAAO) from 2016 to 2019. The primary outcomes were in-hospital mortality, discharge to a facility, length of stay and inflation-adjusted cost of hospitalization.

Graphical depiction of data presented in article
Data were derived from Gupta M, et al. Heart Rhythm. 2022;doi:10.1016/j.hrthm.2022.10.010.

During the study period, the only percutaneous LAAO device approved by the FDA was the Watchman (Boston Scientific).

The number of percutaneous LAAO procedures rose from approximately 5,000 in 2016 to more than 25,000 in 2019, Gupta and colleagues found.

Over time, patients receiving percutaneous LAAO had a greater comorbidity burden, as the proportion of patients with an Elixhauser comorbidity index score of 5 or more rose from 38.44% in 2016-17 to 41.45% in 2018-19 (P for trend = .015), according to the researchers.

Major adverse events declined from 2.8% in 2016 to 2.1% in 2019 (P < .05), driven by systemic embolization (2016, 0.57%; 2019, 0.06%; P < .05) and stroke/transient ischemic attack (2016, 0.85%; 2019, 0.5%; P = .19), Gupta and colleagues wrote.

In-hospital mortality dropped numerically but not significantly from 2016 to 2019 (0.28% vs. 0.15%), whereas length of stay shortened from 1.5 days in 2016 to 1.34 days in 2019 (P < .05), according to the researchers.

There were no time-related trends in discharge to facility or inflation-adjusted cost, Gupta and colleagues found.

Pericardial tamponade occurred in 0.69% in the cohort, less than observed in the PROTECT-AF and PREVAIL preapproval trials of the Watchman (4.3% and 1.9%, respectively) and comparable with the 0.86% observed in the National Cardiovascular Data Registry LAAO Registry from 2016 to 2018, according to the researchers.

“As with any new invasive procedure, procedural complications with percutaneous LAAO have decreased as volume and expertise expanded in the years after device approval,” Gupta and colleagues wrote. “Improvements in operator technique, anticoagulation and procedural protocols and patient selection likely underlie this improvement. Large teaching hospitals contribute significantly to realizing these advances, as supported by most procedures being done at such hospitals. Further trends might be influenced by newer-generation devices and expansion of eligible population based on ongoing trials.”