Watchman device migration and embolization: a report from the NCDR LAAO registry

Abstract

Background Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization requiring percutaneous or surgical retrieval. Purpose To report rates and characteristics of in-hospital and post-discharge Watchman device migration and embolization events in the United States. Methods We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and post-discharge events were assessed among patients with 45-day follow-up. Results Of 120,278 Watchman procedures, device migration or embolization occurred in 0.07% of patients (n=84) during the index hospitalization and surgery was performed in 39 patients. The in-hospital mortality rate was 14% among patients with device migration or embolization and 20.5% among patients who underwent surgery. In-hospital migration or embolization was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p<0.0001), with first-generation Watchman versus next-generation Watchman FLX devices (0.08% vs. 0.04%, p=0.0048), with larger LAA ostia (median 23 mm vs. 21 mm, p=0.004), and with a smaller difference between device and LAA ostial size (median difference 4 mm vs. 5 mm, p=0.04). There were no differences by age, sex, hospital type, hospital size, or teaching versus non-teaching status. Of 98,147 patients with 45-day follow-up, device migration or embolization after discharge occurred in 0.06% (n=54) patients and cardiac surgery was performed in 7.4% (n=4) of cases. The 45-day mortality rate was 3.7% (n=2) among patients with post-discharge device migration or embolization. Post-discharge migration or embolization was more common among men (79.7% of events but 58.9% of all procedures, p=0.0019), taller patients (177.9 cm vs. 172 cm, p=0.0005), and those with greater body mass (99.9 kg vs. 85.5 kg, p=0.0055); in contrast to in-hospital events, there were no differences in hospital volume, device characteristics, or LAA characteristics. Conclusions Watchman device migration or embolization is rare but associated with high mortality (Figure 1) and frequently requires surgical retrieval. A substantial proportion of all device migration or embolization cases occur after discharge and different patient and procedure characteristics are associated with in-hospital versus post-discharge cases. Given the morbidity and mortality associated with device migration or embolization, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health

Direct current cardioversion practices following percutaneous left atrial appendage closure

“…Given that the incidence of PDL and LAT/DRT rates were higher with temporal proximity to LAAC, it appears that OAC and LAA imaging become more important with decreased time from LAAC to DCCV. Finally, recent data from the National Cardiovascular Data Registry suggests a 0.06% incidence of LAAC device migration and embolization at 45‐day follow‐up, further emphasizing the benefit of LAA imaging before DCCV in the setting of close temporal proximity to LAAC 19 …”

Early and late Watchman device migration and embolization: Insights from the NCDR LAAO registry

“…Although evaluations of therapeutic efficacy are often confounded in registry data as opposed to randomized trials, procedural success rates, and complication rates, including rare complications, may be more accurately assessed with prospective registry data assuming accurate data abstraction and entry. In the issue of this journal, Friedman et al use the NCDR LAAO registry to assess the incidence of a potentially devastating complication of Watchman LAAO: device migration or embolization (DME) both acutely during the index hospitalization and postdischarge 4 …”

“…In the issue of this journal, Friedman et al use the NCDR LAAO registry to assess the incidence of a potentially devastating complication of Watchman LAAO: device migration or embolization (DME) both acutely during the index hospitalization and postdischarge. 4 It is helpful to first review the evolution of procedural complications and DME rates from the original, premarket clinical trials and registries including PREVAIL (Watchman 2.5), CAP, and PINNACLE FLX (Watchman FLX). PREVAIL was originally mandated by the Food and Drug Administration (FDA) and designed to be additive to the PROTECT AF trial primarily to assess for procedural safety.…”

Who watches the WATCHMAN? A case of recurrent strokes after transcatheter left atrial appendage closure

“…Data from the NCDR LAAO Registry showed a rate of WATCHMAN device migration or embolization detected with 45-day follow-up of 0.06%. 4 The annualized rate of ischemic stroke after LAAC in patients with CHA2DS2-VASc score of 3 or more is 1.4%; 5 however, whether it is associated with devicerelated thrombosis is unclear, as data from literature are conflicting. 5,6 In our case, the protrusion of the device within the atrial cavity left a portion the left auricle uncovered and exposed the thrombogenic inner surface of the WATCHMAN to the blood stream, creating a favourable situation for thrombus production and embolization.…”

“…Data from the NCDR LAAO Registry showed a rate of WATCHMAN device migration or embolization detected with 45-day follow-up of 0.06% 4 …”