Efficacy and Safety

Berlin Heart is your partner during the entire VAD therapy: from the patient selection to the VAD implantation and postoperative management of your patient.

Efficacy and Safety

The benefit of the EXCOR® Pediatric Ventricular Assist Device is discussed in a number of publications (s. bibliography). There are two important prospective North-American studies – the EXCOR® Pediatric IDE Study and the EXCOR® Pediatric Post Approval Study that  emphasize the safety and efficacy of the Berlin Heart device.

IDE Study

The IDE study, a prospective, multicenter, single-arm study, evaluated the safety of the Berlin Heart EXCOR® Pediatric VAD and compared its efficacy with a historical control population supported with ECMO as a bridge to cardiac transplantation in children. 48 patients of 16 years or younger were divided into two cohorts according to body-surface area: Cohort 1: n=24, BSA <0.7 m2, Cohort 2: n=24, BSA ≥0.7 to <1.5 m2

 

Results

  • The survival at 30 days in cohort 1 was 96% (46% transplanted, 50% on support) for the EXCOR® Pediatric VAD group and 75% (off ECMO) for the ECMO group.
  • In cohort 2, the 30-day survival was 96% (21% transplanted, 4% weaned, 71% on support) for the EXCOR® Pediatric VAD group and 67% (off ECMO) for the ECMO group.
  • In the EXCOR® Pediatric VAD group, all patients were off the device at 174 days in cohort 1 and 192 days in cohort 2, respectively. Overall, 88% in cohort 1 and 92% in cohort 2 were bridged to transplant or recovery with acceptable neurological outcome,respectively. In the ECMO group, for cohort 1 and 2 the longest time of support was 21 days and 28 days, respectively. 25% and 33% of the patients had died on ECMO support in cohort 1 and 2, respectively.

Post Approval Study

The IDE Post Approval Study (PAS) confirmed the continud efficacy of the EXCOR® Pediatric device. The demography and outcome of 247 patients from 43 sites were compared to those of the 48 patients from the IDE cohort and to 204 patients of the IDE and compassionate use (CU) cohort.

 

Results

  • In the post approval and comercial phase, the patients were much younger and smaller than the patients included in the primary IDE cohorts with more patients presenting with congenital heart disease and being supported for much longer periods of time
  • While the success rate in the post approval phase is less than the success rate in the primary cohorts, the success rate of 77% is more comparable with IDE and compassionate use group, with better outcomes despite the patients being younger, smaller, sicker, and being supported longer.
  • Comparing the safety outcomes in the Post Approval Study group to the primary IDE cohorts, all of the adverse event rates per 100 months of support, decreased, except for hemorrhagic stroke, which was slightly higher in the Post Approval Study patients.