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

ProtectedPCI
December 22, 2015

Article

 

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.

Objective

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.

Conclusions

  • 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

About Impella

The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi.