Mark Anderson is the vice chair of cardiac surgery services and a cardiothoracic surgeon in the Hackensack University Medical Group. He is a leading expert in minimally invasive heart surgery, robotic techniques and mechanical assist devices. Dr Anderson is a founding member of the A-CURE Working Group.
Dr Anderson began his presentation by highlighting the high incidence of right ventricular (RV) failure during clinical interventions, including implantation with ventricular support devices.1,2 The pathophysiology of RV failure includes impaired RV contractility, RV pressure overload, and RV volume overload.3 Univentricular RV failure does occur, though biventricular involvement is commonly seen. RV failure increases morbidity and mortality rates in all clinical settings. Early management of RV failure is essential to improve survival.
The Impella RP is a modified version of the Impella CP that is designed for right heart support. One important difference is that, rather than pulling blood, it pushes blood from the inferior vena cava to the pulmonary artery. The Impella RP has received approval from the US Food and Drug Administration (FDA).4 Approval was based on the findings of the RECOVER RIGHT study, which investigated the use of Impella RP support system in patients with RV failure (n=30).5 Each study had two cohorts: patients with RV failure after left ventricular assist device implantation and patients with RV failure after cardiotomy or myocardial infarction, with a duration of support of 3 to 4 days. Haemodynamic improvement was seen following Impella implantation. There was also a decrease in the use of inotropes and vasopressors in all patients after Impella RP support. The primary endpoint was defined as survival at 30 days post device explant or hospital discharge (whichever is longer). The overall survival rate at 30 days was 73.3 %. All patients discharged were alive at 180 days. This endpoint was reached in 77 % of patients. The rate of device-related bleeding and haemolysis was low.
A continuous access protocol with same inclusion/exclusion criteria as those in the RECOVER RIGHT study was set up to continue the RECOVER RIGHT study during the initial FDA application. In addition, the Impella RP® Post Approval Study, a prospective, single arm, multi-centre study monitoring the safety and outcomes trends of the Impella RP device in patients with RV failure who require haemodynamic support (n=26), was completed in the last year.
Dr Anderson discussed some unresolved clinical issues that have been identified during these studies, primarily the challenge in accurately predicting and sometimes diagnosing RV failure. He also mentioned that there are still several practices that need further refinement and standardisation, including the anticoagulation approach and weaning protocols.
In conclusion, RV failure is associated with increased mortality rates and is difficult to predict and sometimes to diagnose. The Impella RP device is easy to use and consistently improves patient haemodynamics while providing ventricular unloading. The Impella RP has a favourable safety profile with low adverse events across all studies. The use of Impella RP in RVF has demonstrated improved survival. The Impella RP therefore represents a viable tool to enable recovery or as a bridge to other destination therapies.
References
- Kormos RL, Teuteberg JJ, Pagani FD, et al. Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes. J Thorac Cardiovasc Surg 2010;139:1316–24.
Crossref | PubMed - McIlvennan CK, Magid KH, Ambardekar AV, et al. Clinical outcomes after continuous-flow left ventricular assist device: a systematic review. Circ Heart Fail 2014;7:1003–13.
Crossref | PubMed - Piazza G, Goldhaber SZ. The acutely decompensated right ventricle: pathways for diagnosis and management. Chest 2005;128:1836–52.
Crossref | PubMed - FDA, Impella RP: Summary of safety and probable benefit, https://www.accessdata.fda.gov/cdrh_docs/pdf14/H140001B.pdf (accessed 5 October 2017).
- Anderson MB, Goldstein J, Milano C, et al. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant 2015;34:1549-60.
Crossref | PubMed