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Advances In LVAD Patient Management
Clinical Strategies to Minimize Adverse Events
Mark Slaughter, MD
Professor of Surgery, Division of Thoracic and Cardiovascular Surgery
University of Louisville
J101-0411
Minimizing LVAD Therapy Adverse Events
Improvements in LVAD design and patient management strategies have
led to reductions in adverse events in LVAD therapy.
 Stroke
 Pump failure
 RV failure
 Infection
 Bleeding
HeartMate II®—Designed To Minimize Adverse Events
Sintered titanium encourages
neointima formation and helps
reduce the need for anticoagulation
Optimal flow dynamics
reduce stroke and
thrombosis risk
Small device size
Small percutaneous lead to
reduce infection
Ruby bearings help dissipate heat and
are designed for ultra-long lifespan
Design Improvements Have Resulted In Reduced
Adverse Events
In the recent randomized
Destination Therapy trial,
HeartMate II demonstrated
reductions in most major adverse
event categories compared with
HeartMate I.
HeartMate II
HeartMate I
Statistically significant reductions
were seen for pump
replacements, infection and
rehospitalizations.
 HeartMate II’s smaller size, smaller
percutaneous lead and improved
reliability contributed to these
reductions
HeartMate II Destination Therapy Trial
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.
Advances In Clinical Strategies Have Also Led To
Reductions In Adverse Events
Comprehensive guidelines have been
developed collaboratively by an
interdisciplinary group of
professionals and published by JHLT.
These guidelines were based on the
initial HeartMate II experience and
have been employed to improve
clinical outcomes.
Slaughter MS, Pagani FD, Rogers JG, et al. Clinical management of continuous-flow
left ventricular assist devices in advanced heart failure. J Heart Lung Transplant.
2010;29:S1-39.
Assessing The Impact Of Advances In Clinical Strategies
On Bridge-To-Transplantation
The HeartMate II BTT post-approval study was initiated to assess
outcomes in a broader patient care environment
 First 169 consecutive HeartMate II patients enrolled in the INTERMACS
registry listed, or likely to be listed, for transplant
 77 centers enrolled patients from April to August 2008 and were followed for at
least 1 year post-implant
Endpoints
 The primary endpoint was survival, and secondary endpoints included adverse
events reported upon occurrence and functional status using the 6-minute walk
test and EuroQoL scale—determined at baseline and 3, 6, and 12 months
post-implant
Assessing The Impact Of Advances In Clinical Strategies
On Bridge-to-Transplantation
HeartMate II patients enrolled in the post-approval study experienced a
reduced rate of important adverse events in a broader patient care
environment compared to the HeartMate II pivotal clinical trial.
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.
Starling, Naka, Boyle, et al. JACC, in press 2010.
.
Assessing The Impact Of Advances In Clinical Strategies
On Destination Therapy
To assess whether
advances in clinical
strategies have improved
the rate of adverse events
associated with Destination
Therapy, HeartMate II
patients enrolled in the DT
pivotal trial were compared
to those enrolled in the DT
continued access protocol
(CAP).
Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuousflow left ventricular assist device. N Engl J Med. 2009;361:2241-51.
Park SJ. AHA Scientific Sessions, November 2010.
Assessing The Impact Of Advances In Clinical Strategies
On Destination Therapy
The CAP results show a decrease in major adverse events.
*
* p<0.05
** p<0.01
**
*
Park SJ. AHA Scientific Sessions, November 2010.
Advances In Patient Management Lower Adverse
Event Rates
Several advances in patient management
have been made including:
 Effective anti-coagulation management
 Reduced heparin usage post-operatively
 Percutaneous lead placement and
management
 Blood pressure management
Effective Anticoagulation Management
Boyle, et al. established an
evidenced-based INR target
by evaluating the risk of
thromboembolism and
hemorrhage related to the
degree of anticoagulation.
 The data show that
HeartMate II patients
experience relatively low
rates of stroke and pump
thrombosis with INRs > 1.5
 Clinical experience has
established recommended
INR targets of 1.5 – 2.5
Boyle AJ, Russell SD, Teuteberg JJ, et al. Low thromboembolism and pump thrombosis
with the HeartMate II left ventricular assist device: analysis of outpatient anti-coagulation.
J Heart Lung Transplant. 2009;28:881-87.
Post-Op Heparin May Not Be Required
Slaughter, et al. conducted a retrospective
study to evaluate the effects of heparin
use on thromboembolic and bleeding
complications after implantation of the
HeartMate II
 The results indicate that patients who do not
receive early post-operative anticoagulation
therapy with IV heparin as a transition to
warfarin and aspirin are at decreased risk of
bleeding events
 These patients do not appear to be at any
early elevated risk of thrombotic events
 Eliminating the routine use of post-operative
heparin in patients with low risk of
thrombosis appears to be appropriate for
most cases
Slaughter MS, Yoshifumi N, John R, et al. Post-operative heparin may not be
required for transitioning patients with a HeartMate II left ventricular assist system
to long-term warfarin therapy. J Heart Lung Transplant. 2010;29:616-24.
Post-Op Heparin May Not Be Required
The percentage of patients
requiring transfusion for
bleeding from POD 3-30 was
significantly lower for Group C
than for Groups B and A, and
a trend for less bleeding after
30 days in Group C, although
not significant.
Group A: Therapeutic heparin (n=118) (8.8 pt years)
Group B: Sub-therapeutic heparin (n=178) (13.1 pt years)
Group C: No heparin (n=122) (9.0 pt years)
Slaughter MS, Yoshifumi N, John R, et al. Post-operative heparin may not be
required for transitioning patients with a HeartMate II left ventricular assist system
to long-term warfarin therapy. J Heart Lung Transplant. 2010;29:616-24.
Percutaneous Lead Placement And Management
The HeartMate II percutaneous lead
diameter has been minimized to reduce
infection risk and incorporates polyester
velour to promote skin ingrowth.
Best practices for percutaneous lead
tunneling and immobilization have been
established, leading to remarkable
reductions in infection.
Percutaneous lead externalized
through the abdominal wall
Pelz GB, Hashmi ZA, Moraca RJ, et al. ISHLT, April 2010.
Slaughter MS, Pagani FD, Rogers JG, et al. Clinical management of continuous-flow
left ventricular assist devices in advanced heart failure. J Heart Lung Transplant.
2010;29:S1-39.
Outpatient Blood Pressure Management
Continuous flow LVADs such as the HeartMate II
represent an entirely new physiology
 Patients that have diminished pulse pressure
frequently require a doppler
 Goal is to maintain mean arterial BP of 70-80
mmHg, not to exceed 90 mmHg
 Use of Doppler for measurements has improved
 Managing blood pressure will optimize cardiac
support and may reduce hypertension-related stroke
Slaughter MS, Pagani FD, Rogers JG, et al. Clinical management of continuous-flow
left ventricular assist devices in advanced heart failure. J Heart Lung Transplant.
2010;29:S1-39.
Additional Factors Contributing To Improving Trends In
Adverse Events
 Improved timing of patient referral
 Better patient selection
 Enhanced implantation techniques
 Improved post-op patient management
 More experienced patient care teams and increased knowledge of
continuous-flow physiology
HeartMate II—Ready For Usage In A Broad
Patient Population
 Increased knowledge of new continuous-flow
pathophysiology
 Well designed and reliable device
 Low adverse event rates
 Full set of patient management guidelines