Benefits of a Novel Percutaneous Ventricular Assist Device For Right Heart Failure The prospective RECOVER RIGHT Study of the Impella RP Device
Mark Anderson, Lynn Morris, Salil Shah, Alexandra Tuluca.
Einstein Healthcare Network, Philadelphia, PA, USA.
OBJECTIVE: Right ventricular failure (RVF) increases morbidity and mortality. RECOVER RIGHT study was designed to evaluate the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP, in an FDA approved prospective, multicenter clinical trial under investigational device exemption.
METHODS: Thirty patients with RVF refractory to medical treatment received the Impella RP device. RVF patients (defined as Cardiac Index < 2.2 on high dose inotropes / pressors, >15mmHg or echo criteria such asTAPSE ≤14mm).The study population included two cohorts: Cohort A: Patients who developed RVF post Left Ventricular Assist Device implantation and Cohort B: Patients who developed RVF post-cardiotomy cardiogenic shock or post-myocardial infarction. Baseline, procedural, and hemodynamic data were collected. Primary study endpoint was survival to 30 days or hospital discharge (whichever was longer) after device explant. Major secondary endpoints included both safety and efficacy endpoints.
RESULTS: Of the enrolled,18 were in Cohort A and 12 in Cohort B. Patient characteristics included a mean age of 59±15 years, male 77%, diabetes 53%, history of congestive heart failure 88.5%, renal dysfunction 37.5%. Baseline hemodynamic parameters prior to Impella RP insertion included CI: 1.8±0.2 l/min/m2, CVP: 19.2±4 mmHg, Mean Arterial Pressure (MAP): 70±14 mmHg, TAPSE: 8.9±5 mm, despite patients being on average 3.2 inotropes/pressors. Delivery of the device was achieved in all but one patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in CI from 1.8±0.2 to 3.3±0.23 L/min/m2 (p<0.001) and a decrease in CVP from 19.2±4 to 12.6±1 mmHg (p<0.001). In Cohort A, LVAD flows improved from 3.96±0.16 L/min to 4.62±0.14 L/min (p=0.004) after RP activation. Patients were supported on average for 3.04±1.5 days [0.5, 7.8 days]. The overall survival at 30 days or discharge and at 180 days was 73.3%. There were no thromboembolic complications, no pulmonary embolism and no cardiac structure or vascular perforation or damage.
CONCLUSIONS: In patients with life-threatening RVF, the novel percutaneous Impella RP RVAD support device was safe, easy to deploy and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.
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