Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement

Study Overview
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Brief Summary
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This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.

Detailed Description
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Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture. Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.

Official Title
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Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement

Conditions
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Aortic Stenosis, Ascending Aortic Dilatation

Intervention / Treatment
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* Device: type of transcatheter heart valves


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe aortic stenosis; Transfemoral access; Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm; Anticipated life expectancy >1 year; Age ≥ 65 years. Exclusion Criteria: Dominant aortic regurgitation,; A history of SAVR or TAVR; A history of aortic surgery; Emergent TAVR.

Ages Eligible for Study
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Minimum Age: 65 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Self-expandable valve group vs. Balloon-expandable valve group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-expandable valve group<br>Patients using self-expandable valves | Device: type of transcatheter heart valves<br>* patients undergoing TAVR use either self-expandable valves or balloon-expandable valves<br>|
| Experimental: Balloon-expandable valve group<br>Patients using balloon-expandable valves | Device: type of transcatheter heart valves<br>* patients undergoing TAVR use either self-expandable valves or balloon-expandable valves<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day all-cause mortality | all-cause mortality within 30 days after TAVR procedure | 30 days after TAVR procedure | 
| 30-day adverse aortic events | aortic death, aortic dissection, or aortic rupture | 30 days after TAVR procedure | 
| The rate of device success | Device success is defined as following: Technical success (Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication) Freedom from mortality Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year all-cause mortality | all-cause mortality | 1 year after TAVR procedure | 
| 1-year cardiovascular mortality | Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause | 1 year after TAVR procedure | 
| 1-year adverse aortic events | aortic death, aortic dissection, or aortic rupture | 1 year after TAVR procedure | 
| Ascending aortic diameter expansion rate ≥3mm/year | Expansion rate was calculated as the change of ascending aortic diameters (before the procedure and at the latest follow-up) divided by the follow-up period. | 1 year after TAVR procedure | 
| Hospitalization (or re-hospitalization) | Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay. Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition. Visits to urgent care centres or emergency departments <24 h may also be included if substantive intensification of therapy changes (e.g. heart failure episodes) are enacted (e.g. intravenous diuretics, significant increases in drug therapy dosages or addition of new pharmacotherapy agents) | 1 year after TAVR procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter aortic valve replacement, Self-expandable valve, Balloon-expandable valve