Intravascular Lithotripsy for the Treatment of Peripheral Artery Calcification: Results from the Disrupt PAD III Observational Study

Tuesday, March 7, 2023

3:18 PM – 3:27 PM

Location: Phoenix Convention Center, 225AB

Presenting Author(s)

Andrew Holden, ONZM, MBChB, FRANZCR, EBIR

Associate Professor
Aukland District Health Board / Auckland Hospital

Disclosure(s): Boston Scientific: Advisory Committee or Review Panel Member (Ongoing); Gore: Advisory Committee or Review Panel Member (Ongoing); Medtronic: Advisory Committee or Review Panel Member (Ongoing); Philips: Advisory Committee or Review Panel Member (Ongoing)

Disclosure(s):

Andrew Holden, ONZM, MBChB, FRANZCR, EBIR: Boston Scientific: Advisory Committee or Review Panel Member (Ongoing); Gore: Advisory Committee or Review Panel Member (Ongoing); Medtronic: Advisory Committee or Review Panel Member (Ongoing); Philips: Advisory Committee or Review Panel Member (Ongoing)

Purpose: To evaluate the performance of intravascular lithotripsy (IVL) in the treatment of calcified peripheral artery disease (PAD).

Materials and Methods: The Disrupt PAD III Observational Study (OS) is a prospective, multicenter, single-arm, independent core lab-assessed study designed to evaluate the acute safety and effectiveness of the Shockwave Peripheral IVL System. Multivariate analysis was performed to assess independent predictors of stenosis reduction and angiographic complications.

Results:

1373 patients with 1677 lesions were enrolled between November 2017 and June 2021 (mean age 72.0 ± 9.0 years; 70.5% male) across 30 international sites. 91.3% (1531/1677) of the lesions were core-lab evaluable. Hypertension (93.9%), diabetes mellitus (55.5%), and renal insufficiency (27.4%) were frequent comorbidities; 36% had critical limb ischemia, and 78.7% were smokers. Diameter stenosis, lesion length, and PARC-defined moderate-severe calcification at baseline were 80.6 ± 17.6%, 93.5 ± 74.3mm, and 89.9%, respectively. Treated vessels included femoropopliteal (60.7%), iliac (15.8%), common femoral (10.7%) and infrapopliteal arteries (12.8%). Target lesions included 31% CTOs, 19.3% long lesions (≥15 cm), and 20.1% eccentric lesions. Concomitant use of atherectomy and/or specialty balloon technology was observed in 22.1% of lesions. Residual stenosis immediately following IVL treatment and at the end of the procedure was 32.5 ± 16.3% and 23.8 ± 11.3%, respectively. After final treatment, the rate of serious angiographic complications was low (0.7% flow-limiting dissections, 0.2% perforations) with no abrupt closure, distal embolization, no flow, or thrombotic events. Independent predictors for final residual stenosis ≤30% were lesion length ≥15 cm (OR: 0.384 [0.283-0.521]), female sex (OR: 1.850 [1.376-2.489]), age ≤75 years (OR: 1.625 [1.247-2.117]), IVL balloon to artery ratio ≥1.0 (OR: 1.538 [1.189-1.989]), and CTO (OR: 0.638 [0.482-0.844]). Lesion length ≥15cm was an independent predictor for serious angiographic complications (OR: 16.076 [3.394-76.152]).

Conclusion:

Peripheral IVL demonstrated excellent procedural safety, with low rates of serious angiographic complications, and a marked reduction in the final residual stenosis in heavily calcified, complex PAD lesions. The Disrupt PAD III OS represents the largest analysis of periprocedural outcomes following IVL treatment. The importance of appropriate IVL balloon sizing was confirmed by multivariate analysis.