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Several other recent studies have shown good outcomes with longer times on temporary device pumps and as bridge to transplant.22,23 A review of the Organ Procurement and Transplantation Network data found that prior to 2011, fewer than three of these devices were used per year as a bridge to transplant, with an explosion in use to 50 of these temporary devices being used as bridge to transplant in 2015 In this review, CentriMag/PediMag was by far the most common, used in 65% of patients, followed by the TandemHeart pump (not system), used in 18% Importantly, in comparison to the ECMO cohort, a propensity score-matched short-term MCS cohort had longer survival to transplant, as well as longer overall survival Data have also shown that, if temporary support is used for a chronic heart failure patient with acute cardiogenic failure, the vast majority of these patients will not recover and will require conversion to long-term VAD support Current Devices for Long-Term Mechanical Circulatory Support in Children Berlin Heart EXCOR The Berlin Heart EXCOR is a paracorporeal pulsatile, pneumatically compressed, volume displacement pump It is available in 10-, 15-, 25-, 30-, 50-, and 60-mL blood chamber sizes (Fig 66.3).23 It is the most studied pediatric VAD, with more than 1800 implants, the only to be FDA approved, and the most commonly used worldwide.25 Use of customized polyurethane valves has allowed the manufacture of smaller blood pump sizes than are available with “adult” pumps, which have used commercially available mechanical valves Its first reported successful use as a bridge to transplantation occurred in 1990.26 The longest known support time has been 877 days to successful transplant.27 The experience at the Berlin Heart Institute has been extensively reported.28–30 A total of 74 pediatric patients were supported there from 1990 to 2006, with a mean age of 7.6 years (range, 2 days to 17 years) and a mean support time of 36 days Fifteen percent of these patients were weaned from the device, with 43% receiving a heart transplant; 41% of the children died during VAD support The group notes significant improvement from the year 2000 onward, with a 74% survival rate to transplantation or discharge despite a younger patient population The authors note that changes in their decision-making process from earlier to later in the experience included earlier implementation of support before the development of significant end-organ failure, improvements in cannula design, apical left ventricle rather than atrial cannulation, fewer biventricular VADs (BiVADs), and a focus on the anticoagulation protocol FIG 66.3 The Berlin Heart EXCOR device has six blood chamber sizes (10, 15, 25, 30, 50, and 60 mL) and multiple cannula options to span the pediatric age group (Courtesy Robert Kroslowitz, Berlin Heart, Inc., Berlin, Germany.) The device was first used in North America in 2000, and by 2004 there was widespread use The initial EXCOR experience in the United States from 2000 to 2007 (n = 73) was reported to have a positive outcome in 77% of patients31 and paved the way for a prospective, multicenter, clinical cohort investigational device exemption (IDE) study The IDE study enrolled 48 patients from 2007 to 2010 and conclusively demonstrated EXCOR to be superior to ECMO in bridging children to transplantation.25 The outcomes of all 204 children who underwent EXCOR implantation during the duration of the IDE study was also published and was believed to represent the real-world use of EXCOR in North America.32 In this study, 75% of patients survived to transplantation or recovery, with lower weight, higher bilirubin values, and BiVAD support predicting early mortality (2 months) The most common cause of death was stroke (33%), most often of thromboembolic origin Lower weight at implantation and large pump size to body surface area (BSA) have been associated with neurologic injury in other studies.33,34 Importantly, only one death in the North American experience was attributed to device malfunction Recent studies comparing posttransplant survival in those bridged to transplant with EXCOR versus no MCS showed comparable survival between the groups, with 94%, 90%, and 72% survival at 30 days, 1 year, and 5 years, respectively, in the EXCOR group.35 This was congruent with previous findings, which additionally identified similar 1-year survival between EXCOR patients with and without complications.36 The latter study also noted a significantly higher incidence of death after transplant in patients with CHD compared with those with cardiomyopathy (26.1% vs 7.2%) ... It is available in 10-, 15-, 25-, 30-, 50-, and 60-mL blood chamber sizes (Fig 66.3).23 It is the most studied pediatric VAD, with more than 1800 implants, the only to be FDA approved, and the most commonly used worldwide.25 Use of customized polyurethane valves has... The experience at the Berlin Heart Institute has been extensively reported.28–30 A total of 74 pediatric patients were supported there from 1990 to 2006, with a mean age of 7.6 years (range, 2 days to 17 years) and a mean support time of 36... The Berlin Heart EXCOR device has six blood chamber sizes (10, 15, 25, 30, 50, and 60 mL) and multiple cannula options to span the pediatric age group (Courtesy Robert Kroslowitz, Berlin Heart, Inc., Berlin, Germany.) The device was first used in North America in 2000, and by 2004 there was
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