RV Impella support as a bridge-to-recovery in right ventricular failure

Right ventricular failure refractory to medical therapy is a complication that can arise post-LVAD implantation, after a conventional cardiac surgical procedure or as a consequence of an acute myocardial infarction (MI). It is associated with significant morbidity and mortality. Short-term mechanical support of the RV may be beneficial for these patients as a bridge to recovery, as has been demonstrated in several previous studies involving invasive devices such as TandemHeart or surgically implantable RVADs. Recently, however, a more readily available and minimally invasive percutaneous support device for the RV has been developed for this purpose. The primary objective of the study is to evaluate local implementation, safety, feasibility and efficacy of temporary RV support with the Impella RP circulatory support device. The secondary objective is to evaluate the effect of temporary RV support on several clinical and hemodynamic parameters, to develop a ‘safety-net’ for potential LVAD-candidates at risk for transient postoperative RV dysfunction, to further expand and develop expertise in the field of short-term mechanical circulatory support also with regard to right heart failure. After evaluation of in-and exclusion criteria and after obtaining informed consent, the Impella RP percutaneous right ventricular assist device is implanted in patients with RV failure refractory to medical treatment, who are being monitored in the intensive cardiac care unit (ICCU) or intensive care unit 1 (ICV1). The primary safety endpoint is the occurrence of bleeding (BARC type 2 and above) including tamponade & access site, hemolysis, thrombus formation in RA/RV/PA, right heart valve dysfunction, and arrhythmias up to 30 days after implantation. The primary efficacy endpoints are improvements in cardiac index, inotrope dosage, LVAD flow, pump parameters, urine production, lactate and SvO2 compared to baseline and 4 and 24 hours after implantation.

the prognosis of patients with severe RV failure after LVAD-implantation, post-cardiotomy or post-MI is grim, as medical treatment options are scarce. In a previous study, treatment with the Impella RP has been proven to be safe, feasible and potentially efficacious. Nevertheless, it may be associated with potential complications such as major bleeding, thrombus formation and damage to the right-sided heart valves. Within the current study, we aim to evaluate local implementation of the device into clinical practice.

Baseline, T=4 h, T=24 h, T=48 h, 30 days, 6 months

Implantation of RV Impella