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Currently available aortic stent-grafts require bilateral femoral incisions for device deployment. The incidence of morbidity (infection, lymphatic complications, breakdown) of vertical, infrainguinal incisions used in endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) was assessed, and the natural history of asymptomatic groin fluid collections following such procedures was determined. Between June 1999 and February 2001, 77 consecutive patients underwent EVAR for AAAs utilizing bilateral vertical femoral incisions. Fifty-nine (77%) bifurcated stent-grafts (BSGs), and 18 (23%) aortouniiliac (AUI) devices, with femorofemoral bypass were performed. Patients returned at 2 weeks, 1 month, and 6 months for physical examination, and 1 month and 6 months for abdominal and pelvic computed tomography (CT) scans. The presence of fluid collections was determined from the dictation report of the attending radiologist. Data are reported as (n) mean ± SE. Patient characteristics were compared using Fisher's exact test; p <0.05 considered significant. There were 72 males and 5 females, age 75 ±6.4 years and aneurysm size (77) 5.6 ±0.8 cm. There were no cases of wound breakdown or lymph fistula. Wound infections occurred in 3/150 incisions (2%), 2/34 AUI incisions (6%), and 1/1 16 BSG incisions (0.86%). There was no statistical difference (p =0.13) between graft types (BSG vs AUI). All infections were diagnosed clinically before the 1-month CT scan, treated without operative intervention or hospitalization, and resolved. There was a significant decrease in the BSG group and overall in asymptomatic wound fluid collections from 1 to 6 months postoperatively. At 1 and 6 months, respectively, the BSG group had 17 (14.6%) and 3 (2.6%) fluid collections out of 116 incisions (p = 0.003); the AUI group had 6 (17.6%) and 1 (2.9%) fluid collection(s) out of 34 incisions (p = 0. 13); and overall 23 (15.3%) and 4 (2.6%) out of 150 incisions (p = 0.004). The present study demonstrates that bilateral vertical femoral incisions used in EVAR have a wound infection rate of 2.0%. Infections are usually detected and treated clinically and empirically without the need for hospitalization or surgery. Asymptomatic groin wound fluid collections resolve significantly within 6 months without intervention. Therefore, surgical femoral artery exposure adds little morbidity to the endovascular repair of abdominal aortic aneurysms.

Purpose MDX-060 is a human anti-CD30 immunoglobulin (Ig) G1κ monoclonal antibody that inhibits growth of CD30-expressing tumor cells in preclinical models. To determine the safety, maximum-tolerated dose (MTD), and efficacy of MDX-060 in patients with relapsed or refractory CD30+ lymphomas, sequential phase I and II studies were performed. Patients and Methods In the phase I portion, MDX-060 was administered intravenously at doses of 0.1, 1, 5, or 10 mg/kg weekly for 4 weeks to cohorts of three to six patients. Twenty-one patients—16 with Hodgkin's lymphoma (HL), three with anaplastic large-cell lymphoma (ALCL), and two with CD30+ T-cell lymphoma—were enrolled. Because of the lack of a defined MTD or dose-response correlation, the phase II portion was amended to include several dose levels. In the phase II portion, an additional 51 patients, 47 with HL and four with ALCL, were treated at doses of 1, 5, 10, and 15 mg/kg. Results MDX-060 was well tolerated, and an MTD has not been identified. Only 7% of patients experienced grade 3 or 4 treatment-related adverse events. Among the 72 patients treated, clinical responses were observed in six. Twenty-five patients had stable disease, including five who remained free from progression 1 year after treatment. Conclusion MDX-060 was well tolerated at doses up to 15 mg/kg. MDX-060 has limited activity as a single agent, but the minimal toxicity observed and the significant proportion of patients with stable disease suggests that further study of MDX-060 in combination with other therapies is warranted.

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 EDrelevant 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.

The fitting of mathematical models to physiological sys tems can be tedious and difficult, whether one uses analog or digital computer methods. Both methods have their pros and cons depending on the available hardware and software and on the type of modeling. In recent years many digital simulation languages have been written com bining analog-like and digital features to facilitate model ing, but, for a variety of reasons, none of these was suit able for our applications. We, therefore, designed a new digital simulation control system, SIMCON, which is de scribed in this paper. The primary objectives were to provide: (1) Maximum man-machine interaction at run-time, in cluding visual displays, digital control, and both con tinuous analog and digital parameter adjustment (2) The ability to generate solutions and to fit them to experimental data or other theoretical curves with a minimum of computer memory (3) The option to use a mathematically oriented language, FORTRAN, and block operators with variable input/ output. The result is a relatively general and simple simulation system which is easy to use and has wide versatility.

AbstractBackgroundThe purpose of the present study was to compare surgical and endovascular revascularization for chronic mesenteric ischemia (CMI).MethodsForty‐nine patients underwent surgical (SG) or endovascular (EG) treatment. Relief of symptoms was considered the primary endpoint; patency, morbidity, and mortality were secondary endpoints. For statistical analysis, significance was assumed if P values ≤ 0.05.ResultsTwenty‐six patients (53%) underwent surgical revascularization; 23 patients (47%), endovascular repair. Mean follow‐up was 25 ± 21 months (SG) versus 10 ± 10 (EG) months (P = 0.07). Except for body mass indices (SG 18.9 ± 2.7 versus EG 23.6 ± 4.8; P = 0.001), preoperative data were comparable. Freedom from symptoms was 100% (SG) versus 90% (EG) after intervention (P = 0.194), and 89% (SG) versus 75% (EG) at the end of follow‐up. Reocclusion or re‐stenosis occurred in 8% (SG) versus 25% (EG) (log‐rank test: P = 0.003), and mesenteric ischemia developed in 0% (SG) versus 9% (EG) (P = 0.04). Reintervention for CMI was required in 0% (SG) versus 13% (EG) (P = 0.01). Surgical patients experienced more early complications (42% versus EG 4%; P = 0.02) and longer hospital stays (11.6 ± 10.9 days versus EG 1.3 ± 0.5 days; P < 0.001). Overall mortality at the end of follow‐up was 31% (SG) versus 4% (EG) (log‐rank test: P = 0.08), including all patients with combined open mesenteric and aortic reconstruction (P = 0.001).ConclusionsSurgical treatment has superior long‐term patency and requires fewer reinterventions, but it is also more invasive with greater morbidity and mortality compared to endovascular treatment. Endovascular techniques may be preferable in patients with significant co‐morbidities, concomitant aortic disease, or indeterminate symptoms.

If treatment-emergent central nervous system (CNS) symptoms following triptan therapy represent direct pharmacological effects of the drug, they should occur independent of response to active drug. However, if they represent unmasking of neurological symptoms of the migraine attack after pain is relieved, they should be more common in responders both to active drug and to placebo. To explore this issue, we evaluated the relationship between the CNS adverse events and treatment response following triptan or placebo treatment. We used pooled data from seven double-blind, placebo-controlled trials involving eletriptan 20 mg (E20, n = 402), eletriptan 40 mg (E40, n = 1870), eletriptan 80 mg (E80, n = 1393), sumatriptan 100 mg (S100, n = 275) and placebo (Pbo, n = 1024). Somnolence was more prevalent among 2 h headache responders than non-responders for all treatments, including E80 (8.8% vs. 5.0%; P < 0.05), E40 (6.4% vs. 5.0%; NS), E20 (4.0% vs. 2.0%; NS), S100 (4.7% vs. 3.2%; NS) and Pbo (7.6% vs. 3.0%; P < 0.05). Similarly, the incidence of asthenia was higher among patients who responded to treatment compared with those who did not respond to E80 (15.2% vs. 7.8%; P < 0.05), E40 (6.5% vs. 3.6%; P < 0.05), E20 (6.5% vs. 1.0%; P < 0.05), S100 (10.1% vs. 4.7%; NS) and Pbo (4.4% vs. 2.7%; NS). The generally higher rates of somnolence and asthenia in patients who respond to treatment suggests that these treatment-emergent neurological symptoms may represent the unmasking of CNS symptoms associated with the natural resolution of a migraine attack, rather than simply representing drug-related side-effects. The rate of somnolence in placebo responders is comparable to that in responders to E40 and E80, indicating that somnolence is related, at least in some important part, to headache relief and not treatment.

AbstractOutcomes for older adults with acute myelogenous leukemia (AML) are poor due to both disease and host-related factors. In this phase 2 study, we tested the oral farnesyltransferase inhibitor tipifarnib in 158 older adults with previously untreated, poor-risk AML. The median age was 74 years, and a majority of patients had antecedent myelodysplastic syndrome. Complete remission (CR) was achieved in 22 patients (14%); partial remission or hematologic improvement occurred in 15 patients, for an overall response rate of 23%. The median duration of CR was 7.3 months and the median survival of complete responders was 18 months. Adverse karyotype, age 75 years or older, and poor performance status correlated negatively with survival. Early death in the absence of progressive disease was rare, and drug-related nonhematologic serious adverse events were observed in 74 patients (47%). Inhibition of farnesylation of the surrogate protein HDJ-2 occurred in the large majority of marrow samples tested. Baseline levels of phosphorylated mitogen-activated protein kinase and AKT did not correlate with clinical response. Tipifarnib is active and well tolerated in older adults with poor-risk AML and may impart a survival advantage in those patients who experience a clinical response.