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Published on: December 23, 2022
Outcomes of two suture-mediated closure devices for transfemoral percutaneous access endovascular aortic procedures
Baban Assaf1, Nikolaos Tsilimparis1, Jan Stana1
1Department of Vascular Surgery, University Hospital LMU of Munich, Munich, Germany.
Background:
This study aimed to investigate the effectiveness of percutaneous approach and compare two suture-mediated closure devices, the older generation Pergolide™ and newer generation ProStyle™ (Abbott Cardiovascular, Lake County, Chicago, IL, USA) in patients undergoing endovascular aortic repair.
Methods:
A retrospective, single-center, comparative study on consecutive patients undergoing endovascular aortic procedures from January to November 2022 was undertaken. Arterial calcification was assessed using the peripheral artery calcification scoring system (PACSS). Closure device technical success without the need for open surgical conversion was defined as the primary endpoint. Secondary endpoints were access vessel complications (bleeding, hematoma, vessel occlusion or high-grade stenosis and pseudoaneurysm) and the need for additional closure devices to achieve hemostasis. Logistic regression was used to identify confounders; results are presented as odds ratio (OR) and 95% confidence intervals (CIs).
Results:
Between January and November 2022, 147 patients (mean age 71±10 years; 77.6% males) underwent percutaneous endovascular aortic repair. A total of 237 vessels were punctured, 63.3% were treated with ProGlide™ and 36.7% with ProStyle™. Technical success of closure devices was 91.6% (ProGlide™ 94% vs. ProStyle™ 87.4%, P=0.091). Severe vessel calcification (PACSS 3-4) significantly reduced success rates (81% vs. 95.4%, P=0.001). Major complications occurred in 8.4% of cases, with higher rates in severely calcified vessels (P=0.006) and larger sheath sizes (P=.008). Multivariate analysis identified the number of closure devices used per vessel as the sole independent predictor of technical failure (OR 0.11, 95% CI 0.03-0.36, P=0.001). Additional devices were required in 35.9% of cases, influenced by prior surgery and sheath size.
Conclusions:
Both the older generation ProGlide™ and newer generation ProStyle™ closure devices demonstrated high technical success rates with few access vessel complications. Severe calcification and large sheath sizes could potentially impact technical success negatively.
