فایل تصویری.pdf

CASE REPORT

A two-case series of entrapment of a ruptured balloon in the coronary artery: Avoidable complications and nonsurgical management

Wei-Ting Changa, Ju-Yi Chena, Yi-Heng Li, Liang-Miin Tsai, Cheng-Han Lee*

Division of Cardiology, National Cheng Kung University Hospital, Tainan, Taiwan

Received 19 December 2012; received in revised form 2 May 2013; accepted 11 May 2013

nonsurgical techniques. Coronary interventionists should be aware of the possibility of balloon entrapment during complex coronary interventions; they should also become familiar with nonsurgical catheter-based methods for the retrieval of ruptured and entrapped balloons.

Copyright ª 2013, Elsevier Taiwan LLC & Formosan Medical Association. All rights reserved.

Introduction

With the increasing prevalence of percutaneous coronary

0929-6646/$ - see front matter Copyright ª 2013, Elsevier Taiwan LLC & Formosan Medical Association. All rights reserved. http://dx.doi.org/10.1016/j.jfma.2013.05.008

and ruptured coronary artery balloons during PCI. We also review the literature in reference to the retrieval of entrap-ped coronary devices over the past two decades.

marks seemed to be lengthening as we pulled on the catheter urgently. We were under the impression that the balloon had ruptured and was entrapped in the tight lesion. We then used another 2.5 20 mm Ryujin Plus balloon

A 78-year-old hypertensive patient experienced acute chest pain within 2 hours of admission to the hospital. A 12-lead electrocardiograph showed inferior ST segment elevation, and the patient was diagnosed with an acute inferior myocardial infarction (MI). An emergency transfemoral coronary angiography showed triple vessel disease with

(Fig. 1A). After the SCR (Medtronic, Danvers, USA) 3.5 guiding catheter (7F) was engaged, a Fielder hydrophilic wire (ASAHI, Pathumthani, Thailand) was advanced to the distal RCA, and thrombus aspiration was performed at the proximal to mid RCA using Thrombuster II (Kaneka, Osaka,

2.75 20 mm Ryujin Plus Balloon (Terumo, Tokyo, Japan) in the proximal RCA at 12 bars, but the balloon ruptured (Fig. 1B). Subsequent angiography showed TIMI (Throm-bolysis in Myocardial Infarction) 0 antegrade flow. The pa-

entrapped balloon, but the attempt failed. Finally, we intubated the SCR even more deeply to cover the entrap-ped balloon and successfully removed all devices. We then used the 7F SCR to engage the RCA again. A 3.0 24 mm Driver stent (Metronic, Galway, Ireland) was deployed at the proximal RCA after predilatation with a 2.75 18 mm Sapphire NC Balloon (OrbusNeich, Hoevelaken, Nether-land), a noncompliant balloon, owning better strength and less deformation during inflation than the Ryujin Plus, a semicompliant one. The final coronary angiography showed TIMI 3 antegrade flow in the RCA (Fig. 1C). The post-operative course was uneventful, and the patient was dis-charged 3 days later.

Case 2

A 48-year-old hypertensive patient with a history of end-stage renal disease underwent routine hemodialysis for 5

tient remained        hemodynamically stable.         Initially, the            years. During 1 recent month, he suffered from crescendo

balloon catheter could not be removed. The distal balloon                    angina and a Thallium scan disclosed a perfusion defect over

Figure 1       (A) Coronary angiogram from the right anterior oblique (RAO) view showed a total occlusion at the proximal right coronary

artery (RCA). (B) The distal portion of the 2.75 20 mm Ryujin Plus balloon was entrapped in the proximal RCA. (C). The final coronary

angiogram showed TIMI (Thrombolysis in Myocardial Infarction) 3 flow of the RCA after ruptured balloon retrieval and stent

deployment. (D) The ruptured balloon was separated to the distal curled part and the proximal uncurled part.

Figure 2       (A) Coronary angiogram from the right anterior oblique (RAO) view showed a 90% stenosis at the mid left anterior descending artery (LAD). (B) A 3.0 10 mm IVT cutting balloon failed to fully dilate the lesion and was entrapped. (C) The guiding catheter was deeply intubated to cover the ruptured balloon. (D) Intravascular ultrasound (IVUS) showed a severe 360-degree calcified lesion. (E) The final coronary angiogram showed a well-expanded stent in the mid LAD with TIMI (Thrombolysis in Myocardial Infarction) 3 flow. (F) The retrieved ruptured Flextome Cutting Balloon (Boston Scientific, Galway, Ireland) in vitro.

the apex with reversible redistribution, which implicated the viable myocardium. Thus, he received an elective cor-onary angiogram. Angiography showed 90% stenosis at the mid left anterior descending artery (LAD) and 50% stenosis at the orifice of the second diagonal branch (D2) (Fig. 2A). A transfemoral coronary intervention was performed using a 7F EBU guiding catheter (Metronic, Danvers, USA) to engage the left coronary artery. A Sion wire (ASAHI, Pathumthani, Thailand) was passed through the LAD lesion, and the other Fielder wire (ASAHI, Pathumthani, Thailand) kept the D2

orifice open. A 2.5 15 mm Sprinter Legend Balloon (Met-ronic, Tijuana, Mexico) was used to predilate the D2 orifice at 8 bars. Attempts to predilate the LAD lesion with both a 3.0 15 mm IKAZUCHI (Kaneka, Osaka, Japan) at 12 bars and then a 3.0 15 mm Hiryu noncompliant balloon (Terumo) at 20 bars failed. We then used a 3.0 10 mm Flextome Cutting Balloon (Boston Scientific, Galway, Ireland) to predilate the lesion at 14 bars. However, the balloon ruptured and was entrapped (Fig. 2B). Owing to the size and the disease-free status of the proximal LAD, we deeply intubated with the

guiding catheter to cover the entrapped and ruptured balloon, and the balloon was successfully removed (Fig. 2C). Intravascular ultrasound IVUS (Boston Scientific, Fremont, USA) showed a severe 360-degree calcified lesion where the balloon had ruptured (Fig. 2D). Rotational atherectomy with a rotablator (Boston Scientific, Cork, Ireland) (burr size 1.75 mm and 2.0 mm, sequentially) (Boston, MA, USA) and a noncompliant Hiryu Balloon (Terumo, Tokyo, Japan) fully dilated the lesion, and a 3.0 18 mm Promus stent (Boston Scientific, Galway, Ireland) was deployed with full expan-sion. The final result showed TIMI 3 antegrade flow of the LAD (Fig. 2E). The postoperative course was uneventful, and the patient was discharged the next day.

Surgical intervention was necessary in the other nine cases, with some patients requiring aortocoronary bypass.5e7,10,11     In summary, the entrapment of devices occurs most often in tortuous, angulated, or calcified lesions with sharp edges, especially in lesions involving the proximal portion of the coronary arteries.4e8All inflation beyond the rated burst pressure of the coronary balloon, inadequate deflation, and manufacturing defects may increase the likelihood of entrapment. No differences in the rate of device entrapment were noted in any of the following demographics: age, sex, comorbidities, or whether the procedure was elective or an emergency coronary intervention.9Some factors leading to entrapment have been reported in the literature, such as the lack of back-up-support guiding catheters, the use of the

Lesions that may present a high risk of entrapment require

The incidence of entrapped hardware during PCI is reported at a rate of only 0.4e1%.9However, entrapped hardware may

lead to severe complications, such as systemic thrombosis,

coronary perforation, and compromised distal coronary flow.1e8Wereviewedeightcasesofentrappedballoons1e8and nine cases of entrapped stents10e15from the past two decades (Table 1).1e8,10e15Eight cases of entrapment occurred in the LAD,1,7,10e15four cases in the RCA,2,4,5,8three cases in the LCX,6,10,14one case in the left main coronary artery,12and one case in the iliac artery.3In four cases, the entrapped devices

were abandoned in situ due to either the generally poor con-

dition of the patient or the chronic total occlusion of the coronary circulation.8,10Subsequent coronary angiography revealed no migration of the entrapped devices.9Snare retrieval sets were successful in three cases,3,15while other catheter-based techniques were successful in two cases.1,2

careful evaluation prior to intervention. In the first case, the application of high-pressure inflation, even under the rated burst pressure, and inadequate deflation, followed by the attempt to quickly remove the balloon, were the cause of the rupture and entrapment. High-pressure inflation with a semicompliant balloon, inadequate deflation, and drastic pull-out of the balloon should be avoided. In the second case, under fluoroscopy, we did not believe that the lesion was so intensely calcified. We first attempted dilation with a semi-compliant balloon, then a noncompliant balloon, and finally, with a cutting balloon because the lesion could not be fully dilated. We applied a cutting balloon at high pressure, and the balloon ruptured and became entrapped. IVUS should be routinely used to evaluate complex lesions so that the appropriate devices for lesion dilatation or atherectomy are chosen. When heavily calcified vessels will not dilate with

RCA Z right coronary artery.

cutting balloon takes advantage of the reduction in vessel stretch and injury by scoring the vessel longitudinally, rather than an uncontrolled disruption of the atherosclerotic pla-que. A cutting balloon is widely applied in de novo, instent restenosis, small caliber, and ostial lesions. Rotational atherectomy was designed to debulk lesions and assist in the delivery of stents to the distal location. Lower balloon inflation pressures (4e8 atmospheres) are recommended with a cutting balloon. With high pressure inflation, a cutting balloon may rupture and become entrapped.3,4
Surgical intervention is not the only solution for the man-

We believe that strategies for the retrieval of entrapped catheter remnants should be individualized for each pa-tient situation. Proper and timely steps without panic are important. Calcified and tortuous vessels should be care-fully evaluated, and balloon inflation beyond the rated burst pressure should be avoided. Coronary interventionists should be alert to the possible complications of the entrapment of catheter materials and should be familiar with catheter-based retrieval methods.

fragments and the size of the coronary arteries should be evaluated. The removal of entrapped hardware is not neces-sarily mandatory. If the device fragments are contained within small, chronically occluded coronary vessels or within a distal segment, it is acceptable to leave the fragments in place or to deploy a new stent directly.10However, retrieval is compul-soryintheproximalcoronaryartery,especiallyintheareathat protrudes into the ascending aorta, or in any situation where the coronary flow is compromised to prevent systemic thrombosis. Intracoronary nitroglycerin may assist in the reduction of arterial spasm, but it is of little use in the setting of mechanical complications. Another option is to decrease the balloon viscosity by progressively diluting the contrast material within the balloon with saline: combined with rapid deflation, this method sometimes successfully releases the balloon.10The third choice is to deeply intubate the guiding catheter into the artery, along with the anchor system. With this method, however, the patient may be at risk for the dissection of, or even the perforation of, the proximal vessels. With deep intubation, large caliber arteries with minimal tortuosity of the proximal part are crucial, and the patient must be carefully evaluated.1,2In the two cases we describe in this paper, we deeply seated the guiding catheter to cover the entrapped balloon and were then able to successfully remove all devices. An alternative method, the daughter-in-mother

1.Girish MP, Gupta MD, Tyagi S. Entrapped coronary angioplasty stent balloon due to nondeflation: percutaneous retrieval by a simple technique. Catheter Cardiovasc Interventions 2011;77: 58e61.

2.Blackman D, Dzavik V. Inadvertent detachment of an entrap-ped Cutting Balloon from the balloon catheter during treat-ment of in-stent restenosis. J Invasive Cardiol 2005;17:E27e9. 3.Braun MA, Smith SJ, Merrill TN. Contralateral loop snare removal of a ruptured and entrapped angioplasty balloon. Cardiovasc Intervent Radiol 1996;19:428e30.

4.Madronero JL, Hein F, Bergbauer M. Removal of a ruptured, detached, and entrapped angioplasty balloon after coronary stenting. J Invasive Cardiol 2000;12:102e4.

5.Breisblatt WM. Inflated balloon entrapped in a calcified coro-         nary stenosis. Cathet Cardiovasc Diagn 1993;29:224e8.

6.Nishiwaki N, Kawano Y, Furukawa K. A case report of entrap-ment of PTCA balloon catheter caused by its rupture. Nippon Kyobu Geka Gakkai Zasshi 1991;39:1226e30.

7.Chang TT, Pellegrini D, Ostrovsky A, Marrangoni AG. Surgical     management of entrapped percutaneous transluminal coro-    nary angioplasty hardware. Tex Heart Inst J 2002;29:329e32. 8.Carell ES, Schroth G, Ali A. Circumferential balloon rupture and          catheter fracture due to entrapment in a calcified coronary             stenosis. Cathet Cardiovasc Diagn 1994;32:346e8.

9.Steffenino G, Meier B, Finci L, Velebit V, von Segesser L, Faidutti B, et al. Acute complications of elective coronary angioplasty: a review of 500 consecutive procedures. Br Heart

system, is used to prevent proximal vessel injury. The                                J 1988;59:151e8.

balloon catheter is transected close to the stopcock, and a small-caliber guiding catheter (e.g., ST 01) is advanced over the original catheter shaft to cover the balloon. Once the balloon is covered, the entire device can be withdrawn. A similar retrieval set was described in 1982.9After successful retrieval, except in cases of perforation, intravenous unfrac-tionated heparin (UFH), or even glycoprotein IIb/IIIa receptor blocker, are used to prevent thrombosis formation. The final option for balloon rupture and entrapment is the surgical removal of the device, but this option is often of limited use due to the inevitable time delay. Chang et al14suggested that the full extent of the fractured equipment and the verification of possible ostium involvement should be verified fluoroscop-ically or by transesophageal echocardiography. In the case of any protrusion into the aortic root, which would be a possible thrombogenic source, explosive aortotomy is required. If the retained fragments cannot be easily removed, they should be trimmed within the coronary ostium or retrieved distally through an arteriotomy.4