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.

Endovascular Aortic Repair Follow up Protocol Based on Contrast Enhanced Ultrasound Is Safe and Effective.

OBJECTIVES: The aim of this study was to define the safety and effectiveness of a contrast enhanced ultrasound (CEUS) based follow up for endovascular aortic repair (EVAR) surveillance at a mid-term period (4 years). METHODS: At the tertiary referral centre EVAR surveillance was based on plain abdominal radiograph and duplex ultrasound (CDU), with computed tomography angiography (CTA) reserved for any non-diagnostic imaging during the period 1999-2011 (Group A). From 2012, CEUS was performed when (a) any endoleak was detected at CDU, (b) sac growth > 5 mm within 6 months, and routinely for (c) patients with renal insufficiency (above Stage 3 chronic kidney disease), or (d) iodine contrast allergy (Group B). RESULTS: A total of 880 patients (mean age 75.6 ± 8.4 years; 824 male) who underwent EVAR between 1999 and 2015 and with a minimum of 1 year follow up were included. Six hundred and nineteen patients were in Group A (70%) and the remaining 261 in Group B (30%). Median follow up was 48 months (interquartile range 24-84). During the study period 318 CEUS scans were performed with no related complications. Indications for CEUS were the following: (a) 160 (50%) endoleak presence, (b) 34 (11%) significant sac expansions, (c) 91 (29%) renal insufficiency (Stage 3 or above CKD), and 33 (10%) iodine contrast allergies. CEUS was compared with CTA, with additional confirmation by angiographic and operative findings in the case of repair in the first 100 patients. CEUS had 100% sensitivity and 100% specificity in classifying endoleaks. No differences in endoleak, re-interventions and sac shrinkage percentage were seen between the two groups at 4 years. A 4 year analysis of CTA use found a 90% reduction with the introduction of CEUS. CONCLUSIONS: The introduction of a CEUS based protocol for EVAR follow up was safe and effective and it was similar to the previous CTA based follow up protocol with regard to identification of endoleaks in a mid-term period. Moreover, CEUS allowed for 90% reduction of CTA, thereby decreasing radiation exposure for patients.

Intra-arterial injection of iloprost reduces the risk of early recoil after balloon angioplasty of below-the-knee vessels in patients with critical limb ischemia.

BACKGROUND: Previous studies demonstrated that early recoil is frequently observed in patients undergoing balloon angioplasty. The aim of this study was to evaluate the impact of intra-arterial administration of iloprost (Endoprost®, Italfarmaco S.p.A., Milan, Italy) on early elastic recoil after balloon angioplasty of below-the-knee (BTK) vessels in patients with critical limb ischemia (CLI). METHODS: Between January 2015 and December 2015 32 patients with CLI underwent balloon angioplasty of at least one BTK vessel followed by intra-arterial administration of iloprost. Early elastic recoil was defined as residual lumen compromise >10%. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after BTK balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). RESULTS: Patients were predominantly female (18/32, 56.2%) with a mean age of 79.6 years (range 68-87). Most of the patients were diabetics (25/32, 78.1%). An occlusion was present in 24 cases (75%). Mean BTK lesion length was 144.1 mm (range 22-320). Mean MLD measurements were 0.1 mm (range 0-0.5; MLDbaseline), 2.5 mm (range 1.9-3; MLDpostdilation), and 1.9 mm (range 0.7-3; MLD15min). Early elastic recoil was recorded in 14 patients (43.8%). The mean percentage of elastic recoil after 15 minutes was 21.4%. CONCLUSIONS: In our experience intra-arterial administration of iloprost reduces the risk of early elastic recoil after balloon angioplasty of BTK vessels in patients with CLI. Further analyses with larger population studies and randomized trials are needed to validate this therapeutic option.

Long-term analysis of standard abdominal aortic endovascular repair using different grafts focusing on endoleak onset and its evolution.

OBJECTIVE: To report long-term results of standard EVAR focusing on endoleak onset (ELo) and its evolution. METHODS: 880 EVARs using different stentgrafts (1999-2015) were included. Primary outcomes were all-cause mortality and AAA-related mortality. Timing of ELo after EVAR was categorized as follows: ELo1 = 0-2 years, ELo2 = 2-4 years, ELo3 = 4-6 years, ELo4 = 6-8 years, and ELo5 ≥ 8 years. The rate of sac shrinkage/sac expansion and the need to re-intervene were the variables considered to determine EL evolution. RESULTS: Median follow-up was 60 months (IQR: 36-84). Summary follow-up index was 0.99. Survival rate was 94.5% at 2 years, 57.7% at 10 years, 33.3% at 14 years. Freedom from AAA-related-death rate was 99.3% at 14 years. Freedom from endoleak was 86.4% at 2 years, 68.3% at 10 years, and 48.6% at 14 years. EL rate was 1.9% (n = 19),16.6% (n = 146), 0.8% (n = 7), and 0.4% (n = 4) for type I, II, III and IV, respectively. Only type II EL showed a significant difference in the ELo (Elo1 = 31%; ELo2 = 12.8%; ELo3 = 9.4%; Elo4 = 10.2%; Elo5 = 11.4%; P < .001). Sac shrinkage occurred in 791 (90%) patients while 89 (10%) had a persistent sac expansion at the last follow-up. Freedom from reintervention was 95.6% at 2 years, 86.4% at 10 years, and 80% at 14 years. 48 out of 176 (27.2%) patients with EL underwent reintervention. The re-intervention rate was significantly higher within the first two years of follow-up if compared to the following years (17.6% vs. <10%; P < .001). CONCLUSIONS: An active lifelong surveillance follow-up can guarantee good long-term EVAR outcomes. Reinterventions and type II EL were more frequent in the first two-year of follow-up.

Freeway paclitaxel-releasing balloons to treat recurrent stenosis of arteriovenous fistula in hemodialysis patients.

BACKGROUND: To evaluate early and mid-term outcomes of Freeway paclitaxel-releasing balloons (Eurocor GmbH, Bonn, Germany) in hemodialysis patients with recurrent stenosis of arteriovenous fistula. METHODS: Between July 2013 and December 2016 27 hemodialysis patients with recurrent stenosis of arteriovenous fistula underwent endovascular treatment with a Freeway balloon. About inclusion criteria, all patients were previously treated at the target lesion with a standard balloon angioplasty (BA). The intervals in months between standard BA and procedure with DCB (time BA-DCB) and between procedure with DCB and new restenosis (time DCB-restenosis) were evaluated and compared with T-test. 2-year estimated outcomes in terms of survival, primary patency, primary assisted patency, secondary patency, and freedom from target lesion restenosis (TLR) were assessed with Kaplan-Meier curves. RESULTS: Technical success was obtained in 96.3% of the cases. During the follow-up (mean duration 13.6 months, range 1-33) 13 patients (48.1%) had a new restenosis. Mean time BA-DCB was 4.8 months, and the mean time DCB-restenosis was 7.6 months with a statistically significant difference at T-test (P<0.001). Estimated 2-year rates of primary patency, primary assisted patency, secondary patency, and freedom from TLR were 31.8%, 76.4%, 90.5%, and 30.2%, respectively. CONCLUSIONS: In our experience Freeway paclitaxel-releasing balloons were effective in the treatment of recurrent stenosis in hemodialysis patients previously treated with standard BA. At follow-up about half of patients had no new target lesion restenosis and the time to a new restenosis was much longer compared to recurrence of stenosis after standard BA.

Drug-coated balloons reduce the risk of recurrent restenosis in arteriovenous fistulas and prosthetic grafts for hemodialysis.

BACKGROUND: Aim of this study was to evaluate the early and mid-term outcomes of drug-coated balloons (DCBs) in hemodialysis patients with recurrent stenosis of arteriovenous fistula and previously treated with plain balloon angioplasty (PBA). METHODS: Between July 2013 and June 2016 38 hemodialysis patients with recurrent stenosis of arteriovenous fistula underwent endovascular treatment with a DCB at our center. All patients were previously treated at the target lesion with a PBA. The intervals in months between the standard PBA and the procedure with DCB (time PBA-DCB) and between the procedure with DCB and the restenosis at the target lesion (time DCB-restenosis) were evaluated and compared with T-test. Estimated outcomes at 2 years in terms of patient survival, primary patency, primary assisted patency, secondary patency, and freedom from target lesion restenosis were assessed with Kaplan-Meier curves. RESULTS: Intraprocedural technical success was obtained in 97.4% of the cases. During the follow-up (mean duration 14.3 months, range 2-33) 19 patients (50%) developed a restenotic lesion at the target lesion with an estimated 2-year freedom from target lesion restenosis of 32.8%. Mean time PBA-DCB was 6.4 months, and the mean time DCB-restenosis was 7.9 months with a statistically significant difference at T-test (P<0.001). Estimated 2-year rates of primary patency, primary assisted patency, and secondary patency were 40.8%, 73.1%, and 82.5%, respectively. CONCLUSIONS: In our experience DCBs were safe and effective in the treatment of recurrent stenosis in patients with failing arteriovenous fistula. The time to restenosis at the target lesion was longer respect to that necessary to have a recurrent restenosis after PBA.

The role of infrainguinal bypass surgery in the endovascular era.

The current worldwide trend in the treatment of peripheral arterial disease (PAD) is towards an increase in endovascular procedures either in the aorto-iliac area or in the infrainguinal district. However, the role of the open repair with a femoro-popliteal bypass is still debated and in our opinion there still a room for traditional surgery in the presence of complex lesions involving the superficial femoral artery and the popliteal and tibial vessels. In this field, vein bypass provides better results than prosthetic grafts, but in selected cases and not only in the absence of a suitable vein, new modified grafts may be used with satisfactory results. The choice between the two options, open and endovascular, that in some cases can be associated in hybrid procedures, depends on several factors. Only if we are able to take into account all the different preoperative issues, we could choose the right procedure in the right patient.