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
Transcript of Disclosure · ClosureFast RF vs Laser Ablation Shepherd et al, Br J Surg 2010 127 patients...
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
Lasers and Radiofrequency
Catheters to Achieve GSV
Closure
Lowell S. Kabnick, MD, FACS, FACPhNYU Langone Medical CenterDivision, Vascular SurgeryApril 9, 2011
Basic principles for
endovenous ablation
Collagen triple helix molecule
HEAT
Endothermal Injury
LASERS
810nm 940nm 980nm
1319nm 1320nm 1470nm
Ultrasound Mapping
Preparation of the Patient
Percutaneous Insertion
Supplies
Laser Kit
Local Anesthesia
Insertion of 21 g Needle
Ultrasound-Guided Vein Access
Needle
Insertion of Micropuncture
018” Wire and Sheath
Image courtesy of
Olivier Pichot, MD
Insertion of 035” Guide Wire
4Fr Sheath and 600 micron
Fiber
Locking Device
Tumescent Anesthesia
Recheck Fiber Position
Laser Pullback
Covered Fibers
360 Fiber
Radiofrequency
Set up
Local Anesthesia (skin)
21g needle USG Insertion
RFA Fast
RF FAST Catheter
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
ClosureFAST Animation
Class 2 Compression Hose
Consultant
AngioDynamics
BTG
VeinWave
Advisory Board
AngioDynamics
Vascular Insights
Royalty
TreSheath
RF
Laser
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
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 .
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
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
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
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%)
Water-based Lasers
1320nm 1470nm
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.
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
Pilot Studies
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
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
Conclusion
Both Laser and RF:
Excellent procedures
Durable results
Minimal number of complications
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
