Aortic Stenosis
Conditions
Keywords
trancarotid-TAVI, transaxillary-TAVI, aortic stenosis, alternative accesses
Brief summary
The APTA (Alternative Peripheral TAVI Accesses) registry is an observational multi-center, retrospective and prospective study, including high and medium - risk patients with aortic stenosis (AS) contraindicates for trans-femoral TAVI, treated with TAVI thought to peripheral accesses. Upper Silesian Medical Center, Katowice and the other hospitals will be involved in the study.
Detailed description
Consecutive patients who underwent TAVI with peripheral alternatives accesses between September 2017 and February 2025 will be enrolled for the retrospective registry, while consecutive patients from February 2025 will be enrolled for the prospective registry. Baseline clinical, angiographic, and echocardiographic variables, together with procedural and follow-up outcomes data will be recorded in a dedicated database.
Interventions
PROCEDURETAVI procedures with an alternative access
Transcatheter aortic valve implantation via the common carotid artery and the subclavian or axillary artery
Sponsors
Medical University of Silesia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Males or females qualified by the "heart team" for TAVI procedure, without the possibility of using femoral access. * Possibility of TAVI procedure with peripheral access after multi-slice computed tomography analysis.
Exclusion criteria
* No significant aortic stenosis * Cancer with a short expected survival period * No qualifications for TAVI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary study endpoint will be according to VARC-3 criteria: Mortality Neurologic events, Hospitalization (or re-hospitalization), Bleeding and transfusions, Vascular and access-related complications, Cardiac and other procedural complications. | Preoperative data (on the day of admission to hospital) Operative data ( day of TAVI procedure) Postoperative data (more than 1 day after TAVI procedure to the day of discharge ) | Preoperative data : Age (years), sex (male, female), weight (kg), height (m), BMI (kg/m2), EuroSCORE II (%), NYHA Class (New York Heart Assocation) Labolatory examinations: creatynine (mg/dl), GFR (glomerular filtration rate) ml/min/1,73m2, Troponine T level (ng/ml), Hemoglobin (g/dl), Hematocrit (%) Echocardiography (ECHO): LVEF: left ventricular ejection fraction (%), Pg max: aortic valve maximal gradient (mmHg), Pg mean: aortic valve mean gradient (mmHg), AVA: aortic valve area (cm2), Vmax: transaortic peak instantaneous velocity (m/s). Operative data: procedural success, technical aspect of TAVI procedural time, cerebral oximetry (%), vascular (acces) and cardiac complication. Postoperative data (more than 1 day after TAVI procedure to the day of discharge ), mortality, stroke, TIA (transient ischemic attack) , new onset atrial fibrillation, new pacemaker implantation, cardiac tamponade, psychosis, NYHA Class (New York Heart Assocation) Labolatory examinations as before TAVI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | at 30-days and at 1-year after TAVI procedure | Secondary endpoints will include, according to the VARC-3 criteria: technical success of the device (correct measurements of flow velocity and gradients on echocardiogram and no paravalvular leaks) after 30 days, early safety after 30 days (mortality, neurological complications, rehospitalizations, no cardiac complications) and clinical efficacy (after one year). Analysis of parameters according to the criteria described above. |
Contacts
CONTACTDamian Hudziak MD PhD, MD PhD
Outcome results
None listed