Protein-based tissue adhesive reduces time to haemostasis in peripheral vascular surgery.

OBJECTIVES: The aim of this study was to evaluate the effectiveness of protein-based tissue adhesive (Bioglue®) in reducing time to haemostasis in patients undergoing peripheral vascular surgery. METHODS: From January to December 2021, 100 consecutive patients from 4 centres have been treated with open peripheral vascular surgery including upper and lower limb interventions. Patients have been allocated in each centre into control with no use of Bioglue® (Group no-Bio, 50 patients) or use of Bioglue® (Group Bio, 50 patients) by a block randomization method 10:10 until the required sample size was reached. Perioperative parameters including time to haemostasis, number of adjunctive stitches, and in-hospital bleeding have been analysed and compared in the two groups by means of mean independent-samples tT -test and Gehan-Breslow-Wilcoxon test. RESULTS: Both groups were homogeneous in terms of demographic data, preoperative risk factors, and preoperative medical therapy except for a higher percentage of active smokers in Group Bio (52% vs. 24%, p = 0.004). Femoral endarterectomy was most common in Group Bio (44% vs. 24%, p = 0.03), whilst the percentage of lower limb vein bypasses was higher in Group no-Bio (50% vs. 36%, p = 0.03). Bovine pericardium was the preferred material in Group Bio (20 cases, 40%), whilst autologous vein is mostly used in Group no-Bio (26 cases, 52%) (p = 0.01). Time to haemostasis was faster in Group Bio (4.4 vs. 9.6 minutes, p < 0.001). The need for adjunctive stitches was higher in Group no-Bio (8 cases, 16%, Group Bio vs. 25 cases, 50%, Group no-Bio; p < 0.001). The overall rate of in-hospital bleeding, including those requiring reintervention, was not different between the two groups (9 cases, 18%, Group Bio vs. 7 cases, 14%, Group no-Bio; p = 0.39). CONCLUSIONS: The protein-based tissue adhesive Bioglue® reduced time to haemostasis and need for adjunctive stitches in peripheral vascular surgery. However, it did not affect the overall rate of perioperative bleedings. Further studies with larger sample sizes are needed to validate these outcomes.

Reintervention rate after infrarenal aortic aneurysm repair is lower for open than endovascular repair with aneurysm sac shrinkage: a fifteen-year study.

BACKGROUND: The aim of this study was to report long-term results of infrarenal abdominal aortic aneurysm (AAA) in a single tertiary Hospital. METHODS: One thousand seven hundred seventy-seven consecutive AAA repairs (2003-2018) were included. Primary outcomes were all-cause mortality, AAA-related mortality, reinterventions rate. Open repair (OSR) was offered in case the patient had a functional capacity ≥4 metabolic equivalents (MET), and a predicted >10 year life expectancy. Endovascular repair (EVAR) was offered in case of hostile abdomen, presence of anatomic feasibility for standard endovascular graft, and <4 MET. Sac shrinkage was defined as a reduction of both anterior-posterior and latero-lateral diameter of the sac of at least 5 mm at the last follow-up vs. the first post- operative follow-up imaging. RESULTS: Eight hundred twenty-eight (47%) OSRs and 949 (53%) EVARs were performed 90.6% (N.=1610) were male, mean age was 73.8 years. Mean follow-up was 79 (SD: 51) months. 30-day mortality was 0.7% (N.=6) and 0.6% (N.=6) for OSR and EVAR respectively (P=1). Long-term survival was better for OSR as expected by the selection criteria used (P<0.001), while AAA-related death was similar in the OSR vs. EVAR group (P=0.37); 664 (70%) sac shrinkages occurred at the last follow-up in the EVAR group. Freedom from reintervention was 97% and 96% at 1 year, 96.5% and 88.4% at 5 years, 95.8% vs. 81.7% at 10 years, and 94.6% vs.72.3% at 15 years for OSR and EVAR, respectively (P<0.001). The reintervention rate was significantly lower in the sac shrinkage vs. no-sac shrinkage subgroup and but higher than the OSR (P≤0.001). Any statistical difference was found for the survival outcome in case of sac shrinkage (P=0.1). CONCLUSIONS: Open repair of an infrarenal AAA had a lower reintervention rate than EVAR even in case of a shrinked sac at a long-term follow-up. Further studies with greater sample size are needed.

Mills valvulotome reduces distal vein injuries and improves follow-up freedom from restenosis in patients undergoing infrainguinal in-situ saphenous vein bypass.

BACKGROUND: In this study, the early and mid-term outcomes of the use of the Mills valvulotome in patients with chronic limb-threatening ischemia (CLTI) undergoing infrainguinal in-situ saphenous vein bypass were investigated. METHODS: From January 2018 until December 2019, 153 consecutive CLTI patients from 7 centers have been treated with infrainguinal in-situ saphenous vein bypass. In all patients the devalvulation of the great saphenous vein (GSV) was obtained with the use of the HYDRO LeMaitre® valvulotome (LeMaitre Vascular, Burlington, MA, USA). Eighty-six patients (56.2%) received the additional treatment of the LeMills valvulotome (LeMaitre Vascular) to disrupt the distal valves of the GSV (Group MV), whilst in the remaining 67 patients (43.8%) this adjunctive device was not used (Group no-MV). Initial outcome measures including intraoperative vein injuries were assessed and compared. At 2-year follow-up, estimated outcomes of primary patency, primary assisted patency, secondary patency, freedom from distal vein restenosis, and limb salvage were analyzed using Kaplan-Meier curves and compared between groups using the log-rank test. RESULTS: Intraoperatively, the overall rate of vein injuries related to the devalvulation was 5.2% (8 cases) with four cases in both groups (4/86, 4.6%, Group MV vs. 4/67, 6%, Group no-MV; P=0.49). Overall, 4 lesions occurred in the distal portion of the GSV and were all reported in Group no-MV (0/86, 0%, Group MV vs. 4/67, 6%, Group no-MV; P=0.03). Median duration of follow-up was 12 months (IQR: 6-24). At 2-year follow-up there were no differences between the two groups in terms of primary patency (69.9% Group MV vs. 79.8% Group no-MV, P=0.08), primary assisted patency (85.4% Group MV vs. 90.5% Group no-MV, P=0.37), secondary patency (94.2% Group MV vs. 92.1% Group no-MV, P=0.61), and limb salvage (97.4% Group MV vs. 98.2% Group no-MV, P=0.74). Patients in Group MV had a higher rate of freedom from distal vein restenosis (92.2% Group MV vs. 76% Group no-MV, P=0.03). CONCLUSIONS: Adjunctive use of the Mills valvulotome (LeMaitre Vascular) reduces intraoperative distal vein injuries and improves the 2-year freedom from distal vein restenosis in patients undergoing infrainguinal in-situ saphenous vein bypass.

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.

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.

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.

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.

Outcomes of three types of native arteriovenous fistula in a single center.

OBJECTIVE: To study the outcomes of three different types of native arteriovenous fistula (AVF), the distal (D: radial-cephalic), middle-arm (MA: radial-cephalic) and proximal (P: brachial-cephalic) AVF access creation for hemodialysis patients in a single center. METHODS: An 8-year retrospective review, from 2006 to 2014, was conducted at a single institution in which the surgical outcomes for three different types of native AVF creation were reviewed. Preoperative duplex vein mapping was obtained in all patients to choose the best vein and site for access. RESULTS: There were 317 patients identified with 41 D-AVFs, 120 MA-AVFs and 156 P-AVFs. Younger patients with a lower Charlson's Index were more frequent in the D-AVF group (p = 0.02). Mean operating room time was 15 minutes longer for the MA-AVF group than the two others (p = 0.018). Early failure (thrombosis at 30-day), one-year patency, one-year primary AVF functional patency for the D-AVF, MA-AVF, and P-AVF groups were 2.4% (n = 1), 8% (n = 1), 3.8% (n = 6), (p = 0.14); 97.6% (n = 39), 99% (n = 117), 89% (n = 129), (p<0.001); 80.5% (n = 33), 75.8% (n = 91), and 61.5% (n = 96) (p<0.001), respectively. Reintervention for fistula maturation was required in 17% (n = 7), 23% (n = 28), and 24% (n = 38) (p<0.01). The one-year venipuncture hematoma and steal syndrome occurrences were 9.7% (n = 4), 6.7% (n = 8), 3.8% (n = 6) (p = 0.06); and 0%, 0% and 3.8% (n = 6) (p = 0.04), respectively. In case of failure of either MA-AVF or D-AVF, a P-AVF was always feasible as a second native AVF hemodialysis access. CONCLUSIONS: D-AVF is still the gold-standard access for hemodialysis. If D-AVF is not possible, MA-AVF should be always investigated before committing to a P-AVF.

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.

Hybrid simultaneous treatment of thrombosed prosthetic grafts for hemodialysis.

PURPOSE: The aim of the study was to evaluate our experience in the hybrid simultaneous treatment (open and endovascular) of acute thrombosis of prosthetic grafts for hemodialysis. METHODS: Between January 2011 and June 2013, 23 patients with acute thrombosis of a prosthetic graft for hemodialysis were urgently treated with a hybrid simultaneous treatment in order to obtain a prompt restoration of the flow. A new puncture of the graft was scheduled after 24 hours. RESULTS: Intraoperative technical success was 100% with a completion angiography showing the restored patency of the graft. As adjunctive procedures, in 6 patients (26.1%) locoregional thrombolysis was necessary and in all cases further endovascular manoeuvres (angioplasty/stenting) were immediately performed to solve a significant stenosis of the venous anastomosis/first tract of the vein. At 24 hours when the first puncture was done, three grafts were occluded resulting in a primary patency of 87%. During the follow-up (mean duration 5.6 months) four reocclusions occurred. In-stent restenosis occurred in all patients undergone stenting. At 1 year the rates of primary patency, primary assisted patency and secondary patency were 58.7%, 78.3% and 87%, respectively. CONCLUSIONS: In our series the combined simultaneous hybrid approach in urgency maximizes the use of different available techniques, which appeared to improve overall success rate to save a thrombosed graft for hemodialysis. The great difference showed between primary and primary assisted patency demonstrates the necessity of a close follow-up.

Massively calcified intravascular cast after removal of a tunneled central vein catheter for hemodialysis.

Vascular calcifications usually affect the arteries, while central vein calcifications are rare. A 45-year-old hemodialysis patient underwent a chest CT scan before central vein catheterization required for arteriovenous access thrombosis, in July 2011. He was on hemodialysis since 1995 and from 2005 on warfarin treatment because of repeated thrombosis and dysfunction of arteriovenous fistula and central vein catheters (CVC). A previous tunneled CVC placed in the left external jugular vein was removed in December 2010. Eight months later a chest CT scan showed a 79-mm irregular, linear, tubular radiopaque density in the superior vena cava and left brachiocephalic vein. The possibility of a retained catheter fragment was considered, but the final diagnosis was: calcified "cast" adherent to the vessel wall. This is the first report of an intravenous calcified "cast" (originating from peri-catheter calcification) retained after removal of a tunneled dialysis CVC. This finding is significant because it mimics a retained catheter fragment possibly leading to misdiagnosis and exposing patients to additional risk for unnecessary retrieving interventions. Catheter removal or over the wire substitution in the presence of a calcified cast could also be considered a risky procedure. Retained calcified cast should be included among the long-term complications of hemodialysis CVCs. At the time of publication, the patient is alive without any complication related to the pathology reported.