Ambulatory Heart Failure Patients Research Articles

Impact of Exercise Programs on Hospital Readmission Following Hospitalization for Heart Failure: A Systematic Review.

Given persistently high 30-day readmission rates among patients hospitalized for heart failure, there is an ongoing need to identify new interventions to reduce readmissions. Although exercise programs can improve outcomes among ambulatory heart failure patients, it is not clear whether this benefit extends to reducing readmissions following heart failure hospitalization. We therefore conducted a systematic review of the literature to identify randomized controlled trials examining the impact of exercise programs on hospital readmissions among patients recently hospitalized for heart failure. We searched Ovid MEDLINE, EMBASE, and the Wiley Cochrane Library for studies that fulfilled pre-defined criteria, including that the exercise program pre-specify activity type and exercise frequency, duration, and intensity. Exercise interventions could occur at any location including within the hospital, at an outpatient facility, or at home. Among 1213 unique publications identified, only one study fulfilled inclusion criteria. This study was a single-site randomized controlled trial that consisted of a 12-week exercise program in a cohort of 105 patients with a principal diagnosis of HF at a metropolitan hospital in Australia. This study revealed a reduction in 12-month all-cause and cardiovascular-related hospitalization rates. However, inferences were limited by its single-site study design, small sample size, premature termination, and high risk for selection, performance, and detection bias. As no studies have built upon the findings of this study, it remains unknown whether exercise programs can improve readmission rates among patients recently hospitalized for heart failure, a significant gap in the literature.

Prevalence and Prognostic Impact of Chronic Obstructive Pulmonary Disease in Patients with Chronic Heart Failure: Data from the GISSI-HF Trial

Objectives: Chronic obstructive pulmonary disease (COPD) is a common comorbidity in patients with heart failure (HF). We aimed to assess its prevalence, characterization and long-term prognostic impact in the GISSI-HF population. Methods: The study randomized 6,975 ambulatory HF patients to either n-3 polyunsaturated fatty acids or placebo. We performed a retrospective analysis of clinical characteristics and outcomes of the 1,533 patients diagnosed with COPD (22%). Results: COPD was associated with a worse clinical presentation and an increased burden of comorbidities. At a median follow-up of 3.9 years, COPD was found to be an independent predictor of both predefined primary study end points, including all-cause mortality (HR 1.28, 95% CI 1.15-1.43, p < 0.0001) and all-cause mortality or hospitalization for cardiovascular reasons (HR 1.19, 95% CI 1.10-1.30, p < 0.0001). Both cardiovascular (HR 1.20, 95% CI 1.05-1.36, p = 0.007) and noncardiovascular mortality (HR 1.56, 95% CI 1.26-1.94, p < 0.0001) were significantly increased in COPD-HF patients, as well as hospitalizations for any reason (HR 1.23, 95% CI 1.14-1.34, p < 0.0001), for cardiovascular reasons (HR 1.16, 95% CI 1.06-1.27, p = 0.002) and for HF (HR 1.27, 95% CI 1.14-1.43, p < 0.0001). Conclusions: COPD is an independent predictor of mortality and hospitalizations in ambulatory HF patients. Increased awareness and improved management of COPD may reduce the burden of this morbidity to patients with HF.

Validity of the Seattle Heart Failure Model for prognosis in a population at low coronary heart disease risk.

Validation of the Seattle Heart Failure Model (SHFM) for predicting the risk of death in a population different than the derivation cohort. In a retrospective analysis of a cohort of chronic heart failure patients with left ventricular systolic dysfunction, consecutively referred between 2000 and 2011, we computed the score, according to characteristics at referral. We compared the observed risk of death with that predicted by the model, using receiver operating characteristic (ROC) curves to assess discrimination and a goodness-of-fit test for the comparison of predicted and observed risks. In 565 patients, 68.5% were men, the median age was 70 years, 46.0% had ischemic cause, 89.7% moderate-severe left ventricular systolic dysfunction and 61.2% New York Heart Association class II. The risk of death increased progressively with the model's score, with an area under the ROC curve between 0.69 and 0.72 when considering different follow-up periods. The model underestimated the risk of death (observed vs. predicted: 12.2 vs. 10.4%, P < 0.001; 28.1 vs. 25.1%, P < 0.001; and 43.4 vs. 35.7%, P < 0.001 at 1, 3 and 5 years, respectively). Accurate predictions, with nonsignificant differences between observed and predicted risks in a goodness-of-fit test, were obtained after recalibration. In this study, the SHFM substantially underestimated the absolute risk of death in ambulatory chronic heart failure patients, mostly nonischemic and elderly. After adjustment for sample-specific circumstances, the recalibrated model demonstrated to be credible in clinical practice and may provide useful information to physicians.

229 - Subcutaneous Versus Intravenous Furosemide in the Johns Hopkins Heart Failure Bridge Clinic

Introduction: Subcutaneous (sc) diuretics present a potential alternative to intravenous (IV) diuretics and offer patients an opportunity to receive treatment outside of the hospital setting. However, few studies have looked at the use of sc furosemide in an ambulatory population of chronic heart failure (HF) patients. Hypothesis: This ongoing study seeks to show the clinical efficacy and safety of subcutaneously administered furosemide are similar to the clinical efficacy and safety of IV furosemide in adult patients at the Johns Hopkins heart failure bridge clinic (HFBC). Methods: Chronic HF patients who present with clinical evidence of volume overload are randomized to receive either a bolus of IV furosemide or a sc infusion of furosemide in a non-blinded fashion. Diuretic dosing for patients with IV furosemide is determined based on a standardized conversion of the outpatient oral loop diuretic dose at a 1:1 ratio. Sc furosemide is delivered using a B Braun Perfusor Space Infusion System as 30 mg over the first hour followed by 12.5 mg per hour over the subsequent 4 hours for a total of 80 mg. Since the current formulation of furosemide injection is a buffered alkaline solution with a pH of about 9 and may cause irritation upon sc administration, a novel buffered formulation with a physiologic pH of 7.4 is used in this study. The primary endpoint is urine output at the end of 5 hours. Secondary endpoints include weight loss, natriuresis, and change in symptoms. Admissions at 30 days will also be tracked. Patients are monitored for side effects including hypokalemia and worsening renal function. A total of 40 patients are planned to be enrolled. Results: To date, 12 patients have been enrolled. The average age of the sc cohort (n = 7) is 60.3 years compared to 57.2 years for the IV cohort (n = 5). In the sc group, 29% of the patients are women compared to 20% of women in the IV cohort. In the sc group, 57% have a left ventricular ejection fraction (EF) of less than 55% compared to 80% in the IV group. The average urine output is 1214 mL over 5 hours in the sc group compared to 1325 mL in the IV cohort (P = .73). Patients in the sc furosemide cohort are losing an average of 2.4 pounds compared to 1.9 pounds in the IV furosemide cohort (P = .79). Urine output is similar across patients with reduced or preserved EF. Transient hypokalemia and significant worsening of renal function have not occurred in either the IV or sc furosemide cohorts. Conclusion: In this prospective, randomized study evaluating diuresis in ambulatory chronic HF patients presenting with volume overload, sc furosemide is similar to IV furosemide in urine output, weight loss and safety outcomes. Updated results will be presented at the meeting.

Renal biomarkers and outcomes in outpatients with heart failure: The Atlanta cardiomyopathy consortium

Background/objectivesCystatin-C and beta-2-microglobulin may be superior to serum creatinine, blood urea nitrogen (BUN), or estimated glomerular filtration rate (eGFR) in patients hospitalized with heart failure (HF). We compared these renal markers in ambulatory HF patients. MethodsWe prospectively evaluated the association of baseline renal markers and eGFR (by 4 different formulas) with (1) the composite of death or HF-related hospitalization and (2) rates of hospitalizations and emergency department (ED) visits in 166 outpatients with HF (57.3±11.6years; 57.2% white, 38.6% black, median left ventricular ejection fraction 27.5% [17.5, 40.0]). ResultsAfter a median of 3.9years, 63 (38.0%) patients met the composite endpoint. There were 458 hospitalizations (177 [38.6%] for HF) and 209 ED visits (51 [24.4%] for HF). Cystatin-based eGFR most consistently predicted (1) the composite endpoint (highest-to-lowest tertile adjusted hazard ratio [HR] 4.92 [95% CI 2.07–11.7; P<0.001]); and (2) hospitalization rates, including HF hospitalizations (highest-to-lowest tertile, adjusted relative rate 5.24 [95% CI 1.61–17.01; P=0.006]). Serum creatinine alone was a strong predictor of the composite endpoint (highest-to-lowest tertile, adjusted HR 3.20 [95% CI, 1.51–6.78; P=0.002]). Only the highest tertile of BUN was associated with rates of ED visits. ConclusionsIn outpatients with HF, cystatin-based eGFR provides consistent prognostication across outcomes, except ED visits. Serum creatinine is an adequate prognosticator of death or HF hospitalization.

(47) - Patient Reported Quality of Life with Mechanical Circulatory Support vs Continued Medical Therapy in Ambulatory Heart Failure Patients

(47) - Patient Reported Quality of Life with Mechanical Circulatory Support vs Continued Medical Therapy in Ambulatory Heart Failure Patients

(38) - Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP) - 2 Year Results

(38) - Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP) - 2 Year Results

Abstract 122: Attainment of Optimal Blood Pressure in Hypertensive Ambulatory Heart Failure Patients

Objective: We investigated the prevalence of blood pressure &lt;130/80 mmHg and studied factors associated with elevated blood pressure in hypertensive ambulatory heart failure patients. Methods: Records of 194 unselected consecutive heart failure patients were reviewed. Demographic and clinical data were collected. ANOVA, chi-square, and logistic regression analyses were used. Results: Systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg was achieved in 52.9% of patients, in 58.4% of men and in 41.6% of women (p=0.076). Patients with diabetes (62%) were more likely to achieve optimal blood pressure (46.4% of patients without diabetes, p=0.033). Age, depressed ejection fraction, body mass index, hemoglobin, creatinine clearance, and histories of dyslipidemia, coronary artery disease, or peripheral vascular disease were not predictive of suboptimal blood pressure control. There was no association between treatment with ACE inhibitors (52.5% of patients with optimal blood pressure vs. 47.8% of patients with suboptimal blood pressure, p=0.517), ARBs (16.8 vs. 15.6%, p=0.811), or beta-blockers (90 vs. 85.6%, p=0.336) and achieving optimal blood pressure. Patients with optimal blood pressure were more likely to have been treated with diuretics (65.3 vs. 50%, p=0.032) or aldosterone receptor antagonists (36.6 vs. 16.7%, p=0.017). Increased use of calcium-channel blockers (CCBs) (12.9 vs. 30%, p=0.003) was noted in patients with suboptimal blood pressure control. Conclusions: Only half of the hypertensive patients with heart failure achieved blood pressure less than 130/80 mmHg, and women were less likely than men to attain optimal blood pressure control. Optimal blood pressure control was more prevalent if the therapeutic regimen included diuretics or aldosterone receptor antagonists. Whether CCBs are used more commonly in patients with elevated blood pressure or whether CCBs are less useful for blood pressure control cannot be established.

Comparison of therapy of heart failure patients in the Czech Republic and Europe. Data from the ESC Heart Failure Long-Term Registry

IntroductionThe ESC Heart Failure Long-Term Registry (ESC-HFLTR) is a prospective observational study which takes place in 211 cardiology centres of 21 European and Mediterranean countries, members of the European Society of Cardiology. AimTo compare pharmacological and device therapy of both, the patients hospitalized for acute heart failure (HF) and the patients observed in outpatient clinics for chronic HF in the Czech Republic with published European-wide data. MethodsAltogether 692 consecutive patients were included into the Czech part of HFLTR (5.6% of the whole registry) from May 2011 to April 2013. These patients were either admitted to hospital or examined in outpatient clinic for HF during one predefined day of the week. The pharmacological and device therapy of 160 hospitalized (25.3%) and 532 ambulatory (74.7%) patients was analyzed statistically. The treatment of Czech ambulatory patients was finally compared with available data from the whole HFLTR. ResultsThe Czech in-hospital patients were intravenously treated generally with furosemide (in 89.3%), less frequently with nitrates (in 21.9%) and occasionally with inotropic agents (in 15.0%). In comparison with therapy before the hospital admission the patients at discharge received more frequently diuretics (69.4 vs. 87.5%; p<0.001) and mineralocorticoid receptor antagonist (MRA) (32.4 vs. 55.0%; p<0.001). The majority of Czech patients with chronic HF were treated according to current European guidelines. All prognostically relevant drugs used in HF were administered more often in the Czech HF population than in the whole HFLTR population (inhibitor of angiotensin converting enzyme or angiotensin receptor blocker in 92.8 vs. 89.2%; p=0.018, betablocker in 95.1 vs. 88.9%; p<0.001, MRA in 67.0 vs. 59.3%; p<0.001, respectively). The recommended target doses of these drugs were reached in about 20% of the Czech as well as the European HF patients. In addition, the Czech ambulatory HF patients underwent more often pacemaker implantation (47 vs. 42%; p=0.028), mainly due to more frequently indicated resynchronization therapy (56 vs. 30.2%; p<0.001). ConclusionCzech ambulatory HF patients are pharmacologically treated in accordance with current European HF guidelines and significantly better than the patients in the whole HFLTR. However, the recommended target doses were reached only in the minority of the patients.

Detection and prognostic value of pulmonary congestion by lung ultrasound in ambulatory heart failure patients

Pulmonary congestion is a common and important finding in heart failure (HF). While clinical examination and chest radiography are insensitive, lung ultrasound (LUS) is a novel technique that may detect and quantify subclinical pulmonary congestion. We sought to independently relate LUS and clinical findings to 6-month HF hospitalizations and all-cause mortality (composite primary outcome). We used LUS to examine 195 NYHA class II-IV HF patients (median age 66, 61% men, 74% white, ejection fraction 34%) during routine cardiology outpatient visits. Lung ultrasound was performed in eight chest zones with a pocket ultrasound device (median exam duration 2 min) and analysed offline. In 185 patients with adequate LUS images in all zones, the sum of B-lines (vertical lines on LUS) ranged from 0 to 13. B-lines, analysed by tertiles, were associated with clinical and laboratory markers of congestion. Thirty-two per cent of patients demonstrated ≥3 B-lines on LUS, yet 81% of these patients had no findings on auscultation. During the follow-up period, 50 patients (27%) were hospitalized for HF or died. Patients in the third tertile (≥3 B-lines) had a four-fold higher risk of the primary outcome (adjusted HR 4.08, 95% confidence interval, CI 1.95, 8.54; P < 0.001) compared with those in the first tertile and spent a significantly lower number of days alive and out of the hospital (125 days vs. 165 days; adjusted P < 0.001). Pulmonary congestion assessed by ultrasound is prevalent in ambulatory patients with chronic HF, is associated with other features of clinical congestion, and identifies those who have worse prognosis.

0153: Galectin 3 for risk stratification in ambulatory heart failure patients

Galectin-3 (Gal-3) is an emerging biomarker promising to assess prognosis in various pathophysiological conditions including heart failure (HF). The aim of this work was to investigate the prognosis interest of this marker in ambulatory patients with stable HF. Patients were included in this study in 2010. All patients gave informed consent. Clinical characteristics were registered and biomarkers were assessed. Clinical outcomes were registered regularly by a clinical follow-up or by phone by a dedicated physician. 180 patients (mean age 72.5y±12.5y) were included. Left ventricular ejection fraction was 37.1%±14.2%. Median (1st quartile – 3rd quartile) follow-up was 42.3 (12.3-47.1) months. Survival curves were built and data presented as means±SD when normally distributed. Patients who died during follow up had higher Gal-3 levels at baseline. In partial correlation analysis, Gal-3 level was negatively correlated to renal function assessed by CKD-EPI estimated glomerular filtration rate (Spearman’s rho=-0.252, p=0.003) and positively correlated to NT-proBNP (rho=0.367, p<0.001). Both Galectin-3 and NT-proBNP were significant predictors of all-cause mortality in univariate analysis. In multivariate Cox model, New York Heart Association class (Hazard ratio [95% CI], 1.52 [1-2,33] all cause mortality) and NT-proBNP (2.02 [1.05-3.89], p=0,035 for all cause mortality) remained significantly and indendently predictors of all cause and CV mortality. Galectin-3 provides information regarding risk of death in ambulatory heart failure patients and is tightly correlated to NT-proBNP and renal function.

The Biomarker Utility in Risk Stratification in an Ambulatory Heart Failure: ST2 or Galectin-3?

Heart failure (HF) is multi factorial syndrome with high cardiovascular (CV) morbidity and mortality rates associated with an increasingly prevalence worldwide. Measuring plasma levels of cardiac biomarkers may assist in prognostication of HF. However, the role of biomarker models in prediction of death and re-admission in ambulatory HF patients is not still understood. This editorial comment explores the knowledge regarding head-to-head comparison of galectin-3 and ST2 in risk stratification among ambulatory HF individuals. The comment is indicated sST2 and galectin-3 are recommended as alternate biomarkers with defined predictive value in HF and in generally patient population at high risk of HF manifestation. Recent clinical studies do not allow solving whether sST2 is superior then galectin-3 in ambulatory patient with stable HF because the received results are not obvious, although sST2 appears to be more attractive. Probably, more investigations are required to explain the role of each alternate biomarker in HF prognostication.

Improving the management of iron deficiency in ambulatory heart failure patients

Based on clinical trial data patients with heart failure (HF) and evidence of iron deficiency should be offered intravenous (iv) iron with the aim of improving exercise capacity and symptoms....

The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: A 10-year update

Mandeep R. Mehra, MD (Chair), Charles E. Canter, MD, Margaret M. Hannan, MD, Marc J. Semigran, MD, Patricia A. Uber, PharmD, David A. Baran, MD, Lara Danziger-Isakov, MD, MPH, James K. Kirklin, MD, Richard Kirk, MD, Sudhir S. Kushwaha, MD, Lars H. Lund, MD, PhD, Luciano Potena, MD, PhD, Heather J. Ross, MD, David O. Taylor, MD, Erik A.M. Verschuuren, MD, PhD, Andreas Zuckermann, MD and on behalf of the International Society for Heart Lung Transplantation (ISHLT) Infectious Diseases, Pediatric and Heart Failure and Transplantation Councils

Post-discharge heart failure monitoring program in Turkey: Hit-PoinT.

Objective:The aim of this study was to assess the efficacy and feasibility of an enhanced heart failure (HF) education with a 6-month telephone follow- up program in post-discharge ambulatory HF patients.Methods:The Hit-Point trial was a multicenter, randomized, controlled trial of enhanced HF education with a 6-month telephone follow-up program (EHFP) vs routine care (RC) in patients with HF and reduced ejection fraction. A total of 248 patients from 10 centers in various geographical areas were randomized: 125 to EHFP and 123 to RC. Education included information on adherence to treatment, symptom recognition, diet and fluid intake, weight monitoring, activity and exercise training. Patients were contacted by telephone after 1, 3, and 6 months. The primary study endpoint was cardiovascular death.Results:Although all-cause mortality didn’t differ between the EHFP and RC groups (p=NS), the percentage of cardiovascular deaths in the EHFP group was significantly lower than in the RC group at the 6-month follow up (5.6% vs. 8.9%, p=0.04). The median number of emergency room visits was one and the median number of all cause hospitalizations and heart failure hospitalizations were zero. Twenty-tree percent of the EHFP group and 35% of the RC group had more than a median number of emergency room visits (p=0.05). There was no significant difference regarding the median number of all–cause or heart failure hospitalizations. At baseline, 60% of patients in EHFP and 61% in RC were in NYHA Class III or IV, while at the 6-month follow up only 12% in EHFP and 32% in RC were in NYHA Class III or IV (p=0.001).Conclusion:These results demonstrate the potential clinical benefits of an enhanced HF education and follow up program led by a cardiologist in reducing cardiovascular deaths and number of emergency room visits with an improvement in functional capacity at 6 months in post-discharge ambulatory HF patients.

Association between Spirituality and Adherence to Management in Outpatients with Heart Failure.

BackgroundSpirituality may influence how patients cope with their illness.ObjectivesWe assessed whether spirituality may influence adherence to management of outpatients with heart failure.MethodsCross sectional study enrolling consecutive ambulatory heart failure patients in whom adherence to multidisciplinary treatment was evaluated. Patients were assessed for quality of life, depression, religiosity and spirituality utilizing validated questionnaires. Correlations between adherence and psychosocial variables of interest were obtained. Logistic regression models explored independent predictors of adherence.ResultsOne hundred and thirty patients (age 60 ± 13 years; 67% male) were interviewed. Adequate adherence score was observed in 38.5% of the patients. Neither depression nor religiosity was correlated to adherence, when assessed separately. Interestingly, spirituality, when assessed by both total score sum (r = 0.26; p = 0.003) and by all specific domains, was positively correlated to adherence. Finally, the combination of spirituality, religiosity and personal beliefs was an independent predictor of adherence when adjusted for demographics, clinical characteristics and psychosocial instruments.ConclusionSpirituality, religiosity and personal beliefs were the only variables consistently associated with compliance to medication in a cohort of outpatients with heart failure. Our data suggest that adequately addressing these aspects on patient’s care may lead to an improvement in adherence patterns in the complex heart failure management.

Dose Up-Titration Of Neurohormone Blockers For Chronic Heart Failure Treatment In Real Clinical Practice: Data From Single University Centre

Objective. To describe treatment peculiarities of ambulatory chronic heart failure patients’ in one of Lithuania’s university centres, participating in European Society of Cardiology EURObservation Research Programme (EORP) Heart Failure Long- Term Registry. Methods. 240 ambulatory patients with chronic heart failure were entered in European Society of Cardiology EURObservation Research Programme (EORP) Heart Failure Long-Term Registry from our university centre between May 2011 and March 2013. Follow-up data were collected after 12 months. Registered data about heart failure treatment were included to this study. Statistical analysis was performed with SPSS 22 program. Results. In our centre 67,1% of patients received angiotensin converting enzyme inhibitors at target doses, one third (34,3%) had not reached target doses due to symptomatic hypotension. Beta blockers were up-titrated to target doses for 82,5% of patients and the main reasons for failure to reach their target dose were: symptomatic bradycardia (12,7%), symptomatic hypotension (10,7%). Mineralocorticoid receptor antagonists were up-titrated to a target doses just for half of the patients – 52,1% and the most frequent reason for not reaching target doses was hyperkalemia (15,4%). Conclusions. Angiotensin converting enzyme inhibitors, beta-blockers and mineralocorticoid receptors antagonists, except angiotensin receptor blockers, were prescribed in a guideline-recommended doses. The main reasons why the target doses of neurohormone blockers have not been achieved were symptomatic hypotension for angiotensin converting enzyme inhibitors, symptomatic bradycardia for beta-blockers and hyperkalemia for mineralocorticoid receptors antagonists.

Abstract 12557: INTERMACS Profiles and Clinical Outcomes Among Ambulatory Patients With Systolic Heart Failure

Introduction: The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles are used to classify patients with heart failure (HF) considered for mechanical circulatory support (MCS). Limited data exist on the prognostic value of INTERMACS profiles in the general ambulatory HF population. Hypothesis: INTERMACS profiles identify systolic HF outpatients with distinct disease trajectories. Methods: We evaluated INTERMACS profiles, mortality, and healthcare resources utilization in 474 HF outpatients with left ventricular ejection fraction ≤40% who received care during a 3-month period in 2012 and were not on advanced therapies (MCS, heart transplant, or palliative inotropes). Patients whose HF severity did not meet any INTERMACS profile were classified as stage C. Results: Table 1 presents the distribution of patient characteristics across INTERMACS profiles. After a median follow-up of 3.1 years (interquartile range 1.6, 3.3), 95 patients died (3-year mortality 21.4%); 24 patients received MCS; and 11 received heart transplant (combined 3-year mortality, MCS, and transplant: 29.3%). Compared to stage C patients, mortality and hospitalization rates were higher in all INTERMACS profiles, Table 2 . Patients with profiles 4-5 demonstrated mortality and hospitalization rates similar to those with profiles 2-3, despite a higher use of advanced therapies in the latter. Conclusions: In ambulatory HF patients, all INTERMACS profiles are associated with significantly higher mortality and hospitalization rates compared to stage C patients. Outcomes in patients with profiles 2-3 are similar to those with the theoretically more benign profiles 4-5.

Abstract 13090: Beneficial Effects of Left Ventricular Assist Device Compared to Medical Therapy in Ambulatory Non-inotropic Dependent Heart Failure Patients in INTERMACS Profiles 4 vs 5-7: Results From the ROADMAP Study

Introduction: The role of left ventricular assist devices (LVAD) in advanced heart failure (HF) patients (pts) not dependent on intravenous inotropes is unclear. We hypothesize that the benefits of LVAD vs optimal medical management (OMM) are more pronounced in INTERMACS profile 4 (IM4) than profiles 5-7 (IM5-7). Methods: ROADMAP is a prospective, 41-center, non-randomized study of 200 pts. The objective was to evaluate the effectiveness and relative risks of HeartMate II LVAD support vs OMM in ambulatory NYHA Class IIIB/IV pts who met FDA indications for LVAD destination therapy but were non-inotrope dependent. The primary composite endpoint was survival with improvement in 6MWD ≥ 75m at 1 yr. Results: There were more LVAD pts in IM4 than IM5-7 (Table). Among IM4 pts, LVAD was 4.6X more likely than OMM to meet the primary endpoint, and 1 yr event-free survival as treated on original therapy was significantly greater for LVAD pts (Figure). The most frequent adverse event (AE) was bleeding for LVAD pts and worsening HF for OMM. For IM4 and IM5-7, LVAD pts had a higher composite of AEs compared to OMM, but freedom from rehospitalizations was similar for IM4. In OMM pts, 33% of IM4 and 15% of IM5-7 received delayed LVADs within 1 yr. Health related quality of life (HRQoL), severity of depression (PHQ-9), and NYHA class improved more at 1 yr with LVADs than OMM. Conclusions: Survival with improved functional status was better with LVADs compared to OMM in IM4 pts. HRQoL and depression improved more in all IM profiles with LVADs in spite of AEs being more frequent with LVADs. Results support the use of the HMII LVAD in functionally limited non-inotrope dependent HF patients, particularly those in IM4 profile.

Abstract 15631: The Hemodynamic Determinants and Physiologic Correlates of QTc Interval Using Impedance Cardiography in Heart Failure

Background: Prolonged QTc interval is a known risk factor for adverse cardiac events, including sudden and non-sudden cardiac death. Understanding the determinants and physiologic correlates of QTc can guide the proper strategy for the primary prevention of sudden death in high risk patients. Methods &amp; Results: This was an observational study that recruited ambulatory heart failure patients (NYHA I-III) from an outpatient clinic in NL, Canada. In supine resting position, consented participants underwent non-invasive 12-lead ECG and hemodynamic monitoring using BioZ Dx Impedance Cardiography (Sonosite Inc., WA, USA). ECGs were evaluated by a reviewer blinded to clinical data. Participants with pacing (n=12) or left bundle branch block (n=9) were excluded. Three measures of interest were automatically computed: (1) QTc interval (i.e., from QRS onset to T offset), (2) QRS duration (i.e., from QRS onset to QRS offset), and (3) JTc (i.e., QTc interval minus QRS duration). Effect sizes were computed using Pearson’s r coefficients. The final sample (n=23) was 62±13 years of age and 70% male with LVEF of 34±10%. The mean QTc was 441±39 milliseconds, and 10 patients (43%) had prolonged QTc (≥450 milliseconds). QTc interval negatively correlated with cardiac output (r= -0.57), and positively correlated with systemic vascular resistance (r= +0.57), as well as thoracic fluid content (r= +0.43). QRS duration alone was not specifically associated with any hemodynamic parameter, but JTc interval positively correlated with total arterial compliance (r=+0.42). Conclusions: In heart failure patients, we interestingly found that increased systemic vascular resistance results in QTc interval prolongation, where repolarization time is specifically influenced by arterial compliance. This suggests potential benefit from antihypertensive therapy targeted at lowering systemic vascular resistance in those with prolonged QTc/JTc. Nevertheless, these intervals need to be interpreted with caution in patients with thoracic fluid overload (e.g., pulmonary edema).