Considerations for addressing bias in artificial intelligence for health equity.

Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies, bioethicists, payors and value based care organizations, regulatory agencies, legislators, and creators of artificial intelligence/machine learning (AI/ML)-enabled medical devices. Lack of equitable access to diagnosis and treatment may be improved through new digital health technologies, especially AI/ML, but these may also exacerbate disparities, depending on how bias is addressed. We propose an expanded Total Product Lifecycle (TPLC) framework for healthcare AI/ML, describing the sources and impacts of undesirable bias in AI/ML systems in each phase, how these can be analyzed using appropriate metrics, and how they can be potentially mitigated. The goal of these "Considerations" is to educate stakeholders on how potential AI/ML bias may impact healthcare outcomes and how to identify and mitigate inequities; to initiate a discussion between stakeholders on these issues, in order to ensure health equity along the expanded AI/ML TPLC framework, and ultimately, better health outcomes for all.

Ethical and legal views regarding deactivation of cardiac implantable electrical devices in patients with hypertrophic cardiomyopathy.

Little is known about patients' views surrounding the ethical and legal aspects of managing pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs) near the end of life. Patients with hypertrophic cardiomyopathy (HC) are at heightened risk of sudden cardiac death and are common recipients of such devices. Patients with HC recruited from the membership of the Hypertrophic Cardiomyopathy Association were surveyed about their clinical histories, advance care planning, legal knowledge, and ethical beliefs relating to the withdrawal of PM and ICD therapy. The mean age of the 546 patients was 49.1 years, 47% were women, and 57% had ICDs. Only 46% of the respondents had completed an advance directive, only 51% had a healthcare proxy, and cardiac implantable electrical devices (CIEDs) were commonly not addressed in either (92% and 58%, respectively). Many patients characterized deactivating PMs or ICDs as euthanasia or physician-assisted suicide (29% for PMs and 17% for ICDs), and >50% expressed uncertainty regarding the legality of device deactivation. Patients viewed deactivation of ICDs and PMs as morally different from other life-sustaining therapies such as mechanical ventilation and dialysis, and these views varied substantially according to the CIED type (p <0.0001). The respondents expressed concerns regarding clinical conflicts related to religion, ethical and legal uncertainty, and informed consent. In conclusion, patients who have, or are eligible to receive, CIEDs might require improved advance care planning and education regarding the ethical and legal options for managing CIEDs at the end of life.

Longevity of Sprint Fidelis implantable cardioverter-defibrillator leads and risk factors for failure: implications for patient management.

BACKGROUND: Sprint Fidelis (Fidelis) implantable cardioverter-defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure. Our aim was to assess the longevity of Fidelis leads and to evaluate clinical variables and adverse events associated with Fidelis failure. The results were compared with like data for Quattro Secure (Quattro) implantable cardioverter-defibrillator leads implanted at our centers. METHODS AND RESULTS: This 3-center study included adults ≥18 years of age who received Fidelis or Quattro leads for the prevention of sudden cardiac death. From November 2001 to January 2009,1023 Fidelis and 1668 Quattro leads were implanted and followed up. The failure rate for Fidelis leads was 2.81%/y compared with 0.43%/y for Quattro leads (P<0.0001). No deaths or injuries occurred as a result of lead failure, but 42% of fractures caused inappropriate shocks. The survival of Fidelis leads at 4 years was 87.0% (95% confidence interval, 83.6 to 90.1) compared with 98.7% (95% confidence interval, 97.9 to 99.4) for Quattro leads (P<0.0001). Multivariate predictors of Fidelis failure were younger age (hazard ratio, 0.98; 95% confidence interval, 0.96 to 0.99), female gender (hazard ratio, 0.61; 95% confidence interval, 0.40 to 1.00), and cardiac disease (P=0.041). CONCLUSIONS: Compared with Quattro leads, the survival of Fidelis leads continues to decline, and Fidelis failure is notably higher in younger patients, women, individuals with hypertrophic cardiomyopathy, and patients with arrhythmogenic right ventricular dysplasia or channelopathies. These findings have significant implications for the management of patients who have Fidelis leads, and they demonstrate the importance of weighing clinical variables in assessments of implantable cardioverter-defibrillator lead performance.

An unusual cause of abnormal intrathoracic impedance in a patient with arrhythmogenic right ventricular cardiomyopathy.

A device interrogation for a 32-year-old woman with arrhythmogenic right ventricular cardiomyopathy and an implantable cardioverter-defibrillator capable of monitoring intrathoracic impedance demonstrated a dramatic increase in her OptiVol Fluid index levels in the absence of clinical heart failure. The timing of her intrathoracic impedance changes correlated with plasma volume changes during an uneventful pregnancy without cardiovascular complications. The strengths and limitations of intrathoracic impedance are described in the context of the physiology of pregnancy.

Ethical and legal views of physicians regarding deactivation of cardiac implantable electrical devices: a quantitative assessment.

BACKGROUND: Despite the high prevalence of pacemakers and implantable cardioverter-defibrillators, little is known about physicians' views surrounding the ethical and legal aspects of managing these devices at the end of life. OBJECTIVE: The purpose of this study was to identify physicians' experiences and views surrounding the ethical and legal aspects of managing cardiac devices at the end of life. METHODS: Survey questions were administered to internal medicine physicians and subspecialists at a tertiary care center. Physicians were surveyed about their clinical experience, legal knowledge, and ethical beliefs relating to the withdrawal of PM and ICD therapy in comparison to other life-sustaining therapies. RESULTS: Responses were obtained from 185 physicians. Compared to withdrawal of PMs and ICDs, physicians more often reported having participated in the withdrawal or removal of mechanical ventilation (86.1% vs 33.9%, P <.0001), dialysis (60.6% vs 33.9%, P <.001), and feeding tubes (73.8% vs 33.9%, P <.0001). Physicians were consistently less comfortable discussing cessation of PMs and ICDs compared to other life-sustaining therapies (P <.005). Only 65% of physicians correctly identified the legal status of euthanasia in the United States, and 20% accurately reported the legal status of physician-assisted suicide in the United States. Compared to deactivation of an ICD, physicians more often characterized deactivation of a PM in a pacemaker-dependent patient as physician-assisted suicide (19% vs 10%, P = .027) or euthanasia (9% vs 1%, P <.001). CONCLUSION: In this single-center study, internists were less comfortable discussing cessation of PM and ICD therapy compared to other life-sustaining therapies and lacked experience with this practice. Education regarding the legal and ethical parameters of device deactivation is needed.

Managing financial and nonfinancial conflicts of interest in healthcare delivery.

The issue of conflicts of interest held by physicians and other caregivers has drawn increased attention in recent years. In response, some commentators and institutions have proposed policies intended to protect patients' rights, including disclosure of relationships with for-profit companies. Conflicts of interest policies must balance the need for transparency and patient safety, but must also take into account the positive aspects of such relationships, including innovative product development. This article discusses various types of conflicts that can and do occur in healthcare delivery and potential policy options that may address these issues. The case history, device, physician, and patient described below do not represent actual people or events, but are intended to be emblematic of the challenges faced in the current medical marketplace.

Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

The quality of clinical data submitted by manufacturers to support Food and Drug Administration cardiovascular device premarket approval (PMA) applications varies widely and formal quality assessment has not been previously performed. This study evaluated all original cardiovascular device PMAs with Food and Drug Administration decisions between January 1, 2000, and December 31, 2007, to assess the quality of clinical investigations submitted by manufacturers. Effectiveness and safety end points were judged high quality if they were clearly defined and associated with a specific time point for analysis. Subject accounting was high quality if 90% or greater of the original cohort was accounted for at study conclusion. In total, 88 cardiovascular device PMAs (77.3% permanent implants), 132 clinical studies, 37,328 study subjects (age 61.0 +/- 14.5 years, 33.9% women, 86.3% white), and 29,408 device recipients were analyzed. All PMAs contained clinical data. Primary effectiveness end points, primary safety end points, and subject accounting were deemed high quality in 81.8%, 60.2%, and 77.3% of pivotal studies, respectively. Key cardiovascular comorbidities (coronary artery disease 51.1%, diabetes 36.6%, hypertension 35.2%, heart failure 37.5%, tobacco use 31.8%) and race (14.8%) were infrequently reported, and studies rarely included patients younger than 18 years of age (10.2% of studies). Poorly defined safety and effectiveness end points, poor patient accounting, and incomplete collection of important patient comorbidities make device safety and effectiveness assessments more challenging. Women, pediatric, and nonwhite populations are underrepresented in premarket cardiovascular clinical trials. Manufacturers, regulators, and the clinical community should collaborate to address these study shortcomings to ensure that patients are treated with reliable, safe, and clinically useful medical devices.

Clinically significant magnetic interference of implanted cardiac devices by portable headphones.

BACKGROUND: Little is known about the magnetic field strength of portable headphones and their potential to cause magnetic interference with implanted pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs). OBJECTIVE: The purpose of this study was to evaluate the magnetic field strength of portable headphones and to determine if they can cause clinically relevant magnetic interference. METHODS: PM or ICD function was assessed in 100 patients during exposure to eight different models of portable headphones to determine the incidence of clinically relevant magnetic interference. The magnetic field strength of the headphones also was measured in vitro. RESULTS: Clinically relevant magnetic interference from portable headphones occurred in 30 (30%) of 100 patients and more commonly affected ICD than PM patients (21/55 [38.2%] vs 9/45 [20.0%]; P = .048). All patients affected by magnetic interference experienced a magnet response, characterized by asynchronous pacing in PM patients and by inhibition of tachyarrhythmia detection in ICD patients. In all but one of the 30 cases of magnetic interference, removal of the headphones from the patient's chest immediately restored normal device function. Headphones with a measured magnetic field strength > or =10 gauss at 2 cm were much more likely to cause magnetic interference than were those with lower magnetic field strength (30/100 [30%] patients vs 0/100 [0%] patients; P <.0001). Magnetic interference was not observed when headphones were placed > or =3 cm from the skin surface. CONCLUSION: Clinically significant magnetic interference can occur when portable headphones are placed in close proximity to implanted PMs and ICDs. Patients with such a device should be advised to keep portable headphones at least 3 cm from their device.

Association of electrocardiographic morphology of exercise-induced ventricular arrhythmia with mortality.

BACKGROUND: The prognostic importance of exercise-induced ventricular arrhythmia (EIVA) may be confounded by the presence of lower-risk idiopathic right ventricular outflow tract arrhythmias with left bundle-branch block (LBBB) morphology. OBJECTIVE: To determine whether right bundle-branch block (RBBB)-morphology EIVA was associated with increased mortality. DESIGN: Retrospective cohort. SETTING: Academic medical center. PATIENTS: 585 unique patients with EIVA and 2340 patients without EIVA, matched by age, sex, and risk factor, who were referred for exercise testing in an academic medical center. MEASUREMENTS: Deaths and ischemia and infarction found on perfusion scan. RESULTS: During a mean follow-up of 24 months (SD, 13), 31 deaths occurred in the EIVA group compared with 43 deaths in the group without EIVA (5.3% vs. 1.8%; P < 0.001). Worse survival in patients with RBBB-morphology or multiple-morphology EIVA (6.9%) than in patients without EIVA caused this difference. Patients with LBBB-morphology EIVAs had a mortality rate (2.5%) similar to that of patients without EIVA (P = 0.93, log-rank test). Among patients without known atherosclerotic coronary artery disease, any RBBB-morphology EIVA was associated with death (hazard ratio, 2.73 [95% CI, 1.78 to 4.13]; P < 0.001), but LBBB-morphology EIVA was not (hazard ratio, 0.82 [CI, 0.18 to 2.04]; P = 0.72). LIMITATIONS: Not all LBBB-morphology EIVA can be dismissed, and not all RBBB-morphology EIVA is high risk. Further evaluation of patients for structural heart disease was clinically driven, not protocol-driven. CONCLUSION: Right bundle-branch block- or multiple-morphology EIVA is associated with increased mortality. Inclusion of patients with isolated LBBB-morphology EIVA, which often is idiopathic, may contribute to differences in the prognostic importance of EIVA in previous studies.