Ali Valika,, MD, FACC Advanced Heart Failure & Transplant Cardiologist Advocate Medical Group

Ali Valika,, MD, FACC Advanced Heart Failure & Transplant Cardiologist Advocate Medical Group

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Survival statistics. estimates of prognosis Over 100 different variables that have been looked at that can give prognostic evaluation for the HF patient.

CHARM data: LVEF Solomon et al. Circ 2005 Lee et al., AJC 1993

Anand et al. Circ 2003 Gheorgiade et al. Eur Heart J 2007

Refractory Symptoms Intolerance to cardiac medications Worsening renal function Low blood pressure Hyponatremia Elevated cardiac biomarkers (eg( eg.. BNP, Troponin) Need for inotropes

Cardiopulmonary Exercise Stress Test Standard. Objective evaluation of functional capacity Has certain limitations Heart Failure Survival Score Model drafted prior to device therapy and wide-spread beta-blocker blocker use. Seattle Heart Failure Model Complex calculation. (Overestimates survival)

Mancini, DM et al Circulation 1991; 83:778

Provides the most objective assessment of functional capacity in patients with HF. Value of VO2 for optimal timing of cardiac transplantation in ambulatory patients with HF was illustrated by Mancini,et al, circulation 1991;83:778. Patients with VO2<=12ml/kg/min are likely to experience maximum improvement in survival with transplantation. Patients with VO2 12-14 14 ml/kg/min, remain optimal candidates for transplantation, provided they are on maximal medical therapy.

Limitations Predictive value of a severely reduced peak VO2 only applies when it is caused by HF Factors that prematurely terminate the test and prevent patients from achieving VO2 will confound the results. It is a continuous parameter affected by age, gender, degree of conditioning. It should also be interpreted as a percent of the expected value for a specific patient Several studies have suggested that a peak VO2<50%of predicted is a significant predictor of cardiac death within 1-33 years

Figure 1. Kaplan-Meier survival curves for group 1 (VO 2 12 ml/min/kg, CI 1.8 L/min/m 2 ), group 2 (VO 2 12 ml/min/kg, CI <1.8 L/min/m 2 ), group 3 (VO 2 <12 ml/min/kg, CI 1.8 L/min/m 2 ), and group 4 (VO 2 <12 ml/min/kg, CI <1.8 L/min/m 2 ). Am J Card. 105: 9 May 2010, 1353 1355 1355

Cardiac Transplantation Ventricular Assist Devices

Heart transplantation survival is on the rise thanks to improved therapy. About half the patients now live for more than 11 years, and about one quarter for 17 or more years. Taylor DO et al. J Heart Lung Transplant 2003;22:616 624 There are currently about 20,000 pts living with a transplanted heart in the US. Prolonged survival stresses the need for awareness of drug therapy, drug-drug interactions and common co-morbid conditions 2000 Annual Report of the U.S. Scientific Registry of Transplant Recipients and the Organ Procurement and Transplantation Network: Transplant Data 1989 1998. Rockville, Md, and Richmond, Va:HHS/HRSA/OSP/DOT and UNOS; 2001

J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132 1132

Absolute or Relative Contra-indications Fixed pulmonary hypertension Severe, chronic disabling diseases Severe, irreversible, chronic impairment of other vital organs, such as kidneys, intestines, liver, lungs or central nervous system Recent (<5yrs) or uncontrolled malignancy Symptomatic, severe peripheral, visceral, carotid or cerebrovascular disease that cannot be corrected Inability to discontinue recreational drug, tobacco or alcohol use u Active mental illness that interferes with medical treatment compliance Psychosocial instability, lack of social or family support, ongoing noncompliance with medical treatment 70 years old or older Pulmonary infarction within the past six weeks Very brittle diabetes or diabetes with end organ damage Major chronic disabling diseases, such as arthritis, stroke, neurological disease, severe inflammatory or collagen vascular disease Active, but treatable infection (temporary) Morbid obesity

Cardio-pulmonary stress testing Role of right heart catheterization Co-morbidities: Age, Obesity, cancer, diabetes, renal dysfunction and peripheral vascular disease Tobacco, substance abuse and psychosocial evaluation Baseline screening Malignancy, Infections, etc.

Wait list for Heart Transplant Status 1A Status 1B Status 2 Status 7 Priority on Waiting List Based on status level Duration of time in that status level No credit given for time at a lower status level No advantage for being hospitalized (required for 1A status however)

Pulsatile Continuous Flow Axial Flow Centrifugal Flow

Pump (VAD) Internal or external placement Wearable or portable control system Power source AC power or battery power that is outside of the body The pump can vary in method of operation, size and placement

Bridge to Transplant Non-reversible left heart failure Imminent risk of death Candidate for cardiac transplantation Destination Therapy NYHA Class IIIB or IV heart failure Optimal medical therapy 45 of last 60 days Not candidate for cardiac transplantation Bridge to Recovery 24

Ability to tolerate / allergy toward anticoagulation Social support Nonreversible end organ failure Surgical Risk 25

HeartMate II Improvement Improvement in BTT Outcomes Miller LW, Pagani FD, Russell SD, et al. NEJM. 2007;357:885-96. Pagani FD, Miller LW, Russell SD, et al. JACC. 2009;54:312-21. 21. Starling, Naka, Boyle, et al. JACC. 2011;57:19.

HeartMate II Improvement Improvement in DT Outcomes Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-51. Park SJ. AHA Scientific Sessions, November 2010.

HeartMate II Actuarial Survival Post-Approval Study Starling, Naka, Boyle, et al. JACC. 2011;57:19.

INTERMACS Profiles Starling, Naka, Boyle, et al. JACC. 2011;57:19.

Clinical Outcomes Based on INTERMACS Profile Length of Stay Post-VAD Actuarial Survival Post-VAD Less acutely ill, ambulatory patients in INTERMACS profiles 4 74 7 had better survival and reduced length of stay compared to patients who were more accurately ill in profiles 1 3. 1 Group 1: INTERMACS 1 Group 2: INTERMACS 2 32 Group 3: INTERMACS 4 74 Boyle, Ascheim, Russo, et al. JHLT. 2011;30:4.

Significant improvement in survival. Dramatic improvements in QoL. Factors contributing to improving trends: Improved timing of patient referral Better patient selection Enhanced implantation techniques Improved post-op op patient management Increased knowledge and team training Higher surgery volume More dedicated coordinators and experienced patient care teams 33

End Stage HF is a treatable condition if diagnosed early. Objective assessment of a patient s HF status can be interpreted with CPX stress testing Heart Transplantation remains the gold standard for management of stage D HF Left Ventricular Assist devices have brought a new paradigm of therapy to this subgroup, and will continue to expand the patient population eligible for treatment