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LAACS

Randomized Trial of Surgical Left Atrial Appendage Closure: Protection Against Cerebrovascular Events

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Year of Publication: 2022

Authors: Christoffer V. Madsen, Jesper Park-Hansen, Susanne J.V. Holme, ..., Helena Dominguez

Journal: Seminars in Thoracic and Cardiovascular Surgery

Citation: Semin Thoracic Surg 35:664–672 © 2022

Link: https://doi.org/10.1016/j.ahj.2023.06.003

Clinical Question

Does routine closure of the left atrial appendage in patients undergoing open-heart surgery provide long-term protection against cerebrovascular events independently of atrial fibrillation history, stroke risk, and oral anticoagulation use?

Bottom Line

Left atrial appendage closure during open-heart surgery significantly reduced cerebrovascular events by 53% over long-term follow-up, regardless of pre-surgery atrial fibrillation status or stroke risk, with no increase in mortality.

Major Points

  • First randomized trial to investigate routine LAA closure in patients with and without atrial fibrillation
  • 53% reduction in primary composite endpoint (stroke, TIA, silent cerebral ischemic lesions)
  • Protective effect independent of baseline AF status and CHA2DS2-VASc score
  • No increase in mortality or perioperative complications
  • Mean follow-up of 6.2 years with up to 10 years observation
  • Double closure technique recommended with purse string and running suture

Design

Study Type: Prospective, randomized, open-label, blinded evaluation trial

Randomization: 1

Blinding: Two neurologists blinded for treatment assignment adjudicated cerebrovascular events

Enrollment Period: August 2010 to September 2015

Follow-up Duration: Mean 6.2 years (up to 10 years)

Centers: 2

Countries: Denmark

Sample Size: 186

Analysis: Intention-to-treat and per-protocol analyses using cumulative incidence curves with death as competing risk, Gray's test for group differences, cause-specific Cox regression, RStudio software

Inclusion Criteria

  • Patients undergoing elective first-time open-heart surgery
  • Both patients with and without history of atrial fibrillation

Exclusion Criteria

  • Off-pump surgery
  • Planned LAA closure
  • Planned ablation

Arms

FieldControlLAA Closure
InterventionStandard care (open LAA) during elective open-heart surgeryLeft atrial appendage closure added to elective open-heart surgery, primarily by double closure with purse string and running suture
Duration

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Composite endpoint of ischemic stroke events, transient ischemic attacks, and imaging findings of silent cerebral ischemic lesionsPrimary22.1% (19/86)11.0% (11/100)0.460.033
Clinical stroke events and TIASecondary15.1% (13/86)10.0% (10/100)0.620.252
All-cause mortalitySecondary27.9% (24/86)23.0% (23/100)0.780.401
Stroke aloneSecondary4.7% (4/86)7.0% (7/100)0.715
TIA aloneSecondary9.3% (8/86)3.0% (3/100)0.132
Silent cerebral ischemic lesionsSecondary8.1% (7/86)1.0% (1/100)0.042
Procedure-related adverse events (bleeding)AdverseNot applicable (no LAACS)0/101 (0%) - none reported
All-cause mortality during follow-up (mean 3.7 yrs)Adverse12/86 (14%)12/101 (12%)0.79
Primary composite endpoint (stroke/TIA/SCI)Adverse14/86 (16%)5/101 (5%)HR 0.3 (95% CI 0.1-0.8)0.02
Silent cerebral infarction (post-discharge MRI)AdverseNot separately reported11/74 (14.9%) had SCI on post-discharge MRI

Subgroup Analysis

In patients without AF at baseline (n=154), primary outcome was 22.2% vs 13.4% (control vs LAA closure) with no statistically significant difference. CHA2DS2-VASc score had nonsignificant association with outcomes in both ITT and PP analyses.

Criticisms

  • Moderate sample size with many cross-over cases at single center
  • Many protocol deviations potentially diminishing randomization effect
  • Study included patients undergoing various types of surgery with different baseline characteristics
  • Closure method not always documented in detail in patient files
  • Additional study-specific long-term follow-up cerebral imaging not performed
  • Primary outcome included both ischemic and hemorrhagic stroke which may confound results
  • Percutaneous radiofrequency ablation procedures during follow-up not registered

Funding

Research Council at Herlev Hospital, Research Council at Bispebjerg and Frederiksberg Hospital, IMK Almene Fond, Kaj Hansens Foundation, Skibsreder Per Henriksen Foundation, Novo Nordisk Foundation

Based on: LAACS (Seminars in Thoracic and Cardiovascular Surgery, 2022)

Authors: Christoffer V. Madsen, Jesper Park-Hansen, Susanne J.V. Holme, ..., Helena Dominguez

Citation: Semin Thoracic Surg 35:664–672 © 2022

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