Advances In LVAD Patient ManagementClinical Strategies to Minimize Adverse EventsMark Slaughter, MDProfessor of Surgery, Division of Thoracic and Cardiovascular SurgeryUniversity of Louisville

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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

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

Ruby bearings help dissipate heat and are designed for ultra-long lifespan

Small percutaneous lead to reduce infection

Small device size

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

Design Improvements Have Resulted In Reduced Adverse Events

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.

HeartMate II HeartMate I

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.

Advances In Clinical Strategies Have Also Led To Reductions In Adverse Events

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

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.

Assessing The Impact Of Advances In Clinical Strategies On Bridge-to-Transplantation

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..

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).

Assessing The Impact Of Advances In Clinical Strategies On Destination Therapy

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.

The CAP results show a decrease in major adverse events.

Park SJ. AHA Scientific Sessions, November 2010.

Assessing The Impact Of Advances In Clinical Strategies On Destination Therapy

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* p<0.05** p<0.01

* p<0.05** p<0.01

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

Advances In Patient Management Lower Adverse Event Rates

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.

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

Post-Op Heparin May Not Be Required

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.

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.

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.

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)

Post-Op Heparin May Not Be Required

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 Placement And Management

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.

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

Outpatient Blood Pressure Management

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.

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

Additional Factors Contributing To Improving Trends In Adverse Events

Increased knowledge of new continuous-flow pathophysiology

Well designed and reliable device

Low adverse event rates

Full set of patient management guidelines

HeartMate II—Ready For Usage In A Broad Patient Population