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Cerebral Embolic Protection Device May Not Reduce Stroke Risk After Transcatheter Aortic Valve Implantation

Key findings

  • In this study the Nationwide Readmissions Database was used to determine in-hospital outcomes of patients undergoing transcatheter aortic valve implantation (TAVI) with (n=2,433) or without (n=47,567) the use of a cerebral embolic protective device (CEPD)
  • The CEPD and no-CEPD groups did not differ significantly in terms of in-hospital stroke/transient ischemic attack (2.6% vs. 2.2%), stroke (2.1% vs. 1.9%), transient ischemic attack (0.5% vs. 0.3%) or death from any cause (1.1% vs. 1.5%)
  • In overlap propensity score–weighted analyses, the use of CEPD during TAVI was not associated with significantly lower rates of in-hospital stroke/transient ischemic attack, stroke, transient ischemic attack or mortality
  • Two large randomized, controlled trials of TAVI with or without a CEPD are currently recruiting and may clarify whether such devices are beneficial in reducing the risk of stroke

Stroke is a serious complication of transcatheter aortic valve implantation (TAVI) and can occur intraprocedurally. Small randomized, controlled trials have shown that cerebral embolic protection devices (CEPD) can capture embolic debris during TAVI and fewer ischemic brain lesions occur with CEPD. However, no adequately powered trial has demonstrated a reduction in stroke rates.

Dhaval Kolte, MBBS, PhD, interventional cardiologist at the Corrigan Minehan Heart Center at Massachusetts General Hospital, and Sammy Elmariah, MD, MPH, director of Interventional Cardiology Research, and colleagues examined a large, nationally representative sample of TAVI procedures performed in the U.S. with or without a CEPD. In The American Journal of Cardiology, they report that the use of CEPD during TAVI was not associated with significantly lower rates of in-hospital stroke/transient ischemic attack (TIA), stroke, transient ischemic attack or mortality.

Study Methods

In June 2017, the FDA approved the Sentinel Cerebral Embolic Protection System, the first and so far only CEPD currently available in the U.S. The researchers used the 2017–2018 Nationwide Readmissions Database, an all-payer database maintained by the AHRQ, to review all percutaneous TAVI procedures performed during the initial 18-month period after approval, July 2017 to December 2018. The study included 50,000 TAVI procedures and CEPD was used in 2,433.

In-Hospital Outcomes

None of the following differences were statistically significant:

  • Stroke or TIA (primary outcome)—2.6% of patients in whom CEPD was used vs. 2.2% of those in whom CEPD was not used
  • Stroke—2.1% vs. 1.9%
  • TIA—0.5% vs. 0.3%
  • Death from any cause—1.1% vs. 1.5%

Overlap Propensity Score–Weighted Analyses

To account for non-random allocation to CEPD use and potential confounding, the researchers weighted the CEPD and no-CEPD groups using a propensity score that accounted for differences in demographics, comorbidities and hospital characteristics.

The two groups had similar odds of stroke/TIA, stroke, TIA and death from any cause. The results were consistent across all prespecified subgroups: age (<80 and ≥80), sex, and patients with or without atrial fibrillation/flutter, prior TIA/stroke, chronic kidney disease, bicuspid aortic valve or valve-in-valve TAVI.

Answers May Be Forthcoming

Prior observational studies of CEPD have produced conflicting results about protection against stroke, and the addition of these latest findings suggests genuine uncertainty about whether CEPD use is beneficial. It is hoped two large randomized, controlled trials of TAVI with or without the Sentinel device will provide insight:

  • The Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial, where Mass General is one of the participating sites, intends to enroll 3,000 patients; the primary outcome is the rate of stroke through 72 hours after TAVI or discharge (whichever comes first)
  • The British Heart Foundation Randomized Trial of Routine Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (PROTECT-TAVI) aims to enroll 7,730 patients; the primary outcome is the rate of stroke through 72 hours

Learn more about the Heart Valve Program at Mass General

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