Feasibility of intravascular lithotripsy for calcific coronary lesions: A multi‐institutional experience

Abstract

Objective We sought to determine the safety and performance of intravascular lithotripsy in the treatment of severe calcified atherosclerotic lesions. Background The modification of severe calcified atherosclerotic lesions with noncompliant or specialty balloons, as well as orbital or rotational atherectomy has limitations and may be ineffective, increasing the risk of periprocedural complications and worsening long‐term results. Intravascular lithotripsy has recently been shown to be a safe and feasible alternative to the above methods. Methods All consecutive patients treated with Shockwave Medical Intravascular Lithotripsy (S‐IVL) between May 2019 and June 2020 were included in current analysis. Device safety and efficacy were the critical endpoints of the study. The primary safety endpoint was 30‐day major adverse cardiac events (MACE). In turn, device and clinical success were the primary performance endpoints. Results In total, 46 patients undergoing percutaneous coronary intervention were treated with S‐IVL before stent deployment (65% male; age, 71 ± 7 years). Device success was achieved in 45 (97.8%) patients with reduction of diameter stenosis from 80% to 5.2% with an acute gain of 2.5 mm. Clinical success was demonstrated in 95.6% of cases. During the 30‐day follow‐up, one sudden death was recorded, regarded as probable subacute stent thrombosis. During 6‐month follow up one target lesion and target vessel revascularizations occurred. The rate of MACE after 6 month was 6.2%. Conclusions S‐IVL appears to be a safe and effective treatment modality in coronary calcium modification to optimize stent expansion. In selected cases this device obviates the need for more complex lesion preparation strategies such as atherectomy.

Long‐term outcomes following intravascular lithotripsy (IVL) for calcified coronary lesions: A Real‐World Multicenter European Study

“…In addition, atherectomy devices may be influenced by wire bias and hence may be ineffective in concentric calcium. Intravascular lithotripsy (IVL) is a new technology that delivers pulsatile sonic pressure waves converted to mechanical energy to modify vascular calcium 23–30 . It leverages similar principles to urologic lithotripsy, which has been used as a safe and effective treatment for kidney stones for several decades 31,32 .…”

“…IVL safely and effectively modifies both intimal and medial calcium. Although there are single‐arm studies of IVL in coronary arteries from the Disrupt CAD trials, long‐term data from real‐world populations are scarce 24,28–30 . We had previously reported short‐term data from a real‐world population 33 .…”

“…Intravascular lithotripsy (IVL) is a new technology that delivers pulsatile sonic pressure waves converted to mechanical energy to modify vascular calcium. [23][24][25][26][27][28][29][30] It leverages similar principles to urologic lithotripsy, which has been used as a safe and effective treatment for kidney stones for several decades. 31,32 IVL safely and effectively modifies both intimal and medial calcium.…”

“…Although there are single-arm studies of IVL in coronary arteries from the Disrupt CAD trials, long-term data from real-world populations are scarce. 24,[28][29][30] We had previously reported short-term data from a real-world population. 33 This study reports long-term data from a larger patient database from additional centers.…”

Intravascular ultrasound-guided lithotripsy in a calcified saphenous vein graft

“…Although a severe SVG calcification is rare, its presence can lead to incomplete expansion of stents and, consequently, a higher incidence of stent failure. S-IVL appears to be a safe, effective, and feasible strategy for calcium modification in native coronary arteries [3,4]. We demonstrated intravascular lithotripsy as a safe and effective treatment method of a calcified SVG disease as well.…”