NCDR Study: Next Generation Watchman FLX Devices Safer Than First Generation Watchman For Transcatheter LAAO
Transcatheter left atrial appendage occlusion (LAAO) using the next generation Watchman FLX was linked to lower rates of in-hospital major adverse events when compared with the first-generation Watchman device, according to a recent study published in JACC: Cardiovascular Interventions.
Matthew J. Price, MD, FACC, et al., looked at data from ACC’s LAAO Registry to study 27,013 patients undergoing Watchman FLX implantation and a control group of 27,013 patients receiving the Watchman 2.5 device. They found that the rate of in-hospital major adverse events – defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention and device embolization – was significantly lower for the Watchman FLX device as opposed to the Watchman 2.5 (1.35% vs. 2.40%; adjusted odds ratio [OR], 0.57; 95% CI, 0.50-0.65; p<0.0001), mainly driven by fewer pericardial effusions requiring intervention (0.42% vs. 1.23%; adjusted OR, 0.34; 95% CI, 0.28-0.42; p<0.0001).
The Watchman FLX was also associated with less in-hospital mortality (0.12% vs. 0.24%; p<0.0001), major bleeding (1.08% vs. 2.05%; p<0.0001), cardiac arrest (0.13% vs. 0.24%; p=0.006),and device embolization (0.02% vs. 0.06%; p=0.028). There was no significant difference between the two groups concerning myocardial infarction, stroke and major vascular complications. Additional analysis using propensity score matching reaped similar results.
When it comes to study limitations, Price, et al., acknowledge the scope of their study only looked at in-hospital outcomes, not assessing procedural complications taking place after discharge such as late pericardial effusions. As a result, longer term follow-up will be necessary to determine net clinical benefit.
Regardless, the study authors conclude, “the substantially lower rate of procedural complications with the Watchman FLX, including mortality, pericardial effusion, and major bleeding, may provide a safety advantage for transcatheter LAAO compared with medical therapy in patients at high bleeding risk.”
Keywords: LAAO Registry
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