Influence of lamina vastoadductoria dissection on the outcomes of femoral artery extensive lesion stenting: A pilot randomised investigation.

OBJECTIVE: Aim of the study was to improve the immediate and long-term results of stenting of the superficial femoral artery in extended lesions with the changing of the biomechanics of superficial ffemoral artery and of the first portion of the popliteal artery. METHODS: Pilot randomized prospective single-center study were included 70 patients. Patients were randomized into two groups in 1 × 1 format for 35 people using the envelope method. Self-expanding bare metal stents were used in all cases. At the first group standard revascularization procedures with SFA stenting were performed; in the second group, the superficial femoral artery stenting was supplemented with fasciotomy in the Hunter's canal with the superficial femoral artery intersection. The total observation period was 2 years. During the observation period an assessment of the clinical symptoms of the lower extremities, measurement of the ankle-brachial index and ultrasound duplex scanning of the operated segment were performed. RESULTS: All procedures in both groups were successfully performed. Primary patency through 24 months was 28.5% (10 of 35) in group 1 and 60% (21 of 35) in group 2 (p = 0,015). CONCLUSIONS: Changing the biomechanical properties of the distal of the superficial femoral artery segment and of the first portion of the popliteal artery is safe and contributes to the primary patency improvement during the stenting of extended of the superficial femoral artery lesions compared to standard SFA stenting. Dissection of the lamina vastoadductoria with transection of the collateral branches of the knee joint network reduces frequent and severe damages of stents after the stenting of the superficial femoral artery extended lesion. According to the frequency of complications in the early and mid-term postoperative period, limb salvage, mortality and the secondary patency rates, the new method is comparable with standard of the superficial femoral artery stenting.

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.

Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization.

OBJECTIVES: The aim of this study was to compare procedure-related ipsilateral cerebral embolism with a conventional (Acculink, Abbott Vascular) versus a MicroNet-covered (CGuard, InspireMD) stent in carotid artery stenting (CAS). BACKGROUND: The MicroNet-covered stent may reduce periprocedural cerebral embolism in CAS, but level 1 evidence is lacking. METHODS: A total of 100 consecutive patients were randomized 1:1 to filter-protected CAS using the Acculink or the CGuard device. The study was powered for its primary endpoint of at least 50% reduction in ipsilateral diffusion-weighted magnetic resonance imaging lesion average volume 48 hours postprocedure (blinded external core laboratory analysis). RESULTS: The baseline characteristics of the study groups were similar. Eighty-two (total volume = 18,212 mm3) diffusion-weighted magnetic resonance imaging postprocedural cerebral lesions occurred in 26 Acculink-treated patients and 45 lesions (total volume = 3,930 mm3; 78.4% reduction) in 25 CGuard-treated patients. New cerebral lesion average volume was 171 mm3 vs 73 mm3 (P = 0.017) per affected patient and 222 mm3 vs 84 mm3 (P = 0.038) per lesion (Acculink vs CGuard). In lesion-affected patients, the average sum of lesion volumes was 701 mm3 vs 157 mm3 (P = 0.007). The Acculink significantly increased the risk for multiple (≥5) cerebral lesions (relative risk: 7.8; 95% CI: 1.3-14.9; P = 0.021). At 30 days, new permanent (fluid-attenuated inversion recovery) lesion prevalence was 3:1 (P < 0.001), with total permanent lesion volume 7,474 mm3 vs 574 mm3 (92.3% reduction with the CGuard). There were 6 vs 0 new ipsilateral lesions (P = 0.030) and 2 versus 0 strokes. CONCLUSIONS: The MicroNet-covered stent significantly reduced periprocedural and abolished postprocedural cerebral embolism in relation to a conventional carotid stent. This is consistent with the MicroNet-covered stent's sustained embolism prevention, translating into cerebral protection not only during but also after CAS. The present findings may influence decision making in carotid revascularization. (The SIBERIA Trial [Acculink™ Versus CGuard™]; NCT03488199).

Is it possible to prevent cerebral embolization by improving the design and technology of carotid stent implantation?

INTRODUCTION: The prevention of atherosclerotic plaque fragmentation during carotid artery stenting is a fundamental problem in decreasing the risk of disability of patients. The goal of this review is to clarify whether the stent design can have a decisive impact on the rate of intraoperative and postoperative complications. AREAS COVERED: Different designs of the carotid stents are briefed and the advantages and disadvantages of different stent designs are discussed as well as the results of their clinical use. Various solutions are presented to reduce cerebral embolism during carotid artery stenting. EXPERT OPINION: There is no conclusive evidence for the benefits of closed cell and hybrid stents. The stent design cannot completely resolve the problem of cerebral embolism. Most of the events of cerebral microembolism occur at the stages of stent delivery rather than protrusion of an atherosclerotic plaque in the long-term follow-up. Most likely, minimization of the risks for periprocedural and postprocedural strokes requires not only the new solutions in stent design as well as the corresponding delivery systems and brain embolic protection systems, but also the new strategies of preprocedural drug stabilization of the atherosclerotic plaque in the carotid artery. Abbreviations: CAS, carotid artery stenting; CE, carotid endarterectomy; DW-MRI, diffusion-weighted magnetic resonance imaging; ECA, external carotid artery; ICA, internal carotid artery; IVUS, intravascular ultrasound examination; OCT, optical coherence tomography.

Comparative Analysis of Carotid Artery Stenting and Carotid Endarterectomy in Clinical Practice.

The objective of the study was to describe immediate and long-term results of carotid endarterectomy (CEA) versus carotid stenting (CAS) with embolic protection in patients with severe carotid artery stenosis in clinical practice. MATERIALS AND METHODS: This is a retrospective cohort study, conducted between 2009 and 2017. During the analyzed period, 2132 operations (2006 patients) were performed: 1215 (57%) CEA and 917 (43%) CAS. 278 patients (13.8% of 2006) were not contactable during the follow-up period (>30 days) leaving 1791 cases (1728 patients) for inclusion in the analysis. Propensity score matching was used to compare the treatment results of groups (561 cases were matched out of 1791). The results of 615 CEA (316 eversion, 299 "classic" with patch) and 615 CAS (using a variety of carotid stents) were compared. RESULTS: In the asymptomatic subgroup (n = 455), the 30-day rate of stroke was not significantly different between the CEA group and the CAS group (1.5% versus 2.4%, P = .48). The 5-year rate of stroke was not significantly higher for CAS than for CEA (4.6% versus 3.3%, P = .3). In the symptomatic subgroup (n = 160), the 30-day rate of stroke was significantly higher in the CAS group than in the CEA group (7.5% versus 2.5%, P = .04). The 5-year rate of stroke was 13% for CAS and 8.7% for CEA (P = .2). CONCLUSIONS: In the symptomatic subgroup, the 30-day rate of stroke was significantly higher in the CAS group than in the CEA group, therefore the use of CAS for symptomatic patients in routine practice should be limited. Our study demonstrates that the rates of stroke and survival after CEA and CAS in patients aged 80 years or younger with asymptomatic or symptomatic severe carotid stenosis did not differ significantly over a period of 5 years.

Better treatment option in chronic superficial femoral artery occlusive disease: comparison of methods (meta-analysis).

Introduction: The objective is to evaluate the frequency of primary obstruction events (PrO) during one-year follow-up after performing excisional atherectomy with the SilverHawk/TurboHawk atherectomy device (S/TH) or remote superficial femoral artery endarterectomy (RSFAE) in patients with the chronic superficial femoral artery occlusive disease (СSFAOD). Methods: We included all randomized clinical trials (RCTs) and not-RCTs concerning the treatment of patients with СSFAOD after S/TH and RSFAE without duration. Results: Twenty-nine items (1990-2017) were discovered; 27 articles on the levels of evidence were included in qualitative synthesis; 9 studies (meta-analysis) were included in quantitative synthesis. The results of 2762 patients' treatment were summed up in our analysis (1422 patients S/TH; 1340 patients RSFAE). All included reports were at low risk of bias. According to the criterion "frequency of PrO" during one-year follow-up, the pooled Hazard Ratios indicate significant favours of S/TH if compared it with RSFAE (HR= 0.66 (0.57 to 0.76, P < 0.00001), I2 = 9%). Conclusion: Our study showed that S/TH with the SpiderFX device (distal embolic protection) are safe and effective treatment option for short lesion (<15 cm) in patients with СSFAOD. The usage of S/TH methods significantly reduced number of PrO if compared it with RSFAE. In long-segment lesion (>15 cm) in patients with СSFAOD, RSFAE may be considered better than an endovascular procedure. But still it is necessary to conduct well-planned randomized studies to determine effectiveness and safety of the compared methods (S/TH and RSFAE) in patients with long-segment lesion (>15 cm).

Carotid Endarterectomy with Autoarterial Remodeling of Bifurcation of the Common Carotid Artery and Carotid Endarterectomy with Patch Closure: Comparison of Methods.

BACKGROUND: The objectives of our research were to identify whether the new method of carotid endarterectomy (CEA) with autoarterial remodeling of bifurcation of the common carotid artery (ARBCCA) influences daily parameters of blood pressure and heart rate (HR) while monitoring them on a daily basis and to assess the efficacy of the suggested method. MATERIALS AND METHODS: It is a prospective randomized comparative study. The first group (n = 100) included patients that underwent ARBCCA, the second group (n = 100) included patients that underwent "classic" CEA with xenopericardial patch closure. Diurnal Holter recording of blood pressure and (HR) was performed before and after the surgical treatment in both groups. RESULTS: Surgical treatment in both groups leads to an increase of HR, arterial hypertension time index by systolic blood pressure, and arterial hypertension time index by diastolic arterial blood pressure. The damage of carotid artery bulb increases sympathetic innervation and causes dysregulation of the baroreceptor mechanism. CONCLUSIONS: In our study, we did not reveal a significant difference in the incidence of postoperative hypertension and the dependence of HR on the choice of surgical technique. Thus, the proposed ARBCCA method does not lead to an increased risk of pre-existing arterial hypertension development. A significant difference is found out on the parameter of the clamping time of carotid arteries in favor to ARBCCA group. Another advantage of the suggested technique is the number of restenosis greater than 50% during the 2-year follow-up (4 [4%] cases (ARBCCA group) versus 12 [12%] cases ["classic" CEA], respectively, P = .037).

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.

The role of stump pressure and cerebral oximetry in predicting ischaemic brain damage during carotid endarterectomy.

Objective is to compare the predictive value of stump pressure (SP) and cerebral oximetry (rSO2) levels in the evaluation of ischaemic injury of the cerebrum during clamping of the carotid artery (CCA) without temporary shunt (TS). Methods We included 84 patients with an asymptomatic stenosis (>70%) of the internal carotid artery (ICA) who underwent carotid endarterectomy (CEA) under GA. Cerebral ischaemic tolerance (CIT) was determined on the basis of SP, rSO2 and ∆rSO2 (↓rSO2 from baseline) during CCA. The levels of S100 protein (S100) and neuron-specific enolase (NSE) were measured on each stage of the study. MRI was performed for all patients. Results There were no perioperative strokes and myocardial infarctions during the study. Temporary shutdown of blood flow in CAs during CEA is accompanied by a significant elevation of S100, NSE concentration with their subsequent restoration (three days after surgery). ROC analysis showed that none of the methods for CIT assessment (SP, rSO2 and ∆rSO2) was a valuable predictor of cerebral damage during CEA. Conclusion SP with a threshold value of ≤40 mmHg has an average quality of prediction (AUC = 63). ∆rSO2 of ≥20% and a threshold value of rSO2 ≤ 40% have an unsatisfactory quality of prediction (AUC < 60).

Systemic Thrombolytic Therapy and Catheter-Directed Fragmentation with Local Thrombolytic Therapy in Patients with Pulmonary Embolism.

BACKGROUND: The objective was to compare immediate and long-term results of systemic thrombolytic therapy (STT) and catheter-directed fragmentation (CDF) with local thrombolytic therapy (LTT) in patients with massive pulmonary embolism (PE). METHODS: About 209 patients with massive PE (the high risk of early death) were included in our study. From 2008 till 2010 in the first group (n = 102), STT was performed. From 2011 till 2013 in the second group (n = 107), CDF with LTT was carried out. Echocardiography and pulmonary arteriography were performed in all patients on admission to hospital and in 5 days after treatment. The patients of both groups were re-examined in 6 months, 1, 2, and 3 years after the operation. RESULTS: In the first group, there were 5 (4.9%) cases of in-hospital 30-day mortality. In the second group, there was 1 (0.9%) case of in-hospital 30-day mortality (P = 0.08). In the first group, a clinically significant bleeding was noted in 4 (3.9%) cases, but it caused mortality only in 1 case. In the second group, the clinically significant bleeding was not found (P = 0.038). Persistent postembolic pulmonary hypertension (PPPH) in 9.8% cases of patients in the first group and 2.9% cases of patients in the second group was determined (P = 0.048). CONCLUSIONS: CDF combined with LTT is an effective minimal invasive treatment (helped us to reduce significantly the number of bleeding and PPPH cases), at least in the midterm, in patients with massive PE.

Endovenous laser ablation in patients with severe primary chronic venous insufficiency.

BACKGROUND: The aim of study was to estimate the safety and efficacy of using laser wavelength of 1560 nm with the foam sclerotherapy (FS) of varicose veins (VVs) for the treatment of severe primary chronic venous insufficiency (CVI, C4-C6) in patients with different diameters of the proximal segment (DPS) of the great saphenous vein (GSV). METHODS: We have separated the patients into two groups depending on the size of GSV: group 1 (281 cases; DPS of GSV less than 15 mm) and group 2 (210 cases; DPS of GSV more than 15 mm). Both groups received the endovenous laser ablation (EVLA) of the saphenous vein trunk, incompetent perforator veins (IPs) and FS (Tessari method) of VVs. The linear endovenous energy density (LEED) was personalized depending on the vein size. RESULTS: The healing of ulcers and resolution of venous eczema in 6 months were considered the primary end-point. Healing of ulcers was found in 45/55 (82%) cases in group 1 and in 31/35 (88%) cases in group 2. The resolution of venous eczema in 56 (80%) from 70 cases in group 1 and 45 (85%) from 53 cases in group 2 was observed. Leg ulcer recurrence at 3 years' follow-up in 7.3% cases in group 1 and 8.6% cases in group 2 was determined. CONCLUSIONS: Our experience of using laser wavelength of 1560 nm and FS of VVs for the treatment of severe primary CVI shows the safety and efficacy of this technique in patients with different DPS of GSV.

Endovascular Treatment of the Subclavian Artery Steno-Occlusive Disease.

OBJECTIVE: The aim of our study was to compare immediate and long-term results of endovascular interventions for the treatment of steno-occlusive disease of subclavian arteries (SAs) depending on the length of lesion. MATERIALS AND METHODS: Between 2010 and 2013, we performed 245 endovascular procedures to treat patients with atherosclerotic steno-occlusive disease of SAs. All patients were examined and subdivided according to the received results into 2 groups: 125 patients with stenosis of SA were included in the first group and 120 patients with occlusion of SA were included in the second group. The patients were then followed up at 6, 12, 24, 36, and 48 months after endovascular interventions. Follow-up visits contained symptomatic evaluation, clinical assessment with physical examination, complete neurological evaluation, and serial color Doppler ultrasonography. RESULT: Transitory ischemic attacks in the vertebrobasilar system were intraoperatively developed by 1 patient from the first group (.8%) and 3 patients from the second group (2.5%). Reinterventions in the long-term period were carried out in 9 (7.2%) cases in the first group and 12 (10%) cases in the second group (P = .43). The cumulative primary stent patency at 4 years was 89.8% in the first group and 87% in the second group (P = .4). CONCLUSIONS: In the case of SA occlusion on the first stage, it is expedient to carry out endovascular recanalization followed by stenting. Our study revealed an increased risk of stent thrombosis or in-stent restenosis in patients with stents >40 mm.

Hybrid and open surgery of Trans-Atlantic Inter-Society II type C and D iliac occlusive disease and concomitant lesion of common femoral artery.

BACKGROUND: The purpose of our study was to compare immediate and long-term results of hybrid repair and open aortofemoral reconstructions in the patients with lower extremity peripheral arterial disease of Trans-Atlantic Inter-Society (TASC) II Type C and Type D iliac lesions in combination with the concomitant lesion of common femoral artery (CFA). METHODS: We have included in this prospective case-controlled study 112 patients with extensive iliac and CFA occlusive disease. The study was conducted from 2009 till 2014. In the first group there were 46 patients who received recanalization and stenting of iliac arteries in combination with endarterectomy and angioplasty of common femoral and deep femoral arteries. In the second group there were 66 patients who received aortofemoral bypass. All patients had chronic ischemia (Stage 3-5, Rutherford classification) for TransAtlantic Inter-Society (TASC II) type C and D iliac occlusive disease. RESULTS: We have not found any significant differences in demographic details between the groups. At the same time there were significant differences in clinical data (coronary heart disease and stage of chronic ischemia) between the groups. Early (<30 days) thrombosis of the stented iliac segment or aorto-femoral bypass was detected in three patients (6.5%) in the first group and three cases (4.5%) in the second group. Thrombectomies using a Fogarty catheter were successful performed in both groups. The average length of the follow-up was 3.1 years (in the range of 6 to 48 months), with a mean follow-up of 3.3 years for the open repair (range 6-48 months) and 2.8 years for the hybrid repair (range 6-48 months) group. At the end of the follow-up period, thrombosis of the stented iliac segment or aortofemoral bypass was detected in 5 (10.9%) patients of the 1st group and 5 (7.8%) patients of the 2nd group. The cumulative primary patency rates at 12, 24 and 36 months were 95.7%, 90.8%, 84.3% in the 1st group and 98.5%, 95.4%, 90.4% in the 2nd group, respectively (P=0.84). The limb salvage rates in our study at 12 and 24 months were 97.8% and 93.8% in the 1st group and 100% and 98% in the 2nd group, respectively (P=0.23). CONCLUSIONS: Hybrid surgery including recanalization and stenting of iliac artery in combination with endarterectomy and angioplasty of common femoral and deep femoral arteries is an effective (at least in the mid-term period) minimally invasive treatment for patients with multifocal peripheral artery disease. This single-center study supports the safety and durable efficacy of hybrid procedures in a limited cohort of patients, thus emphasizing the need for larger scale clinical trials to evaluate this approach against aortofemoral bypass.

Hybrid Interventions in the Case of Combined Stenosis of the Carotid Bifurcations and Supra-Aortic Arteries.

OBJECTIVES: The purpose of our study is to describe the technique, safety, and efficacy of hybrid carotid revascularization for the treatment of combined occlusive lesions of the carotid bifurcations and supra-aortic arteries. MATERIALS AND METHODS: We monitored the results of hybrid surgical interventions including carotid endarterectomy (CEA) and stenting either the common carotid artery (CCA) or the brachiocephalic trunk (BCT) in 12 patients. Nine men and 3 women with occlusive atherosclerosis made up the cohort. All surgical interventions were performed with local anesthesia by means of standard operative access to the bifurcation of the carotid artery. After the correction of the proximal stenosis of the CCA or BCT with subsequent angiography, the CEA was performed. The mean follow-up was 33.5 months (range, 6-48). RESULT: Ten patients underwent left CCA stenting in combination with CEA. Among the 10 patients, CEA was performed using the eversion technique in 5 cases and patch angioplasty in the other 5 cases. In the remaining 2 cases, the patients underwent CEA with patch angioplasty of the right internal carotid artery in combination with stenting of the BCT critical stenosis. During the early postoperative period and follow-up to 48 months, a stroke was not registered. CONCLUSION: Hybrid interventions (CEA and stenting of the CCA or BCT) allow combination of the advantages of each method in the treatment of multilevel vascular disease. This study confirms the safety and efficacy of hybrid interventions in a small cohort of patients while emphasizing the need for future randomized controlled trials in larger populations.