Percutaneous nitinol-based vascular closure device for large bore arterial access hemostasis: Results of a prospective multicenter study.
Aged
Aged, 80 and over
Alloys
Arteries
Catheterization, Peripheral
/ adverse effects
Equipment Design
Female
Germany
Hemorrhage
/ etiology
Hemostasis
Hemostatic Techniques
/ adverse effects
Humans
Israel
Male
Prospective Studies
Punctures
Treatment Outcome
Vascular Access Devices
Vascular Closure Devices
TVI-transcatheter valve implantation
VCLO-vascular, closure
VCOM-vascular complications
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
18
08
2019
revised:
04
12
2019
accepted:
28
12
2019
pubmed:
9
1
2020
medline:
7
4
2021
entrez:
9
1
2020
Statut:
ppublish
Résumé
Vascular complications during transcatheter aortic valve replacement (TAVR) still pose a significant concern regarding procedural safety. Designated closure devices for large-bore vascular access are needed. Patients undergoing TAVR were prospectively enrolled into the study. The InSeal vascular closure device (VCD) achieves hemostasis by utilizing a crescent-shaped nitinol scaffold covered by a biodegradable membrane, which is delivered at the arterial puncture site. The coprimary endpoints were predefined as hemostasis within 15 min following vessel access site closure and after activated clotting time falls below 200 s and the rate of related major vascular adverse events in first month. A total of 50 patients were prospectively enrolled into the study, with an average age of 80.8 ± 7.4 years and 62% males. Hemostasis with the Inseal VCD was achieved in 94% of the patients with average time-to-hemostasis of 51 ± 97 s. The rates of in-hospital vascular complications were 12% mostly driven by minor vascular complications (10%). Femoral artery stents were used in three patients due to failed hemostasis. Initial clinical experience indicates that a novel, nitinol-based, large-bore vascular closure device is safe and effective in achieving hemostasis after TAVR.
Sections du résumé
BACKGROUND
Vascular complications during transcatheter aortic valve replacement (TAVR) still pose a significant concern regarding procedural safety. Designated closure devices for large-bore vascular access are needed.
METHODS
Patients undergoing TAVR were prospectively enrolled into the study. The InSeal vascular closure device (VCD) achieves hemostasis by utilizing a crescent-shaped nitinol scaffold covered by a biodegradable membrane, which is delivered at the arterial puncture site. The coprimary endpoints were predefined as hemostasis within 15 min following vessel access site closure and after activated clotting time falls below 200 s and the rate of related major vascular adverse events in first month.
RESULTS
A total of 50 patients were prospectively enrolled into the study, with an average age of 80.8 ± 7.4 years and 62% males. Hemostasis with the Inseal VCD was achieved in 94% of the patients with average time-to-hemostasis of 51 ± 97 s. The rates of in-hospital vascular complications were 12% mostly driven by minor vascular complications (10%). Femoral artery stents were used in three patients due to failed hemostasis.
CONCLUSIONS
Initial clinical experience indicates that a novel, nitinol-based, large-bore vascular closure device is safe and effective in achieving hemostasis after TAVR.
Substances chimiques
Alloys
0
nitinol
2EWL73IJ7F
Types de publication
Journal Article
Multicenter Study
Video-Audio Media
Langues
eng
Sous-ensembles de citation
IM
Pagination
473-478Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 Wiley Periodicals, Inc.
Références
Nakamura M, Chakravarty T, Jilaihawi H, et al. Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure. Catheter Cardiovasc Interv. 2014;84(2):293-300.
Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380(18):1706-1715.
Barbash IM, Barbanti M, Webb J, et al. Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation. Eur Heart J. 2015;36(47):3370-3379.
Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research Consortium-2 consensus document. Eur Heart J. 2012;33(19):2403-2418.
Barbanti M, Capranzano P, Ohno Y, et al. Comparison of suture-based vascular closure devices in transfemoral transcatheter aortic valve implantation. EuroIntervention. 2015;11(6):690-697.
Power D, Schafer U, Guedeney P, et al. Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: a post hoc analysis from the BRAVO-3 randomized trial. Catheter Cardiovasc Interv. 2019;93(7):1374-1381.
Ko TY, Kao HL, Liu YJ, et al. Intentional combination of ProGlide and Angio-seal for femoral access haemostasis in transcatheter aortic valve replacement. Int J Cardiol. 2019;293:76-79.
Mwipatayi BP, Picardo A, Masilonyane-Jones TV, et al. Incidence and prognosis of vascular complications after transcatheter aortic valve implantation. J Vasc Surg. 2013;58(4):1028-36.e1.
Czerwinska-Jelonkiewicz K, Michalowska I, Witkowski A, et al. Vascular complications after transcatheter aortic valve implantation (TAVI): risk and long-term results. J Thromb Thrombolysis. 2014;37(4):490-498.
Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609-1620.
Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376(14):1321-1331.
Thonghong T, Bieliauskas G, De Backer O, Sondergaard L. Economical cost of percutaneous vascular closure with ProGlide and Prostar XL following transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2018;94(2):308-309.
Uguz E, Gokcimen M, Ali S, et al. Predictability and outcome of vascular complications after transfemoral transcatheter aortic valve implantation. J Heart Valve Dis. 2016;25(2):173-181.
Barbanti M, Binder RK, Freeman M, et al. Impact of low-profile sheaths on vascular complications during transfemoral transcatheter aortic valve replacement. EuroIntervention. 2013;9(8):929-935.
Biancari F, Romppanen H, Savontaus M, et al. MANTA versus ProGlide vascular closure devices in transfemoral transcatheter aortic valve implantation. Int J Cardiol. 2018;263:29-31.