Background: 

End-stage heart failure remains a major global health challenge with high mortality. While heart transplantation is the gold-standard treatment, the scarcity of donor hearts necessitates alternative therapies. Left ventricular assist devices effectively support patients with end-stage left heart failure, but no mature biventricular assist devices (BiVAD) currently exist for those with biventricular failure. To address this gap, we developed the DuoCor BiVAD, a novel, integrated, magnetically levitated miniaturized biventricular assist system.

Methods: 

This study reports the results of animal experiments and short-term clinical outcomes focusing on the DuoCor BiVAD. Animal experiments were conducted on three healthy adult male Chinese Merino sheep, with the endpoint being 2 months after device implantation, followed by retrieval and evaluation. Clinical data were collected from 8 patients who underwent DuoCor BiVAD implantation at ** Hospital between July 2024 and December 2024, with a median follow-up period of 6 months. During this period, device parameters, changes in patient heart function, and the occurrence of device-related adverse events (such as infection, thrombosis, and bleeding) were monitored.

Results: 

All animal implants achieved technical success (4.0 ± 0.7 h procedure time) with sustained 60-day hemodynamic stability and absence of device malfunction, thrombosis, or infection. In the clinical study, the median operative time was 5.1 hours, and the median postoperative hospital stay was 35 days. There were no in-hospital mortalities or device-related infections, and all patients were discharged home with DuoCor BiVAD support. During the 6-month postoperative follow-up period, one 81-year-old patient succumbed to frailty and COVID-19 infection two weeks post-discharge. The remaining seven patients survived with ongoing DuoCor BiVAD support, with no incidents of hemolysis, bleeding, device-related infection, or chronic renal insufficiency. This cohort includes one patient who developed right ventricular assist device thrombosis at 2 months post-implantation. Evaluation confirmed recovery of right ventricular function after the acute postoperative phase, prompting to discontinuation of right pump support. This patient subsequently maintained hemodynamic stability with left ventricular assist device support and experienced no further adverse events throughout follow-up.

Conclusion: 

As a feasibility validation study of the first artificial biventricular assist device, DuoCor BiVAD demonstrated acceptable safety profiles during the short-term observation period. Although preliminary clinical outcomes were promising, these findings warrant cautious interpretation due to study size limitations and restricted follow-up duration. Furthermore, the device’s integrated lightweight design and differential ventricular support technology confer advantages over existing solutions. Further validation through prospective multicenter cohort studies remains essential to establish long-term safety and efficacy profiles.