Antithrombotic therapy in pediatric ventricular assist devices

Multicenter survey of the European EXCOR Pediatric Investigator Group

Oliver Miera, Katharina L Schmitt, Hakan Akintuerk, Angele Boet, Robert Cesnjevar, Teresa Chila, Thilo Fleck, Ranny Goldwasser, Luis G Guereta, Beatrice Heineking, Juergen Hoerer, Alexander Horke, Tain Y Hsia, Michael Huebler, Andrzej Kansy, Ann Karimova, Bohdan Maruszewski, Constancio Medrano, Szymon Pawlak, Zdenka Reinhardt & 9 others Birgitta Romlin, Eugen Sandica, Florian Schmidt, René Schramm, Martin Schweiger, Joanna Śliwka, Brigitte Stiller, Josef Thul, Antonio Amodeo

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: Mechanical circulatory support for pediatric heart failure patients with the Berlin Heart EXCOR ventricular assist system is the only approved and established bridging strategy for recovery or heart transplantation. In recent years, the burden of thromboembolic events has led to modifications of the recommended antithrombotic therapy. Therefore, we aimed to assess modifications of antithrombotic practice among the European EXCOR Pediatric Investigator Group members.

METHODS: We sent a questionnaire assessing seven aspects of antithrombotic therapy to 18 European hospitals using the EXCOR device for children. Returned questionnaires were analyzed and identified antithrombotic strategies were descriptively compared to "Edmonton protocol" recommendations developed for the US EXCOR pediatric approval study.

RESULTS: Analysis of 18 received surveys revealed substantial deviations from the Edmonton protocol, including earlier start of heparin therapy at 6-12 h postoperatively and in 50% of surveyed centers, monitoring of heparin effectiveness with aPTT assay, administering vitamin K antagonists before 12 months of age. About 39% of centers use higher international normalized ratio targets, and platelet inhibition is changed in 56% including the use of clopidogrel instead of dipyridamole. Significant inter-center variability with multiple deviations from the Edmonton protocol was discovered with only one center following the Edmonton protocol completely.

CONCLUSION: Current antithrombotic practice among European EXCOR users representing the treatment of more than 600 pediatric patients has changed over time with a trend toward a more aggressive therapy. There is a need for systematic evidence-based evaluation and harmonization of developmentally adjusted antithrombotic management practices in prospective studies toward revised recommendations.

Original languageEnglish
Pages (from-to)385-392
Number of pages8
JournalInternational Journal of Artificial Organs
Volume41
Issue number7
DOIs
Publication statusPublished - Jul 2018

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Pediatrics
Heart-Assist Devices
Research Personnel
clopidogrel
Heparin
Dipyridamole
Vitamin K
Vitamins
Therapeutics
Platelets
International Normalized Ratio
Practice Management
Berlin
Assays
Heart Transplantation
Recovery
Blood Platelets
Heart Failure
Surveys and Questionnaires
Monitoring

Keywords

  • Adolescent
  • Child
  • Child, Preschool
  • Female
  • Fibrinolytic Agents/therapeutic use
  • Health Care Surveys
  • Heart Failure/physiopathology
  • Heart-Assist Devices/adverse effects
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Prospective Studies
  • Thrombosis/etiology
  • Treatment Outcome
  • Young Adult

Cite this

Antithrombotic therapy in pediatric ventricular assist devices : Multicenter survey of the European EXCOR Pediatric Investigator Group. / Miera, Oliver; Schmitt, Katharina L; Akintuerk, Hakan; Boet, Angele; Cesnjevar, Robert; Chila, Teresa; Fleck, Thilo; Goldwasser, Ranny; Guereta, Luis G; Heineking, Beatrice; Hoerer, Juergen; Horke, Alexander; Hsia, Tain Y; Huebler, Michael; Kansy, Andrzej; Karimova, Ann; Maruszewski, Bohdan; Medrano, Constancio; Pawlak, Szymon; Reinhardt, Zdenka; Romlin, Birgitta; Sandica, Eugen; Schmidt, Florian; Schramm, René; Schweiger, Martin; Śliwka, Joanna; Stiller, Brigitte; Thul, Josef; Amodeo, Antonio.

In: International Journal of Artificial Organs, Vol. 41, No. 7, 07.2018, p. 385-392.

Research output: Contribution to journalArticle

Miera, O, Schmitt, KL, Akintuerk, H, Boet, A, Cesnjevar, R, Chila, T, Fleck, T, Goldwasser, R, Guereta, LG, Heineking, B, Hoerer, J, Horke, A, Hsia, TY, Huebler, M, Kansy, A, Karimova, A, Maruszewski, B, Medrano, C, Pawlak, S, Reinhardt, Z, Romlin, B, Sandica, E, Schmidt, F, Schramm, R, Schweiger, M, Śliwka, J, Stiller, B, Thul, J & Amodeo, A 2018, 'Antithrombotic therapy in pediatric ventricular assist devices: Multicenter survey of the European EXCOR Pediatric Investigator Group', International Journal of Artificial Organs, vol. 41, no. 7, pp. 385-392. https://doi.org/10.1177/0391398818773040
Miera, Oliver ; Schmitt, Katharina L ; Akintuerk, Hakan ; Boet, Angele ; Cesnjevar, Robert ; Chila, Teresa ; Fleck, Thilo ; Goldwasser, Ranny ; Guereta, Luis G ; Heineking, Beatrice ; Hoerer, Juergen ; Horke, Alexander ; Hsia, Tain Y ; Huebler, Michael ; Kansy, Andrzej ; Karimova, Ann ; Maruszewski, Bohdan ; Medrano, Constancio ; Pawlak, Szymon ; Reinhardt, Zdenka ; Romlin, Birgitta ; Sandica, Eugen ; Schmidt, Florian ; Schramm, René ; Schweiger, Martin ; Śliwka, Joanna ; Stiller, Brigitte ; Thul, Josef ; Amodeo, Antonio. / Antithrombotic therapy in pediatric ventricular assist devices : Multicenter survey of the European EXCOR Pediatric Investigator Group. In: International Journal of Artificial Organs. 2018 ; Vol. 41, No. 7. pp. 385-392.
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T1 - Antithrombotic therapy in pediatric ventricular assist devices

T2 - Multicenter survey of the European EXCOR Pediatric Investigator Group

AU - Miera, Oliver

AU - Schmitt, Katharina L

AU - Akintuerk, Hakan

AU - Boet, Angele

AU - Cesnjevar, Robert

AU - Chila, Teresa

AU - Fleck, Thilo

AU - Goldwasser, Ranny

AU - Guereta, Luis G

AU - Heineking, Beatrice

AU - Hoerer, Juergen

AU - Horke, Alexander

AU - Hsia, Tain Y

AU - Huebler, Michael

AU - Kansy, Andrzej

AU - Karimova, Ann

AU - Maruszewski, Bohdan

AU - Medrano, Constancio

AU - Pawlak, Szymon

AU - Reinhardt, Zdenka

AU - Romlin, Birgitta

AU - Sandica, Eugen

AU - Schmidt, Florian

AU - Schramm, René

AU - Schweiger, Martin

AU - Śliwka, Joanna

AU - Stiller, Brigitte

AU - Thul, Josef

AU - Amodeo, Antonio

PY - 2018/7

Y1 - 2018/7

N2 - OBJECTIVES: Mechanical circulatory support for pediatric heart failure patients with the Berlin Heart EXCOR ventricular assist system is the only approved and established bridging strategy for recovery or heart transplantation. In recent years, the burden of thromboembolic events has led to modifications of the recommended antithrombotic therapy. Therefore, we aimed to assess modifications of antithrombotic practice among the European EXCOR Pediatric Investigator Group members.METHODS: We sent a questionnaire assessing seven aspects of antithrombotic therapy to 18 European hospitals using the EXCOR device for children. Returned questionnaires were analyzed and identified antithrombotic strategies were descriptively compared to "Edmonton protocol" recommendations developed for the US EXCOR pediatric approval study.RESULTS: Analysis of 18 received surveys revealed substantial deviations from the Edmonton protocol, including earlier start of heparin therapy at 6-12 h postoperatively and in 50% of surveyed centers, monitoring of heparin effectiveness with aPTT assay, administering vitamin K antagonists before 12 months of age. About 39% of centers use higher international normalized ratio targets, and platelet inhibition is changed in 56% including the use of clopidogrel instead of dipyridamole. Significant inter-center variability with multiple deviations from the Edmonton protocol was discovered with only one center following the Edmonton protocol completely.CONCLUSION: Current antithrombotic practice among European EXCOR users representing the treatment of more than 600 pediatric patients has changed over time with a trend toward a more aggressive therapy. There is a need for systematic evidence-based evaluation and harmonization of developmentally adjusted antithrombotic management practices in prospective studies toward revised recommendations.

AB - OBJECTIVES: Mechanical circulatory support for pediatric heart failure patients with the Berlin Heart EXCOR ventricular assist system is the only approved and established bridging strategy for recovery or heart transplantation. In recent years, the burden of thromboembolic events has led to modifications of the recommended antithrombotic therapy. Therefore, we aimed to assess modifications of antithrombotic practice among the European EXCOR Pediatric Investigator Group members.METHODS: We sent a questionnaire assessing seven aspects of antithrombotic therapy to 18 European hospitals using the EXCOR device for children. Returned questionnaires were analyzed and identified antithrombotic strategies were descriptively compared to "Edmonton protocol" recommendations developed for the US EXCOR pediatric approval study.RESULTS: Analysis of 18 received surveys revealed substantial deviations from the Edmonton protocol, including earlier start of heparin therapy at 6-12 h postoperatively and in 50% of surveyed centers, monitoring of heparin effectiveness with aPTT assay, administering vitamin K antagonists before 12 months of age. About 39% of centers use higher international normalized ratio targets, and platelet inhibition is changed in 56% including the use of clopidogrel instead of dipyridamole. Significant inter-center variability with multiple deviations from the Edmonton protocol was discovered with only one center following the Edmonton protocol completely.CONCLUSION: Current antithrombotic practice among European EXCOR users representing the treatment of more than 600 pediatric patients has changed over time with a trend toward a more aggressive therapy. There is a need for systematic evidence-based evaluation and harmonization of developmentally adjusted antithrombotic management practices in prospective studies toward revised recommendations.

KW - Adolescent

KW - Child

KW - Child, Preschool

KW - Female

KW - Fibrinolytic Agents/therapeutic use

KW - Health Care Surveys

KW - Heart Failure/physiopathology

KW - Heart-Assist Devices/adverse effects

KW - Humans

KW - Infant

KW - Infant, Newborn

KW - Male

KW - Prospective Studies

KW - Thrombosis/etiology

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1177/0391398818773040

DO - 10.1177/0391398818773040

M3 - Article

VL - 41

SP - 385

EP - 392

JO - International Journal of Artificial Organs

JF - International Journal of Artificial Organs

SN - 0391-3988

IS - 7

ER -