MRI Assessment of Myocardial Deformation for Risk Stratification of Major Arrhythmic Events in Patients With Non-Ischemic Cardiomyopathy Eligible for Primary Prevention Implantable Cardioverter Defibrillators.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) intervention is an established prophylactic measure. Identifying high-benefit patients poses challenges. PURPOSE: To assess the prognostic value of cardiac magnetic resonance imaging (MRI) parameters including myocardial deformation for risk stratification of ICD intervention in non-ischemic cardiomyopathy (NICM) while accounting for competing mortality risk. STUDY TYPE: Retrospective and prospective. POPULATION: One hundred and fifty-nine NICM patients eligible for primary ICD (117 male, 54 ± 13 years) and 49 control subjects (38 male, 53 ± 5 years). FIELD STRENGTH/SEQUENCE: Balanced steady state free precession (bSSFP) and three-dimensional phase-sensitive inversion-recovery late gadolinium enhancement (LGE) sequences at 1.5 T or 3 T. ASSESSMENT: Patients underwent MRI before ICD implantation and were followed up. Functional parameters, left ventricular global radial, circumferential and longitudinal strain, right ventricular free wall longitudinal strain (RV FWLS) and left atrial strain were measured (Circle, cvi42). LGE presence was assessed visually. The primary endpoint was appropriate ICD intervention. Models were developed to determine outcome, with and without accounting for competing risk (non-sudden cardiac death), and compared to a baseline model including LGE and clinical features. STATISTICAL TESTS: Wilcoxon non-parametric test, Cox's proportional hazards regression, Fine-Gray competing risk model, and cumulative incidence functions. Harrell's c statistic was used for model selection. A P value <0.05 was considered statistically significant. RESULTS: Follow-up duration was 1176 ± 960 days (median: 896). Twenty-six patients (16%) met the primary endpoint. RV FWLS demonstrated a significant difference between patients with and without events (-12.5% ± 5 vs. -16.4% ± 5.5). Univariable analyses showed LGE and RV FWLS were significantly associated with outcome (LGE: hazard ratio [HR] = 3.69, 95% CI = 1.28-10.62; RV FWLS: HR = 2.04, 95% CI = 1.30-3.22). RV FWLS significantly improved the prognostic value of baseline model and remained significant in multivariable analysis, accounting for competing risk (HR = 1.73, 95% CI = 1.12-2.66). DATA CONCLUSIONS: In NICM, RV FWLS may provide additional predictive value for predicting appropriate ICD intervention. LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY: Stage 5.

Incidence, Treatment, and Outcomes of Symptomatic Device Lead-Related Venous Obstruction.

BACKGROUND: The incidence and clinical impact of lead-related venous obstruction (LRVO) among patients with cardiovascular implantable electronic devices (CIEDs) is poorly defined. OBJECTIVES: The objectives of this study were to determine the incidence of symptomatic LRVO after CIED implant; describe patterns in CIED extraction and revascularization; and quantify LRVO-related health care utilization based on each type of intervention. METHODS: LRVO status was defined among Medicare beneficiaries after CIED implant from October 1, 2015, to December 31, 2020. Cumulative incidence functions of LRVO were estimated by Fine-Gray methods. LRVO predictors were identified using Cox regression. Incidence rates for LRVO-related health care visits were calculated with Poisson models. RESULTS: Among 649,524 patients who underwent CIED implant, 28,214 developed LRVO, with 5.0% cumulative incidence at maximum follow-up of 5.2 years. Independent predictors of LRVO included CIEDs with >1 lead (HR: 1.09; 95% CI: 1.07-1.15), chronic kidney disease (HR: 1.17; 95% CI: 1.14-1.20), and malignancies (HR: 1.23; 95% CI: 1.20-1.27). Most patients with LRVO (85.2%) were managed conservatively. Among 4,186 (14.8%) patients undergoing intervention, 74.0% underwent CIED extraction and 26.0% percutaneous revascularization. Notably, 90% of the patients did not receive another CIED after extraction, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with significant reductions in LRVO-related health care utilization (adjusted rate ratio: 0.58; 95% CI: 0.52-0.66) compared with conservative management. CONCLUSIONS: In a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Device extraction was the most common intervention and was associated with long-term reduction in recurrent health care utilization.

Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis.

BACKGROUND AND AIMS: Most patients with heart failure (HF) are diagnosed following a hospital admission. The clinical and health economic impacts of index HF diagnosis made on admission to hospital versus community settings are not known. METHODS: We used the North West London Discover database to examine 34 208 patients receiving an index diagnosis of HF between January 2015 and December 2020. A propensity score-matched (PSM) cohort was identified to adjust for differences in socioeconomic status, cardiovascular risk and pre-diagnosis health resource utilisation cost. Outcomes were stratified by two pathways to index HF diagnosis: a 'hospital pathway' was defined by diagnosis following hospital admission; and a 'community pathway' by diagnosis via a general practitioner or outpatient services. The primary clinical and health economic endpoints were all-cause mortality and cost-consequence differential, respectively. RESULTS: The diagnosis of HF was via hospital pathway in 68% (23 273) of patients. The PSM cohort included 17 174 patients (8582 per group) and was matched across all selected confounders (p>0.05). The ratio of deaths per person-months at 24 months comparing community versus hospital diagnosis was 0.780 (95% CI 0.722 to 0.841, p<0.0001). By 72 months, the ratio of deaths was 0.960 (0.905 to 1.020, p=0.18). Diagnosis via hospital pathway incurred an overall extra longitudinal cost of £2485 per patient. CONCLUSIONS: Index diagnosis of HF through hospital admission continues to dominate and is associated with a significantly greater short-term risk of mortality and substantially increased long-term costs than if first diagnosed in the community. This study highlights the potential for community diagnosis-early, before symptoms necessitate hospitalisation-to improve both clinical and health economic outcomes.

Comparative performance of distinct frailty measures among patients undergoing percutaneous left atrial appendage closure.

AIMS: Frailty is associated with increased morbidity and mortality in patients undergoing left atrial appendage closure (LAAC). This study aimed to compare the performance of two claims-based frailty measures in predicting adverse outcomes following LAAC. METHODS: We identified patients 66 years and older who underwent LAAC between October 1, 2016, and December 31, 2019, in Medicare fee-for-service claims. Frailty was assessed using the previously validated Hospital Frailty Risk Score (HFRS) and Kim Claims-based Frailty Index (CFI). Patients were identified as frail based on HFRS ≥5 and CFI ≥0.25. RESULTS: Of the 21,787 patients who underwent LAAC, frailty was identified in 45.6% by HFRS and 15.4% by CFI. There was modest agreement between the two frailty measures (kappa 0.25, Pearson's correlation 0.62). After adjusting for age, sex, and comorbidities, frailty was associated with higher risk of 30-day mortality, 1-year mortality, 30-day readmission, long hospital stay, and reduced days at home (p < .01 for all) regardless of the frailty measure used. The addition of frailty to standard comorbidities significantly improved model performance to predict 1-year mortality, long hospital stay, and reduced days at home (Delong p-value < .001). CONCLUSION: Despite significant variation in frailty detection and modest agreement between the two frailty measures, frailty status remained highly predictive of mortality, readmissions, long hospital stay, and reduced days at home among patients undergoing LAAC. Measuring frailty in clinical practice, regardless of the method used, may provide prognostic information useful for patients being considered for LAAC, and may inform shared decision-making in this population.

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.

Cost-Effectiveness of Antibiotic-Eluting Envelope for Prevention of Cardiac Implantable Electronic Device Infections in Heart Failure.

BACKGROUND: Use of an antibiotic-eluting envelope (AEE) during cardiac implantable electronic device procedures reduces infection risk but increases procedural costs. We aim to estimate the cost-effectiveness of AEE use during cardiac implantable electronic device procedures among patients with heart failure. METHODS: A state-transition cohort model of heart failure patients undergoing cardiac implantable electronic device implantation or generator replacement was developed with input parameters estimated from randomized trials, registries, surveys, and claims data. Effectiveness was estimated from the World-Wide Randomized Antibiotic Envelope Infection Prevention Trial. AEE was assumed to cost $953 per unit. The model projected mortality, quality-adjusted life-years, costs, and the incremental cost-effectiveness ratio of AEE use compared with usual care from a US healthcare sector perspective over a lifetime horizon. We assumed a cost-effectiveness threshold of $100 000 per quality-adjusted life-year gained. RESULTS: Compared with usual care, AEE use in initial implantations produced an incremental cost-effectiveness ratio of $112 000 per quality-adjusted life-year gained (39% probability of being cost-effective). In generator replacement procedures, AEE use produced an incremental cost-effectiveness ratio of $54 000 per quality-adjusted life-year gained (84% probability of being cost-effective). Results were sensitive to the underlying rate of infection, cost of the AEE, and durability of AEE effectiveness. CONCLUSIONS: Universal AEE use for cardiac implantable electronic device procedures in patients with heart failure with reduced ejection fraction is unlikely to be cost-effective, reinforcing the need for individualized risk assessment to guide uptake of the AEE in clinical practice. Selective use in patients at increased risk of infection, such as those undergoing generator replacement procedures, is more likely to meet health system value benchmarks.

Frailty in patients undergoing percutaneous left atrial appendage closure.

BACKGROUND: Frailty is associated with significant morbidity and mortality in older adults. Whether frailty predicts adverse outcomes after percutaneous left atrial appendage closure (LAAC) remains uncertain. OBJECTIVE: The purpose of this study was to examine the association between frailty and clinical outcomes after percutaneous LAAC. METHODS: We identified patients 65 years and older in Medicare fee-for-service claims who underwent LAAC between October 1, 2016, and December 31, 2019. Patients were identified as frail on the basis of the Hospital Frailty Risk Score (HFRS), a validated frailty measure centered on health resource utilization, with the cohort stratified into low (<5), intermediate (5-15), and high (>15) risk groups. RESULTS: Of the 21,787 patients who underwent LAAC, 10,740 (49.3%) were considered frail (HFRS >5), including 3441 (15.8%) in the high-risk group. The mortality rate (up to 1095 days) were 16.1% in the low-risk group, 26.7% in the intermediate-risk group, and 41.1% in the high-risk group (P < .001). After adjusting for age, sex, and comorbidities, HFRS >15 (compared with HFRS <5) was associated with a higher risk of long hospital stay (odds ratio [OR] 8.29; 95% confidence interval [CI] 5.94-11.57), 30-day readmission (OR 1.80, 95% CI 1.58-2.05), 30-day mortality (OR 5.68, 95% CI 3.40-9.40), and 1-year mortality (OR 2.83, 95% CI 2.39-3.35). In restricted cubic spline models, the adjusted OR for all outcomes monotonically increased with increasing HFRS. CONCLUSION: Frailty is common in patients undergoing LAAC and is associated with increased risks of long hospital stay, readmissions, and short-term mortality.

The Right to Repair Software-Dependent Medical Devices.

The "right to repair" movement highlights opportunities to reduce health care costs and promote public health resilience through increased competition in the way in which medical devices are serviced and updated over their lifespan. We review legislative and legal facets of third-party repair of medical devices, and conclude with specific recommendations to help this market function more efficiently to the benefit of patients and health care systems.

Role of Frailty in Identifying Benefit From Transcatheter Versus Surgical Aortic Valve Replacement.

BACKGROUND: Frailty is associated with a higher risk for adverse outcomes after aortic valve replacement (AVR) for severe aortic valve stenosis, but whether or not frail patients derive differential benefit from transcatheter (TAVR) versus surgical (SAVR) AVR is uncertain. METHODS: We linked adults ≥65 years old in the US CoreValve HiR trial (High-Risk) or SURTAVI trial (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) to Medicare claims, February 2, 2011, to September 30, 2015. Two frailty measures, a deficit-based and phenotype-based frailty index (FI), were generated. The treatment effect of TAVR versus SAVR was evaluated within FI tertiles for the primary end point of death and nondeath secondary outcomes, using multivariable Cox regression. RESULTS: Of 1442 (linkage rate =60.0%) individuals included, 741 (51.4%) individuals received TAVR and 701 (48.6%) received SAVR (mean age 81.8±6.1 years, 44.0% female). Although 1-year death rates in the highest FI tertiles (deficit-based FI 36.7% and phenotype-based FI 33.8%) were 2- to 3-fold higher than the lowest tertiles (deficit-based FI 13.4%; hazard ratio, 3.02 [95% CI, 2.26-4.02], P<0.001; phenotype-based FI 17.9%; hazard ratio, 2.05 [95% CI, 1.58-2.67], P<0.001), there were no significant differences in the relative or absolute treatment effect of SAVR versus TAVR across FI tertiles for all death, nondeath, and functional outcomes (all interaction P>0.05). Results remained consistent across individual trials, frailty definitions, and when considering the nonlinked trial data. CONCLUSIONS: Two different frailty indices based on Fried and Rockwood definitions identified individuals at higher risk of death and functional impairment but no differential benefit from TAVR versus SAVR.

Identification of Frailty Using a Claims-Based Frailty Index in the CoreValve Studies: Findings from the EXTEND-FRAILTY Study.

Background In aortic valve disease, the relationship between claims-based frailty indices (CFIs) and validated measures of frailty constructed from in-person assessments is unclear but may be relevant for retrospective ascertainment of frailty status when otherwise unmeasured. Methods and Results We linked adults aged ≥65 years in the US CoreValve Studies (linkage rate, 67%; mean age, 82.7±6.2 years, 43.1% women), to Medicare inpatient claims, 2011 to 2015. The Johns Hopkins CFI, validated on the basis of the Fried index, was generated for each study participant, and the association between CFI tertile and trial outcomes was evaluated as part of the EXTEND-FRAILTY substudy. Among 2357 participants (64.9% frail), higher CFI tertile was associated with greater impairments in nutrition, disability, cognition, and self-rated health. The primary outcome of all-cause mortality at 1 year occurred in 19.3%, 23.1%, and 31.3% of those in tertiles 1 to 3, respectively (tertile 2 versus 1: hazard ratio, 1.22; 95% CI, 0.98-1.51; P=0.07; tertile 3 versus 1: hazard ratio, 1.73; 95% CI, 1.41-2.12; P<0.001). Secondary outcomes (bleeding, major adverse cardiovascular and cerebrovascular events, and hospitalization) were more frequent with increasing CFI tertile and persisted despite adjustment for age, sex, New York Heart Association class, and Society of Thoracic Surgeons risk score. Conclusions In linked Medicare and CoreValve study data, a CFI based on the Fried index consistently identified individuals with worse impairments in frailty, disability, cognitive dysfunction, and nutrition and a higher risk of death, hospitalization, bleeding, and major adverse cardiovascular and cerebrovascular events, independent of age and risk category. While not a surrogate for validated metrics of frailty using in-person assessments, use of this CFI to ascertain frailty status among patients with aortic valve disease may be valid and prognostically relevant information when otherwise not measured.

Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California.

California has focused on health equity in the state's COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California's 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier's test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must meet an equity metric. California's explicit incorporation of health equity into its reopening plan underscores the interrelated fate of its residents during the COVID-19 pandemic and creates incentives for action. This article evaluates the benefits and challenges of this novel health equity focus, and outlines recommendations for other US states to address disparities in their reopening plans.

Patient and Provider Perspectives on Remote Monitoring of Pacemakers and Implantable Cardioverter-Defibrillators.

The use of remote monitoring technology for cardiovascular electronic implantable devices has grown significantly in recent decades, yet several key questions remain about its integration into clinical care. We performed semi-structured interviews of patients, clinicians, and device clinic technicians involved in clinical remote monitoring of cardiovascular implantable devices at our institution. Twenty-eight interviews comprised of 15 patients and 13 clinicians were conducted from October 2019 through February 2020. Interview transcripts were analyzed using a mixed inductive and deductive approach. Perspectives among clinicians and patients varied regarding familiarity, educational experiences, and preferences regarding how remote monitoring data are handled. Three key domains emerged including knowledge and understanding, managing alerts, and cost transparency. Within these domains, key findings includedvery limited understanding of how remote monitoring functions and how alerts in particular are handled. These knowledge deficits (both patients and providers) appeared to arise in part from different equipment and platforms among manufacturers, the complexity of the technology, and lack of formalized education in remote monitoring. However, interviewees expressed generally high levels of trust in the technology and care systems supporting remote monitoring. Few respondents described concerns around cybersecurity, but patients in particular did raise concerns about cost transparency and frequent billing. In conclusion, conflicting perceptions around remote monitoring persist and indicate important knowledge gaps despite high trust in the care pathway. This qualitative analysis offers insight into patient and clinician understanding of and attitudes toward remote monitoring, and may guide future efforts to improve education and patient-centeredness of remote monitoring.

Statutes Governing Default Surrogate Decision Making for Mental Health Treatment.

OBJECTIVE: The authors sought to describe state-to-state variations in the scope of statutory authority granted to default surrogates who decide on mental health treatment for incapacitated patients. METHODS: The authors investigated state statutes delineating the powers of default surrogates to make decisions about mental health treatment. Statutes in all 50 U.S. states and the District of Columbia were identified and analyzed independently by three reviewers. Research was conducted from August 2017 to November 2018 and updated in January 2020. RESULTS: State statutes varied in approaches to default surrogate decision making for mental health treatment. Eight states' statutes delegate broad authority to surrogates, whereas 25 states prohibit surrogates from giving consent for specific therapies. Thirteen states are silent on whether surrogates may make decisions. CONCLUSIONS: Heterogeneity among state statutory laws contributes to complexity of treating patients without decisional capacity. This variability encumbers efforts to support surrogates and clinicians and may contribute to health disparities.