ADVANCED HEART FAILURE CLINIC. Heart Transplant and Mechanical Circulatory Support

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1 A ADVANCED HEART FAILURE CLINIC Heart Transplant and Mechanical Circulatory Support

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8 MCS UPDATE AND BH RESULTS

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10 Transplant Selection Criteria Inclusion Criteria Includes: End-stage cardiac disease defined by New York Heart Association Call III/IV with limited expected survival of less than 1 year. Psychosocial stability and supportive family/social structure as defined by social assessments. No expectation of improvement with alternative medical or surgical treatment. Long-term adherence to a disciplined medical regimen, must be feasible and realistic.

11 Transplant Selection Criteria Exclusion Criteria Includes: Ongoing emotional instability with uncontrolled psychotic disorder Unresolved malignancy Severe pulmonary disease Active hepatitis, cirrhosis, or chronic liver disease Active illegal drug, tobacco or excessive alcohol use Severe peripheral-arterial disease Diabetes, which is poorly controlled Severe or irreversible pulmonary hypertension BMI >35 (must loose recommended weight before transplant

12 Transplant Selection Criteria Exclusion Criteria Continued: Neurological impairment which prevents understanding of, and active participation in the transplant process and therapies Any existing condition in which of itself would limit life expectancy and/or pose a threat to good outcomes following transplantation Age >70 years unless no other coexisting medial conditions which would threaten a good outcome with transplantation Active infection (systemic) Severe renal disease

13 UNOS Priority Status: 1 A ICU, Swan, High dose Inotropes, IABP, ECMO, Vent, VAD for 30 days 1 B Inotrope infusion, home or hospital Stable VAD 2 Everyone else 7 Inactive 2/19/2016 Baptist Health Transplant Institute

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15 U.S. Transplants 2012 Listed 6669 Median Wait 78 Days 1A 64% Total Transplanted % 1B 31% Median Wait 224 days 2 5% Median Wait 618 days

16 Transplant according to priority Baptist Health Transplant Institute JAN /19/2016 Baptist Health Transplant Institute

17 Adult Heart Transplants Relative Incidence of Leading Causes of Death (Deaths: January 1994 June 2013) CAV Malignancy (non-lymph/ptld) Graft Failure Renal Failure Acute Rejection Infection (non-cmv) Multiple Organ Failure % of deaths Days (N=5,609) 31 Days 1 Year (N=4,800) >1 Year 3 Years (N=3,511) >3 Years 5 Years (N=3,085) >5 Years 10 Years (N=7,117) >10 15 Years (N=5,186) >15 Years (N=2,959) 2014 JHLT Oct; 33(10): Since only leading causes of death are shown, sum of percentages for each time period is less than 100%.

18 Adult and Pediatric Heart Transplants Kaplan-Meier Survival (Transplants: January 1982 June 2012) 100 Median survival = 11 years Median survival conditional on surviving 1 st year= 14 years 75 Survival (%) N = 108,343 N at risk at 27 years = Years 2014 JHLT Oct; 33(10):

19 ADVANCED HEART FAILURE CLINIC Mechanical Circulatory Support

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21 HeartMate III: Design Goals Build upon the highly successful HeartMate II LVAS Enhanced AE profile Increased surgical ease Elevate the patient experience

22 Heartware

23 Indications for Use Mechanical Circulatory Support 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 Does not have to be transplant candidate Inotrope dependent for 2 weeks Supported with short term VAD 23

24 Heartmate Selection Criteria End Stage Ventricular Failure with NYHA Class IV symptoms despite optimal medical therapy for at least 60 of last 90 days Maximum VO2 Less than or equal to 14 ml/kg/min, or inotrope dependent Documented left ventricular EF less than 25%

25 Heartmate Exclusion Criteria AR Medicaid does not reimburse for LVAD Irreversible non-cardiac disease state with less than 2 year survival rate Severe PVD with impending tissue loss History of Noncompliance Inadequate Right Heart Function Severe Cerebrovascular Disease Active systemic infection Severe Irreversible Pulmonary Hypertension Dementia Lack of Caregiver Support End Stage Renal Disease Diseases that would impair effective rehabilitation Current Substance Abuse Inability to take anticoagulation or refusal of blood products

26 Heartmate II and III Implants Total Implants: 203 Currently Following: 107 Heartmate II patients 6 Heartmate III patients Momentum Trial Enrollment 13 patients

27 Baptist Health Heartmate Survival 30 Day Survival: 98.5% One Year Survival: 95.6% Two year survival: 80%

28 Functional Status NYHA Class I or II 98 percent of patients were NYHA Class IV at baseline. 83% 82% 59% 0% n= Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4,

29 Timing Of Patient Referral For Evaluation A range of referral criteria assessments and scoring systems can be utilized to define the right moment to screen a patient for a transplant or MCS implant. 1 Appropriate timing for referral is when a patient presents in Class IIIB or IV heart failure and has more than one of the functional or laboratory risk factors. 1 Russell SD, Miller LW, Pagani FD. Advanced heart failure: a call to action. Congest Heart Fail. 2008;14: Teuteberg J, Lewis E, Nohria A, et al. Characteristics of patients who die with heart failure and low ejection fraction in the new millennium. J Card Fail. 2006;12(1): Functional Assessment Inability to walk one block without shortness of breath Intolerant or refractory to ACE inhibitor, angiotensin receptor blockers, or betablockers One heart failure-related hospital admission in the past 6 months 2 CRT nonresponder High diuretic dose (e.g., 120 mg/d Furosemide) Lab Assessment Serum sodium < 136 mmol/l BUN > 40 mg/dl or Serum Creatinine > 1.8 mg/dl Hemotocrit < 35%