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 NAUTILUS 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.
Keywords: aortic stenosisclinical trialelderly populationtranscatheter aortic valve implantation
References
- Aldalati O, MacCarthy P, Dworakowski R. Trans-catheter aortic valve implantation: Contemporary practice and the future. Cardiol J. 2017; 24(2): 206–215.
- Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002; 106(24): 3006–3008.
- Giordana F, D'Ascenzo F, Nijhoff F, et al. Meta-analysis of predictors of all-cause mortality after transcatheter aortic valve implantation. Am J Cardiol. 2014; 114(9): 1447–1455.
- Eggebrecht H, Mehta RH. Transcatheter aortic valve implantation (TAVI) in Germany 2008-2014: on its way to standard therapy for aortic valve stenosis in the elderly? EuroIntervention. 2016; 11(9): 1029–1033.
- Urena M, Webb JG, Eltchaninoff H, et al. Late cardiac death in patients undergoing transcatheter aortic valve replacement: incidence and predictors of advanced heart failure and sudden cardiac death. J Am Coll Cardiol. 2015; 65(5): 437–448.
- Ribeiro HB, Nombela-Franco L, Muñoz-García AJ, et al. Predictors and impact of myocardial injury after transcatheter aortic valve replacement: a multicenter registry. J Am Coll Cardiol. 2015; 66(19): 2075–2088.
- Gensas CS, Caixeta A, Siqueira D, et al. Predictors of permanent pacemaker requirement after transcatheter aortic valve implantation: insights from a Brazilian registry. Int J Cardiol. 2014; 175(2): 248–252.
- Wenaweser P, Stortecky S, Heg D, et al. Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registry. EuroIntervention. 2014; 10(8): 982–989.
- Ribeiro HB, Webb JG, Makkar RR, et al. Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry. J Am Coll Cardiol. 2013; 62(17): 1552–1562.
- Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol. 2013; 61(15): 1585–1595.
- Tchetche D, Van Mieghem NM. New-generation TAVI devices: description and specifications. EuroIntervention. 2014; 10 Suppl U: U90–U9U100.
- Wenaweser P, Stortecky S, Schütz T, et al. Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve. EuroIntervention. 2016; 12(1): 71–77.
- Leon MB, Piazza N, Nikolsky E, et al. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011; 57(3): 253–269.
- Siontis GCM, Jüni P, Pilgrim T, et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol. 2014; 64(2): 129–140.
- Hayashida K, Morice MC, Chevalier B, et al. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012; 59(6): 566–571.
- Khawaja MZ, Rajani R, Cook A, et al. Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative). Circulation. 2011; 123(9): 951–960.
- Eggebrecht H, Schmermund A, Voigtländer T, et al. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012; 8(1): 129–138.
- Chieffo A, Buchanan GL, Van Mieghem NM, et al. Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration). J Am Coll Cardiol. 2013; 61(8): 830–836.
- Tchetche D, Farah B, Misuraca L, et al. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy. JACC Cardiovasc Interv. 2014; 7(10): 1138–1145.
- Stortecky S, Windecker S, Pilgrim T, et al. Cerebrovascular accidents complicating transcatheter aortic valve implantation: frequency, timing and impact on outcomes. EuroIntervention. 2012; 8(1): 62–70.
