Aortic Stenosis, Ascending Aortic Dilatation
Conditions
Keywords
Transcatheter aortic valve replacement, Self-expandable valve, Balloon-expandable valve
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.
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.
Interventions
DEVICEself-expandable valves
patients undergoing TAVR use self-expandable valves
DEVICEballoon-expandable valves
patients undergoing TAVR use balloon-expandable valves
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Surgeons are aware of randomisation results, however, participants and research staff are all blinded to the randomisation schemes.
Intervention model description
Self-expandable valve group vs. Balloon-expandable valve group
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 1. 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) 2. Freedom from mortality 3. Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication 4. 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 1-year all-cause mortality | 1 year after TAVR procedure | all-cause mortality |
| 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) |
| 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 |
Countries
China
Contacts
Primary ContactKang An, MD
Outcome results
None listed