Assessment of the MANTA closure device in real-life transfemoral transcatheter aortic valve replacement: A single-centre observational study.
TAVR
vascular closure device
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:
Mar 2024
Mar 2024
Historique:
revised:
30
11
2023
received:
15
09
2023
accepted:
31
01
2024
pubmed:
26
2
2024
medline:
26
2
2024
entrez:
26
2
2024
Statut:
ppublish
Résumé
Vascular complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). Data involving suture-based percutaneous vascular closure devices (VCDs) have been extensive. Although promising, data regarding the efficacy and safety of the MANTA VCD (Teleflex) are scarce. We sought to assess the safety and effectiveness of the MANTA device in a real-life unselected cohort of patients undergoing transfemoral-TAVR (TF-TAVR). This single-center retrospective observational study included a cohort of consecutive patients with severe aortic stenosis (AS) treated by our team using TAVR between January 2020 to December 2022. The primary outcome measure was access-related major and minor vascular complications according to the Valve Academic Research Consortium (VARC-3) definition criteria. From January 2020 to December 2022, a total of 347 patients underwent TF-TAVR were treated using the MANTA 18 Fr VCD system for vascular closure. Mean age was 82.4 ± 6.1 years (56-98 years). There were no significant differences in preoperative and procedural characteristics between patients with and without VCD-related major vascular complications. Access site-related major and minor vascular complications occurred in 20 of 347 patients (5.7%). Overall, major vascular complications occurred in 5 patients (1.4%) and device failure was seen in 17 patients (4.9%). This French real world evaluation of large-bore arteriotomy closure in TF-TAVR indicated that MANTA VCD is a feasible alternative with an acceptable low rate of access-site-related complications.
Sections du résumé
BACKGROUND
BACKGROUND
Vascular complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). Data involving suture-based percutaneous vascular closure devices (VCDs) have been extensive. Although promising, data regarding the efficacy and safety of the MANTA VCD (Teleflex) are scarce. We sought to assess the safety and effectiveness of the MANTA device in a real-life unselected cohort of patients undergoing transfemoral-TAVR (TF-TAVR).
METHODS
METHODS
This single-center retrospective observational study included a cohort of consecutive patients with severe aortic stenosis (AS) treated by our team using TAVR between January 2020 to December 2022. The primary outcome measure was access-related major and minor vascular complications according to the Valve Academic Research Consortium (VARC-3) definition criteria.
RESULTS
RESULTS
From January 2020 to December 2022, a total of 347 patients underwent TF-TAVR were treated using the MANTA 18 Fr VCD system for vascular closure. Mean age was 82.4 ± 6.1 years (56-98 years). There were no significant differences in preoperative and procedural characteristics between patients with and without VCD-related major vascular complications. Access site-related major and minor vascular complications occurred in 20 of 347 patients (5.7%). Overall, major vascular complications occurred in 5 patients (1.4%) and device failure was seen in 17 patients (4.9%).
CONCLUSION
CONCLUSIONS
This French real world evaluation of large-bore arteriotomy closure in TF-TAVR indicated that MANTA VCD is a feasible alternative with an acceptable low rate of access-site-related complications.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
650-659Informations de copyright
© 2024 Wiley Periodicals LLC.
Références
Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106(24):3006-3008.
Otto CM, Nishimura RA, Bonow RO, et al. PARTNER 3 investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705.
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.
Van Mieghem NM, Tchetche D, Chieffo A, et al. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation. Am J Cardiol. 2012;110(9):1361-1367.
Généreux P, Webb JG, Svensson LG, et al. Vascular complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;60(12):1043-1052.
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.
Maniotis C, Andreou C, Karalis I, Koutouzi G, Agelaki M, Koutouzis M. A systematic review on the safety of prostar XL versus ProGlide after TAVR and EVAR. Cardiovasc Revasc Med. 2017;18:145-150.
Wood DA, Krajcer Z, Sathananthan J, et al. SAFE MANTA study investigators. pivotal clinical study to evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device. Circ Cardiovasc Interv. 2019;12(7):e007258.
Van Mieghem NM, Latib A, van der Heyden J, et al. Percutaneous plug-based arteriotomy closure device for large-bore access. JACC Cardiovasc Interv. 2017;10(6):613-619.
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.
Kroon HG, Tonino PAL, Savontaus M, et al. Dedicated plug based closure for large bore access-The MARVEL prospective registry. Catheter Cardiovasc Interv. 2021;97(6):1270-1278.
van Gils L, De Jaegere PPT, Roubin G, Van Mieghem NM. The MANTA vascular closure device. JACC Cardiovasc Interv. 2016;9(11):1195-1196.
Koehler T, Buege M, Schleiting H, Seyfarth M, Tiroch K, Vorpahl M. Changes of the eSheath outer dimensions used for transfemoral transcatheter aortic valve replacement. Biomed Res Int. 2015;2015:572681.
Hayashida K, Lefèvre T, Chevalier B, et al. Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv. 2011;4(8):851-858.
Toggweiler S, Gurvitch R, Leipsic J, et al. Percutaneous aortic valve replacement. J Am Coll Cardiol. 2012;59(2):113-118.
Patel MR, Jneid H, Derdeyn CP, et al. Arteriotomy closure devices for cardiovascular procedures: a scientific statement from the American Heart Association. Circulation. 2010;122:1882-1893.
Moccetti F, Brinkert M, Seelos R, et al. Insights from a multidisciplinary introduction of the MANTA vascular closure device. JACC Cardiovasc Interv. 2019;12:1730-1736.
De Palma R, Settergren M, Rück A, Linder R, Saleh N. Impact of percutaneous femoral arteriotomy closure using the MANTATM device on vascular and bleeding complications after transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2018;92:954-961.
Redfors B, Watson BM, McAndrew T, et al. Mortality, length of stay, and cost implications of procedural bleeding after percutaneous interventions using large-bore catheters. JAMA Cardiology. 2017;2(7):798-802.
Hoffmann P, Al-Ani A, von Lueder T, et al. Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide. CVIR Endovascular. 2018;1(1):20.
Moriyama N, Lindström L, Laine M. Propensity-matched comparison of vascular closure devices after transcatheter aortic valve replacement using MANTA versus ProGlide. EuroIntervention. 2019;14(15):e1558-e1565.
van Wiechen MP, Tchétché D, Ooms JF, et al. Suture- or plug-based large-bore arteriotomy closure. JACC: Cardiovascular Interventions. 2021;14(2):149-157.
Gheorghe L, Brouwer J, Mathijssen H, et al. Early outcomes after percutaneous closure of access site in transfemoral transcatheter valve implantation using the novel vascular closure device collagen Plug-Based MANTA. Am J Cardiol. 2019;124(8):1265-1271.
Dumpies O, Kitamura M, Majunke N, et al. Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: initial experience from a large European center. Cardiovasc Revasc Med. 2021;3(S1):553-8389.
Abdel-Wahab M, Hartung P, Dumpies O, et al. Comparison of a pure plug-based versus a primary suture-based vascular closure device strategy for transfemoral transcatheter aortic valve replacement: the CHOICE-CLOSURE randomized clinical trial. Circulation. 2022;145(3):170-183.
Kastengren M, Settergren M, Rück A, et al. Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations. Int J Cardiol. 2022;359:7-13.