Nallamothu, Brahmajee K.

Background Although telehealth cardiac rehabilitation (CR) may improve access, there are concerns about its long‐term effectiveness and impact on equity as compared with in‐person CR. Our objective was to tailor a patient‐centered telehealth CR program for diverse populations. Methods CR patients and caregivers were recruited between January and September 2023 from 4 US academic medical centers. Participants engaged in human‐centered design sessions to iteratively refine a telehealth CR program. Sessions had planned topics, but there was variation across sites to account for site‐specific needs and participant feedback. Sessions were qualitatively analyzed using rapid template analysis with preselected behavioral science constructs and other emergent codes. Results The study included 21 participants (71% aged ≥60 years, 48% women, 62% non‐Hispanic White individuals; 90% CR patients, 10% CR caregivers). Participants thought that telehealth CR could be helpful for personalized support at home and convenience but recognized that technology is not always easy to use. Some expressed concerns about the safety of telehealth CR, especially at the beginning, and desired monitoring through a mobile device or video observation of exercise. Safety protocols and technology training were developed, which addressed concerns about telehealth CR. Opportunities for social support with telehealth CR were also desired. From these findings, an implementation toolkit was developed, including a graphic program description, safety plan, home exercise plan for during and after CR, and scripts for technology training and individual and group telehealth visits. Conclusions A patient‐centered telehealth CR program and implementation toolkit were systematically tailored to address the needs of diverse populations.

Background: Delivering cardiac rehabilitation (CR) by telehealth may increase participation and promote equitable access to CR. Our objective was to tailor a patient-centered telehealth CR program to diverse populations. Methods: We recruited participants with varying CR experience (e.g. attended >1 session, did not attend CR, and caregivers) between January and September 2023 from four US academic medical centers. Participants engaged in human-centered design sessions on CR perspectives and a proposed telehealth CR program. Sessions were qualitatively analyzed using rapid template analysis with pre-selected behavioral science constructs and other emergent codes. Based on participant feedback, we iteratively revised the telehealth CR program and created an implementation toolkit. Results: Among 21 participants (76% ≥65 years, 50% female, 60% non-Hispanic White; 90% attended >1 session, 10% caregiver of a CR participant, 5% prefer not to answer), CR was overall regarded as valuable. Benefits included accountability, confidence, and feeling better. Social support was appreciated from family, friends, program co-participants, and CR staff. Participants emphasized the importance of early goal setting, accountability, and program individualization. Participants thought that using technology for telehealth CR could be helpful for accountability, facilitating relationships, and convenience. However, some participants had concerns about safety, especially at the start of their telehealth program, and desired checks such as a monitoring device or observation of exercise over video. Through human-centered design, safety protocols and technology training were developed, which participants thought addressed their concerns about participating in telehealth CR. The implementation toolkit informed by human-centered design included a participant journey, safety plan, home exercise plan for use during and after CR, and scripts for technology training and telehealth visits. Selected quotes are presented in Figure 1. Conclusions: We developed a patient-centered telehealth CR program and implementation toolkit. Future research will test the comparative effectiveness of in-person and telehealth CR on patient-centered outcomes.

Background: Cardiac rehabilitation (CR) is a class Ia recommendation and endorsed performance measure for the quality of care in acute myocardial infarction (AMI) survivors. While participation in CR after AMI is associated with reduced mortality, conflicting data exists on its association with health status outcomes. Methods: Using data from 2 prospective AMI registries (TRIUMPH and PREMIER), we identified patients for whom baseline and follow-up health status scores and documentation of CR participation (attendance of 1 or more sessions within 6 months post-AMI) were available. Health status was assessed by four Seattle Angina Questionnaire (SAQ) domain scores (quality of life [QoL], angina frequency [AF], treatment satisfaction [TS], and physical limitation [PL]), as well as SF-12 physical and mental health composite scores ( PCS & MCS ). We created propensity matched cohorts of CR participants and non-participants to examine the association between CR participation with health status (6 and 12 months) and all-cause mortality (up to 7 years), using conditional repeated measures and proportional hazards models, respectively. Results: Among 3,957 AMI patients from 31 sites, 2,015 patients (51%) participated in CR after discharge. Compared to non-participants, CR participants were more often Caucasian (83.6% vs. 65.4%), had higher rates of health insurance (90.6% vs. 79.3%), but clinically similar baseline SAQ and SF-12 scores in all domains. After propensity matching, all covariates were well-balanced (Standardized Difference <10 for all patient characteristics) between CR participants and non-participants. In the repeated measures analysis, the mean SAQ and SF-12 domain scores were clinically similar for both groups at 6 and 12 months after hospital discharge (Table). Using a conditional proportional hazards model, a decrease in all-cause mortality was noted in the CR participant group (HR 0.59, 95% CI [0.46, 0.75]). Conclusion: In a large, multi-center AMI cohort, we found that although CR participation seemed to improve survival, CR participants had similar health status improvements after AMI as non-participants. Further investigation is required to identify how CR programs can further maximize the health status benefits to post-AMI participants.

Background. Measurement of PCI quality has previously focused on post-procedure outcomes and processes of care. PCI appropriateness provides an assessment of quality as it relates to patient selection and anticipated procedural benefit relative to potential harm. The relationship, if any, between case selection and in-hospital procedural outcomes is unknown. Methods. We identified 203,531 consecutive patients from 779 hospitals undergoing non-acute (elective) PCI within the CathPCI Registry ® between July, 2009 and April, 2011. We examined the association between a hospital’s proportion of inappropriate PCI in non-acute settings (as assessed by the Appropriate Use Criteria (AUC) for Coronary Revascularization) and (1) risk-adjusted in-hospital mortality; (2) risk-adjusted bleeding complications; and (3) use of optimal guideline directed discharge medications (i.e. aspirin, thienopyridine, and statin on discharge). Results. Of the 24,532 patients who received PCI for non-acute indications, 453 (0.2%) died in-hospital and 3699 (1.8%) suffered bleeding events. The hospital proportion of inappropriate PCI in non-acute settings ranged from 0.0% to 58.6%. Categorized as hospital tertiles, the median proportion of inappropriate PCI was 5.3% in hospitals of the lowest-tertile, 10.9% in the middle-tertile, and 20.0% in the highest-tertile. The hospital proportion of inappropriate PCI was not associated with mortality for PCI in non-acute settings (Risk-adjusted mortality ratio; 0.7 vs. 0.7 vs. 0.8 from lowest to highest-tertile, P=0.75 for trend), risk-adjusted bleeding complications (Risk-adjusted bleeding ratio; 0.6 vs. 0.6 vs. 0.6, P=0.81), or use of optimal PCI discharge medications (85.3% vs. 85.7% vs. 85.2%, P=0.58). Conclusions. In a national cohort of non-acute PCIs from 779 hospitals, hospital proportion of inappropriate PCI indications was not associated with in-hospital mortality, bleeding, or process of care measures of PCI quality. These findings suggest PCI appropriateness and post-procedural outcomes measure different aspects of hospital PCI quality.

Background: While lack of insurance is known to be associated with worse outcomes after myocardial infarction (MI), it is unknown whether health insurance status is associated with rates of non-elective hospitalizations after MI. Methods: Using data on 3571 U.S. MI patients enrolled between April 2005 to December 2008 in the 24-center, prospective TRIUMPH registry, we examined the association between being insured (reference), underinsured, and uninsured on rates of non-elective readmissions (all-cause) in the 1 st year following MI. Insurance status was obtained from medical records, and underinsurance was defined as those patients with insurance but with financial concerns about accessing care from patient interviews. Multivariable modified Poisson regression models were used to adjust for site, demographics, MI severity, risk factors, socio-economic, and psychological factors. Results: A total of 2269 (63.5%) patients were insured; 650 (18.2%) were underinsured; and 652 (18.3%) were uninsured. Emergency readmissions were highest for uninsured patients (25.0%), followed by the underinsured (21.8%), and lowest in insured patients (19.5%) (P<.001). After multivariable adjustment, uninsured patients had significantly higher rates of emergency readmission (adjusted RR, 1.52 [95% CI: 1.22-1.90] while underinsured patients did not (adjusted RR, 0.99 [95% CI: 0.81-1.21]) (Figure). Conclusions: Uninsured patients had a significantly higher adjusted risk of non-elective readmissions after MI, while underinsured patients did not. Future studies are needed to determine if providing even modest insurance coverage to the uninsured can minimize readmission rates.

Objective: To understand the organization of cardiologists in the United States and territories with an emphasis on identifying the characteristics of practices where cardiologists practice. Data: The Healthcare Organization Services database, which provides information on the designation, specialties and business associations, or affiliations, of healthcare professionals across the US and territories. These data were updated as of September 2013. Methods: Cardiologists were defined as providers with an MD or DO, who have an active clinical practice, and either: (1) have Cardiology as primary specialty, or (2) who have Internal Medicine, Pediatrics or Family Medicine indicated as primary specialty, with Cardiology as secondary specialty. Cardiologists were linked to businesses and descriptive analyses were conducted to characterize the organization of cardiologists. Findings: We identified 33,745 cardiologists; 22,461 of these cardiologists had at least one affiliation with an ambulatory practice or independent physician association (AP/IPA), while 30,567 had at least one hospital affiliation. Approximately 57.6% (19,453 of 33,745) of cardiologists were affiliated with both the AP/IPA and hospital settings. The overwhelming majority of ambulatory practices linked to hospital-AP/IPA affiliated cardiologists are medical groups (7,839 of 9,838), while independent physician practices comprise the next largest category (1,498 of 9,838). Of the 7,839 medical groups, 3,809 are cardiology specialty, 1,316 are multispecialty group practices, and 2,060 are family practice, general practice, geriatric medicine, internal medicine, pediatric medicine or primary care. Among all non-multispecialty medical groups (n=6,523), 59.2% (3,862 of 6,523) have 1-2 affiliated cardiologists, 21.7% (1,413 of 6,523) have 3-5, 12.6% (821 of 6,523) have 6-10 and 6.5% (427 of 6,523) have more than 10 affiliated cardiologists. Focusing at the provider level, 17,639 hospital-AP/IPA cardiologists had any affiliation with a medical group (MG), with 12,840 cardiologists with any cardiology specialty MG affiliation, 3,215 with any multispecialty group practice MG affiliation, and 3,051 with any family practice, general practice, geriatric medicine, internal medicine, pediatric medicine or primary care MG affiliation. Overall, 15,476 hospital-AP/IPA cardiologists had any affiliation with at least one non-multi-specialty group practice (non-MSGP), with 4,279 affiliated with one or more non-MSGP(s) with 1-2 cardiologists, 4,378 with one or more non-MSGP(s) with 3-5 cardiologists, and 4,861 and 5,099 affiliated with one or more non-MSGP(s) with 6-10 and >10 cardiologists, respectively. Conclusion: The majority of cardiologists were affiliated with both a hospital and ambulatory practice or IPA. Of this subset, most cardiologists were affiliated with at least one group practice.

Background: Whether patients with STEMI with longer times from symptom onset to hospital presentation are less likely to be treated with any reperfusion therapy or treated with less urgency resulting in longer door-to-balloon and door-to-needle times is not known. The relationship between delay in hospital presentation and the quality of reperfusion therapy for patients with STEMI has not been examined Methods: We constructed 3 cohorts of STEMI patients to analyze use of any reperfusion (n=440,398), door-to-balloon time (n=67,207), and door-to-drug time (n=183,441) as a function of delay in hospital presentation. We constructed multivariable generalized linear models for each outcome to estimate the associations between delay in hospital presentation adjusted for all patient and hospital characteristics. Results: In adjusted analysis, longer times from symptom onset to hospital presentation was associated with lower use of any reperfusion therapy (p<0.0001 for trend). For early presenters with times of ≤1 hour, >1 to 2 hours, and >2 to 3 hours, 77%, 77%, and 73% of patients received any reperfusion therapy, respectively, and late presenters with times >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours were treated with any reperfusion therapy in 53%, 50%, and 46%, respectively. Delay in hospital presentation was associated with longer drug-to-balloon and door-to-drug times (p<0.0001 for trend). For time intervals of ≤ 1 hour, >1 to 2 hours, >2 to 3 hours, >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours, patients with STEMI were treated with door-to-balloon times of 99, 101, 106, 123, 125, and 123 minutes respectively. For delay time intervals of ≤ 1 hour, >1 to 2 hours, >2 to 3 hours, >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours, patients were treated with door-to-drug times of 32, 34, 36, 46, 44, and 46 minutes, respectively. Conclusions: Longer time from symptom onset to hospital presentation has important implications for subsequent treatment and was associated with lower use of any reperfusion therapy and longer door-to-balloon and door-to-drug times. Longer delay in hospital presentation is associated with worse system performance for reperfusion therapy quality and represents an opportunity to improve quality of care for STEMI patients.

Delayed contact with the medical system may lead to worse patient outcomes in acute myocardial infarction (AMI), particularly ST-elevation myocardial infarction (STEMI). We examined the effect of previously unstudied aspects of patients’ characteristics on delays to presentation, including health status, depressive symptoms, and socioeconomic status. Within the Translational Research Investigating Underlying disparities in acute Myocardial infarction Patients’ Health status (TRIUMPH) study, we examined predictors of delays to hospital presentation in 1,476 patients with AMI from 26 sites using multivariable hierarchical ordinal models. Time from symptom onset to hospital presentation was categorized as ≤2 hours, >2 to 6 hours, and >6 hours. Time to hospital presentation was ≤2 hours in 540 (36.6%) patients, between 2– 6 hours in 354 (24.0%) patients, and >6 hours in 582 (39.4%) patients. Factors associated with longer delays to presentation included frequent angina (compared to no angina: daily angina, Odds Ratio [OR] of 3.48 [95% CI: 1.53–7.88]; weekly angina, 2.46 [1.64 –3.67]; and monthly angina, 1.26 [0.96 –1.64]; p for trend<.001), presentation during weekday work hours (8am to 5pm) (compared to weekend: weekday, 1.40 [1.06, 1.85]; weeknight, 1.15 [0.85,1.54]; p for trend = 0.05), cost barriers (1.39 [1.05 to 1.85]; p=0.02), and no healthcare insurance (1.56 [1.15–2.12]; p=0.005). In contrast, patients with STEMI (0.55 [0.43– 0.70]; p<.001), prior coronary revascularization (0.67 [0.48 – 0.92]; p=0.01) and prior AMI (0.68 [0.48 – 0.97]; p=0.03) were more likely to present earlier. No relationship was found for depression, educational level, social support, or marital status. More frequent angina, cost barriers, no healthcare insurance, and time of day are associated with longer delays to hospital presentation, while those with prior AMIs and coronary revascularization were more likely to present earlier. Efforts to reduce delays should address patient issues related to health status (like angina), cost burden, and healthcare access.

Background: Patients with atrial fibrillation and severely decreased kidney function were excluded from the pivotal non–vitamin K antagonist oral anticoagulants (NOAC) trials, thereby raising questions about comparative safety and effectiveness in patients with reduced kidney function. The study aimed to compare oral anticoagulants across the range of kidney function in patients with atrial fibrillation. Methods and Results: Using a US administrative claims database with linked laboratory data, 34 569 new users of oral anticoagulants with atrial fibrillation and estimated glomerular filtration rate ≥15 mL/(min·1.73 m 2 ) were identified between October 1, 2010 to November 29, 2017. The proportion of patients using NOACs declined with decreasing kidney function—73.5%, 69.6%, 65.4%, 59.5%, and 45.0% of the patients were prescribed a NOAC in estimated glomerular filtration rate ≥90, 60 to 90, 45 to 60, 30 to 45, 15 to 30 mL/min per 1.73 m 2 groups, respectively. Stabilized inverse probability of treatment weighting was used to balance 4 treatment groups (apixaban, dabigatran, rivaroxaban, and warfarin) on 66 baseline characteristics. In comparison to warfarin, apixaban was associated with a lower risk of stroke (hazard ratio [HR], 0.57 [0.43–0.75]; P <0.001), major bleeding (HR, 0.51 [0.44–0.61]; P <0.001), and mortality (HR, 0.68 [0.56–0.83]; P <0.001); dabigatran was associated with a similar risk of stroke but a lower risk of major bleeding (HR, 0.57 [0.43–0.75]; P <0.001) and mortality (HR, 0.68 [0.48-0.98]; P =0.04); rivaroxaban was associated with a lower risk of stroke (HR, 0.69 [0.51–0.94]; P =0.02), major bleeding (HR, 0.84 [0.72–0.99]; P =0.04), and mortality (HR, 0.73 [0.58–0.91]; P =0.006). There was no significant interaction between treatment and estimated glomerular filtration rate categories for any outcome. When comparing one NOAC to another NOAC, there was no significant difference in mortality, but some differences existed for stroke or major bleeding. No relationship between treatments and falsification end points was found, suggesting no evidence for substantial residual confounding. Conclusions: Relative to warfarin, NOACs are used less frequently as kidney function declines. However, NOACs appears to have similar or better comparative effectiveness and safety across the range of kidney function.

Background We systematically reviewed trials comparing different reperfusion strategies for ST‐segment–elevation myocardial infarction and used multivariate network meta‐analysis to compare outcomes across these strategies. Methods and Results We identified 31 contemporary trials in which patients with ST‐segment–elevation myocardial infarction were randomized to ≥2 of the following strategies: fibrinolytic therapy (n=4212), primary percutaneous coronary intervention ( PCI ) (n=6139), or fibrinolysis followed by routine early PCI (n=5006). We categorized the last approach as “facilitated PCI ” when the median time interval between fibrinolysis to PCI was <2 hours (n=2259) and as a “pharmacoinvasive approach” when this interval was ≥2 hours (n=2747). We evaluated outcomes of death, nonfatal reinfarction, stroke, and major bleeding using a multivariate network meta‐analysis and a Bayesian analysis. Among the strategies evaluated, primary PCI was associated with the lowest risk of mortality, nonfatal reinfarction, and stroke. For mortality, primary PCI had an odds ratio of 0.73 (95% CI , 0.61–0.89) when compared with fibrinolytic therapy. Of the remaining strategies, the pharmacoinvasive approach was the next most favorable with an odds ratio for death of 0.79 (95% CI , 0.59–1.08) compared with fibrinolytic therapy. The Bayesian model indicated that when the 2 strategies examining routine early invasive therapy following fibrinolysis were directly compared, the probability of adverse outcomes was lower for the pharmacoinvasive approach relative to facilitated PCI . Conclusions A pharmacoinvasive approach is safer and more effective than facilitated PCI and fibrinolytic therapy alone. This has significant implications for ST‐segment–elevation myocardial infarction care in settings where timely access to primary PCI , the preferred treatment for ST‐segment–elevation myocardial infarction , is not available.