"Ranger BTK" a Prospective Single-Centre Cohort Study on a New Drug-Coated Balloon for Below the Knee Lesions in Patients with Critical Limb Ischemia.

PURPOSE: Restenosis remains a limitation of endovascular angioplasty with a patency of 30% in BTK at 12 months. Several studies on drug-coated balloons have not demonstrated any improvements in terms of patency and target lesions revascularization in BTK lesions. This prospective single-centre cohort study evaluates the safety and efficacy of a new generation low-dose drug-coated balloon (DCB) with a reduced crystalline structure to treat below the knee (BTK) lesions in patients with critical limb ischemia (CLI). MATERIALS AND METHODS: Between November 2016 and November 2017, 30 consecutive patients (mean 68.8 ± 12.7 years, 6 female) with BTK lesions and CLI were included in this single-centre, prospective non-randomized cohort study. All patients with rest pain and/or ischemic wound associated with BTK lesions were included in the study. Mean lesion length was 133.6 ± 94.5 mm and 18(60%) were chronic total occlusions. The primary safety outcome parameter was a composite of all-cause mortality and major amputation at 6 months. The primary efficacy outcome parameter was the primary angiographic patency at 6 months (defined as freedom from clinically driven target lesion revascularization and the absence of significant restenosis (> 50%) as determined by core laboratory angiography assessment. Immediate technical success, late lumen loss (LLL), clinical target lesion revascularization (TLR) and ulcer healing rates at 12 months were also evaluated. RESULTS: Immediate technical success was 97%(29/30): one patient had an acute thrombosis at the completion of index procedure. Primary safety outcome parameter was 94%(28/30): one patient underwent major amputation and one patient died of other comorbidities at 2 months. Another patient had a major amputation at 7.5 months. Angiographic follow-up was available in 20 patients. Primary angiographic patency was 57%(12/21 lesions), and LLL was 0.99 ± 0.68 mm at 6 months. Freedom from TLR was 89% at 12 months. The rate of ulcer healing was 76% at 12 months. CONCLUSION: Ranger DCB balloons to treat CLI patients demonstrated a positive trend with good safety outcomes parameters. Further randomized studies are needed to understand the usefulness compared to POBA.

Vascularity of the Proximal Fibula and Its Implications in Vascularized Epiphyseal Transfer: An Anatomical and High-Resolution Computed Tomographic Angiography Study.

BACKGROUND: Various vascular pedicles have been used to supply the proximal fibula for vascularized epiphyseal transfer. The optimal pedicle has, however, not been agreed on. This study aimed to describe the detailed vascular anatomy of the proximal fibula to assist the surgeon in choosing the optimal pedicle. METHODS: Twenty-eight lower extremities were injected with latex or a mixture of latex and barium sulfate. Vessels supplying the proximal fibula were identified and dissected, and the course, diameter, anatomical relations, length, and branches were documented. In the barium group, high-resolution computed tomographic scanning was conducted before dissection. In seven specimens, branches of the deep peroneal nerve to the tibialis anterior muscle were carefully preserved, and their relation to the proximal fibular vascularity was noted. RESULTS: An anastomotic vascular network supplied the proximal fibula. This was formed superiorly by branches of the inferior lateral genicular artery, and inferiorly by branches of the anterior tibial artery, the most important of which were the first and second recurrent epiphyseal arteries. One or more deep peroneal nerve branches passed deep to the first recurrent epiphyseal artery in all specimens examined. In five specimens, all of the branches were superficial to the second recurrent epiphyseal artery, whereas two had branches deep to it. CONCLUSIONS: The proximal fibula can be transferred using the inferior lateral genicular or anterior tibial artery because of the existing anastomosis. Factors including length of pedicle, potential for nerve injury, and diaphyseal portion to be harvested should be considered in the pedicle choice.

Case of lower limb revascularisation using composite sequential bypass graft with a 'diamond' intermediate anastomosis.

In patients with critical infracrural disease, autologous saphenous vein grafting offers the best reported conduit patency and limb salvage rates but is only feasible in approximately 30% of patients due to the lack of available or suitable vein. In the absence of a suitable length of available vein, various composite grafting techniques have been explored with the aim to improve graft longevity, maximise native vein use and improve overall clinical outcomes, including limb salvage rates. We report a case of a 66-year-old man with critical limb ischaemia and a history of venous disease, where a complex composite sequential bypass graft combining both native vein and synthetic graft, incorporated into a novel intermediate anastomotic technique in a 'diamond' configuration, offered promising results in limb salvage. This case highlights the key steps and advantages in this novel technique.

Peripheral Vascular Restenosis: A Retrospective Study on the Use of Drug-Eluting Balloons in Native Arteries, Vein Grafts and Dialysis Accesses.

BACKGROUND AND AIMS: The objective of this study is to analyze outcomes of the first experiences with drug-eluting balloons in native arteries, vein grafts, and vascular accesses. The study is also a pilot for our future prospective, randomized, and controlled studies regarding the use of drug-eluting balloons in the treatment of the stenosis in bypass vein graft and dialysis access. MATERIALS AND METHODS: A total of 93 consecutive patients were retrospectively analyzed and in the end 81 were included in the study. Inclusion criteria included at least one previous percutaneous angioplasty to the same lesion. Patients were divided into three groups according to the anatomical site of the lesion: native lower limb artery, vein bypass graft, or vascular access. Time from the previous percutaneous angioplasty to the drug-eluting balloon was compared to the time from the drug-eluting balloon to endpoint in the same patient. Endpoints included any new revascularization of the target lesion, major amputation, or new vascular access. RESULTS: The median time from the drug-eluting balloon to endpoint was significantly longer than the median time from the preceding percutaneous angioplasty to drug-eluting balloon in all three groups. This difference was clearest in native arteries and vein grafts, whereas the difference was smaller from the beginning and disappeared over time in the vascular access group. No significant differences were seen between the groups with regard to smoking, antiplatelet regime, diabetes, Rutherford classification, or sex. CONCLUSION: Although the setup of this study has several limitations, the results suggest that there could be benefit from drug-eluting balloons in peripheral lesions. Very little data have been published on the use of drug-eluting balloons in vein grafts and vascular accesses, and randomized and controlled prospective studies are needed to further investigate this field.

Bacteria of leg atheromatous arteries responsible for inflammation.

BACKGROUND: Ischaemia of the lower limbs is frequently followed by inflammation and, in advanced cases, necrosis of peripheral tissues. Whether this is caused by arterial hypoperfusion only or by the presence of bacteria in the arterial walI as well remains unclear. The aim of the study was to prove the presence and source of bacteria in arterial specimens and evaluate their chemotactic properties resulting in the formation of periarterial cellular infiltrates. MATERIALS AND METHODS: Bacterial culture and testing for 16sRNA were performed in fragments of popliteal artery harvested from amputated limbs. Carotid artery plaques served as controls. Fragments of arteries were transplanted into scid mice to evaluate their chemotactic activity for macrophages. RESULTS: a) higher prevalence of isolates and 16sRNA in atherosclerotic popliteal than carotid arteries, b) high density of plaque and periarterial infiltrates and mRNA level for pro-inflammatory cytokines in popliteal arteries, c) prevalent microbes were Staphylococcus aureus, S. epidermidis and Enterococci, d) foot skin and arterial bacterial phenotypes and DNA revealed evident similarities, and e) more intensive mouse macrophage accumulation in popliteal than carotid implants into scid mice. CONCLUSIONS: The presence of bacteria in the lower limb arterial wall was documented. They may predispose to inflammation secondary to ischaemic changes.

Thrombolysis of occluded femoropopliteal graft with locally delivered human plasmin.

INTRODUCTION: Acute lower limb ischemia results from thrombosis or embolization of diseased native artery or previously implanted bypass graft. When this occurs, several options are available to restore blood flow: catheter-directed thrombolysis, mechanical thrombectomy or open surgery. Fundamental reasons to apply percutaneous interventions are avoiding open procedures in high risk patients, and avoiding difficult dissection through scar tissue. CASE OUTLINE: A 67-year-old male was admitted at our Institution for critical limb ischemia. After performed angiography the diagnosis of occluded femoropopliteal graft was established. Occlusion was resolved by catheter-directed thrombolysis with plasmin. Culprit lesions were treated by angioplasty. CONCLUSION: Our patient underwent a successful thrombolysis of occluded femoropopliteal graft with locally-delivered human plasmin.

Medial sural artery perforator flap aided by preoperative computed tomography angiography mapping for tongue reconstruction.

The purpose of this paper is to present an innovative method for tongue reconstruction after cancer ablation using the medial sural artery perforator flap with the aid of preoperative computed tomography angiography (CTA) mapping. We describe the case of one patient treated with this technique and illustrate the anatomy of perforator vessels and the surgical techniques used in flap harvest. CTA was applied preoperatively to assess the number and location of medial sural artery perforators. The result obtained was both aesthetically and functionally satisfactory. The flap presented has the advantage of less donor site morbidity, and being thin, it is a suitable option for tongue reconstruction including that of a hemiglossectomy defect. CTA is an effective means of improving the safety of flap harvest.

Contemporary infrapopliteal intervention for limb salvage and wound healing: harmonization of revascularization and wound management.

Infrapopliteal arterial disease is a significant cause of critical limb ischemia (CLI), whether single-segment or multisegment disease. The collaboration between the tremendous advancements in endovascular technology and the refinement of endovascular techniques has renewed the classic infrapopliteal interventions during the past decade. With this paradigm shift in the treatment of CLI, the role of a comprehensive approach of different disciplines for tissue loss is becoming greater. Given the increasing global burden of CLI, we review the cutting-edge diagnostic and endovascular approaches to infrapopliteal artery disease, and the importance of wound management in optimizing clinical outcomes.

[Free vascularized popliteal artery cutaneous branch flap for repair of wound on foot and ankle].

OBJECTIVE: To investigate the feasibility and effectiveness of free popi iteal artery cutaneous branch flap anastomosed with lateral tarsal artery and vein for the repair of wound on the foot and ankle by anatomical observation and clinical application. METHODS: Latex was poured into the blood vessels of 8 cadavers, then perforator vessel of posterolateral upper calf was dissected, and the popl iteal artery cutaneous branch flap was designed with a pedicle of 2.5 cm in length; the lateral tarsal artery of the foot was dissected, could be freed to 6 cm in length; the diameter of these vessels was measured, and the number of the accompanying veins was counted. Between March 2010 and January 2013, 13 cases of foot and ankle wounds were repaired with popliteal artery cutaneous branch flap anastomosed with lateral tarsal artery and vein. The size of flaps ranged from 6.0 cm x 4.0 cm to 7.5 cm x 5.5 cm. There were 11 males and 2 females, aged from 41 to 65 years (mean, 47.3 years). The causes of injury included traffic accident in 8 cases, crushing in 4 cases, and twist by machine in 1 case. The size of wounds, ranged from 5.0 cm x 3.5 cm to 7.0 cm x 5.0 cm. The donor sites were sutured directly. RESULTS: According to anatomical observation, the popliteal artery cutaneous branch flap was designed by using the lateral popliteal artery perforator for shaft. The vessel of the pedicle perforator flaps from the popliteal artery cutaneous branch flap matched well with the lateral tarsal artery. CLINICAL RESULTS: vascular crisis occurred in 2 flaps, which survived after symptomatic treatment; the other flaps survived, with primary healing of wound and incision at donor site. The patients were all followed up 5-18 months (mean, 11 months). The flap had normal color and good elasticity. Second stage operation was performed to make the flap thinner in 3 female patients because of bulky flaps. The remaining patients had no obvious fat flap. According to American Orthopaedic Foot and Ankle Society (AOFAS) score for evaluation of the ankle function at 6 months after operation, the results were excellent in 7 cases, good in 5 cases, and fair in 1 case, with an excellent and good rate of 92.3%. CONCLUSION: Free popliteal artery cutaneous branch flap anastomosed with lateral tarsal artery and vein for the repair of wound on the foot and ankle is simple and effective. The donor site is hidden.

The diabetic patient has a higher benefit from infrapopliteal revascularization than the non-diabetic patient: a 10-year retrospective study.

OBJECTIVE: The objective of this article is to evaluate the limb salvage and patency rates after crural arterial revascularization, differences between graft material and co-morbidities. PATIENTS AND METHODS: All patients with crural artery bypasses were analysed retrospectively in a single centre (Department of Vascular Surgery, Thüringen Kliniken Saalfeld, Rudolstadt, Germany) over a 10-year period (1996-2006); 157 patients with 170 consecutive arterial reconstructions could be included. RESULTS: Follow-up time was 55 months (6-119). Median age of the 56 women and the 101 men at the time of operation was 70 years (45.6-93.6). The five-year secondary patency rates were 71.5 ± 6.22% (vein), 44.3 ± 10.8% (composite; p = 0.0011), 52.6 ± 13.4% (prosthetic graft with distal vein cuff/patch; p = 0.00953) and 42 ± 12% (prosthetic graft without distal vein cuff/patch; p = 0.00443). Limb salvage rates after five years were 79.5 ± 5.8%, 61.6 ± 10.3%, 77.9 ± 11.3% and 70.1 ± 14.7%, respectively. Cumulative limb salvage rate was significantly higher in diabetic patients (78.9 ± 4.9%), than in non-diabetic patients (66.6 ± 6.8); p = 0.023. CONCLUSION: Crural reconstruction is a suitable method for peripheral arterial occlusive disease to prevent amputation, particularly in diabetics.

[Research progress of soft tissue defect repair around the knee].

OBJECTIVE: To review the research progress of the skin flap, fascial flap, muscle flap, and myocutaneous flap for repairing soft tissue defects around the knee so as to provide information for clinical application. METHODS: Domestic and abroad literature concerning the methods of soft tissue repair around the knee in recent years was reviewed extensively and analyzed. RESULTS: Fascial flaps meet the requirements of thin, pliable, and tough skin in the soft tissue repair around the knee. Myocutaneous flaps and muscle flaps have more abundant blood supply and anti-infection function. Free skin flaps are the only option when defects are extensive and local flaps are unavailable. CONCLUSION: Suitable flaps should be chosen for soft tissue repair around the knee according to defect position, depth, and extent. Fascial flaps may be selected as the first flaps for defects repair because of excellent aesthetic results and less injury at the donor site.

[Role of low-dose acetylsalicylic acid in comprehensive postoperative treatment of patients with lower-limb chronic arterial insufficiency].

The study comprised a total of 107 patients (all men) after endured femoropopliteal bypass grafting above the genicular fissure with a synthetic stent graft manufactured by the Gore Company for stage IIB and III chronic arterial insufficiency of the lower extremities according to the Fontain-Pokrovsky classification. Group One I (control group) was composed of fifty-four patients permanently taking in the postoperative period at the out-patient stage pentoxiphylline (trental 400 mg 1 tablet 3 times daily) and xantinol nicotinate at a dose of 150 mg one tablet thrice daily. Group Two (Study Group) consisted of fifty-three patients taking after reconstructive vascular surgery at the out-patient stage in addition to pentoxiphylline and xantinol nicotinate acetylsalicylic acid (cardiomagnil 75 mg 1 tablet once daily). The Control Group patients within 3 to 6 months of follow up were found to have a considerable progressing improvement of the functional abilities of the microcirculatory bed requiring in 44 (81.5%) cases hospitalization to the Surgical Department for intensive vascular therapy. Despite this fact four (7.4%) patients within the time frame from 6 to 9 months after surgery developed thrombosis of the vascular implant requiring a repeat surgical intervention. In the Study Group patients, the degree of functional capabilities of the microcirculatory bed in the postoperative period was less considerable, reaching the maximum after 10-12 months of follow up, with eighteen (34.0%) patients requiring hospitalization for additional vascular therapy to perform. There were no cases of implants' thrombosis in the Study Group patients. Pathological alterations in the functional state of the peripheral vascular bed correlated with viscosimetric indices and activity of blood platelet aggregation. The addition of antithrombocytic agents to conservative postoperative therapy considerably improved the outcomes of surgical treatment.

[Surgical mistakes in treatment of patients with lower limbs' critical ischemia].

The immediate and long-term results of the operative treatment of 473 patients with lower limbs' critical ischemia were analyzed. The ischemia was caused by vascular damage under the level of Pupart ligament. All patients overcame direct and indirect surgical revascularization procedures. The results of the reconstructive operations depended directly upon the transplant permeability both in early and long-term periods. Thus, the shunt thrombosis by femoral-popliteal bypass above the popliteal joint space was 7.5-10.7%, not depending on the operative technique. Whereas, the shunt thrombosis by femoral-popliteal bypass below the popliteal joint space was 8.5-37.0%, directly depending on the operative technique. The thrombosis frequency after femoral-tibial bypass was in between 28.3-100.0%. The comparative analysis proved obvious advantages of direct and combined revascularisations.

The superior lateral genicular artery flap for soft-tissue reconstruction around the knee: clinical experience and review of the literature.

Soft-tissue reconstruction in the knee area needs thin, pliable, and tough skin. The availability of local soft tissue, which would meet the requirements best, is limited. This study is a retrospective analysis of our clinical experience with the superior lateral genicular artery (SLGA) flap for soft-tissue reconstruction around the knee, and a review of the relevant literature. Between 2000 and 2002, 6 SLGA flaps were elevated for reconstruction of defects around the knee in our institution. Indications for the SLGA flap were chronic ulcers after bursectomy of the prepatellar bursa, a pressure ulcer over the patella, and a defect after resection of a malignant fibrous histiocytoma on the anterolateral aspect of the distal thigh. There was no flap loss in any of our 6 patients. Three patients had partial tissue loss at the distal tip of the flap. Two of the 3 resulting wounds were effectively covered with split skin graft, the third one eventually healed with wound care. Primary donor site closure was possible in all cases. There were no late complications, either in the flap area or in the donor site region. We conclude that the SLGA flap is a good option for defect coverage around the knee, because of its fast and easy harvest and the very good aesthetic results.

In situ saphenous vein bypass grafting - still first line treatment? A prospective study comparing surgical results between diabetic and non-diabetic populations.

BACKGROUND: This prospective study compares results of infrainguinal revascularisation with autologous vein in diabetic and non-diabetic populations. PATIENTS AND METHODS: 101 patients (diabetics (A) n = 50 and non-diabetics (B) n = 51) were operated upon with an in situ saphenous vein bypass to the popliteal artery below knee or to crural arteries, due to critical ischemia. Data on operative details, morbidity, mortality, secondary interventions and graft patency, were collected prospectively. All patients were followed up for 5 years. RESULTS: The two groups were similar except that diabetics more often suffered from gangrene or tissue loss. The distal anastomoses were constructed significantly more distally in diabetics. There were no differences in perioperative bleeding, length of operation, hospital stay or 30 d mortality. The 5 year patency did not differ significantly between groups, A 68 % vs. B 72 %. The limb salvage was equal in both groups, 86 % after 5 years. Mortality during follow up was significantly higher among diabetics, at two years A 31 % vs. B 14 %. CONCLUSIONS: Distal revascularisation with in situ technique is a durable procedure that can be performed with very good results in both diabetics and non-diabetics. The survival among diabetics is however significantly lower, although reaching 69 % at two years.

Bypass grafting for infrapopliteal occlusive disease with poor distal flow on angiography.

OBJECTIVE: We aimed to investigate whether limb-salvage bypass operation improves outcomes in patients with critical infrapopliteal ischemia and poor or no distal arterial flow on angiography. METHODS: Forty-nine patients with severe tibial and peroneal occlusive disease and poor distal arterial flow on angiography were included in this prospective study. The age ranged from 57 to 82 years in the surgical group and 63 to 80 in the medical group. Patients had class III or IV disease according to Fontaine classification. Preoperative arterial Doppler ultrasonography and arteriography were performed in all patients. The ankle-brachial index (ABI) was calculated preoperatively and postoperatively in all of the cases. Twenty-three patients underwent distal bypass operation. Other 26 patients were followed with medical therapy. The outflow distal anastomoses were performed on posterior tibial, dorsal pedal, anterior tibial, peroneal, and lateral plantar arteries. All patients were followed-up for 3 years and clinical outcomes were recorded. The statistical analyses were performed using unpaired t, Mann Whitney and Wilcoxon tests. RESULTS: There were 3 early and 2 late graft failures. Limb salvage rates were 84.2%, 84.2%, 73.7% in the surgical group, and 82.8%, 69.9%, 64.3% in the medical group respectively in 6 months, 1 year, and 3 years. According to statistical analysis; the levels of the amputations tend to be lower in the surgical group than in the medical group but it was not significant statistically. Surgical treatment reduced the amputation ratio (p<0.05) but medical therapy did not (p>0.05). The difference between preoperative mean ABI [0.26+/-0.06] and postoperative mean ABI [0.80+/-0.24] was significant (p<0.05). CONCLUSION: We think that limb-salvage bypass operation may be preferred for patients with critical limb ischemia and poor distal flow on angiography. Infrapopliteal bypass will provide limb salvage and a functional extremity.

[Chronic arterial insufficiency of the bellow knee arteries (retrospective study)].

The study involves 70 patients for the period from 1990 till 2001. Male are 60 of them and female are 10 patients. A total of 77 surgical procedures were performed on these patients with highest number per year are 1990 and 2001. Results are as follows: patent reconstruction--47, graft thrombosis not requiring immediate amputation--18, graft thrombosis requiring immediate amputation--11, and death in one case. Fifty five patients had grafts to the bellow the knee popliteal artery, and 23 of them received grafts to a tibial or peroneal artery. The stage distribution of patients is as follows: stage II--5 patients, stage III--50 patients, and stage IV--22 patients. Rethrombosis rate increased with the higher stages of the disease. In six cases ipsilateral deep venous thrombosis was diagnosed by duplex ultrasound study. Synthetic grafts were used in 24 of patients, nine of them received composed grafts, and in 38 cases venous conduits were employed. Diabetes mellitus was a comorbid condition in 13 patients. Thirty one (40.26%) of the grafts thrombosed.

Long term outcome of femoropopliteal bypass for claudication and critical ischemia.

We performed 167 femoropopliteal bypass surgeries in 151 patients (95 patients underwent above-knee bypass and 56 below-knee bypass) from December 1985 to December 2000 with the use of prosthetic graft or autologous vein graft. We compared primary patency rates between age, sex, graft material, distal anastomotic site and severity of ischemia, considering their survival rates to elucidate the long-term outcome of above-knee and below-knee femoropopliteal bypass. The 10 year patency rate for above-knee bypass was 47.4%, compared to 36.9% for below-knee ( p < 0.01). Better results were found after bypass surgery for claudicants than for critical ischemia ( p < 0.05). With regard to graft material and age categories, there were unexpectedly no statistical differences in either above-knee or below-knee anastomosis. The survival rate at 10 years in claudicants was 51.2%, compared to 15.9% with critical ischemia ( p < 0.01). Mortality was much influenced by ischemic heart disease ( p < 0.002) and the age of patient ( p < 0.05). The results after above-knee bypass had comparable patency, whereas the results after below-knee bypass were disappointing. Below-knee arterial reconstruction for claudicants should be carefully considered and might be recommended only to patients with critical ischemia.