Calcified lesions optimal treatment

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1 Calcified lesions optimal treatment I give you the latest innovation in balloon angioplasty. Dr. Mathias TISCHLER Hanusch Krankenhaus, Vienna, Austria 1

2 Nothing to disclose 2 Dienstag, 2. Februar 16

3 Calcification optimal treatment the degree of calcification in arteries appears to correlate highly with the extent of atherosclerosis Solberg LA, Circulation 1971 More calcification -> more advanced and severe atherosclerosis Increased cardiovascular morbidity and mortality coronary artery disease, renal insufficiency, etc.) Increased lesion complexity Optimal therapy = multidisciplinary " " (e.g. Interdisciplinary vascular board Medical Therapy 3

4 Calcification optimal treatment In the absence of coronary artery disease, pharmacological treatments are greatly underutilized in PAD Bonaca et al. 2015, Zeymer et al. 2009, Welten et al. 2008, Hirsch et al References: Conte, Michael S., et al. "Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease 4 of the lower extremities: Management of asymptomatic disease and claudication." Journal of Vascular Surgery 61.3 (2015): 2S-41S.

5 References: Armstrong, Ehrin J., et al. "Adherence to Guideline-Recommended Therapy Is Associated With Decreased Major Adverse Cardiovascular Events and Major Adverse Limb Events Among Patients With Peripheral Arterial Disease." 5 Journal of the American Heart Association 3.2 (2014): e

6 6

7 Calcification - Background Active Process 7 Figures: Abedin, Moeen, Yin Tintut, and Linda L. Demer. "Vascular calcification mechanisms and clinical ramifications." Arteriosclerosis, thrombosis, and vascular biology 24.7 (2004): Qiao, Jian-Hua, et al. "Cartilaginous metaplasia in calcified diabetic peripheral vascular disease: morphologic evidence of enchondral ossification." Human pathology 34.4 (2003):

8 Calcification - Background Atherosclerotic severly calcified lesions 8 Focal or diffuse Any location often flow-limiting Medial artery calcification

9 Calcification - Background Atherosclerotic severly calcified lesions Medial artery calcification Focal or diffuse Any location often flow-limiting Diffuse, concentric Flow-limiting mostly in smaller diameter btk vessels Occurs with and w/o adjacent atherosclerosis Mostly diabetics or patients with chronic renal insufficiency Vascular stiffness 9

10 Calcification - Background Atherosclerotic severly calcified lesions Medial artery calcification 10 Focal or diffuse Any location often flow-limiting Diffuse, concentric Flow-limiting mostly in smaller diameter btk vessels - Is Calcification present? - - Location / Type? - Pattern of Longitudial and Circular Distribution? Occurs with and w/o adjacent atherosclerosis Mostly diabetics or patients with chronic renal insufficiency Vascular stiffness

11 What makes calcified lesions specifically challenging? 11 Dienstag, 2. Februar 16

12 Wire passage Chronic total occlusions Failure rates (mostly failure of wire passage) for complex below-the-knee (BTK) CTOs ~15-20% 12 Dienstag, 2. Februar 16

13 Wire passage Interventionalist s skill with wire and catheter Alternative access routes 13 # Balloon- or catheter assisted techniques to cross subintimal planes Optimize pushability / penetration power Special guidewires / catheters Re-access at closer site Retrograde approach Transbrachial Approach Double-access Pedal-plantar loop technique Subintimal passage J-Wire Dienstag, 2. Februar 16

14 Re-entry Devices Pioneer re-entry catheter Limitation of subintimal angioplasty (10-15%): In case of inability to immediately re-enter the true lumen after subintimal passage of the occluded segment Vulcano Pioneer, Cordis Outback and others Limited use because of high costs Dienstag, 2. Februar 16

15 Limitations of Standard Balloon Angioplasty in calcified lesions dog boning speciality balloons aim to reduce vessle barotrauma and intimal injury

16 Cutting balloons and focal force balloons $ Aim: $ by creating controlled incisions $ lower stenosis resoluting pressure is needed $ severy trauma to the vessel is avoided

17 Cutting balloons and focal force balloons $ Cutting balloon (Boston Scientific) $ Angiosculpt (Spectranetics) $ Vascutrak (BARD) $ These devices still need to proove clinical benefit in controlled trials

18 Chocolate balloon Unique nitinol "constraining structure" Controlled uniform inflation aims to minimize shear stress and "dog-boning" Chocolate BAR Trial: low dissection rate, low bail-out stenting rate Ongoing Trials Chocolate Touch: DEB version (Paclitaxel-coating)

19 Lithoplasty - Shockwave Lesion modification by using lithotripsy in a balloon to disrupt calcification prior to dilatation " Improves vessel wall compliance prior to controlled, low pressure dilatation " Goal: minimize the need for stenting by tackling residual stenosis and dissections/wall stress

20 Lithoplasty - Shockwave Lithoplasty is safe and effective in the treatment of calcified SFA/Popliteal lesions according to DISRUPT PAD I results (n=35) " Good results without the need for stenting " Evidence of a return of physiologic compliance or positive remodeling Until now only limited data/experience in PAD. Enrollment for DISRUPT PAD II (n=60) finished

21 Limitations of standard Nitinol Stent Designs Limited radial force Stent fracture

22 Optimized Stent Designs for Calcified Lesions Abbott Supera Stent " Interwoven nitinol stent " Excellent primary patency in prospective trials and register studies " Flexible; high radial force; no fractures

23

24 Atherectomy Debulking to minimize residual stenosis especially interesting for highly calcified lesions Potential combination with DEBs Evidence for routine use limited Issue of reimbursement depending on country Silverhawk for directional atherectomy Jetstream for rotational atherectomy and thrombectomy

25 DCB + Atherectomy? DEFINITIVE AR 12m results Primary Patency Atherectomy+DCB vs. PTA+DCB Zeller, VIVA 2014

26 Drug-eluting balloons Figure: Fanelli, F., et al. "Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease." Cardiovascular and interventional radiology 37.4 (2014):

27 Optimal treatment of calcified lesions Optimal therapy = multidisciplinary Complex lesions and lenghty complex interventions; success remains challenging even with the newest devices Outcome is less favourable compared to non-calcified lesions With increased understanding of calcification, more sophisticated, individualized treatment regiments will likely evolve to make optimal use of the variety of dedicated technologies Limited data, no standard for calcium scoring, comparison of study outcomes potentially misleading Cost-effectiveness of advanced technologies 27

28 Calcified lesions optimal treatment I give you the latest innovation in balloon angioplasty. Dr. Mathias TISCHLER Hanusch Krankenhaus, Vienna, Austria 28

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