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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-expandable valve group | Experimental | Patients using self-expandable valves |
|
| Balloon-expandable valve group | Experimental | Patients using balloon-expandable valves |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-expandable valves | Device | patients undergoing TAVR use self-expandable valves |
|
| 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:
| 30 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang An, MD | Contact | 0085-15801301740 | ankang913@126.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33888385 | Background | VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19. | |
| 41316413 |
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Self-expandable valve group vs. Balloon-expandable valve group
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Surgeons are aware of randomisation results, however, participants and research staff are all blinded to the randomisation schemes.
| balloon-expandable valves | Device | patients undergoing TAVR use balloon-expandable valves |
|
| 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 |
|
| Derived |
| An K, Zhang F, Ouyang W, Li S, Pan X. Protocol for a randomized controlled trial for comparison of self- and balloon-expandable valves in patients with Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement (AAD-CHOICE). Trials. 2025 Nov 28;27(1):1. doi: 10.1186/s13063-025-09233-7. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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