Upcoming Calcium Trends: SCAI Research Q&A with Dr. Neel Butala
Use of Calcium Modification for Coronary Lesions: National Trends, Hospital Variation, and Disparities IVL has reshaped the calcium treatment landscape. Be sure to be on the lookout for his presentations on this topic throughout 2023 at SCAI events.
What was the rationale behind your research project?
Dr. Butala: Calcified lesions can be very challenging to treat with PCI. There are a variety of different treatment options available, but there is no clear-cut evidence on which approach is better. Therefore, there is a lot of variation in how different operators approach these lesions, but this has not been well characterized. I also wanted to explore the uptake of coronary intravascular lithotripsy (IVL) and how the commercial availability of IVL may have affected treatment of calcified coronary lesions in real-world practice. This work can not only enable us to better understand contemporary treatment of calcified lesions on a national scale, but it can also provide valuable insights into the diffusion of innovation in interventional cardiology.
What are the goals of your research?
Dr. Butala: There are three main aims I plan to explore. First, I want to examine trends in use of calcium modification strategies over time to understand how the introduction of newer technology such as IVL has changed the landscape. Next, I want to examine hospital variation in use of calcium modification strategies. Examining characteristics of patients, lesions, and hospitals among high and low utilizers of IVL in particular can allow us to better understand uptake of future coronary interventional innovations. And finally, I want to examine disparities in use of calcium modification strategies to inform the more equitable dissemination of novel technologies in interventional cardiology more broadly.
What makes this topic so timely?
Dr. Butala: This topic is very timely because the recent introduction of coronary IVL has been a game changer for many. I am very excited to learn more about how coronary IVL has changed the practice of interventional cardiology.
Based on all the different topics you’ll be examining, what are you most intrigued by knowing from the research?
Dr. Butala: I am most intrigued by the interaction between IVL and atherectomy. I am curious to see if IVL has displaced atherectomy in the treatment of calcified coronary lesions or if it has expanded the utilization of calcium modifying therapies in PCI more broadly. In addition, I am interested to see how frequently both are used together and whether the introduction of IVL has expanded the scope of what is considered treatable.
What do you hope will be the clinical implications from your research?
Dr. Butala: I think characterizing trends over time and variation in use of calcium modification strategies in PCI is important to understand the current standard of care nationally. This work can also set the stage for future work using quasi-experimental methods to understand the comparative effectiveness of different calcium modification strategies on outcomes. Finally, this research can help us better understand diffusion of innovation in interventional cardiology and whether there are any inequities in the dissemination of such innovations.
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 non-emergency coronary artery bypass surgery-Emergency or non-emergency 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 extrasystole-Atrial or ventricular capture.
Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events. https://shockwavemedical.com/IFU
Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2 instructions for use containing important safety information.