First name
Seth
Middle name
A
Last name
Hollander

Title

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

Year of Publication

2021

Date Published

2021 Oct 11

ISSN Number

1552-6259

Abstract

<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>

DOI

10.1016/j.athoracsur.2021.10.001

Alternate Title

Ann Thorac Surg

PMID

34648810

Title

Compassionate Deactivation of Ventricular Assist Devices in Children with Heart Failure.

Year of Publication

2021

Date Published

2021 Aug 03

ISSN Number

1538-943X

DOI

10.1097/MAT.0000000000001545

Alternate Title

ASAIO J

PMID

34352820

Title

Haemodynamic profiles of children with end-stage heart failure.

Year of Publication

2017

Number of Pages

2900-2909

Date Published

2017 Oct 07

ISSN Number

1522-9645

Abstract

<p><strong>Aims: </strong>To evaluate associations between haemodynamic profiles and symptoms, end-organ function and outcome in children listed for heart transplantation.</p>

<p><strong>Methods and results: </strong>Children &lt;18 years listed for heart transplant between 1993 and 2013 with cardiac catheterization data [pulmonary capillary wedge pressure (PCWP), right atrial pressure (RAP), and cardiac index (CI)] in the Pediatric Heart Transplant Study database were included. Outcomes were New York Heart Association (NYHA)/Ross classification, renal and hepatic dysfunction, and death or clinical deterioration while on waitlist. Among 1059 children analysed, median age was 6.9 years and 46% had dilated cardiomyopathy. Overall, 58% had congestion (PCWP &gt;15 mmHg), 28% had severe congestion (PCWP &gt;22 mmHg), and 22% low cardiac output (CI &lt; 2.2 L/min/m2). Twenty-one per cent met the primary outcome of death (9%) or clinical deterioration (12%). In multivariable analysis, worse NYHA/Ross classification was associated with increased PCWP [odds ratio (OR) 1.03, 95% confidence interval (95% CI) 1.01-1.07, P = 0.01], renal dysfunction with increased RAP (OR 1.04, 95% CI 1.01-1.08, P = 0.007), and hepatic dysfunction with both increased PCWP (OR 1.03, 95% CI 1.01-1.06, P &lt; 0.001) and increased RAP (OR 1.09, 95% CI 1.06-1.12, P &lt; 0.001). There were no associations with low output. Death or clinical deterioration was associated with severe congestion (OR 1.6, 95% CI 1.2-2.2, P = 0.002), but not with CI alone. However, children with both low output and severe congestion were at highest risk (OR 1.9, 95% CI 1.1-3.5, P = 0.03).</p>

<p><strong>Conclusion: </strong>Congestion is more common than low cardiac output in children with end-stage heart failure and correlates with NYHA/Ross classification and end-organ dysfunction. Children with both congestion and low output have the highest risk of death or clinical deterioration.</p>

DOI

10.1093/eurheartj/ehx456

Alternate Title

Eur. Heart J.

PMID

29019615

Title

Clinical practice patterns are relatively uniform between pediatric heart transplant centers: A survey-based assessment.

Year of Publication

2017

Date Published

2017 Jul 03

ISSN Number

1399-3046

Abstract

<p>Clinical practice variations are a barrier to the study of pediatric heart transplants and coordination of multicenter RCTs in this patient population. We surveyed centers to describe practice patterns, understand areas of variation, and willingness to modify protocol. Pediatric heart transplant centers were identified, and one survey was completed per center. Simple descriptive statistics were used. The response rate was 77% (40 responses from 52 contacted centers, 37 with complete responses). Median center volume of respondents was eight transplants/year (IQR 3-19). Most centers reported tacrolimus (36/38, 95%) and mycophenolate mofetil (36/38, 95%) as maintenance immunosuppression. Other immunosuppression agents reported were cyclosporine (7/38, 18%), everolimus or sirolimus (3/38, 8%), and azathioprine (2/38, 5%). Overall, respondents answered similarly for questions regarding clinical practices including induction therapy, maintenance immunosuppression, and rejection treatment threshold (&gt;85% agreement for all). Additionally, willingness to change clinical practices was over 70% for all practices surveyed (35 total respondents), and 97% of centers (36/37) were willing to participate in a RCT of maintenance immunosuppression. In conclusion, we found many similar clinical practice protocols. Most centers are willing to collaborate on a common protocol in order to participate in a RCT and support a trial investigating maintenance immunosuppression.</p>

DOI

10.1111/petr.13013

Alternate Title

Pediatr Transplant

PMID

28670871

Title

Development and validation of a major adverse transplant event (MATE) score to predict late graft loss in pediatric heart transplantation.

Year of Publication

2018

Number of Pages

441-450

Date Published

2018 Apr

ISSN Number

1557-3117

Abstract

<p><strong>BACKGROUND: </strong>There is inadequate power to perform a valid clinical trial in pediatric heart transplantation (HT) using a conventional end-point, because the disease is rare and hard end-points, such as death or graft loss, are infrequent. We sought to develop and validate a surrogate end-point involving the cumulative burden of post-transplant complications to predict death/graft loss to power a randomized clinical trial of maintenance immunosuppression in pediatric HT.</p>

<p><strong>METHODS: </strong>Pediatric Heart Transplant Study (PHTS) data were used to identify all children who underwent an isolated orthotopic HT between 2005 and 2014 who survived to 6 months post-HT. A time-varying Cox model was used to develop and evaluate a surrogate end-point comprised of 6 major adverse transplant events (MATEs) (acute cellular rejection [ACR], antibody-mediated rejection [AMR], infection, cardiac allograft vasculopathy [CAV], post-transplant lymphoproliferative disease [PTLD] and chronic kidney disease [CKD]) occurring between 6 and 36 months, where individual events were defined according to international guidelines. Two thirds of the study cohort was used for score development, and one third of the cohort was used to test the score.</p>

<p><strong>RESULTS: </strong>Among 2,118 children, 6.4% underwent graft loss between 6 and 36 months post-HT, whereas 39% developed CKD, 34% ACR, 34% infection, 9% AMR, 4% CAV and 2% PTLD. The best predictive score involved a simple MATE score sum, yielding a concordance probability estimate (CPE) statistic of 0.74. Whereas the power to detect non-inferiority (NI), assuming the NI hazard ratio of 1.45 in graft survival was 10% (assuming 200 subjects and 6% graft loss rate), the power to detect NI assuming a 2-point non-inferiority margin was &gt;85% using the MATE score.</p>

<p><strong>CONCLUSION: </strong>The MATE score reflects the cumulative burden of MATEs and has acceptable prediction characteristics for death/graft loss post-HT. The MATE score may be useful as a surrogate end-point to power a clinical trial in pediatric HT.</p>

DOI

10.1016/j.healun.2017.03.013

PMID

28465118

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