In the Disrupt BTK pilot study, intravascular lithotripsy successfully treated calcified and stenotic infrapopliteal arteries, researchers reported.
According to the study background, intravascular lithotripsy (Shockwave Medical Peripheral IVL System, Shockwave Medical) uses pulsatile sonic pressure waves that pass through soft tissue and fracture high-density calcium.
Marianne Brodmann, MD, interim head of the clinical division of angiology, department of internal medicine, Medical University Graz, Austria, and colleagues conducted a pilot study of the technology in 20 patients with moderate to severe below-the-knee arterial calcification. The mean age was 79 years, 14 patients were men and 16 had critical limb ischemia.
The primary safety endpoint was 30-day major adverse events, defined as death, MI, emergency surgical target limb revascularization and target limb amputation. The primary efficacy outcome was acute reduction in percent diameter stenosis.
Delivery of the intravascular lithotripsy catheter was successful in all but one patient, and there were no major adverse events at 30 days, according to the researchers.
Acute reduction in percent diameter stenosis in target lesions was 46.5%, with all patients achieving residual diameter stenosis of 50% or less, Brodmann and colleagues wrote.
After treatment, the mean diameter stenosis was 26.2% compared with 72.6% at baseline, and the acute mean lumen gain was 1.5 mm (range, 0.7-2.3), according to the researchers.
The only major vascular complication was a type B dissection, and no adverse events were related to the device, Brodmann and colleagues wrote.
“Early results with the Shockwave Peripheral Intravascular Lithotripsy System in infrapopliteal lesions show a consistent reduction in stenosis and no procedural complications, including perforation or distal embolization,” Brodmann and colleagues wrote. “Additional evaluation with this promising technology is warranted.” – by Erik Swain
Disclosures: The study was funded by Shockwave Medical. Brodmann and two other authors report they received institutional research grants from and participated in physician advisory meetings for Shockwave Medical.