October 25, 2019
Abiomed Presents Real-World Postapproval Data for Impella RP
October 25, 2019—Abiomed, Inc. announced that real-world outcomes data at approximately 2 years show that when physicians followed the FDA’s approved protocol for the company’s Impella RP device, they achieved 72% patient survival and 88% native heart recovery. These results from the Impella RP’s postapproval study (PAS) match the survival rate in the device’s preapproval study, noted the company.
Led by the principal investigators of the National Cardiogenic Shock Initiative (NCSI) study, the new data were presented at a clinical meeting for the management of patients in cardiogenic shock held in Detroit, Michigan. The company’s chart of detailed data is available online here.
The protocol includes recommendations on patient selection and timely identification of right heart failure with subsequent implantation of Impella RP.
In the United States, the Impella RP device is FDA approved to treat right heart failure or decompensation after left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery. In Europe, the device has received CE Mark approval to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open heart surgery, or refractory ventricular arrhythmia.
According to Abiomed, investigators and thought leaders in the field of cardiogenic shock have made multiple recommendations based on data sets demonstrating that late identification of right heart failure is associated with increased mortality.
- The Cardiogenic Shock Working Group (CSWG) found that cardiogenic shock patients with elevated right arterial pressure (RAP) are at a higher risk for mortality and should be evaluated for right ventricular (RV) failure as soon as possible.
- The NCSI study includes the following escalation protocol: after Impella-supported PCI, and while the patient is in the catheterization lab, if the patient is in RV failure, quickly escalate to Impella RP.
- The cVAD study has demonstrated that patients with a left-side Impella who have an RAP or central venous pressure of 12 mm Hg or above are at higher risk of mortality (P = .035), and rapid assessment for RV failure is recommended.
Navin Kapur, MD, Principal Investigator for the CSWG, commented in the company’s announcement, “When right-sided heart failure is identified early, it is reversable and heart recovery is possible. Elevated RA pressure in a patient with cardiogenic shock is a warning sign that a patient is at an increased risk of dying and should trigger a comprehensive evaluation for underlying causes including right heart failure. If right heart dysfunction is identified, therapy should be escalated to manage this issue as soon as possible.” Dr. Kapur is Executive Director of the CardioVascular Center for Research and Innovation at Tufts Medical Center in Boston, Massachusetts.