Safety and Effectiveness of MANTA Vascular Closure Device After Large-Bore Mechanical Circulatory Support: Real-World Experience.
Aged
Catheterization, Peripheral
/ adverse effects
Female
Heart-Assist Devices
Hemorrhage
/ diagnostic imaging
Hemostatic Techniques
/ adverse effects
Humans
Male
Middle Aged
Prosthesis Design
Prosthesis Implantation
/ adverse effects
Retrospective Studies
Time Factors
Treatment Outcome
Vascular Closure Devices
Large bore access
MANTA
Mechanical circulatory support
Vascular closure device
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
09
02
2020
revised:
31
03
2020
accepted:
31
03
2020
pubmed:
25
4
2020
medline:
26
1
2021
entrez:
25
4
2020
Statut:
ppublish
Résumé
Real world safety and effectiveness of MANTA vascular closure device (VCD) for large bore arteriotomy closure after decannulation of mechanical circulatory support (MCS) devices is not known. All consecutive patients who underwent large bore arteriotomy closure with MANTA VCD following decannulation of MCS between February to October 2019 at a large tertiary care academic medical center were included. Safety and effectiveness of MANTA VCD was assessed on immediate post-closure angiogram for 23 access sites, and immediate post-closure duplex arterial ultrasound or manual vascular examination for 1 access site each. Technical success was defined as achievement of arteriotomy closure in absence of major bleeding or access site endovascular or surgical intervention. A total of 25 MANTA VCD were placed in 22 unique patients by 7 different operators. A 14 Fr or 18 Fr MANTA VCD was used in 15 (60%) and 10 (40%) of deployments, respectively via transfemoral (n = 23, 92%) or transaxillary (n = 2, 8%) access. Technical success was achieved in 24 of 25 (96%) cases. Minor access site bleeding occurred in 3 patients (12%) and failure of MANTA VCD with major access site bleeding occurred in 1 patient (4%) requiring endovascular balloon tamponade. No cases of retroperitoneal bleeding, collagen plug embolization, covered stent placement, or surgical vascular repair were observed. In this single center experience, the use of MANTA VCD for large bore arteriotomy closure following percutaneous decannulation of MCS devices appears to be safe and effective. Larger multicenter studies of efficacy, safety, and cost-effectiveness are needed.
Sections du résumé
BACKGROUND
Real world safety and effectiveness of MANTA vascular closure device (VCD) for large bore arteriotomy closure after decannulation of mechanical circulatory support (MCS) devices is not known.
METHODS
All consecutive patients who underwent large bore arteriotomy closure with MANTA VCD following decannulation of MCS between February to October 2019 at a large tertiary care academic medical center were included. Safety and effectiveness of MANTA VCD was assessed on immediate post-closure angiogram for 23 access sites, and immediate post-closure duplex arterial ultrasound or manual vascular examination for 1 access site each. Technical success was defined as achievement of arteriotomy closure in absence of major bleeding or access site endovascular or surgical intervention.
RESULTS
A total of 25 MANTA VCD were placed in 22 unique patients by 7 different operators. A 14 Fr or 18 Fr MANTA VCD was used in 15 (60%) and 10 (40%) of deployments, respectively via transfemoral (n = 23, 92%) or transaxillary (n = 2, 8%) access. Technical success was achieved in 24 of 25 (96%) cases. Minor access site bleeding occurred in 3 patients (12%) and failure of MANTA VCD with major access site bleeding occurred in 1 patient (4%) requiring endovascular balloon tamponade. No cases of retroperitoneal bleeding, collagen plug embolization, covered stent placement, or surgical vascular repair were observed.
CONCLUSION
In this single center experience, the use of MANTA VCD for large bore arteriotomy closure following percutaneous decannulation of MCS devices appears to be safe and effective. Larger multicenter studies of efficacy, safety, and cost-effectiveness are needed.
Identifiants
pubmed: 32327356
pii: S1553-8389(20)30173-1
doi: 10.1016/j.carrev.2020.03.032
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
875-878Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest AG and SN have received honorarium from Abiomed. MB is a consultant for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, and Zoll. WWO is a consultant for Abiomed and Abbott. KA is a consultant for Abbott Vascular, Boston Scientific, Cardiovascular Systems, Teleflex, and LevaNova. All other authors have no relevant COI to be disclosed.