Anatomically complex lesions in PCI

Anatomically complex lesions in PCI

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Tools for dealing with complex lesions


Complex PCI cases are becoming more common, leading to an increased risk of adverse events. Complex coronary lesions have anatomical complexity that drives the need for advanced imaging, physiological assessment, and innovative treatment tools. Clear procedural guidance and optimal vessel preparation can help you achieve better outcomes. Explore the different challenges seen in complex PCI cases and how Philips’ specialty tools can help you.

IntraSight
Smart. Simple. Seamless.


Introducing the all-new Philips IntraSight interventional applications platform where imaging, physiology, co-registration11 and software come together to simplify complex interventions, speed routine procedures and provide improved patient care.

IntraSight and Azurion

1. Witzenbichler B et al. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents: The ADAPT-DES Study. Circulation 2014 Jan: 129,4;463-470. 

2. Lindstaedt M, et al. How good are experienced interventional cardiologists at predicting the functional significance of intermediate or equivocal left main coronary artery stenoses? Int J Cardiol. 2007;120:254-6. 

3. Arnett, E. N. et al. Coronary artery narrowing in coronary heart disease: comparison of cineangiographic and necropsy findings. Ann. Intern. Med. 91, 350–356 (1979). 

4. Puri R., et al. “Optimizing Outcomes During Left Main Percutaneous Coronary Intervention With Intravascular Ultrasound and Fractional Flow Reserve” JACC Card. Interv. 2012 5(7): 697-707. 

5. Taggart DP, Kaul S, Boden WE, et al. Revascularization for unprotected left main stem coronary artery stenosis stenting or surgery. J Am Coll Cardiol 2008; 51:885. 

6. Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009; 360:961. 

7. Park SJ, Kim YH, Park DW, et al. “Impact Of Intravascular Ultrasound Guidance On Long-term Mortality In Stenting For Unprotected Left Main Coronary Artery Stenosis” Circ Cardiovasc Interv. 2009 Jun;2(3):167-77. 

8. AngioSculpt Test Report SR-1571 (2008). 

9. Costa JR, Mintz GS, Carlier SG, et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol. 2007;100:812-817. 

10. Costa RA, Mooney MR, Teirstein PS, et al. Final results from the multi-center trial of the angiosculpt scoring balloon catheter for the treatment of complex coronary artery lesions Cardiovascular Revascularization Medicine 7 (2006)81–126. 

11. Co-registration tools available within IntraSight 7 configuration via SyncVision. 

12. Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. 

13. Patel et al. Impact of intravascular ultrasound on the long-term clinical outcomes in the treatment of coronary ostial lesions. Catheter Cardiovasc Interv 2013 June 1. In press doi: 10.1002/ccd.25034.

14. Kim, S. H., Kim, Y. H., Kang, S. J., Park, D. W., Lee, S. W., Lee, C. W., Hong, M. K., Cheong, S. S., Kim, J. J., Park, S. W., & Park, S. J. (2010). Long-term outcomes of intravascular ultrasound-guided stenting in coronary bifurcation lesions. The American journal of cardiology, 106(5), 612–618. https://doi.org/10.1016/j.amjcard.2010.04.016. 

15. Weisz, G., Metzger, D. C., Liberman, H. A., O'Shaughnessy, C. D., Douglas, J. S., Jr, Turco, M. A., Mehran, R., Gershony, G., Leon, M. B., & Moses, J. W. (2013). A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch: final results of the AGILITY trial. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions, 82(3), 352–359. https://doi.org/10.1002/ccd.24630. 

16. Stone, G., et. al. (2005). Percutaneous recanalization of chronically occluded coronary arteries: A consensus document: Part 1. Circulation, 112, 2364-2372. 

17. National Cardiac Data Registry (2016). 

18. Kim BK, Shin DH, Hong MK, et al. Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation: randomized study. Circ Cardiovasc Interv 2015;8:e002592. 

19. Luc Bilodeau, MD, et al. Novel Use of a High-Energy Excimer Laser Catheter for Calcified and Complex Coronary Artery Lesions. Catheterization and Cardiovascular Interventions (62:155-161, 2004). 

20. Pratsos et al. GREECE Abstract 10-A-103-CRT presented at CRT 2010. 

21. Gao XF, Ge Z, Kong XQ, et al., Three-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation JACC: Cardiovascular Interventions (2020), doi: https://doi.org/10.1016/j.jcin.2020.10.001. 

22. Ambrosini, V, et.al. Early outcomes of high energy laser (Excimer) facilitated coronary angioplasty on hard and complex calcified and balloon resistant coronary lesions: LEONARDO Study. Card. Revasc. Med 2015: 16: 141-146. 

23. Xu B., Gao R. L., Zhang R. Y., et al. Efficacy and safety of FIREHAWK abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort. Chinese Medical Journal. 2013;126(6):1026–1032. 

24. Ahn J. M., Park D. W., Kim Y. H., et al. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions a randomized LONG-DES IV trial. Circulation: Cardiovascular Interventions. 2012;5(5):633–640. 

25. Hong S-J, et al. “Effect of Intravascular Ultrasound-guided Drug-Eluting Stent Implantation: Five-Year Follow-Up of the IVUS-XPL Randomized Trial, JACC: Cardiovascular Interventions (2020), doi:
https://doi.org/10.1016/j.jcin.2019.09.033.

 

ELCA important safety information indications:

 

The laser catheters are intended for use either as a stand-alone modality or in conjunction with percutaneous transluminal coronary balloon angioplasty (PTCA) in patients who are acceptable candidates for coronary artery bypass graft (CABG) surgery. The following indications for use, contraindications and warnings have been established through multicenter clinical trials. The Philips CVX-300 Excimer laser system and the multi-fiber laser catheter models are safe and effective for the following indications: occluded saphenous vein bypass grafts, ostial lesions, long lesions (greater than 20mm in length), moderately calcified stenosis, total occlusions traversable by a guidewire, lesions which previously failed balloon angioplasty, restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy. These lesions must be traversable by a guidewire and composed of atherosclerotic plaque and/or calcified material. The lesions should be well defined by angiography. Contraindications: Lesion is in an unprotected left main artery. Lesion is beyond acute bends or is in a location within the coronary anatomy where the catheter cannot traverse. Guidewire cannot be passed through the lesion. Lesion is located within a bifurcation. Patient is not an acceptable candidate for bypass graft surgery. Potential adverse events: Use of the Philips CVX-300 Excimer laser system may contribute to the following complications: dissection of the arterial wall, perforation, acute reclosure, embolization, aneurysm formation, spasm, coronary artery bypass graft surgery, thrombus, myocardial infarction, arrhythmia, filling defects, death. No long term adverse effects of ELCA are known at this time. Risks: The primary endpoint defined in the laser angioplasty of restenosis stents (LARS) randomized trial was the absence of major adverse cardiac events (MACE) at 6 months: Death; myocardial infarction; coronary artery bypass surgery. Procedural complications include: any dissection, acute thrombus, haziness, no reflow, arrhythmia, acute vessel closure, occlusion of side branch, occlusion non-target, coronary spasm, coronary embolism, coronary perforation, laser/stent damage, balloon/stent damage, and other serious. Caution: Federal law restricts this device to sale by or on the order of a physician.

 

Summary of safety and effectiveness – PTCA catheter AngioSculpt Evo PTCA important safety information

 

The AngioSculpt Evo scoring balloon catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.

 

The AngioSculpt Evo catheter should not be used for coronary artery lesions unsuitable for treatment by percutaneous revascularization, and coronary artery spasm in the absence of a significant stenosis.

 

Possible adverse effects include, but are not limited to: death; heart attack (acute myocardial infarction); embolism, total occlusion of the treated coronary artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflow of treated vessel; emergency coronary artery bypass (CABG); emergency percutaneous coronary intervention; CVA/stroke/ embolic stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable angina; thromboembolism or retained device components; irregular heart rhythm (arrhythmias, including life-threatening ventricular arrhythmias); severe low (hypotension)/high (hypertension) blood pressure; coronary artery spasm; hemorrhage or hematoma; need for blood transfusion; surgical repair of vascular access site; creation of a pathway for blood flow between the artery and the vein in the groin (arteriovenous fistula); drug reactions, allergic reactions to x-ray dye (contrast medium); and infection. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

 

Caution:

 

Federal law restricts this device to sale by or on the order of a physician.

 

©2021 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. D059578-00 032021 

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