Interdisciplinary Patient Management Following a Controller Fault Alarm in Heartware HVAD

Purpose The Medtronic Corporation announced that the Heartware HVADTM will be removed from the global market for new implants as of June 3, 2021. Even after the official recall optimal care of the estimated 4000 patients worldwide is essential. In light of the past events where the new controller failed to start after a controller exchange, we must now focus on developing an optimal concept for this scenario. Methods Hence, we developed an algorithm to address the optimal patient management following a controller fault alarm in Heartware HVAD including two possible strategies for replacing the Medtronic HVAD with an Abbott HeartMate3 Results Between 06 and 10/2021 out of 215 ongoing HVAD patients 15 of them (5 female,10 male, median support time of 1815 (IQR:1156- 4007) days) contacted our VAD team regarding a controller fault alarm . In 10 patients the controller exchange following the algorithm was uneventful, in three cases minor bleeding events occurred. Two patients refused hospital admission and the exchange was performed at home with supervision via phone. Conclusion Even after the official recall of the Heartware HVAD, optimal care of the estimated 4000 patients with this system worldwide is essential. In light of the past events where the new controller failed to start after a controller exchange, we must now focus on developing an optimal concept for this scenario, as all patients will have to undergo a controller exchange in the next years once or even several times if support extends to another time period of more than approximately 4 years owing to the limited life of the internal battery of the HVAD controller. Even if preoperative echocardiography produces apparently stable findings, patients may experience rapid deterioration if the system fails, so that cardiovascular support must be established and a subsequent exchange of the HVAD to HM3 performed without delay. For patients with absolute contraindication of a pump stop like a thrombosed aortic valve permanently muting the controller fault alarm may be discussed. Continuous operation of the pump is not impaired; however the patient will have to be informed and has to acknowledge the constraints of the changed alarm display functionality and a shortened time of power-off alarm capacity. The Medtronic Corporation announced that the Heartware HVADTM will be removed from the global market for new implants as of June 3, 2021. Even after the official recall optimal care of the estimated 4000 patients worldwide is essential. In light of the past events where the new controller failed to start after a controller exchange, we must now focus on developing an optimal concept for this scenario. Hence, we developed an algorithm to address the optimal patient management following a controller fault alarm in Heartware HVAD including two possible strategies for replacing the Medtronic HVAD with an Abbott HeartMate3 Between 06 and 10/2021 out of 215 ongoing HVAD patients 15 of them (5 female,10 male, median support time of 1815 (IQR:1156- 4007) days) contacted our VAD team regarding a controller fault alarm . In 10 patients the controller exchange following the algorithm was uneventful, in three cases minor bleeding events occurred. Two patients refused hospital admission and the exchange was performed at home with supervision via phone. Even after the official recall of the Heartware HVAD, optimal care of the estimated 4000 patients with this system worldwide is essential. In light of the past events where the new controller failed to start after a controller exchange, we must now focus on developing an optimal concept for this scenario, as all patients will have to undergo a controller exchange in the next years once or even several times if support extends to another time period of more than approximately 4 years owing to the limited life of the internal battery of the HVAD controller. Even if preoperative echocardiography produces apparently stable findings, patients may experience rapid deterioration if the system fails, so that cardiovascular support must be established and a subsequent exchange of the HVAD to HM3 performed without delay. For patients with absolute contraindication of a pump stop like a thrombosed aortic valve permanently muting the controller fault alarm may be discussed. Continuous operation of the pump is not impaired; however the patient will have to be informed and has to acknowledge the constraints of the changed alarm display functionality and a shortened time of power-off alarm capacity.