Cardiovascular revascularization medicine : including molecular interventions · 2026
Hertz contact intravascular lithotripsy for calcified coronary lesions in real-world practice: Primary outcomes of the MY-IVL post-market study.
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Muthusamy Tamil Selvan, Kolanthaivelu Jayakhanthan, Choo Gim Hooi, Wan Rahimi Shah Wan Faizal, Thuraisingham Suren, Omar Al Fazir, Chew David Soon Ping, Goh Khiam Yan, Tan Kim, Chan Lawrence Hon Wah, Melaku Gebremedhin D, Garcia-Garcia Hector M, Mohd Ali Rosli
Аннотация
BACKGROUND: Hertz Contact Intravascular Lithotripsy (HC-IVL) is the first mechanical IVL platform designed to fragment coronary calcium, while minimizing injury to adjacent non-calcified vessel tissue and eliminating the need for external energy source or capital equipment. The PINNACLE-I clinical trial has demonstrated the safety and effectiveness of HC-IVL in treating moderate to severe calcific coronary lesions. In the MY-IVL Study, we aim to evaluate the safety and performance of HC-IVL in a real-world population including patients with multivessel disease, left main disease, chronic total occlusions, and in-stent restenosis.
METHODS: This study includes consecutive patients undergoing HC-IVL between April and September 2025 at a single center with an estimated sample size of 100 subjects. All subjects undergo angiographic and intravascular imaging (OCT / IVUS) at baseline, post-HC-IVL, and post-PCI. Primary safety endpoint was 30-day freedom from MACE (cardiovascular death, MI, target vessel revascularization). Co-primary effectiveness endpoints were residual stenosis <30% without intraprocedural MACE and minimum stent area ≥ 4.9 mm2 by intravascular imaging. All imaging analyses are performed by an independent core laboratory.
RESULTS: A total of 102 patients with 130 calcified lesions were treated with HC-IVL, with successful device delivery in all cases and a median of one IVL catheter used per procedure. The primary safety endpoint was achieved in 96.1%, with 96.3% of stented lesions demonstrating residual stenosis <30% without intraprocedural MACE. The 30-day MACE rate was 3.9%, with no myocardial infarction, no target vessel revascularization, and no device-related complications. By intravascular imaging, the mean minimum stent area was 6.89 mm2 and the lower bound of the 95% confidence interval was 6.50 mm2, which exceeded the PG of 4.9 mm2 (p < 0.0001). Mean stent expansion was 113.7% across a wide spectrum of calcium morphologies including concentric, eccentric, and circumferential arcs up to 360°. Acute angiographic gain averaged 1.75 ± 0.58 mm with a final in-lesion diameter stenosis of 10.7%.
CONCLUSIONS: MY-IVL study demonstrates that the LithiX HC-IVL system provides safe, effective, and efficient calcium modification across diverse calcified lesion morphologies in a high-risk, real-world Asian PCI population, facilitating optimal coronary stent implantation with favorable early clinical outcomes.
METHODS: This study includes consecutive patients undergoing HC-IVL between April and September 2025 at a single center with an estimated sample size of 100 subjects. All subjects undergo angiographic and intravascular imaging (OCT / IVUS) at baseline, post-HC-IVL, and post-PCI. Primary safety endpoint was 30-day freedom from MACE (cardiovascular death, MI, target vessel revascularization). Co-primary effectiveness endpoints were residual stenosis <30% without intraprocedural MACE and minimum stent area ≥ 4.9 mm2 by intravascular imaging. All imaging analyses are performed by an independent core laboratory.
RESULTS: A total of 102 patients with 130 calcified lesions were treated with HC-IVL, with successful device delivery in all cases and a median of one IVL catheter used per procedure. The primary safety endpoint was achieved in 96.1%, with 96.3% of stented lesions demonstrating residual stenosis <30% without intraprocedural MACE. The 30-day MACE rate was 3.9%, with no myocardial infarction, no target vessel revascularization, and no device-related complications. By intravascular imaging, the mean minimum stent area was 6.89 mm2 and the lower bound of the 95% confidence interval was 6.50 mm2, which exceeded the PG of 4.9 mm2 (p < 0.0001). Mean stent expansion was 113.7% across a wide spectrum of calcium morphologies including concentric, eccentric, and circumferential arcs up to 360°. Acute angiographic gain averaged 1.75 ± 0.58 mm with a final in-lesion diameter stenosis of 10.7%.
CONCLUSIONS: MY-IVL study demonstrates that the LithiX HC-IVL system provides safe, effective, and efficient calcium modification across diverse calcified lesion morphologies in a high-risk, real-world Asian PCI population, facilitating optimal coronary stent implantation with favorable early clinical outcomes.