Analysis of Impella that was presented by Amin at AHA is flawed: Abiomed Cardiology2.0 – Cardiology2.0

A new study, Comparative Effectiveness and Costs of Impella vs. Intra-Aortic Balloon Pump in the United States, was presented by Amit Amin, MD, Washington University School of Medicine, at AHA 2019 on Sunday morning late-breaking session. The study illustrated apparent risks associated with different types of devices used in percutaneous coronary intervention(PCI).

Results of the analysis, which included data on more than 40,000 patients with acute coronary syndrome, revealed the Impella device was associated with greater costs and a higher risk of death, bleeding, stroke, and acute kidney injury when compared to intra-aortic balloon pumps.

Abiomed, has issued a response to this analysisciting flawed data and study design.

Abiomed(NASDAQ: ABMD) is committed to improving patient outcomes by performing FDA studies and post-market surveillance, collecting real-world evidence nd identifying and sharing best practices.Impellais 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).

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 reviews findings posted today atthis linkon ProtectedPCI.com.

The AHA analysis is flawed because:

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:

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 ONeill 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.

TheIABP-SHOCK IIRandomized Controlled Trial demonstrated IABP has no hemodynamic benefit, no clinical benefit and no survival benefit. That study published in theNew England Journal of Medicineand 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:

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.

William ONeill, MD:

The real-world, contemporary experience of the National Cardiogenic Shock Initiative prospective clinical study consistently demonstrates improvements in survival and native heart recovery with best practices that include use of Impella, said William ONeill, MD, the principal investigator of NCSI and the medical director of the Center for Structural Heart Disease at Henry Ford Hospital. Payer databases, like the one used in the AHA analysis, are impossibly biased because the sicker patients will always go to Impella.

Jeffrey Moses, MD:

With two Impella RCTs and multiple prospective clinical post-approval studies on Impella, better data exists, says Jeffrey Moses, MD, an interventional cardiologist, founding member of CHIP, and professor of medicine at Columbia University Medical Center who has performed more than 18,000 interventional procedures and authored more than 600 publications. The potential for confounding in these databases presented at AHA is profound.

Daniel Burkhoff, MD, PhD:

With lack of granularity of patient hemodynamic and metabolic characteristics at the time of MCS use, it is impossible to compare cohorts in any meaningful way based simply on basic clinical and demographic data. Since it is well documented that Impella provides greater hemodynamic support, there is the potential for bias, with sicker patients getting Impella, as appears to be the case. Such bias cannot be overcome by statistical approaches. In addition, we know that as native heart function decreases, the amount of support by an intra-aortic balloon pump also decreases which fundamentally limits its effectiveness with failing hearts. On the contrary, Impella takes over the pumping function of the heart and unloads the left ventricle which, in several other studies, has been associated with better clinical outcomes, says Daniel Burkhoff, MD, PhD, director, heart failure, hemodynamics and MCS research at Cardiovascular Research Foundation and primary educator ofTEACH, the premier physician training and education program for learning advanced cardiovascular hemodynamics.

Alexander Truesdell, MD:

Our data, as published inInterventional Cardiology Reviewand theJournal of the American College of Cardiology, suggests that multi-disciplinary care focused on prompt recognition of cardiogenic shock, rapid hemodynamic assessment, collaborative decision-making, safe vascular access, and early use of percutaneous mechanical circulatory support (primarily with the Impella family of devices), for both acute myocardial infarction and acute decompensated heart failure phenotypes, leads to significantly improved 30-day survival, says Alexander Truesdell, MD, an interventional cardiologist at Virginia Heart and INOVA Heart and Vascular Institute.

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Analysis of Impella that was presented by Amin at AHA is flawed: Abiomed Cardiology2.0 - Cardiology2.0