The complete DISRUPT CAD II study findings have been published by the AHA’s journal, Circulation: Cardiovascular Interventions, and while it’s definitely worth the full read, we know that sometimes there just aren’t enough hours in the day. For a quick synopsis, we took the liberty to summarize some of the key data points into a visual-friendly infographic for you to review some of the study’s most important findings.

Download the Infographic PDF Here

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.

Case submitted by Nelson Bernardo, MD, MedStar Health

Summary: Patient was considered high surgical risk due to severity of calcium and involvement of profunda. Shockwave IVL treatment of common femoral artery (CFA) and proximal superficial femoral artery (SFA), followed by treatment of profunda with the same device. Final result shows no dissection, perforation, emboli, need for additional devices and full resolution of symptoms.

Case submitted by Marianne Brodmann, MD, University of Graz

Summary: Proximal total occlusion and distal sub-total occlusion of popliteal artery. Severe calcification throughout. 4.5 mm x 60 mm Shockwave IVL delivered distally, followed by 5.5 mm x 60 mm IVL proximally. Final result shows <30% residual with IVL alone, no complications and no implants.

Case submitted by Sarang Mangalmurti, MD, Mainline Health

Summary: Severe concentric calcification of anterior tibial artery with 100% occlusion. 3.0 mm x 40 mm Shockwave IVL delivered into AT with no difficulty. >12 cm of AT treated. <20% residual stenosis followed stand-alone IVL with no complications.

Case submitted by Roberto Ferraresi, MD, Humanitas Gavazzeni

Summary: CLTI patient (Rutherford 5) with foot ulceration. Diagnostic angiogram shows near-occlusion of distal AT. 2.5 mm percutaneous transluminal angioplasty (PTA) of AT and dorsalis pedia attempted with near-immediate recoil and unsatisfactory result. 2.5 mm x 40 mm Shockwave IVL introduced into distal AT. Post-IVL angiogram shows resolution of stenosis with good distal flow into dorsalis pedis and no complications.

Case submitted by Jean Fajadet and Bruno Farah, Clinique Pasteur

Summary: Severely calcified distal left main and proximal left anterior descending (LAD) lesion; operators were hesitant to use rota; Shockwave IVL advanced with no pre-dilation required; 3.5 x12 mm IVL treatment performed and balloon waist resolved after 20 pulses; final result of widely patent artery with TIMI 3 flow post-stent (3.5 mm) with 4.5 mm NC post-dil.

Case submitted by Javier Escaned, San Carlos Hospital

Summary: Severely calcified mid-left anterior descending artery (LAD) involving septal branch; patient was high-bleeding risk and IABP used for hemodynamic support; operators wanted to avoid distal embolization for this patient and chose Shockwave IVL; 3.0 mm IVL catheter used across diffuse calcified disease; significant fractures seen under OCT in multiple planes; circumferential and well-apposed 3.0 x 32 mm drug-eluting stent (DES).

Case submitted by Javier Escaned, San Carlos Hospital

Summary: Highly angulated left circumflex artery (LCX) with lesions proximal and distal; OCT wouldn’t cross either lesion; guideliner-assisted Shockwave IVL catheter delivery followed by successful IVL therapy; the case was completed with easy deployment of two long drug-eluting stents (DES).

Case submitted by Jonathan Hill, King’s College

Summary: Multi-lesion right coronary artery (RCA); couldn’t advance guideliner to distal lesion despite predilation; advanced 3.5 mm Shockwave IVL catheter as far as possible (1); delivered one cycle (10 pulses) and vessel opened; pulled back to the ostium (2) and vessel opened after one cycle (10 pulses); advanced to distal lesion (3) and vessel opened after one cycle (10 pulses); easily delivered 80 mm of drug-eluting stent (DES).

Case submitted by Antonio Colombo, San Raffaele

Summary: Large eccentric lesion at left circumflex (LCX) ostium; delivered four cycles with 3.5 mm Shockwave IVL catheter; full balloon expansion (and associated lower endoflator pressure) were noted; verified treatment response using a non-compliant balloon; then used the same IVL device to successfully treat the left main (LM).