Cerebral Embolic Protection in Patients Undergoing Surgical Aortic Valve Replacement (SAVR) - Cerebral Embolic Protection Devices During SAVR

Mar 19, 2017
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Presenter/Author:
Michael J. Mack, MD, MACC
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institutes of Health
Date Presented:
03/19/2017
Date Published:
03/19/2017
Original Posted Date:
03/19/2017
References

Contribution To Literature:

The Cerebral Embolic Protection Devices During SAVR trial showed that routine use of two different intraoperative embolic protection devices was not superior to routine management among patients undergoing SAVR.

Description:

The goal of the trial was to assess the safety and efficacy of two embolic protection devices, CardioGard and Embol-X, in reducing central nervous system ischemic injury among patients undergoing surgical aortic valve replacement (SAVR).


Study Design

Patients were randomized in a 1:1:1 fashion to either CardioGard (n = 118), Embol-X (n = 133), or control (n = 132). CardioGard is an embolic protection cannula that sits in the ascending aorta, while Embol-X is an intra-aortic filtration device. The trial had to be stopped early following an interim analysis for futility.

  • Total number of enrollees: 383
  • Duration of follow-up: 90 days
  • Mean patient age: 74 years
  • Percentage female: 37%

Other salient features:

  • Atrial fibrillation: 12%
  • Prior stroke or transient ischemic attack: 9%
  • At least one cognitive deficit: 32%
  • Isolated SAVR: 59%
  • Duration of cardiopulmonary bypass: 105 minutes

Principal Findings:

Primary endpoint, freedom from clinical or radiographic ischemic brain injury at 7 days for CardioGard vs. Embol-X vs. control, occurred in 32.7% vs. 27.1% vs. 34.8%, p = 0.84, p = 0.22, respectively.

Secondary outcomes:

  • Magnetic resonance imaging lesion volume for CardioGard vs. control: 178.5 vs. 476.4 mm3 (p = 0.28); Embol-X vs. control: 321.3 vs. 484.4 mm3 (p = 0.49)
  • Severe clinical stroke for CardioGard vs. control: 1% vs. 3%; Embol-X vs. control: 1% vs. 2%
  • Delirium at 7 days for CardioGard vs. Embol-X vs. control: 6% vs. 8% vs. 15%, p = 0.03, p = 0.07, respectively
  • Overall neurocognitive decline at 90 days for CardioGard vs. control: 30% vs. 31%; Embol-X vs. control: 29% vs. 32%

Interpretation:

The results of this trial indicate that the routine use of two different intraoperative embolic protection devices were not superior to routine management among patients undergoing SAVR. Although clinical event rates were low, radiographically more than a third of patients had evidence of ischemic brain injury following SAVR. The long-term neurocognitive effect of these findings is unclear. Among patients undergoing transcatheter AVR (TAVR), other trials using embolic protection devices have been similarly negative despite a high prevalence of radiographically evident insults during the procedure.

References:

Presented by Dr. Michael Mack at the American College of Cardiology Annual Scientific Session (ACC 2017), Washington, DC, March 19, 2017.

Keywords: ACC17, ACC Annual Scientific Session, Acute Kidney Injury, Aortic Valve, Atrial Fibrillation, Brain, Cardiac Surgical Procedures, Cardiopulmonary Bypass, Cognition, Cognition Disorders, Embolic Protection Devices, Heart Valve Diseases, Heart Valve Prosthesis, Ischemia, Ischemic Attack, Transient, Magnetic Resonance Imaging, Memory, Short-Term, Stroke, Vascular Diseases


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