Complications after intravascular lithotripsy are rare, real-world data confirm
![The use of intravascular lithotripsy (IVL) during percutaneous coronary intervention (PCI) is still safe and effective when patients present with calcified nodules (CNs), according to new long-term data published in EuroIntervention.[1] Researchers compared outcomes from patients with and without CNs, highlighting key similarities in stent expansion and luminal gain.](/sites/default/files/styles/top_stories/public/2024-12/screenshot_2024-12-02_at_11.07.21_am.png.webp?itok=YDi6SyF_)
Complications after intravascular lithotripsy (IVL) are rare, according to new research published in JSCAI.[1] When they do occur, however, they significant increase a patient’s one-year risk of experiencing an adverse cardiovascular event.
“IVL has emerged as a promising treatment for coronary artery calcification (CAC), demonstrating safety and efficacy in previous studies,” Martijn J.H. van Oort, MSc, a clinical researcher with Leiden University Medical Center, and colleagues. “IVL utilizes a balloon-based system that generates shockwaves upon inflation at low pressure, targeting calcium deposits superficially and deeply embedded in the vessel wall. This facilitates calcium modification in the form of calcium fractures, which enables the use and expansion of balloons and stents in the affected calcified lesions.”
However, the group noted, many of the clinical trials focused on the safety and effectiveness of IVL excluded certain high-risk patients, “limiting generalizability to real-world populations.”
To learn more, the study’s authors tracked real-world data from more than 500 IVL patients who underwent treatment from 2019 to 2024 in Europe. All patients were treated with the IVL technology developed by Shockwave Medical, which is now a part of Johnson & Johnson.
The mean patient age was 73 years old, and 75% of patients were male. Overall, complications occurred in 6% of patients. Just 1% of patients experienced a complication immediately following IVL.
Flow-limiting coronary dissections and hemodynamic instability and coronary perforations were the most common complications. A total of 30 additional interventions were required to manage these issues. After one year, the group added, major adverse cardiovascular event (MACEs) occurred in 11% of patients, and they were much more likely if that patient had experienced a procedural complication.
Another key takeaway from this analysis was the fact that there was an association between higher balloon-to-artery ratios and IVL complications. The use of additional plaque modification techniques, meanwhile, did not increase the risk of complications.
“The 6% complication rate observed in this study is consistent with findings from other studies evaluating IVL,” the authors wrote. “In the pooled analysis of the Disrupt CAD studies, a lower complication rate was reported at 2%. However, in this study, patients with acute coronary syndrome (ACS) and complex target lesion subsets were excluded, which may have contributed to the lower complication rate compared to our results. In contrast, the REPLICA-18 study reported an identical complication rate of 6% and included a significant proportion of patients presenting with ACS. This consistency suggests that IVL is applicable and effective in real-world patient populations.”
Van Oort noted that IVL’s complication rates tend to be lower than rotational atherctomy (RA) and orbital atherectomy (OA). The success rates for these different techniques remain comparable.
“Considering IVL’s ease of use and shorter learning curve compared to RA and OA, it appears to be a safer alternative to these techniques if it can be delivered, but randomized trials are needed to demonstrate this conclusively,” the authors wrote.
Shockwave Medical, now a part of Johnson & Johnson MedTech, did fund this analysis. The company did not participate in the trial in any way.
Click here to read the full study in JSCAI.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.