12 research outputs found

    Evolution in Mechanical Circulatory Support Are We at the Precipice of a Disruptive Innovation?∗

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    UNUSUAL CAUSE OF CHEST PAIN, THINK OUTSIDE THE BOX!

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    Inotropes

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    Inotropes have been fundamental to resuscitation of acute cardiogenic shock for decades. Heart failure and cardiogenic shock, in severe cases, are syndromes characterized in many patients by a reduction in myocardial contractile force. While inotropes successfully increase cardiac output, their use has been plagued by excessive mortality due to increased tachycardia and myocardial oxygen consumption leading to arrhythmia and myocardial ischemia. There is a pressing need for new inotropic agents that avoid these harmful effects. This review describes the mechanism of action and the clinical utility of some of the older inotropic agents, which are still commonly used, and provides an update for physicians on the development of newer inotropic drugs. The field is rapidly changing, and it is likely that new agents will be designed that improve systolic performance without necessarily increasing the myocardial oxygen consumption

    HEMOLYSIS SECONDARY TO LVAD THROMBOSIS REQUIRING MANUAL PUMP STOPPAGE

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    Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients

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    BACKGROUND: The Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) clinical trial demonstrated improved 6-month event-free survival, but a detailed analysis of health-related quality of life (HR-QOL) and functional capacity (FC) was not presented. Further, the effect of early serious adverse events (SAEs) on these metrics and on the general ability to live well while supported with a left ventricular assist system (LVAS) warrants evaluation. METHODS: FC (New York Heart Association [NYHA] and 6-minute walk test [6MWT]) and HR-QOL (European Quality of Life [EQ-5D-5L] and the Kansas City Cardiomyopathy [KCCQ]) assessments were obtained at baseline and 6 months after HeartMate 3 (HM3, n = 151; Abbott, Abbott Park, IL) or HeartMate II (HMII, n = 138; Abbott) implant as part of the MOMENTUM 3 clinical trial. Metrics were compared between devices and in those with and without events. The proportion of patients living well on an LVAS at 6 months, defined as alive with satisfactory FC (NYHA I/II or 6MWT \u3e 300 meters) and HR-QOL (overall KCCQ \u3e 50), was evaluated. RESULTS: Although the median (25th-75th percentile) patient KCCQ (change for HM3: +28 [10-46]; HMII: +29 [9-48]) and EQ-5D-5L (change for HM3: -1 [-5 to 0]; HMII: -2 [-6 to 0]) scores improved from baseline to 6 months (p \u3c 0.05), there were no differences between devices (p \u3e 0.05). Likewise, there was an equivalent improvement in 6MWT distance at 6 months in HM3 (+94 [1-274] meters] and HMII (+188[43-340 meters]) from baseline. In patients with SAEs (n = 188), 6MWTs increased from baseline (p \u3c 0.001), but gains for both devices were less than those without SAE (HM3: +74 [-9 to 183] meters with SAE vs +140 [35-329] meters without SAE; HMII: +177 [47-356] meters with SAE vs +192 [23-337] meters without SAE, both p \u3c 0.003). SAEs did not affect the 6-month HR-QOL scores. The living well end point was achieved in 145 HM3 (63%) and 120 HMII (68%) patients (p = 0.44). CONCLUSIONS: Gains in HR-QOL and FC were similar early after HM3 and HMII implant. 6MWT improvements were attenuated in patients experiencing SAEs, but HR-QOL metrics did not change. The development of left ventricular assist device-specific HR-QOL tools is needed to better characterize the effect of SAEs on a patient\u27s well-being. CLINICAL TRIAL NO: MOMENTUM 3 clinical trial #NCT02224755
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