Abiomed Issues Press Release Highlighting Issuance Of Publication Review Of Observational Analysis Of Impella Previously Presented By Amin At American Heart Association Conference On Nov. 17

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.

Benzinga · 11/19/2019 18:15

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).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191119005932/en/

Figure 1: Clinical Variables Poorly Matched in Amin, et al. (Graphic: Business Wire)
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

Importantly, the AHA analysis also removed patients who were escalated to other therapies, which is a major driver of costs and poor outcomes for IABP. This same flaw applies to the recent NCDR study of Impella.

A key finding from an analysis of 11,887 patients in the National Inpatient Sample (NIS) database published by Yale University colleagues Stretch et al., is that patients who were escalated from IABP had much higher cost, longer length of stay, and worse outcomes1 (see Figure 2). NIS is the largest all-payer database in the United States, containing data from Medicare, Medicaid and large commercial payers on more than seven million hospital stays.

The Stretch et al. finding is consistent with the real-world Impella outcomes in cardiogenic shock published by O'Neill et al., which demonstrated a lower survival for patients who were treated with IABP prior to Impella2 (See Figure 3). Therefore, the exclusion of escalation patients from Amin et al. and the NCDR study significantly biases the IABP cohort.

The IABP-SHOCK II Randomized Controlled Trial demonstrated IABP has no hemodynamic benefit, no clinical benefit and no survival benefit. That study published in the New England Journal of Medicine and led to a Class III recommendation (not recommended, may be harmful) for IABP in cardiogenic shock in Europe and Japan.

Furthermore, the authors' stated conclusion conflicts with the conclusions of more robust, previously published, FDA-audited, peer-reviewed, real-world studies and randomized controlled trials, which demonstrate:

Impella is associated with improved survival in cardiogenic shock
Impella reduces MACCE (death, stroke, MI and repeat revascularization) in high-risk PCI, when compared to IABP
Impella enables more complete revascularization and improves ejection fraction and patient quality of life at 90 days
Impella is associated with improved outcomes, reduced cost, reduced readmission and reduced length of stay, when compared to IABP and other therapies
An esteemed group of physicians who are leaders in the field of circulatory support have been studying Impella for more than a decade. Their research has included FDA randomized controlled trials, FDA pre- and post-market studies and physician-led initiatives such as the National Cardiogenic Shock Initiative (NCSI) Study, the INOVA Study and the Cardiogenic Shock Working Group.