Outcomes of 100 Berlin Heart Insertions at a Single Institution

M. Bleiweis¹, J. Phili[p¹, J. Fudge¹, S. Narasimhulu¹, S. Cruz Beltran¹, K. Sullivan¹, A. Pitkin¹, M. Wesley¹, M. Arnold¹, G. Janelle¹, A. Bilgili², L. Brinkley¹, Y. Stukov¹, G. Peek¹, J. Jacobs^1
1University of Florida, Gainesville, Florida ²The University of Florida College of Medicine, Jacksonville, Florida

Purpose: Challenges exist with providing VAD support to children with functionally univentricular circulation. The purpose of this study is to review our experience with all 99 patients at our institution ever supported with Berlin Heart, assess risk factors for mortality, and compare outcomes of those with functionally univentricular versus biventricular circulation.

Methods: This analysis includes all 99 consecutive patients supported Berlin Heart at our institution, with the first patient cannulated on September 29, 2006 and the most recent patient in this consecutive series cannulated on June 17, 2024. (These 99 patients underwent 100 separate episodes of support with Berlin Heart because one biventricular child with myocarditis was successfully bridged to transplant, and then 615 days after the original transplant underwent a second separate episode of support with the Berlin Heart followed by a second cardiac transplant.)

Overall outcomes of all 99 patients were assessed. Outcomes of those with functionally univentricular circulation (n=40) were compared to those with biventricular circulation (n=59). The primary outcome was mortality. Survival was modeled by the Kaplan-Meier method. Univariable Cox proportional hazard models were created to identify prognostic factors for survival. Kaplan-Meier (KM) methods and log-rank tests were used to assess group differences in long-term survival.

Results: Prognostic factors for mortality were:

Variable: Hazard Ratio(95% Confidence Interval);p-value
• Bleeding: 3.91(1.87-8.18);p=0.0002
• Pretransplant Liver Dysfunction: 3.46 (1.56-7.69);p=0.002
• Congenital Heart Disease: 2.25(1.22-4.13);p=0.009
• Biventricular Heart: 0.38(0.18-0.80);p=0.01
• History of ECMO Support: 1.87(0.90-3.87);p=0.09
• Pretransplant Renal Dysfunction: 1.89(0.88-4.07);p=0.11
• CVA: 1.5(0.71-3.18);p=0.29

59 biventricular patients were supported (Age: median=1.3 years, range=17 days-17.7 years; Weight [kilograms]: median=7.8, range=2.54-112), including 49 BiVAD, 9 LVAD only, and 1 LVAD converted to BiVAD. In biventricular patients, duration of VAD support [days]: median=88.5, range=4-315. Of 59 biventricular patients, 45 underwent heart transplantation, 8 died on VAD, 6 weaned off VAD (1 additional patient weaned but underwent heart transplantation 334 days after weaning).

40 univentricular patients were supported with single VAD (sVAD) (Age: median=52 days, range=4 days-13.3 years; Weight [kilograms]: median=3.98, range=2.4-32.6). In univentricular patients, duration of VAD support [days]: median=138, range=4-554. Of 40 univentricular patients, 26 underwent transplantation, 13 died on VAD, and 1 is still on VAD.

One-year survival after VAD insertion was 80.1%(95% CI=69.7-92.0%) in biventricular patients and 58.3%(95%CI=43.9-77.4%) in univentricular patients, p=0.010 Five-year survival after VAD insertion was 77.3%(95%CI=66.1-90.3%) in biventricular patients and 49.3%(95% CI=34.2-71.1%) in univentricular patients, p=0.01.

Longitudinal survival is better in biventricular versus univentricular patients (log-rank p=0.01).

Conclusion: Pulsatile VAD facilitates bridge-to-transplantation in neonates, infants, and children with functionally univentricular circulation; however, survival is worse than in biventricular patients. High-risk functionally univentricular patients who are suboptimal candidates for conventional palliation or who have failed conventional palliation can be successfully stabilized with pulsatile VAD insertion while awaiting cardiac transplantation.

Identify the source of the funding for this research project: None