It’s Good to Be Eccentric…When Trying to Treat Eccentric Calcium
If Shockwave IVL had a personality, we’d like to think that we’d be a bit on the eccentric side. A little unconventional and taking a slightly different path than everyone else. After all, you won’t be successful in introducing a new disruptive technology if you’re marching to the same drumbeat as everyone else.
Which is why we’re excited about the technology’s potential in addressing an unmet need in the treatment of calcium today: eccentricity. Eccentric calcium has challenged current modalities’ ability to adequately modify calcium due to several device-dependent factors. For traditional PTCA balloons, they often expanding the healthy, non-calcified side of the artery, while atherectomy technologies can be subject to wire bias that may often leave rigid calcium on the other side of the vessel untouched.
To begin to address this topic with research, we’re happy to inform that recently at the 2020 EuroPCR e-Course, Prof. Holger Nef (DE) presented the first-ever pooled analysis from the DISRUPT CAD I and II studies comparing angiographic results in concentric and eccentric lesions. He found that coronary IVL was associated with high procedural success and consistent clinical outcomes in both eccentric and concentric calcified lesions, including similar rates of clinical success, residual stenosis and acute gain. As one of the highest rated abstracts submitted to the meeting, his analysis debuted in the “Abstracts & Cases Corner,” and was also featured in a sponsored 5-minute video interview where he talks through the findings. Hope you enjoy the video!
This presentation at PCR comes on the heels of a separate independent Cardiovascular Revascularization Medicine publication looking at a similar analysis with the aid of imaging, entitled, “Intravascular imaging to guide lithotripsy in concentric and eccentric calcific coronary lesions,” published by a team of cardiologists from Careggi University Hospital in Florence, Italy and led by Dr. Alessio Mattesini and Prof. Carlo Di Mario. Their paper similarly concluded that, “A standardized algorithm applying intravascular imaging guidance of IVL facilitated second generation DES expansion delivers excellent immediate lumen expansion and patient outcome, both in concentric and eccentric calcifications.”
Prof. Holger Nef is a paid consultant of Shockwave Medical.
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.
