The role of orbital atherectomy for optimization of BTK ...
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The role of orbital atherectomy for optimization of BTK revascularization results Peter A. Schneider, MD Honolulu, Hawaii
Transcript of The role of orbital atherectomy for optimization of BTK ...
The role of orbital atherectomy for optimization of BTK
revascularization results
Peter A. Schneider, MDHonolulu, Hawaii
Disclosure
Peter A. Schneider, MD
.................................................................................
Potential conflicts of interest to report:
Consulting: Silk Road, Surmodics, Profusa, CSI, Cardinal, Terumo
Chief Medical Officer: Intact Vascular, Cagent, Vesper
Scientific Advisory Board: Abbott, Medtronic, Boston Scientific
Orbital Atherectomy
• Manage calcification
• Create lumen space
• Change compliance
• Vessel more responsive to balloon angioplasty
• Leave healthy tissue behind
• Small particulate
Pulsatile Forces2Before OAS After OAS
* In a phantom non-diseased popliteal artery** Results vary based upon plaque morphology, calcification, and anatomy1. Based on cadaver atherosclerotic lesions, porcine coronary lesions, and graphite blocks2. Test models: Zheng et al., 2016. Med Eng Phys. 2016 Jul;38(7):639-47
• 360° crown contact designed to create a smooth, concentric lumen
• Allows constant blood flow and particulate flushing during orbit
Differential Sanding
• Average particulate size1 = 2 microns
• Bi-directional sanding of superficial calcium
• Healthy elastic tissue flexes away from the crown, minimizing damage to the vessel
• Low frequency (18-40 Hz) represents crown orbit inside
vessel*
• High frequency (1000-1900 Hz) represents rotation of
eccentric crown over the wire, producing pulsatile
mechanical forces*
• These pulsatile forces may affect deeper plaque and
contribute to compliance change**
30 µm diamond coating eccentric-mounted mass
Orbital Atherectomy: Mechanism of Action
Differential Sanding:– 30 micron diamond coating for optimal “catch” of
hard plaque
– Plaque provides resistance allowing diamond coating to “sand” away calcified plaque
– Healthy elastic tissue flexes away minimizing damage to the vessel
Unique Performance:– Micro-particulate: 2 microns1
• RBC diameter 6-8 microns
– “No” to “Minimal” Injury in most sections after
treatment with Diamondback 360° PAD
System1
30 micron Diamond Coating
>400 Histological Porcine Sections
Micro-particulate
1. Adams GL, et al. Optimal techniques with the Diamondback 360° System achieve effective results for the treatment of peripheral arterial disease. J of Cardiovasc Trans Res. 2011;4:220-9.
Orbital Atherectomy: Mechanism of Action Centrifugal Force & Differential Sanding
Most sections showed “No” to “Minimal” Injury After Treatment with Orbital Atherectomy
Non-OAS Technology May Damage the Media
Directional CutterOrbital Atherectomy
OAS Preserves the Media
Internal Elastic Lamina (IEL)
Media
External Elastic Lamina (EEL)
1. Adams GL, et al. Optimal techniques with the Diamondback 360° System achieve effective results for the treatment of peripheral arterial disease. J of Cardiovasc Trans Res. 2011;4:220-9.
2. CSI Data on file.
Differential Sanding Preserves Medial Integrity Demonstrated in >400 Histology Porcine Segments1,2
Study NameNumber Patients
# of Lesions % BTK % DM
Renal Insufficiency
Severe,Moderate Calcium
OASIS1 124 201 86% 55% 11% 55%
CONFIRM I2 733 1146 36% 61% 36% 76%
CONFIRM II2 1127 1734 30% 60% 37% 82%
CONFIRM III2 1275 1886 41% 59% 35% 83%
CALCIUM 3603 50 64 100% 64% 24% *93%
COMPLIANCE 3604 50 65 0% 56% N/R *82%
TRUTH5 25 29 7% 72% 24% 90%7
LIBERTY 3606 1204 1503 52%8 61% 35% 44%9
OASIS: IDE Study
CONFIRM SERIES: Real World, Complex Patients, No Exclusion Criteria
CALCIUM 360: BTK Head-to-Head Trial Comparing OAS+PTA and PTA alone
COMPLIANCE 360: ATK Head-to-Head Trial Comparing OAS+PTA and PTA alone
TRUTH: ATK IVUS Analysis
LIBERTY 360: Real World, All-Comers, All-Treatment Options PAD Study
1. Safian RD, et al. Catheter Cardiovasc Interv. 2009;73(3):406-12.2. Das T, et al. Catheter Cardiovasc Interv. 2014;83(1):115-22. CSI Data on File.3. Shammas NW, et al. J Endovasc Ther. 2012;19(4):480-8.4. Dattilo R, et al. J Invasive Cardiol. 2014;26(8):355-60.5. Babaev A, et al. Vasc Endovascular Surg. 2015;49:188-94.
6. ClinicalTrials.gov NCT01855412; Adams et al. The LIBERTY Study Design. American Heart Journal. 2016;174:14-21. The LIBERTY study is ongoing; subjects will be followed for up to 5 years.
7. Calcified (severity not specified)8. 13% of lesions located ATK + BTK9. Grade 3 or 4 in PACSS
Completed Prospective Peripheral Studies
Focused On Calcified Lesions
In real-world patient populations AND the most challenging lesions Orbital
Atherectomy demonstrates successful lesion modification while maintaining low
rates of procedural adverse events.
OASIS1
n = 201
CONFIRM I Diamondback2
n = 1146
CONFIRM II Predator2
n = 1734
CONFIRM III Outflow2
n = 1886
CALCIUM3
n = 29
COMPLIANCE4
n = 38
Mean Max Inflation Pressure (atm)
N/R 5.7 5.4 5.9 5.9 4.0
Bail-out Stent due to complications
2.5% 3.8%* 5.8%* 5.2%* 6.9% 5.3%‡
Perforation 1.5% 0.9% 0.6% 0.7% 0.0% 0.0%
Embolization 0.5% N/R 2.2% 2.2% 0.0% 2.6%
* Based on reported dissection treatments.‡ Adjunctive Stenting due to >30% residual
stenosis
1. Safian RD, et al. Catheter Cardiovasc Interv. 2009;73(3):406-12.
2. Das T, et al. Catheter Cardiovasc Interv. 2014;83(1):115-22. CSI Data on File.
3. Shammas NW, et al. J Endovasc Ther. 2012;19(4):480-8.
4. Dattilo R, et al. J Invasive Cardiol. 2014;26(8):355-60.
Safety Profile and Complication Rates
• Prospective, multi-center registries to evaluate the
use of OAS in patients with infra-inguinal PAD
• Three consecutive prospective registries
conducted under common protocol from 2009 to
2011
– Over 200 US hospitals
– Over 350 physicians
• Real-world patients
– No inclusion/exclusion criteria
• Three generations of OAS
– Diamondback 360º, Predator 360º, Stealth
360º
CONFIRM I
733pts/
1,146 lesions
CONFIRM II
1127pts/
1,734 lesions
CONFIRM III
1275pts/
1,886 lesions3,135 patients/4,766 lesions
Large PAD real-world patient data set
Das T, et al. Catheter Cardiovasc Interv. 2014;83(1):115-22.
CONFIRM 360°: Study Design
• Average number of lesions per patient: 1.5 ± 0.8
• In most cases, 1 device was used during the
procedure (1.1 ± 0.3)
• Location of the treatment and percent stenosis
reduction were similar across CONFIRM series
– Slight trend toward higher BTK utilization in
CONFIRM III
– Post OAS residual stenosis 35 ± 19%
– Final residual stenosis 10 ± 11%BTK only
28%
POP only
7%
ATK only
42%
Multi vessel (e.g., ATK + BTK): ~20%
Das T, et al. Catheter Cardiovasc Interv. 2014;83(1):115-22.
Prospective, multi-center, acute registries to evaluate the use of OAS
in patients with infra-inguinal PAD (n=4,766 lesions)
CONFIRM 360°: Treatment Parameters
0
2
4
6
8
10
12
Slow Flow Vessel Closure Spasm
% Procedural Complications
CONFIRM I
CONFIRM II
CONFIRM III
CONFIRM I vs II (p<0.001)
CONFIRM I vs III (p<0.001)
CONFIRM I vs II (p=0.04)
CONFIRM I vs III (p=0.13)
CONFIRM I vs II (p<0.001)
CONFIRM I vs III (p<0.001)
Das T, et al. Catheter Cardiovasc Interv. 2014;83(1):115-22.
Prospective, multi-center, acute registries to evaluate the use of OAS in patients
with infra-inguinal PAD (n=4,766 lesions)
Slow Flow Vessel Closure Spasm
Evolution of Safety Profile Based on
Compliance Change in CONFIRM 360° Series
OAS consistently demonstrates plaque modification with
Low inflation pressure
Low bail out stent rates
Low procedural events
Per LesionCONFIRM I
n = 1146
CONFIRM II
n = 1734
CONFIRM III
n = 1886
Mean Max Inflation 5.7 atm 5.4 atm 5.9 atm
Bail-Out Stent
(due to dissections)3.8% 5.8% 5.2%
Perforation 0.9% 0.6% 0.7%
Distal embolization N/R 2.2% 2.2%
Vessel closure 2.1% 1.2% 1.4%
Das T. et al. Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: The CONFIRM series, a prospective multicenter registry. Catheter Cardiovasc Interv.
2014;83:115-22. AND CSI Data on file.
Overall CONFIRM Procedural Outcomes
CONFIRM Series – Sub-analyses –
Acute Complication Rates
1. Lee M, et al. J Invasive Cardiol. 2015;27:381-386.
2. Lee M, et al. J Endovasc Ther. 2015;22:57-62.
3. Lee M, et al. J Endovasc Ther. 2014;21:258-65.
4. Lee M, et al. J Invasive Cardiol. 2014;26:350-354.
5. Mayeda G, et al. Vasc Dis Manag. 2014;11:E37-E43.
6. Adams GL, et al. J Invasive Cardiol. 2015;27:516-20.
7. Lee M, et al. Catheter Cardiovasc Interv. 2016;87:440-445.
Complication rates
Ranges
Flow-limiting dissection
0.0 - 2.6%
Perforation 0.0 – 1.5%
Slow flow 0.0 – 7.7%
Vessel closure 0.9 – 2.8%
Spasm 3.7 – 10.3%
Embolism 0.0 – 5.1%
Thrombus 1.0 – 1.9%
Age1 Gender2 Diabetes3 Renal4
Age<75 (n=1,753)
Age≥75 (n=1,242)
pWomen
(n=1,261)Men
(n=1,870)p DM (n=1,842)
No DM (n=1,247)
pRenal
disease (n=1,105)
No renal disease
(n=1,969)p
Flow-limiting dissection
1.6% 1.5% 0.51 1.6% 1.4% 0.61 1.5% 1.4% 0.81 1.3% 1.7% 0.39
Perforation 0.4% 1.2% 0.01 0.8% 0.7% 0.57 0.5% 1.1% 0.03 0.6% 0.8% 0.55
Slow flow 4.0% 5.3% 0.08 4.4% 4.5% 0.96 5.0% 3.5% 0.02 5.0% 4.2% 0.19
Closure 1.7% 1.1% 0.13 1.8% 1.2% 0.11 1.7% 0.9% 0.06 1.1% 1.6% 0.08
Spasm 6.3% 6.4% 0.96 6.8% 6.0% 0.24 5.5% 7.6% 0.005 6.7% 6.2% 0.40
Embolism 2.5% 1.6% 0.31 2.8% 1.9% 0.07 2.2% 2.4% 0.67 1.7% 2.6% 0.12
Thrombus 1.6% 0.9% 0.03 1.3% 1.2% 0.74 1.3% 1.1% 0.75 1.4% 1.0% 0.56
Office based lab5 CLI/Claudicant6 CLI ATK vs. BTK lesions7
Hospital (n=3,060)
OBL (n=75)
P*RC 1-3
(n=1,697)RC 4-6
(n=1,320)p ATK (n=586) BTK (n=523) p
Flow-limiting dissection
1.5% 0.0% 0.30 1.4% 2.6% 0.15 1.2% 0.4% 0.09
Perforation 0.7% 0.0% 0.98 0.6% 0.0% 0.47 0.2% 1.5% 0.005
Slow flow 4.6% 0.0% 0.19 2.9% 2.6% 0.64 5.0% 7.7% 0.03
Closure 1.4% 2.8% 0.11 1.4% 2.3% 0.29 1.4% 1.3% 0.92
Spasm 6.4% 3.7% 0.58 3.8% 6.3% 0.10 4.2% 10.3% <0.001
Embolism 2.3% 0% 0.32 1.7% 2.6% 0.37 5.1% 0.4% <0.001
Thrombus 1.2% 1.9% 0.17 1.1% 1.3% 0.84 1.1% 1.8% 0.27
*P-values form adjusted logistic regression
Dattilo R, et al. J Invasive Cardiol. 2014;26(8):355-60.
Patency at 12 Months
Mean Max Balloon Pressure
(atm)
Adjunctive
Stenting
Similar patency despite large
difference in stents placed
Patency definition: Freedom from
TLR or restenosis (Peak Systolic
Velocity Ratio (PSVR) ≥2.5)
4.0
9.1
0
5
10
OAS + PTAn=38
PTA ALONEn=27
5.3%
77.8%
0.0%
50.0%
100.0%
OAS + PTAn=38
PTA ALONEn=27
p < 0.001 p < 0.001
81.2% 78.3%
0.0%
50.0%
100.0%
OAS + PTA PTA ALONEn=32
lesions
n=23
lesions
p = 0.998
ORBITAL ATHERECTOMY SYSTEM DEMONSTRATED REDUCED STENTING
WITH DURABLE RESULTS OUT TO 12 MONTHS VS. PTA ALONE
Prospective, randomized, multi-center study that compared acute and
long-term results of OAS+PTA and PTA alone in calcified ATK lesions
COMPLIANCE 360°: Results
ORBITAL ATHERECTOMY SYSTEM CHANGES COMPLIANCE AND PROVIDES DURABLE
RESULTS OUT TO 12 MONTHS VS. PTA ALONE
Mean Max Balloon
Pressure (atm)p = 0.001
Freedom From
Major Adverse Events*p = 0.006
Freedom From
Revascularization
Results at 12 Months
5.9
9.4
0
5
10
OAS + PTA PTA ALONE
93.3%
80.0%
0%
50%
100%
OAS + PTA PTA ALONE
93.3%
57.9%
0%
50%
100%
OAS + PTA PTA ALONE
n=15 patients n=15 patients n=15 patients n=19 patients
*MAE (major adverse events: device- or procedure-related major amputation (above the ankle), all-cause
mortality and TLR/TVR).
Shammas NW, et al. J Endovasc Ther. 2012;19(4):480-8.
p = 0.14
Prospective, randomized, multi-center
study that compared acute and long-
term results of OAS+PTA and PTA alone
in calcified BTK lesions
n=27 lesions n=34 lesions
CALCIUM 360°: Results
Liberty 360-1204 patients
18-Month Freedom from MAE and Amputation Free SurvivalHigh freedom from MAE in all groups with similar MAE outcomes in RC4-5 and RC6. High freedom from major
amputation in all Rutherford Classes (RC2-3, 100%; RC4-5, 95.3%; and RC6, 91.3%).
40% 50% 60% 70% 80% 90% 100%
Rutherford 6
Rutherford 4-5
Rutherford 2-3
At Risk 25
Events 17
Censored 14
At Risk 97
Events 59
Censored 77
At Risk 127
Events 36
Censored 51
Rutherford 2-3
18-Month Freedom from MAE – OAS
Rutherford 4-5
Rutherford 6
FF TVR
Rutherford 6
Rutherford 4-5
Rutherford 2-3
Rutherford 6
Rutherford 4-5
Rutherford 2-3
FF Major Amputation
FF All Death*
100.0%
95.3%
91.3%
81.6%
74.2%
70.7%
94.9%
86.5%
82.9%
18-Month Rates – OAS
50% 60% 70% 80% 90% 100%
Rutherford 6
Rutherford 4-5
Rutherford 2-3
Amputation Free Survival
94.9%
82.5%
75.1%
FF = Freedom From. * All Death rate shown here is at 18 months, but the Freedom from MAE (shown on
left) only includes death within 30-days of the procedure. Amputation free survival defined as freedom from
death and target limb major amputation.
18 Month RC2-3 vs. RC4-5 RC2-3 vs. RC6 RC4-5 vs. RC6
Hazard Ratio P Hazard Ratio P Hazard Ratio P
MAE 0.56 [0.37, 0.84 0.006 0.46 [0.26, 0.81 0.008 0.82 [0.48, 1.41 0.479
MAE rate differences assessed via Cox Proportional Hazards model [MAE: Death to 30 days, Major
amputation, TVR]. Kaplan-Meier method used to obtain estimate rates. Greenwood’s method used to
obtain the 95% confidence interval for the estimate.
30-Oct-2017 Data
63.9%
70.4%
80.9%
Obital AtherectomyConclusion
• Excellent procedural safety.
• Unique mechanism for managing tibial calcification.
• More responsive to angioplasty.
The role of orbital atherectomy for optimization of BTK
revascularization results
Peter A. Schneider, MDHonolulu, Hawaii
