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Adverse Events Associated with Cardiac Catheterization in Children Supported with Ventricular Assist Devices
Children on ventricular assist device (VAD) support can present several unique challenges, including small patient size, univentricular or biventricular congenital heart disease (1V- or 2V-CHD) and need for biventricular VAD (BiVAD) support. While cardiac catheterization can provide valuable information, it is an invasive procedure with inherent risks. We sought to evaluate the safety of catheterization in pediatric patients on VAD support. We performed a retrospective review of patients on VAD support who underwent catheterization at Lucile Packard Children’s Hospital between January 1, 2014 and September 1, 2019. Using...
Source: ASAIO Journal - September 1, 2022 Category: Medical Devices Tags: Pediatric Circulatory Support Source Type: research

Surgical Techniques for Implanting the EVAHEART 2 Double Cuff Tipless Inflow Cannula
The EVAHEART 2 (Sun Medical Technology Research Corporation, Nagano, Japan) is an investigational centrifugal ventricular assist device in the United States, introduced a new type inflow, named “double cuff tipless” inflow cannula intended to mitigate the risks of cannula malposition and subsequent ischemic stroke events associated with thrombi around the inflow cannula. To achieve these performance benefits of the “tipless” design, however, it is crucial to adhere to the recommended surgical procedure. We introduced a polymer-based patient model that mimics a dilated cardiomyopathy apex for inflow cannula implanta...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: How to do it Article Source Type: research

Postapproval Outcomes: The Berlin Heart EXCOR Pediatric in North America
The Berlin Heart EXCOR Pediatric Ventricular Assist Device (BH) was approved for use in the United States in December 2011, based on a prospective investigational device exemption (IDE) trial. Strict exclusion criteria for the trial selected a low-risk “ideal” cohort. We sought to determine whether postapproval usage of the BH in a “real world” cohort of recipients would result in similar outcomes. Preimplant diagnostic information was collected for all patients. Efficacy was evaluated by comparison of all children (efficacy group, n = 247) implanted between FDA approval and April 2015 to those in the IDE trial (ID...
Source: ASAIO Journal - February 25, 2017 Category: Medical Equipment Tags: Pediatric Circulatory Support Source Type: research