The Allegra transcatheter heart valve: Short term results from a multicenter registry.
Catheter Cardiovasc Interv
; 98(6): 1204-1209, 2021 11 15.
Article
in En
| MEDLINE
| ID: mdl-34137483
ABSTRACT
OBJECTIVES:
We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions.BACKGROUND:
The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath.METHODS:
Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium.RESULTS:
This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2 , mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker.CONCLUSIONS:
Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Aortic Valve Stenosis
/
Heart Valve Prosthesis
/
Transcatheter Aortic Valve Replacement
Type of study:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Limits:
Aged
/
Aged80
/
Animals
/
Female
/
Humans
/
Male
Language:
En
Year:
2021
Type:
Article