Catheterization and Cardiovascular Diagnosis 30:245-248 (1 993)
`
`Preliminary Reports
`
`work in progress
`
`Retrieval of Undeployed Stents
`From the Right Coronary Artery:
`Report of Two Cases
`Frank L.M.J. Veldhuijzen, CT,
`Hans J.R.M. Bonnier, MD, H. Rolf Michels, MD,
`Mamdouh I.H. El Gamal, MD, and
`Berry M. van Gelder, BE
`
`Two patients are described in whom an undeployed stent (1
`Wiktor and 1 Palmaz-Schatz) was retained in the proximal seg-
`ment of the right coronary artery during coronary angioplasty.
`In both cases the stent was caught by a technique using a
`second guidewire. The stent was removed in the first patient
`during bypass surgery; in the second patient it was removed
`from the femoral sheath. Q im wiley-u-.
`Inc.
`
`Key words: angioplasty, complication, stent
`
`INTRODUCTION
`One of the major acute complications of coronary an-
`gioplasty is coronary dissection followed by impairment
`of coronary flow and subsequent acute closure. Devel-
`opment of intracoronary stents has proven to be a means
`of alleviating acute or threatened ischemia caused by
`antecedent coronary dissection [ 13.
`Although the success rate of stent placement is rela-
`tively high, it is associated with a minor percentage of
`complications, e.g., bleeding, unsuccessful stent deploy-
`ment, and loss of stents (systemic embolization), usually
`without apparent clinical sequelae [2].
`Unlike stents lost in the systemic circulation, unde-
`ployed stents in the coronary arteries should be removed
`immediately. Bypass surgery of course is one option but
`recently we developed a technique for retrieving unde-
`ployed stents from the coronary circulation that can prob-
`ably avoid surgical intervention.
`
`From the Department of Cardiology, Catharina Hospital, Eindhoven,
`The Netherlands.
`
`Received March 15, 1993; revision accepted July 9, 1993.
`
`Address reprint requests to Frank Veldhuijzen, Department of Cardi-
`ology, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven,
`The Netherlands.
`
`0 1993 Wiley-Liss, Inc.
`
`PATIENT 1
`A 61-year-old female underwent angioplasty for a 90%
`stenosis (type B lesion) in the midsegment of the right
`coronary artery. The right coronary artery was intubated
`with a right Judkins 4 cm guiding catheter. The lesion
`was crossed with a 0.014” high torque floppy guidewire
`(Advanced Cardiovascular Systems, ACS) and subse-
`quently dilated with a 2.5 mm ACX I1 balloon (ACS).
`The balloon was inflated three times for periods ranging
`from 30 to 60 sec.
`Inflation pressure was 6-7 atm. Control angiogram
`after dilatation showed a longitudinal dissection at the
`site of the lesion. A fourth inflation with a pressure of 7
`atm. was performed for a period of 90 sec without im-
`provement. Because of impairment of coronary flow it
`was decided to implant a Palmaz-Schatz stent. Medica-
`tion was started according to the protocol.
`The 2.5 mm dilatation balloon was removed-using
`a
`DOC extension wire-while
`the guidewire was kept in
`position in the right coronary artery. A Palmaz-Schatz
`stent was mounted on a 3.0 mm ACX I1 balloon and
`advanced into the guiding catheter. After entering the
`proximal segment of the right coronary artery it was
`impossible to advance the balloon to the dissected area.
`The balloon was withdrawn into the guiding catheter and
`during this maneuver, the stent slipped off the balloon
`and remained in the proximal segment of the right cor-
`onary artery. The balloon was removed from the guiding
`catheter, while the guidewire was kept in place. A sec-
`ond guidewire (0.014” high torque standard, ACS) was
`inserted into the guiding catheter and advanced into the
`right coronary artery across the stent and the dilated seg-
`ment. Both ends of the guidewires were fixed in a
`torquer device, which was rotated approximately 15
`times, until movement and twisting of the wires was
`observed inside the coronary artery.
`We then tried to pull on the wires; it appeared that the
`stent was caught by both twisted wires because a strong
`resistance was felt; but traction with moderate force was
`unsuccessful in removing wires and stent. Forceful pull-
`ing was avoided because we feared perforation of the
`proximal right coronary artery segment. The patient was
`transferred to the operation room for emergency bypass
`surgery. After opening the ascending aorta both wires
`were visible and a gentle pull by the surgeon was enough
`to remove the stent and the wires from the right coronary
`artery without any sign of perforation (Fig. 1). Bypass
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`246
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`Veldhuijzen et al.
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`Fig. 1. Palmaz-Schatz stent caught by two guidewires and re-
`moved during bypass surgery.
`
`surgery for the right coronary artery was performed with-
`out further complications.
`
`Fig. 2. Angiogram of the right coronary artery (patient 2), left
`anterior oblique position, showing a 70% lesion with dissection
`(arrow) in the midsegment.
`
`guidewires the stent was removed from the coronary ar-
`tery (Fig. 5). Removal from the sheath was performed
`without any problem.
`Angiography revealed a patent vessel without any vis-
`ible damage at the site of stent removal. Because flow
`was unimpaired in the right coronary artery no further
`intervention was required.
`
`PATIENT 2
`A 52-year-old male underwent repeat angioplasty of a
`lesion in the mid-segment of the right coronary artery.
`There was a 70% stenosis associated with a dissection
`from the previous PTCA (Fig. 2). Because of restenosis
`and residual dissection it was decided to implant primar-
`ily a Wiktor (Medtronic, Inc.) stent. The right coronary
`artery wiis intubated with an 8F right Judkins 4 cm guid-
`ing catheter. A 0.014” high torque floppy guidewire (Ad-
`vanced Cardiocascular Systems) crossed the lesion with
`difficulty. The balloon mounted stent could not be ad-
`vanced beyond the proximal segment of the right coro-
`nary artery. During an attempt to withdraw the balloon in
`the guiding catheter, the Wiktor stent slipped off the
`DISCUSSION
`balloon and remained in the proximal segment of the
`right coronary artery. Subsequently a DOC extension
`An increasing number of case reports describe equip-
`wire was connected to the high torque floppy guidewire
`ment used for coronary intervention and its entrapment,
`and the balloon was removed from the guiding catheter.
`fracture, and retention inside the coronary arteries
`An attempt to cross the stent with a second high torque
`[3-161. Fracture of guidewires and detachment of tips of
`floppy guidewire failed. A 0.014” Schneider guidewire
`balloons on wire have been frequently reported. The long
`could be advanced into the proximal segment of the right
`term sequelae of retained guidewire fragments in patent
`coronary artery and just passed the Wiktor stent (Fig. 3)
`coronary arteries is still uncertain. Only one report [17]
`but could not be advanced distally. A subsequent attempt
`describes diffuse narrowing of the arterial segment that
`to cross the stent with a high torque standard 0.018‘’
`contained a retained guidewire fragment from a PTCA 3
`guidewire was successful. Both guidewires were inserted
`months previously. This experience supports the general
`in a torquer device (Fig. 4) and rotated approximately 15
`opinion that is in favour of removal of undesired foreign
`times, until movement and twisting of the wires in the
`bodies from the coronary artery.
`coronary artery was observed. The guiding catheter was
`Several techniques have been reported for retrieval of
`advanced into the proximal segment of the right coronary
`angioplasty wire fragments from a coronary artery, vary-
`artery, and by a forceful pull on the guiding catheter and
`ing from commercially available systems [ 181 to home
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`Stent Retrieval
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`247
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`Fig. 5. Wiktor stent after removal from the proximal right cor-
`onary artery.
`
`ment of undeployed, retained stents in the coronary ar-
`tery.
`Pan et al. [20] recently reported on peripheral stent
`recovery after failed intracoronary delivery, but they re-
`stricted their report to stents lost from the balloon outside
`the coronary artery. The undeployed stents in our two
`patients however were retained inside the coronary artery
`and could not be retrieved by just withdrawing the bal-
`loon, wire, and guiding catheter assembly. The tech-
`nique of stent retrieval is relatively easy. In our experi-
`ence a relatively stiff wire (high torque standard 0.014
`and 0.01 8") was required to recross the undeployed stent.
`In order to snare a stent with two wires it is essential that
`the second wire not follow the central lumen of the stent
`but crosses one of its filaments. In practice this will be
`the case because traversing the central lumen with the
`second wire is exceptional. This is an advantage in those
`cases in which the stent is difficult to see on fluoroscopy,
`such as for instance the Palmaz-Schatz stent.
`The amount of tension resulting from pulling the wires
`is difficult to quantify. In our second patient a brief
`forceful pull was sufficient to retrieve the stent from the
`coronary artery. We advise trying this first; if it fails
`sustained gentle traction for a short period of time should
`be applied followed by one or more short forceful pulls
`if necessary.
`Losing the stents in our patients was unpredictable
`from the anatomical appearance of the proximal vessel
`segment that had to be stented. There were no excessive
`bends, nor visible calcification (Fig. 2). The use of a
`delivery system [21] probably will prevent loss of stents,
`but these systems are not manufactured for all commer-
`cially available stents.
`The technique described is applicable to stents lost in
`proximal vessels without tortuosity . Retrieval of stents
`lost in proximal tortuous vessels or in distal locations
`should be attempted with extreme care. Pulling the wires
`under these conditions will stretch the proximal vessel
`segment with potential damage. Even if retrieval of an
`
`Fig. 3. Left anterior oblique view showing the undeployed, re-
`tained Wiktor stent in the proximal segment of the right coro-
`nary artery. The 0.014" high torque floppy is positioned distally
`in the right coronary artery; the second guidewire (Schneider)
`has just crossed the stent but could not be positioned distally in
`the right coronary artery.
`
`Fig. 4. Torquer device with both wires inserted.
`
`made devices [ 191. Development of intracoronary stents
`for the prevention of restenosis and treatment of acute
`closure after angioplasty is a valuable tool but has added
`one more item on the list of foreign bodies that can be
`retained inside the coronary artery. Failed delivery and
`unsuccessful deployment has been reported. Failed de-
`livery rarely resulted in clinical sequelae for the pa-
`tient-most
`stents were withdrawn-but
`some emobo-
`lized systemically during attempted withdrawal into the
`femoral sheath [l]. No reports describe details on treat-
`
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`Veldhuijzen et at.
`248
`undeployed stent in a coronary artery is not considered,
`snaring it with two wires may be helpful in removing the
`stent during the subsequent surgical procedure.
`
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1018 - Page 4
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