Q&A with Dr. Yasin Hussain about the Disrupt CAD Pooled Female vs. Male Analysis at TCT21
- What do we know about gender analyses from large PCI studies previously conducted?
- Dr. Hussain: In general, moderately to severely calcified lesions are associated with higher rates of target lesion failure, myocardial infarction, stent thrombosis, and cardiac death both in hospital and long-term and independently predict ischemia-driven revascularization in both men and women. Typically, women undergoing PCI have more comorbidities and worse periprocedural complications. When it comes to PCI of severely calcified lesions, women have as much as a 2 fold higher risk of coronary perforations and a 5-fold higher risk of tamponade compared with men, and the risk of in-hospital mortality is reported to be 20% higher compared to men.
- From your perspective, what were the key takeaways from this analysis?
- Dr. Hussain: This pooled analysis of the Disrupt CAD trials is the largest to evaluate the use of IVL to treat severely calcified coronary lesions. The key findings were: First: IVL is safe and effective in both men and women; Second: IVL treatment of severe calcification resulted in the lowest observed rates of procedural complications in both men and women compared to other atheroablative options.
- What is the impact of the Gender Analysis of the DISRUPT CAD Pooled Studies on current practice in both men and women patient populations?
- Dr. Hussain: IVL appears to be the great equalizer of outcomes between men and women showing for the first time lower procedural complications in women compared to men. IVL should be considered first line treatment for severely calcified lesions especially in women given their increased risk of severe procedural complications and the poor associated clinical outcomes including heightened mortality risk.
- How do outcomes from DISRUPT CAD Pooled Gender Analysis compare to previous gender studies conducted with calcium modification tools?
- Dr. Hussain: Several small studies have looked at the differences in outcomes using rotational atherectomy and orbital atherectomy based on sex. Atheroablative devices have 2-5 fold higher periprocedural complications in women compared with men. IVL in our study shows low and similar results in men and women. However, it is important to highlight that this observation is based on small, non-randomized series and will require additional confirmation.
- What should interventional cardiologists expect to learn next about coronary IVL in females – where should the research take us?
- Dr. Hussain: Future studies should compare the safety and efficacy in a randomized manner of an IVL versus a standard atheroablative treatment strategy to confirm and understand the generalizability of our preliminary results.
To learn more and stay in touch, follow @YasinHussainMD and @ShockwaveIVL on Twitter.
Dr. Hussain is a paid consultant for Shockwave Medical.
Important Safety Information
Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2 instructions for use containing important safety information.
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
