Serious Adverse Events with Cyanoacrylate Closure of Varicose Veins: An Initial Report from a Large-Scale National Survey in Japan.

Objective: Cyanoacrylate closure (CAC) is a minimally invasive technique for the treatment of varicose veins. A recent paper reported serious adverse events (AEs) associated with this use. This triggered an urgent survey to determine the incidence of AEs in Japan. Methods: The CAC-AE survey was sent to all 1,030 institutions authorized for CAC treatments. Cases performed between January 2020 and October 2023 were surveyed. Data on serious AEs and mortality were collected. Results: There were 623 surveys returned. There were 16 cases of proximal deep vein thrombosis, 3 cases of pulmonary embolism (PE), and 0 cases of stroke. Deep vein occlusion due to cyanoacrylate extension was observed in 1 case. Vein resection due to infection was observed in 4 cases. There were 299 cases of localized phlebitis and/or allergic reactions requiring steroid administration. Systemic allergic reactions requiring steroid administration were observed in 66 cases. There was no anaphylaxis associated with cyanoacrylate. There was one postoperative death from PE. Conclusion: This report's intent is to provide real world data on serious AEs following CAC from Japan given current concern over these events. An extensive report investigation of individual complications with analysis including causality will be provided following a full investigation separately.

Supplement of Clinical Practice Guidelines for Endovenous Thermal Ablation for Varicose Veins: Overuse for the Inappropriate Indication.

While endovenous thermal ablation (ETA) become first choice of treatment for varicose veins, overuse of ETA for the inappropriate indication is growing problem. ETA is performed not only on varicose cases without symptom but also non diseased cases with segmental reflux of saphenous veins or no reflux. Indications of ETA was demonstrated in "the Clinical Practice Guidelines for ETA for Varicose Veins 2019" by Japanese Society of Phlebology. Purpose of this supplement is description of basics of correct indication for ETA. We also demonstrate the typical case of overuse of ETA for wrong indication. (This is a translation of Jpn J Phlebol 2020; 31: 39-43.).

A Case of Total Excision of a Thrombosed-Venous Aneurysm in the Sural Vein.

Venous aneurysm (VA) is an uncommon vascular disease; however, VA, especially in the lower extremities, can lead to critical complications, such as pulmonary embolism (PE). We report a case with a VA located in the sural vein (SV), which did not lead to PE; however, it had the potential to cause PE. Therefore, we treated this VA by total excision. The popliteal vein (PV) is the most common VA location in the lower extremities, but SV is extremely rare. We should always be aware that, in addition to the PV, VAs may also occur in the SV.

Postoperative Venous Thromboembolism in Patients Undergoing Endovenous Laser and Radiofrequency Ablation of the Saphenous Vein.

Objective: Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) are safe and effective treatments for varicose veins caused by saphenous reflux. Deep venous thrombosis (DVT) and endovenous heat-induced thrombosis (EHIT) are known complications of these procedures. The purpose of this article is to investigate the incidence of postoperative DVT and EHIT in patients undergoing EVLA and RFA. Methods: The patients were assessed by clinical examination and venous duplex ultrasonography before operation and at 24-72 hours, 1 month, and 1 year follow-up after operation. Endovenous ablation (EVA) had been treated for 1026 limbs (835 patients) using an RFA; 1174 limbs (954 patients) using a 1470-nm wavelength diode laser with radial two-ring fiber (1470R); and 6118 limbs (5513 patients) using a 980-nm wavelength diode laser with bare-tip fiber (980B). Results: DVT was detected in 3 legs (0.3%) of RFA, 5 legs (0.4%) of 1470R, and 27 legs (0.4%) of 980B. One patient in three symptomatic DVT treated with 980B developed asymptomatic pulmonary embolus. In all, 31 of the 35 DVTs were confined to the calf veins. The incidence of EHIT classes 2 and 3 was 2.7% following RFA procedure, 6.7% after 1470R, and 7.5% after 980B. Conclusion: The incidence of EHIT following EVA was low, especially the RFA procedure. EHIT resolves within 2-4 weeks in most patients. DVT rates after EVA were compared with those published for saphenous vein stripping. (This is a translation of J Jpn Coll Angiol 2015; 55: 153-161.).

Can Wound Exudate from Venous Leg Ulcers Measure Wound Pain Status?: A Pilot Study.

We investigated the associations between the self-evaluated pain status and two pain biomarker candidates, nerve growth factor and S100A8/A9, in exudate from venous leg ulcer to finally develop an objective pain evaluation method. Patients with venous leg ulcer participated in this cross-sectional observational study conducted between April and October 2014 at two medical facilities. During routine wound care, each participant self-evaluated their pain status at each examination using the 10-point numerical rating scale (present pain intensity) and the short-form McGill Pain Questionnaire 2 (continuous pain, intermittent pain, neuropathic pain, affective descriptors, and total score). Venous leg ulcer exudate sample was collected after wound cleansing. The nerve growth factor and S100A8/A9 concentrations in the venous leg ulcer exudate were measured by enzyme-linked immunosorbent assay and standardized according to the wound area. The association between each pain status and the two standardized protein concentrations was evaluated using Spearman's correlation coefficient. In 30 sample collected from 13 participants, the standardized nerve growth factor concentration was negatively correlated with continuous pain (ρ = -0.47, P = 0.01), intermittent pain (ρ = -0.48, P = 0.01), neuropathic pain (ρ = -0.51, P = 0.01), and total score (ρ = -0.46, P = 0.01). The standardized S100A8/A9 concentration was positively correlated with present pain intensity (ρ = 0.46, P = 0.03) and continuous pain (ρ = 0.48, P = 0.03). Thus, these two proteins may be useful for objective evaluation of wound pain in venous leg ulcer patients.

Detection of peripheral microemboli through collateral circulation by Doppler ultrasound monitoring-report of 2 cases.

It is possible for a proximal arterial source to lead to distal atheroembolism even in the presence of chronic occlusive disease. However, no monitoring technique has been established regarding detection of peripheral emboli through the collateral circulation in the lower limbs. We report a 60-year-old woman and a 73-year-old man with iliac stenosis and complete occlusion of the ipsilateral superficial femoral artery in whom Doppler ultrasound successfully detected microembolic signals (MES) at the tibioperoneal trunk during percutaneous transluminal angioplasty (PTA) and stent placement. By means of continuous Doppler ultrasound monitoring, 29 MES were successfully detected immediately after PTA or stent placement (MESp) and 64 MES were detected immediately after the contrast medium administration (MESc). MESc generated significantly higher intensities (median 28, range 7 to 38) as opposed to MESp (median 21, range 5 to 35, p = 0.017). In addition, the intensity of MES after prestent PTA (n = 8, 25 dB, 12-35 dB) and stenting (n = 18, 22 dB, 9-35 dB) was significantly higher than that of MES after poststent PTA (n = 3, 13 dB, range; 5-16 dB), respectively (p = 0.041, p = 0.034). Iliac PTA and stent placement were successful. Ankle/brachial pressure index and the symptoms improved in both patients, who showed no embolic symptoms after the procedure. This study suggested that it was possible to detect peripheral microemboli through the collateral circulation by Doppler ultrasound monitoring and that this technique would be helpful to investigate the mechanism of embolization in patients with PTA and stent placement.

Comparison of 1470 nm Laser and Radial 2ring Fiber with 980 nm Laser and Bare-Tip Fiber in Endovenous Laser Ablation of Saphenous Varicose Veins: A Multicenter, Prospective, Randomized, Non-Blind Study.

OBJECTIVE: The aim of this study is to compare the clinical efficacy and safety of two laser wavelengths and fiber types in endovenous laser ablation (EVLA) of saphenous varicose veins of the lower limb. DESIGN: Multi-center prospective randomized non-blind clinical trial. PATIENTS AND METHODS: From January 2007 to December 2011, 113 patients (113 limbs) with primary varicose veins were randomized into two groups. They were treated with radial 2ring fiber and 1470 nm laser in Group I (57 limbs) and bare-tip fiber and 980 nm laser in Group E (56 limbs) in order to ablate the saphenous vein. Vein occlusion rates at 12 weeks and pain in treated region were recorded as primary endpoint. Visual analogue scale (VAS) for assessment of pain, rates of bruising, complications and equipment failure were recorded as secondary endpoint of safety. RESULTS: Occlusion rates at 12 weeks were 100% in both groups. Rates of pain (0% vs. 25.0%) and bruising (7.0% vs. 57.1%) were significantly lower in Group I (p <0.0001). VAS of pain was significantly lower on postoperative day 1, day 5 and 2nd week in Group I. CONCLUSION: Treatment of saphenous varicose veins by EVLA using a 1470 nm laser and a radial 2ring fiber resulted in comparable occlusion rates at 12 weeks and less postoperative pain and bruising than EVLA with a 980 nm laser and a bare-tip fiber. (This article is a translation of Jpn J Vasc Surg 2014; 23: 964-971.).

Relationships of circulating nitrite/nitrate levels to severity and multiple organ dysfunction syndrome in systemic inflammatory response syndrome.

Excessive nitric oxide (NO) production has been implicated to be responsible for the development of septic shock. To determine whether plasma nitrite/nitrate (NOx) levels are related to the severity of systemic inflammatory response syndrome (SIRS) and the degree of multiple organ dysfunction, we studied plasma NOx levels in 70 patients with SIRS consisting of noninfectious SIRS (n = 32), sepsis (n = 23), and septic shock (n = 15). Infection is a microbial phenomenon characterized by an inflammatory response to the presence of microorganism. Positive culture for microorganism is regarded as infectious SIRS (sepsis and septic shock) and negative culture is regarded as noninfectious SIRS. Plasma samples collected from each patient within 24 h from admission to the intensive care unit were subjected for measurement of NOx levels, the stable end products of NO, by the high performance liquid chromatography-Greiss system. Mean plasma NOx levels in patients with SIRS were 52.8 +/- 44 microM/L, ranging from 8.1 to 186.2 microM/L. Plasma NOx levels were positively correlated with Acute Physiology, Age, and Chronic Health Evaluation (APACHE) III score (r = 0.414, P < 0.01) and sequential organ failure assessment (SOFA) score (r = 0.433, P < 0.01). Plasma NOx levels in patients with sepsis (51.0 +/- 38.5 microM/L) and septic shock (94.5 +/- 53.7 microM/L) were significantly (P < 0.01) higher than those in patients with noninfectious SIRS (25.8 +/- 16.9 microM/L) and healthy subjects (29.6 +/- 8.9 microM/L). Our study shows that plasma NOx levels are increased in patients with infectious, but not noninfectious SIRS, which increase as the severity of SIRS and the development of multiple organ dysfunction syndrome, suggesting its possible pathogenic role in SIRS.

Comparison of Bare-Tip and Radial Fiber in Endovenous Laser Ablation with 1470 nm Diode Laser.

OBJECTIVE: Major side effects after endovenous laser ablation (EVLA) are pain and bruising. The aim of this study was to compare outcome and side effects after EVLA for primary varicose veins with 1470 nm diode laser using bare-tip orradial fiber. METHODS: From October 2007 to December 2010, 385 patients (453 limbs) with primary varicose veins treated with 1470 nm laser were studied. Bare-tip fiber was used in 215 patients (242 limbs) (BF group) and radial fiber (ELVeS(TM)Radial, Biolitec AG, Germany) was used in 177 patients (211 limbs) (RF group). This study is a retrospective study and radial fiber was started for use from November 2008. Laser energy was administered at 6-12 W of power in the BF group and 10 W of power in the RF group with constant pullback of laser fiber under tumescent local anesthesia. The patients were assessed by clinical examination and venous duplex ultrasonography at 24-48 h, one week, one month, 4 months and one year follow-up postoperatively. RESULTS: Mean operating time, length of treated vein and linear endovenous laser energy of all cases were 42.6 min, 36.2 cm and 83.4 J/cm, respectively. Major complications such as deep vein thrombosis and skin burns were not noted. Bruising (1.9% vs. 19.4%) and pain (0.9% vs. 7.4%) were significantly lower in the RF group. Cumulative occlusion rates by Kaplan-Meier method were 100% at 32 months in the RF group and 99.5% at 4 years in the BF group. CONCLUSION: EVLA using 1470 nm laser with the radial fiber minimized adverse effects compared with bare-tip laser fiber. (English translation of Jpn J Vasc Surg 2013; 22: 615-621).

Anatomical variation at the sapheno-femoral junction.

OBJECTIVE: The aim of this study was to assess the anatomical variations of the sapheno-femoral junction (SFJ) and the incidence of these variations. MATERIALS AND METHODS: Between April 2005 and March 2010, 2552 limbs of 1563 patients with complaints of varicose veins underwent ultrasonography. Ultrasonography was used to identify the anatomical variations of the SFJ, especially the relationship to the femoral artery. RESULTS: Variations were seen in six limbs (0.24%) at the SFJ. The most common anatomical variation was the great saphenous vein crossing posterior to the common femoral artery, which was present in three limbs. CONCLUSION: It is important to investigate the anomalies of the SFJ using preoperative duplex ultrasound, although the incidence of such anomalies is lower than that of the sapheno-popliteal junction. An anomaly of the SFJ always should be taken into consideration in order to minimize surgical complications of varicose veins. (English translation of Jpn J Phlebol 2012; 23: 25-29).

Clinical Study of Phlebitis Migrans and Incompetence of the Leg's Superficial Vein in Buerger Disease.

Three of four (75%) vein biopsy samples from four patients (all male, mean onset: age 33.0, mean biopsy: age 59.7) of chronic phase phlebitis migrans showed positive periodontal bacteria DNA under the PCR (polymerase chain reaction) method. Of the 24 cases of Buerger disease (22 males, 2 females, mean onset: age 31.9, mean examination: age 62.6) that were investigated in our vascular laboratory, 65% of the patients suffered from moderate to severe varicose veins. Eight cases had a history of phlebitis migrans and three had an active ulcer or uncontrollable erosion in the foot. The rate of incidence was significantly higher than that of the well-matched control group. Other findings included one instance of deep vein thrombosis, and one instance of deep vein reflux. We could suggest that some intractable ulcer or erosion cases of Buerger disease may be complicated by superficial vein incompetence or other deep vein insufficiency. We also we need to check Buerger disease patients with duplex for vein reflux and other insufficiencies. Treatment of the varicose veins (including elastic stockings) was effective for all of the patients. (English Translation of Jpn J Phlebology 2011; 22: 25-31.).

Effects of acupressure on lower limb blood flow for the treatment of peripheral arterial occlusive diseases.

PURPOSE: To investigate the effects of acupressure on lower limb blood flow for the treatment of peripheral arterial occlusive diseases (PAOD). METHODS: From February 2004 to February 2005, 30 patients with stage II PAOD underwent measurements of the lower limb blood flow. Six patients (group A) were assigned as controls without any acupoint stimulation, while 24 (group B) underwent stimulation at acupoints by acupressure. The acupoints Yanglingquan (GB34), Zusanli (ST36), Yinlingquan (SP9), and Sanyinjiao (SP6) of the symptomatic lower limbs were stimulated for 3 min. Transcutaneous oximetry (tcPO2) was used to determine the blood flow of the chest wall, bilateral distal crura, and bilateral dorsa of the foot before and during the stimulations at the acupoints. RESULTS: Group A showed no significant change in the lower limb blood flow. In group B, the tcPO2 values of chest wall, bilateral distal crura, and the dorsum of foot of the stimulated lower limb increased significantly during acupressure (P < 0.01), whereas no significant change was shown in the dorsum of the foot of the non-stimulated lower limb. Moreover, the blood flow of the lower limbs that had undergone an ipsilateral sympathectomy increased significantly (P < 0.01). CONCLUSIONS: Acupressure was found to cause significant increases in the lower limb blood flow of stage II PAOD patients. This treatment modality may therefore be effective for improving the symptoms of such patients.

Clinical effectiveness of cognitive behavior therapy in the management of TMD.

PURPOSE: This study aimed to investigate whether cognitive behavior therapy (CBT) was effective as a standard intervention for temporomandibular disorders (TMD). MATERIALS AND METHODS: The subjects were 134 TMD outpatients with no history of treatment for TMD. They had pain persisting for 1 month or more and/or limited jaw movement. All patients underwent CBT. Symptom fluctuation was evaluated by a self-administered questionnaire. RESULTS: Symptoms had disappeared and improved in 112 patients within 2 months. CONCLUSION: It was suggested that most TMD symptoms can be relieved only by CBT in less than 2 months without further intervention.

Vascular closure system type of nonpenetrating arcuate-legged titanium clips for graft-artery and graft-graft anastomoses: review of our clinical experience.

PURPOSE: To assess the durability of Vascular Closure System (VCS) clips for graft-artery and graft-graft anastomoses. METHODS: The subjects were 100 consecutive patients, who had undergone vascular procedures in which VCS clip application was attempted for anastomoses. The operative indications were arteriosclerosis obliterans in 69 patients, aortic aneurysm in 26, and other disorders in 5. Large clips were used for both graft-artery and graft-graft anastomoses, and medium-sized clips were used for the smaller caliber femoral or popliteal arteries. RESULTS: Vascular Closure System clips could not be applied to anastomose the graft to the artery in 13 patients because the arterial wall was too thick or stiff. Anastomosis was accomplished without any problems in 80 patients, although suture-line bleeding occurred in 7 patients. This was ameliorated by an additional clip in four patients, but interrupted sutures were needed to seal the anastomosis in the other three patients. The 1-, 3-, and 5-year cumulative primary patency rates were 98.7%, 97.4%, and 87.7%, respectively. There were two graft failures and two anastomotic aneurysms. CONCLUSION: Vascular Closure System clips were useful to coapt a prosthetic graft to an artery unless the arterial wall was thicker than 2 mm or calcified. Thus, VCS clips could be durable enough for graft-artery anastomoses in the iliac or popliteal region.