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An app-based clinical trial enrolment process can contribute to duplicated records, carrying data management implications. Our objective was to identify duplicated records in real time in the Apple Heart Study (AHS). We leveraged personal identifiable information (PII) to develop a dissimilarity score (DS) using the Damerau-Levenshtein distance. For computational efficiency, we focused on four types of records at the highest risk of duplication. We used the receiver operating curve (ROC) and resampling methods to derive and validate a decision rule to classify duplicated records. We identified 16,398 (4%) duplicated participants, resulting in 419,297 unique participants out of a total of 438,435 possible. Our decision rule yielded a high positive predictive value (96%) with negligible impact on the trial's original findings. Our findings provide principled solutions for future digital trials. When establishing deduplication procedures for digital trials, we recommend collecting device identifiers in addition to participant identifiers; collecting and ensuring secure access to PII; conducting a pilot study to identify reasons for duplicated records; establishing an initial deduplication algorithm that can be refined; creating a data quality plan that informs refinement; and embedding the initial deduplication algorithm in the enrolment platform to ensure unique enrolment and linkage to previous records.

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.

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.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.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.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 was2-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).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.

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.

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.).

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

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. (Am Heart J 2019;207:66–75.)

This cohort study investigates the association of wearable device use with pulse rate and health care use among adults with atrial fibrillation (AF)., Key Points Question Do individuals with known atrial fibrillation (AF) who use smartwatches or wearable devices use more health care resources and achieve better AF control? Findings In this propensity-matched cohort study with 90-day follow-up among 16 320 patients with AF, individuals who used wearable devices had similar pulse rates compared with individuals who did not use these devices. Individuals using wearable devices had significantly increased rates of health care use; among use measures, the difference was significantly increased for ablation procedures. Meaning These findings suggest that individuals with AF using wearable devices may have increased health care use but similar pulse rates on follow-up., 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

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.

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.

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.

Background Bleeding avoidance strategies (BASs) such as radial access and closure device use for femoral access have been increasingly being implemented but its association with bleeding events among East Asians with reported higher bleeding risk remains unclear. Purpose To demonstrate the performance of the National Cardiovascular Data Registry (NCDR) CathPCI bleeding risk score, 10-year trend of BAS utilization rate and its relationship with observed bleeding within a Japanese PCI quality improvement initiative established in collaboration with the American College of Cardiology-NCDR. Methods A cohort of 19,656 consecutive Japanese patients undergoing PCI was included. First, we assessed the discrimination of the validated NCDR CathPCI bleeding score in the study population. We then assessed temporal trends in the implementation of BAS for PCI and calculated the observed versus expected bleeding rate [O/E ratio] in four time periods (T1: 2008–2011, T2: 2012–2013, T3: 2014–2015, T4: 2016–2018). In multivariable logistic models, we calculated the correlation between BAS use and bleeding rates in individual time frames. Results During the study period, the application of BAS increased from 42.2% (T1) to 90.3% (T4) and observed bleeding rate declined from 10.2% (T1) to 7.3% (T4). The discrimination of the NCDR CathPCI bleeding risk score was acceptable in the Japanese population (c-statistics 0.760–0.845). The calculated O/E ratio declined from 1.34 (T1) to 1.14 (T4). The use of radial access and vascular closure devices after transfemoral access use was associated with 46.7–56.6% and 25.6–47.5% bleeding reduction rates, respectively. The correlation between greater BAS adoption and the decline in bleeding rates was greater among elective cases than urgent/emergent cases. Conclusion Our findings support the positive impact of the adoption of BAS in Japanese patients undergoing PCI. This study demonstrates the value of common data standards and risk adjustment developed in registries to support high quality care. Trends in BAS use & Bleeding Rate Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Japan Society for the Promotion of Science

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.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.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.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.

[Figure][1] ![Figure][1] ![Figure][1] The past few months of the coronavirus disease-2019 (COVID-19) outbreak have brought seismic shifts in the fabric of our lives and in medicine. As clinicians, health care systems and communities have risen to the challenge of providing

Contains fulltext : 220353.pdf (Publisher’s version ) (Closed access) The field of observational studies or "real world studies" is in rapid development with many new techniques introduced and increased understanding of traditional methods. For this reason the current paper provides an overview of current methods with focus on new techniques. Some highlights can be emphasized: We provide an overview of sources of data for observational studies. There is an overview of sources of bias and confounding. Next There is an overview of causal inference techniques that are increasingly used. The most commonly used techniques for statistical modelling are reviewed with focus on the important distinction of risk versus prediction. The final section provides examples of common problems with reporting observational data.

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.

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 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.

Dharam J. Kumbhani, MD, SM, FACC, Chair Cathleen Biga, MSN, RN, FACC Thomas J. Lewandowski, MD, FACC Thomas M. Maddox, MD, MSc, FACC James K. Min, MD, FACC Michael J. Wolk, MD, MACC Healthcare transformation is the product of a shared vision between a broad range of stakeholders to

Background Transcatheter aortic valve replacement (TAVR) has been introduced into U.S. clinical practice with efforts to optimize outcomes and minimize the learning curve. Objectives The goal of this study was to assess the degree to which increasing experience during the introduction of this procedure, separated from other outcome determinants including patient and procedural characteristics, is associated with outcomes. Methods The authors evaluated the association of hospital TAVR volume and patient outcomes for TAVR by using data from 42,988 commercial procedures conducted at 395 hospitals submitting to the Transcatheter Valve Therapy Registry from 2011 through 2015. Outcomes assessed included adjusted and unadjusted in-hospital major adverse events. Results Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p Conclusions The initial adoption of TAVR into practice in the United States showed that increasing experience was associated with better outcomes. This association, whether deemed a prolonged learning curve or a manifestation of a volume–outcome relationship, suggested that concentrating experience in higher volume heart valve centers might be a means of improving outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528 )

Objectives The aim of this study was to describe the contemporary incidence of chronic total occlusions (CTOs) and the success rates of CTO percutaneous coronary intervention (PCI), as well as the complications and long-term outcomes of these patients. Background The contemporary prevalence and management of coronary CTOs is understudied. Methods Consecutive veterans undergoing coronary angiography at 79 Veterans Affairs sites between 2007 and 2013 were examined. Detailed baseline clinical, angiographic, and follow-up outcomes were evaluated using national data from the Veterans Affairs Clinical Assessment Reporting and Tracking program. Results Among 111,273 patients with obstructive coronary artery disease, 29,399 (26.4%) had ≥1 CTO, most commonly in the right coronary artery distribution (n = 18,986 [64.6%]). Elective CTO PCI was attempted in 2,394 patients (8.1%), with a procedural success rate of 79.7%. The odds of CTO PCI success increased over the years of the study (odds ratio: 1.08; 95% confidence interval [CI]: 1.01 to 1.16; p = 0.03). Compared with failed CTO PCI, successful CTO PCI was associated with a decreased adjusted risk for mortality (hazard ratio: 0.67; 95% CI: 0.47 to 0.95; p = 0.02) and coronary artery bypass graft surgery (hazard ratio: 0.14; 95% CI: 0.08 to 0.24; p Conclusions Approximately 1 in 4 patients with obstructive coronary artery disease on coronary angiography had CTOs. Among patients who went on to elective CTO PCI, the success rate was 79.7%. Compared with failed CTO PCI, successful CTO PCI was associated with a decreased risk for mortality as well as a decreased need for subsequent coronary artery bypass graft surgery.

Objectives This study sought to determine variability and stability in risk-standardized mortality rates (RSMR) of percutaneous coronary intervention (PCI) operators meeting minimum case volume standards and identify differences in case mix and practice patterns that may account for RSMR variability. Background RSMR has been suggested as a metric to evaluate the performance of PCI operators; however, variability of operator-level RSMR and the stability of this metric over time among the same operator are unknown. Methods The authors calculated mean RSMRs for PCI operators with average annual volume of ≥50 cases in the National Cardiovascular Data Registry CathPCI Registry. Funnel plots were used to account for operator case volume. Demographic, clinical, and treatment variables of patients treated by operators with outlying high or low RSMRs (identified by RMSR greater than or less than 2 σ above or below the mean [analogous to 2 SD], respectively) were compared with nonoutlier operators. RMSR stability was assessed by calculating average annual operator RMSR during the study period and by determining if operators were consistently classified into RMSR categories in each year. Results Between October 1, 2009, and September 30, 2014, a total of 2,352,174 PCIs were performed at 1,373 hospitals by 3,760 operators. Of these, 242 operators (6.5%) had RSMR >2 σ above the mean and 156 operators (4.1%) had RSMR >2 σ below the mean. Both high and low RSMR outlier operators treated patients with lower expected mortality risk, compared with nonoutlier operators. There was significant instability in annual operator RMSR during the study period. Conclusions There is significant variability in risk-standardized PCI mortality among U.S. operators meeting minimum volume standards that is not explained by case mix or procedure characteristics. Operator RMSR was unstable from year to year, thus limiting its utility as a sole performance measure for PCI quality.

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.

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.

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.To examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement.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.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.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-OS60 points), 5.5% had a health status decline from baseline, and 4.6% had both poor health status and health status decline.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.

Background Prasugrel is more effective than clopidogrel in preventing thrombotic complications after percutaneous coronary intervention (PCI) among patients with acute coronary syndromes (ACS), but it increases the risk of bleeding in subgroups of patients. There is limited data on whether prasugrel use in routine practice is targeted to clinical settings with greatest anticipated patient benefit. Methods In a national cohort of 11 617 veterans who underwent PCI between 2010 and 2013 at Veterans Administration hospitals nationwide, we assessed overall trends in the use of prasugrel and the frequency of prasugrel use in patients with contraindications (prior transient ischemic attack or cerebrovascular accident), higher bleeding risk (age ≥75 or weight

Background— The use of transcatheter aortic valve replacement (TAVR) to treat aortic stenosis in the United States is growing, yet little is known about the variation in procedural outcomes in community practice. We developed a TAVR in-hospital mortality risk model and used it to quantify variation in mortality rates across United States (US) TAVR centers. Methods and Results— We analyzed data from 22 248 TAVR procedures performed at 318 sites participating in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 to October 2014). A Bayesian hierarchical model was developed to estimate hospital-specific risk-adjusted mortality rates adjusting for 40 patient baseline factors. A total of 1130 in-hospital deaths (5.1%) were observed. Reliability-adjusted risk-adjusted mortality rate estimates ranged from 3.4% to 7.7% with an interquartile range of 4.8% to 5.4%. A patient’s predicted odds of dying was 80% higher if treated by a hospital 1 standard deviation above the mean compared with a hospital 1 standard deviation below the mean (odds ratio =1.8; 95% credible interval, 1.4%–2.2%). Conclusions— Risk modeling of TAVR in-hospital mortality revealed variation in risk-adjusted mortality rates during the US early commercial experience. Transcatheter Valve Therapy Registry analyses using this model will support research, feedback reporting, and the identification of factors associated with quality.

BACKGROUND Hospital to Home (H2H) is a national quality improvement initiative sponsored by the Institute for Healthcare Improvement and the American College of Cardiology, with the goal of reducing readmission for patients hospitalized with heart disease. We sought to determine the impact of H2H within the Veterans Affairs (VA) health care system. METHODS Using a controlled interrupted time series, we determined the association of VA hospital enrollment in H2H with the primary outcome of 30-day all-cause readmission following a heart failure hospitalization. VA heart failure providers were surveyed to determine quality improvement projects initiated in response to H2H. Secondary outcomes included initiation of recommended H2H projects, follow-up within 7 days, and total hospital days at 30 days and 1 year. RESULTS Sixty-five of 104 VA hospitals (66%) enrolled in the national H2H initiative. Hospital characteristic associated with H2H enrollment included provision of tertiary care, academic affiliation, and greater use of home monitoring. There was no significant difference in mean 30-day readmission rates (20.0% ± 5.0% for H2H vs 19.3% ± 5.9% for non-H2H hospitals; P = .48) The mean fraction of patients with a cardiology visit within 7 days was slightly higher for H2H hospitals (3.0% ± 2.4% for H2H vs 2.0% ± 1.9% for non-H2H hospitals; P = .05). Patients discharged from H2H hospitals had fewer mean hospitals days during the following year (7.6% ± 2.6% for H2H vs 9.2% ± 3.0 for non-H2H; P = .01) early after launch of H2H, but the effect did not persist. CONCLUSIONS VA hospitals enrolling in H2H had slightly more early follow-up in cardiology clinic but no difference in 30-day readmission rates compared with hospitals not enrolling in H2H.

Heart failure (HF)-specific health status (symptom burden, functional status, and health-related quality of life) is an important patient-reported outcome that is associated with palliative care needs, hospitalizations, and death.To identify potentially modifiable patient-reported factors that predict HF-specific health status over one year.This was a prospective cohort study using data from the Patient-Centered Disease Management trial. Participants were identified using population-based sampling of all patients with an HF diagnosis at four VA Medical Centers. Patients were enrolled with reduced HF-specific health status (i.e., significant HF symptoms, limited functional status, and poor quality of life, defined by a Kansas City Cardiomyopathy Questionnaire [KCCQ] score60). Patient-reported factors at baseline were chest pain, other noncardiac pain, dry mouth, numbness/tingling, constipation, nausea, cough, dizziness, depressive symptoms (Patient Health Questionnaire-9), and spiritual well-being (validated, single-item measure). Patients reported HF-specific health status (KCCQ) at 3, 6, and 12 months.Of 384 U.S. veterans, 42% screened positive for depression and 76% described burdensome physical symptoms at baseline. In bivariate analyses, all patient-reported factors were correlated with KCCQ score over one year. Multivariable mixed-effect modeling showed that baseline chest pain, numbness/tingling, depressive symptoms, and higher comorbidity count predicted HF-specific health status over the following year.Burdensome physical and depressive symptoms independently predicted subsequent HF-specific health status in patients with symptomatic HF. Whether addressing these aspects of the patient experience can improve health status and well-being in symptomatic HF should be studied further.

Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines (ACTION Registry-GWTG) was designed to measure and improve the treatment and outcomes of patients with acute myocardial infarction (AMI), yet it is unknown whether performance of Medicare Hospital Compare metrics and outcomes differ between hospitals participating versus those not participating in the registry.Using 2007 to 2010 Hospital Compare data, we matched participating to nonparticipating hospitals based on teaching status, size, percutaneous coronary intervention capability, and baseline (2007) Hospital Compare AMI process measure performance. We used linear mixed modeling to compare 2010 Hospital Compare process measure adherence, 30-day risk-adjusted mortality, and readmission rates. We repeated these analyses after stratification according to baseline performance level.Compared with nonparticipating hospitals, those participating were larger (median 288 vs 139 beds, P.0001), more often teaching hospitals (18.8% vs 6.3%, P.0001), and more likely had interventional catheterization lab capabilities (85.7% vs 34.0%, P.0001). Among 502 matched pairs of participating and nonparticipating hospitals, we found high levels of process measure adherence in both 2007 and 2010, with minimal differences between them. Rates of 30-day mortality and readmission in 2010 were also similar between both groups. Results were consistent across strata of baseline performance level.In this observational analysis, there were no significant differences in the performance of Hospital Compare process measures or outcomes between hospitals in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines and other hospitals not in the registry. However, baseline performance on the Hospital Compare process measures was very high in both groups, suggesting the need for new quality improvement foci to further improve patient outcomes.

Background Cardiac rehabilitation (CR) programs reduce morbidity and mortality in patients with ischemic heart disease but are vastly underutilized in the United States, including the Veterans Health Administration (VA) Healthcare System. Numerous barriers affecting utilization have been identified in other health care systems, but the specific factors affecting Veterans are unknown. We sought to identify barriers and facilitators associated with utilization of CR in VA facilities. Methods We performed a qualitative study of 56 VA patients, providers, and CR program managers at 30 VA facilities across the United States. We conducted semistructured interviews with key informants to explore their attitudes and knowledge toward CR. Interviews were conducted until thematic saturation occurred. Analyses using grounded theory to identify key themes were conducted using the qualitative data analysis package ATLAS.ti. Results We identified 6 themes as barriers and 5 as facilitators. The most common barriers to participation in CR were patient transportation issues (68%), lack of patient willingness to participate (41%), and no access to a nearby VA hospital with a CR program (30%). The most common facilitators were involvement of a dedicated provider or "clinical champion" (50%), provider knowledge of or experience with CR (48%), and patient desire for additional medical support (32%). Conclusions Our findings suggest that addressing access issues and educating and activating providers on CR may increase utilization of CR programs. Targeting these specific factors may improve utilization of CR programs.

The potential for big data analytics to improve cardiovascular quality of care and patient outcomes is tremendous. However, the application of big data in health care is at a nascent stage, and the evidence to date demonstrating that big data analytics will improve care and outcomes is scant. This Review provides an overview of the data sources and methods that comprise big data analytics, and describes eight areas of application of big data analytics to improve cardiovascular care, including predictive modelling for risk and resource use, population management, drug and medical device safety surveillance, disease and treatment heterogeneity, precision medicine and clinical decision support, quality of care and performance measurement, and public health and research applications. We also delineate the important challenges for big data applications in cardiovascular care, including the need for evidence of effectiveness and safety, the methodological issues such as data quality and validation, and the critical importance of clinical integration and proof of clinical utility. If big data analytics are shown to improve quality of care and patient outcomes, and can be successfully implemented in cardiovascular practice, big data will fulfil its potential as an important component of a learning health-care system.

Background Data demonstrating the outcome of transcatheter aortic valve replacement (TAVR) in the very elderly patients are limited, as they often represent only a small proportion of the trial populations. Objectives The purpose of this study was to compare the outcomes of nonagenarians to younger patients undergoing TAVR in current practice. Methods We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. Outcomes at 30 days and 1 year were compared between patients ≥90 years versus Results Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90 years. The 30-day and 1-year mortality rates were significantly higher among nonagenarians (age ≥90 years vs. Conclusions In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality rates were statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in nonagenarians as in younger patients. These data support safety and efficacy of TAVR in select very elderly patients.

Public reporting of health care data continues to proliferate as consumers and other stakeholders seek information on the quality and outcomes of care. Medicare’s Hospital Compare website, the U.S. News & World Report hospital rankings, and several state-level programs are well known. Many rely heavily on administrative data as a surrogate to reflect clinical reality. Clinical data are traditionally more difficult and costly to collect, but more accurately reflect patients’ clinical status, thus enhancing the validity of quality metrics. We describe the public reporting effort being launched by the American College of Cardiology and partnering professional organizations using clinical data from the National Cardiovascular Data Registry (NCDR) programs. This hospital-level voluntary effort will initially report process of care measures from the percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries of the NCDR. Over time, additional process, outcomes, and composite performance metrics will be reported.

Background The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. Objectives This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. Methods The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. Results Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. Conclusions The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.

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., In a retrospective cohort study, Harlan M. Krumholz and colleagues use machine learning techniques in an effort to improve identification of PCI patients who may benefit from AKI risk-mitigation strategies., Author summary Why was this study done? Accurately estimating the risk of developing acute kidney injury (AKI) is important to determine revascularization strategies and inform peri- and postprocedural care. The current AKI risk prediction model was developed by employing prior clinical knowledge to choose and transform candidate variables and applying regression techniques. It is unknown whether and how machine learning techniques could improve predictive performance from the current AKI risk model. What did the researchers do and find? We used data from 947,091 percutaneous coronary intervention (PCI) procedures from the National Cardiovascular Data Registry (NCDR) CathPCI registry to develop AKI prediction models, the same data from which the current AKI risk model was derived. Temporal validation was performed on a more contemporary cohort of 970,869 PCIs from the NCDR CathPCI registry. We compared the performance of the current AKI risk model with a series of new AKI risk models, which were derived using different regression and machine learning techniques. An AKI risk model derived from machine learning techniques had significantly better discrimination, calibration, and risk stratification than the current AKI risk model in both the internal test set and temporal validation set. What do these findings mean? The demonstrated improvement in predictive power supports the potential of machine learning techniques for improving risk prediction modeling. The improved prediction for AKI suggests great potential of the model to improve targeting of risk-mitigation treatment and quality assessment of cardiovascular care. Future studies need to assess the feasibility of integrating the machine learning model into clinical care and evaluate the benefit of the model for patients at the point of care.

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.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.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).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.

Background— Stress testing after percutaneous coronary intervention (PCI) in fee-for-service settings is common and rates vary by hospital. Rates of stress testing after PCI within integrated healthcare systems, such as the Veterans Affairs (VA) are unknown. Methods and Results— We evaluated all VA patients who underwent PCI from October 2007 through June 2010. To avoid the influence of Medicare eligibility on rates of stress testing use in the VA, we excluded Medicare eligible patients during the follow-up period. Hospital-level variation in risk-standardized rates of stress testing and the association with 1-year mortality and myocardial infarction was determined from Markov chain Monte Carlo methods. Among 10 293 patients undergoing PCI at 55 VA hospitals, 2239 (21.8%) had a stress test performed within 1 year of PCI and 3902 (37.9%) within 2 years. Most stress tests after PCI were performed with nuclear imaging (79.8%). The hospital-level risk-standardized rate of stress testing differed significantly from the average at 14 hospitals, with 8 (14.5%) hospitals significantly below and 6 (10.9%) hospitals significantly above the average stress testing rate. Hospital-level risk-standardized stress testing rates were not significantly correlated with risk-standardized mortality (Spearman ρ=−0.24; P =0.08) or myocardial infarction rates (Spearman ρ=0.20; P =0.14). Conclusions— In the VA, nearly 40% of patients underwent stress testing in the 2 years after PCI, which is a third less than published studies from other healthcare systems. However, stress testing rates varied across VA hospitals, suggesting opportunities to optimize the use of stress testing are still present in integrated healthcare systems.

Hospital to Home (H2H) is a national quality improvement (QI) initiative composed of three recommended hospital interventions to improve the transition of care for hospitalized patients with heart disease. A study was conducted to determine if enrollment of Department of Veterans Affairs (VA) hospitals in H2H and adoption of the recommended interventions would both increase following facilitation of an existing Heart Failure (HF) provider-based community of practice (COP) within the VA health care system. The VA HF COP includes more than 800 VA providers and other VA staff from VA inpatient medical centers.In 2010, 122 VA hospitals were randomized to facilitation using the VA HF COP (intervention) or no facilitation (control). COP members from intervention hospitals were invited to periodic teleconferences promoting H2H and received multiple e-mails asking members to report interest and then progress in H2H implementation.Among the 61 hospitals randomized to HF COP facilitation, 33 (54%) enrolled in H2H, compared with 6 (10%) of 61 control hospitals (p.001) at five months after randomization. Of 38 intervention hospitals responding to the follow-up survey, 13 stated they had initiated 22 QI projects as a result of the H2H campaign. Another 7 hospitals had planned H2H projects. Of 20 control hospitals that responded, 5 had initiated 9 projects as a result of H2H, and no additional hospitals had plans to do so.Facilitation using the VA HF COP was successful in increasing enrollment in the H2H initiative and providing implementation support for recommended QI projects. Multihospital provider groups are a potentially valuable tool for implementation of national QI campaigns.