Abstract 18897: Safety and Efficacy of Coronary Intravascular Lithotripsy for Percutaneous Coronary Intervention of Severely Calcified Left Main Stenosis

Abstract

Introduction: Coronary Intravascular Lithotripsy has been shown to be a safe and effective modality for the modification of non-left main calcific stenosis. This study was done to evaluate the safety and efficacy of IVL during percutaneous coronary intervention (PCI) of severely calcified left main (LM) bifurcation disease. Methods: This was a prospective, single-arm observational study in which 22 patients with significant calcific LM bifurcation disease undergoing angioplasty were enrolled. Pre and Post-IVL Optical coherence tomography (OCT) was done in all patients as an imaging modality. The primary safety end-point was peri-procedure complications and freedom from major adverse cardiovascular events (MACE) defined as cardiac death, non-fatal MI, and target vessel revascularization at 30 days, and the primary efficacy endpoint was stent expansion of more than 80% in stratified stented segment. The secondary efficacy endpoint was mean stent area more than the accepted target value of 5.0 mm 2 , 6.3 mm 2 , and 8.2 mm 2 for the ostial LCX, ostial LAD, and distal LM, respectively. Results: 15 (68.2%) patients underwent LM bifurcation angioplasty using provisional strategy and 7(31.81%) using upfront two stent strategy (DKC 22.7% & TAP 9.1%). A total of 55 Ca lesions were modified using one IVL per patient with a mean size of 3.38 ± 0.40mm. Stent expansion at LM was 95.64±5.89%, left anterior descending (LAD) was 87.20±6.81% and left circumflex (LCx) was 85.56±5.89%. The primary efficacy endpoint of more than 80% stent expansion was noticed in all LM segments (22/22), 18/20 (90%) LAD segments, and 9/9 LCX segments. The primary safety endpoints were met in 21 (95.45%) patients undergoing IVL-assisted distal LM bifurcation angioplasty. Target MSAs were achieved in all 22 (100%) of all IVL-treated segments, and stent apposition was achieved in 21 (95%) of all stented segments. No perforation (0%) or slow/no flow (0%) were observed, while minor 3 (13.6%) and major dissections 3 (13.6%) were seen. None of the major dissections were flow-limiting. Conclusions: IVL appears to be a safe and effective device for percutaneous coronary intervention of severely calcific LM disease with a high success rate.