Critical Lower Limb Ischemia Research Articles

Outcomes of endovascular recanalization versus autogenous venous bypass for thromboangiitis obliterans patients with critical limb ischemia due to tibioperoneal arterial occlusion

ObjectiveThis study sought to compare the outcomes of endovascular recanalization (ER) vs autogenous venous bypass (AVB) for tibioperoneal arterial occlusion in thromboangiitis obliterans patients with critical lower limb ischemia. MethodsA total of 90 limbs in 75 patients, successfully treated with ER (ER group, 35 patients, 43 limbs) and AVB (AVB group, 40 patients, 47 limbs) for tibioperoneal arterial occlusions from January 2009 to December 2015 in a single institution, were retrospectively analyzed. The characteristics and outcomes were compared between the two groups. The primary outcome was the amputation-free survival rate during follow-up; the secondary outcomes were patency rates, immediate failure, periprocedural complications, and rates of reintervention. Univariate and multivariate analysis to identify potentially significant predictors of amputation-free survival and primary patency in the whole study group was performed. ResultsNot all patients in the ER group were bypass candidates because of unavailable runoff arteries or adequate conduit for bypass. Other baseline characteristics were similar between groups. Patients in the ER group had a much higher incidence of immediate failure (36.36% in femoropopliteal segment and 65.52% in tibioperoneal segment vs 14.89% in AVB bypass; P = .03 and < .001). Although patients in the ER group had a significantly higher rate of reintervention (62.79% vs 27.66%; P < .001) associated with a significantly lower primary patency rate (18.96% in femoropopliteal segment and 14.37% in tibioperoneal segment vs 60.41% in AVB bypass; P = .008 and < .001) and secondary patency rate (33.85% in femoropopliteal segment and 21.29% in tibioperoneal segment vs 68.78% in AVB bypass; P = .04 and .002) at 3 years, the amputation-free survival in the ER group and AVB group was similar at 1 year (92.9% vs 93.2%; P = .81) and 3 years (87.8% and 90.6%; P = .66). Univariate and multivariate analysis showed that the presence of gangrene was independently associated with major amputation (hazard ratio, 2.24; 95% confidence interval, 1.33-4.3; P = .02); however, the presence of active ulcer was the only risk factor for poorer primary patency during follow-up (hazard ratio, 1.86; 95% confidence interval, 0.55-5.6; P = .04). ConclusionsER is a valid strategy for limb salvage in thromboangiitis obliterans patients who are unsuitable for bypass, contributing an acceptable amputation-free survival as high as with AVB, even though it is associated with lower patency rates and a higher rate of reintervention.

NEAR INFRARED IMAGING FOR ANGIOGRAPHY IN DIABETIC PATIENTS WITH PERIPHERAL ARTERY DISEASE

The results of evaluation of the soft tissue perfusion of the foot in patients with diabetes and critical lower limb ischemia (CLI) via fluorescence angiography (FAG) in the near-infrared range are represented in the article. The study included 4 diabetic patients with CLI. All patients underwent lower-limb balloon percutaneous transluminal angioplasty. To evaluate the soft tissue perfusion of the foot via FAG the following parameters have been used: T0m - time to reach maximum for fluorescence intensity after intravenous administration of Indocyanine green; TIm- time of onset of maximum fluorescence intensity after its appearance in the area of interest; Im - the level of the maximum fluorescence intensity. The region of interest was the skin around the wound of the foot. The median FAG parameters in the region of interest on the foot were as follows: prior to surgery T0m = 164 sec (148–181), TIm = 48 sec (38–56); after surgery: T0m = 80 sec (69–92); TIm = 27 sec (20–39); (p <0,05). No adverse reactions were registered in the study. Despite the small sample we were able to achieve statistical significance in the difference between the parameters prior to and after surgery. Further prospective studies with extended samples of patients are needed.

SS17 Analysis of Wound-Healing Time and Wound-Free Period As Outcomes After Surgical and Endovascular Revascularization for Critical Lower-Limb Ischemia

SS17 Analysis of Wound-Healing Time and Wound-Free Period As Outcomes After Surgical and Endovascular Revascularization for Critical Lower-Limb Ischemia

Bypass surgery for chronic lower limb ischaemia.

Bypass surgery for chronic lower limb ischaemia.

DIFFERENT METHODS OF REVASCULARIZATION OF THE LOWER LIMB IN ORDER TO MAINTAIN SUPPORT ABILITY IN PATIENTS WITH NEUROISCHEMIC DIABETIC FOOT

We attempted to improve the effects of short-term and long-term treatment of patients with neuroischemic diabetic foot. We conclude that X-ray and surgical interventions should be considered as the mainstream option for diabetes mellitus patients with critical lower limb ischemia.

Отдаленные результаты хирургического лечения критической ишемии нижних конечностей после одномоментной прямой и непрямой реваскуляризации

Отдаленные результаты хирургического лечения критической ишемии нижних конечностей после одномоментной прямой и непрямой реваскуляризации

Comparison of Clinical outcomes of Infragenicular Angioplasty between diabetic and non-diabetic patients with Peripheral Arterial Occlusive Disease

Background: Infragenicular angioplasty could salvage most of limbs under amputation impendence. We aim in our study to detect the results of infragenicular angioplasty in diabetic and non-diabetic patients with critical lower limb ischemia (CLI). Patients and methods: Between April 2014 and May 2017,infragenicular angioplasty was carried out on 139 patients out of 154 patients (as 15 patients missed the follow up program or their data were lost) with CLI (Rutherford category 4,5 or 6) whom attended to The Vascular surgery Department of Qena University and Assiut University Hospitals. After obtaining informed written consent from all subjects, they were divided into diabetic group (n=62) and non-diabetic group (n=77).For all subjects pre-procedure, ankle brachial indexes (ABI) and computed tomography angiography (CTA) had been done. The percutaneous transluminal angioplasty (PTA) procedure was done alone or combined with stenting. The investigated outcomes comprised rest ABI, primary, secondary patency rates and finally limb-salvage rates 6, 12, 24 and 36 months after treatment. Results: There were no significant differences between both groups in technical success rate (98.4 vs. 100%, P=0.133).Primary , secondary patency rates and limb salvage rates 6,12,24 and 36 months in both diabetic and non-diabetic groups were not significantly different (p value>0.001) The mean value of ankle brachial indexes was significantly increased after intervention (0.397 ± 0.125 versus 0.779 ± 0.137, t=-25.780, P<0.001) in diabetic group and (0.406 ± 0.101 versus 0.786 ± 0.121, t=-37.221, P<0.001) in non-diabetic group. Perioperative 30 day mortality was 0%. Major complications were groin hematoma in 7.3%, and formation of pseudo- aneurysms in 2.1% of subjects. Conclusion: Infragenicular percutaneous angioplasty is a valuable option in CLI management with low risk of both morbidity and mortality. The efficiency and outcomes of interventional procedures in diabetic patients is similar to that in non-diabetics.

Results of various revascularization methods in patients with critical ischemia of lower limbs due to peripheral atherosclerosis

Results of various revascularization methods in patients with critical ischemia of lower limbs due to peripheral atherosclerosis

Phase Ib Open Clinical Trial to Assess the Safety of Autologous Mesenchymal Stem Cells for the Treatment of Nonrevascularizable Critical Lower Limb Ischemia

Background: Critical limb ischemia is a highly disabling disease, characterized by chronic pain at rest, ulceration and tissue tropism attributable to arterial occlusion. Despite significant advances in recent years in treating this disease, there are patients who, for technical reasons or because of the benefit/risk balance, have no therapeutic options other than amputation of the affected limb. Objective: This study’s objective was to assess the feasibility and safety of autologous Adipose Tissue-Derived Mesenchymal Stem Cell (AT-MSC) implantation in patients with lower limb ischemia who are not candidates for surgical or endovascular revascularization. Methods: This is a pragmatic, phase Ib, open, one-arm clinical trial, with a 1-year follow-up after cell implantation. The dose was 1 × 106 AT-MSCs/kg. AT-MSCs were diluted into a final volume of 25 mL of Ringer solution and injected as 25 aliquots of 1 mL into each injection site on the limb. Injection sites were selected below the knee at 25 different sites of the ischemic calf muscle along the tibial and peroneal arteries. Liposuction was done in the abdomen. Results: A total of 7 patients underwent treatment for 21 months. Two patients showed no serious complications with the liposuction, only pain and mild infection. No serious cell implantation-related adverse event occurred during the follow-up, although 2 patients had to undergo amputation. The ankle-brachial index and clinical assessment of the limb improved during the follow-up. Conclusion: In conclusion, AT-MSC treatment of critical limb ischemia is feasible, safe and has promising initial results for salvaging limbs in the short term.

Follow-up and surveillance of vein grafts: when and how to intervene to prevent complications.

Despite advances in endovascular strategies, surgical infrainguinal lower limb revascularization remains the gold standard treatment for critical lower limb ischemia and disabling claudication. Maintaining patency of infrainguinal vein bypass grafts has been a challenging task for vascular surgeons as they are prone to developing stenoses which may precipitate failure of the bypass. Duplex ultrasound scanning has evolved as the investigation of choice to identify vein graft lesions but graft surveillance programs using this technique remain controversial. The rationale for graft surveillance is that intervention in a patent but failing graft results in improved long-term patency and limb salvage rates compared to rescue of an occluded graft. The six-week postoperative Duplex ultrasound scan is important in identifying flow abnormalities that can predict the natural history of a vein graft and the outlook for the limb in the medium term. There are multiple factors influencing vein graft failure, which means guidelines should be flexible in terms of when and which type of intervention to the graft is optimum. Patency and durability favour open surgical revision over endovascular intervention but this must be counter balanced by the increased morbidity associated with surgical revision.

Lumbar sympathectomy techniques for critical lower limb ischaemia due to non-reconstructable peripheral arterial disease.

Critical lower limb ischaemia (CLI) is a manifestation of peripheral arterial disease (PAD) that is seen in patients with typical chronic ischaemic rest pain or patients with ischaemic skin lesions - ulcers or gangrene - for longer than 2 weeks. Critical lower limb ischaemia is the most severe form of PAD, and interventions to improve arterial perfusion become necessary. Although surgical bypass has been the gold standard for revascularisation, the extent or the site of disease may be such that the artery cannot be reconstructed or bypassed. These patients require other modalities of treatment, for example, vasodilatation by drugs or lumbar sympathectomy to relieve pain at rest and to avoid amputations. A systematic review of randomised controlled trials is required to evaluate the effects of lumbar sympathectomy in treating patients with CLI due to non-reconstructable PAD. The objective of this review is to assess the effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with CLI due to non-reconstructable PAD. The Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (January 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 12). In addition, the CIS searched clinical trials databases for details of ongoing and unpublished studies. Randomised controlled trials (RCTs) comparing any of the treatment modalities of lumbar sympathectomy, such as open, laparoscopic and chemical percutaneous methods, with no treatment or with any other method of lumbar sympathectomy for CLI due to non-reconstructable PAD were eligible. To decrease the bias of including participants that may be incorrectly diagnosed with CLI, review authors defined CLI as persistently recurring ischaemic rest pain requiring regular analgesia for more than two weeks, or ulceration or gangrene of the foot or toes, attributable to objectively proven arterial occlusive disease by measurement of ankle pressure of < 50 mmHg or toe pressure < 30 mmHg. We defined non-reconstructable PAD as a resting ankle brachial index (ABI) < 0.9 when no reasonable open surgical or endovascular revascularisation treatment option is available, as determined by individual trial vascular specialists. Two review authors independently assessed studies identified for potential inclusion in the review. We planned to conduct data collection and analysis in accordance with the Cochrane Handbook for Systematic Review of Interventions. We identified no studies that met the predefined inclusion criteria. To decrease the bias of including participants who may be incorrectly diagnosed with CLI, we based our inclusion criteria on objective tests, as described above. The randomised trials identified by the literature search were performed before such objective criteria for selection were applied and therefore were not eligible for inclusion in the review. We identified no RCTs assessing effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with CLI due to non-reconstructable PAD. High-quality studies are needed.

Use of the directional atherectomy for the treatment of femoro-popliteal lesions in patients with critical lower limb ischemia.

From March 2012 to March 2013 18 consecutive patients with critical limb ischemia were treated with DCA (Turbohawk/Covidien-ev3 Endovascular Inc., North Plymouth, Minnesota, USA) for the treatment of femoro-popliteal obstructive disease. Patients were evaluated at 12 months. Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiovascular events occurred. Primary endpoint: freedom from any amputation was obtained in all patients. Secondary endpoints: clinical (Rutherford class improvement) and hemodynamic success (Ankle-brachial index improvement) was achieved in all patients. The use of DCA for the treatment of femoro-popliteal obstructive disease is a safe and effective therapeutic strategy for patients with critical limb ischemia. The data included in our study should be considered hypothesis-generating in order to design of a randomized trial comparison with conventional PTA.

Role of Operative Lumbar Sympathectomy in Patients with Critical Lower Limb Ischemia not Amenable to Vascular Reconstructive Surgery

Role of Operative Lumbar Sympathectomy in Patients with Critical Lower Limb Ischemia not Amenable to Vascular Reconstructive Surgery

Efecto terapéutico del alprostadil en pacientes con isquemia crítica terminal de los miembros inferiores

ObjetiveManagement of critical lower limb ischemia represents a challenge for the vascular surgeon due to the high rate of amputations and mortality. Current management options include femorodistal bypass, angioplasty with or without stent and laser or mechanical resection of the plaque. They present a low success rate in the long run and a number of supracondylar amputations that still remains high. MethodsThis prospective study included 173 patients diagnosed with advanced stage critical lower limb ischemia who were treated with systemic intravenous alprostadil (60 - 120 mcg/day) during 8 days. Response was measured clinically with improvement of capillary refill and using the visual analog scale for pain. ResultsUpon discharge 94.3% of patients improved their visual analogue scale score for pain (p < 0.0001). Follow-up for more than a year of alprostadil treatment revealed that 97% of patients significantly improved their ischemia status, thus avoiding further amputation. No response to treatment was observed in patients who had previously undergone endovascular surgery (5 patients). ConclusionsTreating patients with critical lower limb ischemia with intravenous alprostadil, administering daily doses of between 60 and 120 mcg during 28 days shows that this drug is safe and causes minimal secondary effects. This therapy significantly improves Rutherford's function state in these patients and avoids further amputations.

Predictors of Amputation in Patients with Critical Lower Limb Ischemia

Back Ground: Chronic critical ischemia of the lower limbs with the respective functional loss, continues to be a major public health problem, particularly in developing countries and patients with diabetes. Despite advances in diagnostic methods and innovations in endovascular treatment, amputation is still common, with great psychosocial impact. This study aims to identify possible predictors factors of major amputations in these patients. Materials and Methods: Prospective cohort study was conducted in which selected patients were submitted to clinical and laboratory evaluation, arterial imaging studies and defined study variables. Results: Between March 2015 and February 2016, 182 patients were selected. Of these, the affected limb was amputated in 66 and salvaged in 116. Amputations were more common among males (40.2%), smokers (37.2%), patients with high blood pressure (40.7%), and as a result of stroke (43.5%), without statistically significant difference. Factors associated with loss of limb were previous amputation (62%, p<0.001), trophic lesion (41.2%, p<0.018), infection (54.5%, p<0.001), chronic kidney disease (67.7%, p<0.001), elevated creatinine (3.64 ± 2.3, p<0.001), and hemoglobin A1C (7.79 ± 0.96 p<0.001), with statistical significance. Furthermore, in the group of amputees, the mean ages (73.5 ± 12.7, p=0.065), hemoglobin (9.7 ± 3.8, p=0.689), triglycerides (142.7 ± 55.4, p=0.233), and fasting glycemic level (247 ± 97, p=0.172), were higher, but without statistical significance. The nonamputee group had greater mean cholesterol HDL (50.9 ± 8.8, p=0.568), cholesterol LDL (150.9 ± 35.09 p=0.715), ankle–brachial index (0.14 ± 0.24; p=0.573), hospitalization time (13.9 ± 11.3, p=0.655), follow-up time (11.26 ± 4.09), and underwent more angioplasties and open revascularizations, but without statistical significance. The rate of limbs salvaged was 63.73%, deaths 9.89%, and follow-up loss 6.04%. The reduced model correctly classifies 90.7% of the cases with sensitivity of 86.4% and specificity of 93.1%. In the ROC, the area under the curve was 0.954 (p<0.001). Conclusion: Chronic kidney disease, ischemic heart disease, uncontrolled diabetes, arterial aneurysms, previous amputation and lack of preventive care are predictors of risk for major amputation in this population.

Free autovenous graft with destructed valves in treatment of severe ischemia of lower extremities

to improve treatment of patients with severe atherosclerotic lesion of lower extremities arteries followed by critical ischemia by optimization of femoropopliteal bypass surgery. Treament and survey of 60 patients with severe atherosclerotic lesion of femoropopliteotibial segment and critical lower limb ischemia were analyzed. Patients were divided into 2 groups depending on technique of femoropopliteal bypass. Conventional in situ autovenous technique was used in group 1. In the second group we used original method of free autovenous graft with destructed valves. Technique of free autovenous graft with destructed valves decreases incidence of early postoperative complications by 13.3%, remote thrombosis of graft by 13.3%. Also it increases physical and mental components of health by 7.9% and 3.1% respectively. Use of free autovenous graft with destructed valves is reasonable and improves results of treatment.

The results of combined surgical treatment of thromboangiitis obliterans and critical lower limb ischemia using prolonged epidural analgesia and autohemotherapy with ozone

to evaluate the results of combined treatment of thromboangiitis obliterans with severe lower limb ischemia using prolonged epidural anaesthesia and autohemotherapy with ozone. It was analyzed treatment of 125 patients with thromboangiitis obliterans and severe lower limb ischemia. Patients were divided into 2 groups. Control group consisted of 60 patients who underwent conventional perioperative therapy with anticoagulants, antiplatelet agents, dextrans, metabolic drugs, glucocorticoids, angioprotectors, narcotic and non-narcotic analgesics. Study group included 65 patients in whom prolonged epidural anaesthesia and autohemotherapy with ozone was applied additionally. In early postoperative period (up to 30 days) the incidence of secondary lower leg amputation was 10% and 1.5% in both groups respectively (p<0.05). Primary healing after limited foot amputation was achieved in 63.6% and 83.3% in control and stugy groups respectively (p<0.05). Ulcerative defect recovery was observed in 62.2% and 76.2% in both groups respectively (p<0.01). Satisfactory result of treatment was obtained in 61.7% and 80.0% of patients. Restoration of magistral and collateral blood flow combined with prolonged epidural anaesthesia and autohemotherapy with ozone improves surgical outcomes and rehabilitation of patients with thromboangiitis obliterans and severe lower limb ischemia.

Complex Vascular Involvement in Fabry Disease: An Unusual Case of Combined Critical Lower Limb Ischemia and Deep Vein Thrombosis

Complex Vascular Involvement in Fabry Disease: An Unusual Case of Combined Critical Lower Limb Ischemia and Deep Vein Thrombosis Fabry disease (FD) is an X-linked disorder of glycosphingolipid metabolism caused by a deficiency of the lysosomal enzyme α-galactosidase A. This results in progressive accumulation of glycolipids in a large spectrum of cells. Males with the classic form of FD suffer from cutaneous lesions (angiokeratomas), hypohidrosis, neuropathic pain, cardiomyopathy, renal function impairment, and premature cerebrovascular complications. We report an unusual case of a 63-year old male Fabry patient with critical ischemia and deep vein thrombosis of the lower limb. On the basis of this unusual case, we discuss the current data and gaps in knowledge regarding venous system disorders and peripheral arterial disease, as well as the question of “blood vessel fragility”, in Fabry patients.

Results of in situ femoropopliteal (tibial) bypass in patients with extended lower limbs arterial bed lesion and critical ischemia

Aim. To specify the indications for in situ femoropopliteal (tibial) bypass, to study complications rate immediately after, within 1 and 2 years of the surgery.&#x0D; Methods. The study group included 33 patients with symptoms of critical lower limb ischemia, who underwent femoral-popliteal or femoral-tibial bypass. 4 (12.1%) cases of type C and 29 (87.9%) cases of type D arterial bed lesions according to TASC II classification were revealed after investigation. Patients were followed up for 2 years period. Shunt thrombosis rate, condition of the trophic ulcers, chronic arterial ischemia stage before and after the surgery, mortality, lower limb amputation were measured outcomes.&#x0D; Results. Repeated reconstructions rate for primary shunt thrombosis immediately after surgery was 30.3±8.0%. Shunt thrombosis (secondary) occurred in only three (9.1±5.0%) patients. The main causes which led to the shunt thrombosis during or at the 1st day after the surgery, were absence of intraoperative valvulotomy quality control and presence of unligated great saphenous vein tributaries. Trophic defects healing was observed in 3 (30.0±14.5%) of 10 patients with ulcers immediately after surgery and in all cases (100.0%) by the end of 1 year follow-up. The total number of high-level amputations within 2 years was 25.8±7.9%, the overall mortality rate within 2 years was 6.1±4.2%. Femoral-popliteal or femoral-tibial bypass surgery allowed to preserve the limb in 74.2% of patients within 2 years of follow-up. Bypass patency was preserved in 41.7% of patients out of 24 in situ bypass surgeries for the follow-up time. In our opinion critical limb ischemia with significant and extended arterial bed lesions of D and C types (according to TASC II score) is one of the indications for in situ femoropopliteal (tibial) bypass as for the surgery of the first choice. Endovascular treatment is also impossible for this type of lesion, as alternative surgeries using reversed autovein and synthetic explant do not meet all the requirements for an extended bypass.&#x0D; Conclusion. The lack of adequate intraoperative valvulotomy quality control and presence of unligated great saphenous vein tributaries may be the causes of early postoperative shunt thrombosis; despite the low femoropopliteal (tibial) bypass patency rate in patients with critical ischemia, the surgery was recognized as efficient as it allowed to preserve the limbs in 74.2% of patients.

Evaluación de la capacidad de difusión tisular de antibióticos en isquemia de miembros inferiores

IntroductionThe aim of the study was to assess whether the penetration of antibiotics is affected by decreased tissue perfusion in patients with limb ischaemia, thus reducing its concentration in tissues below the minimum inhibitory concentration (MIC) breakpoints of antibiotics for different microorganisms. MethodsProspective study. Candidates for major amputation with critical lower limb ischaemia and an infection on antibiotic treatment, were included. Three levels of perfusion in the lower limb were determined by measuring the transcutaneous oxygen pressure (TcPO2). A central line blood specimen, as well as biopsies of the skin, muscle, and bone, were taken at each perfusion level. The antibiotic concentration was determined using HPLC. ResultsThe total number of cases was 61 (46 patients): 6 clindamycin, 9 vancomycin, 8 linezolid, 18 levofloxacin, 9 ceftazidime, and 11 meropenem. Statistically significant differences were found in TcPO2 at all levels (ANOVA, P=.000). The vancomycin, levofloxacin and ceftazidime skin concentration depends on perfusion. Vancomycin and levofloxacin diffusion in bone is worse than in other tissues. Ceftazidime concentration does not exceed the MIC breakpoint of Pseudomonas aeruginosa in ischaemic tissues. ConclusionsMeropenem and linezolid diffuse in all tissues, regardless of perfusion, reaching concentrations above the MIC of the target microorganisms, ensuring its effectiveness in ischaemic tissues.