Endovenous ablation of the great saphenous vein may avert phlebectomy for branch varicose veins

From the American Venous Forum

Endovenous ablation of the great saphenous vein may avert phlebectomy for branch varicose veins Harold J. Welch, MD, Burlington and Boston, Mass Background: Endovenous ablation of the great saphenous vein (GSV) may be performed simultaneously with stab phlebectomy of branch varicose veins or as a stand-alone procedure. A clinical approach of performing radiofrequency ablation (RFA) alone as initial treatment for varicose veins was reviewed. Methods: Patients with duplex ultrasound– documented reflux in the GSV and CEAP clinical stage 2 to 6 were selected for RFA. Patients were examined within a week preoperatively with duplex ultrasound imaging. Patients were seen within a week postoperatively and again at 2 to 3 months to ascertain if further treatment was required. A retrospective review of the initial 184 procedures in a series from June 2002 through February 2005 was performed, allowing for a 9-month follow-up period. Results: Three procedures were performed under general anesthesia and 181 with intravenous sedation and tumescent anesthesia. Postoperative duplex scans showed total occlusion or partial patency of <10 cm in 155 limbs. Seven (4.5%) had concomitant stab phlebectomy, seven subsequently had sclerotherapy, and 39 (25.2%) underwent subsequent stab phlebectomy of persistent symptomatic varicosities. In 101 limbs (65.1%), symptoms resolved and had no further therapy, and 24 limbs had a GSV that was patent for >10 cm on postoperative duplex imaging. Nine limbs had no further therapy (37.5%), eight (33.3%) had subsequent stab phlebectomy, and three had stripping of the GSV and stab phlebectomy. Four limbs had a redo RFA, four limbs had an aborted RFA procedure, and one limb was lost to follow-up. Failure of total GSV occlusion was more often associated with use of a 6F catheter. Complications were generally mild, and there was no postoperative deep vein thrombosis. Conclusion: Endovenous ablation of the GSV can be performed safely and effectively as the initial treatment for lower extremity varicose veins. Because most patients show clinical improvement after RFA, an algorithm of reassessment of the limb and branch varicose veins several months post-RFA allows most patients to defer stab phlebectomy. ( J Vasc Surg 2006;44:601-5.)

Endovenous ablation of the saphenous vein has transformed varicose vein surgery. Many patients with symptomatic or cosmetically displeasing varicose veins, and many referring physicians, have deferred surgery owing to the trepidation of stripping the great saphenous vein (GSV). With the introduction of endovenous ablation, foam sclerotherapy, better duplex ultrasound, and the refinements of techniques, patients can undergo minimally invasive treatment of GSV incompetence with easier recovery than saphenous stripping. Endovenous ablation, either by radiofrequency (RFA) or laser, has been shown to be comparable with stripping of the GSV in the short-term and intermediate-term.1,2 Branch varicosity stab phlebectomy is performed as a matter of course with stripping of the GSV. Many practitioners routinely perform stab phlebectomy or sclerotherapy, or both, of branch varicose veins in conjunction with endovenous ablation.3-6 From the Department of Vascular Surgery, Lahey Clinic and Tufts University School of Medicine. Competition of interest: none. Presented at the Eighteenth Annual Meeting of the American Venous Forum, Miami, Fla, Feb 23, 2006. Correspondence: Harold J. Welch, MD, Department of Vascular Surgery, Lahey Clinic, 41 Mall Rd, Burlington, MA 01805 (e-mail: harold.j. [email protected]). 0741-5214/$32.00 Copyright © 2006 by The Society for Vascular Surgery. doi:10.1016/j.jvs.2006.06.003

Many branch varicosities diminish in size or resolve completely once the saphenous reflux has been eliminated by endovenous ablation.7 The procedure of endovenous ablation lends itself very nicely to performance in an office or a surgical center with quick room turnaround, so that a number of the ablations can be completed in a timely fashion. This study assessed the efficacy of RFA alone as a treatment for symptomatic varicose veins. METHODS The initial 184 procedures of radiofrequency ablation of the GSV in an ongoing personal series performed between June 1, 2002, and February 28, 2005 were retrospectively reviewed. This allowed for at least a 9-month follow-up period. All patients had symptomatic varicose veins and were CEAP class 2 to 6. Although symptoms were not recorded prospectively, typical varicose vein symptoms included pain, throbbing, heaviness, aching, and itching. No procedures were performed for cosmetic purposes only. All patients underwent duplex ultrasound examination for venous reflux in our accredited vascular laboratory. Valve closure times were measured using the standing cuff deflation technique, with values ⬎0.5 seconds considered abnormal. The saphenofemoral junction (SFJ), GSV in the thigh, and short saphenous vein were studied, as were the femoral vein, deep femoral vein, and the popliteal vein. Perforating veins were not routinely examined. The first six procedures were performed in the main operating room at Lahey Clinic; the rest were done at our 601

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satellite ambulatory surgery center. General anesthesia was used in three procedures, and the remaining 181 had intravenous sedation and tumescent anesthesia. Saphenous vein mapping was done in the operating room before the legs were prepared for the procedure. The GSV was initially accessed by a microneedle under duplex guidance in all patients except three, who had venous cutdown. A 4F sheath was placed over the .018inch microguidewire and a .035-inch guidewire inserted through the sheath. A 6F (n ⫽ 124) or an 8F sheath (n ⫽ 60) was then placed over the guidewire, depending on the diameter of the GSV, according to recommendations of the manufacturer. The RFA catheter was advanced under duplex guidance to the saphenofemoral junction, and then withdrawn to just distal to the orifice of the superficial epigastric vein. Tumescent anesthesia (250 mL injectable sodium chloride, 60 mL of 1% lidocaine with epinephrine [1:100,000], and 6 mL 8.4% sodium bicarbonate) was then introduced through a 20-gauge spinal needle around the GSV under duplex guidance from the sheath to the SFJ. Catheter pull back at a rate of 2 to 3 cm/min was monitored by duplex imaging, with temperatures between 85° and 90°C. The entire vein was reimaged after pull back was complete. If the initial ablation was deemed unsatisfactory, the catheter was readvanced and the vein was re-treated. At the completion of the procedure, the leg was placed in a thigh-high thromboembolic deterrent stocking that was worn for 72 hours. Patients had a duplex examination of their treated legs within a week of the procedure at their initial follow-up visit. Saphenous veins were insonated to assess results of RFA, and deep veins were studied for presence of thrombosis. Patients were scheduled for repeat visit 2 to 3 months after the RFA to assess early results, patient satisfaction, and whether further procedures were necessary. Those patients who were not scheduled for subsequent stab phlebectomy or sclerotherapy at that time had telephone follow-up at 9 months to reassess the condition of the treated leg. Statistical analysis on GSV patency was performed using a logistic regression model for catheter size and need to retreat, and also independent sample t-test for time of treatment. SPSS software (SPSS Inc, Chicago, Ill) was used for the analysis. RESULTS A total of 184 RFA procedures were performed in 146 patients (35 men, 111 women) (Table I). Eight men and 25 women had staged bilateral procedures, and one man and three women had repeat procedures. Symptomatic varicose veins without ulcers (CEAP class 2 to 4) were present in 178 limbs, three limbs were CEAP class 5, and three limbs were CEAP class 6. Four procedures were aborted in one limb each because of inability to pass the catheter owing to GSV perforation, inability to pass the catheter owing to severe GSV spasm, access was lost in an obese leg, and the intended vein to treat was too superficial and likely an accessory saphenous vein.

Table I. Demographic and clinical data* Total procedures Total patients Men Women Mean age (y) CEAP Stage 2 3 4 5 6 Anesthesia General IV sedation/tumescent Concurrent procedures Stab phlebectomy Procedures aborted Lost to follow-up

184 146 35 111 48.4 (22-78) 163 5 10 3 3 3 181 8 (4.3) 4 1

IV, Intravenous. *Data are expressed in numbers (%) or means (ranges).

The size of the catheter used was 6F in 124 cases and 8F in 60 cases. Excluding the four aborted cases, the vein was treated with a single pull back in 137 limbs and re-treated at least once in 43 limbs. Hydrophilic glidewires were used in 20 limbs to assist in the advancement of the catheters through tortuous or spasmodic saphenous veins. Postoperative duplex results were unavailable in five patients: in four the procedure was aborted; one was lost to follow-up and did not return for her study. The treated vein was completely occluded in 143 limbs (77.7%), 12 limbs (6.5%) had a partially patent GSV with ⬍10 cm patent, 17 limbs (9.2%) had a partially patent GSV with ⬎10 cm patent, and 7 limbs (3.8%) had a totally patent GSV at initial follow-up despite the appearance of a satisfactory ablation in the operating room. Analysis of the veins that were totally patent showed that a 6F catheter was used in all seven limbs, and four of these had a single pullback. Of the 29 partially patent veins, 25 had a 6F catheter and four had an 8F catheter. In limbs that had a partially patent vein treated with a 6F catheter, 22 of 25 had a single pull back, and three of the four with an 8F catheter had a single pull back. A logistic regression analysis was performed with failure of occlusion as the dependent variable. The use of a 6F catheter was a covariate for failure (odds ratio [OR], 3.7; 95% confidence interval [CI], 1.20 to 11.54; P ⫽ .023), but the need to re-treat a vein was not (OR, 1.5; 95% CI, 0.53 to 4.40; P ⫽ .44) An independent samples t test was performed for time of treatment comparing occluded with patent (any length) vein (Table II). Mean treatment time ⫾ SD for occluded veins was 1001 ⫾ 440 seconds compared with 788 ⫾ 282 seconds (P ⫽ .001). Complications were generally mild, and 102 limbs (55.4%) had no adverse events (Table III). A number of patients had more than one complication. Complications included superficial thrombophlebitis in 8 (4.3%), numbness in 38 (20.1%) that totally resolved ⱕ1 month in 34,

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Table II. Multivariate association with less than total great saphenous vein occlusion

Size 6F catheter Need to re-treat

Table IV. Subsequent procedures with postoperative duplex results

OR

95% CI

P

3.7 1.5

1.20-11.54 0.53-4.40

.023 .44

Table III. Complications Complication None Superficial thrombophlebitis Numbness ⬎1 month Burning sensation Ecchymosis Pigmentation “Pulling” “Discomfort” Cutdown for retained microwire Late reopening of GSV Deep vein thrombosis Skin burns

No of limbs (%)* 102 (55.4) 8 (4.3) 38 (20.1) 4 (2.2) 1 (0.5) 7 (3.8) 6 (3.3) 17 (9.2) 18 (9.8) 1 (0.5) 2 (1.1) 0 0

GSV, Great saphenous vein. *Some limbs had more than one complication.

burning sensation in 1 (0.5%), ecchymosis in 7 (3.8%), mild pigmentation in 6 (3.3%), pulling sensation in 17 (9.2%), discomfort in 18 (9.8%), and cutdown for microwire retrieval in 1 (0.5%). Two GSVs reopened with recurrent symptomatic varicose veins at 5 and 6 months after initially successful ablations. There were no instances of deep vein thrombosis or skin burns. As shown in Table IV, there were 155 limbs in which post-op duplex showed total occlusion or partial patency of 10 cm or less in length. Seven of these had concomitant stab phlebectomy (4.5%). One was a re-do ablation with concomitant stab phlebectomy (0.6%). Seven subsequently had sclerotherapy for remaining branch varicosities (4.5%). Thirty-nine underwent later stab phlebectomy of remaining varicosities (25.2%). One hundred one limbs (65.1%) had resolution of symptoms, with or without resolution of varicosities, and did not have any further treatment. Twenty-four limbs had a GSV that was patent for more than 10 cm on post-operative duplex examination. Of these 24 limbs, 9 (37.5%) had no further therapy. Despite a patent segment of GSV ⬎10 cm, they had resolution of their preoperative symptoms. Eight limbs (33.3%) underwent subsequent stab phlebectomy, and 3 limbs (12.5%) underwent stripping of the GSV with SP. Four limbs (16.7%) had a re-do RFA. One of these had a concomitant SP, and the other three had no further treatment after their repeat RFA. Four limbs had an aborted RFA procedure, 2 of these subsequently underwent stripping of the GSV with SP, 2 elected for no treatment. One patient did not return after her RFA because she was diagnosed with cervical cancer. A life table of post-RFA interventions is exhibited in

Post-op duplex result Total GSV occlusion or ⬍10 cm patent (n ⫽ 155) Subsequent procedures Stab phlebectomy Sclerotherapy None GSV ⬎10 cm patent (n ⫽ 24) Subsequent procedures SP Strip GSV & SP Redo RFA Redo RFA/SP None

N (%)

39 (25.2) 7 (3.8) 101 (65.1) 8 (33.3) 3 (12.5) 3 (12.5) 1 (4.2) 9 (37.5)

GSV, Great saphenous vein; SP, stab phlebectomy; RFA, radiofrequency ablation.

Table V. Excluding the 7 patients with concomitant stab phlebectomy at initial RFA, 110 limbs of 177 (62.1%) had no further treatment of the varicose veins in the 9 month follow-up. DISCUSSION Several options are available for the treatment of an incompetent GSV, including stripping, endovenous ablation, and foam sclerotherapy. These procedures are all effective, but each has side effects and complications as well as a risk of recurrent varicose veins. Stripping of the GSV is considered the gold standard, but it carries higher morbidity and a longer recovery. Subramonia and Lees8 reported an overall 40% sensory abnormality after stripping the GSV in the thigh.8 The the Endovenous Radiofrequency Obliteration (Closure Procedure) Versus Ligation and Stripping (EVOLVeS) study showed significant early advantages for radiofrequency ablation over conventional vein stripping, with earlier return to work and normal activities, with less pain and better cosmesis.1 Much of the literature reporting endovenous ablation describes adjunctive procedures in most if not all of the ablations. A study from the Mayo Clinic comparing RFA with endolaser ablation performed stab avulsion in 97% of limbs, with subfascial endoscopic perforator surgery or short saphenous ablation, or both, in the others. General or epidural anesthesia was used in all patients.5 Others combined high ligation, foam sclerotherapy, or stab avulsion in all limbs.4,9 Merchant and Pichot,3 for the Closure Study Group, performed adjunctive phlebectomy in 52% of limbs and sclerotherapy in 11%, thus leaving 37% of limbs with RFA only. They reported overall that ⬎80% of limbs were asymptomatic even at 5 years, and that ⬎70% of limbs were asymptomatic where there was anatomic failure of the RFA procedure. Although the authors did not state it, more of their patients (80%) had clinical improvement than they did with adjunctive procedures at the time of RFA (63%), thus implying a fair number of their patients improved solely by RFA.3

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Table V. Post initial radiofrequency ablation procedures Months after RFA 0 1 2 3 4 5 6 7 8 9

Limbs

SP

184 174 170 157 146 136 126 120 112 110

7 4 12 8 5 8 5 8 2

Sclero

Abor/No Rx LTFU

Repeat w/SP

Redo RFA

3 1 3 3

1 1

1 1

1

RFA, Radiofrequency ablation; SP, stab phlebectomy; LTFU, lost to follow-up.

Nicolini et al,10 for the Closure Group, reported the 3-year follow-up of RFA-treated patients in which 61% of the patients had a concomitant or subsequent stab phlebectomy, and 39% only had RFA. In follow-up, they found no difference in symptom severity score or the number of asymptomatic limbs in patients who had stab phlebectomy compared with those who did not.10 Finally, Weiss and Weiss11 described their early experience with RFA in which they performed concomitant stab phlebectomy in 62% of RFA cases. They found all limbs showed improvement of visible varicosities and significant improvement in leg pain, whether or not stab phlebectomy was performed with RFA.11 Monahan7 performed a study to observe the sequelae of branch varicose veins after RFA of the GSV. He found spontaneous resolution of 28.4% of varicose veins by 6 months after RFA, with 13% of treated limbs showing complete resolution of varicosities. Almost all of the varicose veins that did not completely resolve exhibited a significant decrease in size. As expected, most of the improvements were seen in the drainage area of the GSV (ie, the medial aspect of the leg and thigh). At the 6-month follow-up, 41% had no further therapy, and the rest underwent sclerotherapy. The complication rates in this study are generally comparable with other published results, although the GSV occlusion rate is lower than others (Table II). Morrison12 reported a primary occlusion of 80% for RFA and 66% for laser ablation, and the EVOLVeS study had a complete GSV occlusion rate of 83.7%.1 Other reports however, have an occlusion rate of at least 90%.2-7,9 The size of the RFA catheter is not mentioned in most reports, but the generally good occlusion rates may not have prompted an examination of the treatment failures. The present series showed a lower success rate when a 6F catheter was used. Selection of catheter sizes was determined by GSV diameter during vein mapping in the operating room with the patient in a supine or reverse Trendelenburg position. After injection of tumescent anesthesia, patients were either positioned supinely or in slight Trendelenburg. It can be surmised that despite the measure-

ments, some of the saphenous veins may have been too large for the 6F catheter, leading to failure. Pullback time was also shorter in the treatment failures, which may also have contributed, but this was not an independent variable. These findings have led to a more liberal use of 8F catheters in later patients. The life table (Table V) shows stab phlebectomy performed in every month (up to 8) after the initial RFA. Most of the later procedures were the result of either scheduling issues (for elective surgery), or the patient eventually deciding the remaining branch varicosities required surgery. Other complications were generally mild. The incidence of paresthesia was higher than most but generally resolved ⱕ1 month. A pulling sensation and vague discomfort are fairly common, but these too resolve. No serious complications of deep vein thrombosis or skin burns occurred in this series, as in most other published reports. RFA has previously been shown to be a very safe and effective procedure in patients aged ⬎70 years.13 The two reasons to operate on varicose veins are symptoms and cosmesis. Although minimal or no scarring is desired for any vein surgery, if surgery is performed on symptomatic legs, the resolution or improvement of the leg symptoms is vital. If the patient does not like the appearance of the leg, then eradication of all varicosities with minimal scarring is paramount. The first option in the treatment of varicose veins is observation, or no treatment. Varicose veins may cause minimal or no symptoms, and many patients are perfectly satisfied to live with a few bulges on their leg. One of the weaknesses of this report is that this is a retrospective review of the author’s experience and that certain data were not collected prospectively; most importantly, the Venous Clinical Severity Score, or Venous Disability Score or both. Thus, although leg symptoms may not have been totally resolved in all patients with the saphenous vein ablation who did not have an adjunctive procedure, they were at least minimized so that the patients were satisfied enough not to want additional surgery. Additionally, this report should not imply that all branch varicosities disappeared with saphenous vein ablation. Many varicosities did resolve or shrink, but as also pointed out by Monahan,7 some persisted and were asymptomatic. CONCLUSION Endovenous ablation can be performed in an office setting or ambulatory surgery center. It is a fairly quick procedure, thereby permitting a schedule of multiple procedures. Oral or intravenous sedation, or a combination, is used for patient comfort. General or regional anesthesia is not necessary unless adjunctive procedures are performed. Patient acceptance of the procedure is excellent. It can be—and is argued—that complete eradication of all varicose veins at the initial operation is the preferred treatment method.14 That is not an unreasonable approach, but it may be changing. This study, and other reports by Monahan,7 Min et al,2 Weiss and Weiss,11 and Nicolini et al,10 have shown that eliminating the source of

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the venous reflux can be effective in relieving patients of the symptoms of varicose veins, and further treatment can be deferred in many patients. Ideally, a randomized controlled study with severity scoring and quality-of-life assessment comparing ablation alone with ablation plus phlebectomy should be performed. Jyotsna Kakullavarapu, Lahey Clinic Biostatistician, performed the statistical analysis. AUTHOR CONTRIBUTIONS Conception and design: HW Analysis and interpretation: HW Data collection: HW Writing the article: HW Critical revision of the article: HW Final approval of the article: HW Statistical analysis: Not applicable Overall responsibility: HW REFERENCES 1. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, et al. Prospective randomized study of endovenous radiofrequency obliteration (Closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surg 2003;38:207-14. 2. Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reflux: long-term results. J Vasc Interv Radiol 2003;14: 991-6. 3. Merchant RF, Pichot O. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 2005;42:502-9. 4. Wagner WH, Levin PM, Cossman DV, Lauterbach SR, Cohen JL, Farber A. Early experience with radiofrequency ablation of the greater saphenous vein. Ann Vasc Surg 2004;18:42-7.

5. Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: analysis of early efficacy and complications. J Vasc Surg 2005;42:488-93. 6. Huang Y, Jiang M, Li W, Lu X, Huang X, Lu M. Endovenous laser treatment combined with a surgical strategy for treatment of venous insufficiency in lower extremity: a report of 208 cases. J Vasc Surg 2005;42:494-501. 7. Monahan DL. Can phlebectomy be deferred in the treatment of varicose veins? J Vasc Surg 2005;42:1145-9. 8. Subramonia S, Lees T. Sensory abnormalities and bruising after long saphenous vein stripping: Impact on short-term quality of life. J Vasc Surg 2005;42:510-4. 9. Ogawa T, Hoshino S, Midorikawa H, Sato K. Clinical results of radiofrequency endovenous obliteration for varicose veins. Surg Today 2005; 35:47-51. 10. Nicolini P; Closure Group. Treatment of primary varicose veins by endovenous obliteration with the VNUS closure system: results of a prospective multicentre study. Eur J Vasc Endovasc Surg 2005;29: 443-9. 11. Weiss RA, Weiss MA. Controlled radiofrequency endovenous occlusion using a unique radiofrequency catheter under duplex guidance to eliminate saphenous varicose vein reflux: a 2-year follow-up. Dermatol Surg 2002;28:38-42. 12. Morrison N. Saphenous ablation: what are the choices, laser or RF energy. Semin Vasc Surg 2005;18:15-18. 13. Tzilinis A, Salles-Cunha SX, Dosick SM, Gale SS, Seiwert AF, Comerota AJ. Chronic venous insufficiency due to great saphenous vein incompetence treated with radiofrequency ablation: an effective and safe procedure in the elderly. Vasc Endovasc Surg 2005;39:341-5. 14. DePalma RG, Rose SS, Bergan JJ. Treatment of varicosities of saphenous origin: a dialogue. In: Goldman MP, Weiss RA, Bergan JJ, editors. Varicose veins and telangectasias: diagnosis and treatment. 2nd edition. St. Louis: Quality Medical Publishing, Inc; 1999. p. 197-216.

Submitted Feb 20, 2006; accepted Jun 3, 2006.

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