Clinical benefits of partial circulatory support in New York Heart Association Class IIIB and Early Class IV patients

• Published in: European journal of cardio-thoracic surgery 2011-05, Vol.39 (5), p.693-698
• Main Authors: Meyns, Bart P., Simon, Andre, Klotz, Stefan, Wittwer, Thorsten, Schlensak, Christian, Rega, Filip, Burkhoff, Daniel
• Format: Article
• Language: English
• Subjects: Adult; Biological and medical sciences; Cardiac Output; Cardiology. Vascular system; Disease Progression; Female; Heart; Heart Failure - physiopathology; Heart Failure - therapy; Heart failure, cardiogenic pulmonary edema, cardiac enlargement; Heart Transplantation; Heart-Assist Devices - adverse effects; Hemodynamics; Humans; Male; Medical sciences; Middle Aged; Pneumology; Prosthesis Design; Prosthesis Implantation - adverse effects; Prosthesis Implantation - methods; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the heart; Treatment Outcome
• ISSN: 1010-7940; 1873-734X
• DOI: 10.1016/j.ejcts.2010.07.049

Objective: Full mechanical support with a left-ventricular assist device (LVAD) is generally limited to end-stage heart-failure patients. We have been studying the safety and efficacy of the partial support Synergy® Pocket Micro-pump as bridge-to-transplant in a less-sick group of patients as a prelude to a study of its use for destination therapy. Methods: The CircuLite® Synergy device is implanted via a small right-sided thoracotomy with an inflow cannula in the left atrium and an outflow graft connected to the right subclavian artery without the use of extracorporeal circulation. The micro-pump is the size of an AA battery, sits in the 'pacemaker' pocket subcutaneously in the right clavicular groove and pumps up to 3.0 l min−1 from the left atrium to the right subclavian artery. Results: The device has been implanted in 27 patients awaiting cardiac transplant (22 males), age 54.8 ± 10.0 years with ejection fraction (EF) 21 ± 6%, mean arterial pressure 73.5 ± 8.8 mm Hg, pulmonary capillary wedge pressure (PCWP) 27.5 ± 7.8 mm Hg and cardiac index (CI) 2.0 ± 0.4 l min−1 m−2. Duration of support has ranged from 6 to 281 days. Right-heart catheterization showed significant hemodynamic improvement in the short- and intermediate term after implant, with increases in CI from 2.0 ± 0.4 to 2.8 ± 0.6 l min−1 m−2 (p ≪ 0.001) and reductions in PCWP from 28 ± 6 to 18 ± 7 mm Hg (p = 0.002) at an average of 9.5 ± 5.5 weeks. Conclusions: The Synergy device provides partial hemodynamic support and its use is associated with significantly improved hemodynamics, thus appearing to interrupt and partially reverse the progressive hemodynamic deterioration typical of end-stage heart failure. Ongoing efforts are aimed at demonstrating additional clinical benefits and continuing to further improve the risk/benefit ratio.