The Value of Guideline Directed Medical Therapy in Heart Failure Steve Dentel RN BSN CPHQ National Director, Field Programs and Integration American Heart Association/American Stroke Association FINANCIAL DISCLOSURE: No relevant financial relationship exists 12/7/2016 2013, American Heart Association 2 1
The Need 5.7 million Americans are currently living with heart failure, and 670,000 new cases are diagnosed each year- up significantly from 500,000 cases annually just a few years ago. As our population ages, this epidemic of heart failure will only continue to grow. The cost of providing heart failure ranks among the leading U.S. healthcare expenditures. Additionally, the toll of heart failure on life, both in quality and longevity, is sobering. 12/7/2016 2010, American Heart Association 3 Estimated Direct and Indirect Costs of HF in US Hospitalization $20.9 53% Total Cost $39.2 billion 14% Nursing Home $4.7 8% Lost Productivity/ Mortality* $4.1 Home Healthcare $3.8 8% 10% 7% Physicians/Other Professionals $2.5 Drugs/Other Medical Durables $3.2 Circ Heart Fail. 2013 If one assumes all costs of cardiac care for HF patients are attributable to HF (no cost attribution to comorbid conditions), the 2030 projected cost estimates of treating patients with HF will be $160 billion in direct costs. 2
The Challenges that We Face Nearly one in four patients hospitalized with HF are rehospitalized within 30 days of discharge 30 day rates of rehospitalizations in HF have risen over the past 2 decades Rehospitalizations for HF vary widely by hospital, even after adjusting for case mix and other factors HF rehospitalizations may be preventable, but effective strategies to prevent rehospitalizations have been traditionally underutilized due to lack of incentives Most of the cost associated with the care of HF patients is attributable to these rehospitalizations 5 HF Readmission in 30 Days 2007-2009; N=1,330,157 329,308 rehospitalization; 24.8% Dharmarajan K et al. JAMA 2013:309:355 363. 3
Complexity of HF Care Albert NM, et al. Circ Heart Fail. 2015;8:384-409. 2013 ACCF/AHA Guideline for the Management of Heart Failure Developed in Collaboration With the American Academy of Family Physicians, American College of Chest Physicians, Heart Rhythm Society, and International Society for Heart and Lung Transplantation Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation American College of Cardiology Foundation and American Heart Association, Inc. 4
Stages, Phenotypes and Treatment of HF GDMT Guideline-Directed Medical Therapy GDMT, which stands for guideline-directed medical therapy. We used to say optimal medical therapy, but this is driven by guidelines. Why is this so important? 5
Maintenance of GDMT During Hospitalization I IIa IIb III In patients with HFrEF experiencing a symptomatic exacerbation of HF requiring hospitalization during chronic maintenance treatment with GDMT, it is recommended that GDMT be continued in the absence of hemodynamic instability or contraindications. I IIa IIb III Initiation of beta-blocker therapy is recommended after optimization of volume status and successful discontinuation of intravenous diuretics, vasodilators, and inotropic agents. Beta-blocker therapy should be initiated at a low dose and only in stable patients. Caution should be used when initiating beta blockers in patients who have required inotropes during their hospital course. 2013 ACCF/AHA Heart Failure Guidelines Pharmacologic Treatment for Stage C HFrEF Yancy C et al. Circulation, 2013 6
Pharmacological Therapy for Management of Stage C HFrEF Recommendations COR LOE Diuretics Diuretics are recommended in patients with HFrEF with fluid retention I C ACE Inhibitors ACE inhibitors are recommended for all patients with HFrEF I A ARBs ARBs are recommended in patients with HFrEF who are ACE inhibitor intolerant ARBs are reasonable as alternatives to ACE inhibitor as first line therapy in HFrEF The addition of an ARB may be considered in persistently symptomatic patients with HFrEF on GDMT Routine combined use of an ACE inhibitor, ARB, and aldosterone antagonist is potentially harmful I IIa IIb III: Harm A A A C Pharmacological Therapy for Management of Stage C HFrEF (cont.) Recommendations COR LOE Beta Blockers Use of 1 of the 3 beta blockers proven to reduce mortality is recommended for all stable patients Aldosterone Antagonists Aldosterone receptor antagonists are recommended in patients with NYHA class II-IV HF who have LVEF 35% Aldosterone receptor antagonists are recommended in patients following an acute MI who have LVEF 40% with symptoms of HF or DM Inappropriate use of aldosterone receptor antagonists may be harmful Hydralazine and Isosorbide Dinitrate The combination of hydralazine and isosorbide dinitrate is recommended for African-Americans, with NYHA class III IV HFrEF on GDMT A combination of hydralazine and isosorbide dinitrate can be useful in patients with HFrEF who cannot be given ACE inhibitors or ARBs I I I III: Harm I IIa A A B B A B 7
Pharmacologic Therapy for Management of Stage C HFrEF (cont.) Recommendations COR LOE Digoxin Digoxin can be beneficial in patients with HFrEF IIa B Anticoagulation Patients with chronic HF with permanent/persistent/paroxysmal AF and an additional risk factor for cardioembolic stroke should receive chronic anticoagulant therapy* The selection of an anticoagulant agent should be individualized I C Chronic anticoagulation is reasonable for patients with chronic HF who have permanent/persistent/paroxysmal AF but without an additional risk factor for cardioembolic stroke* IIa B Anticoagulation is not recommended in patients with chronic HFrEF without AF, prior thromboembolic event, or a cardioembolic source Statins Statins are not beneficial as adjunctive therapy when prescribed solely for HF I III: No Benefit III: No Benefit A B A Omega-3 Fatty Acids Omega-3 PUFA supplementation is reasonable to use as adjunctive therapy in HFrEF or HFpEF patients IIa B Pharmacological Therapy for Management of Stage C HFrEF (cont.) Recommendations COR LOE Other Drugs Nutritional supplements as treatment for HF are not recommended III: No in HFrEF Benefit B Hormonal therapies other than to replete deficiencies are not III: No recommended in HFrEF Benefit C Drugs known to adversely affect the clinical status of patients with HFrEF are potentially harmful and should be avoided or III: Harm B withdrawn Long-term use of an infusion of a positive inotropic drug is not recommended and may be harmful except as palliation III: Harm C Calcium Channel Blockers Calcium channel blocking drugs are not recommended as routine III: No in HFrEF Benefit A 8
New Guidelines Have Emerged- 2016 Pharmacologic Treatment for Stage C HFrEF- 2016 Strategies: Disease Management Genetic Counseling Frailty Assessments Palliative Care Co-morbidities Anemia Sleep disordered breathing Hypertension Atrial Fibrillation Devices Remote PA monitoring Wearable Vests Quality Improvement Process Improvement Patient Education Valsartan/Sacubutril Ivabradine 9
RAAS inhibition- 2016 Ivabradine 2016 10
Evidence-based medical therapy. Mitchell A. Psotka, and John R. Teerlink Circulation. 2016;133:2066-2075 Copyright American Heart Association, Inc. All rights reserved. Medical Therapy for Stage C HFrEF: Magnitude of Benefit Demonstrated in RCTs GDMT RR Reduction in Mortality NNT for Mortality Reduction (Standardized to 36 mo) RR Reduction in HF Hospitalizations ACE inhibitor or ARB 17% 26 31% Beta blocker 34% 9 41% Aldosterone antagonist 30% 6 35% Hydralazine/nitrate 43% 7 33% 11
Evidence-Based, Guideline-Recommended Heart Failure Therapies Guideline Recommended Relative Risk Reduction Number Needed to Treat NNT for Mortality Relative Risk Reduction in Therapy in Mortality for Mortality (standardized to 36 HF Hospitalizations months) ACEI/ARB 17% 22 over 42 months 26 31% ARNI 16% 36 over 27 months 27 21% Beta-blocker 34% 28 over 12 months 9 41% Aldosterone Antagonist 30% 9 over 24 months 6 35% Hydralazine/Nitrate 43% 25 over 10 months 7 33% Ivabradine 10% 100 over 23 months 64 26% CRT 36% 12 over 24 months 8 52% ICD 23% 14 over 60 months 23 NA Updated from Fonarow GC, et al. Am Heart J 2011;161:1024-1030. Potential Impact of Optimal Implementation of Evidence-Based HFrEF Therapies on Mortality Guideline Recommended Therapy HF Patient Population Eligible for Treatment, n* Current HF Population Eligible and Untreated, n (%) Potential Lives Saved per Year Potential Lives Saved per Year (Sensitivity Range*) ACEI/ARB 2,459,644 501,767 (20.4) 6516 (3336-11,260) Beta-blocker 2,512,560 361,809 (14.4) 12,922 (6616-22,329) Aldosterone Antagonist 603,014 385,326 (63.9) 21,407 (10,960-36,991) Hydralazine/Nitrate 150,754 139,749 (92.7) 6655 (3407-11,500) CRT 326,151 199,604 (61.2) 8317 (4258-14,372) ICD 1,725,732 852,512 (49.4) 12,179 (6236-21,045) Total - - 67,996 (34,813-117,497) ARNI (replacing ACEI/ARB) 2,287,296 2,287,296 (100) 28,484 (18,230-41,017) Updated from Fonarow GC, et al. Am Heart J 2011;161:1024-1030. and JAMA Cardiology 2016 12
Affordable Care Act Up to 3% cut to all DRGs for readmissions over the expected % Up to 1% in fiscal year 2013, 2% in fiscal year 2014, and 3% in fiscal year 2015 and beyond Initially AMI, heart failure, and pneumonia Expanded to COPD and hip/knee replacements in 2015 10 year decrease in reimbursement to hospitals $7.1 billion The proposed prospective payment systems began October 2012 (beginning of fiscal year 2013) Affordable Care Act In FY 2016, Medicare is penalizing 2592 hospitals Hospitals receive lower payments for every Medicare patient that stays in the hospital readmitted or not Total penalties FY 2016 are $420 million Average payment reduction is 0.61% Maximum penalty of 3% for 38 hospitals A total of 506 hospitals will lose 1% or more of their Medicare payments 13
Value of Care as Reported by Medicare in Hospital Compare Looking at payment measures together with quality-of-care measures (such as death rates) allows you to assess the value of care in hospitals. The payment measures add up the payments for care starting the day the patient enters the hospital and continuing for the next 30 days. For example, this can include payments to the hospital, doctor s office, skilled nursing facility, hospice, as well as patient co-pays made during this time. Death rate for heart failure patients Payment for heart failure patients No different than the National Rate Greater than the National Average Payment The National Death Rate for HF patients this reporting period was 11.6%. The National Average Payment for HF patients this reporting period was $15,223. Measuring and Improving the Quality of HF Care Heart failure remains a major public health problem resulting in substantial morbidity and mortality. A number of evidence-based, guideline-recommended therapies are available to treat patients with heart failure. However, study after study shows the large gaps, variations, and disparities in the use of these evidence based therapies in eligible patients. 15 14
Bridging the Gap Between Knowledge and Routine Clinical Practice ACC/AHA/H FSA Guidelines Systems Clinical Practice I IIa IIb III Clinical trial evidence National guidelines Implement evidence-based care Improve communications Ensure compliance Adapted from the American Heart Association. Get With The Guidelines; 2001. Improve quality of care Improve outcomes 20 Evidence Based Interventions to Reduce 30 Day Rehospitalization in HF Pre-discharge use of certain GDMT Pre-discharge HF education by trained educators Discharge medication programs Comprehensive discharge planning Early post-discharge physician follow-up Home visits by RNs and/or physicians Comprehensive HF disease management programs Implantable hemodynamic sensors 15
31 Most Comprehensive Measure Set Available Achievement Measures Quality Measures Reporting Measures ACEI/ARBs or ARNi at Aldosterone Antagonist at Blood Pressure Control at Discharge Discharge Discharge Evidence-Based Specific Anticoagulation for Atrial Beta Blocker at Discharge Beta Blockers Fibrillation and Atrial Flutter Beta Blocker Medication at Measure LV Function Hydralazine Nitrate at Discharge Post-Discharge Appointment Discharge Lipid-Lowering Medications for Heart Failure Patients DVT Prophylaxis at Discharge CRT-D or CRT-P Placed or Omega-3 Fatty Acid Prescribed at Discharge Supplement Use at ICD Counseling Provided or Discharge Prescribed or Placed at Diabetes Treatment Discharge Diabetes Teaching Influenza Vaccination During Smoking Cessation Flu Season Discharge Instructions Pneumococcal Vaccination ICD Placed or Prescribed at Follow-Up Visit Scheduled Discharge Within 7 Days or Less Advanced Care Plan ARNi at Discharge QRS Duration Documented Heart Failure Disease Management Program Referral Follow-Up Visit or Contact Within 48 Hours of Discharge Scheduled 12/7/2016 2010, American Heart Association 32 16
Most Comprehensive Measure Set Available Reporting Measures (Continued) Descriptive Measures Mortality & Readmission Measures Follow Up Visit or Contact Within 72 Hours of Discharge Scheduled 60 Minutes of Heart Failure Education Referral to AHA Heart Failure Interactive Workbook Referral to HF Disease Management, 60 Minutes Patient Education, Or HF Interactive Workbook Heart Failure Activity Level Heart Failure Diet Heart Failure Follow-Up Heart Failure Weight Heart Failure Symptoms Worsen Length of Stay Care Transition Record Transmitted Advance Directive Executed Discharge Disposition Ivabradine Prescribed Age Diagnosis Gender Race HF Composite Measure HF Defect-Free Measure JC/CMS HF Defect Free Measure Target: HF Defect Free Measure In-Hospital Mortality Risk Adjusted Mortality Ratio Readmission Frequency & Rate 30, 60 & 90 Day Readmissions & Rate Not equivalent to the CMS 30-Day Risk-Standardized Readmission Measure. It is not risk-adjusted, does not represent all cause readmission, and does not capture readmissions from other hospitals. 12/7/2016 2010, American Heart Association 33 17
35 Get With The Guidelines - Heart Failure Get With The Guidelines - Heart Failure launched in 2005 There are currently 4 Achievement Measures and 10 Quality Measures for participating hospitals to collect and report measuring how well their hospitals follow the AHA guidelines for HF Hospitals enrolled have several opportunities to be recognized for their efforts and are recognized at National events as mentioned above. As of November 2016, there are greater than 80 Get With The Guidelines manuscripts focused on Heart Failure. Please review them at www.heart.org 36 18
The American Heart Association is supported by 7 affiliates throughout the United States and make it possible to have our expert quality improvement field staff covering all 50 states plus Puerto Rico. With this structure, all hospitals throughout the nation are supported by at least one person who has significant experience in hospital/system/region/statewide quality improvement initiatives. Not only will this affiliate field staff review your hospital level data but they will also provide you with realworld recommendations that may help you improve the care your patients receive. Additionally, field staff will keep you updated on what is occurring within your city, state, and the nation in relation to quality improvement in cardiovascular services. Focus on Quality Suite of Programs are Supported by our Expert Field Staff Each affiliate staff person is supported by a Quality Improvement Vice President. With these two people, your hospital is well-supported and represented at the affiliate level and AHA National Center. 37 The Patient Management Tool The Get With The Guidelines Patient Management Tool (PMT) through Quintiles provides applications as easy-to-use web-based tools. o o The tools are online, interactive assessment and reporting systems that aid in Get With The Guidelines program implementation. The tools provide patient-specific American College of Cardiology/American Heart Association guideline information and enable each institution to track its adherence to the guidelines individually and against the AHA s national benchmarks over time. The PMT application is an important part of implementing Get With The Guidelines Heart Failure, Stroke, Resuscitation and AFIB programs because it helps hospital care teams manage each patient to the guidelines and reduces missed cases. These tools have demonstrated effectiveness in improving hospital compliance rates with guidelines. These programs also include technical support from the Quintiles help desk and one-onone support from the American Heart Association field staff. 38 19
Recognition from the American Heart Association Our goal is help hospitals improve care processes to therefore help us reach our Mission of Building Healthier Lives Free of Cardiovascular Disease and Stroke. Because our hospitals join us in this mission and see measurable results, we want to congratulate them for a job well done. Hospitals that meet eligibility criteria may apply for the Get With The Guidelines Performance Achievement Awards and will be recognized in USNWR advertisement, Circulation advertisement and the International Stroke Conference and Scientific Sessions Get With The Guidelines Achievement Awards 85% compliance for module specific Achievement Measures Bronze: 90 consecutive days Silver: 12 consecutive months Gold: 24 consecutive months Get With The Guidelines Plus Awards Must have current Silver or Gold Award for Get With The Guidelines Hospital may self select group of Quality Measures and demonstrate 75% compliance for same time period as Silver or Gold Award 39 GWTG-HF: Data Submission Number of records July 2016 20
GWTG-HF: Achievement Measures 1 0.9 0.8 0.7 Com pliance 0.6 0.5 0.4 0.3 0.2 0.1 0 Evidence-Based Post Discharge Composite LV Function ACEI or ARB at Beta Blocker at Discharge 100% Compliance Beta Blocker at Appointment for Performance Measurement D/C for LVSD Discharge Instructions Measure* D/C for LVSD HF patients Measure* Baseline 90.1% 81.2% 61.0% 87.3% 39.3% 69.7% 80.3% 62.1% Current 98.7% 92.8% 92.6% 98.2% 74.9% 95.7% 96.8% 93.0% Achievement Measure * Modified to include Beta Blocker at Discharge and Discharge Instructions rather than Evidence-Based Beta Blocker at D/C and Post Discharge Appointment Baseline = Admissions Jan2005 Dec2005 July 2016 Current = Overall GWTG-HF: Quality Measures (1) 1 0.9 0.8 0.7 Compliance 0.6 0.5 0.4 0.3 0.2 0.1 0 ICD Counseling or ICD placed or Warfarin at d/c Aldosterone antagonist at d/c for LVSD Hydralazine/Isosorbide at d/c for AA prescribed at D/C Baseline 57.3% 19.9% 10.8% 31.3% Current 84.7% 38.9% 29.8% 53.1% Quality Measure Baseline = Admissions Jan2005 Dec2005 July 2016 Current = Overall 21
GWTG-HF: Quality Measures (2) 1 0.9 0.8 0.7 Compliance 0.6 0.5 0.4 0.3 0.2 0.1 0 Pnemococcal Vaccine Influenza Vaccine Follow-up visit within 7 days or less DVT Management CRT placed or prescribed at discharge Baseline 22.9% 17.7% 61.9% 25.4% 39.9% Current 67.8% 76.9% 78.8% 84.1% 51.7% Quality Measure Baseline = Admissions Jan2009 Dec2009 July 2016 Current = Overall Conclusions Significant opportunities exist to improve the quality of care, care transitions, and outcomes for patients hospitalized with HF Improving care, including GDMT, and reducing preventable hospitalizations in HF is a national focus but very challenging Some programs and strategies have been successful in reducing (re)hospitalizations 22
Questions? 12/7/2016 2010, American Heart Association 45 23