First experience with transfemoral transcatheter aortic valve implantation without prior balloon pre-dilatation using a latest generation repositionable and retrievable transcatheter heart valve†

TY - JOUR

T1 - First experience with transfemoral transcatheter aortic valve implantation without prior balloon pre-dilatation using a latest generation repositionable and retrievable transcatheter heart valve†

AU - Schaefer, Andreas

AU - Harmel, Eva

AU - Seiffert, Moritz

AU - Reichart, Daniel

AU - Deuschl, Florian

AU - Schofer, Niklas

AU - Schneeberger, Yvonne

AU - Blankenberg, Stefan

AU - Reichenspurner, Hermann

AU - Schaefer, Ulrich

AU - Conradi, Lenard

N1 - © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

PY - 2017/5/1

Y1 - 2017/5/1

N2 - OBJECTIVES: : The aim of this study was to prove technical feasibility and document haemodynamic and clinical outcomes of transcatheter aortic valve implantation (TAVI) with the latest generation repositionable and retrievable Lotus™ transcatheter heart valve (THV) without prior balloon-aortic valvuloplasty (BAV). It has been demonstrated for self-expandable and balloon-expandable THV that implantation without prior BAV is not only feasible and safe but also results in lower fluoroscopy times and amounts of contrast agent while yielding non-inferior haemodynamic and clinical outcome. To date no reports exist for TAVI without BAV for the Lotus™ THV.METHODS: : A consecutive patient series received direct transfemoral (TF)-TAVI without prior BAV using the Lotus™ valve system. Baseline, intraprocedural and acute follow-up data up to 30 days were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized Valve Academic Research Consortium (VARC)-2 definitions.RESULTS: : A total of 9 patients received direct TF-TAVI using the Lotus THV (77.7% female, 82.5 ± 5.3 years, logistic European System for Cardiac Operative Risk Evaluation I 14.2 ± 13.7%). Device success according to VARC-2 definitions was achieved in 100% (9/9) of the patients. Peak and mean transvalvular gradients as determined by transthoracic echocardiography prior to discharge decreased from 51.5 ± 17.3 to 24.4 ± 10.4 mmHg and 29.5 ± 9.6 to 13.2 ± 5.2 mmHg (both P  <   0.01). Effective orifice area increased from 0.9 ± 0.2 to 1.9 ± 0.3 cm 2 ( P  <   0.01). No paravalvular leakage (PVL) ≥ moderate was detected. All-cause 30-day mortality was 11.1% (1/9), with one death due to ischaemic enteritis.CONCLUSIONS: : In our series, TF-TAVI without prior BAV using this particular THV technical feasibility, no increased incidence of significant paravalvular leakage, and good haemodynamic and clinical outcome in selected patients. These results will have to be confirmed in larger patient numbers for further clinical evaluation and before general recommendations regarding patient selection can be made.

AB - OBJECTIVES: : The aim of this study was to prove technical feasibility and document haemodynamic and clinical outcomes of transcatheter aortic valve implantation (TAVI) with the latest generation repositionable and retrievable Lotus™ transcatheter heart valve (THV) without prior balloon-aortic valvuloplasty (BAV). It has been demonstrated for self-expandable and balloon-expandable THV that implantation without prior BAV is not only feasible and safe but also results in lower fluoroscopy times and amounts of contrast agent while yielding non-inferior haemodynamic and clinical outcome. To date no reports exist for TAVI without BAV for the Lotus™ THV.METHODS: : A consecutive patient series received direct transfemoral (TF)-TAVI without prior BAV using the Lotus™ valve system. Baseline, intraprocedural and acute follow-up data up to 30 days were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized Valve Academic Research Consortium (VARC)-2 definitions.RESULTS: : A total of 9 patients received direct TF-TAVI using the Lotus THV (77.7% female, 82.5 ± 5.3 years, logistic European System for Cardiac Operative Risk Evaluation I 14.2 ± 13.7%). Device success according to VARC-2 definitions was achieved in 100% (9/9) of the patients. Peak and mean transvalvular gradients as determined by transthoracic echocardiography prior to discharge decreased from 51.5 ± 17.3 to 24.4 ± 10.4 mmHg and 29.5 ± 9.6 to 13.2 ± 5.2 mmHg (both P  <   0.01). Effective orifice area increased from 0.9 ± 0.2 to 1.9 ± 0.3 cm 2 ( P  <   0.01). No paravalvular leakage (PVL) ≥ moderate was detected. All-cause 30-day mortality was 11.1% (1/9), with one death due to ischaemic enteritis.CONCLUSIONS: : In our series, TF-TAVI without prior BAV using this particular THV technical feasibility, no increased incidence of significant paravalvular leakage, and good haemodynamic and clinical outcome in selected patients. These results will have to be confirmed in larger patient numbers for further clinical evaluation and before general recommendations regarding patient selection can be made.

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/diagnosis

KW - Balloon Valvuloplasty

KW - Cardiac Catheterization

KW - Echocardiography

KW - Female

KW - Fluoroscopy

KW - Heart Valve Prosthesis

KW - Humans

KW - Male

KW - Retrospective Studies

KW - Transcatheter Aortic Valve Replacement/methods

KW - Treatment Outcome

U2 - 10.1093/icvts/ivw446

DO - 10.1093/icvts/ivw446

M3 - SCORING: Journal article

C2 - 28329312

VL - 24

SP - 659

EP - 662

JO - INTERACT CARDIOV TH

JF - INTERACT CARDIOV TH

SN - 1569-9293

IS - 5

ER -