CHANGING THE WAY HEART FAILURE IS TREATED. VAD Therapy

Transcription

1 CHANGING THE WAY HEART FAILURE IS TREATED VAD Therapy

2 VAD THERAPY IS BECOMING AN ESSENTIAL PART OF HEART FAILURE PROGRAMS AROUND THE WORLD. Patients with advanced heart failure experience an impaired quality of life and the significant personal and economic impact of recurrent hospitalizations. A substantial number of patients who could benefit from this therapy are not currently being referred or considered for LVAD therapy. 1 Ventricular assist devices (VADs) are transforming the treatment of patients with advanced heart failure. In fact, few advancements in healthcare today have a greater potential to impact heart failure than VADs. VAD therapy is part of the field of Mechanical Circulatory Support (MCS). VADs are mechanical devices designed to help a weakened heart pump blood throughout the body by moving blood from the left ventricle and pumping it into the ascending aorta. VADs positively impact cardiac output and help alleviate the symptoms of heart failure. HeartWare HVAD Ventricular Assist Device

3 WHEN MANAGING PATIENTS WITH ADVANCED HEART FAILURE, CONSIDER DISCUSSING REFERRAL FOR VAD THERAPY WHILE THEY STILL HAVE TIME TO MAKE A CHOICE. If your patient is persistently symptomatic and has one or more of the C.H.O.I.C.E. risk factors, he or she may be a candidate for VAD therapy. From the first consideration of a VAD, emphasis should be placed on the anticipated differences between ongoing medical therapy and VADs with respect to both survival and quality of life. These discussions should occur before consideration of continuous outpatient inotropic infusions for hemodynamic support of deteriorating clinical status. 2 C H O I C E CLASS IIIB / IV NYHA classification symptoms with an ejection fraction (EF) <30% 3 HOSPITALIZATION Each subsequent hospitalization for heart failure is associated with a significant further reduction in survival 1 OPTIMAL Medical management not effective 3,4 INOTROPE Therapy being considered or initiated 4 CLINICAL Parameters worsening 5 EVOLVING Or progressing organ dysfunction 3,4 SYMPTOMS TO WATCH FOR: Shortness of breath on mild exertion/breathless at rest 5 Low six-minute walk test distance (<300 m) 3 Inability to perform an exercise test 3 Inability to climb two flights of stairs Inability to walk two blocks Increased diuretic requirement 3 Intolerance to neurohormonal antagonists 3 (ACEi/ARB/BB) Hypotension 3 CRT non-responder/not indicated 6 Increasing plasma BNP or NTproBNP levels, despite adequate heart failure treatment 7

4 MEDIAN SURVIVAL DECREASES AFTER EACH HEART FAILURE- RELATED HOSPITALIZATION MEDIAN SURVIVAL (YEARS) st Hospitalization (n=14,374) 2 nd Hospitalization (n=3,358) 3 rd Hospitalization (n=1,123) 4 th Hospitalization (n=417) AVERAGE AGE OF HEART FAILURE HOSPITALIZATION IN COMMUNITY = YEARS OBSERVED MORTALITY BY NUMBER OF THE SPECIFIED RISK FACTORS 7 SURVIVAL RATES (%) Risk Factors 1 Risk Factor 2 Risk Factors 3-5 Risk Factors YEARS One or more of the following risk factors should trigger generalist to refer to an advanced heart failure center: 7 Systolic blood pressure 90 mm Hg Creatinine 160 μmol/l Hemoglobin 120 g/l No treatment with renin-angiotensin system antagonist No treatment with beta-blocker NO. AT RISK 0 RISK FACTORS

5 VADS ADDRESS A NEED There is a shortage of hearts heart transplantation rates remain steady, yet demand continues to rise with more patients waiting for a transplant. HEART FAILURE STATISTICS 1 in 5 At 40 years of age, the lifetime risk of developing heart failure for both men and women is 1 in 5. 8,13 49% 49% of the people who are on the heart transplantation wait list have been waiting for over a year % 50% 3,100 Projections show that by 2030, the prevalence of heart failure in the U.S. is projected to rise by 46%, resulting in 8 million people with heart failure. 12 Survival after heart failure diagnosis has improved over time; however, the death rate remains high: 50% of people diagnosed with heart failure will die within five years. 8 On any given day, there are 3,100 people in the United States who are on the heart transplant wait list. 12 MANY HEART FAILURE PATIENTS WAITING FOR A DONOR HEART BECOME INOTROPE- DEPENDENT. 8

6 GLOBAL ENDORSEMENT A simple solution that can transform patients lives. VAD therapy does not cure heart failure, but the data and trends demonstrate that VAD therapy may offer a C.H.O.I.C.E. for your advanced heart failure patients. 51% of heart transplant patients worldwide are bridge-to-transplant with a VAD. 9 VAD therapy has been globally endorsed as an option by the: American Heart Association (AHA) 3 European Society of Cardiology (ESC) 4 International Society for Heart and Lung Transplantation (ISHLT) 14 A decreasing number of patients on the heart transplant waiting list die because of the availability of VAD therapy. However, a significant percentage of that number dies of progressive heart failure without the use of VADs. 1

7 Early referral equals a C.H.O.I.C.E. for your patients. Despite optimal medical management, your patient continues to be readmitted to the hospital for acute heart failure symptoms, becoming a frequent flyer and potentially inotrope-dependent. Of those, 50% who have three hospital stays will die within one year. 3 These patients may be good candidates for referral to an advanced heart failure center for assessment. KEY FACTS: Heart failure is a serious disease that affects an estimated 26 million patients worldwide 10 Heart failure is the leading cause of hospitalization in the U.S. and Europe 10 Heart failure has the highest readmission rate of any diagnosis related group, averaging 20% at 1 month and 50% at 6 months 1 An estimated 10% of heart failure patients have an advanced condition 11 with symptoms, such as shortness of breath, even while resting Worldwide 50,000 candidates are waiting for heart transplantation, 12 yet only approximately 4,000 heart transplants are performed each year 9

8 References 1. Miller, L, et al. Is left ventricular assist device therapy underutilized in the treatment of heart failure? Circulation. 2011;123: Stewart, G, et al. Who wants a left ventricular assist device for ambulatory heart failure? Early insights from the MEDAMACS screening pilot. J Heart Lung Transplant. 2015;34: Peura, J, et al. AHA. Recommendations for the use of mechanical circulatory support: device strategies and patient selection.2012;126: Ponikowski, P, et al ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure Eur Heart J. 2016;37: Thorvaldsen, T, T, et et al. al. Triage of of patients with with moderate to severe to severe heart heart failure failure who who should should be referred be referred to a heart to a heart failure failure center. center. J Am Coll J Am Cardiol. Coll Cardiol. 2014;63: Daubert, 63: J, et al EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: Implant and follow-up 6. recommendations Daubert, J, et al and EHRA/HRS management. expert Europace. consensus 2012;14: statement on cardiac resynchronization therapy in heart failure: Implant and follow-up 7. Banner, recommendations N, et al. UK Guidelines and management. for referral Europace. and assessment 2012;14: of adults for heart transplantation. Heart. 2011;97: Go, Banner, A, et N, al. et AHA al. UK statistical Guidelines update. for referral Heart and disease assessment and stroke of statistics adults for - heart 2013 transplantation. update. A report Heart. from the 2011;97: American Heart Association. 8. Circulation. Go, A, et al. AHA 2013;127:e199-e201. statistical update. Heart disease and stroke statistics update. A report from the American Heart Association. 9. Lund, Circulation. L, et al. 2013;127:e199-e201. For the International Society for Heart and Lung Transplantation, The Registry of the International Society for Heart and Lung 9. Transplantation. Lund, LH et al. The Thirty-second Registry of the Official International Adult Heart Society Transplantation for Heart and Report Lung -- Transplantation: 2015; Focus Theme: Thirty-third Early Adult Graft Failure, Heart Transplantation J Heart Lung Transplant. Report-2016; 2015;34: Focus Theme: Primary Diagnostic Indications for Transplant. JHLT.2016 Oct, 35(10): Ponikowski, Ambrosy, P, et P, et al. al. The Heart global failure: health preventing and economic disease burden and death of hospitalizations worldwide.esc for Heart heart Failure failure. 2014; Lessons 1:4 25. learned from hospitalized heart failure 11. Ambrosy, registries. P, J Am et al. Coll The Cardiol. global health 2014;63:1123 and economic burden of hospitalizations for heart failure. Lessons learned from hospitalized heart failure 11. registries. J Am Coll Cardiol. 2014;63: Accessed April 3, HealthResearchFunding.org. Accessed April 3, Accessed April 3, HealthResearchFunding.org. Heidenreich, P, et al. AHA Policy Accessed Statement. April Forecasting 3, the impact of heart failure in the United States. A policy statement from the American 14. Stehlik, Heart Association. J, et al. The Circ Registry Heart of Fail. the 2013;6: International Society for Heart and Lung Transplantation: 29th official adult heart transplant report J Feldman, Heart Lung D, et Transplant. al. The ;31: International Society for Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support: Executive Summary. 15. Heidenreich, J Heart Lung P, Transplant et al. AHA 2013;32: Policy Statement. Forecasting the impact of heart failure in the United States. A policy statement from the American Heart Association. Circ Heart Fail. 2013;6: Feldman, D, et al. The 2013 International Society for Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support: Executive Summary. J Heart Lung Transplant 2013;32: Brief Statement: HeartWare HVAD System Indications The HeartWare Ventricular Assist System is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter. Contraindications The HeartWare System is contraindicated in patients who cannot tolerate anticoagulation therapy. Warnings/Precautions Proper usage and maintenance of the HVAD System is critical for the functioning of the device. Never disconnect from two power sources at the same time (batteries or power adapters) since this will stop the pump, which could lead to serious injury or death. At least one power source must be connected at all times. Always keep a spare controller and fully charged spare batteries available at all times in case of an emergency. Do not expose batteries to excessive shock or vibration since this may affect battery operation. Do not grasp the driveline cable as this may damage the driveline. Do not pull, kink or twist the driveline or the power cables, as these actions may damage the driveline. Special care should be taken not to twist the driveline including while sitting, getting out of bed, adjusting the controller or power sources, or when using the shower bag. Do not disconnect the driveline from the controller or the pump will stop. If this happens, reconnect the driveline to the controller as soon as possible to restart the pump. Potential complications Implantation of a Ventricular Assist Device (VAD) is an invasive procedure requiring general anesthesia, a median sternotomy, a ventilator and cardiopulmonary bypass. There are numerous risks associated with this surgical procedure and the therapy including but not limited to, death, stroke, device malfunction, peripheral and device-related thromboembolic events, bleeding, infection, hemolysis and sepsis. Refer to the Instructions for Use for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions and potential adverse events prior to using this device. The IFU can be found at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Medtronic NW 60th Ave Miami Lakes, FL USA Telephone: (305) Fax: (954) heartware.com US1212 Rev01 Medtronic Minneapolis, MN. All Rights Reserved. Printed in USA. 04/2017 HeartWare, HVAD, Medtronic and the Medtronic logo are registered trademarks of Medtronic.