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Perspective
Here We Go Again — Another Failure of Postmarketing Device Surveillance
The goal of postmarketing surveillance of medical devices is to enhance public health by gathering information about the incidence of adverse experiences with devices. However, patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after…
- February 14, 2012
- Hauser R.G.
- 10.1056/NEJMp1114695
- Free Full Text
The goal of postmarketing surveillance of medical devices is to enhance public health by gathering information about the incidence of adverse experiences with devices. However, patients in the United States continue to be exposed to underperforming and ...
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Perspective
Time for a Change — A New Approach to ICD Replacement
Clinical trials of implantable cardioverter–defibrillators (ICDs) continue to drive expanding indications for these devices. More than 100,000 ICDs are implanted in the United States annually. Of these procedures, at least 25% are generator replacements required as a result of depleted battery…
- January 26, 2012
- Kramer D.B., Buxton A.E., Zimetbaum P.J.
- N Engl J Med 2012; 366:291 - 293
- Free Full Text
Of the 100,000-plus implantable cardioverter–defibrillators (ICDs) implanted in the United States annually, at least 25% are generator replacements required for depleted batteries. Should all those patients be receiving replacement ICDs?
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Original Article
Subclinical Atrial Fibrillation and the Risk of Stroke
Atrial fibrillation may be asymptomatic and consequently subclinical. Epidemiologic studies indicate that many patients with atrial fibrillation on screening electrocardiograms had not previously received a diagnosis of atrial fibrillation. About 15% of strokes are attributable to documented atrial…
- January 12, 2012
- Healey J.S., Connolly S.J., Gold M.R., et al.
- N Engl J Med 2012; 366:120 - 129
- CME
A cohort of 2580 patients with pacemakers or defibrillators were monitored for 3 months to detect subclinical atrial tachyarrhythmias. Patients with subclinical atrial tachyarrhythmias had a significantly increased risk of subsequent ischemic stroke.
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Editorial
How Much Atrial Fibrillation Is Too Much Atrial Fibrillation?
Modern cardiac pacemakers and defibrillators function as permanently implanted cardiac monitors, detecting atrial and ventricular arrhythmias. Although the principal purpose of collecting this information is to manage the patient's cardiac rhythm, these data can also be used to detect and study…
- January 12, 2012
- Lamas G.
- N Engl J Med 2012; 366:178 - 180
Modern cardiac pacemakers and defibrillators function as permanently implanted cardiac monitors, detecting atrial and ventricular arrhythmias. Although the principal purpose of collecting this information is to manage the patient's cardiac rhythm, these ...
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Clinical Therapeutics
Catheter Ablation for Atrial Fibrillation
Foreword. This Journal feature begins with a case vignette that includes a therapeutic recommendation. A discussion of the clinical problem and the mechanism of benefit of this form of therapy follows. Major clinical studies, the clinical use of this therapy, and potential adverse effects are…
- December 15, 2011
- Wazni O., Wilkoff B., Saliba W.
- N Engl J Med 2011; 365:2296 - 2304
- CME
A 59-year-old man presents with a recurrent episode of symptomatic atrial fibrillation despite attempts to maintain sinus rhythm with antiarrhythmic drugs. Catheter ablation can be effective in such patients, but more than one procedure may be necessary.
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Original Article
Dronedarone in High-Risk Permanent Atrial Fibrillation
Dronedarone is a new antiarrhythmic agent that is used to restore sinus rhythm and to reduce rates of hospitalization for cardiovascular causes in patients with intermittent (paroxysmal or persistent) atrial fibrillation. In ATHENA (A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess…
- December 15, 2011
- Connolly S.J., Camm A.J., Halperin J.L., et al.
- N Engl J Med 2011; 365:2268 - 2276
Patients with permanent atrial fibrillation and additional cardiac risk factors were randomly assigned to receive either dronedarone or placebo. At a median of 3.5 months, the risk of major adverse cardiovascular events was significantly increased with dronedarone.
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Editorial
Dronedarone in Atrial Fibrillation — Jekyll and Hyde?
Atrial fibrillation, the most common type of sustained cardiac arrhythmia, is associated with increased morbidity and mortality and is often therapeutically challenging. Dronedarone is a recently introduced antiarrhythmic drug that was developed by modifying the structure of amiodarone in an effort…
- December 15, 2011
- Nattel S.
- N Engl J Med 2011; 365:2321 - 2322
Atrial fibrillation, the most common type of sustained cardiac arrhythmia, is associated with increased morbidity and mortality and is often therapeutically challenging.¹ Dronedarone is a recently introduced antiarrhythmic drug that was developed by ...
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Review Article
Genomic Medicine: Genomics of Cardiovascular Disease
Cardiovascular disease is the leading cause of death in the United States. Considerable progress has been made in the past 50 years to define, identify, and modify risk factors for cardiovascular disease (e.g. hypertension, dyslipidemia, obesity, type 2 diabetes, cigarette smoking, and physical…
- December 1, 2011
- O'Donnell C.J. and Nabel E.G.
- N Engl J Med 2011; 365:2098 - 2109
- Free Full Text
- Interactive/Multimedia
The authors provide an overview of how genetic and genomic studies have improved our understanding of the cause of cardiovascular disease.
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Clinical Problem-Solving
A Hidden Solution
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 51-year-old woman presented to…
- December 1, 2011
- Pramyothin P., Leung A.M., Pearce E.N., Malabanan A.O., Braverman L.E.
- N Engl J Med 2011; 365:2123 - 2127
- CME
A 51-year-old woman presented to the ER with a 6-month history of intermittent palpitations, which had worsened that day. She described her pulse as fast but regular. She also reported worsening fatigue, heat intolerance, and an 18-kg (40-lb) weight loss.
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Original Article
Comparative Effectiveness of Weight-Loss Interventions in Clinical Practice
Obesity is an important and growing public health problem around the world. In the United States, approximately one third of adults are obese. Obesity adversely affects each of the major cardiovascular risk factors — blood pressure, lipid profile, and diabetes. As a consequence, obese persons…
- November 24, 2011
- Appel L.J., Clark J.M., Yeh H.-C., et al.
- N Engl J Med 2011; 365:1959 - 1968
- CME
This trial showed that two types of behavioral interventions, one based on remote, call-center support and the other on in-person support, resulted in significant weight loss among obese patients. These results provide templates for effective weight-loss programs in primary care practices.
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Clinical Implications of Basic Research
Calcium Handling in the Failing Heart and SUMO — Weighing the Evidence
A key abnormality in heart failure is defective handling of calcium ions by cardiomyocytes. In the healthy heart, the action potential leads to an increase in the level of intracellular calcium (and subsequent systole) through two mechanisms. First, extracellular calcium enters the cell through L…
- November 3, 2011
- McMurray J.J.V. and Smith G.L.
- N Engl J Med 2011; 365:1738 - 1739
Heart failure has been attributed to a deficiency in a calcium ATPase. A recent study shows that tweaking this enzyme may boost its levels and thus guard against heart failure.
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Perspective
Evaluating Rivaroxaban for Nonvalvular Atrial Fibrillation — Regulatory Considerations
On September 8, 2011, the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration (FDA) discussed data submitted in support of the new drug application for rivaroxaban for preventing stroke and non–central nervous system systemic embolic events in patients with…
- October 27, 2011
- Fleming T.R. and Emerson S.S.
- N Engl J Med 2011; 365:1557 - 1559
- Free Full Text
An FDA advisory committee recently considered a new drug application for rivaroxaban for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation, but there are important concerns about interpretation of the results of the key study.
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Original Article
Apixaban versus Warfarin in Patients with Atrial Fibrillation
Patients with atrial fibrillation are at increased risk for stroke. Warfarin and other vitamin K antagonists are highly effective treatments, reducing the risk of stroke by about two thirds, but their use is limited by a narrow therapeutic range, drug and food interactions, required monitoring, and…
- September 15, 2011
- Granger C.B., Alexander J.H., McMurray J.J.V., et al.
- N Engl J Med 2011; 365:981 - 992
- CME
The oral direct factor Xa inhibitor, apixaban, was compared with warfarin in atrial fibrillation. Apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and lowered mortality.
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Editorial
A New Era for Anticoagulation in Atrial Fibrillation
For more than 50 years, warfarin has been the primary medication used to reduce the risk of thromboembolic events in patients with atrial fibrillation. Despite its clinical efficacy, warfarin has multiple, well-known limitations, including numerous interactions with other drugs and the need for…
- September 15, 2011
- Mega J.L.
- N Engl J Med 2011; 365:1052 - 1054
For more than 50 years, warfarin has been the primary medication used to reduce the risk of thromboembolic events in patients with atrial fibrillation. Despite its clinical efficacy, warfarin has multiple, well-known limitations, including numerous ...
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Original Article
Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation
Atrial fibrillation is associated with an increase in the risk of ischemic stroke by a factor of four to five and accounts for up to 15% of strokes in persons of all ages and 30% in persons over the age of 80 years. The use of vitamin K antagonists is highly effective for stroke prevention in…
- September 8, 2011
- Patel M.R., Mahaffey K.W., Garg J., et al.
- N Engl J Med 2011; 365:883 - 891
- CME
In this trial, 14,264 patients with atrial fibrillation were randomly assigned to receive either rivaroxaban or warfarin. In a per-protocol, as-treated analysis, rivaroxaban was noninferior to warfarin with respect to the primary end point of stroke or systemic embolism.
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Editorial
New Options in Anticoagulation for Atrial Fibrillation
The presence of atrial fibrillation significantly increases the risk and burden of thromboembolic stroke. Warfarin is the reference standard treatment for the primary prevention of embolic stroke during atrial fibrillation. However, the long-term use of warfarin has its limitations. Although…
- September 8, 2011
- del Zoppo G.J. and Eliasziw M.
- N Engl J Med 2011; 365:952 - 953
The presence of atrial fibrillation significantly increases the risk and burden of thromboembolic stroke.¹ Warfarin is the reference standard treatment for the primary prevention of embolic stroke during atrial fibrillation.² However, the long-term use of ...
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Original Article
Early versus Later Rhythm Analysis in Patients with Out-of-Hospital Cardiac Arrest
Out-of-hospital cardiac arrest is a common and lethal problem, leading to an estimated 330,000 deaths each year in the United States and Canada. Overall, the rate of survival to hospital discharge among patients with an out-of-hospital cardiac arrest who are treated by emergency medical services…
- September 1, 2011
- Stiell I.G., Nichol G., Leroux B.G., et al.
- N Engl J Med 2011; 365:787 - 797
- CME
Patients with cardiac arrest were assigned to either early analysis of cardiac rhythm (after 30 to 60 seconds of cardiopulmonary resuscitation) or later analysis (after 180 seconds). There was no significant difference between the groups in survival to hospital discharge.
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Original Article
A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest
Standard cardiopulmonary resuscitation (CPR), defined as manual chest compressions with rescue breathing, can be lifesaving but provides only a relatively small fraction of normal cardiac output, even when performed correctly. One proposed strategy to augment cardiac output during CPR is the use of…
- September 1, 2011
- Aufderheide T.P., Nichol G., Rea T.D., et al.
- N Engl J Med 2011; 365:798 - 806
Patients with out-of-hospital cardiac arrest were assigned to the use of either an impedance threshold device (ITD) or a sham ITD. There was no significant difference between the two groups in survival to hospital discharge with satisfactory functional status.
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Editorial
Cardiac Arrest and the Limitations of Clinical Trials
Out-of hospital cardiac arrest accounts for more than 330,000 deaths annually in the United States and Canada. Despite regular updates of guidelines for the management of these arrests, the rate of survival has been stagnant at 7.6% for more than 30 years. In this issue of the Journal, the…
- September 1, 2011
- Sanders A.B.
- N Engl J Med 2011; 365:850 - 851
Out-of hospital cardiac arrest accounts for more than 330,000 deaths annually in the United States and Canada. Despite regular updates of guidelines for the management of these arrests, the rate of survival has been stagnant at 7.6% for more than 30 ...
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Clinical Therapeutics
Antitrypanosomal Therapy for Chronic Chagas' Disease
Foreword. This Journal feature begins with a case vignette that includes a therapeutic recommendation. A discussion of the clinical problem and the mechanism of benefit of this form of therapy follows. Major clinical studies, the clinical use of this therapy, and potential adverse effects are…
- June 30, 2011
- Bern C.
- N Engl J Med 2011; 364:2527 - 2534
- CME
A 42-year-old woman presents after donating blood and receiving a report that she is positive for Chagas' disease. Chagas' disease is caused by a parasite and is endemic in many parts of Latin America.
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