Recently at CRT21, Dr. Matthew Price, Director of the Cardiac Catheterization Laboratory at Scripps Clinic in La Jolla, presented the first sub-analysis of the Disrupt CAD III U.S. pivotal study, looking at clinical outcomes with IVL in lesions <25mm compared to those with ≥25mm. After his presentation, we caught up with Dr. Price to get his perspective on the data and its significance. You can also watch his full presentation at the video below.
- What makes treating calcified long lesions more difficult?
Dr. Price: When using traditional approaches to long calcified lesions – e.g. atherectomy – there is a greater likelihood of clinically significant distal embolization (i.e. slow flow, hypotension, periprocedural MI, etc.). Also, the longer the calcified segment the more the likely there may be a segment of stent underexpansion, that will result in poor longer-term clinical outcomes.
- How would you summarize the results between the two lesion cohorts <25mm vs ≥25mm?
Dr. Price: The fact that device crossing and procedural success were similar, and that the rate of angiographic complications were extremely low (and not more than short lesions) is very encouraging in that it does not appear that the extent of calcium limits the ability to safely and successfully deliver IVL and modify plaque for successful stenting. Not surprisingly, longer lesions had numerically more MACE, driven by NQWMI, but this is likely a result of the complexity of the lesions themselves rather than the IVL technology.
- Were there any surprises or unexpected results in the data?
Dr. Price: The lack of angiographic complications in these very complex lesions was surprising.
- What’s your main takeaway from this analysis?
Dr. Price: IVL is an attractive option for calcified lesions – irrespective of length. And given the known risk of complications with atherectomy in very long lesions (noted above), this would argue that IVL should certainly be the preferred approach in very long calcified lesions (although this might need a RCT to robustly prove).
- When using IVL in longer lesions, do you have any personal best practices to obtain optimal results?
Dr. Price: Based on my experience so far, I’m approaching these lesions with a 7F guide (using a slender-type sheath from radial), an extra back up shape guiding catheter, and a supportive wire (e.g. Grand Slam or Wiggle Wire).
Important Safety Information
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