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  • Health Law, Ethics, and Human RightsOnline First

    Regulation of Medical Devices in the United States and European Union

    Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate…

    • February 14, 2012
    • Kramer D.B., Xu S., Kesselheim A.S.
    • 10.1056/NEJMhle1113918
    • Free Full Text

    Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves ...

  • PerspectiveOnline First

    Postmarketing Surveillance of Medical Devices — Filling in the Gaps

    Failures of implantable medical devices, although rare, can carry a substantial risk of serious injury. From 2000 through 2011, more than 150 new high-risk medical devices were approved by the Food and Drug Administration (FDA) through the premarket approval (known as PMA) process, and an…

    • February 14, 2012
    • Resnic F.S. and Normand S.-L.T.
    • 10.1056/NEJMp1114865
    • Free Full Text

    Failures of implantable medical devices, although rare, can carry a substantial risk of serious injury. From 2000 through 2011, more than 150 new high-risk medical devices were approved by the Food and Drug Administration (FDA) through the premarket ...

  • Correspondence

    Sildenafil for Severe Lymphatic Malformations

    To the Editor: Lymphatic malformations are uncommon congenital vascular anomalies that can cause complications including obstruction of vital organs and their function, recurrent infection, and disfigurement. Current procedural treatments are only partially successful, and lymphatic malformations…

    • January 26, 2012
    • N Engl J Med 2012; 366:384 - 386
    • Free Full Text

    Lymphatic malformations are rare but can cause significant clinical problems in addition to cosmetic disfigurement. Sildenafil was used in a child whose pulmonary hypertension was caused by lymphatic malformation; the result was a marked decrease in the lymphatic malformation.

  • Original Article

    Lifetime Risks of Cardiovascular Disease

    In recent decades, clinical and public health efforts to reduce the burden of cardiovascular disease have emphasized the importance of calculating global, short-term (generally 10-year) risk estimates. However, the majority of adults in the United States who are considered to be at low risk for…

    • January 26, 2012
    • Berry J.D., Dyer A., Cai X., et al.
    • N Engl J Med 2012; 366:321 - 329

      Data from more than 250,000 men and women in 18 cohort studies were used to calculate the lifetime risk of cardiovascular events, stratified according to risk-factor burden, with adjustment for the competing risk of death from noncardiovascular causes.

    • Images in Clinical Medicine

      Jugular Venous C-V Wave in Severe Tricuspid Regurgitation

      Figure 1.

      • January 12, 2012
      • Senguttuvan N.B. and Karthikeyan G.
      • N Engl J Med 2012; 366:e5
      • Free Full Text
      • Video

      An 18-year-old man presented with a history of progressive anasarca and exertional dyspnea. His jugular venous pressure was elevated and showed prominent systolic pulsations that were eliminated when gentle pressure was applied at the base of the neck.

    • Clinical Problem-Solving

      Breathless

      Foreword. In this Journal feature, information about a real patient is presented in stages (boldface type) to an expert clinician, who responds to the information, sharing his or her reasoning with the reader (regular type). The authors' commentary follows. Stage. A 50-year-old woman was admitted…

      • January 5, 2012
      • Gavin M.C., Morse D., Partridge A.H., Levy B.D., Loscalzo J.
      • N Engl J Med 2012; 366:75 - 81
      • CME
      • Video

      A 50-year-old woman presented with fatigue and shortness of breath. Dyspnea after moderate exertion had developed gradually, along with profound malaise and a nonproductive cough. In the 48 hours before admission, her shortness of breath had worsened.

    • Perspective

      200th Anniversary Article: A Reader's Guide to 200 Years of the New England Journal of Medicine

      With this issue, the New England Journal of Medicine marks its 200th anniversary. In January 1812, as the first issue came off the handset letterpress, few of its founders could have predicted such continuity and success. (See Figure 1, from an 1812 issue.) John Collins Warren, the renowned Boston…

      • January 5, 2012
      • Brandt A.M.
      • N Engl J Med 2012; 366:1 - 7
      • Free Full Text
      • Audio

      In the past 200 years, the Journal has covered and participated in seismic change in medical knowledge and practice. Yet the Journal 's history also exposes a stability of orientation and approach to fundamental problems of disease in patients and populations.

    • Perspective

      Timeline: 200 Years of the New England Journal of Medicine

      This interactive timeline represents all the research and review articles and case reports published in the New England Journal of Medicine from 1812 to 2012. The expanding navigation panel at the top of the timeline is an overview of the 200 years, with articles color-coded by medical specialty.…

      • January 5, 2012
      • Müller D.C., Duff E.M.C., Stern K.L.
      • N Engl J Med 2012; 366:e3
      • Free Full Text
      • Interactive/Multimedia

      This interactive timeline represents all the research and review articles and case reports published in the New England Journal of Medicine from 1812 to 2012. The expanding navigation panel at the top of the timeline is an overview of the 200 years, with ...

    • Images in Clinical Medicine

      Pneumopericardium Associated with a Peptic Ulcer

      Figure 1.

      • December 22, 2011
      • Andrianov A. and Nissenbaum M.A.
      • N Engl J Med 2011; 365:2412
      • Free Full Text

      A 63-year-old man with a history of peptic ulcer and recent use of NSAIDs presented to the emergency department with acute shortness of breath and chest pain. He had hypotension and tachycardia.

    • Interactive Medical Case

      Breathless

      A 50-year-old woman presented with fatigue and shortness of breath. One week before presentation, she experienced the gradual onset of dyspnea after moderate exertion, profound malaise, and a non-productive cough. In the 48 hours before admission, her shortness of breath worsened, such that she was…

      • December 22, 2011
      • Ross J.J., Vaidya A., Gavin M.C., Morse D., Partridge A.H.
      • N Engl J Med 2011; 365:e47
      • Free Full Text
      • CME

      A 50-year-old woman presented with fatigue and shortness of breath. One week before presentation, she experienced the gradual onset of dyspnea after moderate exertion, profound malaise, and a non-productive cough. In the 48 hours before admission, her ...

    • Images in Clinical Medicine

      Internal-Carotid-Artery Dissection and Cranial-Nerve Palsies

      Figure 1.

      • December 8, 2011
      • Peltz E. and Köhrmann M.
      • N Engl J Med 2011; 365:e43
      • Free Full Text
      • Video

      A 45-year-old woman presented to the emergency department 3 days after the acute onset of severe dysphagia, breathy dysphonia, and earache and pulsatile tinnitus in the left ear. Her medical history was unremarkable. Physical examination revealed leftward ...

    • Images in Clinical Medicine

      Persistent Stapedial Artery Visualized through a Perforated Tympanic Membrane

      Figure 1.

      • December 1, 2011
      • Lollar K.W. and Bien A.G.
      • N Engl J Med 2011; 365:e42
      • Free Full Text
      • Video

      A 29-year-old woman presented with a perforation of the right tympanic membrane secondary to previously placed tympanostomy tubes. The perforation was 25% of the size of the tympanic membrane. She also reported mild intermittent pulsatile tinnitus and hearing loss.

    • Original Article

      ADHD Drugs and Serious Cardiovascular Events in Children and Young Adults

      Medications that are used to treat attention deficit–hyperactivity disorder (ADHD) are prescribed for more than 2.7 million children in the United States each year and have been considered to be relatively safe.– However, reports of adverse events from Canada and the United States that have…

      • November 17, 2011
      • Cooper W.O., Habel L.A., Sox C.M., et al.
      • N Engl J Med 2011; 365:1896 - 1904

        This large study found no increased risk of cardiovascular events in children and young adults using attention deficit–hyperactivity disorder (ADHD) drugs. Although the data are compatible with nearly a doubling of risk, the study was underpowered and the absolute event rate was quite low.

      • Perspective

        Medical Device Innovation — Is “Better” Good Enough?

        Last year, the United States spent $95 billion on medical devices, nearly half of the $200 billion spent on devices worldwide. Our investment in devices has yielded impressive gains in length and quality of life from products such as implantable cardioverter–defibrillators, pacemakers, and…

        • October 20, 2011
        • Suter L.G., Paltiel A.D., Rome B.N., et al.
        • N Engl J Med 2011; 365:1464 - 1466
        • Free Full Text

        The FDA approves many devices on the basis of similarity to precursors, possibly encouraging development of slightly improved, higher-cost devices. A modeling approach can illuminate interplay among efficacy and durability, patient characteristics, costs, and outcomes.

      • Original Article

        Long Interdialytic Interval and Mortality among Patients Receiving Hemodialysis

        Although some progress has been made in the past two decades, survival rates among patients receiving hemodialysis in the United States remain among the lowest in the world. As in most countries, maintenance hemodialysis in the United States is typically performed three times per week, with two 1…

        • September 22, 2011
        • Foley R.N., Gilbertson D.T., Murray T., Collins A.J.
        • N Engl J Med 2011; 365:1099 - 1107

          Patients receiving thrice-weekly hemodialysis have two 1-day intervals and one 2-day interval between treatments. This study shows that the risks of death and cardiovascular events leading to hospital admission are increased during the long (2-day) interdialytic interval.

        • Images in Clinical Medicine

          Ortner's Syndrome

          Figure 1.

          • September 8, 2011
          • Prada-Delgado O. and Barge-Caballero E.
          • N Engl J Med 2011; 365:939
          • Free Full Text

          A 62-year-old woman presented with a 2-year history of progressive vocal hoarseness. She had had mitral-valve replacement for rheumatic mitral stenosis 21 years earlier, but her severe pulmonary hypertension had not resolved, and progressive clinical manifestations had developed.

        • Perspective

          Global Noncommunicable Diseases — Lessons from the HIV–AIDS Experience

          The ubiquity and impact of noncommunicable diseases such as cardiovascular diseases, type 2 diabetes, cancers, chronic obstructive pulmonary disease, and psychiatric disorders present major global health, development, and societal challenges. Acknowledging this fact, the United Nations (UN) General…

          • September 8, 2011
          • Narayan K.M.V., Ali M.K., del Rio C., Koplan J.P., Curran J.
          • N Engl J Med 2011; 365:876 - 878
          • Free Full Text

          In preparation for the UN General Assembly's upcoming meeting on addressing global noncommunicable diseases, it is worth reexamining the global experience with HIV–AIDS for lessons that may be applicable to initiatives for noncommunicable diseases.

        • Interactive Medical Case

          A Problem in Gestation

          A 39-year-old woman (gravida 2, para 0) presented to her obstetrician at 32 weeks of gestation with pain in her lower back that began 2 days earlier. The pain was abrupt in onset and constant; she reported no fever, chills, nausea, vomiting, dysuria, urinary frequency, hematuria, vaginal bleeding,…

          • August 18, 2011
          • Ross J.J., Chamarthi B., Greene M.F., Dluhy R.G.
          • N Engl J Med 2011; 365:e15
          • Free Full Text
          • CME

          A 39-year-old woman (gravida 2, para 0) presented to her obstetrician at 32 weeks of gestation with pain in her lower back that began 2 days earlier. The pain was abrupt in onset and constant; she reported no fever, chills, nausea, vomiting, dysuria, ...

        • Review Article

          Mechanisms of Disease: Oxygen Sensing, Homeostasis, and Disease

          Hypoxia plays critical roles in the pathobiology of heart disease, cancer, stroke, and chronic lung disease, which are responsible for 60% of deaths in the United States. This review summarizes advances in our understanding of how cells sense and respond to changes in oxygen availability and the…

          • August 11, 2011
          • Semenza G.L.
          • N Engl J Med 2011; 365:537 - 547
          • CME

          Pathways that sense a reduction in available oxygen are critical in the adaptation to lower oxygen tensions at high altitude. Alterations in this system can contribute to the pathogenesis of heart disease, cancer, stroke, chronic lung disease, and many other disorders.

        • Original Article

          Carotid-Wall Intima–Media Thickness and Cardiovascular Events

          Carotid-wall intima–media thickness is a surrogate measure of atherosclerosis associated with cardiovascular risk factors and with cardiovascular outcomes.– The intima–media thickness is the distance from the lumen–intima interface to the media–adventitia interface of the artery wall, as…

          • July 21, 2011
          • Polak J.F., Pencina M.J., Pencina K.M., et al.
          • N Engl J Med 2011; 365:213 - 221
          • Free Full Text
          • CME

          The authors examined carotid-artery intima–media thickness as a risk factor for cardiovascular events. The internal carotid artery measurement had more value in risk assessment than the measurement for the common carotid artery, but the difference was only modest.

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        Medical Meetings Conferences and Meetings

        American Association for the Study of Liver Diseases

        The following courses will be offered in Atlanta, unless otherwise indicated: "Hepatitis Single Topic Conference: HCV Direct Antiviral Agents (DAA): Concepts, Development and Optimal Use" (March 16 and 17); "The Henry M. and Lillian Stratton Basic Research Single Topic Conference: Mitochondria and Hepatotoxicity" (June 8 and 9); "Clinical Research Single Topic Conference: Acetaminophen Poisoning" (June 9 and 10); and "63rd Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting 2012" (Boston, Nov. 9-13).

        Contact AASLD, 1001 North Fairfax St., Suite 400, Alexandria, VA 22314; or call (703) 299-9766; or see http://www.aasld.org .

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