Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure.

BACKGROUND: Patients with heart failure (HF) and reduced ejection fraction suffer from a relapsing and remitting disease course, where early treatment changes may improve outcomes. We assessed the clinical integration and safety of the HeartLogic multisensor index and alerts in HF care. METHODS: The Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) study enrolled 200 patients with HF and reduced ejection fraction (<35%), New York Heart Association functional class II-III symptoms, implanted with a cardiac resynchronization therapy-defibrillator or and implantable cardioverter defibrillator, who had either a hospitalization for HF within 12 months or unscheduled visit for HF exacerbation within 90 days or an elevated natriuretic peptide concentration (brain natriuretic peptide [BNP] of ≥150 pg/mL or N-terminal pro-BNP [NT-proBNP] of ≥600 pg/mL). This phase included the development of an alert management guide and evaluated changes in medical treatment, natriuretic peptide levels, and safety. RESULTS: The mean age of participants was 67 years, 68% were men, 81% were White, and 61% had a HF hospitalization in prior 12 months. During follow-up, there were 585 alert cases with an average of 1.76 alert cases per patient-year. HF medications were augmented during 74% of the alert cases. HF treatment augmentation within 2 weeks from an initial alert was associated with more rapid recovery of the HeartLogic Index. Five serious adverse events (0.015 per patient-year) occurred in relation to alert-prompted medication change. NTproBNP levels decreased from median of 1316 pg/mL at baseline to 743 pg/mL at 12 months (P < .001). CONCLUSIONS: HeartLogic alert management was safely implemented in HF care and may optimize HF management. This phase supports further evaluation in larger studies. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03237858).

An international survey to assess referral thresholds for destination therapy in non-inotrope-dependent patients: results of the CONSENSUS-DT study.

BACKGROUND: Criteria for the identification of patients who may progress to advanced heart failure (HF) have been previously suggested. However, identification of appropriate non-inotrope-dependent (NID) patients for destination therapy (DT) remains a challenge, and referral rates are low. We surveyed expert provider opinion about patient selection for early DT. METHODS: An internet-based survey was sent to international HF providers to investigate opinions about clinical indicators for referral of NID patients for DT. Subjects were identified from membership lists of HF professional organizations. Respondents provided their level of agreement with the use of a 5-point Likert Scale (1 = strongly disagree to 5 = strongly agree) to 10 clinical criteria describing at-risk NID patients. RESULTS: A total of 231 respondents who had been in a position to recommend left ventricular assist device (LVAD) therapy for 7.6 ± 5.8 years identified themselves as HF providers: 41% HF cardiologists, 27% HF nurse practitioners, 21% cardiothoracic surgeons, 9% LVAD coordinators, and 2% general cardiologists. More than two-thirds of the respondents agreed or strongly agreed with 7 of the 10 items. Similar consensus was not seen for 6-minute walk (6MW) or B-type natriuretic peptide (BNP). When asked which criteria would have to be present for LVAD referral, only hemodynamic deterioration reached ≥50% affirmation among respondents. No criteria reached >50% response as being sufficient alone for DT. CONCLUSION: We describe referral thresholds for early LVAD therapy among international HF providers. With the exception of BNP and 6MW, we found overall agreement on the proposed clinical parameters. Despite apparent consensus, in practice implantation rates for LVAD in NID patients remain low. The results of ongoing clinical trials in this population may lower thresholds for early referral for DT.

Gender differences in in-hospital management and outcomes in patients with decompensated heart failure: analysis from the Acute Decompensated Heart Failure National Registry (ADHERE).

BACKGROUND: The impact of gender differences has not been well described in patients hospitalized with acute decompensated heart failure (ADHF). METHODS AND RESULTS: Through review of medical records, data on characteristics, treatments, and outcomes were analyzed on 105,388 patient records according to gender. Women accounted for 52% of these admissions and were older than men (74.5 versus 70.1 years,) and more commonly had preserved left ventricular function (51% versus 28%). Based on history, women were less likely to have coronary artery disease (51% versus 64%) and its risk factors, but more commonly had hypertension (76% versus 70%). Both genders received similar intravenous diuretic regimens, but fewer women received vasoactive therapy (24% vs 31%). Evidence-based oral therapies were underused in both genders. Women consistently received less procedure-oriented therapy. Mean length of stay (women 5.9, men 5.8 days) and the risk-adjusted in-hospital mortality (adjusted odds ratio 0.974 [0.910-1.042], P = .4390) were similar in both genders. CONCLUSION: More women than men are hospitalized with ADHF. Heart failure with preserved left ventricular function predominates in women. Though women are treated less aggressively, treatment gaps exists in both sexes. Despite these differences, length of stay and in-hospital mortality rates are similar.

Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE).

BACKGROUND: The ADHERE is designed to study characteristics, management, and outcomes in a broad sample of patients hospitalized with acute decompensated heart failure. Heart failure is a leading cause of hospitalization for adults older than 65 years in the United States. Most available data on these patients are limited by patient selection criteria and study design of clinical trials and single-center studies. METHODS: Participating hospitals identify patients with a primary or secondary discharge diagnosis of heart failure. Medical history, management, treatments, and health outcomes data are collected through review of medical records and entered into a database via secure web browser technology. RESULTS: As of January 2004, data on 107 362 patients have been received from 282 participating hospitals. Of enrollees with available analyzable data (N = 105 388 from 274 hospitals), the mean age was 72.4 (+/-14.0), and 52% were women. The most common comorbid conditions were hypertension (73%), coronary artery disease (57%), and diabetes (44%). Evidence of mild or no impairment of systolic function was found in 46% of patients. Inhospital mortality was 4.0% and the median hospital length of stay was 4.3 days. CONCLUSIONS: The ADHERE demonstrates both the feasibility and significant implications of gathering representative data on large numbers of patients hospitalized with heart failure. Initial data provided important insights into the clinical characteristics and patterns of care of these patients. Ongoing registry work will provide the framework for improved treatment strategies for patients hospitalized with decompensated heart failure.

Reshaping our perception of the typical hospitalized heart failure patient: a gender analysis of data from the ADHERE Heart Failure Registry.

Heart failure studies have suggested important differences between women and men both in heart failure etiology and in survival. Clinical trials and long-standing perceptions of the typical heart failure patient have related far more to men than to women, while more women than men in the United States may be hospitalized with heart failure. The goal of this study was to analyze ADHERE Registry data, the largest database of acute decompensated heart failure (ADHF) patient hospitalizations available, to gain insight into the effect of gender on medical history, clinical characteristics, and discharge counseling. This preliminary study analyzed the 85,617 ADHF hospitalizations in the ADHERE Registry as of October 2003, with 44,340 (52%) women and 41,276 (48%) men included. Women were significantly older (mean age 74.6 +/- 13.7 years) than men (mean age 70.2 +/- 13.9 years, P < .0001). Women were more likely to have a history of hypertension (75% vs. 69%, P < .0001) and a systolic blood pressure > 140 mm Hg (56% vs. 44%, P < .0001). History of coronary artery disease was more common in men (64% vs. 51%, P < .0001). Other risk factors for atherosclerosis, including smoking (17% vs. 10%, P < .0001) and hyperlipidemia (37% vs. 32%, P < .0001), were also more common in men. Men had a significantly lower mean left ventricular ejection fraction (32.9%, N = 30,831) than women (42.1%, N = 29,744); 51% of women had preserved left ventricular function (EF > 40%) compared to only 28% of men (P < 0.0001). At discharge, adherence to 3 of the 4 JCAHO standardized measures of quality of care far heart failure patients were documented more frequently for men than for women. A significantly smaller proportion of women received discharge instructions on management of diet, weight, and medications (30.1% vs. 32.8%); received or were scheduled for assessment of left ventricular function (81.5% vs. 85.6%); or were discharged with an angiotensin converting enzyme inhibitor prescription if appropriate (72.6% vs. 73.9%). Real-world data from the ADHERE Registry may lead to better recognition of the signs and symptoms of heart failure in women, increase the proportion of women who are correctly diagnosed, and may help to support gender-specific considerations in heart failure guidelines.