- Email: [email protected]
Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter
+Model
ARTICLE IN PRESS
DIII-803; No. of Pages 8
Diagnostic and Interventional Imaging (2016) xxx, xxx—xxx
ORIGINAL ARTICLE /Vascular and interventional imaging
Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter A. Nayman a,∗, I. Yildiz b, N. Koca c, S. Deniz d, M. Koplay a, L. Oguzkurt e a
Selcuk University, Faculty of Medicine, Department of Radiology, 42080 Konya, Turkey Medicana Camlica Hospital, Department of Interventional Radiology, Istanbul, Turkey c Baskent University, Adana Teaching and Medical Research Center, Department of Radiology, Adana, Turkey d Acibadem University, Faculty of Medicine, Department of Radiology, Istanbul, Turkey e Koc University Hospital, Department of Interventional Radiology, Istanbul, Turkey b
KEYWORDS Saphenous vein; Venous insufficiency; Varicose veins; Radiofrequency catheter ablation
∗
Abstract Purpose: The purpose of this study was to determine the occlusion rate of incompetent great saphenous veins (GSVs) and small saphenous veins (SSVs) treated with radiofrequency ablation (RFA) and individualize variables associated with recanalization. Materials and methods: A retrospective review of 311 veins (256 GSVs and 55 SSVs) in 211 patients [177 women, 34 men; mean age, 45 years ± 12 (SD) (range: 18—75 years)] with incompetent GSVs and/or SSVs who were treated using new-generation RFA catheters was performed. The clinical results, occlusion rates, and variables associated with recanalization for the incompetent GSVs and SSVs were analyzed. Results: No major complications were observed in the study population. Ten months after RFA, the occlusion rate was 89% (227/256) for GSVs and 91% (50/55) for SSVs. An increased preprocedure diameter of the incompetent GSVs was associated with a higher rate of recanalization (OR: 0.825; 95% CI: 0.715—0.952) (P < 0.05). No significant differences in age, gender, and side of treated veins were found between patients with recanalization of treated veins and those without recanalization. Conclusion: Our results show that pre-procedure diameter of the GSV is the single risk factor for recanalization after RFA. © 2016 Editions franc ¸aises de radiologie. Published by Elsevier Masson SAS. All rights reserved.
Corresponding author. E-mail address: [email protected] (A. Nayman).
http://dx.doi.org/10.1016/j.diii.2016.06.003 2211-5684/© 2016 Editions franc ¸aises de radiologie. Published by Elsevier Masson SAS. All rights reserved.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
2
A. Nayman et al.
Varicose veins affect almost 25% of Western adults [1]. Until recently, the preferred treatment has been surgery involving high ligation and stripping of the saphenous veins [2—4]. However, substantial morbidity and inconveniences have been reported after surgery [2,5]. In the last decade, alternative minimally invasive treatments, such as endovenous thermal ablation of the saphenous veins using endovenous laser ablation (EVLA), radiofrequency ablation (RFA), or mechanochemical ablation (MOCA), have been introduced [2,6—10]. Endovenous techniques have been recommended for the treatment of saphenous incompetence by the Society for Vascular Surgery and the American Venous Forum because they are safer, more effective, require a shorter recovery time, involve less pain, and yield less morbidity than open surgery [4]. Furthermore, the National Institute for Health and Care Excellence in the United Kingdom has recommended endothermal ablation (RFA or EVLA) as the first-line treatment for saphenous incompetence, followed by ultrasound-guided foam sclerotherapy when endothermal ablation is unsuitable, with surgery being the last option when foam sclerotherapy is unsuitable [11]. Whereas the occlusion rates of RFA reported in the literature are often > 90%, the factors that could affect post-procedure recanalization have been rarely reported [12—18]. To date only two English-language studies are available regarding factors associated with recanalization for saphenous veins treated with the new-generation RFA device using the ClosureFASTTM catheter (Covidien, Mansfield MA, USA). Calcagno et al. evaluated the great saphenous vein (GSV) and the small saphenous vein (SSV) [13]. These researchers reported that vein diameters > 12 mm had no effect on closure rate with the ClosureFASTTM catheter for the GSV [13]. The purpose of this retrospective study was to determine the occlusion rates of incompetent GSVs and SSVs treated with RFA and individualize the factors associated with recanalization of incompetent saphenous veins after RFA.
Material and methods Patients A retrospective study was conducted on a cohort of 211 consecutive patients who underwent saphenous vein thermal ablation via endovenous RFA between June 2013 and July 2014. There were 177 women and 34 men, with a mean age of 45 years ± 12 [standard deviation (SD)], (range: 18—75 years). Patient demographics and clinical data are reported in Table 1. Demographic, procedural, and follow-up data were obtained from the hospital charts. All patients had cosmetic or clinical complaints of varicose veins with documented saphenous vein incompetence. Patients older than 18 yearold with symptomatic GSV/SSV incompetence were enrolled in the study. Patients with any of the following criteria were excluded from the study: allergy to the sclerosing agent, thrombus in the vein of interest or deep vein thrombosis, deep venous reflux, previous surgical or nonsurgical SV treatment, significant peripheral arterial disease, pulmonary
Table 1
Characteristics of the study population. Number
Total number of limbs/total number of veins Number of patients Gender Women Men Age (years) Clinical presentation C 1—3a C 4—6a
276/311 211 177 (84%) 34 (16%) 45 ± 12 (SD) [18—75] 264/311 (85%) 47/311 (15%)
a
C corresponds to the ‘‘C’’ component of CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic).
embolism, pregnancy, or known malignancy. The study protocol was approved by the local ethics committee.
Pre-procedure evaluation Baseline examinations, including color Doppler ultrasonography (CDUS) and a brief, focused physical examination, were performed at the outpatient clinic. Insufficiency of the truncal veins was evaluated using US (Antares; Siemens, Erlangen, Germany) with a linear multifrequency transducer (9.4- or 13.5-MHz), and the CDUS exams were performed in the standing position. The superficial (GSVs, SSVs, and other truncal) veins and deep (femoral and popliteal) veins were evaluated in detail for the presence of insufficiency or previous venous thrombosis. The diameters of GSVs and SSVs were measured 3—5 cm below the saphenofemoral junction (SFJ) or the saphenopopliteal junction (SPJ), in the standing position. Reflux with a duration of > 0.5 s in the superficial veins or > 1 s in the deep veins while squeezing and releasing (or performing the Valsalva maneuver) was considered to be pathological. In addition, a venous map of the related leg was obtained via CDUS. The goal of the CDUS evaluation was to map out all the incompetent venous pathways responsible for the patient’s condition. Such a map is necessary to determine the best combination of treatments appropriate for eliminating the abnormal refluxing veins while preserving the normal veins. Patients on antiplatelet therapy (e.g., acetylsalicylic acid, clopidogrel) and chronic anticoagulation therapy (e.g., warfarin) were instructed to continue taking the medication through the perioperative period.
Procedure All procedures were performed in the interventional radiology treatment room. Legs were prepared in a sterile fashion before the procedure. The patient was then placed supine or prone (depending on the saphenous veins treated) on the table, allowing full access to the treated segments. All procedures were performed under local anesthesia supplemented with intravenous sedation and analgesia using dormicum and fentanyl citrate. Most commonly, the
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
Risk factors associated with recanalization of incompetent saphenous veins insufficient GSV was punctured at just below the knee level because of its large diameter, linear course, and the smaller risk of nerve injury. The SSV was punctured as distally as identifiable using US, usually at the distal third of the SSV. After successful puncture of the vein with a micropuncture needle (Cook Medical), a 0.018-inch guidewire was inserted into the vein (Fig. 1), which was then exchanged with a 0.035-inch standard guidewire through the 4F dilator of the micropuncture set. A 6-F vascular sheath was advanced over the guidewire. The RF catheter was then inserted and parked 2 cm distal to the SFJ or SPJ. US guidance was used to confirm the correct placement of the ClosureFAST® catheter with a 7-cm heating element (Figs. 2 and 3). Next, tumescent anesthesia was applied around the saphenous vein under US guidance (Fig. 4) by means of a power pump (Klein pump). Normal saline (500—1000 mL) and prilocaine 2% (10—20 mL) were used for tumescent anesthesia. tumescent anesthesia has three major benefits. The first is that tumescent anesthesia surrounds and compresses the vein walls around the RFA catheter, ensuring circumferential contact. Additionally, it reduces pain, and tumescent fluid also protects perivenous tissue, including skin, nerves, arteries, or the deep veins via cooling effect. After tumescent anesthesia, RFA was performed with an intraluminally placed RFA catheter. For GSV insufficiency treatment, after positioning the catheter tip 2 cm from the SFJ, segmental energy delivery at 120 ◦ C was delivered in 20-second cycles. Two cycles were applied to the first part of the proximal vein, followed by one cycle to the remaining venous segments. In patients with bilateral incompetent saphenous veins, both of the GSVs and SSVs were treated in the same session. Further ultrasound-guided foam sclerotherapy was performed, if deemed necessary, at the same session. Polidocanol 1% and 2% (Aethosclerol; Kreussler Pharma, Wiesbaden, Germany) foamed in a ratio of 1:3 with air was mixed using a stopcock and a 5- and 2-mL syringe with not fewer than 20 passages using the Tessari technique [19]. We injected the foam to varicose tributaries and reticular varices with 22- to 25-Gauge needles, and the total of injected polidocanol volume was 1—5 mL in one session. Polidocanol 0.5% was injected with a 30-Gauge needle without air mixture for telangiectasias.
3
Post-procedure The patients were advised to use nonsteroidal antiinflammatory medications for pain, to wear class II stockings (30—40 mmHg) for three weeks, and to abstain from heavy exercise for the first week. The retrospective data, including the characteristics and complaints (leg pain, fatigue, heaviness, swelling, burning sensation, night cramps, itchiness, varices, and numbness) of the patients, were evaluated. The Clinical, Etiologic, Anatomic, Pathophysiologic (CEAP) scores and venous clinical severity scores were documented for each limb and compared before and after the procedure. The insufficiency and the diameter of the GSVs and SSVs were extracted from the CDUS examination reports, and the CDUS was used to evaluate all the saphenous veins in the limbs treated with RFA. If a saphenous vein was recanalized with insufficiency upon follow-up, the decision for treatment was based on the patient’s complaints.
Definition of criteria Technical success of RFA was defined as complete closure of the ablated length of the target vein with no visible flow on CDUS (Fig. 5). Failed treatment (i.e., recanalization) was defined as a patent venous segment of any length of the ablated target vein (Fig. 6), with or without reflux, according to the Society of Interventional Radiology [20]. Complications were considered to be major if they required re-intervention or admission to the hospital, or if they led to permanent adverse sequelas or death.
Statistical analysis Statistical Package for the Social Sciences software (SPSS for Windows, version 17.0; SPSS Inc., Chicago, IL, USA) was used to perform all statistical analyses. The data were expressed as mean ± SD for continuous variables and as proportions and percentages (%) for categorical variables. A logistic regression analysis was used to identify the risk factors associated with recanalization of the truncal veins. The results were evaluated at the 95% confidence interval (95% CI). A Pvalue < 0.05 was considered as significant.
Figure 1. Ultrasound images show venous puncture and guidewire insertion: a: the puncture of the vein is performed with a micropuncture needle (arrow) under ultrasonographic guidance; b: the guidewire (arrow) is inserted into the vein.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
4
A. Nayman et al.
Results
Figure 2. Photograph shows the 100-cm length radiofrequency ablation catheter (ClosureFASTTM , Covidien, Mansfield MA, USA) (black arrows) with a distal 7-cm heating element (white arrow).
The technical success rate in this study was 100%. The most common leg complaints prior to the RFA procedure were pain (n = 174), fatigue (n = 160), heaviness (n = 147), swelling (n = 127), burning (n = 124), night cramps (n = 123), itchiness (n = 96), and numbness (n = 61). RFA was performed on 311 veins in 211 patients. The preoperative mean diameters of the GSVs and SSVs were 6.8 mm ± 2.9 (SD) (range: 2.1 mm—19 mm) and 3.8 mm ± 2.3 (SD) (range: 1.5 mm—18 mm), respectively (Table 2). All insufficient saphenous veins of each patient were treated in a single session. UGFS was performed in 190 patients (90%), most for reticular varices and telangiectasias. The total volume of injected polidocanol (Aethoxysklerol; Kreussler Pharma, Wiesbaden, Germany) was 1—5 mL in one session. RFA and concomitant ultrasoundguided foam sclerotherapy were technically successful in all patients. Minor complications after the RFA procedures included pain in 19/211 patients (9%), bruising in 15/211 patients (7.1%), and induration along the course of the ablated vein in 13/211 patients (6.2%). Telangiectatic matting along the course of the GS was observed in 2/211patients (0.9%) and dysesthesia in 3/211 patients (1.4%). No major complications, such as skin burn, deep vein thrombosis, or superficial thrombophlebitis, occurred.
Table 2 Number and diameters of 311 treated saphenous veins in 211 patients.
Figure 3. Ultrasonographic image shows the tip of the catheter (arrow) approximately 2-cm distal from the saphenofemoral junction. GSV: great saphenous vein; SFJ: saphenofemoral junction; FV: femoral vein.
Total number of treated veins Treated single GSV Treated single SSV Treated both GSV and SSV Preoperative mean diameter of GSVs Preoperative mean diameter of SSVs
311 (n = 211 patients) 221 20 70 6.8 mm ± 2.9 (SD) (2.1 mm—19 mm) 3.8 mm ± 2.3 (SD) (1.5 mm—18 mm)
GSV: great saphenous vein; SSV: small saphenous vein. Numbers in brackets are ranges.
Figure 4. a: ultrasonographic image of the saphenous vein shows catheter in the vein; b: after tumescent anesthesia, fluid is visible around the vein.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
Risk factors associated with recanalization of incompetent saphenous veins
5
Figure 5. Ultrasound images at one-month after the procedure. (a) Long-axis ultrasonographic and (b) short-axis Doppler ultrasonographic appearance of the treated saphenous vein. Complete closure of the ablated vein with a lack of flow is consistent with technical success.
Follow-up was performed in 211 patients. The mean follow-up was 6 months ± 4 (SD) (range: 1—27 months). The occlusion rate of the truncal veins was evaluated with CDUS in 311 veins (276 limbs) of 211 patients. Recanalization was detected in 34 (29 GSV, 11% and 5 SSV, 9%) of the 311 truncal veins. The occlusion rates were 89% (227/256) for the GSVs and 91% (50/55) for the SSVs (Fig. 7). Recanalization was used for definition of treatment failure as a Doppler definition. Recanalization was not symptomatic in all cases, and not all patients with recanalization were retreated. Recanalizations in 13/29 GSVs and 2/5 SSVs were not treated because of the absence of reflux (Fig. 8). In those patients, recanalization was in a short segment of the vein (3—11 cm), and the patients had no complaints. Success rate without
recurrent reflux was 94% and 94.5% for GSVs and SSVs, respectively. Logistic regression analysis found no associations between age, gender, limb side, follow-up time and diameter of the incompetent SSV with occlusion rates. However, the increased diameter of the incompetent GSV was associated with a lower occlusion rate (OR: 0.825; 95% CI: 0.715—0.952) (P < 0.05) (Table 3).
Discussion The results of our study show that an increased diameter of incompetent GSVs is associated with a lower occlusion rate,
Figure 6. (a) Long- and (b) short-axis ultrasonographic appearance of the treated saphenous vein one month after the procedure. A short patent segment of treated vein is consistent with treatment failure (recanalization).
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
6
A. Nayman et al.
Figure 7. Obliteration rates in radiofrequency of incompetent (a) great and (b) small saphenous veins. GSV: great saphenous vein; SSV: small saphenous vein.
but not for SSVs. No associations were found between the occlusion rate and gender, limb side, and follow-up times for GSVs and SSVs. All incompetent GSVs and SSVs were treated successfully with RFA, and significant improvements were observed in the clinical and cosmetic complaints of all treated patients. In our study, no major complications, such as postoperative endovenous heat-related deep vein thrombosis or superficial thrombophlebitis, were observed. Of note, telangiectatic matting along the course of the GSV occurred in only two patients after RFA. Only one case report has been published in the literature regarding secondary telangiectasia after RFA [21]. RFA is a safe treatment technique for incompetent saphenous veins with low complication rates. An important point is the choice of endovascular techniques: RFA, EVLA, or MOCA. In a meta-analysis, van den Bos et al. indicated that EVLA was superior in terms of anatomic success at one to five years of follow-up [22]. The more recent randomized, clinical trial of Rasmussen
et al. reported that RFA using the ClosureFASTTM catheter yielded results that were at least similar to those of EVLA. In that trial, RFA was associated with significantly less postprocedural pain than EVLA [2]. Reduced postoperative pain and bruising were the major advantages of RFA over other endovenous thermal procedures. Postoperative pain and bruising are thought to be the results of vein wall perforation. Meissner et al. demonstrated that vein wall perforation occurs more frequently during EVLA than during RFA procedures. The temperature sensor on the RFA catheter and the related temperature feedback mechanism ensure homogenous and controlled delivery of the radiofrequency energy to the vein wall, which prevents overheating of the vein wall and subsequent perforation [23,24]. Another important consideration in choosing ClosureFASTTM catheter is the uniformity of the technique; with EVLA, discussions about different tip designs and wavelengths might occur [9]. ClosureFASTTM catheter results in faster treatment time, and every 20 seconds the catheter is segmentally withdrawn for 7 cm [25]. Markovic and Shortell concluded that the new ClosureFASTTM catheter is an important advancement
Table 3
Figure 8. Patients and treated veins flowchart. Of 211 patients with 311 veins enrolled in the study, recanalization was observed in 34 veins. There were no recurrences in 277 veins (227 GSVs and 50 SSVs). GSV: great saphenous vein; SSV: small saphenous vein.
Results of logistic regression analysis.
Treated vein
P
Odds ratio [95% CI]
GSV Side (R-L)
0.367
Diameter
0.008
Follow-up (month)
0.391
0.646 [0.250—1.668] 0.825 [0.715—0.952] 1.066 [0.921—1.235]
SSV Side (R-L)
0.998
Diameter
0.752
Follow-up (month)
0.728
256735727.594 [0—+∞] 1.086 [0.650—1.815] 0.927 [0.604—1.422]
95% CI: 95% confidence interval; GSV: great saphenous vein; SSV: small saphenous vein; R: right limb; L: left limb.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
Risk factors associated with recanalization of incompetent saphenous veins that combines the speed of EVLA with the expected fewer side effects of RFA [24]. In a meta-analysis Dermody et al. showed that thermal skin burns with RFA occur no more frequently than with EVLA [26]. When comparing RFA with the new MOCA technique, it seems that MOCA is less painful and patients return to work more quickly. However, after more than two years of follow-up, MOCA has not yet proven to be as capable as RFA in terms of clinical and anatomic results [10,16]. Based on findings from this study and the review of the literature, the authors concluded that the new ClosureFASTTM catheter might be the gold standard treatment today in such a setting, and the technique is reimbursed in France. Encouraging occlusion rates (94.1—99.6% for GSVs and 89.1—100% for SSVs) of saphenous veins after RFA have been reported in several studies via a new-generation RFA device using the ClosureFASTTM catheter [12—18]. Although several studies regarding the occlusion rate of saphenous veins were available, only two studies discussed the probable risk factors of occlusion rate with the ClosureFASTTM catheter. One study reported that vein diameters > 12 mm were not correlated with the closure rate achieved with the ClosureFASTTM catheter. However, the types of saphenous veins (GSV or SSV) were not differentiated in that study [13]. In the present study, the increased GSV diameter was associated with a low occlusion rate, but the same was not true of the SSV. Another study evaluated the factors that can affect postoperative SSV recanalization and found that the single significant variable was preoperative peak reflux velocity [27]. In our study, preoperative peak reflux velocity and total length of ablation were not evaluated because of the retrospective nature of the study. In our study, the follow-up time, the side of the treated vein, and the age and gender of the patients were evaluated as potential risk factors for recanalization rate. Those factors were not discussed in previous studies. Large GSV diameter increased the risk of recanalization, and some of these patients required re-treatment. For this reason, the measurement of the insufficient vein diameter in the baseline US examination is very important. More than two cycles for the first part of the proximal vein followed by more than one cycle to the remaining venous segments might be useful for these large insufficient veins. The limitations of our study are its retrospective design and the short follow-up time. Our study included a small sample size of treated SSVs, potentially limiting the statistical power of the results. In addition, recanalization might be affected by large perforators in the thigh, but those veins were not evaluated during routine mapping. Further studies with a larger number of patients are indicated to confirm the observations of the present study. In conclusion, the results of our study show that RFA is a safe and effective modality for treating incompetent varicose veins. We found that the single significant risk factor for recanalization was an enlarged preoperative diameter of the GSV. On the opposite, the preoperative diameter of the SSV does not affect the occlusion rate.
Disclosure of interest The authors declare that they have no competing interest.
7
References [1] Callam MJ. Epidemiology of varicose veins. Br J Surg 1994;81: 167—73. [2] Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011;98:1079—87. [3] Gloviczki P, Gloviczki ML. Guidelines for the management of varicose veins. Phlebology 2012;27:2—9. [4] Gloviczki P, Comerota AJ, Dalsing MC, Society for Vascular Surgery, American Venous Forum, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53: 2S—48S. [5] Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg 2012;44:214—23. [6] Choi JH, Park HC, Joh JH. The occlusion rate and patterns of saphenous vein after radiofrequency ablation. J Korean Surg Soc 2013;84:107—13. [7] Boon R, Akkersdijk GJ, Nio D. Percutaneus treatment of varicose veins with bipolar radiofrequency ablation. Eur J Radiol 2010;75:43—7. [8] Koroglu M, Eris HN, Aktas AR, et al. Endovenous laser ablation and foam sclerotherapy for varicose veins: does the presence of perforating vein insufficiency affect the treatment outcome? Acta Radiol 2011;52:278—84. [9] Boersma D, van Eekeren RR, Kelder HJ, et al. Mechanochemical endovenous ablation versus radiofrequency ablation in the treatment of primary small saphenous vein insufficiency (MESSI trial): study protocol for a randomized controlled trial. Trials 2014;15:421. [10] Witte ME, Reijnen MM, de Vries JP, Zeebregts CJ. Mechanochemical endovenous occlusion of varicose veins using the ClariVein® device. Surg Technol Int 2015;26:219—25. [11] Marsden G, Perry M, Kelley K, Davies AH, Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ 2013;347:f4279. [12] Kapoor A, Kapoor A, Mahajan G. Endovenous ablation of saphenofemoral insufficiency: analysis of 100 patients using RF closure fast technique. Indian J Surg 2010;72:458—62. [13] Calcagno D, Rossi JA, Ha C. Effect of saphenous vein diameter on closure rate with ClosureFASTTM radiofrequency catheter. Vasc Endovascular Surg 2009;43:567—70. [14] Nordon IM, Hinchliffe RJ, Brar R, et al. A prospective doubleblind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg 2011;254:876—81. [15] Monahan TS, Belek K, Sarkar R. Results of radiofrequency ablation of the small saphenous vein in the supine position. Vasc Endovasc Surg 2012;46:40—4. [16] Proebstle TM, Alm BJ, Gockeritz O, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Br J Surg 2015;102:212—8. [17] Proebstle TM, Alm J, Gockeritz O, et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities. J Vasc Surg 2011;54: 146—52. [18] Proebstle TM, Vago B, Alm J, Gockeritz O, Lebard C, Pichot O. Treatment of the incompetent great saphenous vein by
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
8
A. Nayman et al.
[19] [20]
[21]
[22]
endovenous radiofrequency-powered segmental thermal ablation: first clinical experience. J Vasc Surg 2008;47:151—6. Tessari L. Nouvelle technique d’obtention de la scléro-mousse. Phlebologie 2000;53:129. Kundu S, Lurie F, Millward SF, American Venous F, Society of Interventional Radiology, et al. Recommended reporting standards for endovenous ablation for the treatment of venous insufficiency: joint statement of The American Venous Forum and The Society of Interventional Radiology. J Vasc Surg 2007;46:582—9. Pavlovic MD, Adamic M, Schuller-Petrovic S. Secondary telangiectasia after radiofrequency closure of saphenous vein: a result of blocked outflow of a feeding vein? Phlebology 2012;27:265—6. van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a metaanalysis. J Vasc Surg 2009;49:230—9.
[23] Meissner OA, Schmedt CG, Hunger K, et al. Endovascular optical coherence tomography ex vivo: venous wall anatomy and tissue alterations after endovenous therapy. Eur Radiol 2007;17:2384—93. [24] Markovic JN, Shortell CK. Update on radiofrequency ablation. Perspect Vasc Surg Endovasc Ther 2009;21:82—90. [25] van Eekeren RR, Boersma D, de Vries JP, Zeebregts CJ, Reijnen MM. Update of endovenous treatment modalities for insufficient saphenous veins: a review of literature. Semin Vasc Surg 2014;27:118—36. [26] Dermody M, O’Donnell TF, Balk EM. Complications of endovenous ablation in randomized controlled trials. J Vasc Surg Venous Lymphat Disord 2013;1:427—36. [27] Park JY, Galimzahn A, Park HS, Yoo YS, Lee T. Midterm results of radiofrequency ablation for incompetent small saphenous vein in terms of recanalization and sural neuritis. Dermatol Surg 2014;40:383—9.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
ARTICLE IN PRESS
DIII-803; No. of Pages 8
Diagnostic and Interventional Imaging (2016) xxx, xxx—xxx
ORIGINAL ARTICLE /Vascular and interventional imaging
Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter A. Nayman a,∗, I. Yildiz b, N. Koca c, S. Deniz d, M. Koplay a, L. Oguzkurt e a
Selcuk University, Faculty of Medicine, Department of Radiology, 42080 Konya, Turkey Medicana Camlica Hospital, Department of Interventional Radiology, Istanbul, Turkey c Baskent University, Adana Teaching and Medical Research Center, Department of Radiology, Adana, Turkey d Acibadem University, Faculty of Medicine, Department of Radiology, Istanbul, Turkey e Koc University Hospital, Department of Interventional Radiology, Istanbul, Turkey b
KEYWORDS Saphenous vein; Venous insufficiency; Varicose veins; Radiofrequency catheter ablation
∗
Abstract Purpose: The purpose of this study was to determine the occlusion rate of incompetent great saphenous veins (GSVs) and small saphenous veins (SSVs) treated with radiofrequency ablation (RFA) and individualize variables associated with recanalization. Materials and methods: A retrospective review of 311 veins (256 GSVs and 55 SSVs) in 211 patients [177 women, 34 men; mean age, 45 years ± 12 (SD) (range: 18—75 years)] with incompetent GSVs and/or SSVs who were treated using new-generation RFA catheters was performed. The clinical results, occlusion rates, and variables associated with recanalization for the incompetent GSVs and SSVs were analyzed. Results: No major complications were observed in the study population. Ten months after RFA, the occlusion rate was 89% (227/256) for GSVs and 91% (50/55) for SSVs. An increased preprocedure diameter of the incompetent GSVs was associated with a higher rate of recanalization (OR: 0.825; 95% CI: 0.715—0.952) (P < 0.05). No significant differences in age, gender, and side of treated veins were found between patients with recanalization of treated veins and those without recanalization. Conclusion: Our results show that pre-procedure diameter of the GSV is the single risk factor for recanalization after RFA. © 2016 Editions franc ¸aises de radiologie. Published by Elsevier Masson SAS. All rights reserved.
Corresponding author. E-mail address: [email protected] (A. Nayman).
http://dx.doi.org/10.1016/j.diii.2016.06.003 2211-5684/© 2016 Editions franc ¸aises de radiologie. Published by Elsevier Masson SAS. All rights reserved.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
2
A. Nayman et al.
Varicose veins affect almost 25% of Western adults [1]. Until recently, the preferred treatment has been surgery involving high ligation and stripping of the saphenous veins [2—4]. However, substantial morbidity and inconveniences have been reported after surgery [2,5]. In the last decade, alternative minimally invasive treatments, such as endovenous thermal ablation of the saphenous veins using endovenous laser ablation (EVLA), radiofrequency ablation (RFA), or mechanochemical ablation (MOCA), have been introduced [2,6—10]. Endovenous techniques have been recommended for the treatment of saphenous incompetence by the Society for Vascular Surgery and the American Venous Forum because they are safer, more effective, require a shorter recovery time, involve less pain, and yield less morbidity than open surgery [4]. Furthermore, the National Institute for Health and Care Excellence in the United Kingdom has recommended endothermal ablation (RFA or EVLA) as the first-line treatment for saphenous incompetence, followed by ultrasound-guided foam sclerotherapy when endothermal ablation is unsuitable, with surgery being the last option when foam sclerotherapy is unsuitable [11]. Whereas the occlusion rates of RFA reported in the literature are often > 90%, the factors that could affect post-procedure recanalization have been rarely reported [12—18]. To date only two English-language studies are available regarding factors associated with recanalization for saphenous veins treated with the new-generation RFA device using the ClosureFASTTM catheter (Covidien, Mansfield MA, USA). Calcagno et al. evaluated the great saphenous vein (GSV) and the small saphenous vein (SSV) [13]. These researchers reported that vein diameters > 12 mm had no effect on closure rate with the ClosureFASTTM catheter for the GSV [13]. The purpose of this retrospective study was to determine the occlusion rates of incompetent GSVs and SSVs treated with RFA and individualize the factors associated with recanalization of incompetent saphenous veins after RFA.
Material and methods Patients A retrospective study was conducted on a cohort of 211 consecutive patients who underwent saphenous vein thermal ablation via endovenous RFA between June 2013 and July 2014. There were 177 women and 34 men, with a mean age of 45 years ± 12 [standard deviation (SD)], (range: 18—75 years). Patient demographics and clinical data are reported in Table 1. Demographic, procedural, and follow-up data were obtained from the hospital charts. All patients had cosmetic or clinical complaints of varicose veins with documented saphenous vein incompetence. Patients older than 18 yearold with symptomatic GSV/SSV incompetence were enrolled in the study. Patients with any of the following criteria were excluded from the study: allergy to the sclerosing agent, thrombus in the vein of interest or deep vein thrombosis, deep venous reflux, previous surgical or nonsurgical SV treatment, significant peripheral arterial disease, pulmonary
Table 1
Characteristics of the study population. Number
Total number of limbs/total number of veins Number of patients Gender Women Men Age (years) Clinical presentation C 1—3a C 4—6a
276/311 211 177 (84%) 34 (16%) 45 ± 12 (SD) [18—75] 264/311 (85%) 47/311 (15%)
a
C corresponds to the ‘‘C’’ component of CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic).
embolism, pregnancy, or known malignancy. The study protocol was approved by the local ethics committee.
Pre-procedure evaluation Baseline examinations, including color Doppler ultrasonography (CDUS) and a brief, focused physical examination, were performed at the outpatient clinic. Insufficiency of the truncal veins was evaluated using US (Antares; Siemens, Erlangen, Germany) with a linear multifrequency transducer (9.4- or 13.5-MHz), and the CDUS exams were performed in the standing position. The superficial (GSVs, SSVs, and other truncal) veins and deep (femoral and popliteal) veins were evaluated in detail for the presence of insufficiency or previous venous thrombosis. The diameters of GSVs and SSVs were measured 3—5 cm below the saphenofemoral junction (SFJ) or the saphenopopliteal junction (SPJ), in the standing position. Reflux with a duration of > 0.5 s in the superficial veins or > 1 s in the deep veins while squeezing and releasing (or performing the Valsalva maneuver) was considered to be pathological. In addition, a venous map of the related leg was obtained via CDUS. The goal of the CDUS evaluation was to map out all the incompetent venous pathways responsible for the patient’s condition. Such a map is necessary to determine the best combination of treatments appropriate for eliminating the abnormal refluxing veins while preserving the normal veins. Patients on antiplatelet therapy (e.g., acetylsalicylic acid, clopidogrel) and chronic anticoagulation therapy (e.g., warfarin) were instructed to continue taking the medication through the perioperative period.
Procedure All procedures were performed in the interventional radiology treatment room. Legs were prepared in a sterile fashion before the procedure. The patient was then placed supine or prone (depending on the saphenous veins treated) on the table, allowing full access to the treated segments. All procedures were performed under local anesthesia supplemented with intravenous sedation and analgesia using dormicum and fentanyl citrate. Most commonly, the
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
Risk factors associated with recanalization of incompetent saphenous veins insufficient GSV was punctured at just below the knee level because of its large diameter, linear course, and the smaller risk of nerve injury. The SSV was punctured as distally as identifiable using US, usually at the distal third of the SSV. After successful puncture of the vein with a micropuncture needle (Cook Medical), a 0.018-inch guidewire was inserted into the vein (Fig. 1), which was then exchanged with a 0.035-inch standard guidewire through the 4F dilator of the micropuncture set. A 6-F vascular sheath was advanced over the guidewire. The RF catheter was then inserted and parked 2 cm distal to the SFJ or SPJ. US guidance was used to confirm the correct placement of the ClosureFAST® catheter with a 7-cm heating element (Figs. 2 and 3). Next, tumescent anesthesia was applied around the saphenous vein under US guidance (Fig. 4) by means of a power pump (Klein pump). Normal saline (500—1000 mL) and prilocaine 2% (10—20 mL) were used for tumescent anesthesia. tumescent anesthesia has three major benefits. The first is that tumescent anesthesia surrounds and compresses the vein walls around the RFA catheter, ensuring circumferential contact. Additionally, it reduces pain, and tumescent fluid also protects perivenous tissue, including skin, nerves, arteries, or the deep veins via cooling effect. After tumescent anesthesia, RFA was performed with an intraluminally placed RFA catheter. For GSV insufficiency treatment, after positioning the catheter tip 2 cm from the SFJ, segmental energy delivery at 120 ◦ C was delivered in 20-second cycles. Two cycles were applied to the first part of the proximal vein, followed by one cycle to the remaining venous segments. In patients with bilateral incompetent saphenous veins, both of the GSVs and SSVs were treated in the same session. Further ultrasound-guided foam sclerotherapy was performed, if deemed necessary, at the same session. Polidocanol 1% and 2% (Aethosclerol; Kreussler Pharma, Wiesbaden, Germany) foamed in a ratio of 1:3 with air was mixed using a stopcock and a 5- and 2-mL syringe with not fewer than 20 passages using the Tessari technique [19]. We injected the foam to varicose tributaries and reticular varices with 22- to 25-Gauge needles, and the total of injected polidocanol volume was 1—5 mL in one session. Polidocanol 0.5% was injected with a 30-Gauge needle without air mixture for telangiectasias.
3
Post-procedure The patients were advised to use nonsteroidal antiinflammatory medications for pain, to wear class II stockings (30—40 mmHg) for three weeks, and to abstain from heavy exercise for the first week. The retrospective data, including the characteristics and complaints (leg pain, fatigue, heaviness, swelling, burning sensation, night cramps, itchiness, varices, and numbness) of the patients, were evaluated. The Clinical, Etiologic, Anatomic, Pathophysiologic (CEAP) scores and venous clinical severity scores were documented for each limb and compared before and after the procedure. The insufficiency and the diameter of the GSVs and SSVs were extracted from the CDUS examination reports, and the CDUS was used to evaluate all the saphenous veins in the limbs treated with RFA. If a saphenous vein was recanalized with insufficiency upon follow-up, the decision for treatment was based on the patient’s complaints.
Definition of criteria Technical success of RFA was defined as complete closure of the ablated length of the target vein with no visible flow on CDUS (Fig. 5). Failed treatment (i.e., recanalization) was defined as a patent venous segment of any length of the ablated target vein (Fig. 6), with or without reflux, according to the Society of Interventional Radiology [20]. Complications were considered to be major if they required re-intervention or admission to the hospital, or if they led to permanent adverse sequelas or death.
Statistical analysis Statistical Package for the Social Sciences software (SPSS for Windows, version 17.0; SPSS Inc., Chicago, IL, USA) was used to perform all statistical analyses. The data were expressed as mean ± SD for continuous variables and as proportions and percentages (%) for categorical variables. A logistic regression analysis was used to identify the risk factors associated with recanalization of the truncal veins. The results were evaluated at the 95% confidence interval (95% CI). A Pvalue < 0.05 was considered as significant.
Figure 1. Ultrasound images show venous puncture and guidewire insertion: a: the puncture of the vein is performed with a micropuncture needle (arrow) under ultrasonographic guidance; b: the guidewire (arrow) is inserted into the vein.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
4
A. Nayman et al.
Results
Figure 2. Photograph shows the 100-cm length radiofrequency ablation catheter (ClosureFASTTM , Covidien, Mansfield MA, USA) (black arrows) with a distal 7-cm heating element (white arrow).
The technical success rate in this study was 100%. The most common leg complaints prior to the RFA procedure were pain (n = 174), fatigue (n = 160), heaviness (n = 147), swelling (n = 127), burning (n = 124), night cramps (n = 123), itchiness (n = 96), and numbness (n = 61). RFA was performed on 311 veins in 211 patients. The preoperative mean diameters of the GSVs and SSVs were 6.8 mm ± 2.9 (SD) (range: 2.1 mm—19 mm) and 3.8 mm ± 2.3 (SD) (range: 1.5 mm—18 mm), respectively (Table 2). All insufficient saphenous veins of each patient were treated in a single session. UGFS was performed in 190 patients (90%), most for reticular varices and telangiectasias. The total volume of injected polidocanol (Aethoxysklerol; Kreussler Pharma, Wiesbaden, Germany) was 1—5 mL in one session. RFA and concomitant ultrasoundguided foam sclerotherapy were technically successful in all patients. Minor complications after the RFA procedures included pain in 19/211 patients (9%), bruising in 15/211 patients (7.1%), and induration along the course of the ablated vein in 13/211 patients (6.2%). Telangiectatic matting along the course of the GS was observed in 2/211patients (0.9%) and dysesthesia in 3/211 patients (1.4%). No major complications, such as skin burn, deep vein thrombosis, or superficial thrombophlebitis, occurred.
Table 2 Number and diameters of 311 treated saphenous veins in 211 patients.
Figure 3. Ultrasonographic image shows the tip of the catheter (arrow) approximately 2-cm distal from the saphenofemoral junction. GSV: great saphenous vein; SFJ: saphenofemoral junction; FV: femoral vein.
Total number of treated veins Treated single GSV Treated single SSV Treated both GSV and SSV Preoperative mean diameter of GSVs Preoperative mean diameter of SSVs
311 (n = 211 patients) 221 20 70 6.8 mm ± 2.9 (SD) (2.1 mm—19 mm) 3.8 mm ± 2.3 (SD) (1.5 mm—18 mm)
GSV: great saphenous vein; SSV: small saphenous vein. Numbers in brackets are ranges.
Figure 4. a: ultrasonographic image of the saphenous vein shows catheter in the vein; b: after tumescent anesthesia, fluid is visible around the vein.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
Risk factors associated with recanalization of incompetent saphenous veins
5
Figure 5. Ultrasound images at one-month after the procedure. (a) Long-axis ultrasonographic and (b) short-axis Doppler ultrasonographic appearance of the treated saphenous vein. Complete closure of the ablated vein with a lack of flow is consistent with technical success.
Follow-up was performed in 211 patients. The mean follow-up was 6 months ± 4 (SD) (range: 1—27 months). The occlusion rate of the truncal veins was evaluated with CDUS in 311 veins (276 limbs) of 211 patients. Recanalization was detected in 34 (29 GSV, 11% and 5 SSV, 9%) of the 311 truncal veins. The occlusion rates were 89% (227/256) for the GSVs and 91% (50/55) for the SSVs (Fig. 7). Recanalization was used for definition of treatment failure as a Doppler definition. Recanalization was not symptomatic in all cases, and not all patients with recanalization were retreated. Recanalizations in 13/29 GSVs and 2/5 SSVs were not treated because of the absence of reflux (Fig. 8). In those patients, recanalization was in a short segment of the vein (3—11 cm), and the patients had no complaints. Success rate without
recurrent reflux was 94% and 94.5% for GSVs and SSVs, respectively. Logistic regression analysis found no associations between age, gender, limb side, follow-up time and diameter of the incompetent SSV with occlusion rates. However, the increased diameter of the incompetent GSV was associated with a lower occlusion rate (OR: 0.825; 95% CI: 0.715—0.952) (P < 0.05) (Table 3).
Discussion The results of our study show that an increased diameter of incompetent GSVs is associated with a lower occlusion rate,
Figure 6. (a) Long- and (b) short-axis ultrasonographic appearance of the treated saphenous vein one month after the procedure. A short patent segment of treated vein is consistent with treatment failure (recanalization).
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
6
A. Nayman et al.
Figure 7. Obliteration rates in radiofrequency of incompetent (a) great and (b) small saphenous veins. GSV: great saphenous vein; SSV: small saphenous vein.
but not for SSVs. No associations were found between the occlusion rate and gender, limb side, and follow-up times for GSVs and SSVs. All incompetent GSVs and SSVs were treated successfully with RFA, and significant improvements were observed in the clinical and cosmetic complaints of all treated patients. In our study, no major complications, such as postoperative endovenous heat-related deep vein thrombosis or superficial thrombophlebitis, were observed. Of note, telangiectatic matting along the course of the GSV occurred in only two patients after RFA. Only one case report has been published in the literature regarding secondary telangiectasia after RFA [21]. RFA is a safe treatment technique for incompetent saphenous veins with low complication rates. An important point is the choice of endovascular techniques: RFA, EVLA, or MOCA. In a meta-analysis, van den Bos et al. indicated that EVLA was superior in terms of anatomic success at one to five years of follow-up [22]. The more recent randomized, clinical trial of Rasmussen
et al. reported that RFA using the ClosureFASTTM catheter yielded results that were at least similar to those of EVLA. In that trial, RFA was associated with significantly less postprocedural pain than EVLA [2]. Reduced postoperative pain and bruising were the major advantages of RFA over other endovenous thermal procedures. Postoperative pain and bruising are thought to be the results of vein wall perforation. Meissner et al. demonstrated that vein wall perforation occurs more frequently during EVLA than during RFA procedures. The temperature sensor on the RFA catheter and the related temperature feedback mechanism ensure homogenous and controlled delivery of the radiofrequency energy to the vein wall, which prevents overheating of the vein wall and subsequent perforation [23,24]. Another important consideration in choosing ClosureFASTTM catheter is the uniformity of the technique; with EVLA, discussions about different tip designs and wavelengths might occur [9]. ClosureFASTTM catheter results in faster treatment time, and every 20 seconds the catheter is segmentally withdrawn for 7 cm [25]. Markovic and Shortell concluded that the new ClosureFASTTM catheter is an important advancement
Table 3
Figure 8. Patients and treated veins flowchart. Of 211 patients with 311 veins enrolled in the study, recanalization was observed in 34 veins. There were no recurrences in 277 veins (227 GSVs and 50 SSVs). GSV: great saphenous vein; SSV: small saphenous vein.
Results of logistic regression analysis.
Treated vein
P
Odds ratio [95% CI]
GSV Side (R-L)
0.367
Diameter
0.008
Follow-up (month)
0.391
0.646 [0.250—1.668] 0.825 [0.715—0.952] 1.066 [0.921—1.235]
SSV Side (R-L)
0.998
Diameter
0.752
Follow-up (month)
0.728
256735727.594 [0—+∞] 1.086 [0.650—1.815] 0.927 [0.604—1.422]
95% CI: 95% confidence interval; GSV: great saphenous vein; SSV: small saphenous vein; R: right limb; L: left limb.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
Risk factors associated with recanalization of incompetent saphenous veins that combines the speed of EVLA with the expected fewer side effects of RFA [24]. In a meta-analysis Dermody et al. showed that thermal skin burns with RFA occur no more frequently than with EVLA [26]. When comparing RFA with the new MOCA technique, it seems that MOCA is less painful and patients return to work more quickly. However, after more than two years of follow-up, MOCA has not yet proven to be as capable as RFA in terms of clinical and anatomic results [10,16]. Based on findings from this study and the review of the literature, the authors concluded that the new ClosureFASTTM catheter might be the gold standard treatment today in such a setting, and the technique is reimbursed in France. Encouraging occlusion rates (94.1—99.6% for GSVs and 89.1—100% for SSVs) of saphenous veins after RFA have been reported in several studies via a new-generation RFA device using the ClosureFASTTM catheter [12—18]. Although several studies regarding the occlusion rate of saphenous veins were available, only two studies discussed the probable risk factors of occlusion rate with the ClosureFASTTM catheter. One study reported that vein diameters > 12 mm were not correlated with the closure rate achieved with the ClosureFASTTM catheter. However, the types of saphenous veins (GSV or SSV) were not differentiated in that study [13]. In the present study, the increased GSV diameter was associated with a low occlusion rate, but the same was not true of the SSV. Another study evaluated the factors that can affect postoperative SSV recanalization and found that the single significant variable was preoperative peak reflux velocity [27]. In our study, preoperative peak reflux velocity and total length of ablation were not evaluated because of the retrospective nature of the study. In our study, the follow-up time, the side of the treated vein, and the age and gender of the patients were evaluated as potential risk factors for recanalization rate. Those factors were not discussed in previous studies. Large GSV diameter increased the risk of recanalization, and some of these patients required re-treatment. For this reason, the measurement of the insufficient vein diameter in the baseline US examination is very important. More than two cycles for the first part of the proximal vein followed by more than one cycle to the remaining venous segments might be useful for these large insufficient veins. The limitations of our study are its retrospective design and the short follow-up time. Our study included a small sample size of treated SSVs, potentially limiting the statistical power of the results. In addition, recanalization might be affected by large perforators in the thigh, but those veins were not evaluated during routine mapping. Further studies with a larger number of patients are indicated to confirm the observations of the present study. In conclusion, the results of our study show that RFA is a safe and effective modality for treating incompetent varicose veins. We found that the single significant risk factor for recanalization was an enlarged preoperative diameter of the GSV. On the opposite, the preoperative diameter of the SSV does not affect the occlusion rate.
Disclosure of interest The authors declare that they have no competing interest.
7
References [1] Callam MJ. Epidemiology of varicose veins. Br J Surg 1994;81: 167—73. [2] Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011;98:1079—87. [3] Gloviczki P, Gloviczki ML. Guidelines for the management of varicose veins. Phlebology 2012;27:2—9. [4] Gloviczki P, Comerota AJ, Dalsing MC, Society for Vascular Surgery, American Venous Forum, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53: 2S—48S. [5] Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg 2012;44:214—23. [6] Choi JH, Park HC, Joh JH. The occlusion rate and patterns of saphenous vein after radiofrequency ablation. J Korean Surg Soc 2013;84:107—13. [7] Boon R, Akkersdijk GJ, Nio D. Percutaneus treatment of varicose veins with bipolar radiofrequency ablation. Eur J Radiol 2010;75:43—7. [8] Koroglu M, Eris HN, Aktas AR, et al. Endovenous laser ablation and foam sclerotherapy for varicose veins: does the presence of perforating vein insufficiency affect the treatment outcome? Acta Radiol 2011;52:278—84. [9] Boersma D, van Eekeren RR, Kelder HJ, et al. Mechanochemical endovenous ablation versus radiofrequency ablation in the treatment of primary small saphenous vein insufficiency (MESSI trial): study protocol for a randomized controlled trial. Trials 2014;15:421. [10] Witte ME, Reijnen MM, de Vries JP, Zeebregts CJ. Mechanochemical endovenous occlusion of varicose veins using the ClariVein® device. Surg Technol Int 2015;26:219—25. [11] Marsden G, Perry M, Kelley K, Davies AH, Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ 2013;347:f4279. [12] Kapoor A, Kapoor A, Mahajan G. Endovenous ablation of saphenofemoral insufficiency: analysis of 100 patients using RF closure fast technique. Indian J Surg 2010;72:458—62. [13] Calcagno D, Rossi JA, Ha C. Effect of saphenous vein diameter on closure rate with ClosureFASTTM radiofrequency catheter. Vasc Endovascular Surg 2009;43:567—70. [14] Nordon IM, Hinchliffe RJ, Brar R, et al. A prospective doubleblind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg 2011;254:876—81. [15] Monahan TS, Belek K, Sarkar R. Results of radiofrequency ablation of the small saphenous vein in the supine position. Vasc Endovasc Surg 2012;46:40—4. [16] Proebstle TM, Alm BJ, Gockeritz O, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Br J Surg 2015;102:212—8. [17] Proebstle TM, Alm J, Gockeritz O, et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities. J Vasc Surg 2011;54: 146—52. [18] Proebstle TM, Vago B, Alm J, Gockeritz O, Lebard C, Pichot O. Treatment of the incompetent great saphenous vein by
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003
+Model DIII-803; No. of Pages 8
ARTICLE IN PRESS
8
A. Nayman et al.
[19] [20]
[21]
[22]
endovenous radiofrequency-powered segmental thermal ablation: first clinical experience. J Vasc Surg 2008;47:151—6. Tessari L. Nouvelle technique d’obtention de la scléro-mousse. Phlebologie 2000;53:129. Kundu S, Lurie F, Millward SF, American Venous F, Society of Interventional Radiology, et al. Recommended reporting standards for endovenous ablation for the treatment of venous insufficiency: joint statement of The American Venous Forum and The Society of Interventional Radiology. J Vasc Surg 2007;46:582—9. Pavlovic MD, Adamic M, Schuller-Petrovic S. Secondary telangiectasia after radiofrequency closure of saphenous vein: a result of blocked outflow of a feeding vein? Phlebology 2012;27:265—6. van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a metaanalysis. J Vasc Surg 2009;49:230—9.
[23] Meissner OA, Schmedt CG, Hunger K, et al. Endovascular optical coherence tomography ex vivo: venous wall anatomy and tissue alterations after endovenous therapy. Eur Radiol 2007;17:2384—93. [24] Markovic JN, Shortell CK. Update on radiofrequency ablation. Perspect Vasc Surg Endovasc Ther 2009;21:82—90. [25] van Eekeren RR, Boersma D, de Vries JP, Zeebregts CJ, Reijnen MM. Update of endovenous treatment modalities for insufficient saphenous veins: a review of literature. Semin Vasc Surg 2014;27:118—36. [26] Dermody M, O’Donnell TF, Balk EM. Complications of endovenous ablation in randomized controlled trials. J Vasc Surg Venous Lymphat Disord 2013;1:427—36. [27] Park JY, Galimzahn A, Park HS, Yoo YS, Lee T. Midterm results of radiofrequency ablation for incompetent small saphenous vein in terms of recanalization and sural neuritis. Dermatol Surg 2014;40:383—9.
Please cite this article in press as: Nayman A, et al. Risk factors associated with recanalization of incompetent saphenous veins treated with radiofrequency ablation catheter. Diagnostic and Interventional Imaging (2016), http://dx.doi.org/10.1016/j.diii.2016.06.003