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The New England journal of medicine
Massachusetts Medical Society
The New England journal of medicine

Massachusetts Medical Society

0028-4793

The New England journal of medicine/Journal The New England journal of medicine
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    Public Carry versus Public Health — The Harms to Come from the Supreme Court’s Decision in Bruen

    Michael R. Ulrich
    3页
    查看更多>>摘要：In June, the U.S. Supreme Court ruled in New York State Rifle & Pistol Association v. Bruen that the Second Amendment provides a constitutionally protected right to carry firearms in public. The decision is already creating turmoil in the form of political and public backlash and a scramble by policymakers to find new ways to combat the growing gun-violence epidemic in the United States. The majority opinion in Bruen, written by Justice Clarence Thomas, will have a devastating impact on efforts to mitigate gun violence and address racial disparities, but the reasoning used in the decision could cause even more havoc moving forward. In Bruen, the Supreme Court struck down a 1913 New York law requiring persons seeking a permit to carry guns in public to show they had a specific need for doing so.
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    A Grim New Reality — Intimate-Partner Violence after Dobbs and Bruen

    Elizabeth Tobin-Tyler
    3页
    查看更多>>摘要：The Supreme Court’s recent decision in Dobbs v. Jackson Women’s Health Organization, which allows states to ban or restrict access to abortion, will have many implications for the health, economic stability, and equal opportunity of people who can become pregnant. A critical but often overlooked consequence of state abortion restrictions is the profound effect they can have on people experiencing intimate-partner violence (IPV). IPV encompasses physical and sexual violence and intimidation, as well as psychological abuse. Overall, one in three women in the United States experiences contact sexual violence, physical violence, or stalking by an intimate partner (or a combination of these) at some point, with higher rates among women in historically marginalized racial or ethnic groups (see graph).1 At the same time, the Court’s decision in New York State Rifle & Pistol Association v. Bruen to strike down state limits on who may carry a firearm in public could also have important repercussions for people in abusive relationships.
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    The Macro-Harm of Micro-Geography

    Dorothy R. Novick
    3页
    查看更多>>摘要："Every time you turn on news, it’s someone you know that’s been shot,” Ms. T. says. She sits in the same exam room where I’ve seen her for 26 years, first as a patient in my pediatric practice and now as a mother. Philadelphia’s row homes stretch for miles outside the plateglass window, and I try to imagine each shooting striking one of my friends or relatives or neighbors. “My faith gets me by, Dr. Novick,” she says, pulling 4-year-old L. onto her lap. “But. . . you go through each day never knowing who’s next.” I can still see Ms. T. from the time she was born. I was early in residency — each of us new to our worlds — and overcome with wonder and responsibility. I remember her as a toddler, so proud to become a big sister. And on her fifth birthday, twirling and giggling as her silver tiara slipped over her eyes. And in middle school, saying dance was her escape from the violence on her block. And at 16, sobbing and frantic because her little brother had been shot in, the head. The mother before me has the same natural beauty that she had as a child, but her face is more downcast now, and her movements are noticeably slower.
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    Cerebral Embolie Protection during Transcatheter Aortic-Valve Replacement

    Samir R. KapadiaRaj MakkarMartin LeonMohamed Abdel-Wahab...
    11页
    查看更多>>摘要：BACKGROUND Transcatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke. METHODS We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR. RESULTS A total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, -0.6 percentage points; 95% confidence interval, -1.7 to 0.5; P=0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site. CONCLUSIONS Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.)
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    Trial of Intravenous Immune Globulin in Dermatomyositis

    Chafic KaramNina MagnoloRonald NelsonNataliia Pozur...
    15页
    查看更多>>摘要：BACKGROUND Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated. METHODS We conducted a randomized, placebo-controlled trial involving patients with active dermatomyositis. The patients were assigned in a 1:1 ratio to receive IVIG at a dose of 2.0 g per kilogram of body weight or placebo every 4 weeks for 16 weeks. The patients who received placebo and those without confirmed clinical deterioration while receiving IVIG could enter an open-label extension phase for another 24 weeks. The primary end point was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score reflecting the change in a core set of six measures of myositis activity over time; scores range from 0 to 100, with higher scores indicating greater improvement. Key secondary end points included at least moderate improvement (TIS >40) and major improvement (TIS >60), and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index. RESULTS A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<O.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events. CONCLUSIONS In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.)
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    A Bivalent Omicron-Containing Booster Vaccine against Covid-19

    Spyros ChalkíasCharles HarperKeith VrbickyStephen R. Walsh...
    13页
    查看更多>>摘要：Background: The safety and immunogenicity of the bivalent omicron-containing mRNA-1273.214 booster vaccine are not known. Methods: In this ongoing, phase 2-3 study, we compared the 50-μg bivalent vaccine mRNA-1273.214 (25 μg each of ancestral Wuhan-Hu-1 and omicron B.1.1.529 [BA.1] spike messenger RNAs) with the previously authorized 50-μg mRNA-1273 booster. We administered mRNA-1273.214 or mRNA-1273 as a second booster in adults who had previously received a two-dose (100-μg) primary series and first booster (50-μg) dose of mRNA-1273 (≥3 months earlier). The primary objectives were to assess the safety, reactogenicity, and immunogenicity of mRNA-1273.214 at 28 days after the booster dose. Results: Interim results are presented. Sequential groups of participants received 50 μg of mRNA-1273.214 (437 participants) or mRNA-1273 (377 participants) as a second booster dose. The median time between the first and second boosters was similar for mRNA-1273.214 (136 days) and mRNA-1273 (134 days). In participants with no previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the geometric mean titers of neutralizing antibodies against the omicron BA.1 variant were 2372.4 (95% confidence interval [CI], 2070.6 to 2718.2) after receipt of the mRNA-1273.214 booster and 1473.5 (95% CI, 1270.8 to 1708.4) after receipt of the mRNA-1273 booster. In addition, 50-μg mRNA-1273.214 and 50-μg mRNA-1273 elicited geometric mean titers of 727.4 (95% CI, 632.8 to 836.1) and 492.1 (95% CI, 431.1 to 561.9), respectively, against omicron BA.4 and BA.5 (BA.4/5), and the mRNA-1273.214 booster also elicited higher binding antibody responses against multiple other variants (alpha, beta, gamma, and delta) than the mRNA-1273 booster. Safety and reactogenicity were similar with the two booster vaccines. Vaccine effectiveness was not assessed in this study; in an exploratory analysis, SARS-CoV-2 infection occurred in 11 participants after the mRNA-1273.214 booster and in 9 participants after the mRNA-1273 booster. Conclusions: The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. (Funded by Moderna; ClinicalTrials.gov number, NCT04927065.).
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator

    Paul FriedmanFrancis MurgatroydLucas V A BoersmaJaimie Manlucu...
    11页
    查看更多>>摘要：Background: The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. Methods: We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. Results: A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. Conclusions: In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    Prevention of and Emergency Response to Drowning

    Deborah C. GirasekStephen Hargarten
    6页
    查看更多>>摘要：WE DEVELOP FROM EMBRYOS THAT ARE SURROUNDED BY WATER. AFTER being born, we need water to live. Water views relax us, and water sports entertain us. Perhaps that is why many of us have difficulty perceiving water as dangerous. Yet every year, thousands of Americans die from being underwater for too long. According to the World Health Organization, “Drowning is the process of experiencing respiratory impairment from submersion/immersion in liquid.”1 It can result in death, nonfatal injury, or no injury. More than any other factor, the duration of submersion predicts the outcome.2 Because submersion occurs before the health care system comes into play, a discussion of drowning prevention precedes a discussion of treatment.
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    Toxic Megacolon Due to Fulminant Clostridioides difficile Infection

    Sumanth K. Baru
    1页
    查看更多>>摘要：A 40-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT WITH vomiting and diarrhea. He had no known medical history and had not received antimicrobial therapy recently. His heart rate was 132 beats per minute, and other vital signs were normal. Examination was notable for confusion and for diffuse tenderness to palpation of the abdomen with tympany. Laboratory testing showed a white-cell count of 29,000 per cubic millimeter (reference range, 4000 to 10,800) and a positive nucleic acid amplification test for Clostridioides difficile. Computed tomography of the abdomen revealed pancolitis with distention of the sigmoid and descending colon (Panel A; arrowheads indicate the areas of distention, and two-dimensional measurements of colon width are shown). Despite 2 days of treatment with oral and rectal vancomycin and intravenous metronidazole, shock developed in the patient on hospital day 3. An urgently obtained radiograph of the abdomen showed worsening distention of the transverse colon near the hepatic flexure to 120 mm (abnormal width, >60 mm).
      原文链接:
    • NSTL
    • Massachusetts Medical Soc

    Thinking Outside the Heart

    Ryan A. DenuDaniel H. SolomonRichard N. MitchellYee-Ping Sun...
    7页
    查看更多>>摘要：A 50-year-old woman with a history of asthma presented to the emergency department with chest pain and worsening dyspnea. Approximately 1 year before presentation, intermittent episodes of nonradiating chest tightness and shortness of breath had developed. Pulmonary function testing was consistent with asthma. She was treated with inhaled glucocorticoids and albuterol and had some abatement of symptoms. One week before presentation, worsening shortness of breath had developed, which she thought was related to her asthma. She had recently received her third dose of a messenger RNA (mRNA) vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), although she was not certain about the precise temporal relationship to the onset of symptoms. Despite treatment with escalating doses of inhaled glucocorticoids and inhaled albuterol, her symptoms progressed. On the day of presentation, pleuritic chest pain developed, which radiated to the back and was worsened by exertion but not by positional changes. She reported no orthopnea, paroxysmal nocturnal dyspnea, dyspnea when bending forward, fevers, chills, night sweats, weight changes, myalgias, arthralgias, rashes, wheezing, anosmia, dysgeu-sia, or ageusia.
      原文链接:
    • NSTL
    • Massachusetts Medical Soc