Right Heart Failure/Right Ventricular Dysfunction and the Impella RP Flex® with SmartAssist® Heart Pump

What are the causes and incidence of right ventricular dysfunction?

The causes of right ventricular dysfunction are diverse and include acute myocardial infarction (AMI), post-surgery or heart transplant, left ventricular assist device (LVAD) implantation and pulmonary embolism.

Early identification of patients requiring right-heart support is critical because studies have shown 1 in 3 AMI cardiogenic shock (AMICS) patients exhibit right heart dysfunction and is associated with 50% in-hospital mortality. Early detection and management of RVD is associated with improving outcomes in AMICS patients who develop RVF/Acute Right Heart Failure.¹

How is right ventricular dysfunction diagnosed?

Given that right ventricular dysfunction (RVD) is a hemodynamic problem, assessment of hemodynamic parameters including central venous pressure (CVP) and cardiac output or index, using the pulmonary artery (PA) catheter in combination with cardiac echocardiography, represents the gold standard for evaluation of RV function.

Three-dimensional echocardiography represents an accurate method to assess RV size, contractility and ejection fraction.²

A recent analysis by National Cardiogenic Shock Initiative demonstrated that patients with RVD were significantly more likely to have Impella CP with SmartAssist diastolic suction alarms within 24 hours of LV-MCS initiation and Survival to discharge was significantly lower among those with RVD (61.8% vs 73.4%, p=0.031). There was an association between time spent in diastolic suction and impact on survival. Diastolic suction and elevated CVP may indicate possible RVD. Early identification of RVD and placement of RP Flex may have a positive impact on survival. Confirmation in the Cath lab with a Point of Care Ultrasound can rule out or confirm RVD early in the AMICS trajectory.

Which Impella® heart pump is approved for Acute Right Heart Failure?

Early detection and management of RVD is associated with improving outcomes in AMICS patients who develop RVF/Acute Right Heart Failure. The Impella RP with SmartAssist and Impella RP Flex™ with SmartAssist are the only devices designated by the FDA as a safe and effective therapy for acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound sohck, end organ failure, or acute neurologic injury. The Impella RP received FDA pre-market approval (PMA) for use in acute heart failure on September 20, 2017 (P170011).⁵

What clinical evidence was used for FDA approval of Impella RP for acute right heart failure?

The Impella RP platform is the most studied right-sided device and the only percutaneous technology with FDA approval designating it as safe and effective for right heart support. Its exclusive FDA approval is a result of five years of research that included:⁶

• RECOVER RIGHT, an FDA-approved, prospective, multicenter, single-arm study, which commenced after Abiomed received FDA investigational device exemption (IDE) approval in November 2012 and concluded in 2014
• HDE approval study, which was completed in January 2015
• A Continuous Access Protocol (CAP)

What are the results of the post-approval study of Impella RP?

 Is there any new data on survival in Impella RP patients?

A sub analysis recently demonstrated an association between early identification and use of RP in patients with a signficiant survival difference.⁴ The study utilize the global cVAD registry and included patients who had Right Ventricular Failure (RVF) causing cardiogenic Shock, after LVAD placement, post-cardiotomy cardiogenic shock, or due to AMICS. The study concluded that “Patients treated with pRVAD early, before developing refractory shock and/or ischemic brain injury had favorable mortality compared to historical cohorts. pRVAD.” Earlier identification and early utilization of Impella RP may be associated with improved survival.

What are the best practices for use of Impella RP for right-sided support?

Abiomed encourages clinicians to select patients and time Impella RP implantation appropriately. Clinicians should review the inclusion and exclusion criteria for Impella RP. Early identification of Right Ventricular Dysfunction and early use of Impella RP Flex is associated with improved survival.

Maintenance of systemic anticoagulation for the duration of Impella™ RP Flex with SmartAssist® support, in particular when indwelling lines are present:

Anti-coagulate patients as needed to maintain recommended ACT (160-180s), in particular when indwelling central venous lines or cannulas (i.e. hemodialysis, PA catheters, ECMO) are present. ACT below this level may increase the risk of thrombus formation or deposition. If either internal thrombus forms within or external thrombus deposits in the Impella RP Flex™ with SmartAssist®, this may result in reduced flow, loss of support, or hemolysis.

Assess the risk for extraluminal thrombus on indwelling lines prior to initiation of support:

Thrombus formation or deposits on indwelling central venous lines or cannulas (i.e. hemodialysis catheters, PA catheters, ECMO) may break free and enter into the Impella RP Flex™ with SmartAssist® inlet, resulting in reduced flow, loss of support, or hemolysis. Assess the risk for extraluminal thrombus on indwelling lines placed prior to initiation of support.