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LAACS with cardiac surgery

Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study

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Year of Publication: 2018

Authors: Jesper Park-Hansen, Susanne J.V. Holme, Akhmadjon Irmukhamedov, ..., Helena Dominguez

Journal: Journal of Cardiothoracic Surgery

Citation: Park-Hansen et al. Journal of Cardiothoracic Surgery (2018) 13:53

Link: https://doi.org/10.1186/s13019-018-0740-7

Clinical Question

Does left atrial appendage closure with surgery (LAACS) in addition to open heart surgery protect against post-operative ischemic brain injury regardless of atrial fibrillation history?

Bottom Line

LAACS during elective open-heart surgery was associated with a 70% reduction in post-operative ischemic brain events, with protection independent of baseline atrial fibrillation status.

Major Points

  • First randomized study of LAACS in addition to first-time open-heart surgery
  • 187 patients randomized, 141 followed treatment protocol
  • Primary endpoint was composite of stroke, TIA, or silent cerebral ischemia
  • Mean follow-up of 3.7 years (up to 6 years)
  • Significant reduction in primary events: 5% LAACS vs 16% control
  • Effect was independent of baseline AF status, anticoagulation use, or CHA2DS2-VASc score
  • Most events in control group occurred beyond first year
  • No adverse events from LAACS procedure recorded

Design

Study Type: Prospective, randomized, open-label clinical trial

Randomization: 1

Blinding: Radiologists were blinded to randomization for MRI analysis

Enrollment Period: August 2010 to September 2015

Follow-up Duration: Mean 3.7 ± 1.6 years (up to 6 years)

Centers: 1

Countries: Denmark

Sample Size: 187

Analysis: Intention-to-treat and per-protocol analyses using SAS version 9.4, Cox time-to-event analysis, Fine and Gray competing risk regression

Inclusion Criteria

  • Consecutive patients undergoing planned first-time open-heart surgery
  • CABG, valve surgery or combination of both
  • Residence within 40 km radius from hospital

Exclusion Criteria

  • Endocarditis
  • Implanted pacemaker

Arms

FieldControlLAACS
InterventionStandard open heart surgery without left atrial appendage closureStandard open heart surgery with concomitant left atrial appendage closure using double closure with purse string and running suture (recommended)
DurationSingle procedureSingle procedure

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Composite of post-operative symptomatic ischemic stroke, transient ischemic attack or imaging findings of silent cerebral ischemic lesionsPrimary14 (16%)5 (5%)0.30.02
Clinical stroke (excluding imaging-only findings)Secondary8 (10%)3 (3%)0.30.08
All-cause mortalitySecondary12 (14%)12 (12%)0.80.79
Per-protocol primary outcomeSecondary14 (18%)4 (6%)0.30.05
LAACS procedure bleedingAdverseN/A0

Subgroup Analysis

Tests of interaction revealed no dependency of the preventative effect of LAACS on baseline AF status (p=0.55), CHA2DS2-VASc score (p=0.56), or use of oral anticoagulation (p=0.49)

Criticisms

  • Study halted before reaching planned sample size of 200 patients due to competing studies
  • Substantial cross-over rate (46 patients did not follow treatment protocol)
  • Only 40% of patients underwent both planned brain MRIs due to patient frailty and discomfort
  • Only 10 patients from LAACS group underwent TEE to confirm closure
  • Study not powered specifically to demonstrate stroke protection
  • Inclusion of silent cerebral ischemia in primary endpoint may be indirect measure
  • Open-label design without blinding of treatment allocation

Funding

Det Medicinske Selskab i København (research grant), Research Council in Herlev Hospital (research grant) and Research Council in Bispebjerg and Frederiksberg Hospital (research grant). Pfizer sponsored one of the meetings of the LAACS group.

Based on: LAACS with cardiac surgery (Journal of Cardiothoracic Surgery, 2018)

Authors: Jesper Park-Hansen, Susanne J.V. Holme, Akhmadjon Irmukhamedov, ..., Helena Dominguez

Citation: Park-Hansen et al. Journal of Cardiothoracic Surgery (2018) 13:53

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