ß blockers switched to first-line therapy in hypertension.

In their recent guidelines, the European Society of Hypertension upgraded ß blockers, putting them on equal footing with thiazide diuretics, renin-angiotensin system blockers (eg, angiotensin-converting enzyme inhibitors and angiotensin receptor blockers), and calcium channel blockers. The reason offered for upgrading ß blockers was the observation that they are often used for many other clinical conditions commonly encountered with hypertension. This upgrade would allow for the treatment of two conditions with a single drug (a so-called twofer). In most current national and international hypertension guidelines, ß blockers are only considered to be an alternative when there are specific indications. Compared with the other first-line antihypertensive drug classes, ß blockers are significantly less effective in preventing stroke and cardiovascular mortality. To relegate ß blockers to an inferiority status as previous guidelines have done was based on the evidence in aggregate, and still stands. No new evidence supports the switch of ß blockers back to first-line therapy. We are concerned that this move might lead to widespread harm because of inferior stroke protection.

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.

Left atrial appendage occlusion: a critical appraisal updated with recent evidence.

PURPOSE OF REVIEW: To allow readers to fully appreciate the uncertainties with this novel yet invasive approach to stroke prevention. RECENT FINDINGS: Percutaneous left atrial (LA) appendage occlusion has emerged as potential nonpharmacologic means to prevent stroke and systemic embolism in patients with atrial fibrillation. Yet the evidence underpinning this new technology is not definitive. SUMMARY: In this review, we consider the internal and external validity of the regulatory trials, pathophysiologic basis for LA appendage occlusion and clinical tradeoffs of the procedure.

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.

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.

Lessons Learnt from Recent Trials in Ischemic Heart Disease.

Four recently published randomized controlled trials have informed the care of patients with stable ischemic heart disease. The purpose of this clinical focus article is to offer a summary and critical appraisal of the recent evidence. We aim to aid clinicians in the translation of the trial evidence to patient care.

Shared Decision Making in Cardiac Electrophysiology Procedures and Arrhythmia Management.

Shared decision making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.

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.

Coronary Computed Tomography Angiography vs Functional Stress Testing for Patients With Suspected Coronary Artery Disease: A Systematic Review and Meta-analysis.

Importance: Coronary computed tomography angiography (CCTA) is a new approach for the diagnosis of anatomical coronary artery disease (CAD), but it is unclear how CCTA performs compared with the standard approach of functional stress testing. Objective: To compare the clinical effectiveness of CCTA with that of functional stress testing for patients with suspected CAD. Data Sources: A systematic literature search was conducted in PubMed and MEDLINE for English-language randomized clinical trials of CCTA published from January 1, 2000, to July 10, 2016. Study Selection: Researchers selected randomized clinical trials that compared a primary strategy of CCTA with that of functional stress testing for patients with suspected CAD and reported data on patient clinical events and changes in therapy. Data Extraction and Synthesis: Two reviewers independently extracted data from and assessed the quality of the trials. This analysis followed the PRISMA statement for reporting systematic reviews and meta-analyses and used the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. The Mantel-Haenszel method was used to conduct the primary analysis. Summary relative risks were calculated with a random-effects model. Main Outcomes and Measures: The outcomes of interest were all-cause mortality, cardiac hospitalization, myocardial infarction, invasive coronary angiography, coronary revascularization, new CAD diagnoses, and change in prescription for aspirin and statins. Results: Thirteen trials were included, with 10 315 patients in the CCTA arm and 9777 patients in the functional stress testing arm who were followed up for a mean duration of 18 months. There were no statistically significant differences between CCTA and functional stress testing in death (1.0% vs 1.1%; risk ratio [RR], 0.93; 95% CI, 0.71-1.21) or cardiac hospitalization (2.7% vs 2.7%; RR, 0.98; 95% CI, 0.79-1.21), but CCTA was associated with a reduction in the incidence of myocardial infarction (0.7% vs 1.1%; RR, 0.71; 95% CI, 0.53-0.96). Patients undergoing CCTA were significantly more likely to undergo invasive coronary angiography (11.7% vs 9.1%; RR, 1.33; 95% CI, 1.12-1.59) and revascularization (7.2% vs 4.5%; RR, 1.86; 95% CI, 1.43-2.43). They were also more likely to receive a diagnosis of new CAD and to have initiated aspirin or statin therapy. Conclusions and Relevance: Compared with functional stress testing, CCTA is associated with a reduced incidence of myocardial infarction but an increased incidence of invasive coronary angiography, revascularization, CAD diagnoses, and new prescriptions for aspirin and statins. Despite these differences, CCTA is not associated with a reduction in mortality or cardiac hospitalizations.