Dataset Information

Five-Year Outcomes and Cardiac Remodeling Following Left Atrial Appendage Occlusion.

ABSTRACT:

Purpose

LAAO has been an alternative therapy to oral anticoagulants (OACs) for stroke prophylaxis in patients with nonvalvular atrial fibrillation (NVAF) with elevated CHA₂DS₂-Vasc score, but the long-term outcomes of LAAO and its impacts on cardiac electrical and mechanical remodeling remain to be learned. We aimed to describe the impact of left atrial appendage occlusion (LAAO) on atrial remodeling and cardiovascular outcomes within 5-year follow-up.

Patients and methods

A total of 107 patients with nonvalvular atrial fibrillation (NVAF) undergoing LAAO in the Shanghai Tenth People's Hospital between January 2014 and July 2017 were included. All participants were followed for ECG, transthoracic echocardiography (TTE), and clinical outcomes (including cardiovascular death, heart failure, ischemic stroke/systemic embolism, and pericardial effusion) at 6 and 12 months, and thereafter every 12 months after LAAO discharge until 5 years.

Results

After LAAO, the left atrial diameter significantly increased at 6 months (48.6 ± 6.7 vs 46.5 ± 7.0 mm); heart rate decreased immediately after the procedure (78.5 ± 14.7 vs 85.3 ± 21.7 bpm) when compared with the pre-procedure level. The QTc interval prolongated to the highest value of 460.7 ± 46.8 ms at 6 months (pre-procedure level of 433.7±49.0 ms). All these changes return to the pre-procedure level within the follow-up. For clinical outcomes, 51 patients suffered the composite of cardiovascular death (n=4, 3.7%), heart failure (n=25, 23.4%), ischemic stroke/systemic embolism (n=22, 20.6%), and pericardial effusion (n=26, 26.2%).

Conclusion

LAAO did not change ECG or TTE characteristics and nonprocedure-related pericardial effusion is common during long-term follow-up. Further studies are warranted to investigate the optimal time frame of anticoagulation in patients undergoing LAAO.

SUBMITTER: Liu B

PROVIDER: S-EPMC8064621 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background The interrelationships between left atrial appendage (LAA) dimensions and device following implantation are unknown. We aimed to analyze the impact of Watchman device implantation on LAA dimensions following its percutaneous closure and potential predictors of remodeling. Methods and Results All consecutive LAA closure procedures performed at 2 centers between November 2017 and December 2020 were included in the WATCH-DUAL (Watchman 2.5 Versus Watchman FLX in a Dual-Center Left Atrial Appendage Closure Cohort) registry. This study included patients who had pre- and postintervention computed tomography scan analysis. The LAA and device dimensions were measured in a centralized core lab by 3-dimensional computed tomography scan reconstruction methods, focusing on the device landing zone. This analysis included 104 patients (age, 76.0 [range, 72.0-83.0] years; 72% men; 53% Watchman FLX; 47% Watchman 2.5). The baseline characteristics were comparable between Watchman 2.5 and Watchman FLX groups, except for the higher use of oversizing in the latter group. The median delay for computed tomography control was 49 (range, 43-64) days. The landing zone area (median, 446 [range, 363-523] versus 290 [222-366] mm2; P<0.001) and minimal diameter (median, 23.0 [range, 20.7-24.8] versus 16.7 [14.7-19.4] mm; P<0.001) significantly increased after implantation. The absolute (median, 157 [range, 98-220] versus 85 [18-148] mm2, P<0.001) and relative (median, 50% [range, 32%-79%] versus 26% [4%-50%]; P<0.001) increases in landing zone area were more pronounced in patients with oversized device. Baseline LAA dimensions were smaller, landing zone eccentricity larger, and oversized device more frequent in patients with significant overexpansion compared with the others. Conclusions LAA dimensions increased at the site of the Watchman prosthesis after implantation, suggesting a local positive remodeling after the procedure. This phenomenon was more pronounced in the case of oversized devices.

Project description:BackgroundLeft atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.ObjectivesThe purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.MethodsThe authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.ResultsA total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare.ConclusionsThe LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.