CLINICAL TRIAL, PHASE I
COMPARATIVE STUDY
JOURNAL ARTICLE
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Off-pump insertion of continuous flow left ventricular assist devices.

BACKGROUND AND AIM OF THE STUDY: Traditional left ventricular assist device (LVAD) implantation requires extensive dissection and use of cardiopulmonary bypass (CPB). Potential adverse effects of CPB in very ill end-stage heart failure patients include right ventricular dysfunction, end-organ injury, and bleeding. We sought to evaluate the feasibility and outcome of LVAD insertion without CPB.

METHODS: The Jarvik 2000 is an axial-flow pump newly involved in a phase I clinical trial in status I patients as a bridge to transplantation. Seven patients received this pump through thoracotomy or sternotomy with or without the use of CPB.

RESULTS: All patients had NYHA class IV heart failure with end-organ dysfunction requiring inotropic therapy. Two were in cardiogenic shock, necessitating full CPB support. Five patients had the Jarvik implanted off-CPB. The off-CPB patients were associated with decreased length of surgery, mechanical ventilation, blood transfusions, inotropic support, and hospital stay including rehabilitation. Nearly all of the patients had complete resolution of liver and kidney dysfunction.

CONCLUSION: We have demonstrated that off-CPB insertion of axial flow LVADs is feasible, safe, and potentially advantageous. Although we are encouraged by the perioperative simplicity of this strategy, we acknowledge that additional implants and comparisons of outcomes with traditional pulsatile and continuous flow device techniques will be necessary to advocate its widespread adoption.

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