Calcified vessels – balloons that cut

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

2. Indication?

3. Cutting balloon • What? • Why? • When? • How?

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

5. Cutting balloon - Angiosculpt Flextome

6. Angiosculpt

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

8. Why? • Precise dilatation5,8 • Scores plaque by severing the elastic and fibrotic continuity of vessel wall8 • Dilatation at lower pressures with less recoil compared to POBA9,5 • Lumen gain through plaque compression instead of vessel wall expansion5,6,7 • Vessel preparation prior to stent placement reduces mal-apposition10 • Lower residual percent diameter stenosis with CBTM + stent v POBA + stent, post procedure and 6 months follow-up.11 • No slippage on deployment3 • Minimal plaque shift5,6,7 • Low rates of acute complications POBA.3

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

10. 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 slippage1,2 • The scoring mechanism allows controlled dilatation while preventing balloon slippage3. • Ostial and Bifurcation Lesions - Avoid Plaque shift • Challenging lesions with a higher degree of recoil and potential of plaque shift • Cutting Balloons dilate while reducing elastic recoil4 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 fibers • Cutting BalloonTscore through fibrotic plaque providing a strategy for coronary lesions resistant to conventional balloon dilatation15

11. When? • Indications: • Discrete (<15 mm in length), or tubular (10 to 20 mm in length) • Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm • Light to moderate tortuosity of proximal vessel segment • Nonangulated lesion segment (< 45°) • Absence of angiographically visible thrombus • Contraindications: • Avoid passing through struts of previously deployed stent. Deflated balloon could become entangled in the stent on withdrawal. • Warnings: • When treating bifurcations, CB can be used prior to placing a stent, but not taken through the side cell of a stent Calcified vessel?

15. Bifurcations • 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.”

18. In-stent restenosis • 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.

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

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

21. 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) • WINNER Registry (Taniuchi et al. The WINNER registry, Catheter Cardiovasc Interv 2004;62C-36) • NICECUT: Int J Cardiol. 2008 Mar 14;124(3):345-50 • RESCUT: J Am Coll Cardiol. 2004;43(6):943-9

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

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

24. Thank you

25. Glossary • 1. Kurbaan et al, Cutting Balloon Angioplasty for In-Stent Restenosis, Catheterization and Cardiovascular Interventions 50:480-483 (2000) • 2. Alfonso F., Should we use the Cutting Balloon in Patients With In-Stent Restenosis?, JACC Vol 44, No 12, 2004, Dec 21, 2004:2410-9 • 3. Taniuchi et al. The WINNER registry, Catheter Cardiovasc Interv 2004;62C-36 • 4. Inoue et al. J Interven Cariol. 2003;13:7-14 • 5. Hara et al. AM. J Cardiol 2002;89:1253-1256 • 6.Yamaguchi et al. J Interven Cardiol 1998; 11(Suppl) S114-S119 • 7. Suzuki et al. Amer J Cardiol 1999; 84 Suppl;58P • 8. Bonan, J Invasic Cardiol, 1999; 11:230 • 9. Ergene et al, J Invas Cardiol, 1998;10:70-75 • 10.Rizik, et al Benefits of Cutting Balloon Before Stenting J. Invas Cardiol 2003;15:624-628 • 11. Ozaki, Y, et al. Impact of Cutting Balloon Angioplasty (CBA) Prior to Bare Metal Stenting on Restenosis. Circulation Journal. 2007; 71:1-8. • 12.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. 1991 Mar1; 67(6):491-5. • 13.Muramatsu et al. J Invas Cardiol1999;11:201-206 • 14.Van Mieghem et al, Detection and Characterization of coronary bifurcation lesions with 64-slice computed topography coronary angiography, July 2007, EHJ Online, http://ehj.oxfordjournals.org • 15. Bertrand et al, Management of Resistant Coronary Lesions by the Cutting Balloon Catheter: Initial Experience, Catheterization and Cardiovascular Diagnosis41:179-184 (1997)