Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term circulatory support.

OBJECTIVE The Levitronix CentriMag (Levitronix LLC, Waltham, Mass) ventricular assist system is designed for temporary left, right, or biventricular support. Advantages include ease of use, excellent reliability, and low thrombosis risk,. which may allow wider application of short-term support and improved outcomes in patients with cardiogenic shock. This multi-institutional study evaluated safety, effectiveness, and outcomes of the CentriMag in patients with cardiogenic shock. METHODS Thirty-eight patients were supported at 7 centers. Patients included 12 after cardiotomy, 14 after myocardial infarction, and 12 with right ventricular failure after implantable left ventricular assist device placement. Devices were implanted in left (n = 8), right (n = 12), or biventricular (n = 18) configuration. Support was continued until recovery, transplantation, or implantation of long-term ventricular assist device. RESULTS Mean support duration for the entire cohort (n = 38) was 13 days (1-60 days), with 47% of patients (18/38) surviving 30 days after device removal. Mean CentriMag biventricular support (n = 18) duration was 15 days (1-60 days), with 44% (8/18) surviving at 30 days. Mean CentriMag right ventricular support with a commercially available left ventricular assist device (n = 12) duration was 14 days (1-29 days), with 58% (7/12) surviving at 30 days. Complications included bleeding (21%), infection (5%), respiratory failure (3%), hemolysis (5%), and neurologic dysfunction (11%). There were no CentriMag or pump failures. CONCLUSIONS In this preliminary study, the CentriMag provided short-term support for patients with cardiogenic shock with a low incidence of device-related complications and no device failures.

[1]  Adnan Kastrati,et al.  A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. , 2008, Journal of the American College of Cardiology.

[2]  L. Miller,et al.  Experience with the Levitronix CentriMag circulatory support system as a bridge to decision in patients with refractory acute cardiogenic shock and multisystem organ failure. , 2007, The Journal of thoracic and cardiovascular surgery.

[3]  D. Pennington,et al.  Eight years' experience with bridging to cardiac transplantation. , 1994, The Journal of thoracic and cardiovascular surgery.

[4]  J. Pepper,et al.  Bridge to decision using the Levitronix CentriMag short-term ventricular assist device. , 2008, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[5]  J. Narula,et al.  Management of acute cardiac failure with mechanical assist: experience with the ABIOMED BVS 5000. , 2001, The Annals of thoracic surgery.

[6]  G. Fonarow,et al.  Mechanical assist strategy using the BVS 5000i for patients with heart failure. , 2000, The Annals of thoracic surgery.

[7]  R. Bartlett,et al.  The use of extracorporeal life support in adult patients with primary cardiac failure as a bridge to implantable left ventricular assist device. , 2001, The Annals of thoracic surgery.

[8]  R. Hetzer,et al.  Levitronix CentriMag to Berlin Heart Excor: A “Bridge to Bridge” Solution in Refractory Cardiogenic Shock , 2009, ASAIO journal.

[9]  S. Bolling,et al.  Extracorporeal life support to left ventricular assist device bridge to heart transplant: A strategy to optimize survival and resource utilization. , 1999, Circulation.

[10]  M. Lachat,et al.  The CentriMag: a new optimized centrifugal blood pump with levitating impeller. , 2004, The heart surgery forum.

[11]  T. Myers,et al.  Clinical experience with the TandemHeart percutaneous ventricular assist device. , 2006, Texas Heart Institute journal.

[12]  A. Khaghani,et al.  Bridging patients after salvage from bridge to decision directly to transplant by means of prolonged support with the CentriMag short-term centrifugal pump. , 2009, The Journal of thoracic and cardiovascular surgery.

[13]  C. Hoermann,et al.  Outcome evaluation of the bridge-to-bridge concept in patients with cardiogenic shock. , 2006, Annals of Thoracic Surgery.

[14]  N. Smedira,et al.  Clinical experience with 202 adults receiving extracorporeal membrane oxygenation for cardiac failure: survival at five years. , 2001, The Journal of thoracic and cardiovascular surgery.

[15]  M. Oz,et al.  Implantation of a left ventricular assist device and the hub-and-spoke system in treating acute cardiogenic shock: who survives? , 2003, The Journal of thoracic and cardiovascular surgery.

[16]  M. Slaughter,et al.  Results of a multicenter clinical trial with the Thoratec Implantable Ventricular Assist Device. , 2007, The Journal of thoracic and cardiovascular surgery.

[17]  J. Pepper,et al.  Clinical performance with the Levitronix Centrimag short-term ventricular assist device. , 2006, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[18]  M. Olschewski,et al.  The Impella Recover microaxial left ventricular assist device reduces mortality for postcardiotomy failure: a three-center experience. , 2004, The Journal of thoracic and cardiovascular surgery.

[19]  M. Oz,et al.  Role of the Abiomed BVS 5000 Device for Short-Term Support and Bridge to Transplantation , 2004, ASAIO journal.

[20]  A. Bogers,et al.  Connecting the Centrimag Levitronix pump to Berlin Heart Excor cannulae; a new approach to bridge to bridge. , 2008, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[21]  M C Oz,et al.  Implantable left ventricular assist devices. , 1998, The New England journal of medicine.

[22]  W. Cohn,et al.  The TandemHeart as a bridge to a long-term axial-flow left ventricular assist device (bridge to bridge). , 2008, Texas Heart Institute journal.