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

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

Utilization and Outcomes of Children Treated with Direct Thrombin Inhibitors on Paracorporeal Ventricular Assist Device Support.

2019

2019 Nov 20

1538-943X

<p>Thrombotic and bleeding complications have historically been major causes of morbidity and mortality in pediatric ventricular assist device (VAD) support. Standard anticoagulation with unfractionated heparin is fraught with problems related to its heterogeneous biochemical composition and unpredictable pharmacokinetics. We sought to describe the utilization and outcomes in children with paracorporeal VAD support who are treated with direct thrombin inhibitors (DTIs) antithrombosis therapy. Retrospective multicenter review of all pediatric patients (aged &lt;19 years) treated with a DTI (bivalirudin or argatroban) on paracorporeal VAD support, examining bleeding and thrombotic adverse events. From May 2012 to 2018, 43 children (21 females) at 10 centers in North America, median age 9.5 months (0.1-215 months) weighing 8.6 kg (2.8-150 kg), were implanted with paracorporeal VADs and treated with a DTI. Diagnoses included cardiomyopathy 40% (n = 17), congenital heart disease 37% (n = 16; single ventricle n = 5), graft vasculopathy 9% (n = 4), and other 14% (n = 6). First device implanted included Berlin Heart EXCOR 49% (n = 21), paracorporeal continuous flow device 44% (n = 19), and combination of devices in 7% (n = 3). Adverse events on DTI therapy included; major bleeding in 16% (n = 7) (2.6 events per 1,000 patient days of support on DTI), and stroke 12% (n = 5) (1.7 events per 1,000 patient days of support on DTI). Overall survival to transplantation (n = 30) or explantation (n = 8) was 88%. This is the largest multicenter experience of DTI use for anticoagulation therapy in pediatric VAD support. Outcomes are encouraging with lower major bleeding and stroke event rate than that reported in literature using other anticoagulation agents in pediatric VAD support.</p>

10.1097/MAT.0000000000001093

ASAIO J.

31789654

Utilization and Outcomes of Children Treated with Direct Thrombin Inhibitors on Paracorporeal Ventricular Assist Device Support.

2020

939-945

2020 Aug

1538-943X

Thrombotic and bleeding complications have historically been major causes of morbidity and mortality in pediatric ventricular assist device (VAD) support. Standard anticoagulation with unfractionated heparin is fraught with problems related to its heterogeneous biochemical composition and unpredictable pharmacokinetics. We sought to describe the utilization and outcomes in children with paracorporeal VAD support who are treated with direct thrombin inhibitors (DTIs) antithrombosis therapy. Retrospective multicenter review of all pediatric patients (aged <19 years) treated with a DTI (bivalirudin or argatroban) on paracorporeal VAD support, examining bleeding and thrombotic adverse events. From May 2012 to 2018, 43 children (21 females) at 10 centers in North America, median age 9.5 months (0.1-215 months) weighing 8.6 kg (2.8-150 kg), were implanted with paracorporeal VADs and treated with a DTI. Diagnoses included cardiomyopathy 40% (n = 17), congenital heart disease 37% (n = 16; single ventricle n = 5), graft vasculopathy 9% (n = 4), and other 14% (n = 6). First device implanted included Berlin Heart EXCOR 49% (n = 21), paracorporeal continuous flow device 44% (n = 19), and combination of devices in 7% (n = 3). Adverse events on DTI therapy included; major bleeding in 16% (n = 7) (2.6 events per 1,000 patient days of support on DTI), and stroke 12% (n = 5) (1.7 events per 1,000 patient days of support on DTI). Overall survival to transplantation (n = 30) or explantation (n = 8) was 88%. This is the largest multicenter experience of DTI use for anticoagulation therapy in pediatric VAD support. Outcomes are encouraging with lower major bleeding and stroke event rate than that reported in literature using other anticoagulation agents in pediatric VAD support.

10.1097/MAT.0000000000001093

ASAIO J.

32740356

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

Outcomes of pediatric patients supported with continuous-flow ventricular assist devices: A report from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS).

2016

585-90

2016 May

1557-3117

<p><strong>BACKGROUND: </strong>Continuous-flow (CF) ventricular assist devices (VADs) have largely replaced pulsatile-flow VADs in adult patients. However, there are few data on CF VADs among pediatric patients. In this study we aimed to describe the overall use, patients' characteristics and outcomes of CF VADs in this population.</p>

<p><strong>METHODS: </strong>The Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS) is a national registry for U.S. Food and Drug Adminstration (FDA)-approved VADs in patients &lt;19 years of age. Patients undergoing placement of durable CF VADs between September 2012 and June 2015 were included and outcomes were compared with those of adults from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).</p>

<p><strong>RESULTS: </strong>CF VADs were implanted in 109 patients at 35 hospitals. The median age at implantation was 15 years (2.8 to 18.9 years) and median weight was 62 kg (range 16 to 141 kg). The underlying disease was cardiomyopathy in 89 (82%) patients. The INTERMACS level at time of implant was Level 1 in 20 (19%), Level 2 in 64 (61%) and Levels 3 to 7 in 21 (20%) patients. Most were implanted as LVADs (n = 102, 94%). Median duration of support was 2.3 months (range &lt;1 day to 28 months). Serious adverse event rates were low, including neurologic dysfunction (early event rate 4.1 per 100 patient-months with 2 late events). Competing outcomes analysis at 6 months post-implant indicated 61% transplanted, 31% alive with device in place and 8% death before transplant. These outcomes compared favorably with the 3,894 adults supported with CF VADs as a bridge to transplant.</p>

<p><strong>CONCLUSIONS: </strong>CF VADs are commonly utilized in older children and adolescents, with excellent survival rates. Further study is needed to understand impact of patient and device characteristics on outcomes in pediatric patients.</p>

10.1016/j.healun.2016.01.1228

J. Heart Lung Transplant.

27056612

Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report: Pre-implant characteristics and outcomes.

2018

38-45

2018 Jan

1557-3117

<p><strong>BACKGROUND: </strong>Expanded use of pediatric ventricular assist devices (VADs) has decreased mortality in children awaiting heart transplantation. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Heart, Lung, and Blood Institute-sponsored North American database, provides a platform to understand this emerging population.</p>

<p><strong>METHODS: </strong>Between September 2012 and September 2016, patients aged younger than 19 years who underwent VAD implantation were enrolled in Pedimacs. FDA approved durable devices as well as temporary support devices were included. The second annual report updates the current Pedimacs data. Patients implanted with temporary devices are included in Pedimacs and this analysis includes this group of paracorporeal continuous flow VADs.</p>

<p><strong>RESULTS: </strong>Over the 4 years, 42 hospitals implanted 432 devices in 364 patients less than 19 yrs of age. Diagnoses included cardiomyopathy in 223 (61%), myocarditis in 41 (11%), and congenital heart disease in 77 (21%), of which 48 had single-ventricle physiology. At implant, 87% were at Intermacs patient profile 1 or 2. The age distribution of children (59% male) supported on VAD included 69 (19%) aged younger than 1 year, 66 (18%) aged 1 to 6 years, 56 (15%) aged 6 to 10 years, and 173 (48%) aged 11 to 19 years. Median follow-up was 2.2 months (range, 1 day to 41.5 months). Median (interquartile) age at implant was 1.7 (0.3-10.0) years for paracorporeal continuous-flow pumps (n = 60), 1.7 (0.4-5.3) years for paracorporeal pulsatile pumps (n = 105), and 15.0 (11.3-16.9) years for implantable continuous-flow pumps (n = 174). Support strategies included LVAD in 293 (80%), biventricular device in 55 (15%), and total artificial heart in 8 (2%). Nearly 50% of patients underwent transplantation within 6 months, with overall mortality of 19%. Adverse event burden continues to be high.</p>

<p><strong>CONCLUSIONS: </strong>Pedimacs constitutes the largest longitudinal pediatric VAD registry. Preimplant data across centers will be helpful at creating shared protocols with which to improve outcomes. Adverse events continue to be the major challenge, especially among the young critically ill children with complex congenital disease.</p>

10.1016/j.healun.2017.06.017

28965736