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Gepubliceerd in: Netherlands Heart Journal 12/2020

Open Access 28-10-2020 | Commentary

MANTA closure device shows promise in transfemoral transcatheter aortic valve replacement

Auteurs: J. Vendrik, J. Baan Jr.

Gepubliceerd in: Netherlands Heart Journal | Uitgave 12/2020

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In this issue of the Netherlands Heart Journal, Halim et al. report the results of a single-centre study assessing the efficacy and safety of the use of the MANTA large-bore vascular closure device in transfemoral transcatheter aortic valve replacement (TF-TAVR) [1]. The MANTA closure device showed promise in these patients, although a considerable proportion of them had access-site-related vascular complications. The cohort was small, but the authors used a well-designed study protocol and performed an adequate analysis.
The outcomes of earlier studies [27] are in line with those reported by Halim et al., describing a prevalence of access-site-related vascular complications—as defined by the Valve Academic Research Consortium-II criteria [8]—ranging from 2–14%. The authors correctly identified a steep learning curve when using the MANTA device, even though they did not analyse this [1]. Hoffman et al. reported a vast decline of complications after the first 25 cases [4]. This is especially useful information for TAVR centre start-ups in an era in which TAVR is expanding to a broader (i.e. low-risk) population, as the learning curve for suture-based vascular closure devices (i.e. ProGlide and Prostar) is thought to be more extensive in general. The different outcomes for the newer MANTA closure device and the traditionally used suture-based vascular closure devices may very well be explained by each device’s advantages, disadvantages and proper indications, which influence patient selection and therefore outcomes.
Earlier reports have focussed on the occurrence and eventually prevention of access-site-related vascular complications. First, Van Kesteren et al. identified the ‘sheath-to-iliofemoral artery ratio’ to be the only strong predictor of vascular complications, while adding that all vascular complications influence survival [9]. Hence, even minor complications, such as access site bleeding, should be avoided when possible.
Second, focussing on the MANTA closure device, Moccetti et al. recently hypothesised three distinct mechanisms of its failure: (a) elevation of the toggle may lead to occlusion of the artery in vessels with narrow femoral artery diameters; (b) incomplete apposition of the plug may lead to perivascular, potentially retroperitoneal bleeding; or (c) the formation of a pseudoaneurysm may occur [3]. This knowledge could further lower the prevalence of access-related complications surrounding TF-TAVR, in addition to gaining extensive experience in using these kinds of closure devices.
The aforementioned knowledge is much awaited for two reasons: (i) vascular complications are still the most common complications after TF-TAVR; and (ii) adequate vascular closure without complications could ensure both early ambulation and early discharge. Early ambulation can prevent other avoidable complications, such as postoperative delirium and postoperative infections [10], favour patient satisfaction and ultimately enable early discharge. When properly employed, an early discharge strategy can improve the cost effectiveness of TAVR and ultimately improve patient satisfaction, without imposing additional risks for the patient [1114].
The aforementioned parameters, i.e. early ambulation and early discharge, greatly influence cost effectiveness. At this moment, the MANTA device is probably more expensive than the commonly used ProGlide suture-based vascular closure device. To assess the true cost effectiveness and comparability of large-bore closure devices and conventional suture-based systems, outcome measures of future studies should not only include the number of successful closures, access-site-related vascular complications and bleedings, but also the effect of these numbers on subsequent hospitalisation.

Conflict of interest

J. Vendrik declares that he/she has no competing interests. J. Baan Jr. received an unrestricted research grant from Edwards Lifesciences.
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://​creativecommons.​org/​licenses/​by/​4.​0/​.
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Literatuur
2.
go back to reference Biancari F, Romppanen H, Savontaus M, Siljander A, Makikallio T, Piira OP, et al. MANTA versus ProGlide vascular closure devices in transfemoral transcatheter aortic valve implantation. Int J Cardiol. 2018;263:29–31. CrossRef Biancari F, Romppanen H, Savontaus M, Siljander A, Makikallio T, Piira OP, et al. MANTA versus ProGlide vascular closure devices in transfemoral transcatheter aortic valve implantation. Int J Cardiol. 2018;263:29–31. CrossRef
3.
go back to reference Moccetti F, Brinkert M, Seelos R, Ockert S, Bossard M, Cuculi F, et al. Insights from a multidisciplinary introduction of the MANTA vascular closure device. JACC Cardiovasc Interv. 2019;12:1730–6. CrossRef Moccetti F, Brinkert M, Seelos R, Ockert S, Bossard M, Cuculi F, et al. Insights from a multidisciplinary introduction of the MANTA vascular closure device. JACC Cardiovasc Interv. 2019;12:1730–6. CrossRef
4.
go back to reference Hoffmann P, Al-Ani A, von Lueder T, Hoffmann J, Majak P, Hagen O, et al. Access site complications after transfemoral aortic valve implantation—A comparison of Manta and ProGlide. CVIR Endovasc. 2018;1:20. CrossRef Hoffmann P, Al-Ani A, von Lueder T, Hoffmann J, Majak P, Hagen O, et al. Access site complications after transfemoral aortic valve implantation—A comparison of Manta and ProGlide. CVIR Endovasc. 2018;1:20. CrossRef
5.
go back to reference Gheorghe L, Brouwer J, Mathijssen H, Nijenhuis VJ, Rensing BJ, Swaans MJ, 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;124:1265–71. CrossRef Gheorghe L, Brouwer J, Mathijssen H, Nijenhuis VJ, Rensing BJ, Swaans MJ, 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;124:1265–71. CrossRef
6.
go back to reference Moriyama N, Lindstrom L, Laine M. Propensity-matched comparison of vascular closure devices after transcatheter aortic valve replacement using MANTA versus ProGlide. EuroIntervention. 2019;14:e1558–65. CrossRef Moriyama N, Lindstrom L, Laine M. Propensity-matched comparison of vascular closure devices after transcatheter aortic valve replacement using MANTA versus ProGlide. EuroIntervention. 2019;14:e1558–65. CrossRef
7.
go back to reference Van Mieghem NM, Latib A, van der Heyden J, van Gils L, Daemen J, Sorzano T, et al. Percutaneous plug-based arteriotomy closure device for large-bore access: a multicenter prospective study. JACC Cardiovasc Interv. 2017;10:613–9. CrossRef Van Mieghem NM, Latib A, van der Heyden J, van Gils L, Daemen J, Sorzano T, et al. Percutaneous plug-based arteriotomy closure device for large-bore access: a multicenter prospective study. JACC Cardiovasc Interv. 2017;10:613–9. CrossRef
8.
go back to reference Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium‑2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012;42:S45–60. CrossRef Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium‑2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012;42:S45–60. CrossRef
9.
go back to reference Van Kesteren F, van Mourik MS, Vendrik J, Wiegerinck EMA, Henriques JPS, Koch KT, et al. Incidence, predictors, and impact of vascular complications after transfemoral transcatheter aortic valve implantation with the SAPIEN 3 prosthesis. Am J Cardiol. 2018;121:1231–8. CrossRef Van Kesteren F, van Mourik MS, Vendrik J, Wiegerinck EMA, Henriques JPS, Koch KT, et al. Incidence, predictors, and impact of vascular complications after transfemoral transcatheter aortic valve implantation with the SAPIEN 3 prosthesis. Am J Cardiol. 2018;121:1231–8. CrossRef
10.
go back to reference Vendrik J, Vlastra W, van Mourik MS, Delewi R, Beijk MA, Lemkes J, et al. Early mobilisation after transfemoral transcatheter aortic valve implantation: results of the MobiTAVI trial. Neth Heart J. 2020;28:240–8. CrossRef Vendrik J, Vlastra W, van Mourik MS, Delewi R, Beijk MA, Lemkes J, et al. Early mobilisation after transfemoral transcatheter aortic valve implantation: results of the MobiTAVI trial. Neth Heart J. 2020;28:240–8. CrossRef
11.
go back to reference Kotronias RA. Early vs standard discharge after Transcatheter aortic valve implantation: a systematic review and meta-analysis. JACC Cardiovasc Interv. 2018;11:1759–71. CrossRef Kotronias RA. Early vs standard discharge after Transcatheter aortic valve implantation: a systematic review and meta-analysis. JACC Cardiovasc Interv. 2018;11:1759–71. CrossRef
12.
go back to reference Baan J Jr., Vendrik J. The sooner the better?: The doctor knows best. JACC Cardiovasc Interv. 2018;11:1772–4. CrossRef Baan J Jr., Vendrik J. The sooner the better?: The doctor knows best. JACC Cardiovasc Interv. 2018;11:1772–4. CrossRef
13.
go back to reference Barbanti M, van Mourik MS, Spence MS, Iacovelli F, Martinelli GL, Muir DF, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention. 2019;15:147–54. CrossRef Barbanti M, van Mourik MS, Spence MS, Iacovelli F, Martinelli GL, Muir DF, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention. 2019;15:147–54. CrossRef
14.
go back to reference Sathananthan J, Webb JG, Lauck SB, Cairns J, Humphries KH, Nazif T, et al. Impact of local anesthesia only versus procedural sedation using the vancouver clinical pathway for TAVR: insights from the 3M TAVR study. JACC Cardiovasc Interv. 2019;12:1000–1. CrossRef Sathananthan J, Webb JG, Lauck SB, Cairns J, Humphries KH, Nazif T, et al. Impact of local anesthesia only versus procedural sedation using the vancouver clinical pathway for TAVR: insights from the 3M TAVR study. JACC Cardiovasc Interv. 2019;12:1000–1. CrossRef
Metagegevens
Titel
MANTA closure device shows promise in transfemoral transcatheter aortic valve replacement
Auteurs
J. Vendrik
J. Baan Jr.
Publicatiedatum
28-10-2020
Uitgeverij
Bohn Stafleu van Loghum
Gepubliceerd in
Netherlands Heart Journal / Uitgave 12/2020
Print ISSN: 1568-5888
Elektronisch ISSN: 1876-6250
DOI
https://doi.org/10.1007/s12471-020-01511-0