Intravascular lithotripsy beneficial for calcified lesions in various vascular beds
Three publications in JACC: Cardiovascular Interventions showed how intravascular lithotripsy may benefit patients with severely calcified lesions.
A pooled analysis of the DISRUPT CAD studies showed intravascular lithotripsy (Shockwave IVL, Shockwave Medical) safely enabled stent implantation in patients with severely calcified coronary lesions, whereas a paper on 30-day outcomes from the DISRUPT PAD III trial showed the technology effectively facilitated endovascular treatment of calcified femoropopliteal arteries and a separate review explored the mechanisms enabling the technology to act on calcified lesions.
The technology was adapted from extracorporeal shockwave lithotripsy used to break up kidney stones, and the review covers “how the sonic pressure wave had to be modified so that it would not ... damage normal tissue or cause arterial injury,” Dean J. Kereiakes, MD, FACC, FSCAI, president of the Christ Hospital Heart and Vascular Institute, Cincinnati, and professor of clinical medicine at The Ohio State University, told Healio. “It also covers the role of the fluid-filled balloon and heat dissipation. The balloon can minimize what little heat is generated. We designed the device so that heat would not be a problem, even though the relative amount of heat is much less than what is generated from the ablative technologies, which are much less controlled. The application of this technology is quite broad and allows us to treat severely calcified vessels wherever they occur in the vascular tree.”
Patients with CAD
In the pooled analysis of 628 patients (97% with confirmed severe target lesion calcification) from the four prospective DISRUPT CAD studies, the primary safety endpoint of freedom from MACE, defined as cardiac death, MI or target vessel revascularization at 30 days, occurred in 92.7% of patients, and the primary effectiveness endpoint of procedural success, defined as stent delivery with residual stenosis 30% or less by quantitative coronary angiography and no in-hospital MACE, occurred in 92.4%, Kereiakes and colleagues wrote.
At 30 days, 7.2% of patients had target lesion failure, 0.5% died from a cardiac cause and 0.8% had stent thrombosis, according to the researchers.
There were no device-associated perforations, abrupt closures or episodes of no reflow, and the rate of postprocedural serious angiographic complications was 2.1%, whereas the rate of final serious angiographic complications was 0.3%, the researchers wrote.
“This is the largest clinical experience with coronary IVL to date,” Kereiakes told Healio. “There was very consistent safety and effectiveness. The reproducibility and generalizability across more than 70 centers internationally gives us more assurance about the reliability and accuracy of the point estimates for complication rates.”
Patients with PAD
In DISRUPT-PAD III, 306 patients with peripheral artery disease, including moderate or severe calcification of femoropopliteal lesions, were randomly assigned to receive IVL or percutaneous transluminal angioplasty before a drug-coated balloon or stent.
Procedural success, defined as residual stenosis 30% or less without flow-limiting dissection, occurred in 65.8% of the IVL group compared with 50.4% of the PTA group (P = .01), whereas the IVL group had more residual stenosis 30% or less (66.4% vs. 51.9%; P = .02) and less flow-limiting dissections (1.4% vs. 6.8%; P = .03), the researchers wrote.
At 30 days, there was no difference between the groups in major adverse events (IVL, 0%; PTA, 1.3%; P = .16) and clinically driven target lesion revascularization (0.7% in both groups; P = 1), according to the researchers.
‘Treatment of choice’
Kereiakes said he believes there is enough evidence to make IVL the “treatment of choice for heavily calcified vessels. It is now time to expand the purview of IVL to patient populations who were not included in these clinical trials.”
He noted that outside the U.S., there is experience with using IVL to treat in-stent restenosis, a major reason for which is underexpansion of stents, a major reason for which is calcification.
“When a stent is underexpanded due to calcium, that increases risk of thrombosis and restenosis,” Kereiakes told Healio. “We can use IVL to fracture the calcium behind the struts to fully expand the stent, and then apply brachytherapy, or drug-coated balloons when they become available. That is an off-label use in the U.S., but I think it’s going to be one of the next common applications of IVL.”
Also likely to increase in use is the joint utilization of rotational atherectomy and IVL to get the IVL catheter placed where it needs to be, he said.
“And then you let the IVL catheter do the work, because we know it is safer and more effective for deeper calcium than any other technology,” he said.
A favorable reimbursement decision from CMS may also increase use of IVL, Kereiakes told Healio. In June, CMS granted a transitional pass-through payment for use of the technology in outpatient settings.
“This is a huge boost for use of the technology, but a huge boost for patient care, too,” Kereiakes told Healio.
References:
- Kereiakes DJ, et al. JACC Cardiovasc Interv. 2021;doi:10.1016/j.jcin.2021.03.036.
- Tepe G, et al. JACC Cardiovasc Interv. 2021;doi:10.1016/j.jcin.2021.04.010.
For more information:
Dean J. Kereiakes, MD, FACC, FSCAI, can be reached at dean.kereiakes@thechristhospital.com.
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