Anticoagulation Bridging In Patients With Heartmate3 Left Ventricular Assist Device: A Regional Analysis Of The Momentum 3 Trial

Introduction: Advances in left ventricular assist device (LVAD) technologies have led to a significant improvement in pump hemocompatibility. Due to concerns of thromboembolic complications in older generation LVADs, bridging was commonly performed in patients with subtherapeutic INRs. The effects of this strategy on new generation devices are unclear. We analyzed management strategies of subtherapeutic INRs and their effect on outcomes in a subset of patients enrolled in MOMENTUM 3 trial (CAP and IDE). Methods: All patients enrolled in the MOMENTUM 3 trial (CAP and IDE) across 6 centers were screened for inclusion. Patients were included if they underwent implantation of an HMIII device and had a subtherapeutic INR following discharge from their admission for LVAD implant. All episodes of subtherapeutic INR underwent manual chart review to evaluate management strategies taken by clinicians. Strategies were divided into two groups, bridging (with parenteral or intravenous agents) or non-bridging (consisting of adjustments or no change in coumadin dosing). The primary outcome was a composite of death, rehospitalization, CVA, and bleeding events. Results: Of the 225 patients included in the analysis there were total of 235 subtherapeutic INR events. Fifty-six (23.8%) of these INR\u27s were treated with bridging (n= 30 with parenteral agents, n=26 with IV agents) and 179 patients that were not bridged (n=100 coumadin dose adjustment, n=79 no change in coumadin dose). There was no difference in the composite outcome of patients that were bridged compared to those that were not. Conclusion: Subtherapeutic INR is a common event in patients with HM3 LVAD. The management strategy of subtherapeutic INR varies. Management strategy had no effect on mortality, rehospitalization, CVA, or bleeding events

Effects of D-allulose on glucose tolerance and insulin response to a standard oral sucrose load: results of a prospective, randomized, crossover study

Introduction Current dietary guidelines recommend limiting sugar intake for the prevention of diabetes mellitus (DM). Reduction in sugar intake may require sugar substitutes. Among these, D-allulose is a non-calorie rare monosaccharide with 70% sweetness of sucrose, which has shown anti-DM effects in Asian populations. However, there is limited data on the effects of D-allulose in other populations, including Westerners.Research design and methods This was a prospective, randomized, double-blind, placebo-controlled, crossover study conducted in 30 subjects without DM. Study participants were given a standard oral (50 g) sucrose load and randomized to placebo or escalating doses of D-allulose (2.5, 5.0, 7.5, 10.0 g). Subjects crossed-over to the alternate study treatment after 7–14 days of wash out. Plasma glucose and insulin levels were measured at five time points: before and at 30, 60, 90 and 120 min after ingestion.Results D-allulose was associated with a dose-dependent reduction of plasma glucose at 30 min compared with placebo. In particular, glucose was significantly lower with the 7.5 g (mean difference: 11; 95% CI 3 to 19; p=0.005) and 10 g (mean difference: 12; 95% CI 4 to 20; p=0.002) doses. Although glucose was not reduced at the other time points, there was a dose-dependent reduction in glucose excursion compared with placebo, which was significant with the 10 g dose (p=0.023). Accordingly, at 30 min D-allulose was associated with a trend towards lower insulin levels compared with placebo, which was significant with the 10 g dose (mean difference: 14; 95% CI 4 to 25; p=0.006). D-allulose did not reduce insulin at any other time point, but there was a significant dose-dependent reduction in insulin excursion compared with placebo (p=0.028), which was significant with the 10 g dose (p=0.002).Conclusions This is the largest study assessing the effects of D-allulose in Westerners demonstrating an early dose-dependent reduction in plasma glucose and insulin levels as well as decreased postprandial glucose and insulin excursion in subjects without DM. These pilot observations set the basis for large-scale investigations to support the anti-DM effects of D-allulose.Trial registration number NCT02714413

Anticoagulation bridging in patients with left ventricular assist device: A regional analysis of HeartMate 3 recipients

Advances in left ventricular assist device technologies have led to an improvement in pump hemocompatibility and outcomes. Because of concerns of thromboembolic complications in prior generations of left ventricular assist devices, bridging with parenteral anticoagulants was routinely. Management strategies of subtherapeutic INRs and their effects on the current generation of devices deserve review. We performed analysis of the MOMENTUM 3 trial including 6 centers in the mid-America region. Patients with subtherapeutic INRs (INR \u3c 2) occurring after the index admission underwent chart review to determine the management strategies taken by clinicians. Strategies were divided into two groups, bridging or nonbridging. Of the 225 patients included in the analysis, 130 (58%) patients had a total of 235 subtherapeutic international normalized ratio (INR) events. Most (n = 179, 76.2%) of these INRs were not bridged (n = 100 warfarin dose adjustment, n = 79 no change in warfarin dose). Among those INRs (n = 56, 23.8%) treated with bridging, approximately half (n = 30, 53.6%) were treated with subcutaneous agents and other half (n = 26, 46.4%) were treated with intravenous agents. There was no difference in individual outcomes or composite endpoints of death, rehospitalization, CVA, or bleeding events between the groups