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Eugene, OR, United States

Rosenblatt P.,Mount Auburn Hospital | Schumacher J.,American Medical Systems Inc. | Lucente V.,Institute for Female Pelvic Medicine and Reconstructive Surgery | McNevin S.,Sacred Heart Medical Center | And 2 more authors.
Female Pelvic Medicine and Reconstructive Surgery | Year: 2014

Objectives: The TOPAS AMS pelvic floor repair system is a selffixating polypropylene mesh intended for use to reinforce soft tissues where weakness exists in the gynecological and gastroenterological anatomy. It is not available commercially in any country. This was a preliminary study conducted to obtain initial clinical experience with the TOPAS system for the treatment of fecal incontinence (FI) in women. Methods: This was a prospective study conducted at 5 centers in the United States. Women with FI who failed 1 or more conservative therapies were candidates for the study. Fecal incontinence was assessed with a bowel diary, Cleveland Clinic incontinence scores (CCISs), and Fecal Incontinence Quality of Life (FIQOL) questionnaires, and patients were followed prospectively up to 24 months. Treatment success was defined as a reduction in number of FI episodes of 50% or more compared with baseline. Results: A total of 29 women (mean age, 60.6 years) were implanted with the TOPAS system. Mean number of FI episodes per 14 days decreased from 6.9 at baseline to 3.5 at 24 months of follow-up, and the reduction was significant for the entire follow-up period compared with baseline (P G 0.001). A total of 55.6% of the subjects reported treatment success. The CCIS and FIQOL scores for all domains were significantly improved during the overall follow-up period compared with baseline (P G 0.001). The most common procedure and/or device-related adverse events were de novo urinary incontinence, including bladder spasms (n = 6), worsening FI (n = 2), and constipation (n = 2). No device-related erosions or extrusions were reported. Conclusions: Initial experience of the TOPAS system demonstrated a significant improvement in FI episodes, CCIS and FIQOL scores, and a benign safety profile. These results indicate that the TOPAS system has potential as a new therapeutic option for FI, but it needs to be confirmed in a larger study. Copyright © 2014 by Lippincott Williams & Wilkins. Source


Raabe R.D.,Sacred Heart Medical Center
Journal of Vascular and Interventional Radiology | Year: 2010

PURPOSE: This study retrospectively assesses whether significantly accelerating thrombolysis with ultrasound affects fibrinogen levels in the treatment of peripheral arterial occlusions. MATERIALS AND METHODS: Between December 2005 and August 2007, 38 limbs in 38 patients (17 women; mean age, 60.5 ± 19.7 years; age range, 17-94 years) were treated with ultrasound-accelerated thrombolysis for peripheral arterial occlusion (PAO) and deep vein thrombosis (DVT), with serum fibrinogen levels measured at baseline and every 24 hours. All occlusions were treated with alteplase (0.5-1.0 mg/h). RESULTS: Complete or partial lysis was achieved in 92.1% of patients. All patients received thrombolytic therapy with mean infusion time of 42.3 hours (range, 20-96 hours). As part of standard clinical practice, patients were not assessed angiographically overnight. Mean total alteplase dose was 40.6 mg (range, 18-96 mg). Across all patients, the fibrinogen level at the end of infusion decreased by an average of 18.5% from baseline, and no patient exhibited a fibrinogen level < 100 mg/dL during treatment. Fibrinogen depletion was more pronounced among patients with venous occlusions (26.4% from baseline) than those with arterial occlusions (15.8% from baseline). No major hemorrhagic complications occurred. One patient (2.6%) experienced a minor bleeding event at the access site, and use of thrombolytics was discontinued; and one patient with a chronic arterial occlusion and underlying coronary disease who did not respond to thrombolytic therapy, experienced an acute myocardial infarction. Of documented 30-day clinical outcomes in 20 patients, 80.0% remained patent at 30 days. CONCLUSIONS: Ultrasound-accelerated thrombolysis for the treatment of PAO and DVT is associated with a very low complication rate and nominal fibrinogen depletion. © 2010 SIR. Source


Wadie G.M.,Sacred Heart Medical Center | Moriarty K.P.,Pediatric Surgery
Pediatric Nephrology | Year: 2012

Vesicoureteral reflux (VUR) is a heterogeneous disease and its management remains one of the most controversial topics in pediatrics. Management options include surveillance, antibiotics, and surgery. The approval of dextranomer/hyaluronic acid (DHA) as a bulking agent by the Food and Drug Administration was followed by wide acceptance of endoscopic techniques as a major tool in the management of reflux. Pyelonephritis rather than VUR is the most common cause of kidney damage in children. It should be emphasized that the primary goal of diagnosing and treating VUR should be preventing this complication. There are no sufficient data in the literature to address the impact of the different treatment modalities on the incidence of febrile urinary tract infections (feb-UTIs) denoting pyelonephritis, with very few studies evaluating endoscopic treatment in light of this clear and well-defined outcome. The fact that we can correct the anatomy at the vesicoureteral junction with a simple and relatively safe outpatient procedure does not justify offering it to all patients. In this review, we attempt to critically evaluate the available literature pertaining to the impact of different treatment modalities on reducing the incidence of febrile UTIs and kidney damage, with a special emphasis on endoscopic treatment. © IPNA 2011. Source


Neill J.,University College London | Prvulovich E.M.,University College London | Fish M.B.,Sacred Heart Medical Center | Berman D.S.,Cedars Sinai Medical Center | And 9 more authors.
European Journal of Nuclear Medicine and Molecular Imaging | Year: 2013

Purpose: High-speed (HS) single-photon emission computed tomography (SPECT) with a recently developed solid-state camera shows comparable myocardial perfusion abnormalities to those seen in conventional SPECT. We aimed to compare HS and conventional SPECT images from multiple centres with coronary angiographic findings. Methods: The study included 50 patients who had sequential conventional SPECT and HS SPECT myocardial perfusion studies and coronary angiography within 3 months. Stress and rest perfusion images were visually analysed and scored semiquantitatively using a 17-segment model by two experienced blinded readers. Global and coronary territorial summed stress scores (SSS) and summed rest scores (SRS) were calculated. Global SSS ≥3 or coronary territorial SSS ≥2 was considered abnormal. In addition the total perfusion deficit (TPD) was automatically derived. TPD >5 % and coronary territorial TPD ≥3 % were defined as abnormal. Coronary angiograms were analysed for site and severity of coronary stenosis; ≥50 % was considered significant. Results: Of the 50 patients, 13 (26 %) had no stenosis, 22 (44 %) had single-vessel disease, 6 (12 %) had double-vessel disease and 9 (18 %) had triple-vessel disease. There was a good linear correlation between the visual global SSS and SRS (Spearman's ρ 0.897 and 0.866, respectively; p < 0.001). In relation to coronary angiography, the sensitivities, specificities and accuracies of HS SPECT and conventional SPECT by visual assessment were 92 % (35/38), 83 % (10/12) and 90 % (45/50) vs. 84 % (32/38), 50 % (6/12) and 76 % (38/50), respectively (p < 0.001). The sensitivities, specificities and accuracies of HS SPECT and conventional SPECT in relation to automated TPD assessment were 89 % (31/35), 57 % (8/14) and 80 % (39/49) vs. 86 % (31/36), 77 % (10/13) and 84 % (41/49), respectively. Conclusion: HS SPECT allows fast acquisition of myocardial perfusion images that correlate well with angiographic findings with overall accuracy by visual assessment better than conventional SPECT. Further assessment in a larger patient population may be needed to confirm this observation. © 2013 Springer-Verlag Berlin Heidelberg. Source


Saha S.A.,Sacred Heart Medical Center | Saha S.A.,University of Washington | Arora R.R.,The Chicago Medical School
International Journal of Cardiology | Year: 2010

Objective: Fibrates are thought to be useful anti-dyslipidemic agents particularly in patients with diabetes mellitus and dyslipidemia characterized by high triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) levels. We conducted a systematic review and meta-analysis of long-term randomized controlled trials to evaluate the role of fibrates in the prevention of cardiovascular events in patients with type 2 diabetes mellitus. Data sources: English-language journals indexed in Index Medicus/MEDLINE and the Cochrane Collaboration databases (through December 2007), unpublished data from selected clinical trials. Data extraction and analysis: A total of 11,590 patients from 6 published randomized placebo-controlled trials were analyzed using pooled meta-analysis techniques. Relative risks were computed for various cardiovascular outcomes and mortality, and statistical significance was tested using the z-test statistic (two-sided alpha error < 0.05). Results: The use of fibrates did not significantly affect the risk of all-cause mortality or cardiac mortality, and also did not affect the risk of stroke, unstable angina, or invasive coronary revascularization. However, the relative risk of non-fatal myocardial infarction was significantly reduced by about 21% (pooled relative risk 0.79, p = 0.006) with the use of fibrates. Conclusions: Long-term use of fibrates in patients with type 2 diabetes mellitus significantly reduces the risk of non-fatal myocardial infarction, but has no significant effect on mortality or on other adverse cardiovascular outcomes. © 2008 Elsevier Ireland Ltd. All rights reserved. Source

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