SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema.

INTRODUCTION: Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. METHODS AND ANALYSIS: A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. ETHICS AND DISSEMINATION: The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT05064176.

Evaluation of safety and performance of a new prototype self-expandable nitinol venous stent in an ovine model.

Objective: Our study was a prospective in vivo study performed on an animal model to evaluate the safety and performance of a novel venous stent designed specifically for venous applications. Methods: The novel stents were implanted in the inferior vena cava of nine sheep. The stents were deployed with different distances between the closed cell rings to test for if the segments might migrate after being deployed at maximal distance. Three different total lengths were 9, 11, and 13 cm. After 1, 3, and 6 months, vascular injury, thrombus, neointima coverage, and stent migration were evaluated through computed tomography venography and histopathology. Imaging, histology, and integration data were analyzed for each group. Results: All stents were deployed successfully, and all sheep survived until the time of harvesting. In all cases, the native blood vessel sections were intact. The segmented stent parts showed a differently pronounced tissue coverage, depending on the duration of the implantation. Conclusions: The new nitinol stent is safe and feasible to implant in the venous system with a rapid surface coverage. Alteration of stent length did not affect the development of neointimal formation and did not cause migration.

Early Disturbance of Lymphatic Transport as a Risk Factor for the Development of Breast-Cancer-Related Lymphedema.

INTRODUCTION: Breast-cancer-related lymphedema (BCRL) is a frequently occurring and debilitating condition. When lymphedema is diagnosed late, treatment can be expected to be less effective. Lymphofluoroscopy can provide details about the superficial lymphatic architecture and can detect an early disturbance of lymphatic transport (i.e., dermal backflow) before the lymphedema is clinically visible. The main objective of this study is to investigate whether this early disturbance of lymphatic transport visualized by lymphofluoroscopy is a risk factor for the development of BCRL. METHODOLOGY: All patients scheduled for unilateral breast cancer surgery with axillary lymph node dissection or sentinel node biopsy were considered. Patients were assessed at baseline and 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. During each visit, a clinical assessment was performed to determine the volume difference between both arms and hands (through circumference measurements and water displacement). Clinical BCRL was defined as a ≥5% increase in relative arm volume difference compared to the baseline value. Variables related to (1) the disturbance of lymphatic transport (through lymphofluoroscopy), (2) the demographics and general health of the patient and (3) the breast cancer and treatment of the patient were collected. RESULTS: We included data of 118 patients in the present study. Thirty-eight patients (39.8%) developed BCRL. Early disturbance of lymphatic transport was identified as a risk factor for the development of clinical BCRL (HR 2.808). Breast-cancer- and treatment-related variables such as axillary lymph node dissection (ALND) (HR 15.127), tumor stage (HR 1.745), mastectomy (HR 0.186), number of positive lymph nodes (HR 1.121), number of removed lymph nodes (HR 1.055), radiotherapy of the axilla (HR 2.715), adjuvant taxanes (HR 3.220) and postsurgical complications (HR 2.590) were identified as significant risk factors for the development of BCRL. In the multivariate analysis, age and ALND were withheld as independent risk factors for the development of BCRL. CONCLUSION: Lymphofluoroscopy can identify an early disturbance of lymphatic transport after breast cancer treatment. Patients with an early disturbance of lymphatic transport are considered to be a high-risk group for the development of BCRL. This study also confirms that age and ALND are predictors for the development of BCRL. Therefore, a surveillance program of these patients with lymphofluoroscopy could be useful to identify lymphedema in subclinical stages.

A prospective multicenter randomized clinical trial comparing endovenous laser ablation, using a 1470 nm diode laser in combination with a Tulip-TipTM fiber versus radiofrequency (Closure FAST™ VNUS®), in the treatment of primary varicose veins.

BACKGROUND: The treatment of chronic venous disease, has largely shifted from high ligation and stripping to endovenous thermal ablation (EVTA) techniques, because of its comparable efficacy and lack of invasiveness. This clinical trial aimed to compare the efficacy of two thermal ablation techniques, endovenous laser ablation (EVLA) 1470-nm with Tulip-TipTM fiber and radiofrequency ablation (RFA) ClosureFastTM using a non-inferiority design for occlusion rate (primary outcome). METHODS: A prospective multicenter randomized clinical trial randomized 280 patients for the treatment of great saphenous vein (GSV) reflux. Primary outcome was the GSV occlusion rate, secondary outcome factors were the possible side-effects of the treatment such as pain, ecchymosis, quality of Life (CIVIQ-20), revised Venous Clinical Severity Score (r-VCSS). One-year follow-up period. RESULTS: The total occlusion rates at one year follow-up were 96.4% and 94.5% in the EVLA and RFA groups respectively (P=0.15). Regarding secondary outcomes, such as postoperative CIVIQ-20, r-VCSS, analgesia, absenteeism, there was no significant difference between both treatment groups. CONCLUSIONS: RFA and EVLA, using a 1470 nm laser with Tulip-TipTM fiber, of the GSV results in equal occlusion rates at one year, with comparable postoperative pain and improved quality of life.

Relation Between Early Disturbance of lymphatic transport Visualized With Lymphofluoroscopy and Other Clinical Assessment Methods in Patients With Breast Cancer.

INTRODUCTION: Lymphedema of the upper extremity is one of the most feared complications following breast cancer treatment. Lymphofluoroscopy is a sensitive instrument for detection of lymphedema and visualization of superficial lymphatic transport, thus suitable for early detection. Early detection of lymphedema is important as it can prevent lymphedema to progress into more severe stages and minimalize impact on quality of life and medical costs. OBJECTIVE: To determine agreement between the presence of early disturbance of the lymphatic transport and outcome of clinical measurement tools evaluating the development of lymphedema. METHODS: A prospective study was conducted in 128 breast cancer patients scheduled for breast cancer surgery. Patients were evaluated before surgery and 1, 3-, 6-, 9-, and 12-months' post-surgery. Cohen's Kappa was used to determine agreement between presence of early disturbance in lymphatic transport and presence of pitting/increased skinfold thickness/increased Percentage Water Content ratio (PWC)/increased arm-hand volume (circumference measures and water displacement). RESULTS: For pitting status (Kappa 0.23), for skinfold thickness (Kappa 0.29) and the PWC ratio (Kappa 0.21) a minimal agreement was found. The circumference measurement had a minimal agreement for 5% volume difference (Kappa 0.22) and no agreement for 3% volume difference (Kappa 0.19). Sensitivity was weak for all clinical assessments. The specificity was excellent for pitting status, skinfold thickness, PWC ratio, and for 5% volume difference. For 3% a high specificity was found. CONCLUSION: The clinical tools assessed in this study were not able to predict an early disturbance of the lymphatic transport seen on lymphofluoroscopy.

Impact of a compression garment, on top of the usual care, in patients with breast cancer with early disturbance of the lymphatic transport: protocol of a randomised controlled trial.

INTRODUCTION: Breast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible.The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated. METHODOLOGY: All patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven are being considered. Patients are assessed before surgery and at 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. At each visit, a clinical assessment is performed determining the volume difference between both arms and hands (through circumference measurements and water displacement), the water content, the extracellular fluid, the pitting status and the skinfold thickness. Quality of life questionnaires are filled in. At each visit, a lymphofluoroscopy is performed as well. When a disturbance of the lymphatic transport is seen on lymphofluoroscopy, without the presence of clinical lymphoedema, the patient is randomised in either a control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove). ETHICS AND DISSEMINATION: The trial is conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. This protocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses. TRIAL REGISTRATION NUMBER: NCT03210311 CONCLUSION: The investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance.

The influence of gender on patency rates after iliac artery stenting.

OBJECTIVE: The purpose of this study was to investigate the influence of gender on the long-term outcome after iliac artery stenting and to assess gender-specific differences of the influence of risk factors on treatment success and patency rates. METHODS: Between January 2000 and December 2006, 404 percutaneous transluminal angioplasties with primary stent deployment for symptomatic iliac artery occlusive disease were performed at our center. These included 128 interventions in women and 276 interventions in men. RESULTS: Whereas average age was significantly higher (65.9 ± 12.9 years; P = .007) and arterial hypertension more frequent (60.9% vs 49.3%; P = .032) in women, hyperuricemia (7.0% vs 14.1%; P = .047) and a positive smoking status (61.7% vs 74.3%; P = .014) were more frequently observed in men. Fontaine stage was more advanced (stages III and IV) in women than in men (P = .028; P < .001). Technical success was 97.7% in women and 99.3% in men. Overall complication rate was higher in women compared with men (P = .002), mostly caused by access site hematomas (4.7% vs 0.4%) and pseudoaneurysms (8.6% vs 2.5%). Patients were followed up for 45.0 ± 33.3 months. Restenosis developed in 16.8% of cases in women and in 14.6% of cases in men and was treated in 73.7% by an endovascular approach. Primary patency rates at 1, 3, 5, and 7 years were 90.3%, 77.2%, 60.2%, and 46.4% in women and 89.9%, 71.5%, 63.6%, and 59.7% in men, respectively (P = .524; log-rank, .406). Secondary patency rates were 97.2%, 91%, 81.5%, and 70.3% in women and 97.1%, 89.1%, 82.6%, and 78% in men, respectively (P = .959; log-rank, .003). Multivariate analysis identified lower age as the only independent risk factor for recurrent disease in both groups. Age-defined subgroup analysis showed a restenosis/reocclusion rate of 23.9% in men and 22.1% in women older than 63.5 years (P = .861) but 32.1% in men and 49.1% in women younger than that (P = .034). CONCLUSIONS: Our data suggest that although women are older and present with a more advanced stage of peripheral arterial occlusive disease, endovascular therapy is equally effective irrespective of gender. Surprisingly, the subgroup of young female patients had a specifically poor outcome.

Endovascular repair of isolated iliac artery aneurysms.

PURPOSE: To retrospectively evaluate a 12-year experience with endovascular repair of isolated iliac artery aneurysm (IAA). METHODS: From August 1997 through July 2009, 91 patients (81 men; mean age 71 years, range 31-90) underwent endovascular treatment for isolated IAA at our department. Of these, 77 patients received stent-grafts either alone or in combination with coils or an Amplatzer vascular plug (n = 2); 1 patient received a Smart stent combined with coils, and 13 patients were treated with coil embolization only. The aneurysms were classified according to location: type I = common iliac artery (CIA), type II = internal iliac artery (IIA), type III = CIA and IIA, and type IV = external iliac artery with/without CIA and/or IIA involvement. RESULTS: Primary technical success was 90.1% for all aneurysm types and 93.6%, 80%, 88.8%, and 93.3% for types I, II, III, and IV, respectively. Secondary technical success was 96.7% for all types and 97.8%, 95%, 100%, and 93.3%, respectively, for each type. Clinical success was 93.4% for all types and 97.8%, 85%, 100%, and 86.7%, respectively, by type. Complications in 18 (19.8%) patients included 7 type I endoleaks, 3 type II endoleaks, 2 enlarged aneurysm sacs (incomplete embolization), 5 cases of buttock claudication, and 2 stent-graft thromboses. Two patients were converted to open surgery; 10 underwent secondary interventions. Mortality rates were 1.1% (n = 1) at 30 death days and 23.1% (n = 21) over a mean follow-up of 45.9 months (no aneurysm-related death). Cumulative overall survival was 97.7% at 1 year and 47.6% at 10 years. Freedom from aneurysm-related complications was 88.6% at 1 year and 83.5% at 5 years. CONCLUSION: Endovascular repair of isolated IAA is a safe and minimally invasive alternative to surgery. However, it may be associated with several complications and must, therefore, be carefully planned.

Effect of the dual endothelin receptor antagonist bosentan on Raynaud's phenomenon secondary to systemic sclerosis: a double-blind prospective, randomized, placebo-controlled pilot study.

OBJECTIVE: To investigate the efficacy of the endothelin receptor antagonist, bosentan, in patients with RP secondary to SSc without pre-existing digital ulcers. METHODS: Single-centre, randomized, prospective, double-blinded comparison of bosentan and placebo. Patients received either 62.5 mg bosentan twice daily for 4 weeks, followed by 125 mg twice daily for 12 weeks or matching doses of placebo. RESULTS: Of the 17 patients enrolled, 16 completed the study and 1 withdrew from the study due to the reversible development of peripheral oedema. Compared with placebo, bosentan did not improve the frequency, duration, pain or severity of RP attacks. However, in contrast to placebo, bosentan significantly improved the functional scores. With respect to baseline, the scleroderma HAQ disability index changes were in favour of bosentan at Weeks 12 (P = 0.03) and 20 (P = 0.01), and the United Kingdom functional score changes at Weeks 8 (P = 0.038) and 16 (P = 0.039). CONCLUSIONS: Bosentan is not effective in SSc-related RP without pre-existing digital ulcers, but it might benefit functional impairment in those patients. TRIAL REGISTRATION: European Union Drug Regulating Authorities Clinical Trials, https://eudract.emea.europa.eu, EudraCT-Nr 2004-002686-21.

Evaluation of volumetric measurements in patients with acute type B aortic dissection--thoracic endovascular aortic repair (TEVAR) vs conservative.

OBJECTIVE: The aim of this retrospective study was to evaluate aortic volume changes in patients with acute type B aortic dissection (TBD), treated either by thoracic endovascular aortic repair (TEVAR) or conservatively. MATERIALS AND METHODS: From July 1996 through March 2008, 76 patients presenting with acute TBD were referred to our department. To ensure a follow-up of at least 24 months, only 64 of them were included in the present study, with the cut-off for inclusion being March 2006. Twenty-nine of these patients underwent TEVAR and 35 patients underwent conservative treatment. Indications for TEVAR were life-threatening symptoms. Follow-up was performed postinterventionally in patients after TEVAR and at 3, 6, and 12 months, and yearly thereafter in both groups. It included clinical examinations, computed tomography (CT) scans, analysis of volume changes in true thoracic lumen (TTL), false thoracic lumen (FTL), thoracic lumen (TL), abdominal lumen (AL), and aortic diameter measurements. In addition, the extent of thrombosis and its influence on volume changes were assessed. RESULTS: Mean follow-up was 41 months after TEVAR and 46 months in the conservatively-treated patients. At 60 months, cumulative rates of freedom from dissection-related death and rupture-free survival were 82.6% and 93.1% in the TEVAR group, respectively. They were 74.9% and 88.5% in the conservatively-treated group, respectively. In the conservatively-treated patients, 3 patients died of late aortic rupture, 4 were converted to open surgery, and 2 to TEVAR. Evaluation of volume changes showed better results in the TEVAR group within 24 months. However, within 60 months the difference between the two groups was no longer relevant. Relating to thrombosis of the FTL, analyses showed slightly better overall results and promotion of thrombus formation after TEVAR. However, at 60 months the results showed a tendency towards approximation between the two groups. CONCLUSION: Our data suggest that TEVAR seems to delay the natural course of the disease but not to stop it.

Evaluation of subclinical cerebral injury and neuropsychologic function in patients undergoing carotid endarterectomy.

We examined subclinical alterations of cerebral function during carotid endarterectomy (CEA) and predictability of minor cerebral damage by perioperative levels of biochemical markers of brain damage (S100B and neuron-specific enolase [NSE]). Twenty consecutive patients with > or =70% asymptomatic carotid stenosis undergoing elective CEA were enrolled. Pre- and postoperative testing included magnetic resonance imaging (MRI) of the head, a standardized neurological exam, a battery of neuropsychological tests, and measurement of serum levels of S100B and NSE. There were no major ischemic strokes. In one patient, a mild weakness of the contralateral lower extremity was discovered on neurological examination; in another individual, postoperative MRI revealed two new small subcortical lesions without clinical correlate. While S100B increased significantly early after opening of the carotid clamp (p = 0.015), the NSE increase did not reach statistical significance. As a group, participants obtained a significantly higher mean overall neuropsychological score at follow-up testing (p < 0.05). In one patient, a significant decline of cognitive function was observed. This was the only individual to obtain a consistently high S100B and NSE increase. Neuropsychological testing combined with measurements of S100B and NSE may improve sensitivity when assessing subtle cerebral damage following CEA.

Endovascular repair of acute type B aortic dissection: midterm results.

PURPOSE: To evaluate midterm results of endovascular stent-graft placement for acute Stanford type B dissection (TBD). METHODS: A retrospective review was conducted of 35 consecutive patients who were treated with stent-graft implantation for acute TBD between July 1996 and July 2007. Computed tomographic (CT) volumetric analysis of the true lumen (TL) and false lumen (FL) changes in 23 patients was performed, as well as evaluation of the influence of re-entry points and length of stent-graft coverage on volume changes. In addition, complications were evaluated. Follow-up was performed at 6 and 12 months and yearly thereafter. RESULTS: The technical success rate was 82.7%, and the 30-day mortality rate was 8.5%. Mean follow-up was 34 months. The overall survival rate at 5 years was 78.4%. Complications included retrograde type A dissections in 3 patients during the perioperative period and in 1 patient during midterm follow-up. In addition, 5 early and 3 late endoleaks were observed. Three patients were converted to open surgery and 2 needed secondary interventions. In the stented segment, stabilization of the aorta was achieved even during midterm follow-up, with a TL volume increase of 59% at 5 years and nearly stable FL volume. The segment from the distal end of the stent-graft to the celiac artery, however, showed unstable TL and FL volumes, with high standard deviations after the first postinterventional year and circumferential aneurysmal dilatation of the aorta immediately adjacent to the stent-graft in 5 patients. The abdominal aorta showed no substantial volume changes over time. The length of stent-graft coverage and the occurrence of re-entries greatly influenced FL volume changes distal to the stent-graft. CONCLUSION: Serious complications can occur during and after endovascular repair of TBD. Therefore, it should be reserved for high-risk patients.

Natural history of the iliac arteries after endovascular abdominal aortic aneurysm repair and suitability of ectatic iliac arteries as a distal sealing zone.

PURPOSE: To investigate the natural history of dilated common iliac arteries (CIA) exposed to pulsatile blood flow after endovascular abdominal aortic aneurysm repair (EVAR) and the suitability of ectatic iliac arteries as sealing zones using flared iliac limbs. METHODS: Follow-up computed tomograms of 102 CIAs in 60 EVAR patients were investigated. Diameter changes in CIAs < or =16 mm (group 1) were compared with changes in vessels where a dilated segment >16 mm in diameter continued to be exposed to pulsatile blood flow (group 2). Within group 2, cases in which the stent terminated proximal to the dilated artery segment (2a) were compared with those that had been treated with a flared limb (2b). RESULTS: The mean CIA diameter increased by 1.0+/-1.0 mm in group 1 (p<0.001 versus immediately after EVAR) and by 1.5+/-1.7 mm in group 2 (p<0.001 versus immediately after EVAR) within an average follow-up of 43.6+/-18.0 months. Diameter increase was more pronounced in dilated CIAs (p=0.048), and it was not significantly different between groups 2a and 2b (p=0.188). No late distal type I endoleak or stent-graft migration associated with CIA ectasia was observed. CONCLUSION: Dilatation of the CIA is significant after EVAR, and it is more pronounced in ectatic iliac arteries. Although ectatic iliac arteries appear to be suitable sealing zones in the short term, continued follow-up is mandatory.

Unusual etiology of upper extremity ischemia in a scleroderma patient: thoracic outlet syndrome with arterial embolization.

Although the causes of digital ischemia and necrosis are diverse in women, the most common etiology is connective tissue disease. We describe a patient with scleroderma who presented with arm ischemia secondary to arterial embolization from thoracic outlet syndrome. Her sublavian artery was compressed by the anterior scalene muscle and a cervical rib, leading to a stenosis with poststenotic dilation of the artery. Within the aneurysmal formation was a thrombus, which was probably the source of the distal embolization. The patient underwent surgical resection of the cervical and first rib. The abnormal portion of the subclavian artery was resected and replaced with an interposition graft.

Impact of gender on the outcome of endovascular aortic aneurysm repair using the Zenith stent-graft: midterm results.

PURPOSE: To analyze the 2-year outcomes of female patients after endovascular aortic aneurysm repair (EVAR) with the Zenith AAA Endovascular Graft. METHODS: A retrospective analysis was conducted of data from the US Zenith multicenter trial and the Zenith female registry on 40 women (10.9%, study group) and 326 men (89.1%, control group) enrolled. All patients had completed their 2-year follow-up. Primary study endpoints were survival, aneurysm rupture, and conversion rate. Significance was assumed if p<0.05. RESULTS: Overall rates of mortality (12.5% for women versus 13.2% for men, p = 0.94) and aneurysm rupture (2.5% for women versus 0% for men, p = 0.11) were comparable between groups. Conversion to open repair within 2 years was significantly more frequent in women compared to men (7.5% versus 0.6%, p = 0.01). The incidence of endoleaks of any type was equivalent between groups at 2 years (13.3% for women versus 6.9% for men, p = 0.30). No difference was observed in the need for secondary interventions (15% for women versus 13.5% for men, p = 0.81) or aneurysm dilatation >5 mm (10.5% for women versus 2.3% for men, p = 0.10). None of the patients developed device migration >10 mm or required intervention for migration. CONCLUSION: While women underwent conversion to open repair more frequently compared to men at 2 years post EVAR, there was no difference in survival, freedom from aneurysm rupture, or need for secondary interventions between groups. As in men, the Zenith AAA Endovascular Graft provides reliable protection from aneurysm rupture and aneurysm-related death in women in a midterm follow-up.

Abdominal aortic aneurysm neck remodeling after open aneurysm repair.

PURPOSE: Proximal endovascular aortic graft fixation and maintenance of hemostatic seal depends on the long-term stability of the aortic neck. Previous investigations of aortic neck dilation mostly focused on the infrarenal aortic diameter. Fenestrated and branched stent grafts facilitate suprarenal graft fixation and may thereby improve the long-term integrity of the aortic attachment site. For these devices, the natural history of the suprarenal aortic segment is also of interest. We investigated the natural history of the supra- and infrarenal aortic segment after open abdominal aortic aneurysm (AAA) repair. METHODS: For this retrospective analysis, we reviewed the preoperative and the initial postoperative as well as the most recent CT series that were obtained from 52 patients undergoing conventional repair of an infrarenal abdominal aortic aneurysm between January 1998 and December 2002. Measurements were performed using electronic calipers on a "split screen", allowing direct comparison of subsequent CT series at corresponding levels along the vessel. Main outcome measures were changes in postoperative measures of the supra- and infrarenal aortic diameters. RESULTS: The first postoperative exam was at a mean (+/-SD) of 7.0 +/- 3.5 months, and the final exams were at 44.4 +/- 21 months. Over this time period, the estimated rate of change in suprarenal diameter was 0.18 mm/ y with 95% confidence interval (CI) from 0.08 to 0.27. The estimated rate of change for the infrarenal diameter was 0.16 (95% CI: 0.05 to 0.27). A clinically relevant diameter increase of >or=3 mm was observed in seven patients (13%). There was evidence of larger diameter increases associated with larger AAA diameters (P = .003 and <.001 for suprarenal and infrarenal diameters), an inverted funnel shape (P = .002 and <.001), and marginal evidence of association with a history of inguinal hernia (P = .043 and .066). CONCLUSIONS: Although there is statistically significant evidence of increases in the supra- and infrarenal aortic diameters after conventional AAA repair, mean annual increases tended to be small and clinically relevant increases of 3 mm or more were observed in only a small proportion of cases.

Prevalence of erectile dysfunction in vascular surgery patients.

Erectile dysfunction (ED) is frequently associated with cardiovascular disease. Epidemiological data on the frequency of ED in vascular surgery patients is rarely reported. We evaluated the prevalence of this comorbidity in patients consulting the vascular surgery outpatient clinic. Over a 6-month period, a short version of the International Index of Erectile Function (IIEF) questionnaire consisting of six ED-relevant questions was handed out to 440 vascular surgery outpatients. Clinical data were collected from patients' records. Linear regression models with forward selection were used to investigate associations between erectile function score and possible risk factors. The return rate was 31% (137 patients). Eight patients (6%) were taking phosphodiesterase inhibitors. ED, as defined by an erectile function score of 25 or less and/or use of phosphodiesterase inhibitors, was found in 90% (95% CI: 84% to 95%) of cases. Moderate or severe ED, as defined by an erectile function score of 16 or less and/or use of phosphodiesterase inhibitors, was found in 70% (95% CI: 62% to 78%) of cases. Increased age, abdominal aortic aneurysm, peripheral arterial disease, urologic disease, insulin-dependent diabetes mellitus, and use of beta-blockers were significantly associated with a lower erectile function score. In conclusion, erectile dysfunction is a frequent and often missed comorbidity in vascular surgery patients. While ED may have a profound impact on the patient's quality of life, attention should also be paid to the patient's preoperative sexual function, considering the availability of oral pharmacotherapies and possible consequences concerning liability in postoperative patients in whom pre-existing ED was not identified properly.

Effect of age and gender on restenosis after carotid endarterectomy.

Several studies have suggested that the benefits of CEA may be gender-dependent. The purpose of this study was to focus on age and gender outcomes after CEA. Three hundred seventy-two CEAs were performed in 344 patients (115 females, 229 males; mean age 72.9 years). Mean follow-up was 25.8 months. Data were collected retrospectively by chart review, and follow-up data were obtained by clinical examination and duplex ultrasound. Recurrent stenosis was defined as >50% and/or occlusion. Three hundred and seventy-two CEAs were performed in 120 female and 252 male carotid arteries: 97.3% of patients underwent patch angioplasty (bovine pericardium 71.5%, Dacron 21.8%, vein 3.8%, and polytetrafluoroethylene 0.3%) and 2.7% of patients underwent eversion endarterectomy. Perioperative mortality rate (30-day) was 0.8% (0% of females vs. 1.2% of males), and stroke rate was 0.5% (1.7% of females vs. 0% of males), with no significant gender difference (p = 0.554 and p = 0.103, respectively). Follow-up ultrasound revealed 21 (7%) restenoses (>50%) and/or occlusions, with a significantly higher rate of restenosis in females (14% vs. 3.9% in males, p = 0.008) and in patients <70 years of age at time of surgery (p = 0.003). There was no age difference between women and men with restenosis. Although there was no statistical difference in occurrence of restenosis between Dacron and bovine patch (p = 0.62), females who underwent patch angioplasty with Dacron were more likely to develop restenosis (p = 0.052). CEA is a low-risk procedure for significant carotid stenosis; however, females are more likely to develop restenosis after carotid surgery, especially with Dacron patches. Younger patients appear to be at a higher risk of restenosis after surgery.