Dawn Lombardo

Effectiveness of remote patient monitoring after discharge of hospitalized patients with heart failure the better effectiveness after transition-heart failure (BEAT-HF) randomized clinical trial

IMPORTANCE It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization. OBJECTIVE To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF. DESIGN, SETTING, AND PARTICIPANTS We randomized 1437 patients hospitalized for HF between October 12, 2011, and September 30, 2013, to the intervention arm (715 patients) or to the usual care arm (722 patients) of the Better Effectiveness After Transition-Heart Failure (BEAT-HF) study and observed them for 180 days. The dates of our study analysis were March 30, 2014, to October 1, 2015. The setting was 6 academic medical centers in California. Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF. INTERVENTIONS The intervention combined health coaching telephone calls and telemonitoring. Telemonitoring used electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. Centralized registered nurses conducted telemonitoring reviews, protocolized actions, and telephone calls. MAIN OUTCOMES AND MEASURES The primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life at 30 and 180 days. RESULTS Among 1437 participants, the median age was 73 years. Overall, 46.2% (664 of 1437) were female, and 22.0% (316 of 1437) were African American. The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P = .74). In secondary analyses, there were no significant differences in 30-day readmission or 180-day mortality, but there was a significant difference in 180-day quality of life between the intervention and usual care groups. No adverse events were reported. CONCLUSIONS AND RELEVANCE Among patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01360203.

Primary Results of the HABIT Trial (Heart Failure Assessment With BNP in the Home)

OBJECTIVES This study was a multicenter, single-arm, double-blinded observational prospective clinical trial designed to monitor daily concentrations of B-type natriuretic peptide (BNP) and to determine how these concentrations correlate with acute clinical heart failure decompensation (ADHF) and related adverse clinical outcomes in at-risk HF patients. BACKGROUND Although BNP at discharge is predictive of 30-day outcomes, outpatient serial testing may improve the risk of detecting early decompensation. METHODS A total of 163 patients with HF signs and symptoms of ADHF discharged from the hospital or in an outpatient setting measured their weight and BNP levels daily for 60 days with a finger-stick test. Patients and physicians were blinded to BNP levels. The composite outcome was ADHF events: cardiovascular death, admission for decompensated HF, or clinical HF decompensation requiring either parenteral HF therapy or changes in oral HF medications. RESULTS A total of 6,934 daily BNP values were recorded, with a median of 46 measures per patient over a monitoring period of 65 days. Forty patients had 56 events. Correlations between BNP measures weakened over time, and the dispersion between BNP measures grew. During 10,035 patient-days, there were 494 (4.9%) days of weight gain (≥5 lbs). The hazard ratio per unit increase of ln BNP was 1.84, and the hazard ratio on a day of weight gain was 3.63. These effects retained significance when controlling for symptoms. When the monitoring period for each subject was broken into intervals based on ADHF events, there were 39 (18.4%) intervals of upward trending BNP corresponding to a risk increase of 59.8% and 64 (30.2%) downward trending intervals corresponding to a risk decrease of 39.0%. There were 94 (44.3%) intervals with 1 or more days of weight gain corresponding to a risk increase of 26.1%. CONCLUSIONS This pilot study demonstrates that home BNP testing is feasible and that trials using home monitoring for guiding therapy are justifiable in high-risk patients. Daily weight monitoring is complementary to BNP, but BNP changes correspond to larger changes in risk, both upward and downward. (Heart Failure [HF] Assessment with B-type Natriuretic Peptide [BNP] In the Home [HABIT]; NCT00946231).

On-going palliative care enhances perceived control and patient activation and reduces symptom distress in patients with symptomatic heart failure: A pilot study

Introduction: There is a paucity of research about the impact of palliative care (PC) on perceived control (i.e. one’s perceived influence over outcomes or events in the environment) and activation (i.e. ability to self-manage) in patients with symptomatic heart failure (HF). Likewise, little is known about the association between perceived control, activation, and symptom distress in this patient population. We hypothesized that patients with advanced HF who received ongoing PC services (i.e. ≥2 PC consultations) vs no access or a single PC consultation would have greater improvements in perceived control and activation and greater reductions in symptom distress three months post-discharge for HF exacerbation. Methods: Forty-two patients (average age 53.9±8.0 years; predominantly male (72%), White (61%) and married (69%)) participated in the study. However, only 36 (85.7%) patients completed an outpatient PC consultation of which 29 (69%) patients returned for additional follow-up visits with the PC team. Data on perceived control, activation, and symptom distress were collected at baseline and three months. Parametric statistical models were applied to draw conclusions. Results: Findings showed that the patients who received ≥2 PC consultations had greater improvements in perceived control and activation than their counterparts; these increases were associated with greater reductions in symptom distress. Conclusion: Our findings suggest that on-going PC interventions enhance perceived control and activation in patients with advanced HF and open up the possibility of planning larger studies to assess the effect of PC on these variables as possible mediators to improvements in self-management and clinical outcomes.

Does preparedness planning improve attitudes and completion of advance directives in patients with symptomatic heart failure

BACKGROUND AND OBJECTIVE There is little evidence to support whether interventions that engage patients with symptomatic heart failure (HF) in preparedness planning impacts completion of advance directives (ADs). This study was conducted to assess the impact of a palliative care intervention on health perceptions, attitudes, receipt of information and knowledge of ADs, discussion of ADs with family and physicians, and completion of ADs in a cohort of patients with symptomatic HF. METHODS Thirty-six patients hospitalized for HF decompensation were recruited and referred for an outpatient consultation with a palliative care specialist in conjunction with their routine HF follow-up visit after discharge; telephone interviews to assess health status and attitudes toward ADs were conducted before and 3 months after the initial consultation using an adapted version of the Advance Directive Attitude Survey (ADAS). Information pertaining to medical history and ADs was verified through medical chart abstraction. RESULTS AND CONCLUSION The current study found support for enhancing attitudes and completion of ADs following a palliative care consultation in patients with symptomatic HF. Despite a significant increase in attitudes toward completion of ADs following the intervention, only 47% of the participants completed ADs. This finding suggests that although education and understanding of ADs is important and can result in more positive attitudes, it does not translate to completion of ADs in all patients.

Cryptogenic stroke and the left atrial septal pouch: a case report.

The left atrial septal pouch (LASP) is an anatomic variant of the interatrial septum and may be a nidus for thromboembolism. We present the case of a 49 year-old man without known vascular risk factors who experienced bi-hemispheric strokes over the course of 10 days, suggestive of multiple emboli. Transesophageal echocardiography revealed a prominent LASP. We suggest that presence of LASP was a likely cause of stroke in this patient and that further study of a possible association between LASP and ischemic stroke in younger individuals may be warranted.

How B-Type Natriuretic Peptide (BNP) and Body Weight Changes Vary in Heart Failure With Preserved Ejection Fraction Compared With Reduced Ejection Fraction: Secondary Results of the HABIT (HF Assessment With BNP in the Home) Trial

BACKGROUND Heart failure is a common cause of hospitalization and can be divided into types with preserved and reduced ejection fraction (HFpEF and HFrEF, respectively). In this subanalysis of the HABIT (Heart Failure Assessment With BNP in the Home) trial, we examined the differences between home B-type natriuretic peptide (BNP) testing and weight monitoring in patients with HFpEF and with HFrEF before decompensation. METHODS AND RESULTS This was a retrospective review of patients with HFpEF and HFrEF from the HABIT trial. The HFpEF patients compared with HFrEF patients were older and more obese and had lower baseline BNP values. Intra-individual BNP dispersion (spread of distribution over time) was greater in HFpEF than in HFrEF owing to rapid fluctuations (within 3 days). Slowly varying changes in BNP (estimated by a moving average) were equally predictive of ADHF risk in both HFpEF and HFrEF. However, in HFpEF, a rapid rise in BNP >200 pg/mL within 3 days was associated with an increased risk of acute decompensated heart failure (ADHF; hazard ratio 4.0), whereas a similar association was not observed in HFrEF. Weight gain ≥5 lb in 3 days had a high specificity but low sensitivity for ADHF in both HFpEF and HFrEF, whereas a lower threshold of ≥2 lb weight gain over 3 days in patients with HFpEF (but not HFrEF) was a moderately sensitive cutoff associated with decompensation (60% sensitivity). CONCLUSIONS Patients with HFpEF and HFrEF have variations in their BNP and weight before decompensation. The rapid time scale behaves differently between the groups. In those with HFpEF, a 3-day period characterized by ≥2 lb weight gain and/or >200 pg/mL BNP rise was significantly associated with decompensation. Future prospective studies investigating different weight and BNP cutoffs for home monitoring of HFpEF and HFrEF patients should be performed to fully learn the value of BNP changes before clinical deompensation.

Left atrial septal pouch in cryptogenic stroke.

Background: The left atrial septal pouch (LASP), an anatomic variant of the interatrial septum, has uncertain clinical significance. We examined the association between LASP and ischemic stroke subtypes in patients undergoing transesophageal echocardiography (TEE). Methods: We determined the prevalence of LASP among consecutive patients who underwent TEE at our institution. Patients identified with ischemic strokes were further evaluated for stroke subtype using standard and modified criteria from the Trial of Org 10172 in Acute Stroke Treatment (TOAST). We compared the prevalence of LASP in ischemic stroke, cryptogenic stroke, and non-stroke patients using prevalence ratios (PR). Results: The mean age of all 212 patients (including stroke and non-stroke patients) was 57 years. The overall prevalence of LASP was 17% (n = 35). Of the 75 patients who were worked-up for stroke at our institution during study period, we classified 31 as cryptogenic using standard TOAST criteria. The prevalence of LASP among cryptogenic stroke patients (using standard and modified TOAST criteria) was increased compared to the prevalence among other ischemic stroke patients (26 vs. 9%, p = 0.06; PR = 1.8, 95% CI = 1.1–3.1, and 30 vs. 10%, p = 0.04; PR = 2.2, 95% CI = 1.2–4.1, respectively). Conclusion: In this population of relatively young patients, prevalence of LASP was increased in cryptogenic stroke compared to stroke patients of other subtypes. These findings suggest LASP is associated with cryptogenic stroke, which should be verified by future large-scale studies.

Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics.

There is ample research to support the potential benefits of a high protein diet on clinical outcomes in overweight/obese, diabetic subjects. However, nutritional management of overweight/obese individuals with heart failure (HF) and type 2 diabetes mellitus (DM) or metabolic syndrome (MS) is poorly understood and few clinical guidelines related to nutritional approaches exist for this subgroup. This article describes the design, methods, and baseline characteristics of study participants enrolled in Pro-HEART, a randomized clinical trial to determine the short term and long term effects of a high protein diet (30% protein [~110 g/day], 40% carbohydrates [150 g/day], 30% fat [~50 g/day]) versus a standard protein diet (15% protein [~55 g/day], 55% carbohydrates [~200 g/day], 30% fat [~50 g/day]) on body weight and adiposity, cardiac structure and function, functional status, lipid profile, glycemic control, and quality of life. Between August, 2009 and May, 2013, 61 individuals agreed to participate in the study; 52 (85%) - mean age 58.2 ± 9.8 years; 15.4% Blacks; 57.7% Whites; 19.2% Hispanics; 7.7% Asians; 73.1% male; weight 112.0 ± 22.6 kg - were randomized to a 3-month intensive weight management program of either a high protein or standard protein diet; data were collected at baseline, 3 months, and 15 months. This study has the potential to reveal significant details about the role of macronutrients in weight management of overweight/obese individuals with HF and DM or MS.

Association between inflammatory biomarkers and adiposity in obese patients with heart failure and metabolic syndrome.

Obesity, type 2 diabetes mellitus (DM) and metabolic syndrome (MS) are common in patients with heart failure (HF). Studies investigating the association between known biomarkers and adiposity in patient populations are limited. The aim of the present study was to investigate the association between C-reactive protein (CRP) and leptin with adiposity in a sub-group of overweight/obese patients with HF, DM and/or MS. A total of 36 patients (mean age, 56.72±9.78 years; ranging between 27 and 76 years of age; 80.6% male; 52.8% Caucasian) were enrolled and their height, weight, waist circumference and body composition (e.g. percentage body fat and lean mass), as well as the levels of CRP and leptin, were assessed. The results demonstrated that there was a significant association between CRP and leptin, CRP and body mass index (BMI) and gender and percentage body fat (P<0.05, for all associations). Analysis of leptin and CRP levels revealed that patients in the highest BMI quartile (BMI, 40.3–61.2) had higher CRP levels (4.83 μg/ml vs. 3.03 μg/ml; P=0.033) and higher leptin levels (44.97 ng/ml vs. 24.64 ng/ml; P=0.042) compared with patients in the lower BMI quartile (BMI, 28.6–32.4). In conclusion, among obese patients with HF, DM and/or MS, an association between CRP and leptin was identified, providing further evidence that metabolic and inflammatory mechanisms are involved in these diseases. Future investigation to assess the potential impact of inflammation and adiposity, and the role of dietary interventions and weight loss on clinical outcomes in this population of chronically ill patients is warranted.

Studying the pathophysiologic connection between cardiovascular and nervous systems using stem cells

The cardiovascular and nervous systems are deeply connected during development, health, and disease. Both systems affect and regulate the development of each other during embryogenesis and the early postnatal period. Specialized neural crest cells contribute to cardiac structures, and a number of growth factors released from the cardiac tissue (e.g., glial cell line–derived neurotrophic factor, neurturin, nerve growth factor, Neurotrophin‐3) ensure proper maturation of the incoming parasympathetic and sympathetic neurons. Physiologically, the cardiovascular and nervous systems operate in harmony to adapt to various physical and emotional conditions to maintain homeostasis through sympathetic and parasympathetic nervous systems. Moreover, neurocardiac regulation involves a neuroaxis consisting of cortex, amygdala, and other subcortical structures, which have the ability to modify lower‐level neurons in the hierarchy. Given the interconnectivity of cardiac and neural systems, when one undergoes pathological changes, the other is affected to a certain extent. In addition, there are specific neurocardiac diseases that affect both systems simultaneously, such as Huntington disease, Lewy body diseases, Friedreich ataxia, congenital heart diseases, Danon disease, and Timothy syndrome. Over the last decade, in vitro modeling of neurocardiac diseases using induced pluripotent stem cells (iPSCs) has provided an invaluable opportunity to elevate our knowledge about the brain–heart connection, since previously primary cardiomyocytes and neurons had been extremely difficult to maintain long‐term in vitro. Ultimately, the ability of iPSC technology to model abnormal functional phenotypes of human neurocardiac disorders, combined with the ease of therapeutic screening using this approach, will transform patient care through personalized medicine in the future.