title: Feasibility and long-term safety of elective Impella-assisted high-risk percutaneous coronary intervention: a pilot two-centre study.
abstract: OBJECTIVE
  We evaluated the acute and long-term results of the use of a new intracardiac microaxial pump, the Impella Recover LP 2.5, during elective high-risk percutaneous coronary interventions in a two-centre registry.
  
  
  METHODS
  Ten consecutive patients with poor left ventricular function and multivessel or left main coronary artery disease were considered at high risk of haemodynamic compromise and underwent percutaneous coronary interventions with preintervention Impella implantation. Procedural complications, 30-day and 12-month clinical outcome were recorded. Left ventricular ejection fraction was assessed by echocardiography before procedure and after at least 6 months.
  
  
  RESULTS
  The Impella was implanted before percutaneous coronary interventions by femoral approach and percutaneous coronary interventions were successfully performed (by contra lateral femoral or radial approach) in all cases. After percutaneous coronary intervention, Impella was removed in all patients, and haemostasis was obtained by prolonged manual compression or by double suture device preimplantation technique. No access-site complication was observed and no patient required transfusions. One patient died after Impella removal due to acute stent thrombosis. The other patients had an uncomplicated in-hospital course and were discharged within 5 days. At 1-year follow-up, no patient died nor suffered acute myocardial infarction, whereas two patients underwent re-percutaneous coronary intervention. Left ventricular ejection fraction at follow-up increased significantly in this study population (from 31 +/- 7% to 41% +/- 13%, P = 0.02).
  
  
  CONCLUSIONS
  Our results support the feasibility and safety of Impella-assisted percutaneous coronary intervention in high-risk patients. Prospective randomized trials are needed to test the clinical impact of such an innovative approach.
authors.affiliation: Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy. f.burzotta@rm.unicatt.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Burzotta
authors.forename: Leonardo
authors.initials: L
authors.lastname: Paloscia
authors.forename: Carlo
authors.initials: C
authors.lastname: Trani
authors.forename: Marco
authors.initials: M
authors.lastname: Mascellanti
authors.forename: Rocco
authors.initials: R
authors.lastname: Mongiardo
authors.forename: Guido
authors.initials: G
authors.lastname: Materazzo
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Niccoli
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Marco
authors.forename: Antonio Maria
authors.initials: AM
authors.lastname: Leone
authors.forename: Italo
authors.initials: I
authors.lastname: Porto
authors.forename: Mario Attilio
authors.initials: MA
authors.lastname: Mazzari
authors.forename: Antonio Giuseppe
authors.initials: AG
authors.lastname: Rebuzzi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Schiavoni
authors.forename: Filippo
authors.initials: F
authors.lastname: Crea
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D004452:Echocardiography; D017558:Elective Surgical Procedures; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006353:Heart-Assist Devices; D006439:Hemodynamics; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012042:Registries; D018570:Risk Assessment; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left