News Article | February 23, 2017
LA JOLLA, CA - February 22, 2017 - The MagnaSafe Registry, a new multicenter study led by scientists at The Scripps Research Institute (TSRI), has demonstrated that appropriately screened and monitored patients with standard or non-MRI-conditional pacemakers and defibrillators can undergo MRI at a field strength of 1.5 tesla without harm. These devices are not presently approved by the U.S. Food and Drug Administration (FDA) for MRI scanning. The researchers observed no patient deaths, device or lead failures, losses of pacing function or ventricular arrhythmias in 1,500 patients who underwent MRI using a specific protocol for device interrogation, device programming, patient monitoring and follow-up designed to reduce the risk of patient harm from MRI effects. The research will be published as an Original Article in the February 23, 2017 issue of The New England Journal of Medicine. The use of MRI poses potential safety concerns for patients with an implanted cardiac device. These concerns are a result of the potential for magnetic field-induced cardiac lead heating, which could result in cardiac injury and damage to an implanted device. As a result, it has long been recommended that patients with a pacemaker or defibrillator not undergo MRI scanning, even when MRIs are considered the most appropriate diagnostic imaging method for their care. Despite the development of devices designed to reduce the potential risks associated with MRI, a large number of patients have devices that have not been shown to meet these criteria and are considered "non-MRI-conditional." At least half these patients are predicted to have the need for MRI after a device has been implanted. Researchers established the MagnaSafe Registry to determine the frequency of cardiac device-related events among patients with non-MRI-conditional devices, as well as to define a simplified protocol for screening, monitoring and device programming before MRI. "Given the great clinical demand for MRI for patients with a standard pacemaker or defibrillator, we wanted to determine the risk," said study leader Dr. Robert Russo, an adjunct professor at TSRI and director of The La Jolla Cardiovascular Research Institute. In the MagnaSafe Registry, researchers at 19 U.S. institutions tested 1,000 cases with a non-MRI-conditional pacemaker (one not approved for use in an MRI) and 500 cases of patients with a non-MRI-conditional implantable cardioverter defibrillator (ICD), a device that can shock the heart in response to a potentially fatal cardiac rhythm. They scanned regions other than the chest, such as the brain, spine or extremities--where MRI is traditionally the best option for imaging. The researchers tested the devices at an MRI field strength of 1.5 tesla, a standard strength for MRI scanners and reprogrammed some devices according to a prespecified protocol for the MRI examination. "If the patient was not dependent upon their pacemaker, the device was turned off," explained Russo. "If they could not tolerate having the device turned off, it was set to a pacing mode that did not sense cardiac activity. The reason was that the pacemaker could sense the electrical activity (radiofrequency energy) from the MRI scanner and the function of the device could be inhibited, which could be catastrophic if you depend upon your pacemaker for your heartbeat." Russo and his co-investigators did observe adverse effects in a small group of patients. Six patients had a brief period of atrial fibrillation, and in six additional cases pacemaker partial reset (a loss of stored patient information) was noted. But in no cases did the researchers observe device failure or a failure in the leads that connect the device to the heart when the protocol was followed. "One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI," explained Russo. These findings led the researchers to conclude that "device removal and replacement seem unlikely to be safer than proceeding with scanning for patients with a pacemaker or an ICD who require a nonthoracic MRI," provided a protocol similar to the MagnaSafe protocol was followed. "Patients with a standard or non-MRI-conditional pacemaker can undergo clinically indicated MRI without harm if a protocol such as the 'MagnaSafe' protocol used in this study is followed and patients are screened and monitored as described," said Russo. The researchers also noted that their results may not be predictive of findings with all device and lead combinations, higher MRI field strengths, patients younger than 18 years of age and MRI examinations of the chest or cardiac resynchronization devices (those designed to increase the function of a failing heart). The researchers plan to follow up by studying the risk for patients in need of a chest scan at scanner field strength of 1.5 tesla, as well as an MRI of any anatomic area at a higher field strength (3.0 tesla). The study, "Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator," also included authors from the University of California, San Diego; Scripps Memorial Hospital; the University of California, Los Angeles; Providence St. Joseph Medical Center; the University of Arizona; Intermountain Medical Center; Inova Heart and Vascular Institute; Allegheny General Hospital; Abington Memorial Hospital; Yale University School of Medicine; Providence Heart Institute; Oklahoma Heart Institute; the University of Mississippi Medical Center; the Medical College of Wisconsin; Bassett Medical Center; Carnegie Hill Radiology; Methodist DeBakey Heart and Vascular Center and Baptist Health. The study was supported by grants from St. Jude Medical, Biotronik, Boston Scientific and the Hewitt Foundation for Medical Research, and by philanthropic gifts from Mr. and Mrs. Richard H. Deihl, Evelyn F. and Louis S. Grubb, Roscoe E. Hazard, Jr. and the Shultz Steel Company. The Scripps Research Institute (TSRI) is one of the world's largest independent, not-for-profit organizations focusing on research in the biomedical sciences. TSRI is internationally recognized for its contributions to science and health, including its role in laying the foundation for new treatments for cancer, rheumatoid arthritis, hemophilia, and other diseases. An institution that evolved from the Scripps Metabolic Clinic founded by philanthropist Ellen Browning Scripps in 1924, the institute now employs more than 2,500 people on its campuses in La Jolla, CA, and Jupiter, FL, where its renowned scientists--including two Nobel laureates and 20 members of the National Academies of Science, Engineering or Medicine--work toward their next discoveries. The institute's graduate program, which awards PhD degrees in biology and chemistry, ranks among the top ten of its kind in the nation. In October 2016, TSRI announced a strategic affiliation with the California Institute for Biomedical Research (Calibr), representing a renewed commitment to the discovery and development of new medicines to address unmet medical needs. For more information, see http://www. .
Winans A.R.M.,Bassett Medical Center |
Rudd K.M.,Bassett Medical Center |
Triller D.,Pharmacy Services
Annals of Pharmacotherapy | Year: 2010
BACKGROUND: Warfarin is highly efficacious for the treatment and prevention of thromboembolic disorders. However, anticoagulation control has been a longstanding challenge, as patients' lack of knowledge of warfarin therapy is a predictor of nonadherence and compromised patient safety. OBJECTIVE: To ascertain whether hospitalized patients newly initiated on warfarin are provided adequate anticoagulation education during hospitalization, as measured at discharge, as well as determine whether there is a difference in the knowledge obtained by patients educated via a structured program versus those counseled by "usual care." METHODS: A prospective evaluation of warfarin education of inpatients new to warfarin therapy was performed at Bassett Medical Center, Cooperstown, NY. Patients who were admitted to the hospital and receiving warfarin for any given diagnosis, were >18 years of age and able to give informed consent, and spoke English were recruited. Patients with dementia or cognitive impairment, those who were pregnant, or those who had previously been on warfarin therapy were excluded. Recruited patients received warfarin education in the form of a structured program provided by a pharmacist or counseling by usual care during hospitalization. Prior to discharge, the Oral Anticoagulation Knowledge (OAK) test, a prevalidated tool used to measure warfarin knowledge, was administered to evaluate outcomes. Further warfarin education was provided posttest if necessary. RESULTS: The intervention group (n = 20) scored significantly higher on the OAK test than the usual care group (n = 20): 74% versus 55%, respectively (p = 0.004). CONCLUSIONS: This preliminary study demonstrated that there is a large amount of variability regarding patient knowledge of warfarin on discharge from an inpatient facility. A formalized inpatient warfarin education program may empower patients to achieve a larger degree of initial warfarin knowledge than those educated by usual care. Previous studies have demonstrated that this may improve adherence and subsequently increase long-term safety associated with oral anticoagulation. Larger, prospective, randomized studies are necessary to further evaluate patient education and safety outcomes.
Rudd K.M.,Bassett Medical Center |
Dier J.G.,Bassett Medical Center
Pharmacotherapy | Year: 2010
Study Objective. To evaluate the safety and economic impact of three models of anticoagulation management services: usual medical care, a nurse-managed service, and a pharmacist-managed service. Design. Retrospective medical record review. Setting. An eight-county health care system in central New York State. Patients. Nine hundred ninety-six patients (age range 19-99 yrs) who were receiving warfarin therapy for at least 6 months and who had three or more international normalized ratio (INR) values reported during the 1-year study period; 489 patients (6243 INR values) were in the pharmacist-managed group, 307 patients (3618 INR values) were in the nurse-managed group, and 200 patients (3142 INR values) were in the usual care group. Measurements and Main Results. All INR measurements were performed by the central laboratory or by on-site point-of-care testing. Data were queried from calendar year 2003 for the usual care and nurse-managed services and calendar year 2006 for the pharmacist-managed service. Anticoagulation indication, INR goal, baseline characteristics, and rates and costs of hospitalization and emergency department visits directly related to anticoagulation therapy were extracted from the medical record. If the INR goal was not documented, a range was assigned as appropriate from the American College of Chest Physicians anticoagulation guidelines. Markers of anticoagulation control - time in range (percentage of time a patient is maintained within their therapeutic range) and percentage of INR values in range - were calculated for each study group. Baseline characteristics were similar among all study groups. The pharmacist-managed service yielded the lowest rates of hospitalization and emergency department visits, with hospitalizations reduced by 56% versus nurse-managed service and 61% versus usual care (p<0.01). Emergency department visits were reduced by 78% in both the nurse-managed and usual care models (p<0.002). Based on visit rates, the pharmacist-managed service averted $141,277.34 in hospitalization costs and $10,183.76 in emergency department visit costs versus the nurse-managed service and $95,579.08 in hospitalization costs and $5511.21 in emergency department costs compared with the usual caremodel. Conclusion. Pharmacist-managed anticoagulation management services reduced the rates of anticoagulation-related emergency department visits and hospitalizations, with significant financial impact. Based on results of this study, a collaborative clinic using pharmacists, nurses, and physicians may be the optimal structure for an anticoagulation management service, with these results verified in future prospective randomized studies.
Hodgman M.J.,SUNY Upstate Medical University |
Hodgman M.J.,Bassett Medical Center |
Garrard A.R.,SUNY Upstate Medical University
Critical Care Clinics | Year: 2012
Acetaminophen poisoning remains one of the more common drugs taken in overdose with potentially fatal consequences. Early recognition and prompt treatment with N-acetylcysteine can prevent hepatic injury. With acute overdose, the Rumack-Matthew nomogram is a useful tool to assess risk and guide management. Equally common to acute overdose is the repeated use of excessive amounts of acetaminophen. Simultaneous ingestion of several different acetaminophen-containing products may result in excessive dosage. These patients also benefit from N-acetylcysteine. Standard courses of N-acetylcysteine may need to be extended in patients with persistently elevated plasma concentrations of acetaminophen or with signs of hepatic injury. © 2012 Elsevier Inc.
Rudd K.M.,Bassett Medical Center |
Winans A.R.M.,Bassett Medical Center |
Panneerselvam N.,Bassett Medical Center
Pharmacotherapy | Year: 2015
Rivaroxaban, a factor Xa inhibitor, is a direct-acting oral anticoagulant (DOAC) indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for reducing the risk of DVT and PE recurrence. To our knowledge, no data are presently available to guide DOAC dosing in the postpartum period when pharmacokinetic and pharmacodynamic changes induced by pregnancy have an impact on drug clearance and increase hypercoagulability for a period of 6-8 weeks after delivery. We describe the case of a 35-year-old postpartum woman who presented to the emergency department with a diagnosis of a new multiple segmental PE 5 days after starting rivaroxaban therapy for a diagnosis of DVT. No precipitating cause, including noncompliance, was identified as a source of thrombosis embolization or extension. The patient was admitted, a heparin infusion was started for the management of PE, and rivaroxaban was discontinued. She was transitioned to enoxaparin 1 mg/kg (90 mg) subcutaneously every 12 hours the next day, bridged to warfarin, and discharged home on the overlapping regimen with close follow-up by the pharmacist-managed outpatient Anticoagulation Management Service. To our knowledge, this is the first case report of potential failure associated with rivaroxaban therapy in the postpartum period, possibly due to pharmacokinetic alterations seen in the postpartum period contributing to decreased drug exposure, yielding reduced anticoagulant efficacy. Clinicians should carefully weigh the risks and benefits of DOAC therapy in postpartum patients or other special populations requiring anticoagulation therapy. This report also highlights the need for further research identifying the impact of pharmacokinetic changes induced by special populations and the need to develop monitoring assays for such clinical situations. © 2015 Pharmacotherapy Publications, Inc.
Buppajarntham S.,Albert Einstein Medical Center |
Junpaparp P.,Albert Einstein Medical Center |
Kue-A-Pai P.,Bassett Medical Center
American Journal of Emergency Medicine | Year: 2013
Warburg effect is a rare metabolic complication in hematologic malignancies, commonly presented with lactic acidosis and hypoglycemia. Mechanism explained by abnormality of mitochondrial oxidative phosphorylation in cancer cells and energy production is mostly dependent on anaerobic respiration or glycolysis pathway to meet large tumor demand. We present a case with history of lymphoplasmacytic lymphoma and Waldenstörm macroglobulinemia, partial response to chemotherapy. Lymphoplasmacytic lymphoma transformed to diffuse large B-cell lymphoma, which is aggressive and rapid progression, leading to Warburg effect. Patient developed more than 10-cm retroperitoneal mass less than 1 year, and his symptoms were progressively worsening within 3 weeks. Warburg effect represents poor prognosis no matter with or without hypoglycemia. Treatment of choice is cytoreduction with early chemotherapy. Our patient died 2 days after Warburg effect occurred. © 2013 Elsevier Inc.
Oba Y.,University of Missouri |
Lone N.A.,Bassett Medical Center
Therapeutic Advances in Respiratory Disease | Year: 2015
Background: We hypothesized a class effect of currently available long-acting muscarinic antagonists (LAMAs; i.e. tiotropium as a dry powder inhaler or a soft mist inhaler, aclidinium bromide, and glycopyrronium) in preventing chronic obstructive pulmonary disease (COPD) exacerbations. The hypothesis was tested with a network meta-analysis. Methods: Several databases and manufacturer's websites were searched for relevant clinical trials. Randomized, controlled trials, of at least 12 weeks duration, comparing a LAMA with placebo or another LAMA were included. Moderate-to-severe and severe exacerbations were chosen as the outcome assessment criteria. The data were pooled using network metaanalysis. Results: A total of 27 studies with 48,140 subjects were included. All LAMAs reduced moderate-to-severe exacerbations compared with placebo. However, there were no statistically significant differences in preventing moderate-to-severe or severe exacerbations among LABAs. In a subgroup analysis restricting studies to those that had a minimum of 6 months of treatment, glycopyrronium was associated with the least-effective strategy and aclidinium was associated with the greatest probability of being the best therapy in preventing severe exacerbations. Our meta-regression analysis suggested that the prevention of COPD exacerbations were less effective in studies which allowed concomitant use of a long-acting beta agonist (LABA). Conclusion: All LAMAs were equally effective in preventing moderate-to-severe exacerbations. Aclidinium was associated with the lowest risk for severe exacerbations when treatment duration was 6 months or longer. The concomitant use of LABA may not enhance the efficacy of LAMAs in preventing COPD exacerbations. More studies are needed to further examine above findings. © The Author(s), 2015.
Greene M.W.,Bassett Research Institute |
Burrington C.M.,Bassett Research Institute |
Ruhoff M.S.,Bassett Research Institute |
Johnson A.K.,Bassett Research Institute |
And 2 more authors.
Journal of Biological Chemistry | Year: 2010
Hepatic steatosis can progress to the clinical condition of non-alcoholic steatohepatitis (NASH), which is a precursor of more serious liver diseases. The novel PKC isoforms δ and ε are activated by lipid metabolites and have been implicated in lipid-induced hepatic disease. Using a methionine- and choline- deficient (MCD) dietary model of NASH, we addressed the question of whether hepatic PKCδ and PKCε are activated. With progression from steatosis to steatohepatitis, there was activation and increased PKCδ protein content coincident with hepatic endoplasmic reticulum (ER) stress parameters. To examine whether similar changes could be induced in vitro, McA-RH 7777 (McA) hepatoma cells were used. We observed that McA cells stored triglyceride and released alanine aminotransferase (ALT) when treated with MCD medium in the presence of fatty acids. Further, MCD medium with palmitic acid, but not oleic or linoleic acids, maximally activated PKCδ and stimulated ER stress. In PKCδ knockdown McA cells, MCD/fatty acid medium-induced ALT release and ER stress induction were completely blocked, but triglyceride storage was not. In addition, a reduction in the uptake of propidium iodide and the number of apoptotic nuclei and a significant increase in cell viability and DNA content were observed in PKCδ knockdown McA cells incubated in MCD medium with palmitic acid. Our studies show that PKCδ activation and protein levels are elevated in an animal model of steatohepatitis, which was recapitulated in a cell model, supporting the conclusion that PKCδ plays a role in ALT release, the ER stress signal, and cell death. © 2010 by The American Society for Biochemistry and Molecular Biology, Inc.
Lancey R.A.,Bassett Medical Center
Journal of Cardiac Surgery | Year: 2010
Numerous analyses have identified an inverse relationship between case volume in coronary artery bypass graft (CABG) surgery and mortality, and have led some to call for the consideration of minimum-volume standards for open-heart surgery programs. These findings, however, have been questioned by studies that demonstrate a weak or absent association, and by the availability of risk-adjusted mortality data. There is also growing evidence that clinical care processes have greater impact on mortality than sheer numbers alone. Policy decisions that may address this issue in the future need to consider the impact of mandating referrals away from low-volume programs, including the negative financial and programmatic effect on hospitals and both the clinical and social ramifications for patients and families, particularly in rural regions of the country. © 2010 Wiley Periodicals, Inc.
Calore B.L.,Bassett Medical Center |
Cheung R.C.,Stanford University |
Giori N.J.,Stanford University
Journal of Arthroplasty | Year: 2012
Many orthopedic surgeons train or are employed at the Department of Veterans Affairs (VA) hospitals. We sought to determine the prevalence of hepatitis C antibody-positive and hepatitis C-viremic patients in the VA population undergoing total joint arthroplasty. In this prospective cohort study, 381 of 408 patients undergoing primary total joint arthroplasty for 22 consecutive months were tested for hepatitis C virus (HCV) infection preoperatively. Thirty-two (8.4%) of 381 patients were positive for hepatitis C virus antibody. Seventeen were actually viremic at the time of total joint arthroplasty (4.5%). The prevalence of detectable hepatitis C antibody in VA patients undergoing total joint arthroplasty is about 6 times the general population (1.3%). Surgeons practicing on populations with a high prevalence of hepatitis C such as this should do all they can to minimize the risk of sharps injury. © 2012.