JACC. Basic to translational science
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JACC Basic Transl Sci · Feb 2019
ReviewChest Compressions During Sustained Inflation During Cardiopulmonary Resuscitation in Newborn Infants Translating Evidence From Animal Studies to the Bedside.
Newborn infants receiving chest compressions in the delivery room have a high incidence of mortality (41%) and short-term neurological morbidity (e.g., 57% hypoxic-ischemic encephalopathy and seizures). Furthermore, infants who have no signs of life at 10 min despite chest compressions have 83% mortality, with 93% of survivors experiencing moderate-to-severe disability. ⋯ Overall, CC+SI accomplishes the following: 1) significantly reduces time to return of spontaneous circulation, mortality, and epinephrine administration, and improves systemic and regional hemodynamic recovery; 2) significantly increases tidal volume and minute ventilation, and therefore alveolar oxygen delivery; 3) allows for passive ventilation during chest compression; and 4) does not increase lung or brain injury markers compared with the current standard of using 3:1 compression:ventilation ratio. A randomized trial comparing CC+SI versus a 3:1 compression:ventilation ratio during cardiopulmonary resuscitation in the delivery room is therefore warranted.
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JACC Basic Transl Sci · Apr 2018
Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the "Right to Try".
With drug approval times taking an average of 8 years from entry into clinical trials to full U. S. ⋯ The FDA approves over 99% of all single-patient INDs, providing emergency approval within hours, and non-emergency approval within an average of 4 days. "Right-to-try" laws passed in 38 states would allow patients to bypass FDA processes altogether, but contain controversial provisions that some claim risk more harm than benefit to desperate and vulnerable patients. This review focuses on FDA EA to non-approved drugs through a special category of IND-the single-patient IND-and "right-to-try" (R2T) access outside of the FDA.
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JACC Basic Transl Sci · Jan 2016
Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research: National Heart, Lung, and Blood Institute Working Group.
Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engineers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed opportunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care providers, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care.