ABCs of Stroke Prevention
2020; Lippincott Williams & Wilkins; Volume: 13; Issue: 12 Linguagem: Inglês
10.1161/circoutcomes.120.006663
ISSN1941-7705
AutoresChet Villa, Christina VanderPluym, Angela Lorts, David L.S. Morales, Farhan Zafar, Paul Krack, Lauren Smyth, Katrina Fields, David N. Rosenthal, Jenna Murray, Beth Hawkins, David M. Peng, David Sutcliffe, J. Lantz, Scott R. Auerbach, Meghan Williams, Matthew J. O’Connor, Rachel White, Robert A. Niebler, F. Bennet Pearce, Meloneysa Hubbard, Matthew Zinn, Allison Reichhold, Anna Joong, David W. Bearl, Deipanjan Nandi, Robert J. Gajarski, Michelle Ploutz, Lindsay J. May, Mary Mehegan, Kathleen E. Simpson, Jennifer Conway, N. Dubyk, Hari Tunuguntla, Barbara Elias, Aamir Jeewa, Jeffrey G. Gossett, M. Gowen,
Tópico(s)Cardiac Structural Anomalies and Repair
ResumoHomeCirculation: Cardiovascular Quality and OutcomesVol. 13, No. 12ABCs of Stroke Prevention Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toSupplementary MaterialsFree AccessResearch ArticlePDF/EPUBABCs of Stroke PreventionImproving Stroke Outcomes in Children Supported With a Ventricular Assist Device in a Quality Improvement Network Chet R Villa, MD and Christina J VanderPluym, MD Chet R VillaChet R Villa Chet R. Villa, MD, The Heart Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, MLC 2003, Cincinnati, OH 45242. Email E-mail Address: [email protected] https://orcid.org/0000-0002-8195-0694 The Heart Institute, Cincinnati Children's Hospital Medical Center, OH (C.R.V.). and Christina J VanderPluymChristina J VanderPluym Department of Cardiology, Boston Children's Hospital, Harvard School of Medicine, MA (C.J.V.). and on behalf of the ACTION Investigators* Originally published15 Dec 2020https://doi.org/10.1161/CIRCOUTCOMES.120.006663Circulation: Cardiovascular Quality and Outcomes. 2020;13:e006663Goals and VisionHeart failure accounts for >9500 pediatric admissions annually and the number continues to grow.1 Important improvements in outcomes for children with heart failure have resulted from the introduction of ventricular assist devices (VAD).2 Nonetheless, the mortality rates with pediatric VADs remain unacceptably high, and for specific subgroups, mortality rates reach 50%. Additionally, stroke rates range from 10% to 29% in multicenter reports.3 The ACTION (Advanced Cardiac Therapies Improving Outcomes Network) learning network was established in 2017 with a mission to improve critical outcomes and the patient/family experience for children with heart failure. The initial goal of ACTION is to reduce the frequency of stroke associated with VAD care.Local Challenges and Design of the ACTION NetworkDespite increasing use, overall VAD numbers in children remain low with the majority of centers implanting 4 consecutive hours in a 24-hour period. This operational definition was based on network consensus given the lack of data about duration or severity of hypertension in assessing risk. The result of this baseline data formed the basis of the initial interventions which included a series of clinical protocols and harmonization documents focusing on consensus practices among ACTION sites and standardized measurement protocols.Developing harmonized protocols in the absence of data and in the setting of significant practice variability required significant effort. Multiple meetings over a year long period were required to specifically define the problems the network wished to address and develop a consensus how to address the topic in real-time given the lack of data. To address this a transparent and inclusive network structure was created to facilitate broad input and feasibility of assessment (especially about blood pressure measurement technique). Importantly, the structure not just the clinical physician leads at individual centers, but multiple members of the interdisciplinary team as well as families. The challenges inherent to this were reflected in the development of the communication checklist which reviewed the management practices and techniques, as well as the respective goals for the day. Thus, the checklist became a means to review clinical data while also providing a way to monitor uptake of new protocols and approaches network wide. The percentage of days this document was reviewed was subsequently included in the process measures. An individual center was then selected to present the challenges they encountered and the local approach to addressing these issues on a monthly call as way to describe evolution of local approaches, engage all centers and providers, and discuss real-time data.ACTION uses statistical process control methods and charts to track progress and improvement. Stroke outcomes are collected and reported both as the percentage of VAD patients experiencing a stroke and the number of strokes per 100 device days. These charts are used to describe the entire population as well as outcomes for specific devices (eg, Berlin EXCOR, HeartMate 3, HeartWare etc). Process measures and clinical outcomes are reviewed monthly within the network.Results and Intervention: ACTION Quality Improvement RegistryData were collected for the anticoagulation and blood process measures on 31 patients between June 2018 and September 2018. These results highlighted significant center variability in the each of the 3 domains identified for improvement.AnticoagulationBefore the intervention, there was no consistent anticoagulant used in the paracorporeal devices (Berlin EXCOR, CentriMag/PediMag, RotaFlow). Among 15 patients on paracorporeal devices, 9 (60%) were anticoagulated with bivalirudin, 2 with warfarin, 1 with bivalirudin and warfarin, 2 with unfractionated heparin or low molecular weight heparin, and 1 with argatroban. The baseline run chart revealed patients on bivalirudin (73%) had a higher frequency of values within range when compared with those receiving unfractionated heparin (54%).In response to the variability in anticoagulants used, the increased frequency of anticoagulation values in goal range, and variation in lab draw protocols, a series of interventions were made. A laboratory blood draw protocol was developed to minimize contamination by dedicating specific intravenous access to phlebotomy and avoiding any exposure of that line to heparin. Given the prolonged duration of intravenous anticoagulation for many patients on a paracorporeal VAD, the variability of anticoagulants used and preliminary data suggesting the early use of bivalirudin may result in a more favorable thrombotic profile for children on a paracorporeal device, the network developed a bivalirudin protocol and recommended a transition to bivalirudin for intravenous anticoagulation in patients supported on a Berlin EXCOR. Since most centers had limited experience with bivalirudin, a document was created to guide use of bivalirudin as part of the ABCs of Stroke Prevention (Figure in the Data Supplement).Following the deployment of the ABCs of Stroke Prevention, bivalirudin was consistently used in patients on a paracorporeal VAD (32 of 34 Berlin patients [94%]). The 2 patients not supported on bivalirudin were anticoagulated with argatroban. Following network-wide adoption of the bivalirudin protocol to less experienced centers there was a slight decrease in the percentage of values within range from 73% to 64% but remained improved when compared with the 54% within range in the baseline heparin cohort. We are in the process of understanding the decrease in the percentage of values within range over time and the relationship of these metrics to overall outcomes.Blood PressureAt baseline, there was inconsistency in the assessment and interpretation of blood pressure in continuous flow VAD patients. For patients implanted with an intracorporeal VAD who had a palpable pulse, 5 centers (46%) assessed blood pressure using a manual Doppler, 4 centers (36%) maintained an arterial line, and 2 centers (18%) used an automated blood pressure cuff. Centers also varied in the measurement used to determine blood pressure. Eight centers (53%) used mean arterial pressure, 2 (18%) used opening pressure by Doppler, and 1 (9%) used systolic blood pressure. Additionally, only a single-center was using age-/height-derived blood pressure targets, while the remaining centers used hemodynamic goals based on the device-specific instructions for use (which do not have age-/height-derived blood pressure ranges). The initial run chart revealed inpatients supported with a VAD achieved a consistently controlled blood pressure on a daily basis only 70% of the time.Network participants developed a blood pressure assessment tool based on physiological variables for patients supported on a continuous flow device (Figure in the Data Supplement). A simplified, age-specific blood pressure goal was also created, which was derived from the 75 percentile for blood pressure for age with an upper limit set that would not exceed the existing instructions for use recommendations for blood pressure.Following the implementation of the ABCs of Stroke Prevention, the blood pressure protocol was consistently used to guide blood pressure management with centers reporting the protocol was used on 90% of VAD patient days. The percentage of support days with a controlled blood pressure increased from 70% to 93%.CommunicationThe variability described within the anticoagulation and blood pressure domains extended to the communication of target goals. The anticoagulation goal was explicitly documented 55% of the days and blood pressure goal stated 59% of the days before the roll out of ABCs of Stroke Prevention. A one page Stroke Prevention Checklist was created to review the anticoagulation and blood pressure goals to facilitate daily discussion and documentation of these goals (Figure in the Data Supplement). The initial goal was to complete the checklist 70% of the days in a given week. Following the roll out of the ABCs of Stroke Prevention, 83% of patients met this goal.Success of the Initiative: Initial Stroke Outcomes in the ACTION Outcome RegistryBetween December 2018 and September 2019, a total of 86 patients (adjudicated) were implanted with 120 devices for a total of 5597 device days (Table in the Data Supplement). The most common diagnosis was dilated cardiomyopathy (54%), followed by congenital heart disease (36%). Among those with congenital heart disease, 74% had univentricular physiology. The majority of patients were INTERMACS profile 1 (33%) or 2 (50%) at the time of implantation. The median duration of support was 49 days (interquartile range, 17–96; Table). While supported by a VAD, 12 patients (14%) experienced a stroke, including 4 of 33 (12%) Berlin EXCOR pumps and 8 of 30 (27%) paracorporeal continuous flow devices (Table). None of the 33 patients supported with an intracorporeal, continuous flow VAD or the 2 patients on the Syncardia Total Artificial Heart experienced a stroke.Table. Frequency of Strokes and Strokes per Support Day Stratified by Device Type Among Patients in the ACTION Outcome Registry DatabaseTotal number of patients implantedNumber of patients experiencing a strokeTotal device daysStroke/Pt (%)Stroke event/100 device daysAll devices (n=86)125597140.23CentriMag (n=17)5498291.20Berlin heart EXCOR (n=33)42822120.14PediMag (n=10)2232200.86Rotaflow (n=3)171331.41HeartWare HVAD (n=11)05230n/aHeartMate 3 (n=22)014110n/aSynCardia TAH (n=2)0480n/aACTION indicates Advanced Cardiac Therapies Improving Outcomes Network; and TAH, total artificial heart.Translation to Other SettingsThe ABCs of Stroke Prevention was a series of interventions focused on (1) standardizing anticoagulation in patients supported on a Berlin EXCOR, (2) developing and standardizing blood pressure measurement/goals, and (3) developing a method for communicating goals to families and bedside providers. The protocols, patient education, and methods for intranetwork communication were designed to be scalable and adaptable while holding the basic tenets of the original interventions. The network has also created a template for new centers to adopt the ABCs of Stroke Prevention and subsequent projects. This has been successfully adopted as the number of centers has grown from the initial group of 20 centers to >40 centers. We also expect to continue to modify our process measures to reflect novel data as well as sharing of best practices within the network. For example, the network has begun work on further optimizing anticoagulation practices as the roll-out of the ABCs of Stroke Prevention has underscored the potential for further improvement (eg, % in range values).SummaryThe current report describes the development and implementation of the ABCs of Stroke Prevention within ACTION and the most up to date stroke outcomes in a rapidly evolving field. These results have been obtained with help of standardized methods and collaboration. A rigorous comparison to historical data is not feasible with the current study design but is currently underway. We are also exploring the relationships of the current interventions to outcomes (historical and current) to help refine the protocols and data collection as the preexisting data gap regarding outcomes narrows.ACTION has become a multicenter collaborative capable of reporting outcomes in a timely and reliable manner and is capable of effectively developing and implementing standardized care management protocols and guidelines. The ACTION infrastructure will minimize unnecessary variation, identify best practices, and rapidly disseminate effective care strategies in a rapidly evolving field.DisclosuresThe Advanced Cardiac Therapies Improving Outcomes Network (ACTION) has received funding from Medtronic, Abbott, SynCardia, and Berlin Heart, Inc. Dr Lorts discloses a financial relationship Abbot, Berlin Heart and Medtronic.AppendixACTION Investigators: Angela Lorts, David L.S. Morales, Farhan Zafar, Paige Krack, Lauren Smyth, Katrina Fields (Cincinnati Children's Hospital Medical Center, Cincinnati, OH); David N. Rosenthal, Jenna Murray (Lucille Packard Children's Hospital, Palo Alto, CA); Beth Hawkins (Boston Children's Hospital, Boston, MA); David M. Peng (C.S. Mott Children's Hospital, Ann Arbor, MI); David L. Sutcliffe, Jodie Lantz (Children's Health Dallas, Dallas, TX); Scott R. Auerbach, Meghan Williams (University of Colorado Denver, Anschutz Medical Campus, Children's Hospital of Colorado, Aurora, CO); Matthew O'Connor, Rachel White (Children's Hospital of Philadelphia, Philadelphia, PA); Robert A. Niebler (Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI and Herma Heart Institute, Children's Hospital of Wisconsin, Milwaukee, WI); F. Bennet Pearce, Meloneysa Hubbard (Children's of Alabama, Birmingham, AL); Matthew Zinn (Children's Hospital of Pittsburgh, Pittsburgh, PA); Allison Reichhold, Anna Joong (Ann & Robert H. Lurie Children's Hospital, Chicago, IL); David Bearl (Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN); Deipanjan Nandi, Robert Gajarski (Nationwide Children's Hospital, Columbus, OH); Michelle Ploutz (Phoenix Children's Hospital, Phoenix, AZ); Lindsay J. May (Primary Children's Hospital, Salt Lake City, UT); Mary Mehegan, Kathleen Simpson (St. Louis Children's Hospital, St. Louis, MO); Jennifer Conway, Nicole Dubyk (Stollery Children's Hospital, Edmonton, Canada); Hari Tunuguntla, Barbara Elias (Texas Children's Hospital, Houston, TX); Aamir Jeewa (The Hospital for Sick Children, Toronto, Canada); Jeffrey G. Gossett, Mary Gowen (UCSF Benioff Children's Hospital, San Francisco, CA).Footnotes*A list of all ACTION investigators is given in the Appendix.The Data Supplement is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCOUTCOMES.120.006663.Chet R. Villa, MD, The Heart Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, MLC 2003, Cincinnati, OH 45242. Email chet.[email protected]orgReferences1. Burstein DS, Shamszad P, Dai D, Almond CS, Price JF, Lin KY, O'Connor MJ, Shaddy RE, Mascio CE, Rossano JW. Significant mortality, morbidity and resource utilization associated with advanced heart failure in congenital heart disease in children and young adults.Am Heart J. 2019; 209:9–19. doi: 10.1016/j.ahj.2018.11.010CrossrefMedlineGoogle Scholar2. Zafar F, Castleberry C, Khan MS, Mehta V, Bryant R, Lorts A, Wilmot I, Jefferies JL, Chin C, Morales DLS. Pediatric heart transplant waiting list mortality in the era of ventricular assist devices.J Heart Lung Transplant. 2015; 34:82–88. doi: 10.1016/j.healun.2014.09.018CrossrefMedlineGoogle Scholar3. Rosenthal DN, Almond CS, Jaquiss RD, Peyton CE, Auerbach SR, Morales DR, Epstein DJ, Cantor RS, Kormos RL, Naftel DC, et al.. Adverse events in children implanted with ventricular assist devices in the United States:data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS).J Heart Lung Transplant. 2016; 35:569–577. doi: 10.1016/j.healun.2016.03.005CrossrefMedlineGoogle Scholar4. Steiner ME, Bomgaars LR, Massicotte MP; Berlin Heart EXCOR Pediatric VAD IDE study investigators. Antithrombotic therapy in a prospective trial of a pediatric ventricular assist device.ASAIO J. 2016; 62:719–727. doi: 10.1097/MAT.0000000000000434CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited ByGodown J and Lambert A (2021) Minimizing the Risk of Severe Primary Graft Dysfunction in Infant Heart Transplant Recipients: Time for a Paradigm Shift, Journal of the American Heart Association, 10:13, Online publication date: 6-Jul-2021. December 2020Vol 13, Issue 12Article InformationMetrics Download: 902 © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCOUTCOMES.120.006663PMID: 33320692 Originally publishedDecember 15, 2020 Keywordsdiagnosispediatricspopulationheart failurestrokemortalityPDF download Advertisement SubjectsCongenital Heart DiseaseHeart FailureQuality and Outcomes
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