Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins.

BACKGROUND: A variety of minimally invasive techniques are available for the treatment of varicose great saphenous vein (GSVs). Non-tumescent, non-thermal ablation methods have been developed. This study compared mechanochemical ablation (MOCA), a non-tumescent, non-thermal ablation technique, with two endovenous thermal ablation methods requiring tumescence in an RCT. METHODS: Patients with GSV reflux were randomized to undergo MOCA, or thermal ablation with endovenous laser (EVLA) or radiofrequency (RFA). The primary outcome measure was the occlusion rate of the GSV at 1 year. RESULTS: The study finally included 125 patients, of whom 117 (93·6 per cent) attended 1-year follow-up. At 1 year, the treated part of the GSV was fully occluded in all patients in the EVLA and RFA groups, and in 45 of 55 in the MOCA group (occlusion rates 100, 100 and 82 per cent respectively; P = 0·002). The preoperative GSV diameter was associated with the recanalization rate of the proximal GSV in the MOCA group. At 1 year after treatment, disease-specific life quality was similar in the three groups. CONCLUSION: The GSV occlusion rate 1 year after treatment was significantly higher after EVLA and RFA than after MOCA. Quality of life was similar between interventions. Registration number: NCT03722134 (http://www.clinicaltrials.gov).

Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins.

BACKGROUND: New treatment methods have challenged open surgery as a treatment for great saphenous vein (GSV) insufficiency, the most common being ultrasound-guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA). This study evaluated the long-term results of surgery, EVLA and UGFS in the treatment of GSV reflux. METHODS: Patients with symptomatic GSV reflux were randomized to undergo either open surgery, EVLA or UGFS. The main outcome measure was the occlusion rate of the GSV at 5 years after operation. RESULTS: The study included 196 patients treated during 2008-2010; of these, 166 (84·7 per cent) participated in the 5-year follow-up. At 5 years, the GSV occlusion rate was 96 (95 per cent c.i. 91 to 100) per cent in the open surgery group, 89 (82 to 98) per cent after EVLA and 51 (38 to 64) per cent after UGFS (P < 0·001). For patients who had received no additional treatment during follow-up, the occlusion rates were 96 per cent (46 of 48), 89 per cent (51 of 57) and 41 per cent (16 of 39) respectively. UGFS without further GSV treatment was successful in only 16 of 59 patients (27 per cent) at 5 years. CONCLUSION: UGFS has significantly inferior occlusion rates compared with open surgery or EVLA, and results in additional treatments.

Analysis of the Elective Treatment Process for Critical Limb Ischaemia with Tissue Loss: Diabetic Patients Require Rapid Revascularisation.

OBJECTIVES: The number of elderly people is increasing; inevitably, the result will be more patients with critical limb ischaemia (CLI) in the future. Tissue loss in CLI is related to a high risk of major amputation. The aim of this study was to analyze the treatment process from referral to revascularisation, to discover possible delays and reasons behind them, and to distinguish patients benefitting the most from early revascularisation. METHODS: A retrospective analysis was performed of 394 consecutive patients with a combined 447 affected limbs, referred to the outpatient clinic during 2010-2011 for tissue loss of suspected ischaemic origin. RESULTS: For 246 limbs revascularisation was scheduled. After changes in the initial treatment strategy, endovascular treatment (ET) was performed on 221 and open surgery (OS) on 45 limbs. Notably there was crossover after ET in 17.0% of the procedures, and re-revascularisations were required in 40.1% after ET and 31.1% after OS. The median time from referral to revascularisation was 43 days (range 1-657 days) with no significant difference between ET and OS. For 29 (11.8%) patients the ischaemic limb required an emergency operation scheduled at the first visit to the outpatient clinic. For 25 (10.2%) patients the situation worsened while waiting for elective revascularisation and an emergency procedure was performed. Diabetic patients formed the majority of the study population, with 159 diabetic feet undergoing revascularisation. In multivariate analysis, diabetes was associated with poor limb salvage. When revascularisation was achieved within 2 weeks, no difference was seen in limb salvage. However, when the delay from first visit to revascularisation exceeded 2 weeks, limb salvage was significantly poorer in diabetic patients. CONCLUSIONS: Diabetic ulcers always require vascular evaluation, and when ischaemia is suspected the diagnostics should be organised rapidly to ensure revascularisation without delay, according to this study within 2 weeks from the first evaluation.

Angiosome Targeted PTA is More Important in Endovascular Revascularisation than in Surgical Revascularisation: Analysis of 545 Patients with Ischaemic Tissue Lesions.

INTRODUCTION: This study aimed to evaluate the impact of angiosome targeted (direct) revascularisation according to revascularisation method in patients with diabetes. MATERIALS AND METHODS: This retrospective study cohort comprised 545 diabetic patients with critical limb ischaemia and tissue loss (Rutherford 5, 6). All patients underwent infrapopliteal endovascular (PTA) or open surgical revascularisation between January 2008 and December 2013. Differences in the outcome after direct revascularisation, bypass surgery, and PTA were investigated by means of Cox proportional hazards analysis. The endpoints were wound healing, leg salvage, and amputation free survival. RESULTS: Overall, 60.3% of the ischaemic wounds healed during 1 year of follow-up. The highest wound healing rate was achieved after direct bypass (77%) and the worst after indirect PTA (52%). The Cox proportional hazards analysis showed that the number of affected angiosomes <3 (HR 1.37, 95% CI 1.01-1.84) was associated with improved wound healing, whereas wound healing was poorest after indirect PTA (p = .001). When Cox proportional hazard analysis was adjusted for the number of affected angiosomes, direct bypass gave the best wound healing (p = 0.003). The overall amputation rate was 25.1% at 1 year of follow-up, and the Cox proportional hazards analysis indicated that haemodialysis compared with patients with no haemodialysis (HR 2.55, 95% CI 1.49-4.38), C-reactive protein ≥10 mg/dL (HR 2.05, 95% CI 1.45-2.90), atrial fibrillation (HR 1.54, 95% CI 1.05-2.26), and number of affected angiosomes >3 (HR 1.75, 95% CI 1.24-2.46) were significantly associated with poor leg salvage. Direct PTA was associated with a lower rate of major amputation compared with indirect PTA (HR 0.57 95% CI 0.37-0.89). CONCLUSION: In diabetics, indirect endovascular revascularisation leads to significantly worse wound healing and leg salvage rates compared with direct revascularisation. Therefore, endovascular procedures should be targeted according to the angiosome concept. In bypass surgery, however, the concept is of less value and the artery with the best runoff should be selected as the outflow artery.

Randomized clinical trial comparing surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy for the treatment of great saphenous varicose veins.

BACKGROUND: Endovenous ablation techniques and ultrasound-guided foam sclerotherapy (UGFS) have largely replaced open surgery for treatment of great saphenous varicose veins. This was a randomized trial to compare the effect of surgery, endovenous laser ablation (EVLA) (with phlebectomies) and UGFS on quality of life and the occlusion rate of the great saphenous vein (GSV) 12 months after surgery. METHODS: Patients with symptomatic, uncomplicated varicose veins (CEAP class C2-C4) were examined at baseline, 1 month and 1 year. Before discharge and at 1 week, patients reported a pain score on a visual analogue scale. Preoperative and 1-year assessments included duplex ultrasound imaging and the Aberdeen Varicose Vein Severity Score (AVVSS). RESULTS: The study included 214 patients: 65 had surgery, 73 had EVLA and 76 had UGFS. At 1 year, the GSV was occluded or absent in 59 (97 per cent) of 61 patients after surgery, 71 (97 per cent) of 73 after EVLA and 37 (51 per cent) of 72 after UGFS (P < 0·001). The AVVSS improved significantly in comparison with preoperative values in all groups, with no significant differences between them. Perioperative pain was significantly reduced and sick leave shorter after UGFS (mean 1 day) than after EVLA (8 days) and surgery (12 days). CONCLUSION: In comparison with open surgery and EVLA, UGFS resulted in equivalent improvement in quality of life but significantly higher residual GSV reflux at 12-month follow-up.

Long-term Results of Inframalleolar Bypass for Critical Limb Ischaemia.

INTRODUCTION: As the population ages and the incidence of diabetes increases, the expected number of patients with critical limb ischaemia (CLI) requiring distal revascularization will remain high or even increase. The aim of this study was to investigate the long-term results of inframalleolar bypass. MATERIAL AND METHODS: A total of 352 inframalleolar bypasses for CLI performed between 2002 and 2013 were included. Risk factors were evaluated and patency (both clinical and imaging based), leg salvage, survival, and amputation free survival (AFS) assessed. RESULTS: The median follow up was 30 months (mean 42 months, range 1-186 months). The median age of the study population was 73 years, and 67% of the patients were male. The incidence of diabetes was 69%. In the majority of cases (82%), the indication for bypass was an ulcer or gangrene, and the remaining 18% of the patients had rest pain. Primary, assisted primary, and secondary clinical patency was 71.2%, 76.5%, 81.0%, and 59.7%, 69.3%, and 70.7%, and 49.0%, 58.6%, and 68.4% at 1, 5, and 10 years, respectively. The last imaging based secondary patency at 1, 5, and 10 years was 79.3%, 68.1%, and 62.8%, respectively. The popliteal artery as the inflow artery (n = 194) was associated with superior primary (p = .013), assisted primary (p = .028), and secondary patency (p = .014) when compared with bypasses originating from the femoral artery (n = 158). The leg salvage rate at 1, 5, and 10 years was 78.6%, 72.0%, and 67.2%, respectively. Leg salvage was equal in patients with and without diabetes (p = .460). The respective survival and AFS rates at 1, 5, and 10 years were 70.3%, 37.4%, and 15.9%, and 58.4%, 29.8%, and 12.8%. CONCLUSION: Bypass to the foot arteries yielded excellent long-term patency, and good limb salvage can be achieved in both non-diabetic and diabetic patients.

Editor's Choice - Treatment of Aortic Prosthesis Infections by Graft Removal and In Situ Replacement with Autologous Femoral Veins and Fascial Strengthening.

INTRODUCTION: Aortic prosthetic graft infection (AGI) is a major challenge in vascular surgery. Eradicating the infection requires prosthetic material removal, debridement, and lower limb revascularization. For the past 15 years, we have used femoral veins for aorto-iliac reconstruction and tensor fascia lata to strengthen the upper anastomosis. OBJECTIVE: The purpose of this single institution retrospective study is to present results regarding in situ replacement of infected aortic grafts with autologous femoral veins (FVs). METHODS: From October 2000 to March 2013, patients treated for AGI with graft removal and autologous FV reconstruction at Helsinki University Hospital were included. Primary outcome measures were 30 day mortality, long-term treatment related mortality, and re-infection rate. Secondary outcome measures were long-term all cause mortality and event free survival (graft rupture, re-intervention, major amputation). RESULTS: During a 13 year period 55 patients (42 male, 13 female) were operated on using a venous neo-aorto-iliac system for AGI. The mean follow up was 32 months (1-157 months). The 30 day mortality rate was 9% (5) and overall treatment related mortality 18% (10). All cause mortality during follow up was 22 (40%) and overall Kaplan-Meier survival was 90.7% at 30 days, 81.5% at 1 year, and 59.3% at 5 years. Graft rupture occurred in three (5%) cases, two of which were caused by graft re-infection (4%). Four patients required major amputation, one of them on arrival and three (5%) during the post-operative period. Nine (16%) patients needed interventions for the vein graft, and two graft limbs occluded during follow up. CONCLUSION: In situ reconstruction for aortic graft infection with autologous FV presents acceptable rates of morbidity and mortality, and remains the treatment of choice for AGI at Helsinki University Hospital.

Pilot Assessment of the Repeatability of Indocyanine Green Fluorescence Imaging and Correlation with Traditional Foot Perfusion Assessments.

BACKGROUND: Ankle brachial index (ABI), toe pressures (TP), and transcutaneous oxygen pressure (TcPO2) are traditionally used in the assessment of critical limb ischemia (CLI). Indocyanine green (ICG) fluorescence imaging can be used to evaluate local circulation in the foot and to evaluate the severity of ischemia. This prospective study analyzed the suitability of a fluorescence imaging system (photodynamic eye [PDE]) in CLI. MATERIAL AND METHODS: Forty-one patients with CLI were included. Of the patients, 66% had diabetes and there was an ischemic tissue lesion in 70% of the limbs. ABI, toe pressures, TcPO2 and ICG-fluorescence imaging (ICG-FI) were measured in each leg. To study the repeatability of the ICG-FI, each patient underwent the study twice. After the procedure, foot circulation was measured using a time-intensity curve, where T1/2 (the time needed to achieve half of the maximum fluorescence intensity) and PDE10 (increase of the intensity during the first 10 s) were determined. A time-intensity curve was plotted using the same areas as for the TcPO2 probes (n=123). RESULTS: The mean ABI was 0.43, TP 21 mmHg, TcPO2 23 mmHg, T1/2 38 s, and PDE10 19 AU. Time-intensity curves were repeatable. In a Bland-Altman scatter plot, the 95% limits of agreement of PDE10 was 9.9 AU and the corresponding value of T1/2 was 14 s. Correlation between ABI and TP was significant (R=.73, p<.001), and it was weaker in diabetic patients (R=.47, p=.048) compared with non-diabetic patients (R=.89, p=.002). Correlations between ABI and TcPO2 and TP and TcPO2 were weak (R=.37, p=.05 and R=.43, p=.037, respectively). Correlation between TcPO2 and PDE10 was strong in diabetic patients (R=.70, p=.003). CONCLUSIONS: According to this pilot study, ICG-FI with PDE can be used in the assessment of blood supply in the ischemic foot.

The benefit of revascularization in nonagenarians with lower limb ischemia is limited by high mortality.

OBJECTIVE/BACKGROUND: Owing to the increased life expectancy of the population the number of very old patients referred to vascular surgical units has increased. Advanced age is a well known risk factor in patients undergoing surgical interventions for lower limb ischemia. However, amputation performed on an elderly person living independently will lead to permanent institutional care. The aim of this study was to evaluate the outcome of patients aged 90 years and older with lower limb ischemia undergoing surgical or endovascular revascularization. METHODS: Two hundred and thirty-three nonagenarians with either chronic critical limb ischemia (CLI) or acute limb ischemia (ALI) who underwent revascularization at the authors' institution between 2002 and 2013 were included in this retrospective study. Risk factors were evaluated and survival, limb salvage, and amputation free survival (AFS) assessed. RESULTS: The median age of the study population was 92 years (range 90-100 years). The majority (81.1%) of the patients were female. One in four (24.5%) patients had diabetes, and the incidence of coronary artery disease was 79.8%. Seventy-three percent of the patients had CLI and 27% of had ALI. Seventy percent of the patients underwent surgical revascularization and 30% were treated endovascularly. The majority (72.5%) of the patients maintained their independent living status; 27.5% ended up in institutional care post-operatively. Similarly, the majority (82.0%) of the patients maintained their walking ability, while 18% were not able to ambulate independently after revascularization. One year survival, limb salvage, and AFS rates were 50.9% versus 48.6% (p = .505), 85.1% versus 87.0% (p = .259), and 45.7% versus 44.4% (p = .309) in the surgical versus endovascular group, respectively. Dementia was an independent risk factor of poor AFS (odds ratio: 1.56; 95% confidence interval: 1.077-2.272; p = .019). CONCLUSION: Good limb salvage can be achieved by both surgical and endovascular revascularization, and independent living can be maintained in the majority of the patients. However, the benefit of revascularization is limited owing to high mortality, especially in patients with dementia.

Differential impact of bypass surgery and angioplasty on angiosome-targeted infrapopliteal revascularization.

OBJECTIVE: The aim of this study was to evaluate the impact of angiosome targeted revascularization according to the revascularization method. DESIGN: Retrospective observational study. MATERIALS AND METHODS: This study cohort comprised 744 consecutive patients who underwent infrapopliteal endovascular or surgical revascularization between January 2010 and July 2013. Differences in outcomes after bypass surgery and PTA were adjusted by estimating a propensity score, which was employed for one to one matching as well as adjusted analysis. RESULTS: Cox proportional hazards analysis showed that angiosome-targeted revascularization (HR 1.29, 95% CI 1.02-1.65), bypass surgery (HR 1.79, 95% CI 1.41-2.27), C-reactive protein ≤10 mg/dL (HR 1.42, 95% CI 1.11-1.81), and the number of affected angiosomes (HR 0.85, 95% CI 0.74-0.98) were independent predictors of improved wound healing. When adjusted for the number of affected angiosomes and C-reactive protein ≤10 mg/dL, angiosome-targeted bypass surgery was associated with a significantly higher rate of wound healing than non-angiosome-targeted angioplasty (HR 2.27, 95% CI 1.61-3.20). This was confirmed in propensity score adjusted analysis (HR 1.72, 95% CI 1.35-2.16). Among patients who underwent angiosome-targeted revascularization, the propensity score adjusted analysis showed that bypass surgery was associated with a significantly better rate of wound healing (HR 154, 95% CI 1.09-2.16) but similar limb salvage rates when compared with angioplasty (HR 0.79, 95% CI 0.44-1.43). CONCLUSION: Rates of wound healing and limb salvage in patients with critical limb ischemia (CLI) were significantly better after angiosome-targeted revascularization, bypass surgery achieving significantly better wound healing than angioplasty.

Duplex surveillance after endovascular revascularisation for critical limb ischaemia.

OBJECTIVE: Despite the popularity of endovascular therapy (EVT) for critical limb ischaemia (CLI), there are few studies investigating the efficacy of duplex ultrasound (DUS) surveillance after endovascular interventions. The aim of this study was to evaluate DUS surveillance after EVT for CLI. METHODS: 146 endovascular procedures in 134 consecutive patients with CLI between 2011 and 2012 were included. Follow-up visits with ankle-brachial index (ABI), toe pressure, and target vessel DUS were performed at 1, 3, and 6 months after revascularisation. RESULTS: The median age of the study population was 79 years, 58% were males, and 55% had diabetes. The target artery was at the iliac, femoro-popliteal, and infrapopliteal level in 2%, 54%, and 44% of cases, respectively. There were 282 follow-up visits. In 15 (5.3%) DUS examinations, the target vessel was not seen properly. In the remaining 267 DUS, the majority of the target arteries were patent with no or mild restenosis (n = 169, 63.3%), but in 98 (36.7%) examinations, the target artery was stenosed or occluded. When DUS was compared with the clinical presentation, there was no correlation in 30% and when DUS and toe pressure were compared, discrepancy was seen in 29%. A re-angiogram was performed for 29 patients, and the DUS finding was verified in each case. During the mean follow-up of 11 months, a new endovascular intervention was performed on 37 (25.3%) limbs, and 4 (2.7%) underwent surgical bypass. Four (3.0%) patients died and 6 (4.5%) underwent major amputation. CONCLUSION: Clinical status or toe pressure alone were adequate markers of endovascular revascularisation failure in the majority of the patients, but would have missed up to one-third of the clinically significant re-stenoses or occlusions. DUS is therefore a valuable aid in surveillance after EVT for CLI, especially for patients with an ischaemic tissue lesion.

Compression therapy versus surgery in the treatment of patients with varicose veins: A RCT.

OBJECTIVE: Superficial venous reflux and varicose veins are common. The aim of this randomized controlled trial was to assess effectiveness of compression therapy compared with surgery for superficial venous reflux. METHODS: 153 patients with CEAP class C2-C3 and superficial venous reflux were randomized to receive either conservative treatment (compression stockings) (n = 77) or surgery (n = 76). Clinical examination including duplex ultrasound (DUS) was performed at entry and 1 and 2 years after randomization (compression group) or surgery (surgery group). Venous Clinical Severity Score without compression stockings (VCSS-S), Venous Segmental Disease Score (VSDS), Venous Disability Score (VDS), and health-related quality of life (HRQoL) were assessed at entry and at the follow-ups. Data were analysed on an intention-to-treat basis and according to the actual treatment performed. RESULTS: At 2 years, 70/76 patients in the surgery group and 11/77 patients in the compression group had been operated on. VCSS-S decreased from 4.6 to 3.5 in the compression group (p < .01) and from 4.8 to 0.6 in the surgery group (p < .001). VSDS decreased from 7.7 to 7.0 in the compression group and from 8.2 to 0.9 in the surgery group (p < .0001). HRQoL did not change in the compression group, but improved significantly in the surgery group. CONCLUSION: The surgical elimination of non-complicated superficial venous reflux is an effective treatment when compared with providing compression stockings only.

Doppler ultrasound examination of multiple sclerosis patients and control participants: inter-observer agreement and association with disease.

OBJECTIVE: Chronic cerebrospinal venous insufficiency (CCSVI) has been proposed as a major risk factor for multiple sclerosis (MS). The aim of this study was to assess inter-observer agreement between two ultrasound examiners and to compare findings in MS patients and control participants. METHODS: A prospective, blinded, controlled study of MS patients diagnosed within 2 years (MS ≤ 2, n = 39), patients diagnosed more than 10 years ago (MS > 10, n = 43) and age- and sex-matched control participants (n = 40). Ultrasound examinations were performed by two independent examiners. CCSVI criteria 1, 3, 4 and 5 as proposed by Zamboni were explored: (1) reflux in the internal jugular (IJV) and vertebral veins (VV), (3) IJV cross-sectional area (CSA) ≤0.3 cm(2), (4) absence of flow in IJV and VV, and (5) reverted postural control of venous outflow. RESULTS: Criteria 1, 4 and 5 were met in less than 10% of the MS patients and control participants as studied by both examiners. The level of inter-observer agreement was poor for all parameters except assessment of the CSA of IJV at the thyroid level. Findings meeting CCSVI criterion 3 (CSA ≤ 0.3 cm(2)) were observed in 18/40 (45%) of the control participants, in 24/37 (65%) of MS ≤ 2 patients (p = 0.09 vs. control participants) and in 30/43 (70%) of the MS > 10 patients (p = 0.022 vs. control participants). CONCLUSIONS: The feasibility of the CCSVI criteria for common use is questionable because of low inter-observer agreement. Small-calibre IJVs meeting the CCSVI criterion 3 appear common in both Finnish control participants and MS patients, but the clinical significance of this finding is questionable.

The role of chronic kidney disease as a predictor of outcome after revascularisation of the ulcerated diabetic foot.

AIMS/HYPOTHESIS: The aim of the study was to stratify the risk of diabetic patients with leg ulcer or gangrene undergoing infrainguinal revascularisation for critical limb ischaemia. METHODS: The study cohort included 732 revascularisation procedures performed in 597 diabetic patients with ulcer or gangrene. Logistic regression and CART analysis were used for identification of predictors of 1-year outcome. RESULTS: Logistic regression showed that chronic kidney disease (CKD) class (OR 1.38, 95% CI 1.16, 1.65) was an independent predictor of 1-year leg salvage (area under the receiver operating characteristic [ROC] curve 0.60, 95% CI 0.54, 0.65). The terminal nodes of the CART for 1-year leg salvage were CKD classes 4-5, the level (infrapopliteal vs femoropopliteal revascularisation), type of revascularisation (bypass surgery vs percutaneous transluminal angioplasty) and gangrene (area under the ROC curve 0.62, 95% CI 0.57, 0.68). Logistic regression showed that pulmonary disease (OR 1.76, 95% CI 1.11, 2.78), CKD class (OR 1.43, 95% CI 1.24, 1.65), foot gangrene (OR 1.76, 95% CI 1.21, 2.60) and patient age (OR 1.02, 95% CI 1.01, 1.04) were independent predictors of 1-year amputation-free survival (area under the ROC curve 0.65, 95% CI 0.60, 0.69). The terminal nodes of the CART for 1-year amputation-free survival were CKD classes 3-5, patient's age of ≥ 75 years and foot gangrene (area under the ROC curve 0.64, 95% CI 0.60, 0.68). CONCLUSIONS/INTERPRETATION: CKD is a formidable risk factor for poor intermediate outcome after infrainguinal revascularisation in diabetic patients with foot ulcer or gangrene. CART analysis indicates that foot gangrene is also a significant risk factor for adverse outcome.

Infrainguinal percutaneous transluminal angioplasty or bypass surgery in patients aged 80 years and older with critical leg ischaemia.

BACKGROUND: Infrainguinal revascularization for critical leg ischaemia (CLI) in patients aged 80 years and over is associated with increased operative risk. The aim was to compare the results of percutaneous transluminal angioplasty (PTA) and bypass surgery in these patients. METHODS: Some 584 consecutive patients aged at least 80 years treated with either PTA (277) or bypass surgery (307) for CLI between 2000 and 2007 were included in this study. RESULTS: After 2 years PTA achieved better results than bypass surgery (leg salvage: 85.4 versus 78.7 per cent, P = 0.039; survival: 57.7 versus 52.3 per cent, P = 0.014; amputation-free survival (AFS): 53.0 versus 44.9 per cent, P = 0.005). Cox regression analysis showed that increased age (relative risk (RR) 1.05, 95 per cent confidence interval 1.02 to 1.08), decreased estimated glomerular filtration rate (RR 0.99, 0.99 to 1.00), diabetes (RR 1.30, 1.04 to 1.62), coronary artery disease (RR 1.36, 1.05 to 1.75) and bypass surgery (RR 1.55, 1.24 to 1.93) were associated with decreased AFS. In 95 propensity score-matched pairs, leg salvage at 2 years (88 versus 75 per cent; P = 0.010) and AFS (53 versus 45 per cent; P = 0.033) were significantly better after PTA. Classification and regression tree analysis suggested that PTA was associated with better 1-year AFS, especially in patients with coronary artery disease (63.8 versus 48.9 per cent; P = 0.008). CONCLUSION: When feasible, a strategy of PTA first appears to achieve better results than infrainguinal bypass surgery in patients aged 80 years and older.

Femoropopliteal balloon angioplasty vs. bypass surgery for CLI: a propensity score analysis.

OBJECTIVES: To compare the outcomes of femoropopliteal percutaneous transluminal angioplasty (PTA) and bypass surgery for critical limb ischaemia (CLI). DESIGN: The study is retrospective in nature. MATERIALS AND METHODS: This study included 858 consecutive patients, who underwent femoropopliteal revascularisation for CLI at Helsinki University Central Hospital during 2000-2007. As many as 517 patients (60%) underwent PTA and 341 (40%) bypass surgery. Propensity score analysis was used for risk adjustment in multivariable analysis and for one-to-one matching. RESULTS: In the overall series, PTA had poorer long-term results than bypass (5-year leg salvage, 78.2% vs. 91.8%, p < 0.0001; survival 49.2% vs. 57.1%, p = 0.048; amputation-free survival, 42.0% vs. 53.7%, p = 0.003; freedom from surgical re-intervention 86.2% vs. 94.3%, p < 0.0001). When treatment method was adjusted for propensity score as well as in the propensity score-matched pairs, leg salvage and freedom from surgical re-intervention were worse after PTA than after bypass (among the 241 propensity score-matched pairs, 74.3% vs. 88.2%, p = 0.031, and 86.1% vs. 89.8%, p = 0.025, respectively). Differences in survival, amputation-free survival and freedom from any re-intervention were not observed. CONCLUSIONS: In CLI patients, femoropopliteal PTA seems to be associated with poorer long-term leg salvage and freedom from surgical re-intervention than bypass surgery. However, the treatment method did not affect long-term amputation-free survival.

Non-cholesterol sterols in serum and endarterectomized carotid arteries after a short-term plant stanol and sterol ester challenge.

BACKGROUND AND AIMS: It is not known whether dietary intake of plant stanols or sterols changes the composition of arterial sterols. Therefore, we compared serum and carotid artery cholesterol and non-cholesterol sterols after plant stanol (staest) or sterol (steest) ester feeding in endarterectomized patients. METHODS AND RESULTS: Elderly statin-treated asymptomatic patients undergoing carotid endarterectomy were randomized double-blind to consume staest (n=11) or steest (n=11) spread (2 g of stanol or sterol/day) for four weeks preoperatively. Non-cholesterol sterols from serum and carotid artery tissue were analysed with gas-liquid chromatography. Staest spread lowered serum total (17.2%), VLDL, and LDL cholesterol and serum triglycerides, while steest spread lowered serum total (13.8%) and LDL cholesterol levels from baseline (p<0.05 for all). Serum cholestanol and avenasterol were decreased in both groups, but campesterol and sitosterol were decreased by staest and increased by steest from baseline (p<0.05 from baseline and between the groups). Serum sitostanol to cholesterol ratio was increased by staest, but in arterial tissue this ratio was similar in both groups. On staest, lathosterol, campesterol, and sitosterol, and on steest sitosterol and avenasterol correlated significantly between serum and arterial tissue. Cholesterol metabolism, eg. lathosterol/campesterol, suggested that plant sterols were reduced in serum and in arterial tissue during staest. CONCLUSION: The novel observations were that plant stanol ester consumption, in contrast to plant sterols, tended to reduce carotid artery plant sterols in statin-treated patients. Furthermore, despite increased serum sitostanol contents during plant stanol ester consumption, their arterial levels were unchanged suggesting that sitostanol is not taken up into the arterial wall.

High leg salvage rate after infrainguinal bypass surgery for ischemic tissue loss (Fontaine IV) is compromised by the short life expectancy.

BACKGROUND AND AIMS: Most studies analysing the prognosis of infrainguinal bypass surgery (IBS) in patients with critical leg ischemia (CLI) have combined the outcome of patients with rest pain and tissue loss. The aim of the present study was to evaluate amputation-free survival (AFS) after IBS in patients with the most advanced form of peripheral arterial disease, CLI with tissue loss (Fontaine IV), and to analyse the risk factors for an adverse outcome. PATIENTS AND METHODS: 636 patients with CLI and tissue loss who underwent unilateral IBS between January 2000 and December 2006 at our institution were included in this retrospective study. RESULTS: At one year, the leg salvage, survival and amputation-free survival rates were 83%, 71% and 55%, respectively, and at five years 76%, 38% and 30%, respectively. In univariate analysis, diabetes was associated with decreased AFS. In multivariate analysis, age, coronary artery disease, chronic pulmonary disease, gangrene and renal insufficiency were independent risk factors for decreased AFS. CONCLUSION: Infrainguinal bypass grafting results in a high rate of leg salvage. Amputation-free survival was low during the follow-up due to the high mortality of patients with CLI and tissue loss. Several co-morbidities of the CLI patients were associated with decreased amputation-free survival.

Initial experience with a new method of external polyester scaffolding for infrainguinal vein grafts.

OBJECTIVES: This study aims to evaluate the feasibility of external polyester scaffolding in infrainguinal bypass grafting when available vein material is suboptimal due to varicosity or dilatation. Primary objectives were short-term primary patency, assisted primary patency and secondary patency. Secondary objectives were to assess the rate of graft stenoses, infections and other adverse effects related to the use of external scaffolding. MATERIALS AND METHODS: A total of 50 consecutive patients were included in this prospective, multicentre, feasibility study from six centres. The indication for infrainguinal bypass was critical limb ischaemia (64%), severe claudication (34%) or popliteal aneurysm (2%). Indications for the use of the external scaffolding were varicosity of the vein graft, ectatic vein graft or the use of spliced vein grafts with segments of widely differing diameters. Duplex scanning of the graft was done perioperatively and at follow-up visits at 1, 3, 6 and 12 months after operation. RESULTS: Primary patency, assisted primary patency and secondary patency at 6 months were 82.3% (+/-SE 6.2%), 88.6% (+/-SE 4.8%) and 92.1% (+/-SE 4.4%), respectively. Six graft stenoses were detected in duplex surveillance. There were no infections related to polyester mesh. CONCLUSIONS: External scaffolding of infrainguinal vein grafts may be a promising innovation. Early results from this multicentre study show that polyester mesh is safe and feasible adjunct to peripheral revascularization enabling the use of otherwise non-optimal vein grafts with acceptable short-term patency.