Effect of Fluoroscopy-Only Versus Transesophageal Echocardiography/Intracardiac Echocardiography Guidance in Left Atrial Appendage Occlusion on Stroke Prevention: Analysis From the RECORD I Study.

BACKGROUND

Evidence regarding the link between imaging modality and stroke prevention outcomes of left atrial appendage occlusion is currently lacking.

METHODS

The RECORD (Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology) trial prospectively enrolled 3096 consecutive patients undergoing left atrial appendage occlusion from 39 Chinese centers between April 1, 2019, and October 31, 2020. In the current analyses, patients were stratified into the echocardiographic guidance (transesophageal echocardiography/intracardiac echocardiography) group and the fluoroscopy-only group. The primary end point was the composite end point of death, stroke, or systemic embolism at 3 years. Outcomes were estimated using the Kaplan-Meier method. Inverse probability of treatment weighting and 1:1 propensity score matching were performed to calculate hazard ratios (HRs) for each outcome at the time of interest.

RESULTS

Among 3096 participants, 2603 (84.1%) underwent transesophageal echocardiography/intracardiac echocardiography-guided procedures and 493 (15.9%) underwent fluoroscopy-only guided procedures. Before discharge, procedural complications occurred in 34 patients (1.4%) in the transesophageal echocardiography/intracardiac echocardiography group and 3 patients (0.6%) in the fluoroscopy-only group (inverse probability of treatment weighting-adjusted absolute difference, -0.67 [95% CI, -1.39 to 0.05], P=0.066). At 3-year follow-up (completed by 2989 patients, 97.0%), the primary end point occurred in 269 (10.5%) patients in the transesophageal echocardiography/intracardiac echocardiography group and 52 (10.6%) patients in the fluoroscopy-only group (inverse probability of treatment weighting-adjusted HR, 1.13 [95% CI, 0.81-1.57], P=0.469). Ischemic stroke was comparable between groups (3.0% versus 4.1%, inverse probability of treatment weighting-adjusted HR, 1.66 [95% CI, 0.95-2.89], P=0.073). These findings remained consistent across patient risk profiles and operator experience levels.

CONCLUSIONS

Fluoroscopy-only guidance, without compromising long-term stroke prevention efficacy, may serve as a streamlined and potentially accessible alternative for left atrial appendage occlusion procedures performed with the first-generation WATCHMAN 2.5 device, and these findings apply to select patients and experienced centers.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03917563.