Clinical and procedural outcomes of the percutaneous LAA closure in atrial fibrillation patients with high clinical and bleeding risk. Insight from the multi-center LAIT (LAmbre ITalian) registry

Background Left atrial appendage (LAA) closure represents a valuable option for atrial fibrillation (AF) patients at high bleeding risk who cannot tolerate long-term oral anticoagulation. The LAMBRE device offers a novel approach: preliminary data hypothesized some advantages of this system related to the very proximal atrial cavity of the landing zone of the device. To date, real-world data in older, comorbid cohorts remain limited. Purpose We sought to evaluate the peri-procedural safety and procedural outcomes of LAMBRE implantation in a multi-center Italian registry (LAIT registry: LAmbre ITalian registry). Methods A total of 225 consecutive patients (mean age 76.2 ± 7.7 years; 65.3% male) underwent LAMBRE implantation in 10 centers. Comorbidities were frequent, including hypertension (82.2%), dyslipidemia (49.3%), diabetes (32.0%), and a mean Charlson Index of 6.0 ± 2.6. Most patients (98.2%) had AF (53.3% paroxysmal, 31.1% persistent, 12.9% permanent), with mean CHA₂DS₂-VASc and HAS-BLED scores of 4.2 ± 1.5 and 3.4 ± 1.2, respectively. The primary indications included previous major bleeding (56.9%) or high-risk features (e.g., recurrent minor bleeding, fall risk). Intra-procedural imaging was predominantly trans-esophageal echocardiography (97.8%); 10 patients had no follow-up, leaving 215 for outcome assessment (median 3.5 months, IQR 2.0–6.3). Results Procedural success was achieved in 99.1% (223/225), with a mean procedure time of 72.3 ± 28.7 minutes and mean fluoroscopy time of 14.1 ± 9.0 minutes. Device embolization occurred in 1.9% (4/215) patients, including one peri-procedural event and one event detected at 281 days. One patient (0.5%) failed the "tug-test". Cardiac tamponade was noted in 1.4% (3/215) patients at various time points (day of implant, 33 days, 317 days). TIA/stroke occurred in 2.3% (5/215) patients, with a median onset of 265 days. Major bleeding during follow-up was observed in 7.0% (15/215). No device-related mortality was reported; non–device-related deaths occurred in 11.2% (24/215), and 1.4% (3/215) had unknown cause of death. Conclusion In this real-world, high-risk population characterized by advanced age and multiple comorbidities, LAMBRE LAA closure demonstrated a high procedural success rate and a low incidence of significant complications. These findings support LAMBRE as a feasible option for patients contraindicated to long-term anticoagulation, warranting further prospective validation to refine patient selection and optimize management.