Sixth Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report: The Society Of Thoracic Surgeons Pedimacs Annual Report.

2023

1098-1108

05/2023

1552-6259

BACKGROUND: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), supported by The Society of Thoracic Surgeons, provides detailed information on pediatric patients supported with ventricular assist devices (VADs).

METHODS: From September 19, 2012, to December 31, 2021, there were 1355 devices in 1109 patients (<19 years) from 42 North American Hospitals.

RESULTS: Cardiomyopathy was the most common underlying cause (59%), followed by congenital heart disease (25%) and myocarditis (9%). Regarding device type, implantable continuous (IC) VADs were most common at 40%, followed by paracorporeal pulsatile (PP; 28%) and paracorporeal continuous (PC; 26%). Baseline demographics differed, with the PC cohort being younger, smaller, more complex (ie, congenital heart disease), and sicker at implantation (P < .0001). At 6 months after VAD implantation, a favorable outcome (transplantation, recovery, or alive on device) was achieved in 84% of patients, which was greatest among those on IC VADs (92%) and least for PC VADs (69%). Adverse events were not uncommon, with nongastrointestinal bleeding (incidence of 14%) and neurologic dysfunction (11% [stroke, 4%]), within 2 weeks after implantation being the most prevalent. Stroke and bleeding had negative impacts on overall survival (P = .002 and P < .001, respectively).

CONCLUSIONS: This Sixth Pedimacs Report demonstrates the continued evolution of the pediatric field. The complexity of cardiac physiologies and anatomic constraint mandates the need for multiple types of devices used (PC, PP, IC). Detailed analyses of each device type in this report provide valuable information to further advance the care of this challenging and vulnerable population.

10.1016/j.athoracsur.2022.10.042

Ann Thorac Surg

36402175

MILESTONE: More Than 1,200 Children Bridged to Heart Transplantation with Mechanical Circulatory Support.

2022

577-583

2022 Apr 01

1538-943X

<p>Pediatric mechanical circulatory support (MCS) has been successfully used to bridge numerous children to transplantation who otherwise would have been unlikely to survive on the waitlist and, in many cases, make them better transplant candidates. The purpose of this study was to analyze what the pediatric heart failure community has achieved over the last 15 years in reaching 1,200 cases of bridging children to heart transplantation. The United Network for Organ Sharing database was used to identify MCS patients ages 0-18 at the time of listing for heart transplantation between 2005 and 2019, divided into three eras: first (2005-2009), second (2010-2014), and third (2015-2019). From 2005 to 2019, 1,289 pediatric cases were identified. More patients were successfully bridged to transplantation with MCS in the third-era (28%) [vs. first-era (16%), second-era (24%), p ≤ 0.004]. The proportion of discharges on ventricular assist device has increased as well from 3% to 22% (p &lt; 0.001). Post-transplant survival was significantly better in the third era (1-year survival: 96%; 3-year survival: 89%) compared to the two previous eras (p = 0.006). On MCS, renal dysfunction, ventilator dependence, inotrope use, and functional status improved from the time of listing to transplantation (p &lt; 0.01). Hepatic dysfunction (p &lt; 0.001), renal dysfunction (p = 0.004), congenital heart disease (p = 0.023), and infant age (p = 0.002) were risk factors for post-transplant mortality. Over the last 15 years, pediatric MCS has become an accepted and increasingly used strategy for bridging children to transplantation. MCS therapy is associated with improved end-organ function at the time of transplantation, perhaps contributing to the increasing post-transplantation survival of patients bridged with MCS.</p>

10.1097/MAT.0000000000001635

ASAIO J

35349524

Fifth Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report.

2021

2021 Oct 11

1552-6259

<p><strong>BACKGROUND: </strong>The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) provides detailed information on pediatric patients supported with ventricular assist devices (VADs).</p>

<p><strong>METHODS: </strong>From September 19, 2012 to December 31, 2020 there were 1,229 devices in 1,011 patients reported to the registry from 47 North American Hospitals in patients under 19 years of age.</p>

<p><strong>RESULTS: </strong>Cardiomyopathy was the most common underlying etiology (58%), followed by congenital heart disease (CHD) (25%) and myocarditis (10%). The most common devices implanted were implantable continuous (IC) (n=419, 41%), followed by paracorporeal pulsatile (PP) (n=269, 27%), paracorporeal continuous (PC) (n=263, 26%), and percutaneous (n=53, 5%). Overall, at six months after VAD implantation, 83% had a positive outcome (transplant, explant, or alive on device). The freedom from stroke was highest in IC VADs (93% at 3-months), compared to PP VADs (84% at 3-months) and with PC VADs (75% at 3-months. There were differences in survival by device type with patients on IC VADs having the best overall survival and those on PC having the lowest overall survival, though the patient populations being supported by each VAD type differed significantly from each other.</p>

<p><strong>CONCLUSIONS: </strong>This Fifth Pedimacs Report demonstrates the continued robust growth of VADs in the pediatric community, now with over 1000 patients reported to the registry. The multiple available device types (PC, PP, IC) serve different populations with different pre-VAD risk profiles, which may account for differences in survival and AE between device types.</p>

10.1016/j.athoracsur.2021.10.001

Ann Thorac Surg

34648810

Fourth Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report.

2020

2020 Oct 08

1552-6259

<p><strong>BACKGROUND: </strong>Pedimacs, an originally NIH-sponsored U.S. database, provides a platform to understand the population of children supported with VADs during this time of increasing numbers, new devices, expanding indications, and improved outcomes.</p>

<p><strong>METHODS: </strong>Between 9/19/12-12/31/19, 44 hospitals implanted 1031 devices in 856 patients under 19 years-of-age.</p>

<p><strong>RESULTS: </strong>Overall, diagnosis was cardiomyopathy in 497(58%), congenital heart disease(CHD) in 216(25%), myocarditis in 85(10%), and other in 58(7%). Positive outcome (alive on device or bridge to transplantation/recovery) occurred in 82% at 6-months. The patient cohort for implantable continuous flow(IC) pumps (n=365)[age:13.2+/-3.9yrs., 18% INTERMACS profile-1, 23% intubated at implant, 16% with CHD] was significantly different from the paracorporeal continuous flow(PC) pump cohort (n=212)[age:3.6+/-4.9yrs, 46% INTERMACS profile-1, 81% intubated, 42% CHD] and the paracorporeal pulsatile(PP) pump cohort (n=230)[age:2.7 +/-3.5yrs, 31% INTERMACS profile-1, 76% intubated, 26% CHD]. Consistent with their cohort composition, positive outcomes at 6 months based on device type were IC-92%, PC-68%, and PP-81%. The incidence of cerebrovascular accidents(CVA) in the IC, PC, and PP cohorts is 7%, 14% and 15%, respectively.</p>

<p><strong>CONCLUSIONS: </strong>IC VADs, the most common VAD-type placed in children, are associated with improved outcomes compared to PP/PC devices, though PP/PC devices are limited to supporting our most challenging patients. Noteworthy, the incidence of CVA for pediatric VADs has significantly decreased and is now 11% overall. This report demonstrates again that although often attributed to age, size, or device type, much of the burden in mortality and adverse events is correlated to the patient's overall state at VAD implantation.</p>

10.1016/j.athoracsur.2020.09.003

Ann Thorac Surg

33039359

Third Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report: Pre-Implant Characteristics and Outcomes.

2019

2019 Feb 25

1552-6259

<p><strong>BACKGROUND: </strong>The influence of ventricular assist device (VAD) use in the care of children with end-stage heart failure is growing rapidly through increasing numbers, new devices, expanding indications, and improving outcomes. Pedimacs, a NIH-sponsored U.S. database, provides a platform to understand this emerging population.</p>

<p><strong>METHODS: </strong>Between 9/19/12-12/31/17, 30 hospitals implanted 508 devices in 423 patients under 19 years-of-age. This past year was one of evolution for the Database as its management was transitioned to the Society of Thoracic Surgery, therefore data from institutions not under contract by August 1 2018 was not included in this report.</p>

<p><strong>RESULTS: </strong>Of the 423 patients, the diagnosis was cardiomyopathy in 261 (62%), myocarditis in 48 (11%), other in 28 (7%) and congenital heart disease in 86 (20%) with 52 of these patients having single ventricle physiology. The two most common support strategies included LVAD-342 (81%) and BiVAD-64 (15%). Positive Outcome (alive on device or bridge to transplantation/recovery) was 80% at 6-months (overall mortality of 20%). The patient cohort for implantable continuous flow (IC) pumps (n=197) [age at implant 13.4+/-3.8yrs., 19% INTERMACS profile-1, 21% intubated at implant and 12% with CHD] was significantly different from the paracorporeal continuous flow (PC) pump cohort (n=79) [age 3.9+/-5.2yrs, 49% INTERMACS profile-1, 86% intubated at implant, and 38% with CHD] and the paracorporeal pulsatile (PP) pump cohort (n=121) [age 3.3+/-3.9yrs, 41% INTERMACS profile-1, 77 % intubated at implant, and 21% with CHD]. Consistent with their cohort composition, device type positive outcomes at 6 months were PC-63%, PP-77% and IC-92%. Using Parametric Hazard Modeling, an early hazard for death was associated with INTERMACS profile-1, BiVAD, percutaneous devices, PC devices, small volume institutions, low age and low weight, while a constant hazard was associated with intubation and liver dysfunction at time of implant.</p>

<p><strong>CONCLUSIONS: </strong>IC VADs are the most common VAD type placed in children. The positive outcomes for the IC VADs are &gt;90% at 6 months, which may represent our field's maturation in both patient selection and timing of implantation. Currently the PP/PC devices are limited to supporting our most challenging patients, those less than 20kg, and those with CHD. The introduction of new devices and our communities' commitment to shared learning and improvement will lead to more pediatric lives saved by VAD support, and will also focus on improving the quality of life of children supported with VADs.</p>

10.1016/j.athoracsur.2019.01.038

Ann. Thorac. Surg.

30817920