Initial Experience with a Low Profile, High Energy Excimer Laser Catheter for Heavily Calcified Coronary Lesion Debulking: Parameters and Results of First Seven Human Case Experiences

Background: Excimer laser coronary angioplasty (ELCA) has not been used in the setting of highly calcified, tight stenoses because the energies required to use existing catheters would lead to excessive heat damage and dissection. There are, however, cases that frequently benefit from debulking prior to percutaneous intervention. A new, small laser catheter capable of high energies and repetition was previously examined in vitro. This study describes the first in vivo use. Purpose: To determine the safety and feasibility of a new, low profile, high energy laser catheter for creating a pilot hole to facilitate coronary angioplasty and stenting in patients with heavily calcified and occluded coronary arteries where a balloon has either failed to pass or was predicted to perform poorly. These patients represent the first patients treated with this new catheter. Methods: At a high volume center, seven consecutive patients with anatomy as summarized above were treated and studied with QCA and then followed for 30 days postprocedure for complications and Canadian Cardiovascular Society (CCS) angina class. Results: The laser catheter crossed five out of seven lesions and partially penetrated the remaining lesions. The mean maximum luminal diameter (MLD) postlasing was 1.0 mm with Thrombolysis in Myocardial Infarction (TIMI) 3 flow. It was possible to easily balloon and stent after the pilot hole creation in all but one patient. TIMI 3 was achieved for the final result after adjunct therapy in all patients. All patients except one, who died at 3 months postprocedure of stroke, were improved by an average of two angina classes. No late procedural-related complications developed. Conclusions: The new, low profile laser catheter is easy to use and achieved good results in cases where a balloon either failed to pass or was predicted to give poor results. Further trials are warranted for this niche technology.