Case Spotlight: IVL-First Calcium Modification for Female Patients
In this Q&A, Dr. Vamsi Krishna, an Interventional and Endovascular Cardiologist and the Medical Director for Cardiac Catheterization and Cardiac Rehab at Ascension Seton Heart Institute in Austin, TX breaks down his thought process while treating a severely calcified and heavily stenosed lesion within a female patient. Watch the full case breakdown on Murmur - a new social media platform designed for and by cardiologists.
How did the patient characteristics (sex, age, etc.) influence or inform your pre-procedural strategy or thinking?
Dr. Krishna: This patient was an 80 year old female with long standing hypertension. We know that female patients present to the cath lab later in life - as is the case with this patient - with more complex disease and smaller reference vessel diameters as compared to male patients. The above may explain why female patients tend to have worse atherectomy outcomes as compared to male patients.
With this in mind I thought IVL may be an ideal upfront strategy - assuming I could cross the lesion with the device - based on the promising data from the CAD clinical program demonstrating consistent acute and long-term outcomes between male and female patients treated with IVL.
- Angiographically you can appreciate a very tight calcified lesion – a near total occlusion - within the proximal RCA. Can you comment on your strategy to deliver devices (balloons, imaging, etc.) across the lesion within this case? Any reason to not try atherectomy up-front to facilitate device delivery?
Dr. Krishna: I preferred to avoid atherectomy to facilitate device delivery within this female patient for the reasons stated above. Fortunately, with some difficulty, I was able to cross the lesion with a Pilot 200 guidewire and a microcatheter. I then swapped the existing guidewire with a Wiggle wire which is my workhorse wire for calcified lesions and was ultimately able pre-dilate the lesion with a 1.25 mm balloon. This ultimately facilitated delivery of an OCT imaging catheter that allowed me to confirm the severity of calcium present within the lesion.
Knowing that the crossing profile of the OCT catheter is similar to Coronary IVL, I was confident I would be able to deliver IVL across the lesion for calcium modification.
- What was your rationale for using IVL upfront in this case? Why not try another strategy (scoring/cutting balloon, atherectomy) first within this lesion?
Dr. Krishna: Using intravascular imaging every case allows for me to determine disease morphology, treatment length and vessel size. The calcium presentation within the lesion is of great interest since it changes the modification strategy. The OCT image demonstrated circumferential, deep and lengthy calcified disease satisfying the “rule of 5’s” which made it clear to advanced lesion prep was needed.
Given the calcium arc, depth and length of the calcium present along the treatment lesion I simply didn’t think cutting balloons would, for a lack of a better phrase, cut it. In general, I am not keen on using scoring / cutting balloons for calcium given the challenges associated with deliverability. So given my confidence that IVL would cross combined with my desire to avoid atherectomy for the reasons stated above positioned Coronary IVL as an ideal upfront strategy for this case.
- How were the additional pulses found in Shockwave C2+ (120 pulses per catheter) utilized in this case? How would this case look differently if you only had the prior generation of Coronary IVL (80 pulses per catheter)?
Dr. Krishna: In general, the 120 pulses found in Shockwave C2+ allow me to better modify longer and more challenging calcium as compared to the previous version. The additional pulses pairs nicely with the known mechanistic benefits and clinically demonstrated consistency of IVL across calcium morphologies. Notably, I have found that Minimal Stent Area (MSA) on OCT improves when I use all 120 pulses on eccentric, deep calcium patients as demonstrated by this patient’s post PCI OCT image. So, to answer the question, the additional pulses found in Shockwave C2+ allowed me to better address the challenging calcium within this lesion as compared to the prior version.
- Any final thoughts or key takeaways to share regarding this case?
Dr. Krishna: This case reinforces why IVL is a promising therapy option for female patients with balloon crossable, calcified lesions given its safety profile and effectiveness within severe calcium. I’m looking forward to seeing the
results of the EMPOWER CAD which is designed to prospectively study IVL outcomes within female patients. I suspect the results of EMPOWER CAD will confirm the existing, positive results from the retrospective analysis.
Secondly, IVL device delivery is possible within very tight, near sub-total occlusions by utilizing sound delivery strategies such as the use of supportive wires (i.e Wiggle), pre-dilatation with NC balloons, and/or unsheathing techniques with guide extensions.
In short, IVL’s mechanism of action is uniquely designed to safely, effectively and intuitively modify severe calcium – this case is another example of why IVL continues to be my preferred, up-front strategy for balloon crossable calcified lesions.
To keep up with the latest news surrounding Coronary IVL, follow us on X @ShockwaveIVL.
Dr. Vamsi Krishna is a paid consultant for Shockwave Medical.
Views expressed are those of the author and not necessarily those of Shockwave Medical.
Orsiro® is a trademark or registered trademark of the BIOTRONIK Group of Companies
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
