Diagnostic criteria for Buerger's disease: International Consensus of VAS - European Independent Foundation in Angiology/Vascular Medicine.

Buerger's disease (BD) remains a debilitating condition and early diagnosis is paramount for its effective management. Despite many published diagnostic criteria for BD, selective criteria have been utilized in different vascular centers to manage patients with BD worldwide. A recent international Delphi Consensus Study on the diagnostic criteria of BD showed that none of these published diagnostic criteria have been universally accepted as a gold standard. Apart from the presence of smoking, these published diagnostic criteria have distinct differences between them, rendering the direct comparison of patient outcomes difficult. Hence, the expert committees from the Working Group of the VAS-European Independent Foundation in Angiology/Vascular Medicine critically reviewed the findings from the Delphi study and provided practical recommendations on the diagnostic criteria for BD, facilitating its universal use. We recommend that the 'definitive' diagnosis of BD must require the presence of three features (history of smoking, typical angiographic features and typical histopathological features) and the use of a combination of major and minor criteria for the 'suspected' diagnosis of BD. The major criterion is the history of active tobacco smoking. The five minor criteria are disease onset at age less than 45 years, ischemic involvement of the lower limbs, ischemic involvement of one or both of the upper limbs, thrombophlebitis migrans and red-blue shade of purple discoloration on edematous toes or fingers. We recommend that a 'suspected' diagnosis of BD is confirmed in the presence of a major criterion plus four or more minor criteria. In the absence of the major criterion or in cases of fewer than four minor criteria, imaging and laboratory data could facilitate the diagnosis. Validation studies on the use of these major and minor criteria are underway.

An International Delphi Consensus on Diagnostic Criteria for Buerger's Disease.

BACKGROUND: Buerger's disease (BD) remains a debilitating condition. Despite multiple published diagnostic criteria for BD, none is universally accepted as a gold standard. METHODS: We conducted a 2-round modified Delphi consensus study to establish a consensus on the diagnostic. The questionnaire included statements from several commonly used diagnostic criteria for BD. Qualitative and quantitative analysis methods were performed. An agreement level of 70% was applied. RESULTS: Twenty nine experts from 18 countries participated in this study. Overall, 75 statements were circulated in Round 1. Of these, 28% of statements were accepted. Following comments, 21 statements were recirculated in Round 2 and 90% were accepted. Although more than 90% of the experts did not agree that the diagnosis of BD can be based only on clinical manifestation, none of the nonclinical manifestations of BD were agreed as a part of the diagnostic criteria. There was an agreement that a history of tobacco consumption in any form, not necessarily confined to the current use, should be a part of the diagnostic criteria of BD. The history of thrombophlebitis migrans, even if not present at presentation, was accepted as a clue for BD diagnosis. It was also agreed that discoloration of the toes or fingers could be included in the diagnostic criteria of BD. Experts agreed that histology results could differentiate BD from atherosclerosis obliterans and other types of vasculitis. The presence of corkscrew collaterals on imaging and burning pain reached the agreement at the first round but not at the second. There was no consensus regarding age cut-off, the requirement of normal lipid profile, and normal blood glucose for BD diagnosis. CONCLUSIONS: The present study demonstrated discrepancies in the various published diagnostic criteria for BD and their selective utilization in routine clinical practice worldwide. We propose that all published diagnostic criteria for BD be re-evaluated for harmonization and universal use.

Milestones in thromboangiitis obliterans: a position paper of the VAS-European independent foundation in angiology/vascular medicine.

Even today thromboangiitis obliterans has disease features that remain misunderstood or underappreciated. The epidemiology, etiology and pathophysiology of the disease are still unclear. Biomarkers and disease activity markers are lacking, thus clinical assessment is difficult. We are still struggling to establish unique diagnostic, staging and treatment criteria. This is an academic-collaborative effort to describe the pathophysiology, the clinical manifestations, the diagnostic approach, and the challenges of management of patients with TAO. A systematic search for relevant studies dating from 1900 to the end of 2020 was performed on the PubMed, SCOPUS, and Science Direct databases. Given the intriguing nature of presentation of TAO, its management, to some extent is not only different in different regions of the world but also varies within the same region. Following this project, we discovered ambiguity, overlap and lack of clear-cut criteria for management of TAO. An international group of experts however came to one conclusion. They all agree that management of TAO needs a call for action for a renewed global look with multi-center studies, to update the geographical distribution of the disease and to establish a unique set of diagnostic criteria and a consensus-based guideline for best treatment based on current evidence.

Transcutaneous Partial Pressure of Oxygen Measurement in Advanced Chronic Venous Insufficiency as a Marker of Tissue Oxygenation.

PURPOSE: Determination of oxygen concentration in tissues affected by chronic venous insufficiency (CVI) has shown inconsistent results over the years and has confounded the pathophysiology of venous diseases. This study measured transcutaneous partial oxygen pressure (TcPO2) levels in patients with CVI to assess oxygenation and variation in oxygenation according to CVI stage. Materials and. METHODS: A prospective study was performed on consecutive patients with unilateral CVI. TcPO2 of diseased and unaffected limbs was measured in the supine and dependent positions. A single TcPO2 value was measured at the site of greatest skin change or at the edge of the ulcer. The TcPO2 values were analyzed and compared according to stage. RESULTS: A total of 96 patients were included in the study with C4 (24.0%), C5 (19.8%), and C6 (56.3%) disease. The mean age was 44.7 years, and 85 (88.5%) were male. There was a statistically significant (P<0.01) difference in mean TcPO2 levels between the unaffected limb (supine, 32.1 mmHg; dependent, 50.7 mmHg), C5 diseased limb (supine, 16.6 mmHg; dependent, 35.5 mmHg), and C6 diseased limb (supine, 24.2 mmHg; dependent, 40.4 mmHg). In the supine and dependent positions, the mean TcPO2 in the affected limb was significantly lower (P<0.01) than that in the unaffected limb. CONCLUSION: TcPO2 in advanced CVI can be used as a marker of oxygenation status. This is the first study in an Indian population looking at the relevance of TcPO2 in the prognostication of advanced CVI.

Comparison of Clinical Outcomes With Drug Coated Balloons Versus Plain Balloon Angioplasty In Chronic Limb-Threatening Ischemia.

OBJECTIVE: The use of drug coated balloon (DCB) for angioplasty has shown superior efficacy against plain balloons for treating complex infrainguinal arterial disease. We report and compare the clinical outcomes following application of DCB(Paclitaxel) and plain angioplasty (POBA) in our tertiary care centre. METHODS: A retrospective, single centre analysis of 301 patients with chronic limb-threatening ischemia involving the infrainguinal segment was conducted between September 2014 and September 2018, after approval from the Institutional review board. We analyzed clinical outcomes by measuring postoperative ABI improvement, restenosis requiring reintervention procedure, minor and major amputations at the end of 18 months. . To find the association between the group variables (POBA and DCB) and other risk variables, Chi-square test/Fisher's exact test was used. Multivariable logistic regression analysis was used. RESULTS: Patients who underwent treatment with plain balloon (POBA) and DCB(Paclitaxel) angioplasty were 246(81.7%) and 55(18.3%) respectively. Our study group was predominantly male (Male: Female = 6.7:1), most patients were more than 50 years of age (n = 251, 83.4%). Smoking (n = 199, 66.1%) and diabetes (n = 210, 69.8%) were the most common atherosclerotic risk factors. Postoperative Ankle Brachial Pressure Index (ABI) improvement were similar in both groups (POBA = 57.7%; DCB = 69.8%; p = 0.103). Minor and major amputations following POBA were 26% and 22%; and DCB were 12.7% and 16.4% respectively. Re-stenosis requiring a re-interventional procedure within 18 months was 15%, (n = 37) following POBA; and 12.7% (n = 7) following DCB (p = 0.661). CONCLUSIONS: This retrospective study shows similar clinical limb related outcomes following POBA and DCB at 18 months. However, our comparative analysis between the POBA and DCB groups was totally unadjusted and not adjusted for common confounders such as age and sex. Hence, for one to draw definitive conclusions leading to changes in clinical practice; a randomized, prospective study with a larger patient cohort is needed.

Imaging criteria to predict Shamblin group in carotid body tumors - revisited.

PURPOSE: This study aims to compare the imaging findings of carotid body tumors on contrast-enhanced computed tomography (CT) with the intraoperative Shamblin grade and to evolve an imaging-based scoring system that can accurately predict the Shamblin grade. METHODS: Preoperative contrast-enhanced CT scans of 40 patients who underwent surgical excision of carotid body tumors in our institution between 2004 and 2017 were retrospectively reviewed. The angle of contact with the internal carotid artery (ICA), tumor volume, presence of peritumoral tuft of veins, loss of tumor adventitia interface and distance from the skull base were assessed and compared with the intraoperative Shamblin grades of the tumor. Ordinal logistic regression was used to determine which parameters could be predictors of the Shamblin grades. Receiver operator characteristic (ROC) curves were used to score the tumor volumes. RESULTS: Among the 42 tumors evaluated, 6 (14.3%) were surgically classified as Shamblin I, 15 (35.7%) as Shamblin II, and 21 (50%) as Shamblin III tumors. Pairwise comparison between the three Shamblin groups showed a statistically significant difference for angle of contact with ICA, maximum tumor dimension, presence of peritumoral tuft of veins and loss of tumor adventitia interface (p = 0.001, p = 0.001, p = 0.038 and p = 0.003, respectively). However, tumor volumes and distance from skull base were not significantly different between the Shamblin groups (p = 0.136 and p = 0.682). A scoring system, including four of the above mentioned parameters (angle of contact with ICA, tumor volume, presence of peritumoral tuft of veins, and loss of tumor adventitia interface) was developed with a maximum score of 8 and a minimum of 2. A statistically significant difference was found between the final scores among the three Shamblin groups (p < 0.001). Using ROC curves, a final score of ≥6 was found to separate Shamblin grade III tumors from grade I and II tumors (sensitivity, 95.24%; specificity, 71.43%). All patients with documented intraoperative estimated blood loss of >1000 mL had Shamblin grade III tumors. Postoperative complications like stroke, ICA thrombosis and lower cranial nerve palsies were seen only with Shamblin grade II and III tumors. CONCLUSION: The simple scoring system we have proposed correlates well with the Shamblin grade and helps in identifying patients who have a higher risk of developing complications.

D-dimer levels in patients with thromboangiitis obliterans.

Background: Thromboangiitis obliterans (TAO) or Buerger disease is a recurring progressive segmental vasculopathy that presents with inflammation and thrombosis of small and medium arteries and veins of the hands and feet. The exact cause remains unknown, with tobacco use (primarily smoking but also smokeless tobacco) being highly associated with the disease. The diagnosis is clinical and the lack of a diagnostic gold standard is a deterrent to diagnosing it in patients with atypical presentations. Obliterative endarteritis occurs perhaps due to a mixture of thrombosis and inflammation. The diagnostic sensitivity and specificity of D-dimer as a biomarker for thrombosis is well reported from its use in other areas such as deep vein thrombosis. Identification of a biomarker linked to the causation yields a diagnostic adjunct with a role in therapeutic decision-making, aiding diagnosis in atypical presentation, monitoring disease activity and gauging response to therapy. Methods: Between April 2014 and May 2015, we studied serum D-dimer (a marker of thrombosis) in 62 patients with TAO and compared this to 330 normal age- and sex-matched controls. We included all patients with peripheral arterial disease clinically diagnosed to have TAO according to the Shionoya criteria. There was no history of thrombosis or arterial disease in the control group. The control group was matched for baseline characteristics such as age and sex. All patients underwent a standard diagnostic protocol including blood tests (haemoglobin and creatinine), electrocardiogram, chest X-ray and ankle brachial pressure index. Blood was collected using an evacuated tube system into a citrate anticoagulant tube for testing D-dimer. Results: All the 62 patients diagnosed to have TAO were men with an average age of 40 years (range 18-65 years). They all had a history of tobacco use and did not have other atherogenic risk factors (part of the diagnostic criteria). Medium-vessel involvement was present in 53 patients (85%) and the rest presented with additional involvement of the popliteal and femoral vessels. Upper limb involvement or superficial thrombophlebitis was present in 95% of patients. Laboratory and imaging studies were consistent with TAO. The groups were well matched for age (p = 0.3). The median and interquartile range for D-dimer values were 61 ng/ml and 41-88 ng/ml in controls (n = 330) and 247 ng/ml and 126478 ng/ml in patients (n = 62), respectively (p<0.001). Conclusions: D-dimer levels are considerably elevated in patients with TAO. This indicates an underlying thrombotic process and suggests its potential role as a diagnostic adjunct. It also leads us to hypothesize a potential therapeutic benefit of anticoagulants in this disease.

A versatile stretch sensor for measuring physiological movement using a centre loaded, end-supported load cell.

Acquisition of movement of some body parts can provide important physiological information. In clinical practice as well as for research purposes different types of sensors such as piezoelectric crystals, conductive rubber and optical displacement sensors are used for such measurements. Each of these sensors is associated with its problems. This paper discusses the use of a stretch sensor constructed using a small metal bar, approximately the size of a zipper slider that can be sewn into a fabric in the form of a belt. A combination of elastic, and Velcro material attached to the metal bar, provides a sensor that is capable of linear, steady state measurement as well as rapid response detecting slow and fast movement of the target. Incorporating the sensor in an elastic belt, allows measurement of physiological movements such as respiratory chest movements, abdominal and limb movements. This paper also discusses the potential use of the novel stretch sensor in measuring change in calf circumference during different manoeuvres, making it a useful assessment tool for calf venous function.

Consensus on Management of Deep Vein Thrombosis with Emphasis on NOACs (Non-Vitamin K Antagonist Oral Anticoagulants): Recommendations from Inter-Disciplinary Group of Indian Experts.

It is estimated that around 2.5 lac patients are identified as having an acute venous thrombo-embolic event in India annually. This includes patients with deep vein thrombosis and pulmonary embolism, and is estimated to result in more than 3.7 lacs deaths each year in European countries. The 'Consensus on Management of Deep Vein Thrombosis with Emphasis on NOACs (Non-Vitamin K Antagonist Oral Anticoagulants): Recommendations from Inter-Disciplinary Group of Indian Experts' position paper was developed to assist clinicians and institutions with an evidence-based approach to the diagnosis and treatment of acute deep vein thrombosis patients. Key to the evaluation of patients with suspected deep vein thrombosis is the use of the clinician's clinical evaluation with the help of pre-test probability tools as well as judicious use of objective diagnostic tests. Our hope is that we have supplemented clinicians' clinical acumen, and assisted them and their health systems in developing best practice approaches to this ever-interesting population of patients. The Deep Vein Thrombosis Consensus Working Group welcomes your inputs on how improvements might be made on this paper in the future.

Externalized Guidewires to Facilitate Fenestrated Endograft Deployment in the Aortic Arch.

PURPOSE: To describe a precannulated fenestrated endograft system utilizing externalized guidewires to facilitate aortic arch endovascular repair and to report its use in 2 patients with challenging anatomy. TECHNIQUE: For distal arch repair, a fenestration for the left subclavian artery (LSA) is made onsite in a standard thoracic endograft tailored to the patient anatomy; it is precannulated with a nitinol guidewire (NGw), which is passed from the femoral artery and externalized from the left brachial artery prior to endograft delivery system introduction over a parallel stiff guidewire. Steps are then taken to remove guidewire intertwining, prevent NGw wrapping around the delivery system, and orient the LSA fenestration superiorly when the delivery system moves into the arch. Gentle traction on the ends of the NGw during endograft deployment facilitates proper fenestration alignment. A covered stent is deployed in the LSA fenestration. The technique is illustrated in a patient with congenital coarctation of the aorta and descending aortic aneurysm. For total arch repair, endograft fenestrations are made for all 3 arch branches; the left common carotid artery (LCCA) and LSA fenestrations are each cannulated with NGws, which travel together from the femoral artery, pass through a LSA snare loop, and are exteriorized from the LCCA. After endograft deployment, the innominate artery fenestration is separately cannulated using right brachial access. Placement of a parallel externalized hydrophilic guidewire passing through the LCCA fenestration (but not the LSA snare loop) and removal of the LCCA fenestration NGw allows exteriorization of the LSA fenestration NGw from the left brachial artery by pulling the LSA snare. Covered stents are deployed in all 3 fenestrations. The technique is presented in a patient with type B aortic dissection. CONCLUSION: Use of the precannulated fenestrated endograft system described is feasible and has the potential to make aortic arch endovascular repair simpler, more reliable, and safer.

Nonhemophiliac musculoskeletal pseudotumor.

A 24-year-old man presented with impending ulceration of a large thigh swelling which appeared after minor trauma. Imaging revealed a large well-encapsulated lesion with no vascularity. He was diagnosed to have a pseudotumor and underwent successful excision of the mass under blood and cryoprecipitate cover. The unusual presentation was suspected to be secondary to a transient drug-induced factor XIII deficiency because the result of the final coagulation study was normal.

A novel cautery instrument for on-site fenestration of aortic stent-grafts: a feasibility study of 18 patients.

PURPOSE: To report the bench-top evaluation and initial clinical use of an instrument for on-site fenestration of aortic stent-grafts. METHODS: A stainless steel thermal cautery instrument was designed to create circular stent-graft fenestrations from 3 to 10 mm in diameter. Three operators independently bench-tested the instrument on thoracic stent-graft samples to evaluate size, shape, location, and quality of fenestrations created. For clinical use, on-site fenestration was performed 2 days before the endovascular procedure in a sterile room without access to supplemental oxygen. A fenestrator 1 or 2 mm smaller in diameter than the target vessel was used; the edges of the fenestrations were strengthened using flexible radiopaque nitinol wire. The aortic stent-graft was then re-sheathed and sterilized for added safety. Eighteen patients (17 men; mean age 51 years, range 18-80) with a variety of thoracic and juxtarenal pathologies were treated using Zenith TX2, Valiant Captivia, Zenith AAA, and Endurant stent-grafts modified in this manner. RESULTS: After successful bench testing, the instrument was used to create 34 fenestrations in aortic stent-grafts deployed in the 18 patients. Size and location of fenestrations obtained were as desired. Subsequent catheterization of the fenestration/target vessel and covered stent deployment were successfully achieved in 31 (91%) fenestrations; 2 fenestrations had type III endoleaks and 1 fenestration was unused. There was no perioperative mortality, stroke, embolization, vessel dissection, renal failure, or graft infection. Follow-up to 1 year in the majority of patients has revealed no new fenestration-related problems. CONCLUSION: This simple-to-use instrument makes on-site creation of aortic stent-graft fenestrations easy, accurate, and precise. The instrument is inexpensive, robust, and easily sterilized.

Visceral ischemia: could it be segmental arterial mediolysis.

We present two cases of segmental arterial mediolysis, which can present with dissecting aneurysms or thrombosis of the visceral branches of the abdominal aorta. Segmental arterial mediolysis (SAM) causes ischemic bowel disease and has characteristic CT and angiographic features.