Motor vehicle crash risk after cardioverter-defibrillator implantation: a population-based cohort study.

BACKGROUND: Limited empirical evidence informs driving restrictions after implantable cardioverter-defibrillator (ICD) implantation. We sought to evaluate real-world motor vehicle crash risks after ICD implantation. METHODS: We performed a retrospective cohort study using 22 years of population-based health and driving data from British Columbia, Canada (2019 population: 5 million). Individuals with a first ICD implantation between 1997 and 2019 were age and sex matched to three controls. The primary outcome was involvement as a driver in a crash that was attended by police or that resulted in an insurance claim. We used survival analysis to compare crash risk in the first 6 months after ICD implantation to crash risk during a corresponding 6-month interval among controls. RESULTS: A crash occurred prior to a censoring event for 296 of 9373 individuals with ICDs and for 1077 of 28 119 controls, suggesting ICD implantation was associated with a reduced risk of subsequent crash (crude incidence rate, 8.5 vs 10.5 crashes per 100 person-years; adjusted HR (aHR), 0.71; 95% CI 0.61 to 0.83; p<0.001). Results were similar after stratification by primary versus secondary prevention ICD. Relative to controls, ICD patients had more traffic contraventions in the 3 years prior to ICD implantation but fewer contraventions in the 6 months after implantation, suggesting individuals reduced their road exposure (hours or miles driven per week) or drove more conservatively after ICD implantation. CONCLUSIONS: Crash risk is lower in the 6 months after ICD implantation than among matched controls, likely because individuals reduced their road exposure in order to comply with contemporary postimplantation driving restrictions. Policymakers might consider liberalisation of postimplantation driving restrictions while monitoring crash rates.

Is 'Cardiopulmonary' the New 'Cardiometabolic'? Making a Case for Systems Change in COPD.

Chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD) have a syndemic relationship with shared risk factors and complex interplay between genetic, environmental, socioeconomic, and pathophysiological mechanisms. CVD is among the most common comorbidities in patients with COPD and vice versa. Patients with COPD, irrespective of their disease severity, are at increased risk of CVD morbidity and mortality, driven in part by COPD exacerbations. Despite these known interrelationships, CVD is underestimated and undertreated in patients with COPD. Similarly, COPD is an independent risk-enhancing factor for adverse cardiovascular (CV) events, yet it is not incorporated into current CV risk assessment tools, leading to under-recognition and undertreatment. There is a pressing need for systems change in COPD management to move beyond symptom control towards a comprehensive cardiopulmonary disease paradigm with proactive prevention of exacerbations and adverse cardiopulmonary outcomes and mortality. However, there is a dearth of evidence defining optimal cardiopulmonary care pathways. Fortunately, there is a precedent to support systems-level change in the field of diabetes, which evolved from glycemic control to comprehensive multi-organ risk assessment and management. Key elements included integrated multidisciplinary care, intensive risk factor management, coordination between primary and specialist care, care pathways and protocols, education and self management, and disease-modifying therapies. This commentary article draws parallels between the cardiometabolic and cardiopulmonary paradigms and makes a case for systems change towards multidisciplinary, integrated cardiopulmonary care, using the evolution in diabetes care as a potential framework.

A Research Agenda to Improve Outcomes in Patients with Chronic Obstructive Pulmonary Disease and Cardiovascular Disease: An Official American Thoracic Society Research Statement.

Background: Individuals with chronic obstructive pulmonary disease (COPD) are often at risk for or have comorbid cardiovascular disease and are likely to die of cardiovascular-related causes. Objectives: To prioritize a list of research topics related to the diagnosis and management of patients with COPD and comorbid cardiovascular diseases (heart failure, atherosclerotic vascular disease, and atrial fibrillation) by summarizing existing evidence and using consensus-based methods. Methods: A literature search was performed. References were reviewed by committee co-chairs. An international, multidisciplinary committee, including a patient advocate, met virtually to review evidence and identify research topics. A modified Delphi approach was used to prioritize topics in real time on the basis of their potential for advancing the field. Results: Gaps spanned the translational science spectrum from basic science to implementation: 1) disease mechanisms; 2) epidemiology; 3) subphenotyping; 4) diagnosis and management; 5) clinical trials; 6) care delivery; 7) medication access, adherence, and side effects; 8) risk factor mitigation; 9) cardiac and pulmonary rehabilitation; and 10) health equity. Seventeen experts participated, and quorum was achieved for all votes (>80%). Of 17 topics, ≥70% agreement was achieved for 12 topics after two rounds of voting. The range of summative Likert scores was -15 to 25. The highest priority was "Conduct pragmatic clinical trials with patient-centered outcomes that collect both pulmonary and cardiac data elements." Health equity was identified as an important topic that should be embedded within all research. Conclusions: We propose a prioritized research agenda with the purpose of stimulating high-impact research that will hopefully improve outcomes among people with COPD and cardiovascular disease.

The Diagnostic Utility of Holter Monitoring in Catecholaminergic Polymorphic Ventricular Tachycardia.

BACKGROUND: Holter monitoring may raise suspicion of an underlying catecholaminergic polymorphic ventricular tachycardia (CPVT) diagnosis. Although not a primary investigation for CPVT, Holter monitoring is ubiquitously used as a diagnostic tool in the heart rhythm clinic. OBJECTIVES: The objective of this study was to explore Holter monitoring in CPVT diagnosis. METHODS: This retrospective cohort study analyzed off-therapy Holter monitoring from 13 ryanodine receptor 2-positive CPVT and 34 healthy patients from the Canadian Hearts in Rhythm Organization national registry. Using the Edwards method, the ratio of ambient-maximum heart rate during Holter monitoring was correlated with exertion level to separate premature ventricular contractions (PVCs) during periods of adrenergic and nonadrenergic stress. A receiver operating characteristic curve analysis determined the optimal threshold for isolating CPVT-induced PVCs during adrenergic states. RESULTS: PVC burden differed between groups (P = 0.001) but was within population norm, suggesting ambient PVCs are uncommon in CPVT. CPVT patients had higher PVC counts than healthy controls (P = 0.002), with a different distribution based on adrenergic state. The optimal threshold for separating PVCs into periods of adrenergic and nonadrenergic stress in CPVT patients was 76% of the maximum heart rate during the monitoring period. Compared with healthy controls, CPVT patients had a higher PVC count, limited to periods of adrenergic stress, defined by >76% maximum heart rate threshold (P = 0.002; area under the receiver operating characteristic curve: 0.84). Below this threshold, there was no significant PVC difference (P = 0.604). CONCLUSIONS: Holter monitor PVC counts alone are inadequate for CPVT diagnosis, owing to the adrenergic nature of the disease. Quantifying PVC prevalence at a heart rate threshold >76% identified CPVT with moderate sensitivity (69%) and high specificity (94%).

Long-term outcomes among out-of-hospital cardiac arrest survivors with reversible versus non-reversible causes.

BACKGROUND: Reversible cause of out-of-hospital cardiac arrest (OHCA) is vaguely defined in international guidelines as an identifiable transient or potentially correctable condition. Moreover, studies evaluating long-term outcomes of patients experiencing OHCA due to reversible and non-reversible causes are lacking. We aimed to determine differences in long-term outcomes in OHCA-survivors according to different etiology. METHODS: From the British Columbia Cardiac Arrest registry, adults with non-traumatic OHCA (2009-2016) surviving to hospital discharge were identified. Patients were categorized by OHCA etiology combining reversibility and underlying ischemic etiology. The primary outcome was a composite of all-cause mortality, recurrent OHCA, or re-hospitalization for sudden cardiac arrest or ventricular arrhythmias. Using the Kaplan-Meier method and multivariable Cox regression models, we compared the risk of the composite outcome according to different OHCA-etiology. RESULTS: Of 1,325 OHCA hospital-discharge survivors (median age 62.8, 77.9% male), 431 (32.5%) had reversible ischemic, 415 (31.3%) non-reversible ischemic, 99 (7.5%) reversible non-ischemic and 380 (28.7%) non-reversible non-ischemic etiology. At 3 years post-discharge, Kaplan-Meier event-free rate was highest in patients with a reversible ischemic etiology (91%, 95% CI 87-94%), and lowest in those with a reversible non-ischemic etiology (62%, 95% CI 51-72%). In multivariate analyses, compared to non-reversible non-ischemic cause, reversible ischemic cause was associated with a significantly lower hazard ratio (HR) (0.52, 95% confidence interval [CI], 0.33-0.81), reversible non-ischemic cause with a significantly higher HR (1.53, 95% CI, 1.03-2.32) and non-reversible ischemic cause with a non-significant HR 0.92 (95% CI, 0.64-1.33) for the composite outcome. CONCLUSIONS: The presence of a reversible ischemic cause is associated with long-term OHCA-outcomes.

Distinguishing Primary Prevention From Secondary Prevention Implantable Cardioverter Defibrillators Using Administrative Health and Cardiac Device Registry Data.

Background: Administrative health data and cardiac device registries can be used to empirically evaluate outcomes and costs after implantable cardioverter defibrillator (ICD) implantation. These datasets often have incomplete information on the indication for implantation (primary vs secondary prevention of sudden cardiac death). Methods: We used 16 years of population-based cardiac device registry and administrative health data from British Columbia, Canada, to derive and internally validate statistical models that predict the likely indication for ICD implantation. We used chart review data as the reference standard for ICD indication in the Cardiac Device Registry database (CDR; 2004-2012 [Cardiac Services BC]) and nonmissing indication as the reference standard in the Heart Information System registry database (HEARTis; 2013-2019 [Cardiac Services BC]). We created 3 logistic regression prediction models in each database: one using only registry data, one using only administrative data, and one using both registry and administrative data. We assessed the predictive performance of each model using standard metrics after optimism correction with 200 bootstrap resamples. Results: Models that used registry data alone demonstrated excellent predictive performance (sensitivity ≥ 89%; specificity ≥ 87%). Models that used only administrative data performed well (sensitivity ≥ 84%; specificity ≥ 70%). Models that used both registry and administrative data showed modest gains over those that used registry data alone (sensitivity ≥ 90%; specificity ≥ 89%). Conclusions: Administrative health data and cardiac device registry data can distinguish secondary prevention ICDs from primary prevention ICDs with acceptable sensitivity and specificity. Imputation of missing ICD indication might make these data resources more useful for research and health system monitoring.

Contexte: Les données administratives de santé et les registres des dispositifs cardiaques peuvent être utilisés pour évaluer de manière empirique les résultats et les coûts associés aux défibrillateurs cardioverteurs implantables (DCI). Or, ces ensembles de données comportent souvent des informations incomplètes sur l'indication de l'implant (prévention primaire ou secondaire de la mort subite d'origine cardiaque). Méthodologie: Nous avons analysé 16 ans de données provenant du registre populationnel des dispositifs cardiaques et des données administratives de santé de la Colombie-Britannique, au Canada, pour alimenter des modèles statistiques prédisant l'indication probable de l'implant d'un DCI et pour effectuer une validation interne de ces modèles. Nous avons utilisé les données de la revue des dossiers médicaux comme norme de référence de l'indication des DCI dans le registre des dispositifs cardiaques (Cardiac Device Registry; 2004-2012 [Cardiac Services BC]) et les indications consignées comme norme de référence dans la banque de données Heart Information System (HEARTis; 2013-2019 [Cardiac Services BC]). Nous avons créé 3 modèles prédictifs par régression logistique dans chaque base de données : une utilisant seulement les données du registre, une utilisant seulement les données administratives et une utilisant les deux types de données. Nous avons évalué la performance de chaque modèle en matière de prédiction à l'aide de mesures normalisées, après correction pour l'optimisme de l'erreur à l'aide de 200 nouveaux échantillons obtenus par la méthode bootstrap. Résultats: Les modèles utilisant seulement les données du registre avaient une excellente performance prédictive (sensibilité ≥ 89 %; spécificité ≥ 87 %). Les modèles qui n'utilisaient que les données administratives donnaient quant à eux de bons résultats (sensibilité ≥ 84 %; spécificité ≥ 70 %). Enfin, les modèles qui utilisaient les données administratives et les données du registre ont donné des gains modestes par rapport aux modèles qui n'utilisaient que les données du registre (sensibilité ≥ 90 %; spécificité ≥ 89 %). Conclusions: Les données administratives de santé et les données des registres de dispositifs cardiaques permettent de distinguer les DCI implantés en prévention secondaire des DCI implantés en prévention primaire avec une sensibilité et une spécificité acceptables. Dans les cas où elle est absente, l'attribution d'une indication pour les DCI pourrait donc rendre ces ressources plus utiles pour la recherche et la surveillance du système de santé.

Navigating the Landscape of Medical Device Advisories: A Special Report From the Canadian Heart Rhythm Society Device Advisory Committee.

Cardiac implantable electronic devices (CIEDs) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most implanted medical devices, with > 1.5 million devices implanted annually. Although millions of patients have benefited with improved quality of life and survival, CIED systems are becoming increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to health care providers and patients. Medical device recalls are common, with > 35 unique device recalls in the past 5 years. From an ethical standpoint, CIED recalls highlight a range of considerations including the consent process, duty to report, how best to promote autonomous decision-making, trust in the health care system, as well as disproportionate effects of these considerations on equity-deserving groups. The purpose of the current article is to review and advise regarding the process around medical device advisory and recall, with a specific focus on clinicians caring for patients affected by these devices. We have sought the input of a lawyer, a patient advocacy group, and an ethicist to guide the clinical management of, and communications regarding, device recalls and advisories. Diligent surveillance and a clear, transparent patient consent process regarding these small but potentially serious device anomalies is paramount in ensuring patients believe they are safe and informed. Meaningful patient engagement helps to ensure optimal communication and disclosure mechanisms before implantation and throughout follow-up, accessibility of information in the initial implant and recall action process, and trust in health care systems and providers.

Implications of Cardiopulmonary Risk for the Management of COPD: A Narrative Review.

Chronic obstructive pulmonary disease (COPD) constitutes a major global health burden and is the third leading cause of death worldwide. A high proportion of patients with COPD have cardiovascular disease, but there is also evidence that COPD is a risk factor for adverse outcomes in cardiovascular disease. Patients with COPD frequently die of respiratory and cardiovascular causes, yet the identification and management of cardiopulmonary risk remain suboptimal owing to limited awareness and clinical intervention. Acute exacerbations punctuate the progression of COPD in many patients, reducing lung function and increasing the risk of subsequent exacerbations and cardiovascular events that may lead to early death. This narrative review defines and summarises the principles of COPD-associated cardiopulmonary risk, and examines respiratory interventions currently available to modify this risk, as well as providing expert opinion on future approaches to addressing cardiopulmonary risk.

Impact of the method of calculating 30-day readmission rate after hospitalization for heart failure. Data from the VancOuver CoastAL Acute Heart Failure (VOCAL-AHF) registry.

BACKGROUND: Thirty-day readmission rate after heart failure (HF) hospitalization is widely used to evaluate healthcare quality. Methodology may substantially influence estimated rates. We assessed the impact of different definitions on HF and all-cause readmission rates. METHODS: Readmission rates were examined in 1835 patients discharged following HF hospitalization using 64 unique definitions derived from five methodological factors: (1) International Classification of Diseases-10 codes (broad vs. narrow), (2) index admission selection (single admission only first-in-year vs. random sample; or multiple admissions in year with vs. without 30-day blanking period), (3) variable denominator (number alive at discharge vs. number alive at 30 days), (4) follow-up period start (discharge date vs. day following discharge), and (5) annual reference period (calendar vs. fiscal). The impact of different factors was assessed using linear regression. RESULTS: The calculated 30-day readmission rate for HF varied more than two-fold depending solely on the methodological approach (6.5-15.0%). All-cause admission rates exhibited similar variation (18.8-29.9%). The highest rates included all consecutive index admissions (HF 11.1-15.0%, all-cause 24.0-29.9%), and the lowest only one index admission per patient per year (HF 6.5-11.3%, all-cause 18.8-22.7%). When including multiple index admissions and compared with blanking the 30-day post-discharge, not blanking was associated with 2.3% higher readmission rates. Selecting a single admission per year with a first-in-year approach lowered readmission rates by 1.5%, while random-sampling admissions lowered estimates further by 5.2% (P < 0.001). CONCLUSION: Calculated 30-day readmission rates varied more than two-fold by altering methods. Transparent and consistent methods are needed to ensure reproducible and comparable reporting.

Qualitative Analysis of Patient Decisional Needs for Medications to Treat Heart Failure.

BACKGROUND: The development of tools to support shared decision-making should be informed by patients' decisional needs and treatment preferences, which are largely unknown for heart failure (HF) with reduced ejection fraction (HFrEF) pharmacotherapy decisions. We aimed to identify patients' decisional needs when considering HFrEF medication options. METHODS: This was a qualitative study using semi-structured interviews. We recruited patients with HFrEF from 2 Canadian ambulatory HF clinics and clinicians from Canadian HF guideline panels, HF clinics, and Canadian HF Society membership. We identified themes through inductive thematic analysis. RESULTS: Participants included 15 patients and 12 clinicians. Six themes and associated subthemes emerged related to HFrEF pharmacotherapy decision-making: (1) patient decisional needs included lack of awareness of a choice or options, difficult decision timing and stage, information overload, and inadequate motivation, support and resources; (2) patients' decisional conflict varied substantially, driven by unclear trade-offs; (3) treatment attribute preferences-patients focused on both benefits and downsides of treatment, whereas clinicians centered discussion on benefits; (4) quality of life-patients' definition of quality of life depended on pre-HF activity, though most patients demonstrated adaptability in adjusting their daily activities to manage HF; (5) shared decision-making process-clinicians' described a process more akin to informed consent; (6) decision support-multimedia decision aids, virtual appointments, and primary-care comanagement emerged as potential enablers of shared decision-making. CONCLUSIONS: Patients with HFrEF have several decisional needs, which are consistent with those that may respond to decision aids. These findings can inform the development of HFrEF pharmacotherapy decision aids to address these decisional needs and facilitate shared decision-making.