Robert E. Suter

Stroke Outcomes Measures Must Be Appropriately Risk Adjusted To Ensure Quality Care of Patients A Presidential Advisory From the American Heart Association/American Stroke Association

Abstract— Because stroke is among the leading causes of death, disability, hospitalizations, and healthcare expenditures in the United States, there is interest in reporting outcomes for patients hospitalized with acute ischemic stroke. The American Heart Association/American Stroke Association, as part of its commitment to promote high-quality, evidence-based care for cardiovascular and stroke patients, fully supports the development of properly risk-adjusted outcome measures for stroke. To accurately assess and report hospital-level outcomes, adequate risk adjustment for case mix is essential. During the development of the Centers for Medicare & Medicaid Services 30-day stroke mortality and 30-day stroke readmission measures, concerns were expressed that these measures were not adequately designed because they do not include a valid initial stroke severity measure, such as the National Institutes of Health Stroke Scale. These outcome measures, as currently constructed, may be prone to mischaracterizing the quality of stroke care being delivered by hospitals and may ultimately harm acute ischemic stroke patients. This article details (1) why the Centers for Medicare & Medicaid Services acute ischemic stroke outcome measures in their present form may not provide adequate risk adjustment, (2) why the measures as currently designed may lead to inaccurate representation of hospital performance and have the potential for serious unintended consequences, (3) what activities the American Heart Association/American Stroke Association has engaged in to highlight these concerns to the Centers for Medicare & Medicaid Services and other interested parties, and (4) alternative approaches and opportunities that should be considered for more accurately risk-adjusting 30-day outcomes measures in patients with ischemic stroke.

Regional Systems of Care Demonstration Project: American Heart Association Mission: Lifeline STEMI Systems Accelerator.

Background: Up to 50% of patients fail to meet ST-segment–elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact–to–device time of <90 minutes for patients directly presenting to percutaneous coronary intervention–capable hospitals and <120 minutes for transferred patients. We sought to increase the proportion of patients treated within guideline goals by organizing coordinated regional reperfusion plans. Methods: We established leadership teams, coordinated protocols, and provided regular feedback for 484 hospitals and 1253 emergency medical services (EMS) agencies in 16 regions across the United States. Results: Between July 2012 and December 2013, 23 809 patients presented with acute STEMI (direct to percutaneous coronary intervention hospital: 11 765 EMS transported and 6502 self-transported; 5542 transferred). EMS-transported patients differed from self-transported patients in symptom onset to first medical contact time (median, 47 versus 114 minutes), incidence of cardiac arrest (10% versus 3%), shock on admission (11% versus 3%), and in-hospital mortality (8% versus 3%; P <0.001 for all comparisons). There was a significant increase in the proportion of patients meeting guideline goals of first medical contact–to–device time, including those directly presenting via EMS (50% to 55%; P <0.001) and transferred patients (44%−48%; P =0.002). Despite regional variability, the greatest gains occurred among patients in the 5 most improved regions, increasing from 45% to 57% (direct EMS; P <0.001) and 38% to 50% (transfers; P <0.001). Conclusions: This Mission: Lifeline STEMI Systems Accelerator demonstration project represents the largest national effort to organize regional STEMI care. By focusing on first medical contact–to–device time, coordinated treatment protocols, and regional data collection and reporting, we were able to increase significantly the proportion of patients treated within guideline goals. # Clinical Perspective {#article-title-31}Background: Up to 50% of patients fail to meet ST-segment–elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact–to–device time of <90 minutes for patients directly presenting to percutaneous coronary intervention–capable hospitals and <120 minutes for transferred patients. We sought to increase the proportion of patients treated within guideline goals by organizing coordinated regional reperfusion plans. Methods: We established leadership teams, coordinated protocols, and provided regular feedback for 484 hospitals and 1253 emergency medical services (EMS) agencies in 16 regions across the United States. Results: Between July 2012 and December 2013, 23 809 patients presented with acute STEMI (direct to percutaneous coronary intervention hospital: 11 765 EMS transported and 6502 self-transported; 5542 transferred). EMS-transported patients differed from self-transported patients in symptom onset to first medical contact time (median, 47 versus 114 minutes), incidence of cardiac arrest (10% versus 3%), shock on admission (11% versus 3%), and in-hospital mortality (8% versus 3%; P<0.001 for all comparisons). There was a significant increase in the proportion of patients meeting guideline goals of first medical contact–to–device time, including those directly presenting via EMS (50% to 55%; P<0.001) and transferred patients (44%−48%; P=0.002). Despite regional variability, the greatest gains occurred among patients in the 5 most improved regions, increasing from 45% to 57% (direct EMS; P<0.001) and 38% to 50% (transfers; P<0.001). Conclusions: This Mission: Lifeline STEMI Systems Accelerator demonstration project represents the largest national effort to organize regional STEMI care. By focusing on first medical contact–to–device time, coordinated treatment protocols, and regional data collection and reporting, we were able to increase significantly the proportion of patients treated within guideline goals.

Real world effectiveness of warfarin among ischemic stroke patients with atrial fibrillation: observational analysis from Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) study

Objective To examine the association between warfarin treatment and longitudinal outcomes after ischemic stroke in patients with atrial fibrillation in community practice. Design Observational study. Setting Hospitals (n=1487) participating in the Get With The Guidelines (GWTG)-Stroke program in the United States, from 2009 to 2011. Participants 12 552 warfarin naive atrial fibrillation patients admitted to hospital for ischemic stroke and treated with warfarin compared with no oral anticoagulant at discharge, linked to Medicare claims for longitudinal outcomes. Main outcome measures Major adverse cardiovascular events (MACE) and home time, a patient centered outcomes measure defined as the total number of days free from institutional care after discharge. A propensity score inverse probability weighting method was used to account for all differences in observed characteristics between treatment groups. Results Among 12 552 survivors of stroke, 11 039 (88%) were treated with warfarin at discharge. Warfarin treated patients were slightly younger and less likely to have a history of previous stroke or coronary artery disease but had similar severity of stroke as measured by the National Institutes of Health Stroke Scale. Relative to those not treated, patients treated with warfarin had more days at home (as opposed to institutional care) during the two years after discharge (adjusted home time difference 47.6 days, 99% confidence interval 26.9 to 68.2). Patients discharged on warfarin treatment also had a reduced risk of MACE (adjusted hazard ratio 0.87, 99% confidence interval 0.78 to 0.98), all cause mortality (0.72, 0.63 to 0.84), and recurrent ischemic stroke (0.63, 0.48 to 0.83). These differences were consistent among clinically relevant subgroups by age, sex, stroke severity, and history of previous coronary artery disease and stroke. Conclusions Among ischemic stroke patients with atrial fibrillation, warfarin treatment was associated with improved long term clinical outcomes and more days at home. Clinical trial registration Clinical trials NCT02146274.

Recommendations for the Implementation of Telehealth in Cardiovascular and Stroke Care: A Policy Statement From the American Heart Association

The aim of this policy statement is to provide a comprehensive review of the scientific evidence evaluating the use of telemedicine in cardiovascular and stroke care and to provide consensus policy suggestions. We evaluate the effectiveness of telehealth in advancing healthcare quality, identify legal and regulatory barriers that impede telehealth adoption or delivery, propose steps to overcome these barriers, and identify areas for future research to ensure that telehealth continues to enhance the quality of cardiovascular and stroke care. The result of these efforts is designed to promote telehealth models that ensure better patient access to high-quality cardiovascular and stroke care while striving for optimal protection of patient safety and privacy.

Regional systems of care demonstration project

Background: Up to 50% of patients fail to meet ST-segment–elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact–to–device time of <90 minutes for patients directly presenting to percutaneous coronary intervention–capable hospitals and <120 minutes for transferred patients. We sought to increase the proportion of patients treated within guideline goals by organizing coordinated regional reperfusion plans. Methods: We established leadership teams, coordinated protocols, and provided regular feedback for 484 hospitals and 1253 emergency medical services (EMS) agencies in 16 regions across the United States. Results: Between July 2012 and December 2013, 23 809 patients presented with acute STEMI (direct to percutaneous coronary intervention hospital: 11 765 EMS transported and 6502 self-transported; 5542 transferred). EMS-transported patients differed from self-transported patients in symptom onset to first medical contact time (median, 47 versus 114 minutes), incidence of cardiac arrest (10% versus 3%), shock on admission (11% versus 3%), and in-hospital mortality (8% versus 3%; P <0.001 for all comparisons). There was a significant increase in the proportion of patients meeting guideline goals of first medical contact–to–device time, including those directly presenting via EMS (50% to 55%; P <0.001) and transferred patients (44%−48%; P =0.002). Despite regional variability, the greatest gains occurred among patients in the 5 most improved regions, increasing from 45% to 57% (direct EMS; P <0.001) and 38% to 50% (transfers; P <0.001). Conclusions: This Mission: Lifeline STEMI Systems Accelerator demonstration project represents the largest national effort to organize regional STEMI care. By focusing on first medical contact–to–device time, coordinated treatment protocols, and regional data collection and reporting, we were able to increase significantly the proportion of patients treated within guideline goals. # Clinical Perspective {#article-title-31}Background: Up to 50% of patients fail to meet ST-segment–elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact–to–device time of <90 minutes for patients directly presenting to percutaneous coronary intervention–capable hospitals and <120 minutes for transferred patients. We sought to increase the proportion of patients treated within guideline goals by organizing coordinated regional reperfusion plans. Methods: We established leadership teams, coordinated protocols, and provided regular feedback for 484 hospitals and 1253 emergency medical services (EMS) agencies in 16 regions across the United States. Results: Between July 2012 and December 2013, 23 809 patients presented with acute STEMI (direct to percutaneous coronary intervention hospital: 11 765 EMS transported and 6502 self-transported; 5542 transferred). EMS-transported patients differed from self-transported patients in symptom onset to first medical contact time (median, 47 versus 114 minutes), incidence of cardiac arrest (10% versus 3%), shock on admission (11% versus 3%), and in-hospital mortality (8% versus 3%; P<0.001 for all comparisons). There was a significant increase in the proportion of patients meeting guideline goals of first medical contact–to–device time, including those directly presenting via EMS (50% to 55%; P<0.001) and transferred patients (44%−48%; P=0.002). Despite regional variability, the greatest gains occurred among patients in the 5 most improved regions, increasing from 45% to 57% (direct EMS; P<0.001) and 38% to 50% (transfers; P<0.001). Conclusions: This Mission: Lifeline STEMI Systems Accelerator demonstration project represents the largest national effort to organize regional STEMI care. By focusing on first medical contact–to–device time, coordinated treatment protocols, and regional data collection and reporting, we were able to increase significantly the proportion of patients treated within guideline goals.

Use of Strategies to Improve Door-to-Needle Times with Tissue-Type Plasminogen Activator in Acute Ischemic Stroke in Clinical Practice: Findings from Target: Stroke

Background— The implementation of Target: Stroke Phase I, the first stage of the American Heart Association’s national quality improvement initiative to accelerate door-to-needle (DTN) times, was associated with an average 15-minute reduction in DTN times. Target: Stroke phase II was launched in April 2014 with a goal of promoting further reduction in treatment times for tissue-type plasminogen activator (tPA) administration. Methods and Results— We conducted a second survey of Get With The Guidelines-Stroke hospitals regarding strategies used to reduce delays after Target: Stroke and quantify their association with DTN times. A total of 16 901 ischemic stroke patients were treated with intravenous tPA within 4.5 hours of symptom onset from 888 surveyed hospitals between June 2014 and April 2015. The patient-level median DTN time was 56 minutes (interquartile range, 42–75), with 59.3% of patients receiving intravenous tPA within 60 minutes and 30.4% within 45 minutes after hospital arrival. Most hospitals reported routinely using a majority of Target: Stroke key practice strategies, although direct transport of patients to computed tomographic/magenetic resonance imaging scanner, premix of tPA ahead of time, initiation of tPA in brain imaging suite, and prompt data feedback to emergency medical services providers were used less frequently. Overall, we identified 16 strategies associated with significant reductions in DTN times. Combined, a total of 20 minutes (95% confidence intervals 15–25 minutes) could be saved if all strategies were implemented. Conclusions— Get With The Guidelines-Stroke hospitals have initiated a majority of Target: Stroke–recommended strategies to reduce DTN times in acute ischemic stroke. Nevertheless, certain strategies were infrequently practiced and represent a potential immediate target for further improvements.

Blood pressure and in-hospital outcomes in patients presenting with ischaemic stroke

Aims Post-stroke hypertension is associated with poor short-term outcome, although the results have been conflicting. Our objective was to evaluate the association of blood pressure (BP) and in-hospital outcomes in patients with acute ischaemic stroke. Methods and results Patients in the Get With The Guidelines-Stroke registry with acute ischaemic stroke were included. Admission systolic and diastolic BP was used to compute mean arterial pressure (MAP) and pulse pressure (PP). The outcomes of interest were: in-hospital mortality, not discharged home, inability to ambulate independently at discharge and haemorrhagic complications due to thrombolytic therapy. A total of 309 611 patients with an ischaemic stroke were included. There was a J-shaped/U-shaped relationship between systolic BP and outcomes. Both lower and higher systolic BP values, compared with a central reference value, had higher risk of in-hospital death [e.g. adjusted odds ratio (95% confidence interval) (OR[CI]) = 1.16[1.13-1.20] for 120 vs. 150 mmHg and 1.24[1.19-1.30] for 200 vs. 150 mmHg], not discharged home (OR[CI] = 1.11[1.09-1.13] for 120 vs. 150 mmHg and 1.15[1.12-1.18] for 200 vs. 150 mmHg), inability to ambulate independently at discharge (OR[CI] = 1.16[1.13-1.18] for 120 vs. 150 mmHg and 1.09[1.06-1.11] for 200 vs. 150 mmHg). However, risk of haemorrhagic complications of thrombolytic therapy was lower with lower systolic BP (OR[CI] = 0.89[0.83-0.97] for 120 vs. 150 mmHg), while higher with higher systolic BP (OR[CI] = 1.21[1.11-1.32] for 200 vs. 150 mmHg). The results were largely similar for admission diastolic BP, MAP, and PP. Conclusion In patients hospitalized with ischaemic stroke, J-shaped, or U-shaped relationships were observed between BP variables and short-term outcomes. However, haemorrhagic complications with thrombolytic therapy were lower with lower BP.

Acute management of stroke patients taking non–vitamin K antagonist oral anticoagulants Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry: Design and rationale

BACKGROUND Non-vitamin K antagonist oral anticoagulants (NOACs, dabigatran, rivaroxaban, apixaban, and edoxaban) have been increasingly used as alternatives to warfarin for stroke prophylaxis in patients with atrial fibrillation. Yet there is substantial lack of information on how patients on NOACs are currently treated when they have an acute ischemic stroke and the best strategies for treating intracerebral hemorrhage for those on chronic anticoagulation with warfarin or a NOAC. These are critical unmet needs for real world clinical decision making in these emergent patients. METHODS The ARAMIS Registry is a multicenter cohort study of acute stroke patients who were taking chronic anticoagulation therapy prior to admission and are admitted with either an acute ischemic stroke or intracerebral hemorrhage. Built upon the existing infrastructure of American Heart Association/American Stroke Association Get With the Guidelines Stroke, the ARAMIS Registry will enroll a total of approximately 10,000 patients (5000 with acute ischemic stroke who are taking a NOAC and 5000 with anticoagulation-related intracerebral hemorrhage who are on warfarin or a NOAC). The primary goals of the ARAMIS Registry are to provide a comprehensive picture of current treatment patterns and outcomes of acute ischemic stroke patients on NOACs, as well as anticoagulation-related intracerebral hemorrhage in patients on either warfarin or NOACs. Beyond characterizing the index hospitalization, up to 2500 patients (1250 ischemic stroke and 1250 intracerebral hemorrhage) who survive to discharge will be enrolled in an optional follow-up sub-study and interviewed at 3 and 6 months after discharge to assess longitudinal medication use, downstream care, functional status, and patient-reported outcomes. CONCLUSION The ARAMIS Registry will document the current state of management of NOAC treated patients with acute ischemic stroke as well as contemporary care and outcome of anticoagulation-related intracerebral hemorrhage. These data will be used to better understand optimal strategies to care for these complex but increasingly common emergent real world clinical challenges.

Prior Antithrombotic Use Is Associated With Favorable Mortality and Functional Outcomes in Acute Ischemic Stroke

Background and Purpose— Antithrombotics are the mainstay of treatment in primary and secondary prevention of stroke, and their use before an acute event may be associated with better outcomes. Methods— Using data from Get With The Guidelines-Stroke with over half a million acute ischemic strokes recorded between October 2011 and March 2014 (n=540 993) from 1661 hospitals across the United States, we examined the unadjusted and adjusted associations between previous antithrombotic use and clinical outcomes. Results— There were 250 104 (46%) stroke patients not receiving any antithrombotic before stroke; of whom approximately one third had a documented previous vascular indication. After controlling for clinical and hospital factors, patients who were receiving antithrombotics before stroke had better outcomes than those who did not, regardless of whether a previous vascular indication was present or not: adjusted odds ratio (95% confidence intervals) were 0.82 (0.80–0.84) for in-hospital mortality, 1.18 (1.16–1.19) for home as the discharge destination, 1.15 (1.13–1.16) for independent ambulatory status at discharge, and 1.15 (1.12–1.17) for discharge modified Rankin Scale score of 0 or 1. Conclusions— Previous antithrombotic therapy was independently associated with improved clinical outcomes after acute ischemic stroke. Ensuring the use of antithrombotics in appropriate patient populations may be associated with benefits beyond stroke prevention.

Improving Quality of Cardiac Care: A Global Mandate

Sidney C. Smith, Jr.* Gregg C. Fonarow, Ileana L. Piña, Robert Suter, Louise Morgan,Kathryn Taubert, Eduardo Sanchez, and Elliott Antman Heart and Vascular Center, University of North Carolina, Chapel Hill, North Carolina, United States Division of Cardiology, UCLA David Geffen School of Medicine, Los Angeles, California, United States Division of Cardiology, Albert Einstein College of Medicine, Bronx, New York, United States American Heart Association, Dallas, Texas, United States e Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, United States