Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study

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Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study. / Schaefer, Andreas; Schirmer, Johannes; Schofer, Niklas; Schneeberger, Yvonne; Deuschl, Florian; Blankenberg, Stefan; Reichenspurner, Hermann; Conradi, Lenard; Schäfer, Ulrich.

in: CLIN RES CARDIOL, Jahrgang 108, Nr. 7, 07.2019, S. 779-786.

Publikationen: SCORING: Beitrag in Fachzeitschrift/ZeitungSCORING: ZeitschriftenaufsatzForschungBegutachtung

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@article{61f7f71514e3476987c917fbe7501634,
title = "Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study",
abstract = "OBJECTIVES: We herein aimed to evaluate technical feasibility of transaxillary (Tax) transcatheter aortic valve implantation (TAVI) utilizing a novel vascular closure device with a resorbable collagen plug and absence of suture material.METHODS: Between 05/2018 and 8/2018, eight patients (76.0 ± 5.9 years, 62.5% male, logEuroSCORE I 23.6 ± 4.7) received Tax-TAVI using the MANTA{\texttrademark} vascular closure device. Implanted transcatheter heart valves consisted of Edwards Sapien 3, NVT Allegra, Medtronic CoreValve EvolutR and SJM Portico.RESULTS: Puncture location depth was variable (3.5-7.5 cm). The left subclavian artery was used in five cases, the right subclavian artery in three cases. Low-pressure balloon-angioplasty for vessel closure was performed in 5/8 patients. VARC-2 defined device success was met in all patients. Major access site complication occurred in one patient with aneurysma spurium of the subclavian artery and consecutive stent implantation on postoperative day 5.CONCLUSION: The MANTA{\texttrademark} device is applicable in Tax-TAVI, with potential particular advantages regarding easiness of use and marked access for subsequent interventions in case of vascular complications. Before conclusions regarding clinical efficacy and safety can be made, the device has to be evaluated in larger patient cohorts.",
keywords = "Absorbable Implants, Aged, Aged, 80 and over, Angiography, Aortic Valve Stenosis/diagnosis, Axillary Artery, Collagen, Equipment Design, Feasibility Studies, Female, Follow-Up Studies, Humans, Imaging, Three-Dimensional, Male, Retrospective Studies, Tomography, X-Ray Computed, Transcatheter Aortic Valve Replacement/instrumentation, Treatment Outcome, Vascular Closure Devices",
author = "Andreas Schaefer and Johannes Schirmer and Niklas Schofer and Yvonne Schneeberger and Florian Deuschl and Stefan Blankenberg and Hermann Reichenspurner and Lenard Conradi and Ulrich Sch{\"a}fer",
year = "2019",
month = jul,
doi = "10.1007/s00392-018-1407-z",
language = "English",
volume = "108",
pages = "779--786",
journal = "CLIN RES CARDIOL",
issn = "1861-0684",
publisher = "D. Steinkopff-Verlag",
number = "7",

}

RIS

TY - JOUR

T1 - Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study

AU - Schaefer, Andreas

AU - Schirmer, Johannes

AU - Schofer, Niklas

AU - Schneeberger, Yvonne

AU - Deuschl, Florian

AU - Blankenberg, Stefan

AU - Reichenspurner, Hermann

AU - Conradi, Lenard

AU - Schäfer, Ulrich

PY - 2019/7

Y1 - 2019/7

N2 - OBJECTIVES: We herein aimed to evaluate technical feasibility of transaxillary (Tax) transcatheter aortic valve implantation (TAVI) utilizing a novel vascular closure device with a resorbable collagen plug and absence of suture material.METHODS: Between 05/2018 and 8/2018, eight patients (76.0 ± 5.9 years, 62.5% male, logEuroSCORE I 23.6 ± 4.7) received Tax-TAVI using the MANTA™ vascular closure device. Implanted transcatheter heart valves consisted of Edwards Sapien 3, NVT Allegra, Medtronic CoreValve EvolutR and SJM Portico.RESULTS: Puncture location depth was variable (3.5-7.5 cm). The left subclavian artery was used in five cases, the right subclavian artery in three cases. Low-pressure balloon-angioplasty for vessel closure was performed in 5/8 patients. VARC-2 defined device success was met in all patients. Major access site complication occurred in one patient with aneurysma spurium of the subclavian artery and consecutive stent implantation on postoperative day 5.CONCLUSION: The MANTA™ device is applicable in Tax-TAVI, with potential particular advantages regarding easiness of use and marked access for subsequent interventions in case of vascular complications. Before conclusions regarding clinical efficacy and safety can be made, the device has to be evaluated in larger patient cohorts.

AB - OBJECTIVES: We herein aimed to evaluate technical feasibility of transaxillary (Tax) transcatheter aortic valve implantation (TAVI) utilizing a novel vascular closure device with a resorbable collagen plug and absence of suture material.METHODS: Between 05/2018 and 8/2018, eight patients (76.0 ± 5.9 years, 62.5% male, logEuroSCORE I 23.6 ± 4.7) received Tax-TAVI using the MANTA™ vascular closure device. Implanted transcatheter heart valves consisted of Edwards Sapien 3, NVT Allegra, Medtronic CoreValve EvolutR and SJM Portico.RESULTS: Puncture location depth was variable (3.5-7.5 cm). The left subclavian artery was used in five cases, the right subclavian artery in three cases. Low-pressure balloon-angioplasty for vessel closure was performed in 5/8 patients. VARC-2 defined device success was met in all patients. Major access site complication occurred in one patient with aneurysma spurium of the subclavian artery and consecutive stent implantation on postoperative day 5.CONCLUSION: The MANTA™ device is applicable in Tax-TAVI, with potential particular advantages regarding easiness of use and marked access for subsequent interventions in case of vascular complications. Before conclusions regarding clinical efficacy and safety can be made, the device has to be evaluated in larger patient cohorts.

KW - Absorbable Implants

KW - Aged

KW - Aged, 80 and over

KW - Angiography

KW - Aortic Valve Stenosis/diagnosis

KW - Axillary Artery

KW - Collagen

KW - Equipment Design

KW - Feasibility Studies

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Imaging, Three-Dimensional

KW - Male

KW - Retrospective Studies

KW - Tomography, X-Ray Computed

KW - Transcatheter Aortic Valve Replacement/instrumentation

KW - Treatment Outcome

KW - Vascular Closure Devices

U2 - 10.1007/s00392-018-1407-z

DO - 10.1007/s00392-018-1407-z

M3 - SCORING: Journal article

C2 - 30560381

VL - 108

SP - 779

EP - 786

JO - CLIN RES CARDIOL

JF - CLIN RES CARDIOL

SN - 1861-0684

IS - 7

ER -