Disclosure · ClosureFast RF vs Laser Ablation Shepherd et al, Br J Surg 2010 127 patients...
Transcript of Disclosure · ClosureFast RF vs Laser Ablation Shepherd et al, Br J Surg 2010 127 patients...
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Disclosure
Lowell Kabnick, M.D., FACS, FACPh
I disclose the following financial relationship(s):
•Research Grant: BTG;
•Ownership Interest: AngioDynamics, Vascular Insights;
•Consultant/Advisory Board: AngioDynamics, BSN Jobst,
Vascular Insights
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Lasers and Radiofrequency
Catheters to Achieve GSV
Closure
Lowell S. Kabnick, MD, FACS, FACPhNYU Langone Medical CenterDivision, Vascular SurgeryApril 9, 2011
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Basic principles for
endovenous ablation
Collagen triple helix molecule
HEAT
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Endothermal Injury
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LASERS
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810nm 940nm 980nm
1319nm 1320nm 1470nm
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Ultrasound Mapping
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Preparation of the Patient
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Percutaneous Insertion
Supplies
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Laser Kit
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Local Anesthesia
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Insertion of 21 g Needle
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Ultrasound-Guided Vein Access
Needle
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Insertion of Micropuncture
018” Wire and Sheath
Image courtesy of
Olivier Pichot, MD
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Insertion of 035” Guide Wire
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4Fr Sheath and 600 micron
Fiber
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Locking Device
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Tumescent Anesthesia
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Recheck Fiber Position
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Laser Pullback
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Covered Fibers
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360 Fiber
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Radiofrequency
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Set up
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Local Anesthesia (skin)
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21g needle USG Insertion
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RFA Fast
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RF FAST Catheter
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RFA
Design and Mode of Action
RF Energy heats Catheter tip (7cm heating element) to 120° C
Conductive Heat Transfer from heating element to vein wall achieves temperatures of 100-110°C
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ClosureFAST Animation
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Class 2 Compression Hose
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Consultant
AngioDynamics
BTG
VeinWave
Advisory Board
AngioDynamics
Vascular Insights
Royalty
TreSheath
RF
Laser
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Complications related to vein wall perforation
Fiber improvements purported to reduce perforation
Jacketed fibers (metallic or ceramic)
Radially firing fibers
Targeted water vs hemoglobin specific wavelengths
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Systematic review/meta-analysis commissioned by SVS/AVF
Surgery, radiofrequency & laser ablation, sclerotherapy
39 comparative trials
8285 patients
No water based lasers available for direct comparisons of laser vs RF .
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ClosureFast RF vs Laser AblationAlmeida et al, J Vasc Interv Radiol 2009
87 patients randomized to RF vs 980 nm laser
100% saphenous occlusion at 4 weeks
1 and 2 week QoL (CIVIQ) better with RF
p ≤ 0.002 at 48 hrs, 1 & 2 weeks
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ClosureFast RF vs Laser AblationShepherd et al, Br J Surg 2010
127 patients randomized
EVLA – 980 nm bare fiber (n = 61)
ClosureFAST RF (n = 67)
General anesthesia with concurrent phlebectomy
RF ablation associated with
Less pain at 3 days (mean 26.4 vs 36.8, p = .012)
Less pain at 10 days (mean 22.0 vs 34.3, p = .001)
Less analgesics (20.4 vs 35.9 tablets, p = .001)
No differences in
Return to work or usual activities
Quality of life (AVVQ, SF-12) at 6 weeks
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RFF Occlusion Rate at 3 Years - 92.9%
Kaplan Meier Analysis
0 5 10 15 20 25
100
99
98
97
96
95
94
93
92
Time (months)
Occ
lusi
on
Rate
(%
) 1 month
99.7%
n=337 6 Months
98.5%
n=317
1 Year
96.4%
n=286
2 Year
94.7%
n=286
30 35 40
3 Year
92.9%
n=255
Courtesy Alan Dietzek
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ComplicationsFollow-up Time Point All Time 2 Year 3 Year
Post Treatment n = 396 n = 267
Ecchymosis 21 (5.3%) 0 (0.0%) 0 (0.0%)
Erythema 9 (2.3%) 0 (0.0%) 0 (0.0%)
Hematoma 4 (1.0%) 0 (0.0%) 0 (0.0%)
Paresthesia 16 (4.0%) 1 (0.3%) 1 (0.3%)
Phlebitis 6 (1.5%) 0 (0.0%) 1 (0.3%) 1
Skin Pigmentation 12 (3.0%) 1 (0.3%) 0 (0.0%)
Thermal Skin Injury 0 (0.0%) 0 (0.0%) 0 (0.0%)
Thrombus Extension / DVT2 6 (1.5%) 0 (0.0%) 0 (0.0%)
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Water-based Lasers
1320nm 1470nm
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1320nm
1320nm Vs. 810nm split leg study:
LEED=80j/cm
Results:
Less Pain and Bruising 1320nm
Mackay EG, Almeida JI, Raines JK. Do different laser wavelengths
translate into different patient experiences? Endovascular Today.
2006 March:45-48.
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1470nm
Almeida JI, Mackay EG, et al. Saphenous laser ablation at 1470 targets the vein wall, not blood.
21st AVF. Phoenix, AZ. February 2009.
41 GSV 30.7 J/cm with 100% closure
All with minimal side effects
? Durability of the Closure
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Pilot Studies
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Laser Covered-tip Vs RF
85 patients completed treatment and follow-up
examination
43
Modality # PatientsAverage
AgeFemale/Male %
Average Length Treated
(cm)
Average Total J/cm
Average Pain
Average Bruise
Total GSV Closed
980-nm 3551.57 ±
13.7F=86% M=14%
27.6782.34 ±
14.7 0.906 1.21 35
RF 5056.36 ±
15.4F=80% M=20%
35.90 N/A 0.804 1.34 50
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1470 nm Vs. 810 nm
Wavelength n Power
(W)
joules
/cm
Pain (7 day
average)
Bruising
810 nm 52 14 80 1.70 1.42
1470 nm 36 6 45 1.25 0.87
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Conclusion
Both Laser and RF:
Excellent procedures
Durable results
Minimal number of complications
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ClosureFast RF vs Laser AblationAlmeida et al, J Vasc Interv Radiol 2009
ComplicationClosureFAST
(n=46)
Laser
(n=41)p
Phlebitis 0 6 (14.6%) .009
Erythema 0 4 (9.8%) .045
Paresthesia 1 (2.2%) 2 (4.9%) .06
Thromboembolism 0 1 (2.4%) .47
Pigmentation 1 (2.2%) 0 > .99
Infection 0 0 -
Total 2 (4.4%) 9 (22%) .02
Complications