Hertz contact intravascular lithotripsy for calcified coronary artery disease: the PINNACLE-I trial
Stefan Verheye1, Bert Ferdinande2, Valeria Paradies3
1Interventional Cardiology, ZAS Cardiovascular Center Middelheim, Antwerp, Belgium.
Insights
The LithiX device, using Hertz contact intravascular lithotripsy (HC-IVL), safely and effectively fractures calcified coronary lesions, enabling optimal stent expansion. This novel approach shows high success rates and low major adverse cardiovascular events (MACE).
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Calcified coronary lesions are a significant challenge in percutaneous coronary interventions, hindering stent expansion and leading to adverse outcomes.
- Intravascular lithotripsy (IVL) offers a promising solution for pretreatment, optimizing stent implantation in complex calcified lesions.
Purpose of the Study:
- To evaluate the safety and efficacy of the LithiX device, which employs the Hertz contact (HC) mechanism for intravascular lithotripsy (IVL).
- To assess the device's ability to fragment calcium while minimizing soft tissue injury, without external energy sources.
Main Methods:
- A multicenter, prospective clinical trial (PINNACLE-I) enrolled patients with moderately to severely calcified de novo coronary lesions.
- Primary endpoints included achieving <50% residual stenosis without in-hospital major adverse cardiovascular events (MACE) and the 30-day MACE rate.
- Optical coherence tomography (OCT) was used to assess calcium morphology and fracture post-treatment.
Main Results:
- The HC-IVL catheter was successfully delivered and utilized in 63 lesions across 60 patients, with a median procedure time of 59.5 minutes.
- The primary endpoint was met in 98.3% of cases, with all patients achieving <30% residual stenosis post-stenting.
- Calcium fractures were achieved in 90.6% of lesions, with a mean fracture depth of 0.81 mm, leading to excellent stent expansion (96.7%). The 30-day MACE rate was low at 1.7%.
Conclusions:
- The PINNACLE-I trial confirms the feasibility, safety, and efficacy of the novel Hertz contact intravascular lithotripsy (HC-IVL) device.
- HC-IVL effectively fractures calcified coronary lesions across diverse morphologies, facilitating optimal stent expansion.
- The study supports HC-IVL as a valuable tool for complex percutaneous coronary interventions.
Background:
Calcified coronary lesions impede stent expansion and are associated with poor outcomes after percutaneous coronary interventions. Intravascular lithotripsy (IVL) has emerged as a safe and effective pretreatment to optimise stent implantation.
Aims:
This study assesses the LithiX lithotripsy device, which uses the Hertz contact (HC) mechanism to fragment calcium while minimising injury to surrounding soft tissue, without requiring an external energy source.
Methods:
The multicentre, prospective PINNACLE-I clinical trial enrolled patients with up to two moderately to severely calcified de novo lesions. The primary endpoints were <50% residual stenosis without in-hospital major adverse cardiovascular events (MACE) and the 30-day MACE rate. Clinical events were assessed up to 6 months.
Results:
Sixty patients with 63 lesions were treated with successful delivery and use of the HC-IVL catheter and a median procedure time of 59.5 min (interquartile range: 40.5-76.0). The primary endpoint was achieved in 98.3%. All patients had residual stenosis <30% after stent placement. The 30-day MACE rate was 1.7%, due to 1 periprocedural target vessel non-Q-wave myocardial infarction. There were no cardiovascular deaths, no definite or probable stent thromboses, nor any device-related events up to 6 months of follow-up. The optical coherence tomography substudy in 32 subjects identified a wide range of calcium morphologies, including calcium arcs of 96-360° and calcified nodules. Following HC-IVL, calcium fractures were achieved in 90.6% of lesions, and the mean fracture depth was 0.81±0.33 mm. Stent expansion at the minimum stent area site was 96.7±25.5%.
Conclusions:
PINNACLE-I demonstrated the feasibility, safety, and efficacy of the novel HC-IVL to fracture calcified lesions and achieve optimal stent expansion in a broad range of calcium morphologies.
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