• Something wrong with this record ?

Procedural Safety and Device Performance of the PorticoTM Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry

H. Mollmann, A. Linke, L. Nombela-Franco, M. Sluka, JFO. Dominguez, M. Montorfano, WK. Kim, M. Arnold, M. Vasa-Nicotera, L. Conradi, A. Camuglia, F. Bedogni, G. Manoharan

. 2022 ; 11 (16) : . [pub] 20220818

Language English Country Switzerland

Document type Journal Article

Persistent link   https://www.medvik.cz/link/bmc22023499

Grant support
NCT03752866 Abbott (United States)

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 PorticoTM transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNavTM DS. The objective of this registry is to characterize the procedural safety and device performance of the PorticoTM 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 PorticoTM 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 PorticoTM THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the PorticoTM THV with either the first-generation DS or FlexNavTM DS.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22023499
003      
CZ-PrNML
005      
20221031095211.0
007      
ta
008      
221010s2022 sz f 000 0|eng||
009      
AR
024    7_
$a 10.3390/jcm11164839 $2 doi
035    __
$a (PubMed)36013084
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a sz
100    1_
$a Mollmann, Helge $u Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany
245    10
$a Procedural Safety and Device Performance of the PorticoTM Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry / $c H. Mollmann, A. Linke, L. Nombela-Franco, M. Sluka, JFO. Dominguez, M. Montorfano, WK. Kim, M. Arnold, M. Vasa-Nicotera, L. Conradi, A. Camuglia, F. Bedogni, G. Manoharan
520    9_
$a 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 PorticoTM transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNavTM DS. The objective of this registry is to characterize the procedural safety and device performance of the PorticoTM 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 PorticoTM 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 PorticoTM THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the PorticoTM THV with either the first-generation DS or FlexNavTM DS.
655    _2
$a časopisecké články $7 D016428
700    1_
$a Linke, Axel $u Klinik für Innere Medizin/Kardiologie, Universitätsklinik Technische Universität Dresden, Herzzentrum Dresden Fetscherstraße 76, 01307 Dresden, Germany
700    1_
$a Nombela-Franco, Luis $u Cardiovascular Institute, Hospital Clinico San Carlos, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain
700    1_
$a Sluka, Martin $u Department of Medicine-Cardiology, University Hospital Olomouc, 779 00 Olomouc, Czech Republic $1 0000000226255445
700    1_
$a Dominguez, Juan Francisco Oteo $u Interventional Cardiology Unit, Hospital Universitario Puerta de Hierro Hospital, 28222 Madrid, Spain $1 0000000226414135
700    1_
$a Montorfano, Matteo $u Interventional Cardiology Unit, IRCCS Ospedale San Raffaele, 20132 Milan, Italy
700    1_
$a Kim, Won-Keun $u Kerckhoff Heart and Thorax Centre, 61231 Bad Nauheim, Germany
700    1_
$a Arnold, Martin $u Department of Cardiology, Friedrich Alexander Universität Erlangen-Nuremberg, 91054 Erlangen, Germany
700    1_
$a Vasa-Nicotera, Mariuca $u Klinikum der Johann Wolfgang Goethe Universitaet Frankfurt, 60596 Frankfurt, Germany
700    1_
$a Conradi, Lenard $u Department of Cardiovascular Surgery, University Heart and Vascular Center, 20251 Hamburg, Germany
700    1_
$a Camuglia, Anthony $u Department of Cardiology, University of Queensland, Brisbane, QLD 4072, Australia $u Department of Cardiology, The Wesley Hospital, Brisbane, QLD 4066, Australia $1 0000000184353986
700    1_
$a Bedogni, Francesco $u Department of Cardiology, IRCCS Policlinico San Donato, 20097 Milan, Italy
700    1_
$a Manoharan, Ganesh $u Department of Cardiology, Royal Victoria Hospital, Belfast BT12 6BA, UK
773    0_
$w MED00195462 $t Journal of clinical medicine $x 2077-0383 $g Roč. 11, č. 16 (2022)
856    41
$u https://pubmed.ncbi.nlm.nih.gov/36013084 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20221010 $b ABA008
991    __
$a 20221031095209 $b ABA008
999    __
$a ind $b bmc $g 1853888 $s 1174787
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2022 $b 11 $c 16 $e 20220818 $i 2077-0383 $m Journal of clinical medicine $n J Clin Med $x MED00195462
GRA    __
$a NCT03752866 $p Abbott (United States)
LZP    __
$a Pubmed-20221010

Find record

Citation metrics

Archiving options