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.

Improvements in Heart Failure Symptoms^25,26*

The majority of patients demonstrated vast improvement, progressing from severe heart failure symptoms even at rest to being able to resume normal activities with little or no limitation.

* Based on improvement in New York Heart Association Heart Failure classification 6 months after implantation.

HeartMate ll Actuarial Survival²⁵

Actuarial survival (based on Kaplan-Meier analysis) was 82% at 6 months, and 73% at 12 months, and 72% at 18 months.

Improvements in Heart Failure Walk Test^{25, 26**}

Average distance covered in a 6-minute walk improved 163 meters after 1 month of support, and 305 meters by 6 months.

**Based on mean distance walked in 6 minutes

Next: Mechanical Circulatory Support (MCS) Therapy