New balloon catheter for prolonged percutaneous transluminal coronary angioplasty and bypass flow in occluded vessels

Abstract

A new balloon catheter was developed for continuous perfusion of coronary arteries during angioplasty (CPC catheter). Steerable Grüntzig balloon catheters (3.7 mm) with two lumina were formed. The first lumen was used for balloon inflation. Side holes to the second lumen proximally and distally to the balloon were created for coronary perfusion even during inflation phase. At a perfusion pressure of 120 mmHg, a flow rate of 63 ± 3ml/min with 0.9% saline and 43 ±1 ml/min with plasma expander were measured. In experiments on five dogs, dilation time until appearance of signs of ischemia could be prolonged in three of five dogs, from 30 to 40 s, 120 to 203 s, and 180 to 420 s comparing conventional and CPC balloon catheters. In 11 patients with proximal lesions, dilation time could be increased from 39.5 ± 23.9 s to 81.1 ± 36.3 s (p < 0.01) until appearance of angina pectoris. ST segment changes were observed in 10/11 patients using conventional catheters. Using CPC catheters, no ST segment changes were observed in four patients; time until appearance of ST segment changes was delayed in the other seven patients. The CPC catheter seems to be an alternative catheter in proximal lesions of the left and right coronary artery, allowing the possibility of prolonged dilation and increased safety to the patient. In case of dissection or perforation, the CPC catheter can be used for perfusion of the distal part of the coronary vessel until emergency bypass surgery.