Aims Left ventricular assist device therapy has become the cornerstone in the treatment of end-stage heart failure and is increasingly used as destination therapy next to bridge to transplant or recovery. HeartMate 3 (HM3) and HeartWare (HVAD) are centrifugal continuous flow devices implanted intrapericardially and most commonly used worldwide. No randomized controlled trials have been performed yet. Analysis based on large registries may be considered as the best alternative but has the disadvantage of different standard of care between centres and missing data. Bias is introduced, because the decision which device to use was not random, even more so because many centres use only one type of left ventricular assist device. Therefore, we performed a propensity score (PS)-based analysis of long-term clinical outcome of patients that received HM3 or HVAD in a single centre. Methods and results Between December 2010 and December 2019, 100 patients received HVAD and 81 patients HM3 as primary implantation at the University Medical Centre Utrecht. We performed PS matching with an extensive set of covariates, resulting in 112 matched patients with a median follow-up of 28 months. After PS matching, survival was not significantly different (P = 0.21) but was better for HM3. The cumulative incidences for haemorrhagic stroke (P = 0.01) and pump thrombosis (P = 0.02) were significantly higher for HVAD patients. The cumulative incidences for major bleeding, ischaemic stroke, right heart failure, and driveline infection were not different between the groups. We found no interaction between the surgeon who performed the implantation and survival (P = 0.59, P = 0.78, and P = 0.89). Sensitivity analysis was performed, by PS matching without patients on preoperative temporary support resulting in 74 matched patients. This also resulted in a non-significant difference in survival (P = 0.07). The PS-adjusted Cox regression showed a worse but non-significant (P = 0.10) survival for HVAD patients with hazard ratio 1.71 (95% confidence interval 0.91-3.24). Conclusions Survival was not significantly different between both groups after PS matching, but was better for HM3, with a significantly lower incidence of haemorrhagic stroke and pump thrombosis for HM3. These results need to be interpreted carefully, because matching may have introduced greater imbalance on unmeasured covariates. A multicentre approach of carefully selected centres is recommended to enlarge the number of matched patients.
Background: Adverse events are common in high-risk surgical patients, but early detection is difficult.Recent innovations have resulted in wireless and 'wearable' sensors, which may capture patient deterioration at an early stage, but little is known regarding their ability to timely detect events. The objective of this study is to describe the ability of currently available wireless sensors to detect adverse events in high-risk patients.Methods: A descriptive analysis was performed of all vital signs trend data obtained during an observational comparison study of wearable sensors for vital signs monitoring in high-risk surgical patients during the initial days of recovery at a surgical step-down unit (SDU) and subsequent traumatology or surgical oncology ward. Heart rate (HR), respiratory rate (RR) and oxygen saturation (SpO 2 ) were continuously recorded. Vital sign trend patterns of patients that developed adverse events were described and compared to vital sign recordings of patients without occurrence of adverse events. Two wearable patch sensors were used (SensiumVitals and HealthPatch), a bed-based mattress sensor (EarlySense) and a patient-worn monitor (Masimo Radius-7).Results: Twenty adverse events occurred in 11 of the 31 patients included. Atrial fibrillation (AF) was most common (20%). The onset of AF was recognizable as a sudden increase in HR in all recordings, and all patients with new-onset AF after esophagectomy developed other postoperative complications. Patients who developed respiratory insufficiency showed an increase in RR and a decrease in SpO 2 , but an increase in HR was not always visible. In patients without adverse events, temporary periods of high HR and RR are observed as well, but these were transient and less frequent.Conclusions: Current systems for remote wireless patient monitoring on the ward are capable of detecting abnormalities in vital sign patterns in patients who develop adverse events. Remote patient monitoring may have potential to improve patient safety by generating early warnings for deterioration to nursing staff.
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