VenaSeal (Sapheon) Closure System
What does this Vein Glue do?
The most recent innovation in the treatment of varicose veins is the use of medical glue known as VenaSeal (cyanoacrylate) to physically shut down and seal the main defective vein.
VenaSeal Adhesive (Glue), previously known as “Sapheon Glue”, is a safe, medical grade glue that is used to shut the main Saphenous Vein in the thigh. Once the vein has been glued shut, it will undergo a process of hardening (referred to as Sclerosis) and will be gradually absorbed by the body. The procedure is very safe and minimally invasive.
The VenaSeal Procedure involves the placement of a very small amount of VenaSeal Medical Glue into the vein through a small catheter. Once the affected vein is closed, blood is immediately re-routed through other healthy veins in the leg. Unlike other treatments, VenaSeal does not require a Regional Nerve Block or large volumes of Anaesthesia. Furthermore, there are no pre-procedures drugs involved and patients can return to their normal activities right after the treatment. Unlike heat-based procedures such as Endovenous Laser or Radiofrequency Ablation, with VenaSeal there is no risk of skin burns or nerve damage. VenaSeal does not require any immediate post-treatment pain medication or uncomfortable compression stockings.
How Effective is the VenaSeal Procedure?
The published success of the VenaSeal Closure Procedure is up to 98.9% (VeClose Study), with far fewer complications than EVLA or surgery.
VenaSeal has been meticulously trialed in the United States and Europe over the last 5 years. Results published show a low risk of complications and excellent medium-term results. The VeClose Study out of Germany, showed a 98.9% closure rate at 6 months. VenaSeal is considered as effective as Endovenous Laser Ablation but does not involve the use of heat and can therefore be performed with the application of a small amount of local anaesthetic as opposed to a Nerve Block or large volumes of Tumescent Anaesthetic.
It is possible to treat two or more veins in the one session. Stockings are usually not necessary and patients are able to return to normal activities immediately. Surface Varicose Veins are usually treated 2-4 weeks after the VenaSeal Procedure with either Ultrasound Guided Sclerotherapy or Ambulatory Phlebectomy.
What to expect from the VenaSeal Procedure:
- A duplex ultrasound is used to map out your vein.
- Local anaesthetic is then applied to a small area in the lower leg.
- A thin catheter is inserted through a tiny entry point, usually near the knee.
- VenaSeal Glue is then injected through the catheter using a special applicator and into the vein.
- Small amounts of glue (0.1 mls) are injected every 3 cm along the length of the vein.
- A stocking is not required following this procedure. Patients will be instructed to get dressed and will be given all the necessary Post Operative Instructions.
- Walking immediately after the procedure is encouraged. Normal daily activity can be resumed right away - just avoid rigorous activities such as gym workouts.
- There may be minor soreness in the thigh. Usually this can appear a few days to a few weeks later, and should not be a concern. Any discomfort can be treated with over-the-counter, non-steroidal anti-inflammatories only after consultation and discussion with Dr Paraskevas.
As with EVLA, patients often ask if the procedure is painful - the answer again is NO! A small amount of anaesthetic at the entry point is all that is required. Beyond this point, patients will not feel any pain or discomfort. Please ask Dr Paraskevas about further details.
What is Venaseal made of?
As you may already know, Venaseal is a treatment that involves the application of a Medical Grade 'Superglue' into the disease vein, that collapses and permanently seals the vein off. It is a quick, minimally invasive and completely painless procedure that takes approximately 15 minutes in experienced hands.
Venaseal adhesive is a special type of medical super-glue referred to as a 'Cyanoacrylate'. It is very carefully formulated in specially designed labs and has some unique properties when compared to other medical grade glues on the market.
- When it comes into contact with blood within the vein wall, it polymerises rapidly. What this means is that it rapidly seals the vein shut upon application, with minimal migration.
- It is very soft and elastic, so that it is undetectable by the patient after application.
- Has an “anti-microbial” effect against gram positive organisms.
- Has been shown to be extremely safe on administration with no adverse long term effects.
Cyanoacrylates have been in use since the 1950s. They have been used in repairing wounds and skin incisions. As an emergency doctor, one of our “go to” treatments for children with lacerations was “Histoacryl Blue skin adhesive”. It was quick and painless and avoided the need for suturing, particularly when faced with a distressed and alarmed child.
It has also been used in the following areas of medicine:
- Ophthalmic surgery
- Cosmetic Procedures
- Intravascular Occlusion of Cerebral Arterio-Venous Malformations (AVMs), Varicoceles and Pelvic Congestion Syndrome and Gastric Varices.
Frequently Asked Questions:
How does VenaSeal work?
VenaSeal Glue is placed into the vein through a fine catheter and rapidly seals the vein shut.
Is loss of the vein a problem?
No. After treatment, the blood in the faulty veins will be diverted to the many normal veins in the leg.
Am I at risk from the VenaSeal Glue?
No. The glue has been trialed and tested in other areas of medicine for decades. It has been recently been the centre of large trials which show it be both safe and effective. The glue does not have any harmful effects to the body.
How successful is the VenaSeal Procedure?
Published clinical studies show that VenaSeal has an initial success rate of between 94% and 98.9% (6 months post treatment) with excellent long-term results. (The eScope study showed closure rate of 94.3% at 6 months and 92.9% at 12 months. The VeClose study showed closure rate of 98.9% at 6 months)
Further Patient Information - VenaSeal
*Click on headings to expand/contract
- Minimal discomfort as there is no need for injection of Tumescent Anaesthetic along the course of the vein.
- No need for compression stockings.
- Minimal time off work
- Return to Normal Activities
- No admission to hospital or General Anaesthesia
- No chance of Nerve Damage or Thermal Injuries
- Treated Veins may become quite inflamed and require Anti-Inflammatories and time to settle. This is however, no different to Endovenous Laser Treatment of Veins.
- VenaSeal is not covered by Medicare currently and is quite an expensive procedure.
- Do not cease medications prior to treatment unless otherwise advised.
- Do not shave your legs immediately prior to your treatment.
- Do not apply moisturizer on the day of treatment.
- Wear slacks or loose trousers to the appointment and ensure you have a pair of comfortable walking shoes.
- Pre-medication is generally not necessary. If you have a low pain threshold, take 2 paracetamol tablets or 2 Ibuprofen tablets (with food).
- Our Nurse will discuss all the important post treatment instructions in great detail and provide you with a Post Instruction Sheet.
- You will be directed to go for an immediate 10 minute walk before you drive home. As long as you are able to walk unaided without restriction, you are allowed to drive home.
- You will be given Dr Paraskevas’ after hours number should you have any problems or concerns.
- Walking for 10-15 minutes per day is advised.
- Maintain normal daytime activities but avoid standing still for long periods of time.
- Continue with normal exercise activities within 48 hours.
- You will be asked to avoid long haul flights (>4 hours of continuous travel) for at least 3-4 weeks after the treatment. If travel is unavoidable, then you will be protected from Deep Vein Thrombosis with Subcutaneous Low Molecular Weight Heparin (aka Clexane) during your travel.
- An ultrasound check of the treated veins will occur 2 weeks after the treatment. This is to assess the outcome of the treatment and also to exclude the very low chance of deep vein occlusion.
The following symptoms are expected.
- Mild to moderate pain persists for 1-2 weeks along the glued vein. Post VenaSeal discomfort should be managed with a combination of light walking and rest (with leg elevation), anti-inflammatory medication such as Nurofen or Voltaren.
- Phlebitis or inflammation may occur along the inner thigh in line with the treated vein. This is again managed with anti-inflammatories and stockings. Dr Paraskevas must be contacted if this occurs.
- Paraesthesia (skin numbness) – has been reported in some studies and is thought to be a result of inflammation around the treated vein temporarily affecting surrounding nerves.
Complications can occur even with perfect technique.
- Deep vein thrombosis. Internal Vein clots are extremely rare following VenaSeal treatments. Pulmonary Embolus, is also very rare.