Background: Intravascular lithotripsy (IVL) is a valuable additional tool to rotational atherectomy for the treatment of severely calcified coronary stenosis. Moderate-to severe coronary calcification is commonly associated with a greater degree of lesion complexity and is expected to increase with increasing patient age, chronic kidney disease, and diabetes.
The aim of the case series was to determine safety and efficacy of a coronary lithotripsy in patients with chronic coronary syndrome (CCS). 

Methods: The current clinic case series included 12 patients with chronic coronary syndrome and symptomatic or prognostic indication to the coronary intervention. Single de-novo and pretreated stenosis more than 70% with signs of severe calcification and target vessel diameter more than 2.5 mm were decided to be suitable for the treatment with Shockwave coronary IVL catheter (Shockwave Medical, Santa Clara, CA). The evidence of calcification was made by an angiography with reassessment of vessel diameter after completion of revascularization. The number of the balloon rupture, including IVL-catheter balloon rupture, vessel dissection and vessel closure or slow-flow during procedure was assessed. The treatment was estimate to be effective in case of no MACE (cardiac death, target vessel revascularization, stent thrombosis) was registered upon to the discharge.

Results: Between September 2018 and August 2020 twelve patients (mean age, 74±7 years; 66% of male gender) presented with Class III angina or evidence of ischemia were treated with Shockwave C² Coronary IVL Catheter. Seven patients (58.3%) presented with diabetes and 6 of 10 patients (60%) had chronic kidney disease. The left ventricular ejection fraction was 53.9±8.1%. In 50% of all cases it was the second intervention during index hospitalization because of failure to modify the culprit lesion with high-pressure non-compliant balloons and cutting balloons and of failure to deliver stents. In 11 of 12 cases (91.6%) it was a concentric stenosis with no side branch involvement and in 3of 12 cases (25%) it was an in-stent-stenosis treated.  There were no calcifications with a length more than 30 mm.  The maximal grade of restenosis was estimated by 15%. Just one patient has experienced a target vessel dissection type A after rupture of the IVL –catheter balloon preceded by perforation of semi-compliant balloon. Another case with a vessel dissection was registered after IVL treatment without any sign of balloon rupture. In our case series we did not registered vessel closure or slow-flow phenomenon. All patients were discharged without confirmed MACE events.  

Conclusions: In our clinical case series of 12 patients, there was clinical success in 100% of patients.  The low rate of major vessel dissection (0.3% in CAD III study) confirms IVL safety and provides a valid strategy for lesion preparation in severely calcified coronary lesions with high success rate, low procedural complications, and low major adverse cardiovascular event rates.