Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD

Study Summary

Prior studies have shown that left ventricular assist device (LVAD) implantation commonly results in right ventricular failure (RVF). Right ventricular dysfunction and failure after LVAD implantation is known to increase morbidity and mortality and contribute to longer post-implant hospital length of stay. Since RVF is difficult to predict and can have harmful effects such as increased ICU stay, adverse outcomes, and mortality, it could be beneficial to preemptively treat patients through preoperative or intraoperative percutaneous right ventricular assist device (RVAD) placement to prevent RVF. This trial will include both a prospective interventional cohort and a retrospective control cohort. The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will preemptively receive an RVAD (either the ProtekDuo or Impella RP) surrounding LVAD implantation. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be matched with the enrolled prospective interventional patients. The purpose of this study is to compare clinical outcomes of standard of care treatment versus percutaneous RVAD placement perioperatively to LVAD implantation. The investigators hypothesize that the use of the RVAD will mitigate need for inotropic support, reducing the vasoactive-inotrope score (VIS) by 50%, and will improve end organ function in patients compared to standard of care. Subjects who consent to the study will undergo peri-operative placement of an RVAD, which will be left in up to 72 hours postoperatively. The type of RVAD (Impella RP or ProtekDuo) inserted will be determined by patient needs and venous access and will be up to the discretion of the treating physician. 25 subjects will be enrolled in the prospective interventional cohort and compared to 25 subjects in the matched retrospective control co

Primary Outcome

Retrospective review in a patient chart. Score calculated based on dosages of vasopressors and inotropes within first 24-hours post-LVAD implant. The maximum Vasoactive Inotropic Score within the first 24-hours is reported. Vasoactive Inotropic Score= dopamine (μg/kg/min) + dobutamine (μg/kg/min) + 10 x milrinone (μg/kg/min) + 100 x epinephrine (μg/kg/min) + 100 x norepinephrine (μg/kg/min) + 10,000 x vasopressin (U/kg/min). Minimum possible vasoactive inotropic score is 0. It is hypothesized

Interventions

• DEVICE Percutaneous RVAD