Aortic Valve Stenosis, Left Ventricular Dysfunction, Myocardial Fibrosis
Conditions
Keywords
Myocardial fibrosis, Aortic Valve Stenosis, TAVI, Outcome
Brief summary
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.
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.
Interventions
DIAGNOSTIC_TESTDobutamine stress test
Test of myocardial reserve
Sponsors
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome | 1 year | Number of Participants hospitalizated for heart related diseases during 12 month follow-up. |
| Patient quality of life (QoL) | 1 year | 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. |
| 6 Minute Walking Test | 1 year | Favorable outcome defined as improvement in walking distance of 30 meters or longer at one year follow up. |
Countries
Norway
Outcome results
None listed