Treating Advanced Heart Failure Patients
The Unmet Need: Providing Options to Patients Refractory to Optimal Medical Management
Therapy for advanced heart failure patients involves a continuum of options. As optimal medical management (OMM) continues to evolve, medication regimens rely on beta blockers, ACE inhibitors, and angiotensin-receptor blockers to improve function of the failing heart. Implantable cardioverter defibrillators and cardiac resynchronization therapy have become common and appropriate interventions for selected patients whose symptoms continue to progress on optimal medical management.
However, even with these advances, estimates show that over one million patients progress to NYHA Class III or Class IV, experiencing a dramatic reduction in quality of life.1 Cardiac transplantation is limited by the availability of donor hearts. Thousands of eligible patients face an extended waiting period associated with diminished functional capacity and high mortality rates; other patients are not candidates for transplantation.
Patients who become refractory to OMM may be able to experience improved quality of life with the new era of mechanical circulatory support (MCS). With the advent of improved MCS technologies, more patients can now significantly improve their NYHA classification, projected survival and quality of life.
Unprecedented Reduction in Heart Failure Symptoms
The majority of patients who received mechanical circulatory support therapy with the HeartMate II® LVAD experienced a marked improvement in functional capacity and a corresponding reduction in heart failure symptoms. These patients, who previously had severe symptoms even at rest, were able to resume normal activities with little or no limitation. The reduction in symptoms was both dramatic and sustained over time.
- 96% of HeartMate II Destination Therapy trial patients were NYHA Class IIIB/IV status at baseline27
- 75% of patients improved to NYHA Class I or II at 3 months27
- 81% of patients improved to NYHA Class I or II by 24 months32
HeartMate II Provides Dramatic and Sustained Improvements in Quality of Life for Advanced Stage Heart Failure Patients 3, 25, 27
HeartMate II Actuarial Survival
HeartMate II DT Trial Actuarial Survival27(As Treated)
HeartMate II actuarial survival (based on Kaplan-Meier analysis) was 68% at 12 months and 58% at 24 months.
REMATCH Trial Actuarial Survival6
Medical therapy actuarial survival (based on Kaplan-Meier analysis) was 23% at 12 months and 8% at 24 months.
6-minute Walk Test Improvement27
6-minute walk test results for HeartMate II patients in the Destination Therapy trial showed sustained improvement and doubled from baseline to 372m (more than the length of four football fields) at 24 months.
"When advanced heart failure patients lose response to OMM, there frequently are no other options and that's where the field of MCS is designed to be the alternative."
Leslie Miller, MD
Heart Failure Cardiologist
"This is a pioneering therapy for heart failure to get you all the way from Class IV to being basically unstoppable."
Stephanie Moore, MD, Heart Failure Cardiologist