Patient-Tailored Silicone Plug for HeartMate 3™ Left Ventricular Assist Device Explantation

Abstract

Purpose Cardiac recovery after mechanical circulatory support allows explantation of the left ventricular assist device (LVAD). So far, no FDA approved or CE certified plug is available for the explantation of newest generation HeartMate 3TM. Here, we present an individualized explantation strategy with an in-house developed patient-tailored silicone plug for the HeartMate 3™ LVAD avoiding (re-) sternotomy. Methods Hemodynamic evaluation of two HeartMate 3TM patients was performed in order to assess cardiac recovery and hereby planning a LVAD explantation strategy avoiding (re-) sternotomy. A preoperative CT scan was used to define the ideal dimensions of the silicone plug fitting with a HeartMate 3TM mock apical ring. The cylindrical plug was made out of medical grade liquid silicone elastomer MED-4820 (NuSil Silicone Technology LLC, Carpinteria, USA) using a patient specific high quality surface casting mold and subsequently sterilized in a clinical standard process. Its geometry was defined by the inner diameter of the apical cuff and the patient's CT data implementing one rounded end and a cylindrical head with cross-shaped suture guides on the other end. Results Following CT scans of two HeartMate 3TM patients, individualized explantation of the LVAD was planned with a patient-tailored silicone plug. Both patients could be successfully weaned from VAD support and explanted with a lateral thoracotomy. No apical bleeding occurred after VAD removal and silicone plug insertion. The plugs could be inserted easily and reliably secured with crossing sutures. The patients were monitored on ICU and could be discharged home in the following days. Conclusion The surgical removal of HeartMate 3TM is feasible using a patient-tailored silicone plug avoiding (re-) sternotomy. The medical grade liquid silicone elastomer allows perfect patient-specific fitting with pre-operative CT-measured dimensions.