The TEAMMATE Trial: Study Design and Rationale of the First Pediatric Heart Transplant Randomized Clinical Trial

Almond, Christopher S.; Sleeper, Lynn A.; Rossano, Joseph W.; Pahl, Elfriede; Lal, Ashwin K.; Castleberry, Chesney; Lee, J.; Hollander, Seth A.; Klein, Gloria L.; Barkoff, L.; Bock, M.J.; Fenton, Matthew; Daly, Kevin P.

doi:10.1016/j.healun.2020.01.825

Cited by 4 publications

(5 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Following transplantation, all patients were placed on triple immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone, with prednisone weaned off within 4–6 weeks if crossmatch was negative and 6 months if crossmatch was positive. Mycophenolate was transitioned to an mTOR inhibitor in select patients with clinical indications or via recruitment into the everolimus arm of the TEAMMATE trial 13 …”

Section: Methodsmentioning

confidence: 99%

“…Mycophenolate was transitioned to an mTOR inhibitor in select patients with clinical indications or via recruitment into the everolimus arm of the TEAMMATE trial. 13…”

Section: Immunosuppressionmentioning

confidence: 99%

“…4 [3-10], p = .933) and class II nDSA (PLE: 3[2][3][4][5][6] vs. non-PLE: 4[4][5][6][7][8][9][10][11][12][13][14], p = .159). The -DQ subtype represented a substantial proportion of the class II nDSA, occurring in 10/13 (77%) of PLE patients and 3/7 (43%) of non-PLE patients.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Donor‐specific antibodies after heart transplantation for Fontan‐associated protein‐losing enteropathy

Magnetta

Hoch

Pinelli

et al. 2023

Pediatric Transplantation

View full text Add to dashboard Cite

Background: Despite ubiquitous exposure to sensitizing events, most Fontan PLE patients have low panel reactive antibodies (PRA). To assess whether they are at risk for donor-specific antibody (DSA) memory response following heart transplantation (HT) when their PLE resolves, DSA profiles, incidence of rejection, and graft outcomes in Fontan recipients with and without PLE were compared.Methods: Patient characteristics, appearance of newly detected DSA (nDSA), and graft outcomes were compared between patients with and without PLE using Wilcoxon rank-sum and Chi-squared tests. DSA burden was quantified using titers and time to nDSA, incidence of rejection, and graft outcomes were compared using Kaplan-Meier curves and the log-rank test.Results: Characteristics of patients with and without PLE were similar. Lymphocyte and albumin levels were lower in the PLE group, and flow PRA were comparable. Graft failure, CAV, and ACR were similar between the two groups, but AMR occurred more frequently in the PLE group (p = .03). Nearly 50% of PLE patients experienced class II nDSA by 1-year post-HT, compared to 30% of non-PLE patients, but this difference was statistically not significant. Antibody burden did not differ between groups. Conclusions:In this cohort, PLE was associated with AMR within the first-year post-HT, despite no significant difference in nDSA. Small patient numbers limited statistical comparison of nDSA in this cohort. PLE may be a risk factor for AMR post-HT, and the possibility of a clinically important DSA memory response remains. Larger studies are necessary to better understand these preliminary findings.

show abstract

Section: Methodsmentioning

confidence: 99%

“…Mycophenolate was transitioned to an mTOR inhibitor in select patients with clinical indications or via recruitment into the everolimus arm of the TEAMMATE trial. 13…”

Section: Immunosuppressionmentioning

confidence: 99%

See 1 more Smart Citation

Donor‐specific antibodies after heart transplantation for Fontan‐associated protein‐losing enteropathy

Magnetta

Hoch

Pinelli

et al. 2023

Pediatric Transplantation

View full text Add to dashboard Cite

show abstract

“…However, therapy with an mTOR inhibitor is often not initiated until pathologies in the coronary vessels have already appeared 4 . Results from the ongoing multicenter, prospective, randomized TEAMMATE trial comparing immunosuppressive therapy in children with everolimus/low‐dose tacrolimus versus tacrolimus/mycophenolate mofetil from month 6 after HTX on are still pending 5 …”

Section: Introductionmentioning

confidence: 99%

“…4 Results from the ongoing multicenter, prospective, randomized TEAMMATE trial comparing immunosuppressive therapy in children with everolimus/low-dose tacrolimus versus tacrolimus/mycophenolate mofetil from month 6 after HTX on are still pending. 5 We hypothesized that an early initiation of everolimus may reduce the risk of cardiac allograft vasculopathy and chronic renal failure with a low profile of adverse effects.…”

Section: Introductionmentioning

confidence: 99%

mTor‐inhibition within the first days after pediatric heart transplantation is a potentially safe option to prevent cardiac allograft vasculopathy

Kreienbaum,

Stiller,

Kubicki

et al. 2024

Pediatric Transplantation

View full text Add to dashboard Cite

BackgroundImmunosuppression after heart transplantation (HTX) with mammalian target of rapamycin (mTOR) inhibitors serves as a prophylaxis against rejection and to treat coronary vascular injury. However, there is little data on the early, preventive use of everolimus after pediatric HTX.MethodsRetrospective study of 61 pediatric HTX patients (48 cardiomyopathy and 13 congenital heart disease), 28 females, median age 10.1 (range 0.1–17.9) years transplanted between 2008 and 2020. We analyzed survival, rejection, renal function, occurrence of lymphoproliferative disorder, and allograft vasculopathy together with adverse effects of early everolimus therapy combined with low‐dose calcineurin inhibitors.ResultsEverolimus therapy was started at a median 3.9 (1–14) days after HTX. Median follow‐up was 4.3 (range 0.5–11.8) years, cumulative 184 patient years. The estimated 1‐ and 5‐year survival probability was 89% (CI 82%:98%) and 87% (CI 78%:97%). Four patients developed rejection (6.6%) (maximum 2R ISHLT criteria). No patient suffered from chronic renal failure. Three patients (4.9%) developed post‐transplant lymphoproliferative disorder. Five patients suffered relevant wound‐healing disorders after transplantation, four of them carrying relevant risk factors before HTX (mechanical circulatory support (n = 3), delayed chest closure after HTX (n = 3)). No recipient developed cardiac allograft vasculopathy.ConclusionInitiating everolimus within the first 14 days after HTX seems to be well tolerated, enabling a low incidence of rejection, post‐transplant lymphoproliferative disorders, renal failure, and reveals no evidence of cardiac allograft vasculopathy as well as good overall survival in pediatric heart transplant recipients.

show abstract

The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients

Dhital

Azeka

Colvin

et al. 2023

The Journal of Heart and Lung Transplantation

171

114

View full text Add to dashboard Cite

The TEAMMATE Trial: Study Design and Rationale of the First Pediatric Heart Transplant Randomized Clinical Trial

Cited by 4 publications

References 0 publications

Donor‐specific antibodies after heart transplantation for Fontan‐associated protein‐losing enteropathy

Donor‐specific antibodies after heart transplantation for Fontan‐associated protein‐losing enteropathy

mTor‐inhibition within the first days after pediatric heart transplantation is a potentially safe option to prevent cardiac allograft vasculopathy

The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients

Contact Info

Product

Resources

About