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Case Report
Use of SafeCut Balloon‚Ñ¢ for Treatment of In-Stent Restenosis of a Previously Underexpanded (Full title below)
December 2007
ABSTRACT: Calcified lesions are a cause of stent underexpansion which significantly increases the subsequent risks of in-stent restenosis and thrombosis, even when drug-eluting stents are used. In this report, we describe a novel balloon catheter (SafeCut™) that enabled adequate dilatation of in-stent restenosis in a previously underexpanded sirolimus-eluting stent that was unresponsive to high-pressure inflation using a conventional balloon after aggressive rotational atherectomy to treat a heavily calcified plaque.
J INVASIVE CARDIOL 2007;19:E359–E362
In-stent restenosis (ISR) has long remained a major limitation of coronary stenting. Several randomized trials have shown that the use of drug-eluting stent (DES) markedly reduces the risk of ISR following treatment of de novo lesions1–4and even lesions that have a high risk of ISR.5,6
Coronary artery calcification is a common cause of stent underexpansion and is a predictor of late-stent thrombosis.8 Stent underexpansion has been also associated with ISR9 and in-stent thrombosis after successful DES implantation.10 Optimal dilatation prior to stenting thus remains an important factor for prevention of ISR and in-stent thrombosis after implantation, even in the DES era. In addition, optimal treatment of ISR after DES implantation remains challenging.
Previously, we reported that the SafeCut™ balloon catheter (OrbusNeich, Ft. Lauderdale, Florida) was useful for treatment of calcified lesions prior to DES implantation.11 This case report describes the utility of the SafeCut balloon catheter for ISR of a previously underexpanded DES that was unresponsive to high-pressure inflations with a conventional balloon because of the presence of a heavily calcified plaque.
Case Report. The patient was a 79-year-old male with coronary risk factors of hypertension and insulin-dependent diabetes mellitus. He had silent myocardial ischemia that was confirmed by an exercise stress test. Coronary angiography was performed and revealed a long, diffuse 75% stenosis with heavy calcification (Figures 1a and b) in the mid-left anterior descending artery (LAD). Percutaneous coronary intervention (PCI) of the LAD was performed using an 8 Fr JL 4.0 guiding catheter (Cordis Corp., Miami Lakes, Florida) via the right femoral artery in September 2004. A 0.014 inch Unicore guidewire (Guidant Corp., Indianapolis, Indiana) was inserted into the LAD. A 2.5 mm x 30 mm Maverick 2 long balloon (Boston Scientific Corporation, Natick, Massachusetts) was used in an attempt to inflate up to 16 atm, but it could not be fully expanded (Figure 1c) and was ruptured (Figure 1d). Next, the guidewire was exchanged for a floppy Rotawire® (Boston Scientific) for rotational atherectomy. Stepped rotational atherectomy was performed using 1.75 mm and 2.15 mm Rotablator® burrs (Boston Scientific) (Figure 1e). Following this aggressive rotablation, a 2.75 mm x 12 mm Apollo noncompliant balloon (Goodman Corp., Nagoya, Japan) was used in an attempt to inflate up to 22 atm, but it too was unable to be fully expanded (Figure 1f). Although we were unable to fully expand a segment of the proximal SES, overlapping stent implantation was successfully performed with high-pressure inflation using a 3.0 x 28 mm sirolimus-eluting stent (SES) (Cordis) for the distal LAD (Figure 2a) and a 3.0 x 13 mm SES for the proximal LAD (Figures 2b–d). The patient had no ischemia, which was confirmed by an exercise stress test 1 year after SES implantation, but silent ischemia was confirmed by an exercise test at 1.5 years after SES implantation. Radiography without contrast medium showed an underexpanded SES with heavy calcification (Figure 3a). Coronary angiography showed a focal ISR with 90% stenosis at the previously underexpanded SES implantation site (Figures 3b and c). At this time, we used a 3.0 x 15 mm SafeCut balloon catheter for this underexpanded ISR lesion with the heavily calcified plaque. The SafeCut balloon catheter easily passed across this lesion and was gradually inflated. Full balloon expansion was achieved at 18 atm (Figure 4a). Final coronary angiography showed a satisfactory result without the additional procedure (Figures 4b and c). Compared to the intravascular ultrasound (IVUS) finding before angioplasty, the IVUS finding after the SafeCut balloon angioplasty showed a marked improvement in luminal area, with sufficient stent expansion (from 2.5 mm2 to 5.7 mm2 at the same site). The patient had no ischemia 6 months after the SafeCut balloon angioplasty, which was confirmed by an exercise test and thallium exercise myocardial scintigraphy. This novel device was therefore useful for treating ISR of a previously underexpanded SES implanted in a lesion with heavy calcification, which was unresponsive to high-pressure inflations with a conventional balloon, even after aggressive rotational atherectomy.
Discussion. In the present case report, we demonstrated that the SafeCut balloon catheter can safely achieve dilatation of a previously underexpanded SES with a heavily calcified plaque.
It has been reported that stent underexpansion is significantly related to an increased risk of restenosis8 and in-stent thrombosis,9 even when a DES is employed. Calcified lesions are a cause of stent underexpansion. Lesion preparation for enabling optimal stent expansion remains an essential part of current interventional practice, and would be particularly beneficial for patients with undilatable calcified lesions prior to DES implantation. In addition, optimal treatment of ISR after DES implantation remains controversial and challenging, particularly because it is difficult to achieve optimal treatment of ISR after an underexpanded DES with heavily calcified plaques.
Several devices such as those used in directional coronary atherectomy,12 rotational atherectomy13 and cutting balloon14 for calcified lesions have been proposed to achieve optimal dilatation prior to stent implantation. In other studies, rotational atherectomy (“stentablation”) and a cutting balloon were used to dilate lesions with stent underexpansion due to the presence of calcified plaque.15,16 Because a maximum Rota burr (2.15 mm) had been used in a previous procedure, stentablation with repeated rotational atherectomy was considered to be ineffective in this case. The cutting balloon poses the risk of coronary rupture, even for ISR lesions, because of the blades around the surface of the balloon.17,18 For this case of ISR with an underexpaned stent, we used the SafeCut balloon catheter, which is a short monorail-type balloon catheter that has superb passing ability with a lower profile (0.028 inch). The catheter’s hydrophilic coating extends 32 cm from the distal tip.11 Moreover, the SafeCut balloon catheter is more flexible to deliver than a cutting balloon. The SafeCut balloon catheter is a novel semicompliant balloon catheter with dual wires that exert focused inflation forces. It can facilitate controlled plaque fractures because the built-in integral wire and the coronary guidewire on the outside of the balloon create a focused force in a localized region of the plaque.
Focused-force angioplasty is a technique in which the forces resulting from inflating an angioplasty balloon in a stenotic lesion are concentrated and focused at one or more locations within the stenosis.19 This technique, including the conventional buddy wire technique20,21 and cutting balloon, have been shown to be useful in resolving resistant stenosis.22 The buddy wire technique is easy and simple and may be an effective technique for dilatation of calcified lesions.20,21 In our previous report, we demonstrated that the SafeCut balloon was superior to the buddy wire technique for resistant calcified lesions.11 This suggests that the built-in integral wire of the SafeCut balloon may play an important role in facilitating fracture of calcified lesions.11 This device could potentially treat resistant calcified lesions that have failed treatment with other devices, as well as in-stent restenosis lesions and bifurcation lesions because the SafeCut balloon allows enhancement of luminal gain at lower inflation pressures with modification of the plaque than conventional balloon angioplasty.
In this report, we demonstrate that the SafeCut balloon catheter was markedly more effective for treatment of ISR of a previously underexpanded SES with a heavily calcified plaque, which was resistant to conventional balloon inflation after aggressive rotational atherectomy.
Acknowledgements. The authors gratefully acknowledge the technical support of Mr. Ryusuke Higashi for conducting an intravascular ultrasound. References 1. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773–1780. 2. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315–1323. 3. Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003;108:788–794. 4. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221–231. 5. Schofer J, Schluter M, Gershlick AH, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: Double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362:1093–1099. 6. Schampaert E, Cohen EA, Schluter M, et al. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol 2004;43:1110–1115. 7. Weisz G, Leon MB, Holmes DR Jr, et al. Two-year outcomes after sirolimus-eluting stent implantation: Results from the Sirolimus-Eluting Stent in de novo Native Coronary Lesions (SIRIUS) trial. J Am Coll Cardiol 2006;47:1350–1355. 8. Urban P, Gershlick AH, Guagliumi G, et al; e-Cypher Investigators. Safety of coronary sirolimus-eluting stents in daily clinical practice: One-year follow-up of the e-Cypher registry. Circulation 2006;113:1434–1441. 9. Sonoda S, Morino Y, Ako J, et al; SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: Serial intravascular ultrasound analysis from the sirius trial. J Am Coll Cardiol 2004;43:1959–1963. 10. Fujii K, Carlier SG, Mintz GS, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: An intravascular ultrasound study. J Am Coll Cardiol 2005;45:995–998. 11. Mori S, Otsuka Y, Kawamura A. Usefulness of the SafeCut™ dual wire PTCA catheter for treatment of calcified lesion. J Invasive Cardiol 2007;19:E254–E256. 12. Takagi T, Di Mario C, Stankovic G, et al. Effective plaque removal with a new 8 French-compatible atherectomy catheter. Catheter Cardiovasc Interv 2002;56:452–459. 13. MacIsaac AI, Bass TA, Buchbinder M, et al. High-speed rotational atherectomy: Outcome in calcified and noncalcified coronary artery lesions. J Am Coll Cardiol 1995;26:731–736. 14. Asakura Y, Furukawa Y, Ishikawa S, et al. Successful predilation of a resistant, heavily calcified lesion with cutting balloon for coronary stenting: A case report. Cathet Cardiovasc Diagn 1998;44:420–422. 15. Kobayashi Y, Teirstein P, Linnemeier T, et al. Rotational atherectomy (stentablation) in a lesion with stent underexpansion due to heavily calcified plaque. Catheter Cardiovasc Interv 2001;52:208–211. 16. Wilson A, Ardehali R, Brinton TJ, et al. Cutting balloon inflation for drug-eluting stent underexpansion due to unrecognized coronary arterial calcification. Cardiovasc Revasc Med 2006;7:185–188. 17. Quan VH, Stone JR, Couper GS, Rogers C. Coronary artery perforation by cutting balloon resulting in dissecting subepicardial hematoma and avulsion of the vasculature. Catheter Cardiovasc Interv 2005;64:163–168. 18. Ako J, Honda Y, Fitzgerald PJ. Impending coronary perforation after cutting balloon angioplasty. Heart 2005;91:e8. 19. Solar RJ, Ischinger TA. Focused force angioplasty: Theory and application. Cardiovasc Radiat Med 2003;4:47–50. 20. Vijayvergiya R, Swamy AJ, Grover A. Buddy wire technique: A simple technique for treating calcified lesion during percutaneous coronary intervention: A case report. J Invasive Cardiol 2006;18:E129–E30. 21. Hussain F, Kashour T, Rajaram M. Ostial RCA intervention: Guiding catheter challenges and use of a buddy wire to perform focused-force angioplasty on a severely calcific ostial right coronary lesion. J Invasive Cardiol 2006;18:E298–301. 22. Barath P, Fishbein MC, Vari S, Forrester JS. Cutting balloon: A novel approach to percutaneous angioplasty. Am J Cardiol 1991;68:1249–1252.
J INVASIVE CARDIOL 2007;19:E359–E362
In-stent restenosis (ISR) has long remained a major limitation of coronary stenting. Several randomized trials have shown that the use of drug-eluting stent (DES) markedly reduces the risk of ISR following treatment of de novo lesions1–4and even lesions that have a high risk of ISR.5,6
Coronary artery calcification is a common cause of stent underexpansion and is a predictor of late-stent thrombosis.8 Stent underexpansion has been also associated with ISR9 and in-stent thrombosis after successful DES implantation.10 Optimal dilatation prior to stenting thus remains an important factor for prevention of ISR and in-stent thrombosis after implantation, even in the DES era. In addition, optimal treatment of ISR after DES implantation remains challenging.
Previously, we reported that the SafeCut™ balloon catheter (OrbusNeich, Ft. Lauderdale, Florida) was useful for treatment of calcified lesions prior to DES implantation.11 This case report describes the utility of the SafeCut balloon catheter for ISR of a previously underexpanded DES that was unresponsive to high-pressure inflations with a conventional balloon because of the presence of a heavily calcified plaque.
Case Report. The patient was a 79-year-old male with coronary risk factors of hypertension and insulin-dependent diabetes mellitus. He had silent myocardial ischemia that was confirmed by an exercise stress test. Coronary angiography was performed and revealed a long, diffuse 75% stenosis with heavy calcification (Figures 1a and b) in the mid-left anterior descending artery (LAD). Percutaneous coronary intervention (PCI) of the LAD was performed using an 8 Fr JL 4.0 guiding catheter (Cordis Corp., Miami Lakes, Florida) via the right femoral artery in September 2004. A 0.014 inch Unicore guidewire (Guidant Corp., Indianapolis, Indiana) was inserted into the LAD. A 2.5 mm x 30 mm Maverick 2 long balloon (Boston Scientific Corporation, Natick, Massachusetts) was used in an attempt to inflate up to 16 atm, but it could not be fully expanded (Figure 1c) and was ruptured (Figure 1d). Next, the guidewire was exchanged for a floppy Rotawire® (Boston Scientific) for rotational atherectomy. Stepped rotational atherectomy was performed using 1.75 mm and 2.15 mm Rotablator® burrs (Boston Scientific) (Figure 1e). Following this aggressive rotablation, a 2.75 mm x 12 mm Apollo noncompliant balloon (Goodman Corp., Nagoya, Japan) was used in an attempt to inflate up to 22 atm, but it too was unable to be fully expanded (Figure 1f). Although we were unable to fully expand a segment of the proximal SES, overlapping stent implantation was successfully performed with high-pressure inflation using a 3.0 x 28 mm sirolimus-eluting stent (SES) (Cordis) for the distal LAD (Figure 2a) and a 3.0 x 13 mm SES for the proximal LAD (Figures 2b–d). The patient had no ischemia, which was confirmed by an exercise stress test 1 year after SES implantation, but silent ischemia was confirmed by an exercise test at 1.5 years after SES implantation. Radiography without contrast medium showed an underexpanded SES with heavy calcification (Figure 3a). Coronary angiography showed a focal ISR with 90% stenosis at the previously underexpanded SES implantation site (Figures 3b and c). At this time, we used a 3.0 x 15 mm SafeCut balloon catheter for this underexpanded ISR lesion with the heavily calcified plaque. The SafeCut balloon catheter easily passed across this lesion and was gradually inflated. Full balloon expansion was achieved at 18 atm (Figure 4a). Final coronary angiography showed a satisfactory result without the additional procedure (Figures 4b and c). Compared to the intravascular ultrasound (IVUS) finding before angioplasty, the IVUS finding after the SafeCut balloon angioplasty showed a marked improvement in luminal area, with sufficient stent expansion (from 2.5 mm2 to 5.7 mm2 at the same site). The patient had no ischemia 6 months after the SafeCut balloon angioplasty, which was confirmed by an exercise test and thallium exercise myocardial scintigraphy. This novel device was therefore useful for treating ISR of a previously underexpanded SES implanted in a lesion with heavy calcification, which was unresponsive to high-pressure inflations with a conventional balloon, even after aggressive rotational atherectomy.
Discussion. In the present case report, we demonstrated that the SafeCut balloon catheter can safely achieve dilatation of a previously underexpanded SES with a heavily calcified plaque.
It has been reported that stent underexpansion is significantly related to an increased risk of restenosis8 and in-stent thrombosis,9 even when a DES is employed. Calcified lesions are a cause of stent underexpansion. Lesion preparation for enabling optimal stent expansion remains an essential part of current interventional practice, and would be particularly beneficial for patients with undilatable calcified lesions prior to DES implantation. In addition, optimal treatment of ISR after DES implantation remains controversial and challenging, particularly because it is difficult to achieve optimal treatment of ISR after an underexpanded DES with heavily calcified plaques.
Several devices such as those used in directional coronary atherectomy,12 rotational atherectomy13 and cutting balloon14 for calcified lesions have been proposed to achieve optimal dilatation prior to stent implantation. In other studies, rotational atherectomy (“stentablation”) and a cutting balloon were used to dilate lesions with stent underexpansion due to the presence of calcified plaque.15,16 Because a maximum Rota burr (2.15 mm) had been used in a previous procedure, stentablation with repeated rotational atherectomy was considered to be ineffective in this case. The cutting balloon poses the risk of coronary rupture, even for ISR lesions, because of the blades around the surface of the balloon.17,18 For this case of ISR with an underexpaned stent, we used the SafeCut balloon catheter, which is a short monorail-type balloon catheter that has superb passing ability with a lower profile (0.028 inch). The catheter’s hydrophilic coating extends 32 cm from the distal tip.11 Moreover, the SafeCut balloon catheter is more flexible to deliver than a cutting balloon. The SafeCut balloon catheter is a novel semicompliant balloon catheter with dual wires that exert focused inflation forces. It can facilitate controlled plaque fractures because the built-in integral wire and the coronary guidewire on the outside of the balloon create a focused force in a localized region of the plaque.
Focused-force angioplasty is a technique in which the forces resulting from inflating an angioplasty balloon in a stenotic lesion are concentrated and focused at one or more locations within the stenosis.19 This technique, including the conventional buddy wire technique20,21 and cutting balloon, have been shown to be useful in resolving resistant stenosis.22 The buddy wire technique is easy and simple and may be an effective technique for dilatation of calcified lesions.20,21 In our previous report, we demonstrated that the SafeCut balloon was superior to the buddy wire technique for resistant calcified lesions.11 This suggests that the built-in integral wire of the SafeCut balloon may play an important role in facilitating fracture of calcified lesions.11 This device could potentially treat resistant calcified lesions that have failed treatment with other devices, as well as in-stent restenosis lesions and bifurcation lesions because the SafeCut balloon allows enhancement of luminal gain at lower inflation pressures with modification of the plaque than conventional balloon angioplasty.
In this report, we demonstrate that the SafeCut balloon catheter was markedly more effective for treatment of ISR of a previously underexpanded SES with a heavily calcified plaque, which was resistant to conventional balloon inflation after aggressive rotational atherectomy.
Acknowledgements. The authors gratefully acknowledge the technical support of Mr. Ryusuke Higashi for conducting an intravascular ultrasound. References 1. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773–1780. 2. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315–1323. 3. Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003;108:788–794. 4. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221–231. 5. Schofer J, Schluter M, Gershlick AH, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: Double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362:1093–1099. 6. Schampaert E, Cohen EA, Schluter M, et al. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol 2004;43:1110–1115. 7. Weisz G, Leon MB, Holmes DR Jr, et al. Two-year outcomes after sirolimus-eluting stent implantation: Results from the Sirolimus-Eluting Stent in de novo Native Coronary Lesions (SIRIUS) trial. J Am Coll Cardiol 2006;47:1350–1355. 8. Urban P, Gershlick AH, Guagliumi G, et al; e-Cypher Investigators. Safety of coronary sirolimus-eluting stents in daily clinical practice: One-year follow-up of the e-Cypher registry. Circulation 2006;113:1434–1441. 9. Sonoda S, Morino Y, Ako J, et al; SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: Serial intravascular ultrasound analysis from the sirius trial. J Am Coll Cardiol 2004;43:1959–1963. 10. Fujii K, Carlier SG, Mintz GS, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: An intravascular ultrasound study. J Am Coll Cardiol 2005;45:995–998. 11. Mori S, Otsuka Y, Kawamura A. Usefulness of the SafeCut™ dual wire PTCA catheter for treatment of calcified lesion. J Invasive Cardiol 2007;19:E254–E256. 12. Takagi T, Di Mario C, Stankovic G, et al. Effective plaque removal with a new 8 French-compatible atherectomy catheter. Catheter Cardiovasc Interv 2002;56:452–459. 13. MacIsaac AI, Bass TA, Buchbinder M, et al. High-speed rotational atherectomy: Outcome in calcified and noncalcified coronary artery lesions. J Am Coll Cardiol 1995;26:731–736. 14. Asakura Y, Furukawa Y, Ishikawa S, et al. Successful predilation of a resistant, heavily calcified lesion with cutting balloon for coronary stenting: A case report. Cathet Cardiovasc Diagn 1998;44:420–422. 15. Kobayashi Y, Teirstein P, Linnemeier T, et al. Rotational atherectomy (stentablation) in a lesion with stent underexpansion due to heavily calcified plaque. Catheter Cardiovasc Interv 2001;52:208–211. 16. Wilson A, Ardehali R, Brinton TJ, et al. Cutting balloon inflation for drug-eluting stent underexpansion due to unrecognized coronary arterial calcification. Cardiovasc Revasc Med 2006;7:185–188. 17. Quan VH, Stone JR, Couper GS, Rogers C. Coronary artery perforation by cutting balloon resulting in dissecting subepicardial hematoma and avulsion of the vasculature. Catheter Cardiovasc Interv 2005;64:163–168. 18. Ako J, Honda Y, Fitzgerald PJ. Impending coronary perforation after cutting balloon angioplasty. Heart 2005;91:e8. 19. Solar RJ, Ischinger TA. Focused force angioplasty: Theory and application. Cardiovasc Radiat Med 2003;4:47–50. 20. Vijayvergiya R, Swamy AJ, Grover A. Buddy wire technique: A simple technique for treating calcified lesion during percutaneous coronary intervention: A case report. J Invasive Cardiol 2006;18:E129–E30. 21. Hussain F, Kashour T, Rajaram M. Ostial RCA intervention: Guiding catheter challenges and use of a buddy wire to perform focused-force angioplasty on a severely calcific ostial right coronary lesion. J Invasive Cardiol 2006;18:E298–301. 22. Barath P, Fishbein MC, Vari S, Forrester JS. Cutting balloon: A novel approach to percutaneous angioplasty. Am J Cardiol 1991;68:1249–1252.
