Three-year results from a recently published prospective, multicentre trial using the VNUS ClosureFast catheter (Covidien) have demonstrated clinical efficacy and improvement in quality of life for patients treated for varicose veins. Also, laser options are expanding with a new laser system, VenaCure (Angiodynamics) 1470nm laser, being launched at CX33. Recent randomised trials comparing the two modalities with short-term follow-up data have shown comparable results for efficacy.
Thomas Proebstle, Mannheim, Germany, presented the three-year results and exclusively told CX Daily News, “We now have solid data to support the statement that the days of cross ligation and stripping are over. We have such high success rates, good durability of results and a gain in quality of life from pre-procedure impairment compared to traditional surgery, that we need to shift to endovenous approaches of treatment.
“Obviously this type of treatment does not need to be performed in a theatre or hospital, which improves its cost-effectiveness. It can be performed in a modern office with excellent medical facilities, in an outpatient setting.”
Proebstle said that compared to all of the other current technologies such as laser, foam sclerotherapy and the new kid on the block, superheated steam, ClosureFast is the only one with solid mid-term follow-up. “It is the only one combining the highest efficacy with such a smooth side-effect profile. All the other technologies at the moment lack the proof that they can deliver this smooth side-effect profile, and this needs to be proved in randomised studies,” he said.
Shift in principle
Proebstle said, “After ClosureFast, the system which delivered high frequency current into the vein wall, there was a subsequent system developed which no longer delivered current to the tissue, but only heated the coil. So from a current-induced heat generated within the tissue, there was a shift in principle to heat conduction only. The catheter here is actually nothing but very expensive single use water heater. With this type of radiofrequency- powered catheter, we observe that pigmentation is a rare event and at three year follow-up, only one out of nearly 300 limbs showed persistent pigmentation.”
He explained that the three-year follow-up results were from a study of patients treated with the ClosureFast catheter at eight European centres. In the study, 295 greater saphenous veins (from 225 patients) were treated. The mean age of the patients was 50.5 + 13.5 years and 73.8% were female. The majority of the patients were CEAP C2 or C3.
All the patients were treated in an outpatient setting, under local anaesthesia and the protocol of heat delivery was two treatment cycles immediately below the saphenofemoral junction, and one treatment cycle subsequently thereafter. Combined procedures were allowed only at calf level, but not at the thigh.
“Clinical and duplex examination took place at three days during the first week, at three months, six, 12, 24 and 36 months we had a data retrieval rate of 86–87%, if you refer to patients and limbs treated respectively after three years,” he explained.
Proebstle said, “These data include the first-in-man treatment up to the first 295 patients, so this paper actually includes the learning curve for this procedure.
Anybody will know that if you have very good results including in the learning curve period, such a technology could be seen as ‘idiot-proof’.”
Proebstle said, “The initial ablation success rate with VNUS Closure Fast is 100%. Only five of 256 (2%) limbs showed axial reflux 36 months after the procedure and as such radiofrequency segmental thermal ablation shows a high efficacy coupled with a very moderate side effect profile. At baseline, 41.1% of limbs were free of pain. At 24 months, 99.3% (n=278) reported no pain, and between12–24 months, 96.4% (n=270) had no pain.”
He told delegates that at 36 months, 98.0% (n=251) reported no pain, and between 24 to 36 months, 95.7% (n=245) had no pain.
In addition to clinical efficacy, the study has shown a venous clinical severity score reduction at three-year follow-up. “Overall score improved for 256 legs available at 36 months from 3.9 ± 2.1 at baseline to 0.9 ± 1.1 at 36 months, p
The three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation is scheduled for publication in the Journal of Vascular Surgery in 2011.
Responding to a delegate who stated that he frequently saw large veins and asked what the upper limit of the diameters of veins treated in Proebstle’s study was, Proebstle replied, “In this series, the upper limit did not reach the 2cm diameter, but in such cases of large veins you can use this system repetitively. You do not have to adhere to two cycles, you can use three or four cycles for big diameter veins. This is safe, even though it has not been published.”
Alun Davies, London, UK, then said “the reality is that you have just convinced us that VNUS is not as straightforward as it is being sold to us. We all use variations in how we treat a segment, so it is no longer a standard treatment. Do you agree with that?”
Proebstle replied, “I agree that in situations not covered in the study, in extreme situations with large diameters, there may be a necessity for dose adjustment.”
Davies also asked for Proebstle’s thoughts about seeing more pigmentation in severe disease. Proebstle then said that in more severe disease, there was a possibility of an increase seen in the side-effects profile, but clarified that in this study several cases with severe disease were included.
Lowell Kabnick, New York, USA, then asked on what basic scientific evidence the proximal two-cycle protocol was based. He said, “My research has shown that there is just a 1mm difference in coagulation zones between one and two cycles. It really has to do with wall thickness rather than the size of the vessel.”
However, Proebstle argued that it was to do with the size of the vessel and that this was based on “biophysics, like water running down a hill”.
New VenaCure 1470 laser ablation system launched at CX33
AngioDynamics has launched a new laser system for endovenous laser ablation of varicose veins at CX33. The new VenaCure 1470nm laser operates at a peak on the water absorption curve. The VenaCure 1470nm laser is a water-specific laser, meaning it damages the intima, or inner most layer of the vein, by targeting water as the chromophore to absorb the laser energy.
Since the vein structure is mostly water, this laser is able to efficiently heat the vein with little chance of collateral heating, resulting in an optimal vein ablation.
The VenaCure 1470nm laser is designed to work exclusively with AngioDynamics NeverTouch fibre ablation kits, maximising these two technologies and resulting in even better patient outcomes.
A company release says that current clinical evaluations demonstrate clinical efficacy superiority with laser versus other modalities. Post-operative pain and bruising studies combining the VenaCure 1470 laser and NeverTouch fibre are currently running in Europe. AngioDynamics said it strongly believes that the new system provides the clinician and patient with the optimal combination for the minimally invasive treatment of varicose veins.
The new VenaCure 1470 laser has received the CE mark. A 510k application has been submitted to the FDA.
Yesterday, more than 300 delegates participated in the CX Office-based Vein Practice Course.