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

Y1 - 2018

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%), trans-subclavian (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%), trans-subclavian (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.

KW - Aortic stenosis

KW - Femoral

KW - TAVI

U2 - 10.4244/EIJ-D-18-00488

DO - 10.4244/EIJ-D-18-00488

M3 - Journal article

C2 - 29969432

AN - SCOPUS:85053613324

VL - 14

SP - 621

EP - 628

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 6

ER -