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.

Comparison between intermittent claudication versus chronic limb-threatening ischemia in peripheral arterial disease: a retrospective multicenter cohort study.

Purpose: The anatomical distribution, characteristics of lesions, and treatment modalities for peripheral artery disease (PAD) are diverse. Endovascular intervention is popular for symptomatic PAD, for both intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI). We aimed to investigate the endovascular devices used by comparing patients with PAD referred for endovascular revascularization with IC and CLTI. Methods: We identified 736 patients with PAD enrolled in the multicenter PAD registry in South Korea from 2019 to 2022. Of these patients, 636 received endovascular treatment at the time of this study. After excluding missing data, we analyzed 506 patients with IC or CLTI. Patients' characteristics, target lesions, and endovascular device data such as type, length, balloon diameter, and stent, were examined. Procedure outcomes of the aortoiliac, femoropopliteal, and below-the-knee lesions were analyzed. Results: Patients with CLTI were more likely to have diabetes mellitus, below-the-knee interventions, and multilevel PAD than the IC group. Patients with IC had more aortoiliac artery lesions and underwent atherectomies than the CLTI group (63.3% and 61.1% vs. 39.7% and 40.6%, respectively; P < 0.001). In patients with femoropopliteal lesions, those with CLTI were more revascularized with stents than the patients with IC, without significant differences (35.3% vs. 29.1%, P = 0.161). Compared to the IC group, the CLTI patients showed significantly worse rates of primary patency, amputation, and mortality (P = 0.029, P < 0.001, and P < 0.001, respectively). Conclusion: Among Korean patients with PAD, there is a significant difference in baseline and lesion characteristics, endovascular strategies, and short-term follow-up outcomes among those with IC and CLTI.

Single Tract Aortic Revascularization Technique in the Treatment of Aortoiliac Occlusive Disease.

Endovascular treatment is an acceptable option for patients with aortoiliac occlusive disease. However, bilateral passage of guidewires through the aortoiliac occlusion can be a challenging step in achieving successful revascularization. The aim of this article is to present a novel strategy for successfully passing bilateral guidewires through long aortoiliac occlusive lesions. After one guidewire is passed through the aortic and iliac lesions via one side of the femoral artery, the other guidewire is passed using the up-and-over technique and pulled out from the ipsilateral side of the body. This contralateral guidewire is then inserted into the ipsilateral angiographic catheter along with the ipsilateral guidewire. Subsequently, the angiographic catheter is removed in a manner similar to a peel-away sheath. Eventually, bilateral guidewires can be passed through the lesion via a single aortic tract.

Clinical outcomes of nonthermal ablation, thermal ablation, and surgical stripping for varicose veins.

OBJECTIVE: The purpose of this study was to compare the clinical outcomes of radiofrequency ablation (RFA), cyanoacrylate closure (CAC), mechanochemical ablation (MOCA), and surgical stripping (SS) for incompetent saphenous veins and to determine a suitable treatment modality for a specific clinical situation. METHODS: We retrospectively reviewed the data of patients with varicose veins who underwent RFA, CAC, MOCA, or SS from January 2012 to June 2023. The clinical outcomes, including postoperative complications and the Aberdeen Varicose Vein Questionnaire score, were assessed. RESULTS: During the study period, 2866 patients with varicose veins were treated. Among them, 1670 patients (57.9%) were women. The mean age was 55.3 ± 12.9 years. RFA, CAC, MOCA, and SS were performed in 1984 (68.7%), 732 (25.4%), 78 (2.7%), and 88 (3.0%) patients, respectively. The complete target vein closure rate after RFA, CAC, and MOCA was 94.5%, 98%, and 98%, respectively. The absence of a target vein after SS was 98%. Deep vein thrombosis developed in four patients: one in the RFA group and three in CAC group. Surgical or endovenous procedure-induced thrombosis occurred in 2.3%, 4.8%, 6.4%, and 2.3% of the patients after RFA, CAC, MOCA, and SS, respectively. Phlebitis along the target vein occurred in 0.2% and 3.8% of patients after RFA and MOCA, respectively. A hypersensitivity reaction occurred in 3.7% of patients after CAC. Readmission was required for two patients who had undergone SS. Transient nerve symptoms developed in five (0.3%), zero, one (1.3%), and two (2.3%) patients after RFA, CAC, MOCA, and SS, respectively. After treatment, the Aberdeen Varicose Vein Questionnaire score improved significantly in all groups. CONCLUSIONS: The clinical outcomes with improvement in quality of life were comparable among the different treatment modalities. The proximity of the nerve or skin to the target vein is the most important factor in selecting a suitable treatment modality.

Novel Strategies for the Hostile Iliac Artery during Endovascular Aortic Aneurysm Repair.

Successful endovascular aneurysm repair can be achieved with favorable aortic and iliac arterial anatomies. However, patients with challenging iliac anatomy, such as stenotic, calcified, tortuous arteries, or concomitant iliac artery aneurysms, are commonly encountered. Such a hostile iliac anatomy increases the risk of intraprocedural complications and worsens long-term outcomes. This review addresses various technical options for treating patients with a hostile iliac anatomy, including innovative endovascular solutions, physician-modified endografts, and hybrid procedures. These considerations demonstrate the wide scope of therapies that may be offered to patients with an unfavorable iliac anatomy.

Incidence and Risk Factors of Iliac Artery Rupture during Aortoiliac Stenting.

Purpose: Aortoiliac occlusive disease (AIOD) is widely prevalent and leads to severe claudication or chronic limb-threatening ischemia. Stent placement for AIOD demonstrated excellent outcomes in terms of long-term patency. However, iliac artery rupture is the most fearful complication during the aortoiliac stenting (AIS). This study aimed to evaluate the incidence and risk factors of iliac artery rupture during AIS. Materials and Methods: A retrospective review of consecutive patients with AIOD treated with AIS from 2009 to 2021 was completed. We excluded patients with instent restenosis. All types of stents, including self-expanding stent (SES), balloon-expandable stent (BES), or balloon-expandable covered stent (CS), were used. Angiographic characteristics and procedural outcomes were analyzed. Procedural success was defined as the residual stenosis <30%. Results: A total of 242 patients (86.8% male; mean age 68.8±10.0 years) with de novo AIOD were treated with AIS. The procedural success rate was 100%. Rupture occurred in six patients (2.5%) and all ruptures were occurred in the external iliac artery (EIA). Stenting of the EIA and less calcified lesion were risk factors for iliac rupture (P=0.028). All cases of iliac artery rupture were successfully treated with the CSs. Overall primary patency rates were 98.0% and 93.4% at 12 and 36 months, respectively. Primary patency rates of SES, BES, and CS were 87.7%, 88.4%, and 100% at 36 months, respectively. Conclusion: The incidence of iliac artery rupture during AIS was 2.5%. Stent placement in the less calcified lesion and EIA was a risk factor for rupture during AIS. Placement of the CS can be the straightforward solution in case of iliac artery rupture during AIS.

Complex Hypersensitivity and Irritation Reaction (CHAIR) Phenomenon after Cyanoacrylate Closure of Varicose Vein.

Cyanoacrylate glue is a non-thermal, non-tumescent agent used to treat saphenous reflux. It was introduced to overcome heat-related discomfort and complications. Multiple randomized controlled trials using this therapy have demonstrated excellent clinical outcomes at long-term follow-up. However, diffuse injection-site inflammation and systemic urticaria are worrisome complications. In preclinical studies, serial histopathological findings demonstrated acute inflammatory reaction, subacute vasculitis, chronic granulomatous foreign body reaction, fibrotic changes with partial vascular recanalization, and chronic foreign body-type inflammatory response. While the exact nature of this unique complication remains undefined, complex hypersensitivity and irritation reaction phenomena have been suggested based on reported clinical presentations. The incidence of this complication has been reported as ranging from 0.3%-25.4%. Typically, erythematous reactions can occur near treatment sites, with symptoms ranging from mild pruritus and/or erythema that resolves without treatment to recurrent severe inflammation and pruritus requiring nonsteroidal anti-inflammatory drugs, antihistamines, and/or corticosteroids. Surgical excision has been rarely reported in patients with severe intractable inflammation or treatment-site infections. Although several anecdotal studies reported on using antihistaminics or corticosteroids, no effective strategies have been established to prevent this complication.

A nationwide study of compliance of venoactive drugs in chronic venous disease patients.

Purpose: Venoactive drugs are widely used to improve the symptoms and signs of chronic venous disease. This study aimed to analyze the rate of adverse events after venoactive drug prescription and subsequent compliance and switching rates. Methods: Using the National Health Insurance Service database, individuals with at least one chronic venous disease code between January 2009 and December 2019 were identified, and 30% (2,216,780 individuals) of these were sampled. Finally, 1,551,212 patients were included, and we analyzed adverse events, compliance, and switching rates with 8 venoactive drugs, including Vitis vinifera extract, naftazone, micronized purified flavonoid fraction, Vitis vinifera leaf extract, diosmin, diobsilate calcium, bilberry fruit dried extract, and sulodexide. Results: The most commonly prescribed venoactive drug was Vitis vinifera extract (72.2%), followed by sulodexide (9.3%), and Vitis vinifera leaf dry extract (8.2%). Adverse event rates were significantly lower in the naftazone and diosmin groups (P = 0.001 and P = 0.002, respectively) and significantly higher in the Vitis vinifera leaf dry extract group (P = 0.009). Drug adherence to sulodexide was the highest throughout the study period, followed by billberry extract and dobesilate (all P < 0.001). For most drugs, the drug switching rate was low (<5.0%). Conclusion: Vitis vinifera extract was the most commonly prescribed venoactive drug in Korea, and drug adherence to sulodexide was the highest among all venoactive drugs. The adverse event rates were significantly lower in the naftazone and diosmin groups.

Prospective, Multicenter Study of Rotational Atherectomy with Antirestenotic Therapy for Infrainguinal Arterial Disease.

BACKGROUND: Thrombi are common in steno-occlusive lesions of infrainguinal atherosclerotic diseases. Despite the easy passage of guidewires through these lesions, conventional ballooning or stenting cannot effectively treat them, and patients are at risk of distal embolization. This study aimed to investigate the clinical outcomes of using a rotational aspiration atherectomy system to treat infrainguinal atherosclerotic disease. METHODS: Patients underwent revascularization of target lesions using the Jetstream™ Atherectomy System. The primary endpoint was the freedom from clinically driven target lesion revascularization (CD-TLR) 12-month after the procedure. Outcomes were evaluated according to the clinical severity, lesion type, use of drug-coated balloons (DCBs), and lesion length, characteristics, and sites. Survival analysis for CD-TLR over time was plotted. All statistical analyses were performed using SPSS version 22 (IBM; Armonk, NY, USA). P-values <0.05 were considered statistically significant. RESULTS: In total, 150 patients (91.2% male; mean age, 69.8 years; 66.2% with diabetes) with de novo or restenotic infrainguinal lesions were enrolled. The mean lesion length was 17.2 cm, 75.0% were occlusive, and 38.2% had severe calcification. The lesion types were sclerotic (64.7%), thrombosclerotic (20.6%), thrombotic (8.8%), and in-stent (5.9%). Adjunctive DCB was used in 86.8% of patients. The 12-month primary patency rate (PPR) and CD-TLR rates were 81.6% and 90.1%, respectively. The 12-month CD-TLR rate was significantly better in the sclerotic and thrombosclerotic groups than in the thrombotic group (100% and 100% vs. 66.7%; P = 0.001). The 12-month PPR was significant better in TransAtlantic Inter-Society Consensus (TASC) A and B groups than TASC C and D groups (P = 0.02). The 12-month PPR is significantly better after using a DCB or stent placement than after using a simple balloon (P = 0.01). There were no major adverse events, including procedure-related death, myocardial infarction, or major amputation. CONCLUSIONS: The results of this study demonstrated the safety and effectiveness of the Jetstream atherectomy device for complex infrainguinal lesions. This system functions optimally with TASC A/B lesions and sclerotic or thrombosclerotic lesions.

National trend of the treatment for chronic venous diseases in Korea between 2010 and 2020.

Purpose: Limited data are available on the nationwide trend of treatments for chronic venous disease (CVD). The aim of the present study was to identify the nationwide trends of CVD treatments in Korea. Methods: A serial, cross-sectional study was conducted with the use of time trends to analyze patients with CVD between 2010 and 2020. The trends in the number of patients and procedures were analyzed including sclerotherapy, open surgery, and endovenous thermal ablation (ETA). Health Insurance Review and Assessment Service data were used to analyze the trends. For the statistical analysis, MedCalc Statistical software was used. P < 0.05 was considered statistically significant. Results: A total of 1,867,307 patients with CVD were managed in Korea between 2010 and 2020. The annual number of patients with CVD increased from 143,108 in 2010 to 219,319 in 2020 (risk ratio [RR], 1.53; P < 0.001). The percentage of patients with CVD who had venous ulcer gradually decreased from 3.1% in 2010 to 1.7% in 2020 (RR, 0.86; P < 0.001). The number of conventional surgeries including stripping and local resection of varicose veins decreased from 32,384 in 2010 to 21,792 in 2020 (RR, 0.67; P < 0.001). The number of ETAs performed increased, from 290 in 2011 to 12,126 procedures in 2020 (RR, 41.81; P < 0.001). Conclusion: The total number of patients with CVD increased during the last 11 years. The number of conventional open surgery and sclerotherapy procedures decreased. On the contrary, the number of ETAs significantly increased in Korea.

Prevalence and Risk Factors of Abdominal Aortic Aneurysms Detected with Ultrasound in Korea and Belgium.

The objective was to investigate the prevalence of abdominal aortic aneurysms (AAAs) and the diameters of the aorta and common iliac arteries (CIAs) in a Korean cohort and secondly to analyze the differences in aortic diameter by comparison with a European cohort. The Korean cohort included participants ≥ 50 years who consented to AAA screening and data were analysed retrospectively. Aortic and common iliac diameters were measured using the outer-to-outer diameter method and prevalence rates were calculated. Common risk factors such as smoking, body mass index, pulmonary disease, hypertension, diabetes, hyperlipidaemia, ischaemic heart disease, and cerebrovascular disease were reported in association with AAA occurrence and AAA development. The aortic diameters were then compared with those in a Belgian cohort of 2487 participants identified in the Liège AAA Screening Program. An aortic size index (ASI) was also calculated to account for the potential size differences in the Belgian and Korean populations. A total of 3124 Korean participants were examined using ultrasound. The prevalence of AAAs in this cohort was 0.7%. The combined prevalence of subaneurysmal dilatation and AAA was 1.5%. The prevalence in male smokers older than 65 years was 2.7% (19/715). The mean infrarenal aortic diameter was 17.3 ± 3.1 mm in men and 15.7 ± 2.7 mm in women; the corresponding values in Belgian participants were 19.4 ± 3.0 mm in men and 17.9 ± 2.4 mm in women. The median aortic size index was 0.99 (interquartile range 0.88-1.12). The mean infrarenal aortic diameter was significantly smaller in the Korean cohort than in the Belgian cohort. Considering the observed prevalence of AAAs in different age groups, the age groups which would contribute to most cases was male persons above 66 years in both cohorts.

Public awareness of chronic venous disease in Korea.

OBJECTIVE: This study aimed to evaluate the current level of chronic venous disease (CVD) awareness and its relevant influencing factors. METHODS: Online and interview surveys were conducted in two distinct groups from May 14 to June 16, 2020. An online survey was conducted among 900 adults aged 20 to 64 years from the research database, whereas interviews were conducted among 124 patients who presented with CVD symptoms, which covered the awareness of such symptoms and their impact on quality of life. RESULTS: Most respondents reported low levels of CVD awareness by recognizing the disease only by an entity. In 53 respondents who visited the hospital with suspected venous symptoms, the actual diagnosis was made in only 30.2%. CVD diagnosis was associated with increased CVD awareness. Female sex, age of >29 years, higher educational level, and higher income were associated with increased CVD awareness. Approximately 60% of the patients with CVD responded that physical symptoms had a negative impact on their quality of life rather than emotion or appearance. CONCLUSIONS: The public is largely unaware of CVD but not in detail. Educational programs to improve CVD awareness should be implemented to enable appropriate CVD management.

Ultrasound Elastography to Differentiate the Thrombus and Plaque in Peripheral Arterial Diseases.

Purpose: Arterial stiffness and steno-occlusion of the lower-extremity can result from many vascular lesions, including acute thromboembolisms, soft plaques, calcified plaques, or inflammatory disease. Ultrasound (US) elastography measures the tissue deformation response to compression and displays tissue stiffness. This study aimed to evaluate the characteristics of arterial lesions in the lower extremities using US elastography. Materials and Methods: We retrospectively analyzed the data of 20 patients who visited our institute for arterial disease treatment between May 2016 and November 2017. An US examination with B-mode and strain elastography (SE) was performed of four different lesion types at 45 sites: acute and subacute thromboembolisms, soft plaques, calcified plaques, and thromboangiitis obliterans lesions (TAOs). During SE, stress was externally applied by the operator using the transducer. Strain ratio (SR) was calculated as the fraction of the average strain in the reference area divided by the average strain in the lesion. The SR was compared among different lesion types, with the accompanying vein as the reference region of interest. Results: The strain was highest in the soft plaques (0.63%±0.23%), followed by the TAOs (0.45%±0.11%), calcified plaques (0.44%±0.13%), and acute thromboembolisms (0.34%±0.23%), which were statistically significant (P=0.026). However, the mean SR was highest for the calcified plaques (2.33%±0.80%), followed by the TAOs (1.63%±0.40%), acute thromboembolisms (1.60%±0.48%), and soft plaques (1.51±0.39), and which were statistically significant (P=0.013). Conclusion: Despite several limitations, vascular elastography may be useful for differentiating between lesion types in peripheral arterial disease.

Rapid hemostasis of the residual inguinal access sites during endovascular procedures: A case report.

BACKGROUND: In endovascular procedures including total percutaneous endovascular aneurysm repair (pEVAR), percutaneous access through the common femoral artery is most commonly performed. Access-site bleeding is a major concern in percutaneous techniques. Herein, we present a case of successful control of continuous oozing using a vascular closure device (VCD) and the application of Surgicel (Johnson & Johnson, United States) over the access tract. CASE SUMMARY: An 82-year-old man presented with an unruptured abdominal aortic aneurysm measuring 83 mm × 75 mm. The patient had a medical history of atrial fibrillation and was receiving rivaroxaban (15 mg/d). Routine pEVAR was performed using the preclose technique with ProGlide (Abbott, Santa Clara, CA, United States). Significant amount of bleeding was observed at the end of the procedure after the deployment of the closure device at the access site. A sheet of Surgicel was applied to the suture thread using a surgical needle. Surgicel was applied to the surface of the artery along the access tract using a pusher, and hemostasis was immediately attained. CONCLUSION: This simple technique is an excellent adjunct to control residual bleeding from the access site following VCD use.

In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

Changes of stump length depending on starting position of glue injection related to venous diameter during cyanoacrylate closure for incompetent saphenous veins.

OBJECTIVE: A common pattern of recurrence after cyanoacrylate treatment of incompetent saphenous veins has been associated with reflux from the residual stump. The purpose of this study was to analyze the starting point of cyanoacrylate glue injection from the junction to decrease the stump length. METHODS: A retrospective review was performed using prospectively collected data of patients with cyanoacrylate closure (CAC). Preoperatively, the diameter of the saphenous vein was measured. CAC was performed according to the manufacturer's instructions. After the procedure, clinical outcomes including pain, Venous Clinical Severity Score, and quality of life using the Aberdeen Varicose Vein Questionnaire were evaluated. Postoperative duplex scanning was performed to evaluate the occlusion rate of the target vein, stump length, and presence of endovenous glue-induced thrombosis. The stump length was analyzed according to the preoperative venous diameter to determine the proper point of glue injection to decrease the stump length. RESULTS: During the study period, CAC was performed in 408 patients. The mean age was 56.2 ± 11.5 years (range, 19-84 years). A total of 279 patients (68.4%) were women. Occlusion of the target vein was achieved in all patients. After the procedure, pain, Venous Clinical Severity Score, and quality of life were improved (P < .001). Endovenous glue-induced thrombosis developed in 5.8% of patients. There was a 1.53-fold linear increase in the stump length for every 1-mm increment of the preoperative venous diameter. In 20 patients with a venous diameter ≥5 mm, glue injection was performed safely 4 cm distal to the junction to decrease the stump length. CONCLUSIONS: The stump length linearly increased with an increase in the saphenous vein diameter. If the diameter of the saphenous vein is more than 5 mm, cyanoacrylate glue may be injected 4 cm distal to the junction to decrease the stump length.

A multicenter randomized controlled trial of cyanoacrylate closure and surgical stripping for incompetent great saphenous veins.

OBJECTIVE: The treatment of varicose veins has shifted from conventional surgical stripping (SS) to minimally invasive endovenous modalities. Cyanoacrylate closure (CAC) with the VenaSeal system (Medtronic, Dublin, Ireland) has increased in popularity owing to its nonthermal and nontumescent technique. The purpose of the present study was to compare the clinical outcomes of CAC and SS for the treatment of incompetent great saphenous veins. METHODS: An open-label, multicenter, prospective, randomized controlled trial was conducted. The subjects were randomized to either the CAC or SS procedure. The primary endpoint of the present study was to evaluate complete closure of the target vein at 3 months. Target vein occlusion was assessed on the third day and 1, 3, 6, and 12 months postoperatively using duplex ultrasound. The pain and ecchymosis grades were also assessed. Additionally, the clinical outcomes, such as the venous clinical severity score and Aberdeen Varicose Vein Questionnaire score, were assessed. RESULTS: Three-month follow-up data were obtained for all 126 enrolled and randomized subjects (63 with CAC and 63 with SS). At 3 months, complete target vein closure was observed in both groups. The postoperative pain score was significantly better in the CAC group than in the SS group (0.3 ± 0.6 in the CAC group and 1.1 ± 1.5 in the SS group; P < .001). In addition, the mean ecchymosis grade was 0.3 ± 0.5 in the CAC group and 1.1 ± 1.1 in the SS group (P < .001). The venous clinical severity score and quality of life had improved equally in both groups. The adverse events after both procedures were mostly minor complications (9 events in CAC group and 20 events in SS group). Major complications occurred in one patient who had undergone the SS procedure. CONCLUSIONS: The CAC and SS procedures were both associated with complete occlusion of the target vein at 3 months. The postoperative pain and ecchymosis grades were significantly lower in the CAC group. Other differences between the two groups included the frequency and nature of the complications. The results showed that CAC has high success with few complications.

Association of mortality with drug-coated devices in femoropopliteal artery based on the nationwide data.

PURPOSE: Drug-coated devices have been widely accepted as one of the most promising therapies for femoropopliteal artery revascularization. A recent meta-analysis showed increased mortality in patients treated with drug-coated devices. We sought to examine the association between mortality and drug-coated devices after the treatment of the femoropopliteal artery based on the Korea national administrative claims data. METHODS: In the National Health Insurance Service database from August 2015 to December 2017, we identified patients with femoropopliteal artery revascularization using percutaneous transluminal angioplasty (PTA), bare metal stents (BMS), drug-coated balloon (DCB), or drug-eluting stents (DES). Kaplan-Meier methods were used to estimate the survival among devices, and log-rank tests were used to evaluate differences between groups. Adjusted hazard ratios (aHRs) were computed using the inverse probability of treatment weightings (IPTW). RESULTS: There were 1,724 patients (mean age, 70.9 ± period was 552 days (interquartile range, 404-688 days). There was a difference in IPTW-adjusted mortality risk among device types (26.3% in PTA, 22.1% in BMS, 17.7% in DCB, and 17.8% in DES; P = 0.004). IPTW-adjusted Cox nproportional hazard analysis showed that drug-coated devices were associated with decreased all-cause mortality risk (aHR, 0.70; 95% confidence interval, 0.58-0.86). CONCLUSION: Our real-world analysis showed that there was no evidence of increased all-cause mortality after femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

Cyanoacrylate Closure of Small Saphenous Vein Insufficiency.

BACKGROUND: As minimally invasive techniques were issued, endovenous thermal ablations have emerged. However, the thermal-associated complication has been reported in the treatment of small saphenous vein (SSV) insufficiency, such as sural nerve injury. Recently introduced cyanoacrylate closure (CAC) is a nonthermal modality, so this thermal-associated complication can be avoided. OBJECTIVE: This retrospective study analyzed the feasibility, safety, and 2-year results of CAC for treating SSV insufficiency, particularly the incidence of sural nerve injury. MATERIALS AND METHODS: One hundred sixty-three SSV insufficiencies in 128 patients were treated with CAC were reviewed. Pain, venous severity, and quality of life (QoL) scores were evaluated. Postoperative duplex scanning also evaluated anatomical and clinical success rates. RESULTS: The mean patient age was 56.8 years. The initial technical success rate was 100%. The occlusion rate after 2 years was 96.3%. Pain, venous severity, and QoL scores were improved significantly from 2.4 to 0.0, 4.39 to 0.47, and 11.95 to 2.69, respectively, before and 2 years after CAC. No major complications were observed, such as sural nerve injury. CONCLUSION: Cyanoacrylate closure for the ablation of SSV insufficiency could be a great alternative to endothermal ablation with an excellent success rate and shorter procedure time.