Multi-center evaluation of clinical outcomes of intravascular lithotripsy for severely calcified coronary artery lesions: The Israeli Shockwave Registry (ISR)

Introduction:

Intravascular lithotripsy (IVL) is a novel balloon-based technique with acoustic pressure waves for the treatment of severely calcified coronary artery lesions. Methods:

We evaluated clinical outcomes of all consecutive cases with calcified coronary lesions that underwent IVL at several Israeli centers between December 2019 and March 2021. We aimed to describe experience after treatment of calcified coronary artery lesions with IVL in a real-world unselected high-risk population.

Results:

This registry included 42 patients (42 lesions). Patient`s age was 73.8 ± 10.1 years old. Twenty-six patients (61.9%) presented with acute myocardial infarction, three of them (7.1%) were critically ill with cardiogenic shock requiring mechanical support with Impella CP in 1 case and IABP in 2 patients. Other fifteen patients (35.7%) presented with angina pectoris. All lesions were classified as type B2/C. The most frequently treated artery was the LAD. IVL was used in 2 left main coronary artery lesions (4.8%), 9 bifurcation lesions (21.4%), 4 in-stent restenosis (9.5%). Most of lesions were long (>20mm) and severely calcified. Predilatation was performed in 33 lesions (78.6%). Rotablator was used in one lesion pre-IVL (3.4%). Successful IVL cross was achieved in 41 lesions (97.6%). On average, IVL required 3.1±0.4 mm balloons delivering a mean of 60 pulses. After IVL successful stent delivery was achieved in 33 cases (78.6%). The average number of stents per case was 2 [range1-4] according to lesion length and the treatment of residual stent edge dissection. There were no serious procedural complications. During follow-up period, 1 patient (2.4%) presented with myocardial infarction caused by definite stent thrombosis 72 hours after the procedure.

Conclusion:

The data from the Israeli Shockwave multi-center Registry supports the using of IVL for calcified coronary lesions in an unselected and high-risk population with promising results. Long-term outcomes of these procedures will be presented.