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Micropump-based device enhanced outcomes, exercise tolerance, quality of life
Patients with chronic ambulatory HF implanted with a micropump-based ventricular assist device experienced improvements in hemodynamic outcomes, exercise tolerance and quality of life.
Currently, 59 patients at nine clinical sites in Europe have been implanted with the device (Synergy Circulatory Support System, CircuLite). The current results focused on the 20 most recently implanted patients who received the optimized version of the system.
Daniel Burkhoff
The data, presented by Daniel Burkhoff, MD, PhD, medical director of CircuLite and adjunct associate professor of Medicine at Columbia University, associated the micropump-based system with significant and sustained hemodynamic improvements, as measured by cardiac output (3.9 L/min to 4.8 L/min) and capillary wedge pressure (28 mm Hg to 15.1 mm Hg) a median of 3 months after implant. Results also demonstrated improved exercise tolerance, as measured by peak VO2 (10.6 mL/kg/min to 12.6 mL/kg/min) and distance walked during a 6-minute walk test (301 m to 429 m). Further, better quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire, was reported after implantation with the device (71 to 38). Adverse event rate during the first 30 days after implantation also appeared relatively lower than reported for standard full support VADs, according to the study abstract.
“Beyond the hemodynamic and quality of life improvements that we have seen, we have also observed that the simple, off-pump mini-thoracotomy procedure used to implant Synergy allows for potentially quick recovery, with patients often being extubated within hours post-implant and typically ambulatory within 1 to 2 days post-implant,” Burkhoff said in a press release. “The data continue to support the belief that Synergy holds significant potential to benefit ambulatory HF patients who are symptomatic but not sick enough to justify the risks associated with more invasive assist devices.”
The Synergy device recently received CE mark approval in Europe.
For more information:
Burkhoff D. Late breaking science symposium I: Current clinical experience with the Synergy micro-pump system in chronic ambulatory heart failure. Presented at: the Heart Failure Society of America 16th Annual Scientific Meeting; Sept. 9-12, 2012; Seattle.
Disclosure: Burkhoff is medical director of CircuLite.