Thorac Cardiovasc Surg 2014; 62 - SC167
DOI: 10.1055/s-0034-1367428

First clinical results of the novel Heartmate II pocket controller

S.V. Rojas 1, M. Avsar 1, J.S. Hanke 1, S. Rojas Hernandez 2, C. Bara 1, D. Malehsa 1, A. Haverich 1, J.D. Schmitto 1
  • 1Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie, Hannover, Germany
  • 2Medizinische Hochschule Hannover, Klinik für Anästhesiologie und Intensivmedizin, Hannover, Germany

Objectives: The incidence of end-stage heart failure becomes, based on recent demographical changes, increasingly important. Therefore, left ventricular assist device (LVAD)-therapy becomes more and more an alternative therapeutical option and is gaining more and more acceptance in the treatment of heart failure. Based on several technical improvements in LVAD surgery, the perioperative as well as postoperative risk was tremendously reduced during the past years. The aim of our study was to assess the outcome of heart failure-patients who received Heartmate II-implantation with the use of the new pocket controller.

Methods: At our institution, between December 2012 and August 2013 we reviewed the outcome of 30 end-stage heart failure patients, underwent LVAD implantation (Heartmate II, Thoratec) and received the novel pocket controller. The aim of this study was to asses the feasibility and safety of this novel pocket controller. All operationes were performed in elective patients suffering from end-stage heart failure (NYHA IV, Inermacs 3).

Results: Between December 2012 and August 2013 26 newly implanted Heartmate II-LVADs as well as 4 controller-changes (old controller to novel pocket controller) were being performed at our institution. 22 male, 8 female mean age 52 ± 4,2 years; DCM 62%; ICM 38%. All patients suffered from end-stage heart failure (NYHA IV) and underwent LVAD-surgery (Heartmate II) electively (Intermacs 3). Perioperative as well as 30-day survival-rate was 92% (24/26). Bleeding incidence (4%; 1/26) as well as postoperative right heart failure (4%; 1/26) remained low. No technical failure and/or controller change became necessary. LVAD parameters were presented as normal (mean rpms: 8800 rpm; 4.5 l/min; 5.6 Watts). No device-related risks or complications were seen.

Conclusions: Our data show novel pocket controller is prooven to be feasible, safe and is associated with several positive benefits. The perioperative risk remains unchanged and is presented with a low mortality, very low incidence of postoperative bleeding and low incidence of right heart failure. Despite the fact, that this new controller is as safe as its previuos version, the biggest advantage of the novel device is the customer friendly display and its miniaturized size.