Winston Salem Research Articles

55: Treating postpartum anemia with intravenous ferric carboxymaltose in a randomized controlled study

A RANDOMIZED CONTROLLED STUDY MELVIN H. SEID, RALPH ROGERS, QUINN DINH, Lyndhurst Gynecologic Associates, Winston Salem, North Carolina, Women’s Clinical Research, Newburgh, Indiana, American Regent/Luitpold Pharmaceuticals, Norristown, Pennsylvania OBJECTIVE: To evaluate the superiority, safety and tolerability of ferric carboxymaltose (FCM) to oral iron in postpartum women with iron deficiency anemia (IDA). FCM is a novel non-dextran iron agent given in large doses by rapid IV injection. STUDY DESIGN: In a randomized, controlled, superiority designed pivotal trial, 289 women 10 days post-delivery with hemoglobin 10g/dL were randomized and received: (a) FCM up to 1,000mg IV over 15 minutes, repeated weekly to correct anemia up to maximum total calculated dose of 2,500mg, or (b) Oral ferrous sulfate 325mg (65mg elemental iron) thrice daily for 6 weeks. RESULTS: Patients (n 142) received 293 IV doses of FCM (mean total dose 1504mg) in 1, 2, or 3 injection(s) [5%, 84%, or 11% respectively]; 147 received oral iron. FCM group compared with oral iron group was: (1) more likely to achieve hemoglobin (Hb) 12g/dL (91% vs. 67%, p .0001) in a shorter time period (14 days vs. 27 days, p .0002) with sustained success (85% vs. 58%) at Day 42, (p .0001), (2) more likely to achieve Hb rise 3.0g/dL at any time (91% vs. 65%, p .0001) in a shorter time period (15 days vs. 28 days, p .0001), and (3) more likely to attain higher transferrin saturation (TSAT) (36% vs. 28%) and ferritin (647 ng/mL vs. 12 ng/mL), p .0001. Drug-related adverse events (AEs) were lower with FCM (11%) than oral iron (22%). Urticaria (2%) was the only drug-related AE occurring in 2% of the FCM group. Constipation (11%;0%), elevated ALT (4%; 0.7%), elevated AST (2%;0.7%), and nausea (2%;1.4%) were more common with oral iron than FCM, respectively. No hypotensive or drug-related serious AEs such as hypersensitivity or anaphylactic reactions were reported in either treatment group. CONCLUSION: Ferric carboxymaltose (FCM) was safe and well-tolerated. FCM was superior to oral iron in increasing Hb 12g/dL earlier with greater sustained success. FCM was more effective in raising TSAT and ferritin. This non-dextran IV iron agent may fulfill an unmet medical need for safe, rapid administration of iron in single doses up to 1,000mg in postpartum women with IDA.

Letters to the Editor

Wake Forest University Baptist Medical Center Department of Orthopaedic Surgery Winston Salem, North Carolina

Untying the Gordian Knot

In Response: We appreciate the thoughtful comments by Drs. Su, Zuppa, and Adamson (1) in response to our editorial, “Pediatric Research and Scholarship : Another Gordian Knot?” (2). We discussed the difficulties in pediatric pharmaceutical research and in developing data to support pediatric drug labels. We do not suggest that investigator-initiated studies cannot meet the Food and Drug Administration's (FDA) definition for adequate and well-controlled studies. However, most pediatric studies involve small numbers of patients in investigator-initiated trials that do not meet the FDA's definition for adequate and well controlled studies. Adequately trained investigators can and do perform these studies, but usually under the sponsorship of a pharmaceutical company. The Pediatric Pharmacology Research Unit is a very valuable resource allowing implementation of pediatric research trials. The accompanying letter highlights this valuable resource. As the correspondents state, they were unable to engage the previous pharmaceutical sponsor to initiate pediatric studies of dexmedetomidine. As related to one of the authors (JRT, personal communication), the sponsor claimed that they were unable to initiate pediatric trials until the FDA was satisfied with an adult trial with more than 24 h infusion of dexmedetomidine. That study is underway and was not required for the initial approval of the drug. Regardless of the etiology, progress with pediatric studies and labeling has been delayed. Following publication of data which might support a labeling change, it should be acknowledged that only the sponsor can request labeling changes, or special consideration for labeling changes can be considered at the initiative of the FDA. We are delighted to hear of the success of the correspondents in their preparation of the current trials by having contacted the FDA and used an Investigational New Drug application to support the current studies. This route should be considered for any new pharmaceutical that investigators believe will have significant impact in pediatric care but does not have the support of the sponsor. We are pleased to have had initial communications with the manufacturer of dexmedetomidine, Hospira, Inc., in initiating sponsor-funded pediatric trials. A Gordian Knot may not easily be untied, but one historical anecdote states that Alexander the Great “cut through it with a sword.” As Dr. Su and colleagues suggest, maybe the solution is not so complex if interested parties decide it is a priority. We appreciate the opportunity to focus attention on the easily disregarded needs of children's health in anesthesia and other fields of medicine. Joseph R. Tobin, MD Wake Forest University School of Medicine Winston Salem, NC Steven L. Shafer, MD Stanford University Stanford, CA Peter J. Davis, MD University of Pittsburgh School of Medicine Pittsburgh, PA [email protected]

2006 Meeting Southern Thoracic Surgical Association

The Fifty-third Annual Meeting of the Southern Thoracic Surgical Association was held at the Marriott Starr Pass Resort in Tucson, Arizona, on November 8-11, 2006. The President was Ross Ungerleider, MD (Portland, OR). Officers elected for the coming year are as follows: President, Carolyn Reed, MD (Charleston, SC); President Elect, John Hammon, MD (Winston Salem, NC); Vice President, Steves Ring, MD (Dallas, TX). Also elected this year was Councillor, Curt Tribble, MD (Gainesville, FL). Robert Cerfolio, MD (Birmingham, AL) will serve as Secretary/Treasurer for the next 4 years. The following applicants were elected to membership: Rashid Ahmad, MD Nashville, TN Douglas Appleby, Jr, MD Greenville, SC John Armitage, MD Fredericksburg, VA John Artrip, MD Portsmouth, VA Anthony Ascioti, MD Indianapolis, IN Christopher Baird, MD Charlotte, NC Michael Banker, MD Fredericksburg, VA Randy Brown, MD Cape Girardeau, MO Clay Burnett, MD Olathe, KS Paul Chai, MD Tampa, FL Robert Dabal, MD Jacksonville, FL Michael DeFrain, MD Columbia, SC William Douglas, MD Lexington, KY Jason Felger, MD San Angelo, TX Sanjiv Gandhi, MD St. Louis, MO Kristopher George, MD Cleveland, OH James Greelish, MD Nashville, TN Kristine Guleserian, MD Dallas, TX Lawrence Hamner III, MD San Antonio, TX Gavin Henry, MD Baltimore, MD Tain-Yen Hsia, MD Charleston, SC George Hughes IV, MD Durham, NC Kenneth Kesler, MD Indianapolis, IN David Ladden McComb, MS Eric Lambright, MD Nashville, TN Terry Lowry, MD Rochester, NY Blair Marshall, MD Washington, DC Jeffery Martin, MD Columbia, SC Linda Martin, MD Mountain View, CA Christopher Mascio, MD Louisville, KY Bassem Mora, MD Washington, DC Jeff Myers, MD Memphis, TN Carmelo Otero, MD San Antonio, TX V. Seenu Reddy, MD San Antonio, TX Evelio Rodriguez, MD Greenville, NC Joshua Rovin, MD St. Petersburg, FL The President's Award for best scientific paper at the 2005 meeting was presented to V. Seenu Reddy, MD, for the paper he presented titled “Longterm Results of the Endoscopic Atraumatic Coronary Artery Bypass.” In addition, the 2005 Hawley H. Seiler Resident's Award was presented to Edward Hickey, MD, for his paper and presentation titled “Use of a Miniaturized Circuit and Bloodless Prime to Avoid Cerebral No-Reflow Following Neonatal Cardiopulmonary Bypass.” The Fifty-fourth Annual Meeting will be held at the Hyatt Regency Coconut Point Resort & Spa in Bonita Springs, Florida, on November 8-10, 2007. Co-Chairs of the 2007 Program Committee are John Kern, MD, and Marc Moon, MD. Co-Chairs of the 2007 Postgraduate Committee are John Oswalt, MD, and John Puskas, MD. Chair of the 2007 Membership Committee is Martin McMullan, MD. Robert Cerfolio, MD Secretary/Treasurer

Citation classics in Fertility and Sterility, 1975–2004

Citation classics in Fertility and Sterility, 1975–2004

From the footnotes to the headlines: Sterilization apologies and their lessons

Between 1929 and 1975, North Carolina’s eugenic sterilization program authorized more than 7,600 sterilizations. A 2003 newspaper series in the Winston Salem Journal about this history led North Carolina governor Mike Easley to apologize for the program. Recently, the North Carolina legislature considered a restitution bill for sterilization victims, making North Carolina the first state in the nation to consider any kind of restitution for victims of state eugenic sterilization programs. Media characterization of eugenic sterilization programs as racial genocide added a political salience to the story that contributed to the potential for restitution but also distorted a program less concerned with improving racial quality than with controlling the reproduction of welfare recipients. While considerations of restitution to welfare recipients who suffered sterilization as a result of having children outside marriage might be politically unpalatable, restitution to victims of racial genocide seemed politically much more acceptable.

Front Porch

Front Porch Harry L. Watson Click for larger view View full resolution Figure 1. Blain Roberts's "A New Cure for Brightleaf Tobacco: The Origins of the Tobacco Queen during the Great Depression" reveals the creative contests—featuring young women—that were part of a broader effort to breathe new life into the ailing economy of the tobacco South. Photograph courtesy of the North Carolina Office of Archives and History, Raleigh, North Carolina. Long before the South was the Sunbelt, or the Cotton Belt, or even Dixie, a big part of southeastern North America was tobacco country. Widely used for ritual and recreational purposes by Native Americans, Nicotiana tabacum ignited a massive craze for smoke when European explorers first brought it back from their travels in the sixteenth century. The Caribbean variety was especially popular, but when John Smith's Virginians could find no metallic gold to support themselves, it was the golden leaf that saved the Chesapeake colonies from extinction. Spreading from Virginia all over the Southeast and from there to Kentucky and beyond, the "sovran herbe" has flourished here ever since, shaping the people and their [End Page 1] region like no other rival except perhaps the cotton plant and the longleaf pine tree. Without the bewitching sorcery of smoke, the South as we know it might not exist at all. We know by now, of course, that tobacco's high comes mixed with pain and suffering. The stuff is deadly—no doubt about it. The experts claim that smoking kills over 440,000 people every year, and that's just counting the American casualties. It's our leading preventable cause of illness and death, and the simplest Internet check will produce enough grim statistics to keep you aghast for days. Tobacco haters have been around as long as smokers, at least among the Europeans who turned the Indians' ceremony and pastime into a big-time international commodity. King James I famously called smoking "a custom loathsome to the eye, hateful to the nose, harmful to the brain, dangerous to the lungs, and in the black stinking fume thereof nearest resembling the horrible stygian smoke of the pit that is bottomless." Many modern Americans feel exactly the same way about it, and no-smoking ordinances have accordingly crept across the American landscape, even penetrating tobacco's fastnesses in North Carolina itself. And yet. . . . While many of us have sworn off tobacco for good, the filmy bands of vapor still have their unmistakable allure. Poet Michael McFee captures the feeling perfectly in his contribution to this issue, "My Aunt Smokes Another Lucky." The precise, elegant gestures, the snap of the lighter, the flash of red nail polish and matching lipstick, McFee's subject is the epitome of sophistication and desire. And watch any movie or television show—the characters are not only more exciting and better looking than almost anyone you know in real life, they are also more likely to smoke. The connection between being grown up, sexy, and glamorous—and using tobacco—seems indestructible. Presumably that's why almost four thousand youths take their first drag every day, according to the Centers for Disease Control. Reviled as backward for so long, the South has been making people feel modern and up-to-the-minute with the gift of tobacco ever since the 1600s. So we at Southern Cultures thought it was high time for a special issue on tobacco. Duncan Murrell starts us off with a reflection on James Buchanan Duke, the captain of industry who popularized mass cigarette smoking and created a monopoly of the American tobacco business which the Supreme Court broke up in 1911. The spin-off companies kept on flourishing thereafter and came to dominate huge swaths of the upper South's industrial landscape in the twentieth century. Whole towns bowed to King Tobacco: to Duke's old American Tobacco Company in Durham, to R. J. Reynolds in Winston–Salem, to Philip Morris in Richmond. And for lots of southerners, tobacco manufacturing, especially cigarette manufacturing, was a depression-proof industry that paid good money when other jobs were hard to find. How did Buck Duke do it? On the technological side, Murrell explains...

Malignant Melanoma Arising From PAM Without Atypia

Departments of Pathology and Ophthalmology, WFUBMC, Winston Salem, NC Abstracts Presented at the 9th ISDP Joint Meeting, San Francisco, California, March 1–2, 2006

DB2 SELF REPORTED PREDICTORS OF DEPRESSIVE SYMPTOMATOLOGY IN AN ELDERLY POPULATION WITH TYPE 2 DIABETES MELLITUS

DB2 SELF REPORTED PREDICTORS OF DEPRESSIVE SYMPTOMATOLOGY IN AN ELDERLY POPULATION WITH TYPE 2 DIABETES MELLITUS Balkrishnan R, Pawaskar MD,Anderson RT The Ohio State University College of Pharmacy, Columbus, OH, USA, Wake Forest University School of Medicine, Winston Salem, NC, USA OBJECTIVE: Depression is a recurrent and chronic disorder among elderly patients with chronic medical conditions. The objective of this study was to determine predictors of depressive symptomatology in elderly population with type 2 diabetes mellitus. METHODS: A cross sectional study was conducted by administering a health status assessment questionnaire to nearly 1000 older adults (≥65 years) with type 2 diabetes mellitus in the southern United States (Response rate: approximately 85%). The instrument collected information related to demographics, general health status, clinical conditions, medication use, lifestyle, functional status and prior health care service utilization. The Short Form Center for Epidemiologic Studies Depression scale was used to assess depressive symptoms. Partial correlations and multivariate logistic regression analyses were conducted using the linked survey and health care claims data. RESULTS: Of the 885 respondents, about 17% had depressive symptoms. Most participants (60%) were women with mean age of 71 (±8.7) years. Almost 96.7% of patients were using 1 or more antidiabetic medications. Overall, higher general health status was associated with lower level of depression (OR: 0.38, 95% CI: 0.23–0.61). However, impairments in daily activities were associated with higher depression (OR: 1.25, 95% CI: 1.08–1.44). When categorized by type of antidiabetic therapy based on actual prescription claims data, we found that increased number of prescriptions was associated with higher risk of depressive symptoms (OR: 2.39, 95% CI: 1.05–5.44) in patients on insulin compared to those other therapies. In addition, higher risk of depressive symptoms was associated with self reported number of falls (OR: 2.17, 95% CI: 1.1–4.28), and emergency room visits (OR: 1.57, 95% CI: 1.11–2.22) in the previous year in patients on sulphonyl ureas. CONCLUSION: General health status and impairments in daily activities were predictors of depressive symptomatology in elderly with diabetes. Determinants of depression varied according to pharmacotherapeutic class of antidiabetic medications.

Accurate intraocular lens power calculation after myopic laser in situ keratomileusis, bypassing corneal power

To describe a novel method for calculating intraocular lens (IOL) power after myopic laser in situ keratomileusis (LASIK) without using the inaccuracies of the post-LASIK corneal power. Department of Ophthalmology, Wake Forest University Eye Center, Wake Forest University School of Medicine, Winston Salem, North Carolina, USA. This retrospective chart review comprised 9 eyes of 9 patients who had phacoemulsification after LASIK using our method for IOL calculation. This new method assumes the patient never had myopic LASIK to calculate IOL power and then targets the IOL at the pre-LASIK amount of myopia. The pre-LASIK keratometry values, pre-LASIK manifest refraction, and the current axial length are placed in the Holladay formula, bypassing the post-LASIK corneal power. In theory, assuming that the patient had satisfactory LASIK results, the correct IOL can then be determined. The mean spherical equivalent postoperative refraction was +0.03 diopter (D) +/- 0.42 (SD) (range -0.625 to +0.75 D). In all 9 eyes, our method consistently chose the most accurate and precise IOL compared with other methods. The new method of calculating IOL power after LASIK provided excellent results and the most accurate and precise results to date.

School of Medicine Professionalism Website (Out of Print)

OPEN ACCESSJanuary 18, 2006School of Medicine Professionalism Website (Out of Print) Kathy Kreutzer, MEd, Carol Hampton, MMS, Chris Stephens, MS, Jeanne Schlesinger, MEd, John Priestley, MA, Brien White, BFA, Walter Lawrence, MD, Heber Newsome, MD Kathy Kreutzer, MEd New York University School of Medicine Google Scholar More articles by this author , Carol Hampton, MMS Virginia Commonwealth University School of Medicine Google Scholar More articles by this author , Chris Stephens, MS Virginia Commonwealth University School of Medicine Google Scholar More articles by this author , Jeanne Schlesinger, MEd Virginia Commonwealth University School of Medicine Google Scholar More articles by this author , John Priestley, MA Virginia Commonwealth University School of Medicine Google Scholar More articles by this author , Brien White, BFA Virginia Commonwealth University School of Medicine Google Scholar More articles by this author , Walter Lawrence, MD Virginia Commonwealth University School of Medicine Google Scholar More articles by this author , Heber Newsome, MD Virginia Commonwealth University School of Medicine Google Scholar More articles by this author https://doi.org/10.15766/mep_2374-8265.174 SectionsAboutAbstract ToolsDownload Citations ShareFacebookTwitterEmail AbstractAbstractThis resource is a website that was developed to bring together learning material and information in the area of professionalism for students, housestaff, and faculty at medical schools. Features include standards and policies for medical schools, health systems, and medical centers; a description of a professionalism committee and the reporting mechanism for perceived unprofessional behavior; a section to support teaching and learning, including teaching cases, presentations, references, original research, and case studies; and news about local events related to professionalism including ceremonies, awards and other opportunities for recognition, and presentations. Using a logic model, we evaluated this effort by linking activities, outputs, outcomes, and impacts. Outputs and outcomes include dissemination of professionalism policies and standards; a “standard of the month” reminder; and three Group on Education Affairs regional meeting poster presentations. This website has also been included in faculty development for graduate medical educators program directors and undergraduate medical education course directors and in departmental grand rounds. The website does not remain static and is continuously updated and maintained in order to be useful. There has been a very positive reaction to making all of these resources available in one place. This website is an ongoing team effort by the admissions, undergraduate education, housestaff education, faculty, instructional development, and student activities offices at the Virginia Commonwealth University Medical Center and the Hunter Holmes McGuire Veterans Administration Medical Center. Educational Objectives By the end of this resource, students, housestaff, and faculty at medical schools will be able to: Increase their awareness about the expectations for professional behavior.Increase their understanding of specific standards of behavior.Increase their knowledge of the process to address perceived unprofessional behavior.Increase their knowledge about original research in the field.Increase their skill at identifying and addressing instances of professional behavior.Recognize role models of professional behavior. Sign up for the latest publications from MedEdPORTAL Add your email below FILES INCLUDEDReferencesRelatedDetails FILES INCLUDED Included in this publication: Web Link Access_174.pdf To view all publication components, extract (i.e., unzip) them from the downloaded .zip file. Download editor’s noteThis publication may contain technology or a display format that is no longer in use. Copyright & Permissions© 2006 Kreutzer et al. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-No Derivatives license.KeywordsStandards of BehaviorUnprofessional Behavior Disclosures None to report. Funding/Support None to report. Prior Presentations Kreutzer KO, Navarro AM, Waterhouse E, Schlesinger JB, Hampton CL, Hoban JD, Wood IK, O'Donnell MA, Sanders KM, Lawrence W Jr, Newsome HH Jr. A multi-faceted approach to supporting and examining professional behaviors in medical school. Poster presented at: Southern Group on Educational Affairs Conference; April 2005; Winston Salem, NC. Hampton CL, Kreutzer KO, Schlesinger JB, Hoban JD, Navarro AM, O'Donnell MA, Sanders KM, Lawrence W Jr, Newsome HH Jr. A multi-faceted approach to supporting professional behaviors in medical school. Innovations in medical education exhibit at: Association of American Medical Colleges Annual Meeting; November 2004; Boston, MA. Loading ...

Physiological and Pathological Changes in Glucose Regulate Brain Akt and Glycogen Synthase Kinase-3

Insulin regulates the phosphorylation and activities of Akt and glycogen synthase kinase-3 (GSK3) in peripheral tissues, but in the brain it is less clear how this signaling pathway is regulated in vivo and whether it is affected by diabetes. We found that Akt and GSK3 are sensitive to glucose, because fasting decreased and glucose administration increased by severalfold the phosphorylation of Akt and GSK3 in the cerebral cortex and hippocampus of non-diabetic mice. Brain Akt and GSK3 phosphorylation also increased after streptozotocin administration (3 days), which increased blood glucose and depleted blood insulin, indicating regulation by glucose availability even with deficient insulin. Changes in Akt and GSK3 phosphorylation and activities in epididymal fat were opposite to those of brain after streptozotocin treatment. Streptozotocin-induced hyperglycemia and increased brain Akt and GSK3 phosphorylation were reversed by lowering blood glucose with insulin administration. Long term hyperglycemia also increased brain Akt and GSK3 phosphorylation, both 4 weeks after streptozotocin and in db/db insulin-resistant mice. Thus, the Akt-GSK3 signaling pathway is regulated in mouse brain in vivo in response to physiological and pathological changes in insulin and glucose.

The Accuracy of Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) for Diagnosing Solid Pancreatic Lesions Using a New 25-Gauge Needle System

Introduction: EUS-FNA has enhanced our ability to diagnose pancreatic masses. Most of the published data is based on the use of a 22-gauge needle. The aim of this study was to evaluate our center's experience with a new disposable 25-gauge needle system in the diagnosis of solid pancreatic lesions. Methods: Our institution began utilizing this FDA approved 25-gauge EUS-FNA needle system (Echotip, Wilson Cook, Winston Salem, NC) in 2/2001. All patients referred for EUS evaluation of solid pancreatic mass between 2/2001 and 12/2002 were reviewed. Patient demographics, clinical history including follow-up, and pathology findings were recorded. Cytopathology was compared with operative histopathology in patients who had surgery. Patients who did not have surgery were followed clinically. Results: A total of 163 patients (mean age 66, 88 M/75 F) underwent EUS-FNA for solid pancreatic lesions using the 25-gauge needle. FNA was consistent with pancreatic malignancy in 48% (78/163) while 45% (74/163) had no evidence of malignancy. In the remaining 7% (11/163), biopsy was inconclusive. No complications were reported. Of the pancreatic cancer patients, 96% (75/78) had adenocarcinoma and 4% (3/78) had other malignancies. In the group with a definitive FNA diagnosis, 14% (23/163) underwent surgery and operative histopathology was compared with FNA cytopathology. There was one false-negative and no false-positive diagosis; and the sensitivity, specificity, PPV, and NPV were 94%, 100%, 100%, and 86% respectively. In the false-negative case, patient had cytologic evidence of chronic pancreatitis. In patients with an inconclusive FNA, 27% (3/11) had surgery and 2 had adenocarcinoma. The remaining 84% (137/163) of patients who did not undergo surgery were followed clinically. The mean survival for patients with a positive, negative, and inconclusive FNA was 11, 23, and 14 months respectively. Conclusions: 1. EUS-FNA using a 25-gauge needle system can accurately and safely provide a cytologic diagnosis of pancreatic masses. 2. The patient who had a false-negative FNA diagnosis had chronic pancreatitis, confirming previous reports that cytologic evaluation of pancreatic tissue in the setting of chronic inflammation can be difficult. 3. Studies with larger sample size and randomized arms are now needed to further assess the accuracy and complication rate of this smaller needle system.

The US smallpox vaccination plan.

The American Academy of Pediatrics (AAP) recently published a policy statement on the use of the smallpox vaccine in children.1 This commentary expands on issues raised by Congress2 regarding the implementation of a smallpox vaccination program in children. AAP policy states that children should not be offered the smallpox vaccine at this time. This recommendation is based on weighing the fact that infants and children are particularly vulnerable to serious complications caused by the smallpox vaccine, including death, versus the government’s own assessment that the current risk of a smallpox attack is low.3 When the risk of a smallpox attack is low, a ring-vaccination policy that includes a plan for rapid distribution … Address correspondence to Jon S. Abramson, MD, Department of Pediatrics, Wake Forest University School of Medicine, Department of Pediatrics, Medical Center Boulevard, Winston Salem, NC 27157-0001. E-mail: jabrams{at}wfubmc.edu

Endoscopic suturing for treatment of GERD

Swain and Mills first described the concept and technology of endoscopic suturing or sewing in 1986. 1 Swain CP Mills TN. An endoscopic sewing machine. Gastrointest Endosc. 1986; 32: 36-38 Abstract Full Text PDF PubMed Scopus (91) Google Scholar Subsequent animal and cadaver studies documented that endoscopic placement of sutures in the cardia of the stomach was feasible. Early reports demonstrated that the technique increased the overall length of the lower esophageal sphincter (LES) as determined manometrically, its intra-abdominal length, and/or its pressure depending on the configuration of the suture placement. 2 Swain CP Kadirkamanathan SS Gong F Lai KC Ratani RS Brown GJ et al. Knot tying at flexible endoscopy. Gastrointest Endosc. 1994; 40: 722-729 PubMed Google Scholar , 3 Kadirkamanathan SS Evans DF Gong F Yazaki E Scott M Swain CP. Antireflux operations at flexible endoscopy using endoluminal stitching techniques: an experimental study. Gastrointest Endosc. 1996; 44: 133-143 Abstract Full Text Full Text PDF PubMed Scopus (85) Google Scholar , 4 Martinez-Serna T Davis RE Mason R Perdikis G Filipi CJ Lehman G et al. Endoscopic valvuloplasty for GERD. Gastrointest Endosc. 2000; 52: 663-670 Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar Initial use of a similar device in humans with GERD was first described in 2001. 5 Filipi CJ Lehman GA Rothstein RI Raijman I Steigman GV Waring JP et al. Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial. Gastrointest Endosc. 2001; 53: 416-422 Abstract Full Text Full Text PDF PubMed Scopus (281) Google Scholar Two forms of endoscopic suturing devices are currently available (EndoCinch, Bard, Inc., Bellerica, Mass.; Sew-Right Device, Wilson-Cook Medical, Inc., Winston Salem, N.C.). EndoCinch is the only Food and Drug Administration (FDA)-approved device for use as therapy in patients with GERD. GERD affects 20% or more of adult Americans and can be effectively treated in most cases either pharmacologically or surgically. 6 Dent J Brun J Fendrick AM Fennerty MB Janssens J Kahrilas PJ et al. An evidence-based appraisal of reflux-disease management. The Genval Workshop Report. Gut. 1999; 44: 51-516 Google Scholar H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) can control symptoms of reflux in 85% to 95% of patients when escalating doses are used. Similarly, antireflux surgery (Laparoscopic Nissen Fundoplication or LNF) performed by an experienced surgeon will alleviate reflux-related symptoms in 80% to 90% of patients. 6 Dent J Brun J Fendrick AM Fennerty MB Janssens J Kahrilas PJ et al. An evidence-based appraisal of reflux-disease management. The Genval Workshop Report. Gut. 1999; 44: 51-516 Google Scholar , 7 Spechler SJ Lee A Ahnen D Goyal RK Hirano I Ramirez F et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow up of a randomized controlled trial. JAMA. 2001; 285: 2376-2378 Crossref PubMed Scopus (832) Google Scholar Thus, few patients with GERD who have symptoms are truly refractory to pharmacologic and/or surgical approaches to GERD therapy.

Brain temperature, body core temperature, and intracranial pressure in acute cerebral damage.

Department of Anesthesiology; Duke University Medical Center; Durham, North Carolina Department of Anesthesiology; Wake Forest University School of Medicine; Winston–Salem, North Carolina

The use of central venous cannulae in neuroanesthesia.

Department of Anesthesiology; Duke University Medical Center; Durham, North Carolina Department of Anesthesiology; Wake Forest University School of Medicine; Winston–Salem, North Carolina

Hyperacute measurement of intracranial pressure, cerebral perfusion pressure, jugular venous oxygen saturation, and laser Doppler flowmetry, before and during removal of traumatic acute subdural hematoma.

Department of Anesthesiology; Duke University Medical Center; Durham, North Carolina Department of Anesthesiology; Wake Forest University School of Medicine; Winston–Salem, North Carolina

Clinical factors associated with unexpected critical care management and prolonged hospitalization after elective cervical spine surgery.

Department of Anesthesiology; Duke University Medical Center; Durham, North Carolina Department of Anesthesiology; Wake Forest University School of Medicine; Winston–Salem, North Carolina

The Dialysis Outcomes Quality Initiative Guidelines: A New Standard for Everybody?

Correspondence to: J. Burkart, Wake Forest University Baptist Medical Center, Medical Center Boulevard, Winston–Salem, North Carolina 27157-1053 U.S.A. In 1997, the Dialysis Outcomes Quality Initiative (DOQI) clinical practice guidelines initiated by the National Kidney Foundation (NKF) of the United States were published (1). These practice guidelines covered broad areas of care (anemia, vascular access, adequacy of dialysis, and—soon to be published— nutrition) for the patient with end-stage renal disease (ESRD). The guidelines were formulated on evidence-based principles; but, often, where sufficient evidence was lacking, the consensus of expert opinion was accepted. Before publication, the guidelines underwent a series of intense peer reviews and modifications. Soon after publication, questions arose (2). Are the guidelines on target? Do they need further development and modification? Are they for everybody? This paper discusses potential answers to those questions.