Intravascular Ultrasound Balloon Catheter

Background Coronary stenting in conjunction with coronary angioplasty is a valuable tool for treatment of severe coronary dissection and is effective in reducing the frequency of restenoses. Evidence is increasing that the lumen gain within the stent is negatively correlated with the rate of subacute closures and restenoses. Since the assessment of radiolucent coronary stents and complex lumen morphologies by angiography is limited, we hypothesized that the use of a balloon catheter with integrated intravascular ultrasound (IVUS) facility for stent deployment and guidance of its expansion could improve the acute lumen gain without relevant procedural prolongation. Methods and Results Deployment of a single Palmaz-Schatz coronary stent with the combined imaging balloon catheter alone was successful in 18 of 20 patients eligible for this study. Corresponding measurements of minimal lumen diameter (MLD) by angiography and IVUS could be performed in 16 patients, revealing a close correlation between the two methods within the reference segments (3.10±0.38 and 3.08±0.43 mm, r=.79). Despite an adequate angiographic result in most patients after stent deployment, IVUS showed smaller MLD within the stented segment (2.15+0.23 mm) compared with angiography (2.63+0.26 mm, P<.0001) with a poor correlation (r=.27). To achieve IVUS criteria for optimal stent expansion (ratio of 0.9 between IVUS-assessed cross-sectional area of stent and reference segment), an average of three additional balloon inflations with higher pressure and/or a larger balloon diameter were performed without adverse effects in 15 of 16 patients who initially did not fulfill these criteria. This resulted in a significant increase in stent MLD to 2.63±0.27 mm (IVUS, P<.0001 versus initial MLD) and 2.89±0.32 mm (angiography, P<.0002 versus initial MLD) and a better correlation between the two methods (r=.60). The IVUS guidance led to a 40+15% increase of the minimal stent cross-sectional area with an additional time consumption of 21 minutes on average. Conclusions This study demonstrates the application of a combined imaging balloon catheter for delivery and ultrasound-guided expansion of Palmaz-Schatz coronary stents. IVUS offered a comprehensive insight into the stented coronary segments, revealing a substantial overestimation of stent dimensions by angiography. IVUS guidance led to a significant improvement of stent expansion. This additional lumen gain, which was not discernible by angiography in most patients, might result in a reduction of subacute stent thromboses as well as restenoses. (Circulation. 1994;90:1252-1261.)