Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: A pilot prospective study

Abstract

Background: Transcatheter aortic valve implantation (TAVI) has become a standard therapeutic option for patients with severe aortic stenosis (AS) at high cardiac surgical risk. The aim of the NAU-TILUS study was to investigate the safety and performance of the New Valve Technology (NVT) Allegra bioprosthesis in high-risk patients undergoing TAVI. Methods: Twenty seven patients with severe, symptomatic AS at high surgical risk were prospectively enrolled, who underwent treatment using the novel self-expanding NVT Allegra bioprosthesis via transfemoral approach (TF-TAVI). The primary end-point was all-cause mortality at 30 days. Results: Patients were elderly (83 years, range 75-89 years), and predominantly female (70.4%, n = 19). All patients were deemed to be at high surgical risk, with a mean logistic EuroSCORE of 12.4% (range, 2.8-31.8%). The bioprosthesis was successfully implanted in 96% of the cases (n = 25). The echocardiographic assessment confirmed good hemodynamic profile after implantation of the NVT Allegra bioprosthesis. Complications included cardiac tamponade (4%, n = 1) and the need for permanent pacemaker implantation (8%, n = 2). The analysis of procedural aspects showed a short learning effect related to the precise placement of the valve. A significant improvement in clinical symptoms were observed, and no patients died in-hospital or within 30 days of post-discharge observation. Conclusions: This prospective observation shows that the NVT Allegra bioprosthesis was associated with a satisfactory safety profile and a remarkable hemodynamic performance after implantation.

Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study

“…Notably, the survival rate at 30 days was 100%; no coronary obstruction was detected. Mean gradients at discharge and at 30 days as assessed by an independent echocardiographic core lab (16.1±6.4 mmHg and 14.8±6.5 mmHg, respectively) and evaluated invasively post procedure (11.6±3.7 mmHg) were low for ViV procedures, albeit higher than those seen after TAVI in native aortic valves with the ALLEGRA THV 17,18,24 due to the smaller inner diameter of the surgical bioprosthetic valves.…”

“…There was one case (3.3%) with evidence of subclinical prosthetic valve thrombosis after 23 days under treatment with rivaroxaban, which was detected during the standard echo examination at the 30-day follow-up visit. The patient was without symptoms, and mean pressure gradients at discharge and 30 days (19 mmHg (indexed effective orifice area [EOAi] <0.65 cm 2 /m 2 ) at discharge, resulting in an overall device success rate of 60% (18).…”

“…The first-in-human clinical studies with the ALLEGRA transcatheter heart valve (THV) (New Valve Technology GmbH, Hechingen, Germany) showed favourable results, with a haemodynamic performance comparable to other CE-approved THVs 17,18 . Lately, the ViV function of the ALLEGRA was evaluated in vitro (hydrodynamic testing) as well as in a small series of ViV-TAVI (n=4), showing good hydrodynamic and haemodynamic outcomes 19,20 .…”

Choice of transcatheter heart valve: should we select the device according to each patient’s characteristics or should it be “one valve fits all”?

“…Therefore, there is no need for fast or rapid pacing during the implantation process. Data on this THV are limited and includes the first-in-human clinical studies showing results with a hemodynamic performance comparable to that of other THVs (25,26). Due to its hemodynamic properties, a potential use of this THV in valve-in-valve settings has been described (35).…”

Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes

“…The first-in-human clinical trial with implantations of the Allegra took place in 2013 by Wenaweser [2]. To date, several conducted studies showed encouraging short-term outcomes in treating patients with severe aortic native valve stenosis using NVT devices [2][3][4], but longer-term results are lacking. Herein, are presented one-year single-center results with the Allegra.…”