Long-Term Outcomes of a Japanese Prospective Multicenter Registry Using a Heparin-Bonded Expanded Polytetrafluoroethylene Graft for Above-the-Knee Femoropopliteal Bypasses.

BACKGROUND: Despite the widespread use of PROPATEN®, a bioactive heparin-bonded expanded polytetrafluoroethylene graft, in bypass surgery, there are only a few reports of long-term results. We evaluated the long-term results of PROPATEN®use for above-knee femoropopliteal bypass (AKFPB).Methods and Results: After PROPATEN®-based AKFPB, patients were prospectively registered at 20 Japanese institutions between July 2014 and October 2017 to evaluate long-term results. During the median follow-up of 76 months (interquartile range 36-88 months) for 120 limbs (in 113 patients; mean [±SD] age 72.7±8.1 years; 66.7% male; ankle-brachial index [ABI] 0.45±0.27; lesion length 26.2±5.7 cm; chronic limb-threatening ischemia in 45 limbs), there were 8 major amputations; however, clinical improvement was sustained (mean [±SD] ABI 0.87±0.23) and the Rutherford classification grade improved in 105 (87.5%) limbs at the latest follow-up. At 8 years, the primary patency, freedom from target-lesion revascularization, secondary patency, survival, and amputation-free survival, as estimated by the Kaplan-Meier method, were 66.3±4.8%, 71.5±4.4%, 86.5±3.4%, 53.1±5.0%, and 47.4±5.3%, respectively. CONCLUSIONS: This multicenter prospective registry-based analysis showed sustained excellent clinical improvement and secondary patency for up to 8 years following PROPATEN®-based AKFPB. PROPATEN®constitutes a durable and good revascularization option for complex superficial femoral artery lesions, especially when endovascular treatment is inappropriate or an adequate venous conduit is unavailable.

Impact of wound management strategies after revascularization for chronic limb-threatening ischemia.

OBJECTIVE: There is no established consensus or guidelines for wound management after revascularization for patients with chronic limb-threatening ischemia (CLTI) without severe infection. This study is designed to evaluate the clinical effect of the wound management strategy on toe wounds after revascularization for CLTI. METHODS: This retrospective cohort study was performed at eight institutions affiliated with Keio University School of Medicine in Japan and included 261 patients who underwent revascularization for CLTI between April 2019 and July 2021. We identified 132 patients with toe wounds from the database who had restored in-line blood flow to the foot. Patients were divided into two groups by the timing of toe resection after revascularization, which dictated the wound management policy. Group A (62 patients) underwent early toe amputation for suspected osteomyelitis, whereas group B (70 patients) underwent watchful waiting. The primary outcome was wound healing after revascularization; the secondary outcome was major amputation. We compared outcomes between groups A and B after propensity score matching. RESULTS: Using propensity score matching, each patient in group A (33 patients) was matched with a patient in group B (33 patients). Wound healing in matched group A was significantly better than that in matched group B (respectively: 1-year wound healing rate: 90.0% vs 68.2%, P < .001; median wound healing time: 65 days vs 258 days, P < .01). Although five major amputations were necessary in matched group B, none were required in matched group A (P = .05). The high rate of major amputations in group B was attributed to the sudden exacerbation of infection. Limb salvage rate in matched group A exceeded matched group B (100.0% vs 90.5%: 1-year limb salvage rate, P = .02). CONCLUSIONS: Early toe amputation for highly suspected osteomyelitis in patients with CLTI with toe wounds may expedite wound healing compared with watchful waiting, potentially avoiding unnecessary major amputation. Considering the wound management strategy is crucial when evaluating wound healing outcomes in patients with CLTI with revascularization.

Successful treatment of postoperative nonobstructive recurrent cholangitis by tract conversion surgery after total pancreatectomy: a case report.

BACKGROUND: Postoperative cholangitis is a complication of biliary reconstruction during hepatobiliary pancreatic surgery. Most cases are associated with anastomotic stenosis, but there are also cases of cholangitis without stenosis, and treatment can be difficult, especially in patients with recurrent symptoms. In this report, we describe a case of repeated nonobstructive cholangitis in a patient after total pancreatectomy, in which a good outcome was obtained after performing tract conversion surgery. CASE PRESENTATION: The patient was a 75-year-old man. He underwent total pancreatectomy for stage IIA cancer of the pancreatic body, hepaticojejunostomy via the posterior colonic route, gastrojejunostomy and Braun anastomosis via the anterior colonic route using the Billroth II method. The patient had a good postoperative course and was receiving adjuvant chemotherapy on an outpatient basis, but he developed his first episode of cholangitis 4 months after surgery. Although conservative treatment with antimicrobial agents was successful, the patient continued to have recurrent biliary cholangitis and was repeatedly admitted and discharged from the hospital. Since stenosis at the anastomosis was suspected, endoscopic observation of the anastomosis was performed using small bowel endoscopy for close examination, but no apparent stenosis was observed. Small bowel imaging indicated a possible influx of contrast medium into the bile duct, and reflux due to food residue was suspected as the cause of cholangitis. Since conservative treatment alone did not suppress the flare-up of symptoms, the decision was made to perform tract conversion surgery for curative purposes. The afferent loop was cut midstream, and jejunojejunostomy was performed downstream. The postoperative course was good, and the patient was discharged on the 10th day after surgery. He is currently an outpatient and has been free of cholangitis symptoms for 4 years without cancer recurrence. CONCLUSIONS: Although the diagnosis of nonobstructive retrograde cholangitis can be difficult, surgical treatment should be considered in patients with recurrent symptoms and refractory treatment.

Five-Year Outcomes of the Bioresorbable Peripheral Remedy Stent in the Treatment of Iliac Artery Disease.

PURPOSE: To evaluate the 5-year performance of a bioresorbable vascular scaffold, the Remedy stent, for the treatment of iliac artery atherosclerotic disease. MATERIALS AND METHODS: This prospective, multicenter, single-arm clinical study evaluated 97 patients (97 lesions) with symptomatic TransAtlantic Inter-Society Consensus II A/B iliac artery lesions for 5 years after stent placement. The primary efficacy end point was 12-month primary patency compared with the prespecified standard derived from historical data with metallic stents, and the primary safety end point was the occurrence of major adverse clinical events within 5 years. All angiographic and computed tomography angiographic findings were evaluated by an independent core laboratory for quantitative vessel analysis. RESULTS: The 12-month primary patency rate was 88.6% (95% CI, 80.1%-94.4%), which was lower than the prespecified standard. No significant difference was noted between the diameter stenosis at 9 and 12 months. There were no device- or procedure-related deaths, major amputation, or distal embolization during the follow-up period. The ankle-brachial index maintained significant improvement through the 5-year period compared with that at baseline. The Kaplan-Meier estimates of freedom from target lesion revascularization (TLR), major adverse cardiovascular events, and major adverse cardiovascular and limb events were 95.8%, 91.7%, and 87.5% at 12 months and 85.4%, 72.1%, and 62.5% at 5 years, respectively. CONCLUSIONS: The 5-year follow-up outcomes, including freedom from TLR, of the Remedy stent in iliac artery lesions were satisfactory, with a good safety profile. Nevertheless, the 12-month primary patency did not meet the expected standard compared with that of contemporary metallic stents.

Prediction of need for bowel resection in acute superior mesenteric artery occlusion: A retrospective study of 48 Japanese patients.

Aim: This study aimed to predict cases of acute superior mesenteric artery (SMA) occlusion requiring bowel resection using occlusion site and time from symptom onset to diagnosis at five Japanese institutions. Advances in imaging, endovascular treatment, and perioperative management have improved the clinical outcomes of patients with acute SMA occlusion; however, in clinical practice it remains difficult to effectively determine patients requiring bowel resection. Methods: We retrospectively analyzed the data of 48 patients (mean age: 82.5 y; male: 37.5%) diagnosed with acute SMA occlusion between June 2009 and August 2018. Background data of patients who required and did not require bowel resection were compared. A multivariable predictive model was developed using the time from symptom onset to diagnosis and whether SMA occlusion was proximal, including the origin of the middle colic artery. Results: Fifteen patients (31.3%) died during the hospital stay. Atrial fibrillation (83.3%) was the most common comorbidity. The median time from symptom onset to diagnosis was 13.0 (interquartile range, 4.75-24.0) h. Laparotomy, bowel resection, and thrombus embolectomy were performed in 41 (85.4%), 26 (54.2%), and 21 (43.8%) patients, respectively. A logistic regression model achieved 78.6% sensitivity in predicting cases not requiring bowel resection. Proximal occlusion was significantly associated with the requirement for bowel resection (P = .039). Conclusion: The time from symptom onset to diagnosis and occlusion site contributed to high sensitivity in determining the need for bowel resection in patients with acute SMA occlusion. Further prospective studies are warranted to investigate the clinical impact of this model.

Long-term Outcomes of the Endurant and Excluder Stent Grafts for Endovascular Aneurysm Repair in a Japanese Cohort.

PURPOSE: To compare the long-term outcomes of the most widely used third-generation stent grafts, the Endurant and Excluder stent grafts, in Japanese patients using a multicenter registry. MATERIALS AND METHODS: A retrospective analysis of endovascular aneurysm repairs for abdominal aortic and iliac artery aneurysms using either the Endurant or the Excluder stent grafts from January 2012 to July 2019 at 10 Japanese hospitals was performed. RESULTS: A total of 332 and 378 repairs using the Endurant and Excluder stent grafts, respectively, were analyzed. Although the patients' characteristics were generally similar in the two groups, the Endurant group exhibited significantly shorter (Endurant: 31.5±18.6 mm, Excluder: 37.4±21.0 mm; p<0.001), larger (Endurant: 22.4±4.2 mm, Excluder: 21.7±3.8 mm; p=0.029), and more reversed tapered (Endurant: 12.1%, Excluder: 5.8%; p=0.003) proximal necks. The incidence of instructions for use (IFU) violations was similar between the two groups (Endurant: 59.0%, Excluder: 54.5%; p=0.223). However, the Endurant group had significantly more proximal neck-related IFU violations (54.1% and 46.3%, respectively; p=0.039), more access-related IFU violations (8.1% and 4.0%, respectively; p=0.019), and fewer bilateral hypogastric artery embolizations (5.1% and 9.3%, respectively; p=0.035) compared with the Excluder group. The incidence of intraoperative (Endurant: 3.6%, Excluder: 3.7%; p=0.950) and perioperative complications (Endurant: 3.6%, Excluder: 3.4%, p=0.899) was equivalent in the two groups. However, there was a significantly higher incidence of postoperative type II endoleaks in the Excluder group (Endurant: 28%, Excluder: 46.0%, p<0.001). Aneurysm sac regression was more frequent in the Endurant group (Endurant: 40.7%, Excluder: 31.7%, p=0.013). The Endurant group also had significantly higher rates of sac increase (Endurant: 13.0%, Excluder: 7.7%, p=0.020). Kaplan-Meier curve and log-rank analyses revealed no statistical differences in late complications (p=0.868) and overall survival (p=0.926). CONCLUSIONS: There were no statistically significant differences between the Endurant and the Excluder stent grafts in terms of intraoperative, perioperative, and late complication rates; however, the anatomical characteristics of the patients were significantly different.

Ultra-Low-Dose Contrast Using Transluminal Renal Angioplasty: The ULTRA Study.

BACKGROUND: Although severe atherosclerotic renal artery stenosis (ARAS) is a predictor of future cardiovascular events, large trials have not shown the benefits of percutaneous transluminal renal angioplasty (PTRA). This study aimed to validate the safety and efficacy of PTRA using low-concentration digital subtraction angiography (LC-DSA) in patients with severe ARAS and advanced chronic kidney disease (CKD). MATERIALS AND METHODS: This prospective study was conducted between August 2018 and October 2021. Eighteen patients with 20 lesions, CKD stage 3b or worse, and significant renal artery stenosis were included and underwent PTRA using ultra-low-dose contrast medium. The primary endpoint was a change in renal function based on serum creatinine (sCr) level. RESULTS: The mean sCr level significantly improved from 3.34 ± 1.8 mg/dL pre-PTRA to 2.48 ± 1.19 mg/dL at 1 month post-PTRA (P = .02). The mean amount of contrast used was 8.3 ± 3.9 mL per vessel. More severe stenosis and rapid deterioration of renal function before treatment were associated with improved kidney function. No cardiovascular or renal complications such as stroke or contrast-induced nephropathy were observed during the 30-day period. CONCLUSIONS: PTRA using an ultra-low-dose contrast medium is safe and provides acceptable results.

Focal neuroendocrine carcinoma mixed with adenocarcinoma of the gallbladder with aggressive lymph node metastasis in a patient who did not meet the mixed neuroendocrine-non-neuroendocrine neoplasm criteria.

A 70-year-old Japanese woman who was treated for interstitial pneumonia (IP) with steroid therapy developed cholecystitis. A serial computed-tomography (CT) imaging showed irregular thickness of the fundus wall of the gallbladder and two rapidly enlarged lymph nodes (LNs): number (no.) 12 and no. 8a. Positron-emission tomography-computed tomography (PET-CT) scan showed an abnormal uptake at the site of the gallbladder tumor and those LNs. We subsequently performed open radical cholecystectomy and LN dissection of the no. 12 and 8a LNs, following complete remission of IP. The histology showed gallbladder adenocarcinoma, with a single focus of neuroendocrine carcinoma (NEC) component of less than 30%; Ki-67 index > 80%, synaptophysin (Syn) (+), chromogranin A (CgA) (+), and clusters of differentiation (CD) 56 (+) (T2bN1M0, Stage IIIB). LN no. 8a was diffusely metastatic with NEC components. LN no. 12c, which was adjacent to the cystic duct, revealed necrosis without apparent tumor cells, but was highly suspicious for tumor necrosis. The final diagnosis was adenocarcinoma of the gallbladder with focal NEC (< 30%), which did not meet the criteria for mixed neuroendocrine-non-neuroendocrine neoplasm (MiNEN). Postoperatively, she completed 4 cycles of adjuvant chemotherapy for NEC (Cisplatin plus Etoposide), and no recurrence was observed after 12 months.

[A Case of an Advanced Intrahepatic Cholangiocarcinoma Effectively Treated by Conversion Surgery after Neoadjuvant Chemotherapy of Gemcitabine, Cisplatin and S-1].

A 61-year-old male suffered from intrahepatic cholangiocarcinoma in S7 lesion(90 mm diameter), diagnosed by hepatic tumor biopsy. As PET-CT showed para-aortic lymph node metastasis(cT3N1M1, cStage ⅣB), and judged to be unresectable, he received neoadjuvant chemotherapy of gemcitabine, cisplatin, and S-1(GCS). After 7 courses of GCS, CT showed partial response of the primary tumor and PET-CT showed decreased accumulation of FDG at para-aortic lymph node. Resectability was reexamined and the patient underwent S7 extended subsegmentectomy as conversion surgery. Furthermore, after the surgery, he received adjuvant chemotherapy of S-1 for 6 months, and he remained relapse-free for the next 2 years. Cholangiocarcinoma is one of the most poorly prognosed type cancer. Conversion surgery for unresectable intrahepatic cholangiocarcinoma is frequently reported, but there are still few reports of GCS as neoadjuvant chemotherapy. Here, we report a case of unresectable intrahepatic cholangiocarcinoma that was successfully treated with GCS and underwent conversion surgery.

Machine Learning-based Model for Predicting Postoperative Complications among Patients with Colonic Perforation: A Retrospective study.

OBJECTIVES: Surgery for colonic perforation has high morbidity and mortality rates. Predicting complications preoperatively would help improve short-term outcomes; however, no predictive risk stratification model exists to date. Therefore, the current study aimed to determine risk factors for complications after colonic perforation surgery and use machine learning to construct a predictive model. METHODS: This retrospective study included 51 patients who underwent emergency surgery for colorectal perforation. We investigated the connection between overall complications and several preoperative indicators, such as lactate and the Glasgow Prognostic Score. Moreover, we used the classification and regression tree (CART), a machine-learning method, to establish an optimal prediction model for complications. RESULTS: Overall complications occurred in 32 patients (62.7%). Multivariate logistic regression analysis identified high lactate levels [odds ratio (OR), 1.86; 95% confidence interval (CI), 1.07-3.22; p = 0.027] and hypoalbuminemia (OR, 2.56; 95% CI, 1.06-6.25; p = 0.036) as predictors of overall complications. According to the CART analysis, the albumin level was the most important parameter, followed by the lactate level. This prediction model had an area under the curve (AUC) of 0.830. CONCLUSIONS: Our results determined that both preoperative albumin and lactate levels were valuable predictors of postoperative complications among patients who underwent colonic perforation surgery. The CART analysis determined optimal cutoff levels with high AUC values to predict complications, making both indicators clinically easier to use for decision making.

Incidence, diagnosis and treatment of popliteal artery entrapment syndrome in current vascular practice in Japan.

Few data regarding popliteal artery entrapment syndrome (PAES) is available in Japan. In this study, we investigated incidence, diagnosis and treatment of PAES in current vascular practice. A retrospective analysis of all patients with PAES visiting 31 participating institutes between 2003 and 2015 was conducted. Thirty-five limbs (28 patients) were identified during the 13-year study period, and the incidence of PAES was 0.12% of all peripheral artery disease cases revascularized. Mean age was 32.0 ± 16.9 years old, and 60 and more years old was 10.7%. Also, 92.9% were male and 39.3% were athletes. Most frequent initial symptoms were intermittent claudication in 23 limbs (65.7%); 4 limbs (11.4%) had chronic limb-threatening ischemia. CT scan was most frequently (94.3%) used for the diagnostic imaging followed by MRI (45.7%) and duplex ultrasound (45.7%). Stress test such as dorsal flexion during duplex ultrasound was used only in 28.6%. Thirty-two limbs (91.4%) received surgical treatment, including 23 arterial reconstructions (71.9%); there were no major perioperative complications. All patients achieved improvement of their symptoms, and the average ankle brachial index increased from 0.69 ± 0.22 to 1.00 ± 0.14 post-surgery. The average postoperative follow-up period was 26.0 months with only one reintervention during the follow-up. In conclusion, PAES was a rare condition and traditional surgical treatment was solid. However, given a broad spectrum of clinical feature of PAES and less usage of diagnostic duplex ultrasound with stress test, there might be a miss- or delayed diagnosis of PAES even in the current vascular practice.

Heterochronous Suture Line Recurrences in the Jejunal Pouch following Total Gastrectomy for Stage II Gastric Cancer: A Case Report and Literature Review.

We report the case of a 65-year-old male who developed heterochronous local recurrences of gastric cancer in the jejunal pouch (J-pouch) four times after total gastrectomy. He underwent total gastrectomy, J-pouch, and Roux-en-Y reconstruction for stage II gastric cancer in 2005. Four local recurrences appeared on the esophago-jejunal anastomosis, the suture line within the pouch, the esophago-jejunal anastomosis, and the anastomosis between the jejunum and Y-loop, which were resected by partial excision or endoscopic submucosal dissection. Suture line recurrence of gastric cancer is rare. The common features for each recurrence included the surgically negative resection margins, observation of the same histopathological subtype, absence of remote metastasis or peritoneal seeding, and the recurrence on the anastomotic suture line, suggesting that the cause of recurrence was the implantation of exfoliated cancer cells probably in the suture line. However, there is no established procedure for preventing implantation recurrence currently, the effectiveness of lumen lavage is suggested.

Midterm Results of a Japanese Prospective Multicenter Registry of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Above-the-Knee Femoropopliteal Bypass.

BACKGROUND: This study prospectively analyzed the midterm results of above-the-knee femoropopliteal bypass (AKb) using bioactive heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft in patients with femoropopliteal occlusive disease.Methods and Results:This prospective, multicenter, non-randomized study reviewed limbs undergoing AKb with HB-ePTFE graft for femoropopliteal lesion in 20 Japanese institutions between July 2014 and October 2017. Primary efficacy endpoints were primary, primary assisted, and secondary graft patency. Safety endpoints included any major adverse limb event and perioperative mortality. During the study period, 120 limbs of 113 patients (mean age, 72.7 years) underwent AKb with HB-ePTFE grafts. A total of 45 patients (37.5%) had critical limb ischemia and 17 (15.0%) were on hemodialysis (HD). Median duration of follow-up was 16 months (range, 1-36 months). Estimated 1- and 2-year primary, primary assisted, and secondary graft patency rates were 89.4% and 82.7%, 89.4% and 87.2%, and 94.7% and 92.5%, respectively. On univariate analysis of 2-year primary graft patency, having 3 run-off vessels, cuffed distal anastomoses, no coronary artery disease, and no chronic kidney disease requiring HD were significantly associated with favorable patency. CONCLUSIONS: AKb using HB-ePTFE grafts achieved favorable 2-year graft patency. AKb using HB-ePTFE grafts may therefore be an acceptable, highly effective treatment option for femoropopliteal artery lesions.

Impact of Stent Graft Design on External Iliac Artery Limb Occlusion Rates After Endovascular Aneurysm Repair: Post-hoc Analysis of a Japanese Multicentre Database.

OBJECTIVE/BACKGROUND: It was hypothesised that a helical stent with expanded polytetrafluoroethylene (ePTFE) grafts could provide a preventive effect for external iliac artery (EIA) limb occlusion following endovascular aortic aneurysm repair (EVAR). Therefore, a post-hoc analysis of a Japanese multicentre database was conducted to assess the impact of the stent graft design on EIA limb occlusion rates. METHODS: Patients who underwent EVAR with EIA limb deployment between 2008 and 2016 were evaluated. The stent graft limbs were divided into two groups: group A comprised stent graft limbs made of a helical stent with ePTFE grafts (Excluder; n = 255), and group B comprised stent graft limbs made of a Z stent with polyester grafts (Zenith, Flex and Endurant; n = 173). The main outcome was the incidence of limb occlusion and severe limb stenosis (EIA related limb complications). The risk factors for EIA related limb complications were analysed and the midterm results between groups A and B compared. Fine-Gray generalisation of the proportional hazards model was used after propensity score matching to calculate the hazard ratio (HR). RESULTS: One complication occurred in group A and 10 complications occurred in group B. The risk factors for EIA related limb complications for the entire group were a stent graft limb size ≤10 mm (HR 5.41; p = .01) and inclusion in group B (HR 14.9; p = .009). After propensity matching, group A (n = 159) was matched with group B (n = 159). The cumulative incidence function of EIA related limb complications at five years was 0.66% in group A and 7.8% in group B (HR 8.67; p = .039). CONCLUSION: Stent graft design can affect limb patency in EIA limb deployment. When EIA limb deployment is necessary for patients with a small EIA, such as Japanese patients, stent graft limbs made of a helical stent with ePTFE should be used to reduce the risk of limb occlusion.

Type IIIb Endoleak Is Not Extremely Rare and May Be Underdiagnosed after Endovascular Aneurysm Repair.

PURPOSE: To investigate the real incidence of type IIIb endoleaks associated with the Zenith stent graft, currently the most widely used third-generation polyester stent graft, in a Japanese multicenter database. MATERIALS AND METHODS: Retrospective analysis was conducted of 433 patients who underwent endovascular aneurysm repair (EVAR) of aortoiliac aneurysms with the use of Zenith stent grafts from 2007 to 2016. The mean age of patients was 75.6 y ± 7.8, and 85.2% of patients were men. Mean transverse diameters of abdominal aortic aneurysms and common iliac artery aneurysms were 50.8 mm ± 9.9 and 42.2 mm ± 10.3, respectively. RESULTS: During a mean follow-up period of 41.9 mo, 7 type IIIb endoleaks (1.6%) were identified. Four patients were definitively diagnosed during repeat intervention, and 3 were diagnosed based on postoperative CT images. Three patients were treated surgically, 2 were treated by relining with an additional stent graft, and 2 were conservatively followed with CT imaging. Only 1 of 5 patients who underwent repeat intervention had a preoperative diagnosis of type IIIb endoleak, reflecting the difficulty in its diagnosis. CONCLUSIONS: The incidence of type IIIb endoleak in Zenith stent grafts was 1.6% in this study, suggesting that type IIIb endoleaks are not extremely rare. In addition, type IIIb endoleak may be underdiagnosed or misdiagnosed as a different type of endoleak. Type IIIb endoleaks should always be considered in patients with sac expansion after EVAR.

Comparison of olanexidine versus povidone-iodine for preventing surgical site infection in gastrointestinal surgery: study protocol for a multicentre, single-blind, randomised controlled clinical trial.

INTRODUCTION: The prevalence of surgical site infection (SSI) remains higher in gastrointestinal surgery than in other surgeries. Although several guidelines have indicated the efficacy of chlorhexidine and povidone-iodine in reducing the SSI rate, the optimal recommendation has still not been established. Therefore, it is necessary to determine the more effective antiseptic for surgical site preparation. Olanexidine (1.5% olanedine, Otsuka Pharmaceutical Factory, Tokushima, Japan), which is a new antiseptic in Japan, has antimicrobial activity against a wide range of bacteria, including Gram-positive and Gram-negative bacteria. Our study will contribute to determining a new antiseptic for use in gastrointestinal and other surgeries. METHODS AND ANALYSIS: We propose a multicentre, randomised controlled clinical trial for comparing two treatments, that is, 1.5% olanexidine or 10% povidone-iodine, for surgical skin preparation to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. Patients aged ≥20 years at the time of consent will be included. The primary outcome measure is the 30-day postoperative SSI rate. For the primary analysis, which is aimed at comparing the treatment effects, the adjusted risk ratio and its 95% CI will be estimated using the Mantel-Haenszel method. ETHICS AND DISSEMINATION: The protocol was first approved by the Institutional Review Board of Keio University School of Medicine, followed by the institutional review board of each participating site. Participant recruitment began in June 2018. The final results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: UMIN 000031560; Pre-results.

Early sac shrinkage is a good surrogate marker of durable success after endovascular aneurysm repair in Japanese patients.

OBJECTIVE: The applicability of early sac shrinkage as a predictor of a low risk of late complications after endovascular aneurysm repair (EVAR) in Asian populations has not been validated. This study aimed to analyze early sac shrinkage and its relationship with late complications in Asian people using a Japanese multicenter database. We also assessed the impact of endoleaks. METHODS: A retrospective analysis of 697 patients who had undergone EVAR of abdominal aortic aneurysms from 2008 to 2015 and were followed up for at least 1 year was conducted. Late complications were defined as any aneurysm-related events occurring >1 year after EVAR, including >5-mm aneurysm sac enlargements and any reinterventions performed. Endoleaks without any evidence of sac enlargement or a requirement for additional treatment were not considered late complications. RESULTS: Early sac shrinkage, defined as a >5-mm-diameter decrease within 1 year of EVAR, occurred in 335 patients (48.1%); type I endoleaks (T1ELs) and isolated type II endoleaks (iT2ELs; type II endoleaks without evidence of other endoleaks) were observed in 4.0% and 29.4%, respectively. During the mean follow-up period of 45.5 months, 93 late complications (13.3%) occurred. Kaplan-Meier curve and log-rank analyses showed that early sac shrinkage was a significant predictor for a lower risk of late complications (P < .001). Multivariate analysis revealed that early sac shrinkage was independently associated with a lower risk of late complications (adjusted hazard ratio, 0.425; P = .004). Conversely, T1ELs and iT2ELs were positively associated with late complication (adjusted hazard ratio, 11.774 and 5.137, respectively; both P < .001). Subsequent multivariate analysis demonstrated that T1ELs and iT2ELs were negatively associated with early sac shrinkage (adjusted odds ratio, 0.102 and 0.285, respectively; both P < .001). CONCLUSIONS: Early sac shrinkage was associated with a low risk of late complications in Asian people and may be a good surrogate marker of durable success after EVAR. T1ELs and iT2ELs were negatively associated with early sac shrinkage and positively associated with late complications. Along with the high incidence of iT2ELs observed, T2ELs may be an important condition to consider after EVAR in the Asian population.

Comparison of early vascular morphological changes between bioresorbable poly-L-lactic acid scaffolds and metallic stents in porcine iliac arteries.

Bioresorbable scaffolds have the potential to overcome several problems associated with metallic stents. Bioresorbable poly-L-lactic acid (PLLA) scaffold implantation for the treatment of peripheral artery disease has already been reported in animal models and clinical trials; however, no studies comparing PLLA scaffolds and bare metal stents (BMSs) with regard to early vascular morphological changes, identified using intravascular ultrasound (IVUS) analysis, have been reported. In this study, PLLA scaffolds and BMSs were implanted bilaterally in iliac arteries of five miniature pigs. Digital subtraction angiography and IVUS were performed before and immediately after stent implantation and at 6-week follow-up. All PLLA scaffolds and BMSs were patent at 6-week follow-up. Per IVUS analysis, the percent area stenosis did not significantly differ between PLLA scaffolds and BMSs (65.7% vs. 67.2%, P = .761). Furthermore, percent vessel lumen change also did not differ significantly. Neointima formation (the neointimal area plus medial area) was significantly less with PLLA scaffolds than with BMSs (15.65 mm2 vs. 25.69 mm2, P < .001). In conclusion, based on IVUS results, short-term results after stent implantation in porcine iliac arteries were comparable between PLLA scaffolds and BMSs. Therefore, PLLA scaffolds are safe and feasible for implantation in peripheral arteries.

Comparison of Early Sac Shrinkage with Third-Generation Stent Grafts for Endovascular Aneurysm Repair.

PURPOSE: To compare the effects of the currently most-used third-generation stent grafts on early aneurysm sac shrinkage, a proposed marker of successful endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: EVARs performed from 2009 to 2013 at 2 institutions were retrospectively analyzed. Patients treated with a Zenith, EXCLUDER, or Endurant device who completed imaging studies before EVAR and at 1, 6, 12, and 24 months afterward were included. Sac shrinkage was compared by volumetry. RESULTS: Among 296 EVAR procedures, 47 were excluded for the use of different stent grafts and 87 for loss to follow-up or missing required imaging study, leaving 162 EVAR procedures (69 Zenith, 54 EXCLUDER, and 39 Endurant devices) for analysis. Mixed-effects model analysis revealed that the use of a Zenith device resulted in significantly greater shrinkage compared with EXCLUDER and Endurant devices (both P < .001). The differences were statistically significant from 1 month after EVAR (average sac shrinkage at 1 mo for Zenith, EXCLUDER, and Endurant devices of 95.3%, 100.3%, and 102.6%, respectively), indicating an early shrinkage advantage for Zenith devices. In addition, multivariate analysis revealed Zenith device use to be a sole beneficial factor for sac shrinkage at 24 months after EVAR (odds ratio, 2.881; 95% confidence interval, 1.331-6.235; P = .007). Repeat intervention rates (all for treatment of type II endoleaks) for Zenith, EXCLUDER, and Endurant devices were 2.9% (2 of 69), 1.9% (1 of 54), and 2.6% (1 of 39), respectively. CONCLUSIONS: Zenith device use was associated with significantly better early sac shrinkage. In view of the limited follow-up period, whether these differences lead to improved clinical outcomes remains unclear.