Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure device failure during transcatheter aortic valve replacement.

OBJECTIVES: Our aim was to describe our experience with the use of an ePTFE-covered nitinol self-expanding stent graft (GORE® VIABAHN® Endoprosthesis, Gore Medical, USA) placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR).

BACKGROUND: Access site-related vascular complications (VC) following sheath removal related to pre-closure device failure during TAVR are common and treatment options may vary.

METHODS: We performed an observational study on a series of consecutive patients who underwent TAVR between 2013 and 2015.

RESULTS: Included were 25 patients at a mean (±SD) age of 82±9. Failure of the closure device resulted in overt bleeding in 19 patients, dissection or no flow in 5 patients, and angiographic pseudoaneurysm in 1. Overall 29 stents were deployed with diameters ranging from 8 to 11mm and a length of 50mm (26, 90%). All stent-graft deployments achieved complete hemostasis of the arteriotomy site and resulted in normal flow to the distal vessels. None of the patients required open surgical repair. The mean hemoglobin drop was 2.6±1.3g/dl. Blood transfusions were used in 15 (60%) patients. Acute kidney injury occurred in 4 (16%) patients, none of whom was treated with dialysis. Length of hospital stay was 9±5days. All patients survived during a 30-day follow-up period, and none had VC related to the stented site.

CONCLUSIONS: The use of an ePTFE-covered Nitinol self-expanding stent graft is a feasible, safe, and effective treatment modality for access site-related VC following TAVR.

SUMMARY: The use of an ePTFE-covered nitinol self-expanding stent graft placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR) is described in 25 patients. Its use was found to be feasible, safe, and an effective treatment modality for access site-related vascular complications following TAVR.