Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella registry

Catheter Cardiovasc Interv. 2017 Oct 1;90(4):576-581. doi: 10.1002/ccd.26979. Epub 2017 Apr 18.

Abstract

Background: Patients with left main (LM) coronary artery disease are increasingly being treated with percutaneous revascularization (PCI). The safety, feasibility, and efficacy of unprotected LM intervention (ULMI) with hemodynamic support by Impella device have not been evaluated previously.

Objective: Using a large retrospective single center database from the USpella registry, we evaluated the safety, feasibility, and potential benefits of periprocedural left ventricular assist with axial flow Impella 2.5 and Impella CP (Abiomed Inc. Danvers, Mass) during ULMI.

Methods: We analyzed a total of 127 consecutive patients who received hemodynamic support with Impella (2.5 or CP) for ULMI from August 2008 to July 2015. Safety, feasibility and efficacy end points included procedural success rates, in-hospital and 30-day major adverse cardiovascular event (MACE) rates.

Results: Among 127 patients who received hemodynamic support for ULMI (mean age 69.98 ± 10.7 years, 71% men, and mean left ventricular ejection fraction 28.74 ± 15.55%, Society of Thoracic Surgeons' mortality/morbidity 4/23%) the in-hospital and 30 days mortality rates were 1.43% (2/140) and 2.1% (3/141), respectively. The average baseline and post PCI (residual) syntax scores were 31.4 and 7.86, respectively, (P < 0.001). Only one patient (0.8%) had vascular complication that required surgery; 2.36% (3/127) had hematoma and 3.9% (5/127) had bleeding that required transfusion.

Conclusion: This large singe center retrospective evaluation of USpella registry substantiates and strongly supports the feasibility, safety, and hemodynamic usefulness of Impella device for ULMI with acceptable in-hospital and 30-day MACE rates. © 2017 Wiley Periodicals, Inc.

Keywords: impella; left main disease; percutaneous coronary intervention.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / physiopathology
  • Coronary Artery Disease / therapy*
  • Feasibility Studies
  • Female
  • Heart-Assist Devices*
  • Hemodynamics*
  • Hospital Mortality
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Prosthesis Design
  • Registries
  • Retrospective Studies
  • Time Factors
  • Treatment Outcome
  • Ventricular Function, Left*