Anxiety sensitivity, or the belief that anxiety-related sensations can have negative consequences, has been shown to play an important role in the etiology and maintenance of panic disorder and other anxiety-related pathology. Aerobic exercise involves exposure to physiological cues similar to those experienced during anxiety reactions. The present study sought to investigate the efficacy of a brief aerobic exercise intervention for high anxiety sensitivity. Accordingly, 24 participants with high anxiety sensitivity scores (Anxiety Sensitivity Index-Revised scores >28) were randomly assigned to complete either six 20-minute sessions of aerobic exercise or a no-exercise control condition. The results indicated that individuals assigned to the aerobic exercise condition reported significantly less anxiety sensitivity subsequent to exercise, whereas anxiety sensitivity scores among non-exercisers did not significantly change. The clinical research and public health implications of these findings are discussed, and several potential directions for additional research are recommended.

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IMPORTANCE Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively. OBJECTIVES To determine if the manufacturer's recommendations following the recall of a medical device were timely and complete, the follow-up information and data provided to patients and physicians were adequate for managing patient care, and the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate. DESIGN, SETTING, AND PARTICIPANTS This single-center retrospective case series included 90 of 448 patients who were implanted with a cardiac resynchronization therapy pacemaker at the Minneapolis Heart Institute from May 2003 through January 2011; this pacemaker was recalled in November 2015. In addition, returned product reports submitted by the manufacturer to the FDA via the Manufacturer and User Facility Device Experience (MAUDE) database from January 2008 through December 2018 were analyzed. MAIN OUTCOMES AND MEASURES Clinical outcomes were serious adverse clinical events that occurred before and after the November 2015 recall notifying physicians and patients that the device's battery could fail unexpectedly because of high internal impedance. Technical outcomes were signs and causes of failure. RESULTS Five of 90 patients observed during 2015 experienced syncope when their pacemakers stopped pacing owing to battery or wire connection defects prior to the recall. Of the 90 patients, 37 (41%) were men, and the median (interquartile range) age at implantation was 71.3 (66.1-78.2) years. Analysis of the MAUDE data revealed that battery failures prior to the recall were associated with serious adverse events that included 1 death, 1 cardiac arrest, 5 syncopal attacks, and 6 heart failure exacerbations; 3 additional prerecall syncopal events were caused by wire connection defects. The manufacturer and the FDA were aware of the battery and wire connection defects for 19 months before issuing the recall, yet the wire connection problem was not included in the advisory and physicians were not informed that interrogating the pacemaker could result in loss of pacing. The FDA classified the recall as class II rather than the more critical class I. CONCLUSIONS AND RELEVANCE This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.

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Chemotherapy treatment of malignancy accounts for 1–2% of takotsubo syndrome (TS) triggers. Women comprise 60–70% of patients with chemotherapy-associated TS, a distinctly lower prevalence than the 90% female prevalence in TS overall. Fluorouracil is the most commonly reported TS-triggering chemotherapeutic agent, although this must be interpreted in the context of the frequency of worldwide use of this agent. The onset of TS relative to chemotherapy initiation is quite variable, ranging from the initial administration to subsequent chemotherapy cycles several weeks beyond initiation. Limited information suggests chemotherapy can be safely reinitiated once the patient has recovered from the initial TS event. Having a TS event in the setting of chemotherapy treatment for malignancy is associated with substantial mortality.

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