Ventricular Assist Device: An Advanced Surgical Intervention for the Treatment of End Stage Heart Failure

1. Ventricular Assist Device: An Advanced Surgical Intervention for the Treatment of End Stage Heart Failure Laura Coyle, MSN, ACNP-BC VAD Coordinator Advocate Christ Medical Center

2. Impact of Heart Failure with an Aging Population • 5+ millionAmericans* • Nearly 700,000 new cases per year* • More than 280,000 patients die of heart failure in the US each year* - 2nd highest mortality at one year with optimal medical management

3. Impact of Heart Failure with an Aging Population • Nearly 250,000 patients are considered at high risk for repeated hospitalizations -More than 1 million hospitalized for worsening heart failure at a cost of nearly 35 billion* - 20% of hospitalizations are persons over 65* • Currently 100,000 patients have advanced end-stage heart failure characterized by: - frequent hospitalizations - reduced quality of life - a complex therapeutic regimen, and a high mortality rate+ *Rosamond W, Flegal K, Furie K, et al. Heart Disease and stroke statistics 2008 update: a report from the American Heart Association Statistics Committee and Stoke Statistics Subcommittee. Circulation. 2008: 117(4): 25-146 +American Heart Association. Heart Disease and Stroke Statistics: 2007 Update. Dallas, Texas: www.americanheart.org.

4. Progression of Heart Failure

6. 100 10 Survival Rate Hospitalizations 75 Annual Survival Rate 50 1 Hospitalizations / year 25 .1 0 II III IV I Deceased NYHA CLASS Natural History of Heart Failure Class III • 25% of HF Patients • Frequent hospitalizations • Worsening symptoms despite drug therapy • Significant opportunity for new therapies Adapted from Bristow, MR Management of Heart Failure, Heart Disease: A Textbook of Cardiovascular Medicine, 6th edition, ed. Braunwald et al.

7. Treatment Options for Advanced Heart Failure • Optimal Medical Therapy Beta Blockers, ACE Inhibitors, ARBs, Aldosterone Antagonists, Diuretic Therapy, Oral Nitrates and Hydralazine, etc. • Electrophysiologic Testing and the Use of Devices in Heart Failure -Prophylactic ICD Placement -Biventricular Resynchronization Pacing 2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of hEart Failure in Adults. J. Am. Coll. Cardiol. Published March 26, 2009

8. Advanced Surgical Interventions for End-Stage Heart Failure • Cardiac Transplantation “gold standard” -Severely limited by shortage of donors; only 2,163 heart transplants in 2008 in US* • Ventricular Assist Device for Bridge to Transplant or Destination Therapy for patients ineligible for heart transplantation. United States Department of Health and Human Services. www.unos.orgAccessed April 23, 2009.

9. What is a Ventricular Assist Device? • A ventricular assist device (VAD) is an implantable device designed to partially replace the function of the failing heart, restoring circulation of blood flow to the body through mechanical circulatory support. • VADs are designed to assist either the right (RVAD) or left (LVAD) ventricle, or both at once (BiVAD). Which of these types is used depends primarily on the underlying heart disease and the pulmonary arterial resistance that determines the load on the right ventricle

10. Advanced Surgical Interventions for End-Stage Heart Failure • Use of Left Ventricular Assist Devices - Bridge to Decision - Bridge to Recovery - Bridge to Transplant - Permanent Use for “Destination Therapy” • Non Study Device Implants

11. REMATCH Trail • Multi-Center Randomized Controlled Study designed for patients in Class IV (NYHA) end stage heart failure who did not qualify for a heart transplant. • 68 patients randomized to XVE HeartMate LVAD • 61 patients randomized to optimal medical therapy

12. REMATCH Conclusion DT • 51% 1-year survival in the LVAD group • 27% 2-year survival in the LVAD group OMT 28% 1-year survival in the OMT 10% 2-year survival in the OMT

13. OMM Therapy Group VAD Therapy Group CHF Reunionat One Year 52 Alive 28 Alive

14. OMM Therapy 8 Alive VAD Therapy CHF Reunionat Two Years 29 Alive

15. Beginning of Destination Rematch Study Conclusion- Therapy • Risk from death from any cause was 48% lower in the LVAD group • “Using an LVAD in patients with advanced heart failure improves survival and quality of life. An LVAD is an acceptable alternative therapy in some CHF patients” N Engl J Med 2001; 345:1435-1443, Nov 15, 2001

16. Improved survival and quality of life with a LVAD Long JW et al. Long-term Destination Therapy with the HeartMate XVE left Ventricular Assist Device: improved outcomes since the REMATCH study. CHF. 2005;11:133-138.

17. Patient Selection: Who benefits from a VAD? • New York Heart Association (NYHA) Functional Class III to IV or Refractory Heart Failure • Left Ventricular Ejection Fraction ≤ 25% • Peak VO2 < 14 ml/kg/min • Severe HF symptoms despite optimal medical therapy • Inability to tolerate medical therapy • Requiring inotropes • Do not respond to biventricular pacing • One or more heart failure related hospital admissions in past 6 months • Ineligible for cardiac transplantation

18. Ventricular Assist Devices • Provide mechanical circulatory support to restore the circulation of blood flow to the body. • Decreases preload • Decreases cardiac workload • Increases systemic circulation & tissue perfusion • Decreases neurohormonal response • Indications for Use • Bridge to Decision/ Postcardiotomy/Failure to wean from Bypass • Bridge to Recovery • Bridge to Transplant • Permanent Use for “Destination Therapy”

19. Ventricular Assist Devices • A VAD runs on electrical power 24 hours a day 365 days of the year. • Patients may connect to a power base unit to provide consistent power or connect to a set of batteries which must be changed every few hours (varies per device) to maintain a reliable power source. Patients must be connected to power at ALL times.

20. Ventricular Assist Devices • There are several many different VADs. All VADs have the following four parts: • An inflow cannula which takes blood from the ventricular to the pump • A pump • An outflow cannula that takes the pumped blood to the ascending aorta • A power source for the pump

21. Types of Ventricular Assist Devices: Pulsatile vs. Continuous Flow • Pulsatile VADs – mimic the natural pulsing action of the heart using positive displacement • Device Specific – preload/volume dependent • Continuous Flow – normally use either a centrifugal pump or an axial flow pump • Device Specific – HVAD vs. HM II LVAD

22. Indications for Use:Pulsatile vs. Continuous Flow • Pulsatile Devices • PVAD • IVAD • Heartmate XVE LVAD • Continuous Flow • Heartmate II LVAD • Heartware HVAD • FDA Approved Devices for Bridge to Transplant • PVAD/IVAD • Heartmate XVE LVAD • Heartmate II LVAD • Heartware HVAD (currently undergoing clinical trials) • FDA Approved Device for Destination Therapy • Heartmate XVE LVAD • Heartmate II LVAD (pending FDA approval 2009-2010)

23. IVAD PVAD

24. Biventricular Support

25. Portable TLC-II Driver

26. TLC-II® Portable VAD Driver

27. TLC-II® Interface and Control Panel External Power Computer Input Key Switch Full Signal Inputs Battery Clip Battery A Battery B Urgent Alarm Pneumatic Connections Message Display Change Batt. B Light Change Batt. A Light External Power Light VAD Full Lights Mode Button Scroll Button Alarm Silence Button Normal Alarm

28. Heartmate XVE Heartmate II

29. Components of a Ventricular Assist Device

30. Carry On Components of a Ventricular Assist Device Power Base Unit System Display Module All Batteries Emergency Power Pack Back-up System Controller/Driver Battery Module Battery Clips Battery Holster/Pocket Pack Cell Phone Daily Driveline Dressing Supplies Emergency Contact Information *Total Weight 72.5 lbs

31. Components of a Ventricular Assist Device

32. Heartware HVAD

34. HeartWare® System Peripherals IN THE HOSPITAL HeartWare™ Monitor with pump parameters & flow waveforms AT HOME HeartWare™ Controller with LCD display, audible alarms and 30 day data storage HeartWare™ Batteries & Charger: 2 Li-ION batteries last up to 12 hours

35. SO why want a Ventricular Assist Device? • IMPROVED Survival -Improved end organ function -Reduced hospitalizations for HF • IMPROVED Quality Of Life -Return to normal activities of daily living -Live independently -Drive -Work -Travel

36. What They Look Like CHF Infusion Clinic Patient VAD Referral in ICU

37. Enjoying a Ride on his Motorcycle

38. Distance Traveled

39. Patient vacationing in San Juan, Puerto Rico

40. Patient in Puerto Rico following instruction to avoid bathes, swimming pools, and oceans

41. Patient enjoying the streets of Madrid, Spain

42. Patient sightseeing in Seattle, Washington

43. Patient visiting New Orleans, Louisiana