Vitis Vinifera Seed Extract Versus Micronized Purified Flavonoid Fraction for Patients with Chronic Venous Disease: A Randomized Noninferiority Trial.

BACKGROUND: Venoactive drugs (VADs) based on Vitis vinifera extract are widely used in Korea. However, studies on the clinical effects and head-to-head comparisons with other groups of VADs are limited. This trial aimed to evaluate whether Vitis vinifera seed extract was noninferior to the micronized purified flavonoid fraction (MPFF) in relieving venous symptoms and improving quality of life in patients with chronic venous disease. METHODS: In this double-blind prospective randomized trial, patients from 13 hospitals, who were diagnosed with venous incompetence by duplex ultrasound and classified as clinical class 1, 2, or 3 in the Clinical, Etiological, Anatomical, and Pathophysiological classifications were enrolled. The primary outcome was the change in the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score at 8 weeks from baseline. Secondary outcomes included changes in the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score at 4 and 8 weeks from baseline. Moreover, the change in leg circumferences was measured at 8 weeks and compared to baseline. RESULTS: In total, 303 patients were enrolled and randomly assigned to receive either Vitis vinifera seed extract (n = 154) or MPFF (n = 149). The CIVIQ-20 scores at 8 weeks were significantly reduced compared to those at baseline in both groups. No significant intergroup difference in the change of CIVIQ-20 at 8 weeks from baseline was observed (-8.31 ± 14.63 vs. -10.35 ± 14.38, P = 0.29, 95% confidence interval -1.65 to 5.72). The lower limit of the 95% confidence interval was within the predefined noninferiority margin of 6.9. Furthermore, the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score scores significantly decreased at 4 and 8 weeks after randomization compared with baseline in both groups. No significant differences were observed in the reduction of each score between groups. The calf circumference measured at 8 weeks was significantly reduced compared to that at baseline in patients receiving Vitis vinifera seed extract. CONCLUSIONS: Vitis vinifera seed extract was noninferior to MPFF in relieving venous symptoms and improving the quality of life in patients with chronic venous disease.

Initial experience of thrombectomy using vascular snare with multiple loops for chronic organized thrombi in patients with thrombosed native hemodialysis fistulas.

BACKGROUND: Thrombi in native hemodialysis access frequently exhibit chronic organized feature because they have formed over a long period. Removal of these is quite difficult owing to relatively large volume, resilient feature, limitations of the introducer sheath size, etc. In this study, we report our experience using a vascular snare for the removal of these thrombi in native arteriovenous fistula (AVF). MATERIALS AND METHODS: The medical records of patients who underwent recanalization for thrombosed AVFs from January 2019 to August 2023 were reviewed. During the study period, a total of 29 native fistulas (19 brachiocephalic, nine radiocephalic, and one radiobasilic) in 25 patients were treated using a vascular snare with multiple loops (19 men and six women). Characteristics of the AVFs, endovascular procedures, technical and clinical results, and complications were evaluated. RESULTS: Anatomic and clinical success rates were 96.6% and 100%, respectively. Total thrombosis was observed in 21 (72.4%) fistulas. Aneurysmal changes were found in 22 (75.9%) fistulas. The mean fistula age at the time of the procedure was 60.9 months (standard deviation, 52.2). Thrombectomy was initiated using a vascular snare in 14 fistulas. In 15 fistulas for which the procedures were initiated using a rotational percutaneous thrombectomy device (PTD), a vascular snare was subsequently used because recanalization failed or was insufficient due to chronic organizing thrombi. Additional aspiration and balloon angioplasty were performed in 27 (93.1%) and 28 (96.6%), respectively. Pharmacological thrombolysis was performed in one fistula for long segmental thrombosis combined with arterial thrombosis. The mean procedure time, excluding thrombolysis, was 91.9 min (standard deviation, 55.5). No complications related to the use of the vascular snare was observed. CONCLUSION: The use of a vascular snare with multiple loops was safe and highly effective for the removal of chronic organized thrombi in the recanalization of thrombosed AVFs.

A 20-Year Analysis of Ruptured Abdominal Aortic Aneurysm Outcomes and Associated Factors in Korea.

BACKGROUND: Unlike western countries, which have reported distinct decreases in incidence of ruptured abdominal aortic aneurysm (rAAA) over the last few decades, epidemiologic studies in Korea have not shown significant changes in incidence or mortality of rAAA. The purpose of this study was to analyze the changes in rAAA treatment outcomes and various associated risk factors over the past 2 decades. METHODS: A 20-year retrospective multicenter review for rAAA cases from the period of January 2000 to December 2020 was undertaken. Preoperative, intraoperative and postoperative clinical data were extracted for patients diagnosed with rAAA. For analysis, outcomes from the early era, defined as patients treated between January 1, 2000, and December 31, 2010, were compared with outcomes from the late era, defined as patients treated between January 1, 2011, and December 31, 2020. RESULTS: The total in-hospital mortality was 34.1% in the early era compared to 44.8% in the late era. Patients in the late era were older than those in the early era (75.2 ± 10.3 years vs. 70.3 ± 8.9 years; P = 0.009). Treatment with rAAA endovascular aneurysm repair increased from 2.3% in early to 13.8% in late era (P = 0.031). In the early era, more patients were operated by experienced surgeons than the late era (78.1% vs. 45.9%; P = 0.002). The emergency room to operating room time did not show improvement over the 20 years. CONCLUSIONS: The results indicate that mortality rate of rAAA in Korea has not changed over the last 2 decades. The study suggests the need for national preventive strategies, improved systemic coordination, and potential centralization of vascular services to enhance survival rates for rAAA.

Infection of the Aortic Stent Graft to Treat Arterioureteral Fistula.

Arterioureteral fistula is a rare but life-threatening condition. An endovascular treatment approach is commonly used; however, there is a potential risk of infection. We present a case in which a patient presented with abdominal pain and was diagnosed with a ruptured internal iliac artery aneurysm and a subsequent arterioureteral fistula. An aortic stent graft was inserted to treat the arterioureteral fistula, but it subsequently became infected, resulting in the patient's death. This case underscores the importance of early diagnosis and treatment of arterioureteral fistula and the possibility of graft infection.

Treatments for symptomatic class I patients in CEAP classification with saphenous vein reflux: A pilot study.

BACKGROUND: For patients with telangiectasia or reticular veins (CEAP [clinical, etiologic, anatomic, pathophysiologic] class C1), less invasive endovenous (EV) treatments have emerged. However, no prospective studies have compared compression stockings (CSs) and EV ablation treatment for C1 symptomatic refluxing saphenous veins. The present prospective study compared the therapeutic results of the two treatment modalities. METHODS: From June 2020 to December 2021, 46 patients with telangiectasia or reticular veins (<3 mm; class C1) with axial saphenous reflux and venous congestion symptoms were prospectively enrolled. The patients were assigned to CS (n = 21) or EV treatment (n = 25), according to patient preference. Complications, clinical improvement scales (eg, the venous clinical severity score [VCSS]), and quality of life, including the Aberdeen varicose vein symptom severity score (AVSS) and venous insufficiency epidemiological and economic study - quality of life/symptoms (VEINES-QOL/Sym), were evaluated and compared between the two groups at 1, 3, and 6 months after treatment. RESULTS: No major complications occurred in either group. The median VCSS was 2.0 (interquartile range [IQR], 1.0-2.0), 1.0 (IQR, 0.5-2.0), 1.0 (IQR 0.0-1.0), and 0.0 (IQR 0.0-1.0) at baseline and 1, 3, and 6 months after treatment in the CS group, respectively. The corresponding VCSSs were 3.0 (IQR, 1.0-3.0), 1.0 (IQR, 0.0-1.0), 0.0 (IQR, 0.0-0.0), and 0.0 (IQR, 0.0-0.0) in the EV group. The median AVSS was 4.4 (IQR, 3.0-5.5), 2.1 (IQR, 1.3-4.6), 1.0 (IQR, 0.0-2.8), and 0.0 (IQR, 0.0-1.8) at baseline and 1, 3, and 6 months after treatment in the CS group, respectively. The corresponding scores were 6.2 (IQR, 3.8-12.3), 1.6 (IQR, 0.6-2.8), 0.0 (IQR, 0.0-2.6), and 0.0 (IQR, 0.0-0.4) in the EV group. The mean VEINES-QOL/Sym score was 92.7 ± 8.1, 100.4 ± 7.3, 104.3 ± 8.2, and 106.0 ± 9.7 in the CS group at baseline and 1, 3, and 6 months after treatment, respectively. The corresponding scores were 83.6 ± 8.0, 102.9 ± 6.6, 107.9 ± 3.9, and 109.6 ± 3.7 in the EV group. Both groups showed considerable improvement in the VCSS, AVSS, and VEIN-SYM/QOL scores, and no significant between-group differences were observed for ≤6 months. Among the severely symptomatic patients (pretreatment VEINES-QOL/Sym score ≤90), the EV group exhibited more marked improvement (P = .029 for the VCSS and P = .030 for the VEINES-QOL/Sym score). CONCLUSIONS: Both CSs and EV treatment provided clinical and quality of life improvement in symptomatic C1 patients with refluxing saphenous veins, with no significant between-group differences. However, a subgroup analysis revealed that EV treatment provided statistically significant improvement in the severe symptomatic C1 group.

Validation of I71.3 code for ruptured abdominal aortic aneurysm in Korea: misplaced diagnosis in claims data.

Purpose: Studies in western countries have shown a decline in the incidence of ruptured abdominal aortic aneurysm (rAAA) with advancements in endovascular repair and screening. However, according to health insurance data in Korea based on rAAA code (I71.3), overall rAAA has been increasing. This study aimed to validate the I71.3 code for rAAA and attempt to define the true incidence of rAAA in Korea. Methods: A 20-year multicenter retrospective review of rAAA was undertaken from the period of January 1, 2000 to December 31, 2020. All patients were diagnosed with the rAAA code I71.3 in each of the 4 hospitals. The CT images and surgical records of these patients were reviewed to differentiate true rAAA and misdiagnosis. Further data on true rAAA patient outcomes including mortality and treatment success were also collected. Results: A total of 305 rAAA (I71.3) codes were identified in the 4 centers. However, medical record review showed true rAAA in only 131 (43.0%). The remaining 174 cases (57.0%) were misdiagnosed. Impending ruptures were the most common misdiagnoses (37.9%). The total in-hospital mortality including deaths before treatment was 38.9% (n = 51), while mortality of treated patients was 24.4% (n = 15). Conclusion: The analysis of I71.3 code for rAAA showed that only 43.0% were true rAAA and the remaining 57.0% were misdiagnosed. This indicates that the I71.3 code is overestimated in National Health Insurance-based data and that the true incidence of rAAA could be much lower.

Metformin Use and Long-term Clinical Outcomes in Kidney Transplant Recipients.

RATIONALE & OBJECTIVE: Metformin has been recommended for some patients with advanced chronic kidney disease. However, the value of metformin in kidney transplant recipients (KTRs) with pretransplant diabetes mellitus (DM) or posttransplant DM is uncertain. We investigated the clinical effects of metformin in KTRs. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: A total of 1,995 KTRs with diabetes from 6 tertiary referral centers in the Republic of Korea. EXPOSURE: Metformin usage was defined as the use of metformin for>90 days after kidney transplantation; 1,193 KTRs were metformin users, and 802 KTRs did not use metformin. Changing usage of metformin among those exposed for >90 days was also characterized. OUTCOME: Primary outcomes were all-cause mortality and death-censored graft failure (DCGF). Secondary outcomes were biopsy-proven acute rejection (BPAR) and lactic acidosis events. ANALYTICAL APPROACH: Survival analyses were conducted using multivariable Cox regression and competing risk analyses using Fine and Gray models. Changes in metformin use over time were modeled using a time-varying covariate. Metformin usage, mean daily dose, and hemoglobin A1c (HbA1c) changes were considered in the landmark analysis to address time-varying confounding. RESULTS: Metformin use was associated with a lower risk of DCGF (adjusted hazard ratio [AHR], 0.47 [95% CI, 0.23-0.96], P=0.038); there was no significant association with all-cause mortality (AHR, 0.94 [95% CI, 0.32-2.76], P=0.915) or BPAR (AHR 0.98 [95% CI, 0.62-1.54], P=0.942). In the subgroup analysis, metformin usage was associated with a reduced risk of all-cause mortality and a lower risk of DCGF for both pretransplantation DM and posttransplant DM groups. Metformin usage was associated with a lower risk of BPAR in the posttransplant DM group, although it was less effective in the pretransplantation DM group. There was no confirmed case of metformin-associated lactic acidosis (MALA) in the present cohort. A higher dose of metformin was correlated with lower risks of DCGF and BPAR. LIMITATIONS: Data on newer antidiabetic drugs such as SGLT2 inhibitors are limited, and there is potential limited generalizability to other populations. CONCLUSIONS: Metformin usage may benefit KTRs, as evidenced by its association with a reduced risk of DCGF and the absence of MALA events. Randomized controlled trials are needed to validate these observational findings.

A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention.

Optimal antiplatelet therapy after endovascular therapy (EVT) for peripheral artery disease is controversial. This trial aimed to evaluate whether sarpogrelate plus aspirin was non-inferior for preventing early restenosis after femoropopliteal (FP) EVT compared to clopidogrel plus aspirin. In this open-label, prospective randomized trial, 272 patients were enrolled after successful EVT for FP lesions. Patients in each group received aspirin 100 mg and clopidogrel 75 mg or sarpogrelate 300 mg orally once per day for 6 months. The primary outcome was target lesion restenosis at 6 months, tested for noninferiority. Patient characteristics and EVT patterns were similar, except for increased inflow procedures in the sarpogrelate group and increased outflow procedures in the clopidogrel group. The sarpogrelate group showed a tendency of less restenosis at 6 months than the clopidogrel group (13.0% vs. 19.1%, difference 6.1 percentage points, 95% CI for noninferiority - 0.047 to 0.169). Secondary endpoints related to safety outcomes were rare in both groups. Risks of target lesion restenosis of the two intervention arm were uniform across most major subgroups except for those with coronary artery disease. In conclusion, Sarpogrelate plus aspirin is non-inferior to clopidogrel plus aspirin in preventing early restenosis after FP EVT. Larger multi-ethnic trials are required to generalize these findings. Trial registration: National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT02959606; 09/11/2016).

Outcome after early thrombotic occlusion of arteriovenous fistulas.

OBJECTIVE: Arteriovenous fistulas (AVFs) are considered the first choice for venous access in end-stage renal disease patients, however, they are also known to have a high primary failure rate (early thrombosis and maturation failure). Of these, the outcome of thrombosed immature AVFs is not well known. This study aimed to investigate the outcome of AVFs with early thrombosis. METHODS: Patients who underwent AVF creation from January 2009 to December 2019 at Seoul National University Hospital or Seoul Metropolitan Government - Seoul National University Boramae Medical Center were retrospectively reviewed. Patients who received salvage operations due to early thrombosis within 30 days after access creation were analyzed. RESULTS: During the study period, a total of 45 patients (radiocephalic 26; brachiocephalic 19) developed early thrombosis and underwent salvage operations. The median age of patients was 61.0 (54.5-69.5) years, and 51.1% were male. The first salvage operation was performed on the median 1.0 (0.0-4.5) day after AVF creation. The most common cause for early thrombosis was venous stenosis (64.4%) and followed by poor arterial inflow (28.9%), especially in radiocephalic AVFs. About 20 AVFs were salvaged to maturation (46.5%). Post-salvage primary patency and secondary patency at 1 year was 72.6% and 100%. In a multivariate logistic regression, significant risk factors for maturation failures were minimum venous outflow diameter ⩽2.5 mm (OR, 4.433; 95% CI, 1.039-18.921; p = 0.044) and lower in patients with hypertension (OR, 0.064; 95% CI, 0.006-0.637; p = 0.019). CONCLUSIONS: Thrombosed immature AVFs are associated with a high failure rate after salvage operation. However, if the salvage operation is successfully performed, it is associated with an acceptable 1-year outcome.