Systematic Review and Network Meta-analysis of Vessel Preparation Techniques With Plain Balloon Angioplasty, Atherectomy, or Intravascular Lithotripsy Before Application of a Drug Coated Balloon to Treat Atherosclerotic Femoropopliteal Disease.

OBJECTIVE: To compare one year outcomes after atherectomy, intravascular lithotripsy vs. plain balloon angioplasty before application of drug coated balloons for treating femoropopliteal atherosclerotic disease. DATA SOURCES: MEDLINE, EMBASE, and Cochrane Library were screened until May 2023 for randomised controlled trials. REVIEW METHODS: This was a systematic review and network meta-analysis. The inclusion criteria were patients with claudication and those with critical limb threatening ischaemia with lesion characteristics of all lengths, stenosis, calcification, and occlusions. Primary outcome was freedom from target lesion re-intervention at one year. Secondary outcomes were rate of bailout stenting, major amputation, and all-cause mortality at one year. Pooled point estimates were calculated with a standard random effects model. Further sensitivity analyses were completed with a mixed treatment Bayesian model. Risk of bias was assessed by the Revised Cochrane Risk of Bias tool 2 (RoB2) and certainty of evidence assessed via the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. RESULTS: Four RCTs comprising 549 patients (two studies evaluating directional atherectomy, one evaluating rotational atherectomy, one evaluating intravascular lithotripsy against plain balloon angioplasty) were included. Weighted mean length of femoropopliteal lesions was 103.4 ± 6.67 mm. Results of the mixed treatment Bayesian analysis were consistent with pooled analysis for all outcomes. There were no significant differences in freedom from target lesion revascularisation (GRADE, high) (RoB2, low), major amputation (GRADE, low), or mortality (GRADE, moderate). Bailout stenting rates were significantly reduced with intravascular lithotripsy and atherectomy compared with plain balloon angioplasty (RR 0.25, 95% CI 0.07 - 0.89) (GRADE, moderate) (RoB2, low). CONCLUSION: This review found that intravascular lithotripsy or atherectomy did not appear to incur a statistically significant advantage in freedom from target lesion revascularisation, major amputation, or mortality at one year. There was moderate certainty of evidence that bailout stenting is significantly reduced after vessel preparation with intravascular lithotripsy and atherectomy.

SURGICAL INTERVENTION IN PATIENTS WITH IDIOPATHIC INFLAMMATORY BOWEL DISEASE AND PERIANAL DISEASE.

OBJECTIVE: Aim: The aim of the study was to investigate the incidence of IBD in gastrointestinal surgery patients and record the disease's characteristics and treatment. PATIENTS AND METHODS: Materials and Methods: A search was carried out in the archives of the gastroenterology clinics of the University General Hospital of Ioannina and the General Hospital of Ioannina "G. Hatzikosta" in Greece. All cases of operated patients from 1980 to 2018 were examined. The duration of the study was 4 months. Data were analyzed with the SPSS program, v.28. RESULTS: Results: The total sample consisted of 1464 patients (n=1464). Most of them (915-62.5%) came from the University General Hospital of Ioannina, while the rest (549-37.5%) came from the GHI hospital "G. Hatzikosta". The mean age of the patients was 47 years (M=47.26, SD=17.34, Min=<1 month, Max=95 years). From the total sample, 58 patients (4%) suffered from IBD; most were men (42-72.41%). Their mean age was approximately 50 years (M=49.63, SD=16.48, Min=25 years, Max=77 years, range=52 years) and most belonged to the age groups of 31-40 years (11 patients- 19.6%) and 21-30 years and 61-70 years (10 patients-17.9%). The perianal disease was present in 43.1% (25 patients). The most frequent type of operation was fistula resection, ligation, curettage-biopsy (24.1%) and opening-drainage (22.4%-13 patients) and the most frequent type of anesthesia was general anesthesia (93.1%-54 patients). CONCLUSION: Conclusions: This long-term study of the patients' data followed up over time showed that the possibility of surgery in patients with IBD is mitigated through systematic monitoring and multifaceted therapeutic treatment.The perianal disease which appeared more often in men shows that it can be diagnosed early and at an early stage and with the new minimally invasive techniques the patient with IBD can be treated with a better quality of life.

Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial.

BACKGROUND & AIMS: Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of mesalamine with corticosteroids during hospitalization is superior to corticosteroids alone is unknown. METHODS: This was a randomized controlled, investigator-blinded, clinical trial conducted in 10 centers in 7 countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid + mesalamine (4 g/day mesalamine) by a stratified randomization according to mesalamine use before admission. The primary outcome was the percentage of patients who responded to treatment by day 7, defined by a drop >3 points in the Lichtiger score and an absolute score <10 without the need for rescue medications or colectomy. RESULTS: Three hundred forty-six patients were screened, and 149 were included (70/149 female; median age, 41 years). Of these, 73 received corticosteroids + mesalamine, and 76 received corticosteroids alone. For the primary outcome, 53 of 73 patients (72.6%) receiving corticosteroids with mesalamine responded versus 58 of 76 patients (76.3%) on corticosteroids alone (odds ratio, 0.82; 95% confidence interval, 0.39-1.72; P = .60). There was no difference between groups in duration of hospitalization, C-reactive protein normalization rate, or colectomy rate up to day 90. The need for biologics among patients receiving combination of corticosteroids with mesalamine was numerically lower by day 30 (P = .11) and day 90 (P = .07). CONCLUSIONS: In this randomized controlled trial, combination of mesalamine with corticosteroids did not benefit hospitalized patients with ASUC more than corticosteroids alone. An exploratory signal for a reduced need for biologics at 90 days in the mesalamine group merits further evaluation. CLINICALTRIALS: gov ID: NCT01941589.

Validation and Update of the Lémann Index to Measure Cumulative Structural Bowel Damage in Crohn's Disease.

BACKGROUND & AIMS: The Lémann Index is a tool measuring cumulative structural bowel damage in Crohn's disease (CD). We reported on its validation and updating. METHODS: This was an international, multicenter, prospective, cross-sectional observational study. At each center, 10 inclusions, stratified by CD duration and location, were planned. For each patient, the digestive tract was divided into 4 organs, upper tract, small bowel, colon/rectum, anus, and subsequently into segments, explored systematically by magnetic resonance imaging and by endoscopies in relation to disease location. For each segment, investigators retrieved information on previous surgical procedures, identified predefined strictures and penetrating lesions of maximal severity (grades 1-3) at each organ investigational method (gastroenterologist and radiologist for magnetic resonance imaging), provided segmental damage evaluation ranging from 0.0 to 10.0 (complete resection). Organ resection-free cumulative damage evaluation was then calculated from the sum of segmental damages. Then investigators provided a 0-10 global damage evaluation from the 4-organ standardized cumulative damage evaluations. Simple linear regressions of investigator damage evaluations on their corresponding Lémann Index were studied, as well as calibration plots. Finally, updated Lémann Index was derived through multiple linear mixed models applied to combined development and validation samples. RESULTS: In 15 centers, 134 patients were included. Correlation coefficients between investigator damage evaluations and Lémann Indexes were >0.80. When analyzing data in 272 patients from both samples and 27 centers, the unbiased correlation estimates were 0.89, 0,97, 0,94, 0.81, and 0.91 for the 4 organs and globally, and stable when applied to one sample or the other. CONCLUSIONS: The updated Lémann Index is a well-established index to assess cumulative bowel damage in CD that can be used in epidemiological studies and disease modification trials.

VOLume flow assistance for optimizing outcomes of dysfunctional autologous arteriovenous fistula Angioplasty: the VOLA Pilot Study.

OBJECTIVES: To investigate the feasibility of VF-assisted angioplasty (VFA) in dysfunctional AVF using sequential intraprocedural duplex ultrasound (DUS), to utilize intraprocedural VF as a quantifiable, functional endpoint in endovascular treatment. METHODS: This prospective study included 20 consecutive patients (23 lesions; 16 men; mean age 67 ± 16 years) with dysfunctional AVF undergoing fluoroscopically guided balloon angioplasty between June 2019 and May 2020. Primary endpoints were quantification of outcome using sequential DUS VF analysis following each dilation, 6-month target lesion re-intervention (TLR)-free rate, standard technical success, procedural success (achievement of a postprocedural VF value equal (or 10% less) or superior to the baseline steady-state access), and correlation between procedural success and TLR-free rate. Secondary endpoints included 6-month lesion late lumen loss (LLL), correlation between balloon diameter used and intraprocedural VF values, and correlation between VF and LLL at 6 months follow-up. RESULTS: Mean VF increase was 168.5% ± 102.5% (range: 24.24-493.33%). Procedural success was 80% (16/20 cases). VFA improved procedural success by 20% (4/20 cases) compared to standard assessment (< 30% residual stenosis and palpable thrill). TLR-free rate was 78.3% and 67.3% at 6 and 12 months. Significantly less TLR was noted in cases of procedural success (82.4% vs. 66.7% 6 months; p = 0.041). Unweighted linear regression showed a significant positive relationship between diameter of balloon and VF (146.9 ± 42.3 mL/min VF gain per mm of balloon diameter; p = 0.001, R2 = 0.23) and a significant negative relationship between LLL and VF decline at follow-up (102.0 ± 34.6 mL/min loss per mm of LLL; p = 0.01, R2 = 0.35). Optimal VF cutoff value and percentile increase to predict access failure were 720 mL/min (sensitivity 58.3%, specificity 71.4%) and 153% (sensitivity 66.7%, specificity 85.7%), respectively. CONCLUSION: Intraprocedural VF assessment could be used to optimize AVF angioplasty. KEY POINTS: • A newly proposed functional endpoint of angioplasty in dysfunctional dialysis fistula was evaluated and angioplasty outcome was quantified using volume flow (VF) assessment with sequential intraprocedural DUS. • Intraprocedural VF assessment improved immediate procedural success; increased balloon diameter was correlated with VF gain and late lumen loss with VF decline. • Intraprocedural VF values ≥ to baseline steady-state values were correlated with less re-interventions.

Safety and Efficacy of Intentional Celiac Artery Coverage in Endovascular Management of Thoracoabdominal Aortic Diseases: A Systematic Review and Meta-analysis.

PURPOSE: Thoracic endovascular aortic aneurysm repair (TEVAR) has emerged as an attractive alternative option in the treatment of thoracoabdominal aortic aneurysm (TAAA) diseases, reporting lower morbidity and mortality rates compared with open or hybrid repair. A challenging situation arises when the aneurysm involves the celiac artery (CA), precluding a safe distal landing zone. We investigated the safety and efficacy of CA coverage in the treatment of complex TAAA diseases during endovascular management. MATERIALS AND METHODS: A review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. The electronic bibliographic sources searched were MEDLINE and SCOPUS databases. Primary outcomes of interest were perioperative and 30-day mortality. Any type of endoleak, mesenteric ischemia, perioperative spinal cord ischemia, and reintervention rates were secondary end points. A random-effects meta-analysis was performed. Summary statistics of event risks were expressed as proportions and 95% confidence interval (CI). RESULTS: Ten observational cohort studies published between 2009 and 2020, reporting a total of 175 patients, were eligible for quantitative synthesis. Indications for TEVAR were primary TAAAs in 82% of patients, aortic dissection in 14% of patients, type Ib endoleak after previous endograft deployment in 3% of patients, and penetrating aortic ulcer in 1 patient. Reintervention rate was 9% (95% CI, 4%-20%) and spinal cord ischemia was 7% (95% CI, 4%--12%). Type II endoleak was the predominant type of endoleak in 10% of patients (95% CI, 4%-22%), followed by type I endoleak in 5% of patients (95% CI, 2%-12%) and type III endoleak in 1% (95% CI, 0%-16%) of patients. Mesenteric ischemia occurred in 6% of patients (95% CI, 3%-10%). Thirty-day mortality was 5% (95% CI, 2%-13%) and the pooled estimate for overall mortality was 21% (95% CI, 14%-31%). CONCLUSIONS: Celiac artery coverage during TEVAR is a challenging but feasible option for the treatment of TAAA diseases, providing acceptable morbidity and mortality rates. Demonstration of adequate visceral collateral pathways before definitive CA coverage is the sine quo non for the success of the technique.

Percutaneous Arteriovenous Fistula Creation with the WavelinQ 4-French EndoAVF System: A Single-Center Retrospective Analysis of 30 Patients.

PURPOSE: To retrospectively assess the safety and efficacy of percutaneous arteriovenous fistula (pAVF) creation with the WavelinQ 4-F EndoAVF System. MATERIALS AND METHODS: From February 2018 to June 2020, 30 pAVFs were created in 30 consecutive patients (men; age, 55.3 years ± 13.6). Of the 30 patients, 21 (70%) were already on hemodialysis using a central venous catheter. The primary outcome measures were technical success, complications, and cannulation rate. The secondary outcome measures included the number of secondary procedures needed for cannulation, maintenance time to cannulation, and pAVF survival. RESULTS: Technical success was 100%. The adverse event rate was 6.7% (2/30), including a pseudoaneurysm of the brachial artery that developed immediately after sheath removal and an aneurysm of the anastomosis 17 days after the procedure, which was treated with a covered stent placed in the arterial side. The mean follow-up was 547 days ± 315.7 (range, 14-1,071 days). The cannulation rate was 86.7% (26/30). The mean time to cannulation was 61.3 days ± 32.5 (range, 15-135 days). The mean follow-up after cannulation was 566.2 days ± 252.7 (range, 35-1,041 days). Four pAVFs were thrombosed after cannulation, with 2 of them successfully declotted. Sixteen interventions were needed to achieve cannulation after the index procedure in 15 patients (overall, 0.53 procedures/patient). Seven maintenance endovascular interventions (following cannulation) were performed during the follow-up period in 6 patients (overall, 0.27 procedures/patient, 0.17 procedures/patient-years). For the pAVFs that were cannulated, patency was 96% at 1 year, and 82% at 2 and 3 years, according to the Kaplan-Meier survival analysis. CONCLUSIONS: This initial experience suggests that pAVF creation is safe and can be successfully performed with high maturation and long-term patency rates. Larger-scale prospective studies are needed to validate the results.

Editor's Choice - Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD). METHOD: This systematic review was registered with PROSPERO (ID 227761). A broad bibliographic search was performed for RCTs investigating paclitaxel coated balloons in the peripheral arteries (femoropopliteal and infrapopliteal) for treatment of intermittent claudication or critical limb ischaemia (CLI). The literature search was last updated on 20 February 2021 without any restrictions on publication language, date, or status. Major amputations were analysed with time to event methods employing one and two stage models. Sensitivity and subgroup analyses, combinatorial meta-analysis, and a multivariable dose response meta-analysis to examine presence of a biological gradient were also performed. RESULTS: In all, 21 RCTs with 3 760 lower limbs were analysed (52% intermittent claudication and 48% CLI; median follow up two years). There were 87 major amputations of 2 216 limbs in the paclitaxel arms (4.0% crude risk) compared with 41 major amputations in 1 544 limbs in the control arms (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel coated balloons with a hazard ratio (HR) of 1.66 (95% CI 1.14 - 2.42; p = .008, one stage stratified Cox model). The prediction interval was 95% CI 1.10 - 2.46 (two stage model). The observed amputation risk was consistent for both femoropopliteal (p = .055) and infrapopliteal (p = .055) vessels. Number needed to harm was 35 for CLI. There was good evidence of a significant non-linear dose response relationship with accelerated risk per cumulative paclitaxel dose (chi square model p = .007). There was no evidence of publication bias (p = .80) and no significant statistical heterogeneity between studies (I2 = 0%, p = .77). Results were stable across sensitivity analyses (different models and subgroups based on anatomy and clinical indication and excluding unpublished trials). There were no influential single trials. Level of certainty in evidence was downrated from high to moderate because of sparse events in some studies. CONCLUSION: There appears to be heightened risk of major amputation after use of paclitaxel coated balloons in the peripheral arteries. Further investigations are warranted urgently.

Paclitaxel-Coated Balloons for the Treatment of Symptomatic Central Venous Stenosis in Vascular Access: Results From a European, Multicenter, Single-Arm Retrospective Analysis.

INTRODUCTION: This was a European, multicenter, investigator-initiated and run, single-arm retrospective analysis to assess the safety and the clinical benefit of the use of paclitaxel-coated balloon (PCB) for the treatment of symptomatic central venous stenosis (CVS). MATERIALS AND METHODS: Eleven centers from 7 countries across Europe, submitted 86 cases performed during the period between October 2015 and June 2018. Minimum follow-up was 6 months. Patient baseline demographics and procedural details were collected. Mean age was 62.6 years (SD 15.2 years). Median vascular access age was 3.0 years (IQR 1.2-4.8 years). A total of 55 were arteriovenous fistulas (64%) the rest arteriovenous grafts (31/86, 36%). Vessels treated were 43 subclavian veins, 42 brachiocephalic veins and 1 superior vena cava. Median drug-coated balloon diameter was 10 mm (IQR 8-12 mm). Primary outcome measures were clinically assessed intervention-free period (IFP) of the treated segment at 6 months and procedure-related minor and major complications. Secondary outcome measures included access circuit survival, patient survival, and the investigation of independent factors that influence the IFP. RESULTS: IFP was 62.7% at 6 months. Median patient follow-up time was 1.0 year (IQR 0.5-2.2 years). There was 1 minor complication (1/86; 1.2%) and no major complications. Access circuit survival was 87.7% at 6 months. Patient survival was 79.7% at 2 years according to Kaplan-Meier survival analysis. Higher balloon diameters significantly favored IFP [HR 0.71 (0.55-0.92), p=0.006; 5-7 mm group vs 8-12 mm group, p=0.025]. CONCLUSION: In this analysis, use of PCBs for the treatment of symptomatic CVS was safe. Efficacy was comparable to previous trials. Increased balloon size had a significant effect on patency rates.

The Rollercoaster of Paclitaxel in the Lower Limbs and Skeletons in the Closet: An Opinion Review.

There have been concerns about the long-term risk of all-cause death with the use of paclitaxel-coated devices in the lower limbs. Results from a 2018 meta-analysis were corroborated by the US Food and Drug Administration and later confirmed by an individual patient data meta-analysis. However, population-based observational studies have produced contradictory results and often claimed a survival benefit with the use of paclitaxel. The recently published Swedish drug-elution trial in peripheral arterial disease did not confirm a significant mortality risk. In this review, the authors discuss the key elements of the identified mortality signal and stress important facts and figures that remain underrecognized and elusive. They also highlight the important types of epidemiological bias that pertain to the ongoing debate on paclitaxel.

The burden and management of anemia in Greek patients with inflammatory bowel disease: a retrospective, multicenter, observational study.

BACKGROUND: Anemia is a common extraintestinal manifestation of Inflammatory Bowel Disease (IBD) affecting negatively the patients' quality of life. The aim of this study was to determine the frequency and real-life management of anemia in IBD patients in Greece. METHODS: This study was conducted in 17 Greek IBD referral centers. Demographic, clinical, laboratory, IBD and anemia treatment data were collected and analyzed retrospectively. RESULTS: A total of 1394 IBD patients [560 ulcerative colitis (UC), 834 Crohn's disease (CD)] were enrolled. Anemia at any time was reported in 687 (49.3%) patients of whom 413 (29.6%) had episodic and 274 (19.7%) had recurrent/persistent anemia. Anemia was diagnosed before IBD in 45 (6.5%), along with IBD in 269 (39.2%) and after IBD in 373 (54.3%) patients. In the multivariate analysis the presence of extraintestinal manifestations (p = 0.0008), IBD duration (p = 0.026), IBD related surgeries and hospitalizations (p = 0.026 and p = 0.004 accordingly) were risk factors of recurrent/persistent anemia. Serum ferritin was measured in 839 (60.2%) IBD patients. Among anemic patients, 535 (77.9%) received treatment. Iron supplementation was administered in 485 (90.6%) patients, oral in 142 (29.3%) and intravenous in 393 (81%). CONCLUSIONS: The frequency of anemia in IBD patients, followed at Greek referral centers, is approximately 50%. Development of recurrent/persistent anemia may be observed in 20% of cases and is independently associated with the presence of extraintestinal manifestations, IBD duration, IBD related surgeries and hospitalizations. Anemia treatment is administered in up to [Formula: see text] of anemia IBD patients with the majority of them receiving iron intravenously.

Snare Entrapment During EVAR Limb Cannulation Resulting in Open Conversion. A Rare Complication.

We present an unreported complication that occurred during an accidental loss of the ipsilateral limb's wire during EVAR. During an endovascular repair of an abdominal aortic aneurysm (EVAR), unintentional loss of the ipsilateral limb's wire during deployment and withdrawal of the endogaft's main body occurred. The snare's loops were entrapped while attempting to catch the wire through the limb. Multiple maneuvers were performed to detach the snare, but all were unsuccessful. We then performed a conversion to open repair. In conclusion, commercially available endografts should include standard radiopaque markers in the ipsilateral limb to facilitate retrograde cannulation. Retrieval via the snare should not be performed proximal to the gate of the limb.

Effectiveness of revascularisation of the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review.

In patients with diabetes, foot ulceration and peripheral artery disease (PAD), it is often difficult to determine whether, when and how to revascularise the affected lower extremity. The presence of PAD is a major risk factor for non-healing and yet clinical outcomes of revascularisation are not necessarily related to technical success. The International Working Group of the Diabetic Foot updated systematic review on the effectiveness of revascularisation of the ulcerated foot in patients with diabetes and PAD is comprised of 64 studies describing >13 000 patients. Amongst 60 case series and 4 non-randomised controlled studies, we summarised clinically relevant outcomes and found them to be broadly similar between patients treated with open vs endovascular therapy. Following endovascular revascularisation, the 1 year and 2 year limb salvage rates were 80% (IQR 78-82%) and 78% (IQR 75-83%), whereas open therapy was associated with rates of 85% (IQR 80-90%) at 1 year and 87% (IQR 85-88%) at 2 years, however these results were based on a varying combination of studies and cannot therefore be interpreted as cumulative. Overall, wound healing was achieved in a median of 60% of patients (IQR 50-69%) at 1 year in those treated by endovascular or surgical therapy, and the major amputation rate of endovascular vs open therapy was 2% vs 5% at 30 days, 10% vs 9% at 1 year and 13% vs 9% at 2 years. For both strategies, overall mortality was found to be high, with 2% (1-6%) perioperative (or 30 day) mortality, rising sharply to 13% (9-23%) at 1 year, 29% (19-48%) at 2 years and 47% (39-71%) at 5 years. Both the angiosome concept (revascularisation directly to the area of tissue loss via its main feeding artery) or indirect revascularisation through collaterals, appear to be equally effective strategies for restoring perfusion. Overall, the available data do not allow us to recommend one method of revascularisation over the other and more studies are required to determine the best revascularisation approach in diabetic foot ulceration.

Performance of prognostic markers in the prediction of wound healing or amputation among patients with foot ulcers in diabetes: A systematic review.

Clinical outcomes of patients with diabetes, foot ulceration, and peripheral artery disease (PAD) are difficult to predict. The prediction of important clinical outcomes, such as wound healing and major amputation, would be a valuable tool to help guide management and target interventions for limb salvage. Despite the existence of a number of classification tools, no consensus exists as to the most useful bedside tests with which to predict outcome. We here present an updated systematic review from the International Working Group of the Diabetic Foot, comprising 15 studies published between 1980 and 2018 describing almost 6800 patients with diabetes and foot ulceration. Clinical examination findings as well as six non-invasive bedside tests were evaluated for their ability to predict wound healing and amputation. The most useful tests to inform on the probability of healing were skin perfusion pressure ≥ 40 mmHg, toe pressure ≥ 30 mmHg, or TcPO2  ≥ 25 mmHg. With these thresholds, all of these tests increased the probability of healing by greater than 25% in at least one study. To predict major amputation, the most useful tests were ankle pressure < 50 mmHg, ABI < 0.5, toe pressure < 30 mmHg, and TcPO2  < 25 mmHg, which increased the probability of major amputation by greater than 25%. These indicative values may be used as a guide when deciding which patients are at highest risk for poor outcomes and should therefore be evaluated for revascularization at an early stage. However, this should always be considered within the wider context of important co-existing factors such as infection, wound characteristics, and other comorbidities.

Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: A systematic review.

The accurate identification of peripheral artery disease (PAD) in patients with diabetes and foot ulceration is important, in order to inform timely management and to plan intervention including revascularisation. A variety of non-invasive tests are available to diagnose PAD at the bedside, but there is no consensus as to the most useful test, or the accuracy of these bedside investigations when compared to reference imaging tests such as magnetic resonance angiography, computed tomography angiography, digital subtraction angiography or colour duplex ultrasound. Members of the International Working Group of the Diabetic Foot updated our previous systematic review, to include all eligible studies published between 1980 and 2018. Some 15 380 titles were screened, resulting in 15 eligible studies (comprising 1563 patients, of which >80% in each study had diabetes) that evaluated an index bedside test for PAD against a reference imaging test. The primary endpoints were positive likelihood ratio (PLR) and negative likelihood ratio (NLR). We found that the most commonly evaluated test parameter was ankle brachial index (ABI) <0.9, which may be useful to suggest the presence of PAD (PLR 6.5) but an ABI value between 0.9 and 1.3 does not rule out PAD (NLR 0.31). A toe brachial index >0.75 makes the diagnosis of PAD less likely (NLR 0.14-0.24), whereas pulse oximetry may be used to suggest the presence of PAD (if toe saturation < 2% lower than finger saturation; PLR 17.23-30) or render PAD less likely (NLR 0.2-0.27). We found that the presence of triphasic tibial waveforms has the best performance value for excluding a diagnosis of PAD (NLR 0.09-0.28), but was evaluated in only two studies. In addition, we found that beside clinical examination (including palpation of foot pulses) cannot reliably exclude PAD (NLR 0.75), as evaluated in one study. Overall, the quality of data is generally poor and there is insufficient evidence to recommend one bedside test over another. While there have been six additional publications in the last 4 years that met our inclusion criteria, more robust evidence is required to achieve consensus on the most useful non-invasive bedside test to diagnose PAD.

Guidelines on diagnosis, prognosis, and management of peripheral artery disease in patients with foot ulcers and diabetes (IWGDF 2019 update).

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the diagnosis, prognosis, and management of peripheral artery disease (PAD) in patients with foot ulcers and diabetes and updates the previous IWGDF Guideline. Up to 50% of patients with diabetes and foot ulceration have concurrent PAD, which confers a significantly elevated risk of adverse limb events and cardiovascular disease. We know that the diagnosis, prognosis, and treatment of these patients are markedly different to patients with diabetes who do not have PAD and yet there are few good quality studies addressing this important subset of patients. We followed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to devise clinical questions and critically important outcomes in the patient-intervention-comparison-outcome (PICO) format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. We here present the updated 2019 guidelines on diagnosis, prognosis, and management of PAD in patients with a foot ulcer and diabetes, and we suggest some key future topics of particular research interest.

Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

A formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infrapopliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was conducted. Medical databases and online content were last screened in September 2019. The primary safety and efficacy endpoint was amputation-free survival defined as freedom from all-cause death and major amputation. Target lesion revascularization (TLR) constituted a secondary efficacy endpoint. Summary effects were synthesized with a random-effects model. Some 8 randomized controlled trials with 1,420 patients (97% CLI) were analyzed up to 1 year follow-up. Amputation-free survival was significantly worse in case of paclitaxel (13.7% crude risk of death or limb loss compared to 9.4% in case of uncoated balloon angioplasty; hazard ratio 1.52; 95% confidence interval: 1.12-2.07, p = .008). TLR was significantly reduced in case of paclitaxel (11.8% crude risk of TLR versus 25.6% in control; risk ratio 0.53; 95% confidence interval: 0.35-0.81, p = .004). The harm signal was evident when examining the high-dose (3.0-3.5 µg/mm2) devices, but attenuated below significance in case of a low-dose (2.0 µg/mm2) device. Actual causes remain largely unknown, but non-target paclitaxel embolization is a plausible mechanism.

Use of the Covera Stent Graft for the Treatment of Dysfunctional or Thrombosed Arteriovenous Grafts: A Retrospective Analysis of 64 Patients.

PURPOSE: To retrospectively evaluate the safety and effectiveness of the Covera stent graft (SG) for the treatment of dysfunctional or thrombosed arteriovenous grafts (AVGs). MATERIALS AND METHODS: Within 29 months (February 2016-August 2018), 79 patients underwent Covera SG placement in the authors' department for the treatment of dysfunctional AVGs. Data were available for 64 patients who underwent 64 procedures, using 64 devices. Minimum follow-up was 6 months, unless reintervention occurred. Mean follow-up was 277 days (6-923 days). Treatment characteristics were 51 cases with venous-graft anastomosis (VGA) stenosis (79.7%), 13 cases of puncture zone stenosis (20.3%), 14 cases of in SG stenosis (21.9%), 8 cases of pseudoaneurysm treatment (12.5%) (1 treatment area might have had more than 1 characteristic). Thirty-six patients presented with thrombosis (56.2%), and 31 of 64 case were de novo treatment areas (48.4%). Primary outcome measurements were technical success and post-intervention primary patency (PIPP) at 6 months, whereas secondary outcome measurements included factors influencing primary outcome. RESULTS: Technical success was 100%. Median PIPP was 336 days, and 73.6% of treatment areas were patent at 6 months. There were no significant differences in terms of PIPP when de novo treatment areas were compared with restenotic areas (519 vs. 320 days, respectively; P = .1); patients who presented with versus those who presented without thrombosis (320 vs. 583 days, respectively; P = .07); puncture zone stenosis or elsewhere (329 vs. 686 days, respectively; P = .52); and VGA stenosis or elsewhere (336 vs. 335 days, respectively; P = .9). CONCLUSIONS: Use of the Covera SG for AVG treatment was safe and effective in every type of treatment area presented in this retrospective analysis.

Two-Center Prospective Comparison of the Trocar and Seldinger Techniques for Percutaneous Cholecystostomy.

OBJECTIVE. The purpose of this study is to compare the safety and efficacy of the bedside ultrasound (US)-guided trocar technique versus the US- and fluoroscopy-guided Seldinger technique for percutaneous cholecystostomy (PC). SUBJECTS AND METHODS. This prospective noninferiority study compared the bedside US-guided trocar technique for PC (the trocar group; 53 patients [28 men and 25 women]; mean [± SD] age, 74.31 ± 16.19 years) with the US- and fluoroscopy-guided Seldinger technique for PC (the Seldinger group; 52 patients [26 men and 26 women], mean age, 79.92 ± 13.38 years) in consecutive patients undergoing PC at two large tertiary university hospitals. The primary endpoints were technical success and procedure-related complication rates. Secondary endpoints included procedural duration, pain assessment, and clinical success after up to 3 months of follow-up. RESULTS. PC was successfully performed for all 105 patients. The clinical success rate was similar between the two study groups (86.8% in the trocar group vs 76.9% in the Seldinger group; p = 0.09). Mean procedural time was significantly lower in the trocar group than in the Seldinger group (1.77 ± 1.62 vs 4.88 ± 2.68 min; p < 0.0001). Significantly more procedure-related complications were noted in the Seldinger group than in the trocar group (11.5% vs 1.9%; p = 0.02). Among patients in the Seldinger group, bile leak occurred in 7.7%, abscess formation in 1.9%, and gallbladder rupture in 1.9%. No procedure-related death was noted. Minor bleeding occurred in one patient (1.9%) in the trocar group, but the bleeding resolved on its own. The mean pain score during the procedure was significantly lower in the Seldinger group than in the trocar group (3.2 ± 1.77 vs 4.76 ± 2.17; p = 0.01). At 12 hours after the procedure, the mean pain score was significantly lower for patients in the trocar group (0.78 ± 1.0 vs 3.12 ± 1.36; p = 0.0001). CONCLUSION. Use of the bedside US-guided trocar technique for PC was equally effective as the Seldinger technique but was associated with fewer procedure-related complications, required less procedural time, and resulted in decreased postprocedural pain, compared with fluoroscopically guided PC using the Seldinger technique.

90Y-microsphere radioembolization: The method, clinical evidence and perspective.

The current review unfolds the procedural steps and the clinical evidence for yttrium-90 (90Y)-microspheres radioembolization. Radioembolization is part of the loco-regional therapeutic spectrum for liver malignancy and involves the invasive, intra-arterial delivery of microspheres carrying ß-emitter isotopes in order to destroy cancerous tissue via ionizing radiation. The main steps of the therapeutic process are selection of eligible patients, angiographic workup, simulation scintigraphy, pre-treatment dosimetry, actual treatment and post-treatment imaging/dosimetry. Radioembolization is routinely applied in advanced stage hepatocellular carcinoma (HCC), yet its role is being investigated even in earlier stages. Prospective, randomized controlled trials did not verify increased overall survival of radioembolization over systemic treatment with sorafenib in HCC; however, it showed survival benefit in certain sub-groups and a favorable toxicity profile with fewer adverse events. Radioembolization is also applied in metastatic colon cancer showing tumoral liver responses, which however did not translate into an overall survival benefit. Data regarding applications of this method in other neoplasms, such as neuroendocrine tumors, breast cancer and melanoma are also presented. There are ongoing clinical trials to define the role of radioembolization within recent treatments algorithms, to determine optimal combinations of this treatment with systemic and targeted therapies and to decide the patients' sub-groups, who will benefit the most.