IVL is an innovative way to treat calcified plaque buildup in the coronary and peripheral arteries. During an IVL procedure, sonic pressure waves, or shock waves, create mechanical energy that fractures calcium deposits in the arteries. But is an IVL procedure safe? In this article, we review IVL safety, IVL indications, and explain what it’s like to be an IVL patient.

IVL is a Relatively Safe Procedure for the Treatment of Calcified Arteries

IVL is generally considered to be a safe procedure for modifying plaque in coronary and peripheral arteries. Peer-reviewed studies have indicated that IVL has a favorable safety profile, with a low incidence of procedure-related complications.(1) Fewer than 2% of patients experienced an artery dissection, and in vulnerable patients with intricate coronary issues, the in-hospital and 30-day rates of major adverse cardiac events are low – 5.8% and 7.6%, respectively.(1)

IVL is Mostly Painless for Patients

IVL is typically a painless procedure for patients, aside from the discomfort of inserting a catheter. For a patient, going through an IVL procedure is similar to other catheter-based procedures like angioplasty or stent placement. Some IVL patients are given mild sedation to help them relax. However, most patients remain awake during the procedure and can communicate with the medical team. Local anesthesia is applied at the site where the catheter will be inserted to numb the area and ensure the patient is comfortable. IVL can be an outpatient or inpatient procedure.

The Precision of IVL: Procedures are Highly Selective, Targeting Arterial Plaque

IVL is highly selective. The energy from an IVL treatment creates cracks and fissures in hard plaque, while passing harmlessly through soft, fibroelastic tissues in the artery walls. IVL has proven to be an effective way to fracture plaque without harming the vessel.(2) This precision helps the artery to become more compliant, optimizing subsequent interventions like balloon inflations, which require significantly lower pressures than traditional methods.

IVL Indications and Applications: When it’s Safe to Use IVL

Today, intravascular lithotripsy is specifically approved for modifying calcified plaque within the coronary and peripheral arteries. This makes IVL a leading option for the treatment of calcium deposits associated with coronary artery disease (CAD) and peripheral arterial disease (PAD). Treating calcified coronary and peripheral arteries with IVL has an excellent safety profile.

The medical community is hoping to broaden the approved applications of IVL beyond only the coronary and peripheral arteries. IVL is currently under investigation for its potential to address other conditions like chronic total occlusions and structural heart applications. To ensure patient safety, IVL should never be used for purposes beyond its specific approved indications.

IVL Contraindications: When It’s Not Safe to Use IVL

IVL systems, when used with IVL catheters, have contraindications that apply across various applications: 

• Stent delivery: IVL should never be used directly for stent delivery procedures. Although placing a stent is common before or after, IVL shouldn’t be used directly with a stent delivery system.

• Vessels in the neck or brain: IVL is not recommended for use in vessels located in the neck or brain.

• Patients with severely calcified lesions: Patients with pronounced calcified lesions should exercise caution when considering IVL treatment.

• Bleeding disorders and anticoagulant medication: People with a history of bleeding disorders or those currently taking anticoagulant medication should be advised against IVL procedures.

• In-stent restenosis and guidewire issues: Patients with in-stent restenosis or issues related to guidewire passage across the lesion should approach IVL treatment with caution. 

These contraindications are essential to ensure the safe and effective use of IVL across a range of medical applications. Anyone considering IVL should consult their healthcare provider. 

Possible Complications Associated with IVL

The most common complications associated with IVL are similar to those seen in other catheter-based interventions, such as dissection, perforation, or bleeding at the access site. However, the frequency of these complications in initial IVL studies has been relatively low.(1,3,4,5)

Acoustic shock waves used by IVL can activate mechano-sensitive ion channels in cardiomyocytes, potentially causing ectopic heartbeats or "shocktopics." There is also a risk of tachyarrhythmias.(6)

As with all medical procedures, there are limitations and uncertainties associated with IVL. The long-term outcomes of IVL, potential rare complications of IVL, and optimal patient selection are all areas of ongoing research. To date, IVL has proven to be a relatively safe procedure involving few complications and minimal patient discomfort.

Learn more about the science and technology behind IVL in this article.