Transcatheter Aor-c Valve Replacement and Cardiac Rehabilita-on. Derek Zaleski PT, DPT Joe Adler PT, DPT, CCS

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1 Transcatheter Aor-c Valve Replacement and Cardiac Rehabilita-on Derek Zaleski PT, DPT Joe Adler PT, DPT, CCS

2 The learner will: Objec-ves Understand TAVR program at HUP and be able to apply clinical concepts to outside sehngs Apply principles of Phase I and II Cardiac Rehab for pa-ent outcomes Understand current, eligible diagnoses for Phase II outpa-ent cardiac rehab for appropriate d/c recommenda-ons post acute stay Apply EBM principles to physical and psychosocial benefits of apending phase II cardiac rehab

3 Median Sternotomy

4 BYPASS MACHINE

5 Transcatheter Aortic Valve Replacement

6 TAVR Indicated for higher risk pa-ents Frail, mul-ple co- morbidi-es No cardiopulmonary by pass machine No median sternotomy Combined Interven-onal Cards/CT Surgery FDA approval in 2009/2010 Performed in Europe for years 2014 goal 200 pa-ents

7 TAVR Partners Trial Multi-centered Initially trans-femoral approach only High Risk Patients Partners 1 Trial Purpose: Compare TAVR to open approach to medical medical management of aortic valve insufficiency Partners 2 Trial Purpose: Compare types of valves and the use of different sized catheters used to introduce the valves Sapien Study (November-January 2013) Evolution of Gen III valve

8 HUP s TAVR Program Transition to intermediate risk patients Plan to trial transcatheter approach with Mitral Valve surgery Transcatheter approach will end up REPLACING open approach for all valve replacements

9 TAVR CEQI Collaborative project with outpatient TAVR team Inclusion of PT questionnaire in OP EPIC documentation Purpose Retrospective analysis of whether or not patients s/p TAVR, at HUP, are attending phase II Cardiac Rehab

10 History of Cardiac Rehab Dr. Herman Hellerstein founded Cleveland Work Classifica-on Clinic

11 History of Cardiac Rehab First to develop mul-disciplinary approach Pioneered the development of Holter monitoring Published first ar-cle suppor-ng exercise in non- surgical cardiac pa-ents (CAD) 1968: Exercise Therapy in Coronary Disease

12 Cardiac Rehab Guidelines American Associa-on of Cardiac and Pulmonary Rehabilita-on Professionals (AACVRP) American Heart Associa-on (AHA) American Thoracic Society (ATS) American College of Sports Medicine (ACSM)

13 Cardiac Rehabilita-on Phases Phase I- Inpa-ent Phase II- Outpa-ent Phase III- Maintenance Phase IV- Home/Community

14 Phase I Cardiac Rehab Structured program of educa-on and exercise that assists pa-ents with cardiovascular disease achieve op-mal physical and psychosocial health. Surgical and non- surgical pa-ents Educa-on Nutri-on Risk factor modifica-on Post surgical care

15 Common Diagnoses seen at HUP Surgical Pa-ents: AVR MVR CABG Aor-c Dissec-ons/aneurysms Non- surgical pa-ents: Type B Aor-c Dissec-on BP Management CHF (CICU) STEMI/MI/PCI

16 Phase I Hospital Admission to Discharge ***All Phase I cardiac rehab is monitored***

17 Goals of Phase I Enable pa-ent to tolerate ADLs, including: Self- care ac-vi-es; Toile-ng Stair climbing Walking func-onal distances Educa-on is paramount! Ini-ate intensive risk factor and life- style modifica-on Educa-on at HUP provided daily by: RN, PT,OT, CRNP, Nutri-onist MET level goal: 1-4; Use of BORG scale

18 Metabolic Equivalent

19 BORG Scale 6 No exer-on at all Very light Light Somewhat hard Hard (heavy) Very hard Extremely hard 20 Maximal exer-on

20 Phase I Cardiac Rehab Assessment Guidelines* A pa-ent is deemed stable if: No new or recurrent episodes of chest pain in 8 hours Cardiogenic vs. non- cardiogenic No acute signs of decompensated heart failure Dyspnea at rest Hypotension Bilateral crackles greater than half of 1 lung No significant ECG changes in past 8 hours If atrial fibrilla-on: ventricular rate <110bpm Able to speak comfortably with RR <30 breaths/min *Guidelines from AACVPR

21 Standard Phase I Progression for Surgical Pa-ent Day 1-2 (MET level 1-2) Cardiac ICU OOB to chair Toile-ng** Airway clearance and deep breathing/cough/incen-ve spirometry Day 2-3 (MET level 2-3) Cardiac Step- Down Unit SiHng ac-ve UE/LE exercises** transplant Ambula-ng in room Day 4-5 (MET level 3-4) OOB as tolerated Walking 5 mins in hall BID/TID Shower with seat** Standing ac-ve UE/LE exercises Ini-ate stair climbing

22 Eligible Diagnoses per CMS($$) CABG Heart valve repair or replacement Percutaneous transluminal coronary angioplasty (PCTA), or sten-ng (BMS, DES) Heart or heart- lung transplant Acute myocardial infarc-on Stable angina pectoris CHF (EF< 35%) and (NYHA) class II to IV symptoms, on op-mal heart failure therapy for at least six weeks. Pa-ents must be prescribed phase II by physician within 12 months of event

23 Addi-onal Eligible Diagnoses Great vessel surgery (i.e. Aorta) MAZE arrhythmia procedure VAD implant Sustained VTACH or fibrilla-on Survivors of sudden cardiac death. IE: Asystole

24 Transi-on to Phase II Ini-ate phase II 1-6 weeks post discharge TAVR excep-on Require prescrip-on from cardiologist Pa-ent follows exercise and walking program from inpa-ent d/c to phase II

25 Barriers to apending Phase II Not all pa-ents apend phase II rehab Con-nue with exercise and walking program *Financial* Referral Timing of Referral* Geographic Transporta-on

26 Phase II Cardiac Rehab

27 Phase II Cardiac Rehab Usage Rates

28 Phase II Cardiac Rehab Seminal Study Coronary Artery Disease Cardiac Rehabilitation and Survival in Older Coronary Patients. Suaya, JA., et al. J Am Coll Cardiol 2009;54:25 33 Sample Size: 601,099 Medicare beneficiaries Examined 1 and 5 year mortality rates in CR users and non-users Compared 70,040: CR users vs. non-users Results Only 8,4004 (12.2%) utilized phase II CR Significantly lower 1 and 5 year mortality rate between users and non-users.

29 Pa>ent Category Par>cipa>on Rate %Change in Outcomes MI 13.9% 12% ARR in all-cause mortality in elderly 3 ; 56% RRR in all-cause mortality and 28% RRR in recurrent MI 4 CABG 31% 5.3% ARR in all-cause mortality in elderly 3 ; 39% RRR in all-cause mortality and 26% RRR in recurrent MI (36 sessions vs. 1 session) 8 Percutaneous Coronary Interven-on 20.9% 6.3% absolute risk reduction in elderly 3 ; 45-47% RRR in all-cause mortality, trend towards reduced cardiac mortality (HR, 0.69; 95 % CI, ), no reduction in recurrent MI, PCI or CABG 5 Coronary Heart Disease 18.7% 8.3% ARR in all-cause mortality 3 ; 13% RRR in all-cause mortality, 26% RRR in cardiovascular mortality and no reduction in recurrent MI, PCI or CABG 7 ARR= Absolute risk reduction; RRR= Relative risk reduction; HR = Hazard ratio.

30 Phase II Cardiac Rehabilita-on Comprehensive, long term program including: Medical evalua-on Electrocardiographically monitored, prescribed exercise Educa-on Counseling Cardiac risk factor modifica-on Diet Smoking, ETOH

31 Goals of Phase II Cardiac Rehab Op-mize cardiovascular performance in pa-ents with heart disease Reduce risk of future cardiac event through individualized pa-ent educa-on Restore pa-ents confidence in their physical capabili-es post cardiac events

32 Required Personnel Direct physician supervision Physician on- premises, does not have to be in gym Staff who are trained in basic and advanced life support techniques and in exercise therapy for coronary artery disease Usually RN and licensed exercise physiologist or physical therapist Physical therapist care provision

33 Ini-a-on of Phase II 1-6 weeks post hospital discharge Medical Evalua-on Ini-a-on pending mul-ple factors: Physician prac-ce papern Complexity of hospital course Surgical vs. Non- surgical pa-ent Stress test (nuclear vs. treadmill) Op-onal 6 Minute Walk Test performed on Ini-al Evalua-on

34 Standard Phase II CR session Apply 3 lead EKG on arrival Res-ng blood pressure, heart rate, and SpO minutes of endurance exercise: Nustep Treadmill UE ergometer What is measured during ac-vity: Intensity of exercise (miles per hour/revolu-ons per minute) Vital sign response RPE

35 Cost Effec-veness of Phase II Author (year) Perspec>ve Sample Size Pa>ent Popula>on Study Type Currency Levin 1991 Societal N=305 MI CCA SEK 73,500 Ades 1992 Oldridge et al 1992 Ades 1997 Pa-ent/ Payer N=580 MI & CABG CCA $739less in hospital cost Societal N=201 MI CUE/modeling $21,800per liu year gained Pa-ent/ Payers NA Econ Model Econ Model $4,950 per year of life saved Georiou 2001 Societal N=99 Heart Failure CEA $1,773 per life year saved Marchionni 2003 Government N=!58 MI CCA $21,298 per pa-ent Huang 2008 Government N=4,324 CABG CEA $13,887 per year life saved

36 Transla-on of programs Experience in your clinical sehngs Barriers to receive CR II New horizons?? Phase II cardiac rehab via telehealth

37 References Balady GJ, Williams MA, Ades PA, et al. AHA/AACVPR Scien-fic Statement - Core Components of Cardiac Rehabilita-on/ Secondary Preven-on Programs: 2007 Update. CirculaEon 2007;115: Borg G. Perceived exer-on as an indicator of soma-c stress. Scand J Rehabil Med. 1970;2(2):92-8. Cardiac rehabilita-on program and intensive cardiac rehabilita-on program: Condi-ons of coverage. Public Health Code of Federal Regula-ons (42 CFR). Evenson, Kelly R and Fleury, Julie. Barriers to Outpa-ent Cardiac Rehabilita-on Par-cipa-on and Adherence. Journal of Cardiopulmonary RehabilitaEon 2000; 20(4). Hellerstein, HK. Exercise therapy in coronary disease. Bull N Y Academy of Medicine (8):

38 References Jackson, T el al. GeHng the most out of cardiac rehabilita-on: A Review of Referral and Adherence Predictors. Heart 2005;91:10-14 Pack, Q et al. An Early Appointment to Outpa-ent Cardiac Rehabilita-on at Hospital Discharge Improves APendance at Orienta-on. CirculaEon 2013; 127: Suaya, JA., et al. Coronary Artery Disease Cardiac Rehabilita-on and Survival in Older Coronary Pa-ents. Journal of the American College of Cardiology 2009;54:25 33 Wong et al. BMC Health Services Research :243

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