title: Intracoronary hemodynamic effects of pressure-controlled intermittent coronary sinus occlusion (PICSO): results from the First-In-Man Prepare PICSO Study.
abstract: BACKGROUND
  Myocardial reperfusion is frequently suboptimal after ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI). Using a balloon-tipped catheter positioned in the coronary sinus (CS), pressure-controlled intermittent coronary sinus occlusion (PICSO) results in an intermittent obstruction of coronary venous outflow of the left anterior descending artery (LAD), and may improve myocardial perfusion by augmenting redistribution of blood to the border zone of ischemic myocardium. We sought to document the intracoronary hemodynamic effects of PICSO during PCI.
  
  
  METHODS
  We included 15 patients with stable angina scheduled for PCI of the LAD. Balloon occlusion of the LAD was performed twice, once with and once without PICSO and lasting maximally 3 minutes each, to document the effect of PICSO on CS pressure and LAD wedge pressure.
  
  
  RESULTS
  Catheter delivery was successful in all patients. The study protocol could not be conducted in 5 patients due to initial calibration difficulties (n = 3), a pressure wire problem (n = 1), and a vagal response at the start of the procedure (n = 1). In the remaining 10 patients, CS occlusion caused a marked increase in mean CS pressure (4.1 ± 7.3 mmHg vs. 22.0 ± 12.6 mmHg; P < 0.001) and CS pulse pressure (4.3 ± 0.8 mmHg vs. 36.1 ± 6.3 mmHg; P < 0.001). Concomitantly, mean distal LAD wedge pressure and wedge pulse pressure increased (32.4 ± 12.2 mmHg vs. 35.5 ± 12.6 mmHg; P < 0.001 and 39.1 ± 27.2 mmHg vs. 45.9 ± 26.0 mmHg; P < 0.001, respectively). At 30 day follow-up, no device-related events occurred.
  
  
  CONCLUSIONS
  PICSO safely augments CS pressure, thereby increasing LAD coronary wedge pressure. These findings support further evaluation of PICSO in the setting of STEMI.
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands.
authors.forename: Tim P
authors.initials: TP
authors.lastname: Van de Hoef
authors.forename: Froukje
authors.initials: F
authors.lastname: Nolte
authors.forename: Ronak
authors.initials: R
authors.lastname: Delewi
authors.forename: Jose P S
authors.initials: JP
authors.lastname: Henriques
authors.forename: Jos A E
authors.initials: JA
authors.lastname: Spaan
authors.forename: Jan G P
authors.initials: JG
authors.lastname: Tijssen
authors.forename: Maria
authors.initials: M
authors.lastname: Siebes
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Wykrzykowska
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Piek
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D021721:Balloon Occlusion; D001794:Blood Pressure / Q000502:physiology*; D006328:Cardiac Catheterization; D003324:Coronary Artery Disease / Q000628:therapy*; D003326:Coronary Circulation / Q000502:physiology*; D054326:Coronary Sinus / Q000502:physiology*; D003331:Coronary Vessels; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015425:Myocardial Reperfusion / Q000379:methods*; D011446:Prospective Studies