AngioSculpt PTCA Balloon Catheter Entrapment and Detachment Managed with Stent Jailing

ABSTRACT: The AngioSculpt PTCA Scoring Balloon Catheter is an FDA-approved device for plaque modulation. We describe the first case of AngioSculpt EX catheter entrapment and detachment in the right coronary artery during PCI that was successfully managed with stent jailing of the entrapped balloon catheter and its shaft against the vessel wall. J INVASIVE CARDIOL 2010;22:E208–E210 —————————————————————————— Editor’s Note: This is a case involving a challenging scenario of managing the broken material (balloon, wire or AngioSculpt in this case) by a technique called “stent exclusion,” which pushes the retained fragments against the vessel wall. In the long term, this strategy is safe and just requires dual antiplatelet therapy. Despite a few initial rare reports of AngioSculpt catheter breakage, the improved version since January 2010 has had no more reports of device fracture. — Samin K. Sharma, MD Mount Sinai Medical Center, New York, New York —————————————————————————— The AngioSculpt (ASC) PTCA (percutaneous transluminal coronary angioplasty) Scoring Balloon Catheter (AngioScore, Fremont, California) received premarket approval in 2007 from the U.S. Food and Drug Administration (FDA), for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions. There are two types of ASC PTCA balloon catheters: over the wire (OTW) and the easy exchange (EX). Since its approval, there has been one published case report of the entrapment of the OTW balloon catheter during predilatation of a heavily calcified lesion, which was managed with emergent cardiac surgery.¹ To the best of our knowledge, we describe the first case of a distal section detachment from the ASC EX catheter with subsequent balloon shaft entrapment at the proximal edge of a previously placed right coronary artery (RCA) stent. After attempting multiple management strategies, this was successfully managed with bailout stent jailing of the balloon catheter and its shaft. Case Report. A 64-year old Caucasian male with a past medical history of hypertension, dyslipidemia, and coronary artery disease (CAD) presented with unstable angina. In 2005, a bare metal stent (BMS) was implanted in the mid right coronary artery (RCA), and in 2008 this required re-stenting with a drug-eluting stent (DES) due to in-stent restenosis. In 2009, he was diagnosed with an 80% stenosis of the mid left anterior descending artery (LAD) and a 60–70% stenosis in the mid RCA distal to the previous RCA stent. It was decided to proceed with DES implantation of the LAD lesion and to clinically follow the RCA lesion. One month later, due to recurrent unstable angina, an exercise stress echocardiography was ordered. This revealed stress-induced ischemia of the inferior wall, and the decision was made to electively schedule the patient for RCA stenting. The patient received clopidogrel re-loading prior to the procedure, and bivalirudin during the intervention. An Amplatz left (AL 1) guiding catheter (Medtronic, Minneapolis, Minnesota) was used to engage the RCA (anomalous anterior take-off). Next, a Balance MiddleWeight (BMW) guidewire (Abbott Laboratories, Abbott Park, Illinois) was used to cross the target lesion (Figure 1). Due to the calcified nature of the culprit lesion, we elected to pre-dilate with a 2.0 x 10 millimeter (mm) AngioSculpt EX PTCA Scoring Balloon Catheter. Advancement of the balloon catheter, however, was met with resistance at the location of the proximal edge of the previous RCA stent (Figure 2). Multiple attempts at retracting or advancing the balloon catheter using gentle to and fro maneuvers with occasional deep engagements of the guiding catheter resulted in detachment of the distal section of the balloon catheter in the proximal to mid RCA. A buddy wire was advanced into the distal RCA over which an intravascular ultrasound (IVUS) revealed an entrapped distal section of the balloon catheter and its shaft located at the proximal site of a previously placed well-apposed stent with no extension into the aorta. Various strategies were attempted to retrieve the catheter remnant. We were able to noose the entrapped catheter multiple times with over-the-wire Retriever-10 Endovascular Snares (Boston Scientific, Natick, Massachusetts) and Amplatzer Snares (Microvena, White Bear Lake, Minnesota), however, retrieval could not be achieved and the wire eventually kinked. Next, the Spider FX (Ev3, Plymouth, Minnesota), an embolic protection device, was advanced in a parallel fashion past the entrapped balloon and was then retracted in an effort to release the catheter from the stent strut, however, this was unsuccessful. Ultimately, after discussing the case with the patient and his family, the management strategy involved stenting the target lesion first, and then proceeding proximally, to jail the entrapped balloon catheter and its shaft against the vessel wall with stents that would extend proximally to the ostia of the RCA. The other option was surgical management, however, the unanimous decision was to proceed with stenting. The target lesion was crossed with a Whisper Extra Support guidewire (Abbott Vascular), and then a Voyager RX (Abbott Vascular) balloon catheter, sized 2.5 x 30 millimeters (mm), was inflated prior to placement of a 2.5 x 28 mm Xience stent (Abbott Vascular). This was followed by jailing of the entrapped balloon catheter against the vessel wall by inflating a 2.5 x 30 mm Voyager RX balloon catheter, and then subsequently deploying two Xience stents (2.5 x 23 mm and 3 x 18 mm) to successfully cover the entirety of the entrapped balloon catheter (Figure 3). The final angiogram was excellent and demonstrated TIMI 3 flow in the RCA with successful jailing of the entrapped balloon catheter to the vessel wall (Figure 4). The patient was hemodynamically stable throughout the procedure and remained chest pain free with no elevation of cardiac biomarkers for the next 48 hours, after which he was discharged home on aspirin and clopidogrel. He returned several days later due to atypical chest pain, however, his ECG and cardiac biomarkers were negative, and a repeat angiogram revealed no abnormalities. At 6-month follow up, he continues to be asymptomatic. Discussion. Preparing complex lesions prior to stent deployment is a crucial component of PCI. If the stent is not deployed with optimal expansion and apposition to the vessel wall, then this can result in subacute thrombosis, restenosis, and the need for target lesion revascularization. The ASC scoring balloon catheter is the latest of the devices that has been developed to address this issue. Other devices that have been utilized to modify lesion compliance and improve stent expansion include the Cutting Balloon and the FX-miniRail balloon catheters (Boston Scientific).² The ASC PTCA scoring balloon catheter is comprised of a semi-compliant angioplasty balloon surrounded by a flexible nitinol scoring element, which is not embedded within the balloon. This scoring element is a nitinol spiral cage consisting of three spiral wires wrapped around the balloon catheter. As the balloon inflates, the spiral wires slide and rotate over the balloon to achieve its fully open configuration. The expanded configuration provides a linear cutting surface that efficiently scores the plaque, allowing low-pressure dilatation. This catheter is designed to treat complex lesions (fibro-calcific, bifurcation, ostial), in-stent restenosis (ISR), and to avoid device slippage, or "geographic miss," which is commonly seen with conventional balloon angioplasty.³ Dislodgement of a stent or catheter remnant in the coronary circulation is a rare complication, with an overall incidence of 0.3–1.2%, and may result in systemic or intracoronary embolization. Systemic embolization may cause cerebrovascular events, and intracoronary embolization is associated with a high risk of lethal arrhythmias, and coronary thrombosis with ensuing myocardial infarction.^4,5 Multiple non-surgical approaches to retrieve embolized coronary catheter remnants or stents have been described. These include use of a biliary or myocardial biopsy forceps, multipurpose baskets, two twisted guidewires, low-profile angioplasty balloon catheters, and gooseneck snares. If these measures prove to be ineffective, bailout cardiac surgery may be indicated.^4,5 However, small fragments of catheter remnants may be left within the coronary artery without adverse sequelae, if they are located within a distal part of the vessel or within vessels that are small or chronically occluded.⁶ The safety and effectiveness of the ASC balloon catheter was established in a U.S. multi-center trial.³ Since then, there has been one published report describing the entrapment of an over-the-wire version of this device, and this was hypothesized to be secondary to intertwining of the nitinol spirals with calcium spicules on withdrawal. This was managed surgically, however, the patient died 6 months later.¹ We postulate that the mechanism of the entrapment was intertwining of the nitinol spirals of the catheter with struts of a previously placed stent. Unlike the Cutting balloon catheter, in which the blades are embedded within the balloon (blades are hidden until the balloon is inflated), the ASC balloon catheter is composed of nitinol spirals that surround the balloon prior to inflation, predisposing it to entanglement with calcium spicules, or in our case, possibly stent struts. We attempted multiple retrieval strategies in this case and all proved to be futile. After discussing the details of the case with the patient, it was decided to proceed with jailing the entrapped catheter remnant against the vessel wall rather than taking a surgical approach. Surgery would have been the option if the remnant was protruding into the aorta as this would be a potential source for embolic phenomena. Conclusion. This case serves to increase awareness of a potentially unfavorable outcome when utilizing the AngioSculpt PTCA balloon catheter during percutaneous coronary intervention for highly calcified vessels with prior stenting. If entrapment occurs, the management strategy that is utilized must be individualized, and should place the patient at the lowest risk of morbidity and mortality. Our impetus to proceed with stent jailing of the detached balloon shaft was predicated on clinical parameters and discussion with the patient. Acknowledgement. The authors would like to acknowledge Dr. Thomas A. Hennebry for his assistance and involvement with the patient care and manuscript preparation.

References

1. Sanchez-Recalde A, Galeote G, Martin-Reyes R, Moreno R. AngioSculpt PTCA Balloon entrapment during dilatation of a heavily calcified lesion. Rev Esp Cardiol 2008;61:1355–1365. 2. Fonseca AG, Abizaid AS, Abizaid A, et. al. A novel scoring balloon (AngioSculpt™) for the treatment of complex coronary Lesions. Am J Cardiol 2006;98(8), Supplement: 190M. 3. Mooney M, Teirstein P, Moses J, et. al. Final Results from the U.S. Multi-Center Trial of the AngioSculpt Scoring Balloon Catheter for the Treatment of Complex Coronary Artery Lesions. Am J Cardiol 2006;98(8), Supplement: 121M. 4. Eggebrecht H, Haude M, von Birgelen C, et. al. Nonsurgical retrieval of embolized coronary stents. Catheter Cardiovasc Intervent 2000;51:432–440. 5. Alexious K, Kappert U, Knaut M, et. al. Entrapped coronary catheter remnants and stents. Texas Heart Institute J 2006;33:139–142. 6. Hartzler GO, Rutherford BD, McConahay DR. Retained percutaneous transluminal coronary angioplasty equipment components and their management. Am J Cardiol 1987;60:1260–1264.

————————————————————————— From the University of Oklahoma Health Sciences Center, and the Veteran Affairs Medical Center, Cardiovascular Section, Oklahoma City, Oklahoma. The authors report no conflicts of interest regarding the content herein. Manuscript submitted March 15, 2010, provisional acceptance given April 12, 2010, final version accepted April 14, 2010. Address for correspondence: Mazen S. Abu-Fadel, MD, FACC, FSCAI, 920 S. L. Young Blvd., WP 3010, Oklahoma City, OK 73104. E-mail: mazen-abufadel@ouhsc.edu