Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI

Study Overview
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Brief Summary
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Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.

Detailed Description
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A narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk. Transcatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. The procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is known to have higher mortality rates postoperatively. However, it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI.

Official Title
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Long Term Follow-up (=> 5 Years) for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease

Conditions
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Aortic Valve Stenosis, Coronary Artery Disease

Intervention / Treatment
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* Other: Coronary artery disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019. Exclusion Criteria: Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without coronary artery disease<br>No prior coronary intervention and no significant stenosis noted during coronary angiography. | |
| Patients with coronary artery disease<br>Our definition of coronary artery disease is: Prior coronary artery bypass grafting or percutaneous coronary intervention Significant stenosis or occlusion noted during coronary angiography | Other: Coronary artery disease<br>* Exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death after the procedure | Five years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with less favorable early and late mortality | Factors such as renal function or comorbidities associated with higher mortality. | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve stenosis, Coronary artery disease, Transcatheter aortic valve implantation, Mortality