1. 9/5/20151 Ventricular Assist Device (VAD) Patients in the Community Liz Amerman, RN, BSN IU Health Methodist VAD Program Manager April 18, 2012

2. 9/5/20152  Discuss available ventricular assist devices for home use  Review clinical indications for placement of ventricular assist devices  Understand VAD patient care requirements in the home environment  Case studies Learning Objectives

3. 9/5/20153 Heart Failure in the US Heart failure accounts for 34% of cardiovascular-related deaths 670,000 new cases of heart failure are diagnosed in the US every year 277,000 deaths are caused by heart failure each year Heart failure is the most frequent cause of hospitalization in patients older than 65 years, with an annual incidence of 10 per 1,000 Rehospitalization rates during the 6 months following discharge are as much as 50% 2010 estimated total cost of heart failure in US $39.2 billion, representing 1-2% of all health care expenditures

4. 9/5/20154 Disease Progression Jessup, NEJM 2003

5. 9/5/20155 Heart Transplants in US

6. 9/5/20156 Volume of VAD Patients YearPatient VolumeBTTBTDDTDevice Types 20123412422 29 HM II, 5 Heartware, 4 Abiomed Replaced 2 HM II 20112711016 20 HM II, 5 Heartware, 2 Thoratec, 1 Abiomed 1 patient had a HM II and Abiomed 201031184 9 (1 replaced) 19 HMII; 4 Heart Ware; 3 L P/I-VAD, 5 Abiomed 2009321711 4 (2 replaced) 17 HMII, 15 Abiomed, 1 Thoratec 1 patient had a HM II and Abiomed Additional Device Implants: 2012: 19 - 2 TandemHearts, 17 Impella ( 10 – 5.0, 7 – 2.5) 2011: 7 Impella and 3 TandemHeart 2010: 4 Impella We had a total of 52 patients and 57 devices for 2012

7. 9/5/20157 A VAD is designed to circulate the blood in the pulmonary and/or systemic circulation when the natural heart is unable to maintain normal blood flows and pressures. Defining A Ventricular Assist Device

8. 9/5/20158

9. 9 Bridge to Recovery/Decision (BTR/BTD) –Postcardiotomy Shock –Acute MI –Cardiac Disorders such as Viral Myocarditis Bridge to Transplant (BTT) –Cardiomyopathies –Failed Cardiac Transplant Destination Therapy (DT)– improve quality of life when not a transplant candidate Indications for Use

10. 9/5/201510 Central Nervous System damage before or during operative procedure Body Surface Area (BSA) < 1.2m² for some assist devices Contraindications for VAD

11. 9/5/201511 Not everyone can get a VAD!! Physical and psychosocial evaluation Good support group BTT requirements DT requirements Pre-VAD meeting with the VAD team Presented to Advance Heart Failure Board for acceptance Criteria Evaluated Before Getting A VAD

12. 9/5/201512  Does the patient need a Left, Right, or Biventricular Assist Device.  Size of the patient.  Short or long term use needed.  What hospital the patient is in. Choosing the appropriate VAD

13. 9/5/201513 Abiomed Thoratec – IVAD and PVAD HeartMate – XVE and HM II HeartWare Types of VAD’s

14. 9/5/201514  Left, Right, or Biventricular  Short term use - months  Patient size irrelevant  Bridge to Recovery  Bridge to Transplant  NOT for Destination Therapy  Outlying hospitals can implant emergently –Patient then transferred to Methodist by Lifeline Abiomed

15. 9/5/201515  Left, Right, or Biventricular support  Short or long term use  Patient size irrelevant  Bridge to Recovery  Bridge to Transplant  NOT for Destination Therapy Implantable or Paracorpeal Thoratec – PVAD or IVAD

16. 9/5/201516 Thoratec

17. 9/5/201517  Left ventricular assist device only  Long term use  BSA must be >1.2 for HM II and >1.5 for HM XVE Pulsatile or axial flow  Bridge to transplant  Destination therapy HeartMate XVE and II

18. 9/5/201518 HeartMate XVE

19. 9/5/201519 HeartMate II

20. 9/5/201520 Left ventricular assist device only Long term use BSA must be >1.2 Centrifugal pump Bridge to transplant  Destination therapy Heartware

21. 9/5/201521 HeartWare

22. 9/5/201522 Blood Pump Differences Thoratec/Abiomed Pulsatile pump Valves allowing unidirectional flow Vacuum assist filling Asynchronous pulsatile VAD Need to start anticoagulation earlier HeartMate/Heartware  Continuous flow pump  Valveless  Afterload sensitive – retrograde flow  Follows native pulse  Pump output varies over cardiac cycle

23. 9/5/201523 Comparison of Pulsatile and Axial Flow (Both have average flow between 4-5 L/min)

24. 9/5/201524 Pump Rotor and Stators Inflow Bearings Inflow Stator Rotor Outflow Bearings Outflow Stator Flow

25. 9/5/201525 HeartMate II  Blood pump rotor is the only moving part  Rotor spins on blood –lubricated bearings designed for long life

26. 9/5/201526 Recovery Education Excursions Discharge – home environment What it takes to get a patient home!

27. 9/5/201527 Recovery Hemodynamic stability Nitric Oxide or Flolan Dobutrex or Milrinone Cardiac Tamponade Anticoagulation Pain management Infection

28. 9/5/201528 Education Process –Driveline Dressing change –Learning the VAD –Alarms and troubleshooting VAD –Handling an emergency –Excursions What it takes to get a patient home!

29. 9/5/201529  Recording VAD settings  Monitoring trends  Assessing preload and afterload  Alarm tests  Dressing change  Monthly assessing VAD equipment for any problems – i.e.- exposed wires Daily Checks

30. 9/5/201530 Advance Heart Care Clinic has 24/7 on call Local ER Fire station Electric company Caregiver/Ambulance/Lifeline transfer if needed Emergency Resources

31. Emergency Situations Assess patient and VAD monitor Check connections OK to intubate, defibrillate, and give medications If need to defibrillate NO disconnection required Can DO chest compressions if you cant get pump running Close monitoring of fluid status and MAP

32. 9/5/201532 Down the line…… Right Heart Failure Debilitation Cardiac Arrhythmias Device Failure Co-Morbidities Infection Hospice/End of Life Cost

33. 9/5/201533

34. 9/5/201534 A Successful VAD Program MD’s – Surgeon and Cardiologist VAD Coordinator Nurse Practitioners Social Worker Bedside Nurse Pharmacist Dietician Respiratory Therapist Physical and Occupational Therapist Transplant Coordinators Research Nurse’s Chaplin

35. Survival Rates June 2006-Q4 2012 9/5/201535 IU Health Pagani INTERMACS *Patient survival post implant Kaplan-Meier Survival Analysis Pagani et. al, JACC, 2009 n=158

36. Survival Rates 2011-2012 9/5/201536 n = 60 *Patient survival post implant Kaplan-Meier Survival Analysis Pagani et. al, JACC, 2009 IU Health Pagani INTERMACS

37. 9/5/201537 New York Heart Association NYHA ClassSymptoms INo symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc IIMild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. IIIMarked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). Comfortable only at rest. IVSevere limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

38. Quality of Life Functional status six months post-implant 9/5/201538 Benchmark: NYHA Class I & II = 89% at 6 months Pagani et. al, JACC, 2009 Data Source: MCCM *All patients are Class III or IV before VAD implantation NYHA Class assessed for every patient at 6 month visit June 2011 – June 2012, n=25* Class I 17 patients68% 92% Class II 6 patients24% Class III 2 patients 8% Class IV 32 Patients evaluated 25 patients reached 6 months 7 patients NOT Included. 4 deceased, 1 transferred care and 2 transplanted.

39. 9/5/201539 "Advanced Practice Guidelines for HeartMate Destination Therapy." Guidelines 2(2004): 1-38. American Heart Association (2009). Heart disease and stroke statistics 2009 update at a glance (Our guide to current statistics and the supplement to our heart and stroke facts). Retrieved January 2009 from http://wwwamericanheart.org. Thoratec Corporation, "Your Guide to Successful LVAS Patient Discharge." HeartMate Left Ventricular Assist System (LVAS) Community Living Manual. 1st Ed. 2004. United Network For Organ Sharing (2011). Heart transplant statistics for 2011. Retrieved February 2012 http://www.unos.org Mariell Jessup, M.D., and Susan Brozena, M.D. Heart Failure. N Engl J Med 2003; 348:2007-2018 May 15, 2003 References

40. 9/5/201540 www.abiomed.comwww.abiomed.co www.thoratec.com www.americanheartassociation.org www.heartcenteronline.com www.optn.org www.healthatoz.com www.nlm.nih.gov To Learn More About VAD’s