Dr. Price speaks on best practices to modify diffuse disease with Shockwave IVL.

Dr. Singh is a paid consultant for Shockwave Medical.

Coronary IVL

Shockwave C2 and Shockwave C2+ Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 and 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 and 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 nonemergency coronary artery bypass surgery-Emergency or nonemergency 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 indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/IFU.

DISRUPT CAD Pooled Gender Analysis is now in published in JSCAI – the new journal of the Society for Cardiovascular Angiography & Interventions. Read the JSCAI publication here: https://www.jscai.org/article/S2772-9303(21)00011-9/fulltext

“Given the strong safety profile of IVL and the known higher risks of women undergoing PCI, coronary IVL is an attractive option for optimizing outcomes in female patients,” said Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC, Professor of Medicine (Cardiology), Director of Yale Cardiovascular Clinical Research Program Yale University School of Medicine, New Haven, CT, and Editor in Chief of JSCAI. “While this is the first analysis of its kind for coronary IVL, it is highly suggestive that the technology could potentially serve as first-line therapy for women with calcified lesions, particularly if these findings can be confirmed in a larger patient cohort.”

In addition to the publication of the gender analysis in the first issue, it also included a new Expert Consensus Statement from SCAI on Sex-Specific Considerations in Myocardial Revascularization, which includes reference to the new Coronary IVL gender data and the role that IVL can play in women as a potential first-line therapy for plaque modification of calcified lesions in women. Read the SCAI Consensus Statement here: https://www.jscai.org/article/S2772-9303(21)00016-8/fulltext

Please see below for a link to the TCT data slides.

About JSCAI: JSCAI is an online only, peer-reviewed, international, Gold Open Access journal covering the broad field of cardiovascular diseases. JSCAI aims to be a highly credible and well-balanced reference highlighting practical techniques and pathways of care to deliver high impact scientific contributions from clinicians and colleagues in interventional cardiology.

More on DISRUPT CAD Pooled Gender Analysis

Download the TCT slides

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.

Dr. McEntegart is a paid consultant for Shockwave Medical.

Coronary IVL

Shockwave C2 and Shockwave C2+ Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 and 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 and 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 nonemergency coronary artery bypass surgery-Emergency or nonemergency 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 indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/IFU.

Peripheral IVL

Shockwave M5+, Shockwave M5, Shockwave S4, Shockwave L6 and Shockwave E8 Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature.

Contraindications – Do not use if unable to pass 0.014″ (M5, M5+, S4, E8) or 0.018″ (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.

Warnings – Only to be used by physicians who are familiar with interventional vascular procedures–Physicians must be trained prior to use of the device–Use the generator in accordance with recommended settings as stated in the Operator’s Manual.

Precautions – use only the recommended balloon inflation medium-Appropriate anticoagulant therapy should be administered by the physician-Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. Adverse effects-Possible adverse effects consistent with standard angioplasty include-Access site complications-Allergy to contrast or blood thinner-Arterial bypass surgery-Bleeding complications-Death-Fracture of guidewire or device-Hypertension/Hypotension-Infection/sepsis-Placement of a stent-renal failure-Shock/pulmonary edema-target vessel stenosis or occlusion-Vascular complications. Risks unique to the device and its use-Allergy to catheter material(s)-Device malfunction or failure-Excess heat at target site.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/ifu

Shockwave Javelin Peripheral IVL Catheter Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Medical IVL System with the Javelin Peripheral IVL Catheter is intended for lithotripsy-enabled modification and crossing of calcified lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries, prior to final treatment. Not for use in the coronary, carotid, cerebral, or pulmonary vasculature.

Contraindications – Do not use if unable to pass 0.014″ (0.36mm) guidewire across the treatment site-Not intended for treatment of in-stent restenosis or in coronary, carotid, cerebral or pulmonary arteries.

Warnings – Only to be used by physicians who are familiar with interventional vascular procedures-Physicians must be trained prior to use of the device-Use the generator in accordance with recommended settings as stated in the Operator’s Manual.

Precautions – Avoid applying acoustic pressure pulses while IVL window is not filled with sterile saline-Appropriate anticoagulant therapy should be administered by the physician-Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.

Adverse effects – Possible adverse effects consistent with standard angioplasty include-Access site complications-Allergy to contrast or blood thinner-Arterial bypass surgery-Bleeding complications-Death-Fracture of guidewire or device-Hypertension/Hypotension-Infection/sepsis-Placement of a stent-renal failure-Shock/pulmonary edema-target vessel stenosis or occlusion-Vascular complications. Risks unique to the device and its use-Allergy to catheter material(s)-Device malfunction or failure.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/ifu

Transfemoral access represents the gold standard for TAVI, with TF access showing a significant reduction in complications and mortality in comparison to alternative access strategies, which add additional complexity and risk to the procedure. Despite the wide acceptance that the transfemoral route provides the safest access for patients, the approach can be hindered by calcified iliac arteries inhibiting delivery of large bore devices by restricting the luminal diameter and reducing vessel compliance. If calcium is not treated adequately prior to TAVI delivery, this can lead to complications such as flow limiting dissection, vessel rupture and unsuccessful delivery of the implant.

Watch as Dr. Ole De Backer of Rigshospitalet, Copenhagen walks you through how intravascular lithotripsy (IVL) has expanded the boundaries of transfemoral TAVI. During this tutorial series Dr. De Backer will provide a detailed explanation of why, how and when IVL can be utilised to improve procedural safety and outcomes for patients undergoing transfemoral TAVI where calcium proves to be an inhibiting factor.

Why Take the Transfemoral Route? IVL Pre TAVI Tutorial Chapter 1

Unique Mechanism of Action to Treat Calcium: IVL Pre TAVI Tutorial Chapter 2

The Copenhagen Experience: IVL Pre TAVI Tutorial Chapter 3

How to Use IVL to Facilitate TF Access: IVL Pre TAVI Tutorial Chapter 4

IVL in Practice, Patient Selection and Cases: IVL Pre TAVI Tutorial Chapter 5

In addition to the tutorial series, check out the recent publication from Frontiers of Cardiovascular Medicine, which provides a comprehensive overview from Copenhagen of how IVL is simplifying extremely challenging transfemoral access in TAVI: https://doi.org/10.3389/fcvm.2021.739750

The physicians featured are paid consultants for Shockwave Medical.

Important Safety Information

Please contact your local Shockwave representative for specific country availability and refer to the Shockwave S4, Shockwave M5 and Shockwave M5+ instructions for use containing important safety information.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Indication for Use – The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

Contraindications – Do not use if unable to pass 0.014 guidewire across the lesion • Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.

Warnings – Only to be used by physicians who are familiar with interventional vascular procedures • Physicians must be trained prior to use of the device • Use the Generator in accordance with recommended settings as stated in the Operator’s Manual.

Precautions – Use only the recommended balloon inflation medium • Appropriate anticoagulant therapy should be administered by the physician • Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.

Adverse Effects – Possible adverse effects consistent with standard angioplasty include: • Access site complications • Allergy to contrast or blood thinners • Arterial bypass surgery • Bleeding complications • Death • Fracture of guidewire or device • Hypertension/Hypotension • Infection/sepsis • Placement of a stent • Renal failure • Shock/pulmonary edema • Target vessel stenosis or occlusion • Vascular complications. Risks unique to the device and its use: • Allergy to catheter material(s) • Device malfunction or failure • Excess heat at target site.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions, and adverse events. www.shockwavemedical.com

Calcium Masterclass Class 6 featuring James Spratt, Margaret McEntegart, Philippe Genereux, Michael Haude & Holger Nef.

Dr. Srinivasa Potluri, Chair of the Department of Cardiology and Director of the Cardiac Catheterization Laboratory at Baylor Scott and White, The Heart Hospital in Plano, speaks about his valuable experience with Shockwave coronary IVL. Dr. Potluri also shares a clinical case with severe ostial RCA and the value of coronary IVL in vessel preparation strategy in the presence of a heavy coronary calcium burden.

Download the PDF or read The Calcium Corner online here.

This article was developed in collaboration with Cath Lab Digest to bring you the latest calcium insights from the U.S. coronary interventional experts who know it best. A new webpage on the CLD website, The Calcium Corner, contains a series of articles where operators share their perspective on the challenges and treatment of coronary artery calcium. Read about experts’ clinical experience, case studies and treatment algorithms with Shockwave coronary IVL – hope you enjoy the content.

Dr. Srinivasa Potluri is a paid consultant 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.

Q&A with Dr. Ziad Ali about the DISRUPT CAD Pooled OCT Eccentric vs Concentric Analysis at TCT21.

Following its presentation at TCT21 in a moderated poster session, we caught up with Ziad Ali, M.D., DPhil, Director of the DeMatteis Cardiovascular Institute and Investigational Interventional Cardiology at St Francis Hospital & Heart Center, to get his thoughts on the implications of the concentric vs eccentric calcium analysis among those patients enrolled in the DISRUPT CAD clinical program.

Why is eccentric calcium so challenging to modify?

Dr. Ali: Simple. It’s hard to modify. Balloon based modification leads to the creation of a dissection at the site of minimal resistance. That is the fibro-calcific interface, the place where the fibrous tissue meets the calcium. This dissection allows vessel expansion, but the calcium remains unmodified. After stenting the calcium protrudes back into towards the lumen, reducing the potential MSA. With atherectomy, the wire and thus burr must be biased into the calcium. If it is not, there is no chance of lesion modification. With IVL, most of the energy is lost into the soft tissue. So if there is only 90 degrees of calcification, i.e 25% of the vessel circumference, 75% of the energy is dissipated. More specifically, the maximum energy in IVL is immediately perpendicular to the electrode.

Why is the DISRUPT CAD OCT Pooled analysis important for current clinical practice?

Dr. Ali: Simple. There is power in numbers. These data show categorically that the predominant mechanism of IVL is calcium fracture, and that the more the calcium the greater the fracture. The ability of IVL to create luminal gain in severe calcification is unquestionable. Overall the mean stent expansion and stent expansion at the site of max calcium was greater than 100%. The fact that the minimal lumen area was never at the site of maximum calcification is proof in and of itself.

What were the findings in the OCT analysis in concentric and eccentric lesions? How do you explain these results?

Dr. Ali: Fractures are much less common in eccentric rather than concentric lesions. But that’s ok, because you need less fractures in eccentric calcium because the rest of the artery is conformable. In general, lesion modification for an eccentric calcified lesion is unnecessary, unless it’s a calcified nodule. That being said, within a heavily calcified segment of vessel, there will be multiple morphologies along the length of that lesion. Some concentric, some eccentric. IVL helps all the way along the length by creating lots of fractures at the more concentric sites and less fractures, because less are needed, at the eccentric sites. The take home message is that even in eccentric lesions there was a consistent improvement in stent expansion and luminal gain compared to concentric lesions. So IVL liberates vascular compliance through calcium fracture appropriate to need.

From your perspective, how do these outcomes compare to what you see in the clinic?

Dr. Ali: We are definitely still learning, but the clinical experience is very similar to the trial results. Not surprising, there was tremendous consistency in terms of safety and efficacy among all of DISRUPT CAD studies so we wouldn’t expect that different in the real world. At St Francis we have done over 100 commercial cases and one of our more noticeable findings is how well tolerated IVL is in the very high-risk patient. Very low EF, high EDP, severe PAH, multivessel disease. We don’t see the same hemodynamic fluctuations we see sometimes with other lesion prep strategies.

Are there any coronary IVL best practices that will help interventionalists achieve similar results to what was reported?

Dr. Ali: Image image image. Intravascular imaging determines the severity and distribution of calcium. Using the St Francis Calcium Scores can help determine whether or not you even need advanced lesion prep. By OCT, if the calcium is 5 mm long, 0.5 mm thick and 50% of the arc, advanced prep is necessary. By IVUS, circumferential, 270 degrees for 5 mm, < 3.5 mm at the site of calcification and calcified nodule, advanced prep is necessary. Remember the more the rock the better the shock!

Dr. Ali 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

Q&A with Dr. Akiko Maehara about the DISRUPT CAD Pooled OCT Calcific Nodules Analysis at TCT21

How do you define a calcific nodule and what makes them so difficult to modify?

Dr. Maehara: As defined by OCT, the eruptive calcific nodule is accumulation of small calcium fragments underlying the calcified plaque typically protruding the lumen. Nodular calcium¹ (healed calcified nodule, i.e., calcified nodule with thick fibrous cap) is probably more difficult to modify because calcium is hard structured and because nodules protrude into the lumen which makes fracturing them very difficult with sub-optimal stent expansion.

Why is the DISRUPT CAD OCT analysis of calcified nodules relevant to today’s practice?

Dr. Maehara: This analysis is relevant because lesions with calcified nodules present with poor long-term outcomes, even with a good minimum stent area (MSA) at index procedure. There is a very robust recent Japanese article² published in Atherosclerosis by H. Sugane et al which shows that when we compare severe calcified lesions with or without calcified nodules, the lesions with calcified nodules have poor outcomes compared with the lesions without calcified nodules. While MSA is the most important factor to predict the future event, long-term outcomes are still poor in the presence of calcified nodules regardless of the index MSA. In another Japanese article published in Atherosclerosis by H. Sugane et al using the ISR captured by directional coronary atherectomy³, when they studied the ISR cases, the lesions with calcified nodules showed them protruding through the stent struts, and the calcified nodule was pushed out. This is not something we have seen before, and we are still learning about it.

From your perspective, what did we learn from this study on the impact of coronary IVL on nodular calcium?

Dr. Maehara: The nodular analysis is still a preliminary finding as it is looking at procedural results, so we should acknowledge that we need longer-term clinical follow-up of these patients. That said, my sense looking at this OCT analysis and considering my experience with nodular lesions treated without IVL, is that IVL is disrupting the calcified fragments that are bonded together to create the calcific nodule. IVL seems to be reshaping the calcified nodule which might mean more symmetric stent expansion and less protruding calcium through the struts during follow-up, which theoretically may lead to better long-term outcomes than treatments with other calcium modification therapies. We really have to see clinically good outcomes in the IVL cohort compared to a non-IVL cohort or possibly look into the OCT again in the chronic stage to see if the nodules are protruding inside the stent. That’s kind of the data that is needed to support this type of hypothesis, which will come with longer follow-up.

How would you explain IVL’s ability to successfully modify nodules in this analysis to the interventional cardiologist who do not consider the technology a great tool for this calcium morphology?

Dr. Maehara: We all know these cohorts have very poor outcomes even in comparison to severely calcified lesions without nodules. While the calcified nodule looks like a calcium rock, pathologically, the very dense calcium is small calcium fragments connected with fibrous tissue. As such, the IVL acoustic energy can disrupt the small fragments affecting the calcified nodule. Balloons, on the other hand, are subject to wire bias and are not changing the shape of the calcified nodule. Ablation therapies are polishing only one side of the nodule, just 15% of it.⁴ To be able to ablate more of the nodule with atherectomy, say 50%, you would have to ablate multiple times which we can’t typically do. This is why IVL disrupts calcified nodules much easier than other calcium modification modalities.

Given that these are acute procedural outcomes, what is important to look at next from a research perspective with coronary IVL in calcific nodules? 

Dr. Maehara: We have to see clinical outcomes in the long-term. No matter how good stent expansion is, these lesions have poor outcomes because of protruding nodules. Will fracturing the calcified nodule help the long-term outcome? Will the acute appearance correlate with the outcomes? We will see over time.

In addition, we need to better understand different types of calcified nodules and what are the optimal outcomes for each type of nodule, and which calcium treatment device might be ideal for each type.

It is also important to study patients having hemodialysis as they are more likely to have accumulation of calcification, and as a result, more calcified nodules. They are truly a unique cohort with very poor outcomes. This is even more critical to look into for international regions where transplants are not an option.

1: Torii et al, Pathology of Calcified Nodule J A C C V O L . 7 7 , N O . 1 3 , 2 0 2 1 A P R I L 6 , 2 0 2 1 : 1 5 9 9 – 6 1 1
2: H. Sugane et al, Atherosclerosis, https://doi.org/10.1016/j.atherosclerosis.2020.11.005
3: Nakamura et al, J Am Heart Assoc. 2020;9:e016595. DOI: 10.1161/JAHA.120.016595 1
4: Yamamoto et al, Catheter Cardiovasc Interv. 2018;1–8. 

Dr. Maehara is a paid consultant 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.