Early Outcomes After Percutaneous Closure of Access Site in Transfemoral Transcatheter Valve Implantation Using the Novel Vascular Closure Device Collagen Plug-Based MANTA

Gheorghe, Livia; Brouwer, Jorn; Mathijssen, Harold; Nijenhuis, Vincent J.; Rensing, Benno J.; Swaans, Martin J.; Yin, Dean Rpp Chan Pin; Heijmen, Robin H.; Kroon, Thomas de; Sonker, Uday; Heyden, Jan A Van der; Berg, Jürrien M. ten

doi:10.1016/j.amjcard.2019.07.030

Cited by 40 publications

(33 citation statements)

References 24 publications

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“…found much lower major vascular and bleeding complication rates with the suture based device than reported earlier and comparable between both closure techniques (0.6% vs. 1.0%, p = .661 and 0.6% vs. 1.5%, p = .102, respectively). 14 Minor vascular and bleeding complications seemed somewhat more frequently observed with Prostar XL (10.7% vs 18.8%, p = .003 and 13.7% vs. 19.7%, p = .08, respectively). 14 In a retrospective TAVR study, Hoffmann et al compared 75 Manta with 76 Proglide closures and reported fewer vascular complications and need for bail out surgery/interventions with suturebased closure.…”

Section: Discussionmentioning

confidence: 90%

Dedicated plug based closure for large bore access –The MARVEL prospective registry

Kroon

Tonino

Savontaus

et al. 2020

Cathet Cardio Intervent

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Objectives To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers. Background The MANTA is a novel plug‐based device for large bore arteriotomy closure. Methods We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC‐2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications. Results Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS‐score of 2.7 [IQR 2.0–4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20–120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications. Conclusion In this study, MANTA appeared to be a safe and effective device for large bore access closure under real‐world conditions.

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Section: Discussionmentioning

confidence: 90%

Dedicated plug based closure for large bore access –The MARVEL prospective registry

Kroon

Tonino

Savontaus

et al. 2020

Cathet Cardio Intervent

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“…The MANTA ® large-bore vascular closure device has been used for percutaneous closure of large-bore vascular access sites fairly extensively in the setting of transcatheter aortic valve replacement (TAVR) and endovascular aneurysm repair (EVAR). [5][6][7][8][9][10] These studies have demonstrated reliable vascular closure with low complication rates in these populations. The goal of our study was to demonstrate basic feasibility of accessing an ECMO circuit and using the MANTA ® to close the arterial access site.…”

Section: Discussionmentioning

confidence: 90%

Sutureless Closure of Arterial Cannulation Sites

Pasrija

Bernstein

Rice

et al. 2020

Innovations�(Phila)

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Objective Percutaneous femoral cannulation for venoarterial extracorporeal membrane oxygenation (ECMO) is commonly performed but percutaneous removal of arterial cannulas has not been broadly accepted. We hypothesized that a system that allows endovascular access to ECMO circuits along with the MANTA® large-bore vascular closure device could be used to successfully close arterial ECMO cannulation sites in a large animal model. Methods Yorkshire swine (40 to 60 kg, n = 2) were used for this study. In the first swine, the infrarenal abdominal aorta was exposed. The aorta was cannulated once using a 15 Fr cannula and twice with a 19 Fr arterial cannula. A novel adaptor system that facilitates endovascular access to ECMO circuits was connected, and a 0.035″ Benston wire was placed through the adaptor and guided into the aorta. The cannula was removed over the wire and manual pressure was applied. The MANTA® sheath was inserted over the wire followed by the closure unit and was deployed. The process was repeated at 2 separate sites. A similar experiment was performed in a second swine, but through a median sternotomy to cannulate the ascending aorta. Results Good hemostasis was achieved at all cannulation sites. Angiography demonstrated unobstructed flow across all closure sites with no evidence of extravasation. Conclusions The data presented here support the use of the MANTA® vascular closure device for the closure of arterial cannulation sites following ECMO decannulation and demonstrates utility of a novel adaptor system for establishing endovascular access in this context.

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“…43,44 Another development for large-bore procedures is the recent approval of the MANTA ® VCD (Teleflex, Morrisville, NC, USA), a closure device specifically designed for 10-20 Fr large-bore procedures, though predominantly evaluated in TAVR studies published to date. [45][46][47][48] While new techniques and devices are encouraging, larger studies will be required to both identify and confirm the optimal strategies to ultimately reduce bleeding and vascular complications associated with large-bore access for haemodynamic support in HR-PCI. when Impella is used for HR-PCI.…”

Section: Evolving Solutionsmentioning

confidence: 99%

A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention

Vetrovec¹,

Kaki²,

Dahle³

2020

Heart International

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Early Outcomes After Percutaneous Closure of Access Site in Transfemoral Transcatheter Valve Implantation Using the Novel Vascular Closure Device Collagen Plug-Based MANTA

Cited by 40 publications

References 24 publications

Dedicated plug based closure for large bore access –The MARVEL prospective registry

Dedicated plug based closure for large bore access –The MARVEL prospective registry

Sutureless Closure of Arterial Cannulation Sites

A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention

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