Endovascular Denervation for the Improvement of Limb Ischemia in Patients with Peripheral Artery Disease: A Randomized Clinical Trial.

BACKGROUND: To evaluate the safety and efficacy of endovascular denervation (EDN) as an adjunct to percutaneous vascular intervention (PVI) for peripheral artery disease (PAD). METHODS: From August 2019 to April 2021, 38 eligible patients with PAD enrolled in this study were randomly and equally assigned into 2 groups: the PVI group and the PVI + EDN group treated with EDN at the iliac and femoral arteries before PVI. The primary endpoint was the improvement in the ankle brachial index at 6 months after the procedure. The secondary endpoints were transcutaneous oxygen pressure (TcPO2), Rutherford category, numerical rating scale score, and safety. RESULTS: The technical success rates of PVI and EDN were 100%, and no device-related or procedure-related major adverse events occurred in either group. Compared with PVI alone, PVI + EDN demonstrated a significant improvement in limb hemodynamics at 6 months (Δ ankle brachial index 0.44 ± 0.31 vs. 0.24 ± 0.15, P = 0.018). Microcirculatory perfusion of PAD was significantly better at 6 months in the PVI + EDN group (ΔTcPO2, 15.68 ± 16.72 vs. 4.95 ± 13.43, P = 0.036). The Rutherford category was significantly improved in the PVI + EDN group in comparison with the PVI group at the 3-month follow-up (100.00% vs. 68.42%, P = 0.02). The decrease in the numerical rating scale score in the PVI + EDN group was greater than that in the PVI group at 1 week following the procedure (3 [2-5] vs. 4 [4-6], P = 0.022). CONCLUSIONS: In this single-center pilot analysis of a heterogeneous cohort of patients with PAD, PVI with EDN demonstrated a significant improvement in limb ischemia at 6 months compared with PVI alone.

Risk Factors for Access-Related Adverse Events Related to the Preclose Technique in Thoracic Endovascular Aortic Repair.

PURPOSE: To analyze the risk factors for access-related adverse events (AEs) of the preclose technique in thoracic endovascular aortic repair (TEVAR). MATERIALS AND METHODS: Ninety-one patients with Stanford type B aortic dissection who underwent the preclose technique in TEVAR between January 2013 and December 2021 were included. According to the occurrence of access-related AEs, the patients were divided into 2 groups: those with AE and those without AE. Age, sex, combined diseases, body mass index, skin depth, femoral artery diameter, access calcification, iliofemoral artery tortuosity, and sheath size were recorded for risk factor analysis. The sheath-to-femoral artery ratio (SFAR), the ratio of the femoral artery inner diameter (in millimeters) to the sheath's outer diameter (in millimeters), was also included in the analysis. RESULTS: SFAR was identified as an independent risk factor for AEs using multivariable logistic analysis (odds ratio, 251.748; 95% CI, 7.004-9,048.534; P = .002). The cutoff value of SFAR was 0.85 and was related to a higher incidence of access-related AEs (5.2% vs 33.3%, P = .001), especially to a higher stenosis rate (0.0% vs 21.2%, P = .001). CONCLUSIONS: SFAR is an independent risk factor for access-related AEs of preclose in TEVAR with a cutoff value of 0.85. SFAR could be a new criterion for preoperative access evaluation in high-risk patients that may allow the detection and treatment of access-related AEs at the early stage.

Bariatric Embolization of the Left Gastric Arteries for the Treatment of Obesity: 9-Month Data in 5 Patients.

PURPOSE: The purpose of this study is to investigate the safety and 9-month effectiveness of transcatheter left gastric artery embolization (LGAE) for treating patients with obesity. MATERIALS AND METHODS: The protocol of this study was approved by the Institutional Ethics Review Board. Five obese patients (3 men and 2 women) with mean weight of 102.0 ± 16.19 kg (range, 82.1-125.5 kg) and mean body mass index (BMI) of 38.1 kg/m2 ± 3.8 (range, 32.9-42.4 kg/m2) underwent LGAE with polyvinyl alcohol (PVA) particles in diameter of 500-710 µm. The primary endpoint was the safety by grading the adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) within 30 days after LGAE. The secondary endpoints were measured with serum ghrelin and leptin levels, body weight, waist circumference, waist-to-height ratio, and abdominal fat quantity on MRI at the day immediately before LGAE and every 3 months after LGAE. RESULTS: LGAE was successfully performed in all patients. A superficial linear ulceration below the cardia was seen in 1 patient 3 days after LGAE and healed within 30 days. No other serious AEs (grade III or above) occurred. Average body weight loss at 3, 6, and 9 months was 8.28 ± 7.3 kg (p = 0.074), 10.42 ± 8.21 kg (p = 0.047), and 12.9 ± 14.66 kg (p = 0.121), respectively. The level of serum ghrelin decreased by 40.83% (p = 0.009), 31.94% (p = 0.107), and 24.82% (p = 0.151) at 3, 6, and 9 months after LGAE, respectively. There was minimal reduction of leptin levels at 3 and 6 months following LGAE (decreased by 0.26%, p = 0.929, and 4.33%, p = 0.427, respectively), but it declined obviously 9 months after LGAE (decreased by 11.22%, p = 0.295). Both waist circumference and waist-to-height ratio decreased after LGAE. MRI showed the area of subcutaneous adipose tissue decreased from the baseline of 400.90 ± 79.25 to 320.36 ± 68.06 cm2 (decreased by 20.09%, p = 0.006) at 3 months, to 328.31 ± 52.67 cm2 (decreased by 18.11%, p = 0.020) at 6 months, and to 286.40 ± 55.72 cm2 (decreased by 28.52%, p = 0.101) at 9 months after LGAE, respectively. But the decrease of abdominal fat loss at 9 months after LGAE was largely due to the reduction in visceral adipose tissue. CONCLUSIONS: Our study with 9-month data in 5 patients indicates that bariatric embolization of the LGA is a safe and may be a promising strategy to suppress the production of ghrelin and results in weight loss and abdominal fat reduction. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02786108).

Sensitivity and Specificity of CT and Its signs for Diagnosis of Strangulation in Patients with Acute Small Bowel Obstruction.

INTRODUCTION: To perform a meta-analysis to review the sensitivity and specificity of computed tomography and different known computed yomography signs for the diagnosis of strangulation in patients with acute small bowel obstruction. METHODS: A comprehensive Pubmed search was performed for all reports that evaluated the use of CT and discussed different CT criteria for the diagnosis of acute SBO. Articles published in English language from January 1978 to June 2008 were included. Review articles, case reports, pictorial essays and articles without original data were excluded. The bivariate random effect model was used to obtain pooled sensitivity and pooled specificity. Summary receiver operating curve was calculated using Meta-Disc. Software Openbugs 3.0.3 was used to summarize the data. RESULTS: A total of 12 studies fulfilled the inclusion criteria. The pooled sensitivity and specificity of CT in the diagnosis of strangulation was 0.720 (95% CI 0.674 to 0.763) and 0.866 (95% CI 0.837 to 0.892) respectively. Among different CT signs, mesenteric edema had highest Pooled sensitivity of 0. 741 and lack of bowel wall enhancement had highest pooled specificity of 0.991. CONCLUSIONS: This review demonstrates that CT is highly sensitive as well as specific in the preoperative diagnosis of strangulation SBO which are in accordance with the published studies. Our analysis also shows that "presence of mesenteric fluid" is most sensitive, and "lack of bowel wall enhancement" is most specific CT sign of strangulation, and also justifies need of large scale prospective studies to validate the results obtained as well as to determine a clinical protocol.

Polymorphisms of dihydropyrimidine dehydrogenase gene and clinical outcomes of gastric cancer patients treated with fluorouracil-based adjuvant chemotherapy in Chinese population.

BACKGROUND: Dihydropyrimidine dehydrogenase (DPD), a key enzyme involved in the catabolism of 5-fluorouracil (5-FU), is the attractive candidate for pharmacogenetic research on efficacies and toxicities of 5-FU. The aim of this study is to explore the association between polymorphisms of dihydropyrimidine dehydrogenase gene (DPYD) and clinical outcomes of gastric cancer patients treated with fluorouracil-based adjuvant chemotherapy in the Chinese population. METHODS: Three hundred and sixty-two patients with gastric cancer in the Chinese population were treated with fluorouracil-based adjuvant chemotherapy. The single nucleotide polymorphic genotypes of DPYD were determined by matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry (MALDI-TOF-MS) using DNA samples isolated from peripheral blood collected before treatment. RESULTS: The average response rate for chemotherapy was 46.7%. A significantly different distribution of the rs1801159 (c2=8.76, P=0.012) genotypes was observed. Homozygous genotype rs1801159A/A was over-represented in responsive patients. Conversely, carriers of the rs1801159A/G genotype were prevalent in non-responsive patients. In the haplotype association analysis, there was significant difference in global haplotype distribution between the groups (c2=3.96, P=0.0465). CONCLUSIONS: These results suggest that polymorphisms of rs1801159 in DPYD may be used as valuable predictors of the response to fluorouracil-based chemotherapy for gastric cancer patients in the Chinese population. Well-designed, comprehensive, and prospective studies on determining these polymorphisms of DPYD as predictive markers for gastric cancer in response to fluorouracil-based therapies are warranted.