A Bibliometric Analysis on Adherence to Reporting Standards for Endovascular Treatment of Chronic Lower Extremity Peripheral Artery Disease.

BACKGROUND: The treatment of chronic limb-threatening ischemia (CLTI) involves a broad spectrum of therapies including many new and emerging techniques. To standardize the results of studies examining this pathology and to allow critical analysis and comparison between studies, the Society for Vascular Surgery (SVS) recommended reporting standard guidelines for the endovascular management of CLTI in 2016. Research studies that do not adhere to complete reporting standards are often 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 noncompliance with these recommended guidelines. METHODS: 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 peripheral artery disease (PAD)/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. These data were used to calculate descriptive and comparative statistics. RESULTS: Fifty-four manuscripts were identified from this time frame. 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" and were least likely to demonstrate adherence to the 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 < 0.05). 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. CONCLUSIONS: Adherence to reporting standard guidelines for endovascular treatment of lower extremity PAD 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.

Outcomes of kidney, liver, and simultaneous liver and kidney transplants from hepatitis c infected donors to hepatitis c naïve recipients: A large single center experience.

BACKGROUND: With the introduction of direct-acting antiviral therapies (DAAs), the non-use rate of hepatitis C virus (HCV)-positive donor organs (D+) has decreased significantly. We present the donor, recipient, and transplant allograft characteristics, along with recipient outcomes, in one of the largest cohorts of HCV-D+ transplants into HCV-naïve recipients (R-). METHODS: Charts of HCV D+/R- kidney (KT), liver (LT), and simultaneous liver-kidney (SLKT) transplant recipients between January 2019 and July 2022 were reviewed. Primary outcomes of interest included waitlist times and 1-year graft failure. Secondary outcomes included hospital and intensive care unit length of stay, post-transplant complications, effectiveness of DAA therapy, and characteristics of patients who relapsed from initial DAA therapy. RESULTS: Fifty-five HCV D+/R- transplants at our center [42 KT (26 nucleic acid testing positive [NAT+], 16 NAT-), 12 LT (eight NAT+, four NAT-), and one SLKT (NAT+)] had a median waitlist time of 69 days for KT, 87 days for LT, and 15 days for SLKT. There were no graft failures at 1 year. All viremic recipients were treated with a 12-week course of DAAs, of which 100% achieved end of treatment response (EOTR)-85.7% (n = 30) achieved sustained virologic response (SVR) and 14.3% relapsed (n = 5; four KT, one LT). All relapsed recipients were retreated and achieved SVR. The most common post-transplantation complications include BK virus infection (n = 9) for KT and non-allograft infections (n = 4) for LT. CONCLUSIONS: Our study has demonstrated no graft failures or recipient deaths at 1 year, and despite a 14.3% relapse rate, we achieved 100% SVR. Complications rates of D+/R- appeared comparable to national D-/R- complication rates. Further studies comparing D+/R- to D-/R- outcomes are needed.

Cryoablation for Renal Cell Carcinoma Prior to Liver Transplantation: A Case Report.

Extrahepatic malignancies are a relatively rare incidental finding during liver transplant work-up that provides a significant barrier to continued transplant evaluation and requires treatment to limit the risk of recurrence. There have only been 11 previously reported cases of pre-liver transplant renal cell carcinoma (RCC), of which all underwent partial or radical nephrectomy. Percutaneous cryoablation therapy has been gaining acceptance as a curative treatment alternative for RCC and is a new therapeutic standard for patients who are poor candidates for surgical resection. Recent studies have demonstrated the safety and efficacy of cryoablation for RCC in native kidneys and in solid masses in kidney allografts, but there is no data on the efficacy or recurrence of RCC when cryoablation is used for the treatment of RCC in a native kidney prior to solid organ transplantation. The patient underwent percutaneous cryoablation therapy of a T1a RCC of the native kidney 10 months prior to orthotopic liver transplant (OLT) without subsequent partial or radical nephrectomy. At seven years post-ablation therapy, the patient has no evidence of tumor recurrence despite immunosuppressive therapy post-transplantation. Cryoablation is potentially a safe and highly effective means of treating RCC in patients who are not candidates for nephrectomy secondary to complications associated with end-stage liver disease. In our case, the patient was treated with cryoablation and received standard post-transplant immunosuppression without recurrence of RCC at seven years. More studies are needed to determine inclusion and exclusion criteria for cryoablation and to confirm long-term efficacy as well as a strategy for duration and frequency of surveillance in these patients.

Clinically Advanced p38 Inhibitors Suppress DUX4 Expression in Cellular and Animal Models of Facioscapulohumeral Muscular Dystrophy.

Facioscapulohumeral muscular dystrophy (FSHD) is characterized by misexpression of the double homeobox 4 (DUX4) developmental transcription factor in mature skeletal muscle, where it is responsible for muscle degeneration. Preventing expression of DUX4 mRNA is a disease-modifying therapeutic strategy with the potential to halt or reverse the course of disease. We previously reported that agonists of the ß-2 adrenergic receptor suppress DUX4 expression by activating adenylate cyclase to increase cAMP levels. Efforts to further explore this signaling pathway led to the identification of p38 mitogen-activated protein kinase as a major regulator of DUX4 expression. In vitro experiments demonstrate that clinically advanced p38 inhibitors suppress DUX4 expression in FSHD type 1 and 2 myoblasts and differentiating myocytes in vitro with exquisite potency. Individual small interfering RNA-mediated knockdown of either p38α or p38ß suppresses DUX4 expression, demonstrating that each kinase isoform plays a distinct requisite role in activating DUX4 Finally, p38 inhibitors effectively suppress DUX4 expression in a mouse xenograft model of human FSHD gene regulation. These data support the repurposing of existing clinical p38 inhibitors as potential therapeutics for FSHD. The surprise finding that p38α and p38ß isoforms each independently contribute to DUX4 expression offers a unique opportunity to explore the utility of p38 isoform-selective inhibitors to balance efficacy and safety in skeletal muscle. We propose p38 inhibition as a disease-modifying therapeutic strategy for FSHD. SIGNIFICANCE STATEMENT: Facioscapulohumeral muscular dystrophy (FSHD) currently has no treatment options. This work provides evidence that repurposing a clinically advanced p38 inhibitor may provide the first disease-modifying drug for FSHD by suppressing toxic DUX4 expression, the root cause of muscle degeneration in this disease.