Ramesh Daggubati, MD FACC FSCAI Clinical Professor Medicine Director of the Interventional Cardiology Fellowship Program Brody School of Medicine Director of the Cardiac Catheterization Laboratories East Carolina Heart Institute Basics of Rotational Atherectomy

Results sub-optimal Results from case studies are not predictive of results in other cases. Results in other cases may vary. Case images courtesy of Dr. Arthur Lee, Santa Clara Valley Medical Center, Kaiser Permanente, San Jose, CA Clinical Application Case Example – “Rota Regret” Single 2.75 mm stent placed Post Dilatation: 3.5x9mm NC balloon x atm 4.0x9mm NC balloon x atm

Increasing Complexity and Calcification of PCI Patients % OF PATIENTS WITH CALCIFIED LESIONS* *as reported to NHLBI Dynamic Registry. Bortnick, et. al. Am J Cardiol 2014;113: ACC/AHA LESION CLASSIFICATION

Presence of Calcium in ACS Patients 6,855 ACS pts pooled from 2 pivotal randomized controlled trials 1 1 Généreux P, et. al. J Am Coll Cardiol 2014;63:1845–54. 2 Waters, et al. JACC 2014;63: This degree of calcification, because it is grossly visible by fluoroscopy, is much more severe than other estimations (IVUS, etc.) 2

Calcium Inhibits Stent Expansion Hoffman R et al. EHJ 1998;19: PSS= Palmaz-Schatz stent PSS with IVUS in 323 consecutive lesions in 303 pts Ca +2 arc 0-90  n = 120 Ca +2 arc  n = 58 Ca +2 arc  n = 71 Ca +2 arc  n = 74 p Ca +2 by angiography21%40%71%78%<0.001 Age (mean, yrs) Arc of Ca +2 (mean) 20  127  217  322  <0.001 Arc of superficial Ca +2 88 84  200  311  <0.001 Max press. (mean atm.) <0.001 HSRA used0%21%69%76%<0.001 Acute angiographic measures -Acute gain (mean, mm) Final MLD (mean, mm)

POBA Lesion Preparation by Plaque Type Role of Rotational Atherectomy Optimize stent placementChange Lesion Compliance Avoid Slippage Avoid Plaque Shift Cutting Balloon ® Device Rotational Atherectomy Soft/fattyFibroticCalcific

drive shaft guide wire diamond coated burr 1.25 mm mm (0.25 mm increments) sheath 4.3 french O.D. What is Rotablator? A catheter-based interventional cardiology procedure using a high-speed rotational device designed to ablate atherosclerotic plaque and restore luminal patency FDA approved May 1993 Rotablator ® Rotational Atherectomy System

Differential Cutting DIFFERENTIAL CUTTING The ability to cut one material while sparing another based on differences in composition. ELASTIC TISSUE Normal vascular tissue has elastic properties that allow it to deflect away from the advancing diamonds on the rotating burr. INELASTIC TISSUE Selectively ablates inelastic tissue (i.e. plaque) whether composed of calcium, fibrotic tissue, neointima or lipid-rich material. Elastic TissueInelastic Tissue Results in preferential cutting of inelastic substrate are functional at low and high speeds Reisman, M.D, Guide to Rotational Atherectomy. Physicians Press, Birmingham, MI 1997

Rotablator  System Micro Particles Red Blood Cells 5 Micron Bead THE ROTABLATOR ® SYSTEM is designed to ablate plaque into micro particles. The micro particles pass through the coronary circulation and are then removed by the reticuloendothelial system. Particle Size Reisman, M.D, Guide to Rotational Atherectomy. Physicians Press, Birmingham, MI Image Boston Scientific, Inc.

Rotalink TM Advancer Brake Defeat Image Source: Boston Scientific

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

Air Supply Set Up Power cord Dynaglide™ connectors Cylinder Tank. Compressed Air or Nitrogen From Pg , Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN Dual Gauge Regulator Pressure regulator (relieving type is preferred) capable of delivering at least 5 scfm (140 litre / min or 0.1m 3 /min) at 620kPa-758kPa ( psi or bar or atm). Pressure of the gas supplied to the air or nitrogen connector does not exceed 758kPa (110 psi or 7.6 bar). If the pressure in the tank is below 6,205kPa-6,894kPa ( psi or atm) consider changing tanks before the procedure begins.

Foot Pedal Dynaglide™ indicator illuminated on RPM display on console Dynaglide™ button

RotaWire™ Floppy Guidewire Flexible and torqueable Short Soft Spring Tip (2.2cm) More flexible and less rail support than the previous Rotablator™ C wire, significantly reduces guidewire bias 325cm total length From Pg , Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

RotaWire™ Extra Support Guidewire Soft Spring Tip (2.8cm) Lead wire for those cases requiring a “stiffer” wire 325cm total length From Pg , Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

Post-Rotablator ® System Procedure Porcine Model Histology 16 Picture from Pg 8, Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

Post-PTCA Procedure Post-Rotablator ® System Procedure IVUS Image 17 Kocach JA Mintz GS, Pichard AD, et al. Sequential intravascular ultrasound characterization of the mechanisms of rotational atherectomy and adjunct balloon angioplasty. J Am Coll Cardiol 1993; 22 (4):

A Closer Look – RCA Example Rotablator® Atherectomy System, POBA, and Stent Images courtesy of Georg Gaul, MD, FESC, Vienna, Austria After Rotablator® Atherectomy After Pre-Dilation After Stenting

Optimal Technique TECHNICAL CONSIDERATIONS Single burr with burr-to-artery ratio of 0.5 to 0.6 Rotational speed of 140,000 to 150,000 rpm OPERATOR TECHNIQUE Gradual burr advancement using a pecking motion Short ablation runs of 15 – 20 sec Avoidance of decelerations > 5,000 rpm Final polishing run Tomey, et al. Current Status of Rotational Atherectomy JACC Cardiovasc Int. epub ahead of print.

Impact of Rotational Atherectomy on Stent Expansion in Heavily Calcified Lesions Hoffman R et al. EHJ 1998;19: STENT ALONE n = 40 ROTA + STENT n = 105 p FAVORS ROTA + STENT IVUS PRE Arc of superficial Ca +2  225 ± ± Length of Ca +2 (mm)10.0 ± ± Reference CSA (mm 2 )9.89 ± ± Max balloon pressure (atm)16.0 ± ± IVUS POST Acute CSA gain (mm 2 )4.57 ± ± CSA stenosis (%)23 ± 1516 ± QCA FINAL Acute gain (mm)1.72 ± ± Diameter stenosis (%)9 ± 114 ±

Historical Data: SPORT Trial (Stent Implantation Post Rotational Atherectomy Trial) Buchbinder, M., et al, presentations at TCT 2001 & ACT 2001 Study limitations: included a lesion subset of mostly lesions with minimal calcification where de-bulking with RA is known to be of limited value ROTA + STENT (N=360) PTCA + STENT (N=375) P-VALUE FAVORS ROTA + STENT Post Procedure MLD2.81 ± ± Acute Gain1.94 ± ± Technical Success93.1%87.7% Procedural Success93.6%88.1% Clinical Success91.6%87.0%0.0495

Gert Richert. TCT 2011 Angio follow-up at 9 months in 80.5% (N=190) Angio follow-up at 9 months in 80.5% (N=190) Clinical follow-up at 9 months in 96.2% (N=227) Clinical follow-up at 9 months in 96.2% (N=227) 1:1 randomization PTCA + PES (N=120) PTCA + PES (N=120) Rotablator + PES (N=120) Rotablator + PES (N=120) - 2 patients died in-hospital - 6 patients withdrew consent - 5 patients lost at follow-up *Primary endpoint: In-stent late loss Contemporary Data: ROTAXUS Trial Rotablator and DES in Complex Coronary Lesions 240 pts with calcified lesions at 3 clinical sites in Germany

ROTAXUS: Procedural and In-Hospital Outcomes p = 0.03 p = 0.08 p>0.99 p = 0.02 * Defined as angiographic success with no crossover or stent loss ** Defined as <20% residual stenosis + TIMI 3 flow Abdel-Wahab, et al. JACC Cardiovasc Interv Jan;6(1):10-9. p = 0.32p = 0.56p >0.99

ROTAXUS: 9-month Clinical Outcomes 1 No Significant Impact on Late Outcomes Defined as death, MI and TVR. RA= rotational atherectomy. 1. Richert, G presented at TCT Abdel- Wahab, et al. JACC Cardiovasc Interv Jan;6(1):10-9. p = 1.0p = 0.78p = 0.79p = 0.73p= 0.84p = 0.46 “Although routine RA did not improve DES efficacy, RA remains an important tool for uncrossable or undilatable lesions and improves overall procedural success in this setting.” 2

Strategy for Approaching Calcified Lesions NON-ATHERECTOMY STRATEGY ATHERECTOMY STRATEGY Severe PCI Angiographic Calcification Strategic Failure Mild Severe Adapted from Tomey, et. al. Current Status of Rotational Atherectomy. J Am Coll Cardiol Intv. Online ahead of print. IVUS Calcification Mild Moderate

Angiographic Complications Complication Rate Perforation0.7% Abrupt closure post procedure1.1% No flow0.5% Flap/dissection 13.7% 26 N = 2,953 Procedures Wart DC, Leon MB. O’Neill W, et al. Rotational Atherectomy Multicenter Registry. Acute results, complications and 6 month follow-up in 709 patients. J Amer Coll Cardiol 1994; 24(3): (unfinished report). Industry-sponsored Reisman M, Harms V, Feldman T, Fortuna R, Buchbinder et al. Comparison of Early and Recent Results With Rotational Atherectomy. J Am Coll Cardiol 1997; 29: Industry-sponsored.

Complication Rate Death 1.0% Q-Wave myocardial infarction (MI) 1.2% Coronary Artery Bypass Graft (CABG) 2.5% Overall Major Complications 27 N = 2,953 Procedures Wart DC, Leon MB. O’Neill W, et al. Rotational Atherectomy Multicenter Registry. Acute results, complications and 6 month follow-up in 709 patients. J Amer Coll Cardiol 1994; 24(3): (unfinished report). Industry-sponsored Reisman M, Harms V, Feldman T, Fortuna R, Buchbinder et al. Comparison of Early and Recent Results With Rotational Atherectomy. J Am Coll Cardiol 1997; 29: Industry-sponsored.

Least difficult lesion < 10 mm Minimal calcium Straight LV function 50% Good distal runoff Restenotic lesion Patient Selection Criteria 28

More difficult lesion 10 mm Mild tortuosity Tapering vessel Mild eccentricity LV function 40% Patient Selection Criteria 29

Most difficult lesion Long (>15 mm) Heavily calcified Significantly tapered, distal vessel Highly eccentric Reduced LV function, segmental and global Patient Selection Criteria 30

Burr selection for PTCRA 31 From Pg 70-72, Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN Choose a Rotablator™ catheter burr appropriately sized for the procedure. Determine largest final burr size to 0.85 final burr-to-artery ratio Minor burr may be used to begin treatment Step up burr sizes in maximum of 0.5 mm increments Smaller burr should be selected on: tortuousity, eccentricity, angulations > 60º, guidewire bias, excessive plaque burden, slow flow, chest pain, ECG changes and hemodynamic compromise

Inner guiding diameter at least the largest burr + 0.1mm (0.004") Coaxial guide catheter alignment Side holes recommended Guide Catheter Selection 32 From Pg 54 Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

Drip – Saline drip from bottom of advancer and catheter Rotate – Burr is rotating and RPMs are stabile Advancer – Free movement of advancer knob Wire – Wire is visible and brake is functioning Pre procedure test memory rule: D.R.A.W. 33 System Test (Outside Body)

Set baseline RPM proximal to lesion Slowly advance burr Adjust burr RPM SARS Study, and STRATAS Trial: Low speed RA (140, ,000 rpm) Avoid decelerations > 3000 rpm –Intermittent pull back for coronary perfusion and/or contrast injection Ablating Technique 34 Independent Studies: SARS: Catheter Cardiovasc Interv, September 1999 STRATAS: Whitlow et.al., Am J Cardiol 2001;87:

Before advancing burr over wire, position advancer knob 2-3 cm forward and lock Evenly advance burr while pulling back on wire With burr proximal to lesion, relieve tension on drive shaft –Confirm by freely moving advancer knob Confirm proximal positioning and burr/artery ratio with contrast injection Burr Positioning 35 Rotalink™ Instructions for use.

Time of runs 15“ Pecking technique 36 Independent Studies: STRATAS: Whitlow et.al., Am J Cardiol 2001;87: From Pg 89, Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

Technique cautions Do not over-tighten Y-adapter Avoid dottering Never stop burr in lesion Never advance rotating burr to point of contact with guide wire spring tip Do not allow the burr to remain in one location while rotating at high speeds Gently advance or retract the burr while it is in high-speed rotary motion Ablating Technique 37 Rotalink™ Instructions for use.

Final polishing run No RPM drop No tactile resistance Ablating Technique 38

Check wireClip  Torquer attached to end of guide wire Depress switch on DynaGlide™ Foot Pedal Press brake defeat Activate burr at DynaGlide speed 60,000-90,000 RPM Withdraw spinning burr at sheath and advance guide wire Depress button on the Dynaglide Foot Pedal to reactivate high-speed rotation Exchange Procedure 39 From Pg 97, Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

Indications Achieve nominal reference artery size Technique Oversized balloon at < low Pressure inflations If Adjunctive balloon angioplasty is required or deemed desirable to achieve the final result after rotational angioplasty, it is recommended oversized angioplasty balloon inflated to 1 ATM (101kPa) be used to reduce vessel wall barotrauma. Adjunctive PTCA Rotalink™ Instructions for use.

Bradicardia and AV Block Vasospasm Slow flow or no flow Abrupt closure Dissection Perforation Angiographic Complications 41 From Pg 241, Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

Bradicardia and AV Block Ask the patient to cough Atropine Pacemaker Vasospasm IC nitroglycerin Verapamil Low pressure balloon inflations if persistent Management of Angiographic Complications 42 From Pg , Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

Slow flow/no flow IC Nitroglycerin Maintain adequate perfusion pressure and vasopressure drugs if needed. Short balloon inflations at low pressure — distal to proximal Intraortic balloon pump Abrupt Closure Must be distinguished from spasm and slow/no flow Management similar to conventional PTCA Management of Angiographic Complications 43 From Pg , Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

Dissection Once identified, do not go to a larger burr size Management similar to those after PTCA Stent Perforation Management similar to conventional PTCA Management of Angiographic Complications 44 From Pg , Guide to Rotational Atherectomy. Mark Reisman. Physicians Press, Birmingham, Michigan. ISBN

CONTRAINDICATIONS AND RESTRICTIONS: Contraindications 1.Occlusions through which a guidewire will not pass. 2.Last remaining vessel with compromised left ventricular function. 3.Saphenous vein grafts. 4.Angiographic evidence of thrombus prior to treatment with the Rotablator System. Such patients may be treated with thrombolytics (e.g., Urokinase). When the thrombus has been resolved for two to four weeks, the lesion may be treated with the Rotablator system. 5.Angiographic evidence of significant dissection at the treatment site. The patient may be treated conservatively for approximately four weeks to permit the dissection to heal before treating the lesion with the Rotablator System. RESTRICTIONS: Complications Federal (USA) law restricts the use of this system to physicians who are credentialed in angioplasty and who have attended the Rotablator System Physician Training Program. WARNINGS: The risks of Rotational Atherectomy can be reduced if the device and associated accessories are used in the appropriate patient population by a physician who has had adequate training. INTENDED USE/INDICATIONS FOR USE Percutaneous rotational coronary angioplasty with the Rotablator Rotational Atherectomy System, as a sole therapy or with adjunctive balloon angioplasty, is indicated in patients with coronary artery disease who are acceptable candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria: Single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guidewire; Multiple vessel coronary artery disease that in the physician’s judgment does not pose undue risk to the patient; Certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA), and who have a restenosis of the native vessel; or, Native vessel atherosclerotic coronary artery disease that is less than 25 mm in length. The use of Rotablator for in-stent restenosis might lead to damage of stent components and/or Rotablator Systems, which may lead to patient injury. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. Rotablator™ Rotational Atherectomy System Abbreviated Statement

PRECAUTIONS Treating certain types and/or locations of lesions or patients with certain conditions is inherently riskier, regardless of the therapeutic device being used. For many of these applications, relatively few cases have been carried out using the Rotablator System. Physicians should be aware of the higher risk when treating such patients and the lack of scientific evidence for treatment in the following applications: Patients who are not candidates for coronary artery bypass surgery; Patients with severe, diffuse three-vessel disease (multiple diseased vessels should be treated in separate sessions); Patients with unprotected left main coronary artery disease; Patients with ejection fraction less than 30%; Lesions longer than 25mm; Angulated (> 450) lesions; Rotablator System use should only be carried out at hospitals where emergency bypass surgery can be immediately performed in the event of a potentially injurious or life threatening complication. ADVERSE EVENTS Potential adverse reactions which may result from the use of this device include but are not limited to: Angina or unstable angina; Arrhythmias; Bailout stenting; Cardiac perforation; Cardiac tamonade; conduction block; Coronary artery spasm; Death; Drug reaction, allergic reaction to contrast media; Embolism (coronary, cerebral, peripheral); Hemorrhage or hematoma; Infection, local infection, systemic infection; Myocardial ischemia; Myocardial infarction (Q-wave and non q-Wave); Pericardial effusion; Pulmonary edema/cardiogenic shock; Slow flow, no flow, abrupt vessel closure; Stroke; Vascular thrombus; Vessel trauma (dissection, perforation, rupture or injury) There may also be complications associated with distortion, kinks, and fracture of the guidewire and physical deterioration or malfunction of the device, which can lead to patient injury or death. COMPLICATIONS Complications include: access site bleeding of significance, distal embolization, intimal dissection, acute vessel closure, vessel perforation or tear, ventricular perforation, emergency surgery, contrast media reaction, stroke, slow flow, no flow, myocardial infarction, arrhythmia requiring treatment, cardiac tamponade, and death. Diamondback 360 is a trademark of Cardiovascular Systems, Inc. Rotablator and RotaLink are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners. Rotablator™ Rotational Atherectomy System Abbreviated Statement

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