Berlin Heart EXCOR and ACTION Post-Approval Surveillance Study Report

Cerebrovascular accidents (CVA) are a common problem in pediatric VAD support. This Pedimacs analysis investigates rates, risk factors, and outcomes The field of pediatric mechanical circulatory support changed dramatically when the Berlin Heart EXCOR® VAD was FDA-approved for use in children nearly two decades ago. This ACTION publication describes the outcomes of patients with a Berlin Heart reported to ACTION from 2018 to 2020: “Berlin Heart EXCOR and ACTION post-approval surveillance study report.” These data were part of a post-approval surveillance study (PSS) required by the FDA. The PSS data were then compared to a historical, previously reported study group of patients with Berlin Heart EXCOR® implants from 2007‒2014, the Berlin Heart study (BHS) group.

Compared to the BHS group, patients in the PSS group were…
  • Younger and smaller
  • More likely to have CHD
  • Less likely to receive a bi-VAD 
  • Less likely to be in INTERMACS Profile 1
  • Supported for a longer duration
  • Bivalirudin was the primary anticoagulation therapy (92%)

Researchers defined success in patients as being transplanted, weaned for recovery, or alive on a device at 180 days after surgery. Success rate was 86% in the PSS group and 76% in the BHS group. Stroke rate was reduced by 44%, and the frequency of pump exchange was reduced by 40%. All other adverse events, like major bleeding, were reduced in the PSS group as well. Ultimately, the PSS data ACTION collected highlights significantly improved outcomes in a higher-risk population compared with the outcomes in a historical cohort. These improvements directly reflect enhanced collaboration and harmonization of best practices through ACTION, especially in anticoagulation management and the use of bivalirudin.  

The report was published in The Journal of Heart and Lung Transplantation on January 19, 2021.

Congratulations to the ACTION co-authors:

  • Farhan Zafar
  • Jennifer Conway
  • John Dykes
  • Joshua Friedland-Little
  • Beth Hawkins
  • Aamir Jeewa
  • Anna Joong
  • Steven Kindel
  • Angela Lorts
  • Lindsay May
  • Mary Mehegan
  • David Morales
  • Jenna Murray
  • Robert Niebler
  • Matthew O’Connor
  • David Peng
  • Michelle Ploutz
  • Allison Reichhold
  • David Rosenthal
  • Kurt Schumacher
  • Kathleen Simpson
  • Christina VanderPluym
  • Chet Villa

Zafar F, Conway J, Bleiweis MS, Al-Aklabi M, Ameduri R, Barnes A, Bearl DW, Buchholz H, Church S, Do NL, Duffy V, Dykes JC, Eghtesady P, Fisher L, Friedland-Little J, Fuller S, Fynn-Thompson F, George K, Gossett JG, Griffiths ER, Griselli M, Hawkins B, Honjo O, Jeewa A, Joong A, Kindel S, Kouretas P, Lorts A, Machado D, Maeda K, Maurich A, May LJ, McConnell P, Mehegan M, Mongé M, Morales DLS, Murray J, Niebler RA, O’Connor M, Peng DM, Phelps C, Philip J, Ploutz M, Profsky M, Reichhold A, Rosenthal DN, Said AS, Schumacher KR, Si MS, Simpson KE, Sparks J, Louis JS, Steiner ME, VanderPluym C, Villa C; ACTION Learning Network Investigators. Berlin Heart EXCOR and ACTION post-approval surveillance study report. J Heart Lung Transplant. 2021 Jan 19:S1053-2498(21)00024-3. doi: 10.1016/j.healun.2021.01.010. Epub ahead of print. PMID: 33579597.