Q&A: First U.S. “RotaShock” Case Series Publication
In the recent Cardiovascular Revascularization Medicine article, “First United States experience with RotaShock: A case series,” Drs. Gautam Kumar and Rajesh Sachdeva of Emory and Atlanta VA Medical Center recount three successful cases using the RotaShock technique, a combination of rotational atherectomy with IVL for severely calcified vessels. Following its publication, we engaged them in a highly educational Q&A discussion about how the two technologies are very complementary to each other, and the new strategy can be used either electively or as a rescue. We hope you enjoy their additional perspective.
Out of all of your IVL cases performed, what percentage of your cases have been Rota-Shock and do you expect this rate to decrease or increase over time?
Drs. Kumar & Sachdeva: We have done rotational atherectomy plus IVL in about 10% of our cases. We have several other modalities available in our cath lab and we are also actively participating in randomized trials for calcified coronary lesions.
The complementary relationship between atherectomy and IVL that you reference in your manuscript – is it equally effective with both rotational and orbital atherectomy, or is one preferred?
Drs. Kumar & Sachdeva: Rotational atherectomy (RA) works predominantly against superficial calcium but orbital atherectomy does have an effect on fragmenting the deep calcium in addition to sanding the superficial calcium. This has been described in at least a few studies that have done intravascular imaging in conjunction with orbital atherectomy like in our own series - Desai R et al. Plaque modification of severely calcified coronary lesions via orbital atherectomy: Single-center observations from a complex Veterans Affairs cohort. Health Sci Rep. 2018 Oct 27;1(12):e99. The complementary relationship between RA and IVL seems to make intuitive sense.
You make a keen distinction in your study between “Elective” and “Rescue” RotaShock approaches – what percentage of your RotaShock cases would you expect to see in category?
Drs. Kumar & Sachdeva: Having several years of experience treating calcified lesions in the VA population, we have quickly learnt that planning a combination approach upfront is a better methodology especially when you have information from intravascular imaging or CCTA. There are unusual circumstances where IVL will be used as a rescue therapy and we envision that with increased usage of pre-PCI imaging, this will be necessary less often.
In choosing the “Elective” RotaShock strategy, what are you looking for on angio or intravascular imaging to help make that decision?
Drs. Kumar & Sachdeva: The most important factor that we use to identify an elective Rota-Shock case on angiography is the size of the vessel. In general, for a large left main coronary artery (5-6 mm diameter) or a proximal left anterior descending artery (4-5 mm diameter), it is going to be hard to assume that plaque modification with a 1.5 mm burr alone will be adequate prior to stenting to maximize MSA. The depth of calcification is an important factor is determining whether plaque fracturing is adequate, and OCT is superior to IVUS for the assessment of this as the acoustic shadowing of the proximal edge of the calcium precludes depth assessment with IVUS. Post-atherectomy, we can assess the extent of plaque fracturing with OCT or with IVUS as well.
In the “Rescue” RotaShock cases, what were your previous treatment option before IVL was available?
Drs. Kumar & Sachdeva: One could consider rotational atherectomy with a larger size burr prior to stenting. Sometimes, this may be difficult in radial cases as a 7 Fr guide catheter may not have been used initially and thus burr size would have been limited to 1.5 mm as an example. If orbital atherectomy had been chosen, we could consider going back and doing more runs and consider high speed runs at 120k rpm if the vessel was large. Prior to IVL, most operators would have used specialty balloons with variable results. Some operators may consider laser depending upon availability.
Are there any tips or tricks that you use to optimize outcomes in your RotaShock cases?
Drs. Kumar & Sachdeva: Mandatory use of imaging – either IVUS or preferably, OCT is essential. We generally try to evaluate each case pre-plaque modification (if we are able to cross the lesion), post-plaque modification (to assess the adequacy of calcium fracturing prior to stenting) and then post stenting (to assess stent expansion and apposition).
As you’ve gained more experience with RotaShock, what do you know now that you wish you would have known before your first case?
Drs. Kumar & Sachdeva: We are still early in our experience with this technique and continue to learn from each case.
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
