|Year : 2018 | Volume
| Issue : 2 | Page : 185-190
Endovenous radiofrequency ablation of lower extremity varicose veins: short-term outcomes of the initial experience
Ashraf G Taha, Ahmed H.B Elbadawy, Ayman E Hasaballah
Department of Vascular and Endovascular Surgery, Faculty of Medicine, Assiut University, Assiut, Egypt
|Date of Submission||05-Dec-2017|
|Date of Acceptance||17-Jan-2018|
|Date of Web Publication||30-May-2018|
Ashraf G Taha
Department of Vascular and Endovascular Surgery, Assiut University Hospitals, 71526 Assiut
Source of Support: None, Conflict of Interest: None
Context Radiofrequency ablation (RFA) has proven acceptable efficacy and safety in the treatment of truncal varicose veins. Faulty technique may, however, result in primary failure or serious complications, especially during the early time points of the surgeon’s learning curve.
Aim The aim of the present study was to evaluate the safety and effectiveness of RFA procedures in the treatment of great saphenous vein reflux during the initial experience in endovenous thermal ablation.
Materials and methods A retrospective review was conducted on 47 patients with varicose veins of clinical, etiological, anatomical, physiological (CEAP) class 2–6 who received RFA at the Department of Vascular and Endovascular Surgery, Assiut University Hospitals, to treat refluxing great saphenous veins between 2014 and 2016. Outcome measures were technical success rate and perioperative complications. Short-term outcomes included complete occlusion of the ablated veins and symptom improvement at 1 year.
Results RFA achieved a technical success rate of 97.9%. Perioperative complications were paresthesia (10.6%), ecchymosis (6.4%), phlebitis (6.4%), and hyperpigmentation (2.1%). No skin thermal injuries, hematomas, deep venous thrombosis, or endovenous heat-induced thrombosis were detected. One-year complete occlusion rate was 87%. Vascular clinical severity score and venous disability score improved at 1 year to 1.08±0.85 versus 4.03±1.88 (P<0.0001) and 0.60±0.545 versus 1.55±0.552 (P<0.0001), respectively, compared with preoperative values. All treated CEAP-6 patients showed complete healing of their ulcers postoperatively.
Conclusion RFA is an effective and safe procedure, with satisfactory technical success, closure rates, and symptom improvement. The procedure could be performed in centers with initial experience in endovenous thermal ablation, provided careful commitment to the procedure steps and guiding supervision.
Keywords: Initital experience, radiofrequency ablation, varicose veins, venous reflux
|How to cite this article:|
Taha AG, Elbadawy AH, Hasaballah AE. Endovenous radiofrequency ablation of lower extremity varicose veins: short-term outcomes of the initial experience. Egypt J Surg 2018;37:185-90
|How to cite this URL:|
Taha AG, Elbadawy AH, Hasaballah AE. Endovenous radiofrequency ablation of lower extremity varicose veins: short-term outcomes of the initial experience. Egypt J Surg [serial online] 2018 [cited 2018 Jun 21];37:185-90. Available from: http://www.ejs.eg.net/text.asp?2018/37/2/185/233589
| Introduction|| |
Chronic venous disease (CVD) is a common health problem that affects approximately one-quarter of the adult population . The increasing morbidity of untreated varicose vein disease can extend from the usual symptoms such as cosmetic disfigurement, leg pain, and edema to the most serious complications such as bleeding varices and venous ulcers. After decades of considering open surgery [ligation of the saphenofemoral junction (SFJ) and stripping of the great saphenous vein (GSV)] as the sole treatment of venous truncal reflux, the advent of the less invasive endovenous ablation has become the recommended first-line treatment of saphenous vein reflux if the patient is candidate for vein ablation ,,.
Radiofrequency ablation (RFA) has many advantages over the conventional surgery as it can be safely performed in an office-based setting under local anesthesia with less postoperative pain, faster return to full activity , and excellent success rates . RFA, however, has shown to have higher rates of primary failure and superficial thrombophlebitis than surgery ,,, and it may develop serious complications such as skin burns especially during the learning curve of the surgeon’s experience . Therefore, the aim of the present study was to evaluate safety and effectiveness of RFA procedures in the treatment of GSV reflux during our initial experience.
| Materials and methods|| |
The present study is a retrospective review of the vascular registry at Assiut University Hospital (a tertiary referral hospital). The study was approved by the Institutional Review Board of the Faculty of Medicine, Assiut University. All study patients were informed and consented to the RFA procedure upon presentation for treatment.
The study included all patients with symptomatic lower extremity varicose veins of clinical, etiological, anatomical, physiological (CEAP)  class 2–6 who received endovenous RFA at the Department of Vascular and Endovascular Surgery, Assiut University Hospital, to treat refluxing GSVs between 2014 and 2016.
All patients underwent detailed clinical examination at the outpatient clinics to evaluate the severity of symptoms [including a baseline venous clinical severity score (VCSS) and venous disability score (VDS) assessment] . Duplex ultrasound (DUS) examination of the superficial and deep venous systems in both lower limbs was done by the vascular surgeon to measure diameters of the GSV and their reflux time. Patients with suspected abdominal or pelvic venous pathology, deep venous reflux, superficial or deep venous thrombosis, reflux time shorter than 0.5 s, or saphenous vein diameters less than 5 mm or more than 12 mm were excluded from RFA. The study also excluded patients who received previous varicose vein procedures, GSVs that are located within 10 mm distance under the skin, and patients with duplication of the GSV or concomitant reflux in the short or in the anterior accessory saphenous veins.
Under direct supervision of experienced vascular surgeons in endovenous thermal ablation, all RFA procedures in the study were performed by vascular surgeons with a recent experience in endovenous thermal ablation. According to our protocol, RFA is done under local infiltration anesthesia in the operating rooms. We do not use a preoperative prophylactic heparinization. While patients are in supine position, an ultrasound (US)-guided puncture to the GSV is achieved percutaneously below or at the knee level using a micropuncture needle. Over a soft guidewire, a 7-French (F) sheath is secured into the GSV. RFA catheter (ClosureFast; VNUS Medical Technologies, San Jose, California, USA) is advanced from the knee level toward the groin. With the aid of US imaging, the catheter tip is positioned 2–3 cm distal to the SFJ. Tumescent anesthesia (500 ml of 0.9% saline, 50 ml of 1% xylocaine with 1 : 100000 epinephrine, 5 ml of 8.4% sodium bicarbonate 1%) is then injected with a spinal needle around the vein and along the segment to be ablated. The desirable amount of the injected tumescent anesthesia and its precise location in the saphenous compartment are guided by the US imaging.
While the vein is compressed by the DUS transducer probe, the vein is ablated in a groin-to-knee direction. The RF catheter heats a 7-cm segment of the vein to 120° in a 20-second cycle. The most proximal segment is treated with two heating cycles, whereas each distal segment is treated once. At the end of the procedure, a completion US examination of the ablated vein is done to confirm a complete closure of the vein and to exclude any thrombus protrusion into the deep veins. RFA was supplemented with phlebectomy of the small varicosities that were marked preoperatively.
At the end of the procedure, a thigh-high class-3 graded compression stocking is applied. The patient is discharged to home on the same day. The patient is advised to ambulate early after the procedure and to use the stocking day and night for 2 days and then by day only for an additional week.
The first follow-up clinical and DUS examination is typically scheduled on the seventh postoperative day and then after 6 and 12 months postoperatively. Day 7 follow-up is aimed to assess technical success defined as complete ablation of the GSV starting at the 2 cm segment distal to the SFJ till the end of the treated vein with complete absence of color flow Doppler signals.
Partial technical failure is considered when the GSV is completely occluded with a residual patent vein stump of 3 cm or longer distal to the SFJ.
DUS follow-up (sixth and 12th month) examination of the treated vein is categorized into one of the following grades: (1) complete occlusion of the treated vein, (2) asymptomatic recanalization, where the treated vein shows one or more competent recanalization segments without clinical recurrence of varicose veins, (3) symptomatic recanalization, where the recanalization segment(s) were found to be incompetent or associated with clinical recurrence of varicose vein, and (4) complete recanalization of the treated vein. Finally, 12-month VCSS and VDS assessments for included patients were performed.
Our primary end point is achievement of total closure of the ablated GSV (technical success). Failure to access the vein percutaneously or to pass the guidewire, or detection of postoperative residual patent vein segment of 5 cm length (or longer) is considered a technical failure and will be excluded from the follow-up analysis. Delayed patency of a vein segment after an initially successful occlusion is considered a recanalization.
Secondary endpoints included complications (sensory affection and wound and skin problems), improvement in VCSS and VDS values, appearance of varicose veins on follow-up, or the requirement for re-intervention to treat residual or recurrent varicose veins.
Statistical analysis was performed using SPSS 24.0 (SPSS Inc., Chicago, Illinois, USA). Descriptive statistics were used, with continuous variables expressed as mean±SD or median and interquartile range, and categorical variables as frequencies and percentages. Student’s t-test was used to test the difference between the mean of VCSS and VDS score preoperatively and 1 year after the intervention. A value of P less than 0.05 was considered to be statistically significant. Freedom from any recanalization or symptom recurrence was assessed by Kaplan–Meier estimation.
| Results|| |
Between March 2014 and March 2016, 44 patients (47 limbs) underwent RFA procedures to treat symptomatic reflux of the GSV. All limbs that needed stab phlebectomies (n=22) were performed during the same RFA session. Baseline characteristics and CEAP classification for study patients are shown in [Table 1].
|Table 1 Baseline patient characteristics and distribution according to clinical, etiological, anatomical, physiological classification|
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Successful GSV closure using RFA was achieved in 46 limbs resulting in a technical success rate of 97.9%. Technical failure occurred in one limb, and the patient was successfully treated with surgical ligation of the SFJ and stripping of the GSV after 5 weeks.
Our perioperative complications ([Table 2]) included postoperative paresthesia in five (10.6%) limbs, ecchymosis in three (6.4%), phlebitis in three (6.4%), and hyperpigmentation in one (2.1%). There was no postprocedural deep venous thrombosis, endovenous heat-induced thrombosis (EHIT), pulmonary embolism, or procedure-related mortality. None of the patients experienced postprocedural skin thermal injuries, hematomas, infections, or required hospitalization beyond the day of intervention.
|Table 2 Periprocedural complications of radiofrequency ablation-treated limbs|
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A total of 38 (40 limbs) patients completed the 1-year follow-up. Symptom relief at 1 year was judged by the significant improvement in VCSS and VDS scores as compared with their preoperative values (1.08±0.85 vs. 4.03±1.88, P<0.0001, and 0.60±0.545 vs. 1.55±0.552, P<0.0001, respectively). All five patients with active venous ulcers showed a complete ulcer healing on follow-up, with a mean ulcer healing time of 2 months.
Follow-up DUS examination was done to the treated limbs to assess the rate of GSV recanalization after RFA procedures ([Table 3]). At 6 months, 40 limbs (of 42) continued to have total occlusion of the treated GSV. Of the two GSV racanalizations, one limb was symptomatic with recurrent leg varicosities ([Figure 1]) and was successfully treated with duplex-guided foam sclerotherapy. The other limb showed an asymptomatic recanalization of a vein segment that did not require any further treatment.
|Table 3 Outcome of radiofrequency ablation-treated limbs on duplex follow-up examination|
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|Figure 1 Kaplan–Meier survival curve demonstrating probability of great saphenous vein recanalization associated with symptom recurrence.|
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At 1 year, 36 limbs of the examined 40 limbs maintained a complete closure of the GSV, resulting in a cumulative complete occlusion rate of 87% ([Table 3], [Figure 2]). Two limbs showed asymptomatic reflux in recanalized vein segments (grade 2) and required no additional treatment. The remaining two limbs showed recurrent varicosities ([Figure 1]) owing to recanalization of vein segments (grade 3) and were all treated with duplex-guided foam sclerotherapy.
|Figure 2 Kaplan–Meier survival curve demonstrating probability of great saphenous vein freedom from any recanalization.|
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Overall, throughout all time points of follow-up in the study, there were six limbs that were found to have delayed recanalization after an initially successful RFA procedure. Of those, only three limbs that had grade 3 recanalization associated with symptom recurrence and were successfully retreated with duplex-guided foam sclerotherapy.
| Discussion|| |
Endovenous thermal ablation of incompetent GSV has been met with widespread consideration by vascular interventionists. Newer catheter generations, improved technical expertise, and available patient reimbursement all contributed to increased number of these minimally invasive procedures. The scientific evidence for the treatment of refluxing GSV in patients with CVD strongly recommends endovenous thermal ablation in preference to surgery as demonstrated in clinical practice guidelines of the Society of Vascular Surgery, the American Venous Forum , the European Society for Vascular Surgery , and NICE guidelines .
The current study is a retrospective analysis of patients presented with CVD who underwent RFA of incompetent GSV at a tertiary referral hospital. The aim was to evaluate short-term outcomes of this technique performed by interventionists in early time points of their learning curve. However, all procedures were performed under direct supervision of experienced vascular surgeons.
A total of 47 limbs received RFA treatment of refluxing GSV in the current series. Concurrent phlebectomy was performed in 22 (46.8%) limbs. Technical success rate was 97.9% (46/47). DUS examination in the follow-up period identified six limbs with grades 2 and 3 recanalization, reporting a 1-year cumulative occlusion rate of 87%. Recurrent varicose veins were observed in three limbs with a 93.5% cumulative rate of freedom from symptom recurrence.
The reported total occlusion rate using the first-generation RFA device ranged from 75 to 92%, with a partial occlusion rate of between 7 and 26% ,,. Previous studies demonstrated early occlusion rates of 99.6% using the ClosureFast device in 194 patients , 88.7% at 1 year , and 92.4% at 180 days . Nicolini reported a total occlusion rate of 81% and varicose vein free rate of 90.1% at 1 year after RFA using the first-generation device in 330 limbs .
Of the ablated 47 veins in the current study, one limb failed the RFA procedure and was treated with surgical ligation of the SFJ and stripping of the GSV. Technical failure could be attributed to following a wrong technique or missing steps starting with detailed preoperative duplex vein mapping, ideal catheter positioning with optimal visualization, effective tumescence application around all vein segments, and inadequate limb position trying to empty the vein from blood.
In the current cohort, duplex follow-up demonstrated that recurrent varicose veins were noticed in relation to recanalization of incompetent vein segments with absence of neovascularization at the groin. Few studies described neovascularization as an important risk factor for symptom recurrence following high SFJ ligation and GSV stripping operations that may reach 45% at 2 years ,.
Our most frequent complication was paresthesia (10.6%), ecchymosis (6.4%), phlebitis (6.4%), and hyperpigmentation (2.1%). We have not observed any incidents of EHIT or pulmonary embolisms in our patients. Reported EHIT varies from 0 to 16% . Its risk is higher in patients with documented thrombophilia, previous history of DVT, obesity, or old age ,. The newer ClosureFast catheter (VNUS Medical Technologies) and early ambulation were linked to fewer adverse effects .
The current study patients demonstrated a significant clinical improvement after RFA as seen with healing of venous ulcers along with the improvement of VCSS and VDS score from 4.03±1.88 to 1.08±0.85, P value less than 0.0001, and from 1.55±0.552 to 0.60±0.545, P value less than 0.0001, respectively. Our results compare favorably with reported results in several studies ,,.
Our study limitations could be the small sample size and the short follow-up period as we are reporting our initial experience. The retrospective design limited the availability of our retrieved data. We have not included analysis for pain assessment either intraprocedurally or postprocedurally, mean BMI, or for the proximity of the closure level to the SFJ, which is considered as an important factor for EHIT.
| Conclusion|| |
RFA is a simple and safe procedure. The technique is effective with satisfactory technical success and closure rates leading to a significant symptomatic improvement. The procedure could be performed in centers with initial experience in endovenous thermal ablation, provided careful commitment to the procedure steps and the guiding supervision.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]