Spanish Registry of Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) Balloon: Initial Experience and Short-Term Clinical Outcomes

Abstract

Objectives: The mortality of ST elevation myocardial infarction (STEMI) has plateaued in the last decade, with a 30-day mortality of 3%-4%. Previous studies in patients with anterior STEMI treated by primary angioplasty and assisted with the pressure-controlled intermittent coronary sinus occlusion (PiCSO) system have shown a modest but significant absolute reduction of the infarct zone.

Methods: Prospective, observational study were carried out in two hospitals in Spain. The study included patients with acute coronary syndrome and patients with high-risk percutaneous coronary intervention (PCI). PiCSO therapy was provided throughout the PCI (after achieving thrombolysis in myocardial infarction [TIMI] flow two or three in STEMI cases), with a minimum duration of 20 min from stent implantation until the completion of the procedure.

Results: A total of 22 cases were performed. In 20 cases, PiCSO therapy could be successfully applied, and in 2 cases, it was not possible due to the inability to access the coronary sinus. In 95.45%, the PCI was performed in a single coronary artery. Baseline TIMI flow was 0-1 in > 60% of patients, with final TIMI 3 flow achieved in > 95%. There were no complications secondary to the use of the PiCSO system. At 6-month clinical follow-up, 100% of the patients were alive with significant improvement in functional class and angina status.

Conclusions: The use of the PiCSO device during ACS was safe and may offer potential benefits to patients susceptible to reperfusion injury or in whom relevant distal microembolization is anticipated during primary angioplasty or high-risk PCI. More data are needed to validate its widespread clinical use.