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. 2024 Mar 18;20(6):e344-e353.
doi: 10.4244/EIJ-D-23-00750.

A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral TAVI

Oliver Dumpies  1 , Ahmed Abdelhafez  1 , Johannes Rotta Detto Loria  1 , Ines Richter  1 , Hans-Josef Feistritzer  1 , Nicolas Majunke  1 , Steffen Desch  1 , Thilo Noack  2 , Holger Thiele  1 , Mohamed Abdel-Wahab  1
Affiliations

A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral TAVI

Oliver Dumpies et al. EuroIntervention. .

Abstract

Background: Percutaneous suture-based arterial access site closure (ProGlide) is commonly applied in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). However, the failure of a suture-based vascular closure device (VCD) may require additional treatment.

Aims: We aimed to evaluate the efficacy and safety of bailout access site closure using a large-bore plug-based device (MANTA) in patients with failed suture-based closure during transfemoral TAVI.

Methods: Patients undergoing a bailout attempt with the MANTA VCD were identified from a prospectively enrolling, institutional registry. Efficacy was defined as haemostasis at the access site without the need for alternative treatment other than manual compression or endovascular ballooning. Safety was defined as freedom from vascular dissection, stenosis and occlusion requiring intervention.

Results: Of 2,505 patients, 66 underwent a bailout attempt with MANTA as a result of ProGlide failure, which occurred before the large-bore sheath insertion in 16.7% of patients and after the sheath removal in 83.3% of patients. Bailout MANTA was deemed effective in 75.8% of patients (50/66), and the technique was considered safe in 86.4% (57/66) of patients. Failure of bailout MANTA occurred because of its superficial application, resulting in persistent bleeding in 18.2% of patients (12/66), and because of its deep application, resulting in stenosis or occlusion in 6.1% of patients (4/66). Operator experience with the technique (odds ratio [OR] 12.29, 95% confidence interval [CI]: 1.99-75.99; p=0.007) and prior use of three ProGlides (OR 0.02, 95% CI: <0.01-0.39; p=0.010) were the only independent predictors of the efficacy endpoint.

Conclusions: Bailout MANTA after ProGlide failure was effective and safe, but operator experience seems to be crucial. Further technological refinements to facilitate accurate placement appear necessary.

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Conflict of interest statement

M. Abdel-Wahab reports that his hospital receives speaker honoraria and/or consultancy fees on his behalf from Boston Scientific, Abbott, and Medtronic. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Vascular closure and bailout strategies after transfemoral transcatheter aortic valve implantation.
TAVI: transcatheter aortic valve implantation; VCD: vascular closure device
Figure 2
Figure 2. Efficacy of bailout MANTA according to tertiles of patient enrolment.
Figure 3
Figure 3. Failure modes of bailout MANTA.
A) Inadvertent superficial application of the MANTA device resulting in persistent bleeding. B) Deep, partially intravascular, application resulting in stenosis or occlusion.
Central illustration
Central illustration. Efficacy and safety of bailout MANTA.
*Treatment: stenting – 3 patients, surgical vascular repair – 1 patient. TAVI: transcatheter aortic valve implantation
See this image and copyright information in PMC

References

    1. Toggweiler S, Gurvitch R, Leipsic J, Wood DA, Willson AB, Binder RK, Cheung A, Ye J, Webb JG. Percutaneous aortic valve replacement: vascular outcomes with a fully percutaneous procedure. J Am Coll Cardiol. 2012;59:113–8. - PubMed
    1. Hayashida K, Lefèvre T, Chevalier B, Hovasse T, Romano M, Garot P, Mylotte D, Uribe J, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Morice MC. True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device: impact of learning curve on vascular complications. JACC Cardiovasc Interv. 2012;5:207–14. - PubMed
    1. Nara Y, Watanabe Y, Kozuma K, Kataoka A, Nakashima M, Hioki H, Kawashima H, Nagura F, Shirai S, Tada N, Araki M, Naganuma T, Yamanaka F, Yamamoto M, Hayashida K. Incidence, Predictors, and Mid-Term Outcomes of Percutaneous Closure Failure After Transfemoral Aortic Valve Implantation Using an Expandable Sheath (from the Optimized Transcatheter Valvular Intervention [OCEAN-TAVI] Registry). Am J Cardiol. 2017;119:611–7. - PubMed
    1. Batchelor W, Patel K, Hurt J, Totten J, Burroughs P, Smith G, Cuervo M, Davis L, Damluji AA, Epps K, Sherwood M, Barnett S, Geloo N, Yazdani S, Sarin E, Ryan L, Noel T. Incidence, Prognosis and Predictors of Major Vascular Complications and Percutaneous Closure Device Failure Following Contemporary Percutaneous Transfemoral Transcatheter Aortic Valve Replacement. Cardiovasc Revasc Med. 2020;21:1065–73. - PMC - PubMed
    1. van Wiechen, Tchétché D, Ooms JF, Hokken TW, Kroon H, Ziviello F, Ghattas A, Siddiqui S, Laperche C, Spitzer E, Daemen J, de Jaegere, Dumonteil N, Van Mieghem. Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial. JACC Cardiovasc Interv. 2021;14:149–57. - PubMed

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