2/3/2017. Objectives. Effective Heart Failure Management through Evidence Based Practice and Innovation

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1 Effective Heart Failure Management through Evidence Based Practice and Innovation Jennifer Bauerly RN, CHFN, APRN-BC CentraCare Heart and Vascular Center Objectives Describe the scope and impact of heart failure Outline the evidence based practice for effective management of heart failure Identify new technology, medication, and research opportunities SJM-MEM c Item approved for U.S. use only. 1 SJM-MEM c Item approved for U.S. use only. 3 Definitions Heart Failure Epidemic Heart failure / congestive heart failure = HF Heart failure with reduced ejection fraction </= 40% => HFrEF Heart failure with preserved ejection fraction > 40% => HFpEF Kannel, W. B. & Belanger, A. J. (1991). Epidemiology of heart failure. American Heart Journal, 121, SJM-MEM c Item approved for U.S. use only. 2 SJM-MEM c Item approved for U.S. use only. 4 1

2 Heart Failure Epidemic Burden on Society Heart failure is the #1 reason for hospital admission in patients age 65 and older million people in the U.S. with heart failure 2 670,000 new cases each year million hospital days 3 Heart failure costs the United States ~$31 billion annually ($0.31 / $1) 4 30 day readmission rates nationally ~ 25% 5 6 month readmission rate nationally ~ 50% 6 1. Hall MJ, Levant S, DeFrances CJ, et al. NCHS Data Brief: Hospitalization for Congestive Heart Failure: United States, NCHS Data Brief. 2012;(108): Institute for Healthcare Improvement. (2014). Congestive heart failure. Retrieved from 4. Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American HeartAssociation. Circulation. 2011;123(8): Krumholz HM, et al. Circ Cardiovas Qual Outcomes Wexler DJ, et al. Am Heart J SJM-MEM c Item approved for U.S. use only. 5 7 SJM-MEM c Item approved for U.S. use only. 7 U.S. Census Bureau Projections Economic Burden of HF Will Continue to Rise Through 2030* The population age 65 and older is expected to more than double between 2012 and 2060, from 43.1 million to 92.0 million. The older population would represent just over one in five U.S. residents by the end of the period, up from one in seven today. The increase in the number of the oldest old would be even more dramatic those 85 and older are projected to more than triple from 5.9 million to 18.2 million, reaching 4.3 percent of the total population. The AHA estimates that the total medical costs for HF are projected to increase to $70B by 2030 a 2-fold increase from % of the costs are attributed to hospitalization. 2 Graph: Heidenreich PA, et al. Circulation Heart Failure * Study projections assumes HF prevalence remains constant and continuation of current hospitalization practices U.S. Census Bureau 1. Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the impact of heart failure in the United States. A policy statement from the American Heart Association. Circ Heart Fail. 2013;6(3): Yancy CW, Jessup M, Bozkurt B, et al ACCF/AHA Guideline for the Management of Heart Failure: A report of the ACC/AHA Task Force on Practice Guidelines. Circulation. 2013;128(16):e SJM-MEM c Item approved for U.S. use only. 6 8 SJM-MEM c Item approved for U.S. use only. 8 2

3 Prognosis Diuretic Therapy About 50% of patients diagnosed with HF will die within 5 years (1) LVAD Destination Therapy (HMII Trial) Survival (%) % 63% Medical Management (REMATCH, NEJM 2001) 27% 10 8% Months Rev. Hosp. Clín. Fac. Med. S. Paulo 56(2):53-58, Mozzafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics 2016 update: a SJM-MEM c Item approved for U.S. use only. 9 report from the American Heart Association. Circulation. 2016;133:e38-e360 SJM-MEM c Item approved for U.S. use only. 11 Treatment of HFrEF New England Journal of Medicine (Mar 3, 2011) Loop diuretic (DOSE trial) Ace Inhibitor / Angiotensin II receptor blocker Beta-blocker (do not start in acutely decompensated patients) Carvedilol Metoprolol succinate Aldosterone antagonist (Rales, Ephesus, Emphasis-HF) Contraindicated with kidney failure and/or hyperkalemia Hydralazine + nitrate (V-HeFT and A-HeFT) Digoxin (re-hospitalization v. arrhythmia) SJM-MEM c Item approved for U.S. use only. 10 SJM-MEM c Item approved for U.S. use only. 12 3

4 ACE / BB / Aldo Antagonist (Triple Therapy) for HFrEF Shift Trial Results JACC 2003;7: Findings 6558 patients were randomly assigned to treatment groups (3268 ivabradine, 3290 placebo). Data were available for analysis for 3241 patients in the ivabradine group and 3264 patients allocated placebo. Median follow-up was 22 9 (IQR 18 28) months. 793 (24%) patients in the ivabradine group and 937 (29%) of those taking placebo had a primary endpoint event (HR 0 82, 95% CI , p<0 0001). The effects were driven mainly by hospital admissions for worsening heart failure (672 [21%] placebo vs 514 [16%] ivabradine; HR 0 74, ; p<0 0001) and deaths due to heart failure (151 [5%] vs 113 [3%]; HR 0 74, , p=0 014). Fewer serious adverse events occurred in the ivabradine group (3388 events) than in the placebo group (3847; p=0 025). 150 (5%) of ivabradine patients had symptomatic bradycardia compared with 32 (1%) of the placebo group (p<0 0001). Visual side-effects (phosphenes) were reported by 89 (3%) of patients on ivabradine and 17 (1%) on placebo (p<0 0001). Interpretation Our results support the importance of heart-rate reduction with ivabradine for improvement of clinical outcomes in heart failure and confirm the important role of heart rate in the pathophysiology of this disorder. SJM-MEM c Item approved for U.S. use only. 13 SJM-MEM c Item approved for U.S. use only. 15 Ivabradine Blocks the funny channel at the SA node Decreases heart rate Must be in sinus rhythm No effect on BP Visual side effects are possible SJM-MEM c Item approved for U.S. use only. 14 SJM-MEM c Item approved for U.S. use only. 16 4

5 Natriuretic Peptide System Where do ARNIs fit? Yancy CW et al. Heart Failure Focused Update on Pharmacologic Therapy Circulation April 2016 SJM-MEM c Item approved for U.S. use only. 17 SJM-MEM c Item approved for U.S. use only. 19 Sacubitril-valsartan ARNI (angiotensin receptor / neprilisyn inhibitor) FDA approved for the treatment of HFrEF Evidence-based Pharmacotherapy for HFrEF Ace Inhibitor / Angiotensin receptor blocker (LOE 1a) Beta-blocker (LOE 1a) Aldosterone antagonist (LOE 1a) Angiotensin Receptor Neprilisyn Inhibitor (LOE Ib) Ivabradine (LOE 2a) Hydralazine / nitrate (ACE/ARB intolerant or Af-Am) A Taylor, NEJM; Nov2004 SJM-MEM c Item approved for U.S. use only. 18 N Engl J Med 2014; 371: September 11, 2014 SJM-MEM c Item approved for U.S. use only. 20 5

6 ICD and Cardiac Resynchronization Therapy Guidelines on Device Therapy Class 1 Indication for CRT EF 35% or less with a LBBB and QRS 150 ms or greater in NSR Class 2a EF 35% or less with QRS or RV pacing SJM-MEM c Item approved for U.S. use only. 21 SJM-MEM c Item approved for U.S. use only. 23 Cardiac Device Therapy What about HFpEF? Volume control with sodium restriction, fluid restriction, diuretics, and daily weighing Goal directed therapy Heart rate +/- rhythm control Blood pressure control Treat sleep disordered breathing Paragon-HF Study Bardy, et al. N Engl J Med 2005; 352: January 20, 2005 Moss AJ, Hall WJ, Cannom SJM-MEM c DS, et al. Item N approved Engl for J U.S. Med use only SJM-MEM c Item approved for U.S. use only. 24 6

7 Physiology of pulmonary congestion Heart failure with preserved ejection fraction Spironolactone vs. placebo No difference in primary outcomes Benefit in North American population Reduction in hospitalization for heart failure Summary: Consider using spironolactone in HFpEF and GFR > 30 with K <5.0 SJM-MEM c Item approved for U.S. use only. 25 SJM-MEM c Item approved for U.S. use only. 27 Technology & Innovation Pulmonary artery pressure sensor Time Course of Decompensation HF management has relied on patient-reported symptoms, as well as impedance, blood pressure and weight gain changes that often manifest only after decompensation has begun. Physiologic Markers of Acute Decompensation [Insert Institution Logo] SJM-MEM c Item approved for U.S. use only. 26 * Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, SJM-MEM c Item approved for U.S. use only. 28 7

8 Champion Trial Results Using Technology & Innovation to Manage Heart Failure SJM-MEM c Item approved for U.S. use only. 29 SJM-MEM c Item approved for U.S. use only. 31 OnTrack to Health Results SJM-MEM c Item approved for U.S. use only. 30 SJM-MEM c Item approved for U.S. use only. 32 8

9 LVAD Technology SJM-MEM c Item approved for U.S. use only. 33 SJM-MEM c Item approved for U.S. use only. 35 Survival Comparison in Stage D Heart Failure J Am Coll Cardiol. 2015;65(23): SJM-MEM c Item approved for U.S. use only. 34 SJM-MEM c Item approved for U.S. use only. 36 9

10 Early Follow-up after HF Hospitalization HF Research at CentraCare Health PARAGON HF Using sacubitril-valsartan in HFpEF CardioMEMs Post-market approval study VICTORIA Using a PDE5i in HF EMBRACE Using cardiomems to measure PA pressure response with new diabetic medications LINQ Using a subcutaneous monitoring device to measure HF parameters SJM-MEM c Item approved for U.S. use only. 37 SJM-MEM c Item approved for U.S. use only. 39 AHA Get with the Guidelines Heart Failure Summary HF is a burden on the healthcare system and our society and it is projected to get worse Through evidence based therapies and best practices we can improve HF morbidity and mortality Novel technologies are proving to be very useful in the management of HF populations New options exist for patients with End-stage HF that can improve QOL and survival Ongoing research in the area of HF will be important in order to continue to reduce the burden of HF SJM-MEM c Item approved for U.S. use only. 38 SJM-MEM c Item approved for U.S. use only