CRT21 Live Case: IVL in Coronary Nodules

Treatment of nodular calcium in coronary PCI remains a challenge, even for the most skilled operators. Recently, CRT 2021 Virtual featured a live case from Medstar Washington Hospital Center in Washington, DC with nodular calcium from operators Hayder D. Hashim, MD, and Lowell F. Satler, MD, who were joined by an expert panel led by Ron Waksman, MD. During the case the physicians discussed and debated treatment strategies to address nodular calcium, deciding in this case for coronary IVL, which resulted from a baseline MLA of 1.6mm2 to a post-IVL MLA of 4.9mm2 to a post-DES MSA of 7.2mm2.


Watch The CRT 2021 Live Case




After the live case, we caught up with Dr. Hashim to get his perspective on treatment considerations and use of IVL in nodular calcified lesions:


Why did you choose to feature this case at CRT?


Dr. Hashim: As a team, we decided to feature this case as it summarizes the most challenging scenarios of coronary interventions (e.g. calcium and lack of vessel compliance). Our other goal was to highlight and emphasize the absolute obligation to use intravascular imaging prior to make any interventional decision. The days of angiography guided complex PCI should be obsolete. 


What were your biggest concerns or considerations around this calcified lesion?


Dr. Hashim: Our biggest concerns were the lack of vessel compliance and ability to deliver different tools due to the extent of calcium and in-stent restenosis just proximal to the de novo lesion.


Why did you think Shockwave would be a good solution for this case?


Dr. Hashim: Prior to intravascular imaging it was hard to predict what tools to use. However, IVL was on our list given focal lesion, angiographic appearance of severe calcium.  


What tools did you use and what outcome were you able to achieve?


Dr. Hashim: For this case, our approach was left radial (given prior knowledge of severe right radial tortuosity), 7F Judkin right 4 guide catheter, work horse wire (run-through), and Opstar (OCT catheter). Once lesion morphology, length and diameter were determined by OCT, we attempted to use a 3.5x12 C2 IVL catheter, unable to deliver (given lack of compliance from prior RCA proximal stent) we proceeded with guide extension, which was delivered to the distal portion of RCA using "inch worming" technique with a 1:1 pre-dilatation balloon. Once at the nodular lesion we delivered C2 catheter, deployed 5 total treatments on 2 spots. OCT runs verified the lesion modification, and a 3.5x22 Onyx stent was then deployed, following which another OCT run confirmed no medial dissections, full apposition and expansion. 


How would you have treated this case without IVL and what challenges would you anticipate?


Dr. Hasim: Orbital atherectomy is an excellent alternative; it's 6F compatibility and glide assist feature allow delivery to distal segments (overcoming lack of vessel compliance). Given straight segment and minimal or no tortuosity of this specific case, challenges or complications are less likely to occur post atherectomy. Rotational atherectomy with a larger burr 1.5 or 1.75 is another feasible alternative, but requires a 7F system for larger burr sizes. 


Looking at the use of IVL in calcific nodules, what advice would you provide to your colleagues based on this case?


Dr. Hashim: Calcium morphology (depth, thickness, arc, nodularity) are all important features to make decision for debulking/modification options. Intravascular imaging with IVUS or OCT (preferred) is key to define above criteria. Calcium nodularity still imposes a major challenge (wire bias with atherectomy vs the hypothetical loss of shockwave energy in non-calcified portions). The tightest area of the lesion treated in this case featured two thick calcified nodules on opposite sides. While it's not a continuous arc of 180 degrees or more, the opposite nodules gave the lesion a concentric calcified effect. More cases/lesion morphology are needed prior to withdraw conclusions. Coronary IVL is a very intriguing technology, without any doubt it will have its major impact on treating calcified lesions, Case, lesion morphology selection using intravascular imaging will further define its high impact.  




Important Safety Information


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.

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