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

Objectives: Cardiac recovery after mechanical circulatory support allows explantation of the left ventricular assist device (LVAD). So far, no Food and Drug Administration approved or CE certified plug is available for the explantation of newest generation HeartMate 3. 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 3 patients was performed in order to assess cardiac recovery and hereby planning a LVAD explantation strategy avoiding (re)sternotomy. A preoperative computed tomography (CT) scan was used to define the ideal dimensions of the silicone plug fitting with a HeartMate 3 mock apical ring. The cylindrical plug was made out of medical grade liquid silicone elastomer MED-4820 (NuSil Silicone Technology LLC, Carpinteria, United States) 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 3 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 in intensive care unit and could be discharged home in the following days.

Conclusion: The surgical removal of HeartMate 3 is feasible using a patient-tailored silicone plug avoiding (re)sternotomy. The medical grade liquid silicone elastomer allows perfect patient-specific fitting with preoperative CT-measured dimensions.

No conflict of interest has been declared by the author(s).