ABSTRACT
Objective: This work aims at providing novel endovascular instrumentation to overcome current technical limitations of in situ endograft fenestration including challenges in targeting the fenestration site under fluoroscopic control and supplying mechanical support during endograft perforation. Technology: Novel electromagnetically trackable instruments were developed to facilitate the navigation of the fenestration device and its stabilization at the target site. In vitro trials were performed to preliminary evaluate the proposed instrumentation for the antegrade in situ fenestration of an aortic endograft, using a laser guidewire designed ad hoc and the sharp end of a commercial endovascular guidewire. Results: In situ fenestration was successfully performed in 22 trials. A total of two laser tools were employed since an over bending of laser guidewire tip, due to its manufacturing, caused the damage of the sensor in the first device used. Conclusions: Preliminary in vitro trials demonstrate the feasibility of the proposed instrumentation which could widespread the procedure for in situ fenestration. The results obtained should be validated performing animal studies. Clinical Impact: The proposed instrumentation has the potential to expand indications for standard endovascular aneurysm repair to cases of acute syndromes.
ABSTRACT
OBJECTIVE: The aim of the study is to evaluate the safety and effectiveness of common femoral endarterectomy (CFE) in critical limb ischemia (CLI) associated with proximal and distal endovascular (EV) revascularization in diabetic (type 1 and type 2) and non-diabetic patients. PATIENTS AND METHODS: We analyzed patients from January 2008 to December 2011 who underwent one-staged hybrid procedures. Patients were divided into three groups: group 1 = EV reconstruction proximal to the CFE, group 2 = EV procedures distal to the CFE, group 3 = both proximal and distal EV procedures. Patients were evaluated at 6 and 36 months after the procedures, and the mean follow-up was 42 ± 20.3 months. RESULTS: A total of 43 (79% men; aged 74.4 ± 8.6 years) out of 635 (5.5%) patients operated for CLI fulfilled the inclusion criteria; 23 (53.5%) had type 1 or type 2 diabetes mellitus (DM). DM patients were younger than controls (p = 0.048). The patient distribution was 14 in Group 1 (32.5%), 24 in Group 2 (55.8%) and 5 in Group 3 (11.7%). CFE was successful in all cases, while associated EV procedures were successful in 90.7% of patients. Peri-operative morbidity and mortality were 11.6% and 2.3%, respectively. Survival rates at 6 and 36 months were 93% and 71.9%, respectively. Three patients (6.98%) underwent a major amputation. The cumulative limb salvage was 95.2% at 6 months and 92.1% at 36 months. No recurrent CFE stenosis was observed. No differences in survival, amputation or patency rates emerged between DM and non-DM patients or among the three EV revascularization groups. CONCLUSIONS: Hybrid procedures are safe and effective both in CLI patients with or without DM, and they should be taken into consideration whenever indications are present.
