1. Contemporary Outcomes With the HeartMate II® LVAS
David J. Farrar, PhD
Vice President, Research and Scientific Affairs
Thoratec Corporation J

2. HeartMate II® LVAS
A surgically implanted, rotary continuous-flow device in parallel with the native left ventricle
Left ventricle to ascending aorta
Percutaneous driveline
Electrically powered
Batteries and line power
Fixed-speed operating mode
Home discharge with ability to return to activities of daily life (work, school, exercise, hobbies, etc.)
Implantable
Pump
Controller
Percutaneous
Lead
Batteries

3. HeartMate II—Indications for Use
HeartMate II is the first and only FDA-approved continuous-flow device for both Bridge-to-Transplantation (BTT) and Destination Therapy (DT).
Bridge-to-Transplantation
Risk of imminent death from nonreversible left ventricular failure
Candidate for cardiac transplantation
Destination Therapy
NYHA Class IIIB or IV heart failure
Optimal medical therapy 45 of last 60 days
Not a candidate for cardiac transplantation

4. HeartMate II—Worldwide Clinical Experience*
More than 7,000 patients worldwide have now been implanted with the HeartMate II LVAS.
Patients supported ≥ 1 year: 2,439
Patients supported ≥ 2 years: 851
Patients supported ≥ 3 years: 269
Patients supported ≥ 4 years: 83
Patients supported ≥ 5 years: 20
Patients supported ≥ 6 years: 1
Patients supported ≥ 7 years: 1
* Based on clinical trial and device tracking data
As of March, 2011

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

6. HeartMate II—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:
Park SJ. AHA Scientific Sessions, November 2010.

7. HeartMate II—Recent Publications

8. HeartMate II—Post-Approval BTT Study
Initiated post-BTT approval to assess outcomes in a broader patient care environment
First approved study to use INTERMACS
The first 169 consecutive HeartMate II patients enrolled in INTERMACS
Listed or likely to be listed for transplant
Enrolled across 77 centers from April to August 2008
Patients followed for at least 1 year
Starling, Naka, Boyle, et al. JACC. 2011;57:19.

9. Study Endpoints Primary endpoint Secondary endpoint Quality of life
Survival
Secondary endpoint
Adverse events
Reported upon occurrence
Quality of life
EuroQol EQ-5D visual analog scale determined at baseline and 3, 6, and 12 months postimplant
Starling, Naka, Boyle, et al. JACC. 2011;57:19.

10. Demographics and Patient Characteristics
1. Starling, Naka, Boyle, et al. JACC. 2011;57:19.
2. Pagani FD, Miller LW, Russell SD. extended mechanical circulatory support with a
continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009;54:

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

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

13. HeartMate II—Adverse Events
Patients in the post-approval study experienced a reduced or similar rate of adverse events in a broader patient care environment compared to clinical trial patients.
There were zero pump replacements through the first 6 months of HeartMate II support in the post-approval study group.
1. Starling, Naka, Boyle, et al. JACC. 2011;57:19.
2. Pagani FD, Miller LW, Russell SD. Extended mechanical circulatory support with a
continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009;54:

14. Clinical Outcomes Based on INTERMACS Profile
101 BTT / DT continuous-flow LVAD patients at three centers were preoperatively categorized by INTERMACS profiles and followed to determine if there were differences in outcomes.
Hypothesis that patients with higher INTERMACS profiles (lower acuity of heart failure) would have reduced lengths of stay postVAD in comparison to patients with lower INTERMACS profiles (higher acuity of heart failure).
Outcomes observed included actuarial survival, survival to discharge, and length of stay.
Boyle, Ascheim, Russo, et al. JHLT. 2011;30:4.

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

16. Analysis of Response of Four Rotary Pumps
“… the characteristic of the HeartMate II can be considered superior to the centrifugal pumps in so far that the zone of maximum preload sensitivity occurs at the low end of the afterload scale (i.e., mean afterload of 50–90 mmHg) mostly inhabited by patients requiring mechanical assistance to the left ventricle.”
Salamonsen RF, Mason DG, Ayre PJ. Artif Organs

17. HeartMate II—Recent Presentations

18. HeartMate II Risk Score—Study Goals
Derive and then validate a risk model for predicting short- and longer-term survival following continuous flow LVAD implantation.
Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.
Lietz, et al. Circulation. 2007;116:

19. HeartMate II Risk Score—Study Cohorts
Patients undergoing HeartMate II implant enrolled into the HeartMate II Bridge-to-Transplant (N=489)1,2 and Destination Therapy (N=633)3 trials were included (total N=1,122).
Patients were prospectively and randomly assigned to either the derivation cohort or to the validation cohort.
Multivariable analyses were performed to identify the risk factors of death following LVAD implantation.
Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.
1. Miller L, Pagani F, et al. N Engl J Med. 2007;357:
2. Pagani F, Miller L, et al. JACC. 2009;54:
3. Slaughter M, Milano C, Rogers J, et al. N Engl J Med. 2009;361:

20. Multivariate Predictors* of Death PostLVAD
Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.

21. Risk Stratification in HeartMate II Patients Comparison of Derivation and Validation Cohorts
Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.

22. Risk of Bleeding and Stroke in HeartMate II Outpatients
Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

23. Preoperative Predictors of Bleeding
Univariate Correlates
Multivariate Risk Factors
P = 0.003
Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

24. Female Gender—Only Independent Risk Factor for Stroke and Pump Thrombosis
Females were twice as likely to experience a stroke or pump thrombosis event.
Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

25. Impact of Infection on Stroke and Thrombosis
During a ±14 day window around an infection event patients were:
4 times more likely to experience a hemorrhagic stroke event
8 times more likely to experience an ischemic stroke event
9 times more likely to experience a pump thrombosis event
Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

26. Comparison of Velour Versus Silicone Skin Interface
Driveline Exit Site
Comparison of Velour Versus Silicone Skin Interface
Hypothesized that:
Silicone interfaces will be associated with lower infection rates and faster incorporation times
Surface characteristics will differ significantly between velour and silicone
Ledford ID, Miller DV, Mason NO, et al. ISHLT 2011.

27. Velour Versus Silicone Skin Interface
Ledford ID, Miller DV, Mason NO, et al. ISHLT 2011.

28. Histology
Velour exhibits more dermal inflammation and an irregular shaped stratum corneum.
Silicone is smooth and regular, and shows less inflammation.
Ledford ID, Miller DV, Mason NO, et al. ISHLT 2011.

29. Contemporary Destination Therapy Results
Park SJ. AHA Scientific Sessions, November 2010.
1. Slaughter M, Milano C, Rogers J, et al. N Engl J Med. 2009;361:

30. Contemporary Destination Therapy Results
The CAP results show a decrease in major adverse events.
Park SJ. AHA Scientific Sessions, November 2010.

31. Contemporary Destination Therapy Results
Park SJ. AHA Scientific Sessions, November 2010.

32. In Summary
Over 7,000 patients implanted with HeartMate II—long-term durability
Improvements in Bridge-to-Transplant and Destination Therapy survival and adverse event rates
Adverse-event differences in LVAD patients may lead to targeted approaches for men and women
Driveline infections can possibly be reduced by new tunneling techniques
New HeartMate II risk model along with INTERMACS profiles may help guide future patient selection