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Published on: February 18, 2020
Initial experience with the novel 6 Fr-compatible system for debulking de novo coronary arterial lesions
Fumiaki Ikeno1, Alexandre Abizaid, Takeshi Suzuki
1Stanford University Medical Center, Stanford, California, USA.
Insights
The Helixciser De Novo system effectively debulks coronary plaque in new native lesions. This novel catheter-based approach shows promise as an alternative treatment for coronary artery disease.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Interventional Cardiology
Background:
- Atherosclerotic plaque buildup in coronary arteries obstructs blood flow, necessitating effective treatment strategies.
- Current debulking methods have limitations, driving the need for innovative solutions.
- De novo native coronary arterial lesions present a specific challenge in interventional cardiology.
Purpose of the Study:
- To evaluate the efficacy of the novel Helixciser De Novo system for debulking de novo native coronary arterial lesions.
- To assess the feasibility and preliminary outcomes of this new plaque excision technology.
Main Methods:
- The Helixciser De Novo system, a 6 Fr-compatible catheter with a rotating cutter and aspiration pump, was used.
- The device was tested in a porcine model of chronic coronary occlusion and in five human patients with de novo lesions.
- Quantitative angiography (QCA) and intravascular ultrasound (IVUS) were employed for outcome assessment.
Main Results:
- In porcine models, QCA showed an increase in minimal lumen diameter (MLD) from 0.77 to 1.88 mm, and IVUS showed an increase in lumen volume (LV) from 15.8 to 46.4 mm³ post-debulking.
- In human cases, QCA demonstrated an increase in MLD from 0.96 to 2.04 mm, and IVUS showed an increase in LV from 38.40 to 52.05 mm³ post-debulking.
- The system successfully debulked noncalcified atherosclerotic plaque in all cases.
Conclusions:
- The Helixciser De Novo system is feasible for treating focal de novo native coronary arterial lesions.
- Quantitative angiographic and IVUS analyses indicate effective plaque debulking.
- This system may offer an alternative treatment strategy for coronary artery disease.
Abstract:
The purpose of this study was to determine the efficacy of a novel system for debulking of de novo native coronary arterial lesions. The Helixciser De Novo system is a novel 6 Fr-compatible catheter with a cutter encased in a slotted-orifice housing to excise atheromatous plaque. The cutter rotates at 15,000 rpm, debulking the plaque as it tracks through the lesion over a straight wire or a self-expanding nitinol helical-shaped wire. The tissue is aspirated via an Archimedes screw pump to vacuum collection chamber. The device was evaluated in a porcine toxic coronary stent model of chronic occlusion and in five patients with focal de novo native coronary arterial lesions. Procedural variables along with outcomes were reviewed. Quantitative angiography (QCA) and volumetric intravascular ultrasound (IVUS) analysis were performed. In a porcine model of chronic occlusion, QCA demonstrated pretreatment minimal lumen diameter (MLD) increased from 0.77 +/- 0.59 to 1.88 +/- 0.25 mm postdebulking. IVUS analysis demonstrated pretreatment lumen volume (LV) increased from 15.8 +/- 22.2 to 46.4 +/- 28.9 mm(3) postdebulking. In human clinical feasibility cases, QCA demonstrated pretreatment MLD increased from 0.96 +/- 0.40 to 2.04 +/- 0.19 mm postdebulking. IVUS analysis demonstrated pretreatment LV increased from 38.40 +/- 12.78 to 52.05 +/- 15.68 mm(3) postdebulking. Preliminary results document the feasibility of Helixcision De Novo for treatment of focal de novo native coronary arterial lesions. Quantitative angiographic and IVUS analysis indicate that this system can effectively debulk plaque from selected noncalcified atherosclerotic lesions and thus may represent an alternative treatment strategy for coronary artery disease.
