the PICSO® technology
The PICSO® principle is based on the fact that the pressure in the coronary sinus will increase when the vessel is occluded. During the occlusion the pressure will rise from the normal right atrial pressure to a pressure plateau which is different from patient to patient.
Coronary sinus pressure increase during two cycles of PICSO® (clinical data from the Prepare PICSO® study)
Using the current gold standard for coronary revascularization a majority of the coronaries will be opened using a PTCA balloon or a coronary stent (commonly called Percutaneous Coronary Intervention, PCI). The so-called TIMI 3 flow will be achieved in more than 90% of the patients undergoing coronary revascularization according to a study in high risk patients by Stone et al.¹ However, the flow through the reopened artery does not immediately impact the damaged myocardium. The same study found that in only 29% of the patients optimal myocardial flow was achieved measured by myocardial blush. Myocardial blush is directly related to the outcome of patients undergoing coronary revascularization. Another study by Hoffmann et al.² found that 49% of the patients undergoing PCI achieved optimal myocardial blush immediately after PCI. This success rate changed to 73% after 7 ½ months. The patients without optimal tissue perfusion constitute a large patient group at charge and at follow-up after PCI. These patients have poorer outcomes with increased risk of heart failure than patients with optimal outcomes.
PICSO® aims to improve the myocardial perfusion after PCI by redistributing flow into the damaged tissue immediately following PCI.
Blocked artery causes myocardial injury
During a heart attack one or several arteries are blocked due to a build-up of plaque in the coronary vessel. This will limit the flow to the heart tissue thereby destroying the tissue shown as white in this figure.
The flow can be restored using a stent or another method to open the artery. This restored flow is effective to improve the cardiac function after a heart attack. However, not all of the damaged myocardium is revitalized as mentioned in the description above. In addition, the opening of the artery itself can cause damage to the tissue.
Reopened artery restores arterial flow but still some of the myocardial perfusion is not optimal
The Miracor PICSO® Impulse Catheter is inserted on the venous side of the heart and intermittently inflated to increase the pressure in the myocardium. This pressure build-up causes a redistribution of flow into the damaged area and aims to improve myocardial perfusion and cardiac function after PCI.
The Miracor PICSO® Impulse Catheter is inflated and deflated to redistribute flow into the damaged myocardium
¹ Stone et al. Impact of Normalized Myocardial Perfusion After Successful Angioplasty in AMI JACC 2002
² Hoffmann et al. Usefulness of Myocardial Blush Grade Early and Late After Primary Coronary Angioplasty Am J Car 2003