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Maintaining Wire Position With a Single-Operator Technique Utilizing Glide Assist™ With Orbital Atherectomy During Advancement Through the Coronary Guide Catheter
Abstract
The utilization of coronary atherectomy continues to increase in modern percutaneous coronary intervention. To further improve safety and simplify delivery of the Cardiovascular Systems, Inc. (CSI) orbital atherectomy system, we present a technique utilizing the Glide Assist™ function for crown advancement through the coronary guide catheter to maintain wire position and provide a safe, single-operator option. Our series contains 33 patients who successfully underwent this technique without loss of wire position or device complications. The technique was compatible in a variety of arterial access locations and guide catheter French sizes. The ease and safety of this technique makes it a new standard option for delivery of the orbital atherectomy system to the target lesion.
The utilization of coronary atherectomy continues to increase in modern-day percutaneous coronary intervention (PCI), as operators treat an aging population with severe coronary calcification and multiple comorbidities.1 The advantages of coronary atherectomy include better lesion preparation, improved stent delivery, stent expansion, and stent apposition. Disadvantages of coronary atherectomy include increased procedural times, slow or no-reflow, and coronary perforation.1 The Cardiovascular Systems, Inc. (CSI) orbital atherectomy system (OAS) is the only FDA-approved treatment for severely calcified coronary lesions.2,3 This device has been shown to improve acute and long term outcomes with low 30-day major adverse cardiac event (MACE) rates.2,3 The safety and success of coronary atherectomy has been correlated with operator and hospital volume.4 These procedures require careful technique to ensure proper outcomes. The coronary atherectomy procedure begins by delivering the device to the lesion for treatment.3-5 To further improve safety, minimize wire loss, and simplify delivery of the OAS device, we devised a technique utilizing the Glide Assist™ function for crown advancement through the coronary guide catheter while maintaining wire position and allowing a safe, single-operator option.
Technique Description
Once the operator has positioned the OAS wire in the desired location, the device is set up per the manufacturer’s instructions. The device is loaded on the wire and brought in front of the hemostatic hub; for this technique, our preference is a bloodless hemostatic valve: the Copilot (Abbott Vascular) or Guardian II (Teleflex). The brake is depressed and the device is tested on low speed. Then, the brake is released, and the device is advanced until the crown has passed the hemostatic hub and is just inside the guide catheter. This step can be done with or without assistance. Next, the brake is depressed, and the device brought forward so that it sits next to the guide (Figure 1). By depressing the brake, the wire is held in place while the device is repositioned on the table. The device is switched to Glide Assist mode and the brake is released. Under fluoroscopy, the device is then turned on and the crown is advanced through the coronary guide to the desired location in the coronary artery. While performing this technique, the assistant will monitor the back end of the wire, making sure it remains free and without table interaction. Once we are at the desired lesion location, the brake is depressed, and the device is switched back to the standard low setting (full case available, Video 1).
Case Series
Tables 1 and 2 summarize the baseline patient and procedural characteristics in this case series. The average age of our patients was 69.9 years old; the average ejection fraction (EF) was 53.1%. The most common presentation for treatment was angina, at 60.6% of our patients. All major coronary arteries were represented in the target treatment vessel, with the left anterior descending (LAD) coronary artery treated in 16/33 (48.5%) patients. Radial artery access was performed in 26/33 (78.8%) of patients and 26/33 (78.8%) of the cases were completed using a 6 French system. The single-operator Glide Assist technique was utilized in 100% of cases. There were no incidents of wire position loss. There were no complications involving delivery of the device or its removal through the coronary guide catheter. In this case series, there were no wire fractures, device malfunction, equipment loss or entrapment, occurrences of slow or no-reflow, or coronary perforation of the treatment vessel. In one case, a diagonal side branch was lost immediately after atherectomy and was not retrievable, resulting in a post procedural non ST-elevation myocardial infarction (MI); however, there were no clinical sequelae. All patients were successfully discharged home from their procedure or hospital stay.
Video 1. Recorded live case, from start to finish, demonstrating the single-operator technique.
Discussion
To our knowledge, this is the first large case series utilizing the Glide Assist technique feature on the OAS to maintain wire position and allow for a single operator to deliver the device through the coronary guide catheter. As the frequency of calcification and complex lesions increase in the cath lab, so will the need for atherectomy.1 Complex, calcified lesions can be tortuous and difficult to wire. A number of these patients can have associated aortic/subclavian or iliac tortuosity, which makes delivery of atherectomy devices challenging. It can lead to wire loss and result in increased procedure time and possible harm to the patient. Our technique allowed for the maintenance of wire position and successful delivery of the orbital atherectomy device in 100% of cases. After device delivery, all patients underwent successful lesion treatment with no device-related complications and successful removal of the device without loss of wire position. The single-operator Glide Assist technique performed well in a 6 French system and multiple access sites.
Our case series demonstrates the technique’s universal adaptability for operators whenever they choose to use the OAS. Additional benefits include a short learning curve for the operator and their assistant, which allows for easier incorporation of OA into their practice. Technique limitations include the need to initially pass the burr through the hemostatic device, which typically requires the operator to have assistance. This need can be overcome by advancing the knob and bringing the orbital atherectomy crown into the beginning of the guide; however, this is an advanced technique and not typically performed. An additional limitation with this technique occurs in the setting of guide extension catheters. The Glide Assist technique is not recommended for use with 6 French guide extension catheters, due to crown interaction with the distal entrance and push rod; however, the technique has been performed successfully in 7 or 8 French guide extension catheters. If an operator does wish to utilize this technique in a 6 French guide extender, we recommend having the distal entrance of the guide extender at the beginning of the guide catheter, just past the hemostatic valve, manually advancing the crown fully into the guide extender, and then performing this technique. Once the crown is brought to the end of the guide catheter, just before entering the coronary ostium, depress the brake of the OAS system and then advance the guide extender to the desired position. Additional analysis of one of the guide catheters used during this study was performed. Both visual inspection and electron microscopy (EM) were performed (Figure 2). There was no visible damage identified, but on the EM, there were abrasions that occurred in the guide catheter during OAS advancement. However, we observed no clinical effect related to this finding.
Conclusion
This case series demonstrates the safety and efficacy of a simple technique to advance the OAS through the coronary guide catheter as a single operator, while maintaining wire position and preventing device complications. The ease and safety of this technique make it a new standard option for delivery of the OAS to the target lesion.
Disclosures: Dr. Matthew Whitbeck reports he is a consultant/speaker for Cardiovascular Systems Inc. (CSI). Dr. Jeffrey Chambers is the Chief Medical Officer for CSI.
The authors can be contacted via Matthew G. Whitbeck, MD, at matthew.whitbeck@mhvi.com
References
1. Beohar N, Kaltenbach LA, Wojdyla D, et al. Trends in usage and clinical outcomes of coronary atherectomy: a report from the National Cardiovascular Data Registry CathPCI Registry. Circ Cardiovasc Interv. 2020 Feb; 13(2): e008239. doi: 10.1161/CIRCINTERVENTIONS.119.008239
2. Lee M, Généreux P, Shlofmitz R, et al. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017 Jun; 18(4): 261-264. doi: 10.1016/j.carrev.2017.01.011
3. Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014 May; 7(5): 510-518. doi: 10.1016/j.jcin.2014.01.158
4. Isogai T, Yasunaga H, Matsui H, et al. Relationship between hospital volume and major cardiac complications of rotational atherectomy: a nationwide retrospective cohort study in Japan. J Cardiol. 2016 May; 67(5): 442-448. doi: 10.1016/j.jjcc.2015.07.008
5. Sharma SK, Tomey MI, Teirstein PS, et al. North American expert review of rotational atherectomy. Circ Cardiovasc Interv. 2019 May; 12(5): e007448. doi: 10.1161/CIRCINTERVENTIONS.118.007448
