Individualizing and Expanding Care ( Perspectives for the VCN from )

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1 Cardiac Rehabilitation 2018: Individualizing and Expanding Care ( Perspectives for the VCN from ) Philip A. Ades MD University of Vermont College of Medicine Director, CR and Preventive Cardiology Associate Director, Vermont Center on Behavior and Health

2 Outline Current State of the Art: Risk Reduction and Clinical Benefits of CR Changing Patient Populations: Expanding the Model: Dealing with Obesity, T2DM, Elders Underserved d Populations (Low SES) Expanded Diagnostic Categories Future Directions

3 CR: Historical Perspective 1930 s: 6 weeks bed rest s: In hospital re-ambulation x 2 weeks (Phase 1 CR) s: Outpatient C.R. : Highly structured ECG monitoring, MD in room. RCT s Undertaken. 1982: Medicare first covers CR for MI, CABG s s CR as active Multi Risk-Reduction Intervention: (lipids,weight loss,nutrition,bp) 2006: Expanded Populations: PCI, Heart Valve, Transplant 2014: Expand to CR for Systolic CHF (EF < 35%) 2017: Expands to Symptomatic PAD

4 1970 s Approach to CR Exercise NEHDP: A Multicenter U.S. Randomized Trial of Exercise Post-MI Shaw: Am J Cardiol :39-46 (Performed ) Men-only, age (Excluded women and age > 65 years) 8 weeks fully ECG monitored exercise for total of 24 minutes/session 3 x per week. Primarily walking and/or cycling. Minimal counseling.

5 21 st Century Approach to CR Exercise Majority of participants are > 65 years Women participate; about 30% of participants. >80% of CR patients are Overweight / Obese Case Management individualizes Rx of atherosclerosis. Yet, there remains an independent benefit of exercise and fitness.

6 C.R. as Risk Reduction Center: Baseline Risk Factor Measures, ETT Case-Managed to Individualized Goals Specific Risk Factor Programs / Modules Stress Management, Nutrition Counseling Role of Tailored Exercise (Aging, Obesity, Vocational o a Needs). Follow-up / Reassessments Overlap of care with Community Physicians i Ades PA. CR and 2 o Prevention CHD N Eng J Med 345: ,2001 Balady, Williams, Ades et al. Core Components CR: Circulation 2007;115;

7 CR on Total and Cardiovascular Mortality after MI, CABG, PCI: Meta-analysis Systematic Review of 47 RCT s, N 10,794 CR vs. usual care, > 12 months follow up. 26%* cardiovascular mortality 13%* total mortality 31%* hospital admissions (1 year) 7/10 trials, QOL vs. usual care Heran BS et al. Cochrane Database Syst Rev Jul 6;(7):CD

8 Outline Historical Perspective Risk Reduction and Clinical Benefits of CR Changing Patient Populations: Overweight and Older Expanded Diagnostic Categories Expanding the Model

9 Changing Populations in CR: Obesity Indices (N=604) (N=532) P Value * Weight (Kg) 84.7 ± ± Waist (cm) 101 ± ± JCRP 2008 BMI (Kg/m 2 ) 28.5 ± ± <0.001 Obesity (%) <0.001 Type 2 DM (%) % JCRP 2009, 2018

10 Changing Populations in CR (N=604) (N=532) P Value Age 60.6 ± ± y (%) y (%) Women (%) NS Audelin et al. JCRP 2009, Gaalema et al JCRP 2018

11 Weight Loss in Cardiac Rehabilitation: Why Unsuccessful? 1. Low Exercise-Related RltdCl Caloric Expenditure in C. CR. 2. Behavioral weight loss programs are not offered

12 Weight Loss in Cardiac Rehabilitation PROGRAM Patient Baseline Mean Weight Population Wi Weight ht(k (kg) Change U Vermont N = kg 2000 All patients Boston U N = kg 2001 BMI Ochsner N = kg 2003 Met Syndr *Brochu M, Ades PA. J Cardiopulm Rehabil 2000;20:96. Bader DS, Balady GJ. J Cardiopulm Rehabil 2001;21:210. Milani RV, Lavie CJ. Am J Cardiol 2003;79:397.

13 Why do patients in Classic CR not lose weight? Caloric Energy Expenditure in Cardiac Rehab Reference N Kcal / Week Shairer et al JCR 1998; 18:290 Savage et al (Am Heart J 2000:140;527)

14 Weight Loss in CHD Patients: Behavioral Approach Calorie Goals (12 x wt in lbs 500/day) Dietary Records Weekly Review Troubleshooting Nurse or Dietician Coordinated J Harvey-Berino Ph D. Cor. Art Dis:1998 9: Brownell K. LEARN Program

15 High-Caloric Training in Obese Coronary Patients: Walk Daily/Walk Far High-Caloric Expenditure Training: 50-65% Peak VO min, 5-7 days/week, > 2500 cal/week. Primarily walking. Classic CR Training: 60-75% Peak VO minutes, 3x/week +/- 750 cal/week Both Groups received Behavioral Weight loss counseling. Ades PA et al. Circulation 2009

16 High-Caloric Exercise vs. Standard CR Exercise (N= 72, 4-Month Data) High Caloric Ex. Group N Standard CR Exercise Group Weight (kg) ** Waist (cm) ** Fat Mass (kg) ** *= P <0.05 vs. baseline ** = P<0.05 vs. standard CR group

17 High Caloric Expenditure Exercise and Weight Loss on Cardiac Risk Factors Insulin Sensitivity + 26%* (Hyperinsulinemic Euglycemic Clamp) Insulin Level - 31%* Triglycerides mg/dl - 23 mg/dl* HDL-Chol + 12% Cholesterol / HDL Ratio - 15%* Mean Blood Pressure HS-C-Reactive Protein (mg/dl) High Caloric Expenditure Group - 11 mm Hg Additional favorable effects on vasodilatory capacity (endothelial l function) and decreased platelet reactivity (Keating, Schneider) Ades PA et al. Circulation 2009

18 High Caloric Exercise in CR Conclusions High-Caloric Exercise Training is more effective for weight loss than standard CR. Associated with heightened risk factor benefits Exercise : It s like a pill you take daily!

19 Cardiac Rehabilitation in Older Individuals GOALS: Treat/Prevent Coronary Disability Extend Disability-Free Survival

20 Aerobic Capacity Entering Cardiac Rehabilitation. O 2 ) n Peak VO kg -1 *min -1 ) Mean (ml*k 32.5 (58) (304) (605) (637) (410) (67) (28) (90) (198) (257) (214) (33) Men Women < >80 Age Category, years Ades PA, Savage PD, Brawner CA, Keteyian SJ. Circulation ;11:

21 Aerobic Conditioning in Older Coronary Patients (36 sessions CR training) 18-27% Increase in peak aerobic capacity 50+ % increase in treadmill time Improves physical function and QOL by questionnaire Decreased Depression, Anxiety scores. Williams: Am J Cardiol 1985 Ades Circulation 1993

22 CR in Older Women: Role of Strength Training A RCT of strength training (6 mo), > 65 years with CHD and low physical function. Primary outcomes a battery of 15 measurable household physical activities: grocery carry, empty washer/load dryer, pot carry, 1 flight stairs, 6-minute walk.

23 Resistance Training in Older Women with CHD Total Physical Performance Score: +24% Domains: Upper Body Strength th + 18%* Lower Body Strength + 23%* Balance and Coordination + 29%* Upper Body Flexibility +10% Endurance +26%* 6-Minute Walk +15%* * = P<0.05 vs controls Brochu M, Savage PD, Ades PA. J Appl Physiol. 2002: 92;

24 Exercise in Older CR Participants: Caveats Importance of Resistance Exercise Aerobic component optimally based upon ETT Consider Intermittent bouts of exercise to begin Increase duration before intensity

25 Expanding the Model

26 National Participation Rates Center Disease Control: (2008) Post MI Phone survey, 21 states Post MI 35% Participated in CR Medicare Claims Data (2007 / 1997) Age >65, All States, N= 267,427 (MI/CABG), 1997 Overall CR Participation 19 % Post MI 14 % Post CABG 31% Medicare (2018 / 2009): 16% Ayala C et al. MMWR 2008:57;89-94 Suaya J et al. Circulation 2007:116; Beatty A et al. Circulation 2018

27 CR Participation in Medicare Population Predictors of CR participation: Diagnosis (MI > CABG) Age Sex Distance from CR Medicaid (4% vs 19%) Substantial Geographic Variation by State (9-fold) Highest participation North Central States Lowest participation through the South (7-15%) Suaya et al. Circulation 2007.

28 CR Participation by State Use rates were more than four-fold higher in North Central states than in Southern states.

29 CR Participation in Disadvantaged Populations: Background Low SES/Education individuals characterized by higher rates of smoking, physical inactivity, unhealthy diet. 2 x Higher 2 year mortality rates (and hospitalizations) due to higher rates of smoking, obesity, inactivity, poor diet. (Alter 2006, Lindenauer 2013) 2/322 (<1%) Washington State Medicaid patients discharged after MI in 2004 attended CR (Oberg, 2009) In U.S. 4% of CR eligible individuals with dual Medicare / Medicaid status attended CR vs. 19% overall (Suaya 2007) Medicaid insurance covers patient costs for CR participation in most states.

30 Increasing Cardiac Rehabilitation Participation among Medicaid Enrollees: Role of Financial Incentives. (Effective for drug abstinence, smoking cessation) Diann E. Gaalema 1,2,3, Stephen T. Higgins 1,2,3 Philip A. Ades 1,4, Vermont Center on Behavior and Health 1 Departments of Psychiatry 2 and Psychology 3 University of Vermont Department of Medicine 4, Division of Cardiology Supported by National Institutes of Health Center of Biomedical Research Excellence (COBRE) award P20GM from the National Institute of General Medical Sciences (Higgins PI).

31 Methods Recruited 140 Medicaid enrolled patients eligible for CR for randomization Incentives contingent on completing exercise visits Two initial meetings earn $20 Escalating scale for 35 general exercise visits Start at $4 and go up to $50 Reset for unexcused exercise visits Total possible earnings $1200

32 CR Participation and Completion N=100

33 Summary Early results suggest that financial incentives are successful to encourage Medicaid insured insured individuals to attend and complete CR, Subjective observations: stressed, cars don t work, medications problematic, smoke at high rates (40% vs 6%), poor diets : Should benefit greatly from CR Follow up results will include Fitness measures Financial analysis that includes costs vs. medical benefits and follow up costs

34 Expanding the Model; Systems Approaches to Expand CR participation i EMR-based referral CR Liaison Role of MD

35 Increasing Referrals to CR: Automatic Computerized Referral Grace et al, Ontario Canada Hospital EMR prompts a Standard Order for CR Rf Referral Personalized referral letter at hospital discharge 53% CR Participation vs. 32% at Control Hospital Add liaison increases CR Participation to 74% Grace et al. Archives Int Med 2011

36 Increasing Cardiac Rehabilitation Participation from 20% to 70%: A Road Map from the CDC Million Hearts Cardiac Rehabilitation Collaborative 2016 MFMER

37 Cardiac Rehabilitation Participation by Physician Recommendation Physician Recommendation Score 1 = Against or not mentioned, 3 = moderately supportive, 5 = strongly recommended Ades PA et al. Archives Int Med 1992 Affirmed 2013 Keteyian et al:

38 Expanding CR Participation by Diagnosis: CMS Decisions 1982: After MI, CABG, Chronic Stable Angina 2006: After PCI, Heart Valve Replacement- Repair, Heart Transplantation 2014: Chronic Systolic Heart Failure (EF < 35%) 2017: Symptomatic (Claudication ) PAD

39 CR for Chronic Systolic Heart Failure: CMS Coverage Criteria LVEF <35% NYHA Class II-IV On Evidence-based medications ACE-I, IBBDi BB, Diuretic, i Clinically stable 6+ weeks post-hospitalization Does not require a hospitalization Outpatient CHF patients eligible

40 Present and Future of Cardiac Rehabilitation Standard of care for recently diagnosed CHD (MI,PCI,CABG), heart valve replacement, heart transplant, CHF, PAD. Newer approaches to CR should be individualized: HCE for obesity, strength training for women / elders, efforts to include low SES patients, home programs to expand reach. EMR-based referral systems should be established to enhance participation rates CR should be added as a quality indicator after acute cardiac hospitalization to assure higher participation rates and attain benefits of decreased morbidity, mortality and hospitalizations.

41 The Future of Cardiac Rehabilitation Strongly gyadvocated by AHA, ACC, CDC. Capitation/Global Budget Obliges/rewards efficient i care that t keeps patients t out of hospital (CR) Would need to right-size CR participation Attention to Non-CR Attendees: Care Coordinator for these highest risk patients

42 Burlington. Thank You!

43 Maximizing Fitness in CR Aerobic Fitness: Best predictor of prognosis in CR Optimized with Aerobic Interval Training Multiple Studies by Wisloff et al (Norway) document greater effectiveness on fitness. Has been studied Post MI, Post CABG, CHF, Met. Syndrome, Obesity Not yet known if as safe as continuous training Somewhat selective for fittest patients Requires close supervision Subjectively favored by yparticipants p over more monotonous moderate intensity continuous training 8 min warm-up (70% Max HR) 4x4 min intervals at 85-95% Max HR 3 min active recovery at 70% Max HR Keteyian S Am Heart J 2008 Prognosis in CHD Wisloff U Circulation 2007 Interval Training in CHF

44 What Should M.D. Demand from a Cardiac Rehabilitation Referral? Easy transition of patient from inpatient to outpatient setting Early Assessment of Symptoms, Well-Being Baseline assessment of modifiable risk factors BP, Lipids, Diabetic control, Body weight, Fitness Assessment of physical fitness, physical function Assessment of psychosocial function Anxiety, Depression, Social Isolation Assistance with medication I.D. and adherence Communication: (Baseline, Halfway, Exit Reports) A safe and effective, individualize and long-term training program. Optimization of Rx of cardiac risk predictors diet, education, counseling, pharmacology.

45 What Should the Patient Demand from Cardiac Rehabilitation? Seamless transition from inpatient to outpatient care A safe, welcoming, non-threatening environment to embark on a long-term individualized exercise training program. Free parking! Baseline assessments of risk predictors and clear delineation of short-term and longer term goals Clearance for work-related related physical activity and ADL s Nutritional guidance Pharmacologic optimization An improved quantity and quality of life.