Personalized vascular healthcare: insights from a large international survey.

Fragmentation of healthcare systems through limited cross-speciality communication and intermittent, intervention-based care, without insight into follow-up and compliance, results in poor patient experiences and potentially contributes to suboptimal outcomes. Data-driven tools and novel technologies have the capability to address these shortcomings, but insights from all stakeholders in the care continuum remain lacking. A structured online questionnaire was given to respondents (n = 1432) in nine global geographies to investigate attitudes to the use of data and novel technologies in the management of vascular disease. Patients with coronary or peripheral artery disease (n = 961), physicians responsible for their care (n = 345), and administrators/healthcare leaders with responsibility for commissioning/procuring cardiovascular services (n = 126) were included. Narrative themes arising from the survey included patients' desire for more personalized healthcare, shared decision-making, and improved communication. Patients, administrators, and physicians perceived and experienced deficiencies in continuity of care, and all acknowledged the potential for data-driven techniques and novel technologies to address some of these shortcomings. Further, physicians and administrators saw the 'upstream' segment of the care journey-before diagnosis, at point of diagnosis, and when determining treatment-as key to enabling tangible improvements in patient experience and outcomes. Finally, despite acceptance that data sharing is critical to the success of such interventions, there remains persistent issues related to trust and transparency. The current fragmented care continuum could be improved and streamlined through the adoption of advanced data analytics and novel technologies, including diagnostic and monitoring techniques. Such an approach could enable the refocusing of healthcare from intermittent contacts and intervention-only focus to a more holistic patient view.

Refractory Angina: From Pathophysiology to New Therapeutic Nonpharmacological Technologies.

Despite optimal combination of guideline-directed anti-ischemic therapies and myocardial revascularization, a substantial proportion of patients with stable coronary artery disease continues to experience disabling symptoms and is often referred as "no-option." The appraisal of the pathways linking ischemia to symptom perception indicates a complex model of heart-brain interactions in the generation of the subjective anginal experience and inspired novel approaches that may be clinically effective in alleviating the angina burden of this population. Conversely, the prevailing ischemia-centered view of angina, with the focus on traditional myocardial revascularization as the sole option to address ischemia on top of medical therapy, hinders the experimental characterization and broad-scale clinical implementation of strongly needed therapeutic options. The interventionist, often the first physician to establish the diagnosis of refractory angina pectoris (RAP) following coronary angiography, should be aware of the numerous emerging technologies with the potential to improve quality of life in the growing population of RAP patients. This review describes the current landscape and the future perspectives on nonpharmacological treatment technologies for patients with RAP, with a view on the underlying physiopathological rationale and current clinical evidence.

Association Between Cardiac Catheterization Laboratory Pre-Activation and Reperfusion Timing Metrics and Outcomes in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: A Report From the ACTION Registry.

OBJECTIVES: The aim of this study was to describe the prevalence of pre-hospital cardiac catheterization laboratory activation and its association with reperfusion timeliness and in-hospital mortality. BACKGROUND: For patients with ST-segment elevation myocardial infarction diagnosed in the field, catheterization laboratory pre-activation may lead to more timely reperfusion and improved outcomes. METHODS: A total of 27,840 patients with ST-segment elevation myocardial infarction transported via emergency medical services to 744 percutaneous coronary intervention-capable hospitals in the ACTION Registry from January 2015 to March 2017 were evaluated, excluding patients with cardiac arrest or requiring pre-percutaneous coronary intervention intubation. Catheterization laboratory pre-activation was defined as activation >10 min prior to hospital arrival. RESULTS: Catheterization laboratory pre-activation occurred in 41% of patients (n = 11,379), with minor presenting differences between those with and without catheterization laboratory pre-activation. Compared with no catheterization laboratory pre-activation, pre-activation patients were more likely to be directly transported to the catheterization laboratory on hospital arrival (23.3% vs. 5.3%), to have shorter hospital arrival-to-catheterization laboratory arrival time (median 17 min [interquartile range (IQR): 7 to 25 min] vs. 28 min [IQR: 18 to 39 min]), to have shorter door-to-device time (40 min [IQR: 30 to 51 min] vs. 52 min [IQR: 41 to 65 min]), and to have a greater likelihood of achieving first medical contact-to-device time ≤90 min (76.6% vs. 68.6%) (p < 0.001 for all). Pre-activation was associated with lower in-hospital mortality (2.8% vs. 3.4%; p = 0.01). Patients treated at hospitals in the lowest tertile of pre-activation rates had higher mortality than those treated at hospitals in the highest tertile before and after adjustment (3.6% vs. 2.7%; adjusted odds ratio: 1.33; 95% confidence interval: 1.08 to 1.63). CONCLUSIONS: In the United States, catheterization laboratory pre-activation occurred in fewer than one-half of emergency medical services-transported patients with ST-segment elevation myocardial infarction. Its association with faster reperfusion and lower mortality supports greater use of this strategy.

Impact of Regionalization of ST-Segment-Elevation Myocardial Infarction Care on Treatment Times and Outcomes for Emergency Medical Services-Transported Patients Presenting to Hospitals With Percutaneous Coronary Intervention: Mission: Lifeline Accelerator-2.

BACKGROUND: Regional variations in reperfusion times and mortality in patients with ST-segment-elevation myocardial infarction are influenced by differences in coordinating care between emergency medical services (EMS) and hospitals. Building on the Accelerator-1 Project, we hypothesized that time to reperfusion could be further reduced with enhanced regional efforts. METHODS: Between April 2015 and March 2017, we worked with 12 metropolitan regions across the United States with 132 percutaneous coronary intervention-capable hospitals and 946 EMS agencies. Data were collected in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network)-Get With The Guidelines Registry for quarterly Mission: Lifeline reports. The primary end point was the change in the proportion of EMS-transported patients with first medical contact to device time ≤90 minutes from baseline to final quarter. We also compared treatment times and mortality with patients treated in hospitals not participating in the project during the corresponding time period. RESULTS: During the study period, 10 730 patients were transported to percutaneous coronary intervention-capable hospitals, including 974 in the baseline quarter and 972 in the final quarter who met inclusion criteria. Median age was 61 years; 27% were women, 6% had cardiac arrest, and 6% had shock on admission; 10% were black, 12% were Latino, and 10% were uninsured. By the end of the intervention, all process measures reflecting coordination between EMS and hospitals had improved, including the proportion of patients with a first medical contact to device time of ≤90 minutes (67%-74%; P<0.002), a first medical contact to device time to catheterization laboratory activation of ≤20 minutes (38%-56%; P<0.0001), and emergency department dwell time of ≤20 minutes (33%-43%; P<0.0001). Of the 12 regions, 9 regions reduced first medical contact to device time, and 8 met or exceeded the national goal of 75% of patients treated in ≤90 minutes. Improvements in treatment times corresponded with a significant reduction in mortality (in-hospital death, 4.4%-2.3%; P=0.001) that was not apparent in hospitals not participating in the project during the same time period. CONCLUSIONS: Organization of care among EMS and hospitals in 12 regions was associated with significant reductions in time to reperfusion in patients with ST-segment-elevation myocardial infarction as well as in in-hospital mortality. These findings support a more intensive regional approach to emergency care for patients with ST-segment-elevation myocardial infarction.

Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association.

Cardiogenic shock is a high-acuity, potentially complex, and hemodynamically diverse state of end-organ hypoperfusion that is frequently associated with multisystem organ failure. Despite improving survival in recent years, patient morbidity and mortality remain high, and there are few evidence-based therapeutic interventions known to clearly improve patient outcomes. This scientific statement on cardiogenic shock summarizes the epidemiology, pathophysiology, causes, and outcomes of cardiogenic shock; reviews contemporary best medical, surgical, mechanical circulatory support, and palliative care practices; advocates for the development of regionalized systems of care; and outlines future research priorities.

Association of Rapid Care Process Implementation on Reperfusion Times Across Multiple ST-Segment-Elevation Myocardial Infarction Networks.

BACKGROUND: The Mission: Lifeline STEMI Systems Accelerator program, implemented in 16 US metropolitan regions, resulted in more patients receiving timely reperfusion. We assessed whether implementing key care processes was associated with system performance improvement. METHODS AND RESULTS: Hospitals (n=167 with 23 498 ST-segment-elevation myocardial infarction patients) were surveyed before (March 2012) and after (July 2014) program intervention. Data were merged with patient-level clinical data over the same period. For reperfusion, hospitals were grouped by whether a specific process of care was implemented, preexisting, or never implemented. Uptake of 4 key care processes increased after intervention: prehospital catheterization laboratory activation (62%-91%; P<0.001), single call transfer protocol from an outside facility (45%-70%; P<0.001), and emergency department bypass for emergency medical services direct presenters (48%-59%; P=0.002) and transfers (56%-79%; P=0.001). There were significant differences in median first medical contact-to-device times among groups implementing prehospital activation (88 minutes implementers versus 89 minutes preexisting versus 98 minutes nonimplementers; P<0.001 for comparisons). Similarly, patients treated at hospitals implementing single call transfer protocols had shorter median first medical contact-to-device times (112 versus 128 versus 152 minutes; P<0.001). Emergency department bypass was also associated with shorter median first medical contact-to-device times for emergency medical services direct presenters (84 versus 88 versus 94 minutes; P<0.001) and transfers (123 versus 127 versus 167 minutes; P<0.001). CONCLUSIONS: The Accelerator program increased uptake of key care processes, which were associated with improved system performance. These findings support efforts to implement regional ST-segment-elevation myocardial infarction networks focused on prehospital catheterization laboratory activation, single call transfer protocols, and emergency department bypass.

The ixCELL-DCM Trial: Rationale and Design.

Ixmyelocel-T is an investigational patient-specific, expanded, multicellular therapy produced from a patient's own bone marrow. It is produced by selectively expanding two key types of bone marrow mononuclear cells (BM-MNCs), CD90+ mesenchymal stem cells (MSCs), and CD45+CD14+ autofluorescent, alternatively activated macrophages. Earlier clinical trials suggested that intramyocardial ixmyelocel-T might improve clinical, functional, symptomatic, and quality of life outcomes in patients with ischemic dilated cardiomyopathy (IDCM). This ongoing randomized, double-blinded, placebo-controlled phase 2b trial (ixCELL-DCM) was designed to assess the efficacy, safety, and tolerability of catheter-based transendocardial injection of ixmyelocel-T in patients with heart failure due to IDCM. Patients (N = 114) with New York Heart Association class III or IV symptomatic heart failure due to IDCM, who have left ventricular ejection fraction ≤35% and an automatic implantable cardioverter defibrillator, but are ineligible for revascularization procedures, were randomly assigned (1:1 ratio) to ixmyelocel-T or placebo (vehicle control). The primary efficacy endpoint is a composite of the total number of deaths, cardiovascular hospitalizations, or unplanned clinic visits to treat acutely decompensated heart failure during the 12 months following treatment administration. Secondary endpoints include the win ratio analysis for hierarchical occurrences of clinical events in the primary endpoint, total numbers of clinical events, left ventricular structure and function, and quality-of-life assessments. ixCELL-DCM is one of the largest cell therapy trials in heart failure patients to date and the first double-blinded, placebo-controlled study of ixmyelocel-T administered via transendocardial catheter-based injections in patients with heart failure secondary to IDCM.

Implementation of Regional ST-Segment Elevation Myocardial Infarction Systems of Care: Successes and Challenges.

Current guidelines recommend that communities create and maintain a regional system of ST-segment elevation myocardial infarction (STEMI) care that includes assessment and continuous quality improvement of emergency medical services and hospital-based activities. Availability and timely access is a challenge in many areas of the United States. This article reviews clinical trial data supporting the use of primary percutaneous coronary intervention as the optimal reperfusion strategy, and fibrinolysis as an option when this is not possible. It then describes the outcomes and benefits of implementing regional systems of STEMI care, and discusses ongoing challenges for STEMI system implementation, including inadequate data collection and feedback, and hospital and physician competition.

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.

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.

Safety and feasibility of percutaneous retrograde coronary sinus delivery of autologous bone marrow mononuclear cell transplantation in patients with chronic refractory angina.

BACKGROUND: Chronic refractory angina is a challenging clinical problem with limited treatment options. The results of early cardiovascular stem cell trials using ABMMC have been promising but have utilized intracoronary or intramyocardial delivery. The goal of the study was to evaluate the safety and early efficacy of autologous bone marrow derived mononuclear cells (ABMMC) delivered via percutaneous retrograde coronary sinus perfusion (PRCSP) to treat chronic refractory angina (CRA). METHODS: From May 2005 to October 2006, 14 patients, age 68 +/- 20 years old, with CRA and ischemic stress-induced myocardial segments assessed by SPECT received a median 8.19*10(8) ± 4.3*10(8) mononuclear and 1.65*10(7) ± 1.42*10(7) CD34(+) cells by PRCSP. RESULTS: ABMMC delivery was successful in all patients with no arrhythmias, elevated cardiac enzymes or complications related to the delivery. All but one patient improved by at least one Canadian Cardiovascular Society class at 2 year follow-up compared to baseline (p < 0.001). The median baseline area of ischemic myocardium by SPECT of 38.2% was reduced to 26.5% at one year and 23.5% at two years (p = 0.001). The median rest left ventricular ejection fraction by SPECT at baseline was 31.2% and improved to 35.5% at 2 year follow up (p = 0.019). CONCLUSIONS: PRCSP should be considered as an alternative method of delivery for cell therapy with the ability to safely deliver large number of cells regardless of coronary anatomy, valvular disease or myocardial dysfunction. The clinical improvement in angina, myocardial perfusion and function in this phase 1 study is encouraging and needs to be confirmed in randomized placebo controlled trials.

Pharmaco-invasive strategies expand access to percutaneous coronary intervention in ST-elevation myocardial infarction.

Primary percutaneous coronary intervention (PCI) is the preferred method of reperfusion in patients with ST-elevation myocardial infarction (STEMI). Therefore, increasing timely access to PCI is a major national focus. The majority of United States hospitals are not PCI capable, which has stimulated the development of regional STEMI programs using standardized protocols and organized transfer systems. These regional STEMI systems have improved treatment times and clinical outcomes, leading to a recent class I recommendation in the American College of Cardiology/American Heart Association guidelines to develop STEMI systems of care. Despite this, less than 15% of patients transferred from non-PCI hospitals to PCI centers have total door-to-balloon times less than 2 hours. We review the therapeutic options for the STEMI patient with expected delay to PCI focusing on recent pharmacoinvasive trials. Based on these trial results, recent guidelines recommend early transfer and cardiac catheterization for patients treated with fibrinolytic therapy.

Pregnancy-associated plasma protein-A elevation in patients with acute coronary syndrome and subsequent atorvastatin therapy.

Pregnancy-associated plasma protein-A (PAPP-A) was associated with atherosclerotic plaque vulnerability, whereas statin therapy was associated with increased plaque stability. Eighty-six patients presenting with clinical indications (non-ST-elevation myocardial infarction, unstable angina, and stable angina) for invasive coronary angiography and subsequent verified coronary artery disease (CAD) were randomly assigned in a double-blind manner to atorvastatin 10 or 80 mg/day. PAPP-A, high-sensitivity C-reactive protein (hs-CRP), and lipids were measured at baseline (before statin therapy) and at 1 and 6 months. PAPP-A was significantly increased in 35 patients with acute coronary syndrome (ACS) compared with 51 patients with stable CAD (p <0.001). Patients randomly assigned to atorvastatin 10 mg did not show a significant decrease in PAPP-A from baseline at 1 or 6 months. Patients treated with atorvastatin 80 mg showed a significant decrease at 1 month compared with baseline, but not at 6 months. hs-CRP was not significantly different between the ACS and stable CAD groups. Patients receiving atorvastatin 10 mg showed no hs-CRP decrease at 1 or 6 months, whereas it significantly decreased in the 80-mg group at 6 months, but not at 1 month. In conclusion, PAPP-A significantly increased in patients with ACS compared with those with stable coronary disease. High-dose atorvastatin significantly decreased PAPP-A at 1 month and hs-CRP at 6 months in patients with verified CAD. Low-dose atorvastatin did not produce this effect.

Myocardial injury and long-term mortality following moderate to severe carbon monoxide poisoning.

CONTEXT: Carbon monoxide (CO) poisoning is a common cause of toxicological morbidity and mortality. Myocardial injury is a frequent consequence of moderate to severe CO poisoning. While the in-hospital mortality for these patients is low, the long-term outcome of myocardial injury in this setting is unknown. OBJECTIVE: To determine the association between myocardial injury and long-term mortality in patients following moderate to severe CO poisoning. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study of 230 consecutive adult patients treated for moderate to severe CO poisoning with hyperbaric oxygen and admitted to the Hennepin County Medical Center, a regional center for treatment of CO poisoning, between January 1, 1994, and January 1, 2002. Follow-up was through November 11, 2005. MAIN OUTCOME MEASURE: All-cause mortality. RESULTS: Myocardial injury (cardiac troponin I level > or =0.7 ng/mL or creatine kinase-MB level > or =5.0 ng/mL and/or diagnostic electrocardiogram changes) occurred in 85 (37%) of 230 patients. At a median follow-up of 7.6 years (range: in-hospital only to 11.8 years), there were 54 deaths (24%). Twelve of those deaths (5%) occurred in the hospital as a result of a combination of burn injury and anoxic brain injury (n = 8) or cardiac arrest and anoxic brain injury (n = 4). Among the 85 patients who sustained myocardial injury from CO poisoning, 32 (38%) eventually died compared with 22 (15%) of 145 patients who did not sustain myocardial injury (adjusted hazard ratio, 2.1; 95% confidence interval, 1.2-3.7; P = .009). CONCLUSION: Myocardial injury occurs frequently in patients hospitalized for moderate to severe CO poisoning and is a significant predictor of mortality.