Updated SCAI guidance includes Coronary IVL as a treatment option in all U.S. cath labs regardless of surgical backup status.

SCAI has updated the 2014 Expert Consensus on PCI Without Surgical Backup with new guidance that includes Coronary IVL as a potential therapeutic option in all cath labs – including facilities without on-site surgical backup.¹

As seen in the table below, SCAI’s statement lists IVL as a therapy option across the four different surgical and non-surgical facility types. The updated guidance expands the number of hospitals that can access IVL to include sites where calcium modification tools were previously not recommended. The prior guidance, published in 2014, recommended to avoid the treatment of high-risk lesions defined as “more than moderate calcification” in facilities without surgical backup.² Authors of the new guidance acknowledged the limitations of the previous guidance:

“…these [prior] recommendations may have restricted practice, limited patient choice, and exposed interventional cardiologists to legal risk. Such prohibitions have become outdated as the skill of interventional cardiologists and technological advances have expanded treatment options, outcomes data show no harm with PCI with no-SOS, and government policies actively encourage moving care to lower-cost areas. In particular, the prohibition of rotational and other atherectomy devices can paradoxically result in increased risk to the patient when balloon angioplasty is attempted in a calcified vessel.”

Operators and administrators working in non-surgical facilities interested in implementing Coronary IVL into their practice may be interested in reviewing the Cath Lab Digest article: Management of Calcified Lesions in Hospitals Without Surgical Backup.

Shockwave is proud to play a role in expanding care for patients in facilities without surgical backup through its demonstrably safe, effective and intuitive technology.

View Updated Guidance

View Press Release

¹ Grines, C. L., Box, L. C., Mamas, M. A., Abbott, J. D., Blankenship, J. C., Carr, J. G., . . . Seto, A. H. (2023, February). SCAI expert consensus statement on percutaneous coronary intervention without on-site surgical backup. JACC: Cardiovascular Interventions. doi:10.1016/j.jcin.2022.12.016
² Dehmer GJ;Blankenship JC;Cilingiroglu M;Dwyer JG;Feldman DN;Gardner TJ;Grines CL;Singh M;. (n.d.). SCAI/ACC/AHA expert consensus document: 2014 update on percutaneous coronary intervention without on-site surgical backup. Retrieved January 30, 2023, from https://pubmed.ncbi.nlm.nih.gov/24637561/

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. Constantino Peña is a paid consultant for Shockwave Medical.

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  

Dr. Nicolas Mouawad is a paid consultant for Shockwave Medical.

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  

Dr. JD Corl is a paid consultant for Shockwave Medical.

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  

In a late-breaking clinical trial session at VIVA22, Dr. Ehrin Armstrong presented the final 1,373 patient cohort data from the DISRUPT PAD III Observational Study (OS). DISRUPT PAD III OS represents the largest prospective ‘real-world’ evidence for the treatment of complex, heavily calcified peripheral artery disease. Building on the interim results presented at VIVA21, this larger patient data set reinforces the predictability of IVL and its ability to consistently modify calcium across vessel beds, challenging lesions, and complex patients (CLI, dialysis, and female patients). These real-world outcomes mirror the previously reported DISRUPT PAD III Randomized-Controlled Trial showing that IVL safely and effectively modifies challenging calcium in complex patients. 

Check-out the presentation below and hear from Dr. Armstrong on the importance of the largest prospective ‘real-world’ data set in the treatment of heavily calcified PAD. 

In this webcast recorded at TCT 2022, Prof. Javier Escaned and Dr. Nieves Gonzalo from Clinico San Carlos Madrid, and Dr. Angela McInerney, from University Hospital Galway, share their experience with IVL and the results from their most recent studies.

Dr. Mclnerney discusses about the results of a multicentre prospective study conducted within 14 centres in Spain to evaluate IVL in real-world scenarios and to compare MSA post IVL in different calcium morphologies. The results show that IVL is very effective across all calcium morphologies as there was no significant difference in MSE across concentric, eccentric and nodular calcium.

Dr. Gonzalo speaks about a multicentre study conducted in 2 large centres in Spain, with the objective of evaluating the long-term angiographic results following IVL, assess changes in MSA and study patterns of vessel healing after IVL treatment and understand the durability of the therapy. Results from this study showed that MLD and MSA are both maintained at follow up, with a low percentage of restenosis, no signs of recoil, and complete healing of the IVL-induced cracks.

In this short video, Dr. Sundeep Kalra, Royal Free Hospital of London, UK, shares his experience with Shockwave IVL, highlighting his evolution in the use of the technology since he started in 2016. At that time, his main indication for use of IVL was severely calcified coronary arteries with > 270° arc of calcium on intravascular imaging. Nowadays, Dr. Kalra uses Shockwave IVL to treat the whole lesion throughout all calcium morphologies, to ensure good plaque modification and achieve greater stent expansion.

Here, Dr. Kalra presents one of his recent clinical cases with Shockwave IVL: a 77-year-old woman with worsening stable angina and severe calcified left anterior descending artery (LAD). The patient was treated with a 3.0 mm Shockwave C2, using 50 shocks to fracture nodular calcium and 30 shocks for the eccentric plaque, followed by stent placement.

Did you get a chance to watch the educational symposium on nodular calcium at TCT 2022? If you missed it, we’ve got you covered!

In this session, leading complex PCI operators and calcium experts share their challenging nodular calcium cases while reviewing the pros and cons of existing calcium modification devices, including current clinical evidence and knowledge gaps. Listen to their debate on different treatment strategies for nodular calcium via atherectomy, IVL, and atherectomy + IVL.

A very informative session with a great discussion – Enjoy the debate!

Dr. Jaikirshan J. Khatri, MD, FACC, FSCAI Director of Complex Coronary Intervention Heart, Vascular & Thoracic Institute, at Cleveland Clinic; Cleveland, Ohio shares his calcium modification approach with Shockwave coronary IVL, including his best practices for pulse management as well as how calcium is affected by the fractures caused by coronary IVL.

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. Jaikirshan J. Khatri 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.