The Impella CP did not reduce 30-day mortality compared with the intra-aortic balloon pump, according to the results of the IMPRESS Trial presented Oct. 31 at TCT 2016 and simultaneously published in the Journal of the American College of Cardiology.

Dagmar M. Ouweneel, MSc, et al., conducted a randomized, prospective, multi-center trial to determine whether the Impella CP – a new percutaneous circulatory device that provides increased hemodynamic support – would decrease 30-day mortality compared to the intra-aortic balloon pump. The 48 patients in the trial had severe cardiogenic shock complicating acute myocardial infarction.

The results of the trial showed that the 30-day mortality was similar in patients treated with the Impella CP or the intra-aortic balloon pump (46 vs. 50 percent, respectively). At six-months, the mortality rates for both were 50 percent.

A meta-analysis of randomized, controlled trials comparing Impella with the intra-aortic balloon pump, led by Ouweneel, et al., also observed no difference in 30-day and six-month all-cause mortality, in addition to no difference in left ventricular ejection fraction. The authors explain that “the vast majority of patients enrolled in the studies were treated with mechanical support therapy after revascularization. However, large randomized, controlled trials or large-scale observational studies are needed to show which patients may benefit from this therapy.”

In an accompanying editorial comment, Uwe Zeymer, MD, et al., note that “the failure of the Impella CP in the feasibility IMPRESS in SHOCK trial should not be considered as the end of [mechanical circulatory support] device therapy itself. These trials should be more considered as seminal trials for future research in this field to answer all these open questions.”

Keywords: Transcatheter Cardiovascular Therapeutics, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Thrombolytic Therapy, Heart Ventricles, Heart-Assist Devices, Hemodynamics, Myocardial Infarction, Prospective Studies

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