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Association of Surgical Left Atrial Appendage Occlusion With Subsequent Stroke and Mortality Among Patients Undergoing Cardiac Surgery.

ABSTRACT: Importance:Surgical occlusion of the left atrial appendage (LAAO) may be performed during concurrent cardiac surgery. However, few data exist on the association of LAAO with long-term risk of stroke, and some evidence suggests that this procedure may be associated with subsequent development of atrial fibrillation (AF). Objective:To evaluate the association of surgical LAAO performed during cardiac surgery with risk of stroke, mortality, and development of subsequent AF. Design, Setting, and Participants:Retrospective cohort study using a large US administrative database that contains data from adult patients (?18 years) with private insurance or Medicare Advantage who underwent coronary artery bypass graft (CABG) or valve surgery between January 1, 2009, and March 30, 2017, with final follow-up on March 31, 2017. One-to-one propensity score matching was used to balance patients on 76 dimensions to compare those with vs without LAAO, stratified by history of prior AF at the time of surgery. Exposures:Surgical LAAO vs no surgical LAAO during cardiac surgery. Main Outcomes and Measures:The primary outcomes were stroke (ie, ischemic stroke or systemic embolism) and all-cause mortality. The secondary outcomes were postoperative AF (AF within 30 days after surgery among patients without prior AF) and long-term AF-related health utilization (event rates of outpatient visits and hospitalizations). Results:Among 75?782 patients who underwent cardiac surgery (mean age, 66.0 [SD, 11.2] years; 2?2091 [29.2%] women, 25?721 [33.9%] with preexisting AF), 4374 (5.8%) underwent concurrent LAAO, and mean follow-up was 2.1 (SD, 1.9) years. In the 8590 propensity score-matched patients, LAAO was associated with a reduced risk of stroke (1.14 vs 1.59 events per 100 person-years; hazard ratio [HR], 0.73 [95% CI, 0.56-0.96]; P?=?.03) and mortality (3.01 vs 4.30 events per 100 person-years; HR, 0.71 [95% CI, 0.60-0.84]; P?

SUBMITTER: Yao X

PROVIDER: S-EPMC6351069 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Association of Surgical Left Atrial Appendage Occlusion With Subsequent Stroke and Mortality Among Patients Undergoing Cardiac Surgery.

Yao Xiaoxi X Gersh Bernard J BJ Holmes David R DR Melduni Rowlens M RM Johnsrud Daniel O DO Sangaralingham Lindsey R LR Shah Nilay D ND Noseworthy Peter A PA

JAMA 20180501 20

<h4>Importance</h4>Surgical occlusion of the left atrial appendage (LAAO) may be performed during concurrent cardiac surgery. However, few data exist on the association of LAAO with long-term risk of stroke, and some evidence suggests that this procedure may be associated with subsequent development of atrial fibrillation (AF).<h4>Objective</h4>To evaluate the association of surgical LAAO performed during cardiac surgery with risk of stroke, mortality, and development of subsequent AF.<h4>Design ...[more]

PMID: 29800182

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Project description:BackgroundSurgical left atrial appendage occlusion (SLAAO) may be associated with a lower risk of thromboembolism in patients with atrial fibrillation undergoing cardiac surgery. However, evidence regarding the effectiveness of SLAAO in patients undergoing mechanical heart valve replacement (MHVR) is lacking. Therefore, we aimed to evaluate the association between SLAAO and the cardiovascular outcomes in patients with atrial fibrillation undergoing MHVR.MethodsWe retrospectively analyzed data for 497 patients with atrial fibrillation; 27.6% of the patients underwent SLAAO, and the remainder of the patients did not (No-SLAAO group). The primary outcome was a composite of ischemic stroke, systemic embolism, and all-cause mortality. Cumulative event-free survival rates were estimated using Kaplan-Meier curves, and we performed multivariate Cox analyses to evaluate the association between SLAAO and outcomes. We used one-to-one propensity score matching to balance patients' baseline characteristics, and analyzed 120 matching pairs.ResultsFive patients died within 30 days postoperatively, and there were no significant differences between the two groups regarding in-hospital complications (all P > 0.05). After a median follow-up of 14 months, 14 primary events occurred. Kaplan-Meier curves showed no difference in the cumulative incidence of freedom from the primary outcome (log-rank P = 0.830), hemorrhagic events (log-rank P = 0.870), and the secondary outcome (log-rank P = 0.730), between the two groups. Multivariable Cox proportional hazards regression analysis showed no association between SLAAO and any outcome (all P > 0.05). After propensity score matching, cardiopulmonary bypass time and aortic cross-clamp time, and the postoperative length of stay were significantly longer in the SLAAO group (all P < 0.05); results were similar to the unadjusted analyses.ConclusionsConcomitant SLAAO and MHVR was associated with longer length of stay, and cardiopulmonary bypass time and aortic cross-clamp time, but was not associated with additional protective effects against thromboembolic events and mortality during the 14-month follow-up.

Project description:ImportanceThe left atrial appendage is a key site of thrombus formation in atrial fibrillation (AF) and can be occluded or removed at the time of cardiac surgery. There is limited evidence regarding the effectiveness of surgical left atrial appendage occlusion (S-LAAO) for reducing the risk of thromboembolism.ObjectiveTo evaluate the association of S-LAAO vs no receipt of S-LAAO with the risk of thromboembolism among older patients undergoing cardiac surgery.Design, setting, and participantsRetrospective cohort study of a nationally representative Medicare-linked cohort from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2012). Patients aged 65 years and older with AF undergoing cardiac surgery (coronary artery bypass grafting [CABG], mitral valve surgery with or without CABG, or aortic valve surgery with or without CABG) with and without concomitant S-LAAO were followed up until December 31, 2014.ExposuresS-LAAO vs no S-LAAO.Main outcomes and measuresThe primary outcome was readmission for thromboembolism (stroke, transient ischemic attack, or systemic embolism) at up to 3 years of follow-up, as defined by Medicare claims data. Secondary end points included hemorrhagic stroke, all-cause mortality, and a composite end point (thromboembolism, hemorrhagic stroke, or all-cause mortality).ResultsAmong 10 524 patients undergoing surgery (median age, 76 years; 39% female; median CHA2DS2-VASc score, 4), 3892 (37%) underwent S-LAAO. Overall, at a mean follow-up of 2.6 years, thromboembolism occurred in 5.4%, hemorrhagic stroke in 0.9%, all-cause mortality in 21.5%, and the composite end point in 25.7%. S-LAAO, compared with no S-LAAO, was associated with lower unadjusted rates of thromboembolism (4.2% vs 6.2%), all-cause mortality (17.3% vs 23.9%), and the composite end point (20.5% vs 28.7%) but no significant difference in rates of hemorrhagic stroke (0.9% vs 0.9%). After inverse probability-weighted adjustment, S-LAAO was associated with a significantly lower rate of thromboembolism (subdistribution hazard ratio [HR], 0.67; 95% CI, 0.56-0.81; P < .001), all-cause mortality (HR, 0.88; 95% CI, 0.79-0.97; P = .001), and the composite end point (HR, 0.83; 95% CI, 0.76-0.91; P < .001) but not hemorrhagic stroke (subdistribution HR, 0.84; 95% CI, 0.53-1.32; P = .44). S-LAAO, compared with no S-LAAO, was associated with a lower risk of thromboembolism among patients discharged without anticoagulation (unadjusted rate, 4.2% vs 6.0%; adjusted subdistribution HR, 0.26; 95% CI, 0.17-0.40; P < .001), but not among patients discharged with anticoagulation (unadjusted rate, 4.1% vs 6.3%; adjusted subdistribution HR, 0.88; 95% CI, 0.56-1.39; P = .59).Conclusions and relevanceAmong older patients with AF undergoing concomitant cardiac surgery, S-LAAO, compared with no S-LAAO, was associated with a lower risk of readmission for thromboembolism over 3 years. These findings support the use of S-LAAO, but randomized trials are necessary to provide definitive evidence.

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.

Dataset Information

Association of Surgical Left Atrial Appendage Occlusion With Subsequent Stroke and Mortality Among Patients Undergoing Cardiac Surgery.

Publications

Association of Surgical Left Atrial Appendage Occlusion With Subsequent Stroke and Mortality Among Patients Undergoing Cardiac Surgery.

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