title: Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience.
abstract: BACKGROUND
  High-risk percutaneous coronary intervention (PCI) supported by percutaneous left ventricular assist devices offers a treatment option for patients with severe symptoms, complex and extensive coronary artery disease, and multiple comorbidities. The extrapolation from clinical trial to real-world practice has inherent uncertainties. We compared the characteristics, procedures, and outcomes of high-risk PCI supported by a microaxial pump (Impella 2.5) in a multicenter registry versus the randomized PROTECT II trial (NCT00562016).
  
  
  METHODS
  The USpella registry is an observational multicenter voluntary registry of Impella technology. A total of 637 patients treated between June 2007 and September 2013 were included. Of them, 339 patients would have met enrollment criteria for the PROTECT II trial. These were compared with 216 patients treated in the Impella arm of PROTECT II.
  
  
  RESULTS
  Compared to the clinical trial, registry patients were older (70 ± 11.5 vs 67.5 ± 11.0 years); more likely to have chronic kidney disease (30% vs 22.7%), prior myocardial infarction (69.3% vs 56.5%), or prior bypass surgery (39.4% vs. 30.2%); and had similar prevalence of diabetes, peripheral vascular disease, and prior stroke. Registry patients had more extensive coronary artery disease (2.2 vs 1.8 diseased vessels) and had a similar Society of Thoracic Surgeons predicted risk of mortality. At hospital discharge, registry patients experienced a similar reduction in New York Heart Association class III to IV symptoms compared to trial patients. Registry patients had a trend toward lower in-hospital mortality (2.7% vs 4.6, P = .27).
  
  
  CONCLUSIONS
  USpella provides a real-world and contemporary estimation of the type of procedures and outcomes of high-risk patients undergoing PCI supported by Impella 2.5. Despite the higher risk of registry patients, clinical outcomes appeared to be favorable and consistent compared with the randomized trial.
authors.affiliation: University of Miami Hospital, Miami, FL. Electronic address: mgcohen@med.miami.edu.
authors.forename: Mauricio G
authors.initials: MG
authors.lastname: Cohen
authors.affiliation: Keck School of Medicine, University of Southern California, Los Angeles, CA.
authors.forename: Ray
authors.initials: R
authors.lastname: Matthews
authors.affiliation: Pinnacle Health System, Harrisburg, PA.
authors.forename: Brij
authors.initials: B
authors.lastname: Maini
authors.affiliation: William Beaumont University Hospital, Royal Oak, MI.
authors.forename: Simon
authors.initials: S
authors.lastname: Dixon
authors.affiliation: Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.
authors.forename: George
authors.initials: G
authors.lastname: Vetrovec
authors.affiliation: Spectrum Health, Grand Rapids, MI.
authors.forename: David
authors.initials: D
authors.lastname: Wohns
authors.affiliation: Massachusetts General Hospital, Boston, MA.
authors.forename: Igor
authors.initials: I
authors.lastname: Palacios
authors.affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Popma
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.affiliation: Harper University Hospital, Detroit, MI.
authors.forename: Theodore
authors.initials: T
authors.lastname: Schreiber
authors.affiliation: Henry Ford Hospital, Detroit, MI.
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D012042:Registries; D013318:Stroke Volume; D016896:Treatment Outcome; D016277:Ventricular Function, Left