Fibrin Sealant TISSEEL Lyo as a haemostatic agent in vascular surgery: Results of randomized, controlled, patient-blinded, multicentre clinical study in the Russian population.

BACKGROUND: This phase III, controlled, patient-blinded, multicentre study in two parallel, equal-sized treatment groups compared the efficacy and safety of TISSEEL Lyo, fibrin sealant versus Manual Compression (MC) with surgical gauze pads for use as a haemostatic agent in patients who underwent vascular surgery in Russia. METHODS: Adult patients, both genders, who received peripheral vascular expanded polytetrafluoroethylene conduits and had suture line bleeding after surgical haemostasis were enrolled. Patients were randomized to be treated with TISSEEL Lyo or MC. The bleeding needed additional treatment and had to be assessed as grade 1 or 2 bleeding according to the Validated Intraoperative Bleeding scale. The primary efficacy endpoint was the proportion of patients achieving haemostasis at 4 min after treatment application (T4) at the study suture line, which was maintained until the closure of the surgical wound. The secondary efficacy endpoints included the proportion of patients achieving haemostasis at 6 min (T6) and 10 min (T10) after treatment application at the study suture line, which was maintained until closure of the surgical wound, as well as the proportion of patients with intraoperative and postoperative rebleeding. Safety outcomes included incidence of adverse events (AEs), surgical site infections and graft occlusions. RESULTS: A total of 110 patients were screened; 104 patients were randomized: (TISSEEL Lyo: 51 [49%] patients; MC: 53 [51%] patients). T4 haemostasis was achieved in 43 (84.3%) patients in the TISSEEL Lyo group and in 11 (20.8%) patients in the MC group (p < 0.001). Significantly more patients in TISSEEL Lyo group achieved the haemostasis at T6 (relative risk (RR) of achieving haemostasis 1.74 [95% confidence interval (CI) 1.37; 2.35]) and T10 (RR 1.18 [95% CI 1.05; 1.38]) versus MC. No one had intraoperative rebleeding. Postoperative rebleeding was reported only in one patient in the MC group. No treatment-emergent serious AEs (TESAEs) related to TISSEEL Lyo/MC, TESAEs leading to withdrawal and TESAEs leading to death were reported in patients during the study. CONCLUSIONS: Data demonstrated TISSEEL Lyo had clinically and statistically significant superiority to MC as a haemostatic agent in vascular surgery at all measured time points including 4, 6 and 10 min and had proven to be safe.

One-Year Results of Long femoropopliteal Lesions Stenting with Fasciotomy Lamina Vastoadductoria.

BACKGROUND: Fasciotomy can increase the mobility of the superficial femoral artery and decrease the incidence of stent fractures. This study aimed to compare the long-term patency of drug-eluting nitinol stents with and without fasciotomy in patients with prolonged superficial femoral artery occlusions. METHODS: A randomized clinical trial was conducted in 60 (1:1) patients with long femoropopliteal steno-occlusive lesions >200 mm. Patients in group 1 (Zilver) underwent recanalization of femoropopliteal artery occlusion with stenting. In group 2 (ZilverFas), the femoropopliteal occlusion was recanalized with stenting and fasciotomy of Gunter's canal. The follow-up assessment of the patency took place after 6-12 months. RESULTS: Twelve-month primary patency in Zilver and ZilverFas groups was 51% and 80%, respectively (P = 0.02). The freedom from target lesion revascularization in the Zilver and ZilverFas groups was 50% and 76%, respectively (P = 0.04). At 1 year, primary-assisted patency and secondary patency for the ZilverFas and Zilver groups were 83% vs. 62% (P = 0.07) and 86% vs. 65% (P = 0.05), respectively. In the Zilver and ZilverFas groups, the number of stent fractures was 14 and 7, respectively (P = 0.05). The multivariable Cox regression indicated that the stent fracture and diabetes mellitus were independent predictors of restenosis and reocclusion. Fasciotomy reduced the risk of reocclusion and restenosis by 2.94 times. CONCLUSIONS: Our study has shown that decompressing the stented segment with fasciotomy significantly improves the patency of the femoropopliteal segment and significantly reduces the number and severity of stent fractures.

Editor's Choice - Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial.

OBJECTIVE: The aim of this non-inferiority randomised trial was to compare the short and midterm safety and efficacy of hybrid repair (HR) and open reconstruction (OR) for patients with co-existing iliac and common femoral artery (CFA) occlusive disease. METHODS: The study was registered on the ClinicalTrials.gov register (identifier: NCT02580084). From 2015 to 2017, eligible patients presenting with combined iliac and CFA occlusive disease were randomised to either HR or OR. HR group patients underwent recanalisation and stenting of iliac arteries combined with CFA endarterectomy and patch angioplasty. The OR group underwent aortofemoral bypass with simultaneous CFA endarterectomy. Short (30 day) and midterm (36 month) outcomes including morbidity, mortality, and patency rates were compared between groups. RESULTS: Of 427 patients assessed, 202 were randomised (102 HR and 100 OR). The average hospital length of stay was shorter in the HR group (8.2 ± 4.2 days HR group vs. 15.7 ± 6.9 days OR group, p < .001); the 30 day peri-operative morbidity rate was 8.8% in the HR group vs. 21% in the OR group (p = .030). There was no significant difference in the 36 month mortality rate (p = .16). The cumulative primary patency rates were 93% (HR) vs. 93% (OR) at 12 months and 91% (HR) vs. 89% (OR) at 36 months (p = .38). The limb salvage rates were 99% (HR) vs. 99% (OR) at 12 months and 98% (HR) vs. 97% (OR) at 36 months (p = .49). CONCLUSION: The results of this first non-inferiority randomised study support the safety and midterm efficacy of hybrid procedures for patients with iliofemoral peripheral arterial disease. HR patients had a shorter length of stay with reduced peri-operative morbidity and similar medium term patency rates.

A prospective randomized trial on endovascular recanalization with stenting versus remote endarterectomy for the superficial femoral artery total occlusive lesions.

OBJECTIVE: The objective of this randomized study was to compare the short- and long-term safety and efficacy of endovascular recanalization with stenting (EI) and remote endarterectomy (RE) for patients with superficial femoral artery (SFA) total occlusive lesions (≥250 mm). METHODS: Between July 2013 and July 2017, eligible patients with SFA total occlusive lesions were randomized to EI or RE. The EI group underwent recanalization and stenting of long SFA atherosclerotic occlusive lesions. The RE group underwent semiclosed endarterectomy. Short- (30-day) and long-term (48-month) morbidity, mortality, and patency rates were compared between both groups. RESULTS: Of 400 patients assessed, 238 were ultimately randomized (119 EI and 119 RE). The cumulative primary patencies were 83% (EI) vs 82% (RE) at 12 months and 28% (EI) vs 46% (RE) at 48 months (P = .04). The limb salvage was 98% (EI) vs 95% (RE) at 12 months and 87% (EI) vs 92% (RE) at 48 months (P = .26). One-year and 4-year secondary patencies were 98% and 87% in the EI group and 100% and 90% in the RE group, respectively (P = .4). A total of 65 patients in the stenting group and 32 patients in the endarterectomy group underwent endovascular reintervention. Four-year patencies of endovascular reintervention subgroups were 37% and 60% (P = .04), respectively. CONCLUSIONS: RE shows significantly better results in the long term than primary stenting of SFA long lesions (TASC-II D lesions). In case of loss patency, a desobliterated artery can be successfully subjected to endovascular revascularization and stenting with good short- and long-term results.

Post-Traumatic Arteriovenous Fistulas Leading to Heart Failure.

INTRODUCTION: The detection of acquired arteriovenous fistulas (AVFs) is mostly incidental. However, the modification of haemodynamic conditions secondary to AVFs can lead to dramatic systemic complications, including cardiac complications. In this report, two unusual cases of congestive heart failure secondary to acquired AVF are presented. REPORT: A 40 year old man with past history of gunshot wound of the right flank complained of severe right limb swelling and shortness of breath. An AVF between the right external iliac artery and external iliac vein responsible for the cardiac failure was diagnosed. A 40 year old woman with past history of spinal surgery complained of breathlessness and lower limb oedema. She presented with recurrent episodes of ascites and dyspnoea. An AVF between the right common iliac artery and the common iliac vein responsible for high output cardiac failure was diagnosed. Open surgery was performed in both patients and treatment of the AVFs led to the resolution of all symptoms. Follow up at four and three years, respectively, was uneventful in both cases. DISCUSSION: Although rare, heart failure secondary to an AVF can be encountered. These rare cases highlight the significance of careful inquiry into the patient's medical history and meticulous follow up physical examinations for patients with injuries in close proximity to vessels.

Remote Endarterectomy and Lamina Vastoadductoria Dissection Improves Superficial Femoral Artery Biomechanical Behavior during Limb Flexion.

BACKGROUND: Superficial femoral artery (SFA) remote endarterectomy offers the advantage of preserving anatomy and geometry of the native artery, but the risk of restenosis still exists. The particular role of the adductor canal (AC) in mechanical constraints has been highlighted. The aim of this study was to assess if a surgical protocol associating remote SFA endarterectomy and AC freeing would modify the SFA geometrical changes during physiological limb flexion. METHODS: From January 2015 to March 2015, 10 patients (Rutherford 3-5) with unilateral SFA occlusion were included. Functional postoperative assessments were performed through duplex ultrasound (DUS) examinations with flow velocity measurements in both straight and flexed positions and anatomical measurements through 3-dimensional computed tomography angiography (CTA) reconstructions with arterial angulations examination. Functional results were compared with similar findings in healthy volunteers, and anatomical results were compared with contralateral limb findings. RESULTS: Mean occlusion length was 243.0 ± 17.7 mm. Technical success was achieved in all cases. No difference of peak flow velocities was noticed between operated patients and volunteers. CTA results showed that limb flexion induced SFA shortening in all segments, with a maximal value for the popliteal artery (PA) (10.4 ± 4.4%). Comparisons between the operated and contralateral limbs showed that angles were less sharp during bending in the operated limb. CONCLUSIONS: This preliminary study demonstrates that freeing the AC modifies the biomechanical properties of the SFA. These results could potentially help in proposing future hybrid techniques that could improve technical performances for SFA occlusive disease treatment.