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AIMS: After an ischaemic stroke, atrial fibrillation (AF) detection allows for improved secondary prevention strategies. This study aimed to compare AF detection and oral anticoagulant (OAC) initiation in patients with an insertable cardiac monitor (ICM) vs. external cardiac monitor (ECM) after ischaemic stroke. METHODS AND RESULTS: Medicare Fee-for-Service (FFS) insurance claims and Abbott Labs device registration data were used to identify patients hospitalized with an ischaemic stroke in 2017-2019 who received an ICM or ECM within 3 months. Patients with continuous Medicare FFS insurance and prescription drug enrolment in the prior year were included. Patients with prior AF, atrial flutter, cardiac devices, or OAC were excluded. Insertable cardiac monitor and ECM patients were propensity score matched 1:4 on demographics, comorbidities, and stroke hospitalization characteristics. The outcomes of interest were AF detection and OAC initiation evaluated with Kaplan-Meier and Cox proportional hazard regression analyses. A total of 5702 Medicare beneficiaries (ICM, n = 444; ECM, n = 5258) met inclusion criteria. The matched cohort consisted of 2210 Medicare beneficiaries (ICM, n = 442; ECM, n = 1768) with 53% female, mean age 75 years, and mean CHA2DS2-VASc score 4.6 (1.6). Insertable cardiac monitor use was associated with a higher probability of AF detection [(hazard ratio (HR) 2.88, 95% confidence interval (CI) (2.31, 3.59)] and OAC initiation [HR 2.91, CI (2.28, 3.72)] compared to patients monitored only with ECM. CONCLUSION: Patients with an ischaemic stroke monitored with an ICM were almost three times more likely to be diagnosed with AF and to be prescribed OAC compared to patients who received ECM only.
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Fibrilación Atrial , Isquemia Encefálica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Femenino , Anciano , Estados Unidos/epidemiología , Masculino , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/epidemiología , Isquemia Encefálica/prevención & control , Medicare , Anticoagulantes/efectos adversos , PrescripcionesRESUMEN
BACKGROUND: Burden of atrial fibrillation (AF), as a continuous measure, is an emerging alternative classification often assumed to increase linearly with progression of disease. Yet there are no descriptions of AF burden distributions across populations. METHODS: We examined patterns of AF burden (% time in AF) across 3 different cohorts: outpatients with AF undergoing Holter monitoring in a national registry (ORBIT-AF II), routine outpatients undergoing Holter monitoring in a tertiary healthcare system (UHealth), and patients >= 65 years with cardiac implantable electronic devices (Merlin.netTM linked to Medicare). RESULTS: We included 2,058 ORBIT-AF II patients, 4,537 UHealth patients, and 39,710 from Merlin.net. Mean age ranged from 56 to 77 years, sex ranged from 40% to 61% male, and mean CHA2DS2-VASc scores ranged from 2.2 to 4.9. Across all cohorts, AF burden demonstrated skewed frequency towards the extremes, with the vast majority of patients having either very low or very high AF burden. This bimodal distribution was consistent across cohorts, across clinically-documented AF types (paroxysmal v persistent), patients with or without a known AF diagnosis, and among patients with different types of cardiac implantable electronic devices. CONCLUSIONS: Across 3 broad, diverse cohorts with continuous monitoring, distribution of AF burden was consistently skewed towards the extremes without an even, linear distribution or progression. As AF burden is increasingly recognized as a descriptor and potential risk-stratifier, these findings have important implications for future research and patient care.
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Fibrilación Atrial , Anciano , Fibrilación Atrial/diagnóstico , Electrocardiografía Ambulatoria , Femenino , Humanos , Masculino , Medicare , Persona de Mediana Edad , Sistema de Registros , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: As the prevalence of atrial fibrillation (AF) increases, a greater understanding of the costs associated with AF care is required. While individuals with greater arrhythmic burden may interact with the health system more frequently, the relationship between AF burden and costs remains undefined. METHODS: In a longitudinal patient cohort with paroxysmal AF and newly implanted cardiovascular implantable electronic devices (CIED) (2010-2016), we linked CIED remote-monitoring data with Medicare claims to assess the association between the 30-day averaged device-detected daily percentage of time in AF ("AF burden") and healthcare costs. RESULTS: Among 39,345 patients, the mean age was 77.1 ± 8.7 years, 60.7% were male, and the mean CHA2DS2-VASc score was 4.9 ± 1.3. The mean total 1-year costs were $18,668 ± 29,173, driven by hospitalization costs where two-thirds of admissions were due to heart failure. Increasing AF burden was associated with increasing costs: $17,860 ± 28,525 for 0% daily AF burden; $18,840 ± 29,104 for 0-5% daily AF burden; and $20,968 ± 31,228 for 5-98% daily AF burden. There was a linear relationship between AF burden expressed as a continuous variable and 1-year costs (adjusted cost rate ratio 1.031 per 10% daily duration in AF, 95% confidence interval 1.023-1.038; P < .001). CONCLUSIONS: Among older patients with paroxysmal AF and CIEDs, increasing AF burden is associated with higher healthcare costs. As the observational study design is unable to determine causal relationships, prospective study is required to explore the intriguing hypothesis that targeted AF strategies, including comorbidity management, that reduce AF burden may also reduce the high annual costs associated with AF.
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Fibrilación Atrial , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/complicaciones , Fibrilación Atrial/epidemiología , Fibrilación Atrial/terapia , Electrónica , Humanos , Masculino , Medicare , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
AIMS: The aim of this study is to quantify healthcare resource utilization among non-responders to cardiac resynchronization therapy (CRT-NR) by heart failure (HF) events and influence of comorbidities. METHODS AND RESULTS: The ADVANCE CRT registry (2013-2015) prospectively identified responders/CRT-NRs 6 months post-implant using the clinical composite score. Heart failure event rates and associated cost, both overall and separated for inpatient hospitalizations, office visits, emergency room visits, and observational stays, were quantified. Costs of events were imputed from payments for similar real-world encounters in subjects with CRT-D/P devices in the MarketScan™ commercial and Medicare Supplemental insurance claims databases. Effects of patient demographics and comorbidities on event rates and cost were evaluated. Of 879 US patients (age 69 ± 11 years, 29% female, ischaemic disease 52%), 310 (35%) were CRT-NR. Among CRT-NRs vs. responders, more patients developed HF (41% vs. 11%, P < 0.001), HF event rate was higher (67.0 ± 21.7 vs. 11.4 ± 3.7/100 pt-year, P < 0.001), and HF readmission within 30 days was more common [hazard ratio 7.06, 95% confidence interval (2.1-43.7)]. Inpatient hospitalization was the most common and most expensive event type in CRT-NR. Comorbid HF was increased by diabetes, hypertension, and pulmonary disorders. Over 2 years, compared to CRT responders, each CRT-NR resulted in excess cost of $6388 ($3859-$10 483) to Medicare (P = 0.015) or $10 197 ($6161-$17 394) to private insurances (P = 0.014). CONCLUSION: Healthcare expenditures associated with contemporary CRT non-response management are among the highest for any HF patient group. This illustrates an unmet need for interventions to improve HF outcomes and reduce costs among some CRT recipients.
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Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Insuficiencia Cardíaca , Anciano , Anciano de 80 o más Años , Dispositivos de Terapia de Resincronización Cardíaca , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Medicare , Persona de Mediana Edad , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Glycemic control is suboptimal in many individuals with type 2 diabetes. Although use of flash continuous glucose monitoring (CGM) has demonstrated A1C reductions in patients with type 2 diabetes treated with a multiple daily injection or insulin pump therapy regimen, the glycemic benefit of this technology in patients with type 2 diabetes using nonintensive treatment regimens has not been well studied. METHODS: This retrospective, observational study used the IBM Explorys database to assess changes in A1C after flash CGM prescription in a large population with suboptimally controlled type 2 diabetes treated with nonintensive therapy. Inclusion criteria were diagnosis of type 2 diabetes, age <65 years, treatment with basal insulin or noninsulin therapy, naive to any CGM, baseline A1C ≥8%, and a prescription for the FreeStyle Libre flash CGM system during the period between October 2017 and February 2020. Patients served as their own control subject. RESULTS: A total of 1,034 adults with type 2 diabetes (mean age 51.6 ± 9.2 years, 50.9% male, baseline A1C 10.1 ± 1.7%) were assessed. More patients received noninsulin treatments (n = 728) than basal insulin therapy (n = 306). We observed a significant reduction in A1C within the full cohort: from 10.1 ± 1.7 to 8.6 ± 1.8%; Δ -1.5 ± 2.2% (P <0.001). The largest reductions were seen in patients with a baseline A1C ≥12.0% (n = 181, A1C reduction -3.7%, P <0.001). Significant reductions were seen in both treatment groups (basal insulin -1.1%, noninsulin -1.6%, both P <0.001). CONCLUSION: Prescription of the flash CGM system was associated with significant reductions in A1C in patients with type 2 diabetes treated with basal insulin or noninsulin therapy. These findings provide evidence for expanding access to flash CGM within the broader population of people with type 2 diabetes.
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INTRODUCTION: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs. METHODS: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates. RESULTS: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (101 ± 50 vs 698 ± 195, P < .001) and 2 years (366 ± 149 vs 801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01). CONCLUSIONS: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up.
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Terapia de Resincronización Cardíaca/economía , Costos de la Atención en Salud , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/terapia , Anciano , Anciano de 80 o más Años , Terapia de Resincronización Cardíaca/efectos adversos , Ahorro de Costo , Análisis Costo-Beneficio , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Costos de Hospital , Hospitalización/economía , Humanos , Italia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Recuperación de la Función , Sistema de Registros , Volumen Sistólico , Factores de Tiempo , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
AIMS: Atrial fibrillation (AF) is associated with increased mortality, but the temporal relationship between AF burden (AFB) and death among patients with cardiac implanted electronic devices is unknown. We sought to characterize the timing and progression of AFB before death. METHODS AND RESULTS: Using Merlin.netTM remote monitoring (RM) data, we analysed weekly AFB in patients age ≥55 years implanted with dual-chamber pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices whose death was verified in the Social Security Death Index and who had continuous RM from 1 year to 4 weeks preceding death. Atrial fibrillation burden was defined as amount of time per week atrial rate exceeded a set threshold of 180 b.p.m. Case-crossover analysis was used to compare the AFB at every week to 6 control weeks at the start of the year before death. There were 3131 patients meeting analysis criteria (age at death 76 ± 8 years, 70% men). Weekly increase in AFB >6 h was associated with increased odds of death, which was greatest at 4 weeks before death [odds ratio (OR) 2.30, 95% confidence interval (CI) 2.09-2.53; P < 0.001]. Atrial fibrillation progression week-to-week >24 h was associated with the greatest odds of death (OR 12.95, 95% 8.72-19.22; P < 0.001). A combination of AFB >6 h per week and activity <0.5 h per day was associated with an increased odds of death. CONCLUSION: In this large patient cohort, AFB progression accelerated in the weeks leading to death. Continuous monitoring of AFB may help identify device patients who may be at risk for adverse outcomes, including death.
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Fibrilación Atrial/diagnóstico , Fibrilación Atrial/mortalidad , Desfibriladores Implantables , Marcapaso Artificial , Tecnología de Sensores Remotos/instrumentación , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/terapia , Dispositivos de Terapia de Resincronización Cardíaca , Progresión de la Enfermedad , Femenino , Humanos , Masculino , Valor Predictivo de las Pruebas , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de TiempoRESUMEN
AIMS: In times of evolving cardiac resynchronization therapy, intra-procedural characterization of left ventricular (LV) mechanical activation patterns is desired but technically challenging with currently available technologies. In patients with normal systolic function, we evaluated the feasibility of characterizing LV wall motion using a novel sensor-based, real-time tracking technology. METHODS AND RESULTS: Ten patients underwent simultaneous motion and electrical mapping of the LV endocardium during sinus rhythm using electroanatomical mapping and navigational systems (EnSite™ NavX™ and MediGuide™, SJM). Epicardial motion data were also collected simultaneously at corresponding locations from accessible coronary sinus branches. Displacements at each mapping point and times of electrical and mechanical activation were combined over each of the six standard LV wall segments. Mechanical activation timing was compared with that from electrical activation and preoperative 2D speckle tracking echocardiography (echo). MediGuide-based displacement data were further analysed to estimate LV chamber volumes that were compared with echo and magnetic resonance imaging (MRI). The lateral and septal walls exhibited the largest (12.5 [11.6-15.0] mm) and smallest (10.2 [9.0-11.3] mm) displacement, respectively. Radial displacement was significantly larger endocardially than epicardially (endo: 6.7 [5.0-9.1] mm; epi: 3.8 [2.4-5.6] mm), while longitudinal displacement was significantly larger epicardially (endo: 8.0 [5.0-10.6] mm; epi: 10.3 [7.4-13.8] mm). Most often, the anteroseptal/anterior and lateral walls showed the earliest and latest mechanical activations, respectively. 9/10 patients had concordant or adjacent wall segments of latest mechanical and electrical activation, and 6/10 patients had concordant or adjacent wall segments of latest mechanical activation as measured by MediGuide and echo. MediGuide's LV chamber volumes were significantly correlated with MRI (R2= 0.73, P < 0.01) and echo (R2= 0.75, P < 0.001). CONCLUSION: The feasibility of mapping-guided intra-procedural characterization of LV wall motion was established. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov; Unique identifier: CT01629160.
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Potenciales de Acción , Fenómenos Electromagnéticos , Monitoreo Ambulatorio/instrumentación , Telemetría/instrumentación , Transductores , Función Ventricular Izquierda , Anciano , Ecocardiografía , Técnicas Electrofisiológicas Cardíacas , Diseño de Equipo , Estudios de Factibilidad , Femenino , Frecuencia Cardíaca , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Monitoreo Ambulatorio/métodos , Proyectos Piloto , Valor Predictivo de las Pruebas , Estudios Prospectivos , Volumen Sistólico , Sístole , Telemetría/métodos , Factores de TiempoRESUMEN
BACKGROUND: Shock therapy delivery by implantable cardioverter-defibrillators (ICD) can be painful and may have adverse consequences. Reducing shock burden for patients with ICDs would be beneficial. METHODS: PROVIDE was a prospective, randomized study of primary prevention ICD patients. Patients in the experimental group received a combination of programmed parameters with higher detection rates, longer detection intervals, empiric antitachycardia pacing (ATP), and optimized supraventricular tachycardia (SVT) discriminators, while those in the control group were programmed with conventional parameters. Shock therapy and arrhythmic syncope were compared. RESULTS: Of 1,670 patients enrolled (846 in the experimental group, 824 in the control group) and monitored over a follow-up of 530 ± 241 days, 202 patients received shock therapy for any cause (82 in the experimental group and 120 in the control group). The median time to first shock was significantly prolonged (13.1 vs 7.8 months, hazard ratio [HR]: 0.62, 95% confidence interval [CI]: 0.47 to 0.82, P = 0.0005) and the 2-year shock rate significantly reduced (12.4% vs 19.4%, P < 0.001) in the experimental group compared to the control group. There was no increase in arrhythmic syncope (HR: 1.64, 95% CI: 0.69 to 3.90, P = 0.26), while the overall mortality was reduced (HR: 0.7, 95% CI: 0.50 to 0.98, P = 0.036) in the experimental group compared to the control group. CONCLUSION: A combination of programmed parameters utilizing higher detection rate, longer detection intervals, empiric ATP, and optimized SVT discriminators reduced ICD therapies without increasing arrhythmic syncope and was associated with reduction in all-cause mortality among ICD patients.
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Arritmias Cardíacas/prevención & control , Desfibriladores Implantables , Cardioversión Eléctrica/métodos , Prevención Primaria/métodos , Anciano , Arritmias Cardíacas/mortalidad , Arritmias Cardíacas/fisiopatología , Cardioversión Eléctrica/instrumentación , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Prevención Primaria/instrumentación , Estudios Prospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: Both glucagon-like peptide-1 receptor agonists (GLP-1 RA) and continuous glucose monitoring (CGM) improve glycemia in patients with type 2 diabetes (T2D). However, it is unknown whether adding CGM to GLP-1 RA therapy further improves A1c. We evaluated changes in A1c levels 6 months after initiation of FreeStyle Libre (FSL) in adults with sub-optimally controlled T2D already on GLP-1 RA therapy. METHODS: This retrospective, observational study used Optum's de-identified Market Clarity Data, a linked electronic health record-claims database to assess changes in A1c after FSL acquisition. Inclusion criteria were T2D diagnosis, ≥ 18 years, baseline A1c ≥ 8%, with the first FSL acquisition between 2018 and 2022. Patients were required to be on GLP-1 RA prior to FSL with at least one GLP-1 RA prescription within 90 days of FSL acquisition. GLP-1 RA initiation was defined as the earliest GLP-1 RA prescription from 2017 onwards. Paired changes in A1c were assessed at 6 months after initial FSL acquisition. RESULTS: The study cohort included 1454 adults with T2D (age 55 ± 10 years, 52% male, 38% with intensive insulin therapy, median 471 days from GLP-1 RA initiation to FSL, and baseline A1c 9.8 ± 1.5%). After FSL acquisition, patients experienced an A1c decrease of 1.5 ± 1.9% (p < 0.001). Patients with a baseline A1c > 10% had the largest reduction (n = 497, - 2.7 ± 2.2%, p < 0.001). Significant improvements were observed in subgroups based on insulin therapy and GLP-1 RA formulation. Those initiating GLP-1 RA therapy > 24 months before FSL acquisition also showed improvements in A1c (n = 478; - 1.3 ± 1.7%, p < 0.001). CONCLUSIONS: In a large, real-world study of adults with T2D, those on prior GLP-1 RA therapy experienced significant A1c improvements after acquiring FSL, irrespective of GLP-1 RA duration, GLP-1 RA formulation, or insulin therapy type. These findings support the use of FSL in adults with T2D treated with GLP-1 RA.
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Background and Aim: Glucagon-like peptide-1 receptor agonists (GLP-1 RA) therapy provides glycemic benefits to individuals with type 2 diabetes (T2D). However, the effects of GLP-1 RA therapy in combination with FreeStyle Libre systems (FSL) are unknown. This study aimed to compare changes in hemoglobin A1c (HbA1c) between people acquiring GLP-1 with FSL (GLP-1+FSL) versus GLP-1 without FSL (GLP-1). Methods: This real-world study used Optum's de-identified Market Clarity Data, a linked electronic health records (EHR)-claims database, and included adults with T2D and HbA1c ≥8% who acquired their first GLP-1 RA medication between 2018 and 2022. GLP-1+FSL subjects acquired their first FSL within ±30 days of their first GLP-1 acquisition. Cohorts were matched 1:5 on baseline insulin therapy, age, sex, baseline HbA1c, and GLP-1 type. Paired changes in HbA1c were compared between unmatched and matched groups at 6 months. Results: The study included 24,724 adults in the unmatched cohort (GLP-1+FSL, n = 478; GLP-1, n = 24,246). The matched cohort included 478 GLP-1+FSL users and 2,390 GLP-1 users: mean age 53.5 ± 11.8 and 53.5 ± 11.3 years, HbA1c 10.25 ± 1.68% and 10.22 ± 1.69%, respectively. HbA1c reduction was greater in the GLP-1+FSL group compared with the GLP-1 group in the unmatched cohort (-2.43% vs. -1.73%, difference 0.70%, P < 0.001, respectively) and in the matched cohort (-2.43% vs. -2.06%, difference 0.37%, P < 0.001). GLP-1+FSL vs. GLP-1 treatment was associated with greater HbA1c reduction in the intensive insulin (-2.32% vs. -1.50%), nonintensive insulin (-2.50% vs. -1.74%), and noninsulin group (-2.46% vs. -1.78%), as well as in patients using semaglutide (-2.73% vs. -1.92%) and dulaglutide (-2.45% vs. -1.71%) GLP-1 RA, all P < 0.001. Conclusions: Adults with suboptimally controlled T2D, initiating GLP-1 RA with FreeStyle Libre, had greater improvement in HbA1c compared with those treated with GLP-1 RA only. These results suggest an additional glycemic benefit of FSL when used with a GLP-1 RA in T2D treatment.
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BACKGROUND: Traditional post-approval study (PAS) designs have been accepted by regulatory authorities to fulfill postmarketing requirements for cardiac leads, but they have several limitations. OBJECTIVE: We conducted a proof-of-concept study of alternative methods that use real-world data (RWD) to evaluate lead safety in large populations of patients. METHODS: Abbott patient device databases were linked with Medicare Fee-For-Service (FFS) claims to identify lead complications in patients implanted with Abbott Optisure lead. A 1:1 comparison between the PAS method and RWD method of detecting mechanical lead-related complication events was conducted in 444 PAS participants who were enrolled in Medicare FFS. Agreement between methods was evaluated by McNemar test and Cohen κ. Survival free from complications at 3 years was compared between the PAS and RWD cohorts with an equivalence acceptance criterion of ±2.5%. RESULTS: There were 1171 PAS patients and 5804 Medicare FFS patients who received an Optisure lead between August 27, 2014, and June 14, 2016. Patients were observed through December 31, 2018. Complete agreement was found between PAS-reported and claims-detected complications (McNemar P value = 1; Cohen κ = 1). Survival free from complications at 3 years by the RWD method was 98.4% (95% confidence limit, 98.0%-98.7%), which was within the acceptable range of the PAS 98.4% (95% confidence limit, 97.6%-99.0%). CONCLUSION: These results show a close agreement between RWD-detected and PAS-reported lead complication rates, which highlights the potential benefits of RWD-based methods to enhance the generation of clinical evidence for lead safety.
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Aims: Remote monitoring (RM) is the standard of care for follow up of patients with cardiac implantable electronic devices. The aim of this study was to compare smartphone-based RM (SM-RM) using patient applications (myMerlinPulse™ app) with traditional bedside monitor RM (BM-RM). Methods and results: The retrospective study included de-identified US patients who received either SM-RM or BM-RM capable of implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators (Abbott, USA). Patients in SM-RM and BM-RM groups were propensity-score matched on age and gender, device type, implant year, and month. Compliance with RM was quantified as the proportion of patients enrolling in the RM system (Merlin.net™) and transmitting data at least once. Connectivity was measured by the median number of days between consecutive transmissions per patient. Of the initial 9714 patients with SM-RM and 26 679 patients with BM-RM, 9397 patients from each group were matched. Remote monitoring compliance was higher in SM-RM; significantly more patients with SM-RM were enrolled in RM compared with BM-RM (94.4 vs. 85.0%, P < 0.001), similar number of patients in the SM-RM group paired their device (95.1 vs. 95.0%, P = 0.77), but more SM-RM patients transmitted at least once (98.1 vs. 94.3%, P < 0.001). Connectivity was significantly higher in the SM-RM, with patients transmitting data every 1.2 (1.1, 1.7) vs. every 1.7 (1.5, 2.0) days with BM-RM (P < 0.001) and remained better over time. Significantly more SM-RM patients utilized patient-initiated transmissions compared with BM-RM (55.6 vs. 28.1%, P < 0.001). Conclusion: In this large real-world study, patients with SM-RM demonstrated improved compliance and connectivity compared with BM-RM.
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Objectives: We compared clinical outcomes after acquiring a FreeStyle Libre© Flash Continuous Glucose Monitoring System (FSL) or Dexcom (DEX) continuous glucose monitoring (CGM) device in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) treated with intensive insulin therapy. Design and Methods: This retrospective analysis of the IBM® MarketScan® Research Databases and IBM® Explorys® Electronic Health Records Database assessed differences in acute diabetes-related events (ADE), all-cause hospitalizations (ACH) and glycated hemoglobin (HbA1c) in T1D and T2D populations 6 months post CGM acquisition. Analyses were conducted in two study cohorts (Cohort 1, n = 7,494; Cohort 2, n = 678). Participants were T1D or T2D, age ≥ 18 years, treated with short or rapid-acting insulin and naïve to CGM, who acquired a CGM system. Users were propensity score matched on demographics and clinical factors. Results: Cohort 1: Post-CGM ADE-free rates at 6 months ranged from 94.8 to 96.7% and ACH-free rates ranged from 90.4 to 95.4%, for both T1D and T2D groups, with no significant differences between CGM systems. Cohort 2: Significant HbA1c reductions were associated with use of the DEX and FSL devices in the T1D (-0.35% and -0.37%, respectively) and T2D (-0.73% and -0.79%, respectively) cohorts, both p < 0.001, with no significant differences in the magnitude of reduction between systems (T1D p = 0.99 and T2D p = 0.84). Conclusions: Acquisition of the FSL and DEX systems was associated with similar rates of acute diabetes-related events and all-cause hospitalizations and similar HbA1c reductions in adults with T1D and T2D.
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Post-market evaluation is important to ensure the ongoing safety and effectiveness of cardiovascular implantable electronic device (CIED) leads. The Twenty-First Century Cures Act and subsequent Food and Drug Administrative (FDA) Guidance provide an opportunity to leverage real-world data sources for this purpose. The past 4 years have seen the development of EP PASSION: a multi-stakeholder, collaborative effort between the FDA, CIED manufacturers, Heart Rhythm Society, and academics. Using real-world data, EP PASSION enables longitudinal evaluation of the long-term safety of CIED leads, addressing limitations of current approaches to generate evidence that informs regulatory, clinical, and manufacturer decision-making. This state of the art article describes the impetus for and launch of EP PASSION, the lessons learned, its current state, the current analytic approach, and the strengths and limitations of leveraging extant data sources for post-market lead evaluation. We also compare EP PASSION to traditional post-approval studies and describe possible future directions.
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Electrofisiología Cardíaca , Desfibriladores Implantables , Humanos , Pulmón , Sistema de RegistrosRESUMEN
BACKGROUND: A subcutaneous photoplethysmography (PPG) sensor uses light to detect changes in vascular volume from a location outside the bloodstream. Incorporation into a chronically implanted device, such as a pacemaker or an implantable cardioverter defibrillator, may facilitate therapy optimization and disease monitoring by providing continuous assessment of hemodynamic function and arterial oxygen saturation. However, performance of a chronically placed subcutaneous sensor has not been established. METHODS: Six dogs were implanted with 2-4 PPG sensors subcutaneously in the neck or posterior thorax. Half of the sensors were directed toward deep tissue and half toward overlying cutaneous tissue. Each sensor contained a red and an infrared light emitting diode, a photodetector, and supporting electronics, which were encapsulated in epoxy and attached to a transcutaneous connector. Data were collected at implant and every 3 ± 1 days for 4-9 months starting 3 weeks postimplant. At explant, the fibrous encapsulation was histologically analyzed. RESULTS: A minimally to moderately neovascularized encapsulation formed over all sensors, consisting of fibrous and granulation tissue. Higher cardiac pulse amplitudes and direct current (DC) components were recorded in sensors oriented toward deep tissue, but no significant difference between orientations was found in respiratory wave amplitude. Cardiac pulse amplitude, respiratory wave amplitude, and DC component amplitude, as recorded by the sensor, did not significantly change over time. CONCLUSIONS: Despite fibrous encapsulation of PPG sensors, cardiac pulses and respiratory waves could easily be measured throughout the study and remained constant over time. These results suggest suitability of subcutaneous PPG technology for chronic applications.
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Hemodinámica , Fotopletismografía/instrumentación , Animales , Perros , Técnicas Electrofisiológicas Cardíacas , Femenino , Corazón/fisiología , Masculino , Oximetría/instrumentación , Oximetría/métodos , Fotopletismografía/métodos , Prótesis e ImplantesRESUMEN
BACKGROUND: Whether the amount of atrial fibrillation (AF) patients experience conveys important prognostic information beyond that provided by the diagnosis of AF is uncertain. The study objective was to assess the dose-response relationship between device-detected AF burden and subsequent cardiovascular outcomes. METHODS: Among patients with paroxysmal AF who underwent cardiac implantable electronic device implantation (2010-2016), Merlin.net remote-monitoring data were linked to Medicare claims to assess the magnitude and strength of the associations between device-based AF burden (defined as a daily percentage of time spent in AF or maximal AF episode duration ascertained at baseline over 30 days) and key cardiovascular outcomes. RESULTS: Among 39 710 patients (mean age 77.1±8.7 years, 60.7% male, and a mean CHA2DS2-VASc score 4.9±1.3), all-cause mortality at 1-year increased with baseline AF burden: 8.54% with AF burden 0%, 8.9% with AF burden 0% to 5%, and 10.9% with AF burden 5% to 98% (P<0.001) There was also a dose-response relationship between increasing AF burden and all-cause or cardiovascular hospitalization and ischemic stroke. Updating AF burden data every 30 days did not alter the AF burden-prognostic relationships determined from the use of baseline data alone. Results were also consistent when 3-year outcomes were considered and after accounting for the use of oral anticoagulants. CONCLUSIONS: In paroxysmal AF, there is a clinically relevant dose-response relationship between increasing AF burden and rates of adverse outcomes at 1- and 3-years, including increasing risks of cardiovascular hospitalization, ischemic stroke, and mortality.
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Fibrilación Atrial/diagnóstico , Desfibriladores Implantables , Frecuencia Cardíaca , Marcapaso Artificial , Tecnología de Sensores Remotos/instrumentación , Potenciales de Acción , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/mortalidad , Fibrilación Atrial/fisiopatología , Terapia de Resincronización Cardíaca , Bases de Datos Factuales , Progresión de la Enfermedad , Femenino , Hospitalización , Humanos , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/mortalidad , Masculino , Valor Predictivo de las Pruebas , Pronóstico , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVES: We evaluated the effects of acquiring a flash continuous glucose monitoring (CGM) system in the population with type 2 diabetes (T2D) treated with basal or noninsulin therapy. STUDY DESIGN: This was a retrospective database analysis of the IBM MarketScan Commercial Claims and Medicare Supplemental databases that assessed rates of acute diabetes-related events (ADEs) and all-cause inpatient hospitalizations (ACHs) in a large population with T2D treated with basal insulin therapy or noninsulin medications. ADE and ACH rates 6 months prior to and 6 months post CGM acquisition were compared. METHODS: Inclusion criteria for analysis were diagnosis of T2D; age 18 years or older; treatment with long-acting, neutral protamine Hagedorn, or premixed insulin or noninsulin therapy; naïve to CGM; and acquisition of their flash CGM system between October 2017 and March 2019. Patients served as their own controls. Event rates were compared using weighted Cox regression with Andersen-Gill extension for repeat events. RESULTS: A cohort of 10,282 adults with T2D (mean [SD] age, 53.1 [9.6] years; 51.9% male) who met inclusion criteria were assessed. ADE rates decreased from 0.076 to 0.052 events per patient-year (HR, 0.68; 95% CI, 0.58-0.80; P < .001). ACH rates decreased from 0.177 to 0.151 events per patient-year (HR, 0.85; 95% CI, 0.77-0.94; P = .002). CONCLUSIONS: Acquisition of the flash CGM system was associated with significant reductions in outpatient and inpatient ADEs and ACHs. These findings provide compelling evidence that use of flash CGM in patients with T2D treated with basal insulin therapy or noninsulin therapy improves clinical outcomes and potentially reduces costs.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Hipoglucemia , Adolescente , Adulto , Anciano , Glucemia , Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Femenino , Hemoglobina Glucada/análisis , Humanos , Hipoglucemiantes/uso terapéutico , Masculino , Medicare , Persona de Mediana Edad , Estudios Retrospectivos , Estados UnidosRESUMEN
BACKGROUND: Increased physical activity (PA) through cardiac rehabilitation (CR) improves outcomes in patients with heart failure and coronary disease, but CR referral remains infrequent. Implantable cardioverter-defibrillators (ICDs) can provide daily PA measurements to patients that may motivate them to increase PA, but it remains unclear if increased ICD measured PA is associated with improved outcomes with and without CR. METHODS: This is a retrospective observational study of 41 731 Medicare beneficiaries with ICD implantation between January 1, 2014 and December 31, 2016. We linked daily ICD PA measurements and Medicare claims data to determine if increased PA is associated with a reduction in the likelihood of death or heart failure hospitalization. To determine if CR participation altered the effect of PA on outcomes, we performed two additional analyses matching CR participants and nonparticipants using propensity scores. The first match included demographics, comorbidities, and baseline PA measurements. The second match also included the change in PA measured during CR or the same time frame after ICD implant among nonparticipants. RESULTS: The mean age was 75 (SD, 10) years, 30 182 beneficiaries (72.3%) were male, and 1324 (3%) participated in CR. Increased ICD detected PA was associated with improved survival. CR participants had a mean PA change of +9.7 (SD, 57.8) min/d, whereas nonparticipants had a mean change of -1.0 (SD, 59.7) min/d (P<0.001). After matching for demographics, comorbidities and baseline PA, CR participants had significantly lower 1- to 3-year mortality (hazard ratio, 0.76 [95% CI, 0.69-0.85], P=0.03). After additionally matching for the ICD measured change in PA during CR there were no differences in mortality with and without CR (hazard ratio, 1.00 [95% CI, 0.82-1.21], P=0.87). Every 10 minutes of increased daily PA was associated with a 1.1% reduction in all-cause mortality in both groups. CONCLUSIONS: Among Medicare beneficiaries with ICDs, small increases in PA were associated with significant reductions in all-cause mortality.
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Rehabilitación Cardiaca , Desfibriladores Implantables , Insuficiencia Cardíaca , Anciano , Muerte Súbita Cardíaca , Ejercicio Físico , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Medicare , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: SyncAV, a device-based cardiac resynchronization therapy (CRT) algorithm, promotes electrical optimization by dynamically adjusting atrioventricular intervals. OBJECTIVE: The purpose of this study was to evaluate the impact of SyncAV on heart failure hospitalizations (HFHs) and related costs in a real-world CRT cohort. METHODS: Patients with SyncAV-capable CRT devices followed by remote monitoring and enrolled in Medicare fee-for-service for at least 1 year preimplant and up to 2 years postimplant were studied. Patients with SyncAV OFF were 4:1 matched to those with SyncAV ON on preimplant HFH rate, demographics, comorbidities, disease etiology, and left bundle branch block. HFHs were determined from the primary diagnosis of inpatient hospitalizations, and the cost for each event was the sum of Medicare, supplemental insurance, and patient payment. RESULTS: After 4:1 propensity score matching, 3630 patients were studied (mean age 75 ± 8 years; 1386 [38%] female), including 726 (25%) patients with SyncAV ON. The pre-CRT HFH rate was 0.338 HFH events per patient-year. Overall, CRT diminished the HFH rate to 0.204 events per patient-year (P < .001). SyncAV elicited a larger reduction in HFH rate (SyncAV ON: hazard ratio [HR] 0.52; 95% confidence interval [CI] 0.41-0.66; P < .001 and SyncAV OFF: HR 0.68; 95% CI 0.59-0.77; P < .001). After 2 years, the HFH rate was lower in the SyncAV ON group than in the SyncAV OFF group (0.143 HFHs per patient-year vs 0.193 HFHs per patient-year; HR 0.70; 95% CI 0.55-0.89; P = .003) and fewer HFHs were followed by 30-day HFH readmissions (4.41% vs 7.68%; P = .003) and 30-day all-cause hospital readmissions (7.04% vs 10.01%; P = .010). The total 2-year HFH-associated costs per patient were lower with SyncAV ON (difference $1135; 90% CI $93-$2109; P = .038). CONCLUSION: This large, real-world, propensity score-matched study demonstrates that SyncAV CRT is associated with significantly reduced HFHs and associated costs, incremental to standard CRT.