Chuck Kitchen, MA, FAACVPR [email protected]



http://www.cms.gov/medicare-coverage database/details/nca-decision memo.aspx?NCAId=270

NCD 20:10  Effective date: February 18, 2014   CAG # 00437N HF patients are not eligible for ICR  Evidence of benefit based on CR model, not ICR 4

   Same regulation for HF: 42 CFR 410.49

 1-2 hour sessions/day  > 91 minutes=2 sessions  < 90 minutes=1 session Up to 36 sessions per course Up to 36 weeks to complete CR course Required components  Physician-prescribed exercise (CR team)  Cardiac risk factor reduction interventions 5

  CMS criteria were derived from HF ACTION Trial for patient eligibility.

Research design often differs from “real world” procedure for valid reasons.

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Beneficiaries with stable, chronic heart failure meeting ALL of following: 1.

Left ventricular ejection fraction < 35% 2.

3.

NYHA class II-IV symptoms despite being on optimal heart failure therapy for at least 6 weeks Stable=have not had recent (< 6 weeks) or planned (< 6 months) major cardiovascular hospitalizations or procedures 7

Beneficiaries with stable, chronic heart failure meeting all of following:

1.

Left ventricular ejection fraction < 35%

  Measurement by any method is OK ▪ EF >35% not eligible EF not always an exact measurement 8

Beneficiaries with stable, chronic heart failure meeting all of following:

2.

NYHA class II-IV symptoms despite being on optimal heart failure therapy for at least 6 weeks

 Goal for HF patients is not symptom-free, but that patients are able to monitor and control their symptoms  Similar to stable angina 9

Beneficiaries with stable, chronic heart failure meeting all of following:

3.

Stable=have not had recent (< 6 weeks) or planned (< 6 months) major cardiovascular hospitalizations or procedures

  Hospitalization is not required No per year or per lifetime limit, as with all CR dx 11

 30-day all-cause re-admission penalties for HF dx  Role for CR to provide transitional treatment to improve care coordination ▪ Start education earlier post-DC?

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  What about patient with AMI who has EF < 35%?

What about patient who would benefit from > 36 sessions?

 Similarities to stable angina diagnosis  Goal is to prepare patient for self management 13

      5.1 MILLION people have CHF 825,000 new cases per year 279,000 total mention mortality-2010 57,000 underlying cause 2010 1,084,000 hospital discharges-2005 Estimated cost 2005-34.8 BILLION

  YES!!!

HF-ACTION TRIAL

  There was a small reduction in the combined end-point of all cause death or all-cause hospitalization. This was the primary endpoint for the trial and is what is driving some of the media headlines. There was a modest reduction in the important protocol specified disease-specific combined end-point of CV death or HF hospitalization. Yes, this ~14% reduction is modest, but please note that this improvement occurred in patients already receiving (on-top-of) excellent evidence-based background therapy…. ~92% were on ACE inhibitors or angiotensin receptor blockers; 95% on beta-blockade; and 40% were enrolled with ICD device already implanted. 19

   Exercise did not increase the risk for events. There was a modest improvement in quality of life scores among the patients in the exercise group. Finally, “Based on the safety of exercise training and the modest reduction in clinical events, the HF ACTION study results support a prescribed exercise training program for patients with reduced LV function and HF symptoms in addition to evidence based therapy.” Steven Keteyian, PhD CEPA website 20

“Cardiac Rehabilitation Exercise and Self-Care for Chronic Heart Failure”. Ades PA, Keteyian SJ, Balady GJ, Houston-Miller N, et al. JACC Heart Fail 2013;1:540-547.  Evidence to support  Exercise prescription  Self-care counseling 21

  Constant Work Rate (CWR)  The workload is fixed and remains the same throughout the exercise session  Example: Treadmill 3.0mph 2% grade for 20 min Interval Training  The workload varies throughout the exercise session.

 Example: Treadmill 2.5mph 2% grade for 5 min increase to 3.0mph 3.5% grade for 5 min, etc 22

    AIT-Aerobic Interval Training MCT-Moderate Continuous Training MICE-Moderate Intensity Aerobic Continuous Exercise HIIE-High Intensity Aerobic Interval Exercise

     Exercise Intensity Domains  Assumes the use of CWR method Light to Moderate Moderate to High High to Severe Severe to Extreme 24

     All work rates with steady state VO2 below the 1 st VT.

Blood lactate does not elevate above resting levels Metabolism is aerobic Generally well tolerated with modest fatigue Able to maintain for greater than 30-40 minutes 25

  Work rates between 1 st VT and CP Typically can be sustained for about 30 min 26

     All work rates above CP No steady state is achieved Blood lactate continually rises Duration less than 20 minutes Can only be used for interval training, not continuous 27

   Work rate is so high that fatigue comes before peak VO2 can be reached Less than 3 minutes duration As a result of short duration blood lactate levels not as high as with High to Severe intensity 28

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Warm-up 60-70% 8-10 minutes 100 90 80 70 60 50 40 30 20 10 0 Intervals-Green Arrows 85-95% 4 minutes Cool-down 60-70% 3-5 minutes Active Recovery-Blue 60-70% 3 minutes 31

40 35 30 25 20 15 10 5 0 Baseline AIT * End * Baseline End MCT CAD CHF 32

     Meta analysis, over 5800 patients High intensity, vigorous intensity, moderate intensity, low intensity groups Peak VO2 increased 23% in High intensity vs control Vigorous and moderate intensity also showed significant improvement Low intensity did not show improvement ▪ Ismail H, McFarlane JR, Nojoumian AH, et al. “Clinical Outcomes and Cardiovascular Responses to Different Exercise Training Intensities in Patients with Heart Failure” JACC Heart Fail 2013; 1(6): 515-522

Ismail H, McFarlane JR, Nojoumian AH, et al. “Clinical Outcomes and Cardiovascular Responses to Different Exercise Training Intensities in Patients with Heart Failure”

JACC Heart Fail

2013; 1(6): 515-522

    Higher intensity groups increased VO2 the most Higher peak VO2 equals lower mortality NO DEATHS with over 123,000 patient hours of exercise training!!

Higher intensity exercise is safe and effective

  Women showed similar increases in peak VO2 as men However, women had larger decrease in hospitalization and larger reduction in all cause mortality.

▪ Pina IL, Bittner V, Clare RM, et al. “Effects of Exercise Training on Outcomes in Women with Heart Failure: Analysis of HF-ACTION by Sex” JACC Heart Fail Published online February 26, 2014.

    Frequency Intensity Time Type F.I.T.T. PRINCIPLE

  FREQUENCY 3 Days per week initially Build up to 4-5 days per week

   RPE Scale Dyspnea Heart Rate INTENSITY

INTENSITY RPE SCALE 6 7 very, very light 8 9 very light 10 11 light 12 13 somewhat hard

14 15 hard 16 17 very hard

18 19 very, very hard 20

2 3 4

0 None INTENSITY DYSPNEA SCALE (Modified Borg) 0.5 Very, Very slight 1 Very slight 5 Severe 6 7 Very Severe

Slight Moderate Somewhat severe

8 9 Very, Very Severe 10 Maximum

     INTENSITY HEART RATE 40% to 85% of HR reserve method Start slowly and progress slowly Progress to 60 to 85% of HR reserve Beware of failure of HR to rise appropriately!

With increased HR’s use interval training

   TIME Initially 10 to 20 minutes 20 to 40 minutes/session May have to use shorter bouts (2-6 mins) more frequently with 2 to 4 minute rest periods

 TYPE Aerobic Interval Training

  Exercise Prescription is an Art!!

Every patient is different 46

   Ades PA, Keteyian SJ, Balady GJ, Houston-Miller N, et al. “Cardiac Rehabilitation Exercise and Self-Care for Chronic Heart Failure” JACC Heart Fail 2013;1(6): 540-547 Go AS, Mozaffarian D, Roger VL, et al. “Heart Disease and Stroke Statistics 2014 Update: A Report From the American; Heart Association” Circulation 2014 129: e28-e292 Ismail H, McFarlane JR, Nojoumian AH, et al. “Clinical Outcomes and Cardiovascular Responses to Different Exercise Training Intensities in Patients with Heart Failure” JACC Heart Fail 2013; 1(6): 515-522

 Mezzani, A, Hamm, LF, Jones AM, et al. Aerobic Exercise Intensity Assessment and Prescription in Cardiac Rehabilitation: A Joint Position Statement of the European Association for Cardiovascular Prevention and Rehabilitation, The American Association of Cardiovascular and Pulmonary Rehabilitation, and the Canadian Association of Cardiac Rehabilitation. JCRP 2012; 32(6): 327-350  O’Connor CM, Whellan DJ, Lee KL, et al. “Efficacy and Safety of Exercise Training in Patients with Chronic Heart Failure: HF ACTION Randomized Controlled Trial” JAMA 2009; 301(14): 1439 1450  Pina IL, Bittner V, Clare RM, et al. “Effects of Exercise Training on Outcomes in Women with Heart Failure: Analysis of HF-ACTION by Sex” JACC Heart Fail Published online February 26, 2014.