Plague Modification in 2012: Cutting/Scoring Balloons and atherectomy

Transcription

1 Plague Modification in 2012: Cutting/Scoring Balloons and atherectomy Coronary Therapies Mark Reisman,MD Swedish Heart and Vascular Institute Seattle,Wa

2 Disclosure I, Mark Reisman, MD SAB- Boston Scientific Honorarium from Boston Scientific and, Advisory Board: Biostar Ventures

3 Heavily calcified RCA

4 Final result 1.5 f/b 2.0mm Burr f/b stenting And high pressure Post dilation The patient did develop Slow flow after the 1.5 Burr.waited.ST segments resolved

5 Role in Drug Eluting Stenting Managing moderate to severe calcification Advancement of stents (balloons) in rigid calcified lesions??? Strut symmetry Ostial Lesions (RCA) LMCA 70% stretch? With debulking

6 Catheter Components Forward Pressure defines depth of diamonds digging Into vessel drive shaft diamond coated burr 1.25 mm mm (0.25 mm increments) sheath 4.3 french O.D. guide wire Continuous movement keeps device from becoming Warm especially in angled/tortuous vessels

7 Console rotational speed display (tachometer) procedure timer reset button turbine pressure gauge (delivered to advancer) event timer turbine pressure control knob (adjusts RPM) advancer fiber optic tachometer connector Dynaglide connector power switch advancer turbine power lamp (pneumatic) connector

8 Rotablator System Mechanism of Action Orthogonal Displacement Of friction Differential Cutting

9 Mechanism of Action Orthogonal Displacement of friction frictional forces are minimized in the longitudinal plane permits the burr to negotiate tortuous segments of vessel without much resistance STILL tortuous segments can lead to decreases in RPM s and that needs to be differentiated from lesions (may require using smaller burr size)

10 Differential Cutting Differential Cutting Elastic tissue Inelastic tissue Results in preferential cutting of inelastic substrate Is functional at low and high speeds Reisman, M.D, Guide to Rotational Atherectomy. Physicians Press, Birmingham, MI 1997 The burr will cut (ablate) inelastic tissue (calcium, fibrous material) while sparing elastic tissue Therefore burr may be somewhat ineffective in softer lesions AND In cases of guide wire bias, where the wire is not centered (majority of cases) the wire may press on the lesion and convert elastic tissue to inelastic tissue, thus cutting will take place, i.e. tortuous vessels, severely angulated vessels

11 Lesion Modification, Not Calcium Removal Concentric plaque with superficial circumferential calcium Make one thin segment in circumferential calc Good dissection before stent

12 GuideWire Bias and Ablation Proximal Distal

13 Minimizing Particle size Controlling Particle size Gentle advancement Minimal decelerations Start proximal to the lesion Don t allow the device to jump forward Rotablator Micro Particles s Red Blood Cells 5 Micron Bead t

14 Temp. (C) Manufactured for Heat reduction Sources of Heat RotaLink TM Effluent Peak Temperatures Advancement of burr/tortuous anatomy Between vessel wall and burr Between guidewire and burr Long run times (excess of 45 seconds Time (min.) Temp w/saline Temp. w/rotaglide Reduction in Vasospasm and?? Platelet Reduction

15 The game plan Preprocedure Guide catheter selection Guide wire selection Burr selection Platforming speed Advancing the burr

16 Preprocedure Issues Good Hydration Knowing segmental and global LV function (including valvular pathology) Anticoagulation-prefer heparin if risk of perforation greater than standard Pressors available/atropine/ temp. wire in cases of RCA/LMCA/ or usage of larger burrs 2.38mm etc

17 Guide Catheter Issues/TPM Support usually not an issue, coaxial guide is the most important Larger guides may be helpful for better visualization We no longer use side hole guides for Rotablator, only if anatomy dictates Guide orientation will dictate orientation of guidewire which sets the platform for the entire case Six french can accommodate up to a 1.75mm burr TPM when to use..it depends

18 Guidewire Issues-makes a difference in ablation Two available- (floppy and extrasupport) Extrasupport Delivery Directional cutting Floppy Tortuosity Workhorse

19 Selecting a burr Keep it Small, in almost all cases Rotational atherectomy is being used for lesion modification Traditionally start with a 1.5mm or 1.75mm, 1.25mm in CTOs when PCI fails to dilate lesion, in the absence of a dissection would start with a 1.75mm or 2.0mm burr If severe decelerations (especially on bends) downsize the burr.

20 Operating the device Bring the burr to the lesion, then slightly retract to take the compression out of the system Inject contrast to confirm egress of dye Begin treatment Often the speed will be lower than the outside the body 150k test, that is okay Advance burr gently with forward and backward motion Take occasional injections to see progress Minimize decelerations (listening should be enough) Run time seconds

21 Operating the device II Once treatment completed should be no resistance and no drop in rpms Remove the device immediately, anything that is subsequently required will not be helped by further rotational atherectomy Assess for flow (I pay more attention to the downstream vessel then the lesion site) Assess for spasm (general vessel diameter) Assess patients hemodynamics, chronotropic reponse to the burr and chest pain

22 Adverse events Slow flow/no Reflow Vasodilators Low pressure undersized balloon in distal vessel (switch guidewire out usually done with rotational atherectomy at this point Time Spasm Vasodilators Low pressure PCI distally Hypotension Pressors sooner than later/iabp if secondary to slow flow things may get worse quickly

23 Why all the concern STRATAS TRIAL STRATAS tested an aggressive vs. Routine strategy for debulking. Restenosis high in the both arms Avs.R(57% vs58%),. No or slow reflow was 15.7% in the aggressive arm (burr to artery ratio >7) and 7.7% in the routine arm (burr to artery ratio <.7) (p=.008). Independent predictors were decelerations of >5000 rpm for more than 5 seconds. **This study was performed prior to the recommendation of reduced rpms (150,000). The lower rpms put less torque in the system and thus for any given reduction release less energy essentially, less heat. Whitlow PL, Bass TA, Kipperman RM, Sharaf BL, Ho KK, Cutlip DE, et al. Results of the study to determine rotablator and transluminal angioplasty strategy (STRATAS). Am J Cardiol 2001;87(6):

24 Results-The SPORT TRIAL PTCA + Stent N = 318 Rota + Stent N = 312 Angiographic Success 100% (318) 100 % (312) NS P value Clinical Success 84.5 % (267) 80.3% (244) NS (angio success w/ no MACE) MLD post procedure (mm) P=0.42

25 Adverse effects II If Slow/no reflow, severe chest pain Recommend no further Rotational atherectomy, check compliance of lesion with balloon and if okay proceed to stenting, if still undilatable need to measure risks of further dilation If severe bradycardia and stepping up to larger burr TPM Prepare the patient to cough, stop device with slowing of heart rate, (remember always pull back device to platform segment

26 Lesion specific management Calcification Bifurcations Ostial lesions ISR Tortuosity

27 Calcification USE The Rotablator-will shorten procedure, and Simplify procedure If unsure whether to upsize burr, attempt PCI up to atms, if lesion expands go to stenting Advance gently, these lesions usually respond very well m/p higher rate of slow flow, and more predominant in RCA

28 Bifurcations Cannot double wire Care on severe diagonal/om branches, highest risk for perforations (1.25mm burrs indicated here) Do not sit on these highly angulated lesions, guidewire bias often forces eccentric cut. Proximal to bifurcation if there is a lesion can change cutting orientation by moving wire from parent to branch vessel therefore get greater cutting from a single burr

29 Rotational atherectomy of Both Limbs

30 Instent Restenosis With DES results done much less frequently Still helps in diffuse ISR Very low risk cases and terrific cases to get feel for device Great care if going through stent struts for any reason, can get caught on opposite side if burr watermelon seeds through

31 Long Lesions Do NOT have to pass entire lesion in one run Remember gentle not slow, some long lesions can be done relatively quickly Take injections during run to get locator Do NOT stop burr mid way in lesion always bring back to platform segment Second third runs will have lower platform speed, not to worry (anything above about 120K for burrs mm is okay) Assess with nitro, often will have spasm with longer lesions Overburdening the distal bed is rare, slow flow and no reflow most probably secondary to platelet activation, these are good cases for glycoprotein IIB/IIIA inhibitors

32 Long Lesion

33 Tortuosity Try to pick most coaxial guide, especially in lesions like ostial circumflex Undersize burr Significantly if lots of pseudolesions and wrinkling of the vessel Be clear where lesion is since deformation my make things very difficult Be sure to start the burr in platform segment with adequate clearance

34 CTO No antegrade flow use 1.25mm burr Abrupt deceleration m/p subintimal Vasospasm may hinder antegrade flow in the presence of significant retrograde colaterals. Results Tsuchikane et. al demonstrated reduction in restenosis with stenting (52vs.29%p=.02) Tsuchikane E, Otsuji S, Awata N, Azuma J, Nakaoka Y, Uesugi H, et al. Impact of pre-stent plaque debulking for chronic coronary total occlusions on restenosis reduction. J Invasive Cardiol 2001;13(8): Dietz U, Erbel R, Rupprecht HJ, Weidmann S, Meyer J. High frequency rotational ablation: an alternative in treating coronary artery stenoses and occlusions. Br Heart J 1993;70(4):

35 Rotational atherectomy and. Angiomax-. The use of Bivalirudin in patients undergoing RA was studied retrospectively in a cohort of 253 patients. no difference in incidence of myonecrosis between the two groups, but the heparin treated group was significantly more likely to be treated with GP IIb/IIIa (91% vs. 25%; p = 0.001). Statins-reduced incidence of myonecrosis (21% vs. 7%) Nicorandil-lower incidence of slow and no reflow (9% vs. 2%) compared to verapamil Plavix- The recent use of antiplatelet drugs such as Plavix has not been studied as to the effect on slow/no reflow in the context of RA Gurm HS, Rajagopal V, Bhatt DL, Ellis SG, Lincoff AM. The safety of a bivalirudin-based approach in patients undergoing rotational atherectomy. J Invasive Cardiol 2007;19(5): Gurm HS, Breitbart Y, Vivekanathan D, Yen MH, Fathi R, Ziada KM, et al. Preprocedural statin use is associated with a reduced hazard of postprocedural myonecrosis in patients undergoing rotational atherectomy--a propensity-adjusted analysis. Am Heart J 2006;151(5):1031 e1-6. Matsuo H, Watanabe S, Watanabe T, Warita S, Kojima T, Hirose T, et al. Prevention of no-reflow/slow-flow phenomenon during rotational atherectomy--a prospective randomized study comparing intracoronary continuous infusion of verapamil and

36 But you need to choose carefully

37 Unprotected LMCA

38 LMCA II

39 LMCA III

40 Undilatable lesion

41 Undilatable lesion-ii

42 Undilatable lesion-iii

43 Undilatable lesion IV

44 Angles.

45 Angles II

46 Cutting Balloons Atherotomes affixed to a balloon. Expand radically as balloon is inflated to score arterial plaque.

47 Cutting Balloons Advantages - controlled dissection - non-compliant balloon material Disadvantages - cost - profile - limited lengths, limited use - stiff, bulky catheter

48 Minimizing Vessel Trauma Cutting Balloon Device Plaque Modification Atherotome Wire The atherotomes severs the elastic and fibrotic continuity of the vessel wall allowing plaque compression with less vessel trauma 1 Atherotome 3-5 x Sharper than Surgical Blade 1 Bonan, J Invasiv Cardiol, 1999; 11: 230

49 Minimizing Vessel Trauma Cutting Balloon Device Alteration via Plaque Modification Microsurgical incision Dissection flap Cutting Balloon Device Linear Incision Conventional Balloon Traumatic Dilatation Photo Courtesy of Prof. K Mizuno

50 AngioSculpt Semi-compliant balloon with an external nitinol shape memory helical scoring edge 2 component system Rapid exchange or or OTW delivery Laser cut nitinol spiral cage

51 AngioSculpt Mechanical Forces Edges lock in ~15-25x force 1x force

52 OCT of RCA Lesions Post-AngioSculpt De Novo (E) and ISR (F) Lesions Post-AngioSculpt OCT of De Novo Lesion Post-AngioSculpt demonstrating scoring (white arrowheads) OCT of ISR Lesion Post- AngioSculpt demonstrating scoring (white arrowheads) Takano et al, Int J Cardiol 2008, doi: /j.ijcard

53 Quantitative Angio Analysis Acute Gain (mm) ± 0.2 Group I (Direct Stent) p < ± 0.4 Group II (Pre-dilatation with semi-compliant balloon) 1.2 ± 0.4 group III (AngioSculpt) Costa JR et al; Amer J Cardiol 2007;100:812-17

54 AGILITY: Baseline Lesion Characteristics Bifurcation Angle (distal): 48.94±15.35 degrees Range degrees 9.7% of lesion bifurcation angles > 70 degrees Medina Class (N=93) 1, 1, 1 68 (73.1) 0, 1, 0 2 (2.1) 1, 0, 1 1 (1.1) 1, 0, 0 1 (1.1) 0, 1, 1 16 (17.2) 0, 0, 1 1 (1.1) 1, 1, 0 4 (4.3) 0, 0, 0 0 (0) 92.5% of lesions were Medina Class (x, x, 1) by core lab analysis

55 AGILITY Trial Final Results AGILITY OPC P-Value Primary Endpoint Procedural Success 91.4% 88.2% * Secondary Endpoints Side-Branch Bailout Stenting 10.9% 27% <0.001** Final Kissing Balloon 16.3% 50% <0.001** * Non-inferiority ** superiority Angiographic success: 93.5%

56 Diamondback 360 Crowns CLASSIC CROWN Up to 1.5 x orbit Crown sizes: 1.25, 1.5, 1.75, 2.0 SOLID CROWN Up to 1.75 x orbit Crown sizes: 1.5, 1.75, 2.0, 2.25

57 Unique Mechanism of Action Differential Sanding Diamond-coating crown differentially sands noncompliant plaque; elastic tissue flexes away Minimal damage to arterial wall Maximal luminal gain achieved with increased centrifugal force Centrifugal Force CF=mass*rotational speed 2 radius of the orbit Effective plaque removal Crown flexes away from compliant tissue

58 Conclusion What is complex for PCI is often easy for rotational atherectomy-i.e. Left main calcified lesions/ostial lesions As we do MORE will NEED more rotational atherectomy Earlier you decide in complex lesions to use it the faster the case the better the outcome, almost universally Get your feet wet in ISR cases if have not used it in a while Remember no evidence in restenosis, so use it for lesion modification for optimal stenting

59 conclusion Essential device, and must have comfort with using it. Reserved for the most complex cases Often what is complex for PCI is straightforward when using rotational atherectomy Get the experience.

60 Which of the following is incorrect regarding Rotational atherecomy A-differential cutting favors ablation of inelastic plaque B-lower speed is associated with decreased platelet activation C-double wire techniques is advisable to protect side branches D-rotational atherectomy is contraindicated in ostial lesions

61 Which of the following is incorrect regarding Rotational atherecomy A-differential cutting favors ablation of inelastic plaque B-lower speed is associated with decreased platelet activation C-double wire techniques is advisable to protect side branches D-rotational atherectomy is contraindicated in ostial lesions Answer C

62 The effectiveness of Rotational atherectomy is best seen in A-undilatable lesions B acute MI patients C to reduce restenosis D large vessels E saphenous vein grafts

63 The effectiveness of Rotational atherectomy is best seen in A-undilatable lesions B acute MI patients C to reduce restenosis D large vessels E saphenous vein grafts Answer A

64 Regarding guidewire bias which of the following is incorrect A-Can be favorable and unfavorable B may be source of perforation in angulated lesions C Can be reduced with the use of a more flexible guidewire D Can result in more efficient debulking E in cases where it is seen larger burrs should be employed

65 Regarding guidewire bias which of the following is incorrect A-Can be favorable and unfavorable B may be source of perforation in angulated lesions C Can be reduced with the use of a more flexible guidewire D Can result in more efficient debulking E in cases where it is seen larger burrs should be employed Answer E

66 Which of the following are true regarding using lower rotational speeds during treatment with the Rotablator: A-the operator has greater sensitivity when advances since the device has lower power and thus lower torque B-lower speeds do not achieve the critical speed to produce microcavitation c- heat generation for any drop in rpm at the lower speed is less then seen with higher rpms. D-stalls or rapid decelerations with the rotablator may be seen with rapid advancement of the device when in atherosclerotic plaque E- all of the above

67 Which of the following are true regarding using lower rotational speeds during treatment with the Rotablator: A-the operator has greater sensitivity when advances since the device has lower power and thus lower torque B-lower speeds do not achieve the critical speed to produce microcavitation c- heat generation for any drop in rpm at the lower speed is less then seen with higher rpms. D-stalls or rapid decelerations with the rotablator may be seen with rapid advancement of the device when in atherosclerotic plaque E- all of the above Answer E- all of the above. Using rotational speeds of approximately 150,000 makes the ablation or sanding process much more sensitive to advancement through stenoses. Heat and microcavitation have been shown to have a negative impact on arterial vessels and thus lower speeds may mitigate and reduce those effects.

68 Which of the following regarding dynaglide is false: a-it is the method of using rotational reduction in friction to remove the device from the body b-since it is a lower speed selection it should be used to ablate lesions c- it works on a servocontrol, thus when the speed is reduced for whatever reason more power is put into the system. d- it is activated with the footpedal e all of the above are true.

69 Which of the following regarding dynaglide is false: a-it is the method of using rotational reduction in friction to remove the device from the body b-since it is a lower speed selection it should be used to ablate lesions c- it works on a servocontrol, thus when the speed is reduced for whatever reason more power is put into the system. d- it is activated with the footpedal e all of the above are true. Answer B- It should never be used to advance through a lesion since it is on a servocontrol mechanism, thus the operator would loss completely the feedback of decelerations when treating the lesion.

70 Rotational atherectomy increases the late loss in Drug eluting stents and in stented Calcified lesions 1-true 2-false

71 Rotational atherectomy increases the late loss in Drug eluting stents and in stented Calcified lesions 1-true 2-false False-results have shown comparable results for rotational atherecomy and stenting (DES or BMS ) and stenting alone.