INTRODUCTION
Fractured guidewire, ruptured balloon and intra-procedure damage to other catheterization laboratory hardware are not rare complications of percutaneous coronary interventions (PCI) and can have potentially catastrophic outcomes.1,2 With improved angioplasty hardware particularly development of more flexible and high-quality guidewire this complication might be expected to decrease. However, the risk of wire entrapment has remained same or perhaps even increased because physicians are now approaching more complex lesions. The damaged material if left in situ can have an innocuous outcome or it can lead to thrombosis and ischemic occlusion or it can even embolize leading to thromboembolic complications.3 Attempts to correct the situation by force can lead to worsening of the problem, e.g. unraveling of the coiled tip of the wire, progressing to formation of knot and finally possibility of knot detachment and embolization.4 Thus treatment has to be individualized and may vary from masterly inactivity to retrieval to cardiac surgery.5 The key to addressing this problem like any other complications in cath lab lies in 3 “As”: Anticipation, Avoidance and Amelioration of the complication once it occurs.
FRACTURED GUIDEWIRE
Etiology
Fractured guidewire can be a consequence of:
- Inherent faults in design or in the manufacturing process of the guidewire or reused wire (Case 1).
- Wire entrapment in a side-branch while stenting main branch or wire wedging into a distal or winding vessel.
- Wire damage by rotational or directional atherectomy catheter.
Management
Anticipation
This problem can be anticipated while using reused material, during certain anatomies like bifurcation (when main vessel is stented while keeping wire 2 jailed in side-branch), calcific lesions or tortuous lesions and with certain technical procedures like rotablation6 (Table 1.1).
Avoidance
While performing main vessel stenting, the wire in side-branch should be placed deep in so that coil part of guidewire (nonmetallic tip) should not be in contact with main vessel undergoing provisional stent. Hydrophilic or polymer coated wire should not be used in side-branch and finally, jailed wire technique should not be used in some 2 stent techniques like crush technique (Table 1.1).
Amelioration
The treatment of this complication once it appears is unclear and should be based on the situation. Any hardware retained in the lumen of a vessel may serve as a nidus for endothelial injury and platelet deposition, putting the vessel at risk for acute thrombosis.
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On the other hand, vigorous attempts to remove the material can, by itself, cause a trauma to the vessel and prove counter-productive. Further, another device used to retrieve it can itself get trapped. Thus, the treatment options may vary ranging from masterly inactivity, percutaneous extraction of the guidewire, balloon dilatation or stent implantation over the guidewire remnants and finally surgical management (Table 1.2).
Masterly Inactivity
Guidewire remnants can be left alone in a small side-branch if it is not obstructing flow and the original procedure has not damaged the vessel wall of the side-branch. These patients may be carefully followed up on systemic anticoagulation.7 This strategy may be especially useful with hydrophilic or nonmetallic remnants (which are less likely to thrombose). However, the coronary segment which contains these fragments tends to develop progressive stenosis and therefore this strategy may not be useful in hemodynamically significant vessels.8
Guidewire Retrieval
Retrieval represents perhaps the most effective and popular strategy to remove entrapped material, particularly in a proximal segment.9 However, the success rate of this strategy may be lower in a very tortuous vessel and with very mobile fragments. Guidewire retrieval may involve a simple procedure like entangling the fractured guidewire with another guidewire, making a knot together and subsequent withdrawal of the knot. However, commonly guidewire retrieval is carried out using a homemade or commercially available snare catheter using balloon as a wedge to extract damaged guidewire remnants. Details of use of snares for extraction of catheterization laboratory material are discussed in a greater detail in Chapter 2.
Crushing onto Coronary Bed
Mobilizing and fixing the guidewire fragments to coronary bed is an option when the guidewire fragment has completely detached. Hydrophilic and nonmetallic or polymer coated fragments are less thrombogenic and being slippery it is easier to mobilize.10 Small and underinflated balloon catheters can be used to drag these fragments and lodge them to the vessel wall. Finally, the fragments can be isolated from vessel lumen by stenting over it. This strategy also takes care of damaged vessel wall likely during the index procedure. Any type of stent, bare-metal stents (BMS), drug-eluting stents (DES) or a covered stent can be used but a covered stent should generally be avoided unless there is accompanying perforation or very extensive vessel damage (Case 1).
Surgery
Surgery is the last option for these patients and should be reserved for those patients where guidewire entrapment occurs in a hemodynamically significant vessel with flow limitations and percutaneous removal of the fragments has either failed or considered too risky (entrapment into left main). Isolated removal of trapped guidewire can be attempted but often the guidewire is so firmly embedded in the vessel wall that some kind of endartectomy would be required. In those cases where the percutaneous procedure has resulted in too much damage to the vessel, graft anastomosis may be the only safe option.
CASE EXAMPLE
Case 1
Case of bifurcation lesion: Left anterior descending (LAD)-Diagonal. Provisional stenting strategy was planned. A floppy ZingerTM guidewire placed in LAD and a reused guidewire placed in diagonal branch. Following LAD stent deployment the jailed diagonal wire got entrapped between the vessel wall and LAD stent. While attempting to pull out the entrapped guidewire the guide-catheter was getting sucked in the left main repeatedly. Ultimately there was unraveling of the guidewire into microfilaments. Attempts were made to entangle the damaged guidewire filaments by 2 guidewires but they were not successful. Finally, an attempt was made to snare the microfilaments in toto into the guiding catheter but the damaged guidewire completely snapped with damaged and broken filaments floating into, LAD, left main and even proximal aorta. Patient developed slow flow which was initially managed by nitroglycerin and an extra bolus of heparin. At this point it was decided to crush the damaged guidewire and a new stent was deployed over it in left main crossing over to LAD, overlapping with the original stent. The stent was post dilated particularly at the ostium of left main 5 and also at the overlapped segment. Some filaments were allowed to remain in ascending aorta. Patient was discharged on dual antiplatelet therapy and low dose warfarin (INR maintained at 2). On follow-up at 4 months the stents were found patent and echocardiography demonstrated microfilaments and a few protruding stent struts out of left main into ascending aorta. On late follow-up patient remains free of angina, stress test remained negative.
Analysis of the case: There were several issues: (1) A reused guidewire was used in the side-branch (more liable to break). (2) A lot of force was applied to pull out the trapped wire as evidenced by sucking in of guide-catheter. In this case, retrieval is the best strategy which was indeed tried, first with entanglement technique and later by use of a snare. But again perhaps the force applied to pull was too aggressive which led to breaking of the wire and unraveling the microfilaments in left main. Finally, the exposed wire parts were crushed on left main which seems to be right strategy at this point. Some filaments were floating in aorta, but extra-coronary fragments, even embolization is generally benign and therefore a strategy of not intervening upon them as pursued here was the right approach. A strategy of putting the patient on triple antiplatelet therapy in this case can be debated but perhaps operators felt more safe with this approach.
NONDEFLATION OF BALLOON
Balloon deflation failure is a serious and sometimes catastrophic complication of PCI procedure. The cause could be a faulty balloon material or a reused balloon but it could also be due to inappropriate balloon preparation (use of high dye concentration vis a vis saline during preparation of diluted contrast for balloon inflation).11
Management
Standard deflation does not work because of development of valve mechanism inside the balloon. However, it is important not to panic and pull the inflated balloon into proximal vessel as it can lead to vessel injury, dissection or even rupture of the vessel (Case 2).
- Nondeflating balloon can be inflated at a higher pressure and ruptured but it carries a risk of vessel injury, dissection, perforation and even vessel rupture and also possibility of air embolism.
- Puncturing the balloon with a hard end of regular guidewire or using a microcatheter guided penetration with a penetrating wire like Conquest Pro may be a better solution.
- Use of laser wire for perforating the undeflated balloon is another option.
- Repeated inflations and deflations with distilled water can also sometimes lead to success in deflating the balloon.
- In some cases surgery may be the final option.
CASE EXAMPLES
Case 2
A 70-year-old lady with past history of AMI (6 months back) presented with class II angina on exertion and mild left ventricular dysfunction. Coronary angiography revealed critical stenosis in proximal LAD, distal circumflex and mid RCA with a SYNTAX Score of 19. Patient was taken up for multi-vessel PCI via right radial approach. Left coronary artery was hooked with 6 F XB 3.0 guiding catheter, lesion crossed with ACS Hi TorqueTM Floppy wire and LAD directly stented with 3.5 × 21 mm Paclitaxel Stent (deployed at 14 atm.). Immediately after stent deployment patient started having chest pain with bradycardia and hypotension. Fluoroscopy revealed nondeflated proximal portion of balloon with no flow in LAD. Repeated negative suction with indeflator resulted in partial deflation of balloon but still no flow in artery was restored. In view of hypotension and bradycardia, IV Atropine was given and IV dopamine was started. A gentle tug was given to the balloon so as to pull balloon in guide-catheter and re-establish flow. However, when balloon was attempted to be pulled back only part of inflated balloon shaft came out within guide catheter while ruptured broken balloon fragment was left behind. This led to development of no flow in LAD. Since snare was not immediately available in catheterization laboratory, it was decided to inter-twine the broken balloon shaft with two guidewires. A new BMWTM wire was passed in the vessel alongside the broken ruptured balloon catheter and inter-twined with pre-existing wire and whole assembly attempted to be withdrawn in the guide-catheter. However, the above maneuver was un-successful in balloon withdrawal but on the other hand resulted in loss of first wire from balloon. No flow in LAD persisted. A second 2.5 × 10 mm balloon was introduced over the second wire in distal portion of vessel beyond ruptured balloon and inflated at 14 atm (Fig. 1.1). A gentle tug was given which resulted in withdrawal of both balloons (ruptured balloon and the new balloon) into the guide-catheter. Post balloon withdrawal flow was established in LAD and patient settled hemodynamically, the whole sequence lasting 8 minutes. The procedure was completed by postdilating LAD stent with 3.5 × 15 noncompliant balloon. Examination of ruptured balloon revealed that the balloon had broken at monorail shaft junction, the usual site of balloon catheter rupture.
Analysis of the case: Probably, the saline:contrast ratio was not optimal to begin with. Secondly, more aggressive approach was used to deflate the balloon. Finally, attempt was made to retrieve the broken fragment. Initially two wire technique was tried but when that was not successful, pulling inflated balloon beyond the broken fragment and pulling back worked.
Case 3
A 50-year-old gentleman presented with non ST elevation MI, Trop T was positive. Echocardiography revealed mild basal anterolateral hypokinesia with overall normal ejection fraction.7
Fig. 1.1: Cartoon demonstrating proximal inflated fragment of balloon catheter in guide-catheter, ruptured broken distal fragment of balloon catheter in the vessel and a new guidewire passed alongside
Courtesy: Dr Shantanu Deshpande
Coronary angiography revealed tight LAD lesion and total occlusion of left circumflex. Patient was taken up for multivessel PCI. LAD was stented with 2.75 × 30 mm DES and the lesion postdilated with reused 3.5 noncompliant balloon. However, balloon failed to deflate and patient started getting chest pain and systolic BP dropped from 130 mm Hg to 90 mm Hg. Indeflators were changed and attempts to aspirate with 10 cc syringe failed. Saline contrast mixture was then changed to normal saline. Attempts to rupture balloon using hard end of wire were made but failed. Patient now was having severe pain and needed sedation. As a last ditch attempt balloon was inflated at very high pressure 30 atm after confirming availability of Stent Graft on shelf. Balloon got ruptured and flow was established and there was no dissection or perforation. Inspection of balloon revealed that part of the balloon catheter was missing. Attempts to entangle the damaged balloon flap with two twisted wires and remove them failed. There was brief movement of portion of balloon into left main but it migrated back to proximal LAD. Finally, the damaged balloon portion was crushed in the LAD vessel wall by a 4 × 13 mm stent. Patient did well after stent implantation with, no further pain and is doing well almost into 6 months of follow-up.
Analysis of the case: Again, probably, the saline:contrast ratio was not optimal to begin with. Trying high pressure inflation could have been dangerous because it could have ruptured the vessel (stent graft would have worked for perforation but not ruptured vessel). Maybe trying to puncture the balloon was a better strategy but perhaps there was not enough time to do it. It is very 8 important to carefully inspect the retrieved hardware in a case like this and indeed it revealed that the part of it was left behind. The ideal approach is to retrieve the remaining fragment but if not possible an alternate strategy of crushing it to the vessel wall may be mandatory.
BALLOON RUPTURE
Balloon rupture is a common but generally innocuous complication of PCI. However, rarely the complication can be catastrophic. The complications encountered may be of 2 types: Injury to integrity of balloon catheter and injury to adjacent vessel. Damage to vessel wall as a result of balloon rupture can be easily understood. Complications pertaining to lack of balloon integrity relate to difficulty in removing the damaged balloon catheter without injuring the vasculature and without embolization. Occasionally the catheter can get embedded in the vessel wall creating difficulties in removal.
Etiology
There are 3 types of rupture that can happen during dilatation with balloon catheter.12
- Circumferential rupture: This occurs due to over-dilatation of the balloon, generally substantially beyond the recommended burst pressure. Typically, balloon rupture may occur with ≥50% diameter overdilation (compared to vessel size) but vessel rupture mostly occurs with only ≥100% over dilation (Fig. 1.2).13
- Horizontal rupture: This can occur when there is structural defect in the balloon catheter due to defective manufacturing process. The balloon in this situation can rupture even before rated burst pressure (RBP).
- Pinhole rupture: This is a localized rupture, which can occur in the balloon due to injury by a calcified spicule or an exposed stent strut. The balloon can rupture even before RBP (Fig. 1.3).
Management
- Avoidance of balloon rupture
- Avoid using reused balloon
- Try not to go beyond rated burst pressure
- Push balloon before retrieving it
- Do not pull out the balloon if resistance is faced, rather give a gentle torque.
Trauma Inflicted Upon the Vessel Wall
This is classic “Egg first or Chicken First” debate. An elegant experimental study by Zollikofer et al. demonstrated that arterial rupture always preceded balloon rupture.13 Thus horizontal rupture with its underlying structural defect may be completely innocuous, whereas in circumferential rupture there may be injury to all layers of the vessel caused by severe over-distension, followed by secondary rupture of the balloon because it had lost its external support. Thus, it is only balloon pin-hole rupture with subsequent jet effect where-in balloon rupture per se can cause damage to the vessel wall. Most of the complications due to balloon rupture can be managed conservatively. Occasionally, type 3 perforation is caused by balloon rupture may require placement of covered stents or even surgery Case 4.
Complications Associated with Retrieval of Ruptured Balloon Material
Management of ruptured balloon material has same underlying principle like other entrapped hardware including guidewire fracture. While in most cases ruptured catheter can be withdrawn without difficulty at the end of withdrawal it is very important to carefully inspect the balloon catheter to make sure that all the fragments have been recovered. Even if the balloon can be retrieved easily, intimal tears are very common and may occur in nearly 1/3rd of cases.14 In some situations the balloon material can get fragmented and may require complex retrieval techniques mentioned earlier. In some cases, the fragments can be crushed to the side-wall by a stent Case 5. Rarely, however, even surgery may be required.
CASE EXAMPLES
Case 4
A 69-year-old gentleman presented with acute inferior MI with a window period of 6 hours with ongoing chest pain. He was hypertensive, diabetic and a chronic smoker. Coronary angiography revealed RCA lesion. Lesion was predilated and subsequently stented with 3 × 18 DES deployed at 12 atm. However, the stent balloon ruptured and post stent patient developed chest pain, hypotension and unfortunately the guidewire was also lost. Cine shoot revealed proximal dissection. The vessel was rewired and stented with 3 × 23 BMS and suitable post dilated. Finally, good result.
Case 5
A 65-year-old male presented with complaint of chest pain from last 5–6 days. ECG demonstrated ST-T changes in lateral leads. Troponin – T was negative. Echocardiography was essentially normal. Coronary angiography revealed LCX was a normal vessel but OM 1 showed tight 90% lesion. PCI of OM lesion was planned via right radial approach. Left coronary hooked with 6F EBU 3.5 catheter and OM lesion crossed with 0.014 Choice PTTM Extra support guidewire and predilated with 2.0 × 10 mm reused balloon. However, while withdrawing balloon shaft gave away with balloon in LCx. Lesion recrossed with another 0.014′ guidewire. Both guidewires were entangled with each other and pulled out simultaneously thus withdrawing the broken balloon along with the guidewires. Finally, good result.
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- Arce-Gonzales JM, Schwartz L, Ganassin L, et al. Complications associated with the guide wire in percutaneous transluminal coronary angioplasty. J Am Coll Cardiol.1987;10:218–21.
- Ojeda Delgado JL, Jimenez Mena M, Barrios Alonso V, et al. Guide-wire rupture as a complication of coronary angioplasty. Apropos 2 cases and a review of the literature. Rev Esp Cardiol.1992;451:41–4.
- Doorey AJ, Stillabower M. Fractured and retained guide-wire. Fragment during coronary angioplasty: Unforeseen late sequelae. Cathet Cardiovasc Diagn. 1990; 20:238–40.
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- Zollikofer CL, Salomonowitz E, Castaneda-Zuniga WR, et al. The relation between arterial and balloon rupture in experimental angioplasty. AJR Am J Roentgenol. 1985;144(4):777–9.
- Simpfendorfer CC, Dimas AP, Zaidi A, Hollman J, Franco I, Knezinek V, et al. Balloon rupture during coronary angioplasty. Angiology.1986;11:828–31.