Intravascular Lithotripsy for Treatment of Calcified, Stenotic Iliac Arteries: A Cohort Analysis From the Disrupt PAD III Study
Ehrin J Armstrong1, Peter A Soukas2, Nicolas Shammas3
1University of Colorado School of Medicine, Aurora, CO, United States of America.
Insights
Peripheral intravascular lithotripsy (IVL) effectively treats calcified iliac artery disease, showing promising safety and efficacy. This approach is suitable for both peripheral artery disease symptoms and improving large-bore access.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Iliac artery calcification complicates endovascular interventions, increasing risks and reducing success rates.
- Peripheral artery disease (PAD) management often involves treating calcified lesions, posing significant challenges for traditional methods.
Purpose of the Study:
- To evaluate the safety and efficacy of peripheral intravascular lithotripsy (IVL) for treating calcified iliac artery lesions in patients with PAD.
- To assess the 'real-world' performance of the Shockwave Peripheral IVL System in a diverse patient cohort.
Main Methods:
- Prospective, multi-center, single-arm study (Disrupt PAD III Observational Study) analyzing 118 patients with calcified iliac lesions.
- IVL catheter delivery was assessed for successful treatment of de novo calcified lesions, with a focus on lesion characteristics and procedural outcomes.
- Data collected included lesion length, stenosis severity, calcification extent, and need for adjunctive therapies like stenting.
Main Results:
- Successful IVL catheter delivery was achieved in all 118 patients, treating 200 lesions.
- Severe calcification was present in 82% of cases, with a mean residual stenosis of 12.0% post-procedure.
- Minimal angiographic complications were observed, with no flow-limiting dissections, indicating a favorable safety profile.
Conclusions:
- Peripheral IVL demonstrates safety and efficacy as a treatment option for calcified, stenotic iliac lesions.
- IVL is a viable tool for managing PAD symptoms and optimizing iliac vasculature for large-bore access procedures.
Purpose:
The presence of calcification in the iliac arteries is associated with decreased procedural success and increased complication risk during endovascular intervention. The objective of this study was to evaluate the safety and efficacy of peripheral intravascular lithotripsy (IVL) during endovascular treatment of iliac arterial peripheral artery disease (PAD).
Methods:
The Disrupt PAD III Observational Study is a prospective, non-randomized, multi-center single-arm study to assess the 'real-world' safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified lesions in the peripheral arteries, with a goal of treating 1500 patients. This is an analysis of consecutive patients enrolled for treatment of an iliac artery, a specified sub-group, with at least moderate calcification and a minimum length of 20 mm.
Results:
Between December 2017 and July 2019, 118 patients with a total of 200 lesions were enrolled across 20 sites. 101 patients were treated primarily for claudication or critical limb ischemia, while 17 patients were treated to optimize the iliac vasculature for large-bore access. All 118 patients had successful IVL catheter delivery. The average reference vessel diameter was 7.3 mm ± 1.9 mm, with an average diameter stenosis of 83.1% ± 13.4% and an average lesion length of 58.3 mm ± 57.6 mm. Severe calcification was present in 82.0% of overall cases. Stent placement was performed in 72.9% of the overall cases. As expected, the access group received less adjunctive therapies including stents (41.2%, p < 0.001). Angiographic complications were minimal with no flow-limiting dissections and a final mean residual stenosis of 12.0% ± 12.1% with no differences between the groups.
Conclusions:
Acute results with IVL in calcified iliac lesions suggest that it is a safe and effective option for calcified, stenotic iliac disease. IVL can be used successfully both for treatment of PAD symptoms and to optimize access for large-bore procedures.
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