Third Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report: Preimplant Characteristics and Outcomes

Morales, David L.S.; Rossano, Joseph W.; VanderPluym, Christina; Lorts, Angela; Cantor, Ryan S.; Louis, James D. St.; Koeh, Devin; Sutcliffe, D.; Adachi, Iki; Kirklin, James K.; Rosenthal, David N.; Blume, Elizabeth D.; Investigators, Pedimacs

doi:10.1016/j.athoracsur.2019.01.038

Cited by 135 publications

(174 citation statements)

References 6 publications

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“…However, some differences should be noted. First, in Pedimacs, a larger percentage of patients had INTERMACS patient profile 1 (33%) vs 21% in our study [2]. Furthermore, the percentage of patients requiring mechanical ventilation prior to VAD implantation was reported to be almost twice as high in Pedimacs (45% compared to 25.3% in Paedi-EUROMACS).…”

Section: Discussioncontrasting

confidence: 52%

“…Apart from the aim to provide professionals in the field of MCS with data for scientific research, the EUROMACS registry strives to generate benchmarking data for participants. Additionally, patient and device outcomes are structured in such a way that they are comparable with the Paediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) (2) and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) outcomes (3).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): second EUROMACS Paediatric (Paedi-EUROMACS) report

By¹,

Antonides

Schweiger

et al. 2020

European Journal of Cardio-Thoracic Surgery

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OBJECTIVES A second paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight. METHODS Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (≤19 years of age) performed from 1 January 2000 to 1 July 2019 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding. RESULTS Twenty-nine hospitals contributed 398 registered implants in 353 patients (150 female, 203 male) to the registry. The most frequent aetiology of heart failure was any form of cardiomyopathy (61%), followed by congenital heart disease and myocarditis (16.4% and 16.1%, respectively). Competing outcomes analysis revealed that a total of 80% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 20% died while on support. At 12 months, 46.7% received transplants, 8.7% were weaned from their device and 18.5% died. The 3-month adverse events rate was 1.69 per patient-year for device malfunction including pump exchange, 0.48 for major bleeding, 0.64 for major infection and 0.78 for neurological events. CONCLUSIONS The overall survival rate was 81.5% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age) (P = 0.01) and lower weight (<20 kg) (P = 0.015). Transplant rates at 6 months continue to be low (33.2%) The fact that the EUROMACS registry is embedded within the European Association for Cardio-Thoracic Surgery Quality Improvement Programme offers opportunities to focus on improving outcomes.

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Section: Discussioncontrasting

confidence: 52%

Section: Introductionmentioning

confidence: 99%

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): second EUROMACS Paediatric (Paedi-EUROMACS) report

By¹,

Antonides

Schweiger

et al. 2020

European Journal of Cardio-Thoracic Surgery

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“…Based solely on listing weight, 49% of DCM candidates in these cohorts would theoretically be suitable for an ambulatory VAD. Because younger/smaller children, who are usually not able to be supported by continuous‐flow, intracorporeal VADs must remain hospitalized while awaiting transplantation on paracorporeal devices like the EXCOR, application of a time‐limited status 1A listing window may not be appropriate for these patients.…”

Section: Discussionmentioning

confidence: 99%

Impact of the 2016 revision of US Pediatric Heart Allocation Policy on waitlist characteristics and outcomes

Magnetta

Godown

West

et al. 2019

American Journal of Transplantation

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US Pediatric Heart Allocation Policy was recently revised, deprioritizing candidates with cardiomyopathy while maintaining status 1A eligibility for congenital heart disease (CHD) candidates on “high‐dose” inotropes. We compared waitlist characteristics and mortality around this change. Status 1A listings decreased (70% to 56%, P < .001) and CHD representation increased among status 1A listings (48% vs 64%, P < .001). Waitlist mortality overall (subdistribution hazard ratio [SHR] 0.96, P = .63) and among status 1A candidates (SHR 1.16, P = .14) were unchanged. CHD waitlist mortality trended better (SHR 0.82, P = .06) but was unchanged for CHD candidates listed status 1A (SHR 0.92, P = .47). Status 1A listing exceptions increased 2‐ to 3‐fold among hypertrophic and restrictive cardiomyopathy candidates and 13.5‐fold among dilated cardiomyopathy (DCM) candidates. Hypertrophic (SHR 6.25, P = .004) and restrictive (SHR 3.87, P = .03) cardiomyopathy candidates without status 1A exception had increased waitlist mortality, but those with DCM did not (SHR 1.26, P = .32). Ventricular assist device (VAD) use increased only among DCM candidates ≥1 years old (26% vs 38%, P < .001). Current allocation policy has increased CHD status 1A representation but has not improved their waitlist mortality. Excessive DCM status 1A listing exceptions and continued status 1A prioritization of children on stable VADs potentially diminish the intended benefits of policy revision.

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“…However, these devices are still extracorporeal, generally require patients to remain in intensive care, and have worse survival based on contemporary registry data. 2,5 The enormous technology gap between adult and pediatric ventricular assist devices provides a compelling illustration of the stiff headwinds facing pediatric device development in the US. In contrast to pediatric drug development where industry financial incentives abound, there are almost no incentives for industry to develop pediatric medical devices.…”

Section: Post-operativementioning

confidence: 99%

First human implantation of a miniaturized axial flow ventricular assist device in a child with end-stage heart failure

Amodeo

Filippelli

Perri

et al. 2020

The Journal of Heart and Lung Transplantation

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Third Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report: Preimplant Characteristics and Outcomes

Cited by 135 publications

References 6 publications

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): second EUROMACS Paediatric (Paedi-EUROMACS) report

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): second EUROMACS Paediatric (Paedi-EUROMACS) report

Impact of the 2016 revision of US Pediatric Heart Allocation Policy on waitlist characteristics and outcomes

First human implantation of a miniaturized axial flow ventricular assist device in a child with end-stage heart failure

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