Oliver Dumpies; Ahmed Abdelhafez; Johannes Rotta detto Loria; Ines Richter; Hans-Josef Feistritzer; Nicolas Majunke; Steffen Desch; Thilo Noack; Holger Thiele; Mohamed Abdel-Wahab

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 Dumpies¹, MD; Ahmed Abdelhafez¹, MD; Johannes Rotta detto Loria¹, MD; Ines Richter¹, MD; Hans-Josef Feistritzer¹, MD; Nicolas Majunke¹, MD; Steffen Desch¹, MD; Thilo Noack², MD; Holger Thiele¹, MD; Mohamed Abdel-Wahab¹, MD

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.

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com