Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial.

BACKGROUND: Endovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty. METHODS: This randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months. DISCUSSION: Although concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated. TRIAL REGISTRATION: ClinicalTrials.gov NCT04475783 . Registered on 17 July 2020 EUDAMED No. CIV-20-11-035172, DRKS00022452.

Implementation of the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block into a multimodal analgesic pathway for total knee replacement.

BACKGROUND: The Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block is a new anesthesiologist- administered analgesic technique for controlling posterior knee pain that has not yet been well studied in total knee arthroplasty (TKA) patients. We compared pain outcomes in TKA patients before and after implementation of the IPACK with the hypothesis that patients receiving IPACK blocks will report lower pain scores on postoperative day (POD) 0 than non-IPACK patients. METHODS: With Institutional Review Board approval, we retrospectively reviewed data for consecutive TKA patients by a single surgeon 4 months before (PRE) and after (POST) IPACK implementation. All TKA patients received adductor canal catheters and peri-operative multimodal analgesia. The primary outcome was pain on POD 0. Other outcomes were daily pain scores, opioid consumption, ambulation distance, length of stay, and adverse events within 30 days. RESULTS: Post-implementation, 48/50 (96%) of TKA patients received an IPACK block, and they were compared with 32 patients in the PRE group. On POD 0, the lowest pain score (median [10th-90th percentiles]) was significantly lower for the POST group compared to the PRE group (0 [0-4.3] vs. 2.5 [0-7]; P = 0.003). The highest patient-reported pain scores on any POD were similar between groups with no differences in other outcomes. CONCLUSIONS: Within a multimodal analgesic protocol, addition of IPACK blocks decreased the lowest pain scores on POD 0. Although other outcomes were unchanged, there may be a role for new opioid-sparing analgesic techniques, and changing clinical practice change can occur rapidly.

Traumatic Anterior Knee Dislocation with Popliteal Artery Injury: The Importance of a Prompt Diagnosis and Treatment to Obtain Lower Limb Salvage.

We report a case of traumatic anterior dislocation of the left knee in association with disruption of the soft tissues including knee ligaments, popliteal artery, and common peroneal nerve, resulting in lower limb acute ischemia. All components of this complex trauma were recognized and treated promptly. First, he was submitted to closed reduction of the dislocated knee under general anesthesia; right after he underwent superficial femoro-tibioperoneal trunk bypass using a reversed saphenous contralateral vein recurring to a posterior approach through a popliteal S-shaped incision; rehabilitation program was initiated early; a second and final reconstructive orthopedic operation was carried out in a different center. The present case is important in 2 aspects. First, it reports a very rare occurrence of simultaneous anterior dislocation of the knee associated with vascular insult and common peroneal nerve injury, which was rarely reported in the current literature; second, it highlights that with timely intervention and a team approach, excellent results could be achieved.

Endovascular revascularization of TASC C and D femoropopliteal occlusive disease using carbon dioxide as contrast.

OBJECTIVE: To analyze the results of ten angioplasties of TASC C and D femoropopliteal lesions using CO2 as primary contrast in patients with no formal contraindication to iodine, aiming to decrease allergic reactions and potential nephrotoxicity in high-risk patients. METHODS: We describe the results of ten angioplasties of TASC C and D femoropopliteal lesions using CO2 as primary contrast in patients with high risk for open revascularization and no formal contraindication to iodine. We analyzed feasibility of the procedures, complications, quality of the angiographic images, clinical and surgical outcomes, and costs of C and D lesions treated using CO2 as contrast medium. RESULTS: The use of CO2 in C and D lesions needed iodine complementation in most of the cases (nine cases) but decreased the potential nephrotoxicity of iodine contrast medium by the reduction of its volume in this group of high-risk patients. The extension of the arterial lesions was the factor that most contributed to the need for iodine supplementation due to the difficulty to visualize the refill after a long arterial occlusion. CONCLUSION: The use of CO2 as contrast in patients with C and D lesions with no restriction for iodine contrast medium was an alternative that did not dismiss the need of iodine supplementation in most of the cases, but could decrease the potential nephrotoxicity of iodine constrast medium. OBJETIVO: Analisar os resultados de dez angioplastias de lesões fêmoro-poplíteas TASC C e D utilizando CO2 como meio de contraste primário em pacientes sem restrição ao meio de contraste iodado com o objetivo de diminuir reações alérgicas e potencial de nefrotoxicidade em pacientes de alto risco. MÉTODOS: Descrevemos os resultados de dez angioplastias de lesões fêmoro-poplíteas TASC C e D utilizando CO2 como meio de contraste primário em pacientes de alto risco para revascularização aberta e sem contraindicação formal a iodo. Analisamos possibilidade de execução dos procedimentos, complicações, qualidade das imagens obtidas, desfechos clínicos e cirúrgicos e custos das lesões C e D tratadas com CO2 como meio de contraste. RESULTADOS: O uso de CO2 nas lesões C e D necessitou de complementação de iodo na maioria dos casos (nove casos), porém reduziu o potencial de nefrotoxicidade do meio de contraste iodado, diminuindo seu volume nesse grupo de pacientes de alto risco. A extensão das lesões arteriais foi o fator que mais contribuiu para necessidade de suplementação de iodo, devido à dificuldade de visualizar o reenchimento após oclusão arterial longa. CONCLUSÃO: O uso de CO2 como contraste em pacientes com lesões C e D sem restrição ao meio de contraste iodado foi uma alternativa que não excluiu a necessidade de suplementação com iodo na maioria dos casos, porém pôde diminuir o potencial de nefrotoxicidade do meio de contraste iodado.

Endovascular revascularization of TASC C and D femoropopliteal occlusive disease using carbon dioxide as contrast / Revascularização endovascular de doença oclusiva fêmoro-poplítea TASC C e D com o uso de dióxido de carbono como meio de contraste

ABSTRACT Objective To analyze the results of ten angioplasties of TASC C and D femoropopliteal lesions using CO2 as primary contrast in patients with no formal contraindication to iodine, aiming to decrease allergic reactions and potential nephrotoxicity in high-risk patients. Methods We describe the results of ten angioplasties of TASC C and D femoropopliteal lesions using CO2 as primary contrast in patients with high risk for open revascularization and no formal contraindication to iodine. We analyzed feasibility of the procedures, complications, quality of the angiographic images, clinical and surgical outcomes, and costs of C and D lesions treated using CO2 as contrast medium. Results The use of CO2 in C and D lesions needed iodine complementation in most of the cases (nine cases) but decreased the potential nephrotoxicity of iodine contrast medium by the reduction of its volume in this group of high-risk patients. The extension of the arterial lesions was the factor that most contributed to the need for iodine supplementation due to the difficulty to visualize the refill after a long arterial occlusion. Conclusion The use of CO2 as contrast in patients with C and D lesions with no restriction for iodine contrast medium was an alternative that did not dismiss the need of iodine supplementation in most of the cases, but could decrease the potential nephrotoxicity of iodine constrast medium.

RESUMO Objetivo Analisar os resultados de dez angioplastias de lesões fêmoro-poplíteas TASC C e D utilizando CO2 como meio de contraste primário em pacientes sem restrição ao meio de contraste iodado com o objetivo de diminuir reações alérgicas e potencial de nefrotoxicidade em pacientes de alto risco. Métodos Descrevemos os resultados de dez angioplastias de lesões fêmoro-poplíteas TASC C e D utilizando CO2 como meio de contraste primário em pacientes de alto risco para revascularização aberta e sem contraindicação formal a iodo. Analisamos possibilidade de execução dos procedimentos, complicações, qualidade das imagens obtidas, desfechos clínicos e cirúrgicos e custos das lesões C e D tratadas com CO2 como meio de contraste. Resultados O uso de CO2 nas lesões C e D necessitou de complementação de iodo na maioria dos casos (nove casos), porém reduziu o potencial de nefrotoxicidade do meio de contraste iodado, diminuindo seu volume nesse grupo de pacientes de alto risco. A extensão das lesões arteriais foi o fator que mais contribuiu para necessidade de suplementação de iodo, devido à dificuldade de visualizar o reenchimento após oclusão arterial longa. Conclusão O uso de CO2 como contraste em pacientes com lesões C e D sem restrição ao meio de contraste iodado foi uma alternativa que não excluiu a necessidade de suplementação com iodo na maioria dos casos, porém pôde diminuir o potencial de nefrotoxicidade do meio de contraste iodado.

Acupuncture-induced popliteal arteriovenous fistula successfully treated with percutaneous endovascular intervention.

A 39-year-old female visited our cardiovascular outpatient department with paresthesia and soreness around the right popliteal fossa, where thrill was palpable. There was no history of trauma, apart from her having undergone acupuncture several years previously. An arteriovenous fistula (AVF) was diagnosed by vascular ultrasonography and magnetic resonance imaging. Angiography confirmed the presence of an AVF fed by the medial geniculate artery. Transarterial embolization was performed to close the AVF using coils and tissue adhesive. To the best of our knowledge, acupuncture-induced AVF has not been previously reported. We present a case demonstrating the merits of percutaneous endovascular intervention for treating this rare complication. The additional administration of a tissue adhesive can achieve complete closure of the AVF in the event of an unsatisfactory result following coil embolization. Doctors should be aware of the potential vascular complications of acupuncture, and of the management options.

[Color Doppler ultrasound study on pathological changes of lower extremity arteries in patients with metabolic syndrome].

OBJECTIVE: To explore the pathological changes of lower extremity arteries of patients with metabolic syndrome. METHODS: Fifty patients with metabolic syndrome (MS) and 30 normal volunteers were included in this study. The inner diameters, peak systolic velocities and intima-media thicknesses of the lower extremity arteries, and the sizes and numbers of the plaques in the lower extremity arteries were obtained with color Doppler ultrasound (CDU). RESULTS: In the fifty MS patients, the intima-media thicknesses of forty-one were thicker than 1.1 mm and thirty-three had plaques which had brought stenosis in different degrees. The intima-media thicknesses of the common femoral, popliteal and posterior tibial arteries in the MS patients were significantly thicker than those in the normal volunteers (P<0.01 or P<0.05), and a greater number of plaques in the lower extremity arteries were observed in the patients, as compared with the normal volunteers (P<0.01). CONCLUSION: Various pathological changes had taken place in the lower extremity arteries of the MS patients. The sites and degrees of the lower extremity arterial diseases in MS patients can be definitely detected with CDU.

A non-contact complete knee dislocation with popliteal artery disruption, a rare martial arts injury.

Complete knee dislocation is a rare injury and an associated incidence of popliteal artery damage ranges from 16-60% of cases. It occurs commonly in road traffic accidents and in high velocity trauma where significant contact remains as the usual mode of injury. We describe a rare case of non-contact knee dislocation with popliteal artery injury sustained while practising Aikido, a type of martial art. This patient successfully underwent closed reduction of the knee with an emergency vein bypass graft. Similar injury in association with Aikido has not been described in the English literature previously. Various martial art injuries are briefly discussed and safety recommendations made.

[Staging-syndrome differentiation in treating diabetic foot disorder and its effect on hemodynamic changes of lower extremities with arterial ultrasonic Doppler diagnostic apparatus].

OBJECTIVE: To observe the therapeutic effect of staging-Syndrome Differentiation of TCM in treating the diabetic foot disorder and the corresponding hemodynamic changes in lower extremities. METHODS: Chromatic ultrasonic Doppler diagnostic apparatus (ATL-ULTRAMARK 9 HDI, made in USA) was used to determine the arterial hemodynamic changes and clinical effect on the treatment of diabetic foot disorder in 60 non-insulin dependent diabetes mellitus (NIDDM) patients, among them 30 were treated by staging-Syndrome Differentiation of TCM, and the other 30 as control group treated with 654-2, and the 30 cases of nondiabetic foot disorder as normal control group in comparison. RESULTS: Compared to the normal control, the intravascular diameter, blood flow of both treated groups reduced, maximal and minimal speed of blood flow, and the mean speed were accelerated. Values in dorsal pedis artery had present the most sensitive one. In the comparison between before and after treatment, both treated groups were hemodynamic improvement in the lower extremities' artery, more obviously the dorsal pedis artery, while the comparison between these two groups showed that TCM staging-Syndrome Differentiation had a superior effect on lower extremities' hemodynamics to that of 654-2 group. The comprehensive assessment revealed that the treated groups was also significant different in comparing to that of normal control group (P < 0.05). CONCLUSION: The comprehensive TCM treatment of staging-Syndrome Differentiation as the main therapeutic component was prominently better than that of 654-2 application in the treatment.

Percutaneous transluminal angioplasty: importance of anticoagulant and fibrinolytic drugs.

At the Medical University of Pécs, Hungary, percutaneous transluminal angioplasty was performed on 252 lesions in 235 patients. Primary success rate was 75%. Long femoral artery occlusions were recanalized with a 66% patency rate in lesions 10-20 cm long and a 47% patency rate in lesions longer than 20 cm. These relatively high patency rates were attributed to the use of SP 54, a fibrinolytic agent. In a group of 52 patients treated with SP 54 there were only four reocclusions, two of these occurring 12 months after angioplasty when SP 54 was discontinued. It was concluded that long occlusions may be amenable to angioplasty provided that appropriate fibrinolytic therapy is instituted after the procedure.