Phillips F.M.,Rush University Medical Center |
Lee J.Y.B.,Rush University Medical Center |
Geisler F.H.,Chicago Back Institute |
Cappuccino A.,Buffalo Spine Surgery |
And 6 more authors.
Spine | Year: 2013
Study Design.: Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial. Objective.: To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1. Summary of Background Data.: Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series. The PCM Cervical Disc is a nonconstrained motion-sparing alternative to ACDF. Methods.: Patients 18 to 65 years of age with single-level symptomatic cervical spondylosis with radiculopathy and/or myelopathy unresponsive to nonoperative treatment were enrolled, including patients with prior nonadjacent or adjacent single-level fusions. The per-protocol patient sample at 2 years included 342 patients (189 PCM, 153 ACDF). Longitudinal outcomes were comparatively evaluated. Results.: At 2 years postoperatively, clinical measures-neck and arm pain visual analogue scale, Neck Disability Index (NDI), SF-36, and neurological status-were significantly improved from preoperative baselines in both groups. Mean NDI score at 2 years was significantly lower in PCM group (P = 0.029). There were no statistical differences between groups in rates of surgery-related serious adverse events (5.6% PCM, 7.4% ACDF) or secondary surgical procedures (5.2% PCM, 5.4% ACDF). Patients with PCM reported lower dysphagia scores (8.8/100 vs. 12.1/100; P = 0.045) and higher patient satisfaction (82.8/100 vs. 81.4/100). Overall success, a composite endpoint including minimum 20% NDI improvement, no major complications, no neurological worsening, no secondary surgical procedures, and meeting radiographical criteria of motion for PCM and fusion for ACDF, was significantly greater in the PCM group (75.1% vs. 64.9%; P = 0.020). Conclusion.: The treatment of symptomatic single-level cervical spondylosis with PCM achieves clinical outcomes that are at least equivalent to ACDF while maintaining motion. At 2 years, patients with PCM had lower NDI scores, statistically lower rate of prolonged dysphagia, greater patient satisfaction, and superior overall success. Copyright © 2013 Lippincott Williams & Wilkins.
Nair N.,Scott and White Hospital |
Nair N.,Texas A&M University |
Nair N.,Scott and White Memorial Hospital |
Ball T.,Texas A&M University |
And 2 more authors.
Journal of Heart and Lung Transplantation | Year: 2011
Antibody-mediated rejection (AMR) continues to present a challenge for the survival of the cardiac allograft. AMR appears to be on the rise, likely secondary to changing trends in clinical practice, including selection of patients for transplantation on mechanical circulatory support and development of more effective combinations of immunosuppressive drugs against acute cellular rejection. Most current strategies are aimed at treating acute AMR, but the treatment of chronic AMR is still not well defined. Clinically, AMR can often be more severe than cellular rejection and more difficult to treat, often not responding to typical protocols of increased immunosuppression. Complex steps involved in the antibody response allows for several potential targets for therapeutic intervention, including suppression of T and B cells, elimination of circulating antibodies, and inhibition of residual antibodies. Existing evidence suggests a multiregimen approach is the best option. Sustenance of accommodation and induction of tolerance could be viewed as viable options if adequate immune surveillance can be achieved in this setting. This review discusses the challenges in treating AMR and provides a critical analysis of current and possible future therapies. © 2011 International Society for Heart and Lung Transplantation. All rights reserved.
Pham C.D.,Centers for Disease Control and Prevention |
Purfield A.E.,Centers for Disease Control and Prevention |
Fader R.,Scott and White Hospital |
Lockhart S.R.,Centers for Disease Control and Prevention
Journal of Clinical Microbiology | Year: 2015
Multilocus sequence typing (MLST) is the gold standard genotyping technique for many microorganisms. This classification approach satisfies the requirements for a high-resolution, standardized, and archivable taxonomic system. Here, we describe the development of a novel MLST system to assist with the investigation of an unusual cluster of surgical site infections caused by Bipolaris spp. in postoperative cardiothoracic surgery (POCS) patients during January 2008 to December 2013 in the southeastern United States. We also used the same MLST system to perform a retrospective analysis on isolates from a 2012 Bipolaris endophthalmitis outbreak caused by a contaminated product. This MLST system showed high intraspecies discriminatory power for Bipolaris spicifera, B. hawaiiensis, and B. australiensis. Based on the relatedness of the isolates, the MLST data supported the hypothesis that infections in the POCS cluster were from different environmental sources while confirming that the endophthalmitis outbreak resulted from a point source, which was a contaminated medication. Copyright © 2015, American Society for Microbiology. All Rights Reserved.
Mirza A.,Oregon Health And Science University |
Moriarty A.M.,Washington University in St. Louis |
Probe R.A.,Scott and White Hospital |
Ellis T.J.,Ohio State University
Journal of Orthopaedic Trauma | Year: 2010
Objectives: To assess the risk of injury to the superficial peroneal nerve, saphenous nerve, and saphenous vein in percutaneous fixation of the distal fibula and tibia. Methods: Ten adult cadaver lower extremities were instrumented with precontoured periarticular plates for the distal tibia and fibula. Plates were inserted percutaneously along the medial distal tibia and lateral fibula. Smooth wires were inserted percutaneously into each screw hole. Dissection of the superficial peroneal nerve, saphenous nerve, and saphenous vein was performed along their respective course. The position of the neurovascular structures relative to the smooth wires was recorded. Results: The saphenous nerve and vein had a predictable course along the medial aspect of the ankle. Both structures were injured in every specimen. This occurred consistently at 2.0 to 4.7 cm from the tip of the medial malleolus. The superficial peroneal nerve demonstrated large variance in the exit point from the lateral compartment crural fascia, exiting at an average of 11.6 cm from the tip of the lateral malleolus. Injury occurred in a single specimen at 11.5 cm from this point. Conclusions: The superficial peroneal nerve, saphenous nerve, and saphenous vein are at risk during percutaneous submuscular plating of the distal fibula and tibia. Careful dissection proximally for the fibula and distally for the tibia can minimize the risk of damage to these structures. © 2010 Lippincott Williams & Wilkins.
Gerber D.E.,University of Texas Southwestern Medical Center |
Stopeck A.T.,Arizona Cancer Center |
Wong L.,Scott and White Hospital |
Rosen L.S.,Premiere Oncology |
And 3 more authors.
Clinical Cancer Research | Year: 2011
Purpose: Bavituximab is a chimeric immunoglobulin G1 phosphatidylserine- targeting monoclonal antibody that triggers vascular disruption and enhances antitumor immune response. This phase I study assessed the safety and pharmacokinetics of bavituximab in patients with advanced solid tumors. Experimental Design: Patients with refractory advanced solid tumors were enrolled into four sequential dose-escalation cohorts (0.1, 0.3, 1, or 3 mg/kg bavituximab weekly) with two dosing schedules. Patients in the 0.1 and 0.3 mg/kg cohorts received bavituximab on days 0, 28, 35, and 42. Patients in the 1 and 3 mg/kg cohorts were administered bavituximab on days 0, 7, 14, and 21. Safety, pharmacokinetics, and tumor response were assessed. Results: Twenty-six patients were accrued. No maximum tolerated dose was reached. Six serious adverse events occurred in five patients, including one pulmonary embolism at 3 mg/kg, which was the only dose-limiting toxicity (DLT) in the study. Bavituximab half-life ranged from 37 to 47 hours, with no accumulation seen following administration of multiple doses. Activated partial thromboplastin time was modestly prolonged in vitro at the highest dose tested. As assessed on day 56, a total of 18 patients were evaluable for efficacy, of whom 10 had disease progression and none had an objective response. Conclusions: Bavituximab was well tolerated at doses ranging up to 3 mg/kg weekly. Pharmacokinetic studies support a weekly dosing regimen. Additional phase I and II clinical trials are in progress to investigate bavituximab in combination with chemotherapy and other molecularly targeted agents. ©2011 AACR.
Engel J.D.,George Washington University |
Sutherland D.E.,George Washington University |
Williams S.B.,Harvard University |
Wagner K.R.,Scott and White Hospital
Journal of Endourology | Year: 2011
Background and Purpose: Radical prostatectomy is commonly performed for the treatment of patients with prostate cancer. Several studies have demonstrated a reduction in penile size after open radical retropubic prostatectomy. The objective of this study is to describe changes in penile length after after robot-assisted laparoscopic radical prostatectomy (RALRP). Patients and Methods: We performed a randomized, open label, multicenter study in men with normal erectile function who underwent bilateral nerve-sparing radical prostatectomy. We evaluated changes in measured stretched penile length (SPL), a secondary end point of the study, in a subset of men from a single site who underwent RALRP by one surgeon. They were randomized to either intraurethral alprostadil 125 to 250 mg daily or oral sildenafil citrate 50mg daily for 9 months. SPL was measured from pubic bone to coronal sulcus using a semirigid ruler before surgery and at 1, 3, 6, 9, 10, and 11 months. Results: A total of 127 patients were enrolled and 94 completed the 11-month follow-up. The mean patient age was 56.5 years. Baseline mean SPL (cm) before surgery was 11.77 and decreased to 11.13 at 1 month (P<0.0001). A trend toward recovery of SPL was seen at 3 and 6 months. Mean SPL was not significantly different from baseline at 9, 10, and 11 months. Conclusions: This report describes changes in SPL over time after RALRP for prostate cancer. The expected decrease in length was observed shortly after surgery, but, by 9 months, penile length had returned to the preoperative measurement. Copyright © Mary Ann Liebert, Inc.
Hai B.,Texas A&M University |
Yang Z.,Texas A&M University |
Shangguan L.,Texas A&M University |
Zhao Y.,Texas A&M University |
And 2 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012
Purpose: Many head and neck cancer survivors treated with radiotherapy suffer from permanent impairment of their salivary gland function, for which few effective prevention or treatment options are available. This study explored the potential of transient activation of Wnt/β-catenin signaling in preventing radiation damage to salivary glands in a preclinical model. Methods and Materials: Wnt reporter transgenic mice were exposed to 15 Gy single-dose radiation in the head and neck area to evaluate the effects of radiation on Wnt activity in salivary glands. Transient Wnt1 overexpression in basal epithelia was induced in inducible Wnt1 transgenic mice before together with, after, or without local radiation, and then saliva flow rate, histology, apoptosis, proliferation, stem cell activity, and mRNA expression were evaluated. Results: Radiation damage did not significantly affect activity of Wnt/β-catenin pathway as physical damage did. Transient expression of Wnt1 in basal epithelia significantly activated the Wnt/β-catenin pathway in submandibular glands of male mice but not in those of females. Concurrent transient activation of the Wnt pathway prevented chronic salivary gland dysfunction following radiation by suppressing apoptosis and preserving functional salivary stem/progenitor cells. In contrast, Wnt activation 3 days before or after irradiation did not show significant beneficial effects, mainly due to failure to inhibit acute apoptosis after radiation. Excessive Wnt activation before radiation failed to inhibit apoptosis, likely due to extensive induction of mitosis and up-regulation of proapoptosis gene PUMA while that after radiation might miss the critical treatment window. Conclusion: These results suggest that concurrent transient activation of the Wnt/β-catenin pathway could prevent radiation-induced salivary gland dysfunction. © 2012 Elsevier Inc. All rights reserved.
Foresti M.L.,Scott and White Hospital |
Foresti M.L.,Central Texas Veterans Health System |
Arisi G.M.,Scott and White Hospital |
Arisi G.M.,Central Texas Veterans Health System |
And 3 more authors.
Brain Research Reviews | Year: 2011
The black reaction allowed Golgi to describe with amazing detail the morphology of glial cells as well as their proximal location and intimate connections with neurons and blood vessels. Based on this location, Golgi hypothesized that glial cells were functional units in the nervous system and were not merely a structural support medium. Relatively recent advances have confirmed the importance of glial cells in nervous system function and disease. The occurrence of gliosis is considered the hallmark of damaged tissue. Gliosis can differentially influence disease development and it is a prevailing characteristic of temporal lobe epilepsy. Its presence in the epileptic hippocampi might contribute to hyperexcitability, the development of aberrant neurogenic changes and inflammatory processes related to seizures. Considering the accumulating data regarding the pathological role of glial cells in epilepsy, novel therapeutic approaches that target glial cells are being explored. Such therapeutic approaches directed to glial cells present a novel perspective for the management of refractory pathologies. © 2010 Elsevier B.V.
Buckley C.J.,Scott and White Hospital |
Rutherford R.B.,Scott and White Hospital |
Diethrich E.B.,Scott and White Hospital |
Buckley S.D.,Scott and White Hospital
Journal of Vascular Surgery | Year: 2010
Randomized clinical trials (RCTs) offering an observation/no treatment (OBS/NoRx) arm as control and which are focused on the management of a condition with potentially life-threatening consequences, however small the risk, often experience a significant rate of crossover to treatment by those randomized to the OBS/NoRx arm. Results of these trials when analyzed on intent-to-treat basis often fail to resolve the issue at which they were directed. The authors have observed this in trials of abdominal aortic aneurysms with this design and use these to exemplify the dilemmas RCTs of such design create, with crossovers ranging from 27% to over 60% (EVAR II, UKSAT, ADAM, PIVOTAL). Results of these trials are frequently used as level I medical evidence and their potential impact on clinical decision making and reimbursement can be quite significant and long-lasting. Recommendations regarding trial end points and suggestions to mitigate the high crossover effect are offered. It may be that some clinical conditions dealing with potentially life-threatening problems should not be studied in randomized prospective clinical trials containing an OBS/NoRx arm.
Driver V.R.,Boston University |
Fabbi M.,Boston University |
Lavery L.A.,Scott and White Hospital |
Gibbons G.,Boston University
Journal of Vascular Surgery | Year: 2010
Background: In 2007, the treatment of diabetes and its complications in the United States generated at least $116 billion in direct costs; at least 33% of these costs were linked to the treatment of foot ulcers. Although the team approach to diabetic foot problems is effective in preventing lower extremity amputations, the costs associated with implementing a diabetic foot care team are not well understood. An analysis of these costs provides the basis for this report. Results: Diabetic foot problems impose a major economic burden, and costs increase disproportionately to the severity of the condition. Compared with diabetic patients without foot ulcers, the cost of care for patients with a foot ulcer is 5.4 times higher in the year after the first ulcer episode and 2.8 times higher in the second year. Costs for the treatment of the highest-grade ulcers are 8 times higher than for treating low-grade ulcers. Patients with diabetic foot ulcers require more frequent emergency department visits, are more commonly admitted to hospital, and require longer length of stays. Implementation of the team approach to manage diabetic foot ulcers within a given region or health care system has been reported to reduce long-term amputation rates from 82% to 62%. Limb salvage efforts may include aggressive therapy, such as revascularization procedures and advanced wound healing modalities. Although these procedures are costly, the team approach gradually leads to improved screening and prevention programs and earlier interventions, and thus seems to reduce long-term costs. Conclusions: To date, aggressive limb preservation management for patients with diabetic foot ulcers has not usually been paired with adequate reimbursement. It is essential to direct efforts in patient-caregiver education to allow early recognition and management of all diabetic foot problems and to build integrated pathways of care that facilitate timely access to limb salvage procedures. Increasing evidence suggests that the costs for implementing diabetic foot teams can be offset over the long-term by improved access to care and reductions in foot complications and in amputation rates. © 2010 Society for Vascular Surgery and the American Podiatric Medical Association.