WASHINGTON —The FDA issued an Emergency Use Authorization (EUA) for Impella Left Ventricular (LV) Support Systems as an LV unloading therapy for patients hospitalized with Covid-19 with heart and lung complications.
This is the second EUA that the FDA has granted for Impella devices over the course of the Covid-19 pandemic — the first, issued May 29, expanded use of Impella RP to treat patients with Covid-19 with right ventricular complications, such as acute pulmonary embolism. With this new EUA, left-sided Impella heart pumps are authorized to provide LV unloading for Covid-19 patients undergoing extracorporeal membrane oxygenation (ECMO) who have developed myocarditis or pulmonary edema, according to a press release from Abiomed, the device’s manufacturer.
“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” said Christian Bermudez, MD, surgical director, lung transplantation and ECMO, and professor of surgery at the University of Pennsylvania, in a statement. “The superior clinical outcomes from the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion.”
The manufacturer noted four academic studies that were presented to the FDA to demonstrate “the feasibility of ECpella [combination ECMO and Impella heart pump] to improve left ventricular function and provide oxygenation to patients,” including:
- “Pappalardo et al, European Journal of Heart Failure, 2017: This study compared ECpella patients with patients treated with ECMO only and found patients in the ECpella group had a significantly lower hospital mortality (47% versus 80%, P< 0.001) and a higher rate of successful bridging to either recovery or further therapy (68% versus 28%, P< 0.001) compared with ECMO patients.
- “Schrage et al, Journal of the American College of Cardiology, 2018: In this study, 106 consecutive patients were treated with Impella in addition to VA-ECMO for cardiogenic shock and 51.9% of all patients were successfully weaned from VA-ECMO support. In the overall cohort, survival at day 30 was 35.8%, which was higher than predicted by the SAVE score (20%) or by the SAPS-II score (6.9%).
- “Patel et al, ASAIO Journal, 2019: This retrospective study compared mortality outcomes and duration of support, stroke, major bleeding, hemolysis, inotropic score, and cardiac recovery for patients treated for refractory cardiogenic shock with ECMO versus ECpella. ECpella patients were associated with lower mortality rates, lower inotrope use, and comparable safety profiles as compared with ECMO alone.
- “Russo et al, Journal of the American College of Cardiology, 2019: This meta-analysis examined the efficacy and safety of left ventricular unloading strategies during ECMO in patients with cardiogenic shock and found left ventricular unloading was associated with decreased mortality.”
Abiomed also pointed to the story of 42-year-old Devan Smith, a warehouse worker from Pennsylvania who was hospitalized with Covid-19 in May 2020.
“After contracting Covid-19, Devan became severely ill with severe myocarditis, multiorgan failure and respiratory failure,” the manufacturer explained. “Dr. John Finley, interventional cardiologist at Mercy Catholic Medical Center-Fitzgerald Campus in Darby, Pennsylvania, placed venous arterial (V-A) ECMO to combat the respiratory effects of Covid-19 and placed Impella CP to unload Devan’s heart and allow it to rest and recover. After four days of support, Devan’s heart showed dramatic improvement and he was weaned off Impella. The next morning, he was taken off ECMO support. After three weeks in the hospital, Devan returned home with his native heart functioning normally. In July, he returned to work.”
John McKenna, Associate Editor, BreakingMED™
Cat ID: 3
Topic ID: 74,3,730,933,3,914,190,926,192,927,725,928