Clinical outcomes from profundoplasty performed as a sole procedure for revascularization in critically ischaemic limbs.

OBJECTIVES: The aim of this study is to investigate the durability and clinical efficacy of profundoplasty as a sole procedure in patients presenting with critical limb ischaemia associated with profunda femoral artery disease and superficial femoral artery occlusion. METHODS: Retrospective analysis of outcomes from all patients who underwent surgical profundoplasty in a single tertiary referral centre was performed. Patients who presented with either rest pain or tissue loss and had combined profunda femoral artery disease and superficial femoral artery occlusion were included in the study. Outcomes were compared between the rest pain and the tissue loss groups. RESULTS: Between 2009 and 2019, 51 procedures were performed in 49 patients; 27 (53%) procedures were performed for rest pain and 24 (47%) for tissue loss. Technical success was 100% in both groups. Procedure success was significantly better in the rest pain group owing to lower procedure-related complications (p = 0.037). Incidence of major adverse cardiovascular events was higher in the tissue loss group with five reported cases compared to only one in the rest pain group (p = .05); 85.2% of patients with rest pain experienced clinical improvement compared to only 33.3% in the tissue loss group (p < .001). Higher rates of re-intervention were recorded in the tissue loss group, but this was not statistically significant. Amputation-free survival at 3, 6 and 12 months was 96%, 96% and 92% in the rest pain group, respectively, compared to 77%, 67% and 54% in the tissue loss group (p = .004). At one-year, freedom from major adverse limb events was lower in patients with tissue loss at 43% compared to 81% in patients with rest pain (p = .009). CONCLUSIONS: Profundoplasty performed as a sole procedure for revascularisation of the critically ischaemic limb is a viable straightforward option. However, our results suggest that it may be more effective in the treatment of rest pain rather than in the setting of tissue loss when a combined superficial femoral artery angioplasty or distal bypass may be required.

[Chronic spinal stimulation in treatment of lower limb critical ischaemia syndrome]. / Khronicheskaia spinal'naia stimuliatsiia v lechenii sindroma kriticheskoi ishemii nizhnikh konechnostei.

Obliterating peripheral artery disease is a commonly occurring pathological condition, most often resulting from an atherosclerotic lesion of vessels with progressive narrowing of their lumens. The consequences of decompensation of chronic arterial insufficiency such as ischaemic pain, claudication, and trophic impairments are in some instances difficult to treat, despite using multicomponent medicamentous therapy and/or performing revascularizing interventions. This article describes a clinical case report regarding the use of spinal stimulation in a patient presenting with stage IV chronic lower limb ischaemia according to the Fontaine classification. This is accompanied and followed by depicting the dynamics of the laboratory, instrumental, and clinical parameters over a two-year follow-up period. In order to explain the choice of the intervention and the causes of the described picture, discussed are the existing theories of the mechanisms of action of spinal stimulation. To this is added a literature review of using this method in treatment of lower limb critical ischaemia when performing reconstructive angiosurgical treatment is unavailable. Mention is also made of the incidence and types of probable complications, as well as possibilities and limitations of the method.

Endovascular arterialization of deep crural and pedal veins in a patient with critical lower limb ischaemia. / Éndovaskuliarnaia arterializatsiia glubokikh ven goleni i stopy u patsienta s kriticheskoi ishemiei nizhnikh konechnostei.

Described in the article is a clinical case report regarding complete endovascular arterialization of deep crural and pedal veins in a male patient with accompanying pathology and impossibility of intraluminal restoration of the arterial bed. Peculiarities of the presented case report consisted in creation of an arteriovenous anastomosis in the upper third of the crus using an endovascular technique. During treatment, a repeat intervention was required, i. e., balloon angioplasty of veins and implantation of an additional stent graft due to reocclusion of veins because of long-term local treatment of wounds and cytostatic therapy for background diseases (chronic myeloleukaemia and rheumatoid arthritis). The performed treatment resulted in a clear trend towards healing of the wounds on the foot and limb salvage.

[Therapeutic potential of a biomedical cellular product in rats with lower limb ischaemia]. / Terapevticheskii potentsial biomeditsinskogo kletochnogo produkta pri ishemii nizhnikh konechnostei u krys.

Critical ischaemia of lower limbs is a cause of death and invalidity in the whole world. Stem cells and products of their secretion find wide application in treatment of vascular diseases, including critical ischaemia of the lower limbs. Erythropoietin promotes an increase in the angiogenic potential of stem cells. The authors examined the therapeutic potential of a biomedical cellular product (mesenchymal stem cells and products of their secretion) and mesenchymal stem cells with erythropoietin on the processes of restoration of vessels in the hind legs of Wistar male rats following induction of lower limb critical ischaemia. Mesenchymal stem cells were derived from the bone marrow of male Wistar rats. Critical ischaemia of hind legs was modulated by transaction of the femoral artery. The parameters of microcirculation in the foot were assessed with the help of laser Doppler flowmetry. In the blood serum and crural muscles by means of solid-phase enzyme immunoassay we examined the levels of cytokines, growth factors, and persistent metabolites of nitrogen oxide - nitrites. Muscles morphology and the number of blood vessels were assessed by the findings of histological examination. It was shown that the biomedical cellular product alone and in combination with erythropoietin stimulated angiogenesis. The results of Doppler flowmetry revealed restoration of the parameters of microcirculation in the lower limb by 35-75% of the baseline values. Besides, we observed a decrease of muscle necrosis, connective tissue proliferation, and an increase in the number of the vessels supplying the muscles in the experimental groups. It was also determined that the biomedical cellular product influenced the levels of cytokines in blood serum and crural muscles. Hence, the obtained findings proved the therapeutic potential of the biomedical cellular product in critical ischaemia of lower limbs.

[Does an attempt to save a limb always prolong the patient's life?] / Vsegda li popytka sokhranit' konechnost' prodlevaet zhizn' patsienta?

AIM: The purpose of the study was to examine overall survival and the incidence of major adverse cardiovascular events, as well as economic expenditures for treatment of patients with occlusion of the femoropopliteal-tibial segment and critical ischaemia in low competence of the outflow channel, with a poor prognosis for endovascular or open revascularization of lower-limb arteries. PATIENTS AND METHODS: We studied the results of treating a total of 68 patients with lower-limb critical ischaemia and low parameters of the outflow channel competence. Primary arterial reconstruction was performed in 48 cases. At various terms after revascularization due to thrombosis of the reconstruction zone and the development of gangrene, amputation of the lower limb was performed: at 3 to 11 (n=25) and at 12 to 24 (n=25) months. Primary amputation of the lower limb was performed in 20 patients. The endpoints of the study included overall survival, the incidence of major adverse cardiovascular events, and economic expenditures for the in-hospital treatment. The average duration of follow-up amounted to 2 years. RESULTS: The obtained findings demonstrated that in patients with lower-limb critical ischaemia and low parameters of the outflow channel competence, redo arterial reconstructions and amputation within 11 months, as well as a high level of surgical risk were associated with a low overall survival rate and the development of major adverse cardiovascular events in the remote period. Secondary surgical interventions on the major vessels significantly increased the cost of treatment.

[Problems and prospects of cell therapy for critical ischaemia of lower limbs]. / Problemy i perspektivy kletochnoi terapii kriticheskoi ishemii nizhnikh konechnostei.

BACKGROUND: Cell therapy was proposed as a procedure of indirect revascularization for patients with critical ischaemia of lower extremities for whom endovascular and surgical revascularization is impossible. We present herein a review of the state of the art of studies in the field of cell therapy of this cohort of patients. BASIC PROVISIONS: Cell therapy has proved safe, however, the results of studies of efficacy are relatively ambiguous and unconvincing. The number of patients in separately taken clinical trials is minimal. The reviewed studies differed not only by heterogeneity of the cell types used but by the routes of administration of cells (cells were delivered either intramuscularly (predominantly) or intraarterially) and the duration of follow up (time of assessment and duration of follow up varied from 1 month to 2 years). One of the problems became the lack of the routine study of the angiogenic potential of stem cells prior to their clinical application. It is known that the angiogenic activity of multipotent cells of apparently healthy patients may differ from that of patients suffering from atherosclerosis, chronic renal failure, diabetes. CONCLUSIONS: It is supposed that treatment with stem cells or precursor cells is more efficient as compared to protein or gene therapy not only owing to direct vasculogenic properties but a paracrine action through excretion of proangiogenic biologically active substances. More studies with larger cohorts are necessary to provide stronger safety and efficacy data on cell therapy. Besides, a promising trend in the field of cellular approaches is modulation of regenerative capability of stem cells, which may help overcome difficulties in understanding the place of cell therapy in therapeutic angiogenesis.

[Efficacy of treatment of lower-limb critical ischaemia by methods of indirect revascularization]. / Éffektivnost' lecheniia kriticheskoi ishemii nizhnikh konechnostei metodami nepriamoi revaskuliarizatsii.

AIM: The study was aimed at comparing the efficacy of implantation of autologous bone marrow cells with that of revascularizing osteotrephination in treatment of lower limb chronic critical ischaemia in patients with a poor distal vascular bed. PATIENTS AND METHOD: We analysed the results of comprehensive examination and treatment of a total of 60 patients presenting with lower limb chronic critical ischaemia due to atherosclerotic lesions of the femoropopliteal-tibial segment. According to the technology of treatment, the patients were divided into two statistically homogenous groups of 30 people each. Group One patients underwent standard revascularizing osteotrephination and Group Two patients in accordance with the original technique received intramuscular implantation of 40 ml of autologous bone marrow cells, with this volume distributed in 2-ml injections to 20 points of the muscles of the crus and femur along the internal and external surface. RESULTS: The use of the original technique of treatment made it possible to achieve the clinical status in the form of moderate or minimal improvement 6 months after bone marrow cells implantation in 29 (96.7%) patients and after 12 months in 28 (93.3%) patients, whereas after revascularizing osteotrephination in 25 (83.3%) and 20 (66.7%) patients, respectively. In the remote period after 12 months, the limb was saved in 28 (93.3%) and 26 (86.7%) patients in Group Two and Group One, respectively. The patients of the second group as compared with those of the first group after 12 months demonstrated a statistically significant increase in the physical health component by 19.8% and the mental health component by 9.8%. CONCLUSION: Implantation of autologous bone-marrow cells in chronic critical limb ischaemia is pathogenetically substantiated and makes it possible to optimize the results of treatment of patients.

[Outcomes of revascularizing operations on lower-limb arteries in patients with critical ischaemia and multifocal atherosclerosis]. / Iskhody revaskuliariziruiushchikh operatsii na arteriiakh nizhnikh konechnostei u bol'nykh s kriticheskoi ishemiei i mul'tifokal'nym aterosklerozom.

The purpose of this study was to evaluate the amputation-free survival rate and predictors of major adverse cardiovascular events (extracardiac and cardiac mortality, non-fatal myocardial infarction, non-fatal stroke) in patients with atherosclerotic occlusive-stenotic lesions of the femoropopliteal-tibial segment and critical ischaemia. We analysed the results of treating a total of 122 patients with atherosclerotic lesions of the superficial femoral artery and lower limb critical ischaemia. Of these, 35 patients had no lesions of other arterial basins, 24 patients presented with a concomitant lesion of the carotid basin, 41 subjects had lesions of the coronary basin, and 22 had lesions of the coronary and carotid basins. The patients were subjected to either bypass graft operation (n=75) or endovascular intervention (n=47). The evaluated outcome measures were amputation-free survival and the frequency of major adverse cardiovascular events. The average duration of follow up amounted to 38.2±4.3 months. The carried out multivariate logistic regression analysis demonstrated that the factors associated with lower limb amputation and the development of major adverse cardiovascular events were as follows: a concomitant lesion of the coronary (p=0.044) and coronary-carotid (p<0.05) basins, a history of endured myocardial infarction (p=0.003), a C-reactive protein level not less than 17.0 mg/l (p<0.05) and the value of the apolipoprotein B/A1 ratio above 1.0 (p=0.004).

[Choice of reconstructive operation in lesions of femoropopliteotibial segment and dubious outflow pathways]. / Vybor rekonstruktivnoi operatsii pri porazheniiakh arterii bedrenno-podkolenno-bertsovogo segmenta i somnitel'nykh putiakh ottoka.

We analysed the results of surgical treatment of 40 patients with lower limb critical ischaemia induced by atherosclerotic lesion of arteries of the femoropopliteotibial segment with dubious outflow pathways. The patients were divided into two groups of 20 each. Group One patients underwent autovenous femoropopliteal or tibial bypass grafting below the fissure of the knee joint and Group Two patients were subjected to profundoplasty with closure of the arteriotomic opening with an autovenous patch. The outflow pathway index in Group One amounted to 7.5±0.09 and in Group Two to 7.45±0.08. Our findings suggest that the use of profundoplasty as reconstructive operation in patients with dubious outflow pathways is pathogenetically substantiated, because it makes it possible to decrease the rate of early postoperative complications by 20% and that of late bypass thromboses by 25%, as well as to increase the level of the physical component of health by 12.1% and that of mental health by 3.2%. A conclusion drawn is that performing profundoplasty in this cohort of patients is appropriate and effective.

Diagnosis and surgical treatment of a persistent sciatic artery aneurysm. / Diagnostika i khirurgicheskoe lechenie anevrizmy atipichnoi sedalishchnoi arterii.

The persistent sciatic artery is situated superficially in the gluteal region wherein it can be traumatized in normal daily activities: during a prolonged sitting position or while attempting to sit down. This leads to an early atherosclerotic lesion of the sciatic artery, to the development of aneurysmatic dilatation, and damage to the arterial wall. The present article describes a 72-year-old female patient presenting with a persistent sciatic artery of the left leg and a PSA aneurysm which consequently resulted in critical ischaemia of her left lower limb. This abnormality was detected during an examination and the woman was subjected to the operation of internal iliac-posterior tibial bypass grafting using an autologous vein with ligation of the sciatic artery. The bypass graft has been functioning for 5 months, with no events of critical ischaemia.

Plasma exchange and intravenous immunoglobulin for the peri-operative management of type 2 heparin-induced thrombocytopaenia in a patient requiring urgent surgery for critical limb ischaemia.

We report the case of a 61-year-old female who developed heparin-induced thrombocytopaenia following treatment of a submassive pulmonary embolism, and who then required an above knee amputation for critical limb ischaemia. Heparin-induced thrombocytopaenia is a rare, immune-mediated complication associated with an in-hospital mortality rate of 10%. It is more common in surgical patients, with patients undergoing orthopaedic surgery more likely to develop it than patients undergoing cardiac surgery, but heparin-dependent immunoglobulin G antibodies are more likely to be formed in the latter. Peri-operative management remains a challenge. Ideally, it is preferable to wait for the platelet count to improve; but in certain cases, surgery cannot be delayed. Heparin-induced thrombocytopaenia is usually managed with direct thrombin inhibitors, such as argatroban and bivalirudin. Newer therapeutic modalities, such as plasmapheresis and intravenous immunoglobulin, as used in this case, can rapidly remove antibodies, but the certainty of evidence is low. Our case adds to the literature regarding the use of these modalities and highlights the multidisciplinary team approach required to manage such complex cases.

Mechanical rotational thrombectomy with Rotarex system augmented with drug-eluting balloon angioplasty versus stenting for the treatment of acute thrombotic and critical limb ischaemia in the femoropopliteal segment.

INTRODUCTION: Mechanical thrombectomy is an alternative to local thrombolysis for the treatment of severe ischaemia in the femoropopliteal segment, but stent implantation is usually required after this procedure. The use of drug-eluting balloons (DEBs) may overcome long-term problems associated with stents, but it remains unclear how often such a treatment is technically feasible and efficient. AIM: This post hoc single-centre study was aimed at assessment of the feasibility, safety and efficacy of mechanical thrombectomy followed by application of DEBs. MATERIAL AND METHODS: Fifty-one patients, aged 69.1 ±11.6 years, were managed for acute thrombotic or chronic critical ischaemia in the femoropopliteal segment using the Rotarex device. Following mechanical thrombectomy, on condition that there was no significant residual stenosis or dissection, lesions were managed with paclitaxel-coated DEBs, which was a desired strategy (24 patients). The remaining 25 patients underwent stent implantations, which was regarded as bailout treatment. Final follow-up was scheduled 12 months after the procedure. RESULTS: The primary-assisted patency rate after mechanical rotational thrombectomy with additional balloon angioplasty and/or stenting was 97.1% (49 patients). The early mortality rate was 2.0% (1 patient) and the amputation rate was 4.1% (2 patients). There were no late mortalities or limb amputations at 12-month follow-up, but significant restenoses occurred in 13 (27.1%) patients. These restenoses were more frequent in patients who underwent stent implantation (45.5%) than those managed with DEBs (12.5%), and in patients managed for secondary lesions. CONCLUSIONS: In selected patients mechanical rotational thrombectomy in the femoropopliteal segment followed by application of DEB is a safe, effective and long-lasting method of revascularisation.

Perioperative and long-term all-cause mortality in patients with diabetes who underwent a lower extremity amputation.

INTRODUCTION: Long-term mortality of patients with diabetes who undergo lower extremity amputation (LEA) has not been reported in Spain. METHODS: The retrospective cohort included all subjects who underwent LEAs from January 1, 2005 to December 31, 2015 in San Jorge Hospital, Huesca, Spain. Live status of every patient up to September 2017 and the date of death were retrieved using the national death index. RESULTS: The series included 203 patients: 116 patients (57.1%) underwent a minor amputation and 87 patients (42.9%) underwent a major amputation. Twenty-five patients (12.3%) died in the perioperative period. Significant risk factors of perioperative mortality were undergoing an above-the-knee amputation, postoperative cardiac complications, age >74 years and acute renal failure. Survival rates at 1, 3, and 5 years were 90.6, 72.8, and 55.5% in patients who underwent a minor amputation compared with 70.8, 41.3, and 34.4% in patients who underwent a major amputation, respectively. Log-rank test between the two groups was χ2 = 12.7 (p < 0.01). CONCLUSIONS: Long-term survival was worse in patients who underwent a major amputation with a 5-year mortality of 65.6%. This mortality is worse than what has been reported for some types of common malignancies.

Evidence-based management of Raynaud's phenomenon.

Raynaud's phenomenon (RP) is relevant to the rheumatologist because it may signify an underlying connective tissue disease and also because it can be very challenging to treat, especially when it has progressed to digital ulceration or critical ischaemia. This review article discusses diagnosis (does this patient have an underlying connective tissue disease?), including the role for nailfold capillaroscopy, and treatment. Management of 'uncomplicated' RP is first described and then treatment of RP complicated by progression to digital ulceration or critical ischaemia, highlighting recent advances (including phosphodiesterase type 5 inhibition, and endothelin 1 receptor antagonism) and the evidence base underpinning these. Possible future therapies are briefly discussed.