Intravascular lithotripsy for calcific coronary and peripheral artery stenoses

Abstract

Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher rates of target lesion revascularisation (TLR). High-pressure non-compliant balloon angioplasty may be of insufficient force to modify calcium and, even when successful, may be limited in its ability to modify the entire calcified lesion. Scoring and cutting balloons hold theoretical value but data to support their efficacy are lacking and, because of their high lesion crossing profile, they often fail to reach the target lesion. Rotational and orbital atherectomy target superficial calcium; however, deep calcium, which may still impact on vessel expansion and luminal gain, is not affected. Intravascular lithotripsy (IVL), based on lithotripsy for renal calculi, is a new technology which uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue. Energy is delivered via a balloon catheter, analogous to contemporary balloon catheters, with transmission through diluted ionic contrast in a semi-compliant balloon inflated at low pressure with sufficient diameter to achieve contact with the vessel wall. With coronary and peripheral balloons approved in Europe, peripheral balloons approved in the USA and multiple new trials beginning, we review the indications for these recently introduced devices, summarise the clinical outcomes of the available trials and describe the design of ongoing studies.

Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient‐level pooled data analysis

“…Endovascular therapy in patients with significantly calcified PAD remains a challenge as these lesions render balloon and stent expansion difficult and increase the risk for flow limiting dissection and other peri‐procedural complications . Moreover, the fact that patients included in these trials all had significant peripheral artery calcification and would have likely been excluded from clinical studies of other technologies suggests the critical need for further investigation to optimize treatments and outcomes in this high‐risk patient population.…”

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

“…While angiography alone underestimates calcium and does not easily allow its quantification, multidetector coronary computed tomography (CT), a non-invasive technique able to measure calcium score and assess prognosis. It is considered by many to be the technique with greatest diagnostic utility [12]. Napkin-ring sign, low CT attenuation, spotty calcification, and the remarkable positive remodeling are the four signs of risky plaques.…”

“…Risk unique to the device includes -allergy to catheter material, device malfunction or failure, excess heat at the target sites, effects on cardiac rhythm causing 'shock topics,' and asynchronous cardiac pacing have been reported. The adverse effects with standard angioplasty include access site complications, allergy to contrast, bleeding complications, arterial bypass surgery, fracture of guide-wire or device, death, hypertension or hypotension, placement of a stent, infection/sepsis, target vessel stenosis or occlusion, shock/pulmonary edema, renal failure, vascular complications [12].…”

“…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.…”

“…[12].While comparing Latest Disrupt CAD II vs. ROTAXUS,120 vs. 240 patients were enrolled, respectively. Successful delivery and use of the IVL catheter were achieved in 100% patients, whereas 92.5% with RA.…”