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Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement (COSTA)

Primary Purpose

Postoperative Delirium, Postoperative Cognitive Dysfunction, Transcatheter Aortic Valve Replacement

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transcatheter Aortic Valve Implantation
Surgical Aortic Valve Replacement
Sponsored by
Heart and Brain Research Group, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Delirium

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Heart team decision that both TAVI and SAVR are medically justified based on

    • Degenerative aortic valve stenosis:

      • Mean gradient > 40 mmHg or
      • Jet velocity > 40 m/s or
      • Surface of aortic valve < 1.0 cm²

    • Patient shows symptoms of aortic stenosis

      • NYHA functional class ≥ II or
      • Angina pectoris or
      • Syncope
    • Low to intermediate surgical risk (STS: 2-6%)
    • A transfemoral or alternative access for TAVI can be implemented
  2. Patient has agreed in writing to participate in the study
  3. Patient is able to understand the patient information and sign it personally
  4. Patient agrees to undergo SAVR if randomization into the control group occurs
  5. Readiness for MRT examination and neuropsychological testing after 3 months
  6. Patients aged 65 to 85 years.
  7. Native German speaker (since a neuropsychological test is language dependent)

Exclusion Criteria:

  1. Congenital aortic valve defects
  2. Untreated clinically significant coronary artery disease or severe mitral or tricuspid insufficiency or mitral stenosis
  3. Previous heart surgery
  4. Percutaneous coronary intervention performed within one month prior to the study
  5. Hemodynamic instability requiring inotropic support or mechanical circulatory support
  6. Ischemic stroke or intracranial bleeding within the month before the start of the study
  7. Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by echocardiogram
  8. Hypertrophic obstructive cardiomyopathy or severe basal septum hypertrophy
  9. Echocardiographic detection of intracardiac mass, thrombus, vegetation, or endocarditis
  10. Any other atherosclerotic disease that is considered as a contraindication for isolated aortic valve surgery
  11. Symptomatic carotid or vertebral artery disease
  12. Existing neurological or psychiatric disease (particularly cerebral infarction, cranio- cerebral trauma, manifest depression or dementia) that may interfere with neuropsychological testing.
  13. Contraindications for MRI examination (e.g. cardiac pacemaker, vena cava filter, claustrophobia)

Sites / Locations

  • Department of Cardiac Surgery, Kerckhoff-Klinik GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transcatheter Aortic Valve Implantation

Surgical Aortic Valve Replacement

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
The objective neuropsychological parameters measure cognitive domains like immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), Block Tapping Test (BTT), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT).
Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed by the "Intensive Care Delirium Screening Checklist" (ICDSC)
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.

Secondary Outcome Measures

Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed by the "Cognitive Failures Questionnaire" (CFQ)
The "Cognitive Failures Questionnaire" (CFQ) measure the frequency of failures in daily living in terms of memory, attention, action, and perception. It comprises 29 questions, which are answered on a 5-step Likert scale. Higher scores mean a worse outcome.
Change from baseline health-related quality of life at 3 months after surgery as assessed by the "36-Item Short Form Health Survey" (SF36)
The "36-Item Short Form Health Survey" (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health. An aggregated percentage score is calculated for each of the eight factors. The percentage scores range from 0% to 100%. Higher scores mean a better outcome.
Change from baseline anxiety at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
With the "Hospital Anxiety and Depression Scale" (HADS), an instrument will be used that refers to the psychological core aspects of depression and anxiety. Each scale contains 7 questions to be answered on a 4-step Likert scale by the patients themselves. After inverting negative questions, higher scores mean a worse outcome.
Change from baseline depression at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
With the "Hospital Anxiety and Depression Scale" (HADS), an instrument will be used that refers to the psychological core aspects of depression and anxiety. Each scale contains 7 questions to be answered on a 4-step Likert scale by the patients themselves. After inverting negative questions, higher scores mean a worse outcome.
Number of participants with postoperative acute ischemic lesions at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Cranial MRI will be performed using a 3-T scanner (Skyra; Siemens, Erlangen, Germany). The protocol of imaging will include a T2-weighted turbo spin-echo sequence, a T2-weighted turbo spin-echo sequence for dark fluid, a T1-weighted FLASH sequence and a diffusion-weighted echo-planar imaging sequence.
Number of participants with postoperative microemboli at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Cranial MRI will be performed using a 3-T scanner (Skyra; Siemens, Erlangen, Germany). The protocol of imaging will include a T2-weighted turbo spin-echo sequence, a T2-weighted turbo spin-echo sequence for dark fluid, a T1-weighted FLASH sequence and a diffusion-weighted echo-planar imaging sequence.

Full Information

First Posted
August 27, 2020
Last Updated
September 21, 2023
Sponsor
Heart and Brain Research Group, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04535076
Brief Title
Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
Acronym
COSTA
Official Title
Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart and Brain Research Group, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery, especially for high-risk patients. Recently, increased surgeon experience and improved transcatheter valve systems have led to a global trend to use TAVI in patients with low or intermediate risk. Although cognitive impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has not yet been adequately investigated. The aim of this study is to compare the occurrence and progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted (TAVI) and surgical (SAVR) aortic valve replacement.
Detailed Description
The present project is a substudy of the DEDICATE Trial (ID: NCT03112980). It is a randomized intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI vs. SAVR) with a focus on cognitive outcome. A detailed assessment of psychological and health-related functions will be performed before intervention, during hospitalization and 3 months after intervention. During hospitalization, the occurrence and progression of delirium will be assessed with the Intensive Care Delirium Screening Checklist (ICDSC). Other cognitive data will be collected before and 3 months after surgery with a selected and comprehensive neuropsychological test battery, including the evaluation of attention, word fluency, executive functions and various functional areas of memory. In addition, parameters of health-related QOL will be collected before and 3 months after the intervention using the SF-36, and information on anxiety and depression will be collected using the Hospital Anxiety and Depression Scale (HADS). A few days after the intervention, magnetic resonance images of the brain will be acquired to assess cerebral infarction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, Postoperative Cognitive Dysfunction, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Aortic Valve Implantation
Arm Type
Experimental
Arm Title
Surgical Aortic Valve Replacement
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Transcatheter Aortic Valve Implantation
Intervention Description
Transcatheter Aortic Valve Implantation
Intervention Type
Procedure
Intervention Name(s)
Surgical Aortic Valve Replacement
Intervention Description
Surgical Aortic Valve Replacement
Primary Outcome Measure Information:
Title
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
Description
The objective neuropsychological parameters measure cognitive domains like immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), Block Tapping Test (BTT), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT).
Time Frame
Immediately pre-surgery to 3 months post-surgery
Title
Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
Description
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Time Frame
Immediately pre-surgery to approximately 1 week post-surgery
Title
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed by the "Intensive Care Delirium Screening Checklist" (ICDSC)
Description
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
Time Frame
Immediately post-surgery to approximately 7 days post-surgery
Secondary Outcome Measure Information:
Title
Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed by the "Cognitive Failures Questionnaire" (CFQ)
Description
The "Cognitive Failures Questionnaire" (CFQ) measure the frequency of failures in daily living in terms of memory, attention, action, and perception. It comprises 29 questions, which are answered on a 5-step Likert scale. Higher scores mean a worse outcome.
Time Frame
Immediately pre-surgery to 3 months post-surgery
Title
Change from baseline health-related quality of life at 3 months after surgery as assessed by the "36-Item Short Form Health Survey" (SF36)
Description
The "36-Item Short Form Health Survey" (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health. An aggregated percentage score is calculated for each of the eight factors. The percentage scores range from 0% to 100%. Higher scores mean a better outcome.
Time Frame
Immediately pre-surgery to 3 months post-surgery
Title
Change from baseline anxiety at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
Description
With the "Hospital Anxiety and Depression Scale" (HADS), an instrument will be used that refers to the psychological core aspects of depression and anxiety. Each scale contains 7 questions to be answered on a 4-step Likert scale by the patients themselves. After inverting negative questions, higher scores mean a worse outcome.
Time Frame
Immediately pre-surgery to 3 months post-surgery
Title
Change from baseline depression at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
Description
With the "Hospital Anxiety and Depression Scale" (HADS), an instrument will be used that refers to the psychological core aspects of depression and anxiety. Each scale contains 7 questions to be answered on a 4-step Likert scale by the patients themselves. After inverting negative questions, higher scores mean a worse outcome.
Time Frame
Immediately pre-surgery to 3 months post-surgery
Title
Number of participants with postoperative acute ischemic lesions at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Description
Cranial MRI will be performed using a 3-T scanner (Skyra; Siemens, Erlangen, Germany). The protocol of imaging will include a T2-weighted turbo spin-echo sequence, a T2-weighted turbo spin-echo sequence for dark fluid, a T1-weighted FLASH sequence and a diffusion-weighted echo-planar imaging sequence.
Time Frame
Once within the 6th-10th day immediately post-surgery
Title
Number of participants with postoperative microemboli at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Description
Cranial MRI will be performed using a 3-T scanner (Skyra; Siemens, Erlangen, Germany). The protocol of imaging will include a T2-weighted turbo spin-echo sequence, a T2-weighted turbo spin-echo sequence for dark fluid, a T1-weighted FLASH sequence and a diffusion-weighted echo-planar imaging sequence.
Time Frame
Once within the 6th-10th day immediately post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart team decision that both TAVI and SAVR are medically justified based on Degenerative aortic valve stenosis: Mean gradient > 40 mmHg or Jet velocity > 40 m/s or Surface of aortic valve < 1.0 cm² Patient shows symptoms of aortic stenosis NYHA functional class ≥ II or Angina pectoris or Syncope Low to intermediate surgical risk (STS: 2-6%) A transfemoral or alternative access for TAVI can be implemented Patient has agreed in writing to participate in the study Patient is able to understand the patient information and sign it personally Patient agrees to undergo SAVR if randomization into the control group occurs Readiness for MRT examination and neuropsychological testing after 3 months Patients aged 65 to 85 years. Native German speaker (since a neuropsychological test is language dependent) Exclusion Criteria: Congenital aortic valve defects Untreated clinically significant coronary artery disease or severe mitral or tricuspid insufficiency or mitral stenosis Previous heart surgery Percutaneous coronary intervention performed within one month prior to the study Hemodynamic instability requiring inotropic support or mechanical circulatory support Ischemic stroke or intracranial bleeding within the month before the start of the study Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by echocardiogram Hypertrophic obstructive cardiomyopathy or severe basal septum hypertrophy Echocardiographic detection of intracardiac mass, thrombus, vegetation, or endocarditis Any other atherosclerotic disease that is considered as a contraindication for isolated aortic valve surgery Symptomatic carotid or vertebral artery disease Existing neurological or psychiatric disease (particularly cerebral infarction, cranio- cerebral trauma, manifest depression or dementia) that may interfere with neuropsychological testing. Contraindications for MRI examination (e.g. cardiac pacemaker, vena cava filter, claustrophobia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Jünemann, Dr.med.M.Sc.
Organizational Affiliation
Clinic for Neurology, University Hospital Giessen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marius Butz, Dipl.-Psych.
Organizational Affiliation
Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tibo Gerriets, Prof.Dr.med.
Organizational Affiliation
Department of Neurology, Gesundheitszentrum Wetterau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Schönburg, Prof.Dr.med.
Organizational Affiliation
Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Won-Keun Kim, Dr.med.
Organizational Affiliation
Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiac Surgery, Kerckhoff-Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany

12. IPD Sharing Statement

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Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement

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