Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study

Abstract

Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study ( ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease.

Current Treatment Modalities for Calcified Coronary Artery Disease: A Review Article Comparing Novel Intravascular Lithotripsy and Traditional Rotational Atherectomy

“…The PAD III Observational Study is representing the most extensive IVL utilization report in daily clinical practice. Comparing to the prior IVL controlled trials, the use of peripheral IVL in treating severely calcified stenotic lower limb lesions continued to demonstrate consistent acute effectiveness and safety outcomes [28].…”

“…In high-volume centers, it is limited to expert operators, and in Europe, it is employed in only 1%-3% of PCIs [31], apparently due to potential complexities and the expenses, which are not negligible, or when there is weak insurance recruitment. A comparison of IVL studies with RA study is made in [12,28,30]. The major interpretations from these studies are as follows: Firstly, with the IVL catheter crossing the lesion and delivering therapy in all cases, it was demonstrated that a feasible frontline tool for CAC plaque modification.…”

The direct extravascular calcium interruption arterial procedure technique for heavily calcified vessels

“…Although this might be a solution for heavily calcified lesions, its use is accompanied by increased costs, and the safety and efficacy are poorly studied in infrapopliteal arteries. 8 In our series, the DECIAP technique was used to allow a small low-profile balloon to cross the lesion and to perform predilation or to treat persistent recoil. No major procedure-related events occurred during or after the procedure, and the equipment necessary for the procedure is already present in the interventional suite and therefore does not require capital investment of consoles used in some atherectomy systems.…”

“…Although this might be a solution for heavily calcified lesions, its use is accompanied by increased costs, and the safety and efficacy are poorly studied in infrapopliteal arteries. 8 …”

Intravascular Lithotripsy for Treatment of Calcified Lesions During Carotid Artery Stenting

“…As such, IVL has a minimal risk of debris formation or embolization. [8][9][10][11][12][13] The mechanism of IVL is based on mechanical pulse waves created from ultrasonic energy. 14,15 Calcium disruption increases vessel compliance and improves acute lumen gain after balloon angioplasty with/without stent implantation.…”