The ROADMAP Study Results
The first study of its kind to compare HeartMate II LVAD therapy with optimal medical management in patients who are not yet treated with inotropes, met the primary endpoint of survival with improved functional status and supported the use of HeartMate II in this patient population.
ROADMAP Study Results
The ROADMAP study is the first trial to explore the use of LVAD support in patients who are not yet treated with inotropic support and meet the FDA approved indications for HeartMate II destination therapy. This prospective clinical evaluation compared outcomes of patients with advanced ambulatory heart failure treated with either a HeartMate II LVAD or optimal medical management. ROADMAP results support the use of HeartMate II LVAD in this patient population.
ROADMAP is a prospective, nonrandomized clinical trial of 200 patients treated with either a HeartMate II left ventricular assist device (LVAD) or with optimal medical management (OMM). The objective of this study was to examine the impact of mechanically assisted circulation using the HeartMate II LVAD in patients who meet current FDA approved indications for HeartMate II destination therapy but are not yet receiving intravenous inotropic therapy. Less than 20% of contemporary registrants in the Interagency Registry for Mechanically Assisted Circulation (INTERMACS) are not treated with inotropic support at the time of implant despite the fact that this less-sick cohort has statistically better survival than patients with more advanced disease.9
The primary endpoint of ROADMAP is a composite of survival and improvement in 6 minute walk test (6MWT) distance of ≥75m at 12months. Secondary endpoints include actuarial survival (as-treated), health-related quality of life, depression using Patient Health Questionnaire-9 (PHQ-9), functional status using 6-MWT distance and NYHA classification and adverse events.
Highlights of the data include:
ROADMAP results support the use of HeartMate II LVAD in functionally limited, non-inotrope dependent heart failure patients.
- Survival with improved functional status was better with LVADs vs OMM
- There was low LVAD operative mortality (1%)
- HRQoL and depression improved more with LVADs, even with more frequent adverse events
9 INTERMACS report
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ROADMAP One Year
Listen to Dr. Jerry Estep present and discuss the ROADMAP one year data as presented at ISHLT here
See the full 2015 ISHLT Presentation here