Publications by authors named "John S Rumsfeld"

315 Publications

Association of Wearable Device Use With Pulse Rate and Health Care Use in Adults With Atrial Fibrillation.

JAMA Netw Open 2021 May 3;4(5):e215821. Epub 2021 May 3.

Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City.

Importance: Increasingly, individuals with atrial fibrillation (AF) use wearable devices (hereafter wearables) that measure pulse rate and detect arrhythmia. The associations of wearables with health outcomes and health care use are unknown.

Objective: To characterize patients with AF who use wearables and compare pulse rate and health care use between individuals who use wearables and those who do not.

Design, Setting, And Participants: This retrospective, propensity-matched cohort study included 90 days of follow-up of patients in a tertiary care, academic health system. Included patients were adults with at least 1 AF-specific International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) code from 2017 through 2019. Electronic medical records were reviewed to identify 125 individuals who used wearables and had adequate pulse-rate follow-up who were then matched using propensity scores 4 to 1 with 500 individuals who did not use wearables. Data were analyzed from June 2020 through February 2021.

Exposure: Using commercially available wearables with pulse rate or rhythm evaluation capabilities.

Main Outcomes And Measures: Mean pulse rates from measures taken in the clinic or hospital and a composite health care use score were recorded. The composite outcome included evaluation and management, ablation, cardioversion, telephone encounters, and number of rate or rhythm control medication orders.

Results: Among 16 320 patients with AF included in the analysis, 348 patients used wearables and 15 972 individuals did not use wearables. Prior to matching, patients using wearables were younger (mean [SD] age, 64.0 [13.0] years vs 70.0 [13.8] years; P < .001) and healthier (mean [SD] CHA2DS2-VASc [congestive heart failure, hypertension, age ≥ 65 years or 65-74 years, diabetes, prior stroke/transient ischemic attack, vascular disease, sex] score, 3.6 [2.0] vs 4.4 [2.0]; P < .001) compared with individuals not using wearables, with similar gender distribution (148 [42.5%] women vs 6722 women [42.1%]; P = .91). After matching, mean pulse rate was similar between 125 patients using wearables and 500 patients not using wearables (75.01 [95% CI, 72.74-77.27] vs 75.79 [95% CI, 74.68-76.90] beats per minute [bpm]; P = .54), whereas mean composite use score was higher among individuals using wearables (3.55 [95% CI, 3.31-3.80] vs 3.27 [95% CI, 3.14-3.40]; P = .04). Among measures in the composite outcome, there was a significant difference in use of ablation, occurring in 22 individuals who used wearables (17.6%) vs 37 individuals who did not use wearables (7.4%) (P = .001). In the regression analyses, mean composite use score was 0.28 points (95% CI, 0.01 to 0.56 points) higher among individuals using wearables compared with those not using wearables and mean pulse was similar, with a -0.79 bpm (95% CI -3.28 to 1.71 bpm) difference between the groups.

Conclusions And Relevance: This study found that follow-up health care use among individuals with AF was increased among those who used wearables compared with those with similar pulse rates who did not use wearables. Given the increasing use of wearables by patients with AF, prospective, randomized, long-term evaluation of the associations of wearable technology with health outcomes and health care use is needed.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.5821DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160588PMC
May 2021

Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Circ Cardiovasc Interv 2021 04 20;14(4):e009963. Epub 2021 Apr 20.

Duke Clinical Research Institute, Durham, NC (M.W.S., S.V., Z.L., J.P., J.K.H., A.N.V., E.D.P.).

Background: Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States.

Methods: Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables.

Results: In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05–1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93–1.47]).

Conclusions: There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009963DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8300574PMC
April 2021

Optimizing the Potential for Telehealth in Cardiovascular Care (in the Era of COVID-19): Time Will Tell.

Am J Med 2021 08 15;134(8):945-951. Epub 2021 Apr 15.

Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Emory University School of Medicine, Atlanta, Ga. Electronic address:

Before the coronavirus disease 2019 (COVID-19) pandemic, use of telehealth services had been limited in cardiovascular care. Potential benefits of telehealth include improved access to care, more efficient care management, reduced costs, the ability to assess patients within their homes while involving key caretakers in medical decisions, maintaining social distance, and increased patient satisfaction. Challenges include changes in payment models, issues with data security and privacy, potential depersonalization of the patient-clinician relationship, limitations in the use of digital health technologies, and the potential impact on disparities, including socioeconomic, gender, and age-related issues and access to technology and broadband. Implementation and expansion of telehealth from a policy and reimbursement practice standpoint are filled with difficult decisions, yet addressing these are critical to the future of health care.
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http://dx.doi.org/10.1016/j.amjmed.2021.03.007DOI Listing
August 2021

Use of Machine Learning Models to Predict Death After Acute Myocardial Infarction.

JAMA Cardiol 2021 Jun;6(6):633-641

Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.

Importance: Accurate prediction of adverse outcomes after acute myocardial infarction (AMI) can guide the triage of care services and shared decision-making, and novel methods hold promise for using existing data to generate additional insights.

Objective: To evaluate whether contemporary machine learning methods can facilitate risk prediction by including a larger number of variables and identifying complex relationships between predictors and outcomes.

Design, Setting, And Participants: This cohort study used the American College of Cardiology Chest Pain-MI Registry to identify all AMI hospitalizations between January 1, 2011, and December 31, 2016. Data analysis was performed from February 1, 2018, to October 22, 2020.

Main Outcomes And Measures: Three machine learning models were developed and validated to predict in-hospital mortality based on patient comorbidities, medical history, presentation characteristics, and initial laboratory values. Models were developed based on extreme gradient descent boosting (XGBoost, an interpretable model), a neural network, and a meta-classifier model. Their accuracy was compared against the current standard developed using a logistic regression model in a validation sample.

Results: A total of 755 402 patients (mean [SD] age, 65 [13] years; 495 202 [65.5%] male) were identified during the study period. In independent validation, 2 machine learning models, gradient descent boosting and meta-classifier (combination including inputs from gradient descent boosting and a neural network), marginally improved discrimination compared with logistic regression (C statistic, 0.90 for best performing machine learning model vs 0.89 for logistic regression). Nearly perfect calibration in independent validation data was found in the XGBoost (slope of predicted to observed events, 1.01; 95% CI, 0.99-1.04) and the meta-classifier model (slope of predicted-to-observed events, 1.01; 95% CI, 0.99-1.02), with more precise classification across the risk spectrum. The XGBoost model reclassified 32 393 of 121 839 individuals (27%) and the meta-classifier model reclassified 30 836 of 121 839 individuals (25%) deemed at moderate to high risk for death in logistic regression as low risk, which were more consistent with the observed event rates.

Conclusions And Relevance: In this cohort study using a large national registry, none of the tested machine learning models were associated with substantive improvement in the discrimination of in-hospital mortality after AMI, limiting their clinical utility. However, compared with logistic regression, XGBoost and meta-classifier models, but not the neural network, offered improved resolution of risk for high-risk individuals.
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http://dx.doi.org/10.1001/jamacardio.2021.0122DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7948114PMC
June 2021

Innovation in Cardiology: The ACC Innovation Program.

Methodist Debakey Cardiovasc J 2020 Oct-Dec;16(4):304-308

ST. FRANCIS HOSPITAL, CATHOLIC HEALTH SERVICES OF LONG ISLAND, ROSLYN, NEW YORK.

The last half century has seen extraordinary advances in the field of cardiology, including innovations in medications, diagnostic modalities, and therapeutics. Even so, cardiovascular disease remains the leading cause of morbidity and mortality globally, with suboptimal quality of care, inconsistent health outcomes, and unsustainable costs. It is clear that cardiovascular medicine must undergo a digital transformation to enhance the delivery of quality care and to improve outcomes. To meet this need, the American College of Cardiology developed an innovation program focused on the digital transformation of cardiovascular care, with the goal of improving heart health for individuals and populations.
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http://dx.doi.org/10.14797/mdcj-16-4-304DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812854PMC
February 2021

Bleeding avoidance strategies and percutaneous coronary intervention outcomes: A 10-year observation from a Japanese Multicenter Registry.

Am Heart J 2021 05 17;235:113-124. Epub 2021 Jan 17.

Department of Cardiology, Keio University School of Medicine, Tokyo, Japan. Electronic address:

Background: Bleeding avoidance strategies (BASs) are increasingly adopted for patients undergoing percutaneous coronary intervention (PCI) due to bleeding complications. However, their association with bleeding events outside of Western countries remains unclear. In collaboration with the National Cardiovascular Data Registry (NCDR) CathPCI registry, we aimed to assess the time trend and impact of BAS utilization among Japanese patients.

Methods: Our study included 19,656 consecutive PCI patients registered over 10 years. These patients were divided into 4-time frame groups (T1: 2008-2011, T2: 2012-2013, T3: 2014-2015, and T4: 2016-2018). BAS was defined as the use of transradial approach or vascular closure device (VCD) use after transfemoral approach (TFA). Model performance of the NCDR CathPCI bleeding model was evaluated. The degree of bleeding reduction associated with BAS adoption was estimated via multilevel mixed-effects multivariable logistic regression analysis.

Results: The NCDR CathPCI bleeding risk score demonstrated good discrimination in the Japanese population (C-statistics 0.79-0.81). The BAS adoption rate increased from 43% (T1) to 91% (T4), whereas the crude CathPCI-defined bleeding rate decreased from 10% (T1) to 7% (T4). Adjusted odds ratios for bleeding events were 0.25 (95% confidence interval, 0.14-0.45, P< .001) for those undergoing TFA with VCD in T4 and 0.26 (95% confidence interval 0.20-0.35, P< .001) for transradial approach in T4 compared to patients that received TFA without VCD in T1.

Conclusions: BAS use over the studied time frames was associated with lower risk of bleeding complications among Japanese. Nonetheless, observed bleeding rates remained higher compared to the US population.
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http://dx.doi.org/10.1016/j.ahj.2021.01.010DOI Listing
May 2021

Comparative Trends in Percutaneous Coronary Intervention in Japan and the United States, 2013 to 2017.

J Am Coll Cardiol 2020 09;76(11):1328-1340

Japanese Association of Cardiovascular Intervention and Therapeutics, Tokyo, Japan.

Background: Adoption of the results of large-scale randomized controlled trials in percutaneous coronary intervention (PCI) may differ internationally, yet few studies have described the potential variations in PCI practice patterns.

Objectives: Using representative national registries, we compared temporal trends in procedural volume, patient characteristics, pre-procedural testing, procedural characteristics, and quality metrics in the United States and Japan.

Methods: The National Cardiovascular Data Registry CathPCI was used to describe care in the United States, and the J-PCI was used to assess practice patterns in Japan (numbers of participating hospitals: 1,752 in the United States and 1,108 in Japan). Both registries were summarized between 2013 and 2017.

Results: PCI volume increased by 15.8% in the United States from 550,872 in 2013 to 637,650 in 2017, primarily because of an increase in nonelective PCIs (p for trend <0.001). In Japan, the volume of PCIs increased by 36%, from 181,750 in 2013 to 247,274 in 2017, primarily because of an increase in elective PCIs (p for trend <0.001). The proportion of PCI cases for elective conditions was >2-fold greater in Japan (72.7%) than in the United States (33.8%; p < 0.001). Overall, the ratio of nonelective PCI (vs. elective PCI; 27.3% vs. 66.2%; p < 0.001) and the performance of noninvasive stress testing in patients with stable disease (15.2% vs. 55.3%; p < 0.001) was lower in Japan than in the United States. Computed tomography angiography was more commonly used in Japan (22.3% vs. 2.0%; p < 0.001).

Conclusions: Elective PCI is more than twice as common in Japan as in the United States in contemporary practice. Computed tomography angiography is much more frequently used pre-procedurally in Japan than in the United States.
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http://dx.doi.org/10.1016/j.jacc.2020.07.037DOI Listing
September 2020

Management of Acute Myocardial Infarction During the COVID-19 Pandemic: A Position Statement From the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the American College of Emergency Physicians (ACEP).

J Am Coll Cardiol 2020 09 21;76(11):1375-1384. Epub 2020 Apr 21.

The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio.

The worldwide pandemic caused by the novel acute respiratory syndrome coronavirus 2 has resulted in a new and lethal disease termed coronavirus disease-2019 (COVID-19). Although there is an association between cardiovascular disease and COVID-19, the majority of patients who need cardiovascular care for the management of ischemic heart disease may not be infected with this novel coronavirus. The objective of this document is to provide recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic. There is a recognition of two major challenges in providing recommendations for AMI care in the COVID-19 era. Cardiovascular manifestations of COVID-19 are complex with patients presenting with AMI, myocarditis simulating an ST-elevation myocardial infarction (STEMI) presentation, stress cardiomyopathy, non-ischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury, and the prevalence of COVID-19 disease in the U.S. population remains unknown with risk of asymptomatic spread. This document addresses the care of these patients focusing on 1) the varied clinical presentations; 2) appropriate personal protection equipment (PPE) for health care workers; 3) role of the Emergency Department, Emergency Medical System and the Cardiac Catheterization Laboratory; and 4) Regional STEMI systems of care. During the COVID-19 pandemic, primary PCI remains the standard of care for STEMI patients at PCI capable hospitals when it can be provided in a timely fashion, with an expert team outfitted with PPE in a dedicated CCL room. A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option.
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http://dx.doi.org/10.1016/j.jacc.2020.04.039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7173829PMC
September 2020

Management of acute myocardial infarction during the COVID-19 pandemic: A Consensus Statement from the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the American College of Emergency Physicians (ACEP).

Catheter Cardiovasc Interv 2020 08 13;96(2):336-345. Epub 2020 May 13.

The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio.

The worldwide pandemic caused by the novel acute respiratory syndrome coronavirus 2 has resulted in a new and lethal disease termed coronavirus disease 2019 (COVID-19). Although there is an association between cardiovascular disease and COVID-19, the majority of patients who need cardiovascular care for the management of ischemic heart disease may not be infected with this novel coronavirus. The objective of this document is to provide recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic. There is a recognition of two major challenges in providing recommendations for AMI care in the COVID-19 era. Cardiovascular manifestations of COVID-19 are complex with patients presenting with AMI, myocarditis simulating an ST-elevation myocardial infarction (STEMI) presentation, stress cardiomyopathy, non-ischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury, and the prevalence of COVID-19 disease in the US population remains unknown with risk of asymptomatic spread. This document addresses the care of these patients focusing on (a) varied clinical presentations; (b) appropriate personal protection equipment (PPE) for health care workers; (c) the roles of the emergency department, emergency medical system, and the cardiac catheterization laboratory (CCL); and (4) regional STEMI systems of care. During the COVID-19 pandemic, primary percutaneous coronary intervention (PCI) remains the standard of care for STEMI patients at PCI-capable hospitals when it can be provided in a timely manner, with an expert team outfitted with PPE in a dedicated CCL room. A fibrinolysis-based strategy may be entertained at non-PCI-capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option.
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http://dx.doi.org/10.1002/ccd.28946DOI Listing
August 2020

Development and Validation of a Model for Predicting the Risk of Acute Kidney Injury Associated With Contrast Volume Levels During Percutaneous Coronary Intervention.

JAMA Netw Open 2019 11 1;2(11):e1916021. Epub 2019 Nov 1.

Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut.

Importance: Determining the association of contrast volume during percutaneous coronary intervention (PCI) with the risk of acute kidney injury (AKI) is important for optimizing PCI safety.

Objective: To quantify how the risk of AKI is associated with contrast volume, accounting for the possibility of nonlinearity and heterogeneity among different baseline risks.

Design, Setting, And Participants: This prognostic study used data from the American College of Cardiology National Cardiovascular Data Registry CathPCI Registry for 1694 US hospitals. Derivation analysis included 2 076 694 individuals who underwent PCI from July 1, 2011, to June 30, 2015. Validation analysis included 961 863 individuals who underwent PCI from July 1, 2015, to March 31, 2017. Data analysis took place from July 2018 to May 2019.

Exposure: Contrast volume during PCI.

Main Outcomes And Measures: Acute kidney injury was defined using 3 thresholds for preprocedure to postprocedure creatinine level increase (ie, ≥0.3 mg/dL, ≥0.5 mg/dL, and ≥1.0 mg/dL). A model quantifying the association of contrast volume with AKI was developed, and the existence of nonlinearity and heterogeneity were examined by likelihood ratio tests. The model was derived in the training set (a random 50% of the derivation cohort), and performance was evaluated in the test set (the remaining 50% of the derivation cohort) and an independent validation set by area under the receiver operating characteristic curve (AUC) and calibration slope of observed vs predicted risks.

Results: The 2 076 694 patients in the derivation set had a mean (SD) age of 65.1 (12.1) years, and 662 525 (31.9%) were women; 133 306 (6.4%) had creatinine level increases of at least 0.3 mg/dL, 66 626 (3.2%) had creatinine level increases of at least 0.5 mg/dL, and 28 378 (1.4%) had creatinine level increases of at least 1.0 mg/dL. In the validation set of 961 843 patients (mean [SD] age, 65.7 [12.1] years; 305 577 [31.8%] women), these rates were 62 913 (6.5%), 34 229 (3.6%), and 15 555 (1.6%), respectively. The association of contrast volume and AKI risk was nonlinear (χ226 = 1436.2; P < .001) and varied by preprocedural risk (χ220 = 105.6; P < .001). In the test set, the model yielded an AUC of 0.777 (95% CI, 0.775-0.779) for predicting risk of a creatinine level increase of at least 0.3 mg/dL, 0.839 (95% CI, 0.837-0.841) for predicting risk of a creatinine level increase of at least 0.5 mg/dL, and 0.870 (95% CI, 0.867-0.873) for predicting risk of a creatinine level increase of at least 1.0 mg/dL; it achieved a calibration slope of 0.998 (95% CI, 0.989-1.007), 0.999 (95% CI, 0.989-1.008), and 0.986 (95% CI, 0.973-0.998), respectively, for the AKI severity levels. The model had similar performance in the validation set (creatinine level increase of ≥0.3 mg/dL: AUC, 0.794; 95% CI, 0.792-0.795; calibration slope, 1.039; 95% CI, 1.030-1.047; creatinine level increase of ≥0.5 mg/dL: AUC, 0.845; 95% CI, 0.843-0.848; calibration slope, 1.063; 95% CI, 1.054-1.074; creatinine level increase of ≥1.0 mg/dL: AUC, 0.872; 95% CI, 0.869-0.875; calibration slope, 1.103; 95% CI, 1.089-1.117).

Conclusions And Relevance: The association of contrast volume with AKI risk is complex, varies by baseline risk, and can be predicted by a model. Future research to evaluate the effect of the model on AKI is needed.
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http://dx.doi.org/10.1001/jamanetworkopen.2019.16021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902830PMC
November 2019

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

N Engl J Med 2019 11;381(20):1909-1917

From the Division of Cardiovascular Medicine (M.V.P.), Stanford Center for Clinical Research (K.W.M., A.R., N.T.), the Quantitative Sciences Unit (H.H., A.G., V.B., J.L., S.E.G., M.D.), Information Resources and Technology (T.F., G.H.), Department of Medicine (S.D.), and the Center for Digital Health (M.P.T.), Stanford University, Stanford, Apple, Cupertino (L.C., D.N., A.B., S.D.), and the Veterans Affairs Palo Alto Health Care System, Palo Alto (M.P.T.) - all in California; the University of Colorado School of Medicine, Aurora (J.S.R.); the Division of Cardiovascular Disease, Cooper Medical School of Rowan University, Camden, NJ (A.M.R.); the Lankenau Heart Institute and Jefferson Medical College, Philadelphia (P.K.); StopAfib.org, American Foundation for Women's Health, Decatur, TX (M.T.H.); and the Duke Clinical Research Institute, Duke University, Durham, NC (C.B.G.).

Background: Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown.

Methods: Participants 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.

Results: We 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.

Conclusions: The 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.).
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http://dx.doi.org/10.1056/NEJMoa1901183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112605PMC
November 2019

Relationship Between Troponin on Presentation and In-Hospital Mortality in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

J Am Heart Assoc 2019 10 24;8(19):e013551. Epub 2019 Sep 24.

Division of Cardiovascular Medicine Department of Internal Medicine University of Michigan Ann Arbor MI.

Background Troponin release in ST-segment-elevation myocardial infarction (STEMI) has predictable kinetics with early levels reflective of ischemia duration. Little research has examined the value of admission troponin levels in STEMI patients undergoing primary percutaneous coronary intervention. We investigated the relationship between troponin on presentation and mortality in a large, real-world cohort of STEMI patients undergoing primary percutaneous coronary intervention. Methods and Results We used multivariable adaptive regression modeling to examine the association between admission troponin levels and in-hospital mortality for patients who underwent primary percutaneous coronary intervention for STEMI. We adjusted for known clinical risk factors using a validated mortality risk model derived from the NCDR (National Cardiovascular Data Registry) CathPCI database, and this same model was used to calculate patients' predicted mortality based on clinical and demographic factors. Patients were then stratified by troponin groups to compare predicted versus observed mortality. Of the 14 061 patients included in the cohort, 47.2% had initial troponin levels that were undetectable or within the reference range. Admission troponin was an independent predictor of in-hospital mortality, and any value above the reference range was associated with increased mortality (1.8% versus 5.1%, [standardized difference, 18.2%]). Patients with the highest predicted risk for mortality (13% predicted) in the highest admission troponin grouping experienced an observed mortality of 19.5%. Patients in low troponin groupings consistently demonstrated lower than predicted mortality based on their clinical and demographic risk profile. Conclusions Nearly half of patients undergoing primary percutaneous coronary intervention had normal troponin on presentation and had a relatively good outcome. Mortality increases with elevated admission troponin levels, regardless of baseline clinical risk. The substantial number of patients who present with markedly elevated troponin and their relatively worse outcomes highlights the need for continued improvement in prehospital STEMI detection and care.
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http://dx.doi.org/10.1161/JAHA.119.013551DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6806038PMC
October 2019

Myocardial infarction with non-obstructive coronary arteries as compared with myocardial infarction and obstructive coronary disease: outcomes in a Medicare population.

Eur Heart J 2020 02;41(7):870-878

The Queen Elizabeth Hospital, Discipline of Medicine, University of Adelaide, 28 Woodville Road, Woodville South, 5011, South Australia.

Aims: The prognosis of patients with MINOCA (myocardial infarction with non-obstructive coronary arteries) is poorly understood. We examined major adverse cardiac events (MACE) defined as all-cause mortality, re-hospitalization for acute myocardial infarction (AMI), heart failure (HF), or stroke 12-months post-AMI in patients with MINOCA versus AMI patients with obstructive coronary artery disease (MICAD).

Methods And Results: Multicentre, observational cohort study of patients with AMI (≥65 years) from the National Cardiovascular Data Registry CathPCI Registry (July 2009-December 2013) who underwent coronary angiography with linkage to the Centers for Medicare and Medicaid (CMS) claims data. Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis. The primary endpoint was MACE at 12 months, and secondary endpoints included the components of MACE over 12 months. Among 286 780 AMI admissions (276 522 unique patients), 16 849 (5.9%) had MINOCA. The 12-month rates of MACE (18.7% vs. 27.6%), mortality (12.3% vs. 16.7%), and re-hospitalization for AMI (1.3% vs. 6.1%) and HF (5.9% vs. 9.3%) were significantly lower for MINOCA vs. MICAD patients (P < 0.001), but was similar between MINOCA and MICAD patients for re-hospitalization for stroke (1.6% vs. 1.4%, P = 0.128). Following risk-adjustment, MINOCA patients had a 43% lower risk of MACE over 12 months (hazard ratio = 0.57, 95% confidence interval 0.55-0.59), in comparison to MICAD patients. This pattern was similar for adjusted risks of the MACE components.

Conclusion: This study confirms an unfavourable prognosis in elderly patients with MINOCA undergoing coronary angiography, with one in five patients with MINOCA suffering a major adverse event over 12 months.
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http://dx.doi.org/10.1093/eurheartj/ehz403DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7778433PMC
February 2020

Transcatheter Aortic Valve Replacement in Patients With End-Stage Renal Disease.

J Am Coll Cardiol 2019 06;73(22):2806-2815

Baylor Scott and White Health, Plano, Texas.

Background: In patients with end-stage renal disease (ESRD), surgical aortic valve replacement is associated with higher early and late mortality, and adverse outcomes compared with patients without renal disease. Transcatheter aortic valve replacement (TAVR) offers another alternative, but there are limited reported outcomes.

Objectives: The purpose of this study was to determine the outcomes of TAVR in patients with ESRD.

Methods: Among the first 72,631 patients with severe aortic stenosis (AS) treated with TAVR enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT (Transcatheter Valve Therapies) registry, 3,053 (4.2%) patients had ESRD and were compared with patients who were not on dialysis for demographics, risk factors, and outcomes.

Results: Compared with the nondialysis patients, ESRD patients were younger (76 years vs. 83 years; p < 0.01) and had higher rates of comorbidities leading to a higher STS predicted risk of mortality (median 13.5% vs. 6.2%; p < 0.01). ESRD patients had a higher in-hospital mortality (5.1% vs. 3.4%; p < 0.01), although the observed to expected ratio was lower (0.32 vs. 0.44; p < 0.01). ESRD patients also had a similar rate of major vascular complications (4.5% vs. 4.6%; p = 0.86), but a higher rate of major bleeding (1.4% vs. 1.0%; p = 0.03). The 1-year mortality was significantly higher in dialysis patients (36.8% vs. 18.7%; p < 0.01).

Conclusions: Patients undergoing TAVR with ESRD are at higher risk and had higher in-hospital mortality and bleeding, but similar vascular complications, when compared with those who are not dialysis dependent. The 1-year survival raises concerns regarding diminished benefit in this population. TAVR should be used judiciously after full discussion of the risk-benefit ratio in patients on dialysis.
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http://dx.doi.org/10.1016/j.jacc.2019.03.496DOI Listing
June 2019

Translational Medicine in the Era of Big Data and Machine Learning.

Circ Res 2018 11;123(11):1202-1204

University of Colorado School of Medicine, Aurora (J.S.R.).

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http://dx.doi.org/10.1161/CIRCRESAHA.118.313944DOI Listing
November 2018

Social Determinants of Health in the Digital Age: Determining the Source Code for Nurture.

JAMA 2019 Jan;321(3):247-248

Departments of Medicine, Epidemiology, and Public Health, Yale School of Medicine, New Haven, Connecticut.

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http://dx.doi.org/10.1001/jama.2018.19763DOI Listing
January 2019

Questions for Artificial Intelligence in Health Care.

JAMA 2019 Jan;321(1):31-32

Institute for Informatics, Washington University School of Medicine, St Louis, Missouri.

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http://dx.doi.org/10.1001/jama.2018.18932DOI Listing
January 2019

Enhancing the prediction of acute kidney injury risk after percutaneous coronary intervention using machine learning techniques: A retrospective cohort study.

PLoS Med 2018 11 27;15(11):e1002703. Epub 2018 Nov 27.

Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, United States of America.

Background: The current acute kidney injury (AKI) risk prediction model for patients undergoing percutaneous coronary intervention (PCI) from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) employed regression techniques. This study aimed to evaluate whether models using machine learning techniques could significantly improve AKI risk prediction after PCI.

Methods And Findings: We used the same cohort and candidate variables used to develop the current NCDR CathPCI Registry AKI model, including 947,091 patients who underwent PCI procedures between June 1, 2009, and June 30, 2011. The mean age of these patients was 64.8 years, and 32.8% were women, with a total of 69,826 (7.4%) AKI events. We replicated the current AKI model as the baseline model and compared it with a series of new models. Temporal validation was performed using data from 970,869 patients undergoing PCIs between July 1, 2016, and March 31, 2017, with a mean age of 65.7 years; 31.9% were women, and 72,954 (7.5%) had AKI events. Each model was derived by implementing one of two strategies for preprocessing candidate variables (preselecting and transforming candidate variables or using all candidate variables in their original forms), one of three variable-selection methods (stepwise backward selection, lasso regularization, or permutation-based selection), and one of two methods to model the relationship between variables and outcome (logistic regression or gradient descent boosting). The cohort was divided into different training (70%) and test (30%) sets using 100 different random splits, and the performance of the models was evaluated internally in the test sets. The best model, according to the internal evaluation, was derived by using all available candidate variables in their original form, permutation-based variable selection, and gradient descent boosting. Compared with the baseline model that uses 11 variables, the best model used 13 variables and achieved a significantly better area under the receiver operating characteristic curve (AUC) of 0.752 (95% confidence interval [CI] 0.749-0.754) versus 0.711 (95% CI 0.708-0.714), a significantly better Brier score of 0.0617 (95% CI 0.0615-0.0618) versus 0.0636 (95% CI 0.0634-0.0638), and a better calibration slope of observed versus predicted rate of 1.008 (95% CI 0.988-1.028) versus 1.036 (95% CI 1.015-1.056). The best model also had a significantly wider predictive range (25.3% versus 21.6%, p < 0.001) and was more accurate in stratifying AKI risk for patients. Evaluated on a more contemporary CathPCI cohort (July 1, 2015-March 31, 2017), the best model consistently achieved significantly better performance than the baseline model in AUC (0.785 versus 0.753), Brier score (0.0610 versus 0.0627), calibration slope (1.003 versus 1.062), and predictive range (29.4% versus 26.2%). The current study does not address implementation for risk calculation at the point of care, and potential challenges include the availability and accessibility of the predictors.

Conclusions: Machine learning techniques and data-driven approaches resulted in improved prediction of AKI risk after PCI. The results support the potential of these techniques for improving risk prediction models and identification of patients who may benefit from risk-mitigation strategies.
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http://dx.doi.org/10.1371/journal.pmed.1002703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6258473PMC
November 2018

Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 Year: Analysis of the Transcatheter Valve Therapy Registry.

JAMA Cardiol 2018 12;3(12):1151-1159

Saint Luke's Mid America Heart Institute, Kansas City, Missouri.

Importance: Improvements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation.

Objective: To examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement.

Design, Setting, And Participants: This cohort study used the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, which contains data on patients with severe mitral regurgitation treated with TMVR from 2013 through 2017 in 217 US hospitals.

Main Outcomes And Measures: Change in disease-specific health status (Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS]; range 0-100 points, with higher scores indicating better health status) at 30 days and 1 year after TMVR. We also examined factors associated with health status at 30 days after TMVR, by means of multivariable linear regression using a generalized estimating equations approach to account for clustering of patients within sites.

Results: The KCCQ data were available in 81.2% at baseline, 69.3% of survivors at 30 days, and 47.4% of survivors at 1 year. Among 4226 patients who underwent TMVR, survived 30 days, and completed the KCCQ at baseline and follow-up, the KCCQ-OS increased from 41.9 before TMVR to 66.7 at 30 days (mean change 24.8 [95% CI, 24.0-25.6] points; P < .001), representing a large clinical improvement. The KCCQ scores remained stable from 30 days to 1 year after TMVR, with no further significant increase or decline. On multivariable analysis, atrial fibrillation (-2.2 [95% CI, -3.7 to -0.6] points; P = .01), permanent pacemaker (-2.1 [95% CI, -3.7 to -0.4] points; P = .01), severe lung disease (-3.9 [95% CI, -6.2 to -1.5] points; P = .001), home oxygen (-2.7 [95% CI, -4.9 to -0.4] points; P = .02), and lower KCCQ scores at baseline (3.9 points for each 10-point increase [95% CI, 3.6-4.2]; P < .001) were independently associated with lower 30-day KCCQ-OS scores. In-hospital renal failure was uncommon but was also associated with significant reductions in 30-day KCCQ-OS scores (-7.3 [95% CI -13.3 to -1.2] points). In estimates calculated with inverse probability weighting, after 1 year after TMVR, 54.2% (95% CI 52.2%-56.1%) of patients were alive and well; 23.0% had died, 21.9% had persistently poor health status (KCCQ-OS <60 points), 5.5% had a health status decline from baseline, and 4.6% had both poor health status and health status decline.

Conclusions And Relevance: In a national cohort of US patients undergoing edge-to-edge TMVR in clinical practice, health status was impaired prior to the procedure, improved within 30 days, and remained stable through 1 year among surviving patients with available data. While long-term mortality remains high, most surviving patients demonstrate improvements in symptoms, functional status, and quality of life, with only modest differences by patient-level factors.
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http://dx.doi.org/10.1001/jamacardio.2018.3359DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6583100PMC
December 2018

Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study.

Am Heart J 2019 01 8;207:66-75. Epub 2018 Sep 8.

Division of Cardiovascular Medicine, Stanford University, Stanford, CA. Electronic address:

Background: Smartwatch and fitness band wearable consumer electronics can passively measure pulse rate from the wrist using photoplethysmography (PPG). Identification of pulse irregularity or variability from these data has the potential to identify atrial fibrillation or atrial flutter (AF, collectively). The rapidly expanding consumer base of these devices allows for detection of undiagnosed AF at scale.

Methods: The Apple Heart Study is a prospective, single arm pragmatic study that has enrolled 419,093 participants (NCT03335800). The primary objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch (Apple Inc, Cupertino, CA) with AF on subsequent ambulatory ECG patch monitoring. The secondary objectives are to: 1) characterize the concordance of pulse irregularity notification episodes from the Apple Watch with simultaneously recorded ambulatory ECGs; 2) estimate the rate of initial contact with a health care provider within 3 months after notification of pulse irregularity. The study is conducted virtually, with screening, consent and data collection performed electronically from within an accompanying smartphone app. Study visits are performed by telehealth study physicians via video chat through the app, and ambulatory ECG patches are mailed to the participants.

Conclusions: The results of this trial will provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF. The Apple Heart Study will help provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening.
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http://dx.doi.org/10.1016/j.ahj.2018.09.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099048PMC
January 2019

Variation in post-TAVR antiplatelet therapy utilization and associated outcomes: Insights from the STS/ACC TVT Registry.

Am Heart J 2018 10 9;204:9-16. Epub 2018 Jul 9.

Duke Clinical Research Institute, Durham, NC.

Background: Dual antiplatelet therapy (DAPT) is recommended following transcatheter aortic valve replacement (TAVR); however, the optimal antiplatelet strategy is undefined, and little is known about practice patterns. We aimed to describe contemporary practice patterns of antiplatelet therapy and their relationship to outcomes post-TAVR.

Methods: The population was derived from the National Cardiovascular Data Registry, Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry with Center for Medical Services linkage for 1-year outcomes from October 1, 2011 to June 30,2016. The primary outcome measured was DAPT use in patients without anticoagulation. Secondary outcomes included death, major bleeding, myocardial infarction (MI), and stroke at 1 year.

Results: Overall, 16,694 patients underwent transfemoral TAVR at 444 hospitals and were discharged without anticoagulation. Among these, 13,546 (81.1%) patients were discharged on DAPT, whereas 3,148 patients (18.9%) were discharged on monotherapy. Patients discharged on DAPT versus monotherapy were similar in age, sex, and most comorbid illnesses but had higher rates of coronary artery disease (64.6% vs 52.3%; P < .01) and peripheral artery disease (25.2% vs 22.3%; P < .01). Hospital prescribing patterns varied significantly (median frequency of DAPT 85.7%, interquartile range 94.1%-74.2%). DAPT (vs monotherapy) patients had a similar mortality risk at 1 year (adjusted hazard ratio 0.92, 95% CI 0.81-1.05), significantly higher risk for major bleeding (1.48, 1.10-1.99), and similar hazard for stroke (1.04, 0.83-1.31) and MI (1.00, 0.72-1.39).

Conclusions: In the United States, most patients were discharged on DAPT following TAVR. Practice patterns varied significantly among hospitals. Patients discharged with DAPT had a similar adjusted risk of mortality, stroke, and MI compared to antiplatelet monotherapy, although risk for bleeding was significantly higher. Future investigation is needed to define the optimal antiplatelet therapy for patients undergoing TAVR.
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http://dx.doi.org/10.1016/j.ahj.2018.06.006DOI Listing
October 2018

Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care.

J Am Coll Cardiol 2018 06;71(23):2680-2690

Duke Clinical Research Institute, Duke University, Durham, North Carolina.

As we enter the information age of health care, digital health technologies offer significant opportunities to optimize both clinical care delivery and clinical research. Despite their potential, the use of such information technologies in clinical care and research faces major data quality, privacy, and regulatory concerns. In hopes of addressing both the promise and challenges facing digital health technologies in the transformation of health care, we convened a think tank meeting with academic, industry, and regulatory representatives in December 2016 in Washington, DC. In this paper, we summarize the proceedings of the think tank meeting and aim to delineate a framework for appropriately using digital health technologies in healthcare delivery and research.
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http://dx.doi.org/10.1016/j.jacc.2018.03.523DOI Listing
June 2018

Appropriateness and Outcomes of Percutaneous Coronary Intervention at Top-Ranked and Nonranked Hospitals in the United States.

JACC Cardiovasc Interv 2018 02 12;11(4):342-350. Epub 2017 Nov 12.

Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan; Division of Cardiovascular Medicine, VA Ann Arbor Healthcare System, Ann Arbor, Michigan. Electronic address:

Objectives: This study sought to compare the appropriate use and outcomes of percutaneous coronary intervention (PCI) between top-ranked and nonranked hospitals.

Background: The U.S. News & World Report "Best Hospitals" rankings are an influential consumer-directed publication of hospital quality, and are commonly used in promotional campaigns by hospital systems.

Methods: Hospitals in the National Cardiovascular Data Registry CathPCI registry between July 1, 2014, and June 30, 2015, were classified as top-ranked if they were included in the 2015 U.S. News & World Report 50 best "Cardiology and Heart Surgery" hospitals. The remaining were classified as nonranked. We compared in-hospital mortality, post-procedural bleeding, post-procedural acute kidney injury, and the proportion of appropriate PCI procedures between top-ranked and nonranked hospitals.

Results: A total of 509,153 PCIs at 654 hospitals were included, of which 55,550 (10.9%) were performed at 44 top-ranked hospitals. After adjusting for patient case mix, PCIs performed at top-ranked hospitals had similar odds of in-hospital mortality (adjusted odds ratio [aOR]: 0.96; 95% confidence interval [CI]: 0.83 to 1.12; p = 0.64), acute kidney injury (aOR: 1.10; 95% CI: 0.98 to 1.22; p = 0.099), and bleeding (aOR: 1.15; 95% CI: 0.99 to 1.31; p = 0.052). Top-ranked hospitals had a slightly lower proportion of appropriate PCI compared with nonranked hospitals (89.2% vs. 92.8%; OR: 0.56; 95% CI: 0.45 to 0.69; p < 0.001).

Conclusions: PCI performed at top-ranked hospitals was not associated with superior outcomes compared with PCI at nonranked hospitals. The inclusion of metrics based on clinical data may be important for hospital quality rankings.
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http://dx.doi.org/10.1016/j.jcin.2017.10.042DOI Listing
February 2018

Payment Reform to Enhance Collaboration of Primary Care and Cardiology: A Review.

JAMA Cardiol 2018 01;3(1):77-83

Duke-Robert J. Margolis Center for Health Policy, Duke University, Durham, North Carolina.

Importance: The US health care system faces an unsustainable trajectory of high costs and inconsistent outcomes. The fee-for-service payment model has contributed to inefficiency, and new payment methods are a promising approach to improving value. Health reforms are needed to increase patient access, reduce costs, and improve health care quality, and the landmark Medicare Access and CHIP Reauthorization Act presents a roadmap for reform. The product of a collaboration between primary care and cardiology clinicians, this review describes a conceptual approach to delivery and payment reforms that aim to better support primary care-cardiology comanagement of chronic cardiovascular disease (CVD).

Observations: Few existing alternative payment models specifically address long-term management of CVD. Primary care medical homes and accountable care organizations come closest, but both emphasize primary care, and cardiologists have often not been well engaged. A collaborative care framework should articulate distinct roles and responsibilities for primary care and cardiology in CVD comanagement. Finally, a series of payment models aim to better support clinicians in providing accountable, seamless, and patient-centered cardiac care.

Conclusions & Relevance: Clinical leadership is essential during this time of change in the health care system. Patients often struggle to navigate a fragmented and expensive system, whereas clinicians often practice with incomplete information about tests, treatments, and recommendations by their colleagues. The payment models described in this review offer an opportunity to create more satisfying approaches to patient care while improving value. These models have potential to support more effective coordination and to facilitate broader health care system transformation.
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http://dx.doi.org/10.1001/jamacardio.2017.4308DOI Listing
January 2018

Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis and Mitral Regurgitation.

Ann Thorac Surg 2017 Dec 29;104(6):1977-1985. Epub 2017 Sep 29.

Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.

Background: Many patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis also have significant mitral regurgitation (MR). We sought to understand the association of concomitant MR with TAVR clinical outcomes, as well changes in MR after TAVR.

Methods: Patients who underwent TAVR in the US Transcatheter Valve Therapy Registry from January 3, 2012, to December 31, 2013, were studied, with longer-term clinical outcomes from Center for Medicare Services data.

Results: Of 11,104 patients, 3,481 (31.3%) had moderate MR, and 605 (5.5%) had severe MR. At 1 year, mortality was 21.0%, 21.5%, 26.3%, and 28.0% (p < 0.0001) and heart failure (HF) rehospitalization was 13.9%, 15.8%, 20.3%, and 23.4% (p < 0.0001) in the no, mild, moderate, and severe MR patients, respectively. After adjustment for baseline differences, significant MR was associated with increased risk of 1-year mortality or HF rehospitalization, with a HR of 1.16 (95% CI, 0.99 to 1.35) for moderate MR and 1.21 (95% CI, 0.97 to 1.50) for severe MR, compared with no MR. MR improved early after TAVR grade ≥ 1 in 79% of the severe MR patients and 66% of the moderate MR patients. Patients whose baseline moderate or severe MR improved had lower mortality (p = 0.022) and HF rehospitalization (p < 0.001) compared with patients whose MR did not improve.

Conclusions: Moderate or severe MR accompanying severe AS treated with TAVR is associated with increased mortality or HF rehospitalization. This increased risk may be attributable to the minority of patients whose MR does not improve, suggesting a potential role for surveillance and targeted intervention for those patients.
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http://dx.doi.org/10.1016/j.athoracsur.2017.05.065DOI Listing
December 2017

Hospital Practice of Direct-Home Discharge and 30-Day Readmission After Transcatheter Aortic Valve Replacement in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry.

J Am Heart Assoc 2017 Aug 21;6(8). Epub 2017 Aug 21.

Leon H. Charney Division of Cardiology, Department of Medicine, New York University School of Medicine, New York, NY.

Background: Nearly 17% of patients are readmitted within 30 days of discharge after transcatheter aortic valve replacement. Selected patients are discharged to skilled nursing facilities, yet the association between a hospital's practice to discharge home versus to skilled nursing facilities, and readmission remains unclear.

Methods And Results: The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry was used to evaluate readmissions among patients undergoing transcatheter aortic valve replacement (2011-2015). Hospitals were divided into quartiles (Q1-Q4) based on the percentage of patients discharged directly home. We assessed patient and hospital level characteristics and used hierarchical logistic regression to analyze the association of discharge disposition with 30-day readmission. Our cohort included 18 568 transcatheter aortic valve replacement patients at 329 US hospitals, of whom 69% were discharged directly home. Hospitals in the highest quartile of direct home discharge (Q4) compared with hospitals in the lowest (Q1) were more likely to use femoral access (75.2% versus 60.1%, <0.001), had fewer patients receiving transfusion (26.4% versus 40.9%, <0.001), and were more likely to be located in the Southern United States (48.8% versus 18.3%, <0.001). Median 30-day readmission rate was 17.9%. There was no significant difference in 30-day readmissions among quartiles (=0.14), even after multivariable adjustment (odds ratio Q4 versus Q1=0.89, 95%CI 0.76-1.04; =0.15). Factors most strongly associated with 30-day readmission were glomerular filtration rate, in-hospital stroke or transient ischemic attack, and nonfemoral access.

Conclusions: There was no statistically significant association between hospital practice of direct home discharge post-transcatheter aortic valve replacement and 30-day readmission. Further research is needed to understand regional variations and optimum strategies for postdischarge care.
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http://dx.doi.org/10.1161/JAHA.117.006127DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5586454PMC
August 2017
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