Pilot Study of Cognitive and Functional Outcomes Following TAVI

Cognitive and Functional Outcomes Following Transcatheter Aortic Valve Implantation (TAVI): a Pilot Study

Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood delivery and is associated with poor quality of life and death. In the elderly with considerable medical burden, a relatively new non-invasive valve replacement technique called Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery. However, long term changes in cognition after TAVI remain unclear and previous studies have suggested an increased risk of cognitive decline in patients following the surgical procedure. In this pilot study, the investigators will characterize changes in cognition, physical capacity, overall quality of life and neuropsychiatric symptoms (depression and apathy) over 6 months after TAVI.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis

Detailed Description

Cardiovascular disease including valvular heart disease, contributes to an estimated 36% of all deaths over the age of 70. In particular, severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and is associated with reduced quality of life and increased mortality. TAVI has been shown to improve survival, with an all-cause mortality at 1 year similar to surgical aortic valve replacement (SAVR) with favourable outcomes long-term including improved functional capacity and quality of life. Recent evidence from randomized controlled trials suggests an increased risk of neurological events (e.g. cognitive decline) up to 1 year after TAVI in comparison to both SAVR and medical treatment. Studies have shown no change in short-term memory, working memory, verbal learning, delayed recognition and verbal fluency 3 months after TAVI. In addition, patients with severe aortic stenosis have an increased risk of mortality and future health complications. This study will be an observational, prospective cohort pilot study to examine changes in cognitive performance and functional outcomes after TAVI. We propose to recruit 34 patients for this study. Cognitive performance will be measured using a standardized cognitive battery prior to TAVI and 6 months post-TAVI. Functional capacity, changes in neuropsychiatric symptoms and quality of life will also be assessed prior to TAVI and 6 months post-TAVI. We hypothesize there will a change in cognitive performance, functional capacity, mood outcomes and quality of life over 6 months after TAVI.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of severe symptomatic aortic stenosis (aortic valve area < 1 cm2, mean gradient across the aortic valve of 40 mm Hg or more and a peak aortic jet velocity of 4.0 m/s or more) undergoing transcatheter aortic valve implantation

Description

Inclusion Criteria:

• diagnosis of severe symptomatic aortic stenosis
• undergoing TAVI
• speak and understand English

Exclusion Criteria:

• emergency TAVI
• any medical conditions that will affect their ability to complete the protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
transcatheter aortic valve implantation; This study recruits individuals that are undergoing transcatheter aortic valve implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance	The 30-minute neuropsychiatric assessment battery recommended by NINDS-CSN (National Institute of Neurological Disorders and Stroke- Canadian Stroke Network) harmonized standards	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	The Timed Up and Go Test (TUG) and Hand Grip Strength Test	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	The Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D-5L questionnaires	6 months
Depression	Centre for Epidemiologic Studies Depression Scale (CES-D)	6 months
Apathy	Apathy Evaluation Scale (AES)	6 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Krista L Lanctôt, PhD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; cognition; severe aortic stenosis; functional capacity; transcatheter aortic valve implantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 503-2013