IVL Found to Be Safe and Effective for the Treatment of Extensively Calcified PAD Lesions

The use of intravascular lithotripsy (IVL) for the treatment of moderately to severely calcified peripheral arterial disease (PAD) lesions was found to be a safe and effective therapeutic option, according to study results published in Catheterization and Cardiovascular Interventions.

The immediate success and long-term patency of endovascular therapy for PAD using calcium modification devices can be hampered by significant calcification. The use of IVL, in which sonic waves target and disrupt medial and luminal calcium, in the treatment of PAD has not be extensively examined.

In this study, investigators conducted a pooled analysis of individual patient-level data (IPD) across available studies to evaluate the safety and efficacy of IVL for PAD. The pooled IPD was derived from 5 prospective trials in which the use of IVL using the Shockwave Medical Peripheral IVL System was assessed in patients with PAD and extensive peripheral calcification. The primary efficacy outcome was the final postprocedural percent diameter stenosis (%DS) and the primary safety outcome was the incidence of several complications. All study findings were analyzed using angiography conducted by an independent core laboratory.

A total of 336 patients (mean age, 72.9±8.8 years; 75.6% men; 96.5% white) who underwent IVL-based endovascular revascularization were included in the analysis. At baseline, 95.8% of participants had hypertension, 84.6% had hyperlipidemia, 61.8% had coronary artery disease, and 49.8% had diabetes mellitus. The procedure was successful in 335 patients (99.7%), with 170 patients (51.1%) receiving IVL as standalone therapy.

When comparing pre-procedural and final %DS, there was a significant decrease from 78.8% (95% CI, 77.1-80.5) to 23.6% (95% CI, 22.7-24.6), or a difference of 55.1% (95% CI, 53.3-57.0%; P <.0001). A final DS ≤50% was found in 98.8% of all treated lesions. There was no difference in final %DS detected between patients who underwent IVL as standalone therapy vs patients who received IVL plus adjunctive therapies (24.0% vs 23.2%, respectively; P =.46).

Lesion-level complications, including thrombus, vessel perforation, abrupt closure, distal embolization, no reflow, and types D-F flow-limiting dissections, were found to occur in 1.22% of all treated lesions. No cases of thrombus, embolization, closure, or no reflow were reported. No emergent revascularizations or target limb amputations occurred.

Study limitations include the use of data from trials without comparator groups, difficulty in distinguishing IVL benefits secondary to the use of adjunctive therapies in some patients, and a lack of discharge and follow-up assessments in some of the trials analyzed.

“The present IPD of 5 prospective studies, marking the largest analysis to date evaluating the use of IVL in significantly calcified PAD lesions, demonstrates this treatment strategy to be both effective and safe,” noted the authors. They recommended that future research involve comparisons of IVL and non-IVL approaches for PAD treatment, with the goal of optimizing therapeutic strategies.

Disclosures: This study was funded through a research grant from Shockwave Medical.

Reference

Madhavan MV, Shahim B, Mena‐Hurtado C, Garcia L, Crowley A, Parikh SA. Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient‐level pooled data analysis [published online January 20, 2020]. Catheter Cardiovasc Interv. doi:10.1002/ccd.28729