Device Migration, Embolization of Watchman LAAO Device Rare; Associated With High Surgical Risk, Mortality

Device migration or embolization (DME) due to incomplete anchoring of the Watchman left atrial appendage occlusion (LAAO) device was found to occur rarely, but was associated with a high risk of surgical intervention and mortality, according to a recent study published in the Journal of Cardiovascular Electrophysiology.

In their retrospective analysis, Daniel J. Friedman, MD, FACC, et al., evaluated 120,278 Watchman procedures captured by the NCDR LAAO Registry from January 2016 to March 2021, excluding patients with prior LAAO interventions, no device released and missing device information. They analyzed both in-hospital events and events following discharge with 45-day follow-up.

The in-hospital rate of DME was 0.07% (n=84, of which 51 were embolizations) with surgery performed in 49 of the identified cases. The in-hospital mortality rate was 14% among patients with DME and increased to 20.5% among those who underwent surgery. At the 45-day follow-up, among 98,147 patients, DME occurred in 54 patients (0.06%), of which 23 were embolizations; cardiac surgery was performed in four patients (7.4%). Two patients died, for a postdischarge mortality rate of 3.7% among patients with DME.

“Approximately half of all DME cases occur after discharge and different patient and procedure characteristics are associated with in-hospital versus post discharge cases,” the authors write.

They found that characteristics associated with in-hospital device embolization included hospitals with a lower median annual procedure volume (24 vs. 41 procedures; p<0.0001), Watchman 2.5 vs. Watchman FLX devices (0.08% vs. 0.04%; p=0.0048), larger LAA ostia (median 23 vs. 21 mm; p=0.004), and a smaller difference between device and LAA ostia size (median difference 4 vs. 5 mm; p=0.04).

Postdischarge events were associated with these patient characteristics: male sex (79.7% of events but 58.9% of all procedures; p=0.0019), taller height (177.9 vs. 172 cm; p=0.0005), and increased weight (99.9 vs. 85.5 kg; p=0.0055). Of note, among patients with postdischarge DME compared with those without, AFib at the time of the procedure was less common (38.9% vs. 46.9%; p=0.0098).

“Although we observed substantially less DME compared to the pivotal trials, given the morbidity and mortality associated with DME, maintaining risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance,” the authors state.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Atrial Appendage, Electrophysiology, Morbidity, Registries, Follow-Up Studies, Patient Discharge, Retrospective Studies, Aftercare, Atrial Fibrillation, LAAO Registry, National Cardiovascular Data Registries

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