The risk and extent of neurologic events are equivalent for high-risk patients treated with transcatheter or surgical aortic valve replacement

Thomas G Gleason; John T Schindler; David H Adams; Michael J Reardon; Neal S Kleiman; Louis R Caplan; John V Conte; G Michael Deeb; G Chad Hughes Jr; Sharla Chenoweth; Jeffrey J Popma

doi:10.1016/j.jtcvs.2016.02.073

The risk and extent of neurologic events are equivalent for high-risk patients treated with transcatheter or surgical aortic valve replacement

J Thorac Cardiovasc Surg. 2016 Jul;152(1):85-96. doi: 10.1016/j.jtcvs.2016.02.073. Epub 2016 Mar 12.

Authors

Affiliations

¹ University of Pittsburgh School of Medicine, Pittsburgh, Pa. Electronic address: gleasontg@upmc.edu.
² University of Pittsburgh School of Medicine, Pittsburgh, Pa.
³ Department of Surgery Mount Sinai Medical Center, New York, NY.
⁴ Houston-Methodist-Debakey Heart and Vascular Center, Houston, Tex.
⁵ Beth Israel Deaconess Medical Center, Boston, Mass.
⁶ Johns Hopkins University School of Medicine, Baltimore, Md.
⁷ University of Michigan, Ann Arbor, Mich.
⁸ Duke University Medical Center, Durham, NC.
⁹ Medtronic, Inc, Minneapolis, Minn.

PMID: 27085389
DOI: 10.1016/j.jtcvs.2016.02.073

Abstract

Objectives: This study was designed to characterize the incidence of new clinically detectable neurologic events, or any comparative change in indices of higher cognitive function following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) within the framework of a prospective, randomized clinical trial for high-risk patients.

Methods: High-risk patients (predicted SAVR mortality 15%) with severe aortic stenosis (n = 750) were randomized 1:1 to TAVR or SAVR and underwent evaluation using the National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale assessment at each follow-up and any suspected event. Neurologic outcomes were ascertained by a neurologist and further evaluated by Mini-Mental State Examination (MMSE), visual fields testing, gait assessment, hand function, writing evaluation, and drawing assessment.

Results: The 30-day, 1-year, and 2-year stroke rates were 4.9%, 8.7%, and 10.9%, respectively, for TAVR and 6.2%, 12.5%, and 16.6%, respectively, for SAVR (P = .46, .11, and .05, respectively). All-cause mortality in patients with a major stroke was 83.3% for TAVR and 54.5% for SAVR at 2 years (P = .29). Late major stroke was disproportionately higher (23.8% at 2 years) among patients with poor iliofemoral access randomized to SAVR. Peripheral vascular disease and falls within 6 months predicted early stroke, and severe aortic calcification and high Charlson score (≥5) predicted 1-year stroke post-TAVR. NIHSS and MMSE scores trended higher after SAVR than after TAVR. Lack of dual antiplatelet therapy use during and after TAVR was associated with early stroke.

Conclusions: This study defines an equivalent postprocedural stroke risk, stroke extent, and degree of cognitive change after TAVR or SAVR in a high-risk population, and also defines several predictors of stroke after TAVR.

Keywords: aortic stenosis; neurologic outcomes; stroke; surgical aortic valve replacement; transcatheter aortic valve replacement.

Publication types

Randomized Controlled Trial

MeSH terms

Aged, 80 and over
Aortic Valve / surgery*
Aortic Valve Stenosis / surgery*
Diagnostic Techniques, Neurological
Female
Heart Valve Prosthesis / adverse effects*
Humans
Male
Postoperative Complications / diagnosis
Postoperative Complications / epidemiology
Postoperative Complications / etiology*
Prospective Studies
Risk Factors
Severity of Illness Index
Stroke / diagnosis
Stroke / epidemiology
Stroke / etiology*
Transcatheter Aortic Valve Replacement / adverse effects*