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

Abstract 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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Comparison of Vascular Closure Device Strategies for Transfemoral Transcatheter Aortic Valve Replacement and Associated Vascular Complications

Cardiovascular Revascularization Medicine ◽

10.1016/j.carrev.2021.06.097 ◽

2021 ◽

Vol 28 ◽

pp. S42

Author(s):

Raza Naim Yunus ◽

Talal Alzahrani ◽

Jonathan Reiner ◽

Ramesh Mazhari ◽

Farzad Najam ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Vascular Complications ◽

Closure Device ◽

Vascular Closure Device ◽

Transcatheter Aortic Valve

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Incidence, Prognosis and Predictors of Major Vascular Complications and Percutaneous Closure Device Failure Following Contemporary Percutaneous Transfemoral Transcatheter Aortic Valve Replacement

Cardiovascular Revascularization Medicine ◽

10.1016/j.carrev.2020.01.007 ◽

2020 ◽

Vol 21 (9) ◽

pp. 1065-1073 ◽

Cited By ~ 3

Author(s):

Wayne Batchelor ◽

Krishna Patel ◽

Julian Hurt ◽

James Totten ◽

Penny Burroughs ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Vascular Complications ◽

Percutaneous Closure ◽

Closure Device ◽

Device Failure ◽

Transcatheter Aortic Valve

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Peripheral access site vascular complications in Transcatheter Aortic-Valve Replacement (TAVR)

Heart Lung and Circulation ◽

10.1016/j.hlc.2015.06.424 ◽

2015 ◽

Vol 24 ◽

pp. S292-S293

Author(s):

E. Shaw ◽

V. Tan ◽

D. Murdoch ◽

V. Subban ◽

M. Savage ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Vascular Complications ◽

Access Site ◽

Transcatheter Aortic Valve

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Abstract 17539: Conventional vs. Transcatheter Aortic Valve Replacement - Propensity Score Adjusted Comparison of 3,751 Unselected Patients

Circulation ◽

10.1161/circ.132.suppl_3.17539 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Jochen Börgermann ◽

Eric Emmel ◽

Smita Scholtz ◽

Stephan Ensminger ◽

Werner Scholtz ◽

...

Keyword(s):

Myocardial Infarction ◽

Aortic Valve ◽

Propensity Score ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Vascular Complications ◽

Bleeding Complications ◽

Moderate Risk ◽

Transcatheter Aortic Valve

Background and Hypothesis: Transcatheter aortic valve replacement (TAVR) is an established method in high-risk patients. Two aspects of this procedure are currently under discussion: 1.) Do the data acquired from randomized studies and registers justify expansion of the procedure to include younger and healthier patients? 2.) Is the transfemoral approach superior to the transapical approach with regard to mortality and periprocedural complications? Against this background we examined the mortality and morbidity of all patients who received an isolated conventional, transapical or transfemoral aortic valve replacement in accordance with the criteria of the Valve Academic Research Consortium (VARC)-2. Methods: A prospective register was taken from a single center recording all conventional (CONV, n=2,881), transapical (TAVR-TA, n=363) and transfemoral (TAVR-TF, n=570) aortic valve implantations during the period from 07/2009 to 10/2014. Using propensity score (PS) matching, first CONV and TAVRall (TA+TF) and then TAVR-TA and TAVR-TF were paired on the basis of 21 risk variables, creating comparable groups. Results: 393 pairs CONV vs. TAVRall within a moderate risk could be created (EuroSCORE 18.7 vs. 18.5; STS 5.0 vs. 5.4). Comparison revealed no difference for 30d mortality (4.6% CONV vs. 5.1% TAVRall, p=0.74), stroke (2.8% vs. 2.0%, p=0.48) or myocardial infarction (0.0 vs. 0.3%, p=0.50). Bleeding complications were significantly more frequent in the CONV, SM implantations and vascular complications in the TAVRall group. In the PS-adjusted comparison TAVR-TA vs. TAVR-TF (289 pairs; EuroSCORE 25.1 vs. 22.1; STS 6.8 vs. 6.7) there was also no difference in the hard endpoints (30d mortality 4.9% TA vs. 4.2% TF, p=0.70; stroke 3.1% vs. 2.8%, p=0.81; myocardial infarction 0.4% vs. 0.4%, p=1.00). Here bleeding complications were significantly more frequent in the TA group, SM implantations and vascular complications in the TF group. Subgroup analyses show an advantage of the TAVR procedure in patients with high STS or low LVEF. Conclusions: These data show that 1.) conventional aortic valve replacement and TAVR are comparable in the moderate risk group, and 2.) the two approaches, transapical and transfemoral, produce comparable results.

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Vascular complications with a plug‐based vascular closure device after transcatheter aortic valve replacement: Predictors and bail‐outs

Catheterization and Cardiovascular Interventions ◽

10.1002/ccd.29506 ◽

2021 ◽

Author(s):

Maarten P. Wiechen ◽

Herbert Kroon ◽

Thijmen W. Hokken ◽

Joris F. Ooms ◽

Marjo J. Ronde‐Tillmans ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Vascular Complications ◽

Closure Device ◽

Vascular Closure Device ◽

Transcatheter Aortic Valve

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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 ◽

10.1161/circulationaha.121.057856 ◽

2021 ◽

Author(s):

Mohamed Abdel-Wahab ◽

Philipp Hartung ◽

Oliver Dumpies ◽

Danilo Obradovic ◽

Johannes Wilde ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Vascular Complications ◽

Closure Device ◽

Vascular Closure Device ◽

Primary Suture ◽

Access Site ◽

Transcatheter Aortic Valve ◽

The Mean

Background: Transcatheter aortic valve replacement (TAVR) is an established treatment option for patients with severe symptomatic aortic stenosis (AS), and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. Methods: The CHOICE-CLOSURE (Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation) trial is an investigator-initiated, multicenter study, in which patients undergoing transfemoral TAVR were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex, Wayne, Pennsylvania) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular, Abbott Park, Illinois) potentially complemented by a small-plug. The primary endpoint consisted of access-site or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary endpoints included the rate of access-site or access-related bleeding, VCD failure, and time to hemostasis Results: A total of 516 patients were included and randomized. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary endpoint occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk [RR]: 1.61, 95% confidence interval [CI]: 1.07-2.44, p=0.029). Access-site or access-related bleeding occurred in 11.6% vs. 7.4% (RR: 1.58, 95%CI: 0.91-2.73, p=0.133) and device failure in 4.7% vs. 5.4% (RR: 0.86, 95%CI: 0.40-1.82, p=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32, 180] vs. 240 [174, 316] seconds, p<0.001). Conclusions: Among patients treated with transfemoral TAVR, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access-site or access-related vascular complications but a shorter time to hemostasis compared to a primary suture-based technique using the ProGlide VCD.

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Transcatheter aortic valve replacement using the iSleeve expandable sheath in small femoral arteries

Open Heart ◽

10.1136/openhrt-2021-001703 ◽

2021 ◽

Vol 8 (2) ◽

pp. e001703

Author(s):

Natalie Glaser ◽

Crochan J. O'Sullivan ◽

Nawzad Saleh ◽

Dinos Verouhis ◽

Magnus Settergren ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Femoral Artery ◽

Transcatheter Aortic Valve Replacement ◽

Vascular Complications ◽

Bleeding Complications ◽

Femoral Arteries ◽

Transcatheter Aortic Valve ◽

Significant Difference

BackgroundSmall femoral arteries have been associated with a higher risk of vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We investigated the feasibility and safety of TAVR in patients with small femoral arteries.MethodsIn this observational study, we included 82 patients who underwent transfemoral TAVR with the ACURATE neo system using the expandable 14F iSleeve sheath between 2018 and 2019 at Karolinska University Hospital, Sweden. Of these, 41 patients had a minimal femoral artery diameter of ≥5.5 mm (mean 6.5, range 5.5–9.2), and 41 patients had a minimal femoral artery diameter <5.5 mm (mean 4.9, range 3.9–5.4).ResultsThere was no significant difference in major vascular and bleeding complications between the small femoral artery group (7%) and the normal femoral artery group (2%) (p=0.62). The total of major and minor vascular complications did not differ significantly according to femoral artery size (17% vs 5%) (p=0.16). The iSleeve sheath was not correlated with any of the complications. The use of the iSleeve sheath was unsuccessful in four patients (5%), of which one patient had a small femoral artery diameter.ConclusionTransfemoral TAVR with the ACURATE neo system using the iSleeve sheath is a promising method for patients with small femoral arteries even though we found a trend towards higher rates of complications in these patients. The use of expandable sheaths may expand the spectrum of patients that can be treated with transfemoral TAVR, and thus may improve the prognosis in patients with severe aortic valve stenosis.

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