Does the WATCHMAN FLX Pro 40-mm device provide comparable safety and efficacy (peri-device leakage) compared to the 35-mm device in patients undergoing left atrial appendage closure?
The novel 40-mm WATCHMAN FLX Pro device allows for closure of larger left atrial appendages with comparable procedural safety to the 35-mm device, but carries a higher risk of significant peri-device leakage at 3 months.
Key Points The novel WATCHMAN FLX Pro 40‐mm device enables closure of larger left atrial appendages with procedural safety comparable to that of the 35‐mm device. During the transition from the WATCHMAN FLX to the WATCHMAN FLX Pro, the overall use of large devices (≥ 35‐mm) remained similar between groups (WATCHMAN FLX: 35‐mm, 35%; WATCHMAN FLX Pro: 35‐mm, 25%; 40‐mm, 10%). The 40‐mm device was more frequently implanted in male patients and in those with non‐paroxysmal atrial fibrillation. However, the largest 40‐mm device was associated with a higher incidence of significant peri‐device leakage both at the time of the procedure and at the 3‐month follow‐up, suggesting careful patient selection and procedural planning are warranted.
Chatani et al. (Sun,) studied this question.