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Transcatheter aortic valve implantation with the self-expanding Portico valve system in an all-comers population: procedural and clinical outcomes

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@article{7c71ab78660048bf975f5ab0439a287b,
title = "Transcatheter aortic valve implantation with the self-expanding Portico valve system in an all-comers population: procedural and clinical outcomes",
abstract = "AIMS: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). The aim of this study was to evaluate the newer-generation Portico TAVI system in an all-comers population.METHODS AND RESULTS: This single-centre study included 216 patients with severe AS (Society of Thoracic Surgeons [STS] score 4.3±3.0{\%}). The Portico valve was implanted using the transfemoral (91.2{\%}), transsubclavian (5.6{\%}) and transcaval (3.2{\%}) access. Device success was achieved in 94.4{\%} of cases. At 30 days, mortality and stroke rates were 2.3{\%} and 0.5{\%}, respectively. Early safety was achieved in 91.7{\%} of cases. More-than-mild paravalvular leak (PVL), as assessed by echocardiogram, was observed in 3.4{\%} of the patients, with rates of 4.9{\%} and 1.9{\%} in the first and second half of the cohort, respectively. A permanent pacemaker was implanted in 15.8{\%} of those without prior pacemaker, with a rate of 11.1{\%} in the second half of the cohort. At one year, incidence rates for all-cause mortality and stroke were 12.3{\%} and 2.3{\%}, respectively. In the low-risk group (STS <4{\%}; n=128), Kaplan-Meier estimates at 30 days and one year were 0{\%} and 7.5{\%} for all-cause mortality and 0.8{\%} and 2.2{\%} for stroke, respectively. Haemodynamic improvements persisted over time with a mean transvalvular gradient of 7.0±3.0 mmHg at one-year follow-up.CONCLUSIONS: The Portico TAVI system was safe to implant and achieved a high device success rate. With learning curve effects, the device achieves lower rates of PVL and pacemaker implantation and provides adequate clinical and haemodynamic outcomes up to one year.",
author = "Oscar Millan-Iturbe and {De Backer}, Ole and Gintautas Bieliauskas and Tasalak Thonghong and Manik Chopra and Nikolaj Ihlemann and Lars S{\o}ndergaard",
year = "2018",
month = "8",
day = "20",
doi = "10.4244/EIJ-D-18-00488",
language = "English",
volume = "14",
pages = "621--628",
journal = "EuroIntervention",
issn = "1774-024X",
publisher = "Europa Edition",
number = "6",

}

RIS

TY - JOUR

T1 - Transcatheter aortic valve implantation with the self-expanding Portico valve system in an all-comers population

T2 - procedural and clinical outcomes

AU - Millan-Iturbe, Oscar

AU - De Backer, Ole

AU - Bieliauskas, Gintautas

AU - Thonghong, Tasalak

AU - Chopra, Manik

AU - Ihlemann, Nikolaj

AU - Søndergaard, Lars

PY - 2018/8/20

Y1 - 2018/8/20

N2 - AIMS: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). The aim of this study was to evaluate the newer-generation Portico TAVI system in an all-comers population.METHODS AND RESULTS: This single-centre study included 216 patients with severe AS (Society of Thoracic Surgeons [STS] score 4.3±3.0%). The Portico valve was implanted using the transfemoral (91.2%), transsubclavian (5.6%) and transcaval (3.2%) access. Device success was achieved in 94.4% of cases. At 30 days, mortality and stroke rates were 2.3% and 0.5%, respectively. Early safety was achieved in 91.7% of cases. More-than-mild paravalvular leak (PVL), as assessed by echocardiogram, was observed in 3.4% of the patients, with rates of 4.9% and 1.9% in the first and second half of the cohort, respectively. A permanent pacemaker was implanted in 15.8% of those without prior pacemaker, with a rate of 11.1% in the second half of the cohort. At one year, incidence rates for all-cause mortality and stroke were 12.3% and 2.3%, respectively. In the low-risk group (STS <4%; n=128), Kaplan-Meier estimates at 30 days and one year were 0% and 7.5% for all-cause mortality and 0.8% and 2.2% for stroke, respectively. Haemodynamic improvements persisted over time with a mean transvalvular gradient of 7.0±3.0 mmHg at one-year follow-up.CONCLUSIONS: The Portico TAVI system was safe to implant and achieved a high device success rate. With learning curve effects, the device achieves lower rates of PVL and pacemaker implantation and provides adequate clinical and haemodynamic outcomes up to one year.

AB - AIMS: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). The aim of this study was to evaluate the newer-generation Portico TAVI system in an all-comers population.METHODS AND RESULTS: This single-centre study included 216 patients with severe AS (Society of Thoracic Surgeons [STS] score 4.3±3.0%). The Portico valve was implanted using the transfemoral (91.2%), transsubclavian (5.6%) and transcaval (3.2%) access. Device success was achieved in 94.4% of cases. At 30 days, mortality and stroke rates were 2.3% and 0.5%, respectively. Early safety was achieved in 91.7% of cases. More-than-mild paravalvular leak (PVL), as assessed by echocardiogram, was observed in 3.4% of the patients, with rates of 4.9% and 1.9% in the first and second half of the cohort, respectively. A permanent pacemaker was implanted in 15.8% of those without prior pacemaker, with a rate of 11.1% in the second half of the cohort. At one year, incidence rates for all-cause mortality and stroke were 12.3% and 2.3%, respectively. In the low-risk group (STS <4%; n=128), Kaplan-Meier estimates at 30 days and one year were 0% and 7.5% for all-cause mortality and 0.8% and 2.2% for stroke, respectively. Haemodynamic improvements persisted over time with a mean transvalvular gradient of 7.0±3.0 mmHg at one-year follow-up.CONCLUSIONS: The Portico TAVI system was safe to implant and achieved a high device success rate. With learning curve effects, the device achieves lower rates of PVL and pacemaker implantation and provides adequate clinical and haemodynamic outcomes up to one year.

U2 - 10.4244/EIJ-D-18-00488

DO - 10.4244/EIJ-D-18-00488

M3 - Journal article

VL - 14

SP - 621

EP - 628

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 6

ER -

ID: 56380079