Cardiac Rehabilitation for Heart Failure Patients. Jia Shen MD, MPH Assistant Professor of Medicine UC San Diego Health System

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1 Cardiac Rehabilitation for Heart Failure Patients Jia Shen MD, MPH Assistant Professor of Medicine UC San Diego Health System

2 Disclosures There are no conflict of interests related to this presentation.

3 Overview of Talk Historical Perspective of Cardiac Rehabilitation Current principles of Cardiac Rehabilitation Eligibility criteria for cardiac rehabilitation (Medicare) Current AHA/ACC Recommendations Evidence behind recommendations: Effect of Exercise Training on cardiac function and skeletal muscle Effect of Exercise Training on Systolic Heart Failure HF-Action Study Effect of Exercise Training on Diastolic Heart Failure Effect of Self-Care on Heart Failure Outcomes Barriers to Cardiac Rehabilitation Participation The Cardiac Rehab Program at UCSD.

4 Historical Perspective 1930 s restriction of physical activity and prolonged bedrest were standard of care for patient s with HR and MI s chair therapy s daily walks 3-5 minutes in duration s structured inpatient CR programs for early ambulation post MI. Present multidisciplinary, comprehensive CR programs.

5 AHA/ACC Recommendations Patients with HF should receive specific education to facilitate HF self-care. (Class IB) Exercise training (or regular physical activity) is recommended as safe and effective for patients with HF who are able to participate to improve functional status. (Class IA) Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, HRQOL, and mortality. (Class IIA)

6 Currently Covered Indications for Cardiac Rehabilitation(CR) Recent myocardial infarction (within 1 year) Post Percutaneous coronary intervention (PCI) Coronary artery bypass grafting (CABG) Chronic stable angina Cardiac transplantation Heart valve repair or replacement Stable, chronic systolic heart failure (EF<35%) Peripheral Arterial Disease *Systolic heart failure (EF >35%) and diastolic dysfunction are not currently covered.

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8 Total Number of Sessions covered 72 (max per day is 6 sessions) over 18 weeks Ornish Ornish Versus Pritikin 72 sessions (divided into 18 sessions that are 4 hours each) Pritikin 72 sessions (can customize how many sessions per day) Diet 100% plant based Allows for lean meat and fish Format Outcome Data All with live instructors: 1 hour of exercise 1 hour of nutrition counseling 1 hour of yoga and 1 hour of group therapy Patients are in groups of and stay with the same cohort throughout the program The Lifestyle Heart Trial showed significant regression of coronary atherosclerosis measured by angiography in the experimental group randomly assigned to intensive lifestyle changes. (5 year results reported by Ornish JAMA 1998) Some parts are Video Instruction. Sessions duration can be customized over 18 weeks Data from Pritikin residential treatment centers showed improvement in lipids, A1c, blood pressure and weight. (Barnard Am J Cardiol 1992)

9 Pleiotropic Effects of Cardiac Rehabilitation (Sandesara et al., JACC (2015)

10 Heart Failure and Skeletal Muscle: Chronic heart failure results in structural abnormalities in skeletal muscle reflecting reduced oxidative capacity of working muscle. Skeletal muscle is more reliant on anaerobic metabolism, resulting in lactic acidosis, and early fatigue. Changes in oxidative capacity correlate with changes in exercise capacity. Drexler et al., Circulation (1992)

11 Effect of Exercise Training on Skeletal Muscle: Sustained exercise training can reverse changes in oxidative capacity in skeletal muscle. Resulting in re-shifting from type II fast-twitch fibers to type I slow- twitch fibers, and increased mitochondrial density. This is associated with increased exercise capacity unrelated to changes in peripheral perfusion. Hambrecht et al., JACC (1997)

12 Effect of Exercise Training in CHF: Controlled crossover trial of 8 weeks of exercise training against 8 weeks of rest in 17 men with stable heart failure (LVEF 19.6% ± 2.3%). Training program: exercise on stationary bicycles at 50 rpm for 20 minutes 5 days per week for a target heartrate 60-80% of maximum HR. Results: Increased exercise tolerance, peak oxygen uptake, cardiac output, vagal tone, and decreased systemic vascular resistance. Coats et al., Circulation (1992)

13 Effect of Long-Term Exercise Training in CHF: Randomized controlled trial of 99 patients (59 ± 14 years, 88 men) with stable heart failure (EF 28.4% ± 6%). Intervention: Exercise Training at 60% of VO2 3x per week x 8 weeks, then 2x per week x 1 year. Results: Increased peak VO2 (18%) and thallium activity score (24%), and improved quality of life. Reduced mortality (RR =0.37; 95% CI: , p=0.01) and hospital readmission for heart failure (RR=0.29; 95% CI: , p=0.02). Belardinelli et al., Circulation (1999)

14 Effect of Exercise Training in CHF: HF-ACTION Multicenter RCT from 82 centers in Canada, USA, and France with a median follow up of 30 months. Randomized Controlled Trial 2331 patients (median age 59 years, 28% women) with stable heart failure (median LVEF 25%, 37% NYHA Class III-IV symptoms). Intervention: Aerobic exercise training (36 supervised sessions) followed by home-based training. Primary endpoints: all-cause mortality or hospitalization. Secondary endpoints: CVD mortality, hospitalization, or HF hospitalization. O Connor et at., JAMA (2009)

15 Study Design Chronic heart failure, NYHA Class II-IV, LVEF 35%, optimal medical therapy, and capable of exercising. Pre-randomization CPX and ECHO Randomization 1:1 (Stratified by center and HF etiology) Usual Care Exercise Training Optimized medical treatment Patient education Phone calls Recommendation: Moderate intensity activity 30 minutes/day Optimized medical treatment Patient education Phone calls Supervised training Home training

16 Exercise Training Protocol: Structured, group-based, supervised exercise program. 3 sessions per week for a total of 36 sessions in 3 months. Performed walking, treadmill, or stationary cycling as their primary training mode. Exercise was initiated at minutes per session at a heartrate corresponding to 60% of heartrate reserve. After 6 sessions, duration of exercise was increased to minutes, and intensity increased to 70% of heartrate reserve. Home-based exercise training began after 18 supervised sessions and were fully transitioned after 36 sessions. Patients were given exercise equipment and HR monitors. Target home training was 5x per week for 40 minutes at a HR 60-70% of HR reserve.

17 HF-ACTION Results HR=0.93 (95% CI: ), p=0.13 Adjusted HR 0.89 (95% CI: ), p=0.03 O Connor et at., JAMA (2009)

18 Summary of Major Outcomes Hazard Ratio All-cause mortality and hospitalization (primary) 95% CI p-value Main analysis , Adjusted analysis , CV mortality and CV hospitalization Main analysis , Adjusted analysis , CV mortality and HF hospitalization Main analysis , Adjusted analysis , *No difference in the occurrence of adverse events.

19 Conclusions: Exercise training results in non-significant reductions in the primary end point of all-cause mortality or hospitalization. After adjustment for highly prognostic predictors of primary endpoints, exercise training was associated with a 13% risk reduction in cardiovascular mortality or heart failure hospitalization in patients already receiving standard of care. Significance may have been diluted do to high crossover rates between groups - 55% of participants in the usual care groups were dissatisfied with their assignment and likely continue some level of physical activity. Difficult for chronically ill patients to maintain exercise prescription over time minimizing effects due to drop out.

20 Exercise Training for Diastolic Heart Failure Ex-DHF Trial: Prospective, multicenter, RCT in patients with symptomatic (NYHA II/III) and HFpEF (EF 50%). 64 patients (age 65 ± 7 years, 56% female) randomized 2:1 to supervised endurance/resistance training or usual care alone. Intervention: Weeks 1-4: aerobic endurance training (cycling 2 /week) of increasing intensity and duration (from 20 to 40 min) for target HR 50-60% of peak VO2. Weeks 5-12: training 3x/week with target HR 70% of peak VO2 + resistance training 2x/week. Endpoints: Primary change in peak VO2 after 3 months. Secondary effects on cardiac structure, diastolic function, and QoL. Edelmann et al., JACC (2011)

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22 Exercise Training in Diastolic Heart Failure Exercise training improves exercise capacity and physical functioning in patients with diastolic HF. This benefit is associated with improved diastolic function and reverse atrial remodeling. ET is safe, well-tolerated, and may be beneficial in patients with HFpEF, where there are have been few proven effective treatment modalities. Edelmann et al., JACC (2011)

23 Self-Care in Heart Failure Self-management programs aim to enable patients to assume primary role in managing their condition: monitor symptoms, adjust medications and determine when additional medical attention is necessary. Examples Include: Limit daily sodium intake <2 g and fluid intake < 2 L Obtain daily weights, monitor for early signs of volume overload Contact provider immediately if change in symptoms or weight Avoidance of drugs (cocaine/meth) and alcohol use Following heart healthy diets Self-care is associated with better quality of life, functional status, and reduced symptom burden in patients with HF. Jovicic et al., BMC (2006)

24 Self-Care and Heart Failure Outcomes 44 vs. 69%, p=0.01 OR=0.20, CI = vs. 93%, p=0.03 OR=3.85, CI = Davidson et al., Euro J of CVD Pre Rehab (2010)

25 Depression and Heart Failure 1 out of 5 patients with heart failure are clinically depressed (this proportion increases with NYHA Class). Depressed patients are less likely to engage in self-care, have increased healthcare utilization, ER visits, and readmissions. Depressed patients are more than 2x as likely to die then their non-depressed peers. Pharmacologic treatment of depression has not been shown to improve clinical outcomes or mortality. ET as a part of a structural CR program is effective in treating depression and improves long-term survival. Survival benefits of CR are concentrated to those patients that improved exercise capacity with underlying undiagnosed depression. Rutledge et al., JACC (2006), Milani et al., Am J Cardiol (2011)

26 Social Support and Heart Failure Patients with a high level of support reported significantly better self-care than patients with low or moderate levels of social support. Patients with a high level of social support reported being significantly more likely to consult with a health professional for weight gain, to limit the amount of fluids they have, take their medication, to get a flu shot, and to exercise on a regular basis than those with medium or low levels of social support. Social support provided by partners needs to be of a quality and content that matches HF patients' perception of need to influence self-care. Support networks and partners are an integral in the treatment of HF patients. Gallagher et al., J Cardiovasc Nurs (2011)

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28 Barriers to Cardiac Rehabilitation Participation: Fewer than 20% of all eligible patients participate in a CR Of those who are referred to CR only 34% actually enroll. Systemic Barriers: lack of a centralized method for referral inadequate communication among treatment teams, patients, and CR facilities unfamiliarity with CR among potential referring physicians limited access to facilities Patient Barriers: Poor self-care and understanding of medical condition Anxiety/depression/addiction Poor social or financial support Language barriers Sandesara et al, JACC (2015)

29 Current Reimbursement for Cardiac Rehabilitation With the affordable care act there is a focus on preventive services There has been a gradual increase in reimbursement for cardiac rehabilitation Currently in California Medicare: $107 per session Commercial Payers (e.g Anthem Blue Cross): $132 per session For intensive cardiac rehab (ICR), 72 covered sessions revenue is $7700 to $9500 per patient

30 Conclusions: ET results in improvements in cardiac and skeletal muscle function and modifies the biochemical, neurohumoral, and inflammatory responses to heart failure. In patients with reduced systolic function, ET is safe and reduces HF symptoms, hospitalizations, and mortality. In patients with diastolic dysfunction, ET is safe and reduces HF symptoms, improves diastolic function and QoL. Self-care and patient education are important components heart failure therapy and can significantly reduce HF symptoms, readmissions, and mortality. Multidisciplinary cardiac rehabilitation programs are an integral component of the management of chronic heart failure and are increasingly covered by insurers. Every effort should be made to find appropriate patients for referral.

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