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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

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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, Vol. 11, No. 16, 4839, 18.08.2022.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Mollmann, H, Linke, A, Nombela-Franco, L, Sluka, M, Dominguez, JFO, Montorfano, M, Kim, W-K, Arnold, M, Vasa-Nicotera, M, Conradi, L, Camuglia, A, Bedogni, F & Manoharan, G 2022, 'Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry', J CLIN MED, vol. 11, no. 16, 4839. https://doi.org/10.3390/jcm11164839

APA

Mollmann, H., Linke, A., Nombela-Franco, L., Sluka, M., Dominguez, J. F. O., Montorfano, M., Kim, W-K., Arnold, M., Vasa-Nicotera, M., Conradi, L., Camuglia, A., Bedogni, F., & Manoharan, G. (2022). Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry. J CLIN MED, 11(16), [4839]. https://doi.org/10.3390/jcm11164839

Vancouver

Mollmann H, Linke A, Nombela-Franco L, Sluka M, Dominguez JFO, Montorfano M et al. Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry. J CLIN MED. 2022 Aug 18;11(16). 4839. https://doi.org/10.3390/jcm11164839

Bibtex

@article{cf77e6f0ab0c4039ac74ecc2013b7a82,
title = "Procedural Safety and Device Performance of the Portico{\texttrademark} Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry",
abstract = "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{\texttrademark} transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav{\texttrademark} DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico{\texttrademark} 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{\texttrademark} 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{\texttrademark} THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico{\texttrademark} THV with either the first-generation DS or FlexNav{\texttrademark} DS.",
author = "Helge Mollmann and Axel Linke and Luis Nombela-Franco and Martin Sluka and Dominguez, {Juan Francisco Oteo} and Matteo Montorfano and Won-Keun Kim and Martin Arnold and Mariuca Vasa-Nicotera and Lenard Conradi and Anthony Camuglia and Francesco Bedogni and Ganesh Manoharan",
year = "2022",
month = aug,
day = "18",
doi = "10.3390/jcm11164839",
language = "English",
volume = "11",
journal = "J CLIN MED",
issn = "2077-0383",
publisher = "MDPI AG",
number = "16",

}

RIS

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 -