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.

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.

PEPE II--a multicenter study with an end-point heparin-bonded expanded polytetrafluoroethylene vascular graft for above and below knee bypass surgery: determinants of patency.

AIM: The Propaten European Product Evaluation (PEPE II) study was a product evaluation intended to characterize the performance of the GORE PROPATEN vascular graft in above-knee (AK) and below-knee bypass (BK) surgery. METHODS: This prospective multicenter trial enrolled 142 patients with peripheral arterial disease. In 87 patients AK and in 52 patients BK bypasses (including 15 femorocrural) were implanted (67.6% males, 32.4% females). RESULTS: The one-year overall primary and secondary patency rates were 80% and 84.7%, respectively. Overall limb salvage rate at 12-months was 96.2%. The primary patency rate for AK bypasses was 82.7%, for BK femoro-popliteal bypasses 74.2% and for BK tibial-peroneal bypasses 79.4%. Secondary patency rates were 87.3%, 78.8% and 85.1%, respectively. Primary patency rates decreased depending on the number of patent run-off vessels (three 84.3%, two 80.8%, one 73.3%). Subgroup analysis showed that female patients had a significantly higher primary patency rate for BK bypasses (95.5% vs. 67.8%, P=0.037 ) compared to male patients. Subgroup analysis comparing patients younger and older than 70 years did not show a statistically significant difference in patency rates. Twenty-one patients underwent 42 reinterventions after bypass surgery. CONCLUSIONS: Present data show that the end-point heparin-bonded polytetrafluoroethylene graft yields patency rates comparable to those obtained with other graft material in above-knee locations. The encouraging results for BK bypasses suggests that this graft is an excellent option for small diameter vascular reconstructions when autologous vein is unavailable.

Are adverse events after carotid endarterectomy reported comparable in different registries?

OBJECTIVES: To assess the extent of discrepancies between different vascular registries, at various levels of validation, and to investigate whether such differences might alter the morbidity and mortality rates obtained from the gold standard dataset for carotid endarterectomy (CEA). METHODS: All CEA operations in Helsinki University Central Hospital from 2000-2005 were retrieved from the local vascular registry (HUSVASC) and the Hospital Discharge Registry (HILMO). Both registries were validated at different levels to form the final dataset. Total and indication-specific perioperative morbidity and mortality rates were estimated from each level of validation and compared with those from the final dataset and with pooled rates from systematic reviews. RESULTS: Initial search provided 675 and 681 CEAs from HUSVASC and HILMO, respectively, decreasing to 636 (94%) and 614 (90%) when using the specific operative codes for thrombendarterectomy and patch angioplasty. Manual verification of initial HUSVASC results proved that 655 (97%) operations were true CEAs. 18 further proven CEAs, registered only in HILMO, were added to form the final CEA dataset (n=673). The peri-operative morbidity and combined morbidity and mortality rates were 2.23% and 2.67%, respectively. Comparable rates were obtained from both registries, irrespective the level of verification. CONCLUSION: Registry data do not appear to be biased by random loss of some operations and thus they are reliable for decision-making. However, further research is still needed to estimate the permissible volume of omissions in a registry for the data-base to remain trustworthy.

Acute renal injury and dysfunction following elective abdominal aortic surgery.

OBJECTIVES: To evaluate the incidence of kidney injury and acute renal dysfunction (ARD) and associated risk factors in open abdominal aortic surgery. MATERIALS AND METHODS: 69 patients undergoing elective infrarenal aortic repair were included in a prospective study. Anaesthesia and haemodynamic management were standardised targeting a mean arterial pressure (MAP) of 70-90 mmHg, pulmonary artery occlusion pressure of 12-14 mmHg and cardiac index >or=2.4 l/min/m(2). Urinary albumin-creatinine and N-acetyl-B-D-glucosaminidase-creatinine ratios were measured as indicators of kidney injury. The definition of ARD was based on the RIFLE criteria. RESULTS: Kidney injury was found in most patients. ARD developed in 22% of the patients, and acute renal failure in 4%. The patients with ARD were older, and had lower plasma creatinine and estimated GFR before surgery. ARD was associated with intraoperative hypotension (MAP <60 mmHg >15 min), low cardiac index (<2.4 l/min/m(2)), rhabdomyolysis, and early reoperation. Intraoperative hypotension and postoperative low cardiac output were independent risk factors for ARD in multivariate analysis. CONCLUSIONS: Kidney injury occurs in most patients undergoing infrarenal aortic surgery, but only 22% develop acute renal dysfunction. Hypotension and low cardiac output are risk factors that could be avoided by optimizing perioperative management.

CT angiographic analysis of carotid artery stenosis: comparison of manual assessment, semiautomatic vessel analysis, and digital subtraction angiography.

BACKGROUND AND PURPOSE: To compare multisection CT angiography (CTA) analyzed with source/maximum intensity projection (MIP) images as well as semiautomated vessel analysis software with intra-arterial digital subtraction angiography (DSA) in detection and grading of carotid artery bifurcation stenosis. METHODS: Consecutive patients with sonography evidence of a marked internal carotid artery stenosis underwent both carotid CTA and DSA (37 patients, 73 vessels). In CTA, the grade of stenosis was determined using axial source and MIP images as well as vessel analysis. The scans were blind-analyzed by 2 neuroradiologists using the NASCET criteria. RESULTS: Correlation of CTA source/MIP images versus DSA estimates of stenosis (R = 0.95) was higher than for the vessel analysis method versus DSA (R = 0.89). Compared with DSA, CTA source/MIP images underestimated high (78.2% versus 86.4%, P < .05) and moderate grades of stenosis (57.3% versus 63.1%, P < .05) to a lesser extent than the vessel analysis method (68.5% versus 83.5% and 51.8% versus 63.1%, P < .05). For a high-grade stenosis, sensitivity and specificity of source/MIP image CTA were 75% and 96%, respectively, whereas for the vessel analysis method, they were 47% and 96%, respectively. For moderate stenosis, the source/MIP image CTA sensitivity and specificity were 88% and 82%, respectively, and for vessel analysis method, 62% and 82%, respectively. CTA detected all 4 occlusions. CONCLUSION: In evaluation of carotid stenosis, CTA provides an adequate, less invasive alternative with a high correlation to conventional DSA, though it tends to underestimate clinically relevant grades of stenosis. Its accuracy is not improved by semiautomated analysis. The data support the use of CTA in confirming carotid occlusion.

Infra-inguinal percutaneous transluminal angioplasty for limb salvage: a retrospective analysis in a single center.

PURPOSE: To review the feasibility of infra-inguinal angioplasty in the management of critical limb ischemia (CLI). MATERIAL AND METHODS: Data on 221 patients with 230 critically ischemic limbs, treated with consecutive percutaneous transluminal angioplasty (PTA) at Helsinki University Central Hospital between January 2000 and December 2002 were collected and analyzed retrospectively. Patency, limb salvage, and survival rates were calculated on an intention-to-treat basis. Comparisons were done with univariate (Kaplan-Meier) and multivariate analysis (Cox regression). RESULTS: Overall primary patency, secondary patency, limb salvage, and survival rates were 47%, 59%, 92%, and 76%, respectively, at 12 months. In the multivariate analysis, low toe pressure (< or =30 mmHg) was a significant risk factor for poor patency. Uremia with hemodialysis, low toe pressure (< or =30 mmHg), and hemodynamic failure of the endovascular procedure were found to increase significantly the risk of amputation. Uremia with hemodialysis, coronary artery disease, tissue loss as indication for PTA (Fontaine stage IV), and age over 70 years were all found to increase significantly the risk of death. CONCLUSION: Infra-inguinal PTA is feasible in patients with CLI and resulted in good limb salvage.

Does an adjuvant AV-fistula improve the patency of a femorocrural PTFE bypass with distal vein cuff in critical leg ischaemia?--a prospective randomised multicentre trial.

INTRODUCTION: A lack of suitable veins can cause serious problems when attempting to revascularise critically ischaemic legs. Prosthetic grafts have much worse patency in the femocrural position, despite the use of distal anastomotic cuffs. The use of adjuvant AV-fistula at the distal anastomosis should increase the graft flow above the thrombotic threshold velocity and thus increase prosthetic graft patency. AIM: The aim of the study was to evaluate the benefit of an adjuvant AV-fistula on the patency of a femorocrural PTFE bypass with a distal vein cuff. MATERIALS AND METHODS: This prospective randomised multicentre trial was conducted in four centres. A total of 59 patients with critical leg ischaemia and no suitable veins for grafting were randomised to receive a femocrural PTFE bypass and distal vein cuff, with or without an adjuvant AV-fistula. Thirty-one patients were randomised to the AV-fistula group (AVFG) and 28 to the control group (CG). Six patients were lost to follow-up during the 2-year study time. RESULTS: There were six immediate occlusions in each treatment group, but half of these were saved by re-operation. The mean postoperative ankle-brachial index (ABI) was 0.85 in the AVFG and 0.94 in the CG. The primary and secondary patency rate at 2 years was 29 and 40% for the AVFG and 36 and 40% for the CG (NS). Leg salvage at 2 years was 65 and 68%, respectively (NS). CONCLUSION: Adjuvant AV-fistula does not improve the patency of a femorocrural PTFE bypass with a distal vein cuff.

Lower limb amputations in Southern Finland in 2000 and trends up to 2001.

OBJECTIVES: To assess the current incidence of major lower limb amputations in Southern Finland and epidemiological trends during the last 17 years. MATERIALS AND METHODS: In a retrospective survey for the year 2000 patient data was gathered from hospital records in the eight surgical hospitals in the area studied. Follow-up was 1 year. Amputation data for years 1984-1995 was gathered from reports done before at the same area and amputation figures for years 1990-2001 also from the National Research and Development Centre for Welfare and Health. RESULTS: In year 2000, the incidence of major amputations was 154/million inhabitants. The reason for major amputation was chronic critical lower limb ischaemia in 71.8% and acute ischaemia in 16.5% of the cases. The below-knee (BK)/above-knee (AK) ratio was 0.76. After 1 year only 48% of the patients were alive. From 1984 to 2000 amputation incidence showed a decrease of 41%. The decline in age-adjusted amputation incidence from 1990 to 2000 was 30% and by 2001 as much as 40%. There was a significant inverse correlation both between incidence of infrainguinal bypass and amputation (r=-0.682, p=0.021) and between infrapopliteal bypass and amputation (r=-0.682, p=0.021). CONCLUSIONS: There was a reduction in the number of amputations in Southern Finland during the past 17 years. This occurred synchronously with the increase in vascular reconstructions. Our data suggests that vascular surgery saves patients from BK-amputations and therefore relative amount of AK-amputations inevitably rises.

Ankle brachial index measurements in critical leg ischaemia--the influence of experience on reproducibility.

BACKGROUND AND AIMS: While the use of ankle brachial indices (ABI) in the screening for peripheral arterial obstructive disease is widely accepted, the applicability of ABI in the identification of critical leg ischaemia (CLI) is far from settled. The aim was to assess inter-observer variability of ABI measurements in patients with CLI. MATERIAL AND METHODS: The study was conducted in two parts. In both parts a hand-held 9.5 MHz Doppler device was used. PART A: ABI was measured by 7 measurers with variable measurement experience in 22 limbs of patients admitted to the surgical ward because of CLI. The agreement between the measurements was assessed. PART B: Inter-observer agreement in measuring ABI was assessed between 2 trained vascular technicians measuring 33 limbs in patients with CLI on the vascular outpatient clinic. RESULTS AND CONCLUSIONS: Part A: 16% of the ABI-values differed 0.15 or more from the median and the mean coefficient of variation was 56.1. Part B: The difference between measurements did not exceed 0.14 with a mean coefficient of variation of 3.2. To obtain reproducible and quantitative measurement values the measurements have to be performed by trained personnel. Measurements performed by untrained personnel can only be regarded as qualitative.

Preliminary results with endoluminal femoropopliteal thrupass.

BACKGROUND AND AIMS: Results of endovascular procedures to the superficial femoral artery and popliteal artery are not as good as at the iliac level. The purpose of this study is to evaluate the long-term results of a new endoluminal stent-graft for the management of lesions of the femoropopliteal segment. MATERIAL AND METHODS: Fifteen patients underwent endoluminal treatment of femoropopliteal lesions with a PTFE covered stent-graft. Nine patients had critical leg ischaemia, two patients had acute leg ischaemia, two patients were claudicants, one patient had a ruptured popliteal artery aneurysm, and one had a large adjuvant therapeutic arteriovenous fistula. RESULTS: The procedure was successfully carried out in all patients. Thrombosis occurred in two stent-grafts 4.5 months and 12.5 months after the procedure. One of them was successfully thrombolysed. During the two-year follow-up, a haemodynamically significant decrease in ankle/brachial index was observed in two patients. Ankle/brachial index was the same or higher than the immediately postoperative value in six patients. Primary patency rates at 1 month, 1 year and 2 year follow-up were 100%, 93% and 84%, respectively. Assisted primary patency rates at the same intervals were 100%, 93% and 93%, respectively. No patient had limb loss during the follow-up period. CONCLUSIONS: Endoluminal femoropopliteal bypass using PTFE covered stent-graft can be successfully performed with good two-year results.

Increased preoperative c-reactive protein level as a prognostic factor for postoperative amputation after femoropopliteal bypass surgery for CLI.

BACKGROUND AND AIMS: We evaluated the possible predictive role of C-reactive protein (CRP) on the immediate postoperative outcome after femoropopliteal bypass surgery for critical leg ischaemia (CLI). MATERIAL AND METHODS: 138 patients with CLI who underwent 143 femoropopliteal reconstructions. RESULTS: The immediate postoperative period secondary patency rate was 87%, leg salvage rate was 94%, and survival rate 97%. Nine patients (6.3%) had 30-day postoperative major amputation, three of them despite a patent bypass graft because of progression of foot infection. The preoperative serum concentration of CRP was the only predictor of postoperative major amputation (p = 0.004; for an increase of 10 mg/l: OR, 1.188; CI 95%, 1.059-1.332). The median preoperative serum concentration of CRP among patients who did not have major amputation was 13.0 mg/l (range, 1-185), whereas it was 47.5 mg/l (range, 5-168) among those who had amputation after bypass graft occlusion, and 115.0 mg/l (range, 34-222) among those who had amputation despite a patent bypass graft (p = 0.008). CONCLUSIONS: CRP may be a useful marker in risk stratification for postoperative amputation in patients undergoing femoropopliteal bypass surgery for CLI.

Redo bypass surgery to the infrapopliteal arteries for critical leg ischaemia.

OBJECTIVES: to evaluate the results of redo bypass surgery to the infrapopliteal artery and the value of adjuvant arteriovenous fistula (AVF) in this setting. DESIGN: retrospective study. MATERIALS: fifty-one redo reconstructions to the infrapopliteal arteries were done for critical leg ischaemia in 45 patients who have had primary infrainguinal reconstructions to the popliteal artery in 20 cases (39%), the crural arteries in 18 (35%), and the pedal arteries in 13 (25%). METHODS: a PTFE prosthesis was used in 21 cases (41%). A Miller cuff was used in 16 prosthetic grafts. Adjuvant AVF was added to three autogenous vein and 12 prosthetic grafts. RESULTS: at 2 years, the primary patency rate was 42%, the secondary patency was 43%, the limb salvage was 67%, the survival was 77%, and 53% of patients were alive with salvaged leg. The primary patency rate with a vein graft was 44% at 1 year, with prosthesis plus AVF 67%, but with prosthesis without AVF only 19%. Secondary patency rates were similar. Prosthetic graft with AVF and those without AVF achieved a 1-year leg salvage rate of 100% and 51%, respectively (p =0.01). Patients with adjuvant AVF had a worse 2-year survival rate that those without AVF (31% vs 89%) (p =0.007; RR: 8.87, CI 95%: 1.62-48.42). CONCLUSIONS: redo bypass surgery using autogenous vein graft may achieve satisfactory long-term results. The use of adjuvant AVF may improve patency of redo infrapopliteal prosthetic bypass grafts.

Ki-67, p53, Er-receptors, ploidy and S-phase as prognostic factors in T1 node negative breast cancer.

The prognostic value of Ki-67, p53 and ER immunohistochemical labelling and flow-cytometric S-phase fraction and ploidy was evaluated in 212 pT1N0M0 breast carcinomas. The mean follow-up time was 8.3 years. Patients with breast carcinomas with high Ki-67 expression (> or = 10%) had a less favourable disease-free survival than those with low Ki-67 expression (< 10%) (p = 0.008). A positive p53 staining and high SPF were associated with a less favourable disease-free survival although it did not reach statistical significance. The subset of patients with ER negative, Ki-67 > or = 10% and p53 > or = 20% tumours, had a shorter disease-free survival compared with that of all the other patients (p = 0.03). We conclude that the potential value of Ki-67 labelling for prognostic evaluation of T1N0M0 breast carcinoma is good.

Preoperative assessment of proliferative activity and hormonal receptor status in carcinoma of the breast: a comparison of needle aspiration and needle-core biopsies to the surgical specimen.

The applicability and reliability of estimates of proliferative activity in breast carcinomas using fine-needle aspiration (FNA) and needle-core biopsies (NC) was evaluated in 98 breast carcinoma patients. The Ki-67, Estrogen receptor (ER), and progesteron receptor (PR) immunolabelling of FNA and NC was compared with that of the surgical specimen. A statistically significant consistency between labelling was found in the Ki-67-NC (kappa = 0.474), ER-FNA (kappa = 0.318), ER-NC (kappa = 0.518), and PR-FNA (kappa = 0.404) groups. The consistency in the Ki-67-FNA group was less significant (kappa = 0.182), and there was no consistency in the PR-NC group (kappa = 0.062). There was a positive correlation of Ki-67 labelling in FNA and NC biopsies (Spearman rank, rho = 0.4; P = 0.0007), and also in ER labeling (Spearman rank rho = 0.6; P = 0.0001). These results indicate that NC and FNA can be used for preoperative assessment of proliferative activity and hormonal status in breast carcinoma.

Flow cytometric DNA measurements in aspiration biopsies and surgical specimens of breast cancer.

OBJECTIVE: One of the prognostic factors in breast cancer is the proliferation activity of the tumor. This study sought knowledge of this activity before surgery to benefit the design and timing of therapy. STUDY DESIGN: Flow cytometric DNA analysis data from 52 diagnostic fine needle aspirates were compared with data from subsequent surgical specimens. RESULTS: The data showed that the coefficient of variation of the G1 peak was lower in the aspirates. Small, near-diploid peaks were detected more frequently in aspirate histograms than in surgical specimens. DNA analyses by flow cytometry from aspirates, which can be obtained prior to surgical treatment, were as reliable as those obtained from surgical specimens, provided that the cellular material was diagnostic of cancer. CONCLUSION: Our results suggest that flow cytometry DNA analysis from the first preoperative cytologic specimen from a breast tumor will permit faster planning and coordination of breast cancer care.