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Objective: To investigate the combined beneficial effect of statin and beta-blocker use on perioperative mortality and myocardial infarction (MI) in patients undergoing abdominal aortic aneurysm surgery (AAA)., Background: Patients undergoing elective AAA-surgery identified by clinical risk factors and dobutamine stress echocardiography (DSE) as being at high-risk often have considerable cardiac complication rate despite the use of beta-blockers., Methods: We studied 570 patients (mean age 69 ±9 years, 486 males) who underwent AAA-surgery between 1991 and 2001 at the Erasmus MC. Patients were evaluated for clinical risk factors (age>70 years, histories of MI, angina, diabetes mellitus, stroke, renal failure, heart failure and pulmonary disease), DSE, statin and beta-blocker use. The main outcome was a composite of perioperative mortality and MI within 30 days of surgery., Results: Perioperative mortality or MI occurred in 51 (8.9%) patients. The incidence of the composite endpoint was significantly lower in statin users compared to nonusers (3.7% vs. 11.0%; crude odds ratio (OR): 0.31, 95% confidence interval (CI): 0.13-0.74; p = 0.01). After correcting for other covariates, the association between statin use and reduced incidence of the composite endpoint remained unchanged (OR: 0.24,95% CI: 0.10-0.70; p = 0.01). Beta-blocker use was also associated with a significant reduction in the composite endpoint (OR: 0.24, 95% CI: 0.11-0.54). Patients using a combination of statins and beta-blockers appeared to be at lower risk for the composite endpoint across multiple cardiac risk strata; particularly patients with 3 or more risk factors experienced significantly lower perioperative events., Conclusions: A combination of statin and beta-blocker use in patients with AAA-surgery is associated with a reduced incidence of perioperative mortality and nonfatal MI particularly in patients at the highest risk., (Copyright © 2011. Published by Elsevier Ltd.)

Objectives: The aim of this study is to investigate whether variation in mortality at hospital level reflects differences in quality of care of peripheral vascular surgery patients., Design: Observational study., Materials: In 11 hospitals in the Netherlands, 711 consecutive vascular surgery patients were enrolled., Methods: Multilevel logistic regression models were used to relate patient characteristics, structure and process of care to mortality at 1 year. The models were constructed by consecutively adding age, sex and Lee index, then remaining risk factors, followed by structural measures for quality of care and finally, selected process of care parameters., Results: Total 1-year mortality was 11%, ranging from 6% to 26% in different hospitals. Large differences in patient characteristics and quality indicators were observed between hospitals (e.g., age>70 years: 28-58%; beta-blocker therapy: 39-87%). Adjusted analyses showed that a large part of variation in mortality was explained by age, sex and the Lee index (Akaike's information criterion (AIC)=59, p<0.001). Another substantial part of the variation was explained by process of care (AIC=5, p=0.001)., Conclusions: Differences between hospitals exist in patient characteristics, structure of care, process of care and mortality. Even after adjusting for the patient population at risk, a substantial part of the variation in mortality can be explained by differences in process measures of quality of care., (Copyright (c) 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

The use of spinal cord stimulation (SCS) has been advocated for the management of ischemic pain and the prevention of amputations in patients with inoperable critical limb ischemia (CLI), although data on benefit are conflicting. Several reports described apparently differential treatment effects in subgroups. The purpose of this study was to analyze the data on the efficacy of SCS and to clarify preselection issues. Five randomized trials have been performed with a total number of 332 patients. Primary outcome measures were mortality and limb survival. In the largest multicenter randomized trial (n = 120), which compared SCS treatment and best medical treatment alone in patients with inoperable CLI, we determined the incidence of amputation and its relation to various predefined risk factors. We used Kaplan-Meier and Cox regression analyses to quantify prognostic effects and differential treatment effects. Meta-analysis yielded a relative risk for amputation of 0.79 and a risk difference of -0.07 (p = 0.15). The risk factor analysis clearly showed that patients with ischemic skin lesions (ulcerations or gangrene) had a worse prognosis (i.e., higher risk of amputation) (relative risk 2.30, p = 0.01). We did not observe significant interactions between this prognostic factor (or any other) and the effect of SCS. The analysis did not indicate a subgroup of patients who might specifically be helped by SCS. Meta-analysis including all randomized data shows insufficient evidence for higher efficacy of SCS treatment compared with best medical treatment alone. Although some factors provide prognostic information as to the risk of amputation in patients with CLI, there are no data supporting a more favorable treatment effect in any group.

Objectives: Peripheral arterial disease (PAD) is associated with adverse cardiovascular events and can significantly impair patients' health status. Recently, marked methodological improvements in the measurement of PAD patients' health status have been made. The Peripheral Artery Questionnaire (PAQ) was specifically developed for this purpose. We validated a Dutch version of the PAQ in a large sample of PAD patients., Design: Cross-sectional study., Methods: The Dutch PAQ was completed by 465 PAD patients (70% men, mean age 65+/-10 years) participating in the Euro Heart Survey Programme. Principal components analysis and reliability analyses were performed. Convergent validity was documented by comparing the PAQ with EQ-5D scales., Results: Three factors were discerned; Physical Function, Perceived Disability, and Treatment Satisfaction (factor loadings between 0.50 and 0.90). Cronbach's alpha values were excellent (mean alpha=0.94). Shared variance of the PAQ domains with EQ-5D scales ranged from 3 to 50%., Conclusions: The Dutch PAQ proved to have good measurement qualities; assessment of Physical Function, Perceived Disability, and Treatment Satisfaction facilitates the monitoring of patients' perceived health in clinical research and practice. Measuring disease-specific health status in a reliable way becomes essential in times were a wide array of treatment options are available for PAD patients.

Background: The prevalence of death due to cardiovascular disease increases steeply in vascular surgery patients with increasing age. Observational data in coronary heart disease and heart failure patients suggest that elderly patients are less optimally treated compared to younger patients. The aim of this study was to examine the differences in clinical characteristics and medical therapy of the elderly compared to younger patients in vascular surgery. Furthermore, we assessed the effect of statins on 1-year mortality in an unselected patient population., Methods: Data on 711 consecutive peripheral vascular surgery patients were collected from 11 hospitals in The Netherlands in 2004. Elderly patients were defined as patients with an age above 70 years. Multivariable logistic regression analysis was used to identify clinical characteristics and medical therapy associated with older age. The effect of statins on 1-year mortality was assessed with Cox proportional hazard regression analysis., Results: The mean age was 67 +/- 10 years and 299 (42%) patients were older than 70 years of age. Elderly patients showed a significant higher cardiac risk profile according to the Lee Cardiac Risk Index (Lee-Index) (>/=2 risk factors: 50% vs 32% in younger patients, P < .001). Multivariable analysis showed that older patients presented with a significant higher Lee-Index, a higher incidence of cardiac arrhythmias (odds ratio [OR] = 1.9; 95% confidence interval [CI] = 1.1-3.3) and chronic obstructive pulmonary disease (COPD) (OR = 2.8; 95% CI = 1.7-4.7). However, smoking (OR = 0.5; 95% CI = 0.3-0.7) was less common in the elderly. Statins were significantly less often prescribed in the elderly (OR = 0.6; 95% CI = 0.4-0.8), although a beneficial effect of statins on 1-year mortality (HR = 0.3, 95% CI = 0.1-0.7) was observed., Conclusion: Elderly patients undergoing vascular surgery had a higher cardiac risk profile than younger patients. Despite this high cardiac risk and the beneficial effect, our study demonstrated that statins were less often used in elderly patients.

Objectives: To assess the relation between beta-blocker use, underlying cardiac risk, and 1-year outcome in vascular surgery patients, including the effect of beta-blocker withdrawal., Design: Prospective survey., Materials: 711 consecutive peripheral vascular surgery patients from 11 hospitals in the Netherlands between May and December 2004., Methods: Patients were evaluated for cardiac risk factors, beta-blocker use and 1-year mortality. Low and high risk was defined according to the Revised Cardiac Risk Index. Propensity scores for the likelihood of beta-blocker use were calculated and regression models were used to study the relation between beta-blocker use and mortality., Results: 285 patients (40%) received beta-blockers throughout the perioperative period (continuous users). Only 52% of the 281 high risk patients received continuous beta-blocker therapy. Beta-blocker therapy was started in 29 and stopped in 21 patients, respectively. One-year mortality was 11%. After adjustment for potential confounders and the propensity of its use, continuous beta-blocker use remained significantly associated with a lower 1-year mortality compared to non-users (HR=0.4; 95%CI=0.2-0.7). In contrast, beta-blocker withdrawal was associated with an increased risk of 1-year mortality compared to non-users (HR=2.7; 95%CI=1.2-5.9)., Conclusions: We demonstrated an under-use of beta-blockers in vascular surgery patients, even in high-risk patients. Perioperative beta-blocker use was independently associated with a lower risk of 1-year mortality compared to non-use, while perioperative withdrawal of beta-blocker therapy was associated with a higher 1-year mortality.

Perioperative cardiovascular complications in vascular surgery remain a significant problem despite recent advancements in perioperative care. This clinical update summarizes the results of recent studies on the effectiveness and safety of perioperative statin use for the prevention of these perioperative cardiovascular complications. Five studies in patients undergoing major noncardiac vascular surgery and two studies in patients undergoing carotid endarterectomy are described. All studies reported a significant reduction in perioperative cardiovascular events in statin users compared with nonusers. The safety of perioperative statin use has not yet been fully elaborated, although current evidence suggests there is no extra risk from statin-induced side effects in the perioperative period.

Objective: To evaluate the effect of statins on aneurysm growth in a group of consecutive patients under surveillance for infrarenal aortic aneurysms (AAA)., Materials and Methods: All patients (59 statin users, 91 non-users) under surveillance between January 2002 and August 2005 with a follow-up for aneurysm growth of at least 12 months and a minimum of three diameter evaluations were retrospectively included in the analysis. Multiple regression analysis, weighted with the number of observations, was performed to test the influence of statins on AAA growth rate., Results: During a median period of 3.1 (1.1-13.1) years the overall mean aneurysm growth rate was 2.95+/-2.8 mm/year. Statin users had a 1.16 mm/year lower AAA growth rate compared to non-users (95% CI 0.33-1.99 mm/year). Increased age was associated with a slower growth (-0.09 mm/year per year, p = 0.003). Female gender (+1.82 mm/year, p = 0.008) and aneurysm diameter (+0.06 mm/year per mm, p = 0.049) were associated with increased AAA growth. The use of non-steroidal anti-inflammatory drugs, chronic lung disease, or other cardiovascular risk factors were not independently associated with AAA growth., Conclusions: Statins appear to be associated with attenuation of AAA growth, irrespective of other known factors influencing aneurysm growth.

Objective: To quantify the costs of treatment in critical limb ischaemia (CLI) and to compare costs and effectiveness of two treatment strategies: spinal cord stimulation (SCS) and best medical treatment., Methods: One hundred and twenty patients with CLI not suitable for vascular reconstruction were randomised to either SCS in addition to best medical treatment or best medical treatment alone. Primary outcomes were mortality, amputation and cost. Cost analysis was based on resources used by patients for 2 years after randomisation. Both medical and non-medical costs were included., Results: Patient and limb survival were similar in the two treatment groups. Costs of in-hospital-stay and institutional rehabilitation constituted the predominant part (+/-70%) of the total costs of medical care in CLI. Cost of SCS-implantation and complications (7950 euro per patient) exceeded by far cost due to amputation procedures (410 euro per patient). The total costs of treatment were 36,600 euro per patient over 2 years for the SCS-group vs. 28,700 euro for best medical treatment alone (28% higher for SCS-group, p=0.009)., Conclusions: Total costs of treatment in CLI are high. Major components are hospital and rehabilitation costs. In contrast to recent reviews, there were no long-term benefits of SCS-treatment. Therefore, cost-effectiveness is reduced to cost-minimisation and SCS-treatment is considerably more expensive than best medical treatment.

Objective: To compare end-to-side (ETS) and end-to-end (ETE) distal anastomoses for femoropopliteal bypasses., Design: Prospective, randomized, multicenter trial., Methods: Patients from 14 centers were randomized to either ETS or ETE distal anastomosis, with stratification according to center and four categories: venous and prosthetic above knee bypass, and venous and prosthetic below knee bypass. Follow-up, with history, physical examination, ankle-brachial pressure index and duplex scan was performed at 3 months, 6 months and every 6 months thereafter until 36 months postoperatively., Results: A total of 328 femoropopliteal bypass operations were performed in 274 patients. Due to anatomical considerations at the time of surgery, 15 procedures (4.6%) were excluded from further analysis. Patient characteristics, cardiovascular risk factors, Rutherford classification and number of open run-off vessels were similar for both groups. Primary patency was 75 vs 74%, 65 vs 66% and 63 vs 55% for ETE vs ETS after 1, 2 and 3 years, respectively, (p = 0.26). During follow up major amputations were necessary in 20 ETE bypasses and in nine ETS bypasses (p = 0.028)., Conclusion: ETE distal anastomosis infemoropopliteal bypasses does not improve patency compared to ETS anastomosis. Major amputations, after failure of the bypass, were required more frequently for ETE distal anastomoses.

Objective: To investigate the combined beneficial effect of statin and beta-blocker use on perioperative mortality and myocardial infarction (MI) in patients undergoing abdominal aortic aneurysm surgery (AAA)., Background: Patients undergoing elective AAA-surgery identified by clinical risk factors and dobutamine stress echocardiography (DSE) as being at high-risk often have considerable cardiac complication rate despite the use of beta-blockers., Methods: We studied 570 patients (mean age 69+/-9 years, 486 males) who underwent AAA-surgery between 1991 and 2001 at the Erasmus MC. Patients were evaluated for clinical risk factors (age>70 years, histories of MI, angina, diabetes mellitus, stroke, renal failure, heart failure and pulmonary disease), DSE, statin and beta-blocker use. The main outcome was a composite of perioperative mortality and MI within 30 days of surgery., Results: Perioperative mortality or MI occurred in 51 (8.9%) patients. The incidence of the composite endpoint was significantly lower in statin users compared to nonusers (3.7% vs. 11.0%; crude odds ratio (OR): 0.31, 95% confidence interval (CI): 0.13-0.74; p=0.01). After correcting for other covariates, the association between statin use and reduced incidence of the composite endpoint remained unchanged (OR: 0.24, 95% CI: 0.10-0.70; p=0.01). Beta-blocker use was also associated with a significant reduction in the composite endpoint (OR: 0.24, 95% CI: 0.11-0.54). Patients using a combination of statins and beta-blockers appeared to be at lower risk for the composite endpoint across multiple cardiac risk strata; particularly patients with 3 or more risk factors experienced significantly lower perioperative events., Conclusions: A combination of statin and beta-blocker use in patients with AAA-surgery is associated with a reduced incidence of perioperative mortality and nonfatal MI particularly in patients at the highest risk.

Background: Cardiac troponin T (cTnT) is a sensitive and specific marker for myocardial injury, but elevations of cTnT without clinical evidence of ischemia and persistent or new electrocardiographic (ECG) abnormalities are common in patients undergoing major vascular surgery. We explored the long-term prognostic value of cTnT levels in these patients., Methods: A follow-up study was conducted between 1996-2000 in 393 patients who underwent successful aortic or infrainguinal vascular surgery and routine sampling of cTnT. Patients were followed until May 2003 (median of 4 years [25th-75th percentile, 2.8-5.3 years]). Total creatine kinase (CK), CK-MB, and cTnT were routinely screened in all patients, and included sampling after surgery and the mornings of postoperative days 2, 3 and 7. Electrocardiograms were also routinely evaluated for sign of ischemia. An elevated cTnT was defined as serum concentrations >/=0.1 ng/ml in any of these samples. All-cause mortality was evaluated during long-term follow-up., Results: Eighty patients (20%) had late death. The incidence of all-cause mortality (41% vs. 17%; p<0.001) was significantly higher in patients with an elevated cTnT level compared to patients with normal cTnT. After adjustment for baseline clinical characteristics, the association between an elevated cTnT level and increased incidence of all-cause mortality (adjusted hazard ratio, 1.9; 95% CI, 1.1-3.1) persisted. Elevated cTnT had significant prognostic value in patients with and without renal dysfunction, abnormal levels of CK-MB, and in patients with transient ECG abnormalities., Conclusions: Elevated cTnT levels are associated with an increased incidence of all-cause mortality in patients undergoing major vascular surgery.

Background and Objective: intimal hyperplasia (IH) and constrictive remodelling are important causes of restenosis following endovascular interventions, such as percutaneous transluminal angioplasty. Photodynamic therapy (PDT) with 5-aminolaevulinic (ALA) may prevent restenosis by cellular depletion and the elimination of cholinergic innervation., Study Design/materials and Methods: rats (n=90) were subdivided into 4 main groups. In the experimental group (n=36: 3 replications x 4 doses x 3 examination time-points), ALA was administered (200mg/kg i.v.) 2-3h before balloon injury (BI) of the common iliac artery followed by endovascular illumination with 633nm at either 12.5, 25, 50 or 100J/cm diffuser length (dl BI+PDT group). As control groups served the BI+Light only (LO) group (n=36) that received no ALA, the BI only group (n=9) (BI), and a group (n=9) that received a Sham procedure (Sham group)., Results: planimetric analysis showed IH of 0.28+/-0.12mm(2) (BI), 0.27+/-0.12mm(2) (BI+LO at 100J/cmdl) in contrast to 0.02+/-0.02mm(2) after BI+PDT at 100J/cmdl at 16 weeks (p<0.05). In the BI+PDT groups, a light-dose increase of a factor 2 led to an IH decrease of 17% (p<0.05). In the BI and BI+LO groups constrictive remodelling was found, in contrast to BI+PDT treated groups at 16 weeks. The staining of cholinergic innervation of the tunic media of the blood vessel wall in BI+PDT showed no damage at the highest fluence., Conclusion: endovascular ALA-PDT prevents IH and constrictive remodelling after BI without damage of cholinergic innervation of the tunica media. The effective light fluence rate in the rat is 50-100J/cmdl.

Objective: to compare the additional prognostic value of Dobutamine Stress Echocardiography (DSE), Dipyridamole Stress Echocardiography (DiSE) and Perfusion Scintigraphy (DTS) on clinical risk factors in patients undergoing major vascular surgery., Design: retrospective analysis., Materials: 2204 consecutive patients who underwent DSE (n=1093), DiSE (n=394), or DTS (n=717) testing before major vascular surgery were studied., Methods: primary endpoint was a composite of cardiac death and non-fatal myocardial infarction (MI). Logistic regression analysis was performed to evaluate the relation between cardiac risk factors, stress test results and the incidence of the composite endpoint., Results: there were 138 patients (6.3%) with cardiac death or MI. Patients with 0, 1-2, and 3 or more risk factors experienced respectively 3.0, 5.7 and 17.4% cardiac events. We found no statistically significant difference in the predictive value of a positive test result for DiSE and DSE (Odds ratio (OR) of 37.1 [95% CI, 8.1-170.1] vs 9.6 [95% CI, 4.9-18.4]; p=0.12), whereas a positive test result for DTS had significantly lower prognostic value (OR=1.95 [95% CI, 1.2-3.2])., Conclusion: a result of stress echocardiography effectively stratified patients into low- and high-risk groups for cardiac complications, irrespective of clinical risk profile. In contrast, the prognostic value of DTS results was more likely to be dependent on patients' clinical risk profile.

This study shows the usefulness of a small, portable hand-held echo ultrasound device for the screening for abdominal aortic aneurysms., (Copyright 2001 Harcourt Publishers Limited.)

Objectives: to compare end-to-side (ETS) and end-to-end (ETE) distal anastomoses. Design retrospective cohort study., Methods: retrospective cohort study. Between 1988 and 1992, 204 femoropopliteal bypasses (188 patients) were performed for claudication (55%), rest pain (22%) and tissue loss (23%). One hundred and eighteen ETS were compared with 86 ETE in terms of patency or a mean (range) follow-up of 68 (0.5-120) months., Results: overall patency was 86%, 66% and 57% at 1, 5 and 8 years, respectively. Multivariate analysis showed ETE anastomoses (p =0.04), and also knee bypass ( p =0.05) and venous conduit ( p =0.004) to be significantly associated with impaired patency., Conclusions: ETE may improve femoropopliteal bypass patency., (Copyright 2001 Harcourt Publishers Limited.)

Our objective was to investigate the preliminary use of endovascular stent-grafts for the treatment of femoropopliteal artery aneurysm. Ten patients with an aneurysm of the femoropopliteal artery referred for endovascular treatment were investigated. The series consisted of patients with a true aneurysm of the superficial femoral artery (n = 2); a true aneurysm of the popliteal artery (n = 4); an aneurysmal dilatation of a Biograft bypass (n = 2); a false aneurysm of the superficial femoral aneurysm (n = 1); and a false aneurysm of a composite bypass (n = 1). In 8 of the 10 patients the stent-graft was composed of one or more Palmaz stents sutured to an ePTFE tube graft; in the other 2 patients a venous covering was used in combination with Palmaz stents. The procedure was guided by angiography and intravascular ultrasound. The results of our investigation showed that endovascular stent-grafting of aneurysms of the femoropopliteal artery is a feasible but experimental technique that should be restricted to a selected group of patients.

Purpose: The purpose of this study was to assess the accuracy of intravascular ultrasound (IVUS) parameters of abdominal aortic aneurysm, used for endovascular grafting, in comparison with computed tomographic angiography (CTA)., Methods: This study was designed as a descriptive study. Between March 1997 and March 1998, 16 patients with abdominal aortic aneurysms were studied with angiography, IVUS (12.5 MHz), and CTA. The length of the aneurysm and the length and lumen diameter of the proximal and distal neck obtained with IVUS were compared with the data obtained with CTA. The measurements with IVUS were repeated by a second observer to assess the reproducibility. Tomographic IVUS images were reconstructed into a longitudinal format., Results: IVUS results identified 31 of 32 renal arteries and four of five accessory renal arteries. A comparison of the length measurements of the aneurysm and the proximal and distal neck obtained with IVUS and CTA revealed a correlation of 0.99 (P <.001), with a coefficient of variation of 9%. IVUS results tended to underestimate the length as compared with the CTA results (0.48 +/- 0.52 cm; P <.001). A comparison of the lumen diameter measurements of the proximal and distal neck derived from IVUS and CTA showed a correlation of 0.93 (P <.001), with a coefficient of variation of 9%. IVUS results tended to underestimate aneurysm neck diameter as compared with CTA results (0.68 +/- 1.76 mm; P =.006). Interobserver agreement of IVUS length and diameter measurements showed a good correlation (r = 1.0; P <.001), with coefficients of variation of 3% and 2%, respectively, and no significant differences (0.0 +/- 0.16 cm and 0.06 +/- 0.36 mm, respectively). The longitudinal IVUS images displayed the important vascular structures and improved the spatial insight in aneurysmal anatomy., Conclusion: Intravascular ultrasound scanning results provided accurate and reproducible measurements of abdominal aortic aneurysm. The longitudinal reconstruction of IVUS images provided additional knowledge on the anatomy of the aneurysm and its proximal and distal neck.

Background: For patients with critical limb ischaemia, spinal-cord stimulation has been advocated for the treatment of ischaemic pain and the prevention of amputation. We compared the efficacy of the addition of spinal-cord stimulation to best medical treatment in a randomised controlled trial., Methods: 120 patients with critical limb ischaemia not suitable for vascular reconstruction were randomly assigned either spinal-cord stimulation in addition to best medical treatment or best medical treatment alone. Primary outcomes were mortality and amputation. The primary endpoint was limb survival at 2 years., Findings: The mean (SD) age of the patients was 72.6 years (10.3). Median (IQR) follow-up was 605 days (244-1171). 40 (67%) of 60 patients in the spinal-cord-stimulator group and 41 (68%) of 60 patients in the standard group were alive at the end of the study, (p=0.96). There were 25 major amputations in the spinal-cord-stimulator group and 29 in the standard group, (p=0.47). The hazard ratio for survival at 2 years without major amputation in the spinal-cord stimulation group compared with the standard group was 0.96 (95% CI 0.61-1.51)., Interpretation: Spinal-cord-stimulation in addition to best medical care does not prevent amputation in patients with critical limb ischaemia.

Purpose: Subfascial division of incompetent perforating veins plays an important role in the surgical treatment of patients with venous ulceration of the lower leg. To minimize the high incidence of postoperative wound complications after open exploration, endoscopic approaches have recently been developed. We carried out a prospective, randomized comparison of open and endoscopic treatment of these patients that was aimed at ulcer healing and postoperative wound complications., Methods: Patients with current venous ulceration on the medial side of the lower leg were randomly allocated to open exploration by the modified Linton approach or endoscopic exploration by use of a mediastinoscope., Results: Thirty-nine patients were randomized, 19 to open exploration and 20 to endoscopic exploration. The incidence of wound infections after open exploration was 53%, compared with 0% in the endoscopic group (p < 0.001). Patients in the open group needed longer hospital stays (mean, 7 days; range, 3 to 39 days) than patients in the endoscopic group (mean, 4 days; range, 2 to 6 days; p = 0.001). Four months after operation, the ulcers of 17 patients (90%) in the open group and 17 patients (85%) in the endoscopic group had healed. During a mean follow-up of 21 months (range, 16 to 29 months), no recurrences were noticed in either group., Conclusions: Endoscopic division of incompetent perforating veins is equally as effective as open surgical exploration for the treatment of venous ulceration of the lower leg but leads to significantly fewer wound healing complications. Endoscopic division is therefore the preferred method.

Purpose: The purpose of this study was to investigate the efficacy of subfascial endoscopy by use of a mediastinoscope in the identification and ligation of incompetent perforating veins in patients with venous ulceration of the lower leg., Methods: All patients who underwent subfascial endoscopy for venous ulceration between Jan. 1, 1994, and Mar. 1, 1995, at the Sint Franciscus Gasthuis in Rotterdam underwent duplex ultrasound scans of the lower leg before and 6 weeks after operation. The number and localization of the perforating veins on the mediodorsal side were compared with the findings during subfascial endoscopy., Results: In 20 patients, preoperative duplex examination showed 46 incompetent and six competent perforating veins. During operation the site of 43 incompetent and all competent perforating veins was confirmed. Five additional perforating veins were found at operation (false-negatives). Postoperative duplex ultrasound scans showed six incompetent perforating veins (four persisting and two recurring perforating veins) in four patients, of which the ulcers did not heal in three. The ulcers of the other 17 patients healed., Conclusions: Subfascial endoscopy is an efficient technique in identifying incompetent perforating veins in patients with chronic ulceration of the lower leg. The persistence of incompetent perforating veins is related to failure of ulcer healing.

Purpose: Incompetent perforating veins play an important role in the etiologic mechanism of venous ulceration and recurrent varicose veins. The anatomic and functional status of the venous system can be evaluated by duplex ultrasonography. To determine the value of this technique in the identification of competent and incompetent perforating veins, a prospective study was performed., Methods: In patients who underwent subfascial exploration for venous ulceration of the lower leg, the preoperative findings of duplex ultrasonography were compared with the findings at surgical exploration., Results: In 20 consecutive patients, 42 incompetent and 8 competent perforating veins were detected by duplex ultrasonography. During operation the location of all 50 perforating veins appeared to be predicted correctly. Eleven additional perforating veins that had not been detected by duplex ultrasonography were found during operation. The sensitivity and specificity of duplex ultrasonography in predicting the site of perforating veins at the medial side of the lower leg in our study were 79.2% and 100%, respectively, for incompetent perforating veins and 82% and 100%, respectively, for competent and incompetent perforating veins., Conclusion: These figures indicate that duplex-guided local exploration of the lower leg in patients with venous ulceration as a result of incompetent perforating veins would miss a substantial number of perforating veins, possibly leading to incomplete healing or recurrent ulceration.

Objectives: To prospectively evaluate the incidence and consequences of residual arteriovenous (AV)-fistulae after "closed" in situ bypass grafting., Methods: In 34 patients, 35 "closed" in situ bypasses were performed. Postoperative assessment of residual AV-fistulae and bypass patency was performed with duplex scanning., Results: Postoperative mortality was 3%. During 35 "closed" in situ bypass procedures 216 side branches were coil embolised. Postoperatively 39 AV-fistulae were detected (15% of the total number of 216 + 39 = 255 side branches). Of these, 13 (5%) closed spontaneously. Fifteen (6%) remained unchanged and 11 (4%) were treated. In three patients four asymptomatic residual AV-fistulae were treated. In four patients seven symptomatic AV-fistulae were treated for: decreased distal bypass flow in one; persistent leg oedema in one; pain and redness of the skin in two. One-year primary patency was 80% (SE 8.4%). Residual AV-fistulae were detected in none of six bypass occlusions during follow-up., Conclusion: Residual AV-fistulae detected following "closed" in situ bypass grafting only need treatment if they are symptomatic, which is uncommon.

Objectives: The "closed" in situ bypass results in a reduction of wound complications compared to the "open" technique. This advantage is partly diminished by extra costs for the "closed" procedure and a larger percentage of residual arteriovenous (AV)-fistulae. This aim of this study was to analyse costs related to "closed" and "open" procedures., Methods: The cost affecting parameters: (1) duration of operation; (2) length of hospital stay; and (3) number of treated residual AV-fistulae, were analysed in a randomised group of 73 patients (35 "closed" and 38 "open") in two centres. In addition, costs of the operation, nursing care and treatment of AV-fistulae were analysed., Results: The "closed" and "open" group showed a median duration of operation of 210 min (range 105-570) and 154 min (range 90-355) (p < 0.05), length of hospital stay of 16 days (range 5-51) and 25 days (range 12-65) (p < 0.01), and a percentage of patients treated for residual AV-fistulae of 40% and 5%, respectively (p < 0.01). The median "closed" operation was US$798 more expensive than the "open". Median postoperative care was US$2664 less for the "closed" group. Mean estimated costs for treatment of AV-fistulae was US$9 in the "open" and US$167 in the "closed" group., Conclusion: The "closed" in situ vein bypass technique is cost-effective in comparison with the "open" technique.

Objectives: Review of the design of a clinical study to evaluate of the efficacy of epidural spinal cord electrical stimulation (ESES) as compared to best medical treatment in patients with nonreconstructible critical limb ischaemia., Design: Randomised controlled clinical trial of pragmatic type, which will be analysed according to the intention-to-treat principle. The treatment strategies are ESES, in addition to best medical treatment, and best medical treatment alone. Patients are followed-up for at least 18 months., Setting: The ESES-trial is an ongoing multicentre trial in 17 hospitals in The Netherlands., Patients: Patients with critical limb ischaemia, nonsuitable for either primary intervention or reintervention after failing reconstructions., Chief Outcome Measures: Limb survival, patient survival, quality of life and cost-effectiveness., Main Results: From November 1991 until May 1994 120 patients had been enrolled. Using life-table analysis, at one year 76% of these randomised patients were alive: 41% without amputation and 35% with amputation. Quality of life of the trial patients was low, even compared to other severely ill patient groups, such as liver and heart transplant candidates., Conclusions: Considering the high incidence of death and amputation, 18 months of follow-up seems adequate to detect a clinically relevant outcome improvement from ESES-treatment, if present. We hope to present the results of this study at the end of 1995.

Objective: This study investigates the potential role of intravascular ultrasound (IVUS) in the outcome in patients undergoing percutaneous transluminal angioplasty (PTA) of the superficial femoral artery., Materials: Angiographic and the qualitative and quantitative IVUS data obtained at the narrowest site derived from 39 patients before and after PTA were analysed., Results: Angiographically the diameter of the remaining stenosis seen after PTA was classified as < 50% in 31 patients (success); in eight patients a failure was encountered. Evaluating at 6 months the functional and anatomic results of the PTA in 31 patients, the intervention was a success in 14 patients (Group I) and a failure in 17 patients (Group II). The remaining eight patients defined as angiographic failure following PTA comprised Group III. Neither qualitative nor quantitative IVUS data obtained before PTA could predict outcome. Conversely, after PTA, the extent of dissection was significantly more severe in Groups II and III than in Group I. Similarly, significant differences were found between Groups I and II for mean free lumen area (13.2 vs. 9.7 mm2, respectively) and mean free lumen diameter (4.1 vs. 3.5 mm, respectively). Quantitative data obtained in Group II were similar to those in Group III., Conclusion: This preliminary study demonstrates that following PTA the extent of dissection, free lumen area and diameter seen with IVUS are predictive factors of patency. Future studies with more patients are mandatory to further highlight the sensitivity of these observations.

Objectives: This prospective randomised multicentre trial was conducted to test whether a new "closed" technique for in situ vein bypass would result in a lower frequency of wound complications, without negative effects on patency rates and without an intolerable increase in residual arteriovenous fistulae compared to the conventional "open" technique., Methods: We have developed a new "closed" technique using a co-axial catheter embolisation system for intra-operative coil embolisation of side branches, in order to avoid long incisions., Patients: In four centres and 95 patients, 97 in situ bypasses were performed: 47 "closed" and 50 "open". Randomisation was stratified for below knee femoropopliteal bypasses (60) and femorocrural bypasses (37). Indications were disabling intermittent claudication (29), restpain (26) or ulcers and/or necrosis (42)., Results: Postoperative mortality was 2% (one in the "closed", one in the "open" group). A total number of 16 (34%) wound complications (grade 1, 2 and 3) occurred in the closed group compared to 36 (72%) in the open group (p < 0.05). Deep wound complications (grade 2) occurred in six patients (13%) of the "closed" group, compared to 15 (30%) in the "open" group. In both groups, three patients (6%) developed deep wound complications including the bypass area (grade 3). In the "closed" group, 20 patients needed additional treatment for arteriovenous fistulae, compared to four in the "open" group. One-year patency rates did not show a statistically significant difference: primary patency rates were 65% and 61% and secondary patency rates were 86% and 76% respectively for the "closed" and "open" group., Conclusion: These results indicate that a "closed" technique reduces wound complication rate, without negative effects on the short term patency rates. The "closed" technique results in an increased number of postoperative treatments for residual arteriovenous fistulae.

Objective: To evaluate the feasibility of intravascular ultrasound imaging during femorodistal venous bypass procedures to assess qualitative and quantitative parameters of the greater saphenous vein and to detect potential causes for (re)stenosis and/or occlusion., Methods: Intravascular ultrasound data obtained from 15 patients were reviewed and compared with angiographic data., Results: Intravascular ultrasound enabled differentiation between normal and thickened vein wall. Venous side-branches could be located. Intact valves could be differentiated from valves disrupted by valve cutting. Patent anastomoses could be distinguished from anastomoses with some degree of obstruction. Intravascular ultrasound imaging of the inflow and outflow tracts revealed obstructive lesions, not evidenced angiographically. Quantitative analysis revealed that the median normal vein wall thickness (tunica intima and tunica media) was 0.25 mm (range 0.17-0.40 mm). The distinct vein wall thickening encountered in three patients measured 0.82, 0.95 and 1.06 mm, respectively, and was associated with narrowing in two patients. In five of 15 patients intravascular ultrasound findings altered surgical management., Conclusion: Intravascular ultrasound is able to assess qualitative and quantitative parameters of the venous bypass and has the potential to influence surgical management based on morphologic and quantitative data.

Objectives: Intraarterial pressure measurement is the most reliable method to assess haemodynamically significant stenoses in the aortoiliac tract. We have tried to develop a simple and quick, non-invasive method to assess stenoses of this type., Design: Prospective semi-blinded clinical study., Methods: It was postulated that a haemodynamically significant aortoiliac tract stenosis would result in a lesser degree of vascular resistance decrease after vasodilatation, compared to patients only suffering from femorodistal stenoses. We approximated vascular resistance by: (brachial pressure-ankle pressure)/femoral artery mean Doppler velocity. By dividing vascular resistance at rest by vascular resistance after exercise, we calculated the Resistance Change Ratio (RCR)., Patients and Results: In 34 patients (50 legs) with arterial stenoses, the pressure gradient over the aortoiliac segment was compared to the RCR. Legs were divided in three groups: group 1 consisted of 22 legs that showed a pressure gradient > 10 mmHg at rest; group 2 showed a pressure gradient > 10 mmHg after papaverine; group 3 showed a pressure gradient of 10 mmHg or less. The median RCR was: 0.74 (range: 0.23-4.04) for group 1, 0.71 (range: 0.36-1.80) for group 2 and 0.93 (range 0.36-2.06) for group 3. There was no significant difference between the groups (p = 0.19)., Conclusion: The RCR could not be used to accurately detect stenoses in the aortoiliac.

Objectives: To assess the technique of subfascial endoscopic ligation of incompetent perforatory veins by use of a mediastinoscope., Design: Prospective open clinic study., Setting: Two Departments of Surgery., Materials and Methods: Thirty-eight consecutive patients (40 legs) with recurrent or protracted venous ulceration of the lower leg were treated. Through a short, transverse incision of the skin and fascia in the proximal 1/3 of the lower leg a mediastinoscope (length 18 cm, diameter 12 mm) is inserted after which the perforating veins are ligated by haemoclips under direct vision., Main Results: All legs showed signs of incompetent perforating veins by clinical examination, confirmed with continuous wave ultrasonography and in 31 legs there was associated deep vein incompetence. Sixteen patients had active ulceration at the moment of operation and 22 had a history of recent or recurrent ulceration. One patient developed an inflammatory reaction at the wound and in two legs a subfascial infection occurred, necessitating surgical drainage. No postoperative mortality was seen. All 16 ulcers healed within 2 months (mean: 34 days; range: 21-55 days). During a mean follow-up of 3.9 (range: 2-5) years only one out of 38 patients (2.5%) developed a recurrent ulcer., Conclusions: Subfascial endoscopic ligation of incompetent perforating veins by use of a mediastinoscope is a relatively simple technique with a low postoperative complication rate and a low recurrent ulcer rate which makes it a valuable method for treating incompetent perforating veins.

Purpose: To compare the additional capacity of intravascular ultrasonography versus angiography to assess morphologic features and lumen dimension, 37 patients undergoing vascular intervention of the common iliac or superficial femoral artery were studied. A total of 181 ultrasonic cross sections were analyzed (94 before and 87 after intervention)., Methods and Results: Before intervention intravascular ultrasonography distinguished normal cross sections (n = 17) from cross sections with a lesion (n = 77): soft (51%) versus hard (31%) lesions, and eccentric (75%) versus concentric (7%) lesions. After intervention intravascular ultrasonography documented dissection (43%), plaque rupture (10%), and internal elastic lamina rupture (8%). A good correlation between ultrasonography and angiography was found for the recognition of eccentric or concentric lesions and dissections. The degree of stenosis was assessed semiquantitatively by visual estimation of the degree of luminal narrowing from the angiograms and intravascular ultrasonic images and was categorized into four classes: (1) normal, (2) less than 50% stenosis, (3) 50% to 90% stenosis, and (4) greater than 90% stenosis. Intravascular ultrasonographic assessment of stenosis was in agreement with angiography in 78% of cases and showed more severe lesions in 22% before intervention. Similar data were observed after intervention, with 72% of results being in agreement and 28% of cases showing more severe lesions. The degree of stenosis was also quantitatively evaluated by computer-aided analysis of the intravascular ultrasonic images. The semiquantitative analysis by intravascular ultrasonography corresponded well with the quantitative analysis done by the computer-aided system. When both echography and angiography suggested that arteries were normal, quantitative intravascular ultrasonography identified lesions that occupied an average of 18% of the cross-sectional area of the vessel., Conclusions: This in vivo study shows that intravascular ultrasonography is capable of documenting detailed morphologic features. Semiquantitative ultrasonic data correlate closely with those of angiography, albeit stenoses were assessed as more severe on ultrasonography.

Perioperative monitoring has demonstrated that administration of heparin on an empirical basis is associated with a wide variation in patient response and elimination rate. This problem may be overcome by intervention on the basis of perioperative monitoring or by using forms of heparin with different pharmacokinetic properties. When compared with unfractionated heparin, low-molecular-weight heparin has a higher bioavailability after subcutaneous administration, a linear clearance mechanism with a prolonged half-life, and is at least as effective in preventing postoperative vein thrombosis. Theoretically these characteristics of low-molecular-weight heparin could lead to more predictable levels of heparin activity. In this study we compared the pharmacokinetics of low-molecular-weight heparin and unfractionated heparin after an intravenous injection in patients undergoing aortic graft surgery. Heparin activity was measured before heparin administration and at 5, 20, 35, 50, 65, 80, 95, and 110 minutes after administration. The anti-Xa activity in the low-molecular-weight heparin group showed less variation and was more sustained when compared to the unfractionated heparin group. Fibrin degradation products were moderately correlated with the anti-factor Xa levels of the low-molecular-weight heparin group, but no correlation was found in the unfractionated heparin group. The anti-factor Xa activity of low-molecular-weight heparin was, in contrast to that of unfractionated heparin, not completely reversible by protamine administration. The blood loss was comparable in both groups. In contrast to what was expected, the pharmacokinetic profiles of low-molecular-weight heparin and unfractionated heparin showed a similarity after intravenous injection in patients undergoing aortobifemoral bypass grafting. Factors that could have influenced the pharmacokinetic behavior of heparin are discussed.