title: Pressure-controlled intermittent coronary sinus occlusion (PICSO) in acute ST-segment elevation myocardial infarction: results of the Prepare RAMSES safety and feasibility study.
abstract: OBJECTIVE
  Pressure-controlled intermittent coronary sinus occlusion (PICSO) may improve myocardial perfusion after pPCI. We evaluated the safety and feasibility of PICSO after pPCI for STEMI, and explored its effects on infarct size and myocardial function.
  
  
  RESULTS
  Thirty patients were enrolled following successful pPCI of a left anterior descending coronary artery culprit lesion for anterior STEMI, in whom PICSO for 90 minutes was attempted. Infarct size and myocardial function were assessed by cardiovascular magnetic resonance (CMR) at two to five days and four months post pPCI. An independent core laboratory selected matched historical control patients with CMR data for comparison. PICSO was initiated in 19 patients (63%), and could be maintained for 90 (±2) minutes in 12 patients (40%). Major adverse safety events occurred in one patient (3%). Comparing all PICSO-treated patients to matched controls demonstrated no significant differences in infarct size or myocardial recovery. However, infarct size reduction from two to five days to four months was greater for patients successfully treated with PICSO compared with matched controls (41.6±8.2% vs. 27.7±9.9%, respectively; p=0.04).
  
  
  CONCLUSIONS
  PICSO is safe in the setting of STEMI, although feasibility was limited. Administration of sufficient PICSO therapy may be associated with enhanced myocardial recovery during follow-up, warranting further evaluation of this novel therapy.
authors: AMC Heartcenter, Academic Medical Center - University of Amsterdam, Amsterdam, The Netherlands.
authors: Tim P
authors: TP
authors: van de Hoef
authors: Robin
authors: R
authors: Nijveldt
authors: Martin
authors: M
authors: van der Ent
authors: Thomas
authors: T
authors: Neunteufl
authors: Martijn
authors: M
authors: Meuwissen
authors: Ahmed
authors: A
authors: Khattab
authors: Rudolf
authors: R
authors: Berger
authors: Wichert J
authors: WJ
authors: Kuijt
authors: Joanna
authors: J
authors: Wykrzykowska
authors: Jan G P
authors: JG
authors: Tijssen
authors: Albert C
authors: AC
authors: van Rossum
authors: Gregg W
authors: GW
authors: Stone
authors: Jan J
authors: JJ
authors: Piek
mesh_terms: D000368:Aged; D056988:Anterior Wall Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D021721:Balloon Occlusion / Q000009:adverse effects / Q000295:instrumentation; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D062906:Cardiac Catheters; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D003326:Coronary Circulation; D054326:Coronary Sinus / Q000503:physiopathology*; D004867:Equipment Design; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008833:Microcirculation; D008875:Middle Aged; D009206:Myocardium / Q000473:pathology; D009336:Necrosis; D062645:Percutaneous Coronary Intervention; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014690:Venous Pressure; D016277:Ventricular Function, Left