Cerebral Embolic Protection During Surgical Aortic Valve Replacement - Cerebral Embolic Protection During SAVR

Aug 08, 2017
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institutes of Health
Date Published:
08/08/2017
Date Updated:
08/08/2017
Original Posted Date:
08/08/2017
References

Contribution To Literature:

The trial showed that cerebral embolic protection during SAVR failed to prevent CNS infarction.

Description:

The goal of the trial was to evaluate cerebral embolic protection compared with standard of care among patients undergoing surgical aortic valve replacement (SAVR).

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients undergoing SAVR were randomized to cerebral embolic protection (suction-based extraction, n = 118; or intra-aortic filtration, n = 133) vs. standard of care (n = 132).

  • Total number of enrollees: 383
  • Duration of follow-up: 30 days
  • Mean patient age: 74 years
  • Percentage female: 38%
  • Percentage with diabetes: 41%

Inclusion criteria:

  • Patients ≥60 years of age undergoing SAVR

Exclusion criteria:

  • Stroke within prior 3 months
  • Planned carotid, cerebral, or arch angiography within 3 days of surgery
  • Active endocarditis

Principal Findings:

The primary outcome, incidence of imaging-based central nervous system (CNS) infarction, occurred in 74.4% of the intra-aortic filtration group vs. 68.0% of the suction-based group vs. 67.6% of the control group (p = 0.22 for aortic filtration vs. control; p = 0.84 for suction vs. control).

Secondary outcomes:

  • Clinically apparent stroke within 7 days: 8.3% of the intra-aortic filtration group vs. 5.1% of the suction-based group vs. 6.1% of the control group (p = 0.50 for aortic filtration vs. control; p = 0.81 for suction vs. control)
  • Delirium at 7 days: 8.1% of the intra-aortic filtration group vs. 6.3% of the suction-based group vs. 15.6% of the control group (p = 0.07 for aortic filtration vs. control; p = 0.03 for suction vs. control)
  • Debris captured in filter: 99.1% of the intra-aortic filtration group vs. 74.5% of the suction-based group

Interpretation:

Among patients undergoing SAVR, cerebral embolic protection failed to prevent either imaging-based CNS infarction or clinically apparent CNS infarction. This was despite capture of embolic debris in the majority of the embolic protection devices. A potential benefit for cerebral embolic protection could be reduction in postoperative delirium. Percutaneous cerebral embolic protection devices have also failed to prevent CNS infarction after transcatheter AVR (TAVR).

References:

Mack MJ, Acker MA, Gelijns AC, et al. Effect of cerebral embolic protection devices on CNS infarction in surgical aortic valve replacement: a randomized clinical trial. JAMA 2017;318:536-47.

Keywords: Aortic Valve, Cardiac Surgical Procedures, Central Nervous System, Diabetes Mellitus, Delirium, Embolic Protection Devices, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Infarction, Intracranial Embolism, Standard of Care, Stroke, Transcatheter Aortic Valve Replacement


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