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
Impact of Heart Failure with an Aging Population 5+ million Americans* Nearly 700,000 new cases per year* More than 280,000 patients die of heart failure in the US each year* - 2 nd highest mortality at one year with optimal medical management
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): American Heart Association. Heart Disease and Stroke Statistics: 2007 Update. Dallas, Texas:
Progression of Heart Failure
I IIIIIIV 1 10 NYHA CLASS Annual Survival Rate Hospitalizations / year.1.1 Deceased Adapted from Bristow, MR Management of Heart Failure, Heart Disease: A Textbook of Cardiovascular Medicine, 6th edition, ed. Braunwald et al. Class III n 25% of HF Patients n Frequent hospitalizations n Worsening symptoms despite drug therapy n Significant opportunity for new therapies Survival Rate Hospitalizations Natural History of Heart Failure
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
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. Accessed April 23,
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
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
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
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
CHF Reunion at One Year OMM Therapy Group VAD Therapy Group 28 Alive 52 Alive
CHF Reunion at Two Years OMM Therapy 8 Alive VAD Therapy 29 Alive
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: , Nov 15, 2001
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:
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
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”
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.
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
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
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 )
IVAD PVAD
Biventricular Support
Portable TLC-II Driver
TLC-II ® Portable VAD Driver
Mode Button Scroll Button Alarm Silence Button Message Display External Power Light VAD Full Lights Change Batt. A Light Battery A Battery B Change Batt. B Light External Power Computer Input Key Switch Pneumatic Connections Full Signal Inputs Normal Alarm Urgent Alarm Battery Clip TLC-II ® Interface and Control Panel
Heartmate XVE Heartmate II
Components of a Ventricular Assist Device
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
Components of a Ventricular Assist Device
Heartware HVAD
HeartWare ® System Peripherals IN THE HOSPITAL AT HOME HeartWare™ Controller with LCD display, audible alarms and 30 day data storage HeartWare™ Monitor with pump parameters & flow waveforms HeartWare™ Batteries & Charger: 2 Li-ION batteries last up to 12 hours
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
What They Look Like CHF Infusion Clinic Patient VAD Referral in ICU
Enjoying a Ride on his Motorcycle
Distance Traveled
Patient vacationing in San Juan, Puerto Rico
Patient in Puerto Rico following instruction to avoid bathes, swimming pools, and oceans
Patient enjoying the streets of Madrid, Spain
Patient sightseeing in Seattle, Washington
Patient visiting New Orleans, Louisiana