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ROADMAP: LVAD improved survival, functional status in patients with advanced HF
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Left ventricular assist device therapy was associated with improved survival and functional status at 1 year compared with optimal medical management in patients with advanced HF, according to new data from the ROADMAP study presented at the International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions.
The multicenter, prospective, controlled trial included 200 patients with NYHA class IIIb/IV HF recruited from 41 centers. All patients had left ejection fraction of less than 25%, had received optimal medical management for 45 or more days in the prior 60 days, had unscheduled HF hospitalization within the previous year and had a 6-minute walk test distance of less than 300 m. Patients elected to continue on optimal medical therapy (n = 103) or receive treatment with an LVAD (HeartMate II, Thoratec Corp.; n = 97).
The primary endpoint was a composite of patient survival and functional improvement at 1 year, as indicated by at least a 75-m improvement in 6-minute walk test results, according to a company press release.
“ROADMAP is an important study that improves understanding of the benefits and risks with LVAD therapy in ambulatory advanced HF patients not dependent on inotropic support,” Jerry D. Estep, MD, assistant professor of medicine and medical director of the heart transplant and LVAD program at the Methodist DeBakey Heart and Vascular Center at Houston Methodist, said in the release. “Many of these patients continue to get worse over time without an LVAD, so there is a penalty for watchful waiting and delayed decisions.”
The survival rate at 1 year was 80% for patients assigned the LVAD vs. 64% for patients assigned optimal medical management. At 1 year, 39% of patients assigned the LVAD increased their walking distance by 75 m vs. 21% of patients assigned optimal medical management (P = .017). More patients in the LVAD group had improvement to NYHA class I or II at 1 year (77% vs. 29%), according to the release.
Bleeding was the most frequently observed adverse event in the LVAD group. Pump thrombus occurred in 1.1% of patients at 90 days vs. 6.4% at 1 year. Both LVAD recipients and those assigned optimal medical therapy had a 30-day mortality rate of 1%, according to the release.
“This unique study provides evidence that the probability of survival with improved functional status is enhanced with LVAD support compared with optimal medical management, supporting the value of evaluating functionally limited ambulatory advanced HF patients for LVAD therapy,” Joseph G. Rogers, MD, professor of medicine and senior vice chief for clinical affairs in the cardiology division at Duke University, said in the release. – by Adam Taliercio
Reference:
Estep JD, et al. Abstract #199. Presented at: International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions; April 15-18, 2015; Nice, France.
Disclosure: Estep and Rogers are consultants for Thoratec Corp., which sponsored the study.