Impella device

Impella® Device Support During High-Risk Unprotected Left Main Percutaneous Coronary Intervention Demonstrates Favorable Safety and Efficacy Outcomes

November 21, 2017

Reference: Schreiber T et al. Catheter Cardiovasc Interv. 2017;90(4):576-581.

The use of prophylactic Impella® device support during unprotected left main (ULM) percutaneous coronary intervention (PCI) is safe and effective for improving hemodynamic variables in high-risk, non-cardiogenic shock (CS) patients, according to findings from a large, single-center, retrospective review of the USpella registry from Schreiber et al.1

Coronary artery bypass grafting (CABG) surgery has been considered the “gold standard” approach to anatomically challenging left main lesions; however, PCI in conjunction with additional mechanical and medical support is becoming increasingly adopted for high-risk and surgically ineligible patients.2,3,4 The rationale for utilizing prophylactic mechanical hemodynamic support during revascularization in these patients is primarily derived from its effect on reducing myocardial ischemia and minimizing hemodynamic collapse.

In this analysis, investigators evaluated consecutive patients with ULM who received Impella device support during ULM PCI (N = 127). Following surgical consultation, approximately 50% refused CABG surgery. The majority of the 24 patients with acute coronary syndrome had non-ST-elevation myocardial infarction (79.17%) compared with 20.83% with ST-elevation myocardial infarction.

To obtain predicted risks for surgical morbidity and mortality, the investigators used the Society for Thoracic Surgery (STS) scores. According to the STS scores, risk for mortality and morbidity were 4% and 23%, respectively.

Approximately 76% of patients received Impella 2.5 (n = 97) vs 24% of those received Impella CP (n = 30). Average support duration was 1.65 ± 4.69/hour. Pre- vs post-PCI SYNTAX scores significantly decreased from 31.4 to 7.86 (P < 0.001) following support.

The endpoint of in-hospital mortality was 1.57%, and 30-day mortality was 2.36%. No device-related mortalities were observed. Five (3.94%) Impella recipients experienced major bleeding which required transfusion, only 1 (0.79%) patient experienced a vascular event requiring surgical intervention, and 1 (0.79%) patient developed an acute kidney injury.

Although this study did not compare ULM PCI with CABG, the investigators state that their findings demonstrate the utility of “prophylactic placement of percutaneous left ventricular hemodynamic support...in high-risk patients with ULM and [an] adverse clinical risk profile.” In addition, the researchers showed that the risk for PCI-related mortality was approximately 50% less than that would have been predicted with CABG (STS score: 2.36% vs 4%, respectively), demonstrating a potential survival benefit associated with ULM PCI in this patient population.

Reference:

  1. Schreiber T, Htun WW, Blank N, et al. Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella registry. Catheter Cardiovasc Interv. 2017;90(4):576-581.
  2. Chaitman BR, Fisher LD, Bourassa MG, et al. Effect of coronary bypass surgery on survival patterns in subsets of patients with left main coronary artery disease. Report of the Collaborative Study in Coronary Artery Surgery (CASS). Am J Cardiol. 1981;48(4):765–777.
  3. Holmes AA, Bangalore S. PCI or CABG for severe unprotected left main coronary artery disease: making sense of the NOBLE and EXCEL trials. J Thorac Dis. 2017;9(5):E451-E456.
  4. Kandzari DE, Ormiston JA. Revascularization for unprotected left main coronary artery disease: an evolution in clinical decision making. Curr Cardiol Rep. 2011;13(5):424-431.

IMP-422-17


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: www.protectedpci.com/indications-use-safety-information/

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