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4,737 results on '"Granger, Christopher"'

1. Combinations of First Responder and Drone Delivery to Achieve 5-Minute AED Deployment in OHCA.

Author

Starks, Monique, Chu, Jamal, Leung, K, Blewer, Audrey, Simmons, Denise, Hansen, Carolina, Joiner, Anjni, Cabañas, José, Harmody, Matthew, Nelson, R, McNally, Bryan, Ornato, Joseph, Granger, Christopher, Chan, Theodore, and Mark, Daniel

Subjects
automated external defibrillation, bystander, cardiopulmonary resuscitation, defibrillation, drone technology, emergency medical services, first responders, unmanned aviation vehicle
Abstract

BACKGROUND: Defibrillation in the critical first minutes of out-of-hospital cardiac arrest (OHCA) can significantly improve survival. However, timely access to automated external defibrillators (AEDs) remains a barrier. OBJECTIVES: The authors estimated the impact of a statewide program for drone-delivered AEDs in North Carolina integrated into emergency medical service and first responder (FR) response for OHCA. METHODS: Using Cardiac Arrest Registry to Enhance Survival registry data, we included 28,292 OHCA patients ≥18 years of age between 1 January 2013 and 31 December 2019 in 48 North Carolina counties. We estimated the improvement in response times (time from 9-1-1 call to AED arrival) achieved by 2 sequential interventions: 1) AEDs for all FRs; and 2) optimized placement of drones to maximize 5-minute AED arrival within each county. Interventions were evaluated with logistic regression models to estimate changes in initial shockable rhythm and survival. RESULTS: Historical county-level median response times were 8.0 minutes (IQR: 7.0-9.0 minutes) with 16.5% of OHCAs having AED arrival times of

Published
2024

3. GRACE scores or high-sensitivity troponin for timing of coronary angiography in non-ST-elevation acute coronary syndromes

Author

Jobs, Alexander, Boeddinghaus, Jasper, Neumann, Johannes Tobias, Goßling, Alina, Sörensen, Nils A., Twerenbold, Raphael, Nestelberger, Thomas, Lopez-Ayala, Pedro, Gimenez, Maria Rubini, Miro, Oscar, Koechlin, Luca, Buergin, Natacha, Feistritzer, Hans-Josef, Collet, Jean-Philippe, Bhatt, Deepak L., Granger, Christopher B., Blankenberg, Stefan, Desch, Steffen, Mueller, Christian, Westermann, Dirk, and Thiele, Holger

Published
2024
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4. Bridging Treatment Implementation Gaps in Patients With Heart Failure: JACC Focus Seminar 2/3.

Author

Jalloh, Mohamed, Averbuch, Tauben, Kulkarni, Prashanth, Granger, Christopher, Januzzi, James, Zannad, Faiez, Yeh, Robert, Yancy, Clyde, Fonarow, Gregg, Breathett, Khadijah, Gibson, C, and Van Spall, Harriette

Subjects
clinical trials, conceptual frameworks, guideline-directed medical therapies, heart failure, implementation science, Humans, Aged, Heart Failure, Stroke Volume
Abstract

Heart failure (HF) is a leading cause of death and disability in older adults. Despite decades of high-quality evidence to support their use, guideline-directed medical therapies (GDMTs) that reduce death and disease burden in HF have been suboptimally implemented. Approaches to closing care gaps have focused largely on strategies proven to be ineffective, whilst effective interventions shown to improve GDMT uptake have not been instituted. This review synthesizes implementation interventions that increase the uptake of GDMT, discusses barriers and facilitators of implementation, summarizes conceptual frameworks in implementation science that could improve knowledge uptake, and offers suggestions for trial design that could better facilitate end-of-trial implementation. We propose an evidence-to-care conceptual model that could foster the simultaneous generation of evidence and long-term implementation. By adopting principles of implementation science, policymakers, researchers, and clinicians can help reduce the burden of HF on patients and health care systems worldwide.

Published
2023

5. Health Information Technology: Meaningful Use and Next Steps to Improving Electronic Facilitation of Medication Adherence

Author

Bosworth, Hayden B, Zullig, Leah L, Mendys, Phil, Ho, Michael, Trygstad, Troy, Granger, Christopher, Oakes, Megan M, and Granger, Bradi B

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundThe use of health information technology (HIT) may improve medication adherence, but challenges for implementation remain. ObjectiveThe aim of this paper is to review the current state of HIT as it relates to medication adherence programs, acknowledge the potential barriers in light of current legislation, and provide recommendations to improve ongoing medication adherence strategies through the use of HIT. MethodsWe describe four potential HIT barriers that may impact interoperability and subsequent medication adherence. Legislation in the United States has incentivized the use of HIT to facilitate and enhance medication adherence. The Health Information Technology for Economic and Clinical Health (HITECH) was recently adopted and establishes federal standards for the so-called "meaningful use" of certified electronic health record (EHR) technology that can directly impact medication adherence. ResultsThe four persistent HIT barriers to medication adherence include (1) underdevelopment of data reciprocity across clinical, community, and home settings, limiting the capture of data necessary for clinical care; (2) inconsistent data definitions and lack of harmonization of patient-focused data standards, making existing data difficult to use for patient-centered outcomes research; (3) inability to effectively use the national drug code information from the various electronic health record and claims datasets for adherence purposes; and (4) lack of data capture for medication management interventions, such as medication management therapy (MTM) in the EHR. Potential recommendations to address these issues are discussed. ConclusionTo make meaningful, high quality data accessible, and subsequently improve medication adherence, these challenges will need to be addressed to fully reach the potential of HIT in impacting one of our largest public health issues.

Published
2016
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6. Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial

Author

Tannu, Manasi, Kaltenbach, Lisa, Pagidipati, Neha J., McGuire, Darren K., Aroda, Vanita R., Pop-Busui, Rodica, Kondamudi, Nitin, Al-Khalidi, Hussein R., Lopes, Renato D., Cavender, Matthew A., Nelson, Adam J., Kirk, Julienne, Lingvay, Ildiko, Magwire, Melissa, Richardson, Caroline Regina, Webb, Laura, Leyva, Monica, Pandey, Ambarish, Washington, Alana, Pak, Jonathan, Gaynor, Tanya, Khan, Waqar, Weston, Patrick, Granger, Christopher B., and Green, Jennifer

Published
2024
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8. RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design

Author

Krychtiuk, Konstantin A., Starks, Monique A., Al-Khalidi, Hussein R., Mark, Daniel B., Monk, Lisa, Yow, Eric, Kaltenbach, Lisa, Jollis, James G., Al-Khatib, Sana M., Bosworth, Hayden B., Ward, Kimberly, Brady, Sarah, Tyson, Clark, Vandeventer, Steve, Baloch, Khaula, Oakes, Megan, Blewer, Audrey L., Lewinski, Allison A., Hansen, Carolina Malta, Sharpe, Edward, Rea, Thomas D., Nelson, R. Darrell, Sasson, Comilla, McNally, Bryan, and Granger, Christopher B.

Published
2024
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12. Effect of Apixaban on Clinical Outcomes in Outpatients With COVID-19: The APOLLO Randomized Clinical Trial

Author

de Barros e Silva, Pedro Gabriel Melo, Macedo, Ariane Vieira Scarlatelli, Bronhara, Bruna, Damiani, Lucas Petri, Mazza Barbosa, Lilian, Lopes, Nathália Rodrigues, Suiama, Mayra Akimi, Antunes, Murillo O., Gonçalves, Mariana Raquel, Gebara, Otávio Celso Eluf, de Aquino Martins, Priscilla, Ribeiro, Mariana Galvão, de Moura Xavier de Moraes, João Batista, Jr, Aguiar, Valéria Cristina Resende, Cavalcanti, Alexandre B., Rosa, Regis G., Berwanger, Otavio, Veiga, Viviane C., Azevedo, Luciano C.P., Ramacciotti, Eduardo, Granger, Christopher B., Alexander, John H., Avezum, Alvaro, and Lopes, Renato D.

Published
2024
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13. Predictors of Recurrent Stroke After Embolic Stroke of Undetermined Source in the RE‐SPECT ESUS Trial

Author

Del Brutto, Victor J, Diener, Han‐Christoph, Easton, J Donald, Granger, Christopher B, Cronin, Lisa, Kleine, Eva, Grauer, Claudia, Brueckmann, Martina, Toyoda, Kazunori, Schellinger, Peter D, Lyrer, Philippe, Molina, Carlos A, Chutinet, Aurauma, Bladin, Christopher F, Estol, Conrado J, and Sacco, Ralph L

Subjects
Neurosciences, Stroke, Brain Disorders, Clinical Trials and Supportive Activities, Clinical Research, Prevention, Aspirin, Cerebral Infarction, Dabigatran, Embolic Stroke, Humans, Intracranial Embolism, Male, Risk Factors, Tomography, Emission-Computed, Single-Photon, embolic stroke of undetermined source, risk factors, secondary prevention, stroke predictors, Cardiorespiratory Medicine and Haematology
Abstract

Background We sought to determine recurrent stroke predictors among patients with embolic strokes of undetermined source (ESUS). Methods and Results We applied Cox proportional hazards models to identify clinical features associated with recurrent stroke among participants enrolled in RE-SPECT ESUS (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) trial, an international clinical trial evaluating dabigatran versus aspirin for patients with ESUS. During a median follow-up of 19 months, 384 of 5390 participants had recurrent stroke (annual rate, 4.5%). Multivariable models revealed that stroke or transient ischemic attack before the index event (hazard ratio [HR], 2.27 [95% CI, 1.83-2.82]), creatinine clearance

Published
2022

14. Characteristics and Outcomes of Adults With Congenital Heart Disease in the Cardiac Intensive Care Unit

Author

Keane, Ryan R., Carnicelli, Anthony P., Loriaux, Daniel B., Kendsersky, Payton, Krasuski, Richard A., Brown, Kelly M., Arps, Kelly, Baird-Zars, Vivian, Dixson, Jeffrey A., Echols, Emily, Granger, Christopher B., Harrison, Robert W., Kontos, Michael, Newby, L. Kristin, Park, Jeong-Gun, Shah, Kevin S., Ternus, Bradley W., Van Diepen, Sean, Katz, Jason N., and Morrow, David A.

Published
2024
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15. Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA

Author

Lopes, Renato D., Granger, Christopher B., Wojdyla, Daniel M., McIntyre, William F., Alings, Marco, Mani, Thenmozhi, Ramasundarahettige, Chinthanie, Rivard, Lena, Atar, Dan, Birnie, David H., Boriani, Giuseppe, Amit, Guy, Leong-Sit, Peter, Rinne, Claus, Duray, Gabor Z., Gold, Michael R., Hohnloser, Stefan H., Kutyifa, Valentina, Benezet-Mazuecos, Juan, Cosedis Nielsen, Jens, Sticherling, Christian, Benz, Alexander P., Linde, Cecilia, Kautzner, Joseph, Mabo, Philippe, Mairesse, Georges H., Connolly, Stuart J., and Healey, Jeff S.

Published
2024
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22. Efficacy and Safety of Non–Vitamin-K Antagonist Oral Anticoagulants Versus Warfarin Across the Spectrum of Body Mass Index and Body Weight: An Individual Patient Data Meta-Analysis of 4 Randomized Clinical Trials of Patients With Atrial Fibrillation

Author

Patel, Siddharth M., Braunwald, Eugene, Steffel, Jan, Boriani, Giuseppe, Palazzolo, Michael G., Antman, Elliott M., Bohula, Erin A., Carnicelli, Anthony P., Connolly, Stuart J., Eikelboom, John W., Gencer, Baris, Granger, Christopher B., Morrow, David A., Patel, Manesh R., Wallentin, Lars, Ruff, Christian T., and Giugliano, Robert P.

Published
2024
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26. Pulmonary Congestion and Left Ventricular Dysfunction After Myocardial Infarction: Insights From the PARADISE-MI Trial

Author

Petrie, Mark C., Rouleau, Jean L., Claggett, Brian, Jering, Karola, van der Meer, Peter, Køber, Lars, Miao, Zi Michael, Lewis, Eldrin, Granger, Christopher, De Pasqulae, Carmine G., Mann, Douglas, Steg, Philippe Gabriel, Maggioni, Aldo, Amir, Offer, Lefkowitz, Marty, Braunwald, Eugene, Solomon, Scott D, McMurray, John J.V., and Pfeffer, Marc A.

Published
2024
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28. Rationale and design of a randomized study comparing the Watchman FLX device to DOACs in patients with atrial fibrillation

Author

Kar, Saibal, Doshi, Shephal K., Alkhouli, Mohamad, Camm, A. John, Coylewright, Megan, Gibson, Michael C., Granger, Christopher B., Gurol, Mahmut E., Huber, Kenneth, Mansour, Moussa, Nair, Devi G., Natale, Andrea, Pocock, Stuart J., Reddy, Vivek R., Saliba, Walid, Christen, Thomas, Allocco, Dominic J., Ellenbogen, Kenneth A., and Leon, Martin B.

Published
2023
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29. Management of Atrial Fibrillation in Older Patients by Morbidity Burden: Insights From Get With The Guidelines‐Atrial Fibrillation

Author

Dalgaard, Frederik, Xu, Haolin, Matsouaka, Roland A, Russo, Andrea M, Curtis, Anne B, Rasmussen, Peter Vibe, Ruwald, Martin H, Fonarow, Gregg C, Lowenstern, Angela, Hansen, Morten L, Pallisgaard, Jannik L, Alexander, Karen P, Alexander, John H, Lopes, Renato D, Granger, Christopher B, Lewis, William R, Piccini, Jonathan P, and Al‐Khatib, Sana M

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Aging, Cardiovascular, Heart Disease, Clinical Research, Management of diseases and conditions, 7.1 Individual care needs, Administration, Oral, Age Factors, Aged, Aged, 80 and over, Anticoagulants, Atrial Fibrillation, Cross-Sectional Studies, Female, Hospitalization, Humans, Logistic Models, Male, Multimorbidity, Odds Ratio, Practice Guidelines as Topic, Practice Patterns, Physicians', Registries, anticoagulation, atrial fibrillation, comorbidities, multimorbidity, oral anticoagulants, prescription, quality of care, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background Knowledge is scarce regarding how multimorbidity is associated with therapeutic decisions regarding oral anticoagulants (OACs) in patients with atrial fibrillation. Methods and Results We conducted a cross-sectional study of hospitalized patients with atrial fibrillation using the Get With The Guidelines-Atrial Fibrillation registry from 2013 to 2019. We identified patients ≥65 years and eligible for OAC therapy. Using 16 available comorbidity categories, patients were stratified by morbidity burden. A multivariable logistic regression model was used to determine the odds of receiving OAC prescription at discharge by morbidity burden. We included 34 174 patients with a median (interquartile range) age of 76 (71-83) years, 56.6% women, and 41.9% were not anticoagulated at admission. Of these patients, 38.6% had 0 to 2 comorbidities, 50.7% had 3 to 5 comorbidities, and 10.7% had ≥6 comorbidities. The overall discharge OAC prescription was high (85.6%). The prevalence of patients with multimorbidity increased from 59.7% in 2014 to 64.3% in 2019 (P trend=0.002). Using 0 to 2 comorbidities as the reference, the adjusted odds ratio (95% CI) of OAC prescription were 0.93 (0.82, 1.05) for patients with 3 to 5 comorbidities and 0.72 (0.60, 0.86) for patients with ≥6 comorbidities. In those with ≥6 comorbidities, the most common reason for nonprescription of OACs were frequent falls/frailty (31.0%). Conclusions In a contemporary quality-of-care database of hospitalized patients with atrial fibrillation eligible for OAC therapy, multimorbidity was common. A higher morbidity burden was associated with a lower odds of OAC prescription. This highlights the need for interventions to improve adherence to guideline-recommended anticoagulation in multimorbid patients with atrial fibrillation.

Published
2020

33. Antithrombotic Treatment of Embolic Stroke of Undetermined Source

Author

Diener, Hans-Christoph, Sacco, Ralph L, Easton, J Donald, Granger, Christopher B, Bar, Michal, Bernstein, Richard A, Brainin, Michael, Brueckmann, Martina, Cronin, Lisa, Donnan, Geoffrey, Gdovinová, Zuzana, Grauer, Claudia, Kleine, Eva, Kleinig, Timothy J, Lyrer, Philippe, Martins, Sheila, Meyerhoff, Juliane, Milling, Truman, Pfeilschifter, Waltraud, Poli, Sven, Reif, Michal, Rose, David Z, Šaňák, Daniel, and Schäbitz, Wolf-Rüdiger

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Brain Disorders, Clinical Trials and Supportive Activities, Stroke, Hematology, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Aged, 80 and over, Aspirin, Dabigatran, Double-Blind Method, Female, Fibrinolytic Agents, Humans, Intracranial Embolism, Kidney Diseases, Male, Middle Aged, Recurrence, anticoagulants, atrial fibrillation, cardiovascular disease, risk factors, secondary prevention, Cardiorespiratory Medicine and Haematology, Neurosciences, Neurology & Neurosurgery, Clinical sciences, Allied health and rehabilitation science
Abstract

Background and Purpose- The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods- RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to

Published
2020

34. Neuroprognostication in the Post Cardiac Arrest Patient: A Canadian Cardiovascular Society Position Statement

Author

Fordyce, Christopher B., Kramer, Andreas H., Ainsworth, Craig, Christenson, Jim, Hunter, Gary, Kromm, Julie, Lopez Soto, Carmen, Scales, Damon C., Sekhon, Mypinder, van Diepen, Sean, Dragoi, Laura, Josephson, Colin, Kutsogiannis, Jim, Le May, Michel R., Overgaard, Christopher B., Savard, Martin, Schnell, Gregory, Wong, Graham C., Belley-Côté, Emilie, Fantaneanu, Tadeu A., Granger, Christopher B., Luk, Adriana, Mathew, Rebecca, McCredie, Victoria, Murphy, Laurel, and Teitelbaum, Jeanne

Published
2023
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36. Prehospital treatment with zalunfiban (RUC-4) in patients with ST‐ elevation myocardial infarction undergoing primary percutaneous coronary intervention: Rationale and design of the CELEBRATE trial

Author

Rikken, Sem A.O.F., Selvarajah, Abi, Hermanides, Renicus S., Coller, Barry S., Gibson, C. Michael, Granger, Christopher B., Lapostolle, Frédéric, Postma, Sonja, van de Wetering, Henri, van Vliet, Risco C.W., Montalescot, Gilles, ten Berg, Jurriën M., and van ’t Hof, Arnoud W.J.

Published
2023
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40. Abstract 12724: High Health-Related Quality of Life Among Survivors of Out-of-Hospital Cardiac Arrest: A Nationwide Survey From 2001-2019

Author

Yonis, Harman Gailan Hassan, Sørensen, Kathrine Kold, Bøggild, Henrik, Bundgaard Ringgren, Kristian, Malta Hansen, Carolina, Granger, Christopher B, Folke, Fredrik, Christensen, Helle Collatz, Jensen, Britta, Andersen, Mikkel Porsborg, Joshi, Vicky, Zwisler, Ann-Dorthe, Torp-Pedersen, Christian, and Kragholm, Kristian

Published
2023
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41. Abstract 12701: Safety and Tolerability of Angiotensin Receptor Neprilysin Inhibitor Initiation in High-Risk Acute Myocardial Infarction Relative to Drug Initiation Setting: A Subgroup Analysis of the PARADISE-MI Trial

Author

De Pasquale, Carmine, Claggett, Brian, Jering, Karola, McMurray, John J, Mann, Douglas L, Granger, Christopher, Kober, Lars, Lewis, Eldrin F, Maggioni, Aldo Pietro P, Rouleau, Jean L, Solomon, Scott, Steg, Philippe G, van der meer, peter, Braunwald, Eugene, and Pfeffer, Marc A

Published
2023
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47. Coordinating Cardiology clinics randomized trial of interventions to improve outcomes (COORDINATE) – Diabetes: rationale and design

Author

Nelson, Adam J., Pagidipati, Neha J., Kelsey, Michelle D., Ardissino, Maddalena, Aroda, Vanita R., Cavender, Matthew A., Lopes, Renato D., Al-Khalidi, Hussein R., Braceras, Rogelio, Gaynor, Tanya, Kaltenbach, Lisa A., Kirk, Julienne K., Lingvay, Ildiko, Magwire, Melissa L., O'Brien, Emily C., Pak, Jonathan, Pop-Busui, Rodica, Richardson, Caroline R., Levya, Monica, Senyucel, Cagri, Webb, Laura, McGuire, Darren K., Green, Jennifer B., and Granger, Christopher B.

Published
2023
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48. Safety and Tolerability of Angiotensin Receptor-Neprilysin Inhibitor Initiation in High-Risk Acute Myocardial Infarction Relative to Care Setting: A Subgroup Analysis of the PARADISE-MI Trial

Author

De Pasquale, Carmine G., primary, Claggett, Brian, additional, Jering, Karola, additional, McMurray, John J.V., additional, Mann, Douglas, additional, Miao, Zi Michael, additional, Granger, Christopher B., additional, Køber, Lars, additional, Maggioni, Aldo P., additional, Rouleau, Jean-Lucien, additional, Solomon, Scott D., additional, Steg, Philippe Gabriel, additional, van der Meer, Peter, additional, Braunwald, Eugene, additional, and Pfeffer, Marc A., additional

Published
2024
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50. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation

Author

Perez, Marco V, Mahaffey, Kenneth W, Hedlin, Haley, Rumsfeld, John S, Garcia, Ariadna, Ferris, Todd, Balasubramanian, Vidhya, Russo, Andrea M, Rajmane, Amol, Cheung, Lauren, Hung, Grace, Lee, Justin, Kowey, Peter, Talati, Nisha, Nag, Divya, Gummidipundi, Santosh E, Beatty, Alexis, Hills, Mellanie True, Desai, Sumbul, Granger, Christopher B, Desai, Manisha, and Turakhia, Mintu P

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Heart Disease, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Good Health and Well Being, Adult, Aged, Algorithms, Atrial Fibrillation, Confidentiality, Electrocardiography, Female, Humans, Male, Middle Aged, Mobile Applications, Predictive Value of Tests, Prospective Studies, Telemedicine, Wearable Electronic Devices, Apple Heart Study Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundOptical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown.MethodsParticipants without atrial fibrillation (as reported by the participants themselves) used a smartphone (Apple iPhone) app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was initiated and an electrocardiography (ECG) patch was mailed to the participant, to be worn for up to 7 days. Surveys were administered 90 days after notification of the irregular pulse and at the end of the study. The main objectives were to estimate the proportion of notified participants with atrial fibrillation shown on an ECG patch and the positive predictive value of irregular pulse intervals with a targeted confidence interval width of 0.10.ResultsWe recruited 419,297 participants over 8 months. Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. Among the 450 participants who returned ECG patches containing data that could be analyzed - which had been applied, on average, 13 days after notification - atrial fibrillation was present in 34% (97.5% confidence interval [CI], 29 to 39) overall and in 35% (97.5% CI, 27 to 43) of participants 65 years of age or older. Among participants who were notified of an irregular pulse, the positive predictive value was 0.84 (95% CI, 0.76 to 0.92) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular pulse notification and 0.71 (97.5% CI, 0.69 to 0.74) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. There were no reports of serious app-related adverse events.ConclusionsThe probability of receiving an irregular pulse notification was low. Among participants who received notification of an irregular pulse, 34% had atrial fibrillation on subsequent ECG patch readings and 84% of notifications were concordant with atrial fibrillation. This siteless (no on-site visits were required for the participants), pragmatic study design provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices. (Funded by Apple; Apple Heart Study ClinicalTrials.gov number, NCT03335800.).

Published
2019

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