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• W4377223608 abstract "Treatment of chronic limb-threatening ischemia (CLTI) involves a broad spectrum of therapies including many new and emerging techniques. To standardize results of studies examining this pathology and to allow critical analysis and comparison between studies, the Society for Vascular Surgery (SVS) produced recommended reporting standard guidelines for the endovascular management of CLTI in 2016. Research studies that do not adhere to complete reporting standards are more ambiguous in impact and external validity, leading to bias and misinformation that has potentially damaging effects on clinical-decision making. We thus sought to examine adherence to and factors associated with non-compliance with these recommended guidelines. A literature database search was conducted to include all clinical trials, randomized controlled trials, and retrospective comparative studies written in English examining the endovascular treatment of CLTI from January 2020 to August 2022. Systematic reviews, case reports and meta-analysis were excluded. The manuscripts were reviewed for adherence with the SVS guidelines (overall and by guideline subcategories based on demographics, treatment methods, and outcomes), and factors associated with this adherence were determined. This data was used to calculate descriptive and comparative statistics. Fifty-four manuscripts were identified from this timeframe. On average, articles reviewed reported on 42.0% of the SVS reporting standards (range, 25.0-65.2% (Fig 1) with 74.1% of articles (n = 40) not adhering to at least 50.0% of the standards. Manuscripts most completely followed guidelines regarding “Patient Factors” (Table I) and were least likely to demonstrate adherence to description of CLTI and study complications. Within the guideline subcategories, complete adherence to guidelines was not demonstrated in any manuscript in stent trials, disease outcome measures, technical outcome measures, patient factors, and critical limb ischemia description, and complete adherence rates within the other subcategories was low (range, 5.6%-18.6%). Studies conducted within the United States and those with industry sponsorship were more likely to adhere to >50% of the reporting standards (P < .05). Journal impact factor, year of publication, and number of authors had no correlation to the percent adherence to guidelines in specific categories or adherence overall. Adherence to reporting standard guidelines for endovascular treatment of lower extremity peripheral artery disease specifically outlined by the SVS is suboptimal regardless of the quality of the journal the research is published in. Increasing adherence to reporting standards to provide a framework for comparison of studies across techniques used should be prioritized by authors, journal editors, and vascular societies.TableNumber of articles following each reporting standard outlined by the Society of Vascular Surgery (SVS), categorized into subgroups based on demographics, treatment methods, and outcomesClaudication (n = 43)No.%Stent trials (n = 48)No.%Paper reports on patients with claudication (y/n)43100.0Stent use/trial (y/n)48100.0Resting or exercise ABI to support diagnosis of PAD3786.0Pre-dilatation with balloon3675.0Rutherford classification4297.7Intention to treat design2552.1Baseline functional assessment1227.9Length and diameter of stent1327.1Was functional assessment 6MWT?920.9Balloon or self-expanding stent noted1939.6Validated disease-specific quality of life?1944.2Coated or covered stent with specific agent/dose510.4Which QOL measure?2660.5Final treatment diameter1020.8Critical Limb Ischemia (n=53)#Atherectomy (n=10)#Paper reports on patients with CLTI (y/n)53100.0Atherectomy device used (y/n)10100.0Documented ankle or toe pressure with diagnosis of CLTI59.4Device specific use data110.0Rest pain and tissue loss patients reported separately47.5Use of balloon or stent therapy as well990.0Wound ischemia and foot infection classification59.4Use of embolic device440.0Documented standardized wound care protocol23.8Atherectomy device as primary therapy or adjust for placement880.0Patient Factors (n=54)#Technical Outcome Measures (n=54)#Patient factors reported with grading system00.0(1) Patency measures; (2) freedom from hemodynamic1629.6Gender reported5398.1failure; and (3) reported in a life table4685.2Race reported916.7Anatomic imaging assessing patency4685.2Age reported54100.0Patency reported in a vessel specific manner23.7Diabetes reported54100.0Target lesion revascularization is not used in place of patency4175.9Hypertension reported4990.7Additional interventions in target limb are described00.0Tobacco use reported5398.1Disease Outcome Measures (n=54)#Renal function reported2037.0Disease-specific QOL measure, functional assessment2342.6Hyperlipidemia reported4787.0Use of CLTI OPGs for patients with CLTI47.4All patient factors reported00.0Cost-effectiveness of endovascular therapies risk-stratified23.7Anatomic (n=54)#Lower extremity endovascular interventions for PAD reported3259.3Anatomic characterization technique reported2851.9Complications (n=54)#TASC II grade2240.7All procedural related adverse events are reported and categorized59.3Bollinger score or SVS runoff score1425.9Minimum of 30 days of complication reporting1935.2Target lesion length and calcium score2648.1Balloon Trials (n=47)#Balloon angioplasty use/trial (y/n)?47100.0Location of intervention noted1736.2Primary vs. repeat intervention4595.7Wire noted to be intraluminal or subintimal714.9Length and diameter of definitive balloon and type1531.9Inflation pressure and time noted1429.8ABI, Ankle-brachial index; CLTI, chronic limb-threatening ischemia; PAD, peripheral artery disease; QOL, quality of life; 6MWT, 6-minute walk test. Open table in a new tab" @default.
• W4377223608 created "2023-05-23" @default.
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• W4377223608 date "2023-06-01" @default.
• W4377223608 modified "2023-10-03" @default.
• W4377223608 title "Adherence to Reporting Standards for Endovascular Treatment of Chronic Lower Extremity Peripheral Artery Disease—A Bibliographic Analysis" @default.
• W4377223608 doi "https://doi.org/10.1016/j.jvs.2023.03.246" @default.
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