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Case Report
Novel Use of a Local Drug Delivery Catheter for Coronary Perforation
January 2011
ABSTRACT: Coronary perforation is a complication of percutaneous coronary intervention that may be fatal. Conventionally, a perfusion balloon catheter is used for treatment, but may not always be available. We report a case in which bleeding due to coronary perforation was successfully treated without induction of ischemia using a local drug delivery catheter as a perfusion device.
J INVASIVE CARDIOL 2011;23:E236–E239
Key words: local drug delivery catheter, perfusion, percutaneous coronary intervention
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Coronary perforation is one of the most serious complications of percutaneous coronary intervention (PCI). Various methods and devices are available to treat coronary perforation,1–5 with prolonged balloon dilatation being the most common. However, the conventional perfusion dilatation balloon used in such a situation is not always available and alternative methods are required. Here, we report a case in which we treated coronary perforation successfully using a local drug delivery catheter (the “clot-shooter” catheter; Kaneka Inc., Japan) as a perfusion device. This is an off-label use of the device that has not been extensively studied.
Device description. The clot-shooter catheter was designed as a percutaneous 
transluminal local drug delivery device for the coronary or peripheral artery. This device is not available outside Japan. The monorail catheter has several holes in the distal portion that allow infusion of thrombolytic drugs to the target site. The drugs are injected from the proximal port into the catheter lumen and infused from these holes (0.125 × 0.3 mm) (Figures 1A and 1B). Twelve holes are located spirally in a proximal location and 14 holes are located distally. Each hole is connected to a lumen that runs from the proximal port to the hole, and the lumen is identical to the wire lumen. The diameter of this catheter is 2.7 French (Fr), and a compliant balloon and a clot-shooter catheter can be accommodated in a 6 Fr guiding catheter.
Case Report. A 60-year-old man presented with troponin-negative unstable angina and an ST change on electrocardiogram. His medical history included hypertension. 
Coronary angiography (CAG) demonstrated severe stenosis of the mid-left anterior descending (LAD) artery and moderate stenosis of the proximal LAD (Figures 2A and 2B). The patient had not received anticoagulant therapy, and therefore aspirin 100 mg and clopidogrel 75 mg daily were started immediately after CAG and administered for 1 week until PCI was performed for the LAD lesion. An intraarterial bolus of heparin 7000 units was administered prior to PCI.
After cannulation of an 8 Fr FCL 3.5 mm guiding catheter with side holes (Mach 1; Boston Scientific, Natick, Massachusetts) into the left coronary artery, a 0.014" wire (Route; Asahi Intecc, Newport Beach, California) was passed through the lesion into the LAD and intravascular ultrasound (IVUS) was performed. The IVUS image showed both fibrous and partial attenuated plaque with positive vessel remodeling in the mid-LAD, and hard plaque in the proximal LAD (Figures 2C and 2D). We considered that there was a risk of distal embolism and deployed a filter-wire (Filtrap; Nipro, Osaka, Japan) in the distal LAD. The lesions were then dilated at 8 atm with a 4.0 × 10 mm cutting balloon (Boston Scientific) from the mid to proximal region. After dilation, the lesions were not sufficiently widely opened and additional dilatation with the same balloon was performed. The mid-portion was dilated at 10 
atm and the proximal portion at 14 atm (Figure 3A). The angiogram immediately after dilatation showed a clearly visible jet of contrast material pouring into the pericardial space (Figure 3B). The cutting balloon was immediately inserted into the perforated site and inflated at low pressure (4 atm) to seal the site (Figure 3C).
Because the cutting balloon had a risk of making the perforation worse, we changed it to a normal, semi-compliant balloon (4.0 x 15 mm Maverick; Boston Scientific) and prolonged inflation was performed again (Figure 3D). At the same time, an intravenous bolus of protamine 30 mg was administered to reverse the heparin effect. Five minutes after the injection, the activated coagulation time (ACT) was 147 seconds. During inflation of the balloon, the patient complained of chest pain and the ST segment in the anterior chest leads 
was elevated because the balloon blocked the vessel flow. We then crossed another 0.014" wire through the side of the obstructed balloon and inserted the clot-shooter catheter. The angiogram after insertion of the clot-shooter showed sufficient flow in the distal LAD with control of the coronary perforation (Figure 4A). After 30 minutes of balloon inflation without chest pain and ST segment elevation, the coronary perforation was treated. IVUS performed before the final angiogram demonstrated that the perforation site was located on the opposite side to the 1st diagonal branch (Figure 4B). The final angiogram showed sufficient dilatation without bleeding (Figures 4C and 4D). The patient was discharged 7 days later without further cardiac events and has remained symptom-free during 3 months of follow up.
Discussion. Coronary artery perforation is a serious complication of PCI with high mortality and morbidity6–12 due to rapid development of cardiac tamponade, myocardial infarction or death. Prompt management of the bleeding is important, and often includes reversal of heparin, platelet transfusion, pericardiocentesis and emergency cardiac surgery. Treatments of perforation may also include prolonged balloon inflation, use of covered stents, injection of polyvinyl alcohol, coil embolization, and intracoronary administration of autologous blood.1–5 Of these approaches, heparin reversal and prolonged balloon inflation or use of a covered stent are most common. Since prolonged balloon dilatation blocks the blood flow distal to the inflation site and produces ischemia, a perfusion balloon that can seal the defect while permitting distal vessel perfusion is often used. However, such a balloon may not always be available. Therefore, delivery of a covered stent has become routine for treating coronary perforation, but this also has several problems, including difficulty of delivery and side-branch occlusion.
Since the side holes between the proximal and distal parts of the clot-shooter catheter are connected to the same lumen, as described above, the blood flow comes in through the proximal holes and out of the distal holes, even when the balloon is inflated between the proximal and distal regions to seal the perforation site. Thus, the system works like a perfusion balloon catheter (Figure 5A) and the technique allows treatment of coronary 
perforation with preservation of coronary flow and maintenance of the major branch. Therefore, this catheter may serve as a substitute for the perfusion balloon catheter. This technique can be applied in many cases of coronary perforation because the tip of the catheter has good trackability and flexibility and can be inserted into a severely tortuous or calcified lesion. In addition, if the distal blood flow is insufficient, the catheter can be inserted more deeply until the proximal holes advance to distal of the dilated balloon and blood withdrawn from the guiding catheter can be injected from the proximal port to the distal holes (Figure 5B). Any type of local drug-delivery catheter can be used with this method. We conclude that this novel use of the clot-shooter catheter is an option for treatment of coronary perforation, instead of use of a perfusion balloon.
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From the Department of Cardiovascular Medicine, Toyohashi Heart Center, Toyohashi, Japan.
The authors report no conflicts of interest regarding the content herein.
Manuscript submitted March 23, 2010, revised version accepted April 1, 2010, final version accepted June 4, 2010.
Address for correspondence: Maoto Habara, MD, Department of Cardiovascular Medicine, Toyohashi Heart Center, 21-1Gobudori, Oyama-cho, Toyohashi 441-8530, Japan. E-mail: habara@heart-center.or.jp
transluminal local drug delivery device for the coronary or peripheral artery. This device is not available outside Japan. The monorail catheter has several holes in the distal portion that allow infusion of thrombolytic drugs to the target site. The drugs are injected from the proximal port into the catheter lumen and infused from these holes (0.125 × 0.3 mm) (Figures 1A and 1B). Twelve holes are located spirally in a proximal location and 14 holes are located distally. Each hole is connected to a lumen that runs from the proximal port to the hole, and the lumen is identical to the wire lumen. The diameter of this catheter is 2.7 French (Fr), and a compliant balloon and a clot-shooter catheter can be accommodated in a 6 Fr guiding catheter.
Case Report. A 60-year-old man presented with troponin-negative unstable angina and an ST change on electrocardiogram. His medical history included hypertension. 
Coronary angiography (CAG) demonstrated severe stenosis of the mid-left anterior descending (LAD) artery and moderate stenosis of the proximal LAD (Figures 2A and 2B). The patient had not received anticoagulant therapy, and therefore aspirin 100 mg and clopidogrel 75 mg daily were started immediately after CAG and administered for 1 week until PCI was performed for the LAD lesion. An intraarterial bolus of heparin 7000 units was administered prior to PCI.
After cannulation of an 8 Fr FCL 3.5 mm guiding catheter with side holes (Mach 1; Boston Scientific, Natick, Massachusetts) into the left coronary artery, a 0.014" wire (Route; Asahi Intecc, Newport Beach, California) was passed through the lesion into the LAD and intravascular ultrasound (IVUS) was performed. The IVUS image showed both fibrous and partial attenuated plaque with positive vessel remodeling in the mid-LAD, and hard plaque in the proximal LAD (Figures 2C and 2D). We considered that there was a risk of distal embolism and deployed a filter-wire (Filtrap; Nipro, Osaka, Japan) in the distal LAD. The lesions were then dilated at 8 atm with a 4.0 × 10 mm cutting balloon (Boston Scientific) from the mid to proximal region. After dilation, the lesions were not sufficiently widely opened and additional dilatation with the same balloon was performed. The mid-portion was dilated at 10 
atm and the proximal portion at 14 atm (Figure 3A). The angiogram immediately after dilatation showed a clearly visible jet of contrast material pouring into the pericardial space (Figure 3B). The cutting balloon was immediately inserted into the perforated site and inflated at low pressure (4 atm) to seal the site (Figure 3C).
Because the cutting balloon had a risk of making the perforation worse, we changed it to a normal, semi-compliant balloon (4.0 x 15 mm Maverick; Boston Scientific) and prolonged inflation was performed again (Figure 3D). At the same time, an intravenous bolus of protamine 30 mg was administered to reverse the heparin effect. Five minutes after the injection, the activated coagulation time (ACT) was 147 seconds. During inflation of the balloon, the patient complained of chest pain and the ST segment in the anterior chest leads 
was elevated because the balloon blocked the vessel flow. We then crossed another 0.014" wire through the side of the obstructed balloon and inserted the clot-shooter catheter. The angiogram after insertion of the clot-shooter showed sufficient flow in the distal LAD with control of the coronary perforation (Figure 4A). After 30 minutes of balloon inflation without chest pain and ST segment elevation, the coronary perforation was treated. IVUS performed before the final angiogram demonstrated that the perforation site was located on the opposite side to the 1st diagonal branch (Figure 4B). The final angiogram showed sufficient dilatation without bleeding (Figures 4C and 4D). The patient was discharged 7 days later without further cardiac events and has remained symptom-free during 3 months of follow up.
Discussion. Coronary artery perforation is a serious complication of PCI with high mortality and morbidity6–12 due to rapid development of cardiac tamponade, myocardial infarction or death. Prompt management of the bleeding is important, and often includes reversal of heparin, platelet transfusion, pericardiocentesis and emergency cardiac surgery. Treatments of perforation may also include prolonged balloon inflation, use of covered stents, injection of polyvinyl alcohol, coil embolization, and intracoronary administration of autologous blood.1–5 Of these approaches, heparin reversal and prolonged balloon inflation or use of a covered stent are most common. Since prolonged balloon dilatation blocks the blood flow distal to the inflation site and produces ischemia, a perfusion balloon that can seal the defect while permitting distal vessel perfusion is often used. However, such a balloon may not always be available. Therefore, delivery of a covered stent has become routine for treating coronary perforation, but this also has several problems, including difficulty of delivery and side-branch occlusion.
Since the side holes between the proximal and distal parts of the clot-shooter catheter are connected to the same lumen, as described above, the blood flow comes in through the proximal holes and out of the distal holes, even when the balloon is inflated between the proximal and distal regions to seal the perforation site. Thus, the system works like a perfusion balloon catheter (Figure 5A) and the technique allows treatment of coronary 
perforation with preservation of coronary flow and maintenance of the major branch. Therefore, this catheter may serve as a substitute for the perfusion balloon catheter. This technique can be applied in many cases of coronary perforation because the tip of the catheter has good trackability and flexibility and can be inserted into a severely tortuous or calcified lesion. In addition, if the distal blood flow is insufficient, the catheter can be inserted more deeply until the proximal holes advance to distal of the dilated balloon and blood withdrawn from the guiding catheter can be injected from the proximal port to the distal holes (Figure 5B). Any type of local drug-delivery catheter can be used with this method. We conclude that this novel use of the clot-shooter catheter is an option for treatment of coronary perforation, instead of use of a perfusion balloon.
References
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