Safety and efficacy of coronary intravascular lithotripsy for calcified coronary arteries– a systematic review and meta-analysis

Abstract

Objectives: Intravascular lithotripsy (IVL) clinical efficacy and safety in the treatment of calcified coronary artery disease (CAC) is not well known. We sought to assess IVL safety and efficacy in CAC. Methods:A comprehensive online databases search were performed to identify intravascular lithotripsy studies in patients with coronary artery disease. The primary outcome was IVL related change in the mean pre and post-procedural diameter of the coronary artery.Results: A total of 4 studies with 282 patients were included. The mean pre-IVL coronary diameter for all patients was 1.01mm, while the mean post-IVL coronary diameter was 2.70mm. The mean pre-post IVL diameter difference of coronary arteries on the pooled analysis was significantly lower by 4.08 mm (95% CI -4.94 to -3.30, p≤0.00001). The Overall increase in the post-IVL lumen diameter was significantly higher than the pre-IVL diameter with a mean difference of -4.16 (95% CI -5.08 to -3.24, p=0.000001).However, compared to pre-IVL, there was a significant reduction in the overall mean difference of luminal calcium angle after IVL of the stented coronary arteries (0.09, 95% CI 0.002-0.16, p=0.01). Conclusion:Intravascular lithotripsy can offer a significant improvement in the vessel lumen to facilitate coronary stent delivery and deployments in severely calcified coronary arteries.

Intravascular Lithotripsy as a Novel Treatment Method for Calcified Unprotected Left Main Diseases—Comparison to Rotational Atherectomy—Short-Term Outcomes

“…These findings might be linked to the decreased rate of periprocedural complications after S-IVL. Relatively lower rates of perforation were observed, and the slow/no-flow phenomena have been confirmed in the non-LM studies [ 31 , 32 , 33 ], which are also associated with the mechanism of action in S-IVL. Since lithotripsy leads to defragmentation and fractures of the calcific plaque without affecting a vessel wall, it does not generate the plaque ablation, meaning that the occurrence of the no-flow phenomenon or perforation is very unlikely.…”

Use of Intravascular Lithotripsy in Heavily Calcified Renal Artery Stenosis: A Case Report

“…Early non-randomized observational studies, such as the Disrupt CAD I, II, III and IV and the Disrupt PAD I and II trials, have shown that the IVL system is a safe and effective option for the preparation and dilation of highly calcified lesions in coronary and femoropopliteal arteries that are difficult to treat with conventional endovascular techniques. 3,[7][8][9][10][11] To date, the only randomized controlled trial with the IVL system is the Disrupt PAD III trial. 7 In this single-blind study, patients with arterial insufficiency due to calcified superficial femoral or popliteal lesions received vessel preparation with the IVL system or a plain balloon percutaneous transluminal angioplasty (PTA), followed by stenting or drug coated balloon application if required.…”

Safety and Short-Term Efficacy of Intravascular Lithotripsy for Treatment of Peripheral Arterial Disease: A Systematic Review

“…Six-hundred seventy-nine of the 976 enrolled patients had the locations of their lesion (s) identified. Four-hundred thirty-six patients had a single identified lesion, either in the common iliac artery (77), external iliac artery (17), left iliac artery (3), right iliac artery (4), common femoral artery (66), superficial femoral artery (191), popliteal artery (79), unnamed infrapopliteal vessel (5), anterior tibial artery (47), posterior tibial artery (26), tibioperoneal trunk (40), or the peroneal artery (21). Sixty-two patients had multiple lesions treated, including 47 with both the common and external iliac artery, 5 with both the superficial femoral and popliteal artery, 9 with the anterior tibial, posterior tibial and peroneal arteries, 27 and 1 with the anterior tibial and posterior tibial arteries.…”

“…[16][17][18] The technology emits high-intensity sonic pressure waves into the body to fragment stones without harming surrounding important soft tissue. 19 Over the past decade, this technology has been adapted to break up calcified plaques and improve the compliance of vasculature in patients with cardiovascular disease [20][21][22] and now in more recent years, has been used in patients with PAD. Termed intravascular lithotripsy (IVL) (Shockwave Medical, Fremont, California, United States), 23 the novel application of this existing technology serves as an adjunctive minimally invasive endovascular treatment for calcified plaques in the lower extremities of patients.…”