Same evidence different recommendations: a methodological assessment of transatlantic guidelines for the management of valvular heart disease.

OBJECTIVES: The aim of this study was to identify methodological variations leading to varied recommendations between the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) valvular heart disease guidelines and to suggest foundational steps towards standardizing guideline development. METHODS: An in-depth analysis was conducted to evaluate the methodologies used in developing the transatlantic guidelines for managing valvular heart disease. The evaluation was benchmarked against the standards proposed by the Institute of Medicine. RESULTS: Substantial discrepancies were noted in the methodologies utilized in development processes, including Writing Committee composition, evidence evaluation, conflict of interest management and voting processes. Furthermore, despite their mutual differences, both methodologies demonstrate notable deviations from the Institute of Medicine standards in several essential areas, including literature review and evidence grading. These dual variances likely influenced divergent treatment recommendations. For example, the ESC/EACTS recommends transcatheter edge-to-edge repair for patients with chronic severe mitral regurgitation ineligible for mitral valve surgery, while the ACC/AHA recommends transcatheter edge-to-edge repair based on anatomy, regardless of surgical risk. ESC/EACTS guidelines recommend a mechanical aortic prosthesis for patients under 60, while ACC/AHA guidelines recommend it for patients under 50. Notably, the ACC/AHA and ESC/EACTS guidelines have differing age cut-offs for surgical over transcatheter aortic valve replacement (<65 and <75 years, respectively). CONCLUSIONS: Variations in methodologies for developing clinical practice guidelines have resulted in different treatment recommendations that may significantly impact global practice patterns. Standardization of essential processes is vital to increase the uniformity and credibility of clinical practice guidelines, ultimately improving healthcare quality, reducing variability and enhancing trust in modern medicine.

Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial.

BACKGROUND: Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians' experience implementing and using the DAs. METHODS: This included semi-structured individual interviews with electrophysiology clinicians at participating sites across the US, at least 6 months following conversion into the implementation phase of the trial (from June 2020 through February 2022). The interview guide was structured according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance [implementation evaluation model]) framework, assessing clinician experiences, which can impact implementation domains, and was qualitatively assessed using a mixed inductive/deductive method. RESULTS: We completed 22 interviews post-implementation across all 7 sites. Participants included both physicians (n=16) and other clinicians who counsel patients regarding treatment options (n=6). While perception of SDM and the DA were positive, participants highlighted reasons for uneven delivery of DAs to appropriate patients. The CMS mandate for SDM was not universally viewed as associating with patients receiving DA's, but rather (1) logistics of DA delivery, (2) perceived effectiveness in improving patient decision-making, and (3) match of DA content to current patient populations. Remaining tensions include the specific trial data used in DAs and reconciling timing of delivery with when patients are actively making decisions. CONCLUSIONS: Clinicians charged with delivering DAs to patients considering primary prevention implantable cardioverter defibrillators were generally supportive of the tenets of SDM, and of the DA tools themselves, but noted several opportunities to improve the reach and continued use of them in routine care. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT03374891.

Resource Utilization Following Coronary Computed Tomographic Angiography and Stress Echocardiography in Patients Presenting to the Emergency Department With Chest Pain.

This study aimed to assess long-term resource utilization and outcomes in patients with acute chest pain who underwent coronary computed tomography angiography (CCTA) and stress echocardiography (SE). This was a retrospective, propensity-matched analysis of health insurance claims data for a national sample of privately insured patients over the period January 1, 2011, to December 31, 2014. There were 3,816 patients matched 1:1 who received either CCTA (n = 1,908) or SE (n = 1,908). Patients were seen in the emergency department (ED) between January 1, 2011, and December 31, 2011 with a primary diagnosis of chest pain and received either CCTA or SE within 72 hours as the first noninvasive test and maintained continuous enrollment in the database from the time of the ED encounter through December 31, 2014. All individual patient data were censored at 3 years. Compared with SE, CCTA was associated with higher odds of downstream cardiac catheterization (9.9% vs 7.7%, adjusted odds ratio [AOR] 1.28, 95% confidence interval (CI) 1.00 to 1.63), future noninvasive testing (27.7% vs 22.3%, AOR 1.22, 95% CI 1.05 to 1.42), and return ED visits or hospitalization for chest pain at 3 years (33.1% vs 24.2%, AOR 1.37, 95% CI 1.19 to 1.59). There were no statistically significant differences in new statin use (15.5% vs 14.9%, AOR 1.04, 95% CI 0.85 to 1.28), coronary revascularization (2.7% vs 2.2%, AOR 1.25, 95% CI 0.77 to 2.01) or hospitalization for acute myocardial infarction (0.9% vs 0.9%, AOR 0.96, 95% CI 0.47 to 1.99). In conclusion, in patients who present to the ED with chest pain, CCTA is associated with increased downstream resource utilization compared with SE with no differences in long-term cardiovascular outcomes.

Left Atrial Appendage Occlusion: Past, Present and Future.

There are several situations whereby oral anticoagulation may be unsuitable for stroke prevention in patients with atrial fibrillation (AF). Percutaneous left atrial appendage (LAA) occlusion has received much attention in this area. Various devices have already been developed and tested for this purpose. Data from registries and cohort studies have indicated favourable short- and long-term outcomes with LAA occlusion, and several international guidelines recommend its use in AF patients with contraindications to oral anticoagulation. However, prospective controlled trials in this very population are lacking. Furthermore, while modelling studies on cost analyses have suggested that LAA occlusion may be a cost-effective strategy compared with standard medical therapy, these have not been performed in high-risk patients who may have limited survival in the medium to long term. Thus, while LAA occlusion offers promise, there is a strong need for additional research to investigate its exact role, its long-term outcomes and cost efficacy.

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

Digital Health: Should We Be Concerned?

Type "health and fitness apps" into any search engine, and thousands of options will appear-so many, in fact, that people can now measure their own heart rate, sleep habits, and dozens of other health parameters that once required a doctor's visit. While anecdotes of a personal health device capturing early signs of disease may garner media attention, the increasing quantification of human physiology can have downsides. In essence, the enhanced ability to assess surrogate measures of health, such as temperature, minute-to-minute blood pressure, and genomics, are an expansion of anticipatory health-that is, an attempt to detect and avoid events that might happen in the future. While patients used to seek out doctors when they were sick, digital tools will send increasing numbers of people to their physicians before they are sick. In a Cartesian model of the human body, wherein one system could potentially be fixed independent of another system, having more data may be beneficial. The human body, however, is far more complex than any Cartesian model could explain. This article explores the limitations of digital devices to improve health.

The Future of Wearable Technologies and Remote Monitoring in Health Care.

Mobile technology has become a ubiquitous part of everyday life and is changing the way we offer clinical care and perform clinical research. We have unprecedented access to data for one's self-care as well as for sharing with health care providers. Meeting the challenge posed by the influx of wearable device data requires a multidisciplinary team of researchers, clinicians, software developers, information technologists, and statisticians. Although the possibility of what can be achieved with the ever-evolving wearable technologies seems to be unlimited, regulatory agencies have provided a framework to establish standards for clinical applications, which will also affect research applications. Clinical programs and electronic medical records vendors should prepare to establish a framework to implement these technologies into clinicians' workflow and to allow feedback to measure the impact on clinical outcome. In this article, we discuss how a new brand of multidisciplinary care is evolving around mobile health devices and present a vision of up-and-coming technology in this space.

Heavy Heart: The Economic Burden of Heart Disease in the United States Now and in the Future.

The United States spends more on health care than any other industrialized nation. In 2016, health care expenditure reached an estimated $3.35 trillion or $10,345 per individual. Cardiovascular disease represents the leading cause of death and disability as well as the most significant source of health care spending. This article reviews the current economic burden of heart disease in the United States, presents future projections, and explores factors driving cost growth in cardiovascular care.