AIMS: The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population. METHODS AND RESULTS: From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak. CONCLUSIONS: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.
AIMS: The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population. METHODS AND RESULTS: From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak. CONCLUSIONS: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.
Authors: Antonio Mangieri; Claudio Montalto; Matteo Pagnesi; Giuseppe Lanzillo; Ozan Demir; Luca Testa; Antonio Colombo; Azeem Latib Journal: Front Cardiovasc Med Date: 2018-07-03
Authors: Victor Mauri; Thomas Frohn; Florian Deuschl; Kawa Mohemed; Kathrin Kuhr; Andreas Reimann; Maria Isabel Körber; Niklas Schofer; Matti Adam; Kai Friedrichs; Elmar W Kuhn; Smita Scholtz; Volker Rudolph; Thorsten C W Wahlers; Stephan Baldus; Navid Mader; Ulrich Schäfer; Tanja K Rudolph Journal: Open Heart Date: 2020-05
Authors: Roberto Scarsini; Giovanni L De Maria; Jubin Joseph; Lampson Fan; Thomas J Cahill; Rafail A Kotronias; Francesco Burzotta; James D Newton; Rajesh Kharbanda; Bernard Prendergast; Flavio Ribichini; Adrian P Banning Journal: J Am Heart Assoc Date: 2019-09-14 Impact factor: 5.501
Authors: Paola Angela Maria Purita; Luisa Salido Tahoces; Chiara Fraccaro; Luca Nai Fovino; Won-Keun Kim; Cláudio Espada-Guerreiro; Ole De Backer; Morritz Seiffert; Luis Nombela-Franco; Raul Moreno Gomez; Antonio Mangieri; Anna Franzone; Francesco Bedogni; Fausto Castriota; Tiziana Attisano; Lars Søndergaard; Rosana Hernandez Antolin; Giuseppe Tarantini Journal: Int J Cardiol Heart Vasc Date: 2020-02-12