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Advances In LVAD Patient Management. Mark Slaughter, MD Professor of Surgery, Division of Thoracic and Cardiovascular Surgery University of Louisville. Clinical Strategies to Minimize Adverse Events. J101-0411. Minimizing LVAD Therapy Adverse Events.

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advances in lvad patient management

Advances In LVAD Patient Management

Mark Slaughter, MD

Professor of Surgery, Division of Thoracic and Cardiovascular Surgery

University of Louisville

Clinical Strategies to Minimize Adverse Events

J101-0411

minimizing lvad therapy adverse events
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
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
slide4

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 II’s smaller size, smaller percutaneous lead and improved reliability contributed to these reductions

HeartMate I

HeartMate II

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.

slide5

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
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
slide7

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.

.

slide8

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. 2009;361:2241-51.

Park SJ. AHA Scientific Sessions, November 2010.

slide9

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.

slide10

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
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
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 required13
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.

slide14

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.

slide15

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.

slide16

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
slide17

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