[Cardiomyopathies: a practical approach to the assessment and management of patients and their families]. / Kardiomyopathien: ein praktischer Ansatz für Abklärung und Management der betroffenen Patienten und deren Familien.

INTRODUCTION: The new 2023 European Society of Cardiology (ESC) Guidelines for the management of cardiomyopathies addresses all cardiomyopathies in a single document for the first time. The focus is on a phenotype-oriented diagnostic approach, multimodal imaging and genetic testing to establish the most accurate diagnosis possible. Additionally, new recommendations for risk stratification for sudden cardiac death in various cardiomyopathy phenotypes are provided. MRI and genetic testing have significantly gained importance in this context. Recommendations for comprehensive clinical and genetic cascade screening in relatives of individuals with cardiomyopathies have been revised. This article presents the most important innovations of these guidelines in a practice-oriented approach.

Arrhythmias and ion channelopathies causing sudden cardiac death in Hispanic/Latino and Indigenous populations.

The limited literature and increasing interest in studies on cardiac electrophysiology, explicitly focusing on cardiac ion channelopathies and sudden cardiac death in diverse populations, has prompted a comprehensive examination of existing research. Our review specifically targets Hispanic/Latino and Indigenous populations, which are often underrepresented in healthcare studies. This review encompasses investigations into genetic variants, epidemiology, etiologies, and clinical risk factors associated with arrhythmias in these demographic groups. The review explores the Hispanic paradox, a phenomenon linking healthcare outcomes to socioeconomic factors within Hispanic communities in the United States. Furthermore, it discusses studies exemplifying this observation in the context of arrhythmias and ion channelopathies in Hispanic populations. Current research also sheds light on disparities in overall healthcare quality in Indigenous populations. The available yet limited literature underscores the pressing need for more extensive and comprehensive research on cardiac ion channelopathies in Hispanic/Latino and Indigenous populations. Specifically, additional studies are essential to fully characterize pathogenic genetic variants, identify population-specific risk factors, and address health disparities to enhance the detection, prevention, and management of arrhythmias and sudden cardiac death in these demographic groups.

Cost effectiveness of implantable cardioverter defibrillators for 1.5 primary prevention of sudden cardiac arrest in China: an analysis from the Improve SCA study.

OBJECTIVES: Implantable cardioverter defibrillator (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) is underutilized in developing countries. The Improve SCA study has identified a subset of 1.5 primary prevention (1.5PP) patients with a higher risk of SCA and a significant mortality benefit from ICD therapy. From the perspective of China's healthcare system, we evaluated the cost-effectiveness of ICD therapy vs. no ICD therapy among 1.5PP patients with a view to informing clinical and policy decisions. METHODS: A published Markov model was adjusted and verified to simulate the course of the disease and describe different health states of 1.5PP patients. The patient characteristics, mortality, utility and complication estimates were obtained from the Improve SCA study and other literature. Cost inputs were sourced from government tender prices, medical service prices and clinical experts' surveys in 9 Chinese public hospitals. For both ICD and no ICD therapy, the total medical costs and quality-adjusted life-years (QALYs) were modelled over a lifetime horizon and the incremental cost-effectiveness ratio (ICER) was calculated. Deterministic and probabilistic sensitivity analyses were performed to assess the uncertainty of the model parameters. We used the willingness-to-pay (WTP) threshold recommended by China Guidelines for Pharmacoeconomic Evaluations, one to three times China's GDP per capita (CNY85,698-CNY257,094) in 2022 Chinese Yuan. RESULTS: The incremental cost effectiveness ratio (ICER) of ICD therapy compared to no ICD therapy is 139,652 CNY/QALY, which is about 1-2 times China's GDP per capita. The probability that ICD therapy is cost effective was 92.1%. Results from sensitivity analysis supported the findings of the base case. CONCLUSIONS: ICD therapy compared to no ICD therapy is cost-effective for the 1.5PP patients in China.

Arrhythmogenic Right Ventricular Cardiomyopathy Post-Mortem Assessment: A Systematic Review.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a genetic disorder characterized by the progressive fibro-fatty replacement of the right ventricular myocardium, leading to myocardial atrophy. Although the structural changes usually affect the right ventricle, the pathology may also manifest with either isolated left ventricular myocardium or biventricular involvement. As ARVC shows an autosomal dominant pattern of inheritance with variable penetrance, the clinical presentation of the disease is highly heterogeneous, with different degrees of severity and patterns of myocardial involvement even in patients of the same familiar group with the same gene mutation: the pathology spectrum ranges from the absence of symptoms to sudden cardiac death (SCD) sustained by ventricular arrhythmias, which may, in some cases, be the first manifestation of an otherwise silent pathology. An evidence-based systematic review of the literature was conducted to evaluate the state of the art of the diagnostic techniques for the correct post-mortem identification of ARVC. The research was performed using the electronic databases PubMed and Scopus. A methodological approach to reach a correct post-mortem diagnosis of ARVC was described, analyzing the main post-mortem peculiar macroscopic, microscopic and radiological alterations. In addition, the importance of performing post-mortem genetic tests has been underlined, which may lead to the correct identification and characterization of the disease, especially in those ARVC forms where anatomopathological investigation does not show evident morphostructural damage. Furthermore, the usefulness of genetic testing is not exclusively limited to the correct diagnosis of the pathology, but is essential for promoting targeted screening programs to the deceased's family members. Nowadays, the post-mortem diagnosis of ARVC performed by forensic pathologist remains very challenging: therefore, the identification of a clear methodological approach may lead to both a reduction in under-diagnoses and to the improvement of knowledge on the disease.

Socioeconomic deprivation and racialised disparities in competitive athletes with sudden cardiac arrest from the USA.

OBJECTIVE: To explore the association of socioeconomic deprivation and racialised outcomes in competitive athletes with sudden cardiac arrest (SCA) in the USA. METHODS: SCA cases from the National Center for Catastrophic Sports Injury Research (July 2014 to June 2021) were included. We matched Area Deprivation Index (ADI) scores (17 metrics to grade socioeconomic conditions) to the 9-digit zip codes for each athlete's home address. ADI is scored 1-100 with higher scores indicating greater neighbourhood socioeconomic deprivation. Analysis of variance was used to assess differences in mean ADI by racial groups. Tukey post hoc testing was used for pairwise comparisons. RESULTS: 391 cases of SCA in competitive athletes (85.4% male; 16.9% collegiate, 68% high school, 10.7% middle school, 4.3% youth) were identified via active surveillance. 79 cases were excluded due to missing data (19 race, 60 ADI). Of 312 cases with complete data, 171 (54.8%) were white, 110 (35.3%) black and 31 (9.9%) other race. The mean ADI was 40.20 (95% CI 36.64, 43.86) in white athletes, 57.88 (95% CI 52.65, 63.11) in black athletes and 40.77 (95% CI 30.69, 50.86) in other race athletes. Mean ADI was higher in black versus white athletes (mean difference 17.68, 95% CI 10.25, 25.12; p=0.0036) and black versus other race athletes (mean difference 17.11, 95% CI 4.74, 29.47; p<0.0001). CONCLUSIONS: Black athletes with SCA come from areas with higher neighbourhood socioeconomic deprivation than white or other race athletes with SCA. Our findings suggest that socioeconomic deprivation may be associated with racialised disparities in athletes with SCA.

Incidence, risk assessment and prevention of sudden cardiac death in cardiomyopathies.

Cardiomyopathies are a significant contributor to cardiovascular morbidity and mortality, mainly due to the development of heart failure and increased risk of sudden cardiac death (SCD). Despite improvement in survival with contemporary treatment, SCD remains an important cause of mortality in cardiomyopathies. It occurs at a rate ranging between 0.15% and 0.7% per year (depending on the cardiomyopathy), which significantly surpasses SCD incidence in the age- and sex-matched general population. The risk of SCD is affected by multiple factors including the aetiology, genetic basis, age, sex, physical exertion, the extent of myocardial disease severity, conduction system abnormalities, and electrical instability, as measured by various metrics. Over the past decades, the knowledge on the mechanisms and risk factors for SCD has substantially improved, allowing for a better-informed risk stratification. However, unresolved issues still challenge the guidance of SCD prevention in patients with cardiomyopathies. In this review, we aim to provide an in-depth discussion of the contemporary concepts pertinent to understanding the burden, risk assessment and prevention of SCD in cardiomyopathies (dilated, non-dilated left ventricular, hypertrophic, arrhythmogenic right ventricular, and restrictive). The review first focuses on SCD incidence in cardiomyopathies and then summarizes established and emerging risk factors for life-threatening arrhythmias/SCD. Finally, it discusses validated approaches to the risk assessment and evidence-based measures for SCD prevention in cardiomyopathies, pointing to the gaps in evidence and areas of uncertainties that merit future clarification.

Cost-effectiveness and diagnostic accuracy of focused cardiac ultrasound in the pre-participation screening of athletes: the SPORT-FoCUS study.

AIMS: The role of pre-participation screening (PPS) modalities in preventing sudden cardiac death (SCD) in athletes is debated due to a high false-positive rate. Focused cardiac ultrasound (FoCUS) has shown higher sensitivity and specificity, but its cost-effectiveness remains uncertain. This study aimed to determine the diagnostic performance and cost-effectiveness of FoCUS use in PPS. METHODS AND RESULTS: A total of 2111 athletes (77.4% male, mean age 24.9 ± 15.2years) underwent standardized family and medical history collection, physical examination, resting electrocardiography (ECG), FoCUS (10 min/5 views protocol), comprehensive echocardiography and exercise stress test. We prospectively evaluated three PPS incremental models: Model A, standardized medical history and physical examination Model B, Model A plus resting and stress ECG and Model C, Model B plus FoCUS (10 min/5 views protocol). We determined their incremental diagnostic accuracy and cost-effectiveness ratio. A total of 30 athletes were diagnosed with a cardiac condition associated with SCD: 3 were identified by Model A, 14 by Model B, and 13 athletes by Model C. The introduction of FoCUS markedly increased the sensitivity of PPS, compared with Model A and Model B (sensitivity 94% vs. 19% vs. 58% specificity 93% vs. 93% vs. 92%). The total screening costs were as follows: Model A 35.64 euros, Model B 87.68 euros, and Model C 120.89 euros. Considering the sole conditions at risk of SCD, the incremental cost-effectiveness ratio was 135.62 euros for Model B and 114.31 for Model C. CONCLUSIONS: The implementation of FoCUS into the PPS allows to identify a significantly greater number of athletes at risk of SCD and markedly lowers the false negative rate. Furthermore, the incorporation of FoCUS into the screening process has shown to be cost-effective.

A significant electrocardiography false-positive rate makes pre-participation screening (PPS) for sudden cardiac death (SCD) in athletes controversial. Focused cardiac ultrasound (FoCUS) may increase sensitivity and specificity however, its cost-effectiveness is unknown. This study evaluates the diagnostic performance and cost-effectiveness of FoCUS in PPS. Incorporating a simplified echocardiographic exam called FoCUS into PPS resulted in higher diagnostic reliability, with a lower rate of false negatives and a higher number of athletes at risk for SCD identified.The integration of FoCUS into the screening process resulted to be cost-effective in our athletes' cohort.

Sudden Death Risk Assessment in Hypertrophic Cardiomyopathy Across the Lifespan: Reconciling the American and European Approaches.

Hypertrophic cardiomyopathy (HCM) is the most prevalent inherited cardiac disease. Since the modern description of HCM more than seven decades ago, great focus has been placed on preventing its most catastrophic complication: sudden cardiac death (SCD). Implantable cardioverter-defibrillators (ICD) have been recognized to provide effective prophylactic therapy. Over the years, two leading societies, the European Society of Cardiology (ESC) and the American Heart Association/American College of Cardiology (AHA/ACC), have proposed risk stratification models to assess SCD in adults. European guidelines rely on a risk calculator, the HCM Risk-SCD, while American guidelines propose a stand-alone risk factor approach. Recently, risk prediction models were also developed in the pediatric population. This article reviews the latest recommendations on the risk stratification of SCD in HCM and summarises current indications for ICD use.

Utilization and Outcomes of Primary Prevention Implantable Cardioverter-Defibrillators in Patients With Hypertrophic Cardiomyopathy.

Background There is uncertainty about the appropriate use of primary prevention implantable cardioverter-defibrillators (ICDs) among older patients with hypertrophic cardiomyopathy. Methods and Results Patients with hypertrophic cardiomyopathy who received a primary prevention ICD between 2010 and 2016 were identified using the National Cardiovascular Data Registry ICD Registry. Trends in ICD utilization and patient characteristics were assessed over time. Using linked Centers for Medicare and Medicaid Service claims data, Cox proportional hazard models assessed factors associated with mortality and postdischarge hospitalization for cardiac arrest/ventricular arrhythmia. Of 5571 patients with hypertrophic cardiomyopathy, 1511 (27.1%) were ≥65 years old. ICD utilization increased over time in all age groups. There were no changes in the prevalence of risk factors for sudden cardiac death over time. The variables most strongly associated with postdischarge mortality were older age (adjusted hazard ratio (aHR) 1.80 [95% CI, 1.47-2.21]), New York Heart Association class (III/IV versus I/II aHR 2.17 [95% CI, 1.57-2.98]), and left ventricular ejection fraction (left ventricular ejection fraction ≤35% versus >50% aHR 2.34 [95% CI, 1.58-3.48]; left ventricular ejection fraction 36%-50% versus >50% aHR 2.98 [95% CI, 2.02-4.40]), while history of nonsustained ventricular tachycardia (aHR 2.38 [95% CI, 1.62-3.51]) and New York Heart Association class (III/IV versus I/II aHR 1.84 [95% CI, 1.22-2.78]) were strongly associated with hospitalization for ventricular arrhythmia/cardiac arrest. Conclusions Primary prevention ICD utilization in patients with hypertrophic cardiomyopathy increased over time, including among those ≥65 years old. Among older patients, the strongest risk factors for hospitalization for ventricular arrhythmia/cardiac arrest following ICD implantation were history of nonsustained ventricular tachycardia and New York Heart Association class.

Manual vs. automatic assessment of the QT-interval and corrected QT.

AIMS: Sudden cardiac death (SCD) is challenging to predict. Electrocardiogram (ECG)-derived heart rate-corrected QT-interval (QTc) is used for SCD-risk assessment. QTc is preferably determined manually, but vendor-provided automatic results from ECG recorders are convenient. Agreement between manual and automatic assessments is unclear for populations with aberrant QTc. We aimed to systematically assess pairwise agreement of automatic and manual QT-intervals and QTc. METHODS AND RESULTS: A multi-centre cohort enriching aberrant QTc comprised ECGs of healthy controls and long-QT syndrome (LQTS) patients. Manual QT-intervals and QTc were determined by the tangent and threshold methods and compared to automatically generated, vendor-provided values. We assessed agreement globally by intra-class correlation coefficients and pairwise by Bland-Altman analyses and 95% limits of agreement (LoA). Further, manual results were compared to a novel automatic QT-interval algorithm. ECGs of 1263 participants (720 LQTS patients; 543 controls) were available [median age 34 (inter-quartile range 35) years, 55% women]. Comparing cohort means, automatic and manual QT-intervals and QTc were similar. However, pairwise Bland-Altman-based agreement was highly discrepant. For QT-interval, LoAs spanned 95 (tangent) and 92 ms (threshold), respectively. For QTc, the spread was 108 and 105 ms, respectively. LQTS patients exhibited more pronounced differences. For automatic QTc results from 440-540 ms (tangent) and 430-530 ms (threshold), misassessment risk was highest. Novel automatic QT-interval algorithms may narrow this range. CONCLUSION: Pairwise vendor-provided automatic and manual QT-interval and QTc results can be highly discrepant. Novel automatic algorithms may improve agreement. Within the above ranges, automatic QT-interval and QTc results require manual confirmation, particularly if T-wave morphology is challenging.

Arrhythmic Mitral Valve Prolapse: Risk Assessment and Management.

Arrhythmic mitral valve prolapse (MVP) has gained great interest recently because of the increasing recognition of its potential role in unexplained cardiac arrest. Although evidence has accumulated to show the association of arrhythmic MVP (AMVP) with sudden cardiac death (SCD), risk stratification and management remain unclear. Physicians are faced with the challenges of screening for AMVP among MVP patients and the dilemma of when and how to intervene to prevent SCD in these patients. In addition, there is little guidance to help approach MVP patients who present with an otherwise unexplained cardiac arrest to know whether MVP was the primary cause of cardiac arrest or just an innocent bystander. Herein we review the epidemiology and definition of AMVP, the risk and mechanisms of SCD, and summarize the clinical evidence behind risk markers of SCD and therapeutic interventions that could potentially prevent it. We also propose an algorithm that provides guidance as to how to screen for AMVP and what therapeutic interventions to use. Last, we propose a diagnostic algorithm for approaching patients with otherwise unexplained cardiac arrest who are shown to have MVP.

Multicenter assessment of the outcomes of subcutaneous ICD implantation in patients with prior or future sternotomy.

BACKGROUND: The subcutaneous ICD (S-ICD) is a viable alternative to transvenous ICD and avoids intravascular complications in patients without a pacing indication. The outcomes of S-ICD implantation are uncertain in patients with prior sternotomy. OBJECTIVE: We aim to compare the implant techniques and outcomes with S-ICD implantation in patients with and without prior sternotomy. METHODS: Multicenter retrospective cohort study including adult patients with an S-ICD implanted between January 2014 and June 2020. Outcomes were compared between patients with and without prior sternotomy. RESULTS: Among the 212 patients (49 ± 15 years old, 43% women, BMI 30 ± 8 kg/m2 , 68% primary prevention, 30% ischemic cardiomyopathy, LVEF median 30% IQR 25%-45%) who underwent S-ICD implantation, 47 (22%) had a prior sternotomy. There was no difference in the sensing vector (57% vs. 53% primary, p = 0.55), laterality of the S-ICD lead to the sternum (94% vs. 96% leftward, p = 0.54), or the defibrillation threshold (65 ± 1.4 J vs. 65 ± 0.8 J, p = 0.76) with versus without prior sternotomy. The frequency of 30-day complications was similar with and without prior sternotomy (n = 3/47 vs. n = 15/165, 6% vs. 9%, p = 0.56). Over a median follow-up of 28 months (IQR 10-49 months), the frequency of inappropriate shocks was similar between those with and without prior sternotomy (n = 3/47 and n = 16/165, 6% vs. 10%, p = 0.58). CONCLUSION: Implantation of an S-ICD in patients with prior sternotomy is safe with a similar risk of 30-day complications and inappropriate ICD shocks as patients without prior sternotomy.

Dynamic Change of Cardiovascular Health Metrics and Long-Term Risk of Sudden Cardiac Death: The ARIC Study.

Background The change of cardiovascular health (CVH) status has been associated with risk of cardiovascular disease. However, no studies have explored the change patterns of CVH in relation to risk of sudden cardiac death (SCD). We aim to examine the link between baseline CVH and change of CVH over time with the risk of SCD. Methods and Results Analyses were conducted in the prospective cohort ARIC (Atherosclerosis Risk in Communities) study, started in 1987 to 1989. ARIC enrolled 15 792 individuals 45 to 64 years of age from 4 US communities (Forsyth County, North Carolina; Jackson, Mississippi; suburbs of Minneapolis, Minnesota; and Washington County, Maryland). Subjects with 0 to 2, 3 to 4, and 5 to 7 ideal metrics of CVH were categorized as having poor, intermediate, or ideal CVH, respectively. Change in CVH over 6 years between 1987 to 1989 and 1993 to 1995 was considered. The primary study outcome was physician adjudicated SCD. The study population consisted of 15 026 subjects, of whom 12 207 had data about CVH change. Over a median follow-up of 23.0 years, 583 cases of SCD were recorded. There was a strong inverse association between baseline CVH metrics and time varying CVH metrics with risk of SCD. Compared with subjects with consistently poor CVH, risk of SCD was lower in those changed from poor to intermediate/ideal (hazard ratio [HR], 0.67 [95% CI, 0.48-0.94]), intermediate to poor (HR, 0.73 [95% CI, 0.54-0.99]), intermediate to ideal (HR, 0.49 [95% CI, 0.24-0.99]), ideal to poor/intermediate CVH (HR, 0.23 [95% CI, 0.10-0.52]), or those with consistently intermediate (HR, 0.49 [95% CI, 0.36-0.66]) or consistently ideal CVH (HR, 0.31 [95% CI, 0.13-0.76]). Similar results were also observed for non-SCD. Conclusions Compared with consistently poor CVH, other patterns of change in CVH were associated with lower risk of SCD. These findings highlight the importance of promotion of ideal CVH in the primordial prevention of SCD.

The assessment of cardiac risk in patients taking lamotrigine; a systematic review.

OBJECTIVE: The Food and Drug Administration (FDA) warned about lamotrigine's arrhythmogenicity based on in vitro data. This systematic review investigates lamotrigine's effect on cardiac conduction and risk of sudden cardiac death (SCD) in individuals with and without cardiovascular disease. METHODS: We searched Web of Science and PubMed from inception through August 2021. We included studies measuring electrocardiogram (ECG) changes, laboratory abnormalities, or SCD among patients taking lamotrigine. Studies examining sudden unexpected death in epilepsy were excluded for scope. Two reviewers assessed articles and extracted data. We used the Effective Public Healthcare Panacea Project tool to evaluate confidence in evidence. RESULTS: Eight randomized controlled trials, 9 nonrandomized observational studies, and 24 case reports were identified, with >3054 total participants, >1606 of whom used lamotrigine. One randomized trial of older patients found an average QRS increase of 3.5 +/- 13.1 ms. Fifteen studies reported no changes in ECG parameters. Case reports documented QRS widening (13), Brugada syndrome (6), QTc prolongation (1) and SCD (2), though many ingested toxic quantities of lamotrigine and/or other medications. CONCLUSIONS: Evidence is insufficient to support the breadth of the FDA warning concerning lamotrigine's cardiac risk. Lamotrigine at therapeutic doses may be associated with modest, non-dangerous QRS widening.

Longitudinal Arrhythmic Risk Assessment Based on Ejection Fraction in Patients with Recent-Onset Nonischemic Dilated Cardiomyopathy.

BACKGROUND: Practice guidelines suggest the use of implantable cardioverter-defibrillators in patients with left ventricular ejection fractions (LVEF) ≤ 35% despite 3 to 6 months of guideline-directed medical therapy (GDMT). It remains unclear whether this strategy is appropriate for patients with dilated cardiomyopathy (DCM), who can experience reverse ventricular remodeling for up to 24 months after the initiation of GDMT. The aim of this study was to assess the longitudinal dynamic relationship between LVEF ≤ 35% and arrhythmic risk in patients with recent-onset nonischemic DCM on GDMT. METHODS: A retrospective analysis was conducted among patients with recent-onset DCM (≤6 months) and recent initiation of GDMT (≤3 months) consecutively enrolled in a longitudinal registry. Risk for major ventricular arrhythmic events or sudden cardiac death was assessed in relationship to LVEF ≤ 35% at enrollment and 6 and 24 months after initiation of GDMT. RESULTS: Five hundred forty-four patients met the inclusion criteria. LVEF ≤ 35% identified patients with increased risk for major ventricular arrhythmic events or sudden cardiac death starting from 24 months after initiation of GDMT (hazard ratio, 2.126; 95% CI, 1.065-4.245; P = .03). However, LVEF ≤ 35% at presentation or 6 months after enrollment did not have prognostic significance. Sixty-seven percent of 131 patients with LVEF ≤ 35% at 6 months after initiation of GDMT had improved LVEFs (to >35%) by 24 months. This late LVEF improvement correlated with lower arrhythmic risk (P = .012) and was preceded by a reduction of LV dimensions in the first 6 months of GDMT. CONCLUSIONS: In patients with DCM, the present findings suggest that risk stratification for major ventricular arrhythmic events or sudden cardiac death on the basis of LVEF ≤ 35% is effective after 2 years of GDMT, but not after 6 months. In selected patients with DCM, it would be appropriate to wait 24 months before primary prevention ICD implantation.

The value of wearable cardioverter defibrillator in adult patients with recent myocardial infarction: Economic and clinical implications from a health technology assessment perspective.

AIMS: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness. METHODS & RESULTS: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis - based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276. CONCLUSION: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well.

Longitudinal Outcomes of Subcutaneous or Transvenous Implantable Cardioverter-Defibrillators in Older Patients.

BACKGROUND: The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking. OBJECTIVES: The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD. METHODS: The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models. RESULTS: A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161). CONCLUSIONS: In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients.