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

ClinicoEconomics and Outcomes Research Dovepress open access to scientific and medical research ClinicoEconomics and Outcomes Research downloaded from https://www.dovepress.com/ by 88.198.20.149 on 09-Oct-2019 For personal use only. Open Access Full Text Article ORIGINAL RESEARCH 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 This article was published in the following Dove Press journal: ClinicoEconomics and Outcomes Research Antonio HernándezMadrid 1 Xiaoxiao Lu 2 Stelios I Tsintzos 3 Dedra H Fagan 2 Ruth Nicholson Klepfer 2 Roberto Matía 1 Eugene S Chung 4 1 Arrhythmia Unit, Cardiology Department, Ramón y Cajal Hospital, Alcalá University, Madrid, Spain; 2 Medtronic, plc, Mounds View, MN, USA; 3 Medtronic, Tolochenaz, Switzerland; 4 The Christ Hospital Heart and Vascular Center, The Lindner Center for Research and Education, Cincinnati, OH, USA 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. Keywords: heart failure, ventricular pacing, effective pacing, hospitalization reduction, cost savings Introduction Correspondence: Antonio HernándezMadrid Arrhythmia Unit, Cardiology Department, Ramón y Cajal Hospital, Alcalá University, Ctra Colmenar Viejo, Km 9,1000, Madrid 28304, Spain Tel +34 91 336 9006 Email 385 submit your manuscript | www.dovepress.com ClinicoEconomics and Outcomes Research 2019:11 385–393 DovePress © 2019 Hernández-Madrid et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress. com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). http://doi.org/10.2147/CEOR.S205501 Powered by TCPDF (www.tcpdf.org) Heart failure (HF) is a complex disease in which the heart has an impaired ability to pump or fill with blood. Globally, an estimated 26 million people have heart failure, a number which is expected to increase with the aging population.1 In 2012, the total cost for HF in the USA was estimated to be US$30.7 billion dollars.2 The impact on the healthcare system and the patient is substantial, with approximately 1.1 million emergency department visits, 1 million hospitalizations, and 80,000 deaths due to primary HF in the USA in 2014 alone.3 Patients with HF experience significant impairment in both physical and mental aspects of quality of life along with a decline in day-to-day physical functioning.4 Dovepress ClinicoEconomics and Outcomes Research downloaded from https://www.dovepress.com/ by 88.198.20.149 on 09-Oct-2019 For personal use only. Hernández-Madrid et al Cardiac resynchronization therapy (CRT) is an established treatment for patients with symptomatic HF and reduced left ventricular ejection fraction (LVEF).5–7 Randomized, controlled clinical trials have consistently demonstrated a benefit in mortality, reduction in heart failure hospitalization (HFH), and symptomatic improvement.8–10 Although CRT has proven to be beneficial, not all patients respond to CRT, with nearly onethird of patients being classified as non-responders due to failure to respond symptomatically and/or lack of ventricular reverse remodeling.11,12 Failure to respond results in progression of HF, worsening of symptoms, increased hospitalization for HF, and increased mortality.13 Reasons for suboptimal response include both patient factors, such as arrhythmia, scar burden, lead location, and QRS morphology and duration as well as device factors, such as suboptimal atrioventricular (AV) timing and <90% biventricular (BiV) pacing.14 Maintaining delivery of CRT pacing is essential to these benefits, as even <10% reductions in pacing percentage have been shown to reduce survival benefit.15–17 In addition, ventricular pacing percentage as recorded by the device may not be an accurate index of consistent capture of the myocardium, which is required for effective pacing. The hOLter for Efficacy analysis (OLE) CRT study showed that the average percent ventricular (%V) pacing as reported by the device significantly overestimated the percent effective CRT (%e-CRT) pacing that captured the myocardium (94.8% vs 87.5%, P<0.001).18 A significant minority of subjects (18%) had a discrepancy of at least 3% points between the device recorded %V pacing and the %e-CRT pacing (mean 39% ±41%). When patients receive suboptimal CRT, more adverse events would be expected to increase the cost of care, primarily through increased hospitalizations. We sought to determine the impact of maximizing effective pacing delivery on HF hospitalizations and associated health-care expenditures from the US payer perspective. described in detail.19,20 The model estimated the expected number of hospital admissions due to HF, and respective financial impact in patients with effective pacing versus conventional pacing, over a lifetime (30 years) horizon. Figure 1 shows the Markov model structure that d (...truncated)