IMPORTANCE Health care workers (HCWs) caring for patients with coronavirus disease 2019 (COVID-19) are at risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, to our knowledge, there is no effective pharmacologic prophylaxis for individuals at risk. OBJECTIVE To evaluate the efficacy of hydroxychloroquine to prevent transmission of SARS-CoV-2 in hospital-based HCWs with exposure to patients with COVID-19 using a pre-exposure prophylaxis strategy. DESIGN, SETTING, AND PARTICIPANTS This randomized, double-blind, placebo-controlled clinical trial (the Prevention and Treatment of COVID-19 With Hydroxychloroquine Study) was conducted at 2 tertiary urban hospitals, with enrollment from April 9, 2020, to July 14, 2020; follow-up ended August 4, 2020. The trial randomized 132 full-time, hospital-based HCWs (physicians, nurses, certified nursing assistants, emergency technicians, and respiratory therapists), of whom 125 were initially asymptomatic and had negative results for SARS-CoV-2 by nasopharyngeal swab. The trial was terminated early for futility before reaching a planned enrollment of 200 participants. INTERVENTIONS Hydroxychloroquine, 600 mg, daily, or size-matched placebo taken orally for 8 weeks. MAIN OUTCOMES AND MEASURES The primary outcome was the incidence of SARS-CoV-2 infection as determined by a nasopharyngeal swab during the 8 weeks of treatment. Secondary outcomes included adverse effects, treatment discontinuation, presence of SARS-CoV-2 antibodies, frequency of QTc prolongation, and clinical outcomes for SARS-CoV-2-positive participants. RESULTS Of the 132 randomized participants (median age, 33 years [range, 20-66 years]; 91 women [69%]), 125 (94.7%) were evaluable for the primary outcome. There was no significant difference in infection rates in participants randomized to receive hydroxychloroquine compared with placebo (4 of 64 [6.3%] vs 4 of 61 [6.6%]; P > .99). Mild adverse events were more common in participants taking hydroxychloroquine compared with placebo (45% vs 26%; P = .04); rates of treatment discontinuation were similar in both arms (19% vs 16%; P = .81). The median change in QTc (baseline to 4-week evaluation) did not differ between arms (hydroxychloroquine: 4 milliseconds; 95% CI, −9 to 17; vs placebo: 3 milliseconds; 95% CI, −5 to 11; P = .98). Of the 8 participants with positive results for SARS-CoV-2 (6.4%), 6 developed viral symptoms; none required hospitalization, and all clinically recovered. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, although limited by early termination, there was no clinical benefit of hydroxychloroquine administered daily for 8 weeks as pre-exposure prophylaxis in hospital-based HCWs exposed to patients with COVID-19. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04329923
IMPORTANCEIn patients with mechanical valves in the aortic and mitral positions, percutaneous access to the left ventricle (LV) via a transfemoral approach for catheter ablation of ventricular tachycardia (VT) has been considered infeasible.OBJECTIVE To describe the outcomes of a novel percutaneous trans-right atrial (RA) access to the LV via a femoral venous approach for catheter ablation of VT in patients with mechanical aortic and mitral valves. DESIGN, SETTING, AND PARTICIPANTSThis observational study included consecutive patients with mechanical valves in the aortic and mitral positions and recurrent monomorphic drug-refractory VT associated with an LV substrate. Percutaneous LV access was performed from a transfemoral venous route with the aid of a deflectable sheath and a radiofrequency wire by creating an iatrogenic Gerbode defect with direct puncture of the inferior and medial aspect of the RA, adjacent to the inferior-septal process of the LV (ISP-LV), under intracardiac echography guidance. Once the wire crossed to the LV, balloon dilatation of the ventriculotomy site (with a noncompliant balloon; diameter, 8 to 10 mm) was performed to facilitate passage of the sheath within the LV.EXPOSURES Percutaneous trans-RA access to the LV via puncture of the ISP-LV to perform catheter ablation of VT in patients with mechanical aortic and mitral valves. MAIN OUTCOMES AND MEASURESFeasibility and safety of a trans-RA access to the LV for catheter ablation of VT. RESULTS A total of 4 patients (mean [SD] age, 60 [7] years; mean [SD] LV ejection fraction, 31% [9%]) with recurrent VT associated with an LV substrate (ischemic cardiomyopathy, 3 patients; nonischemic cardiomyopathy, 1 patient) and mechanical valves in the aortic and mitral position underwent trans-RA access through the ISP-LV for catheter ablation of VT. The time to obtain LV access ranged from 60 minutes (first case) to 22 minutes (last case) (mean [SD], 36 [15] minutes). No complications associated with the access occurred. In particular, in the 3 patients with preserved atrioventricular conduction at baseline, no new conduction abnormalities were observed after the access. Complete VT noninducibility at programmed ventricular stimulation was achieved in 3 cases, and no patient had VT recurrence at a median follow-up of 14 months (range, 6-21 months). CONCLUSIONS AND RELEVANCEA percutaneous trans-RA access to the LV via a femoral venous approach for catheter ablation of VT in patients with mechanical aortic and mitral valves is feasible and appears safe. This novel technique may allow for catheter ablation of VT in a population of patients in whom conventional LV access via retrograde aortic or atrial transseptal routes is not possible.
Enhanced risk stratification of patients with aortic stenosis (AS) is necessary to identify patients at high risk for adverse outcomes, and may allow for better management of patient subgroups at high risk of myocardial damage. The objective of this study was to identify plasma biomarkers and multimarker profiles associated with adverse outcomes in AS.
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