LAUSR

Oral anticoagulation (OAC) has been the mainstay for thromboembolic prevention in atrial fibrillation, yet many patients are ineligible for or cannot tolerate its long‐term use. As a result, ~40% of patients with an indication for OAC are left unprotected from stroke due to dissatisfaction and non‐adherence with OACs. Left atrial appendage closure (LAAC) is a mechanical, nonpharmacologic option for patients with nonvalvular atrial fibrillation (NVAF) to prevent cardioembolic events in those who require an alternative to OAC. The safety and efficacy of LAAC devices (e.g., Watchman, Boston Scientific; Amplatzer Amulet, Abbot Vascular) compared to warfarin (PREVAIL, PROTECT AF) and direct oral anticoagulants (PRAGUE‐17) have been well established. The Ultraseal (Cardia) is a self‐expandable bulb‐and‐sail device for transcatheter LAAC. The first generation Ultraseal, introduced in 2016, is a fully retrievable and repositionable nitinol device composed of a soft distal bulb anchoring to the left atrial appendage (LAA) through 12 stabilizing hooks and a three‐leaflet sail with a proximal polyvinyl alcohol foam and a distal polyester layer for occlusion. The Ultraseal device has unique features when compared to other LAAC devices. Its delivery system is smaller (10–12 F), and it can be partially or fully retrievable and redeployed up to five times. Additionally, soft distal bulb and the three‐leaflet sail are connected by a dual articulating joint which can be useful in left atrial appendage anatomies with acute take‐offs. In this issue of Catheterization and Cardiovascular Interventions, Pivato et al. have analyzed the feasibility and safety of the second generation Ultraseal device in 52 consecutive patients with NVAF. Compared to the first‐generation device, the second‐generation Ultraseal has updates including removal of the distal center port from the bulb, decrease in the overall length of the device, and modification of the sail covering. Removal of the distal center port from the bulb allows for more flexibility and a lower radial force, reducing the need for oversizing and providing for a safer deep implant. The sail covering polyester layer is now on the luminal surface of the device and the articulating joint has a lesser degree of movement to aid in deployment and retrieval. According to this multicenter, retrospective, single‐arm study, device and technical success was observed in 100% and 96% of patients, respectively. One device‐related perforation and one severe leak were noted, with total procedural success achieved in 94%. These success rates compare favorably to the first‐ generation device reported by Asmarts et al., as well as to other LAAC devices. In‐hospital major adverse events (MAEs) occurred in 6%, including major bleeding in two patients and a minor stroke in one patient. In‐hospital MAEs were higher than those reported by Asmarts et al., but similar to initial experiences for other LAAC devices. Follow‐up at 6 months revealed peri‐device leak in 12% of patients with only 3% of patients classified as severe or greater than 5 mm. Cardiovascular events at 6 months were 12%, including three deaths that were considered unrelated to the device. No device‐related adverse events were reported during follow‐up. The authors are to be congratulated on their laudable efforts. Their analysis has however several limitations including the small sample size and relatively short follow‐up, which render their study underpowered for a robust assessment of cardiovascular events. The limited follow‐up period may be also inadequate to understand the potential long‐term implications of the device (e.g., fracture, peri‐ device leak). Furthermore, greater than 20% of patients did not have a follow‐up TEE echo to assess for peri‐device leak, and authors may therefore have underreported this outcome. Notably, 43 of the 52 patients received echocardiographic follow‐up, 9 of whom were