Real-World Economic Burden Among Patients With And Without Heart Failure Worsening After Cardiac Resynchronization Therapy.

INTRODUCTION: Although cardiac resynchronization therapy (CRT) has the potential to improve cardiac function in patients with heart failure (HF), a considerable portion of patients do not respond to therapy. This study assessed the economic burden among patients with and without HF worsening after receiving CRT in real-world practice. METHODS: In this retrospective claims-based study using Optum's de-identified Clinformatics® Data Mart Database (January 2007-December 2018), adults who received CRT were stratified into two cohorts based on whether they showed evidence of HF worsening within 180 days post-CRT implantation. Inverse probability of treatment weighting (IPTW) was used to adjust for confounding, accounting for demographics (e.g., age, sex), the Quan-Charlson Comorbidity Index, other clinical characteristics, healthcare resource utilization (HRU), and healthcare costs during the 180 days pre-CRT (baseline period). Annualized all-cause and congestive HF-related HRU and healthcare costs from payer and patient perspectives were assessed from day 181 post-CRT (follow-up period), and compared between cohorts using incidence rate ratios (IRRs) and cost ratios (CRs). RESULTS: This study included 12,753 patients (n = 4785 with HF worsening; n = 7968 without). Mean age was 72 years and roughly two-thirds were male. Baseline characteristics were balanced between cohorts post-IPTW. During follow-up, patients with HF worsening had significantly greater annual all-cause inpatient [adjusted IRR (95% confidence interval) = 1.55 (1.44, 1.66), p < 0.001], outpatient [adjusted IRR = 1.46 (1.32, 1.61), p < 0.001], and emergency department [adjusted IRR = 1.31 (1.22, 1.41), p < 0.001] visits. Mean annual total per patient payer-paid amounts were significantly higher for patients with HF worsening versus without HF worsening [adjusted CR = 1.68 (1.56, 1.80), p < 0.001]. Annual patient-paid medical costs were also higher for patients with HF worsening [adjusted CR = 1.31 (1.25, 1.38), p < 0.001]. Results were similar for congestive HF-related HRU and costs. CONCLUSIONS: The incremental economic burden among patients with HF worsening following CRT is substantial. Efforts aimed at CRT optimization may help reduce this burden.

Economic value and cost-effectiveness of biventricular versus right ventricular pacing: results from the BLOCK-HF study.

Aims: The Biventricular vs Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK-HF) demonstrated that biventricular (BiV) pacing resulted in better clinical and structural outcomes compared to right ventricular (RV) pacing in patients with atrioventricular (AV) block and reduced left ventricular ejection fraction (LVEF; ≤50%). This study investigated the cost-effectiveness of BiV vs RV pacing in the patient population enrolled in the BLOCK-HF trial. Methods: All-cause mortality, New York Heart Association (NYHA) Class distribution over time, and NYHA-specific heart failure (HF)-related healthcare utilization rates were predicted using statistical models based on BLOCK-HF patient data. A proportion-in-state model calculated cost-effectiveness from the Medicare payer perspective. Results: The predicted patient survival was 6.78 years with RV and 7.52 years with BiV pacing, a 10.9% increase over lifetime. BiV pacing resulted in 0.41 more quality-adjusted life years (QALYs) compared to RV pacing, at an additional cost of $12,537. The "base-case" incremental cost-effectiveness ratio (ICER) was $30,860/QALY gained. Within the clinical sub-groups, the highest observed ICER was $43,687 (NYHA Class I). Patients receiving combined BiV pacing and defibrillation (BiV-D) devices were projected to benefit more (0.84 years gained) than BiV pacemaker (BiV-P) recipients (0.49 years gained), compared to dual-chamber pacemakers. Conclusions: BiV pacing in AV block patients improves survival and attenuates HF progression compared to RV pacing. ICERs were consistently below the US acceptability threshold ($50,000/QALY). From a US Medicare perspective, the additional up-front cost associated with offering BiV pacing to the BLOCK-HF patient population appears justified.

Heart failure hospitalization reduction and cost savings achieved by improved delivery of effective biventricular pacing: economic implications of the OLE study under the US setting.

Background: The hOLter for Efficacy analysis (OLE) study demonstrated that current device pacing diagnostics overestimate the amount of cardiac resynchronization therapy (CRT) pacing that effectively stimulates the cardiac tissue. Sub-optimal pacing increases mortality, hospitalizations, and associated health-care costs. We sought to estimate the expected number of hospital admissions due to heart failure (HF) and its respective financial impact in patients with maximized effective pacing versus conventional pacing. Methods: A Markov model was developed to project HF hospitalizations and quantify the costs that could be avoided if pacing was maximally effective. OLE data were used to inform the prevalence of ineffective pacing among CRT patients and and average loss of pacing by causes. Adaptive CRT trial data quantified the reduction in underlying hospitalization risk by increasing effective pacing delivered. Survival was informed by a meta-analysis of 5 randomized clinical trials. Costs were analyzed from a US payer perspective. Results: Projected average hospitalizations totaled 4.58 over a lifetime horizon for CRT patients with conventional pacing. Maximizing effective pacing delivery was projected to avoid 1.83 HF admissions/patient over the lifetime. This equates to a savings of 40% (US$22,802) compared with conventional pacing from the Medicare perspective. In a sensitivity analysis, CRT with effective pacing was projected to provide cost savings in all scenarios. Conclusions: Maximized effective pacing leads to a lower number of HF hospitalizations, thus allowing significant cost offsets in the US setting.

Heart Failure Site-Based Research in the United States: Results of the Heart Failure Society of America Research Network Survey.

OBJECTIVES: This study sought to determine clinician and scientist involvement in heart failure (HF) clinical research and to describe the challenges of conducting clinical trials in the United States. BACKGROUND: Improvements in the current capability, potential, and deficiencies of the HF clinical research infrastructure in the United States are needed in order to enhance efficiency and impact. METHODS: The Heart Failure Society of America (HFSA) distributed an electronic survey regarding HF clinical trial activity for the purpose of understanding the barriers that exist to conducting high-quality HF clinical research. RESULTS: Overall, 1,794 HFSA members were queried, and 434 members (24%) completed surveys, whereas a total of 7,589 individuals with interest in HF were queried, and 615 completed surveys. Of the respondents, 410 (67%) were actively engaged in HF research and 120 (20%) were interested in research. Most respondents, 270, were physicians (44%); 311 of the total (76% of the total and 80% of physicians) practiced in academic institutions; 333 respondents (81%) had served as principal investigators and 73 (18%) as site coordinators. Respondents active in clinical research usually participated in 1 to 5 trials and enrolled 1 to 20 patients annually. Institutional review board (IRB) approval typically required 3 months, and contract completion required 3 to 6 months per site. The greatest barriers to research were insufficient site budgets, delay in contracting, inability to find participants meeting trial entry criteria, and unavailability of qualified study coordinators. CONCLUSIONS: Many U.S. clinical research sites are constrained by budgetary, staffing, and contractual issues. The HFSA Research Network seeks to unify interested sites and deconstruct barriers to permit high-value HF research.

Algorithm-based assessment of target weight removal in acute decompensated heart failure.

Acute decompensated heart failure (ADHF) remains a leading cause of hospitalization. The majority of these patients are admitted for volume overload, with fluid removal as the main therapeutic target. Practice guidelines do not appoint methods for determining the amount of volume that should be removed. The authors hypothesize that rigorous, protocol-driven establishment of a target weight to be removed would enhance actual volume removal and short-term outcomes. Forty-seven patients admitted with ADHF were enrolled. Each patient had target weight removal (TWR) determined by a heart failure (HF) specialist (serving as the gold standard). Separately, a nurse practitioner calculated the TWR from an algorithm using: (1) baseline weight, (2) renal function, and (3) degree of lower extremity edema. There was good correlation of TWR from an algorithmic approach compared with expert determination (r2 =0.8). A total of 87% of patients reached a discharge weight within 20% of the TWR. A more standardized approach to estimating target weight loss for hospitalized HF patients approximates those of HF specialists. Furthermore, this algorithm could be utilized by general practitioners in settings where an HF specialist is not readily available.

Echocardiographic dyssynchrony and health status outcomes from cardiac resynchronization therapy: insights from the PROSPECT trial.

OBJECTIVES: This study sought to assess the prognostic utility of echocardiographic dyssynchrony for health status improvement after cardiac resynchronization therapy (CRT). BACKGROUND: Echocardiographic measures of dyssynchrony have been proposed for patient selection for CRT, but prospective validation studies are lacking. METHODS: A prospective cohort of 324 patients from 53 centers with moderate to severe heart failure, left ventricular dysfunction, QRS > or =130 ms, and available echocardiographic and health status information were identified from the PROSPECT (Predictors of Response to Cardiac Re-Synchronization Therapy) trial, which evaluated the prognostic utility of dyssynchrony measures in CRT recipients. The association of 12 echocardiographic dyssynchrony parameters with 6-month improvement in health status, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), was assessed both as a continuous variable and by responder status (DeltaKCCQ > or =+10 points reflecting moderate to large improvement). RESULTS: Of 12 pre-defined dyssynchrony parameters, only 3 were consistently reported: interventricular mechanical delay (IVMD), left ventricular filling time relative to the cardiac cycle (LVFT), and left ventricular pre-ejection interval. After multivariable adjustment, IVMD (+5.18, 95% confidence interval [CI]: +0.76 to +9.60; p = 0.02) and LVFT (+5.19, 95% CI: +0.45 to +0.94; p = 0.03) were independently associated with 6-month improvements in KCCQ. Patients with 6-month improvements in KCCQ had lower subsequent mortality (adjusted hazard ratio [HR] for each 5-point improvement: 0.83; 95% CI: 0.72 to 0.93; p = 0.03). Additionally, IVMD was associated with CRT responder status (for DeltaKCCQ > or =+10 points: odds ratio [OR]: 1.85; 95% CI: 1.12 to 3.05; p = 0.03), whereas LVFT was not (OR: 1.63; 95% CI: 0.85 to 3.11; p = 0.14). Patients classified as health status responders had a 76% lower subsequent risk of all-cause mortality (adjusted HR: 0.24; 95% CI: 0.07 to 0.84; p = 0.03). CONCLUSIONS: The presence of pre-implantation IVMD and LVFT was associated with 6-month health status improvement, and IVMD was associated with a significant CRT response. These echocardiographic factors may help clinicians counsel patients regarding their likelihood of symptomatic improvement with CRT. ( PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy; NCT00253357).