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 |
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Format: | Artikel |
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. |
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ISSN: | 1053-2498 1557-3117 |
DOI: | 10.1016/j.healun.2010.06.014 |