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Biomedical subjects

J Woody

Publications and source records attributed to J Woody.

At least 19 recordsLinked to original sources

Computed tomography assessment of abdominal aortic aneurysm morphology after endograft exclusion.

OBJECTIVES: Assessment of the long-term function of endografts to exclude abdominal aortic aneurysm (AAA) includes determination of aneurysm dimensions and morphologic changes that occur after implantation. This study reports the dimensional analysis of patients treated with AneuRx bifurcated endoprostheses with postintervention, 1-year (n = 51), 2-year (n = 28), and 3-year (n = 10) postimplantation contrast computed tomography data. METHODS: Maximal diameter (D) and cross-sectional area (CSA) of the AAA were measured from axial computed tomography images. Total volume, AAA thrombus volume (AAA volume minus the volume of the device and luminal blood flow), diameter of the aorta at the level of the renal arteries and within the device, distance from the renal arteries to the device, length of the device limbs, and the angle of the proximal neck were also determined at the same follow-up intervals after deployment with computed tomography angiograms reconstructed in an interactive environment. RESULTS: Fifty-one of 98 consecutively treated patients with the AneuRx bifurcated prosthesis (29 "stiff" and 22 "flexible" body devices) had complete data from the postprocedure and follow-up computed tomography studies available for analysis. Max D, CSA, total volume of the AAA, and AAA thrombus volume decreased sequentially from year to year compared with the postimplantation values. D and CSA decreased or were unchanged in all except four patients, two who had unrestricted enlargement of the aneurysm with eventual rupture and one who had surgical conversion for continued expansion despite four diagnostic angiograms and attempted embolizations. Total volume of the AAA increased in 11 of 51 patients at 1 year, eight of whom had endoleaks at some interval during the follow-up. Thrombus volume increased more than 5% in four of these patients, including the two with eventual rupture and the one conversion. Patients with endoleaks who had spontaneous thrombosis or were successfully treated either remained at the same volume or had decreased volume on subsequent examinations. D at the renal arteries increased an average of 0.9 mm during the first year, with a concomitant increase of 2.8 mm within the proximal end of the device related to the self-expanding nature of the Nitinol suprastructure. Subsequent enlargement of the proximal neck continued at a slow rate in some cases but never exceeded the diameter of the endoluminal device. The distance from the renal arteries to the device increased by an average of 3 mm over the first year, with the greatest increases occurring in patients with a "stiff" body device and those with rapid regression (>10% total volume) in 1 year. As regression of the AAA occurred, the angle of the proximal neck varied from -5 degrees to +25 degrees from the original alignment. Limb length varied from -8 mm to +10 mm, with no consistent pattern for the change, that is, ipsilateral or contralateral limb. CONCLUSION: Significant variation in the quantitation of aneurysm size occurs depending on the technique of computed tomography assessment used. In most patients diameter assessment is adequate, although volumetric analysis appears to be very helpful in certain patients who do not show aneurysm regression, or in whom the diameter increases or where endoleaks persist. Three-dimensional reconstruction and volumetric analysis are also useful to assess the mechanism by which the endovascular device accommodates to morphology changes and to determine criteria for reintervention.

Angiography↗

Endovascular exclusion of descending thoracic aortic aneurysms and chronic dissections: Initial clinical results with the AneuRx device.

OBJECTIVE: The objective of this study was to analyze a single-center experience in which descending thoracic aortic aneurysms (TAAs) were treated with a new self-expanding endovascular prosthesis (Medtronic AVE). METHODS: Twenty-six patients (13 men, 13 women) with American Society of Anesthesiology grades II to IV and ages ranging from 53 to 92 years (average, 74 years) consented as part of a Phase I Food and Drug Administration-approved trial. Treated lesions included TAAs that were 5 to 10 cm in diameter, 12 diffuse dilations or fusiform aneurysms, and four saccular aneurysms. There were also nine chronic dissections (2 aneurysmal dilations and 7 symptomatic acute recurrent dissections). Three patients (2 with diffuse/fusiform and 1 with dissection) presented with hemothorax, contrast extravasation, or both. RESULTS: Twenty-five of the 26 patients who consented (96% technical success) were treated successfully with no surgical conversions. Eighteen patients have been followed up from 1 to 22 months (average, 9 months). One patient is lost to follow-up, and six patients have died (24%). One procedure-related death (4%) occurred within the 30-day postoperative period and was caused by diffuse embolization. There were no device-related deaths. Five additional patients (20%) have died during the study of comorbid conditions. Complications included one massive myocardial infarction 24 hours after the procedure requiring balloon counterpulsation and long-term dialysis, one cardiac tamponade resulting from central line placement before the procedure, one progression of aneurysm dilation proximal to the device at 1 year, and one bilateral lower extremity paralysis occurring 12 hours after successful deployment. Seven patients (5 women) had femoral artery reconstructions or iliac artery grafts to repair injuries during deployment catheter passage. Other significant parameters included average procedure time (2 hours 40 minutes; range, 1 hour 30 minutes to 5 hours 30 minutes), 450 cc average blood loss (n = 25; 100-3000 cc) being replaced by means of autotransfusion with only two patients receiving banked blood products, and an average 2 days to resumption of normal diet, 1 day in the intensive care unit, and 5 days' hospitalization postprocedure in uncomplicated cases (n = 22). One patient had an endoleak immediately after the procedure that sealed without treatment. Follow-up of all patients ranging from 1 to 22 months (average, 9 months; n = 18) demonstrates continued exclusion of the aneurysm with no endoleaks and either stable or decreasing aneurysm volume, except in one patient with volume increase and no obvious etiology who continues to be investigated. CONCLUSIONS: The study suggests that endovascular prosthesis exclusion of TAAs with an AneuRx self-expanding tubular device may be effective in many patients who are at significant risk for open surgical repair and substantiates further clinical investigation to confirm these findings.

Aged↗

Abdominal pain and hemoperitoneum: sole presenting symptoms for "leaking AAA" after endovascular repair.

PURPOSE: To describe an unusual presentation of impending aortic endograft rupture and successful endovascular rescue. CASE REPORT: A 77-year-old man with an enlarging aortic aneurysm was treated with a Talent bifurcated endoprosthesis; a moderate endoleak that appeared to be related to either proximal or distal fixation sites was noted in the body of the aneurysm. The patient was observed for 1 month, and repeat imaging demonstrated persistent endoleak without major increase in the aneurysm diameter. Another examination was scheduled for 3 months hence, but, 2 months later, the patient presented with abdominal pain and a hemoperitoneum. A proximal extension cuff resolved the leak and led to resolution of the hemoperitoneum. CONCLUSIONS: A leaking aneurysm can be repaired using endovascular techniques in patients with an existing endograft. The need for frequent imaging surveillance of patients with endoleak is underscored.

Abdominal Pain↗

Failed AAA endograft exclusion due to type II endoleak: explant analysis.

PURPOSE: To report the patient history and analysis of an explanted modular bifurcated endograft that was implanted to exclude an abdominal aortic aneurysm (AAA). CASE REPORT: An 80-year-old man with a 6-cm AAA underwent uneventful endovascular implantation of a bifurcated AneuRx stent-graft. His postprocedural clinical course was uneventful, although persistent contrast enhancement of the aneurysm remained via the inferior mesenteric artery (IMA). By 6 months, an endoleak connecting to the lumbar and mesenteric arteries became apparent. Over the ensuing 12 months, the endoleak and aneurysm enlarged; branch artery embolization was attempted in 4 percutaneous procedures. Despite successful IMA occlusion, the aneurysm continued to increase in diameter and volume, necessitating conversion to a conventional bypass at 20 months. Analysis of the explanted specimen revealed an intact endograft with fibrous incorporation of the stent framework at the proximal and distal fixation sites only; no incorporation of the endograft was noted within the aneurysm. The feeding channel for the endoleak was not identified. CONCLUSIONS: Serial imaging is a vital component of endograft surveillance, and persistent type II endoleaks that cannot be completely embolized endanger the longevity of the aneurysm exclusion. Explant analysis can play an important role in understanding the mechanisms of endograft failure.

Aged↗

Treatment with a chimeric CD4 monoclonal antibody is associated with a relative loss of CD4+/CD45RA+ cells in patients with rheumatoid arthritis.

This study investigates immunogenicity and in vivo effects on T-cells of long-term CD4 monoclonal antibody treatment of patients with rheumatoid arthritis. Patients were treated with several dosage regimens of a chimeric CD4 monoclonal antibody entitled cM-T412 over the course of 1 year. The circulating CD4+ T-cell count sharply decreased after the first cM-T412 injection and slowly recovered after the last injection. Within the CD4+ subset there was a selective depletion of CD45RA+ T cells, HLA-DR+, and CD25+ cells, providing evidence that activated/memory CD4+ cells resist the effect of CD4 monoclonal antibodies. Studies on cytokine production by peripheral blood mononuclear cells cultures in vitro revealed no differential effect on the production of interleukin-4 compared to interferon-gamma, indicating that a shift from a Th1 to a Th2 lymphokine production profile was not achieved. Human anti-monoclonal antibodies (HAMA) were induced in a minority of the patients predominantly after the first treatment course. All the sera containing HAMA specifically inhibited the binding of cM-T412 to T-cells. However, HAMA formation does not interfere with the biological effect of repeated cM-T412 administration since the degree of CD4 depletion following repeated administration of cM-T412 to patients with and without blocking antibodies was similar. We conclude that the currently available data are of critical importance in the interpretation of the obtained clinical experience and for further development of this therapeutic strategy.

Adult↗

In vivo blockade of TNF-alpha by intravenous infusion of a chimeric monoclonal TNF-alpha antibody in patients with rheumatoid arthritis. Short term cellular and molecular effects.

Due to the unknown etiology of RA, specific treatment is not available. Recently, in a double-blinded, placebo-controlled clinical trial, in vivo blockade of TNF-alpha by a single infusion of a chimeric TNF-alpha-blocking mAb, cA2, has proven to be highly effective in the treatment of RA. In parallel to this trial, we tested the consequences of cA2 infusion in ex vivo and in vitro experiments. In this paper, we describe an increase in CD4+ and CD8+ T lymphocyte counts on day 1 and a marked decrease in monocyte counts preferentially on day 7 after cA2 treatment, without major changes in B lymphocyte or NK cell counts. In addition, we found an increased responsiveness of PBMC to CD28 mAb/PMA, but not to CD3 mAb, superantigen staphylococcus enterotoxin B, or PHA on day 1 after infusion. The increase in DNA synthesis of PBMC was paralleled by increased IL-2 mRNA and IL-4 mRNA expression and IL-2 protein secretion in culture supernatants after in vitro stimulation of PBMC with CD28 mAb/PMA. In PBMC, we did not find any significant changes in mRNA or protein expression of CD28 Ag or CD28 ligands, B7-1 and B7-2. Serum concentrations of IL-1 beta, IL-6, and soluble CD14 were significantly diminished after in vivo TNF-alpha blockade. We did not see relevant changes in granulocyte function in vitro after cA2 infusion. Finally, we observed a statistically significant decrease in slCAM-1 molecules in the serum of patients treated with verum compared with that in the serum of subjects given placebo. This change in slCAM-1 concentration was evident on days 1 and 7 after the infusion of 10 mg/kg cA2, whereas it occurred only on day 7 in the serum of patients treated with the low dose (1 mg/kg) of cA2.

Adult↗

Percentage of anti-CD4 monoclonal antibody-coated lymphocytes in the rheumatoid joint is associated with clinical improvement. Implications for the development of immunotherapeutic dosing regimens.

OBJECTIVE: We assessed the effect of a daily dosing schedule of the chimeric anti-CD4 monoclonal antibody (MAb), cM-T412, in rheumatoid arthritis (RA) patients, and compared lymphocyte changes in the peripheral blood (PB) and synovial fluid (SF) of these patients. METHODS: Twelve patients received 50 mg/day of cM-T412 for 5 days, followed by a maintenance treatment of 50 mg/week for 5 weeks (6 patients), or a retreatment course of 50 mg/day for 5 days after 5 weeks (6 patients). Paired PB and SF samples were obtained during treatment for analysis. RESULTS: Changes in lymphocyte count and coating with the MAb in PB did not reflect changes in the SF. After 5 daily treatments, the percentage of cM-T412-coated CD4+ lymphocytes in SF correlated with the degree of clinical improvement seen in patients at 2 weeks after the initiation of therapy (r = 0.75, P < 0.05). CONCLUSION: These results demonstrate the importance of antibody dosage and treatment regimen in determining clinical benefit. Our findings suggest that the percentage of cM-T412-coated CD4+ lymphocytes in SF may be a predictor of clinical outcome.

Adult↗

Treatment of Crohn's disease with anti-tumor necrosis factor chimeric monoclonal antibody (cA2).

BACKGROUND & AIMS: Increased concentrations of tumor necrosis factor (TNF), a potent proinflammatory cytokine, can be shown in the mucosa of patients with active Crohn's disease. Neutralization of TNF has been shown to decrease recruitment of inflammatory cells and granuloma formation in several animal models. The aim of this study was to investigate the safety and potential efficacy of an anti-TNF monoclonal antibody in the treatment of active Crohn's disease. METHODS: Ten patients with active Crohn's disease that was unresponsive to therapy were administered a single infusion of an anti-TNF human/mouse chimeric monoclonal antibody (cA2) in an open-label treatment protocol while the baseline anti-inflammatory therapy was continued. RESULTS: Eight patients showed normalization of Crohn's Disease Activity Index scores and healing of ulcerations as judged by colonoscopy within 4 weeks after treatment. One patient had a perforation after colonoscopy and recovered completely after surgery. One elderly patient showed a poor response. The average duration of response after a single infusion was 4 months. No adverse experiences related to cA2 were observed. CONCLUSIONS: The results support the hypothesis that TNF is of major importance in the pathogenesis of Crohn's disease. Treatment with cA2 was safe and may be useful in patients with Crohn's disease that is unresponsive to steroid treatment.

Adult↗

Efficacy of flexion and extension treatments incorporating braces for low-back pain patients with retrodisplacement, spondylolisthesis, or normal sagittal translation.

Radiographic instability seemingly enjoys the status of a well-defined clinical syndrome. The concept is widely used, and specific treatments, usually spinal fusion, are routinely performed based on the diagnosis. The minimum standards necessary to establish radiographic instability as a legitimate clinical syndrome have not been established, however. The primary purpose of this study was to determine if treatment involving bracing, exercise, and education controlling either flexion or extension postures, would result in a distinctive pattern of favorable or unfavorable results, depending on the type of radiographic instability (retrodisplacement or spondylolisthesis). Fifty-six patients meeting strict study inclusion and radiographic evaluation criteria were assigned signed to a bracing treatment (flexion, extension, placebo-control) according to a randomization scheme, designed to ensure equal representation of translation categories (retro, normal, spondy) across treatment groups, and assessed at admission and 1-month follow-up. The sample was relatively evenly divided between men (46%) and women (54%), and by age. Translation classification was related to both gender and age, with men more likely classified as retro and women more likely spondy and patients in their 20s having lower incidence of spondy and higher incidence of normal translation. Translation classification was not related to selected indices of low-back pain history. Brace treatments were not shown to reduce patient range of motion or lessen trunk strength. A significant treatment by time interaction for the modified pain interference (VAS) scale indicated improvement for patients in extension compared with patients in flexion and control-placebo treatments. In conjunction with no significant three-way interaction between treatment, translation classification, and time, it was hypothesized that radiographic instability might more appropriately be considered a corroborative sign of advanced discogenic problems. Improvement in extension treatment, regardless of the type of radiographic abnormality, suggests that the treating clinician might consider extension treatment for chronic low-back pain patients. Causes and implications for the failure of this study to provide support for considering radiographic instability as a clinical syndrome are considered and future directions for this area of research suggested.

Adult↗

Isolated L4-L5 fusions using the variable screw placement system: unilateral versus bilateral.

Thirty-six patients were retrospectively followed an average of 25.1 months to evaluate the relative effectiveness of unilateral (16 patients) versus bilateral (20 patients) variable screw placement (VSP) instrumentation in isolate L4-L5 fusions. Demographic variables and preoperative diagnoses were similar between treatment groups. Outcome was assessed primarily through evaluation of plain roentgenograms and self-report questionnaires. Use of VSP instrumentation at the L4-L5 level with autogenous posterolateral grafting achieved a successful fusion rate of 97% with minimal complications. Fusion results with unilateral instrumentation were nearly identical to those of bilateral; in both cases, results were better than most historical controls for noninstrumented fusions in situ. Clinical outcome, as obtained through standardized measurement techniques of pain and function, demonstrated 69% excellent and good results. Clinical outcome was similar between treatment groups yet was not significantly related to the fusion status obtained at follow-up.

Adult↗

Serological evidence of arboviral infections among humans of coastal Kenya.

A serosurvey was conducted during September 1987 for evidence of human arboviral infections in the Coast Province of Kenya. Sera were collected from 1624 outpatients at three hospitals and tested for antibody to eight arboviruses by the indirect immunofluorescent antibody technique. Antibody prevalence rates were: Rift Valley fever, 2.8%; Sindbis, 2.6%; dugbe, 2.1%; dengue-2, 1.0%; West Nile, 0.9%; chikungunya, 0.7% and Nairobi sheep disease, 0.3%. Evidence of Crimean-Congo haemorrhagic fever viral antibody was not detected. The data suggested low arbovirus activity since 1982, when an epidemic of dengue occurred in this region, and revealed the first evidence of dugbe viral infection among humans in Kenya.

Adolescent↗

The treatment and outcome of intracranial infections of otogenic origin.

Of 1321 patients with intracranial (IC) infection studied, the infection occurred as a direct result of middle ear disease in 36 (3%). The presenting clinical symptoms were those of diffuse meningeal irritation in 23 and of localized infection in the remaining 13. In the 23 patients with diffuse meningitis, the IC infection followed Acute Suppurative Otitis Media (ASOM) in only four and followed Chronic Suppurative Otitis Media (CSOM) in the remaining 19. Five of these 23 patients died soon after admission as their general condition was very severe. The final diagnosis in the 13 patients with localized meningeal inflammation was, brain abscess in seven, extradural abscess in four, lateral sinus thrombosis in two. All these patients underwent surgery, and except for one patient who died 3 days post-operative all recovered without sequelae.

Adolescent↗