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

Oliver Dumpies (Leipzig)1, A. Abdelhafez (Leipzig)2, J. Rotta Detto Loria (Leipzig)1, I. Richter (Leipzig)1, H.-J. Feistritzer (Leipzig)1, N. Majunke (Leipzig)1, S. Desch (Leipzig)1, T. Noack (Leipzig)3, H. Thiele (Leipzig)1, M. Abdel-Wahab (Leipzig)1

1Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; 2Herzzentrum Leipzig - Universität Leipzig Kardiologie Leipzig, Deutschland; 3Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland



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


To evaluate the efficacy and safety of bailout access site closure using a large-bore plug-based device (MANTA, Teleflex, Pennsylvania, USA) in patients with failed suture-based closure during transfemoral TAVI.


Patients undergoing bailout attempt with the MANTA VCD were identified from a prospectively-enrolling institutional registry. Efficacy was defined as hemostasis 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 or occlusion requiring intervention.

Sixty-six of 2505 patients underwent a bailout attempt with MANTA due to ProGlide failure, which occurred before large-bore sheath insertion in 16.7% and after sheath removal in 83.3%. Bailout MANTA was effective in 75.8% of patients (50/66), and the technique was safe in 86.4% (57/66). Failure of bailout MANTA occurred due to superficial application resulting in persistent bleeding in 18.2% (12/66) and due to deep application resulting in stenosis or occlusion in 6.1% (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.

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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