Slide 1
Orbital Atherectomy in Coronary Arteries  

ICD-10-CM/PCS Coordination and Maintenance Committee Meeting 
March 18, 2015 

Jeffrey W. Chambers, MD 
 
Metropolitan Heart and Vascular Institute,  Mercy Hospital Minneapolis, Minnesota 



Slide 2

DISEASE STATE  

Coronary artery disease  –  large and growing problem in the US
  
Coronary Heart Failure – 5.1 Million(2) 
Stroke – 6.8 Million(2) 
Cancer – 13 Million(5) 
Coronary Artery Disease – 16.3 Million(*1) 
Peripheral Artery Disease – 18 Million(6) 
Diabetes – 26 Million(3) 
Kidney Disease – 31 Million(4) 
*Includes myocardial infarction and angina pectoris 

1.Dolor RJ, et al. Comparative Effectiveness Reviews, No. 66. 2012 Aug. 
2.Go AS, et al. Circulation. 2014;129:e28-292. 
3.American Diabetes Association Diabetes Fact Sheet. Accessed April 21, 2014. 
4.American Kidney Fund Website. Accessed July 30, 2013. 
5.Howlader N, et al. SEER Cancer Statistics Review, 1975-2010. Accessed April 17, 2014. 
6.Schiavetta A, et al. Stem Cells Translational Medicine. 2012;1:572-578. 



Slide 3
RISK FACTORS FOR CORONARY CALCIFICATION

ADVANCED AGE  
41.4M 65+yrs old in U.S.(2)  
85+ age group is the fastest gowing in the U.S. 

DIABETES  
Up to 26M in U.S.(1)  
New epidemic, the fastest growing health problem in the US. 

KIDNEY DISEASE  
Up to 31M in U.S.(3)  
Diabetes is leading cause of kidney disease   
  
1.American Diabetes Association Diabetes Fact Sheet. March, 2013 Accessed on April 21, 2014. 
2.U.S. DHHS. Administration on Aging. Accessed Nov. 24,  2014. 
3.American Kidney Fund. Accessed July 30, 2013. 



Slide 4

WHAT IS CORONARY ARTERY CALCIFICATION AND HOW WE DEFINE IT?   

.Two definitions of coronary calcification as proposed to the ICD-10-CM/PCS Committee: angiographic or IVUS 
NONE or MILD calcification  
– Radiopacities barely visible in close examination before contrast injection(1) or IVUS reveals arc of calcium less than 90 degrees or no calcium arc(4)  

MODERATE calcification    
– Radiopacities noted only during the cardiac cycle before contrast injection(1,2,3) or IVUS reveals arc of calcium 90 to 180 degrees(4,5)  

SEVERE calcification  
– Radiopacities noted without cardiac motion before contrast injection generally compromising both sides of the arterial lumen(1,2,3) or IVUS reveals arc of calcium greater than 180 degrees(4,5,6) 

.Incidence of severe calcification: 6%(7) to 20%(8) 

1.Torre Hernandez JM, et al. J Invasive Cardiol. 2005;17:365-368. 
2.Mintz GS, et al. Circulation. 1995;91:1959-1965. 
3.Nishida K, et al. Am J Cardiol. 2013;112:647-655. 
4.Honye J, et al. Circulation. 1992;85:1012-1025. 
5.Rathore S, et al. CCI. 2010;75:919-927. 
6.Kume T, et al. Circ J. 2007;71:643-647. 
7.Genereux P, et al. J Am Coll Cardiol. 2014;63:1845-54. 
8.Bourantas CV, et al. Heart. 2014;100:1158-64



Slide 5

WHY DO WE CARE ABOUT CORONARY CALCIFICATION? 
 
.Respond poorly to angioplasty(1) 

.Difficult to completely dilate(2) 

.Prone to dissection during balloon angioplasty or predilatation(1) 

.Preclude stent delivery to the desired location(2,3) 

.Can prevent adequate stent expansion(4) - restenosis, stent thrombosis, readmissions 

.May result in stent malapposition(5) 

.Insufficient drug penetration and subsequent restenosis(6) 


1.Fitzgerald PJ, et al. Circulation. 1992;86:64-70. 
2.Cavusoglu E, et al. Cathet Cardivasc Intervent. 2004;62:485-498. 
3.Gilutz H, et al. Cathet Cardiovasc Intervent. 2000;50:212-214. 
4.Moussa I, et al. Circulation. 1997;96:128-136. 
5.Mosseri M, et al. Cardiovasc Revasc Med. 2005;6:147-53. 
6.Ichihashi S & Kichikawa K. Ther Clin Risk Manag. 2014;10:467-474. 
7.Buckley CJ. Vascular Disease Management. 2011;8:87-92. 
8.Dardas P, et al. Hellenic J Cardiol. 2011;52:399-406. 
9.Hernandez J, et al. J Invasive Cardiol. 2014;26:E122-E123.       



Slide 6

WHAT IS THE CURRENT STANDARD OF CARE TO TREAT CORONARY CALCIFICATION?: Balloon angioplasty and Coronary stents 
 


Slide 7

CLINICAL OUTCOMES IN PATIENTS WITH SEVERE CALCIUM 

Severe calcium results in higher procedural complication rates and higher incidence of major adverse cardiac events(1-3)
Patients with severely calcified coronary arteries tend to be older with higher prevalence of diabetes, kidney disease, and hypertension(4-6)

Graph
Death: 2.8% for none/mild calcification vs. 4.2% for moderate vs. 6.3% for severe (p=0.0001)(3) 
Cardiac death: 1.8% for none/mild calcification vs. 2.8% for moderate vs. 4.0% for severe (p=0.0017)(3) 
MI: 7.3% for none/mild calcification vs. 7.6% for moderate vs. 9.4% for severe (p=0.22)(3) 
TLR: 6.0% for none/mild calcification vs. 8.2% for moderate vs. 8.7% for severe (p=0.002)(3) 
MACE: 12.9% for none/mild calcification vs. 15.3% for moderate vs. 19.9% for severe (p=0.003)(3)  
 
Severely calcified lesions:
Requires more time and equipment to treat(7,8) 
More costly to treat(7,8) 
  
Patients with severe calcification have worse outcomes.(1-3)    


1.Fitzgerald PJ, et al. Circulation. 1992;86:64-70. 
2.Kawaguchi R, et al. Cardiovasc Revasc Med. 2008;9:2–8. 
3.Genereux P, et al. J Am Coll Cardiol. 2014;63:1845-54. 
4.Won KB, et al. Diabetol Metab Syndr. 2014;6:134. 
5.Shemesh J, et al. Am J Cardiol. 2012;109:844-850. 
6.Kramer H, et al. J Am Soc Nephrol. 2005;16:507-513. 
7.Meerkin D, et al. J Invasive Cardiol. 2002;14:547-551. 
8.Parikh K, et al. Catheter Cardiovasc Interv. 2013;81:1134-1139. 
   


Slide 8

OTHER OPTIONS FOR TREATING CALCIFIED CORONARY ARTERIES 
.Atherectomy 

 - modify calcified deposits and plaques(1) 
 - may change artery compliance(2)  
 - low rate of dissections and perforations(3) 
 - facilitate stent delivery and expansion(1)  

Adequate lesion preparation with atherectomy appears to help stent implantation in severely calcified lesions.(4,5)   
 

1.Abdel-Wahab M, et al. JACC Cardiovasc Interv. 2013;6:10-9.   
2.Parikh K, et al. Catheter Cardiovasc Interv. 2013;81:1134-1139 
3.Chambers JW, et al.  J Am Coll Cardiol Intv. 2014;7:510-8. 
4.Ullah M, et al. Cardiovasc J. 2014;6:149-163. 
5.Moussa I, et al. Circulation. 1997;96:128-36. 



Slide 9

ATHERECTOMY PROCEDURES 
.Rotational  
Forward drill-like mechanism  
Rotating burr in constant contact with the lesion circumference 
Not indicated for calcified lesions   

.Laser 
Utilizes pulsed laser energy to vaporize the plaque into particles 
Suited for removal of soft or medium plaque  

.Directional  
Direct and orient the cutting blade to plaque for removal 
Does not discriminate between diseased plaque and arterial tissue 
Suited for removal of soft or medium plaque 




SLide 10
ROTAXUS  
240 pts with calcified lesions enrolled between August 2006 and March 2010 at 3 clinical sites in Germany 
 
1:1 randomization 
IVUS not used 
Rotablator + PES (N=120) 
PTCA + PES (N=120) 
 

Clinical follow-up at 9 months in 96.2% (N=227) Angio follow-up at 9 months in 80.5% (N=190)  
- 2 patients died in-hospital 
- 6 patients withdrew consent 
- 5 patients lost at follow-up 


*Primary endpoint: In-stent late loss 
Mean age 71 DM 28% MVD 74% 
Ostial 18% Bifurc 48% B2/C 90% 

Abdel-Wahab M, et al. JACC Cardiovasc Interv. 2013;6:10-9.   



Slide 11

ROTAXUS: Procedural Outcomes  

* Defined as <20% residual stenosis + TIMI 3 flow 
** Defined as angiographic success with no crossover or stent loss 
 
 
Angiographic success (p=1.0)  
Rota+PES: 97%  
PTCA+PES: 96.7%  

Stent loss (p=0.08)  
Rota+PES: 0  
PTCA+PES: 2.5%  

Crossover (p=0.02)  
Rota+PES: 4.2%  
PTCA+PES: 12.5%  

Strategy success (p=0.03)  
Rota+PES: 92.5%  
PTCA+PES: 83.3%   

Abdel-Wahab M, et al. JACC Cardiovasc Interv. 2013;6:10-9.  



Slide 12

ROTAXUS PRIMARY ENDPOINT

Graph
9-month late lumen loss:
RA + PES: 0.44 mm
PTCA + PES: 0.31 mm

Abdel-Wahab M, et al. JACC Cardiovasc Interv. 2013;6:10-9.  



Slide 13

ROTAXUS: 9-MONTH FOLLOW-UP

Graph
Death (p=0.78):
RA + PES: 5.0%
PTCA + PES: 5.8%

MI (p=0.79):
RA + PES: 6.7%
PTCA + PES: 5.8%

TVR (p=0.73):
RA + PES: 16.7%
PTCA + PES: 18.3%

TLR (p=0.84):
RA + PES: 11.7%
PTCA + PES: 12.5%

MACE (Defined as death, MI and TLR) (p=0.46):
RA + PES: 24.2%
PTCA + PES: 28.3%

Define ST (p=1.0):
RA + PES: 0.8%
PTCA + PES: 0%

Abdel-Wahab M, et al. JACC Cardiovasc Interv. 2013;6:10-9.  



Slide 14

Diamondback 360° Coronary Orbital Atherectomy System (OAS)
 - Coronary Orbital ATherectomy Device
 - Diamond-coated Crown
 - ViperWire Advance Coronary Guide Wire (Designed to enhance navigation)
 - ViperSLide Coronary Lubricant (esigned for smooth operation)
 - Saline Infusion Pump (Infuse fluidity into every procedure)  

The first and only FDA approved atherectomy device specifically indicated for severe calcium 
 


Slide 15

DIAMONDBACK 360 CORONARY OAS MECHANISM OF ACTION VIDEO
https://www.youtube.com/watch?v=PVr7Ftzl5Mc



Slide 16

UNIQUE MECHANISM OF ACTION 
Coronary Orbital Atherectomy utilizes an orbiting mechanism of action: 

.Differential, circumferential (orbital) sanding mechanism 
Differentiates between hard, calcified plaques and soft arterial tissue 

.Variable size of lumen modification
Higher speed, larger treatment area (speed controlled by the operator) – one device treat multiple vessel sizes 

.Non-occlusive
Continuous flow of blood during orbit – constant cooling oftissue – minimizes thermal injury 

.Bi-directional treatment 
The device circumferentially sands plaque when pushed forward or pulled back 



Slide 17

ORBIT II  
Study Design 

Prospective, multi-center trial 
Single arm trial as there are no FDA-approved percutaneous treatments for patients with severely calcified lesions 
 
To evaluate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement 

443 patients enrolled in 49 U.S. sites 
30-day follow-up – published(1) 
1 year follow-up – published(2) 
2-year follow-up - published(3) 

1.Chambers JW, et al.  J Am Coll Cardiol Intv. 2014;7:510-8. 
2.Chambers JW. Presented at SCAI 2014.
3.Chambers JW. Presented at CRT 2015.



Slide 18

ORBIT II  
Patient Demographics & Lesion Characteristics 

Table
Demographics 
            ORBIT II (N=443)    ROTAXUS (N=120)     ACUITY/HORIZONS (N=402) 
 
Age (yrs)    71.4                 70.5                  65.3 
Male         64.6%                72.3%                 72.6% 
History of diabetes mellitus 
             36.1%                27.7%                 25.6% 
History of hypertension 
             91.6%                89.1%                 61.9% 
History of dyslipidemia 
             91.9%                76.5%                 50.4% 
Prior CABG   14.7%                7.6%                  14.4% 

Vessel & Lesion Characteristics 
             N=440                N=146                 N=402 
Severe calcification 
             100%                 44.5%                 100% 
Mean pre-procedure target lesion length 
             18.9 mm              20.6 mm               14.9 mm 
Mean pre-procedure minimum lumen diameter 
             0.5 mm               -                     0.44 mm 
Mean pre-procedure percent stenosis 
             84.4%                81.5%                 84.3% 
 

Real-world patients are older, more often females, with higher predicted risk of mortality, and have substantially more comorbidities such as diabetes, hypertension or dyslipidemia.(1-6)  

1.Udell JA, et al. JAMA. 2014;312:841-843. 
2.Zulman DM, et al. J Gen Intern Med. 2011;26:783-90. 
3.Cherubini A, et al. Arch Intern Med. 2011;171:550-556.       
4.Niederseer  D, et al. International Journal of Cardiology. 2013;168:1859–1865. 
5.Lind KD.  AARP Public Policy Institute. 2011  
6.Lempereur M, et al. EuroIntervention. 2014; doi: 10.4244/EIJY14M12_11. [Epub ahead of print] 



Slide 19
 
ORBIT II - Results 

PRIMARY EFFICACY ENDPOINT 
Performance goal: 82%  
Procedural Success: 88.9%* 
 
Successful Stent Delivery                 97.7% 
Residual Stenosis < 50%                   98.6% 
Freedom from MI (CK-MB>3x ULN)            90.7% 
        Non Q-wave                91.4% 
        Q-wave                    99.3% 
Freedom from TVR/TLR                      99.3% 
Freedom from Cardiac Death                99.8%  

PRIMARY SAFETY ENDPOINT 
Performance goal:                         83%  
Freedom from 30 day MACE:                 89.6%  
 
Freedom from MI (CK-MB>3x ULN)            90.3% 
        Non Q-wave              91.2% 
        Q-wave                  99.1% 
Freedom from TVR/TLR                     98.6% 
Freedom from Cardiac Death               99.8% 
 
 
*Subjects may have more than one event. 
 


Slide 20

MORTALITY  

Orbital Atherectomy has demonstrated substantial clinical improvement in reducing mortality rates in treating severely calcified lesions. 

Graph
9 months results 
ORBIT II 1 y OAS+BMS/DES: 3.0% 
ROTAXUS 9 mos RA+DES:     15.0% 
ROTAXUS 9 mos DES alone:  5.8% 

1 year results 
ORBIT II 1 y OAS+BMS/DES:              4.4% 
ACUITY/HORIOZNS 1 y All PCI (BMS/DES): 6.3% 

ORBIT II, 100% severely calcified lesions – Chambers JW, et al.  J Am Coll Cardiol Intv. 2014;7:510-8. 
ROTAXUS, ~50%/50% moderate/severely calcified lesions – Abdel-Wahab M, et al.  J Am Coll Cardiol Intv. 2013;6:10-9. 
ACUITY/HORIZONS, 100% severe calcified lesions – Genereux P, et al. J Am Coll Cardiol. 2014;63:1845-54. 

*The cited clinical trials did not involve direct device-to-device comparison and they varied in study design. The comparison shown is based upon peer-reviewed reports of the studies and is intended to show differences in classes of adverse events to support  CMS need for data showing clinical improvement. 



Slide 21

MACE Rates 

Orbital Atherectomy has demonstrated substantial clinical improvement in reducing MACE rates in treating severely calcified lesions. 

Graph
9 months results 
ORBIT II 1 y OAS+BMS/DES: 14.8% 
ROTAXUS 9 mos RA+DES:     24.2% 
ROTAXUS 9 mos DES alone:  28.3% 

1 year results 
ORBIT II 1 y OAS+BMS/DES:              16.4% 
ACUITY/HORIOZNS 1 y All PCI (BMS/DES): 19.9% 

ORBIT II, 100% severely calcified lesions – Chambers JW, et al.  J Am Coll Cardiol Intv. 2014;7:510-8. 
ROTAXUS, ~50%/50% moderate/severely calcified lesions – Abdel-Wahab M, et al.  J Am Coll Cardiol Intv. 2013;6:10-9. 
ACUITY/HORIZONS, 100% severe calcified lesions – Genereux P, et al. J Am Coll Cardiol. 2014;63:1845-54. 

*The cited clinical trials did not involve direct device-to-device comparison and they varied in study design. The comparison shown is based upon peer-reviewed reports of the studies and is intended to show differences in classes of adverse events to support  CMS need for data showing clinical improvement. 



Slide 22

Target Lesion Revascularization Rates 

Orbital Atherectomy has demonstrated substantial clinical improvement in reducing TLR rates in treating severely calcified lesions. 

Graph
9 months results 
ORBIT II 1 y OAS+BMS/DES: 3.5% 
ROTAXUS 9 mos RA+DES:     11.7% 
ROTAXUS 9 mos DES alone:  12.5% 

1 year results 
ORBIT II 1 y OAS+BMS/DES:              4.7% 
ACUITY/HORIOZNS 1 y All PCI (BMS?DES): 8.7% 

ORBIT II, 100% severely calcified lesions – Chambers JW, et al.  J Am Coll Cardiol Intv. 2014;7:510-8. 
ROTAXUS, ~50%/50% moderate/severely calcified lesions – Abdel-Wahab M, et al.  J Am Coll Cardiol Intv. 2013;6:10-9. 
ACUITY/HORIZONS, 100% severe calcified lesions – Genereux P, et al. J Am Coll Cardiol. 2014;63:1845-54. 

*The cited clinical trials did not involve direct device-to-device comparison and they varied in study design. The comparison shown is based upon peer-reviewed reports of the studies and is intended to show differences in classes of adverse events to support  CMS need for data showing clinical improvement. 



Slide 23

ORBIT II STUDY OBJECTIVE - SAFETY

OAS has demonstrated that is safe in treating de novo, severely calcified coronary lesions.

Graph
2-year outcomes
Cardiac death: 4.3%
TVR:           8.1%
MI*:           10.9%
MACE:          19.4%

*Not per protocol analysis. CLinically driven evaluation based on CEC adjudication of MI.



SLide 24

ORBIT II 1 and 2 YEAR TVR/TLR RATES WITHIN RANGE OF DES LITERATURE*

Table
				       1-year	                       2-year
                               	TVR		TLR		TVR		TLR
ORBIT II - all stent types:	1.9%		4.7%		2.9%		6.2%
ORBIT II  - DES only:		1.6%		3.4%		2.7%		5.2%
ROTAXUS - RA + DES(1):		NR		NR		19.6%		NR
DES RCT - severe Ca included:	0.7-7.6%(2)	0.0-7.8%(3)	3.7-14.9%(4)	3.5-11.0%(5)

*Literature search of coronary drug eluting stent (DES) randomized controlled trials (RCT) is on file at CSI. This summary table shows the TVR/TLR events as presented in the literature, but is not  a direct device-to-device comparison since the studies described vary in design.

Abdel-Wahab M, et al. Rotational atherectomy before paclitaxel-eluting stent implantation in complex coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial. Presented at EuroPCR 2013--Paris, France.
COMPARE (Lancet. 2010;375:201-9.), DESSERT (Am J Cardiol. 2008;101:1560-6.), ESSENCE-DIABETES (Circulation. 2011;124:886-92.), EXAMINATION (Lancet. 2012;380:1482-90.), EXCELLENT (J Am Coll Cardiol. 2011;58:1844-54.), LONG-DES III (JACC Cardiovasc Interv. 2011;4:1096-103.), MISSION (Am J Cardiol. 2010;106:4-12.), PRISON II (Circulation. 2006;114:921-8.), RESET (Circulation. 2012;126:1225-36. ), RESOLUTE (J Am Coll Cardiol. 2011;57:2221-32.), SESAMI (J Am Coll Cardiol. 2007;49:1924-30.),TWENTE (J Am Coll Cardiol. 2012;59:1350-61.), ZEST (J Am Coll Cardiol. 2010;56:1187-95.)
COMPARE (Lancet. 2010;375:201-9.), DESSERT (Am J Cardiol. 2008;101:1560-6.), ESSENCE-DIABETES (Circulation. 2011;124:886-92.), EXAMINATION (Lancet. 2012;380:1482-90.), EXCELLENT (J Am Coll Cardiol. 2011;58:1844-54. ), ISAR Left Main (J Am Coll Cardiol. 2009;53:1760-8.), KOMER-AMI (EuroIntervention. 2011;7:936-43.), LONG-DES III (JACC Cardiovasc Interv. 2011;4:1096-103.), MISSION (Am J Cardiol. 2010;106:4-12.), PASEO (JACC Cardiovasc Interv. 2009;2:515-23.), PRISON II (Circulation. 2006;114:921-8.), PROSIT (Catheter Cardiovasc Interv. 2008;72:25-32.), RESET (Circulation. 2012;126:1225-36.), RESOLUTE (J Am Coll Cardiol. 2011;57:2221-32.), SESAMI (J Am Coll Cardiol. 2007;49:1924-30.), TWENTE (J Am Coll Cardiol. 2012;59:1350-61.), ZEST (J Am Coll Cardiol. 2010 ;56:1187-95.)
BASKET-PROVE (N Engl J Med. 2010;363:2310-9.), DES-Diabetes (JACC Cardiovasc Interv. 2011;4:310-6.), GISSOC II-GISE (Eur Heart J. 2010;31:2014-20.)
DES-Diabetes (JACC Cardiovasc Interv. 2011;4:310-6.), GISSOC II-GISE (Eur Heart J. 2010 ;31:2014-20.), ISAR Left Main (J Am Coll Cardiol. 2009;53:1760-8.), PASEO (JACC Cardiovasc Interv. 2009;2:515-23.)



Slide 25

SUMMARY OF CLINICAL DATA  

.Calcified vessels are technically challenging to treat, requiring more time and resources.  
.Using the DIAMONDBACK Coronary OAS, the first and only device approved by FDA specifically to treat severely calcified lesions, offers an effective method to treat calcified coronary lesions to facilitate stent placement in these difficult-to-treat patients.  
.Compared to the currently available treatments coronary orbital atherectomy has demonstrated substantial clinical improvement in treating severely calcified coronary lesions as shown by reduced rates of cardiac death, mortality, MACE, and TLR, as well as by reduced length of stay and costs.  



Slide 26

NEED FOR CHANGES TO THE CODE STRUCTURE 

.Current coding does not have a means of identifying the use of orbital atherectomy in coronary artery interventions 
.Establishing a unique qualifier will identify coronary orbital atherectomy from other currently available  atherectomy treatments  
.A unique qualifier will provide the ability to collect and track: 
 - clinical data for treatment of severely calcified lesions 
 - utilization and resource costs 
 - more accurate coding for reimbursement  



Slide 27

MEDICAL RECORD DOCUMENTATION  

Orbital atherectomy procedures are typically described within the Medical Record as follows: 
.DIAMONDBACK 360®  
.Orbital Atherectomy System (OAS)  
.Coronary orbital atherectomy with severely calcified lesions    
.Coronary orbital atherectomy with DES/BMS delivery  
.Coronary orbital atherectomy with PTCA    







