Effectiveness, utilisation and cost associated with implantable loop recorders versus external monitors after ischaemic or cryptogenic stroke.

OBJECTIVE: Implantable loop recorders (ILRs) are increasingly used for long-term rhythm monitoring after ischaemic and cryptogenic stroke, with the goal of detecting atrial fibrillation (AF) and subsequent initiation of oral anticoagulation to reduce risk of adverse clinical outcomes. There is a need to determine the effectiveness of different rhythm monitoring strategies in this context. METHODS: We conducted a retrospective cohort analysis of individuals with commercial and Medicare Advantage insurance in Optum Labs Data Warehouse who had incident ischaemic or cryptogenic stroke and no prior cardiovascular implantable electronic device from 1 January 2016 to 30 June 2021. Patients were stratified by rhythm monitoring strategy: ILR, long-term continuous external cardiac monitor (>48 hours to 30 days) or Holter monitor (≤48 hours). The primary outcome was risk-adjusted all-cause mortality at 12 months. Secondary outcomes included new diagnosis of AF and oral anticoagulation, bleeding, and costs. RESULTS: Among 48 901 patients with ischaemic or cryptogenic stroke, 9235 received an ILR, 29 103 long-term continuous external monitor and 10 563 Holter monitor only. Mean age was 69.9 (SD 11.9) years and 53.5% were female. During the 12-month follow-up period, patients who received ILRs compared with those who received long-term continuous external monitors had a higher odds of new diagnosis of AF and oral anticoagulant initiation (adjusted OR 2.27, 95% CI 2.09 to 2.48). Compared with patients who received long-term continuous external monitors, those who received ILRs had similar 12-month mortality (HR 1.00; 95% CI 0.89 to 1.12), with approximately $13 000 higher costs at baseline (including monitor cost) and $2500 higher costs during 12-month follow-up. CONCLUSIONS: In this large real-world study of patients with ischaemic or cryptogenic stroke, ILR placement resulted in more diagnosis of AF and initiation of oral anticoagulation, but no difference in mortality compared with long-term continuous external monitors.

Left Ventricular Ejection Fraction and the Future of Heart Failure Phenotyping.

Heart failure (HF) is a complex syndrome traditionally classified by left ventricular ejection fraction (LVEF) cutpoints. Although LVEF is prognostic for risk of events and predictive of response to some HF therapies, LVEF is a continuous variable and cutpoints are arbitrary, often based on historical clinical trial enrichment decisions rather than physiology. Holistic evaluation of the treatment effects for therapies throughout the LVEF range suggests the standard categorization paradigm for HF merits modification. The multidisciplinary Heart Failure Collaboratory reviewed data from large-scale HF clinical trials and found that many HF therapies have demonstrated therapeutic benefit across a large range of LVEF, but specific treatment effects vary across that range. Therefore, HF should practically be classified by association with an LVEF that is reduced or not reduced, while acknowledging uncertainty around the precise LVEF cutpoint, and future research should evaluate new therapies across the continuum of LVEF.

Progression from prediabetes to type 2 diabetes mellitus in adolescents: a real world experience.

Background: Obesity in pediatric patients is strongly associated with increased vascular and metabolic risk. Prediabetes is present in up to 1 in 5 adolescents, aged 12-18 years-old, though is thought to remit spontaneously in a significant portion. Pediatric patients with type 2 diabetes mellitus (T2D) have a more rapid decline of beta-cell function and progression to treatment failure than adult T2D patients. Thus, there is a strong interest in better understanding the natural history of prediabetes in these youth. We aimed to evaluate the real-world rate of progression of prediabetes to T2D in adolescent patients. Methods: This is a retrospective study of 9,275 adolescent subjects aged 12-21 years-old with at least 3 years of de-identified commercial claims data and a new diagnosis of prediabetes during the observation period. Enrollees with a T2D diagnosis and/or diabetes medication use in the 1 year prior to prediabetes diagnosis or a T2D diagnosis in the 1 month following prediabetes diagnosis were excluded. Enrollees with diagnoses of type 1 diabetes (T1D) or polycystic ovarian syndrome over the 3 years were also excluded. Progression to T2D was defined by claims data of two T2D diagnoses at least 7 days apart, HbA1c ≥ 6.5%, and/or prescription of insulin without known T1D. Enrollees were followed for 2 years after prediabetes diagnosis. Results: Overall, 232 subjects (2.5%) progressed from prediabetes to T2D. There were no differences found in T2D progression based on sex or age. Progression to T2D occurred at a median of 302 days after prediabetes diagnosis (IQR 123 to 518 days). This study was limited by the lack of laboratory/anthropometric data in administrative claims, as well as the exclusion of 23,825 enrollees for lack of continuous commercial claims data over 3 years. Conclusion: In the largest sample to date on adolescent prediabetes, we found a 2.5% progression of prediabetes to T2D over a median duration of about one year.

Long-term Outcomes in Use of Opioids, Nonpharmacologic Pain Interventions, and Total Costs of Spinal Cord Stimulators Compared With Conventional Medical Therapy for Chronic Pain.

Importance: Spinal cord stimulators (SCSs) are increasingly used for the treatment of chronic pain. There is a need for studies with long-term follow-up. Objective: To determine the comparative effectiveness and costs of SCSs compared with conventional medical management (CMM) in a large cohort of patients with chronic pain. Design, Setting, and Participants: This was a 1:5 propensity-matched retrospective comparative effectiveness research analysis of insured individuals from April 1, 2016, to August 31, 2018. This study used administrative claims data, including longitudinal medical and pharmacy claims, from US commercial and Medicare Advantage enrollees 18 years or older in Optum Labs Data Warehouse. Patients with incident diagnosis codes for failed back surgery syndrome, complex regional pain syndrome, chronic pain syndrome, and other chronic postsurgical back and extremity pain were included in this study. Data were analyzed from February 1, 2021, to August 31, 2022. Exposures: SCSs or CMM. Main Outcomes and Measures: Surrogate measures for primary chronic pain treatment modalities, including pharmacologic and nonpharmacologic pain interventions (epidural and facet corticosteroid injections, radiofrequency ablation, and spine surgery), as well as total costs. Results: In the propensity-matched population of 7560 patients, mean (SD) age was 63.5 (12.5) years, 3080 (40.7%) were male, and 4480 (59.3%) were female. Among matched patients, during the first 12 months, patients treated with SCSs had higher odds of chronic opioid use (adjusted odds ratio [aOR], 1.14; 95% CI, 1.01-1.29) compared with patients treated with CMM but lower odds of epidural and facet corticosteroid injections (aOR, 0.44; 95% CI, 0.39-0.51), radiofrequency ablation (aOR, 0.57; 95% CI, 0.44-0.72), and spine surgery (aOR, 0.72; 95% CI, 0.61-0.85). During months 13 to 24, there was no significant difference in chronic opioid use (aOR, 1.06; 95% CI, 0.94-1.20), epidural and facet corticosteroid injections (aOR, 1.00; 95% CI, 0.87-1.14), radiofrequency ablation (aOR, 0.84; 95% CI, 0.66-1.09), or spine surgery (aOR, 0.91; 95% CI, 0.75-1.09) with SCS use compared with CMM. Overall, 226 of 1260 patients (17.9%) treated with SCS experienced SCS-related complications within 2 years, and 279 of 1260 patients (22.1%) had device revisions and/or removals, which were not always for complications. Total costs of care in the first year were $39 000 higher with SCS than CMM and similar between SCS and CMM in the second year. Conclusions and Relevance: In this large, real-world, comparative effectiveness research study comparing SCS and CMM for chronic pain, SCS placement was not associated with a reduction in opioid use or nonpharmacologic pain interventions at 2 years. SCS was associated with higher costs, and SCS-related complications were common.

Evaluación económica de stents coronarios en pacientes con infarto del miocardio con elevación del ST en Colombia: un paso hacia la implementación de políticas / Economic assessment of coronary stenting in patients with ST elevation myocardial infarction in Colombia: A step toward policy implementation

El control de los gastos de la atención médica sigue siendo uno de los retos más importantes que muchos países del mundo están afrontando actualmente, debido a su potencial de afectar la prestación de servicios básicos de atención de la salud dentro de la próxima década. Como se observa en este gráfico del Banco Mundial (fig. 1), el gasto en salud per cápita en Colombia, ha seguido la misma tendencia al alza observada en la mayoría de los países más desarrollados y en vía de desarrollo1 . Puesto que la enfermedad cardiovascular sigue siendo la principal causa de morbimortalidad, cualquier intervención a gran escala tendrá un impacto significativo en los presupuestos sanitarios. El análisis de costo-efectividad es una herramienta que ofrece diferentes costos asociados con los resultados de salud, compara los costos de las alternativas de tratamiento y evalúa qué alternativa vale la pena en cuanto al costo. Esta información proporcionará a los diseñadores de políticas elementos para las decisiones de asignación de recursos. El objetivo es conseguir el máximo rendimiento de los recursos financieros existentes y proyectados. Los anos ˜ de vida ajustados por calidad, o AVAC, reflejan el número de anos ˜ de vida de alta calidad que gana un paciente con una intervención determinada. Otro parámetro utilizado para medir su valor es la relación costo-efectividad. Este es el precio de comprar anos ˜ más saludables con un nuevo tratamiento, en comparación con el tratamiento estándar, y si este es relevante.

Estimación del riesgo cardiovascular en Colombia: ¿qué tan cerca estamos? / Cardiovascular risk estimation in Colombia: how close are we?

A medida que la práctica de la medicina se dirige más hacia la prevención y menos al tratamiento de la enfermedad, es fundamental contar con las herramientas precisas para evaluar el riesgo futuro de las poblaciones en las cuales se enfoca este esfuerzo. El estudio de seguimiento longitudinal más famoso en Cardiología es indudablemente el que se inició en Framingham en 1948; gracias a este se generó la función de riesgo de Framingham, y de manera similar se creó la función de PROCAM en una población masculina alemana. En este número de la Revista Colombiana de Cardiología, Munoz ˜ et al. reportan los hallazgos encontrados al evaluar la posible aplicabilidad de las funciones de riesgo de Framingham y PROCAM en la población colombiana, con un enfoque similar al de Empana et al., quienes evaluaron estos dos modelos en poblaciones francesas e irlandesas1 . En este análisis de estos modelos hecho por primera vez en una población suramericana, Munoz ˜ et al. encontraron que en pacientes de riesgo bajo e intermedio, el número deeventos cardiovasculares predichos por la función de riesgo de Framingham sobrestimó los observados, mientras que en el de PROCAM se ajustó un poco más a lo visto. Cabe anotar que en este estudio los hallazgos en el grupo de alto riesgo no fueron estadísticamente significativos. Concluyeron que la función de riesgo de Framingham debía usarse con precaución en la población colombiana de riesgo bajo e intermedio, en tanto que la función de riesgo de PROCAM es una mejor opción.

Do baseline diastolic echocardiographic parameters predict outcome after resynchronization therapy? Results from the PROSPECT trial.

INTRODUCTION: Cardiac resynchronization therapy (CRT) can improve clinical and cardiac structural status in heart failure patients. The role of baseline diastolic echocardiographic parameters to characterize the likelihood of positive outcomes is not well known. We explored relationships between diastolic parameters and outcomes 6 months after CRT implant in the Predictors of Response to CRT (PROSPECT) Trial. HYPOTHESIS: We hypothesized that diastolic echocardiographic parameters were associated with clinical and structural outcomes in CRT patients. METHODS: For 426 patients in PROSPECT, a prospective observational trial of CRT, baseline E/A ratio, left atrial (LA) area, isovolumic relaxation time, left ventricular inflow deceleration time, E' velocity, and E/E' ratio were evaluated and related to 6-month clinical composite score (CCS) and left ventricular end-systolic volume (LVESV) reduction using Spearman rank-order correlations. Parameters associated with outcomes were analyzed further by discrete categorization. RESULTS: As continuous variables, only E/A ratio and LA area correlated with CCSs (P = 0.017, P = 0.045, respectively) and relative change in LVESV at 6 months (P < 0.0001, P = 0.001, respectively). As discrete variables, E/A ratio and LA area also correlated with CCSs and LVESV. CONCLUSION: Diastolic echo parameters E/A ratio and LA area were associated with clinical and structural outcomes in CRT patients at 6 months.

Expanding the clinical spectrum of late-onset Pompe disease: dilated arteriopathy involving the thoracic aorta, a novel vascular phenotype uncovered.

PURPOSE: Cerebro-vascular arteriopathy has been reported in late-onset Pompe disease (LOPD). Evidence of increased aortic stiffness in some patients and smooth muscle involvement in LOPD raises the possibility of aortic involvement. Our aim was to determine if aortic arteriopathy may be a complication of LOPD. METHODS: One patient with LOPD was diagnosed with aortic dilatation at Duke Metabolic clinic, 4 others were diagnosed at University of Mainz, Germany, where chest X-ray and echocardiography are routinely done for patients. Other causes of aortic vascular disease were assessed. RESULTS: We report evidence of dilated arteriopathy involving primarily the ascending thoracic aorta in 5 females with late-onset Pompe disease. One patient had a bicuspid aortic valve and developed dissection. Another patient with juvenile onset disease had both thoracic and basilar artery aneurysms. CONCLUSIONS: Aneurysmal dilatation of the thoracic aorta is an underreported vascular complication of LOPD, probably due to the same pathological process that occurs in the brain. Chest X-ray together with echocardiography should be incorporated as initial screening tools for aortic aneurysms in patients with LOPD. When ectasia is suspected, or the ascending aorta is not visualized, contrast- mediated thoracic CT or MRA may be necessary. Large-scale studies are warranted to determine the prevalence and extent of aortic vascular involvement.

Racial disparities in health literacy and access to care among patients with heart failure.

BACKGROUND: Previous work has shown that there is a higher frequency of hospitalizations among black heart failure patients relative to white heart failure patients. We sought to determine whether racial differences exist in health literacy and access to outpatient medical care, and to identify factors associated with these differences. METHODS: We evaluated data from 1464 heart failure patients (644 black and 820 white). Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine-Revised (ie, REALM-R), and access to care was assessed through participants' self-report. RESULTS: Black race was strongly associated with worse health literacy and all measures of poor access to care in unadjusted analyses. After adjusting for demographics, noncardiac comorbidity, social support, insurance status, and socioeconomic status (income and education), the strongest associations were seen between race and: health literacy (OR 2.13, 95% CI 1.46 to 3.10), absence of a medical home (OR 1.76, 1.19-2.61), and cost as a deterrent to seeking health care (OR 1.55, 1.07 to 2.23). CONCLUSIONS: Our findings highlight that important racial differences in health literacy and access to care exist among patients with heart failure. These differences persist even after adjustment for a broad range of potential mediators, including educational attainment, income, and insurance status.

The effect of left ventricular pacing site on cardiac resynchronization therapy outcome and mortality: the results of a PROSPECT substudy.

AIMS: Left ventricular pacing site (LV-PS) was prospectively collected to test the influence of the anatomical LV-PS on the outcome of cardiac resynchronization therapy (CRT) and mortality. METHODS AND RESULTS: Four hundred and twenty-six patients with standard indications for CRT underwent echocardiographic and clinical evaluation before and after CRT implantation. The LV-PS was determined from fluoroscopy using the clockwise principle (CP). The LV-PS was categorized into three prospectively defined groups: between 3 and 5 o'clock and longitudinal basal/mid-position (Group A, 'optimal'); between 12 and 2 o'clock and longitudinal mid-apical anterior position (Group B, 'non-optimal'); and all other (Group C, 'other'). Of 333 patients, followed for 0.9 years (mean), adequate images were available to define the LV-PS. Left ventricular pacing site was Group A for 118 patients, Group B for 56, and Group C for 159. The three groups were comparable regarding gender, aetiology, and NYHA class; however, patients in Group A were younger. No relation was found between the LV-PS groups and CRT outcome or all-cause mortality. However, further exploratory subanalyses suggest that LV-PS may impact outcomes in non-ischaemic patients, those with left bundle branch block, and when LV-PS is apical in location. CONCLUSION: Using the CP to define anatomical LV-PS, no relation was found between the LV-PS groups and CRT outcome and mortality. Exploratory analyses warrant further studies.

Optimal atrioventricular delay in CRT patients can be approximated using surface electrocardiography and device electrograms.

UNLABELLED: Electrocardiographic AV Delay Adjustment. BACKGROUND: Optimization of the atrioventricular (AV) delay (AVD) may result in an improvement in cardiac resynchronization therapy (CRT) outcome. Previous studies have shown positive correlation between interatrial conduction time measured invasively during the implant procedure and optimal AVD determined postimplant using Doppler echocardiography. We hypothesized that the optimal AVD can be predicted noninvasively from surface electrocardiogram (ECG). METHODS: The optimal sensed (SAV) and paced (PAV) AVDs were determined for CRT patients (n = 63) by programming different AVDs (in 20 ms steps, in random sequence) and evaluating Doppler images of the mitral flow (iterative method). The time intervals between atrial sensing (As) and pacing (Ap) to the end of the P-wave (Pend) and to the right ventricular sensing (RVs) were measured from 5 ECG leads (limb, V1, and V3) and device telemetry during sinus rhythm and atrial pacing. RESULTS: Optimal SAV was 120 ± 30 ms and correlated with As-Pend (R = 0.69, P < 0.0001) and As-RVs (R = 0.45, P = 0.0003). Optimal PAV was 172 ± 38 ms and correlated with Ap-Pend (R = 0.65, P < 0.0001) and Ap-RVs (R = 0.60, P < 0.0001). Regression analysis suggested a simple method of AVD adjustment by pacing the ventricles 40 ms after the end of the sensed P-wave or 30 ms after the end of the paced P-wave but not at the expense of biventricular capture. Such a method would have resulted in significantly lower deviation from echo-optimal AVDs compared with programming fixed values. CONCLUSION: A simple method of providing 30-40 ms separation between the end of the P-wave and ventricular pacing pulse can be used to approximate echocardiographically optimal AV delays.

Results of the Predictors of Response to CRT (PROSPECT) trial.

BACKGROUND: Data from single-center studies suggest that echocardiographic parameters of mechanical dyssynchrony may improve patient selection for cardiac resynchronization therapy (CRT). In a prospective, multicenter setting, the Predictors of Response to CRT (PROSPECT) study tested the performance of these parameters to predict CRT response. METHODS AND RESULTS: Fifty-three centers in Europe, Hong Kong, and the United States enrolled 498 patients with standard CRT indications (New York Heart Association class III or IV heart failure, left ventricular ejection fraction < or = 35%, QRS > or = 130 ms, stable medical regimen). Twelve echocardiographic parameters of dyssynchrony, based on both conventional and tissue Doppler-based methods, were evaluated after site training in acquisition methods and blinded core laboratory analysis. Indicators of positive CRT response were improved clinical composite score and > or = 15% reduction in left ventricular end-systolic volume at 6 months. Clinical composite score was improved in 69% of 426 patients, whereas left ventricular end-systolic volume decreased > or = 15% in 56% of 286 patients with paired data. The ability of the 12 echocardiographic parameters to predict clinical composite score response varied widely, with sensitivity ranging from 6% to 74% and specificity ranging from 35% to 91%; for predicting left ventricular end-systolic volume response, sensitivity ranged from 9% to 77% and specificity from 31% to 93%. For all the parameters, the area under the receiver-operating characteristics curve for positive clinical or volume response to CRT was < or = 0.62. There was large variability in the analysis of the dyssynchrony parameters. CONCLUSIONS: Given the modest sensitivity and specificity in this multicenter setting despite training and central analysis, no single echocardiographic measure of dyssynchrony may be recommended to improve patient selection for CRT beyond current guidelines. Efforts aimed at reducing variability arising from technical and interpretative factors may improve the predictive power of these echocardiographic parameters in a broad clinical setting.

Acute myocardial infarction in the elderly with diabetes.

OBJECTIVE: Diabetes mellitus (DM) has been associated with an elevated, short-term risk of death after myocardial infarction (MI). Among the studies of DM, however, few studies have included elderly subjects. The purpose of the present investigation was to determine if non-insulin-treated DM (NIRxDM) and insulin-treated DM (IRxDM) were associated with specific comorbid conditions, clinical findings on arrival, and MI characteristics, as well as a higher 30-day mortality rate in elderly patients with acute MI. DESIGN: The study design was a retrospective medical record review and secondary data analysis of previously collected data from the Cooperative Cardiovascular Project. SETTING: Study setting was Connecticut from June 1, 1992, through February 28, 1993. PATIENTS: Subjects included the entire Medicare population (n = 2050), aged 65 years or older who were hospitalized for acute MI. OUTCOME MEASURES: Mortality rate at 30 days after MI was measured. RESULTS: A history of DM was observed in 29% of the study population. DM status was associated with previous comorbid conditions, poorer functional status, higher body mass index, heart failure on arrival, non-Q-wave MI, and development of atrial fibrillation and oliguria during hospitalization. Patients with DM were less likely to have chest pain on arrival to the hospital. Diabetic status was not a significant predictor of short-term mortality; at 30 days after MI, 17% (n = 242) of the subjects without DM, 19% (n = 71) of those with NIRxDM, and 18% (n = 39) of the subjects with IRxDM died (P = .460). After adjustment for other prognostic factors, it was noted that MI characteristics present on hospital arrival predicted mortality at 30 days in both patients with NIRxDM and patients with IRxDM. CONCLUSIONS: The slightly, but not significantly, increased mortality risk in patients with DM should not minimize the importance of monitoring DM in the acute MI setting. Hospitalization for MI provides an opportunity to provide aggressive lipid and blood pressure management, optimize blood glucose, control heart failure, and institute other secondary preventive interventions in the elderly population with DM.

Cardiac outcomes after myocardial infarction in elderly patients with diabetes mellitus.

OBJECTIVES: To examine the association between (1) comorbid conditions related to diabetes mellitus, clinical findings on arrival at the hospital, and characteristics of the myocardial infarction and (2) risk of heart failure, recurrent myocardial infarction, and mortality in the year after myocardial infarction in elderly 30-day survivors of myocardial infarction who had non-insulin- or insulin-treated diabetes. METHODS: Medical records for June 1, 1992, through February 28, 1993, of Medicare beneficiaries (n = 1698), 65 years or older, hospitalizedfor acute myocardial infarction in Connecticut were reviewed by trained abstractors. RESULTS: One year after myocardial infarction, elderly patients with non-insulin- and insulin-treated diabetes mellitus had significantly greater risk for readmission for heart failure and recurrent myocardial infarction than did patients without diabetes mellitus, and risk was greater in patients treated with insulin than in patients not treated with insulin. Diabetes mellitus, comorbid conditions related to diabetes mellitus, clinical findings on arrival, and characteristics of the myocardial infarction, specifically measures of ventricular function, were important predictors of these outcomes. Mortality was greater in patients not treated with insulin than in patients treated with insulin; the increased risk was mostly due to comorbid conditions related to diabetes mellitus and poorer ventricular function. CONCLUSIONS: Risk of heart failure, recurrent myocardial infarction, and mortality is elevated in elderly patients who have non-insulin- or insulin-treated diabetes mellitus. Comorbid conditions related to diabetes mellitus and ventricular function at the time of the index myocardial infarction are important contributors to poorer outcomes in patients with diabetes mellitus.