Calcified vessels – balloons that cut Azfar Zaman Freeman Hospital, Newcastle-upon-Tyne

Indication?

Cutting balloon What? What? Why? Why? When? When? How? How?

Cutting balloons – What? non compliant balloons non compliant balloons with cutting tomes or wires on balloon to score plaque with cutting tomes or wires on balloon to score plaque monorail monorail

- Angiosculpt Cutting balloon Flextome

Angiosculpt

Semi-compliant balloon, dual wires exert focused inflation force Facilitate controlled plaque fractures - creation of focused force in a localized region of the plaque Scoreflex

Why? Precise dilatation 5,8 Precise dilatation 5,8 Scores plaque by severing the elastic and fibrotic continuity of vessel wall 8 Scores plaque by severing the elastic and fibrotic continuity of vessel wall 8 Dilatation at lower pressures with less recoil compared to POBA 9,5 Dilatation at lower pressures with less recoil compared to POBA 9,5 Lumen gain through plaque compression instead of vessel wall expansion 5,6,7 Lumen gain through plaque compression instead of vessel wall expansion 5,6,7 Vessel preparation prior to stent placement reduces mal- apposition 10 Vessel preparation prior to stent placement reduces mal- apposition 10 Lower residual percent diameter stenosis with CB TM + stent v POBA + stent, post procedure and 6 months follow-up. 11 Lower residual percent diameter stenosis with CB TM + stent v POBA + stent, post procedure and 6 months follow-up. 11 No slippage on deployment 3 No slippage on deployment 3 Minimal plaque shift 5,6,7 Minimal plaque shift 5,6,7 Low rates of acute complications POBA. 3 Low rates of acute complications POBA. 3

creates controlled incision planes which help to relieve hoop stress allows dilatation at lower pressures CB POBA Why?

Cutting balloons – when?  In-Stent Restenosis Lesions - Avoid balloon slippage Lesions with a high composition of neo-intimal hyperplasia offer greater resistance to dilatation and cause balloon slippage 1,2Lesions with a high composition of neo-intimal hyperplasia offer greater resistance to dilatation and cause balloon slippage 1,2 The scoring mechanism allows controlled dilatation while preventing balloon slippage 3.The scoring mechanism allows controlled dilatation while preventing balloon slippage 3.  Ostial and Bifurcation Lesions - Avoid Plaque shift Challenging lesions with a higher degree of recoil and potential of plaque shiftChallenging lesions with a higher degree of recoil and potential of plaque shift Cutting Balloons dilate while reducing elastic recoil 4 and allowing more plaque compression with minimal plaque shift 5,6,7Cutting Balloons dilate while reducing elastic recoil 4 and allowing more plaque compression with minimal plaque shift 5,6,7  Fibrotic lesions - Change lesion compliance Resistant lesions with a higher concentration of elastin and muscle fibersResistant lesions with a higher concentration of elastin and muscle fibers Cutting Balloon T score through fibrotic plaque providing a strategy for coronary lesions resistant to conventional balloon dilatation 15Cutting Balloon T score through fibrotic plaque providing a strategy for coronary lesions resistant to conventional balloon dilatation 15

When? Indications: Indications: Discrete (<15 mm in length), or tubular (10 to 20 mm in length) Reference vessel diameter (RVD) of 2.00 mm mm Light to moderate tortuosity of proximal vessel segment Nonangulated lesion segment (< 45°) Absence of angiographically visible thrombus Contraindications: Contraindications: Avoid passing through struts of previously deployed stent. Deflated balloon could become entangled in the stent on withdrawal.Avoid passing through struts of previously deployed stent. Deflated balloon could become entangled in the stent on withdrawal. Warnings: Warnings: When treating bifurcations, CB can be used prior to placing a stent, but not taken through the side cell of a stentWhen treating bifurcations, CB can be used prior to placing a stent, but not taken through the side cell of a stent Calcified vessel?

Bifurcations NICECUT NICECUT “Cutting-balloon angioplasty effectively facilitates the interventional procedure and leads to a low rate of recurrent stenosis in ostial bifurcation coronary lesions: It is associated with a low rate of binary stenosis and TLR. ”

In-stent restenosis RESCUT RESCUT CBA did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional POBA. However, CBA was associated with procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and lower incidence of balloon slippage.

How? Selecting diameter Selecting diameter Balloon to artery ratio should not exceed 1.1:1.0 (in vessels ≥ 3.0 mm)Balloon to artery ratio should not exceed 1.1:1.0 (in vessels ≥ 3.0 mm) For vessels < 3.00 mm; 1:1 more appropriateFor vessels < 3.00 mm; 1:1 more appropriate If using IVUS, measure media to media and maintain 1:1 balloon to artery ratioIf using IVUS, measure media to media and maintain 1:1 balloon to artery ratio Selecting length Selecting length Shorter lengths easier to deliver in tortuous anatomy than longer lengthsShorter lengths easier to deliver in tortuous anatomy than longer lengths Re-inflation along length of lesion acceptableRe-inflation along length of lesion acceptable

How? Guide catheterGuide catheter ideally 6F ideally 6F Guide wireGuide wire moderate to extra support moderate to extra support hydrophilic coating may be helpful hydrophilic coating may be helpful 20 cc syringe filled with diluted contrast20 cc syringe filled with diluted contrast 3-way stopcock3-way stopcock

Data? REDUCE III clinical trial ( Ozaki, Y, et al. Impact of Cutting Balloon Angioplasty (CBA) Prior to Bare Metal Stenting on Restenosis. Circulation Journal. 2007; 71:1-8 ) REDUCE III clinical trial ( Ozaki, Y, et al. Impact of Cutting Balloon Angioplasty (CBA) Prior to Bare Metal Stenting on Restenosis. Circulation Journal. 2007; 71:1-8 ) WINNER Registry ( Taniuchi et al. The WINNER registry, Catheter Cardiovasc Interv 2004;62C-36 ) WINNER Registry ( Taniuchi et al. The WINNER registry, Catheter Cardiovasc Interv 2004;62C-36 ) NICECUT : Int J Cardiol Mar 14;124(3): NICECUT : Int J Cardiol Mar 14;124(3): RESCUT : J Am Coll Cardiol. 2004;43(6):943-9 RESCUT : J Am Coll Cardiol. 2004;43(6):943-9

Conclusion (1 of 2) Cutting or “scoring” balloons: are safe are safe paucity of data confirming clinical benefits paucity of data confirming clinical benefits procedural benefits procedural benefits relatively (laser/rota) simple to use relatively (laser/rota) simple to use cheaper than laser/rota cheaper than laser/rota limited indications for use limited indications for use

Conclusion (2 of 2) Cutting (or scoring) balloons effective for resistant fibrotic lesions resistant fibrotic lesions in-stent restenosis in-stent restenosis and finally…..calcified vessels? and finally…..calcified vessels? Yes, but only in mild to moderate calcified arteries with minimal vessel/lesion tortuosity to favourably alter vessel compliance

Thank you

Glossary 1. Kurbaan et al, Cutting Balloon Angioplasty for In-Stent Restenosis, Catheterization and Cardiovascular Interventions 50: (2000) 1. Kurbaan et al, Cutting Balloon Angioplasty for In-Stent Restenosis, Catheterization and Cardiovascular Interventions 50: (2000) 2. Alfonso F., Should we use the Cutting Balloon in Patients With In-Stent Restenosis?, JACC Vol 44, No 12, 2004, Dec 21, 2004: Alfonso F., Should we use the Cutting Balloon in Patients With In-Stent Restenosis?, JACC Vol 44, No 12, 2004, Dec 21, 2004: Taniuchi et al. The WINNER registry, Catheter Cardiovasc Interv 2004;62C Taniuchi et al. The WINNER registry, Catheter Cardiovasc Interv 2004;62C Inoue et al. J Interven Cariol. 2003;13: Inoue et al. J Interven Cariol. 2003;13: Hara et al. AM. J Cardiol 2002;89: Hara et al. AM. J Cardiol 2002;89: Yamaguchi et al. J Interven Cardiol 1998; 11(Suppl) S114-S119 6.Yamaguchi et al. J Interven Cardiol 1998; 11(Suppl) S114-S Suzuki et al. Amer J Cardiol 1999; 84 Suppl;58P 7. Suzuki et al. Amer J Cardiol 1999; 84 Suppl;58P 8. Bonan, J Invasic Cardiol, 1999; 11: Bonan, J Invasic Cardiol, 1999; 11: Ergene et al, J Invas Cardiol, 1998;10: Ergene et al, J Invas Cardiol, 1998;10: Rizik, et al Benefits of Cutting Balloon Before Stenting J. Invas Cardiol 2003;15: Rizik, et al Benefits of Cutting Balloon Before Stenting J. Invas Cardiol 2003;15: Ozaki, Y, et al. Impact of Cutting Balloon Angioplasty (CBA) Prior to Bare Metal Stenting on Restenosis. Circulation Journal. 2007; 71: Ozaki, Y, et al. Impact of Cutting Balloon Angioplasty (CBA) Prior to Bare Metal Stenting on Restenosis. Circulation Journal. 2007; 71: Mathias DW et al. Frequency of success and complications of coronary angioplasty of a stenosis at the ostium of a branch vessel.Am J Cardiol Mar1; 67(6): Mathias DW et al. Frequency of success and complications of coronary angioplasty of a stenosis at the ostium of a branch vessel.Am J Cardiol Mar1; 67(6): Muramatsu et al. J Invas Cardiol 1999;11: Muramatsu et al. J Invas Cardiol 1999;11: Van Mieghem et al, Detection and Characterization of coronary bifurcation lesions with 64-slice computed topography coronary angiography, July 2007, EHJ Online, 14.Van Mieghem et al, Detection and Characterization of coronary bifurcation lesions with 64-slice computed topography coronary angiography, July 2007, EHJ Online, Bertrand et al, Management of Resistant Coronary Lesions by the Cutting Balloon Catheter: Initial Experience, Catheterization and Cardiovascular Diagnosis 41: (1997) 15. Bertrand et al, Management of Resistant Coronary Lesions by the Cutting Balloon Catheter: Initial Experience, Catheterization and Cardiovascular Diagnosis 41: (1997)