Poor inter-observer agreement in anatomical classifications of infrapopliteal arterial disease due to mandatory selection of only one target artery.

BACKGROUND: Established anatomical classifications of infrapopliteal arterial lesion severity are based on assessment of only one target artery, not including all infrapopliteal arteries although multivessel revascularization is common. PURPOSE: To investigate the reproducibility of one of these classifications and a new aggregated score. MATERIAL AND METHODS: A total of 68 patients undergoing endovascular infrapopliteal revascularization at Sahlgrenska University Hospital during 2008-2016 were included. Preoperative magnetic resonance angiographies (MRA) and digital subtraction angiographies (DSA) were evaluated by three blinded observers in random order, using the infrapopliteal TransAtlantic Inter-Society Consensus (TASC) II classification. An aggregated score, the Infrapopliteal Total Atherosclerotic Burden (I-TAB) score, including all infrapopliteal arteries, was constructed and used for comparison. RESULTS: Inter-observer agreement on lesion severity for each evaluated artery was good; Krippendorff's α for MRA 0.64-0.79 and DSA 0.66-0.84. Inter-observer agreement on TASC II grade, based on the selected target artery as stipulated, was poor; Krippendorff's α 0.14 (95% confidence interval [CI]=-0.05 to 0.30) for MRA and 0.48 (95% CI=0.33-0.61) for DSA. Inter-observer agreement for the new I-TAB score was good; Krippendorff's α 0.76 (95% CI=0.70-0.81) for MRA and 0.79 (95% CI=0.74-0.84) for DSA. CONCLUSION: Reproducible assessment of infrapopliteal lesion severity can be achieved for separate arteries with both MRA and DSA using the TASC II definitions. However, poor inter-observer agreement in selecting the target artery results in low reproducibility of the overall infrapopliteal TASC II grade. An aggregated score, such as I-TAB, results in less variability and may provide a more robust evaluation tool of atherosclerotic disease severity.

Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.

BACKGROUND: The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS: We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS: No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS: In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).

Comparison of Magnetic Resonance Angiography and Digital Subtraction Angiography for the Assessment of Infrapopliteal Arterial Occlusive Lesions, Based on the TASC II Classification Criteria.

This paper aimed to study the agreement and repeatability, both intra- and interobserver, of infrapopliteal lesion assessment with magnetic resonance angiography (MRA), using the TransAtlantic Inter-Society Consensus (TASC) II criteria, with perioperative digital subtraction angiography (DSA) as a reference. Sixty-eight patients with an MRA preceding an endovascular infrapopliteal revascularization were included. Preoperative MRAs and perioperative DSAs were evaluated in random order by three independent observers using the TASC II classification. The results were analyzed using visual grading characteristics (VGC) analysis and Krippendorff's α. No systematic difference was found between modalities: area under the VGC curve (AUCVGC) = 0.48 (p = 0.58) or intraobserver; AUCVGC for Observer 1 and 2 respectively, 0.49 (p = 0.85) and 0.53 (p = 0.52) for MRA compared with 0.54 (p = 0.30) and 0.49 (p = 0.81) for DSA. Interobserver differences were seen: AUCVGC of 0.63 (p < 0.01) for DSA and 0.80 (p < 0.01) for MRA. These results were confirmed using Krippendorff's α for the three observers showing 0.13 (95% confidence interval (CI) -0.07-0.31) for MRA and 0.39 (95% CI 0.23-0.53) for DSA. Poor interobserver agreement was also found in the choice of a target vessel on preoperative MRA: Krippendorff's α = 0.19 (95% CI 0.01‒0.36). In conclusion, infrapopliteal lesions can be reliably determined on preoperative MRA, but interobserver variability regarding the choice of a target vessel is a major concern that appears to affect the overall TASC II grade.

Antibiotics as first-line therapy for acute appendicitis: evidence for a change in clinical practice.

BACKGROUND: Randomized studies have indicated that acute appendicitis may be treated by antibiotics without the need of surgery. However, concerns have been raised about selection bias of patients in such studies. Therefore, the present study was aimed to validate previous findings in randomized studies by a full-scale population-based application. METHODS: All patients with acute appendicitis at Sahlgrenska University Hospital (May 2009 and February 2010) were offered intravenous piperacillin plus tazobactam according to our previous experience, followed by 9 days out-hospital oral ciprofloxacin plus metronidazole. Endpoints were treatment efficacy and complications. Efficient antibiotic treatment was defined as recovery without the need of surgery beyond 1 year of follow-up. RESULTS: A total of 558 consecutive patients were hospitalized and treated due to acute appendicitis. Seventy-nine percent (n = 442) received antibiotics as first-line therapy and 20 % (n = 111) had primary surgery as the second-line therapy. Seventy-seven percent of patients on primary antibiotics recovered while 23 % (n = 100) had subsequent appendectomy due to failed initial treatment on antibiotics. Thirty-eight patients (11 %) of the 342 had experienced recurrent appendicitis at 1-year follow-up. Primary antibiotic treatment had fewer complications compared to primary surgery. CONCLUSIONS: This population-based study confirms previous results of randomized studies. Antibiotic treatment can be offered as the first-line therapy to a majority of unselected patients with acute appendicitis without medical drawbacks other than the unknown risk for long-term relapse, which must be weighed against the unpredicted but well-known risk for serious major complications following surgical intervention.