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2 Get With The Guidelines Heart Failure PMT Spring Update September 9, 2013 Clyde W. Yancy, MD, MSc, FACC, FAHA, MACP Magerstadt Professor of Medicine Chief, Division of Cardiology Northwestern University, Feinberg School of Medicine & Associate Director, Bluhm Cardiovascular Institute Northwestern Memorial Hospital Winfred Kao Project Manger Outcome 9/9/2013 Sciences, Inc. a Quintiles Company 2010, American Heart Association 2

3 GWTG-HF PMT Status Year Initiated: 2005 Number of Hospitals Participating: 541 Total Patients Entered: 733,636 Total Patient Records Entered: 860,817 9/9/ , American Heart Association 3

4 GWTG-HF: Data Submission Number of records Jan-12 Apr-12 Jul-12 Oct-12 Jan-13 Apr-13 April 2013

5 GWTG-HF: Achievement Measures 100.0% 90.0% 80.0% 70.0% 60.0% Compliance 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% LV Function Measurement ACEI or ARB at D/C for LVSD Evidence-Based Beta Blocker at D/C for LVSD Beta Blocker at Discharge Post Discharge Appointment for HF patients Discharge Instructions Composite Performance Measure* 100% Compliance Measure* Baseline 90.1% 81.2% 61.0% 87.3% 39.3% 69.7% 80.3% 62.1% Current 96.6% 95.2% 84.2% 97.3% 50.6% 93.5% 93.6% 88.8% 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 April 2013 Current = Overall

6 GWTG-HF: Quality Measures (1) 100.0% 90.0% 80.0% 70.0% Compliance 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Warfarin at d/c Aldosterone antagonist at d/c for LVSD Hydralazine/Isosorbide at d/c for AA ICD Counseling or ICD placed or prescribed at D/C Baseline 57.3% 19.9% 10.8% 31.3% Current 79.0% 28.2% 20.6% 39.7% Quality Measure Baseline = Admissions Jan2005 Dec2005 April 2013 Current = Overall

7 GWTG-HF: Quality Measures (2) 100.0% 90.0% 80.0% 70.0% Compliance 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 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 56.6% 57.1% 78.5% 66.1% 49.8% Quality Measure Baseline = Admissions Jan2009 Dec2009 April 2013 Current = Overall

8 Active Heart Failure Achievement Awards Bronze Silver Silver Plus Gold Gold Plus Target HF Total Awards Data source: Microsoft Dynamics as of

9

10 General Update Timelines Fall 2013 Release (Important Dates) User Acceptance Testing September 26 th October 7 th. Release goes live on Saturday, October 19 th, 2013 Spring 2014 Release User Acceptance Testing March 2013 Release goes live April 2013

11 Heart Failure PMT Update- Highlights Updated Data Elements New Data Elements Retired Data Element New Measures Data Elements and Measures to Support Advanced Certification in Heart Failure 08/21/ , American Heart Association 11

12 Updated Data Element If yes, DVT therapies: Retiring GCS as a response option from DVT Therapies. Updating therapies to be multi-select Element NOT used in DVT measure and DVT measure will NOT change 9/9/ , American Heart Association 12

13 Updated and Retired Data Elements Anticoagulant Medication at discharge: - Adding 15mg and 20mg response options to rivaroxaban - Adding Other and Unknown response options to Dose and Frequency for the Pradaxa, Iprivask, Atrixa, Eliquis, and Xareleto so user can select Other in the event the dose or frequency is not available for selection the list or Unknown in the event it is not known. Beta Blocker Medications at discharge : - Retiring Cartol 9/9/ , American Heart Association 13

14 Retired Data Element Retiring data element In-Hospital Death as it is redundant of Discharge Disposition. Adding a Mortality section to the bi-annual Data Quality Reports provided to individual sites. Sites with 50 or more records entered for the last 12 months and <.5% mortality rate would be flagged in the report with a notation regarding the importance of entering all patients, including in-hospital deaths. Two mortality measures: In-Hospital Mortality and Risk Adjusted Morality Ratio, will be modified to include either a response of Yes to In-hospital Death or a Discharge Disposition/status of Expired. 9/9/ , American Heart Association 14

15 New Element: If Home, special discharge circumstances Optional for record completion Tracks patients who fall under the broader CMS discharge category of 1- Home, but may have special circumstances hindering care transitions such as homelessness, incarceration or are international. NOT used to exclude patients from any post-discharge follow-up or care transition measure. New 9/9/ , American Heart Association 15

16 New Data Elements to Support New Advanced HF Measures Three new data elements will be added to support ACHF Measures Coding will be pulled from TJC ACHF Manual for these elements

17 New GWTG Advanced HF Measures TJC Measure Beta-Blocker Therapy (i.e., Bisoprolol, Carvedilol, or Sustained-Release Metoprolol Succinate) for LVSD Prescribed at Discharge Post Discharge Appointment for HF Patients: Patients for whom a follow-up appointment for an office or home health visit for management of heart failure was scheduled within 7 days postdischarge and documented, including location, date and time. Post-Discharge Evaluation for Heart Failure Patients: Patients who receive a re-evaluation for symptoms worsening and treatment compliance by a program team member within 72 hours after inpatient discharge. Care Transition Record Transmitted. Discussion of Advance Directives/Advance Care Planning Advance Directive Executed GWTG Measure Evidence-Based Specific Beta Blockers: Percent of heart failure patients who were prescribed with evidencebased specific beta blockers (Bisoprolol, Carvedilol, Metoprolol Succinate CR/XL) at discharge. Follow-up Visit Within 7 Days or Less: Percent of eligible heart failure patients who underwent a follow-up visit within 7 days or less from time of hospital discharge. Follow-Up Visit or Contact Within 72 Hours of Discharge Scheduled: Percent of heart failure patients who had a follow-up visit or phone call scheduled to take place within 72 hours or less of hospital discharge. Care Transmission Record Transmitted Advance Care Plan/Surrogate Decision Maker Advance Direction Executed New! New!

18 Advance Directive Executed: Percent of patients who have documentation in the medical record that an advance directive was executed. Denominator Patients with a principle diagnosis of heart failure Exclude Patients less than 18 years of age Comfort Measures only Patients who had a Left Ventricular Assist Device implanted or a heart transplant during this hospitalization Patients who are discharged to home hospice, hospice in a healthcare facility, transferred to another acute care hospital, discharged to other healthcare facility, or expired. Numerator Patients for whom there is documentation in the medical that an advance directive was executed ICD-9 Principle Diagnosis Code: HF OR Cardiac Diagnosis: Heart Failure, no CAD or Heart Failure with CAD Age: < 18 years OR Comfort Measures Only: Day 0 or 1, Day 2 or after, or Time unclear) OR Procedures: Left Ventricular Assist Device OR Transplant (Heart) OR Discharge Disposition: 2 Hospice Home, 3 Hospice Health Care Facility, 4 Acute Care Facility, 6 Expired Advance Directive Executed?: Yes

19 Care Transition Record Transmitted: A care transition record is transmitted to a next level of care provider within 7 days of discharge containing ALL of the care transition record components Denominator Patients with a principle diagnosis of heart failure ICD-9 Principle Diagnosis Code: HF OR Cardiac Diagnosis: Heart Failure, no CAD or Heart Failure with CAD Exclude Patients less than 18 years of age Comfort Measures only Patients who had a Left Ventricular Assist Device implanted or a heart transplant during this hospitalization Patients who are discharged to home hospice, hospice healthcare facility, transferred to acute care hospital, discharged to other, expired, or AMA Numerator Patients for whom a care transition record was transmitted within 7 days of discharge to a that included all of the following: discharge Must medications, contain follow-up ALL requisite treatment(s) and service(s) components needed, procedures performed during this hospitalization, reason for hospitalization, and treatment(s)/service(s) provided. AND Be transmitted by 7 th post discharge day. Age: < 18 years OR Comfort Measures Only: Day 0 or 1, Day 2 or after, or time unclear OR Procedures: Left Ventricular Assist Device OR Transplant (Heart) Discharge Disposition: 2 Hospice Home, 3 Hospice Health Care Facility, 4 Acute Care Facility, 5 Other Healthcare Facility, 6 Expired, 7 Left Against Medical Advice/AMA Care Transition Record-Discharge Medications: Yes AND Care Transition Record-Follow-Up Treatment(s) and Service(s) Needed: Yes AND Care Transition Record-Procedures Performed During Hospitalization: Yes AND Care Transition Record-Reason for Hospitalization: Yes AND Care Transition Record-Treatment(s)/Service(s) Provided: Yes AND Care Transition Record Transmitted: By the7th post-discharge day

20 Report Bundles for ACHF Adding a measure bundle to the Limited and Full HF forms report drop down called "GWTG Advanced HF Measures so sites can run GWTG AHF Measures with one selection.

21 Under Consideration for January 2014 TJC ACHF Tab Sites using GWTG to collect and submit ACHF measures to TJC will need the elements and measures exactly as specified in the TJC algorithm. Outcome may create a TJC-ACHF tab, similar to what they have done in GWTG Stroke with the Core Measures Tab. GWTG Elements Elements that are not 100% equivalent will appear on the TJC- ACHF Tab and where possible would be auto-populated. TJC ACHF

22 New Measures - Reporting Specific Type of Beta Blocker : We will add two Reporting measures that provide a specific breakdown of the percent of patients discharged one each of the eleven Beta Blocker Medications tracked in GWTG-HF. Beta Blocker Medication at Discharge (eligible patients) follows the exclusion logic (EF >40, contraindications, CMO, and applicable discharge destinations) of our Evidenced Based Beta Blocker Achievement Measure Beta Blocker at Discharge (all patients) includes all patients discharged on a beta blocker regardless of eligibility criteria. Discharge Disposition: Provides a breakdown of patients by discharge disposition.

23 Sample Report Beta Blocker Medication at Discharge (eligible patients)

24 Updated Data Elements Payment Source: Updated to more appropriately reflect the response categories. What is the patient s source of payment for this episode of care?: To streamline data collection, we will move What is the patient s source of payment for this episode of care? to the Admin/Core Measure tab. It will be auto-populated Medicare and Non-Medicare based on appropriate Payment Source response options. This aligns with how it is implemented within stroke. 9/9/ , American Heart Association 27

25 Enhanced Patient Records Report Report will now show Unknown if selected as response option in date/time fields. This will allow users to distinguish between elements that were marked as Unknown by the abstractor and elements that were left blank. Unknown

26 Adding PLUS Award Display Option Plus Award Goal 75% Adding Plus Goal Display

27 1) Adding Referral to HF Disease Management, 60 minutes of HF Education, or Referral to the HF Interactive Workbook measure to the tab so sites can run ALL THF measures at the patient level. 2) Adding a link to Measure Logic and Rationale document.

28 2013 ACCF/AHA Guideline for the Management of Heart Failure 829e8776 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.

29 ACCF/AHA Heart Failure Guideline Writing Committee Members Clyde W. Yancy, MD, MSc, FACC, FAHA, Chair Mariell Jessup, MD, FACC, FAHA, Vice Chair* Biykem Bozkurt, MD, PhD, FACC, FAHA Javed Butler, MBBS, FACC, FAHA* Donald E. Casey, Jr, MD, MPH, MBA, FACP, FAHA Mark H. Drazner, MD, MSc, FACC, FAHA* Gregg C. Fonarow, MD, FACC, FAHA* Stephen A. Geraci, MD, FACC, FAHA, FCCP Tamara Horwich, MD, FACC James L. Januzzi, MD, FACC* Maryl R. Johnson, MD, FACC, FAHA Edward K. Kasper, MD, FACC, FAHA Wayne C. Levy, MD, FACC* Frederick A. Masoudi, MD, MSPH, FACC, FAHA # Patrick E. McBride, MD, MPH, FACC** John J.V. McMurray, MD, FACC* Judith E. Mitchell, MD, FACC, FAHA Pamela N. Peterson, MD, MSPH, FACC, FAHA Barbara Riegel, DNSc, RN, FAHA Flora Sam, MD, FACC, FAHA Lynne W. Stevenson, MD, FACC* W.H. Wilson Tang, MD, FACC* Emily J. Tsai, MD, FACC Bruce L. Wilkoff, MD, FACC, FHRS* *Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply; see Appendix 1 for recusal information. ACCF/AHA Representative. ACCF/AHA Task Force on Practice Guidelines Liaison. American College of Physicians Representative. American College of Chest Physicians Representative. International Society for Heart and Lung Transplantation Representative. #ACCF/AHA Task Force on Performance Measures Liaison. **American Academy of Family Physicians Representative. Heart Rhythm Society Representative.

30 Stages, Phenotypes and Treatment of HF

31 efinition of Heart Failure Classification I. Heart Failure with Reduced Ejection Fraction (HFrEF) Ejection Description Fraction 40% Also referred to as systolic HF. Randomized clinical trials have mainly enrolled patients with HFrEF and it is only in these patients that efficacious therapies have been demonstrated to date. II. Heart Failure with Preserved Ejection Fraction (HFpEF) 50% Also referred to as diastolic HF. Several different criteria have been used to further define HFpEF. The diagnosis of HFpEF is challenging because it is largely one of excluding other potential noncardiac causes of symptoms suggestive of HF. To date, efficacious therapies have not been identified. a. HFpEF, Borderline 41% to 49% These patients fall into a borderline or intermediate group. Their characteristics, treatment patterns, and outcomes appear similar to those of patient with HFpEF. b. HFpEF, Improved >40% It has been recognized that a subset of patients with HFpEF previously had HFrEF. These patients with improvement or recovery in EF may be clinically distinct from those with persistently preserved or reduced EF. Further research is needed to better characterize these patients.

32 Classification of Heart Failure A B C D ACCF/AHA Stages of HF At high risk for HF but without structural heart disease or symptoms of HF. Structural heart disease but without signs or symptoms of HF. Structural heart disease with prior or current symptoms of HF. Refractory HF requiring specialized interventions. None I I II III IV NYHA Functional Classification No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF. Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF. Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest.

33 Treatment of Stages A to D Pharmacological Treatment for Stage C HFrEF

34 Pharmacologic Treatment for Stage C HFrEF

35 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%

36 Treatment of Stages A to D Treatment for Stage C HFpEF

37 Treatment of HFpEF Recommendations COR LOE Systolic and diastolic blood pressure should be controlled according to published clinical practice guidelines I B Diuretics should be used for relief of symptoms due to volume overload Coronary revascularization for patients with CAD in whom angina or demonstrable myocardial ischemia is present despite GDMT Management of AF according to published clinical practice guidelines for HFpEF to improve symptomatic HF Use of beta-blocking agents, ACE inhibitors, and ARBs for hypertension in HFpEF ARBs might be considered to decrease hospitalizations in HFpEF Nutritional supplementation is not recommended in HFpEF I IIa IIa IIa IIb III: No Benefit C C C C B C

38 Treatment of Stages A to D Device Treatment for Stage C HFrEF

39 Indications for CRT Therapy

40 Guideline for HF The Hospitalized Patient

41 Hospital Discharge Recommendation or Indication COR LOE Performance improvement systems in the hospital and early postdischarge outpatient setting to identify HF for GDMT I B Before hospital discharge, at the first postdischarge visit, and in subsequent follow-up visits, the following should be addressed: a) initiation of GDMT if not done or contraindicated; b) causes of HF, barriers to care, and limitations in support; c) assessment of volume status and blood pressure with adjustment of HF therapy; d) optimization of chronic oral HF therapy; e) renal function and electrolytes; f) management of comorbid conditions; g) HF education, self-care, emergency plans, and adherence; and h) palliative or hospice care. I B Multidisciplinary HF disease-management programs for patients at high risk for hospital readmission are recommended A follow-up visit within 7 to 14 days and/or a telephone follow-up within 3 days of hospital discharge is reasonable Use of clinical risk-prediction tools and/or biomarkers to identify higher-risk patients is reasonable I IIa IIa B B B

42 ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set Measure Description* Care Setting 1. LVEF Percentage of patients aged 18 y with a diagnosis of HF for whom the assessment quantitative or qualitative results of a recent or prior (any time in the 2. LVEF assessment 3. Symptom and activity assessment past) LVEF assessment is documented within a 12 mo period Percentage of patients aged 18 y with a principal discharge diagnosis of HF with documentation in the hospital record of the results of an LVEF assessment that was performed either before arrival or during hospitalization, OR documentation in the hospital record that LVEF assessment is planned for after discharge Percentage of patient visits for those patients aged 18 y with a diagnosis of HF with quantitative results of an evaluation of both current level of activity and clinical symptoms documented Level of Measurement Outpatient Individual practitioner Inpatient Individual practitioner Facility Outpatien t Individual practitioner *Please refer to the complete measures for comprehensive information, including measure exception. Adapted from Bonow et al. J Am Coll Cardiol. 2012;59:

43 ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set (cont.) Measure Description* Care Setting 4. Symptom Percentage of patient visits for those patients aged 18 y with a Outpatient management diagnosis of HF and with quantitative results of an evaluation of both level of activity AND clinical symptoms documented in which patient symptoms have improved or remained consistent with treatment goals since last assessment OR patient symptoms have demonstrated clinically important deterioration since last assessment with a documented plan of care 5. Patient selfcare education 6. Beta-blocker therapy for LVSD (outpatient and inpatient setting) Percentage of patients aged 18 y with a diagnosis of HF who were provided with self-care education on 3 elements of education during 1 visits within a 12 mo period Percentage of patients aged 18 y with a diagnosis of HF with a current or prior LVEF <40% who were prescribed beta-blocker therapy with bisoprolol, carvedilol, or sustained release metoprolol succinate either within a 12 mo period when seen in the outpatient setting or at hospital discharge Outpatient Inpatient and Outpatient Level of Measurement Individual practitioner Individual practitioner Individual practitioner Facility *Please refer to the complete measures for comprehensive information, including measure exception. Test measure designated for use in internal quality improvement programs only. These measures are not appropriate for any other purpose, e.g., pay for performance, physician ranking or public reporting programs. New measure. Adapted from Bonow et al. J Am Coll Cardiol. 2012;59:

44 ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set (cont.) Measure Description* Care Setting Level of Measurement Percentage of patients aged 18 y with a diagnosis of HF with a Inpatient Individual current or prior LVEF <40% who were prescribed ACE inhibitor or and practitioner ARB therapy either within a 12 mo period when seen in the outpatient Outpatient Facility setting or at hospital discharge 7. ACE Inhibitor or ARB Therapy for LVSD (outpatient and inpatient setting) 8. Counseling regarding ICD implantation for patients with LVSD on combination medical therapy 9. Post-discharge appointment for heart failure patients Percentage of patients aged 18 y with a diagnosis of HF with current LVEF 35% despite ACE inhibitor/arb and beta-blocker therapy for at least 3 mo who were counseled regarding ICD implantation as a treatment option for the prophylaxis of sudden death Percentage of patients, regardless of age, discharged from an inpatient facility to ambulatory care or home health care with a principal discharge diagnosis of HF for whom a follow-up appointment was scheduled and documented including location, date and time for a follow-up office visit, or home health visit (as specified) Outpatient Inpatient Individual practitioner Facility *Please refer to the complete measures for comprehensive information, including measure exception. Test measure designated for use in internal quality improvement programs only. These measures are not appropriate for any other purpose, e.g., pay for performance, physician ranking or public reporting programs. New measure. Adapted from Bonow et al. J Am Coll Cardiol. 2012;59:

45 Conclusions Evidence-based guideline directed diagnosis, evaluation and therapy should be the mainstay for all patients with heart failure Effective implementation of guideline directed best quality care reduces mortality, improves QOL and preserves health care resources Ongoing research is needed to answer the remaining questions including: prevention, non-pharmacological therapy of HF including dietary adjustments, treatment of HFpEF, management of hospitalized heart failure, effective reduction in HF readmissions, more precise use of device based therapy, smaller mechanical circulatory support platforms and cell based regenerative therapy.