Two Year ROADMAP Data Showcases the Potential Benefits of HeartMate II LVAD in Ambulatory Heart Failure Patients
In the ROADMAP
study, patients with a HeartMate II™ LVAD had a functional improvement in
quality of life compared to optimal medical management
The ROADMAP study was a prospective, multi-center observational study of 200 patients that evaluated the effectiveness of the HeartMate II LVAD compared to OMM in a patient population not dependent on inotropic medications (medications that alter the force of muscular contractions).
Seventy percent of the HeartMate II LVAD patients survived at two years, compared with 41 percent of those treated with medications alone (medically managed patients) on an as-treated basis. At two years of follow-up, 30 percent of patients in the HeartMate II LVAD group versus 12 percent of patients on OMM, met the primary endpoint of survival on the original therapy along with a 75 meter increase in six minute walk test distance (6MWD), a difference, which was statistically significant (p=0.012). These benefits were apparent even though the LVAD cohort was more severely ill, with 65 percent of HeartMate II LVAD patients compared with just 34 percent in the medical management group designated as INTERMACS profile 4 at baseline.
“The ROADMAP study shows that
LVAD therapy is a treatment option for advanced heart failure patients not yet
on inotropic therapy. Patients who desire to improve their quality of life and
functional capacity may choose the option of LVAD before they become
hospitalized and more critically ill,” said Dr.
Mechanical circulatory support (MCS) is a proven therapy for treating patients in the most advanced stages of heart failure. The majority of LVAD implants are performed in patients who are dependent on inotropic medications. Though indicated for HeartMate II LVAD therapy, less than 20 percent of patients in the INTER agency Registry for Mechanically Assisted Circulatory Support (INTERMACS), are non-inotrope dependent.
“We continue to see positive
results from the ROADMAP study and are pleased these data provide confirmation
of the importance for physicians to educate patients about early intervention
with LVAD therapy,” said Dr.
Similar to the one year results,
two-year survival on original therapy with overall functional improvement
significantly favored HeartMate II LVAD support as measured by changes in
There were 23 patients originally in the medical management arm who received an LVAD during the two year follow up period. Although this group of patients is referred to as the “delayed” LVAD group in the study, approximately half of them were implanted in INTERMACS profile 4-6, which is still earlier than when the average patient is implanted. The study found that delaying the LVAD implant did not increase mortality; the opportunity to improve quality of life and functional status is delayed with OMM.
Source: St. Jude Medical
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