Еще немного воды на ту же мельницу, но в игру включились и более серезные игрушки......
J Vasc Surg. 2005 Sep;42(3):494-501; discussion 501. Links
Endovenous laser treatment combined with a surgical strategy for treatment of venous insufficiency in lower extremity: a report of 208 cases.Huang Y, Jiang M, Li W, Lu X, Huang X, Lu M.
Department of Vascular Surgery, Ninth People's Hospital, affiliated to Shanghai Second Medical University, China.
yvhuang772@yahoo.comBACKGROUND: We assessed the safety and efficacy of endovenous laser treatment (EVLT) of the saphenous vein combined with a surgical strategy for treatment of deep venous insufficiency in the lower extremity. METHODS: Two hundred thirty venous insufficiencies of the lower limbs in 208 consecutive patients (93 men and 115 women; mean age, 54.15 years) were treated with EVLT combined with surgical strategies. All patients were symptomatic. There were 84 limbs (36.5%) in C(2), 25 (10.9%) in C(3), 109 (47.7%) in C(4), 1 (0.4%) in C(5), and 9 (3.9%) in C(6) (CEAP), and Klippel-Trenaunay syndrome was present in 2 limbs. A total of 119 (51.7%) had perforator vein incompetence. Four therapeutic methods were included in this series according to symptoms, CEAP classification, and venous reflux. Simple EVLT was performed for 15 patients with only great saphenous vein (GSV) incompetence or Klippel-Trenaunay syndrome in 19 lower limbs. EVLT combined with high ligation of the GSV and open ligation of perforators was performed for 5 patients with GSV and perforator incompetence in 5 lower limbs. [b]EVLT was combined with high ligation of the GSV for 76 patients with GSV incompetence in 94 lower limbs. EVLT was combined with external banding of the first femoral venous valve and high ligation of the GSV for 112 patients with primary deep venous insufficiency in 112 lower limbs. All patients were followed up on an outpatient basis for physical examinations and postoperative complaints, and duplex ultrasonography was performed 2 weeks, 6 months, and 1 year after operation. RESULTS: All patients tolerated the procedure well and returned to normal daily activities immediately, achieving a 100% immediate clinical success rate. Spot skin burn injuries occurred in 2 patients (1.0%). Paresthesia in the gaiter area was noted in 15 patients (7.2%). No postprocedural symptomatic deep venous thrombosis or pulmonary embolism occurred. Three patients had local recurrent varicose veins in the calf (1.4%) during a 2- to 27-month follow-up (mean, 6.12 months). Postoperative clinical classes were significantly improved between 2 weeks and 24 months (P = .0001 at 2 weeks and 3 to 18 months; P = .0055 at 24 months compared with before operation), especially in preoperative C(2) to C(3) stage patients, who achieved complete amelioration. CONCLUSIONS: EVLT is a novel minimally invasive treatment with advantages of safety, effectiveness, and simplicity, and it leaves no scars. Its indications can be expanded by combining EVLT with surgical strategies.[/b]
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Endovenous laser treatment combined with a surgery strategy for treatment of venous insufficiency in lower extremity: A report of 208 cases
Background
We assessed the safety and efficacy of endovenous laser treatment (EVLT) OF the asthenias vein combined with a surgical strategy for treatment of deep venous insufficiency in the low extremity.
Methods: Two hundred thirty venous insufficiencies of the low limbs in 208 consecutive patients were treated EVLT combined with surgical strategies. All patients were symptomatic. There were 84limbs, and Klippel-Trenaunay syndrome was present in 2 limes total of 119 had perforator vein incompetence. Four therapeutic methods were included in this series according to symptoms, CEAP classification, and venous reflux, Simple EVLT was performer for 15 patients with only great sphenoid vein (GSV) incompetence or Klippel-Trenaunay syndrome in 19 lower limbs with GSV and perforator incompetence in 94 lower limbs, EVLT was combined with high legation of the GSV for 76 patients with SGV incompetence in 95 lower limbs, EVLT was combined with external banding of the first femoral venous valve and high legation of the GSV for 112 patients with primary deep venous insufficiency in 112 lower limbs. All patients were followed up on an outpatient basis for physical examinations and postoperative complaints, and duplex ultrasonography was performed 2 weeks,6 months, and 1 year after operation.
Results: All patients tolerated the procedure well and returned to normal daily activities immediately, achieving a 100% immediate clinical success rate. Spot skin burn injuries occurred in 2 patients (1.0%). Parenthesis in the gaiter area was noted in 15 patient��s (7.2%). No post procedural symptomatic deep venous thrombosis or pulmonary embellish accrued. Three patients had local recurrent varicose veins in the calf (1.4) during a 2 to 27-month follow-up (mean,6.12 months). Postoperative clinical classes were significantly improved between 2 weeks and 24 months, especially in preoperative C2 to C3 state patients, who achieved complete amelioration.
Conclusions: EVLT is a novel minimally in evasive treatment with advantages of safety, effectiveness, and simplicity, and it leaves no scares. Its indications can be expanded by combining EVLT with surgical strategies.
Superficial varicosity in the lower extremity is a common disorder in the Chinese population. Its most frequent causes are primary deep venous insufficiency (PDVI) and great saphenous vien ((GSV) incompetence. The classic surgical strategies include reconstruction of the GSV, legation of perforators, excision of superficial varicosities, and so on. The drawbacks of surgery include risks associated with surgical complications, increased in-hospital costs, and prolonged recovery periods. Also surgery does not ensure freedom from recurrence. In recent years, with the development of minimally invasive techniques and the advent of new surgical apparatus, less invasive alternatives to surgical treatments of superficial varicose veins have emerged. From June 2001 to 2003 to September 2003,208 consecutive patients were successfully treated by endovenous laser treatment (EVLT) combined with surgical interventions in our department. Herein we report our experience and a retrospective study to evaluate the safety of this method.
METHODS
Patients, all patients were selected from our department as they came for their symptomatic varicositities. Thorough history and physical examinations were performed. All patients were frit screened by air plethysmography and ankle-brachial index measurement, and those with normal venous outflow in air plethysmography and an ankle-brachial index greater than 0.9 underwent further testing .Duplex scanning was performed to document further testing. Duplex scanning was performed to document potency of the deep veins and to evaluate the value reflux time. Venous reflux was defined as reverse flow of more than 0.5 seconds. Combined with the reflux index, a value greater than 2.5 would be considered a severe reflux. Perforators were considered incompetent if the diameter was 4mm or more and/or had an outward directional flow exceeding 0.5 seconds. On account of certain limitations in the abovementioned testing, ascending venography was performed to confirm the diagnosis and further exclude postthrom botic syndrome with total recanalization and the manythurner syndrome, which might be missed in ultrasonic raphy.
The contour of deep veins, valves, and perforators could be visualized, and the function of the first valve of the femoral vein was tested by the Valsalva maneuver.Perforators could be localized under duplex scanning combines with venography. The severity of venous insufficiency was categorized according to the CEAP classification. On the basis of duplex scanning, ascending venography, and CEAP classification, patients with PDVI were stratified into mild, moderate, and severe groups so implify the choice of therapeutic modalities. The mild group was defined as patients at stage C2 to C3 with venous reflux to the knee level in ultrasonogrphy, mild reflux but nearly normal contour in the frist valve of the femoral vein, mildly dilated deep veins, and nearly normal configuration of other valves in the deep veins as visualized by venography. The moderate group were patients at stage C4 to C5, with venous reflux to below the knee level in ultrasonography, moderate reflux in the first valve of the femoral vein( with its vale contour being retained),dilated deep veins, and less definitive visualization of the contours of the other valves in deep veins on venography. the severe group were patients at stage C6 with venous reflux to the ankle level in ultrasonography, severe reflux in the first valve of the femoral vein (with obscure valve contour), more dilated deep veins, and other valves in the deep veins poorly visualized by venography, patients with actuate superficial thrombophlebitis, aneurysmal veins pulses, or deep venous feeding,or in poor general condition were not candidates for EVLT.
Procedures: All patients were treated with EVLT or EVLT combined with surgery under epidural or lumbar anesthesia. The 810nm diode laser was used togenerate heat sufficient to cause thermal damage to the venous endothelium. Four therapeutic strategies were included simple EVLT was performed fr 15 patients with GSV incompetence or Klippel-Treat syndrome (KTS) in 19 lower limbs during our early stage of EVLT. Procedures were followed as previous reported and were bases on the technoques of Navarro et al. In some patients who had significant enlargement of the sapherous trunk, the technique was improved for the treatment of GSV trunk. After introduction of the optical fiber to the GSV from the ankle level to the varicose veins was fully evacuated30, and blood in the varicose veins was fully evacuated. A laser-emission power of 12 or 14w in continuous mode was chosen to treat GSV from below the saphenofemoral joint (SFJ) to the knee level, and then 12w and I pulse duration was used in the GSV from the knee level to the ankle level. A wavelength of 810nm of diode laser energy was delivered along the course of the GSV as the laser fiber and catheter were slowly withdrawn in 3-to 5 mm increments. During the procedure, manual compression was applied over the red aiming beam, which could be visualized thought the skin, to improve the vein wall apposition around the laser fiber tip; thus, better laser fiber-endothelial contact and even emission by laser energy were achieved to completely shrink and occlude the venous trunk. For mild or moderate varicosities caused by tributaries of the GSV,EVLT with multiple percutaneous introductions of the laser fiber through n 18-gauge needle was performed.
EVLT was combined with high legation of the GSV and open legation of perforators for 5 patients with GSV and perforator incompetence in 5v lower limbes. This intervention was performed after we realized that pulmonary embolism (PE) might occur though the SFJ and that the perforator could be obliterated by direct EVLT through an 18-gauge needle. EVLT was combined with high legation of the GSV for 76 patients with GSV incompetence in 94 lower limbs. EVLT was combined with external banding of the first femoral venous valve and high legation of the GSV for 112 patients with PDVI in 112 lower limbs Femoral banding was indicated for patients of C4 to C6 with axial reflux in duplex and venography examinations or with complex skin changes but in whom the configuration of the frist valve had not been totally destroyed. Among those, 25 limbs underwent additional phlebectomy because of extensive varicose masses in the calf region. The indications for intervention are shown in Table I All operated limbs were managed with compressive bandaging after the procedure. All patients were compressive bandaging fret the procedure. All patients were followed up on an outpatient basis for physical examinations and postoperative complaints, and duplex ultrasonography was performed 2 weeks, 6 months and 1 year after operation.
Parameters: The diode laser fiber in the treatment of GSV and superficial varicosities is normally 400 to 600 um in diameter; the 600um-diameter fiber and a wavelength of 810nm were chosen in our series. pulses ranging from 80 to 500 seconds were used for the entire procedure, with a mean of 205,According to the severity of varicosities, it took 0.5 hours to 1 hour to perform entire procedure, with a mean of 50 minutes.
Postoperative management: Ambulatory activities were encouraged after operation. Elastic compressive bandaging was instructed for at least 14 days or was changed to graduated compression stocking 3 days after operation. A thing or pantyhose stocking was recommended. Oral administration of aspirin 75 mg was recommended for 1 to 2 months.
Statistical analysis: SAS software was used, Statistical analysis of the data was performed with decriptive statistics and the Wilcoxon rank sum test for comparison of preperative and postoperative C classes.
RESULT
Patient characteristics: Two hundred thirty venousinsufficient lower limbs in 208 consecutive patients were included in this series. Among those, two limbs had had previous treatment of sclerotherapy,and another three had previos treatment of sclerotherapy, and another three had had GSV and varicose vein ablation. Their ages ranged from 7 to 79 years, with a mean of 54.15 years, their courses of disease were 1.5 to 30 years, with a mean of 12.61 years. According to the CEAP classification and more than half had a class 4 or higher clinical stage (15.7%) Patients�� demographic data and CEAP classifications are listed in Tables II and III.
Therapeutic effects: Successful percutaneous access and endovenous placement of laser fibers were achieved in all patients�� .All patients tolerated the procedure well and recovered uneventfully, with dissappearance of varices. Patients without venous banding were encouraged to undertake ambulatory activates the day after operation. They returned to their normal daily activities 3 days after the operation and returned to work 14 days after operations, The duration for patients with venous banding were 3,14,and 28 days after operation, respectively. Patients who received only EVLT had no incision, and the others had stage I would healing, Gaiter ulcerations in all 9 npatients were healed in 2 to 5 weeks after the procedure., on the basis of a quetionnaire that measures preperative and postoperative venous symptoms, all patients had relief of their symptoms and were satisfied with EVLT and the corresponding combines surgery.
Complications: Symptoms such as indurations, pain, paresthesia,skin burn injury, leg swelling ,cough, thoracicpain, hemoptysis, and fever were investigated after operation and in follow-up to evaluate operation of DVT or PE occurred, further investigations including duplex scan, pulmonary radiograph, computed tomography, and isotope scan were performed to diagnose and guide treatment.
Follow-up: Patients were followed up from 2 to 6 months, with a median of 6 months, Duplex ultrasonophy was performed 2 weeks after operation with the find .that there was no detectable flow and that total closure of the GSV was achieved in all 230 limbs. Three patients had local recurrent various veins in the calf (1.4) 3 weeks after operation and were successfully treated with EVLT under local anesthesia. No recurrence was seen in other patients, No patient experienced sympotoms of DVT or PE.Postoperative clinical classes of patients are listed in Table IV They were significatly improved between 2 weeks and 24 months, especially preoperative C2 to C3 patients, who achieved complete amelioration at a mean of 6 months of follow-up. Duplex ultrasonography 1 year after operation demonstrated a thin, fibrous cord along the original GSV.
DISCUSSION
Compared with classic surgery for PDVI and GSV incompetence, the objective of less invastive treatment alternative is to reduce risk, morbidity, and cost while leading to acceptable shprt-and long-term results; cosmetic reasons are important as well. Techniques such as miniphlebectomy, cryotherapy, sclerothapy, and electrocautery have been developed as less invasive means for the treatment of superficial varicosities in the lower extremities. Among all minimally invasive treatments, subfascial endoscopic perforator surgery, endoluminal radiofrequency, and EVLT have shown promise .EVLT seen particularly promising in the minimally invasive treatment of varicose veins. EVLT consists of percutanceous transvenous catheter-guided laser fiber introduction, a minimal access site size, transmission of laser energy through a small-diameter and flexible fiber, and direct operation through skin visualization of the laser tip by its red aiming beam light. This cause contributes to procedural case and safety, improved effectiveness, and an absence of surgical scarring.
The endovenous laser generates bursts of hear enough to form steam bubbles, which cause thermal injury to the venous target vein. EVLT is indicated in which the clinical manifiestations are superficial varicose veins. Navarro et al reported a 100% rate of GSV closure in 40 limbs after EVLT by using 810nm with a mean numbers and only short-term data ,the efficacy of EVLT for the treatment pf incompetent GSV has been reported to be greater than 95%,our results showed the same successful rate. Priestley reported a series of 77 patients who received EVLT of 106 GSVs in which 6 GSVs (10%) were not occluded at 3 months and indicated the EVLT failure might be related to the administration of low laser fluence,its unit is J/cm2.
To achieve optimal effects, the selection of patients is most important, Patients with potential risks for DVT and PE should be excluded .Duplex scanning combined with ascending vanography was performed routinely, because the latter can directly visualize the configuration of deep veins, valves, and perforators and can compensation of the draebacks of duplex scanning. The duplex scan has its predominant advantage in reflux detection and quantitative evaluation. Complete recanalization of deep veins in patients with postthrombotic syndrome and may-Thurner syndrome were excluded in this series to prevent possible postoperative DVT and subsequent PE. Because of examiner preference, some cases were detected only in venography, although it��s invasive and requires contrast media.
To decrease the postprocedural recurrence of both the GSV and tribitaries for other than technical reasons,we performed different therapeutic strategies according to symptoms,CEAP classification,and venous reflux,Duplex and ascending venography were performed to evaluzte the deep vien patency,venous reflux,valve cntour,and perforator localization .For patients with PDVI and deep reflux,especially those with obvious skin changes,EVLT combined with external banding of the frist femoral venous valve and high ligation of GSV was performed at one stage.In 1975,Kistner advocated the femoral valve repair operated tha method of PDVI .In 1982,Jones et reported the method of triangual venous valvuoplasty.From 1982 to 1987,more than 200 patients were operated on with these2 methods in our department.We found that satisfactory results were most likely to be expected in lower limbs with mild and moderate deep venous reflus.In a study of 50 adult cadavers (100 lower extremities),it was suggested that the valves of the common femoral vein could withstand a retrograde pressure of 180 to 250mm Hg,the valves of the femoral vein,260 to 350mm Hg;the valves of the femoral vein,260 t350mm.
Reconstruction of the frist valve of the femoral vein seemed to be more effective in patients of C4 to C6 with total deep venous reflux only if the valve was not totally destroyed.To avoid the postoperative complication of thrombosis due to intravenous manipulation,this abnding valvulopasty operation was chosen and clinically applied,with excellent results.Camilli and Guarnera,Guarnera et,and Belcaro et have reported their successful experience with external banding valvuloplasty,Thus,external banding of the frist femoral venous valve was chosen for valve recomstruction in this series.For bothGSV and perforator incompetence,to avoid recurrence,high lighation and ligation were perforatored,repectively ,in our early cases;localization of perforators by ultrasonography and direct puncture to permit EVLT obliteration was used after we gained experience with this technique.Also,ultiplw puncture of tributary varices for EVLT was performed,for patients who had an enlarged mass in the GSV or its tributaries,phlebectomy was used.
Although the postoperative clinical classes were significantly improved in our follow-up study,especially those in the C2 to C3classes before operation, limbs in preoperative C4 to C 6 showed no significant change in clinical classes after operation.Advanced cases with skin changes are unlikely to change significantly after treatment,and the healing of an active ulcer would drop the patient from C6 to C5 thus,venous severity scoring seems to be more accurate than the CEAP classification for assessing the efficacy of the treatment.
Most cases in our study were treated by EVLT combined with syrgical strategies .The advantages are as follows .Using a longitudinal incision of 6 to 8 cm at the inner side of the upper thigh for the external banding operation and a 2-cm incision along the dermatoglyph in the groin region just over the SFJ for high ligation of the GSV,placement of the fiber could be accurately confirmed by direct visualization.This is a simple procedure for a vascular surgeon.Intradermic suture was performed with absorbable suture.The incision was sheltered,with no scar left,and was easily accepted by patients .High ligation of the GSV was performed with EVLT except for 15 patients in our early stage.High ligation of the GSV was used to decrease the risk of thrombus in the deep vein and GSV recanalization caused by SFJ reflux and to facilitate complete GSV thrombosis and fibrosis.We had no complications of clinically apparent DVT or PE in our patient cohort and had varices in the calf region and more advanced skin changes in the gaiter area than those reported in the literature,we treated the entire incompetent GSV from groin to ankle in all cases.To avoid thermal injury to the saphenous nerve during the procedure,12W in discontinuous mode with a 1-second pulse duration,1-second intervals,and relatively quick withdrawal was used in the GSV from the knww to ankle level,and subcutancous tumescence of saline along the course of the GSV was recommeded.EVLT combined with surgical strategies can be used to broaden the clinical application .For patients with PDVI,especially those with total deep reflux ,deep venous valvuloplasty can be performed and followed with EVLT ,This combined therapeutuc method was performed to achieve better efficacy.In our 208 cases,EVLT combines with external banding of the first femoral venous valve was performed for 112 patients in 112 lower limbs .In our experience,EVLT combined with high ligation of the GSV,perforator ligation,and valvular repair,when complicated with PDVI,could reduce recurrence and recanalization due to blood reflux and further enhance the shrinkage and fibrosis of treated varicoses.Reports of clinical results of GSV surgery in the presence of deep reflux are not consistent,and recently,the definition of deep axial reflux was advocated to be of great importance in the choice of surgery.Two cases of KTS were reported in our series.KTS with superficial varicose veins and deep veins is optimal for EVLT.
If the GSV was too toruous to allow a catheter to pass multiple puncture was indicated and ultrasound-guided catheterization was used if necessary.If vericosities were very close or the dermis,then subcutaneous tumescence of saline over the treated vein was indicated to form a protectitve barrier between varicosities and the skin,thus preventing skin burn injury,Quick withdrawal was important as well.Two skin burn injuries occurred at an early stage in our series.Because subcutaneous tumescence of saline and rhe terminal highligh were used,such complication were seldom seen.The diode laser is an endovenous one that has a contact efect.We suggest that elevation of the involved limbs before the emission of laser energy,to fully empty venous blood and collapse the venous wall by compression,will help to obtain better fiber endothelial contact and reduce the postoperative reaction of thrombophlebitis as well,In addition,laser power of 12 to 14w in continuous to knee level for increasing laser energy to completely achieve a therapeutic effect.
Induration along the course of the GSV or over treated varicose veins will cause local pain,such a tissue reaction in most distinct 1 to 2 weeks after operatin and then gradually subsides and diminishes in 3 to 6 weeks,The more complete the emptying of the vein lumen,the less tissue reaction will be produced ,and better results will be achieved ,in addition,postoperative compressive bandaging or compressive stockings are most important after EVLT to avoid early recanalization and enhance the therapeutic effect.
Early results with EVLT have been impressive with very effective closure of incompetent GSV and varicose veins, but its long-term evaluation awaits long-term follow-up and multimember investigations. On the basis of continuous improvement of this technique, EVLT will render favorable prospects for extensive application because of its advantage of safety, effectiveness, minimal invasiveness, fewer complications, and easy operation.
For an extraordinarily enlarged GSV unmatching of the laser fiber caliber to the venous caliber should be considered. Radiofrequency is another endovascular technique for the elimination of saphenofemoral reflux and truncal GSV. Because we now perform both EVLT and radiofrequency in our department, further study to compare EVLT vs. radiofrequency in the treatment of GSV is under way to achieve better selection of these two minimally invasive techniques.
This report from one of china��s leading centers for venous disease is of special importance because it��s indicative of the series have high level of venous practice currently used in china,where patients in this series have been well studied and carefully observed after surgery with clinical and ultrasound scans.
The Chinese apparently harbor a high percentage of primary reflux cases. The aggressive management of reflux espoused in this article differs from the usual practice in the west and may be useful in stimulating healthy debate. Regardless of the differences in management between east and west, the disease processes are clearly the same, and the diagnostic workups are similar. The CEAP classification is used to good advantage in this study to identify the patient population being treated ,and this will make it possible to compare results from this source with different theories of management in other parts of the world. As the difference are defined ,investigations to study and resolve the newly recognized problems will emerge.
Participation of the Chinese in the discourse concerning management of chronic venous disease provides many advantages that will increase the opportunity for progress in the field .With the realization that we are now using the same instruments to measure the same aspects in patients who have the same diseases, it is possible to reap some of the benefits that were predicted to flow from progress in noninvasive diagnosis and from uniformity of classification.
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