Abiomed Medical Office Completes Review of Observational Analysis of Impella Presented at AHA
Abiomed (NASDAQ: ABMD) is committed to improving patient outcomes by performing FDA studies and post-market surveillance, collecting real-world evidence and identifying and sharing best practices. Impella is the most studied mechanical circulatory support device in the history of the FDA with real-world clinical data on more than 110,000 patients in the Impella Quality (IQ) Database, FDA randomized controlled trials (RCT) and post-approval studies with greater than 5,000 patients, and more than 550 peer-reviewed publications. Impella is proven to provide superior hemodynamic support over the intra-aortic balloon pump (IABP).
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Figure 1: Clinical Variables Poorly Matched in Amin, et al. (Graphic: Business Wire)
Today the Abiomed medical office is issuing a publication review of the observational analysis of Impella that was presented by Amin et al. at the American Heart Association Conference (AHA) on November 17. A video summarizing the review’s findings posted today at this link on ProtectedPCI.com.
The AHA analysis is flawed because:
- The data source has significant limitations, containing just a fraction of Impella patients and unable to delineate between common adverse events
- The Impella patients were much sicker and had greater baseline and procedural risks
- The analysis excluded the costliest IABP patients who were escalated to other therapies
Additionally, the conclusion is aggressive because administrative coding data cannot delineate between adverse events common to high-risk patients and device related events.
Data Source Has Significant Limitations
The AHA analysis is an observational, unaudited data analysis based on a retrospective, administrative sample coding database that does not identify device related adverse events and lumps multiple indications together, including elective high-risk and emergent cardiogenic shock cases. This makes it impossible to properly propensity match. The sample coding database only includes 4% of the Impella patients who are studied in the IQ Database.
Impella Patients Were Much Sicker
Compared to the IABP patients, the Impella patients:
- Were older
- Had nearly 50% greater rate of diabetes
- Had 50% greater rate of heart failure
- Had nearly 2x the rate of chronic renal failure at baseline
- Had 2x the rate of multi-vessel disease
- Underwent 4x the rate of LASER atherectomy
- Underwent 5x the rate of rotational atherectomy
- Had nearly 2x the rate of NSTEMI
The Analysis Excluded the Costliest IABP Patients Who Were Escalated to Other Therapies