Abstract 19525: Heart Failure Readmission Rates: Clinical Experience With the C-Pulse® Extra-Aortic Counterpulsation System
Introduction:Heart failure-related readmission rates remain high. In the EFFECT phase I study, 61.3% of patients had repeat hospitalization within one year of initial discharge, with the majority occurring shortly postdischarge or near end of life. Analysis of Medicare beneficiaries from 2007-2009 of 1,330,157 heart failure (HF) hospitalizations found 35% of patients readmitted for the same condition within 30 days. Readmission (RA) reflects increased morbidity, impaired quality of life, and a growing economic burden on health care resources.
Hypothesis:The US feasibility investigational study gathered data to evaluate readmission in class III/ambulatory IV HF patients receiving an extra-aortic counterpulsation system (C-Pulse®, Sunshine Heart, Inc.) designed to increase coronary blood flow, reduce the workload of the left ventricle, and improve cardiac function.
Methods: Between April 2009 and June 2011, twenty HF patients were enrolled in a prospective US feasibility study undergoing C-Pulse device implantation procedures at 7 centers. RA data was collected at 30 days, 6 and 12 months post implant.
Results: The study included 12 males, 18 NYHA class III and 2 ambulatory NYHA class IV patients, 7 ischemic and 13 non-ischemic. Mean age was 56±7 years. Baseline ejection fraction (EF) was 28% ± 6.1. Over 12 months, 3 of the 20 implanted C-Pulse feasibility study patients (15%) had 5 HF hospitalizations after device implantation (Clinical Events Committee adjudicated, occurring at 208 days, 205 and 245 days, 33 and 52 days). Two of the three patients had low device usage compliance prior to HF events (<30% use).
Conclusion: Recently published data has demonstrated preliminary indications of safety and efficacy of counterpulsation therapy with the C-pulse system for the management of chronic HF. Lifetime analysis work from the EFFECT study has shown an overall RA rate of 61.3% at 12 months in patients suffering from HF. In comparison, RA rates for patients undergoing C-pulse implantation appear to be greatly reduced at 30 days and at one year. In addition, RA rates for patients undergoing C-pulse implantation are lower than RA rates reported for other forms of durable mechanical circulatory support at 30 days and 1 year.
Author Disclosures: S. Aggarwal: None. A. Kao: Speakers Bureau; Modest; Care DX. S.D. Prabhu: Consultant/Advisory Board; Modest; Sulfagenix, Genzyme. M.S. Slaughter: Consultant/Advisory Board; Modest; Sunshine Heart.
- © 2015 by American Heart Association, Inc.