EMPOWER CAD Study: Unveiling the First European Patient's Journey
Enrollments in the EMPOWER CAD study are picking up pace! Dr Nieves Gonzalo (Hospital Clìnico San Carlos, Madrid), the study’s European lead, recently shared with the medical community the journey of her first patient included in the study.
In this first case, Dr Gonzalo treated an 81-year-old woman with a severely calcified LAD stenosis. The treatment decision was supported by intravascular imaging: the OCT run showed diffuse disease with more eccentric calcium in the proximal area. The lesion was treated with a 2.5mm Shockwave C2+ achieving very good balloon expansion already after 70 pulses.
For those not familiar with the study, EMPOWER CAD is the first prospective clinical study in the interventional space that is completely dedicated to female patients. The study wants to bridge the PCI inequality gap between females and males, with a dedicated focus on calcium modification with IVL. The objective of the study is to provide robust data with longer-term outcomes in a larger, all-comers patient cohort. It is designed to determine whether coronary IVL should be considered the front-line calcium modification approach in female patients.
Watch this 7-minute video if you want to find out the outcome of this case (spoiler alert: it goes very well!).
Watch the Video:
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!
Dr Nieves Gonzalo is a paid consultant for Shockwave Medical. See Important Safety information below.
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 Important Safety Information for more information on indications, contraindications, warnings, precautions and adverse events. https://shockwavemedical.com/IFU
Please contact your local Shockwave representative for specific country availability.