Real-World Data Show Protected PCI Patients Had Significant CHF Symptom Improvement at Discharge

December 22, 2015



publication-highlight-real-world-vs-clinical-trial-experience-with-impella-for-high-risk-pciThe abstract for this article was presented by Dr. Mauricio Cohen at TCT 2015 and reported by the Protected PCI blogging team during the conference.


Cohen, et al. (2015) compared the experiences of high-risk PCI patients in the PROTECT II clinical trial with a similar group of patients treated in certain “real world” clinical settings. Patients enrolled in the now global cVAD Registry™ (formerly USpella) comprised the “real world” patient groups.

Study Design

A total of 637 patients treated between June 2007 and September 2013 were included in the USpella registry (now cVAD registry™). Of them, 339 patients would have met the enrollment criteria for the PROTECT II trial. These were compared with 216 patients treated in the Impella® arm of PROTECT II.

Key points

Baseline patient characteristics

  • Patients in both the USpella and PROTECT II-like groups were (P<0.055) older than the PROTECT II group, with a mean age of 70.2 and 69.6, respectively compared to 67.5 years (PROTECT II).
  • Left ventricular ejection fraction (LVEF) for patients in the PROTECT II-like group in the USpella registry (21.6) was similar to the LVEF in the PROTECT II group (23.4) (P=0.004).

10.5% of the Protect II-like patients had 3VD, a comparative number to the 14.4% of the Protect II group that had 3VD

Angiographic and Procedural Characteristics

  • More diseased vessels (P<0.001) and lesions (P<0.01) were observed in the Registry groups (USpella 2.20 vessels, 3.10 lesions; PROTECT II-like 2.22, 3.07) compared to the PROTECT II group (1.78; 2.73).
  • Fewer lesions and stents were placed in Registry patients (USpella 2.47 lesions, 2.21 stents; PROTECT II-like 2.48, 2.24) compared to the PROTECT II group (2.88; 3.08)(P<0.001).
  • During the Protected PCI™ procedure, systolic and diastolic blood pressures and mean arterial pressures increased from pre-Impella levels in all groups(P<0.001) .

In Hospital Outcomes and Discharge

  • Left ventricular function increased substantially from baseline to discharge in the registry group (21.4% to 28.4%; P < .000)
  • Compared to baseline, at discharge both groups reported significant reductions in New York Heart Association (NYHA) Class III and IV symptoms: Registry (P<0.001, 42.2% reduction, n=128) and PROTECT II (P=0.008, 27.8% reduction, n=87).
  • There were no cases of stroke or TIA, emergency CABG, acute aortic regurgitation, or valve injury.


  • Similar outcomes were observed between the Registry and PROTECT II groups, demonstrating that the clinical trial experience is representative of “real world” clinical settings.
  • Significant improvements in congestive heart failure symptoms were reported at discharge.

Next Steps:

  1. Read a summary of this study
  2. Read about the PROTECT II Study
  3. Learn more about the use of Impella 2.5 for PCI
  4. Review more clinical data from Protected PCI using Impella 2.5
  5. Learn more about identifying patients for Protected PCI

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: