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Background: Arterial reconstruction (AR) for limb ischemia may improve ambulatory function (AF) and health-related quality of life (HR-QoL). However, the efficacy of AR in terms of HR-QoL varies in studies, probably because of cohort differences in disease severity, hemodynamic outcomes, and observation duration. We assessed HR-QoL for patients with various severities of ischemia in a 3-year observational study., Methods: We conducted a single-center 3-year observational study using Short Form 36 in patients with chronic limb ischemia. Between 2001 and 2009, 515 consecutive patients had AR, and 330 who underwent elective AR consented to the study. Of the 330 patients (claudicants 49%, critical limb ischemia [CLI] 51%), 307 underwent bypass and 23 endovascular therapy. Postal questionnaires were sent after AR, and 8 domains, the physical and mental component summary (PCS and MCS) scores, and the patient-reported AF were compared, and negative predictors were identified., Results: Overall, the MCS was minimally affected, but AF and the PCS were impaired. After AR, these measures were significantly improved, and maximum recovery was attained at 6 months. In subgroup analysis, significant predictors of a negative impact on postoperative PCS included age ≥80, CLI, physical aftereffects of stroke (PAS), and previous major amputation (PMA). Of these, PMA was associated with the lowest PCS score, followed by PAS; for these patients, AR contributed minimally to HR-QoL recovery. PCS scores of claudicants attained a maximum value at 6 months; however, PCS scores of CLI patients were significantly lower than intermittent claudication patients (P < 0.0001), and patients with major tissue loss required 2 years to attain maximum PCS recovery., Conclusions: This 3-year observational study verified the efficacy of AR in improving AF and HR-QoL. Age ≥80, CLI, PAS, and PMA were definitive predictors, and for patients with the latter 2, AR contributed minimally to improving HR-QoL., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to elucidate the efficacy of paramalleolar or inframalleolar bypass (PIMB) in hemodialysis-dependent (HD) patients with critical limb ischemia (CLI) and nonhemodialysis-dependent (NHD) patients in terms of clinical outcomes., Methods: Between January 2000 and December 2013, there were 333 consecutive arteriosclerosis obliterans patients with CLI who underwent 401 PIMB procedures for limb salvage (LS). Of the 333 patients, 188 (56.5%) were HD patients. Vein grafts were exclusively used, and 172 paramalleolar and 229 inframalleolar bypasses were performed. Five-year primary and secondary cumulative graft patency, LS, and amputation-free survival (AFS) rates were compared between the two groups, and the independent determinants of these outcomes were identified in each group., Results: The 5-year primary and secondary cumulative graft patency rates were 53% and 82% in HD patients and 69% and 92% in NHD patients (primary cumulative graft patency, P < .05; secondary cumulative graft patency, nonsignificant), respectively. The LS rates were 87% and 99% (P < .01) in HD patients and NHD patients, respectively. Overall, 48% and 70% of HD and NHD patients were ambulatory before PIMB (P < .01), and 73% and 85% of HD and NHD patients were ambulatory 12 months after PIMB (including 1-year survivors; nonsignificant), respectively, demonstrating drastic post-PIMB improvement in HD patients. The 5-year AFS rates in the HD and NHD groups were 27% and 69% (P < .01), respectively, demonstrating very poor AFS rates in HD patients. In HD patients, factors negatively associated with AFS were female gender (hazard ratio [HR], 2.102; 95% confidence interval [CI], 1.254-3.524), history of congestive heart failure (HR, 2.075; 95% CI, 1.395-3.085), and preoperative nonambulatory status (HR, 1.974; 95% CI, 1.305-2.986), whereas older age (HR, 2.601; 95% CI, 1.372-4.931) and history of congestive heart failure (HR, 2.928; 95% CI, 1.496-5.731) were identified as independent factors negatively associated with AFS in NHD patients., Conclusions: The use of PIMB for CLI was associated with excellent LS rates in both HD and NHD patients with low operative mortality and complications. However, the AFS rate observed in HD patients was significantly lower than that observed in NHD patients, indicating the necessity of a specific management program to improve AFS after LS in HD patients., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of the study is to determine factors affecting ischaemic wound healing and role of the angiosome concept in bypass surgery., Design: Single-centre, retrospective clinical study., Materials and Methods: A total of 249 consecutive critical ischaemic limbs with tissue loss in 228 patients who underwent distal bypasses from 2003 to 2009 were reviewed. A total of 81% of patients were diabetic, and 49% of patients had dialysis-dependent renal disease (end-stage renal disease, ESRD). Distal targets of bypasses were the crural artery (57%) and the pedal artery (43%)., Results: The complete healing of ischaemic wounds was achieved in 211 limbs (84.7%). ESRD (odds ratio (OR) 0.127, p < 0.001), diabetes (OR 0.216, p = 0.030), Rutherford category 6 (R6) with heel ulcer/gangrene (OR 0.134, p < 0.001), R6 except heel (OR 0.336, p = 0.025) and low albuminaemia (OR 0.387, p = 0.049) were negative predictors of wound healing. Regarding the angiosome, the healing rate in the indirect revascularisation (IR) group was slower than in the direct revascularisation (DR) group, especially in patients with ESRD (p < 0.001). However, the healing rates of the DR and IR groups were similar after minimising background differences with propensity score methods (p = 0.185)., Conclusions: In the field of bypass surgery, the angiosome concept seems unimportant, at least in non-ESRD cases. The location and extent of ischaemic wounds as well as co-morbidities may be more relevant than the angiosome in terms of wound healing., (Copyright © 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Aim: Hepatocyte growth factor is a potent angiogenic agent. This study investigated the efficacy and safety of intramuscular injection of naked plasmid DNA encoding the human hepatocyte growth factor gene in Japanese patients with Buerger's disease and critical limb ischemia., Methods: An open-label clinical study was performed at eight hospitals in Japan from May 2004 to April 2008. Ten patients were enrolled. They had Buerger's disease with ischemic ulcers, were not candidates for revascularization, and were unresponsive to conventional drug therapy. Treatment consisted of 8 injections (total dose: 4 mg) of hepatocyte growth factor plasmid, which were administered into the calf muscles and/or distal thigh muscles of the ischemic limbs under ultrasound guidance. Administration was done twice at an interval of 4 weeks. If there was no improvement after 2 doses, a 3rd dose could be administered. The response to treatment was evaluated from the reduction of ischemic ulcer size., Results: The size of ischemic ulcers showed a decrease in 6/9 (66.7%) patients and the ulcers healed completely in 5/9 (55.6%) patients after gene therapy. Major amputation was not required. There were no deaths and no major safety concerns., Conclusion: Hepatocyte growth factor gene therapy is safe and effective for critical limb ischemia in patients with Buerger's disease.

Hepatocyte growth factor (HGF) is a potent angiogenic factor. The efficacy and safety of intramuscular injection of a naked plasmid encoding human HGF gene (beperminogene perplasmid, Collategene) was investigated in patients with critical limb ischemia (CLI) in a multicenter, randomized, double-blind, placebo-controlled trial. The randomization ratio for plasmid to placebo was 2:1. Injection sites were selected in each patient limb based on angiographic findings. Placebo or plasmid was injected on days 0 and 28. Evaluation of efficacy was carried out after 12 weeks. The primary end point was the improvement of rest pain in patients without ulcers (Rutherford 4) or the reduction of ulcer size in patients with ulcer(s) (Rutherford 5). Secondary end points were ankle-brachial pressure index, amputation, and quality of life (QOL). Forty-four patients were treated, and we performed interim analysis of efficacy in 40 patients. The overall improvement rate of the primary end point was 70.4% (19/27) in HGF group and 30.8% (4/13) in placebo group, showing a significant difference (P=0.014). In Rutherford 5 patients, HGF achieved a significantly higher improvement rate (100% [11/11]) than placebo (40% [2/5]; P=0.018). HGF plasmid also improved QOL. There were no major safety problems. HGF gene therapy is safe and effective for CLI.

Background: We evaluated the mid-term outcome of distal venous arterialization (DVA) and the role of a combined free flap as a bridgehead for blood supply., Methods: In the past 5 years, nine patients with extensive tissue loss and lacking graftable distal arteries underwent DVA. These consisted of four primary DVAs, three combined DVA and free flap procedures, and two adjuvant DVAs for hemodynamically failed distal bypasses. After nine primary DVAs, three redo DVAs were performed for early failure. Etiologies were four Buerger disease and five arteriosclerosis obliterans, including three dialysis patients., Results: Among the nine DVA cases, there were five primary failures: two underwent amputation, two had successful redo DVA, and the remaining one did not require redo DVA. Primary patency, secondary patency, and limb salvage rates were 44.4%, 55.6%, and 77.8%, respectively. The postoperative period was 1-36 months (median 12). Angiography demonstrated DVA was effective in the early period, and development of collaterals or a capillary network from the free flap replaced the DVA function in the intermediate period., Conclusion: DVA can be effective as a procedure for limb salvage in patients without graftable distal arteries, and a combined free flap is effective and functions as a bridgehead for blood supply to the ischemic zone., (Copyright (c) 2010 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.)

Objectives: we determined the incidence and specific markers of postoperative delirium in elderly patients with chronic lower limb ischaemia., Patients and Methods: since April, 1995, 110 patients aged 60 years or older (mean: 71.6+/-6.6 years) who underwent bypass surgery were assessed regarding aetiological factors of delirium: age, sex, dementia, body-mass index, hypertension, diabetes, cerebral disease, laboratory test results, severity of limb ischaemia, type of arterial occlusion, operative time, and blood transfusion., Results: discriminant analysis showed statistical significance in the following five variables: age >/=70 years; critical limb ischaemia (and/or ankle pressure <40 mmHg); dementia; duration of operation >/=7 hours; low serum albumin. The overall percentage of cases correctly classified was 78.2% (Wilks>> Lambda=0.695, p<0.001); the standardized regression coefficients of the five variables were 0.648, 0.500, 0.329, 0.218, and 0.200, respectively. In logistic regression, the regression coefficients for old age and critical limb ischaemia were 2.646 (14.1 of odds ratio; 95% confidence interval, 2.7-72.0) and 1.337 (3.8; 1.3-10.9), respectively., Conclusions: the incidence of postoperative delirium in elderly patients with chronic lower-limb ischaemia was as high as 42.3%, and an age of over 70 years and critical limb ischaemia were identified as specific markers, with 14.1 times and 3.8 times the odds of suffering from delirium after bypass surgery., (Copyright 2000 Harcourt Publishers Ltd.)

To evaluate the role of three-dimensional computed tomographic angiography (3D-CT) in peripheral artery bypass surgery, 49 patients with chronic lower limb ischemia underwent 3D-CT before and after a bypass operation. 3D-CT had a sensitivity of 96.8%, a specificity of 95.0% and an overall accuracy of 96.1% for the diagnosis of arterial and graft stenosis or obstructions. The ability to observe the acquired images at any angle was very useful for assessing the implanted graft in both aortoiliac and infrainguinal bypasses. Although these images equally identified arterial stenosis, obstruction, and the anastomotic morphology of bypass grafts as well as conventional angiography, the diagnostic accuracy was not helpful in the small arteries and grafts. 3D-CT is a low-invasive imaging method that is sufficient for forming strategies for bypass operations. In aortofemoral or femoropopliteal bypass surgery, 3D-CT thus provides sufficient imaging accuracy for bypasses up to the popliteal artery below the knee in patients with chronic limb ischemia.

A series of 241 consecutive autogenous vein bypasses for chronic lower-limb ischaemia performed by two surgeons since 1980 was reviewed. After 1985, in situ vein bypass was employed preferentially and was compared with reversed vein bypass. The two groups of patients had similar risk factors, indications and outflow. Of the 241 bypasses, 157 were to the below-knee popliteal artery and 84 to infrapopliteal arteries. The utilization rates of a single ipsilateral saphenous vein were 57.5% for reversed and 71.9% for in situ vein bypass. However, in situ vein bypass was impossible in 43 procedures and these were changed to the reversed operation with contralateral vein. The primary 5-year patency rates of reversed and in situ vein bypass grafts to the popliteal artery were 82.5 versus 74.5%, and the primary 4-year patency rates for infrapopliteal bypass 68.5 versus 80.0%. The respective secondary patency rates were 94.2 versus 92.1% and 85.7 versus 91.1%. The main cause of graft failure was vein graft stenosis (reversed vein bypass, 13.0%; in situ, 11.1%), which usually occurred in the first 2 years after surgery. Of 23 grafts revised for stenosis, 21 were salvaged and restenosis rarely occurred. Both reversed and in situ vein bypass grafts were equally effective, but careful surveillance for 2 years and aggressive revision were extremely important after either type of reconstruction.

Objectives: We investigated the alterations of acid-base characteristics of the blood cardioplegia (BCP) solution during aortic cross-clamping in hearts arrested with BCP and during in vitro-simulated ischemia. Methods: Following aortic cross-clamping, the hearts of 40 patients undergoing cardiac surgery were intermittently infused with an 18°C BCP solution and finally with a 34°C BCP solution prior to aortic cross-clamp release. We measured the pH, partial CO2 pressure (pCO2), [HCO3-], and [Cl-] of the coronary sinus effluent in the final BCP solution. The BCP solution was assessed under in vitro gassing at 34°C with 95% N2 + 5% CO2 (n = 6), 50% N2 + 50% CO2 (n = 3), or 100% CO2 (n = 6). Results: The coronary sinus effluent, compared with the preinfusion BCP solution, exhibited a significantly lower pH and a greater pCO2 with no change in the [HCO3-] level. In vitro, the 95% N2 + 5% CO2 gassing (simulated hypoxia) group exhibited a slight increase in [HCO3-] with no change in pCO2 or pH whereas the 50% N2 + 50% CO2 gassing and the 100% CO2 gassing (simulated hypoxia and hypercapnia) groups exhibited a significant increase in [HCO3-] under high pCO2-induced acidification. Conclusions: Under anoxia and CO2 retention during aortic cross-clamping, the BCP solution can be a bicarbonate donor to the myocardium. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]