Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra‐annular device. The Spanish Allegra valve‐in‐valve (SAVIV) registry

Abstract

Objectives The objective was to evaluate the results of valve‐in‐valve procedures performed with the Allegra device. Background Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve‐in‐valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. Methods All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30‐day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve‐in‐valve procedure was 8.4 ± 3.9 years (range 3.3–22.1). Results After the procedure, maximum and mean trans‐valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para‐valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. Conclusions The Allegra trans‐catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.

Novel self‐expanding ALLEGRA transcatheter aortic valve for native aortic stenosis and degenerated bioprosthesis

“…This is comparable to the post ViV gradients seen in a first report on ALLEGRA use in ViV procedures, the VIVALL study 6 . In the recent published data from the SAVIV registry, 10 even lower mean gradients were observed, which might be explained by somewhat different patient population and treatment approach. In two cases of our series VARC‐2 defined device success could not be obtained, because mean gradient reached values >20 mmHg.…”

“…In other registries, reported pacemaker rate was 16.6% in the German Aortic Valve Registry (GARY) 18 and similar after use of the EvolutPro THV in the United Kingdom and Ireland Implanters' registry 19 . In contrast to data from the Spanish ALLEGRA valve‐in‐valve (SAVIV) registry, none of our patients requiring a ViV‐procedure for degenerated aortic valve prosthesis developed pacemaker dependency 10 …”

“…We therefore did not see a need for bioprosthetic valve fracture maneuvers to further lower transvalvular gradients. Of interest, in the SAVIV registry 10 also no valve cracking was done in any case, indicating that in most cases excellent gradients can be reached in ViV procedure using the Allegra valve even without bioprostethic valve cracking.…”

“…Two small single center studies exist, though involving no ViV cases 3,5 . Even earlier multi center registries did not involve a considerably higher number of patients 4,6,10 . Parallel to our study period another group analyzed data from a multi‐center registry, including more patients.…”

“…Beyond that, we gathered more procedural data 11 . In addition we provide in hospital and three month follow‐up echocardiographic data, while most former studies and registries included only a 30‐day follow‐up, some lacking echocardiographic analyses 3–5,10 …”