News Release Details
New Shockwave Coronary IVL Publications Confirm Safety and Efficacy Across Multiple Calcium Morphologies
“While the majority of the robust, core-lab adjudicated evidence supporting coronary IVL to date has studied concentric calcium, we are beginning to see a shift in evidence reinforcing IVL use across all calcium morphologies, both in retrospective analyses and ‘real-world’ prospective registries,” said
IVL in Eccentric Calcium
Published in Circulation: Cardiovascular Intervention and titled, “Impact of Calcium Eccentricity on the Safety and Effectiveness of Coronary Intravascular Lithotripsy: Pooled Analysis from the Disrupt CAD studies,” the eccentric analysis divided individual patient-level data (N=230) analyzed by an independent OCT core laboratory into quartiles from eccentric to concentric based on maximum continuous calcium arc.
While there were no differences in pre-procedure minimum lumen area (MLA), diameter stenosis, or maximum calcium thickness across the different calcium arcs, the calcium length and overall volume index increased progressively with concentric calcium, and a higher minimum calcium thickness was increased with eccentric calcium. Post-procedure, the number of calcium fractures, fracture depth and width increased with increasing concentricity; however, there were no significant differences in mean stent area (7.39mm2 vs 7.22mm2 vs 7.26mm2 vs 8.09mm2; p= 0.07) or stent expansion (98.7% vs 100.3% vs 95.4% vs 101.9%; p=0.74) across quartiles at the site of maximum calcification. These excellent results were achieved in the absence of any procedural complications.
“IVL was initially adopted in clinical practice because of its ability to modify concentric calcium in a safe and predictable manner, and we are now seeing the utility increase as the consistency of the safety and efficacy outcomes related to IVL expand across calcium arcs,” said Dr.
IVL in Nodular Calcium
Published in JACC: Cardiovascular Interventions and titled, “Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Calcified Nodules,” the patient-level pooled analysis from the Disrupt CAD studies was the first investigation of IVL in calcified nodules, examining 54 nodules found within 248 lesions (22%) analyzable by OCT. In lesions with calcific nodules, IVL was found to be highly effective in modifying the calcium prior stent implantation, reducing stenosis to a residual area of less than 15 percent with an acute gain of 1.8 mm2 in a safe manner with no major procedural complications.
When comparing lesions with and without calcific nodules treated with IVL, there were no significant differences in minimum stent area (6.3mm2 vs 6.0 mm2), mean stent area (8.3mm2 vs 7.9 mm2), or stent expansion at the maximum site of calcification (104.9% vs 99.4%). There was a trend toward more calcium fractures (78.7% vs 65.2%; p=0.07) in lesions with calcific nodules as well as an increased fracture length (5.2mm vs 3.6mm p=0.02) in nodular lesions.
“These new acute data with IVL are very encouraging and reconfirm the safety of IVL with no procedural complications in lesions with calcific nodules, which is generally a high-risk setting, however, there is still a lot to learn about this challenging calcium morphology to reduce long-term events associated with calcific nodular protrusion into the stent,” said
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Source: Shockwave Medical, Inc.