Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry
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Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry. / Mollmann, Helge; Linke, Axel; Nombela-Franco, Luis; Sluka, Martin; Dominguez, Juan Francisco Oteo; Montorfano, Matteo; Kim, Won-Keun; Arnold, Martin; Vasa-Nicotera, Mariuca; Conradi, Lenard; Camuglia, Anthony; Bedogni, Francesco; Manoharan, Ganesh.
in: J CLIN MED, Jahrgang 11, Nr. 16, 4839, 18.08.2022.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry
AU - Mollmann, Helge
AU - Linke, Axel
AU - Nombela-Franco, Luis
AU - Sluka, Martin
AU - Dominguez, Juan Francisco Oteo
AU - Montorfano, Matteo
AU - Kim, Won-Keun
AU - Arnold, Martin
AU - Vasa-Nicotera, Mariuca
AU - Conradi, Lenard
AU - Camuglia, Anthony
AU - Bedogni, Francesco
AU - Manoharan, Ganesh
PY - 2022/8/18
Y1 - 2022/8/18
N2 - A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected 'standard-of-care' clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.
AB - A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected 'standard-of-care' clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.
U2 - 10.3390/jcm11164839
DO - 10.3390/jcm11164839
M3 - SCORING: Journal article
C2 - 36013084
VL - 11
JO - J CLIN MED
JF - J CLIN MED
SN - 2077-0383
IS - 16
M1 - 4839
ER -