Safety And Efficacy Of Impella RP Support For Acute Right Ventricular Failure Complicated By Cardiogenic Shock: Post Market Approval Sub-Analysis Of The CVAD Registry

Document Type

Article

Publication Date

1-9-2024

Publication Title

J Card Fail

Abstract

Introduction: There is limited data on the use of Impella RP, a percutaneous right ventricular assist device (pRVAD) for hemodynamic support in acute right ventricular failure (RVF). This study aims to address this knowledge gap.

Hypothesis: pRVAD support is safe and efficacious in patients with RVF.

Methods: This observational, prospective, multicenter study includes patients from the global cVAD registry who had RVF causing cardiogenic shock (CS) after left ventricular assist device placement (LVAD) or due to acute myocardial infarction (AMI) or post-cardiotomy CS treated with pRVAD. Patients were divided into a non-salvage and salvage group. The non-salvage group included adult patients who received Impella RP for acute RVF within 48 hours of the precipitating event (LVAD implantation, AMI, or surgery), while the salvage group included patients who received Impella RP support for rapidly deteriorating/refractory shock or any non-approved indications, such as delayed (> 48 hours) support. We report clinical and safety outcomes of the pRVAD from the final analysis of this study.

Results: Between Sept. 2017 to Nov. 2020, a total of 110 patients (mean age 63.8, 67.3% male) were treated with pRVAD (23 post LVAD and 87 AMI or post-cardiotomy CS). Prior to pRVAD implantation, salvage patients (n=73) significantly more often had a duration of shock > 48 hours compared to non-salvage patients (n=37) (42.5% vs. 0%, p=0.0054) and higher rates of out-of-hospital cardiac arrests (20.8% vs. 5.7%, p=0.04). They also had numerically higher ongoing cardiopulmonary resuscitation at the time of pRVAD insertion (21.8% vs. 13.8%, p=0.37) and ischemic brain injury (10% vs. 0%, p=0.10) prior to Impella implant. Greater than 85% of patients in both groups were on inotropes/vasopressors (median 3.0). pRVAD support resulted in a numerical decrease in CVP (-0.8 ± 6.21 mmHg) and increase in cardiac index (0.1 ± 0.61 L/min/m 2 ) in treated patients. In-hospital mortality was 32.4% in the non-salvage group and 80.8% in the salvage group (p<0.001) with no difference by etiology of RVF. For patients surviving to hospital discharge, survival at 1-year follow-up was 94.9%. Rates of in-hospital adverse events were comparable in each group and the totals were as follows: major bleeding (19.1%), hemolysis (10.9%), PE (0%), and device malfunction (4.5%).

Conclusion: Patients treated with pRVAD early, before developing refractory shock and/or ischemic brain injury had favorable mortality compared to historical cohorts. pRVAD support in patients with acute RVF causing CS appears to be safe with complication rates comparable to percutaneous LVADs. Larger trials to further evaluate the efficacy of Impella RP are needed.

Volume

30

Issue

1

First Page

269

Find It @ Sladen

Share

COinS