Sex-based outcomes of subcutaneous implantable cardioverter-defibrillator and impact of surgical technique.

BACKGROUND: Because of differences in chest wall anatomy, female patients may have higher rates of subcutaneous implantable cardioverter-defibrillator (S-ICD) pocket-related complications. OBJECTIVE: We sought to evaluate sex-based outcomes after S-ICD implantation. METHODS: Patients implanted with an S-ICD at Emory Healthcare between 2010 and 2023 were included in the analysis. Patients' clinical characteristics and post-S-ICD implantation complications were collected. RESULTS: There were 429 male patients (68%) and 199 female patients (32%) observed for a median duration of 2.3 years (0.6-4.4 years). Male and female patients had comparable rates of diabetes (28%), end-stage renal disease (29.5%), ejection fraction (30.2% ± 13.4%), and body mass index (29.1 ± 6.6 kg/m2). There was no statistical difference in the incidence of shocks between men and women (26.3% vs 20.1%; P = .09), including appropriate shocks (14.7% vs 12%; P = .98) and inappropriate shocks (11.7% vs 9.5%; P = .98). Pocket-related complications occurred in 21 patients; these included pocket infection (n = 12), wound dehiscence (n = 7), and hematoma requiring drainage (n = 2). Female patients had a significantly higher pocket-related complication rate compared with male patients (7.2% vs 2.5%; P = .016). In controlling for age, body mass index, diabetes, and end-stage renal disease, female patients had higher odds of pocket-related complications compared with male patients (odds ratio, 3.15; 95% confidence interval, 1.27-7.75). Pocket-related complications decreased after 2018 compared with before 2018 (6% vs 2.6%, P = .052), mainly driven by reduction in complications in women (12.3% vs 3.2%; P = .034) but not in men (2.8% vs 2.4%; P = 1). CONCLUSION: In this cohort of S-ICD patients, women had a higher rate of post-S-ICD pocket-related complications that could be explained by sex-based differences in anatomy.

Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF): A Trial Providing Out-of-Pocket Costs for Heart Failure Medications during Clinical Encounters.

BACKGROUND: Evidence-based medical therapy for heart failure with reduced ejection fraction (HFrEF) often entails substantial out-of-pocket costs that can vary appreciably between patients. This has raised concerns regarding financial toxicity, equity, and adherence to medical therapy. In spite of these concerns, cost discussions in the HFrEF population appear to be rare, partly because out-of-pocket costs are generally unavailable during clinical encounters. In this trial, out-of-pocket cost information is given to patients and clinicians during outpatient encounters with the aim to assess the impact of providing this information on medication discussions and decisions. HYPOTHESIS: Cost-informed decision-making will be facilitated by providing access to patient-specific out-of-pocket cost estimates at the time of clinical encounter. DESIGN: Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF) is a multicenter trial based at Emory Healthcare and University of Colorado Health. Adapting an existing patient activation tool from the EPIC-HF trial, patients and clinicians are presented a checklist with medications approved for treatment of HFrEF with or without patient-specific out-of-pocket costs (obtained from a financial navigation firm). Clinical encounters are audio-recorded, and patients are surveyed about their experience. The trial utilizes a stepped-wedge cluster randomized design, allowing for each site to enroll control and intervention group patients while minimizing contamination of the control arm. DISCUSSION: This trial will elucidate the potential impact of robust cost disclosure efforts and key information regarding patient and clinician perspectives related to cost and cost communication. It also will reveal important challenges associated with providing out-of-pocket costs for medications during clinical encounters. Acquiring medication costs for this trial requires an involved process and outsourcing of work. In addition, costs may change throughout the year, raising questions regarding what specific information is most valuable. These data will represent an important step towards understanding the role of integrating cost discussions into heart failure care. GOV IDENTIFIER: NCT04793880.

Patients' Perspectives Regarding Generator Exchanges of Implantable Cardioverter Defibrillators.

BACKGROUND: Shared decision-making is mandated for patients receiving primary prevention implantable cardioverter defibrillators (ICDs). Less attention has been paid to generator exchange decisions, although at the time of generator exchange, patients' risk of sudden cardiac death, risk of procedural complications, quality of life, or prognosis may have changed. This study was designed to explore how patients make ICD generator exchange decisions. METHODS: Emory Healthcare patients with primary prevention ICDs implanted from 2013 to 2021 were recruited to complete in-depth interviews exploring perspectives regarding generator exchanges. Interviews were conducted in 2021. Transcribed interviews were qualitatively coded using multilevel template analytic methods. To investigate benefit thresholds for pursuing generator exchanges, patients were presented standard-gamble type hypothetical scenarios where their ICD battery was depleted but their 5-year risk of sudden cardiac death at that time varied (10%, 5%, and 1%). RESULTS: Fifty patients were interviewed; 18 had a prior generator exchange, 16 had received ICD therapy, and 17 had improved left ventricular ejection fraction. As sudden cardiac death risk decreased from 10% to 5% to 1%, the number of participants willing to undergo a generator exchange decreased from 48 to 42 to 33, respectively. Responses suggest that doctor's recommendations are likely to substantially impact patients' decision-making. Other drivers of decision-making included past experiences with ICD therapy and device implantation, as well as risk aversion. Therapeutic inertia and misconceptions about ICD therapy were common and represent substantive barriers to effective shared decision-making in this context. CONCLUSIONS: Strong defaults may exist to continue therapy and exchange ICD generators. Updated risk stratification may facilitate shared decision-making and reduce generator exchanges in very low-risk patients, especially if these interventions are directed toward clinicians. Interventions targeting phenomena such as therapeutic inertia may be more impactful and warrant exploration in randomized trials.

Deciding Whether to Take Sacubitril/Valsartan: How Cardiologists and Patients Discuss Out-of-Pocket Costs.

Background Out-of-pocket costs have significant implications for patients with heart failure and should ideally be incorporated into shared decision-making for clinical care. High out-of-pocket cost is one potential reason for the slow uptake of newer guideline-directed medical therapies for heart failure with reduced ejection fraction. This study aims to characterize patient-cardiologist discussions involving out-of-pocket costs associated with sacubitril/valsartan during the early postapproval period. Methods and Results We conducted content analysis on 222 deidentified transcripts of audio-recorded outpatient encounters taking place between 2015 and 2018 in which cardiologists (n=16) and their patients discussed whether to initiate, continue, or discontinue sacubitril/valsartan. In the 222 included encounters, 100 (45%) contained discussions about cost. Cost was discussed in a variety of contexts: when sacubitril/valsartan was initiated, not initiated, continued, and discontinued. Of the 97 cost conversations analyzed, the majority involved isolated discussions about insurance coverage (64/97 encounters; 66%) and few addressed specific out-of-pocket costs or affordability (28/97 encounters; 29%). Discussion of free samples of sacubitril/valsartan was common (52/97 encounters; 54%), often with no discussion of a longer-term plan for addressing cost. Conclusions Although cost conversations were somewhat common in patient-cardiologist encounters in which sacubitril/valsartan was discussed, these conversations were generally superficial, rarely addressing affordability or cost-value judgments. Cardiologists frequently provided patients with a course of free sacubitril/valsartan samples without a plan to address the cost after the samples ran out.

Impact of Financial Considerations on Willingness to Take Sacubitril/Valsartan for Heart Failure.

Background Sacubitril/valsartan improves health outcomes for heart failure with reduced ejection fraction relative to angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, but it carries higher out-of-pocket costs. Neither the impact of cost nor how to integrate cost into medical decisions is well studied. Methods and Results To evaluate the impact of out-of-pocket costs and a novel cost-priming intervention on willingness to take sacubitril/valsartan for heart failure with reduced ejection fraction, participants with self-reported heart disease were surveyed using the online Ipsos Knowledge Panel. Participants were presented with a modified decision aid for sacubitril/valsartan and then, in a 3×2 factorial design, randomly assigned to 1 of 3 cost conditions ($10, $50, or $100/month) and to a control group or cost-priming intervention, defined by being asked questions about their financial situation before learning about the benefits of sacubitril/valsartan. Of the 1013 participants included in the analysis, 85% of respondents were willing to take sacubitril/valsartan at $10, 62% at $50, and 33% at $100 (P<0.0001). In a multivariable logistic regression model, participants were more likely to take sacubitril/valsartan at $10 versus $100 (odds ratio [OR], 14.3 [95% CI, 9.4-21.8]) and $50 compared with $100 (OR, 3.6 [95% CI, 2.5-5.1]). Overall, participants in the cost-primed group were more willing to take sacubitril/valsartan than those not primed to consider their financial situation (63% versus 56%, P=0.04). There was no statistically significant interaction between cost conditions and cost priming. Perceived benefit of sacubitril/valsartan over angiotensin-converting enzyme inhibitors or angiotensin receptor blockers decreased as cost increased but did not vary by cost priming. Conclusions Commonly encountered out-of-pocket costs of sacubitril/valsartan may impact individuals' willingness to take the medication even when recommended by their physicians. Priming individuals to consider personal finances before learning about the drug increased willingness to take sacubitril/valsartan.

Digging Deeper: Understanding Trajectories and Experiences of Shared Decision-Making for Primary Prevention ICD Implantation.

BACKGROUND: Shared decision-making using a decision aid is required for patients undergoing implantation of primary prevention implantable cardioverter-defibrillators (ICD). It is unknown how much this process has impacted patients' experiences or choices. Effective shared decision-making requires an understanding of how patients make ICD decisions. A qualitative key informant study was chosen to capture the breadth of patients' experiences making ICD decisions in the context of required shared decision-making. METHODS AND RESULTS: We conducted in-depth interviews with 20 patients referred to electrophysiology clinics for the consideration of primary prevention ICD implantation. Purposeful sampling from a prior survey study evaluating mandated shared decision-making was based on patient characteristics and responses to the initial survey questions. Qualitative descriptive analysis of the interviews was performed using a multilevel coding strategy. Patients' paths to an ICD decision often involved multiple visits with multiple clinicians. However, the decision aid was almost exclusively provided to the patient during electrophysiology clinic visits. Some patients used the numeric data in the decision aid to make an ICD decision based on the risk-benefit profile; others made decisions based on other data or based on trust in clinicians' recommendations. Patients highlighted information related to living with the device as particularly important in helping them to make their ICD decisions. Some patients struggled with the emotional aspects of making an ICD decision. CONCLUSIONS: Patients' ICD decision-making paths poses a challenge to episodic shared decision-making and may make tools such as decision aids perfunctory if used solely during the electrophysiology visit. Understanding patients' ICD decision-making paths, especially in the context of encounters with primary cardiologists, can inform the implementation strategies of shared decision-making help to enhance its impact. Components of decision aids focusing on the experience of living with an ICD rather than probabilistic data may also be more impactful, although the nature of their impact will differ.

The impact of government-mandated shared decision-making for implantable defibrillators: A natural experiment.

BACKGROUND: In 2018, the Centers for Medicare and Medicaid Services (CMS) mandated that patients considering implantation of an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death undergo shared decision-making (SDM) using a decision-aid. OBJECTIVE: To observe the impact of the CMS's mandate on core measures of SDM using a natural experiment. RESEARCH DESIGN, SUBJECTS, AND MEASURES: Patients who underwent implantation of a primary prevention ICD within the Emory Healthcare system between 2017-2019 (pre and post SDM mandate) were surveyed. Survey domains included knowledge about the ICD, decisional conflict, values-choice concordance, and engagement in decision-making. Patients who had an ICD implant after the mandate were also asked about their views of the decision aid (DA). Responses of patients who had ICD implanted prior to the mandate were compared to those after the mandate using either Student t test or Chi-Squared tests. RESULTS: Of 101 patients who completed the survey, 45 had an ICD placed before the mandate and 56 had an ICD placed after. There were no major differences between knowledge, decisional conflict, values choice concordance, or patient engagement. Compared to patients with ICDs placed before the mandate, patients with ICDs after the mandate were more likely to subjectively feel more informed about the benefits of the procedure but were less likely to be able to correctly identify the frequency of complications. CONCLUSIONS: Policy effects to promote SDM that solely focus on a decision-aid may not substantively impact patient centered care.

Framing Benefits in Decision Aids: Effects of Varying Contextualizing Statements on Decisions About Sacubitril-Valsartan for Heart Failure.

Background. Presenting numeric data alone may result in patients underappreciating clinically significant benefits. Contextualizing statements to counter this may raise concern about absence of neutrality. These issues arose during construction of a decision aid for sacubitril-valsartan, a heart failure medication associated with a ∼3% absolute reduction in 2-year mortality that carries high out-of-pocket cost. A contextualizing statement framing this as a "pretty big benefit" was incorporated. The impact of statements like this within decision aids is unknown. Objective. This online Qualtrics survey sought to deepen understanding of benefit framing by testing the impact of varying contextualizing statements within a decision aid for sacubitril-valsartan. Design. Participants were randomly assigned to receive one of six abbreviated versions of a decision aid for sacubitril-valsartan that varied only by contextualizing statement (ranging from strongly neutral to strongly positive and using relative and absolute risk reductions). Participants were asked to answer questions regarding the likelihood of taking the medication at a cost of $50/month and their perception of the drug's benefits. Results. A total of 1873 participants who were demographically similar to the heart failure population completed the survey. Fifty-four percent were willing to take sacubitril-valsartan at $50/month. Each of the five experimental contextualizing statements was compared with the baseline version; no significant differences were observed in reported likelihood of taking sacubitril-valsartan. After controlling for demographics and covariates, group assignment did not predict likelihood of taking the medication. Higher income, better self-reported health status, and younger age were associated with increased likelihood of taking sacubitril-valsartan. Limitations. This study used a hypothetical scenario and evaluated one method of delivering contextualizing statements. Conclusions. Contextualizing statements as tested within this decision aid did not affect decision making.

Premature atherosclerotic peripheral artery disease: An underrecognized and undertreated disorder with a rising global prevalence.

Premature atherosclerotic peripheral artery disease (PAD) of the lower extremities is characterized by disease diagnosis before the age of 50 years. The global prevalence of premature PAD has increased, and the disease is often underdiagnosed given heterogenous patient symptoms. Traditional cardiovascular risk factors like smoking, diabetes, hypertension, and hyperlipidemia as well as non-traditional risk factors like elevated lipoprotein(a), family history of PAD, hypercoagulability, and systemic inflammation are associated with premature PAD. Patients with premature PAD tend to have an aggressive vascular disease process, a high burden of cardiovascular risk factors, and other concomitant atherosclerotic vascular diseases like coronary artery disease. Prevention of cardiovascular events, improvement of symptoms and functional status, and prevention of adverse limb events are the main goals of patient management. In this review, we discuss the epidemiology, risk factors, clinical evaluation, and management of patients with premature PAD.

Shared Decision-Making for Implantable Cardioverter-Defibrillators: Policy Goals, Metrics, and Challenges.

Shared decision-making has become a new focus of health policy. Though its core elements are largely agreed upon, there is little consensus regarding which outcomes to prioritize for policy-mandated shared decision-making.

Heart Failure and Shared Decision-Making: Patients Open to Medication-Related Cost Discussions.

BACKGROUND: Discussions of medication costs between patients and clinicians are infrequent and often suboptimal. In the context of recently introduced drugs that are effective but expensive, patients with heart failure with reduced ejection fraction provide an ideal population to understand the perspectives of patients with chronic illness on medication cost and cost discussions. METHODS: To explore patients' perspectives on discussing out-of-pocket medication costs with clinicians, 49 adults, aged 44 to 70 years, with heart failure with reduced ejection fraction were recruited from outpatient heart failure clinics. Descriptive qualitative analysis was performed on open-ended text data. RESULTS: Participants who had prior medication-related cost discussions described their experience as generally positive, but about half of the participants had never had a cost discussion with their clinician. Most participants were open to cost discussions with clinicians and preferred that the clinician initiate discussions regarding medication cost. Importantly, these preferences held constant across reported levels of financial burden. CONCLUSIONS: These data suggest a substantial willingness on the part of patients with heart failure with reduced ejection fraction to incorporate cost discussions into their care and identify important aspects of these discussions for clinicians to consider when engaging in conversations where cost is relevant. Improving understanding about how to integrate patient preferences regarding cost discussions into clinical encounters is an important priority for advancing patient-centered care.

The Safety and Feasibility of Same-Day Discharge After Implantation of MICRA Transcatheter Leadless Pacemaker System.

BACKGROUND: Data suggests that same day discharge after implantation of trans-venous pacemakers is safe and feasible. We sought to determine whether same day discharge was feasible and safe following implantation of Medtronic MICRA leadless pacemakers. METHODS: We retrospectively identified all patients undergoing MICRA placement at our institution between April 2014 to August 2018 (n=167). Patients were stratified into two groups: those discharged on the same day as their procedure (SD, n=25), and those observed for at least one night in the hospital (HD, n=142). The primary endpoint included a composite of major complications including: access site complications, new pericardial effusion, device dislodgement, and need for device revision up to approximately 45 days of follow up. RESULTS: SD and HD had similar age (75±13 vs. 75±13 years, p=0.923), prevalence of male sex (49 vs. 44%, p=0.669), and frequency of high-grade heart block as an indication for pacing (38 vs. 32%, p=0.596). There were more Caucasians in the SD group (72 vs. 66%, p=0.038). The rate of the composite endpoint was statistically non-significantly higher in the HD group (3.5% vs. 0.0%, p=1.00). The rates of each individual components comprising the composite endpoint were similar between groups. CONCLUSIONS: Our data suggest that in appropriately selected patients, same day discharge can occur safely following Micra leadless pacemaker implantation.

Development of a Risk Score to Predict New Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to define risk factors and develop a predictive risk score for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR has become an accepted treatment alternative for patients with severe aortic stenosis at elevated surgical risk. New PMI is a common occurrence after TAVR and is associated with poorer outcomes. METHODS: All patients without prior valve procedures undergoing elective TAVR with the Edwards SAPIEN 3 at a single institution (n = 1,266) were evaluated. Multivariate analysis was performed to evaluate for predictors of PMI in this population in a derivation cohort of patients with complete data (n = 778), and this model was used to develop the Emory risk score (ERS), which was tested in a validation cohort (n = 367). RESULTS: Fifty-seven patients (7.3%) in the derivation cohort required PMI. In a regression model, history of syncope (odds ratio [OR]: 2.5; p = 0.026), baseline right bundle branch block (OR: 4.3; p < 0.001), QRS duration ≥138 ms (OR: 2.5; p = 0.017), and valve oversizing >15.6% (OR: 1.9; p = 0.041) remained independent predictors of PMI and were included in the ERS. The ERS was strongly associated with PMI (per point increase OR: 2.2; p < 0.001) with an area under the receiver-operating characteristic curve of 0.778 (p < 0.001), which was similar to its performance in the derivation cohort. CONCLUSIONS: A history of syncope, right bundle branch block, longer QRS duration, and higher degree of oversizing are predictive of the need for PMI after TAVR. Additionally, the ERS for PMI was developed and validated, representing a simple bedside tool to aid in risk stratification for patients for undergoing TAVR.

Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation.

BACKGROUND: Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period. METHODS: We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow-up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off-OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion. RESULTS: OAC and Off-OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end-stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off-OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off-OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108). CONCLUSION: Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.

Long-term performance of a pacing lead family: A single-center experience.

BACKGROUND: The performance of Abbott/St. Jude Medical (Sylmar CA) Tendril pacing leads has not been well characterized. OBJECTIVE: We sought to assess the performance of Tendril leads as compared with that of different pacing leads. METHODS: We retrospectively identified patients implanted with the following leads: Tendril leads 1888 TC, 2088 TC, and 1688 TC, Medtronic (Fridely, MN) 4076 CapSureFix Novus, and Boston Scientific (Natick, MA) FINELINE II Sterox Pacing EZ leads (models 4469, 4470, and 4471). The primary end point was the incidence of lead malfunction assessed by Kaplan-Meier analysis. RESULTS: During the study period, 9782 leads were implanted, including 8512 Tendril leads, 731 Medtronic 4076 CapSureFix Novus leads, and 539 FINELINE II leads. A total of 540 leads (5.5%) malfunctioned during a mean follow-up of 3.6 ± 2.9 years. Lead malfunction manifested predominantly as noise and/or low impedance (95%). Lead malfunction rates were significantly higher at 5 years for Tendril vs non-Tendril leads (7.0% vs 2.1%; P < .001). The highest rate of failure at 5 years was seen in the Tendril 1888 TC leads (9.9%), followed by Tendril 1688 (5.7%) and Tendril 2088 (5.2%) leads. In contrast, malfunction rates were significantly lower for the Medtronic 4076 (2.6%) and FINELINE II (1.7%) leads. During follow-up to 10 years, the incidence of lead malfunction for Optim-insulated Tendril leads (models 1888 TC and 2088 TC) was significantly higher than that for the non-Optim-insulated Tendril 1688 TC lead (24.5% vs 7.1%) (P = .008). CONCLUSION: Tendril leads appear to have a higher rate of malfunction than do comparator leads. Optim insulation may partly explain the higher failure rate.

Rapidly Sequential and Fatal Hemorrhaging in a Case of Cerebral Amyloid Angiopathy.

BACKGROUND Cerebral amyloid angiopathy (CAA) is an increasingly recognized cause of lobar intracerebral hemorrhage (ICH) and cognitive impairment in the aging population. Magnetic resonance imaging (MRI) of cerebral microbleeds is the most reliable option for clinical diagnosis of suspected CAA. The pathophysiology of microbleeds and ICH in CAA is not well understood, but it is thought to be the result of vessel weakening and rupture secondary to amyloid deposition. Little evidence has been established pertaining to the time course of recurrent CAA-related microbleeds or larger hemorrhages. Although several risk factors have been associated with an increased risk of ICH in CAA, there are no current treatment guidelines for recurrent hemorrhaging in CAA. CASE REPORT We present a rare case of rapidly sequential and fatal lobar hemorrhaging in the setting of suspected CAA, diagnosed by numerous microbleeds on MRI, compounded by the use of subcutaneous heparin in a 63-year-old female patient. CONCLUSIONS This case broadens our understanding of a rarely identified progression of CAA and illustrates the need for further investigation of the use of subcutaneous heparin in the setting of probable CAA.