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VnUS Closure and Foam Sclerotherapy

VNUS Closure:

VNUS Closure is a surgical technique similar to EVLT. The vein is treated in the same way as during EVLT but using a different type of energy – it uses radiofrequency rather than lasers. The first type of VNUS treatment used to take quite a long time to do and required a general anaesthetic but recently a newer version has been developed which is faster and seems to do the job in a very similar way to EVLT although it is more expensive.

The authors of this website prefer using the EVLT laser rather than the VnUS system for the following reasons:

• Early results suggest that there is a higher rate of recurrence after VnUS closure compared to EVLT lasering
• There have been some concerns that there is a high rate of Deep vein thrombosis and pulmonary embolus after VnUS closure than EVLT. These are serious complications that can result in significant injury to the patient or in death. The following paragraph is taken from the latest annual report of the company that makes the VnUS closure device:

‘….regulations require us to report to the FDA if our products cause or contribute to a death or serious injury or if they malfunction. As of December 31, 2007, we have submitted 114 medical device reports. In 52 cases, a thrombus, or blood clot, was noticed at varying lengths of time after our Closure procedure was performed. In 17 cases, the patient developed a pulmonary embolism, 13 of which related to the Company’s ClosurePLUS catheter, and 4 related to the Company’s ClosureFAST catheter. We are aware of three patient deaths following treatment with our catheter, all of which are believed to be a result of pulmonary embolism……, it is possible that claims could be made against us alleging that our products are defective or unsafe. Our failure to comply with applicable regulatory requirements could result in an enforcement action by the FDA, which could include any of the sanctions set forth below. In addition, the identification of serious safety risks could result in product recalls or withdrawal of our clearance or approval. The imposition of any one or more of these penalties could have a negative effect on our business, product sales and profitability.’ [VnUS Medical Technologies inc annual report March 14 2008]

• There are some technical differences between the lasering and the VnUS technique which lead us to favour the EVLT procedure – we think EVLT is more versatile to use.

 Foam Sclerotherapy:

• Foam sclerotherapy is a technique where a chemical is mixed with air to make a foam. The foam is then injected into a varicose vein. The chemical in the foam causes the vein to be burned on the inside and this makes the vein close down and blocks the passage of blood through it. The vein needs to be compressed by bandages and stockings for several weeks after the injections.
• Foam sclerotherapy can be used to treat big varicose veins but we think that it is not as effective as EVLT when used in this way because the veins do have a tendency to come back. A recent review of the technique has suggested that it works in about 68% of cases compared to 98% for EVLT.

FOAM SCLEROTHERAPY SOLUTION BEING MIXED UP BEFORE and USE BEING INJECTED INTO VARICOSE VEINS

POTENTIAL SIDE EFFECTS OF FOAM SCLEROTHERAPY:  

• The other problems with foam sclerotherapy include potential side effects of injecting air bubbles into the patient’s circulation. These can cause immediate side effects such as chest pain and there have been reports of patients having loss of vision after foam sclerotherapy. It is thought this is due to bubbles passing through the blood vessels at the back of the eyes. In addition, patients suffering from migraine headaches should not have foam sclerotherapy as this creates a very serious headache.  
• In the last few months, one of the major medical insurance companies (BUPA) in the UK has withdrawn approval for foam sclerotherapy to be carried out. The reason given for this was that they think the technique carries too many risks as outlined above.
• Foam sclerotherapy can also create a nasty mark on the skin (called skin staining). These marks are really bruises in the fine layers of the skin caused by blood leaking out of the vein after treatment. They do go away in time but can take several months to fade completely and some patients don’t like this.
• Having said that, foam sclerotherapy does work well to seal larger varicose veins and it is quite cheap when compared to some of the other surgical methods.
• Foam Sclerotherapy is certainly useful for treating any smaller varicose veins that might be left over after EVLT or other types of vein surgery.