Christopher T Salerno, Christopher Hayward, Shelley Hall, Daniel Goldstein, Diyar Saeed, Jan Schmitto, David Kaczorowski, Ezequiel Molina, Daniel Zimpfer, Steven Tsui, Edward Soltesz, Duc Thin Pham, Nahush A Mokadam, Arman Kilic, Erin Davis, Erika Feller, Angela Lorts, Scott Silvestry, Mark S Slaughter, Evgenij Potapov, Pavan Atluri, Jennifer Cowger, Francis D Pagani
The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device...
June 15, 2022: European Journal of Cardio-thoracic Surgery