“Rise of the Machines”

Todd D. Edwards MD FACC FACP FASNC

Merging of the Body and Machine

DisclosuresI have nothing to disclose (unfortunately)

The Future?• Number of heart transplant US 2013—2531 (down

to 2174 in 2014)

• Number of LVADs US 2013—-over 2000

• “in the future, heart transplants may be for patients than cannot take anticoagulation for their LVAD”-paraphrased from David Taylor MD, 2014 ISHLT President, Cleveland Clinic

• “I know you have an LVAD on the shelf and you don’t have a heart on the shelf”-paraphrased from Charles Nix, local LVAD recipient, Mississippi

Current survival statistics• Sixth INTERMACS -JHLT June 2014

• 8 years of enrollment from >10,000 patients

• 80 percent 1 year and 70% 2 year survival at 2 years with continuous flow pumps

LVAD Survival Compared To OMM Therapy

Park SJ. AHA Scientific Sessions, November 2010.

• a

HeartMate II—Widespread Approval And Adoption

Received European CE Mark in November 2005

Received FDA approval for BTT in April 2008

Received Health Canada approval in May 2009

Received FDA approval for DT in January 2010

Distributed throughout Asia and Australia

2010

2005

2008

2007

2006

2009

FDA approval for BTTApril 2008

European CE MarkNovember 2005

FDA approval for DTJanuary 2010

Operative 30-day survival was 96% and

patients achieved 90% successful

outcomes at 6 months and 85% at 1 year.

HeartMate II Post-Approval Study Actuarial Survival

Starling, Naka, Boyle, et al. JACC, in press 2010.

Design FeaturesOptimized blood

flowLow thrombosis

riskLow

anticoagulation requirements

Reliability

Drugs and devicesused post implant

• Beta blockers

• ACE inhibitors (or alternatives)

• Digoxin

• Spirinolactone

• AICD

LVAD versus BIVAD

• CVP less than 10

• CVP/PAW ratio less than 0.65

• RVSWI greater than 600 and ideally 900

• RV appearance on echo with size and contractility

• Severity of pulmonary hypertension

LVAD preimplant goals

• Renal-BUN less than 50 and Cr less than 2.5

• Heme-INR less than 1.2/Hgb greater than 10/platelets greater than 150k

• Nutrition-albumin greater than 3/prealbumin greater than 15/transferrin greater than 250

• Hepatic-total bilirubin less than 2.5/ast and alt less than 2X normal

• Hemodynamics-RA less than 15 and PAW less than 24

Michigan RV risk score

• Vasopressors—4 points

• AST greater than 80-2 points

• Total Bilirubin greater than 2-2.5 points

• Creatinine greater than 2.3

• Total ——less than 3.0 -low risk

• Total——greater than or equal to 5.5-high risk

TAH versus BIVAD• BIVAD failure less ominous than TAH failure

• TAH eliminate issues of malfunctioning heart valves, arrhythmias, and AICD issues

• Survival to transplant- TAH 89%, BIVAD 50%, and LVAD 79%

• Survival post transplant same in TAH and BIVAD

What pump?

• choices are LVAD, longterm BIVAD, intermediate term Centrimag, not eligible for any pump

What pump?

• 1) 22 male with fulminant myocarditis over 2 week course with nonspecific endomyocardial biopsy with LVEF 15, Milrinone at 0.75 mcg/kg/min, Dobutamine at 10 mcg/kg/min, CVP 18, RVSWI 350, IABP 1:1, CI 2.0, GFR has dropped over past 3 days but still 45 cc/min

What pump?

• 1) LVAD

• 2) longterm BIVAD

• 3) intermediate term Centrimag

• 4) no pump

What pump?

• 45 female with dilated cardiomyopathy with LVEF 20, mastectomy for breast cancer 2 years ago, CVP 20, RVSWI 450, PVR 3.5 with Flolan challenge, PA mean 45

What pump?

• 1) LVAD

• 2) longterm BIVAD

• 3) intermediate term Centrimag

• 4) no pump

What pump?

• 72 male with ischemic cardiomyopathy with LVEF 25, CPX mvO2 12, PVR 2.5, cvp/paw 0.5, RVSWI 850, GFR 50, bilirubin 1.5

What pump?

• 1) LVAD

• 2) longterm BIVAD

• 3) intermediate term Centrimag

• 4) no pump

What pump?

• 32 male with dilated cardiomyopathy with LVEF 20, active transplant listed at 3 centers due to O blood type, 2 inotropes in ICU, IABP, CVP 14, RVSWI 450, GFR 45, bilirubin 1.8, SVO2 at rest 52 and drops to mid 30”s getting into chair

What pump?

• 1) LVAD

• 2) longterm BIVAD

• 3) intermediate term Centrimag

• 4) no pump

I would like to thank my tech support.