Influence of pedal arch quality on 5-year survival and limb salvage in patients with diabetic foot ulcers undergoing peripheral angiography.

INTRODUCTION: The aim of this study was to evaluate the influence of pedal arch quality on 5-year survival and limb salvage in diabetic patients with foot wounds undergoing peripheral angiography. METHODS: Between January 2014 and December 2014, 153 diabetic patients with foot wounds underwent peripheral angiography. Final foot angiograms were used to allocate patients according to pedal arch: complete pedal arch (CPA), incomplete pedal arch (IPA), and absent pedal arch (APA). Five-year survival and limb salvage rates were analyzed with Kaplan-Meier curves and compared by means of Gehan-Breslow-Wilcoxon test. Associations of patient and procedure variables with overall survival and limb salvage outcomes were sought with univariate and multivariate analyses. RESULTS: A below-the-knee (BTK) artery was the target vessel in 80 cases (52.3%). Five-year Kaplan-Meier rates of survival were similar in all groups (p = 0.1): CPA 30%, IPA 27.5%, and APA 26.4%. Five-year limb salvage rates were significantly better in patients with CPA/IPA (p < 0.001): CPA 95.1%, IPA 94.3%, and APA 67.3%. In the whole population study, multivariate analysis showed significant association of smoking (p = 0.01), chronic renal failure (p = 0.02), and severity of foot wounds (p < 0.001) with survival. Coronary artery disease (p = 0.03), severity of foot wounds (p = 0.001), and pedal arch status (p = 0.05) showed strong association with limb salvage. CONCLUSIONS: Pedal arch quality significantly affected limb salvage but not survival at 5 years in patients with diabetic foot ulcers. Smoking, chronic renal failure, and severity of foot wounds affected overall survival, whilst coronary artery disease, and severity of foot wounds limb salvage.

Benefits and Role of Carbon Dioxide Angiography in Case of Misalignment Between Fenestration and Target Vessel During Fenestrated Endovascular Aneurysm Repair.

PURPOSE: To report the benefits and the role of carbon dioxide (CO2) angiography in case of misalignment between fenestration and target vessel during fenestrated endovascular aneurysm repair (F-EVAR). TECHNIQUE: During F-EVAR, misalignment between fenestration and target vessel is a potentially catastrophic complication. In 2 patients, we experienced that one of the target vessels were not visible during standard angiography in different projections after positioning a fenestrated graft and even after cannulation of the corresponding fenestration. In both cases, the graft was sealed to the aortic wall but not in the predictable position. Consequently, acute occlusion of the target vessel was hypothesized. However, CO2 angiography was useful to evaluate patency of the target vessel clarifying the relative position of the fenestration versus the target vessel. Rescue maneuvers were feasible under the guidance of CO2 angiography in order to obtain the cannulation of both renal arteries. In both cases, the procedure was successfully accomplished. CONCLUSION: In case of misalignment of a fenestration during F-EVAR and non-visualization of the target vessel with standard angiography, CO2 angiography could have the unique and complementary role of clarifying the patency and position of the target vessel. In addition, CO2 could guide the rescue maneuvers.

Timing to Carotid Endarterectomy Affects Early and Long Term Outcomes of Symptomatic Carotid Stenosis.

BACKGROUND: The aim of this study is to evaluate early and long-term outcomes according to the timing to carotid endarterectomy (CEA) of symptomatic carotid stenosis. METHODS: Consecutive CEAs with selective shunting for symptomatic carotid stenosis ≥50% performed between 2009 and 2020. Patients had acute neurological impairment on presentation, defined as <5 points on the National Institutes of Health Stroke Scale (NIHSS). We grouped patients according to time between index event and CEA: the first group was operated between 0 and 2 days, the second group between 3 and 7 days, the third group between 8 and 14 days and the last group after 15 days. Thirty-day neurological status improvement was defined as a decrease (≥1) in the 30-day NIHSS score versus NIHSS score immediately before surgery. RESULTS: Five hundred CEAs were performed. The perioperative combined stroke and mortality rate was 3.6% (18/500), representing a perioperative mortality rate of 0.2 (n = 1) and stroke rate of 3.4% (n = 17). Overall freedom from stroke was 95% at 1 year, 89 % at 6 years, and 88% at 10 years. Annual stroke rate was 0.6% after the 30-day period. Thirty-day improvement in neurologic status occurred in 103 patients (20.6%), while in 380 (76%) neurologic status was unchanged, and 17 (3.4%) experienced worsening of their neurologic status. Patients treated within 7 days from the index event had significant benefit (OR = 2.6) in the 30-day neurological improvement versus those treated after 7 days from the index event. Timing to CEA <2 days increased significantly the risk of late stroke (OR = 9.7). CONCLUSIONS: The ideal timing for performing CEA is between 3 and 7 days from the index event if NIHSS <5 as it is associated with the best rates of improvement in neurological status and durability in the long term. Very early CEA (<48 hrs) was associated with increased late stroke occurrence.

Staged in situ aorto-iliac hybrid technique: an original technique to treat complex juxtarenal and iliac aneurysms.

BACKGROUND: To report a novel staged hybrid technique to treat complex juxtarenal abdominal aortic aneurysm (JAAA) associated with at least one iliac artery aneurysm (IA) with no adequate distal fixation zone. METHODS: The novel technique herein described has two main "staged" steps. The first step consists in creating an adequate distal fixation zone by endovascular means; after hypogastric embolization an iliac stent-graft has placed from 5 mm above the aortic bifurcation to the external iliac artery. The second step is the surgical resection of the JAAA and graft placement sutured distally to the stent-graft which was always performed the day after. RESULTS: The five cases included (mean age 74 years), were rejected for fenestrated or branched endovascular aortic repair or iliac branch devices. Four tube grafts and one aorto-bi-iliac graft were sutured to one stent-graft (N.=3), two stent-grafts in iliac kissing configuration (N.=1) and to a main body of a bifurcated stent-graft (N.=1). Mean follow-up duration was 14 (4-27) months with no mortality. Technical success was obtained in all cases (2 suprarenal clamping). Postoperative complications included two pleural effusions, two transient gluteal intermittent claudications, and one renal failure. CONCLUSIONS: The technique herein described seems to be a feasible and cost-effective alternative treatment for selected concomitant complex JAAAs and IAs unsuitable for totally endovascular treatment.

Tight systolic blood pressure control with combination therapy decreases type 2 endoleaks in patients undergoing endovascular aneurysm repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) has revolutionized the treatment of abdominal aortic aneurysm (AAA) disease. However, the survival advantage is lost in the long term due the occurrence of endoleaks affecting the late rupture of aneurism sac. Few data are available on the role of blood pressure control in affecting the incidence of type 2 endoleaks in patients undergoing EVAR. OBJECTIVE: Aim of this study was to evaluated whether systolic blood pressure (SBP) control to target 130 mmHg reached after preoperative cardiology consultant might decrease the incidence of type II endoleak(T2E), sac expansion and related aortic reintervention after elective endovascular aneurysm repair(EVAR). METHODS: We analyzed 386 patients undergoing EVAR between 2008 and 2016. The primary endpoints were T2E, sac expansion and related aortic re-intervention or sac shrinkage during a median follow-up of 24 months [12-48]. The secondary endpoint was every cause of vascular or cardiac morbidity and mortality. RESULTS: The SBP value of 130 mmHg at the time of EVAR resulted, at ROC curve analysis, the most sensitive and specific for all the analyzed endpoints (T2E, n = 74; sac expansion n = 19; re-intervention, n = 10, sac shrinkage, n = 72). The combination antihypertensive therapy showed a significant inverse relationship with T2E occurrence. The incidence of primary endpoints was significantly higher (p < 0.001) in patients with SBP ≥ 130 mmHg. Cardiovascular death was significantly more prevalent (p < 0,001) in patients with SBP ≥130 mmHg. These findings were confirmed at the multivariable Cox regression analysis [primary endpoint HR = 0.09(0.06-0.15), p < 0.001; cardiovascular death HR = 0.33(0.12-0.85), p = 0.023]. CONCLUSIONS: Tight SBP control at the target of 130 mmHg at the time of elective EVAR significantly decreases TE2 occurrence, need of re-intervention and cardiovascular death in a prolonged follow-up of a large sample of patients.

Impact of Pedal Arch Patency on Tissue Loss and Time to Healing in Diabetic Patients with Foot Wounds Undergoing Infrainguinal Endovascular Revascularization.

Objective: To retrospectively evaluate the impact of pedal arch quality on tissue loss and time to healing in diabetic patients with foot wounds undergoing infrainguinal endovascular revascularization. Materials and Methods: Between January 2014 and June 2015, 137 consecutive diabetic patients with foot wounds underwent infrainguinal endovascular revascularization (femoro-popliteal or below-the-knee, arteries). Postprocedural angiography of the foot was used to divide the patients into the following three groups according to the pedal arch status: complete pedal arch (CPA), incomplete pedal arch (IPA), and absent pedal arch (APA). Time to healing and estimated 1-year outcomes in terms of freedom from minor amputation, limb salvage, and survival were evaluated and compared among the three groups. Results: Postprocedural angiography showed the presence of a CPA in 42 patients (30.7%), IPA in 60 patients (43.8%), and APA in 35 patients (25.5%). Healing within 3 months from the procedure was achieved in 21 patients with CPA (50%), 17 patients with IPA (28.3%), and in 7 patients with APA (20%) (p = 0.01). There was a significant difference in terms of 1-year freedom from minor amputation among the three groups (CPA 84.1% vs. IPA 82.4% vs. APA 48.9%, p = 0.001). Estimated 1-year limb salvage was significantly better in patients with CPA (CPA 100% vs. IPA 93.8% vs. APA 70.1%, p < 0.001). Estimated 1-year survival was significantly better in patients with CPA (CPA 90% vs. IPA 80.8% vs. APA 62.7%, p = 0.004). Conclusion: Pedal arch status has a positive impact on time to healing, limb salvage, and survival in diabetic patients with foot wounds undergoing infrainguinal endovascular revascularization.

Carbon-coated self-expandable stents in patients with atherosclerotic iliac artery disease.

BACKGROUND: The aim of this study was to evaluate the safety and effectiveness of carbon-coated self-expandable stents in the revascularization of atherosclerotic iliac artery lesions. METHODS: Between January 2012 and June 2016 54 carbon-coated self-expandable stents (Easy HiFlype and Easy Flype; manufactured by CID S.p.A., a member of Alvimedica Group, Istanbul, Turkey) in 40 patients were implanted in our Center. Early and 2-year outcomes have been evaluated in terms of major morbidity, mortality, primary patency, primary assisted patency, secondary patency, absence of target lesion restenosis (TLR), healing of the lesions/relief of symptoms, and limb salvage. RESULTS: The patients were predominantly males (32/40, 80%) with a mean age of 71 years (range 46-94). One patient (2.5%) had a documented nickel allergy. Mean duration of follow-up was 13.9 months (range 1-48). At 30 days no patient died and 1 patient underwent surgical revision of percutaneous femoral access. The estimated 2-year primary patency, primary assisted patency, secondary patency, absence of TLR, and limb salvage were 92.8%, 93.1%, 95.7%, 79.5%, and 100%, respectively. At univariate analysis none of the pre- or intra-operative factors significantly affected the primary and primary assisted patency rates. Secondary patency was significantly affected by absence of post-stent balloon dilatation (P=0.003). Absence of TLR was significantly affected by age more than 80 years (P=0.01) and common iliac artery lesions (P=0.02). These significances were confirmed at Cox regression analysis. CONCLUSIONS: Use of carbon-coated self-expandable stents in atherosclerotic iliac lesions was safe and effective. At 2 years, the patency rates and the absence of TLR were encouraging. Post-stent balloon dilatation should be recommended in all cases. Older patients and common iliac artery lesions were risk factors for restenosis in the mid-term period.

Pedal arch patency and not direct-angiosome revascularization predicts outcomes of endovascular interventions in diabetic patients with critical limb ischemia.

BACKGROUND: The aim of this study was to evaluate the impact of pedal arch status and direct-angiosome revascularization (DAR) on clinical outcomes in diabetic patients with foot wounds undergoing endovascular revascularization. METHODS: Between January 2014 and June 2015, 93 diabetic patients with foot wounds underwent endovascular revascularization of at least one below-the-knee vessel. Patients were divided into three groups according to the pedal arch status: complete pedal arch (CPA), incomplete pedal arch (IPA) and absent pedal arch (APA). Healing within 3 months and 1-year outcomes in terms of freedom from minor amputation, limb salvage, and survival were evaluated on the basis of DAR and pedal arch status. RESULTS: DAR did not affect healing within 3 months from the procedure (DAR, 13/55 cases, 23.6% vs. n-DAR, 9/38 cases, 23.7%; P=1), estimated 1-year freedom from minor amputation (DAR 74.4% vs. n-DAR 76.8%, P=0.80), limb salvage (DAR 88.2% vs. n-DAR 89.5%, P=0.44), and survival (DAR 83.3% vs. n-DAR 66.6%, P=0.15). Pedal arch had positive impact on wound healing within 3 months from the procedure (CPA 45.8% vs. IPA 12.5% vs. APA 20.7%, P=0.009), estimated 1-year limb salvage (CPA 100% vs. IPA 90.9% vs. APA 76.1%, P=0.02), and 1-year survival (CPA 100% vs. IPA 87.2% vs. APA 60.3%, P=0.02). CONCLUSIONS: DAR is not a predictor of good outcomes in diabetic patients undergoing endovascular procedure. Pedal arch patency seems to be a key factor to obtain good outcomes in terms of wound healing, and limb salvage.

Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study.

PURPOSE: To report the 3-year safety and effectiveness outcomes from the prospective all-comers DEBATE-ISR study (ClinicalTrials.gov identifier NCT01558531) of symptomatic diabetic patients with femoropopliteal in-stent restenosis (ISR) undergoing treatment with paclitaxel-eluting balloons compared with historical diabetic controls. METHODS: From January 2010 to December 2011, 44 consecutive diabetic patients (mean age 74±11 years; 32 men) were treated with drug-eluting balloons (DEBs) and enrolled in the study. The control group comprised 42 consecutive diabetic patients (age 76±7 years; 23 men) treated with conventional balloon angioplasty (BA) from 2008 to 2009. RESULTS: No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Critical limb ischemia was present in the majority of patients. Tosaka class III ISR was observed in more than half of the patients. Mean lesion length was 132±86 and 137±82 mm in the DEB and BA groups, respectively (p=0.7). At 3-year follow-up, the rate of target lesion revascularization (TLR) was 40% in the DEB group vs 43% in the BA group (p=0.8); Kaplan-Meier analysis showed no significant differences in terms of freedom from TLR. The presence of a Tosaka class III occlusion was associated with a worse outcome in both study groups (odds ratio 3.96, 95% confidence interval 1.55 to 10.1, p=0.004). CONCLUSION: Using DEBs for femoropopliteal ISR yielded similar results to BA in terms of TLR at 3-year follow-up. The treatment of more complex ISR lesions was associated with an increased rate of TLR, irrespective of the technology used.

Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study.

PURPOSE: To test the ability of a drug-eluting balloon (DEB) to reduce recurrent in-stent restenosis (ISR) in diabetic patients with femoropopliteal stents. METHODS: A prospective all-comers study [Drug-Eluting Balloon in Peripheral Intervention for In-Stent Restenosis (DEBATE-ISR); ClinicalTrials.gov identifier NCT01558531] of symptomatic diabetic patients with femoropopliteal ISR undergoing treatment with paclitaxel-eluting balloons was designed to compare their 12-month recurrent restenosis rate with that of historical diabetic controls. From January 2010 to December 2011, 44 consecutive diabetic patients (32 men; mean age 74±11 years) were treated with DEBs and enrolled in the study. The control group comprised 42 diabetic patients (23 men; mean age 76±7 years) treated with a conventional balloon for femoropopliteal ISR from 2008 to 2009. RESULTS: No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Lesion length was 132±86 mm in the DEB group vs. 137±82 mm in the BA group. Procedural success, defined as a residual stenosis <30% in the restenotic segment (stent +5 mm at proximal and distal edges), was obtained in all treated lesions. At 1-year follow-up, 6 patients died (3 in each group), and 1 patient in the BA group underwent major amputation. Recurrent restenosis, assessed by angiography (66%) or ultrasound (34%), occurred in 8/41 (19.5%) patients in the DEB group vs. 28/39 (71.8%) in the BA group (p<0.001). Target lesion revascularization for symptomatic recurrent restenosis was performed in 6/44 (13.6%) patients in the DEB vs.13/42 (31.0%) in the BA group (p=0.045). CONCLUSION: Using DEB for treating femoropopliteal ISR led to a significant reduction in recurrent restenosis and repeat angioplasty at 1-year follow-up as compared to historical controls.

Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery).

OBJECTIVES: This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis. BACKGROUND: PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma. METHODS: A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach. RESULTS: Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach. CONCLUSIONS: Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).

Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia.

BACKGROUND: The 1-year restenosis rate after balloon angioplasty of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy of a paclitaxel drug-eluting balloons versus conventional percutaneous transluminal angioplasty (PTA) for the reduction of restenosis in diabetic patients with critical limb ischemia undergoing endovascular intervention of below-the-knee arteries. METHODS AND RESULTS: The Drug-Eluting Balloon in Peripheral Intervention for below the knee angioplasty evaluation (DEBATE-BTK) is a randomized, open-label, single-center study comparing drug-eluting balloons and PTA. Inclusion criteria were diabetes mellitus, critical limb ischemia (Rutherford class 4 or higher), significant stenosis or occlusion >40 mm of at least 1 below-the-knee vessel with distal runoff, and life expectancy >1 year. Binary in-segment restenosis at a 1-year angiographic or ultrasonographic follow-up was the primary end point. Clinically driven target lesion revascularization, major amputation, and target vessel occlusion were the secondary end points. One hundred thirty-two patients with 158 infrapopliteal atherosclerotic lesions were enrolled. Mean length of the treated segments was 129±83 mm in the drug-eluting balloon group compared with 131±79 mm in the PTA group (P=0.7). Binary restenosis, assessed by angiography in >90% of patients, occurred in 20 of 74 lesions (27%) in the drug-eluting balloon group compared with 55 of 74 lesions (74%) in the PTA group (P<0.001); target lesion revascularization, in 12 (18%) versus 29 (43%; P=0.002); and target vessel occlusion, in 12 (17%) versus 41 (55%; P<0.001). Only 1 major amputation occurred, in the PTA group (P=0.9). CONCLUSIONS: Drug-eluting balloons compared with PTA strikingly reduce 1-year restenosis, target lesion revascularization, and target vessel occlusion in the treatment of below-the-knee lesions in diabetic patients with critical limb ischemia.

[Clinical outcome of percutaneous revascularization by stent-assisted balloon angioplasty of femoro-popliteal and tibial vessels in diabetic patients with critical limb ischemia]. / Efficacia clinica del trattamento percutaneo mediante angioplastica e provisional stenting dei vasi femorali, poplitei e tibiali in pazienti diabetici con ischemia critica dell'arto.

BACKGROUND: The aim of this study was to assess the long-term clinical outcome of percutaneous peripheral interventions in diabetic patients with critical limb ischemia (CLI) in terms of occurrence of major amputation and mortality. METHODS: From January 2004 to December 2007, all diabetic patients undergoing peripheral angiography and percutaneous revascularization for the presence of CLI were enrolled in this registry and followed prospectively. Limb salvage, mortality, and repeat revascularization were reported at long term. RESULTS: 267 diabetic patients (mean age 72.2 +/- 9.6 years) with 290 ischemic limbs represent the study population. Hypertension was present in 227 patients (85%), hypercholesterolemia in 85 (32%), chronic renal failure in 61 (23%). Ischemic heart disease was present in 80 patients (30%), carotid disease in 75 (28%). According to the Texas Diabetic Ulcers Classification, 203 patients (70%) had type CIII lesion, 29 (10%) CII, 9 (3%) CI, 20 (7%) DIII, 23 (8%) DII, and 6 (2%) DI; 440 lesions (169 tibial arteries, 261 femoro-popliteal arteries, and 10 iliac arteries) were dilated with stent implantation in 290 of them (66%). The procedure was successful in 415 (94%) with restoration of direct flow in at least one tibial artery. The ankle-brachial index was 0.32 +/- 0.11 before procedure and increased to 0.77 +/- 0.23 (p<0.001). One patient died suddenly during hospital stay. Mean follow-up length was 17 +/- 11 months. Of the 290 limbs, major amputation was necessary in 17 (6%) of which 10 had an unsuccessful procedure. Amputation was fatal in 7 cases (41%). Complete foot lesion healing was obtained in 238 (82%) and partial healing in 35 (12%). Death occurred in 42 patients (16%) and it was related to cardiac events in 16 (6%), cerebrovascular events in 8 (3%), acute renal failure in 8 (3%), and cancer in 10 (4%). Repeat revascularization occurred in 67 patients (23%) in the target limb and in 29 (11%) in the contralateral limb. CONCLUSIONS: Peripheral angioplasty with stent implantation is an effective procedure for limb salvage in diabetic patients with CLI. The high mortality is probably related to the systemic atherosclerosis process with involvement of coronary and cerebral circulation that leads to heart and cerebral fatal ischemic events.