Thoratec® HeartMate 3® LVAS Implant Kit

Description of Event or Problem

It was reported that the article ¿Preemptive Versus Reactive Use of a Right Ventricular Assist Device in HeartMate 3 Patients¿ reported a single-center, retrospective cohort study of adults who underwent left ventricular assist device (LVAD) implantation between November 2014 and December 2022 and were monitored for post-operative right ventricular failure. The study characterized right ventricular assist device (RVAD) utilization strategies and assessed patient outcomes, as reactive RVAD placement presents a persistent threat associated with significant clinical burden and mortality. Data was collected for all patients through a 3-year post-implant tracking period. The demographics, clinical characteristics, specific RVAD timing types, and clinical outcomes were examined. Of the patients tracked, 293 were successfully implanted with the HeartMate 3 (HM3) device. Patients were predominantly managed with isolated left-heart support, with final device strategies including No RVAD (78.2%), Preemptive RVAD (11.3%), and Reactive RVAD (10.6%). The first preemptive RVAD interventions occurred simultaneously during the primary surgery, with advanced biventricular failure or cardiogenic shock being common on initial presentation. After the primary surgery, 31 patients (10.6%) experienced unexpected right heart failure requiring reactive intervention, and 8 of them (25.8%) suffered in-hospital mortality. Throughout the cohort study, isolated HM3 patients without right-heart complications were the most common cohort type (78.2%), followed by preemptive patients (11.3%) and reactive patients (10.6%). In-hospital outcomes showed significant complications post-implant. The reactive group experienced a 16.1% stroke rate, compared to 5.7% in the no-RVAD group and 3.1% in the preemptive group. Takeback for bleeding occurred in 30.3% of preemptive patients, 12.9% of reactive patients, and 8.3% of the no-RVAD group. Takeback for chest closure was required in 27.3% of the preemptive group, 25.8% of the reactive group, and 3.1% of the no-RVAD group. Reactive patients experienced a 32.3% rate of respiratory failure requiring a tracheostomy, compared to 18.2% for preemptive and 3.5% for no-RVAD patients. Acute renal failure requiring new dialysis was 35.5% for the reactive group, 12.1% for the preemptive group, and 5.7% for the no-RVAD group. Device infections were reported in 6.1% of the preemptive group, 0.9% of the no-RVAD group, and 0% of the reactive group. Long-term tracking over the 3-year survival window demonstrated an overall 3-year survival rate of 85.5% for the no-RVAD group, 83.5% for the preemptive group, and a low 46.6% for the reactive group, with three-year mortality tracking at 12.2%, 9.1%, and 45.2% respectively. Successful weaning from temporary right-side support was achieved in 87.5% of the combined RVAD patients, while 16.1% of the reactive group experienced death on biventricular assist device support compared to 0% in the preemptive group. Regarding long-term device endpoints, 9.1% of preemptive patients were bridged to a heart transplant on biventricular assist device support. The LVAD was removed due to recovery in 6.1% of the preemptive group, 1.3% of the no-RVAD group, and 0% of the reactive group. Death on LVAD occurred in 54.8% of the reactive group, 18.2% of the preemptive group, and 18.3% of the no-RVAD group. Late death was noted in 34.8% of reactive, 15.6% of preemptive, and 16.5% of no-RVAD patients. Furthermore, late hospital readmission for right heart failure affected 26.1% of the reactive group, 9.4% of the preemptive group, and 18.3% of the no-RVAD group. Hospital readmission for arrhythmia occurred in 26.1% of reactive, 3.1% of preemptive, and 14.7% of no-RVAD patients. The high rates of in-hospital complications, late hospital readmissions, and mortality in the reactive cohort highlighted the need for better early risk-prediction and management strategies.

Additional Manufacturer Narrative

Section A, D: Specific patient information and device serial number are documented as Unknown. Vinogradsky, A. V., Patel, K., Moroi, M. K., Kurlansky, P., Zhao, Y., Kaku, Y., Hynds, M. A., Sayer, G., Uriel, N., Yuzefpolskaya, M., Braghieri, L., Colombo, P., & Takeda, K. (2025). https://doi.org/10.1097/mat.0000000000002609.Section B: Date of Death was unable to be determined.Manufacturer's Investigation Conclusion:A direct correlation between the HeartMate 3 Left Ventricular Assist System (LVAS) and the reported patient outcomes could not be conclusively established through this evaluation.No product was evaluated under this complaint. The HeartMate 3 device serial numbers, as well as other specific case/patient information, are not available.A review of the relevant sections of the Device History Records could not be performed as the serial number of the device was not communicated/identified. The HeartMate 3 Left Ventricular Assist System (LVAS) Instructions for Use (IFU) is currently available. The current revision of the IFU can be found on the eIFU page of the Abbott website. Section 1 of the IFU, ¿Introduction,¿ lists potential adverse events, including death, that may be associated with the use of the HeartMate 3 LVAS. No further information was provided. The manufacturer is closing the file on this event.