Assessment of 3-Year Patency after Endoluminal versus Surgical Bypass Therapy for Complex Femoropopliteal Artery Disease.

PURPOSE: To compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass for complex femoropopliteal (FP) arterial lesions. MATERIALS AND METHODS: In this retrospective multicenter study, 530 patients with symptomatic peripheral artery disease (Rutherford classification 1-3, 66.0%; 4-6, 34.0%) who underwent either endoluminal bypass with Viabahn stent grafts (n = 276) or surgical bypass (n = 254) (with saphenous vein grafts, 74.4%; prosthetic grafts, 25.6%) for FP arterial lesions between 2010 and 2018 were analyzed. The propensity score-matched analysis was performed to compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass. The primary end point was primary patency (freedom from restenosis). The secondary end points were secondary patency, freedom from target lesion revascularization (TLR), limb salvage, and overall survival. The interaction effect of baseline characteristics on the association of the revascularization strategy with the risk of restenosis was analyzed using the Poisson mixed-effect model. RESULTS: The propensity score-matched analysis extracted 107 pairs. After propensity score matching, the primary patency rate at 1, 2, and 3 years was 84.5%, 75.1%, and 70.9%, respectively, for the endoluminal bypass group versus 78.6%, 73.3%, and 72.0%, respectively, for the surgical bypass group (P = .65). There was no significant difference in secondary patency, freedom from TLR, limb salvage, and overall survival (all P > .05). The subsequent interaction analysis revealed that the involvement of popliteal lesions, small distal reference vessel diameters, and long lesions favored surgical bypass over endoluminal bypass because of improved primary patency (all P for interaction < .05). CONCLUSIONS: The 3-year clinical outcomes after endoluminal bypass or surgical bypass for FP arterial lesions were similar.

Impact of cilostazol on prevention of late failure of autologous vein grafts.

OBJECTIVES: The effectiveness of postoperative medication for the prevention of late graft failure is controversial. We conducted the present study to investigate whether cilostazol improved the mid-term outcomes after infrainguinal autologous vein bypass for chronic limb-threatening ischemia (CLTI). METHODS: From April 1994 to March 2022, we performed 590 de novo infrainguinal bypass procedures using autologous vein grafts (AVGs) in three hospitals. The bypass grafts were classified according to the postoperative prescription of cilostazol. The loss of graft patency and major adverse limb events (MALEs) were set as endpoints. Patients who died within 30 days and grafts that lost primary patency within 30 days after surgery were excluded. Data up to 3 years were analyzed. The cumulative primary patency (PP), assisted primary patency (AP), secondary patency (SP), and freedom from MALE (ffMALE) rates were calculated by the Kaplan-Meier method and compared between the cilostazol group and the non-cilostazol group. After a propensity score matching, same statistical analyses were performed. In addition, a Cox proportional hazards regression analysis that included preoperative factors, intraoperative factors, and postoperative medications was performed to identify whether cilostazol is an independent predictor for the outcomes. RESULTS: A total of 523 AVGs met inclusion criteria. Kaplan-Meier curves showed that the cilostazol group was superior to the non-cilostazol group in all outcomes, while the cilostazol group was superior to the non-cilostazol group in AP and SP after a propensity score matching. A multivariable analysis showed that non-use of cilostazol was identified as an independent predictor for loss of AP, SP, and ffMALE. CONCLUSIONS: Cilostazol improved the mid-term outcomes after infrainguinal autologous vein bypass.

Drug-coated stent implantation vs. bypass surgery for in-stent occlusion after femoropopliteal stenting.

The optimal revascularization for in-stent occlusion (ISO) lesions after femoropopliteal (FP) bare-nitinol stenting has not been established. We, therefore, investigated the comparison between drug-coated stent (DCS) implantation and bypass surgery (BSX) for ISO lesions after FP bare-nitinol stenting. This study was a dual-center, observational study from January 2004 to December 2015. A total of 172 ISO lesions were observed, and after excluding 120 ISO lesions, 52 ISO lesions (50 patients; mean age, 71.0 ± 9.2 years; male, 59.6%) after FP bare-nitinol stenting were enrolled. The included patients with clinical symptoms underwent either DCS implantation (n = 28) or BSX (n = 22). The primary endpoint was recurrent in-stent restenosis (ReISR); secondary endpoints were recurrent target lesion revascularization (ReTLR), recurrent occlusion (reocclusion) and major adverse limb events (MALE), and perioperative complications (POCs), respectively. ReISR or reocclusion was defined as ISR or occlusion after TLR. Stent restenosis was defined as a peak systolic velocity ratio (PSVR) > 2.4 on a duplex scan or ≥ 50% stenosis on angiography. Graft restenosis was defined as a PSV > 300 cm/s and velocity ratio 3.5 or uniformly low PSV < 45 cm/s throughout the entire graft based on graft surveillance. The mean follow-up period was 36.6 ± 25.5 months. At 2 years, the rates of freedom from ReISR, ReTLR, and MALE were not significantly different between the DCS implantation and BSX groups (68.9% vs. 73.7%, p = 0.81; 84.7% vs. 73.7%, p = 0.45; 84.7% vs. 78.6%, p = 0.60, respectively). However, the freedom from reocclusion rate was significantly lower in the DCS implantation group (81.6% vs. 100%, p = 0.04). The occurrence of POCs was not significantly different between the DCS implantation and BSX groups (7.1% vs 4.2%, p = 1.0). Although BSX was the gold-standard therapy for ISO lesions after FP bare-nitinol stenting, DCS implantation might be a good option because the rates of freedom from ReISR, ReTLR, and MALE were similar.

Preoperative nutritional status is independently associated with wound healing in patients undergoing open surgery for ischemic tissue loss.

OBJECTIVES: The aim of this study was to determine the relationship between preoperative nutritional status and wound healing in patients undergoing surgical reconstruction for ischemic tissue loss. METHODS: The preoperative nutritional status of patients who underwent surgical reconstruction for ischemic tissue loss for the years 2011-2018 was retrospectively estimated using the Controlling Nutritional Status (CONUT) score. Patients were allocated to two groups: Group I, normal nutrition or mild malnutrition (CONUT score ≤4), and Group II, moderate-to-severe malnutrition (CONUT score ≥5). Wound healing was set as the primary endpoint and major amputation and death as the secondary endpoints. The wound healing, limb salvage, and overall survival rates were calculated after two years using the Kaplan-Meier method, and Cox proportional hazards regression analysis was performed to determine which variables were independently associated with these outcomes. RESULTS: Forty-eight patients with missing values for the CONUT score were excluded. A total of 174 limbs in 147 patients were studied (Group I: 115 limbs in 100 patients; Group II: 59 limbs in 47 patients). The mean duration of the study was 519 ± 270 days. The Kaplan-Meier curves showed that wound healing in Group I was superior to that in Group II (Group I vs. II: two-year wound healing, 97% vs. 79%; time to 50% wound healing, 83 vs. 150 days, p < 0.001), and multivariate analysis showed that the CONUT score was an independent predictor of wound healing (hazard ratio, 0.63; 95% confidence interval, 0.41-0.98; p = 0.038). CONCLUSIONS: Patients with better preoperative nutritional status are more likely to experience wound healing earlier than those with excessive malnutrition.

Efficacy of Balloon Angioplasty for Infrainguinal Vein Graft Stenosis.

BACKGROUND: Vein graft stenosis is a critical complication of lower-limb bypass surgery. For vein graft stenosis, balloon angioplasty has been performed instead of surgical revision in recent years. We therefore investigated the effectiveness of the balloon angioplasty for vein graft stenosis. METHODS AND RESULT: We conducted a retrospective analysis of prospectively collected data for 115 vein graft stenoses performed via balloon angioplasty from August 2011 to January 2018. The rate of freedom from reintervention after balloon angioplasty was 54.3%, 44.4%, and 38.0% at 1, 2, and 3 years, respectively. The rate of freedom from graft occlusion after balloon angioplasty was 79.9%, 71.9%, and 61.3% at 1, 2, and 3 years, respectively. Predictors of freedom from graft occlusion after balloon angioplasty by a multivariate analysis were a single treated lesion (hazard ratio [HR]: 0.38; 95% confidence interval [CI]: 0.17-0.85; P = 0.0189), balloon angioplasty within 90 days after bypass surgery (HR: 3.59; 95% CI: 1.56-8.07; P = 0.0033), and using a cutting balloon (HR: 0.42; 95% CI: 0.17-0.97; P = 0.0426). CONCLUSIONS: The freedom from graft occlusion rate after balloon angioplasty remained relatively high. Furthermore, better results can be expected in single treated lesions and cases of balloon angioplasty occurring 90 days after bypass surgery or in which a cutting balloon was used. Balloon angioplasty for lower-limb bypass graft stenosis was shown to be a useful treatment.

Analysis of wound healing time and wound-free period as outcomes after surgical and endovascular revascularization for critical lower limb ischemia.

BACKGROUND: Traditional end points, such as amputation-free survival, used to assess the clinical effectiveness of lower limb revascularization have shortcomings because they do not account independently for wound nonhealing and recurrence or patient survival. Wound healing process and maintenance of a wound-free state after revascularization were not well-studied. The aim of this study was to elucidate the long-term clinical course of ischemic wounds after revascularization. We focused on initial wound healing process as well as the maintenance of a wound-free state after achievement of wound healing. We introduced a wound-free period (WFP; the period during which limbs maintained an ulcer-free state) and Wound Recurrence and Amputation-free Survival (WRAFS) as parameters and tested their effectiveness in evaluating clinical outcomes of limbs treated using endovascular therapy (EVT) and surgical revascularization. METHODS: The medical records of patients developing lower critical limb ischemia with tissue loss who underwent surgical or endovascular revascularization of the infrainguinal vessels between 2009 and 2013 were reviewed retrospectively. The risk factors for achieving wound healing and WRAFS were analyzed using Kaplan-Meier survival curves and Cox regression model. Risk factors to prolong wound healing time (WHT) and reduce WFP were determined by the least squares method. RESULTS: In total, 233 patients underwent 278 limb revascularizations; 138 endovascular and 140 surgical procedures were performed as first treatments. The proportion of healed wounds 1, 2, and 3 years after primary revascularization was 64.0%, 69.7%, and 70.5%, respectively. Significant risk factors for wound healing were an EVT-first strategy (risk ratio [RR], 2.47), congestive heart failure (RR, 2.05), and wound, ischemia, and foot infection wound grade (RR, 1.59). The mean WHT was 143.7 days. An EVT-first strategy and wound infection contributed to significantly longer WHT. The mean WFP was 711.0 days. An EVT-first strategy, history of coronary artery disease, and dialysis dependence were associated with significantly shorter WFPs. WRAFS at 1 and 2 years after achievement of wound healing were 76.9% and 64.2%, respectively. Significant risk factors against WRAFS were a history of coronary artery disease (RR, 1.68), dialysis dependence (RR, 2.03), and being wheel chair bound (RR, 1.64). CONCLUSIONS: EVT revascularization was associated with longer WHT, reduced wound healing rate, and a shorter WFP compared with surgical revascularization. wound, ischemia, and foot infection grade was associated with longer WHT and reduced wound healing rate, but not associated with a shorter WFP. Systemic conditions such as dialysis dependence, congestive heart failure, and being wheel chair bound were associated with reduced wound healing rate and shorter WFP, presumably because they limited life expectancy. WHT and WFP are useful criteria for evaluating limb outcomes in patients with critical limb ischemia.

Clinical Outcome of Surgical Endarterectomy for Common Femoral Artery Occlusive Disease.

BACKGROUND: Although common femoral artery endarterectomy (CFE) is the standard treatment for occlusive disease of the common femoral artery (CFA), several studies have noted encouraging results for endovascular therapy in this anatomical area. METHODS AND RESULTS: A retrospective multi-center study of 118 consecutive limbs from 111 symptomatic patients undergoing CFE between April 1998 and December 2014 was performed. Seventy-five CFE were performed on limbs for intermittent claudication and 43 CFE were performed for critical limb ischemia (CLI). The prevalence of perioperative complications was higher in patients with CLI than in the claudication patients. The technical success rate was 99% in all cases. The 1- and 5-year primary patency rates were 100% and 100% for claudication and 95% and 95% for CLI, respectively. The assisted-primary patency rates were 100% at both time points in both groups. Freedom from major amputation at 1 and 5 years was 100% and 100% in the claudication patients and 93% and 82% in the CLI patients, respectively. The 1- and 5-year overall survival rates were 97% and 89% in the claudication patients and 69% and 33% in the CLI patients, respectively. CONCLUSIONS: CFE is a safe, effective and durable procedure for occlusive disease of the CFA. This procedure should remain the standard treatment for this anatomical region.

Raison d'etre of Tibial Artery Bypass for Intermittent Claudication in the Era of Endovascular Therapy.

BACKGROUND: There is currently no positive opinion regarding infrapopliteal revascularization for intermittent claudication (IC) in any guidelines. The aim of this study was to analyze the outcomes of infragenicular bypass and verify the adequacy of tibial artery bypass for IC. METHODS AND RESULTS: Over a 21-year period, 58 below-knee popliteal artery (BKPOP) bypasses and 35 tibial artery bypasses were performed for IC caused by arteriosclerosis obliterans. Graft patency and major amputation (MA) were examined as primary endpoints and the predictor of each outcome was estimated by multivariate analysis. The primary patency (PP), secondary patency (SP), and freedom from MA (ffMA) rates of a prosthetic/vein graft in all cases at 5 years were 19/68%, 22/86%, and 78/100% (P<0.01 in all). Limited to vein graft cases, PP and SP rates of popliteal/tibial bypass at 5 years were 73/62% (P=0.32) and 92/80% (P=0.22), respectively. In tibial artery bypass with a vein graft, the PP and SP rates of a single saphenous vein/spliced vein graft at 5 years were 71/46% (P=0.11) and 89/61% (P=0.03). A prosthetic graft was a common negative predictor for graft patency and MA by multivariate analysis. CONCLUSIONS: Tibial artery bypass is an acceptable treatment option for IC when a single saphenous vein can be harvested as a graft conduit. (Circ J 2016; 80: 1460-1469).

Predictors of 2-Year Mortality and Risk Stratification After Surgical or Endovascular Revascularization of Infrainguinal Artery Disease in Hemodialysis Patients With Critical Limb Ischemia.

PURPOSE: To examine the 2-year mortality in hemodialysis (HD) patients with critical limb ischemia (CLI) and determine predictors that may aid in the selection of a revascularization strategy [bypass surgery or endovascular therapy (EVT)] according to current guidelines. METHODS: From 2007 to 2009, 246 consecutive CLI patients (mean age 69±10 years; 170 men) on HD underwent revascularization for de novo infrainguinal lesions (178 EVT and 68 bypass grafting). The majority of the patients had diabetes (170, 69%) and tissue loss (194, 79%); nearly half (111, 45%) were nonambulatory. Overall survival after revascularization was estimated by Kaplan-Meier analysis. Predictors for 2-year mortality after revascularization were determined using a Cox proportional hazards model; results are given as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: Overall survival rate was 77% at 1 year and 66% at 2 years. Predictors of 2-year mortality after revascularization were age >75 years (HR 1.82, 95% CI 1.14 to 2.91, p=0.012), albumin <3 g/dL (HR 2.31, 95% CI 1.39 to 3.84, p=0.001), and ejection fraction <50% (HR 1.73, 95% CI 1.06 to 2.83, p=0.027). Patients with more predictors had a higher incidence of death within 2 years after revascularization. CONCLUSION: Advanced age, low albumin level, and low ejection fraction were independently associated with 2-year mortality after revascularization in HD patients with CLI. Risk stratification by these factors would be useful for deciding on a revascularization strategy.

Bypass Surgery vs. Drug-Eluting Stent for Trans-Atlantic Inter-Society Consensus-II (TASCII) C or D Femoropopliteal Lesions.

BACKGROUND: Bypass surgery (BSX) as first-line therapy for Trans-Atlantic Inter-Society Consensus-II (TASCII) C/D femoropopliteal (FP) lesions is recommended. Recent reports have shown that a drug-eluting stent (DES) provides good durability up to the mid-term. We investigated clinical outcomes after BSX vs. DES for TASCII C/D FP lesions. METHODS AND RESULTS: As treatment of de novo TASCII C/D FP lesions, 274 patients who underwent DES implantation and 201 patients who had BSX were identified and analyzed. Each group had at least 1 year of follow-up data. The primary endpoint was binary restenosis. Secondary endpoints were major amputation, reintervention, reocclusion and major adverse limb event (MALE; including major amputation or any reintervention and restenosis). Before matching, the binary restenosis rate was significantly higher in the DES group than in the BSX group (42% vs. 18%, P<0.001). After propensity matching, the 1-year restenosis rate was still higher in the DES group (44% vs. 18%, P<0.001). The DES group also had a significantly higher incidence of reintervention and MALE. Major amputation and reocclusion showed no significant difference. The subsequent stratification analysis reconfirmed no significant interaction effect of any background characteristics on the association of DES implantation vs. BSX with the 1-year restenosis risk. CONCLUSIONS: BSX is still a feasible and recommended treatment for TASCII C/D FP lesions in Japanese patients, based on good durability up to 1 year.

Ultrasound-guided percutaneous thrombin injection for post-catheterization pseudoaneurysm.

BACKGROUND: The efficacy and safety of ultrasound-guided thrombin injection (UGTI) for the treatment of post-catheterization femoral and brachial artery pseudoaneurysms (PSA) is unclear in Japan. METHODS AND RESULTS: A retrospective study of 32 consecutive patients undergoing percutaneous UGTI of post-catheterization PSA between February 2011 and February 2014 was performed. There were 23 femoral PSA and 9 brachial PSA treated with UGTI. The prevalence of CAD and smoking history were higher in the brachial PSA patients, but there were no statistically significant differences in other patient demographic factors or in the preprocedural antiplatelet therapy between the femoral and brachial PSA patients. The median dose of thrombin injected was 200 U (range, 100-600 U). The initial success rate, early recurrence rate and surgical conversion rate were 91%, 0% and 4% in the femoral PSA, and 89%, 11% and 11% in the brachial PSA, respectively. There were 2 cases of medial nerve compression in the brachial PSA group, but there were no complications in the femoral PSA group (P=0.0198). On outpatient clinical follow-up in the successfully treated patients, there were no recurrences after an average follow-up of 16 months. CONCLUSIONS: UGTI is a feasible, safe and effective less-invasive treatment for post-catheterization PSA. Brachial PSA, however, might require additional attention because of their tendency toward higher recurrence and complications.

Infrapopliteal bifurcated dual run-off bypass in critical limb ischemia: a report of 2 cases.

Recently, angiosome-oriented direct revascularization was advocated for infrapopliteal bypass in patients with critical limb ischemia. However, angiosome-matched target vessels, which supply direct blood flow into the ischemic tissue, are frequently small in diameter, severely calcified, have a very poor vascular bed, and might not be suitable technically for distal anastomosis. In such cases, creating a bifurcation in the graft could enable perfusion of a "direct" target vessel with poor quality and an "indirect" run-off vessel with better features. In this report, we present 2 cases of bifurcated dual run-off bypass (BDRB) in which we added a secondary outflow to the original single tibial bypass. Careful investigation and evaluation of the status of the collateral vessels and additional information regarding successful and unsuccessful cases are required to further understand the advantages and disadvantages of BDRB.

Prearterial external iliac vein as a rare anomaly of the iliac vein.

The coexistence of a retroperitoneal venous anomaly requires special consideration during open aortoiliac surgery. Anomalies of the external iliac vein are rare, and no anomalies of the right external iliac vein, which passes ventral to the external iliac artery, have been reported in the English literature to the best of our knowledge. We herein report the first case of Leriche syndrome combined with a prearterial external iliac vein treated with bypass surgery and a synthetic bifurcated graft.

Midterm outcomes of endovascular repair for abdominal aortic aneurysms with the on-label use compared with the off-label use of an endoprosthesis.

PURPOSE: Endovascular repair of an abdominal aortic aneurysm (EVAR) is sometimes not performed in accordance with the instructions for use (IFU) of the endoprosthesis ("off-label use"). We investigated whether the off-label use of the endograft affected the outcomes of EVAR. METHODS: Demographic, anatomical, intraoperative and follow-up data on 100 patients in whom the endograft was used on-label in EVAR were compared retrospectively with the corresponding data of 50 patients with off-label endograft use. RESULTS: The endograft IFU were most often not followed in patients with challenging aortic neck anatomy or iliac access or fixation, steep neck angulation or bilateral hypogastric artery embolization. Compared with patients in whom the device was used on-label, patients with off-label use had significantly higher rates of intraoperative type I or III endoleaks and proximal aortic cuff placement or other adjunctive procedures. However, there were no midterm differences between the two groups in the rates of type 1b or II endoleaks, sac enlargement, device-limb occlusion or patient survival. CONCLUSIONS: Most midterm outcomes of EVAR in which the endografts were used off-label were similar to those associated with on-label use of the devices. Off-label use of EVAR endoprostheses is feasible, but requires the use of special techniques in patients with challenging anatomical features.

Propensity score analysis of clinical outcome after bypass surgery vs. endovascular therapy for infrainguinal artery disease in patients with critical limb ischemia.

PURPOSE: To compare endovascular therapy (EVT) outcomes to those of bypass surgery (BSG) for infrainguinal artery disease in patients with critical limb ischemia (CLI). METHODS: A retrospective review was conducted of 1053 CLI patients (1053 first treated limbs) who underwent BSG (n=230) or EVT (n=823) for de novo infrainguinal lesions between January 2004 and December 2009 at 14 Japanese centers. Propensity score analysis was used for risk adjustment in multivariate analysis and for one-to-one matching (n=200 in each group). Amputation-free survival, overall survival, limb salvage, and freedom from major adverse limb events (any repeat revascularization or major amputation) were calculated. RESULTS: Mean follow-up was 30±16 months. In the overall series, there was no significant difference at 3 years between the EVT and BSG groups in amputation-free survival (60.5% vs. 62.1%, p=0.84), limb salvage (88.7% vs. 85.4%, p=0.24), or overall survival (65.8% vs. 69.2%, p=0.40). However, freedom from adverse limb events was significantly lower in the EVT group (56.6% vs. 69.2%, p=0.02) at 3 years. In the matched pairs analysis, there was no significant difference in any outcome between BSG and EVT at 3 years: amputation-free survival 66.3% vs. 62.0 (p=0.44), limb salvage 88.8% vs. 84.8% (p=0.44), survival 73.8% vs. 68.8% (p=0.61), and freedom from adverse limb events 61.3% vs. 69.1% (p=0.27). CONCLUSION: Our cohort suggested that the frequency of serious adverse events after EVT was comparable to that after BSG in CLI patients who underwent their first infrainguinal revascularization.

Comparison of long-term outcome after endovascular therapy versus bypass surgery in claudication patients with Trans-Atlantic Inter-Society Consensus-II C and D femoropopliteal disease.

BACKGROUND: Although endovascular therapy (EVT) has advanced, few reports have compared EVT and bypass surgery in claudication patients with femoropopliteal disease. The present study used data from a multicenter registry in Japan to analyze outcomes of EVT and bypass surgery for claudication patients with Trans-Atlantic Inter-Society Consensus (TASC)-II C and D femoropopliteal lesions. METHODS AND RESULTS: Of 1,156 patients who underwent revascularization, 696 patients were treated for intermittent claudication. A total of 263 patients with femoropopliteal lesion were classified into TASC-II C and D. The primary and secondary patency rates of the EVT and bypass surgery groups were analyzed. The overall complication rate was 14.4% in the bypass surgery group and 3.5% in the EVT group (P<0.01). The 1- and 5-year primary patency rates were 82.1% and 69.4% in the bypass surgery group and 67.8% and 45.2% in the EVT group, respectively. Although the bypass surgery group had a higher primary patency rate than the EVT group (P<0.01, log-rank test), secondary patency rates did not differ significantly between the two groups. CONCLUSIONS: Although bypass surgery is clearly feasible for claudication patients with TASC-II C and D femoropopliteal disease, EVT is also a good option because of its lower complication rate and good secondary patency rate in patients in poor condition for bypass.

DVC1-0101 to treat peripheral arterial disease: a Phase I/IIa open-label dose-escalation clinical trial.

We here report the results of a Phase I/IIa open-label four dose-escalation clinical study assessing the safety, tolerability, and possible therapeutic efficacy of a single intramuscular administration of DVC1-0101, a new gene transfer vector based on a nontransmissible recombinant Sendai virus (rSeV) expressing the human fibroblast growth factor-2 (FGF-2) gene (rSeV/dF-hFGF2), in patients with peripheral arterial disease (PAD). Gene transfer was done in 12 limbs of 12 patients with rest pain, and three of them had ischemic ulcer(s). No cardiovascular or other serious adverse events (SAEs) caused by gene transfer were detected in the patients over a 6-month follow-up. No infectious viral particles, as assessed by hemagglutination activity, were detected in any patient during the study. No representative elevation of proinflammatory cytokines or plasma FGF-2 was seen. Significant and continuous improvements in Rutherford category, absolute claudication distance (ACD), and rest pain were observed (P < 0.05 to 0.01). To the best of our knowledge, this is the first clinical trial of the use of a gene transfer vector based on rSeV. The single intramuscular administration of DVC1-0101 to PAD patients was safe and well tolerated, and resulted in significant improvements of limb function. Larger pivotal studies are warranted as a next step.

Recurrent brachial artery embolism caused by a crutch-induced axillary artery aneurysm: report of a case.

We report a case of axillary artery aneurysm with brachial artery embolism in a 60-year-old man who had walked with the assistance of axillary crutches all of his life since poliomyelitis during infancy had left him with lower limb paralysis. We performed bypass grafting from the axillary to brachial artery with exclusion of the aneurysm. An axillary artery aneurysm is rare, but potentially lethal for the upper extremity; therefore, surgical treatment should be considered.

Endovascular aneurysm repair for an abdominal aortic aneurysm and a left ruptured common iliac artery aneurysm in a patient with hepatocellular carcinoma: report of a case.

We performed an endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysm (AAA) and a ruptured common iliac artery aneurysm (rCIAA) in a patient complicated by severe liver dysfunction due to obstructive jaundice resulting from hepatocellular carcinoma (HCC). A 68-year-old male presented with acute lower abdominal pain. Abdominal computed tomography (CT) showed a 4.5-cm infrarenal AAA, a 6.0-cm left rCIAA with retroperitoneal hematoma and a 13-cm mass in the liver, which was suspected to be HCC. His laboratory data showed severe liver dysfunction. An emergency EVAR was done under local anesthesia because of his liver dysfunction. He was transferred to another hospital without any complications.

Successful treatment of an abdominal aortic aneurysm with a severely angulated and large aortic neck using a modified Zenith.

This report presents the case of an abdominal aortic aneurysm (AAA), in which the aortic neck was severely angulated. Furthermore, there was moderate stenosis and a severe angle with calcification of the suprarenal aorta. EVAR was performed with a commercial Zenith stent-graft, with a slight modification, because an open aneurysm repair was risky in general condition. No complications occurred during the follow-up period.