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Therapy guided by pulmonary artery (PA) pressure monitoring reduces PA pressures and heart failure hospitalizations (HFH) during the first year, but the durability of efficacy and safety through 2 years is not known.The CardioMEMS Post-Approval Study investigated whether benefit and safety were generalized and sustained. Enrollment at 104 centers in the United States included 1200 patients with NYHA Class III symptoms on recommended HF therapies with prior HFH. Therapy was adjusted toward PA diastolic pressure 8-20 mmHg. Intervention frequency and PA pressure reduction were most intense during first 90 days, with sustained reduction of PA diastolic pressure from baseline 24.7 mmHg to 21.0 at 1 year and 20.8 at 2 years for all patients. Patients completing two year follow-up (n = 710) showed similar 2-year reduction (23.9 to 20.8 mmHg), with reduction in PA mean pressure (33.7 to 29.4 mmHg) in patients with reduced left ventricular ejection. The HFH rate was 1.25 events/patient/year prior to sensor implant, 0.54 at 1 year, and 0.37 at 2 years, with 59% of patients free of HFH during follow-up.Reduction in PA pressures and hospitalizations were early and sustained during 2 years of PA pressure-guided management, with no signal of safety concerns regarding the implanted sensor.

Introduction Hemodynamic monitoring has been shown to reduce admissions for heart failure in both the large randomized CHAMPION Trial (CHMP) and a 1200 patient Post Approval Study registry (PAS). A persistent observation in heart failure (HF) studies is that trial patient populations differ from patients who are treated in clinical practice. After identifying patients who could be propensity matched to the CHMP trial patients, we studied the characteristics and outcomes of the patients who could not be matched. Methods PAS was an FDA mandated registry to determine if results of the CHMP trial could be replicated in clinical practice, as reported previously. Propensity matching was done between CHMP Control and PAS patients. 387 PAS patients could be propensity matched and can be considered “Trial-Type” patients (TT) and 813 were not match able (NM). For each patient group heart failure (HFH) and all-cause (ACH) hospitalization rates at 1 year were compared to the rate in the year prior to enrollment. Results Compared to CHMP Treatment patients, NM patients were older 61.3 vs 71.8, more likely to be female (18.1% vs 39.6%) and have heart failure with normal ejection fraction (HFpEF) (23% vs 55.9%), p Conclusion Of the 1200 patients in the PAS, 67% (813/1200) patients were not match able to typical trial subjects. Nonetheless, these patients with older age, worse renal function, and more hospitalizations still had significant reduction in rates of HFH and ACH during ambulatory hemodynamic monitoring.

Introduction Central sleep apnea (CSA) and heart failure (HF) often present with similar symptoms. Treatment of CSA primarily focuses on management of CSA-related symptoms such as frequent night-time awakenings or arousals, daytime sleepiness and reduced quality of life (QoL). Transvenous phrenic nerve stimulation (TPNS) has demonstrated improvements in sleep metrics and patient reported outcomes (PROs). Hypothethis To identify symptoms experienced by patients with HF and CSA and determine what types of improvements occur in the most symptomatic patients using TPNS. Methods Post-hoc analysis of baseline and 12-month data collected from patients (N = 75) with HF and moderate to severe CSA from the remedē System Pivotal Trial. Responses to questions pertaining to PROs (Epworth Sleepiness Scale [ESS] and Minnesota Living with Heart Failure Questionnaire [MLHFQ]) and clinical symptoms were analyzed to assess impact of TPNS therapy. Results Baseline clinical symptoms including nocturia (72%), reduced exercise capacity (61%), fatigue or weakness (69%), daytime sleepiness (77%), difficulty falling or staying asleep (52%), snoring (56%) and insomnia/fragmented sleep (51%) were reported by over half of the patients. By 12 months, 24%, 41%, 44%, 45%, 51%, 60% and 66% of the patients, respectively, no longer reported these specific clinical symptoms. On the baseline ESS, > = 50% of patients with HF reported moderate to high (2-3 on the scale) chance of dozing while sitting and reading (55%), watching television (56%) and lying down to rest in the afternoon (68%). For these patients with > = moderate at baseline, 71%, 52% and 35%, respectively, improved to less than moderate chance at 12 months. On the MLHFQ, 6/21 questions had > = 50% of subjects report that HF prevented them from living as they wanted moderately to very much (3-5 on the scale). Following 12 months of TPNS therapy, 33% to 71% of subjects improved from > = moderate at baseline to below moderate (Figure). NYHA functional class improved or remained stable in 89% (67/75) of subjects. Conclusion In the most symptomatic patients with CSA and HF, TPNS may improve symptoms and QoL, specifically related to sleep, sleepiness and fatigue. Heart failure patients with these symptoms may benefit from screening and subsequent treatment of CSA with TPNS.

Introduction Sex is often associated with divergent outcomes in cardiovascular disease. Response to pharmacologic and device-based therapy for heart failure (HF) may vary by sex, yet women are often underrepresented in clinical trials. We sought to examine possible sex differences in the response to ambulatory hemodynamic monitoring in clinical practice using the CardioMEMS Post-Approval Study (PAS). Methods The PAS was a prospective, single arm, multi-center, open-label study of 1200 adults (>18 years) with NYHA Class III HF and at least one HF hospitalization (HFH) within 12 months. Changes in PAP over time were stratified by EF ( Results The 452 (38% of total) women enrolled in the PAS were less likely to be white (78% vs. 86%, p Conclusions Women and men enrolled in the PAS had similar reductions from baseline in PAP over 1 year and experienced similar reductions in HFH at one year compared with the year prior. There were no differences in all-cause mortality between women and men when adjusting for baseline covariates. Hemodynamic monitoring provides similar benefit with regard to HF events in both women and men.

Introduction The most common type of central sleep apnea (CSA) breathing pattern in patients with heart failure (HF) is Cheyne-Stokes respiration (CSR). CSR manifests as a cyclical pattern of apnea and hyperventilation, with absence of airflow and respiratory effort followed by hyperventilation in a crescendo-decrescendo pattern. CSR may be a predictor of negative clinical outcomes in HF patients. Purpose Examine the response to transvenous phrenic nerve stimulation (TPNS) in patients with HF and different amounts of CSR. Methods Patients with CSA and HF who participated in the remedē System Pivotal Trial were divided into clinically relevant subgroups based on percentage of sleep in CSR (%CSR: 50%) during their baseline polysomnogram. The subgroups were analyzed for efficacy and safety by randomized group (TPNS vs control [no TPNS]). Epworth sleepiness scale (ESS) was also collected. Results At baseline, higher percentage CSR subgroups had lower left ventricular ejection fraction (median 45% for CSR 50%). Baseline apnea-hypopnea index (AHI) indicated severe CSA in all subgroups. All CSR subgroups receiving TPNS therapy had more than 50% of patients achieve ≥50% reduction in AHI at 6 months (see Table); control response rates were ≤11% in each CSR subgroup. The AHI decreased by ≥21 events/hour in each CSR subgroup on therapy while Control subgroups had little or no improvement. The central apnea index decreased to median ≤3 events/hour in each TPNS CSR subgroup; each control subgroup had median 22-24 events/hour remaining at 6 months. Baseline daytime sleepiness was worse in lower %CSR subgroups, however improved in all subgroups. No apparent relationship existed between %CSR and cardiovascular death in patients using TPNS therapy through 6 months, with the only death being in the 20-50% CSR subgroup; the death was determined not related to device, therapy or procedure by the clinical events committee. Further, 2/22 control subjects with CSR>50% experienced a cardiovascular death compared to 0/12 in the TPNS treated subgroup. Conclusions Transvenous phrenic nerve stimulation can treat CSA in HF patients regardless of the percentage of sleep in CSR and no signal of increased mortality was observed.

Introduction Central sleep apnea (CSA) is common in patients with heart failure. Many of these patients also have cardiac implantable electronic devices (CIED). The remedē® System is an implantable neurostimulator for CSA which transvenously stimulates the phrenic nerve to contract the diaphragm, restoring a normal breathing pattern and improving sleep, oxygenation and quality of life. In the remedē System Pivotal Trial, 44% (64/151) of patients had a prior CIED at the time of phrenic nerve stimulation (PNS) implant. Interaction testing was conducted at implant and therapy initiation (1 month post implant). Hypothesis PNS for the treatment of CSA is effective and safe in patients with a prior CIED. Methods Implant metrics, sleep metrics and related serious adverse events (AE) were compared based on the presence or absence of a CIED in patients enrolled in the remedē System Pivotal Trial. Results Of 64 subjects with a CIED, 33 (52%) had an ICD, 20 (31%) CRT-D, 10 (16%) PM, and 1 (2%) CRT-P. Implant metrics: remedē System implant time (2.7 ± 0.8 hours with vs 2.7 ± 0.9 hours without), fluoroscopy time (42 ± 22 min with vs 44 ± 23 min without) and contrast used (57 ± 51 cc with vs. 59 ± 59 cc without) were similar with or without CIED. Successful placement of a left-sided lead for PNS was similar with and without CIED (60% (38/64) vs. 67% (58/87)) as were improvements in central apnea index (-25.7 ± 18.0 events/hour with vs -19.8 ± 17.9 events/hour without) and oxygen desaturation ≥4% index (-23.4 ± 15.7 events/hour with vs -20.9 ± 19.2 events/hour without). Related serious AE through 24 months were lower in the CIED group overall with 8 events reported in 6 (9%) patients compared to 13 events in 11 (13%) patients in the group without CIED. The only event more prevalent in the CIED group was concomitant device interaction, with 4 CIED oversensing events reported in 3 patients resulting in the delivery of ICD therapy in 2 patients (1 shock, 1 anti-tachycardia pacing). Device interactions could be resolved by re-programming the PNS System in all patients without need for surgical revision. Improved concomitant device interaction testing procedures are part of device training and product labeling. Conclusion Phrenic nerve stimulation can effectively and safely treat CSA in patient with a CIED. Rare device interactions could be handled by reprogramming.

Background Acute decompensated heart failure (ADHF) is associated with a high rate of readmissions and mortality. Remote dielectric sensing (ReDS) fluid monitoring provides an accurate tool for non-invasive measurement of absolute lung fluid content, providing actionable information and a new tool for managing HF. Methods The SMILE trial was a prospective, multicenter, randomized clinical trial testing the hypothesis that post-discharge HF management guided by frequent in-home ReDS assessment is superior to usual care. Patients with a current hospitalization for ADHF, regardless of the LVEF, were enrolled in 43 US centers. Subjects randomized to the treatment arm were discharged home with the ReDS fluid monitor system and managed using ReDS measurements, according to protocol-defined algorithms. Control patients received usual care, without ReDS. The primary endpoint was recurrent (cumulative) ADHF hospitalizations, analyzed using the Andersen-Gill model with treatment group as the only covariate. Patients were followed for up to 9 months, until the last patient enrolled reached 3 months of follow-up. Results Between October 2015 and October 2017, 268 patients were randomized - 135 to treatment and 133 to control - and followed for 6.1±3.4 months. Patients were aged 68±12 years; 30% were women and 29% had LVEF≥40%. Pre-specified analysis of the per-protocol cohort demonstrated 21 readmissions in 15 ReDS patients compared to 43 readmissions in 34 control patients (HR 0.52, 95% CI [0.31-0.87], P=0.01) or a 48% readmissions reduction (Figure). Subgroup analysis by LVEF Conclusions The SMILE trial demonstrates a substantial reduction in recurrent ADHF hospitalizations and improvement in other outcome measures in recently discharged ADHF patients managed using daily ReDS assessment of absolute lung fluid content.

Background Risk stratification models using integrated device diagnostics have been developed to predict heart failure (HF) events. However, effective management strategies to reduce this HF risk have not been developed. The purpose of the INTERVENE-HF study was to determine whether a physician-directed, nurse-implemented ambulatory medication intervention strategy could be safely and effectively instituted in HF patients with an increased HF risk score. Methods A prospective, non-randomized, single arm, multi-center feasibility study was conducted in HF patients implanted with a Medtronic CRT-D device with Triage HF dynamic risk score (HFRS) diagnostic feature. HFRS was based on Bayesian analysis of CRT-D measured variables: transthoracic impedance, heart rate, heart rate variability, arrhythmia parameters, and activity. Ambulatory medication intervention strategy was remotely implemented by certified HF nurses (CHFN) following a guided action pathway triggered by a risk based alert. CHFN received alert notification to evaluate a patient when there was an impedance based OptiVolTM fluid threshold crossing. Patients not excluded due to safety or protocol-mandated criteria were managed by CHFN using a personalized, 3 day course of diuretic up titration (PRN Tx) prescribed by a physician at enrollment. Safety was monitored through daily CHFN remote review of weight, blood pressure and symptoms. Sufficient recovery after PRN Tx was defined as ≥ 70% recovery of impedance to baseline levels on day 4. If recovery criterion was not met on day 4, a second PRN Tx was initiated and impedance was reassessed on day 8. Results 66 patients had the alert feature enabled and were followed by CHFNs for 8.2 ± 3.9 months. CHFNs received alerts triggered by 49 OptiVolTM crossings. 23 of 49 crossings were not acted on due to safety or protocol-mandated criteria. 26 of 49 crossings received PRN Tx, 19 with 1 round, 7 with two rounds. Of 26 PRN Tx, 22 were completed, 19 led to ≥ 70% impedance recovery within 4 - 8 days. 4 interventions were stopped early for safety without leading to a serious adverse event (AE). 1 of 26 PRN Tx was followed by a HF event within 30 days of PRN Tx. Safety endpoint (# of PRN Tx without PRN Tx AE / # of PRN Tx) was 22/26 (85%). Effectiveness endpoint (# recovered without HF event within 14 days and without PRN Tx AE / # of PRN Tx) was 18/26 (69%). Conclusion An individualized risk stratification based ambulatory medication intervention strategy that is physician-directed and CHFN-implemented can be safely and successfully instituted in HF patients using an integrated device diagnostics based HF risk score.

Background Compare outcomes of ultrafiltration (UF) versus standard intravenous (IV) diuretics by continuous infusion or bolus injection in volume overloaded heart failure (HF) patients. In the Ultrafiltration versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated heart Failure (UNLOAD) study, UF produced greater fluid reduction and fewer HF rehospitalizations than IV diuretics in 200 hospitalized HF patients. Outcomes may be due to greater fluid removal, but UF removes more sodium/unit volume than diuretics. Methods and Results Outcomes of 100 patients randomized to UF were compared with those of patients randomized to standard IV diuretic therapy with continuous infusion (32) or bolus injections (68). Choice of diuretic therapy was by the treating physician. Forty-eight hour weight loss (kg): 5.0 ± 3.1 UF, 3.6 ± 3.5 continuous infusion, and 2.9 ± 3.5 bolus diuretics ( P = .001 UF versus bolus diuretic; P > .05 for the other comparisons). Net fluid loss (L): 4.6 ± 2.6 UF, 3.9 ± 2.7 continuous infusion, and 3.1 ± 2.6 bolus diuretics ( P P > .05 for the other comparisons). At 90 days, rehospitalizations plus unscheduled visits for HF/patient (rehospitalization equivalents) were fewer in UF group (0.65 ± 1.36) than in continuous infusion (2.29 ± 3.23; P = .016 versus UF) and bolus diuretics (1.31 ± 1.87; P = .050 versus UF) groups. No serum creatinine differences occurred between groups up to 90 days. Conclusions Despite similar fluid loss with UF and continuous diuretic infusion, fewer HF rehospitalizations equivalents occurred only with UF. Removal of isotonic fluid by UF compared with hypotonic urine by diuretics more effectively reduces total body sodium in congested HF patients.

Background Central sleep apnea is common in patients with cardiovascular disease and worsens outcomes. There is a lack of established therapies for central sleep apnea, and those available are limited by poor patient adherence and potentially adverse cardiovascular effects, at least in a subset of patients. The rem edē System (Respicardia, Minnetonka, Minnesota) is a new physiologic treatment that uses transvenous phrenic nerve stimulation to contract the diaphragm, thereby stabilizing gas exchange and restoring normal breathing throughout the sleep period. Methods This is a prospective multicenter randomized trial with blinded end points evaluating the safety and efficacy of the rem edē System. Up to 173 patients with central sleep apnea will be randomized 1:1 to rem edē System therapy initiated at 1 month after implantation (treatment) or to an implanted rem edē System that will remain inactive for 6 months (control). Primary efficacy end point is the percentage of patients who experience a reduction in apnea-hypopnea index by a ≥50% at 6 months (responder analysis). Primary safety end point is freedom from serious adverse events through 12 months. Secondary end points include sleep-disordered breathing parameters, sleep architecture, Epworth Sleepiness Scale score, and Patient Global Assessment. Conclusions This is the 1st randomized controlled trial of the safety and efficacy of the rem edē System for the treatment of central sleep apnea.

Background Daily measurements of left atrial pressure (LAP) may be useful for guiding adjustments in medical therapy that prevent clinical decompensation in patients with severe heart failure (HF). Study Design LAPTOP-HF is a prospective, multicenter, randomized, controlled clinical trial in ambulatory patients with advanced heart failure in which the safety and clinical effectiveness of a physician-directed patient self-management therapeutic strategy based on LAP measured twice daily by means of an implantable sensor will be compared with a control group receiving optimal medical therapy. The trial will enroll up to 730 patients with New York Heart Association functional class III symptoms and either a hospitalization for HF during the previous 12 months or an elevated B-type natriuretic peptide level, regardless of ejection fraction, at up to 75 investigational centers. Randomization to the treatment group or control group will be at a 1:1 ratio in 3 strata based on the ejection fraction (EF > or ≤35%) and the presence of a de novo CRT device indication. Summary LAPTOP-HF will provide essential information about the role of implantable LAP monitoring in conjunction with a new HF treatment paradigm across the spectrum of HF patients.

Background Left ventricular (LV) remodeling predicts poor outcomes in heart failure (HF) patients. The HeartNet ® cardiac restraint device (Paracor Medical Inc., Sunnyvale, CA) may reduce LV remodeling and improve functional capacity, quality of life, and outcomes in HF patients. To evaluate the safety and efficacy of the HeartNet Ventricular Support System in HF patients receiving optimal medical therapy. Methods and Results Prospective, randomized, controlled, multicenter trial in patients with symptomatic HF and LV ejection fraction ≤35% on optimal medical and device therapy. The primary efficacy end points were changes in peak VO 2 , 6-minute walk (6MW) distance, and Minnesota Living with Heart Failure (MLWHF) quality of life score at 6 months. The primary safety end point was all-cause mortality at 12 months. Because the planned adaptive interim analysis of the first 122 subjects with a completed 6-month follow-up indicated futility to reach the peak VO 2 end point, trial enrollment was suspended. Hence, the results on the 96 treatment and 114 control subjects are reported. Groups were similar at baseline. At 6 months, responder frequency for a prespecified improvement was similar between groups for peak VO 2 ( P = .502) and MLWHF score ( P = .184) but borderline higher for improvement in 6MW distance in the treatment compared with the control group (33 [38%] vs. 25 [25%]; P = .044). At 6 months, the treatment group had a significantly greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) ( P P = .032), LV end-diastolic diameter ( P = .015), LV end-systolic diameter ( P = .032), and LV end-diastolic volume ( P = .031) as compared with controls. At 12 months, all-cause mortality and responder rates were similar in the 2 groups. Success rate for the HeartNet implantation was 99%. Conclusion Enrollment in the trial was stopped because an interim analysis showed futility of reaching the peak VO 2 end point. However, because of the device safety and favorable signals for LV remodeling and quality of life, further investigation of this device is warranted.

Background The prevalence of renal dysfunction in patients hospitalized with acute decompensated heart failure remains poorly characterized. Methods and Results Data from 118,465 hospitalization episodes were evaluated. Glomerular filtration rate (GFR) was estimated using the abbreviated Modification of Diet in Renal Disease formula. At admission, 10,660 patients (9.0%) had normal renal function (GFR ≥ 90 mL·min·1.73 m2), 32,423 patients (27.4%) had mild renal dysfunction (GFR 60–89 mL·min·1.73 m2), 51,553 patients (43.5%) had moderate renal dysfunction (GFR 30–59 mL·min·1.73 m2), 15,553 patients (13.1%) had severe renal dysfunction (GFR 15–29 mL·min·1.73 m2), and 8276 patients (7.0%) had kidney failure (GFR < 15 mL·min·1.73 m2 or chronic dialysis). Despite this, only 33.4% of men and 27.3% of women were diagnosed with renal insufficiency. Diuretic dose, inotrope use, and nesiritide use increased, whereas angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker use decreased, with increasing renal dysfunction (all P < .0001 across stages). In-hospital mortality increased from 1.9% for patients with normal renal function to 7.6% and 6.5% for patients with severe dysfunction and kidney failure, respectively (P < .0001). Conclusions The majority of patients admitted with acute decompensated heart failure have significant renal impairment, which influences treatment and outcomes.

Differences in mortality are thought to exist between African Americans and Caucasians with heart failure. These differences may be due to a variety of factors, including differences in disease process, socioeconomic status, and access to health care. Additionally, little data exist on racial differences between these two groups after cardiac transplantation. This study examines a single center, urban experience in treating African Americans and Caucasians with heart failure and after cardiac transplantation. We hypothesize that treatment in a specialized, comprehensive heart failure/cardiac transplantation program results in similar survival between African Americans and Caucasians.We retrospectively reviewed the Rush Heart Failure and Cardiac Transplant Database from July 1994 to August 2000. Variables analyzed in the cardiomyopathy patients included survival (until death, placement of left ventricular assist device or cardiac transplantation), number of hospitalizations per year, length of stay per year, and utilization of outpatient resources. Follow-up period was from initial visit to death, transplantation, or implantation of left ventricular assist device. In those who underwent cardiac transplantation, we examined rejection rates (cellular and humoral), rejection burden, hospitalization data, and 5-year survival. A subgroup bridged to cardiac transplantation with a left ventricular device was also analyzed.Seven hundred thirty-four cardiomyopathy patients were identified: 203 were African Americans and 531 were Caucasians. The etiology of cardiomyopathy was more commonly ischemic in Caucasians as compared to non-ischemic in African Americans (P.01). African Americans had more admissions to the hospital per year compared with Caucasians, 1.2 +/- 2.1 versus.5 +/- 1.1 (P.01) with longer length of stay per year, 1.4 +/- 25.2 days versus 4.4 +/- 14.3 days (P.01). Utilization of outpatient resources was significantly higher in African Americans compared with Caucasians with more use of continuous inotropes (13% versus 6%, P.01), intermittent inotropes (11% versus 5%, P.01), and home nursing after hospital discharge (52% versus 32% of hospital discharges, P.01). Survival by Kaplan-Meier analysis was comparable between the two groups (mean survival 1,470 +/- 72 days in African Americans versus 1521 +/- 46 days in Caucasians, log rank test [P =.6]). During this time, 30 African Americans and 73 Caucasians underwent cardiac transplantation. Fifty-three were bridged to transplantation with a left ventricular assist device (20 African Americans, 33 Caucasians). There were no differences in 5-year survival by Kaplan-Meier analysis despite higher peak preoperative panel reactive antibody levels in African Americans versus Caucasians (12% +/- 30% compared with 5% +/- 15%, P =.04), more overall treated rejection episodes per year in the African Americans (P.01), as well as more posttransplant hospitalizations (2.2 +/- 1.2 times per year as compared with 1.7 +/- 2.1 times per year, P =.04).Delivery of care to heart failure patients in a comprehensive, specialized program results in similar survival regardless of race despite higher utilization of inpatient and outpatient resources. The finding that, after cardiac transplantation, African Americans do not have higher mortality rates, despite having higher rates of rejection overall and more hospitalizations, further supports the hypothesis that optimal care can improve outcomes despite unfavorable baseline clinical characteristics.

The goal of this double-blind, randomized, placebo-controlled trial was to evaluate the effects of a cross-linked polyelectrolyte (CLP) on serum potassium and measures of congestion in patients with heart failure (HF) and chronic kidney disease (CKD). The pre-specified primary endpoint was change in serumK+ over time, with an associated goal of facilitating the initiation of aldosterone blockers in patients at risk for hyperkalemia. Since CLP also removes fluid through the GI tract, we also hypothesized that this intervention would ameliorate congestion as assessed by serial weights and its associated symptoms, as assessed by NYHA class, quality of life (assessed by the KansasCityCardiomyopathyQuestionnaire (KCCQ), and 6minutewalk test (6MWT) after 8 weeks of CLP treatment. Results: 111 patients (mean age 69; 59% men) were randomized to CLP or placebo. Unexpectedly, CLP did not have a significant effect on serum K+, and there was no significant difference in the number of patients who could be titrated to a 50 mg spironolactone dose. However, as shown in Figure 1 below, weight loss was significantly greater in the CLP group at week 1 (-0,716 1.5 vs. -0.11 6 2.0 Kg, p50.014, and week 2 (-0.83 6 1.8 kg vs. -0.29 6 2.3 kg, p50.004). In addition, the proportion of subjects with marked or disabling dyspnea on exertion was lower in the CLP group and this difference increased over time (Figure 2). A highly significant (p50.005) improvement in the KCCQ was also observed after 4 weeks of treatment in the CLP group, with a somewhat lesser change at week 8. Safety evaluation: CLP was generally well tolerated, with 21 active patients and 16 placebo patients reporting adverse events, the majority of which were gastrointesFigure 1. Change in weight. tinal (abdominal discomfort (7 vs. 2), distension (3 vs. 1) or nausea (3 vs. 0). There were 4 deaths, all of which were in the CLP group. One occurred at Week 3 in a 70 year old man with NYHA class IV ischemic heart failure (LVEF520%). The second occurred at Week 4 in a 60 year old diabetic man with NYHA class III ischemic heart failure (LVEF 520%). The third death occurred at Week 6 in a 63 year old man with ischemic HF, worsening fluid retention, and progressive CKD. The fourth death Figure 2. Improvement in dyspnea. Figure 3. Improvement in KCCQ. SAEs (Events/Patient Year) Selected Adverse Events CircuLite (n514)*

Reliability and Validity Testing of the MD Anderson Symptom Inventory-Heart Failure (MDASI-HF): A Pilot Study of an Evaluative Instrument for Symptom Identification in Heart Failure Patients with Cancer Anecita P. Fadol, Jeanette G. Kernicki, Daniel J. Lenihan, Tito Mendoza, Charles S. Cleeland; Cardiology, The University of Texas MD Anderson Cancer Center, Houston, TX; College of Nursing, Texas Woman’s University, Houston, TX; Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX