Advances In LVAD Patient Management

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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
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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

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HeartMate IIDesigned 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
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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.
• Statistically significant reductions were seen
  for pump replacements, infection and
  rehospitalizations.
• HeartMate IIs 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. 20093612241-51.
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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. 201029S1-39.
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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 scaledetermined
  at baseline and 3, 6, and 12 months post-implant

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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. 200954312-21. Starlin
g, Naka, Boyle, et al. JACC, in press 2010. .
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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
continuous-flow left ventricular assist device. N
Engl J Med. 20093612241-51. Park SJ. AHA
Scientific Sessions, November 2010.
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Assessing The Impact Of Advances In Clinical
Strategies On Destination Therapy

• The CAP results show a decrease in major adverse
  events.

plt0.05 plt0.01


Park SJ. AHA Scientific Sessions, November 2010.
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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

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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 gt 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. 200928881-87.
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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. 201029616-24.
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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 (n118) (8.8 pt
years) Group B Sub-therapeutic heparin (n178)
(13.1 pt years) Group C No heparin (n122) (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. 201029616-24.
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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. 201029S1-39.
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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. 201029S1-39.
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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

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HeartMate IIReady 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