Health economics for treatment of diabetic foot ulcers: a cost-effectiveness analysis of eight skin substitutes.

AIM: Skin substitutes are frequently used to treat chronic diabetic foot ulcers (DFU), and many different options are available. While the clinical efficacy of many products has been evaluated, a comprehensive cost-effectiveness analysis comparing the most popular skin substitutes and using the most recent cost data has been lacking. METHODS: This study compared eight skin substitutes using published efficacy rates combined with the Centers for Medicare and Medicaid Services (CMS) 2018 cost data. The study criteria resulted in the inclusion of seven studies that described efficacy rates for treatment of DFUs using the skin substitutes. RESULTS: The results revealed wide discrepancies between these skin substitutes for the costs of treatments and healing rates in hospital outpatient departments and physician office settings. Healing rates for 12 and 16 weeks ranged from 28% to 68%, while the average cost for treating one DFU varied from $2001 to $14,507 and $1207 to $8791 in the hospital outpatient department and physician's office setting, respectively. The estimated patient share of costs for treating a single DFU ranged from $400 to $2901 and $241 to $1758 in the hospital outpatient department and physician's office setting, respectively. Most importantly, the estimated number of wounds healed out of 100 DFUs per $1000 expenditure with each patient ranged from 3.9-26.5 DFUs in the hospital outpatient department, and 4.3-36.4 DFUs in the physicians' office setting. CONCLUSIONS: This study revealed that the costs of a skin substitute itself did not necessarily correlate with its healing efficacy. These results provide a comprehensive cost-effectiveness analysis to enable integrated health-care systems, health professionals and reimbursement payers to make informed value decisions when treating DFUs.

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix.

OBJECTIVE: This prospective, multicenter study evaluated the efficacy and safety of an acellular dermal matrix allograft, DermACELL (D-ADM; LifeNet Health, Virginia Beach, Virginia), in the treatment of large, complex diabetic foot ulcers (DFUs) that probed to tendon or bone. METHODS: Inclusion criteria were Wagner grade 3 or 4 DFUs between 4 weeks and 1 year in duration. All participants received one application of D-ADM at baseline and could receive one additional application if wound healing arrested. Ulcers were assessed weekly for 16 weeks using a laser measuring device. RESULTS: Sixty-one participants were enrolled, with an average wound area of 29.0 cm; 59 of these ulcers showed exposed bone. The entire per-protocol population (n = 47) achieved 100% granulation. The mean time to 100% granulation was 4.0 weeks with an average of 1.2 applications of D-ADM. Mean percent wound area reduction was 80.3% at 16 weeks. Those DFUs 15 cm or smaller were substantially more likely to close than DFUs larger than 29 cm (P = .0008) over a 16-week duration. No complications were associated with the use of the studied matrix. CONCLUSIONS: The D-ADM demonstrated the ability to rapidly reduce the size of large, complex DFUs with exposed bone. Some wounds did not completely heal by 16 weeks; however, the significant reduction in size suggests that these large, complex wounds may heal if given more time.

Emergency medical services management of ST-segment elevation myocardial infarction in the United States--a report from the American Heart Association Mission: Lifeline Program.

OBJECTIVE: ST-segment elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality in the United States. Emergency medical services (EMS) agencies play a critical role in its initial identification and treatment. We conducted this study to assess EMS management of STEMI care in the United States. METHODS: A structured questionnaire was administered to leaders of EMS agencies to define the elements of STEMI care related to 4 core measures: (1) electrocardiogram (ECG) capability at the scene, (2) destination protocols, (3) catheterization laboratory activation before hospital arrival, and (4) 12-lead ECG quality review. Geographic areas were grouped into large metropolitan, small metropolitan, micropolitan, and noncore (or rural) by using Urban Influence Codes, with a stratified analysis. RESULTS: Data were included based on responses from 5296 EMS agencies (36% of those in the United States) serving 91% of the US population, with at least 1 valid response from each of the 50 states and the District of Columbia. Approximately 63% of agencies obtained ECGs at the scene using providers trained in ECG acquisition and interpretation. A total of 46% of EMS systems used protocols to determine hospital destination, cardiac catheterization laboratory activation, and communications with the receiving hospital. More than 75% of EMS systems used their own agency funds to purchase equipment, train personnel, and provide administrative oversight. A total of 49% of agencies have quality review programs in place. In general, EMS systems covering higher population densities had easier access to resources needed to maintain STEMI systems of care. Emergency medical services systems that have adopted all 4 core elements cover 14% of the US population. CONCLUSIONS: There are large differences in EMS systems of STEMI care in the United States. Most EMS agencies have implemented at least 1 of the 4 core elements of STEMI care, with many having implemented multiple elements.

Emergency medical services as a strategy for improving ST-elevation myocardial infarction system treatment times.

BACKGROUND: Reducing delays in time to treatment is a key goal of ST-elevation myocardial infarction (STEMI) emergency care. Emergency medical services (EMS) are a critical component of the STEMI chain of survival. STUDY OBJECTIVE: We sought to assess the impact of the careful integration of EMS as a strategy for improving systemic treatment times for STEMI. METHODS: We conducted a study of all 747 nontransfer STEMI patients who underwent primary percutaneous coronary intervention (PCI) in Dallas County, Texas from October 1, 2010 through December 31, 2011. EMS leaders from 24 agencies and 15 major PCI receiving hospitals collected and shared common, de-identified patient data. We used 15 months of data to develop a generalized linear regression to assess the impact of EMS on two treatment metrics-hospital door to balloon (D2B) time, and symptom onset to arterial reperfusion (SOAR) time, a new metric we developed to assess total treatment times. RESULTS: We found statistically significant reductions in median D2B (11.1-min reduction) and SOAR (63.5-min reduction) treatment times when EMS transported patients to the receiving facility, compared to self-transport. In addition, when trained EMS paramedics field-activated the cardiac catheterization laboratory using predefined specified protocols, D2B times were reduced by 38% (43 min) after controlling for confounding variables, and field activation was associated with a 21.9% reduction (73 min) in the mean SOAR time (both with p < 0.001). CONCLUSION: Active EMS engagement in STEMI treatment was associated with significantly lower D2B and total coronary reperfusion times.

Growth in percutaneous coronary intervention capacity relative to population and disease prevalence.

BACKGROUND: The access to and growth of percutaneous coronary intervention (PCI) has not been fully explored with regard to geographic equity and need. Economic factors and timely access to primary PCI provide the impetus for growth in PCI centers, and this is balanced by volume standards and the benefits of regionalized care. METHODS AND RESULTS: Geospatial and statistical analyses were used to model capacity, growth, and access of PCI hospitals relative to population density and myocardial infarction (MI) prevalence at the state level. Longitudinal data were obtained for 2003-2011 from the American Hospital Association, the U.S. Census, and the Centers for Disease Control and Prevention (CDC) with geographical modeling to map PCI locations. The number of PCI centers has grown 21.2% over the last 8 years, with 39% of all hospitals having interventional cardiology capabilities. During the same time, the US population has grown 8.3%, from 217 million to 235 million, and MI prevalence rates have decreased from 4.0% to 3.7%. The most densely concentrated states have a ratio of 8.1 to 12.1 PCI facilities per million of population with significant variability in both MI prevalence and average distance between PCI facilities. CONCLUSIONS: Over the last decade, the growth rate for PCI centers is 1.5× that of the population growth, while MI prevalence is decreasing. This has created geographic imbalances and access barriers with excess PCI centers relative to need in some regions and inadequate access in others.

Developing an ST-elevation myocardial infarction system of care in Dallas County.

BACKGROUND: The American Heart Association Caruth Initiative (AHACI) is a multiyear project to increase the speed of coronary reperfusion and create an integrated system of care for patients with ST-elevation myocardial infarction (STEMI) in Dallas County, TX. The purpose of this study was to determine if the AHACI improved key performance metrics, that is, door-to-balloon (D2B) and symptom-onset-to-balloon times, for nontransfer patients with STEMI. METHODS: Hospital patient data were obtained through the National Cardiovascular Data Registry Action Registry-Get With The Guidelines, and prehospital data came from emergency medical services (EMS) agencies through their electronic Patient Care Record systems. Initial D2B and symptom-onset-to-balloon times for nontransfer primary percutaneous coronary intervention (PCI) STEMI care were explored using descriptive statistics, generalized linear models, and logistic regression. RESULTS: Data were collected by 15 PCI-capable Dallas hospitals and 24 EMS agencies. In the first 18 months, there were 3,853 cases of myocardial infarction, of which 926 (24%) were nontransfer patients with STEMI undergoing primary PCI. D2B time decreased significantly (P < .001), from a median time of 74 to 64 minutes. Symptom-onset-to-balloon time decreased significantly (P < .001), from a median time of 195 to 162 minutes. CONCLUSION: The AHACI has improved the system of STEMI care for one of the largest counties in the United States, and it demonstrates the benefits of integrating EMS and hospital data, implementing standardized training and protocols, and providing benchmarking data to hospitals and EMS agencies.

A composite model of survival from out-of-hospital cardiac arrest using the Cardiac Arrest Registry to Enhance Survival (CARES).

OBJECTIVE: Using CARES data, to develop a composite multivariate logistic regression model of survival for projecting survival rates for out-of-hospital arrests of presumed cardiac etiology (OHCA). METHODS: This is an analysis of 25,975 OHCA cases (from October 1, 2005 to December 31, 2011) occurring before EMS/first responder arrival and involving attempted resuscitation by responders from 125 EMS agencies. RESULTS: The survival-at-hospital discharge rate was 9% for all cases, 16% for bystander-witnessed cases, 4% for unwitnessed cases, and 32% for bystander-witnessed pVT/VF cases. The model was estimated separately for each set of cases above. Generally, our first equation showed that joint presence of a presenting rhythm of pVT/VF and return of spontaneous circulation in the pre-hospital setting (PREHOSPROSC) is a substantial direct predictor of patient survival (e.g., 55% of such cases survived). Bystander AED use, and, for witnessed cases, bystander CPR and response time are significant but less sizable direct predictors of survival. Our second equation shows that these variables make an additional, indirect contribution to survival by affecting the probability of joint presence of pVT/VF and PREHOSPROSC. The model yields survival rate projections for various improvement scenarios; for example, if all cases had involved bystander AED use (vs. 4% currently), the survival rate would have increased to 14%. Approximately one-half of projected increases come from indirect effects that would have been missed by the conventional single-equation approach. CONCLUSION: The composite model describes major connections among predictors of survival, and yields specific projections for consideration when allocating scarce resources to impact OHCA survival.

Systems of care for ST-segment-elevation myocardial infarction: a report From the American Heart Association's Mission: Lifeline.

BACKGROUND: National guidelines call for participation in systems to rapidly diagnose and treat ST-segment-elevation myocardial infarction (STEMI). In order to characterize currently implemented STEMI reperfusion systems and identify practices common to system organization, the American Heart Association surveyed existing systems throughout the United States. METHODS AND RESULTS: A STEMI system was defined as an integrated group of separate entities focused on reperfusion therapy for STEMI within a geographic region that included at least 1 hospital that performs percutaneous coronary intervention and at least 1 emergency medical service agency. Systems meeting this definition were invited to participate in a survey of 42 questions based on expert panel opinion and knowledge of existing systems. Data were collected through the American Heart Association Mission: Lifeline website. Between April 2008 and January 2010, 381 unique systems involving 899 percutaneous coronary intervention hospitals in 47 states responded to the survey, of which 255 systems (67%) involved urban regions. The predominant funding sources for STEMI systems were percutaneous coronary intervention hospitals (n = 320, 84%) and /or cardiology practices (n = 88, 23%). Predominant system characteristics identified by the survey included: STEMI patient acceptance at percutaneous coronary intervention hospital regardless of bed availability (N = 346, 97%); single phone call activation of catheterization laboratory (N = 335, 92%); emergency department physician activation of laboratory without cardiology consultation (N = 318, 87%); data registry participation (N = 311, 84%); and prehospital activation of the laboratory through emergency department notification without cardiology notification (N = 297, 78%). The most common barriers to system implementation were hospital (n = 139, 37%) and cardiology group competition (n = 81, 21%) and emergency medical services transport and finances (n = 99, 26%). CONCLUSIONS: This survey broadly describes the organizational characteristics of collaborative efforts by hospitals and emergency medical services to provide timely reperfusion in the United States. These findings serve as a benchmark for existing systems and should help guide healthcare teams in the process of organizing care for patients with STEMI.

Trial to end ambulance diversion in Boston: report from the conference of the Boston teaching hospitals consortium.

INTRODUCTION: Annual ambulance diversion hours in Boston increased more than six-fold from 1997 to 2006. Although interventions and best practices were implemented, there was no reduction in the number of diversion hours. OBJECTIVES: A consortium of Boston teaching hospitals instituted a two-week moratorium on citywide diversion from 02 October 2006 to 15 October 2006. The hypothesis was that there would be no significant difference in measures of hospital and emergency medical services (EMS) efficiency compared with the two weeks immediately prior. METHODS: A total of nine hospitals and the municipal emergency medical services in Boston submitted data for analysis. The following mean daily hospital measures were studied: (1) emergency department volume; (2) number of emergency department admissions; (3) length of stay (LOS) for all patients; and (4) number of elopements. Mean EMS at-hospital time by destination and the percent of all Boston EMS transports to each hospital destination were calculated. The median differences (MD) were calculated as "before" minus "during" the study period and were compared with paired, Wilcoxon, non-parametric tests. Additional mean EMS measures for all destinations included: (1) to hospital time; (2) number of responses with transport initiated per day; (3) incident entry to arrival; and (4) at-hospital time. RESULTS: The LOS for admitted patients (MD = 0.30 hours; IQR 0.10,1.30; p = 0.03) and number of daily admissions (MD = -1.50 patients; IQR -1.50, -0.10; p = 0.04) were significantly different statistically. The results for LOS for all patients, LOS for discharged patients, ED volume, EMS time at hospital by destination, number of elopements, and percent of Boston EMS transports to each hospital revealed no statistically significant differences. The difference between the study and control periods for mean EMS to hospital time, at-hospital time, and incident entry to arrival was a maximum of 0.6 minutes. The vast majority of EMS respondents to an online survey believed that the "no diversion" policy should be made routine practice. CONCLUSIONS: The LOS for admitted patients decreased by 18 minutes, and the number of admissions increased by 1.5 patients per day during the study period. The "no diversion" policy resulted in minimal changes in EMS efficiency and operations. Diversion was temporarily eliminated in a major city without significant detrimental changes in ED, hospital, or EMS efficiency.

A model of survival from out-of-hospital cardiac arrest using the Boston EMS arrest registry.

OBJECTIVES: To characterize the survival rate for out-of-hospital arrests of cardiac aetiology and predictor variables associated with survival in Boston, MA, and to develop a composite multivariate logistic regression model for projecting survival rates. METHODS: This is a retrospective analysis of all arrests of presumed cardiac aetiology (from January 1, 2004 to December 31, 2007) where resuscitation was attempted (n=1156) by 911 emergency responders. RESULTS: The survival-at-hospital discharge rate was 11% (vs. 1-10% often reported). The coefficients and odds ratios in the first equation of the model show that joint presence of presenting rhythm of ventricular fibrillation/tachycardia (VF/VT) and return of spontaneous circulation in the pre-hospital setting (ROSC) is a substantial direct predictor of survival (e.g., 54% of such cases survive). Response time, public location, witnessed, and age are significant but less sizable direct predictors of survival. A second equation shows that these four variables make an additional indirect contribution to survival by affecting the probability of joint presence of VF/VT and ROSC; bystander CPR also makes such an indirect contribution but no significant direct one as shown in the first equation. The projected survival rate if cases had always experienced bystander CPR and rapid response time of less than four minutes is 21%. CONCLUSIONS: The unique model describes the major contribution of VF/VT and ROSC, and key relationships among predictors of survival. These connections may have otherwise gone underreported using standard approaches and should be considered when allocating scarce resources to impact cardiac arrest survival.

Saved by the nose: bystander-administered intranasal naloxone hydrochloride for opioid overdose.

Administering naloxone hydrochloride (naloxone) during an opioid overdose reverses the overdose and can prevent death. Although typically delivered via intramuscular or intravenous injection, naloxone may be delivered via intranasal spray device. In August 2006, the Boston Public Health Commission passed a public health regulation that authorized an opioid overdose prevention program that included intranasal naloxone education and distribution of the spray to potential bystanders. Participants were taught by trained nonmedical needle exchange staff. After 15 months, the program provided training and intranasal naloxone to 385 participants who reported 74 successful overdose reversals. Problems with intranasal naloxone were uncommon. Overdose prevention education with distribution of intranasal naloxone is a feasible public health intervention to address opioid overdose.

Recommendation to develop strategies to increase the number of ST-segment-elevation myocardial infarction patients with timely access to primary percutaneous coronary intervention.

Although evidence suggests that primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy in the majority of patients with ST-segment-elevation myocardial infarction (STEMI), only a minority of patients with STEMI are treated with primary PCI, and of those, only a minority receive the treatment within the recommended 90 minutes after entry into the medical system. Market research conducted by the American Heart Association revealed that those involved in the care of patients with STEMI recognize the multiple barriers that prevent the prompt delivery of primary PCI and agree that it is necessary to develop systems or centers of care that will allow STEMI patients to benefit from primary PCI. The American Heart Association will convene a group of stakeholders (representing the interests of patients, physicians, emergency medical systems, community hospitals, tertiary hospitals, and payers) and quality-of-care and outcomes experts to identify the gaps between the existing and ideal delivery of care for STEMI patients, as well as the requisite policy implications. Working within a framework of guiding principles, the group will recommend strategies to increase the number of STEMI patients with timely access to primary PCI.

Heat-related illness.

Heat-related illness represents a continuum of disorders from minor syndromes such as heat cramps, heat syncope, and heat exhaustion to the severely life-threatening disorder known as heat stroke. It represents an important cause of wilderness-related morbidity and mortality.

Implications of the mechanical (PCI) vs thrombolytic controversy for ST segment elevation myocardial infarction on the organization of emergency medical services: the Boston EMS experience.

With the many advances in rapid reperfusion therapy for management of acute ST segment elevation myocardial infarction (STEMI), there is a need to revisit the current plan for prehospital triage (point of entry). Until recently in Boston, and nationwide, there has been a policy that patients with suspected acute MI were brought to the nearest hospital. Then, if ST segment elevation was present, patients were treated with either thrombolytic therapy or primary percutaneous coronary intervention (PCI). Recent data, however, have shown that with advances in interventional devices, techniques and institutional experience, primary PCI is associated with improved outcomes compared with thrombolytic therapy for all patients with STEMI when provided at expert centers with high institutional volumes, with experienced interventional cardiologists as the operators, and with relatively short time to treatment. We describe the rationale for and the implementation of the Boston EMS STEMI Triage Plan and Treatment Registry. Many of the issues that prompted the implementation of the Boston STEMI plan are relevant to all EMS systems. Among these issues are the accuracy of prehospital identification of STEMI patients, the availability of mechanical reperfusion therapy, the appropriate triage of patients with complicated myocardial infarction or shock, as well as the local consensus regarding strength of the evidence favoring mechanical reperfusion. This article describes the history of the Boston EMS STEMI Triage Plan and Treatment Registry and suggests the need for other EMS systems to develop a systematic approach to patients with STEMI.