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Contemporary Outcomes With the HeartMate II ® LVAS. David J. Farrar, PhD Vice President, Research and Scientific Affairs Thoratec Corporation. J138-0711 . HeartMate II ® LVAS. A surgically implanted, rotary continuous-flow device in parallel with the native left ventricle

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slide1

Contemporary Outcomes With the HeartMate II® LVAS

David J. Farrar, PhD

Vice President, Research and Scientific Affairs

Thoratec Corporation

J138-0711

slide2

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

Percutaneous

Lead

Controller

Batteries

slide3

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
slide4

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

slide5

HeartMate II—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.

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

slide6

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;361:2241-51.

Park SJ. AHA Scientific Sessions, November 2010.

slide8

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.

slide9

Study Endpoints

  • Primary endpoint
    • 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.

slide10

Demographics and Patient Characteristics

1. Starling, Naka, Boyle, etal. 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;54:312-21.

slide11

INTERMACS Profiles

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

slide12

HeartMate II—Actuarial Survival

Post-Approval Study

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

slide13

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, etal. 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;54:312-21.

slide14

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.

slide15

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.

slide16

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. 2011.

slide18

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;116:497-505.

slide19

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;357:885-96.

2. Pagani F, Miller L, et al. JACC.2009;54:312-21.

3. Slaughter M, Milano C, Rogers J, et al. N Engl J Med. 2009;361:2241-51.

slide20

Multivariate Predictors* of Death PostLVAD

Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.

slide21

Risk Stratification in HeartMate II PatientsComparison of Derivation and Validation Cohorts

Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.

slide22

Risk of Bleeding and Stroke in HeartMate II Outpatients

Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

slide23

Preoperative Predictors of Bleeding

Univariate Correlates

Multivariate Risk Factors

P = 0.003

Russell SD, Boyle A, Sun B, et al. ISHLT 2011.

slide24

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.

slide25

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.

slide26

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.

slide27

Velour Versus Silicone Skin Interface

Ledford ID, Miller DV, Mason NO, et al. ISHLT 2011.

slide28

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.

slide29

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;361:2241-51 .

slide30

Contemporary Destination Therapy Results

The CAP results show a decrease in major adverse events.

Park SJ. AHA Scientific Sessions, November 2010.

slide31

Contemporary Destination Therapy Results

Park SJ. AHA Scientific Sessions, November 2010.

slide32

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