Publication Review: Amin Analysis on Impella and IABP
Review of Trends, Variation and Outcomes in Impella® Use
Dr. Seth Bilazarian, Abiomed’s Chief Medical Officer, provides a review of the observational analysis published in Circulation and presented at AHA 2019 by Amin, et al., comparing Impella to IABP.
Dr. Bilazarian notes that the study is an observational, non-FDA audited analysis that is fundamentally flawed because it is based on poor quality, retrospective, payer coding data. The data lumps all indications together – including elective and urgent cases – and that makes it impossible to properly propensity match, he adds. “In this dataset, a patient arriving for an elective procedure is included in the same dataset as a patient in cardiac arrest with cardiogenic shock,” says Dr. Bilazarian.
According to Dr. Bilazarian, in the data set the authors selected, Impella patients are much sicker and have greater baseline and procedural risks, including higher rates of multi-vessel disease, diabetes and chronic renal failure. With those flaws, Dr. Bilazarian says it’s not surprising that the authors’ opinions conflict with the conclusions of more robust, previously published, FDA-audited, prospective real-world studies and randomized controlled trials.
Dr. Bilazarian notes that multiple peer-reviewed studies, including the PROTECT II Randomized Controlled Trial, demonstrate Impella improves survival in cardiogenic shock and reduces death, stroke, MI and repeat revascularization in high-risk PCI. Robust studies also demonstrate Impella enables more complete revascularization and improves ejection fraction and patient quality of life at 90 days. Notably, says Dr. Bilazarian, data from PROTECT, which compares truly similar Impella and IABP patients, shows that patients treated with Impella had numerically lower rates of vascular complications compared with patients treated with IABP.
Finally, Dr. Bilazarian says that the observational analysis by Amin, et al., fails to reference multiple publications demonstrating the cost-effectiveness of Impella. This includes the 2014 Yale paper by Stretch, et al., that examined data from the National Inpatient Sample (NIS) and found PVADs reduced costs and reduced mortality by 58%. Dr. Bilazarian also notes that the Amin analysis removed patients who were escalated to other therapies, which is the major driver of costs and poor outcomes for IABP.
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- Bleeding and Vascular Complications Data Sheet
To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/