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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dobutamine stress test | Diagnostic Test | Test of myocardial reserve |
|
| 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 |
| 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 |
| Patient quality of life (QoL) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for transfemoral aortic valve implantation at Oslo University Hospital-Rikshospitalet
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| Name | Affiliation | Role |
|---|---|---|
| Erik Fosse, Professor | The Intervention Centre, Oslo University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo Universtity Hospital | Oslo | 0424 | Norway | |||
| The Intervention Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25062952 | Background | 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. | |
| 27241050 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Routine blood tests on admittance and after one year. These include markers of heart failure as S-proBNP/troponin and kindey failure as S-kreatinin/S-Cystatin C, electrolytes, Hgb
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 |
| 6 Minute Walking Test | Favorable outcome defined as improvement in walking distance of 30 meters or longer at one year follow up. | 1 year |
| Oslo |
| 0424 |
| Norway |
| Background |
| 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. |
| 40418351 | Derived | Saevik M, Andersen MH, Beitnes JO, Aaberge L, Halvorsen PS. Health Related Quality of Life (HRQoL) after transcatheter aortic valve implantation in aortic stenosis patients: exploring a novel threshold for clinically significant improvement after 12 months. J Patient Rep Outcomes. 2025 May 26;9(1):58. doi: 10.1186/s41687-025-00894-1. |
| D014694 |
| Ventricular Outflow Obstruction |
| D018754 | Ventricular Dysfunction |