In Search for the Right Partner. First Multicenter Results of the Hybrid VAD Procedure cfLVAD and Durable Paracorporeal RVAD

Abstract

<h3>Purpose</h3> Continuous-flow durable left ventricular assist devices (cfLVAD) has become routine treatment for severe heart failure nowadays. Fully implantable cfLVAD are safe, reduce mortality and allow for high patient comfort. However, right ventricular (RV) failure (early or late after cfLVAD) remains a crucial limitation and is associated with high morbidity and mortality. Temporary RVAD fails to reverse RV-Failure in 9-42%. RV-Failure prediction models exhibit heterogeneous derivation and validation methodologies with insufficient power of prognosis of RV-Failure. Results of cf-BIVAD are limited and application remains "off-label-use" while pulsatile paracorporeal RVAD treatment is approved with excellent data. Pulsatile RVAD flow is precise, physiological and prevents lung hyperperfusion. The purpose of this national multi-center trial was to evaluate the results of the durable Hybrid VAD strategy using 3rd generation continuous flow left ventricular assist devices (cf-LVAD) and a paracorporeal pulsatile right ventricular Assistent device (RVAD). <h3>Methods</h3> We retrospectively analyzed 10 consecutive patients (8 male, 80%; 43.1 ± 17.9 years) who underwent permanent cfLVAD and durable pulsatile RVAD implantation (Berlin Heart EXCOR) subsequently for end-stage heart failure and impaired right heart function. The durable RVAD implantation was performed on CPB and beating heart with a sternotomy approach. Bridge-to-transplantation (BTT) was intended in all cases. The procedure was performed one-staged in 50% of all cases. <h3>Results</h3> INTERMACS class on cfLVAD at time of pulsatile RVAD implantation was class I in 9 (90%) and class II in 1 case (10%) with temporary MCS in 9 cases (90%) using ECLS in 7 (77.8%) and temporary RVAD in 2 patients (22.2%). Upon follow up survival was 70% with 5 (50%) patients transplanted, 2 patients on ongoing hybrid support and 3 patients deceased. Time on hybrid-device was 140.3 ± 122.1 days. <h3>Conclusion</h3> Intention to treat heart failure with cfLVAD alone is comprehensive and sensible if applicable. There is a need for bail-out strategy for early/late RV-Failure beyond temporary RVAD. With our initial results we here provide the very first evidence of the Hybrid VAD support with promising results. Hybrid VAD procedure is associated with good survival (70%) allowing for sufficient preparation for heart transplant (BTT).