- Treating Challenging Calcium Morphologies with the new Shockwave C2+
-
Hot off the press! Check out the latest Cardiovascular News supplement sponsored by Shockwave Medical.
This set of articles has a fresh perspective on today’s management of coronary calcium. It includes a deep dive into the use of intravascular lithotripsy for treating calcified nodules, and early experience with the new Shockwave C2+ coronary catheter.
Dr. Tom Johnson (University Hospitals Bristol & Weston NHS Foundation Trust, Bristol, UK) outlines how Shockwave IVL disrupted the landscape of UK interventional cardiology early in 2018. When introduced, it generated renewed enthusiasm for the management of complex calcific coronary disease and it impacted coronary calcium treatment in his centre over these last five years. Simplicity of use has been pivotal to make IVL the ‘go-to’ adjunctive tool for calcium modification.
The second article focuses on management of eccentric and nodular calcium, frequently present in CAC, associated with poor PCI outcomes and adverse long-term results. Dr. Nicolas Amabile (Institut Mutualiste Montsouris, Paris, France) discusses the best strategies to adequately manage these calcium morphologies and reports a case in which IVL was successfully used to treat calcified nodules in a challenging location.
Dr. Kambis Mashayekhi and his team at Herzzentrum Lahr/Baden (Lahr, Germany) detail their intravascular lithotripsy journey in the last article. They explain how the new Shockwave C2+ catheter can change the treatment of calcified coronary lesions and share a case study involving a diffuse calcified left main bifurcation.
Visit our website to learn more about Intravascular Lithotripsy (IVL) and Contact Us if you have any questions or would like to meet with a local representative.
Follow us on Twitter at @ShockwaveIVL to stay up to date on all Shockwave IVL news and events. We look forward to staying in touch!
Drs. Spratt and Wilson are paid consultants for 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.
