Insights From a Multidisciplinary Introduction of the MANTA Vascular Closure Device

Moccetti, Federico; Brinkert, Miriam; Seelos, Robert; Ockert, S.; Bossard, Matthias; Cuculi, Florim; Kobza, Richard; Toggweiler, Stefan

doi:10.1016/j.jcin.2019.06.049

Cited by 56 publications

(75 citation statements)

References 12 publications

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“…11 In a recent study, the total rate of any site related complications for Manta closure after TAVI, endovascular aortic replacement or Impella left ventricular support was 7%. 8 Our rate of stenosis is higher than reported in TAVI patients with 1.6-3.4% for the ProGlide device and 0.6% for the ProStar XL device. 12,13 Nevertheless, the situation and the femoral access site are considerably different when comparing TAVI and V-A ECMO explantation.…”

Section: Discussioncontrasting

confidence: 61%

“…Complications in V-A ECMO patients frequently relate to the cannulation site, being reported in 16. [7][8][9][10][11][12][13][14][15][16].9% of all V-A ECMO patients. [2][3][4] Cannulation site complications mainly involve bleedings and ischaemia due to obstruction of the access artery during V-A ECMO and are an independent predictor of poor outcome with an odds ratio of 3.91.…”

Section: Introductionmentioning

confidence: 99%

“…7 In a recent study, the Manta VCD was successfully used for vascular access management after removal of, among other things, an Impella left ventricular support device (arterial sheath diameter of 8-10 Fr.). 8 At our centre, the Manta VCD is routinely used for post-transcatheter aortic valve implantation (TAVI) vascular access haemostasis as previously reported elsewhere. 9 The design for post-procedural-only access site closure seems specifically suitable for decannulation from V-A ECMO.…”

Section: Introductionmentioning

confidence: 99%

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Venoarterial extracorporeal membrane oxygenation decannulation using the novel Manta vascular closure device

Bemtgen

Heidt

Zotzmann

et al. 2020

European Heart Journal: Acute Cardiovascular Care

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Aims: Removal of large calibre arterial sheaths, as employed in venoarterial extracorporeal membrane oxygenation, is still associated with a high risk for vascular access site complications. In this study, we investigated the large bore Manta closure device as an option for venoarterial extracorporeal membrane oxygenation decannulation. Methods and results: Sixteen patients weaned from venoarterial extracorporeal membrane oxygenation between January–June 2019 were prospectively included in a registry (eight during extracorporeal cardiopulmonary resuscitation, seven with severe cardiogenic shock and one patient with fulminant pulmonary embolism). All patients had an arterial sheath removed at bedside using the Manta device achieving rapid haemostasis without clinically relevant complications afterwards. A computed tomography angiography was available for 11 patients (68.8%) and reassessed with regards to relevant pathologies at the closure device. Average intraluminal area was 40.4 mm2 (12.2–76.3 mm2) at the closure site. All devices but one were correctly deployed. Three patients (27.3%) had a visible thrombus at the closure device resulting in a >60% stenosis, two of which had a puncture site distal of the femoral artery bifurcation. Conclusion: Decannulation from venoarterial extracorporeal membrane oxygenation using the Manta closure device is a viable approach for rapid haemostasis, but is also associated with a significant risk of thrombotic vessel stenosis. These preliminary findings indicate that puncture in near proximity or distal to the femoral bifurcation might identify patients at risk and further studies are needed.

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Section: Discussioncontrasting

confidence: 61%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Venoarterial extracorporeal membrane oxygenation decannulation using the novel Manta vascular closure device

Bemtgen

Heidt

Zotzmann

et al. 2020

European Heart Journal: Acute Cardiovascular Care

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“…The efficacy of these VCDs has been extensively reported in previous studies [3]. The MANTA VCD (Teleflex, Morrisville, NC, USA) is a collagen-based device that has shown promising results in TF-TAVR [4][5][6][7][8][9]. However, data regarding the vascular complication rate in comparison to the well-known suture-based VCDs are scarce.…”

Section: What's Newmentioning

confidence: 99%

Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study

et al. 2020

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Objectives The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR). Background To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs. Methods In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device. Results Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients. Conclusions This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

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“…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.…”

mentioning

confidence: 99%

MANTA closure device shows promise in transfemoral transcatheter aortic valve replacement

Vendrik

Baan

2020

Neth Heart J

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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 [2-7] 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 startups 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.

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Insights From a Multidisciplinary Introduction of the MANTA Vascular Closure Device

Cited by 56 publications

References 12 publications

Venoarterial extracorporeal membrane oxygenation decannulation using the novel Manta vascular closure device

Venoarterial extracorporeal membrane oxygenation decannulation using the novel Manta vascular closure device

Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study

MANTA closure device shows promise in transfemoral transcatheter aortic valve replacement

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