Coronary IVL: A Paradigm Shift in Complex PCI
A new publication titled “Use of Calcium Modification during Percutaneous Coronary Intervention after Introduction of Coronary Intravascular Lithotripsy” details an overall increase in the use of calcium modification tools for percutaneous coronary interventions (PCI) and a rapid uptake in the use of coronary IVL since the U.S. launch of Shockwave C2 in early 2021. The research, led by Dr. Neel Butala, Assistant Professor, Medicine-Cardiology at the University of Colorado School of Medicine, was recently published in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI).
The research analyzed data from the ACC/NCDR® (National Cardiovascular Data Registry) CathPCI® Registry from April 2018 to December 2022 and revealed that in less than two years, coronary IVL expanded the appreciation of lesion preparation and use of calcium modification tools more broadly and has rapidly become the most used calcium modification technology in the U.S. Of the PCI cases analyzed during the second quarter of 2018, 8.7% were performed with calcium modification tools, including cutting or scoring balloon angioplasty, rotational and orbital atherectomy. By the fourth quarter of 2020, this number increased to 11.1%. By the fourth quarter of 2022, in conjunction with the U.S. commercial introduction of coronary IVL in early 2021, the use of calcium modification tools increased to 16.0% of PCI cases. In only 18 months of availability in the U.S., coronary IVL was used in 7.8% of PCI cases, while the use of atherectomy decreased from 5.4% to 4.4% of cases during the same timeframe.
“Our research shows a rapid uptake in coronary IVL, likely driven by its safety profile and ease of use relative to atherectomy, which makes calcium modification as simple as balloon angioplasty,” said Dr. Butala, the first author on the publication. “I would like to thank SCAI for the opportunity to conduct this research as part of the society’s Early Career Research Grants program and I look forward conducting deeper analyses into the ACC/NCDR CathPCI Registry, particularly with respect to identifying predictors of calcium modification strategies and their correlated outcomes.”
If you want to learn more about this research, click the video below where Dr. Butala, speaking at TCT 2023, shares his initial findings.
To keep up with Dr. Butala's research, follow us and Dr. Butala on Twitter @ShockwaveIVL and @nmbutala.
Coronary Important Safety Information:
In the United States: Rx only
Indications for Use— The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
Contraindications— The Shockwave C2+ Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.
Warnings—Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.
Precautions— Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.
Potential adverse effects consistent with standard based cardiac interventions include– Abrupt vessel closure – Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or nonemergency coronary artery bypass surgery-Emergency or nonemergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)- Hemorrhage-Hypertension/Hypotension-Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm.
Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extra systole-Atrial or ventricular capture.
Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. https://shockwavemedical.com/IFU
