Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial.

BACKGROUND: A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis. METHODS: The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months. DISCUSSION: Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04470934.

Mobile point-of-care MRI demonstration of a normal volunteer in a telemedicine-equipped ambulance.

OBJECTIVE: Several centers have implemented ambulances equipped with CT scanners and telemedicine capabilities, known as mobile stroke units (MSU), to expedite acute stroke care delivery in the pre-hospital setting. While MSUs have been shown to improve outcomes compared with standard emergency medical management, there are limitations to incorporating CT, including radiation exposure to emergency medical services personnel. Recently, a portable, low-field strength MRI (Swoop®, Hyperfine, Inc., Guilford, CT) received FDA clearance for in-hospital use. Here, as proof-of-concept, we explore the possibility of performing MRI in a telemedicine-equipped ambulance during active transport. MATERIALS AND METHODS: In this initial technical demonstration, we imaged an MR phantom and a normal human volunteer using a standard stroke protocol during active ambulance transport. RESULTS: Images of the MR phantom and volunteer were successfully obtained and were immediately available for viewing in the hospital PACS system. The images were deemed of diagnostic quality by the radiologist. Active motion correction maintained superior image quality despite vehicle and scanner motion. In-plane, low contrast resolution of greater than 4 × 4 mm was achieved. Average transmit speeds were calculated to be 3.54 Megabits/second and upload data rates varied while in transit ranging from 8.54 to 4.13 Megabits/second. CONCLUSION: While MRI is not yet ready for clinical use in the MSU setting, our initial experience suggests potential technological feasible of this approach following future technical and MRI sequence development. Additional studies, incorporating patients, would be required to determine clinical feasibility.

[Recommendations of the S3 Guideline "Use of Extracorporeal Circulation (ECLS/ ECMO) for Cardiac and Circulatory Failure" of the Association of Scientific Medical Societies in Germany]. / Empfehlungen der S3-Leitlinie (AWMF) "Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen".

In recent years, the use of mechanical support for patients with cardiac or circulatory failure has continuously increased, leading to 3,000 ECLS/ECMO (extracorporeal life support/extracorporeal membrane oxygenation) implantations annually in Germany. Due to the lack of guidelines, there is an urgent need for evidence-based recommendations addressing the central aspects of ECLS/ECMO therapy. In July 2015, the generation of a guideline level S3 according to the standards of the Association of the Scientific Medical Societies in Germany (AWMF) was announced by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS). In a well-structured consensus process, involving experts from Germany, Austria and Switzerland, delegated by 16 scientific societies and the patients' representation, the guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" was created under guidance of the GSTCVS, and published in February 2021. The guideline focuses on clinical aspects of initiation, continuation, weaning and aftercare, herein also addressing structural and economic issues. This article presents an overview on the methodology as well as the final recommendations.

Considerations for Developing an Agenda for Gun Violence Prevention Research.

In December 2019, for the first time in more than 20 years, the US Congress appropriated, and the president signed, a bill that included $25 million for gun violence prevention research at the Centers for Disease Control and Prevention and the National Institutes of Health. This research should find ways to reduce injury, death, and suffering while protecting the right of law-abiding citizens to own firearms. Four questions can structure this research agenda. First, what is the problem: How many people get shot, who are they, where does it happen, what is the relationship between the shooter and the victim, what other types of damage are incurred, and are the shootings increasing or decreasing? Second, what are the causes: What is the role of alcohol and drugs; what is the role of gangs, poverty, and systemic racism; what is the role of mental illness, robbery, and domestic violence; what is the role of private gun ownership (both positive and negative) and easy access to guns? What are the factors that protect us, such as stable families and safe environments? Third, what works: Which practices, interventions, policies, and laws work best to prevent these deaths and injuries? And fourth, how do you do it: How do you implement the findings and translate them into policies, legislation, and practices that can be scaled up?

United States Best Practice Guidelines for Primary Palliative Care in the Emergency Department.

The growing palliative care needs of emergency department (ED) patients in the United States have motivated the development of ED primary palliative care principles. An expert panel convened to develop best practice guidelines for ED primary palliative care to help guide frontline ED clinicians based on available evidence and consensus opinion of the panel. Results include recommendations for screening and assessment of palliative care needs, ED management of palliative care needs, goals of care conversations, ED palliative care and hospice consults, and transitions of care.

Does social capital interact with economic hardships in influencing older adults' health? A study from China.

BACKGROUND: The importance of social and economic capital as predictors of health is widely documented, yet the complexity of interactions between them and effects on older people's health is still unclear. Combining the material and psychosocial explanations of health, this study explores the potential interactions between social and economic capital in influencing older adults' health in urban and rural China. METHODS: Using data from the China Family Panel Survey, physical and mental health in 2018 were regressed on social and economic capital indicators in 2016, controlling for sociodemographic characteristics of 3535 respondents aged 65 and older. Rothman's synergy index was calculated to investigate potential interaction effects. RESULTS: Economic hardships were significantly related to both self-reported health and mental health. Neighborhood cohesion and social participation were significantly associated with mental health for all, bonding trust was significantly associated with mental health for urban older people. We found no significant associations between social capital components and self-reported health. There was an interaction effect between low neighborhood cohesion and economic hardships, and between low social participation and economic hardships, creating an increased burden of poor mental health. The interaction effect between low bonding trust and economic hardships on mental health was apparent only among urban older people. CONCLUSIONS: Geographical settings are important factors in the complexity between social and economic capital in affecting older health. Intervention efforts directed towards reducing simultaneously multiple dimensions of deprivation, such as poverty, social exclusion, social isolation, could be helpful in improving older people's health. In materially deprived places, policies to promote health equity by improving social capital but without eliminating poverty may be less effective.

[Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure : Short version of the S3 guideline]. / Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen : Kurzversion der AWMF-S3-Leitlinie.

In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF). Although the clinical application of ECMO/ECLS represents the main focus, the presented guideline also addresses structural and economic issues. Experts from 17 German, Austrian and Swiss scientific societies and a patients' organization, guided by the GSTCVS, completed the project in February 2021. In this report, we present a summary of the methodological concept and tables displaying the recommendations for each chapter of the guideline.

Haemodynamics of an iatrogenic atrial septal defect after MitraClip implantation.

BACKGROUND: The MitraClip procedure requires transseptal access of the left atrium with a 24F guiding sheath. We evaluated invasively whether a MitraClip induced iatrogenic atrial septal defect (IASD) leads to development of a relevant interatrial shunt and right ventricular overload. METHODS: A total of 69 patients who underwent a MitraClip procedure due to a severe mitral valve regurgitation (MVR) were included in the observational, retrospective cohort study. All pressures were directly measured throughout the procedure. Cardiac index (CI), systemic (Qs) and pulmonary (Qp) flow were calculated using the Fick method. RESULTS: Successful MitraClip implantation increased CI (2.5 ± 0.62 vs 3.05 ± 0.77 L/min/m2 ; P < .0001), whereas SVR (1491 ± 474 vs 997 ± 301 dyn s/cm5 ; P < .0001), PVR (226 ± 121 vs 188 ± 96 dyn/s/cm5 ; P = .04), PCWP (23 ± 6.1 vs 20 ± 4.7 mm Hg; P = .0031), PA pressure (33.6 ± 7.2 vs 31.9 ± 6.6 mm Hg; P = .1437) and LA pressure (21.5 ± 5.4 vs 18.7 ± 4.9 mm Hg; P < .0001) all decreased. The effect on LA pressure was further enhanced by guiding catheter retrieval (14.4 ± 4.6 mm Hg; P < .0001). At the end of the procedure, Qp (6.033 ± 1.3 L/min) exceeded Qs (5.537 ± 1.3 L/min) by 0.496 L/min leading to a Qp:Qs ratio of 1.09 (P = .007). After 6 months, echocardiography revealed no changes in RV diameter (42.96 ± 6.95 mm vs 43.81 ± 7.67 mm; P = .62) and TAPSE (17.13 ± 3.33 mm vs 17.36 ± 3.24 mm; P = .48). CONCLUSION: Our data show that the MitraClip procedure does not induce a relevant interatrial shunt or right ventricular overload. In fact, future studies will have to show whether the IASD may even be beneficial in selected patient populations by left atrial volume and pressure relief.

Colonoscopy resource availability and its association with the colorectal cancer diagnostic interval: A population-based cross-sectional study.

BACKGROUND: Colonoscopy is a key resource used to diagnose colorectal cancer (CRC). This study evaluated the relationship between colonoscopy availability and the length of the CRC diagnostic interval. METHODS: This is a cross-sectional study of CRC patients diagnosed in Ontario, Canada, in 2008-2012. We used administrative health data to characterise colonoscopist density, private colonoscopy clinic access, distance to the closest colonoscopist and the diagnostic interval, defined as the time from patients' first cancer-related healthcare encounter to their cancer diagnosis date. We used multivariable quantile regression to evaluate the association between colonoscopy availability and the diagnostic interval, modelling the median and 90th percentile. RESULTS: The median diagnostic interval was 84 days (90th percentile 323 days). The diagnostic interval was longer in patients residing in areas with lower colonoscopists density or private clinic access (adjusted median difference = 9 and 19 days, respectively), with evidence of effect modification by symptom status. Increased distance to a colonoscopist was associated with a longer diagnostic interval in asymptomatic patients, but a shorter diagnostic interval in symptomatic patients (adjusted median difference = 29 and -25 days, respectively). CONCLUSIONS: This study demonstrated that reduced colonoscopy resource availability is associated with longer diagnostic intervals for CRC patients.

Prospective, large-scale multicenter trial for the use of drug-coated balloons in coronary lesions: The DCB-only All-Comers Registry.

OBJECTIVES: This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions. BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited. METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months. RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates. CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.

Drug Coated Balloon-Only Strategy in De Novo Lesions of Large Coronary Vessels.

OBJECTIVES: We analyzed the efficacy of drug coated balloons (DCB) as a stand-alone-therapy in de novo lesions of large coronary arteries. DCBs seem to be an attractive alternative for the stent-free interventional treatment of de novo coronary artery disease (CAD). However, data regarding a DCB-only approach in de novo CAD are currently limited to vessels of small caliber. METHODS: By means of propensity score (PS) matching 234 individuals with de novo CAD were identified with similar demographic characteristics. This patient population was stratified in a 1:1 fashion according to a reference vessel diameter cut-off of 2.75 mm in small and large vessel disease. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 9 months. RESULTS: Patients with small vessel disease had an average reference diameter of 2.45 ± 0.23 mm, while the large vessel group averaged 3.16 ± 0.27 mm. Regarding 9-month major adverse cardiac event (MACE), 5.7% of the patients with small and 6.1% of the patients with large vessels had MACE (p=0.903). Analysis of the individual MACE components revealed a TLR rate of 3.8% in small and 1.0% in large vessels (p=0.200). Of note, no thrombotic events in the DCB treated coronary segments occurred in either group during the 9-month follow-up. CONCLUSIONS: Our data demonstrate for the first time that DCB-only PCI of de novo lesions in large coronary arteries (>2.75 mm) is safe and as effective. Interventional treatment for CAD without permanent or temporary scaffolding, demonstrated a similar efficacy for large and small vessels.

AN OUTCOMES-BASED APPROACH ACROSS THE MEDICAL EDUCATION CONTINUUM.

The medical education continuum spans undergraduate medical education (i.e., medical school), graduate medical education (i.e., residency and fellowship), and continuing medical education. This article provides three examples across the medical education and practice continuum where an outcomes-based approach is being used. By focusing on outcomes instead of process, a more predictable product of undergraduate medical education will be a medical student capable on day 1 of performing the work required of residency. Assessing the quality of medical education by the quality of care a graduate delivers once they enter practice will allow more effective design of medical education to improve care. A more comprehensive assessment of lifelong physician competence will help ensure the health of patients, their health care experience, and the value of care are of the highest possible standard and are continually improving.

Is extreme climate or moderate climate more conducive to longevity in China?

Climate is closely related to human longevity. In China, there are many climate types. According to national population censuses from 1982 to 2000, most provinces with a high ratio of centenarians are located in western and northwestern China far from the sea; these areas are characterized by a dry, cold climate, very high altitude, very high daily temperature range, strong winds, and partial hypoxia. Meanwhile, provinces with a high ratio of nonagenarians from 1982 to 2000 are located in southern China near the sea. Previous studies have attributed the high ratio of centenarians in western and northwestern China to the extreme local climate. However, centenarians in these areas decreased greatly in 2010, whereas residents in southern China frequently reached 90 to 100 years old in 2010. This study aims to explain this strange phenomenon and find whether extreme climate in Tibetan plateau and northwestern China or moderate climate in southern China is more conducive to longevity. The study found that mortality rate in Tibetan plateau is much higher than southern China, then a population evolution experiment was proposed to compare longevity indicators between low mortality rate and high mortality rate and shows that longevity indicators will decrease in the near future and increase above their original levels after several decades when the mortality rate is decreased. Results of this study show individuals in northwestern China do not live as long as those in eastern and southern China. A moderate climate is more conducive to longevity than extreme climate in China. The longevity of a region should be judged by long-term longevity indicators.

"Futile Care"-An Emergency Medicine Approach: Ethical and Legal Considerations.

Futility often serves as a proposed reason for withholding or withdrawing medical treatment, even in the face of patient and family requests. Although there is substantial literature describing the meaning and use of futility, little of it is specific to emergency medicine. Furthermore, the literature does not provide a widely accepted definition of futility, and thus is difficult if not impossible to apply. Some argue that even a clear concept of futility would be inappropriate to use. This article will review the origins of and meanings suggested for futility, specific challenges such cases create in the emergency department (ED), and the relevant legal background. It will then propose an approach to cases of perceived futility that is applicable in the ED and does not rely on unilateral decisions to withhold treatment, but rather on avoiding and resolving the conflicts that lead to physicians' believing that patients are asking them to provide "futile" care.

Telehealth by an Interprofessional Team in Patients With CKD: A Randomized Controlled Trial.

BACKGROUND: Telehealth and interprofessional case management are newer strategies of care within chronic disease management. We investigated whether an interprofessional team using telehealth was a feasible care delivery strategy and whether this strategy could affect health outcomes in patients with chronic kidney disease (CKD). STUDY DESIGN: Randomized clinical trial. SETTING & PARTICIPANTS: Minneapolis Veterans Affairs Health Care System (VAHCS), St. Cloud VAHCS, and affiliated clinics March 2012 to November 2013 in patients with CKD (estimated glomerular filtration rate < 60mL/min/1.73m(2)). INTERVENTIONS: Patients were randomly assigned to receive an intervention (n=451) consisting of care by an interprofessional team (nephrologist, nurse practitioner, nurses, clinical pharmacy specialist, psychologist, social worker, and dietician) using a telehealth device (touch screen computer with peripherals) or to usual care (n=150). OUTCOMES: The primary end point was a composite of death, hospitalization, emergency department visits, or admission to skilled nursing facilities, compared to usual care. RESULTS: Baseline characteristics of the overall study group: mean age, 75.1±8.1 (SD) years; men, 98.5%; white, 97.3%; and mean estimated glomerular filtration rate, 37±9mL/min/1.73m(2). Telehealth and interprofessional care were successfully implemented with meaningful engagement with the care system. One year after randomization, 208 (46.2%) patients in the intervention group versus 70 (46.7%) in the usual-care group had the primary composite outcome (HR, 0.98; 95% CI, 0.75-1.29; P=0.9). There was no difference between groups for any component of the primary outcome: all-cause mortality (HR, 1.46; 95% CI, 0.42-5.11), hospitalization (HR, 1.15; 95% CI, 0.80-1.63), emergency department visits (HR, 0.92; 95% CI, 0.68-1.24), or nursing home admission (HR, 3.07; 95% CI, 0.71-13.24). LIMITATIONS: Older population, mostly men, potentially underpowered/wide CIs. CONCLUSIONS: Telehealth by an interprofessional team is a feasible care delivery strategy in patients with CKD. There was no statistically significant evidence of superiority of this intervention on health outcomes compared to usual care.

Implementation of a Life-Sustaining Management and Alternative Protocol for Actively Dying Patients in the Emergency Department.

PROBLEM: The aging population and the growing number of home hospice patients have resulted in increased utilization of emergency departments. This situation poses a clinical challenge to the ED staff in determining when lifesaving treatment is indicated and when end of life care begins. METHODS: Through a shared governance model, ED physicians and nursing staff aimed to implement a best practice model for the care of dying patients. An ED interdisciplinary team identified gaps and brainstormed methods to improve palliative measures and comprehensive care for actively dying patients. RESULTS: A best practice initiative called "Life Sustaining Management and Alternatives" was developed and implemented to provide palliative care services and comprehensive care for patients who are actively dying in the emergency department. IMPLICATIONS FOR PRACTICE: The emergency department became better equipped to handle end of life care, providing adequate pain management, optimal comfort measures, and emotional support with respect and dignity for the dying patient and family. The practices implemented resulted in improved patient care, increased patient satisfaction, and reduced overall hospital admissions.

Pivot Nursing: An Alternative to Traditional ED Triage.

PROBLEM: A 7.2% increase in patient volume from 130,700 to 140,800 in 2012 prompted St Joseph's Regional Medical Center Emergency Department to review existing triage processes to decrease turnaround time. "Pivot triage" is a new, efficient intake process that entails use of 4 rather than 8 determinants to identify acuity levels. The purpose of this performance improvement project was to create alternatives to traditional triage to decrease ED length of stay and door-to-physician time. METHODS: After education, the pivot process was implemented using 4 determinants established by a multidisciplinary team. The pivot process was slowly implemented for 6 hours over a 1-week period to work out processing issues. Arrival time, door-to-physician time, and departure time from the emergency department were elements used to calculate the patient's turnaround time. Length of ED stay was collected monthly beginning in the fourth quarter of 2011. Comparisons were made after Pivot implementation in the fourth quarter of 2012. RESULTS: Despite the increasing volume, the mean door-to-physician time decreased from 71 to 40 minutes, a 43.7% reduction. The overall turnaround time decreased from 220 to 181 minutes, representing approximately a 17.7% reduction. The percentage of patients who left without being seen decreased from 2.5% to 1.0%. The pivot process improved patient flow in the emergency department, reducing time spent by the patient in the department. IMPLICATIONS FOR PRACTICE: The pivot process is a viable alternative to traditional triage. Nurses are able to accurately pivot patients with a reduced amount of information.