Outcomes Analysis of 677 Cases from the Multicenter Italian Registry on Primary Endovascular Treatment of Iliac and Aorto-Iliac Arteries Obstructive Disease (Iliacs Registry)

Introduction - Endovascular revascularization has become the first-line strategy for iliac obstructive lesions (IOL), and also used increasingly as an alternative to conventional surgery for complex aorto-iliac obstructive disease (AIOD). Owing to the good results resembling those of open sur- gery, an endovascular-first strategy have been considered for complex AIOD even in the most recent guidelines if done by an experienced team and if it does not compromise subsequent surgical options. The aim of this study was to analyze the results of the endovascular treatment of IOL and AIOD in a multicenter Italian registry. Methods - Over a 3-year period, ending in December 2017, 677 treatments were performed for IOL and AIOD in eleven Italian hospitals and collected into a dedicated registry database. Intermittent claudication was an indication in 376 (55.5%) patients, whereas critical limb threatening ischemia in 298 (44.0%). Postoperative anti-thrombotic therapy was left at center’s discretion: follow-up evalua- tion was performed at 1, 6 and 12 months after the intervention. Early (<30 days) major end-points were mortality and major complications; late major end-point was freedom from reintervention. Early results were compared with the Chi-square test and the Wilcoxon’s signed rank test; follow-up results were analyzed with Kaplan-Meier survival estimates andcompared with log- rank test. Univariate and multivariate (forward Cox regression) analysis was used to identify potentially sig- nificantpredictors of need for reintervention. Results - We treated 511 (75.4%) males. Overall, mean age was 68 10 (range, 22-96; IQR, 62-76). Accordingly to the TASC II classification we treated 98 (14.5%) type A, 163 (24.1%) type B, 164 (24.2%) type C, and 248 (36.6%) type D lesions: stenoses were 370 (56.2%) and occlusions were 288 (43.8%). We used a totally percutaneous approach in 473 (69.9%): hybrid intervention was carried out in 204 (30.1%) patients, mostly with femoral endarterectomy plus patch plasty. A covered stent was implanted in 207 (30.6%) cases. Overall, a kissing-stent configuration was performed in 243 (36.1%) lesions. Primary technical success was ob- tained in 671 (99.3%) cases: earl mortality occurred in 3 (0.4%) cases, and postoperative complication was observed in 51 (7.5%) patients. Mean ankle-brachial index improved significantly from preoperative to postoperative period (0.5 0.2 vs. 0.9 0.1, P < 0.001). Median hos- pitalization was 5 days (IQR, 2-7). Early thrombosis, major amputation, and mortality was observed in 10 (1.5%), 3 (0.5%), and 4 (0.6%) cases, respectively. During the follow- up 21 (3.1%) died: the estimated survival was 96.3% at 12 months (95%CI: 93.8-97.8) and 90.2% at 36 months (95% CI: 82.7-94.7). Follow-up thrombosis occurred in 17 (2.5%) cases. Estimated primary patency and freedom from rein- tervention was 96% (IC95%: 93.3-97.7) and 97.2% (95%CI: 94.5-98.6) at 12 months, and 95% (95%CI: 89.0-97.6) for both outcomes at 36 months. At Cox regression analysis, no pre/intra/or-postoperative parameters independently predicted loss of primary patency and need for reintervention. Conclusion - In this “real world” registry experience, endovascular revascularization showed to be safe and effective. No independent predictors were found to be associated with the need of reintervention thus indicating that endovascular revascularization for IOL and AOID can be an effective and durable first-line alternative even for the treatment of complex AOID