Transcript a Powerpoint of this Presentation

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
 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
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
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
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.
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.
HeartMate II—Recent Publications
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.
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.
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;54:312-21.
INTERMACS Profiles
Starling, Naka, Boyle, et al. JACC. 2011;57:19.
HeartMate II—Actuarial Survival
Post-Approval Study
Starling, Naka, Boyle, et al. JACC. 2011;57:19.
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;54:312-21.
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.
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.
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.
HeartMate II—Recent Presentations
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.
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.
Multivariate Predictors* of Death PostLVAD
Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.
Risk Stratification in HeartMate II Patients
Comparison of Derivation and Validation Cohorts
Cowger J, Sundareswaran K, Rogers J, et al. ISHLT 2011.
Risk of Bleeding and Stroke in HeartMate II Outpatients
Russell SD, Boyle A, Sun B, et al. ISHLT 2011.
Preoperative Predictors of Bleeding
Univariate Correlates
Multivariate Risk Factors
Age > 65
Albumin <=3.3
Female
P = 0.003
Ischemic Etiology
0.0
0.5
1.0
1.5
2.0
2.5
Hazards Ratio
Russell SD, Boyle A, Sun B, et al. ISHLT 2011.
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.
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.
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.
Velour Versus Silicone Skin Interface
Velour
Silicone
N=16
N=16
Mean Age (years)
55
51
Gender (M/F)
14/2
13/3
Indication (BTT/BTC/DT)
11/1/4
13/1/2
Ledford ID, Miller DV, Mason NO, et al. ISHLT 2011.
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.
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 .
Contemporary Destination Therapy Results
The CAP results show a decrease in major adverse events.
Park SJ. AHA Scientific Sessions, November 2010.
Contemporary Destination Therapy Results
Park SJ. AHA Scientific Sessions, November 2010.
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