Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Self-expandable valve group Patients using self-expandable valves |
Device: type of transcatheter heart valves
patients undergoing TAVR use either self-expandable valves or balloon-expandable valves
|
| Experimental: Balloon-expandable valve group Patients using balloon-expandable valves |
Device: type of transcatheter heart valves
patients undergoing TAVR use either self-expandable valves or balloon-expandable valves
|
Outcome Measures
Primary Outcome Measures
- 30-day all-cause mortality [30 days after TAVR procedure]
all-cause mortality within 30 days after TAVR procedure
- 30-day adverse aortic events [30 days after TAVR procedure]
aortic death, aortic dissection, or aortic rupture
- The rate of device success [30 days]
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)
Secondary Outcome Measures
- 1-year all-cause mortality [1 year after TAVR procedure]
all-cause mortality
- 1-year cardiovascular mortality [1 year after TAVR procedure]
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 adverse aortic events [1 year after TAVR procedure]
aortic death, aortic dissection, or aortic rupture
- Ascending aortic diameter expansion rate ≥3mm/year [1 year after TAVR procedure]
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.
- Hospitalization (or re-hospitalization) [1 year after TAVR procedure]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Severe aortic stenosis;
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Transfemoral access;
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Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm;
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Anticipated life expectancy >1 year;
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Age ≥ 65 years.
Exclusion Criteria:
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Dominant aortic regurgitation,;
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A history of SAVR or TAVR;
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A history of aortic surgery;
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Emergent TAVR.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing | Beijing | China | 100037 |
Sponsors and Collaborators
- China National Center for Cardiovascular Diseases
Investigators
- Principal Investigator: Xiangbin Pan, MD, Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
- 2023-2024