Early commercial experience from transcatheter aortic valve implantation using the Portico™ bioprosthetic valve: 30-day outcomes in the multicentre PORTICO-1 study

TY - JOUR

T1 - Early commercial experience from transcatheter aortic valve implantation using the Portico™ bioprosthetic valve: 30-day outcomes in the multicentre PORTICO-1 study

AU - Maisano, Francesco

AU - Worthley, Stephen

AU - Rodés-Cabau, Josep

AU - Linke, Axel Hans-Peter

AU - Fichtlscherer, Stephan

AU - Schäfer, Ulrich

AU - Makkar, Raj R

AU - Fontana, Gregory

AU - Asch, Federico M

AU - Søndergaard, Lars

PY - 2018/10/20

Y1 - 2018/10/20

N2 - AIMS: The aim of this study was to investigate the procedural and short-term outcomes of transcatheter aortic valve implantation (TAVI) with the Portico™ self-expanding, resheathable TAVI system from an ongoing long-term multicentre study.METHODS AND RESULTS: A total of 941 patients (82.4±5.9 years, 65.7% female, STS score 5.8±4.9%) with severe symptomatic aortic stenosis underwent TAVI using the Portico bioprosthesis. Patients were clinically and echocardiographically assessed at implantation, discharge and 30 days post TAVI. An independent CEC and core laboratory adjudicated adverse events (according to VARC-2) and follow-up echocardiograms, respectively. Implantation was successful in 96.0% of patients. Thirty-day all-cause, cardiovascular mortality and disabling stroke rates were 2.7%, 2.4% and 1.6%, respectively. Major vascular complications and life-threatening bleeding occurred in 5.5% and 3.1% of patients, respectively. A new pacemaker was implanted in 18.7% of patients. Aortic valve area (0.70±0.33 cm2 vs. 1.79±0.48 cm2) and transvalvular gradient (49.7±15.3 mmHg vs. 8.6±3.9 mmHg) improved significantly. The 30-day rate of moderate or higher paravalvular leak (PVL) was 3.9%.CONCLUSIONS: The Portico TAVI system allows safe and effective treatment of aortic stenosis in patients at increased surgical risk. At 30 days, mortality was low, and good haemodynamic performance was indicated by low transvalvular gradient and a low rate of moderate or higher PVL.

AB - AIMS: The aim of this study was to investigate the procedural and short-term outcomes of transcatheter aortic valve implantation (TAVI) with the Portico™ self-expanding, resheathable TAVI system from an ongoing long-term multicentre study.METHODS AND RESULTS: A total of 941 patients (82.4±5.9 years, 65.7% female, STS score 5.8±4.9%) with severe symptomatic aortic stenosis underwent TAVI using the Portico bioprosthesis. Patients were clinically and echocardiographically assessed at implantation, discharge and 30 days post TAVI. An independent CEC and core laboratory adjudicated adverse events (according to VARC-2) and follow-up echocardiograms, respectively. Implantation was successful in 96.0% of patients. Thirty-day all-cause, cardiovascular mortality and disabling stroke rates were 2.7%, 2.4% and 1.6%, respectively. Major vascular complications and life-threatening bleeding occurred in 5.5% and 3.1% of patients, respectively. A new pacemaker was implanted in 18.7% of patients. Aortic valve area (0.70±0.33 cm2 vs. 1.79±0.48 cm2) and transvalvular gradient (49.7±15.3 mmHg vs. 8.6±3.9 mmHg) improved significantly. The 30-day rate of moderate or higher paravalvular leak (PVL) was 3.9%.CONCLUSIONS: The Portico TAVI system allows safe and effective treatment of aortic stenosis in patients at increased surgical risk. At 30 days, mortality was low, and good haemodynamic performance was indicated by low transvalvular gradient and a low rate of moderate or higher PVL.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve

KW - Aortic Valve Stenosis

KW - Bioprosthesis

KW - Female

KW - Humans

KW - Male

KW - Transcatheter Aortic Valve Replacement

KW - Treatment Outcome

U2 - 10.4244/EIJ-D-18-00343

DO - 10.4244/EIJ-D-18-00343

M3 - SCORING: Journal article

C2 - 30111522

VL - 14

SP - 886

EP - 893

JO - EUROINTERVENTION

JF - EUROINTERVENTION

SN - 1774-024X

IS - 8

ER -