- This analysis of the FDA Manufacturer and User Facility Device Experience database included 2,257 patients who experienced adverse events (AEs) after receiving a Watchman device after FDA approval
- Of 3,652 reported AEs, the most common was pericardial effusion (n=704, 1.6% incidence and 19% of all reported AEs); 29% of the 704 patients developed pericardial tamponade, 0.9% developed pericarditis and 6% died
- Other important AEs were device-related thrombi (0.6%), death (0.4%), stroke (0.3%) and device embolization (0.3%)
- Most AEs occurred during the implant procedure (59%) or on the day after (15%), but each of the five major AE types exhibited a distinct time course
- The rates and distribution of major complications were comparable to those reported in the key clinical trials of the Watchman device, but the incidence of pericardial effusion was lower
In March 2015, the FDA approved the Watchman device for left atrial appendage closure (LAAC). This new strategy aims to reduce the risk of stroke in patients with non-valvular atrial fibrillation who are not candidates for long-term anticoagulation because of the elevated risk for life-threatening bleeding.
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Jeremy N. Ruskin, MD, founder and director emeritus of the Telemachus & Irene Demoulas Family Foundation Center for Cardiac Arrhythmias at the Corrigan Minehan Heart Center at Massachusetts General Hospital and professor of Medicine at Harvard Medical School, Leon M. Ptaszek, MD, PhD, cardiac electrophysiologist and assistant professor of Medicine at Harvard Medical School, Pablo A. Ledesma, MD, medical resident and former research fellow in the Telemachus & Irene Demoulas Family Foundation Center for Cardiac Arrhythmias, examined real-world data on patients who had the original Watchman device implanted after FDA approval. In The American Journal of Cardiology, they report outcomes generally comparable to those observed in the key clinical trials.
The researchers analyzed records in the FDA Manufacturer and User Facility Device Experience database between March 2015 and February 2019. They identified reports of 3,652 adverse events (AEs) in 2,257 patients who underwent implantation of a Watchman device after FDA approval.
Using other national databases, the researchers estimated that 43,802 Watchman implantations were performed during the study period.
Pericardial effusion was the most frequently reported AE, affecting 1.6% of all 43,802 patients. A cause was reported in only 28% of cases, but 93% of those cases were attributed to left atrial appendage perforation.
Of the 704 patients with pericardial effusion, 29% developed pericardial tamponade, 0.9% developed pericarditis and 6% died.
Other Common AEs
- Device-related thrombi—260 patients (0.6%); of these, 9% had a stroke or transient ischemic attack
- Death—178 (0.4%); the most frequent causes were cardiac tamponade, stroke, pericardial effusion, sepsis or device embolization, but for 35% of deaths, no cause was reported
- Stroke—149 (0.3%)
- Device embolization—143 (0.3%); 108 patients required device removal, and five of them died
Timing of Events
Most AEs occurred during the implant procedure (59%) or on the day after (15%). For 8% of events, the timing of the AE was not reported.
Each of the five major AE types exhibited a distinct time course:
- Pericardial effusion—66% of events occurred intraoperatively; 27% on the first day after implantation
- Device-related thrombi—63% of events occurred one to 12 months after implantation
- Deaths—58% occurred within the first 30 days; 12% one to 12 months after implantation, 7% more than 12 months after implantation
- Strokes—5.4% occurred intraoperatively, 11.4% on the first day after implantation, 17.4% two to 30 days after, 10.1% one to 12 months after, 13.4% more than 12 months after (timing unreported for 42.3%)
- Device embolization events—39% occurred intraoperatively and 15% on the first day after implantation, but later embolization was also common (15% of events occurred two to 30 days after implantation, and 25% one to 12 months after)
Putting the Findings in Context
The rates and distribution of major complications were comparable to those reported in the clinical trials that guided the regulatory approval of the Watchman. In fact, the incidence of pericardial effusion was lower. However, it is noteworthy that so many AEs occurred more than one month after implantation.
Watchman FLX, a second-generation device designed to enhance the safety profile, was recently approved by the FDA.
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