Coronary IVL CathPCI Analysis: A Paradigm Shift in Practice?
We sat down with Dr. Neel Butala, Interventional Cardiologist, University of Colorado Anschutz School of Medicine, University of Colorado Hospital after presenting the first results from his SCAI Early Career Research Award, “Use of Calcium Modification for Coronary Lesions after Introduction of Coronary IVL: National Trends and Hospital Variation” at SCAI2023 to get his perspective on the first data cut.
View Dr. Butala's presentation here.
- How has coronary IVL impacted the calcium modification landscape?
Dr. Butala: Coronary IVL has dramatically changed how people treat coronary calcium. In a little over two years since initial approval in the United States, coronary IVL became the most frequently used calcium modification strategy for treatment of coronary lesions. Although it displaced other forms of calcium modification slightly, the spread of coronary IVL has generally led to an overall increase in use of calcium modification strategies. However, it is important to keep in mind that the dissemination of this technology has not been even. There is wide variation in use of calcium modification strategies as well as in use of coronary IVL in particular. As the landscape of calcium modification continues to evolve and this technology is introduced to more centers, I suspect that use of coronary IVL will continue to grow.
- How would you interpret these findings – why is this so?
Dr. Butala: Our findings on trends in use of calcium modification strategies suggest that coronary IVL is truly a game changer. The speed with which coronary IVL has become the dominant calcium modification strategy speaks to the benefits of the technology and ease of use.
- What are your key takeaways from this research project so far?
Dr. Butala: My key takeaways are that the introduction of coronary IVL has rapidly changed how physicians treat calcified coronary lesions and has led to greater use of calcium modification strategies overall. However, there is still wide variation in use of calcium modification strategies as well as coronary IVL and these are used in only a minority of cases at most centers.
- How do these findings align with your current practice?
Dr. Butala: The findings make sense to me and reflect my practice. Since introduction of coronary IVL, my approach to calcified lesions has changed considerably. I am using IVL in many cases that would have previously required atherectomy, and I am also more comfortable taking on challenging lesions now that I have IVL in my toolbelt.
- Were any of the findings surprising to you?
Dr. Butala: I was most surprised by how quickly IVL took over to become the most commonly used calcium strategy.
- How do you anticipate the IC community to react to this data?
Dr. Butala: I think this will be in line with what many expected. I also think this will encourage more physicians to try coronary IVL if they haven’t already.
- What should we look for next as you further dig into this topic?
Dr. Butala: The next step is for me to look at predictors of calcium modification strategy and IVL use to see if there are any disparities in care. Coronary IVL is a great case study in dissemination of a novel technology in the IC community, and it is important to investigate whether anyone was left behind. I also hope to update the trends and variation analyses with additional quarters of data and present it at a future meeting.
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 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.
