Recording Out-of-Hospital Cardiac Arrest Treatment via a Mobile Smartphone Application: A Feasibility Simulation Study.

BACKGROUND: Given the demanding nature of out-of-hospital cardiac arrest (OHCA) resuscitations, recordings of the times of interventions in EMS patient care reports (PCRs) are often inaccurate. The American Heart Association developed Full Code Pro (FCP), a smartphone application designed to assist EMS personnel in recording the timing of interventions performed. Through OHCA simulations, this study assessed the group size necessary to use the FCP recording functions accurately and safely without compromising patient care. Program evaluation was based on participant feedback surveys, data accuracy, delays between recording and performing interventions, and delays in care attributed to using the application, stratified by group size. METHODS: Simulations of a standard OHCA scenario using the Gaumard TraumaHal mannequin and a dedicated iPhone 5 preloaded with FCP version 3.4 were run with group sizes of 2-6 participants, with group sizes determined by participant availability. Participants included Connecticut certified paramedics and paramedic students who had completed the appropriate coursework. A 7-item feedback survey using a Likert scale established participant feedback on the application. Videos of the simulations were analyzed to assess for delays. One-way analysis of variance with trend analysis was used to test whether outcomes differed by group size and whether differences tended in one direction in parallel with group size. RESULTS: There were 37 simulations, including 142 participants. The feedback survey questions achieved a Cronbach's alpha of 0.91, signifying high reliability, and demonstrated a linear trend supporting greater satisfaction with FCP as group size increases (p < 0.001). Similarly, increasing group size displayed linear trends with greater numbers of interventions recorded (p = 0.009) and fewer missed and false recordings (p = 0.002). Delays revealed significant linear trends (p = 0.018 for delays in recording and p < 0.001 for delays in care), as increasing group size corresponded with lesser delays. Greatest improvement was noted to be between groups of 3 and 4 participants. CONCLUSIONS: OHCA simulations using FCP demonstrate increased provider comfort, increased recording accuracy, and decreased delays as the group size increased. While the application may improve recordings for PCRs and future research, the data suggest a sufficient number of EMS personnel (>3) should be present to achieve reliable data without compromising patient care.

Facial Soft-Tissue Fillers: Assessing the State of the Science conference---Proceedings report.

The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report summarizes the deliberations and key points made by the panel and presenters to the panel, and includes a summary of the panel's near-term and longer term recommendations for next steps to help guide future efforts to address the safety, efficacy, and effectiveness of facial soft-tissue fillers. This report represents the panel's assessment of the medical knowledge available on facial soft-tissue fillers at the time of the conference.

Facial Soft-Tissue Fillers conference: Assessing the State of the Science.

The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.

2016 Annual Report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. RESULTS: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%. CONCLUSIONS: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.

2016 Annual Report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. RESULTS: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%. CONCLUSIONS: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.

Demystifying the U.S. Food and Drug Administration: understanding regulatory pathways.

BACKGROUND: The field of plastic surgery has been at the forefront of ideation and innovation. Surgeon scientists today continue to develop novel products that fulfill the needs of the medical community and patients. Part of this process requires the approval from various regulatory agencies and offices, including the U.S. Food and Drug Administration. Unfortunately, medical training does not include regulatory knowledge, and many surgeon scientists find the regulatory pathway and U.S. Food and Drug Administration perplexing, overly complicated, and insurmountable. The authors aim to clearly outline the path of the regulatory process as it pertains to the U.S. Food and Drug Administration and its various jurisdictions that may relate to the plastic surgeon. METHODS: The authors aim to demystify the classification system, 510(k), and Premarket Approval processes for devices; clarify the Investigational New Drug and New Drug Application requirements for drugs; and explain how human cells, tissues, and cellular or tissue-based products are classified and approvals obtained. RESULTS: The structure of the U.S. Food and Drug Administration, its offices, and their roles are delineated, and the complex process of obtaining approval to market devices, drugs, biologics, and combination products is explained in a manner that is broadly useful to innovators whether new or experienced. CONCLUSION: The authors provide information for innovators and inventors developing promising technologies to be more knowledgeable and motivated to embrace the process in a fashion that will potentially save time and errors in U.S. Food and Drug Administration submissions.

A report of the ASPS Task Force on regenerative medicine: opportunities for plastic surgery.

In 2011, the American Society of Plastic Surgeons (ASPS) created the Task Force on Regenerative Medicine to address the Society's strong interest in the emerging field of regenerative medicine, particularly cell- and tissue-based therapies applicable to plastic surgery procedures. The Task Force's U.S. Food and Drug Administration's Workgroup is informing ASPS interactions with the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research. Engaging in dialogue with the agency to determine which research protocols will produce scientific data necessary to determine safety and efficacy for regenerative cellular therapies can allow research to be targeted to gather data that prove safety and efficacy of specific categories of therapies and/or products. This article reviews the regulatory backdrop of regenerative medicine, briefly reviews the history of regenerative medicine, and then looks at current research and potential future areas of research and clinical application. The historic ability of plastic surgeons to innovate and apply translational research positions the specialty of plastic surgery as a strong leader in clinical applications of regenerative medicine therapies.

Facial soft-tissue fillers conference: assessing the state of the science.

SUMMARY: : The American Society of Plastic Surgeons and the American Academy of Dermatology, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Society of Plastic Surgeons and the American Academy of Dermatology established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.