Background:The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with the use of HeartMate 3 (HM3) device. This single-center study investigated the real-world experience in HM3 patients since FDA approval.Methods: This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017 and March 2020. Patients were divided into trial group and postapproval group. The primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection.Results: A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher preoperative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% versus 93.8% (p = .88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs. 46.3, p = .01) than the trial group. Conclusion:In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.
Future autonomous vehicles will rely heavily on sharing and communicating information with other vehicles to maximize their efficiency. These interactions, which will likely include details about the positions of surrounding vehicles and obstacles on the road, are essential to their decision-making and the prevention of accidents. However, malicious vehicles—those that intentionally communicate false information—have the capacity to adversely influence other vehicles in the network. This paper presents and evaluates a reputation management system, capable of identifying malicious actors, to mitigate their effects on the vehicle network. The viability of multiple report weighting schemes to calculate reputation is evaluated through a simulation, and a blockchain-based backend for the reputation management system to securely maintain and communicate reputation data is proposed. Storage and computational challenges are considered. This paper shows that weighting schemas, related to the number and reputation of witnesses, positively affect the accuracy of the model and are able to identify malicious vehicles in a network with consistent accuracy and scalability.
Background The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with use of HeartMate 3 (HM3) device. This single center study investigated the real-world experience in HM3 patients since FDA approval. Methods This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017-March 2020. Patients were divided into trial group and postapproval group. Primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection. Results A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher pre-operative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% vs. 93.8% ( p=0.88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs 46.3, p=0.01) than the trial group. Conclusion In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.
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