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Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.
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Monitorização Fisiológica , Telemetria , HumanosRESUMO
BACKGROUND: Leadless pacemakers (LPs) provide ventricular pacing without the risks associated with transvenous leads and device pockets. LPs are appealing for patients who need pacing, but do not need defibrillator or cardiac resynchronization therapy. Most implanted LPs provide right ventricular pacing without atrioventricular synchrony (VVIR mode). The Mode Selection Trial in Sinus Node Dysfunction (MOST) showed similar outcomes in patients randomized to dual-chamber (DDDR) versus ventricular pacing (VVIR). We compared outcomes by pacing mode in LP-eligible patients from MOST. METHODS: Patients enrolled in the MOST study with an left ventricular ejection fraction (LVEF) >35%, QRS duration (QRSd) <120 ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population). Cox proportional hazards models were used to test the association between pacing mode and death, stroke or heart failure (HF) hospitalization and atrial fibrillation (AF). RESULTS: Of the 2010 patients enrolled in MOST, 1284 patients (64%) met inclusion criteria. Baseline characteristics were well balanced across included patients randomized to DDDR (N = 630) and VVIR (N = 654). Over 4 years of follow-up, there was no association between pacing mode and death, stroke or HF hospitalization (VVIR HR 1.28 [0.92-1.75]). VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], P = .007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], P < .001). CONCLUSION: In patients without reduced LVEF or prolonged QRSd who would be eligible for LP, DDDR, and VVIR pacing demonstrated similar rates of death, stroke or HF hospitalization; however, VVIR pacing significantly increased the risk of AF development.
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Fibrilação Atrial/terapia , Estimulação Cardíaca Artificial/métodos , Marca-Passo Artificial , Síndrome do Nó Sinusal/terapia , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/fisiopatologia , Desenho de Equipamento , Feminino , Humanos , Masculino , Síndrome do Nó Sinusal/fisiopatologia , Estados UnidosRESUMO
BACKGROUND: Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) are lifesaving treatments for patients at risk for sudden cardiac death. Effective physician-patient communication during the shared decision-making process is essential. Electrophysiologist-patient conversations were targeted to obtain objective data on the interaction, understand the conversation framework, and uncover opportunities for improved communication. METHODS: Individuals previously identified as requiring an ICD/CRT-D but declined implantation were recruited for this four-stage interview and survey-based study. Quantitative analysis of surveys and AI analysis of conversation videos was conducted to evaluate patient participant expectations, analyze feedback about the conversations with study physicians, and gauge willingness for device implantation. RESULTS: The study included 27 patients (mean age 51 years, 51.9% female) and 9 study physicians. Patients were significantly more willing to undergo ICD/CRT-D implantation after conversing with study physicians compared to their own physicians and pre-conversation surveys (mean scores: 5.0, 3.1, and 4.4 out of 7, respectively; p < 0.001). Patient participants had higher satisfaction with the study conversation, rating study physicians higher in effectiveness of explanations, responsiveness to questions, and overall quality of the conversation compared to their own physicians (all p < 0.001). CONCLUSIONS: In a cohort of patients who previously declined ICD/CRT-D implantation, patient satisfaction and willingness to undergo implantation of a guideline-directed device therapy increased significantly following a structured conversation with study physicians. Identified key elements could be integrated into user-friendly tools and educational materials to facilitate these conversations, improving patient engagement with the decision-making process and enhancing informed acceptance of indicated device therapies.
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BACKGROUND: Alert-driven remote patient monitoring (RPM) or fully virtual care without routine evaluations may reduce clinic workload and promote more efficient resource allocation, principally by diminishing nonactionable patient encounters. OBJECTIVE: The purpose of this study was to conduct a cost-consequence analysis to compare 3 postimplant implantable cardioverter-defibrillator (ICD) follow-up strategies: (1) in-person evaluation (IPE) only; (2) RPM-conventional (hybrid of IPE and RPM); and (3) RPM-alert (alert-based ICD follow-up). METHODS: We constructed a decision-analytic Markov model to estimate the costs and benefits of the 3 strategies over a 2-year time horizon from the perspective of the US Medicare payer. Aggregate and patient-level data from the TRUST (Lumos-T Safely RedUceS RouTine Office Device Follow-up) randomized clinical trial informed clinical effectiveness model inputs. TRUST randomized 1339 patients 2:1 to conventional RPM or IPE alone, and found that RPM was safe and reduced the number of nonactionable encounters. Cost data were obtained from the published literature. The primary outcome was incremental cost. RESULTS: Mean cumulative follow-up costs per patient were $12,688 in the IPE group, $12,001 in the RPM-conventional group, and $11,011 in the RPM-alert group. Compared to the IPE group, both the RPM-conventional and RPM-alert groups were associated with lower incremental costs of -$687 (95% confidence interval [CI] -$2138 to +$638) and -$1,677 (95% CI -$3134 to -$304), respectively. Therefore, the RPM-alert strategy was most cost-effective, with an estimated cost-savings in 99% of simulations. CONCLUSIONS: Alert-driven RPM was economically attractive and, if patient outcomes and safety are comparable to those of conventional RPM, may be the preferred strategy for ICD follow-up.
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Desfibriladores Implantáveis , Insuficiência Cardíaca , Idoso , Estados Unidos , Humanos , Medicare , Monitorização Fisiológica , Análise Custo-BenefícioRESUMO
Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.
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Desfibriladores Implantáveis , Tecnologia de Sensoriamento Remoto , HumanosRESUMO
Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.
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Despite advances in syncope evaluation strategies and risk stratification, the high cost of syncope is largely driven by extensive and often repetitive testing. This analysis of a large deidentified US claims database compared the use of diagnostic tests, therapeutic procedures, and the recurrence rate of acute syncope events before and after placement of an insertable cardiac monitor (ICM) in syncope patients. The patients had a minimum of 1 year of continuous enrollment before and 2 years after ICM placement. Among 2140 patients identified, a statistically significant reduction in the use of 14 out of 18 tests was observed during follow-up compared with pre-ICM testing. During the 2-year follow-up, 28.3% of patients underwent cardiac therapeutic interventions after a median of 127 days. Significantly fewer patients experienced acute syncope events during the 1st and 2nd years of ICM follow-up compared with the 1-year pre-ICM period, and the frequency of events per patient also decreased. In conclusion, reductions in diagnostic testing and acute syncope events were observed after ICM placement in a large real-world cohort of unexplained syncope patients. Further studies are needed to prospectively assess the impact of ICM vs. short-term monitoring on patient outcomes and healthcare utilization.
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Importance: The proportion of women and underrepresented racial and ethnic groups (UREGs) matriculating into general cardiology fellowships remains low. Objective: To assess a systematic recruitment initiative aimed at ensuring adequate matriculation of women and UREGs in a general cardiology fellowship. Design, Setting, and Participants: This quality improvement study took place at a large, tertiary academic medical center and associated Accreditation Council for Graduate Medical Education Cardiovascular Disease fellowship. Participants included cardiology fellowship and divisional leadership and general cardiology fellow applicants to the Duke Cardiovascular Disease Fellowship Program from 2017 to 2019. Data analysis was performed from December 2019 to May 2020. Exposure: Multipronged initiative that created an environment committed to ensuring equity of opportunity. This included the creation of a fellowship diversity and inclusivity task force that drafted recommendations, which included reorganization of the fellowship recruitment committee, and changes to the applicant screening process, the interview day, applicant ranking process, and postmatch interventions. Main Outcomes and Measures: The percentage of matriculating and overall women and UREGs before and after the interventions were recorded. Results: The fellowship received a mean (SD) of 462 (55) applications annually before the interventions (2006-2016) and 611 (27) applications annually after the interventions (2017-2019). Between the 10-year period before the interventions and the 3-year period during the interventions, there was a significant increase in the annual mean (SD) percentage of women (22.4% [2.9%] vs 26.4% [0.07%]; P < .001) and UREG applicants (10.5% [1.1%] vs 12.5% [1.9%]; P = .01) to the program. Among applicants interviewed, the percentage of women increased from 20.0% to 33.5% (P = .01) and that of and UREGs increased from 14.0% to 20.0% (P = .01). Before the interventions, a mean (SD) of 23.2% (16.2%) women and 9.7% (7.8%) UREGs matriculated as first-year fellows, whereas after the interventions, a mean (SD) of 54.2% (7.2%) women and 33.3% (19.0%) UREGs matriculated as first-year fellows. The proportion of the entire fellowship who were women increased from a 5-year mean (SD) of 27.0% (8.8%) to 54.2% (7.2%) after 3 years of interventions, and that of UREGs increased from 5.6% (4.6%) to 33.3% (19.0%). Overall, the proportion of applicants in the entire population who were either women or from UREGs increased from 27.8% to 66.7%. Conclusions and Relevance: After implementing interventions to promote equity of opportunity in the cardiovascular disease fellowship, the percentage of women and UREGs significantly increased in the fellowship over a 3-year time period. These interventions may be applicable to other cardiovascular disease fellowships seeking to diversify training programs.
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Cardiologia , Etnicidade/estatística & dados numéricos , Bolsas de Estudo , Grupos Raciais/estatística & dados numéricos , Cardiologia/educação , Cardiologia/organização & administração , Diversidade Cultural , Bolsas de Estudo/organização & administração , Bolsas de Estudo/estatística & dados numéricos , Feminino , Humanos , Masculino , Grupos Minoritários/estatística & dados numéricos , North Carolina , Universidades , MulheresRESUMO
PURPOSE: Cardiac resynchronization therapy (CRT) improves outcomes in patients with heart failure, yet response rates are variable. We sought to determine whether physician-specified CRT programming was associated with improved outcomes. METHODS: Using data from the ALTITUDE remote follow-up cohort, we examined sensed atrioventricular (AV) and ventricular-to-ventricular (VV) programming and their associated outcomes in patients with de novo CRT from 2009-2010. Outcomes included arrhythmia burden, left ventricular (LV) pacing, and all-cause mortality at 4 years. RESULTS: We identified 5709 patients with de novo CRT devices; at the time of implant, 34% (n = 1959) had entirely nominal settings programmed, 40% (n = 2294) had only AV timing adjusted, 11% (n = 604) had only VV timing adjusted, and 15% (n = 852) had both AV and VV adjusted from nominal programming. Suboptimal LV pacing (<95%) during follow-up was similar across groups; however, the proportion with atrial fibrillation (AF) burden >5% was lowest in the AV-only adjusted group (17.9%) and highest in the nominal (27.7%) and VV-only adjusted (28.3%) groups. Adjusted all-cause mortality was significantly higher among patients with non-nominal AV delay >120 vs. <120 ms (adjusted heart rate (HR) 1.28, p = 0.008) but similar when using the 180-ms cutoff (adjusted HR 1.13 for >180 vs. ≤180 ms, p = 0.4). CONCLUSIONS: Nominal settings for de novo CRT implants are frequently altered, most commonly the AV delay. There is wide variability in reprogramming. Patients with nominal or AV-only adjustments appear to have favorable pacing and arrhythmia outcomes. Sensed AV delays less than 120 ms are associated with improved survival.