It is said that as many as one in three adults in the UK suffers from venous reflux and / or varicose veins at some point in their life, and varicose vein treatment is one of the most common hospital procedures. Almost 90,000 varicose vein operations were carried-out by the NHS in 2005-06 (Source: Hansard), whilst approximately 20,000 similar operations were conducted privately (Source: Univ. of Birmingham) producing a total of around 110,000 procedures per year. As long ago as 1999, a study conducted by the University of Edinburgh, put the total cost to the NHS at between £400m and £600m.
It is difficult to compare accurately the direct costs of conventional surgery and VNUS Closure, but as the procedure is carried out under local anaesthetic without an overnight stay, and performed with minimal staff in a simple treatment room, it is clear that, by freeing-up staff and hospital operating theatres and reducing both treatment and recovery times, this technique offers significant benefits for the NHS. Cost savings are estimated to be between £40 and £450 per patient, depending on whether or not the patient requires an overnight stay.
There are wider economic benefits too, with patients being able to return to work almost immediately after their procedure with little or no pain.
The VNUS Closure system consists of a radiofrequency (RF) generator and disposable single-patient use catheters. The radiofrequency generator delivers RF energy to the catheter, enabling controlled vein lumen contraction. Temperature and power are continuously monitored for optimal performance. A simple and intuitive user interface, combined with a large, colour screen and optimised internal software, helps make the procedure easy to administer.
The catheter runs over a .025 guide-wire and is controlled by the Surgeon with a built- in energy delivery control switch. The catheter’s unique Segmental Ablation Technology delivers controlled radiofrequency energy to the vein wall. Unlike other endovenous ablative methods, that depend on a manual pull-back method, this catheter delivers in seven centimeter segments whilst the catheter is stationary. Segmental Ablation Technology thus eliminates problems of uncontrolled and inadequate energy delivery with too slow or too fast pull-back.
VNUS Closure® and VNUS RFG Plus™ are registered trademarks of VNUS Medical Technologies, Inc.
The key benefits for patients are a hospital stay of just a couple of hours, treatment under local rather than general anaesthetic and a much faster recovery time; patients can usually walk out of the treatment room unaided and are usually able to return home and resume work within a day with little or no pain.
The major benefits for the NHS lie in the fact that this procedure is much less resource-intensive than surgery. Conventional varicose vein stripping is a common operation, taking-up a great deal of operating theatre time. Because the VNUS Closure procedure can be carried-out in a treatment room, it has the potential to free-up theatre-time, enabling the NHS to treat other serious conditions more quickly and so reduce waiting-times.
A recent US study, commissioned by VNUS Technologies, compared the VNUS Closure procedure with another non-invasive treatment option - Endovenous Laser Ablation ( EVL or EVLT). This ‘head to head’ randomised controlled trial, found that VNUS Closure patients experienced significantly less pain, less bruising and fewer complications than those treated with endovenous laser.
Eur J Vasc Endovasc Surg. 2010 Jul 22. [Epub ahead of print]
Vein Thrombosis (DVT) after Venous Thermoablation Techniques: Rates of
Endovenous Heat-induced Thrombosis (EHIT) and Classical DVT after
Radiofrequency and Endovenous Laser Ablation in a Single Centre.
Marsh P, Price BA, Holdstock J, Harrison C, Whiteley MS.
The Whiteley Clinic, 1, Stirling House, Stirling Road, Guildford GU2 7RF, UK.
vein thrombosis (DVT) after varicose vein surgery is well recognised.
Less well documented is endovenous heat-induced thrombosis (EHIT),
thrombus extension into a deep vein after superficial venous
thermoablation. We examined the rates of DVT in our unit after
radiofrequency (RFA) and endovenous laser ablation (EVLA) with specific
attention to thrombus type.
analysis of all cases of RFA under general anaesthesia and EVLA under
local anaesthesia was performed. Cases of DVT were identified from the
unit database and analysed for procedural details.
total, 2470 cases of RFA and 350 of EVLA were performed. Post-RFA, DVT
was identified in 17 limbs (0.7%); 4 were EHIT (0.2%). Concomitant small
saphenous vein (SSV) ligation and stripping was a risk factor for
calf-DVT (OR 3.4, 95%CI 1.2-9.7, P=0.036), possibly due to an older
patient group with more severe disease. Post-EVLA, 4 DVTs were
identified (1%), of which 3 were EHIT (0.9%).
DVT rate including EHIT was similar in patients treated with RFA and
EVLA and was low. Routine post-operative duplex ultrasound scanning is
recommended until the significance of EHIT is better understood, in
accordance with consensus guidelines. DVT rates for both techniques
compare favourably with those published for saphenous vein stripping.
PMID: 20655773 [PubMed - as supplied by publisher]
One-year outcomes of radiofrequency ablation of incompetent perforator veins using the radiofrequency stylet device.
Marsh P, Price BA, Holdstock JM, Whiteley MS.
The Whiteley Clinic, 1 Stirling House, Stirling Road, Guildford, GU2 7RF, UK. firstname.lastname@example.org.
OBJECTIVES: Early success treating incompetent perforator veins (IPVs) with radiofrequency ablation (RFA) and the trend to move varicose vein surgery into a walk-in walk-out service led to the design of a specific device enabling RFA of IPVs using local anaesthesia (ClosureRFS stylet). Our aim was to assess one-year outcomes of a clinical series of patients undergoing treatment with this device. Truncal reflux, where present, was treated initially, and RFA of IPVs was performed as a secondary procedure. METHOD: Duplex ultrasound examinations were performed and the presence of IPVs documented. Results were compared with preoperative scans. IPVs were classified as closed, not closed/reopened or de novo. RESULTS: Of the 75 patients invited for follow-up, 53 attended at a median time of 14 months (range 11-25). Sixty-seven limbs were analysed (M:F 1:2.1, median age 62, range 25-81). Of the 124 treated IPVs, 101 were closed (82%). Clinical, aetiological, anatomical and pathological clinical score was improved in 49.3% limbs. IPV closure was reduced in patients with recurrent varicose veins compared with primary varicose veins (72.3% versus 87%, P = 0.056). CONCLUSION: These results demonstrate the radiofrequency stylet device to be an effective treatment for IPVs.
PMID: 20348454 [PubMed - indexed for MEDLINE]
Vasc Endovascular Surg. 2009 Dec; vol. 43(6) pp. 567-70
Effect of saphenous vein diameter on closure rate with ClosureFAST radiofrequency catheter.
Calcagno D, Rossi JA, Ha C
PURPOSE: Radiofrequency ablation (RFA) of veins >12 mm in diameter has been a controversial subject since the first-generation device was submitted for Food and Drug Administration (FDA) approval. Veins >12 mm were excluded in the initial study. Many insurance carriers used >12 mm size as reason to not approve the procedure. As the concept of tumescent anesthesia was better communicated, RFA was used for large veins. The 12-mm size limit was not used in the studies for the newer ClosureFAST catheter approval, yet remains in force with some insurance companies. Our objective was to determine whether vein diameter >12 mm had effect on closure rates with the Closure-FAST catheter. METHODS: ClosureFAST RFA was used to eliminate saphenous reflux in consecutive cases in 1 center. Retrospective analysis was performed on prospectively gathered data. Veins were divided into < or =12 mm diameter (group A) or >12 mm diameter (group B). Duplex scans were scheduled for 2 to 5 days and 6 months postprocedure. RESULTS: A total of 338 great and small saphenous veins were treated, 246 saphenous veins in group A (mean 8 +/- 2 mm) and 96 in group B (mean 17 +/- 4 mm). Early duplex showed complete closure in 231 veins in group A (94%) and 92 veins in group B (96%; NS). The remaining veins showed partial closure with none showing retrograde flow. Six-month duplex scans were completed in 155 veins. Complete closure was seen in 110 veins in group A (98%) and 43 veins in group B (100%; NS). All veins partially open on early scan had closed by 6 months. The 2 veins open at 6 months in group A were closed on initial scan. CONCLUSIONS: Vein diameter >12 mm had no effect on closure rate with the ClosureFAST catheter.
URL - http://www.ncbi.nlm.nih.gov/pubmed/19828586?dopt=Citation
Ann Vasc Surg. 2010 Apr; vol. 24(3) pp. 360-6
Radiofrequency-powered segmental thermal obliteration carried out with the ClosureFast procedure: results at 1 year.
Creton D, Pichot O, Sessa C, Proebstle TM, ClosureFast Europe Group
This prospective and multicenter study shows the results at 1 year of radiofrequency-powered segmental thermal obliteration (RSTO) carried out with the ClosureFast procedure. The RSTO clinical and duplex ultrasound imaging results were evaluated at 3 days, 3 months, 6 months, and 1 year. All procedures were carried out on outpatients under tumescent local anesthesia. Among the 295 members who were treated, 289 were reexamined at 3 days, 290 at 3 months, 289 at 6 months, and 220 at 1 year. Occlusion scores were 99.7%, 99.3%, 98.6%, and 96.9% at, respectively, 3 days, 3 months, 6 months, and 1 year. At 3 cm below the saphenofemoral junction, before the procedure, the greater saphenous vein (GSV) diameter was 5.4+/-2 mm (range 2-18). It decreased to 4.5+/-1.7 mm at 3 days, 2.4+/-1.5 mm at 6 months, and 1.3+/-0.9 mm at 1 year. In members reexamined at 1 year, the decrease in diameter of the treated vein compared with the preprocedural measurement was 79% (p<0.001, t-test). At 1 year, in 58% of the cases, duplex ultrasound imaging at mid-thigh level could not show the GSV trunk. Preprocedural pain that was present in 57.5% of the cases decreased to 10.8% of the cases at 3 days and 2% of the cases at 1 year (p<0.001, chi2 test). Among the treated limbs, 70.1% did not present with any postprocedural pain at any time of the follow-up. On the third day, the patients evaluated the mean pain intensity at 0.7+/-1.6 on a visual analog scale of 0-10. During the follow-up, no painful indurations were noticed in 67.7% of the legs. No thromboembolic complications were reported. Paresthesias were observed in 3.4% of the cases. Invalidity clinical score, evaluated at 3.9+/-2 before the procedure, decreased to 3.5+/-1.2 on the third day, 0.9+/-1.5 at 3 months, 0.7+/-1.2 at 6 months, and 0.5+/-1.1 at 1 year. This study confirms the efficacy of RSTO when using ClosureFast, which allows obliteration of the GSV trunk in 97% of cases at 1 year with few side effects and almost no postprocedural pain.