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1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications.

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Presentation on theme: "1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications."— Presentation transcript:

1 1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. © 2014 HeartWare, Inc. TM00017 Rev03 02/14 Module 2/10 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Ventricular Assist System Patient Selection

2 2 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Objectives Identify patients that may benefit from VAD support Discuss clinical indicators associated with higher morbidity and mortality in VAD patients Provide an overview of indications and contraindications for the HeartWare ® System

3 3 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Natural History of Heart Failure Adapted from Bristow, MR Management of Heart Failure, Heart Disease: A Textbook of Cardiovascular Medicine, 6th edition, ed. Braunwald et al. Overall, 50% of HF patients are dead at 4 years, and 40% of patients hospitalized with HF are dead or readmitted within 1 year. 1 Most patients would consider LVAD therapy when presented with a scenario of end-stage heart failure Overall, 50% of HF patients are dead at 4 years, and 40% of patients hospitalized with HF are dead or readmitted within 1 year. 1 Most patients would consider LVAD therapy when presented with a scenario of end-stage heart failure 1 Dickstein K, Cohen-Solal A, Filippatos G, et al. ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure Eur Heart J. 2008; 29:

4 4 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Transplant as an Option for Advanced Heart Failure UNOS data: –17% of patients on the waiting list for a heart died –48% of patients had spent more than 2 years on the wait list 1 J Heart Lung Transplant Oct; 29 (10): Lietz K and Miller L. J Am Coll Cardiol 2007;50:1282–90 2 ISHLT Website Heart transplant is an option, however, limited donor availability is an issue 2

5 5 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. INTERMACS – Estimated 1-Year Survival European Journal of Heart Failure (2010) 12, doi: /eurjhf/hfq006

6 6 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Predictors of Mortality in Patients with Heart Failure A strong association between NYHA class and outcomes in patients with systolic heart failure has been consistently reported in the literature 1 Both NYHA classification and peak VO 2 are significantly associated with survival time in patients with mild to moderate CHF, but peak VO 2 subdivides patients more clearly into subgroups according to the severity of functional impairment and lifetime prognosis. 2 Exercise VO 2 is an objective way to measure exercise tolerance, and perhaps predict mortality with heart failure VO 2 <14ml/kg/min high predictor of mortality; 1-yr survival (47%) 2-yr survival (32%) 3 1 Ahmed, et al, (2006). Higher New York Heart Association Classes and Increased Mortality and Hospitalization in Heart Failure Patients with Preserved Left Ventricular Function, Am Heart Journal 2006 February; 151(2): Broek, et al. Comparison between New York Heart Association Classification and peak oxygen consumption in the assessment of functional status and prognosis in patients with mild to moderate chronic congestive heart failure secondary to either ischemic or idiopathic dilated cardiomyopathy. The American Journal of Cardiology, 1992; 70(3): Mancini, et al, Circulation, 1991 NYHA Functional Capacity Exercise Testing – pVO 2

7 7 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Considerations of VAD Therapy Potentially reversible cause of heart failure Recent or evolving stroke Neurological deficits impairing the ability to manage device Coexisting terminal condition (e.g., metastatic cancer, cirrhosis) Abdominal aortic aneurysm > 5 cm Symptomatic right heart failure Active systemic infection or major chronic risk for infection Fixed pulmonary hypertension Severe pulmonary dysfunction (e.g., FEV1<1 L) Current or impending renal or hepatic failure Multisystem organ failure Heparin-induced thrombocytopenia Significant underlying psychiatric illness or lack of social support

8 8 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Considerations for Surgical Implant Aortic and/or tricuspid insufficiency or mitral stenosis Pre-existing mechanical valves Intracardiac shunts

9 9 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® System Indications for Use The HeartWare Ventricular Assist System is intended 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 WARNING! Serious and life threatening adverse events, including stroke, have been associated with use of this device. A user must fully consider the risks of this device with that of other treatment modalities before deciding to proceed with device implantation.

10 10 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® System Contraindications The HeartWare System is contraindicated in patients who cannot tolerate anticoagulation therapy. WARNING! Do not use in pregnant women. Any women receiving the HeartWare System who is of child bearing age should use a reliable method of birth control. CAUTION: Safety and effectiveness in persons less than 18 years of age and in persons with a BSA of less than 1.5m 2 have not been established. CAUTION: The HeartWare Ventricular Assist System has had limited use in patients with artificial mitral or aortic valves and therefore the risks are currently unknown. CAUTION: Safety and effectiveness in persons less than 18 years of age and in persons with a BSA of less than 1.5m 2 have not been established. CAUTION: The HeartWare Ventricular Assist System has had limited use in patients with artificial mitral or aortic valves and therefore the risks are currently unknown.

11 11 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Summary The natural history of heart failure leads to multiple hospitalizations, worsening symptoms, use of IV inotropic medications and eventually to orthotopic heart transplantation for those that are eligible A lack of organs for transplant has led to longer wait times and therefore significant mortality risk for those waiting The HeartWare System is an option to bridge patients to heart transplant Timing and patient selection, although still being studied in continuous flow devices, are essential to continued optimal outcomes and reduction of mortality

12 12 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. References 1.Kormos RL, Teuteberg JJ, Pagani FD, Russell SD, John R, Miller LW, Massey T, Milano CA, Moazami N, Sundareswaran KS, Farrar DJ; HeartMate II Clinical Investigators. Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes. J Thorac Cardiovasc Surg May;139(5): Lund LH, Matthews J, Aaronson K. Patient selection for left ventricular assist devices. Eur J Heart Fail May; 12(5): Sasaki H, Mitchell JD, Jessen ME, Lavingia B, Kaiser PA, Comeaux A, Dimaio JM, Meyer DM. Bridge to heart transplantation with left ventricular assist device versus inotropic agents in status 1 patients. J Card Surg Nov-Dec; 24(6): Kwon MH, Moriguchi JD, Ardehali A, Jocson R, Marelli D, Laks H, Shemin RJ, Esmailian F. Use of ventricular assist device as a bridge to cardiac transplantation: impact of age and other determinants on outcomes. Tex Heart Inst J. 2009; 36(3): Lietz K, Miller LW. Patient selection for left-ventricular assist devices. Curr Opin Cardiol May;24(3): Review. 6.Holman WL, Pae WE, Teutenberg JJ, Acker MA, Naftel DC, Sun BC, Milano CA, Kirklin JK. INTERMACS: interval analysis of registry data. J Am Coll Surg May; 208(5):755-61; discussion Wilson SR, Mudge GH Jr, Stewart GC, Givertz MM. Evaluation for a ventricular assist device: selecting the appropriate candidate. Circulation Apr 28;119(16): Review.

13 13 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. References 8.Sandner SE, Zimpfer D, Zrunek P, Rajek A, Schima H, Dunkler D, Grimm M, Wolner E, Wieselthaler GM. Renal function and outcome after continuous flow left ventricular assist device implantation. Ann Thorac Surg Apr; 87(4): Schulman AR, Martens TP, Russo MJ, Christos PJ, Gordon RJ, Lowy FD, Oz MC, Naka Y. Effect of left ventricular assist device infection on post-transplant outcomes. J Heart Lung Transplant Mar; 28(3): Levy WC, Mozaffarian D, Linker DT, Farrar DJ, Miller LW; REMATCH Investigators. Can the Seattle heart failure model be used to risk-stratify heart failure patients for potential left ventricular assist device therapy? J Heart Lung Transplant Mar;28(3): Holman WL, Kormos RL, Naftel DC, Miller MA, Pagani FD, Blume E, Cleeton T, Koenig SC, Edwards L, Kirklin JK. Predictors of death and transplant in patients with a mechanical circulatory support device: a multi-institutional study. J Heart Lung Transplant Jan; 28(1): Rao V, Oz MC, Flannery MA, Catanese KA, Argenziano M, Naka Y. Revised screening scale to predict survival after insertion of a left ventricular assist device. J Thorac Cardiovasc Surg Apr;125(4): Miller LW. Patient selection for the use of ventricular assist devices as a bridge to transplantation. Ann Thorac Surg Jun;75(6 Suppl):S Review. 14.Ahmed, et al, (2006). Higher New York Heart Association Classes and Increased Mortality and Hospitalization in Heart Failure Patients with Preserved Left Ventricular Function, Am Heart Journal 2006 February; 151(2): Broek, et al. Comparison between New York Heart Association Classification and peak oxygen consumption in the assessment of functional status and prognosis in patients with mild to moderate chronic congestive heart failure secondary to either ischemic or idiopathic dilated cardiomyopathy. The American Journal of Cardiology, 1992; 70(3): HeartWare® Ventricular Assist System, Instructions for Use


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