Chronic extra-aortic balloon counterpulsation: First-in-human pilot study in end-stage heart failure

Background Some patients continue to have significant heart failure symptoms despite optimal medical therapy. Methods We describe a first-in-human experience with an implantable non–blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure pa...

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Veröffentlicht in:The Journal of heart and lung transplantation 2010-12, Vol.29 (12), p.1427-1432
Hauptverfasser: Hayward, Christopher S., MD, FRACP, Peters, William S., MD, Merry, Alan F., FANZCA, FRCA, Ruygrok, Peter N., MD, FRACP, Jansz, Paul, FRACS, PhD, O'Driscoll, Gerry, PhD, FRACP, Larbalestier, Robert I., FRACS, Smith, Julian A., FRACS, Ho, Betty, FRACP, Legget, Malcolm E., MD, FRACP, Milsom, F. Paget, FRACS
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Sprache:eng
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Zusammenfassung:Background Some patients continue to have significant heart failure symptoms despite optimal medical therapy. Methods We describe a first-in-human experience with an implantable non–blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years. Results All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60%) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway. Conclusions Although feasibility of this device is suggested by this pilot study, safety and efficacy will need to be examined in a larger cohort with longer follow-up.
ISSN:1053-2498
1557-3117
DOI:10.1016/j.healun.2010.06.014