Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement

Minnesota Veterans Medical Research and Education Foundation63 enrolled

Overview

The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.

The investigators are conducting a pilot study to compare cognitive outcomes in up to 60 Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the Minneapolis VA Health Care System. Participants will be administered a short battery of cognitive tests before and three months after TAVR or SAVR over/up to a two year study period.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiovascular Disease Aortic Valve Stenosis Cognitive Assessments Valve Surgery

Eligibility

Sex: ALLMax age: 104 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or \> 40 mmHg and/or peak velocity \> 4 m/s) * Scheduled to undergo either surgical or transcatheter aortic valve replacement at the Minneapolis VA Health Care System Exclusion Criteria: * Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures) * Unable or unwilling to provide informed consent

Outcomes

Primary Outcomes

Montreal Cognitive Assessment

Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR.

Time frame: Three Months

Trail Making

Time frame: 3 months