Better Patient Selection to Transcatheter Aortic Valve Implantation

This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.

Study Overview

• Status: Completed
• Conditions: Myocardial Fibrosis; Aortic Valve Stenosis; Left Ventricular Dysfunction
• Intervention / Treatment: Diagnostic test: Dobutamine stress test

Detailed Description

In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo Universtity Hospital
  • Oslo, Norway, 0424
    • The Intervention Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients scheduled for transfemoral aortic valve implantation at Oslo University Hospital-Rikshospitalet

Description

Inclusion Criteria:

• Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.

Exclusion Criteria:

• Aortic valve endocarditis
• aortic annulus >31mm
• preoperative pacemaker
• severe aortic insufficiency (>grad 3)
• rapid atrial fibrillation
• unprotected left main coronary stenosis not suitable for percutaneous intervention.
• unstable angina
• life expectancy less than 12 months
• mental disorder including dementia and condition which interferes with protocol compliance.
• renal failure (glomerular filtration rate < 45 ml/min/m2), only have T1 mapping by CMRI.
• Patients with metal not suitable for MRI.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preoperative myocardial reserve yes/no; Patients with extensive myocardial fibrosis typically presents with limited myocardial contractile reserve that can be assessed by a dobutamine stress test. The patients will be allocated to a responder and non-responder group according to the results from this test.	Diagnostic test: Dobutamine stress test; Test of myocardial reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	MACE at 12 months follow-up after TAVI, MACE definition: rehospitalization for heart failure or other valve related complications, nonfatal myocardial infarction, nonfatal stroke, or (cardiovascular) death	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome	Number of Participants hospitalizated for heart related diseases during 12 month follow-up.	1 year
6 Minute Walking Test	Favorable outcome defined as improvement in walking distance of 30 meters or longer at one year follow up.	1 year
Patient quality of life (QoL)	Quality of life record (SF 36), Physical function (age adjusted normal value 71.6 (SD 26.9)) and Physical role (age adjusted normal value 57.0 (SD 43.8)) , the patients were divided into groups using the predefined minimal change of 15 and 18,75 points, respectively. Changes above these tresholds at 12 month follow-up indicat better QoL outcomes.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	SF 36	1 year
Left ventricular function	Dimensions, and systolic and diastolic function	1 year

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Erik Fosse, Professor, The Intervention Centre, Oslo University Hospital

Publications and helpful links

General Publications

• Bax JJ, Delgado V, Bapat V, Baumgartner H, Collet JP, Erbel R, Hamm C, Kappetein AP, Leipsic J, Leon MB, MacCarthy P, Piazza N, Pibarot P, Roberts WC, Rodes-Cabau J, Serruys PW, Thomas M, Vahanian A, Webb J, Zamorano JL, Windecker S. Open issues in transcatheter aortic valve implantation. Part 1: patient selection and treatment strategy for transcatheter aortic valve implantation. Eur Heart J. 2014 Oct 7;35(38):2627-38. doi: 10.1093/eurheartj/ehu256. Epub 2014 Jul 25.
• Eidet J, Dahle G, Bugge JF, Bendz B, Rein KA, Aaberge L, Offstad JT, Fosse E, Aakhus S, Halvorsen PS. Long-term outcomes after transcatheter aortic valve implantation: the impact of intraoperative tissue Doppler echocardiography. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):403-9. doi: 10.1093/icvts/ivw159. Epub 2016 May 30.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Outcome; Aortic Valve Stenosis; TAVI; Myocardial fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Fibrosis; Aortic Valve Stenosis; Ventricular Dysfunction; Ventricular Dysfunction, Left; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: 535444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No