Atrial Fibrillation is Associated with Femoropopliteal Totally Occlusive In-Stent Restenosis: A Single-Center, Retrospective, Observational Study.

INTRODUCTION: The proportion of patients with comorbid atrial fibrillation (AF) and peripheral artery disease (PAD) has increased in this era. This study aimed to assess the relationship between AF and totally occlusive in-stent restenosis (ISR) in femoropopliteal (FP) lesions. METHODS: In this study, 363 patients (461 stents) who underwent endovascular therapy with de novo stent implantation in our hospital between April 2007 and December 2016 were retrospectively evaluated. The patients were divided into two groups according to the AF status (AF group, 61 patients; sinus group, 302 patients). The primary endpoint was the incidence of totally occlusive ISR within 3 years. The secondary endpoint was the incidence of acute limb ischemia (ALI) due to FP stent occlusion. RESULTS: Baseline characteristics were similar, except for higher age and a lower prevalence of dyslipidemia in the AF group. The incidence of a totally occlusive ISR was higher in the AF group than in the sinus group (29.5% vs. 14.6%, p=0.004). A multiple Cox regression model suggested that presence of AF (hazard ratio, 2.10) and CTO lesion (hazard ratio, 1.97) which were the independent predictors of a totally occlusive ISR within 3 years. The incidence of ALI was significantly higher in the AF group than in the sinus group (3.9% vs. 0%, p=0.0001). In the AF group, the introduction of an anticoagulant did not prevent the occurrence of totally occlusive ISR (p=0.71) for ALI (p=0.79). CONCLUSIONS: AF is independently associated with totally occlusive ISR of FP stents; however, anticoagulant use does not prevent stent occlusion.

Frequency, predictors, and effect of the slow-flow phenomenon after drug-coated balloon angioplasty for femoropopliteal lesions.

Drug-coated balloon (DCB) angioplasty for femoropopliteal (FP) lesions has been available in Japan since 2018. In daily practice, we encountered cases of the slow-flow phenomenon after DCB angioplasty. However, no data regarding the slow-flow phenomenon after DCB angioplasty for FP lesions are available. This study aimed to investigate the frequency, predictors, and effect of the slow-flow phenomenon following DCB angioplasty for FP lesions. This single-center, retrospective, observational study analyzed 88 FP lesions treated by DCB angioplasty between April 2018 and July 2019. Patients were divided into the slow-flow group (n = 7) and non-slow-flow group (n = 81) and were analyzed. The primary endpoint was primary patency at 6 months. The slow-flow phenomenon was observed in seven cases (8.0%). The slow-flow group had higher incidence rates of critical limb ischemia (CLI) (71% vs. 25%, p < 0.01), chronic total occlusion (CTO) lesions (86% vs. 26%, p < 0.01), and poor tibial vessel runoff (86% vs. 33%, p < 0.01) and had a longer DCB length (237 ± 56 mm vs. 159 ± 97 mm, p = 0.03) than the non-slow-flow group. The primary patency rate at 6 months was 71% in the slow-flow group and 91% in the non-slow-flow group (p = 0.09). The rate of freedom from target lesion revascularization at 6 months was 71% in the slow-flow group and 97% in the non-slow-flow group (p < 0.01). The amputation-free survival rate at 6 months was 71% and 95% (p = 0.02), whereas the survival rate at 6 months was 71% and 95% (p = 0.02). The incidence rate of the slow-flow phenomenon after DCB angioplasty for FP lesions was 8.0%. CLI, a CTO lesion, poor tibial vessel runoff, and total DCB length were associated with the slow-flow phenomenon. Our results indicate that the slow-flow phenomenon is associated with poor short-term clinical outcomes.

Usefulness of ultrasound-guided intraluminal approach for long occlusive femoropopliteal lesion.

To investigate the usefulness of ultrasound-guided (USG) intraluminal approach for femoropopliteal (FP) lesion. 64 patients (73 limbs) with de novo long occlusive (> 15 cm) FP lesions underwent USG intralumial approach from April 2012 to October 2016. Periprocedural intravascular ultrasound findings were collected. Clinical outcome and predictors of restenosis after USG intraluminal approach for de novo long occlusive FP lesion were investigated. Among the study participants, 34% were female, 50% had diabetes mellitus, and 10% received hemodialysis. Lesion and chronic total occlusion (CTO) lengths were 222 ± 55 mm and 201 ± 55 mm, respectively. Procedural success was achieved in 72 lesions (99%). Distal puncture was performed in 7 limbs (10%). The proportion of within-CTO intraplaque, subintimal, and medial routes were 87 ± 21%, 9 ± 15%, and 4 ± 11%, respectively. Primary patency was 71% and 69% at 1 and 2 years. Multivariate analysis revealed that within-CTO intraplaque route proportion [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.67-0.98, p = 0.0339] and lesion length (HR 1.11; CI 1.00-1.22; p = 0.0447) were independent predictors of restenosis.USG intraluminal approach facilitated acquisition of within-CTO intraplaque route in long occlusive FP lesions and could improve clinical outcome.

A phase II study of FOLFIRINOX with primary prophylactic pegfilgrastim for chemotherapy-naïve Japanese patients with metastatic pancreatic cancer.

BACKGROUND: Although FOLFIRINOX is currently one of the standard therapies for chemotherapy-naïve patients with metastatic pancreatic cancer (MPC), the high rate of febrile neutropenia (FN) presents a clinical problem. This study aimed to evaluate the safety and efficacy of primary prophylactic pegfilgrastim with FOLFIRINOX in Japanese MPC patients. METHODS: FOLFIRINOX (intravenous oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, levofolinate 200 mg/m2, 5-fluorouracil (5-FU) bolus 400 mg/m2 and 5-FU 46 h infusion 2400 mg/m2) and pegfilgrastim 3.6 mg on day 4 or 5, every 2 weeks was administered to previously untreated MPC patients. The primary endpoint was the incidence of FN during the first 3 cycles. The planned sample size was 35 patients, but the trial was predefined to discontinue enrollment for safety if 4 patients developed FN. RESULTS: At the enrollment of 22 patients, 4 patients developed FN in the first cycle, resulting in an incidence of FN of 18% {95% confidence interval [CI], 0.5-40.3%}, and enrollment was discontinued early. The incidence of grade 3 or higher neutropenia was 36.4%. Median relative dose intensities during the initial 3 cycles of oxaliplatin, irinotecan, bolus 5-FU, infusional 5-FU, and levofolinate maintained high (100%, 89.0%, 100%, 66.0%, and 100%, respectively). Response rate and median overall survival were 54.5% (95% CI 32.7-74.9) and 15.7 months (95% CI 7.9-18.8), respectively. CONCLUSIONS: This phase II study could not demonstrate any reduction in the incidence of FN, nevertheless some patients experience benefits for efficacy by maintaining dose intensity using prophylactic pegfilgrastim. TRIAL REGISTRATION: http://www.umin.ac.jp/ctr/index-j.htm , UMIN000017538. Date of registration: May/13/2015.

The ARAHKEY technique: A novel method for the management of access site bleeding during percutaneous transfemoral transcatheter aortic valve replacement.

OBJECTIVE: This retrospective study assessed the safety and efficacy of the ARAHKEY (ARterial sealing with Additional Hemostatic device Kissing with Extravascular and suture-based device deeplY) technique during transcatheter aortic valve replacement (TAVR). BACKGROUND: Access site complications are still a major issue to be solved during TAVR using a large caliber sheath. METHODS: From February 2014 to June 2019, a total of 302 patients underwent TAVR in our hospital. Twenty-five patients (10.2% of patients who underwent percutaneous transfemoral TAVR [n = 246]) were treated using the ARAHKEY technique, which is the additional use of Exoseal for the common femoral artery puncture site when hemostasis was not achieved with ProGlide alone. RESULTS: Complete hemostasis was achieved in all patients (100%). The mean procedural time for hemostasis was 9.8 ± 4.5 min. No complications, including recurrent bleeding, infection, and late acquired hematoma, were observed in this study cohort. CONCLUSION: The ARAHKEY technique is a safe method and should be considered as a secondary option when hemostasis is not achieved with ProGlide during TAVR.

A Comparative Analysis between Ultrasound-Guided and Conventional Distal Transradial Access for Coronary Angiography and Intervention.

OBJECTIVES: To compare feasibility and safety between ultrasound-guided and conventional distal transradial access (dTRA). BACKGROUND: Distal transradial access, a new technique for coronary angiography (CAG) and percutaneous coronary interventions (PCI), is safe and feasible and will become popular worldwide. Ultrasound-guided dTRA has been advocated to reduce failure rate and access-site complications. However, to date, the comparison of feasibility and safety between ultrasound-guided and conventional dTRA has not been reported. METHOD: Overall, 137 patients (144 procedures) who underwent CAG or PCI using dTRA between September 2018 and February 2019 were investigated. These patients were classified into two groups: C (dTRA with conventional punctures; 76 patients, 79 procedures) and U (dTRA with ultrasound-guided punctures; 61 patients, 65 procedures) groups. Successful procedural rate, procedural outcomes, and complication rate during hospital stays were compared between the two groups. RESULTS: The procedural success rate was significantly higher in the U group than in the C group (97% vs. 87%, P=0.0384). However, the rate of PCI, puncture time, total fluoroscopy time, the volume of contrast medium, the rate of access-site ecchymosis, and incidence of nerve disorder were similar between the two groups. Additionally, radial artery occlusion after the procedure did not occur in this study. CONCLUSION: The ultrasound-guided dTRA for CAG or PCI was associated with a lower failure rate than conventional dTRA. However, there were no significant differences in puncture time and complication rate between the two procedures.

Clinical Impact and Predictors of the Slow-Flow Phenomenon after Endovascular Treatment of Infrapopliteal Lesions Using the Crosser Catheter in Patients with Critical Limb Ischemia.

PURPOSE: To determine the clinical impact and predictors of slow flow after endovascular treatment (EVT) using the Crosser catheter for debulking infrapopliteal lesions associated with critical limb ischemia. MATERIALS AND METHODS: This retrospective study included 65 patients with critical limb ischemia (70 limbs, 90 infrapopliteal lesions), who underwent EVT using the Crosser catheter between November 2011 and February 2017. The Crosser catheter was used when the balloon catheter could not be passed through the lesion or could not be dilated sufficiently. Slow flow was evaluated after atherectomy using Crosser and was defined as delayed antegrade flow to the foot (total number of cine frames >35). RESULTS: Following atherectomy, slow flow developed in 37 infrapopliteal lesions (41.1%). Despite secondary treatment, slow flow persisted in 29 of 37 lesions (78%). After atherectomy using the Crosser catheter, the balloon could be passed through the lesion in all cases. The wound healing rate at 1 year after EVT (overall, 67.8%) was significantly poorer in the presence of slow flow (rate with vs. without slow flow, 45.3% vs. 84.4%, respectively; P = .006), especially among patients with stage ≥3 baseline wound, ischemia, and foot infection. The active length of the Crosser catheter was a predictor of slow flow (odds ratio, 1.05; 95% confidence interval, 1.03-1.08; P < .001), with an optimal cutoff of 100 mm. CONCLUSIONS: Slow flow is associated with a poorer wound healing rate at 1 year, especially for patients with severe baseline ischemia. To reduce the risk of slow flow, the active length of the Crosser catheter should be kept at <100 mm.

Radiologic Assessment for Endoscopic US-guided Biliary Drainage.

Endoscopic US-guided biliary drainage (BD) is performed for various types of biliary obstruction and is mainly indicated for unsuccessful conventional transpapillary endoscopic retrograde cholangiodrainage. In endoscopic US BD, an extra-anatomic drainage route between the gastrointestinal (GI) tract and the biliary system is created with a covered metallic stent or plastic stent. Procedural types of endoscopic US BD include hepaticogastrostomy, hepaticojejunostomy (after gastrectomy), choledochoduodenostomy, hepaticoduodenostomy, and endoscopic US-guided gallbladder drainage. The technical and clinical success rates of endoscopic US BD are reported to be 94%-97% and 88%-100%, respectively. CT is crucial both in preprocedural assessment and postprocedural monitoring. CT is used to determine the indications for endoscopic US BD, which include the type of biliary obstruction, collateral vessels in the puncture route, ascites, the volume of the liver segment, the distribution of an intrahepatic tumor, and GI tract patency. After endoscopic US BD, common subclinical findings are a small amount of intraperitoneal gas, localized edematous change in the GI tract, a notch in the placed stent, and localized biliary dilatation caused by stent placement. Stent malfunction after endoscopic US BD is caused by impaction of debris and/or food, stent migration into the GI tract, or tumor overgrowth and/or hyperplasia. Complications that can occur include internal stent migration, intraperitoneal biloma, arterial bleeding or pseudoaneurysm, perforation of the GI tract, and portobiliary fistula. The incidence of clinical endoscopic US BD-related complications is 11%-23%. ©RSNA, 2020.

Usefulness of a Guide Extension Catheter in Endovascular Therapy of Infrapopliteal Lesions.

Guide extension catheters have been available since 2015 for peripheral endovascular intervention. These devices are commonly used for active backup support. We successfully managed 2 cases of infrapopliteal arterial disease with the assistance of a guide extension catheter. In a patient with a posterior tibial artery occlusion, early elastic recoil occurred after balloon dilatation. We then deployed the guide extension catheter to maintain blood flow while ballooning for 15 min, resulting in good blood flow to the toes after device removal. Another patient had a severely calcified stenotic anterior tibial artery lesion. Although a guidewire could be advanced to the lesion, no device could be passed through the calcification. Using the guide extension catheter, we then safely delivered a 0.035-inch guidewire's tail to drill through the calcification. Thereafter, a balloon could be passed, and successful angioplasty was achieved. These cases illustrate the usefulness of a guide extension catheter in endovascular therapy of complex infrapopliteal lesions.

Phase I study of resminostat, an HDAC inhibitor, combined with S-1 in patients with pre-treated biliary tract or pancreatic cancer.

Resminostat is an oral hydroxamate inhibitor of class I, IIb, and IV histone deacetylases. S-1 is widely used to treat biliary tract cancer and pancreatic cancer in Japan. We performed a phase I study of resminostat combined with S-1 as second-line or later therapy in Japanese patients with biliary tract or pancreatic cancer. A total of 27 patients were enrolled. We determined the optimal regimen for resminostat/S-1 therapy in part 1, and investigated its safety and efficacy in part 2. In part 1, 17 patients were enrolled. One DLT (anorexia and stomatitis, respectively) occurred with each of regimens 2 and 3. In part 2, an additional 10 patients received regimen 3, which was selected in part 1. Regimen 3 was resminostat (200 mg/day on Days 1 to 5 and Days 8 to 12: 5 days on/2 days off) plus S-1 (80-120 mg/day according to body surface area on Days 1 to 14) repeated every 21 days. A total of 16 patients (13 with biliary tract cancer and 3 with pancreatic cancer) received regimen 3 and it was well tolerated. The most frequent treatment-related adverse events were thrombocytopenia and anorexia (11 patients each, 69%). The disease control rate was 81.3% (84.6% for biliary tract cancer and 66.7% for pancreatic cancer, respectively). Median progression-free survival was 3.1 months (5.5 and 2.3 months), while median overall survival was 8.8 months (10.2 and 4.7 months). In conclusion, regimen 3 was well tolerated by patients with pre-treated biliary tract or pancreatic cancer.

Comparison of 12-month angiographic outcomes between repeat drug-eluting stent implantation and drug-coated balloon treatment for restenotic lesion caused by stent fracture.

We aimed to compare the angiographic outcomes between repeat drug-eluting stent (DES) implantation and drug-coated balloon (DCB) treatment for restenotic lesion caused by stent fracture (SF). The treatment of restenotic lesion caused by SF after DES implantation has not been well evaluated. From April 2007 to April 2015, 9320 lesions were implanted with a DES during percutaneous coronary intervention in our hospital; of those, 815 lesions (8.7%) showed restenosis on the follow-up angiogram. The study subjects were 47 consecutive patients with 69 restenotic lesions caused by SF and treated by target lesion revascularization (TLR); of those, 27 patients with 45 lesions were treated with repeat DES during TLR (either a cobalt-chromium or platinum-chromium everolimus-eluting stent or zotarolimus-eluting stent; DES group), and 20 patients with 24 lesions were treated with DCB (DCB group) during TLR. The 12-month cumulative incidence of repeat TLR and predictors of repeat TLR was evaluated. Restenosis and re-restenosis were defined as % diameter stenosis > 50% on the follow-up angiogram. SF was defined as complete or partial separation of the stent strut as assessed by plain fluoroscopy. Baseline characteristics were similar between the groups. The 12-month binary re-restenosis rate and cumulative incidence of repeat TLR between the DES group and DCB group were 44.4% and 37.5% (p = 0.58) and 43.9% and 31.9% (p = 0.31), respectively. On multivariate analysis, a lesion with vessel hinge movement was an independent predictor of repeat TLR (p = 0.02, hazard ratio: 6.54, 95% confidence interval 1.30-32.8). The 12-month repeat TLR rate was high in both groups. After treating restenosis lesions caused by SF after DES implantation, mechanical stress leads to further interventional treatment, regardless of the type of device used.

Impact of infection severity on clinical outcomes in critical limb ischemia with tissue loss after endovascular treatment.

Critical limb ischemia with infected wounds is known to have a poor prognosis and evaluation of infection severity using the Wound, Ischemia, and foot Infection classification system has been recommended. However, little is known about how infection severity influences the clinical outcomes of critical limb ischemia in patients with tissue loss. We investigated the impact of infection severity on the clinical outcomes in critical limb ischemia with tissue loss after endovascular treatment. In April 2007-August 2014, we enrolled 263 patients (328 limbs) who received endovascular treatment for critical limb ischemia with tissue loss. In the limbs examined, 369 individual wounds existed. We evaluated wound infection using the Infectious Disease Society of America (IDSA) classification. We also investigated wound healing rates at 12 months and limb salvage and major amputation-free survival rates at 2 years after endovascular treatment. Wound healing rates at 12 months for class 0, 1, 2, and 3 were 89, 81, 58, and 33%, respectively (log rank P < 0.001). Limb salvage and major amputation-free survival rates at 2 years were lower in patients with lower vs. higher IDSA classes (classes 0-3: limb salvage rate: 97, 90, 61, and 0%, respectively; P < 0.001; major amputation-free survival: 67, 61, 38, and 0%, respectively; P < 0.001). In Rutherford category 5, only wound healing rates at 12 months and limb salvage and major amputation-free survival rates at 2 years were stratified according to wound infection severity (wound healing rates: 87% in classes 0 and 1 and 65% in classes 2 and 3; P < 0.001; limb salvage rates: 93% in classes 0 and 1 and 69% in classes 0 and 2; P < 0.0001; major amputation-free survival rates: 61% in classes 0 and 1 and 46% in classes 2 and 3; P < 0.001). Wound infection severity affects clinical outcomes of critical limb ischemia with tissue loss, especially in critical limb ischemia with systemic inflammatory response syndrome. In Rutherford category 5, only clinical outcomes of critical limb ischemia were well-stratified according to infection severity. Wound infection affects clinical outcomes of patients with critical limb ischemia with tissue loss.

Ultra-Long Inflation in Superficial Femoral Artery Stenosis and Occluded Lesions Using Guide Liner ("Ultra SOUL"): A Case Report.

Following an era of the use of several drug-coated balloons in angioplasty, "leave nothing behind" and stentless strategies have been gaining attention. In stentless strategies, it is necessary to avoid major dissections and limit flow. Balloon dilation is an important step in vessel preparation. In this study, we report a novel predilation technique. We performed prolonged balloon inflation for >10 min after normal ballooning in a procedure to treat an occluded lesion in the superficial femoral artery (SFA). We used a guide extension catheter to avoid foot ischemia and obtained better angiographic results than those using short duration balloon inflation. We named this technique "Ultra-Long Inflation in SFA Stenosis and Occluded Lesions Using Guide Liner" or "Ultra SOUL." The Ultra SOUL technique may be considered a useful option in balloon dilation.

Use of the Wound, Ischemia, foot Infection classification system in hemodialysis patients after endovascular treatment for critical limb ischemia.

OBJECTIVE: The Wound, Ischemia, foot Infection (WIfI) classification system is used to predict the amputation risk in patients with critical limb ischemia (CLI). The validity of the WIfI classification system for hemodialysis (HD) patients with CLI is still unknown. This single-center study evaluated the prognostic value of WIfI stages in HD patients with CLI who had been treated with endovascular therapy (EVT). METHODS: A retrospective analysis was performed of collected data on CLI patients treated with EVT between April 2007 and December 2015. All patients were classified according to their wound status, ischemia index, and extent of foot infection into the following four groups: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions in each group were analyzed. The prognostic value of the WIfI classification was analyzed on the basis of the wound healing rate and amputation-free survival at 1 year. RESULTS: This study included 163 consecutive CLI patients who underwent HD and successful endovascular intervention. The rate of the high-risk group (36%) was the highest among the four groups, and the proportions of very-low-risk, low-risk, and moderate-risk patients were 10%, 18%, and 34%, respectively. The mean follow-up duration was 784 ± 650 days. The wound healing rates at 1 year were 92%, 70%, 75%, and 42% in the very-low-risk, low-risk, moderate-risk, and high-risk groups, respectively (P <.01). A similar trend was observed for the 1-year amputation-free survival among the groups (76%, 58%, 61%, and 46%, respectively; P = .02). CONCLUSIONS: The WIfI classification system predicted the wound healing and amputation risks in a highly selected group of HD patients with CLI treated with EVT, with a statistically significant difference between high-risk patients and other patients.

Simple classification and clinical outcomes of angiographic dissection after balloon angioplasty for femoropopliteal disease.

OBJECTIVE: Angiographic dissection is considered to be associated with restenosis. However, little is known about the impact of the severity of angiographic dissection on future restenosis. METHODS: A total of 319 consecutive de novo femoropopliteal lesions were treated by balloon angioplasty alone. All of these lesions were divided into three groups: group A, no angiographic dissection; group B, mild dissection, the width of the dissection was less than one-third of the lumen; and group C, severe dissection, the width of the dissection was more than one-third of the lumen. Kaplan-Meier analysis estimated the primary patency rate at 3 years between the groups. RESULTS: The primary patency rates at 3 years were 66.0% in group A, 63.8% in group B, and 32.5% in group C (log-rank, P < .001). Cox proportional hazards analysis revealed that a lesion length >100 mm (hazard ratio, 1.734; 95% confidence interval, 1.099-2.735; P = .018) and severe angiographic dissection (hazard ratio, 1.956; 95% confidence interval, 1.276-2.997; P = .002) were predictors of primary patency loss at 3 years. When the lesions were divided into two groups according to the lesion length >100 mm or not, angiographic dissection had a larger impact on restenosis in a long lesion >100 mm (≤100 mm: 65.5% in group A, 75.6% in group B, and 48.0% in group C [log-rank, P = .015]; >100 mm: 68.8% in group A, 42.5% in group B, and 24.2% in group C [log-rank, P = .017]). CONCLUSIONS: Severe angiographic dissection was associated with future restenosis after balloon angioplasty for femoropopliteal lesions, but mild angiographic dissection was not. Angiographic dissection had more impact on future restenosis particularly in treated long lesions. Stents might not be necessary in short lesions with mild dissection.

Prognostic Factors for Survival in Patients with Advanced Intrahepatic Cholangiocarcinoma Treated with Gemcitabine plus Cisplatin as First-Line Treatment.

OBJECTIVES: Intrahepatic cholangiocarcinoma (ICC) is a rare type of liver cancer. No clinically useful prognostic factors have been reported for patients with advanced ICC. In the present study, we aimed to evaluate the clinical prognostic factors of patients with advanced ICC receiving gemcitabine plus cisplatin combination therapy (GC) as standard first-line chemotherapy. METHODS: A retrospective analysis was performed of the data of patients with ICC treated at our institution from March 2011 to January 2016. We used the Cox regression model and estimated the hazard ratios of potential prognostic factors for survival. RESULTS: Of 216 patients with biliary tract cancer receiving GC as first-line chemotherapy, we extracted data for 77 patients who were diagnosed with ICC and received GC as first-line chemotherapy. The median overall survival was 13.8 months (95% CI, 8.9-18.6). In multivariate analysis, pretreatment serum lactate dehydrogenase (hazard ratio [HR]: 2.53, p = 0.005), C-reactive protein (HR: 3.06, p = 0.001), and carcinoembryonic antigen (HR: 2.39, p = 0.03) levels were significantly associated with overall survival. CONCLUSIONS: Readily available clinical laboratory values reliably predicted the prognosis of ICC patients receiving GC therapy. If validated in other studies, these results may provide a useful tool for individual patient-risk evaluation and the design and interpretation of future trials.

Efficacy and safety of a coagulated thrombus injection for peripheral artery perforation: The coagulated thrombus hemostasis method.

BACKGROUND: This retrospective study assesses the safety and efficacy of using a thrombus injection for treatment a peripheral artery perforation. METHODS AND RESULTS: From March 2013 to April 2016, we performed 1,152 endovascular treatment (EVT) at our hospital. Of these, 28 peripheral artery perforations occurred during the EVT procedure and 20 were treated with a thrombus, which we artificially created. The thrombus comprised the patient's blood and thrombin. It was injected into the perforation site from the tip of an over-the-wire balloon using ballooning method. The perforated arteries occurred in below-the-knee artery (45%), superficial femoral artery (35%), deep femoral artery (10%), popliteal artery (5%), and external iliac artery (5%). Thrombus injection was successful in 19 of the 20 perforations (95%). One patient required coil embolization. There were no complications during or after admission. CONCLUSIONS: Thrombus injection is a safety method and might be considered as one of the approaches for stopping peripheral artery perforation.

Characteristics and clinical outcomes of repeat endovascular therapy after infrapopliteal balloon angioplasty in patients with critical limb ischemia.

OBJECTIVES: We clarified characteristics and clinical outcomes of critical limb ischemia (CLI) patients who underwent repeat endovascular therapy (EVT) for infrapopliteal lesions. BACKGROUND: High restenosis rate after infrapopliteal EVT remains a major concern. METHODS: Patients with CLI who underwent EVT between April 2007 and February 2014, were divided into the following three groups according to how often EVT was repeated: Group A, no repeat of EVT; Group B, EVT repeated once/twice; and Group C, EVT repeated ≥3 times. RESULTS: Wound healing rates at 1 year were 93.9% in Group A, 77.1% in Group B, and 27.3% in Group C (P < 0.001). Limb salvage rates at 3 years were 93.0, 88.5, and 57.1%, respectively (P = 0.001). Amputation-free survival rates at 3 years were 60.8, 51.2, and 29.2%, respectively (P = 0.019). Multivariate analysis revealed that hemodialysis (OR 3.413, 95% CI 1.263-9.225, P = 0.016), low ejection fraction (OR 7.758, 1.049-57.360, P = 0.045), and clinical stage assessed by SVS WIfI (OR 2.440, 1.417-4.203, P = 0.001) were independent predictors of repeat EVT. The rate of requirement for repeat EVT significantly increased as clinical stage became more severe (repeat EVT rate: 0% in CS 1, 28.6% in CS 2, 34.0% in CS 3, and 45.7% in CS 4, P < 0.001). CONCLUSIONS: The clinical outcomes of CLI patients requiring repeat EVT three or more times were poor. The SVS WIfI clinical stage may be useful to predict the necessity of repeat EVT.