การรักษาเส้นเลือดขอดด้วย เลเซอร์

1. Perform preprocedural DUS for mapping of the venous segments to be treated. Mark the course of the vein(s) to be treated and important anatomical landmarks associated with the ablation on the skin, including the proposed venous access site(s) and deep vein junctions. The access site is ideally at the inferior end of the incompetent segment or segments of the treated vein. In most cases, the entire incompetent segment(s) can be treated with 1 puncture. If microphlebectomy will be performed along with ELA, the veins to be removed should be marked at this time as well.
2. Prepare the operative tray and equipment. Aside from the thermal ablation device and a venous access kit, only basic supplies such as gauze, a sterilizing solution, sterile barriers, and the tumescent solution, with delivery syringes and needle and an ultrasound probe cover, are needed.
3. Carry out sterile preparation and draping of the leg to be treated. Preprocedural antibiotics are not necessary in almost all circumstances as the procedure is performed sterilely and is considered clean.
4. Visualize the access site with DUS. Placing the patient in a reverse Trendelenburg or partly sitting position prior to the venous puncture keeps the vein more distended and may facilitate venous access.
5. Anesthetize the access site. Nick the skin just large enough to facilitate entry of the sheath through the skin.
6. Insert the access needle into the great saphenous vein (GSV) under sonographic guidance. Use of a 21G puncture set, as discussed previously, is preferred particularly when the target vein is < 4 mm in diameter when supine. Cutdown is rarely needed and usually only if percutaneous access fails.
7. Place a 0.035-in guidewire into the vein.
8. Confirm intravenous placement with ultrasonography.
9. Place the introducer sheath over the wire.
10. Position the sheath for ELA to the starting point for ablation. Some physicians typically advance the ELA sheath beyond the starting point and later withdraw it with the laser fiber to the starting spot. The movement of withdrawal helps in to accurately identify the tip and position it at the starting point.
11. Remove the wire and its dilator if one is used with the sheath. Check for venous return by aspirating the syringe attached to the sheath and flush. Recognize that the sheath tip may be against the vein wall and may not aspirate freely. Also realize that when flushing, microbubbles of air introduced into the vein may produce an acoustic shadow that may limit the ability to see venous detail and device positions.
12. Introduce the laser fiber into the sheath so that the fiber reaches the sheath tip. There is generally a mark on the fiber to show this. Then fix the laser fiber and carefully pull back the sheath to expose about 2–3 cm of fiber. Then withdraw the entire sheath-laser fiber to the ablation starting spot.
Fine tune the location of the tip of the laser fiber to just below the superficial epigastric vein, anterior accessory GSV (AAGSV), or other large normal junctional vein for the GSV, and just below the thigh extension junction with the short saphenous vein (SSV) for SSV ablations. Some operators choose to position the laser fiber 1-3 cm below the saphenofemoral junction (SFJ) without consideration of the position of the junctional branches. No data support superiority of any of the above procedures in terms of ablation success, junctional recurrences, or common femoral vein thrombosis post procedure. See the image below.Longitudinal (sagittal) duplex ultrasound image of the saphenofemoral junction during the positioning of the tip of a laser fiber during an endovenous laser ablation. The laser tip is in the greater saphenous vein (GSV) just beyond the superficial epigastric vein (SEV) origin and is marked by the arrow. FV=femoral vein.
13. Connect the laser fiber to its generator and confirm that the tip is in the correct general location by viewing the visible light aiming beam that can be delivered into the laser fiber tip and visualized through the skin. This is an additional way to ensure that the tip of the laser is being visualized accurately and that the laser connections were made appropriately. If the light is not seen in the expected location, troubleshoot the position of the laser or the connection to the laser to understand why.
14. Administer tumescent anesthesia with ultrasound guidance after the patient has been placed into the Trendelenburg position to help drain the vein.
15. Place appropriate laser safety goggles on everyone in the procedure room and use other appropriate laser safety measures. Connect the laser fiber to the laser and verify proper laser settings. Setting recommendations vary, but aim to deliver at least 70–80 J/cm length of vein treated: at 14 W this is achieved with a pullback rate of 2 mm/s.
16. Set the laser to continuous mode and select the power to be used. Re-verify placement of the laser tip with ultrasound.
17. Activate the laser and withdraw the fiber and sheath at the speed that is dependent on the amount of energy you wish to deliver at the power setting selected with the laser in continuous mode. Many operators deliver 70-100 J/cm at 14 W in continuous mode at 810 nm throughout the length of the abnormal vein. For the GSV and AAGSV, the author uses more energy for the first 10-12 cm (140 J/cm) and less as the laser tip progresses lower down the leg (100 J/cm to the knee and 70 J/cm below the knee). This is done to ensure closure of the proximal vein segment just below the deep vein junction, where failure occurs most, and to decrease the risk of nerve injuries lower in the leg. For the SSV, the author uses about 112 J/cm for the first 3-4 cm, then 100 J/cm for the next 3-4 cm, and then 70 J/cm for the remaining vein.
18. Stop laser energy delivery at the distal aspect of the vein and place the laser in standby mode.
19. Remove the fiber/sheath from the vein. Be sure the entire fiber is removed to exclude the possibility of a fracture of the device intravascularly.
20. Record the watts, laser on-time, total joules delivered, and length of the segment treated. Calculate the withdrawal rate and joules delivered per cm to ensure you have reached the targets for successful ablation.

Technique considerations

The amount of thermal energy delivered is correlated to the success of ELA. With laser, energy deposition has been described as either that deposited per centimeter of vein length (J/cm) or as that deposited to the vein wall using a cylindrical approximation of the inner surface area of the vein (J/cm2), which can be considered a fluence equivalent. Durable vein occlusion was demonstrated in an observational series as more likely when the energy delivered exceeded 80 J/cm with a median observation of 30 weeks.[8] High rates of vein occlusion and ultimate DUS disappearance was noted in a series where the thermal dose in each segment of the GSV was tailored to the diameter in that segment. The ranges of energies used to achieve durable ablation included 50 J/cm for veins ≤4.5 mm and 120 J/cm for veins >10 mm in diameter. No increase in complications was seen with any of the higher energy strategies.[9]

To date, a prospective, randomized evaluation of the relationship of the different variables that can be controlled by the operator on the rate of anatomically successful vein obliteration and complication rates has not been performed. These variables include amount of laser energy deposition (J/cm or J/cm2), the rate of energy deposition (power setting), wavelength, and fiber design. Most combinations of treatments above the 70-80 J/cm seem to result in durable closure and some data support the notion that complications and adverse effects are not increased with energies up to 140 J/cm.

The differences between the current thermal ablation technologies are relatively small. Several retrospective analyses of observational data have demonstrated qualitatively similar occlusion and complication rates with a trend toward quicker treatments and better outcomes with ELA compared with the first generation RFA. In a study comparing Closure Fast (CF) and ELA, equivalent treatment times and anatomical success at 6 months were seen with slightly less immediate postprocedure bruising and postprocedure discomfort noted with CF.[10]

ELA bruising and discomfort have been thought to be less with continuous mode laser deposition than with pulsed mode. Limited data suggest that these side effects may be lessened with the use of a laser fiber with its tip covered with a glass cap and metal sleeve as opposed to a bare fiber. This effectively makes the fiber larger and presumably more coagulating than cutting. The prevention of wall contact produced by the jacket-tipped fibers results in less postprocedure bruising and pain in one study that evaluated 20 patients who were treated with bare-tip fibers and jacket-tip fibers.[11]

Excellent anatomic success of 90-100% occlusion rates has been shown for lasers with wavelengths between 810 and 1470 nm.[12] Recently, the 1470-nm radial laser fiber has been shown to have the lowest amount of postprocedure bruising, pain, parasthesia, induration, and superficial phlebitis due to the water-specific wavelength that is thought to directly act on the vessel wall.[13] Moreover, this study showed equivalent anatomic success of 99.6% closure at 1 year following use of the 1470-nm radial fiber.

Adverse events and complications

Adverse events following ELA occur, but almost all are minor. Ecchymosis over the treated segment frequently occurs and normally lasts for 7-14 days. About one week after ELA, the treated vein may develop a feeling of tightness similar to that after a strained muscle. This transient discomfort, likely related to inflammation in the treated vein segment, is self-limited and may be ameliorated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), ambulation, stretching, and graduated compression stockings. Both of these side effects are more commonly described after ELA using existing laser protocols than for RFA, but the differences in severity are very small when studied objectively.[10]

Superficial phlebitis is another uncommon side effect of ELA, being reported after about 5% of treatments as mentioned previously. There are no published reports of superficial phlebitis after ELA progressing to deep vein thrombosis and it has been managed in most series with NSAIDs, graduated compression stockings, and ambulation. Anecdotally, superficial phlebitis seems to be more common in larger diameter tributary varicose veins or in varicose veins that have their inflow and outflow ablated by ELA. Concurrent phlebectomy of these veins at the time of ELA has been recommended to decrease the risk of this side effect, but at this point no data substantiate this claim.

More significant adverse events reported following ELA include neurologic injuries, skin burns, and DVT. The overall rate of these complications has been shown to be higher in low-volume centers than high-volume centers. The nerves at highest risk include the saphenous nerve, adjacent to the GSV below the mid-calf perforating vein, and the sural nerve adjacent to the SSV in the mid and lower calf. Both of these nerves have only sensory components. The most common manifestation of a nerve injury is a paresthesia or dysesthesia, most of which is transient. The nerve injuries can occur with the trauma associated with catheter introduction, during the delivery of tumescent anesthesia, or by thermal injury related to heating of the perivenous tissues.

Tumescent anesthesia has been demonstrated to reduce perivenous temperatures with laser and RF ablation. The delivery of the perivenous fluid is felt to be responsible for the low rate of cutaneous and neurologic thermal injuries seen in the series of patients treated using perivenous fluid. Neurologic injuries are seen after truncal vein removal and are related to injury to nerves adjacent to the treated vein. The incidence of these adverse events are related to the degree to which objective testing is performed to identify them. In general, paresthesias caused by ELA are usually temporary with the rate of permanent paresthesias typically reported for GSV and SSV as 0–10%.

The one-week paresthesia rate following RFA was shown to decrease from 15% to 9% after the introduction of tumescent anesthesia. Patients treated with laser ELA performed without tumescent anesthetic infiltrations also demonstrated a high rate of such injuries. Evidence suggests a higher rate of nerve injuries when treating the below knee GSV as compared with the above knee segment and the SSV. Treatment of the below knee GSV or lower part of the SSV may be necessary in many patients to treat to eliminate symptoms or skin disease caused by reflux to the ankle.

A retrospective review demonstrated that below knee laser ablation can be performed with an 8% rate of mild but permanent paresthesias with adequate amounts of tumescent anesthesia. This data also suggests that sparing the treatment of the distal 5–10 cm may have clinical benefit and reduce saphenous nerve injury risk in patients with reflux to the medial malleolus. Skin burns following ELA have been reported. Skin burns are fortunately relatively rare and seem to be avoidable with adequate tumescent anesthesia. The rate of skin burn in 1 series using RFA was 1.7% before and 0.5% after the initiation of the use of tumescent technique during RFA. The early experience had rates as high as 4% that decreased to almost 0% as the use of tumescent anesthesia became a standard of practice.

DVT following ELA is unusual. DVT can occur as an extension of thrombus from the treated truncal vein across the junctional connection into the femoral or popliteal veins. The reported rates of junctional thrombosis following GSV ELA varies widely. This variability may relate to the time of the follow-up examination and the methods used. Most published series using early DUS (around 72 hours or less after ELA) document a proximal extension for the GSV around 1%.

The risk of venous thromboembolism (VTE) is higher in patients with a history of prior DVT or phlebitis, CEAP (clinical, etiological, anatomical and pathological) classification of 3 or greater, and male sex.[14] Endothermal heat-induced thrombosis (EHIT) defines the extent of superficial thrombosis and its extension into the deep venous system as proposed by Kabnick.[14] EHIT 1 represents thrombus up to the SFJ, EHIT 2 represents thrombus extending into the femoral vein occupying less than 50% of luminal diameter, EHIT 3 represents thrombus occupying greater than 50% of femoral vein luminal diameter, and EHIT 4 represents occlusive thrombus in the femoral vein. EHIT 1 is treated conservatively. If identified, EHIT 2 is usually treated with anticoagulation (full or prophylactic intensity are both used), although some advocate early re-examination and conservative care for more minor forms. EHIT 3 and 4, which are much less common, probably merit full anticoagulation.

Those performing the DUS at a later interval identify a lower rate of EHIT. Possibly, the rates are different for different operators with different protocols or the proximal extension of thrombus may be self-limited and may resolve by 1 month without a clinical event. Pooling data from several sources suggest that the incidence is approximately 0.3% after ELA. This type of DVT is almost universally asymptomatic. The significance of this type of thrombus extension into the femoral vein seems to be different from that found with native GSV thrombosis with extension or when compared with typical femoral vein thrombosis.

The incidence of junctional extension of thrombus after SSV ablation has also been described to be low (0-6%). In one study, the rate of popliteal extension of SSV thrombus at 2-4 days after ELA was related to the anatomy of the SPJ. The incidence at 48-72 hours of follow-up was 0% when no SPJ existed, 3% when a thigh extension exists, but 11% when no thigh extension could be identified just above the SPJ. Heparin was used to treat identified thrombus extensions and all regressed. No published data are available on conservative management of transjunctional thrombus extension at either the SPJ or SFJ. However, given that popliteal or femoral vein obstruction develops in significantly less than 1% of patients, including in those series where DUS is not done until 1 month after ELA, the practice of performing early DUS surveillance and aggressive anticoagulation of such findings is controversial.

Neovascularity at the SFJ after ELA, as a form of recurrence of varicose veins, seems to be rare at 1- to 3-year follow-up. Neovascularization was seen in only 2 of the 1222 limbs followed for up to 5 years in an industry-sponsored registry of patients treated with RFA. Longer follow-up may be necessary to feel confident with this observation. However, neovascularization is common and often an early event following high-ligation and stripping (HL/S). Neovascularization may be less common following endovenous procedures because the junctional tributary flow, which was usually ligated at their confluence with the SFJ, is generally not affected with GSV ELA.

Anecdotal reports of laser fiber fracture or retained venous access sheaths have been made to the device manufacturers and a case report exists describing a retained vascular sheath after laser ablation. Respecting the fragile glass laser fibers and being gentle with its handling should help minimize laser fiber fractures. The possibility of a laser fiber fracture should be considered with the removal of the device in each case. Care to deliver thermal energy only beyond the introducer sheath and away from any other parallel placed sheaths when treating 2 veins during the same procedure is essential to avoid severing segments of these catheters. No specific management recommendations of retained intravenous laser fiber or sheath fragments can be made based on the data. However, anecdotally, retained short segments of the distal end of the laser fiber seem to be well tolerated without incident and efforts to remove them may be more prone to adverse events than managing them conservatively.

A case report of an arteriovenous fistula (AVF) between a small popliteal artery branch near the SPJ and the SSV exists. Anecdotal references have been made of additional AVFs between the proximal GSV and the contiguous superficial external pudendal artery. Although thought to be related to a heat-induced injury caused by the thermal device, an AVF could be caused by a needle injury during tumescent anesthetic administration. Ways to minimize the risk of these AVFs include careful advancement of the intravascular devices, atraumatic delivery of the tumescent anesthetic, the use of copious amounts of tumescent fluid, and avoidance of treating the subfascial portion of the SSV where popliteal artery branches exist adjacent to the SSV.

Postoperative Care and Instructions

Postoperative care is designed to improve efficacy and minimize side effects and the risk of complications. There is a diversity of opinion about what is necessary as no evidence supports any specific recommendations. Immediately postoperatively, almost all physicians recommend some form of compression. The most common recommendation is for class II compression stockings (30–40 mm Hg) applied immediately after the procedure and worn for 1–2 weeks. The clinical value of this practice is not substantiated by data. Anecdotally, patients feel better with the use of compression, especially during the second week when the pulled-muscle feeling occurs.

Patients are encouraged to ambulate for at least 30–60 minutes after leaving the procedure room and at least 1–2 hours daily for 1–2 weeks. Hot baths, running, jumping, heavy lifting, and straining are discouraged by many physicians for 1–2 week. NSAIDs may be taken on an as-needed basis for discomfort.

Patients are generally seen at 1 month after the procedure to assess the results by clinical examination and DUS. Some physicians recommend a follow-up DUS 24–72 hours after the procedure as surveillance for junctional thrombus extension from the treated vein into the contiguous deep vein. However, as mentioned, the yield of this early examination for identifying extension of thrombus beyond the deep junction extending into the femoral vein for GSV or popliteal vein for SSV ablation is at most 1%. Moreover, treatment of such nonocclusive extensions is controversial and increasingly conservative care is recommended. Most physicians agree that repeat DUS at about 9-12 months after the procedure ultimately determines the anatomical success of the ablation.

Results of ELA

General comments

ELA is safely and effectively performed using local anesthesia in an office setting requiring about 45–90 minutes of room time to be performed. Procedure times are dependent on the number of concurrent treated veins, length of segment(s) treated, and whether ancillary procedures, such as ambulatory phlebectomy, are carried out. Patient satisfaction has been reported to be very high.

The total cost (cost of the procedure plus societal cost) of endovenous procedures is likely equal to or better than that of surgery. This is debatable in a hospital setting, but is almost certainly true if the ELA can be performed in a nonspecialized office setting. These techniques are being rapidly adopted and are now being performed more often than traditional HL/S in the United States.

Anatomical success rates

The anatomical outcomes following endovenous treatment include occlusion of the treated segment, early failure (complete or segmental), or late recanalization (complete or segmental). Anatomic success following ELA should result in the treated vein having no lumen and either shrink to a fibrous cord < 2.5 mm in diameter or become sonographically absent 6–12 months after treatment. Anatomical success with ELA of the GSV has been reported between 93–100%. The follow-up for these evaluations varies from 3 months to 4 years.

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• Veins carry blood low in oxygen content from the body to the lungs and heart.
• Varicose veins can lead to aching or even ulceration of the legs.
• Varicose veins can be caused be weakened valves in the veins or weakened walls of the veins, or by inflammation in the veins (phlebitis).
• Varicose veins and spider veins are not dangerous (with rare exceptions).
• Interventions and treatments such as surgery, "ablation" by laser, radiofrequency or other technology is necessary in settings where veins cause significant symptoms that do not respond to non-interventional treatment.
• Treatments available for venous disease include surgery and sclerotherapy, among other techniques.