|Year : 2019 | Volume
| Issue : 1 | Page : 37-41
Evaluation of radiofrequency ablation for primary varicose veins: A preliminary study
Jayachandra Reddy Metta1, Rohit Mehra2, Shyam S Jaiswal2, Anand R Bhagwat3, Gagandeep Singh3
1 Department of Surgery, KAMSRC, Hyderabad, Telangana, India
2 Department of Surgery, AFMC, Pune, Maharashtra, India
3 Department of Surgery, Command Hospital, Pune, Maharashtra, India
|Date of Web Publication||8-Mar-2019|
Dr. Jayachandra Reddy Metta
Department of Surgery, KAMSRC, Hyderabad, Telangana
Source of Support: None, Conflict of Interest: None
Background: Endovenous radiofrequency ablation is gaining popularity as an alternative to conventional surgical treatment of varicose veins. The initial experience with this treatment modality is presented along with review of literature. Methods: A prospective study of 31 consecutive patients with primary great saphenous vein varicosities was undertaken. The procedure was performed under spinal anesthesia using bipolar radiofrequency induced thermotherapy CELON (Olympus) system with continuous pull-back technique. Additionally, multiple stab phlebectomies were performed to deal with tributary varices. Post-operatively; at one, four, twelve and twenty four weeks, the patients were followed up in out-patient department with clinical examination and ultrasound duplex imaging. The occlusion of great saphenous vein trunk, length of residual patent proximal great saphenous vein and improvement in quality of life using revised Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire were recorded and analysed using appropriate statistical methods. Results: The mean (SD) age of patients was 41.8 (14.1) years with an average BMI of 23.4 kg/m2. Ten patients had C2 disease, four C3, thirteen C4, and two each; C5 and C6 disease. Average length of great saphenous vein ablated was 41.9 cm with a mean ablation time of 62.3 (18.6) seconds. Post procedure total occlusion rate at 24 weeks follow-up, was 93.1% and the quality of life indices showed a statistically significant improvement. Conclusion: Endovenous radiofrequency ablation holds immense promise as a safe and effective modality for the treatment of varicose veins of lower limbs.
Keywords: Endovenous treatment, radiofrequency ablation, varicose veins
|How to cite this article:|
Metta JR, Mehra R, Jaiswal SS, Bhagwat AR, Singh G. Evaluation of radiofrequency ablation for primary varicose veins: A preliminary study. Indian J Vasc Endovasc Surg 2019;6:37-41
|How to cite this URL:|
Metta JR, Mehra R, Jaiswal SS, Bhagwat AR, Singh G. Evaluation of radiofrequency ablation for primary varicose veins: A preliminary study. Indian J Vasc Endovasc Surg [serial online] 2019 [cited 2019 Jul 15];6:37-41. Available from: http://www.indjvascsurg.org/text.asp?2019/6/1/37/253741
| Introduction|| |
Varicose veins as a disease entity has been acknowledged since the dawn of humanity. Modern surgical understanding of this condition was pioneered by Friedrich Trendelenburg, toward the latter half of the 18th century, and the surgical principles of treatment espoused by him have been still accepted as the “gold standard.” However, in recent times, the potential to harness radiofrequency or laser-based thermal energy for percutaneous endovenous ablation of veins is emerging as a formidable adversary to this time-tested “gold standard.”,
The use of radiofrequency for percutaneous thermal ablation of primary varicose veins is not routinely performed in the centers of Armed Forces Medical Services, and hence this study was undertaken to evaluate the efficacy, safety, and outcomes of this modality in our setup.
| Materials and Methods|| |
A prospective study of 31 consecutive patients from the civic population, presenting for the treatment of primary great saphenous vein (GSV) varicosities, was undertaken at a tertiary care center which is permitted to treat civilians, serving personnel, and their dependents, after obtaining written informed consent.
The patients were classified in clinical scales using Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification. Those in clinical scales C2–C6, of primary etiology, in GSV anatomical territory, and with reflux as the underlying pathology (Pr), were included in this study.
A preoperative duplex ultrasound (DUS) examination of venous system for the target lower limb was performed for each patient to identify the condition of deep veins, competency of the saphenofemoral junction (SFJ), and suitability of the truncal vein for radiofrequency ablation (RFA), using established protocols. Linear transducer 7 L4s (7.5 MHz) of Mindray M7 ultrasound diagnostic system (Mindray DS USA, Inc.) was used.
Patients with superficial or deep vein thrombosis, aneurysms, pacemakers, and an Ankle-Brachial Index <0.9 were excluded from the study. In addition, those with distance between skin surface and truncal vein <5 mm and a GSV with diameter >20 mm were also excluded from the study. The study was approved by the Institutional Ethics Committee.
The procedure was performed under spinal anesthesia, in a well-hydrated patient, in warm surroundings to prevent vasospasm. Access site to target GSV was identified and the vein was percutaneously cannulated with 18G × 7 cm needle under intraoperative ultrasound guidance [Figure 1]. Through the needle, a 0.018-inch guidewire was inserted in the GSV; thereafter, the needle was removed, and a 7 Fr × 11-cm introducer sheath was advanced over the guidewire. Then, the guidewire was removed, and a flexible bipolar radiofrequency-induced thermotherapy (RFITT) applicator (5.4 Fr) was introduced through the sheath [Figure 2]. Under ultrasound guidance, the RFITT applicator was advanced till the tip was placed 2 cm below the SFJ or at the ostium of superficial epigastric vein, whichever was proximal.
|Figure 1: Percutaneous cannulation of the great saphenous vein under duplex ultrasound|
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|Figure 2: Sheath and radiofrequency-induced thermotherapy applicator in place|
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Tumescent anesthesia (TA) was manually delivered in the fascial envelope of GSV, using a 24G spinal needle [Figure 3]. Prior to starting the endovenous ablation, the position of RFITT applicator tip was reconfirmed with intraoperative ultrasound. Thereafter, the radiofrequency generator setting was kept at 18 and the RFITT applicator was gradually withdrawn [Figure 4] while continuously pressing the foot switch. The withdrawal velocity of the RFITT applicator was monitored using audio feedback mechanism of the CELON (Olympus) RFITT system. Simultaneously, intraoperative ultrasound imaging was used to confirm vein shrinkage and increase in vein wall echogenicity. Multiple phlebectomies were then carried out to tackle the tributary varices. All the wounds were dressed and the treated limb was wrapped in Elastocrepe® bandage which was kept in place for 24 h.
|Figure 3: Tumescent anesthesia being infiltrated under duplex ultrasound|
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|Figure 4: Ablation of the great saphenous vein using continuous pullback technique|
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Postoperatively, tablet paracetamol 500 mg was administered as an analgesic, on as required basis. All patients were ambulated as soon as they had recovered from the spinal anesthesia and were discharged on postoperative day 1 or 2, with an instruction to wear below-knee Class I graduated compression stockings for 2 weeks.
Postoperatively, at 1, 4, 12, and 24 weeks, the patients were examined in the outpatient department, clinically and with DUS, for any immediate and late postoperative complications. The occlusion of GSV trunk, length of residual patent proximal GSV, and improvement in quality of life (QoL) using the revised Venous Clinical Severity Score (rVCSS) and Aberdeen Varicose Vein Questionnaire (AVVQ) were recorded. The QoL indices (rVCSS and AVVQ) were analyzed as a continuous variable by using Wilcoxon signed-rank test and paired t-test, respectively. CEAP was analyzed as an ordinal variable. P < 0.05 was considered statistically significant.
| Results|| |
A total of 31 patients with 31 limbs were enrolled for this study. The group comprised of 26 males and 5 females. One patient could not undergo the procedure due to technical impediment and has therefore been excluded from the statistical analysis, as has been the patient who was lost to follow-up (n = 29).
The mean (standard deviation [SD]) age of patients was 41.8 (14.1) years, with an average body mass index (BMI) of 23.4 kg/m2. They were spread across a varied socioeconomic status and the average modified Kuppuswamy socioeconomic index was 17.87. When evaluated as per the CEAP clinical classification, ten patients were in C2, four in C3, thirteen in C4, two in C5, and two in C6 [Table 1].
|Table 1: Distribution of patients as per clinical Stage (C), of the Clinical-Etiology-Anatomy-Pathophysiology classification|
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On preoperative DUS, SFJ valvular incompetence and lower-limb perforator incompetence were seen in 23 and 8 patients, respectively. The preoperative mean (SD) GSV diameter, 3 cm distal to the SFJ, was 5.5 (1.1) mm. It reduced to 3.1 (0.6) mm, immediately after the thermal ablation. Intraoperatively, an aberrant GSV anatomy was encountered in three patients; however, we were able to perform the procedure on all of them. RFA was augmented with stab phlebectomies in 12 patients.
The average volume of TA administered in the fascial envelope of target GSV was 73.8 ml. The average length of GSV that was ablated using RFA was 41.9 cm, with a mean ablation time of 62.3 (18.6) s. Since the TA was administered in addition to the spinal anesthesia, it proved sufficient. Postablative vein wall thickening was noted in all patients.
The average hospital stay of patients was 1.5 days. Return to habitual activity by the postoperative evening was seen in 100% of the patients. None of the patients had any immediate peri-operative adverse events. The postoperative complications seen in these patients, at the end of 24-week follow-up period, are reflected in [Table 2]. The most common complication was palpation of a cord-like mass in the target GSV territory, present in five patients (17%).
The mean GSV stump length from SFJ assessed immediately postoperatively was 1.5 (0.1) cm. It remained almost unchanged at 1.4 (0.1) cm, after 24 weeks of follow-up. The postprocedural total occlusion rate of target GSV at 24-week follow-up was 93.10%. The most common occlusion pattern of GSV found on DUS was total truncal occlusion of treated GSV, with patent superficial epigastric vein.
The pre- and post-operative comparison of clinical outcome and QoL are summarized in [Table 3] and [Table 4], respectively. There was a significant improvement in clinical outcome (C score of CEAP classification) of patients following endovenous RFA at the end of 24 weeks, as compared to preoperative period (P ≤ 0.001). Mean rVCSS preoperative score of 7.6 (4.1) showed improvement in the follow-up period, with values at 1 week – 6.2 (3.1); 4 weeks – 4.8 (2.2); 12 weeks – 3.4 (1.8); and at 24 weeks – 2.4 (1.3). When “Wilcoxon signed-rank test” was used for statistical analysis, it showed that endovenous RFA of primary varicose veins elicited a statistically significant improvement in QoL score (P < 0.001).
|Table 3: Clinical outcomes at 24 weeks: Values are depicted as mean (standard deviation)|
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Analysis of the AVVQ data for QoL outcome assessment, using paired t-test, showed a descending trend in the mean AVVQ preoperative score of 33.7 (19.1) to a statistically significant value of 5.4 (5.6) at 24 weeks postoperatively (P < 0.001). During follow-up DUS, blood flow in few parts of treated GSV, from 2 cm below SFJ, was seen in two patients. One of the patients was found to have an aberrant short saphenous vein and GSV communication; the other had a reflux originating from a perforator vein. However, none of them was clinically symptomatic.
| Discussion|| |
Varicose veins as an entity has plagued human civilization from biblical times and finds recognition in the earliest medical texts available to humankind. A common condition in young and middle-aged individuals, the presence of varicose veins, has been reported in a pandemic proportion, affecting nearly half the adult population, by the Edinburgh Vein Study. The world literature has also highlighted the role of age, socioeconomic gradient, high BMI, and male sex in the development of truncal varices and the subsequent clinical deterioration, if left untreated.,
The spectrum of clinical presentation can range from a cosmetic annoyance to a severe enfeebled state., Once admonished by “Ebers papyrus,” surgical management of the disease has stood the test of time and is today considered the “gold standard.” However, over the last decade, the clinical landscape has seen tremendous revolution with the arrival of minimally invasive techniques to manage varicose veins, which are supplanting open surgery.,,
Endovenous advancements over the last decade are today posing as strong adversaries to the “gold standard.” RFA is one such method which was first approved for use in the USA in 1999 and, since then, its high safety profile and better outcome have been corroborated by several studies.,
RFA produces heat which is also conducted to the surrounding nontarget tissues, leading to thermal injuries., The use of TA helps in minimizing these thermal injuries by acting as a heat sink. Despite its use, few patients do develop minor thermal injuries in the form of skin hyperpigmentation and paresthesia. The same were observed in 6.8% and 3.4% of our patients, respectively.
In this study, with a fixed RFITT applicator tip position, the variable GSV diameter did not elicit any correlation with the proximal progression of the thrombus to deep veins and we had no case of DVT in our study. The findings corroborate with that of the world literature. RFA maintains a postprocedural GSV occlusion rate of nearly 90% at 5 years., In our study, the occlusion rate was 93.1%, at 24-week follow-up.
In order to obtain a holistic assessment of QoL, we used two QoL assessment indices: the clinician-administered rVCSS and the disease-specific QoL questionnaire AVVQ. The achievement of clinical success was evident by the significant improvement in all subdomains of rVCSS and AVVQ. Throughout the follow-up period, the score significantly improved with the maximum statistical improvement evident at 4 weeks. Our results conform with the world literature., All our patients were able to resume habitual activity by postoperative evening. This has been proven as one of the best outcomes of RFA.,,
The most important parameters to be considered when comparing a newer treatment modality with an established one are a favorable safety profile, durable results, and improved QoL. The results of this study are clinically and statistically reassuring, as far as these parameters are concerned. The safety of endovenous RFA procedure, along with a high rate of GSV occlusion, as seen in our study, has also been corroborated by several other authors. This treatment modality has the potential to provide faster recovery and reduce the loss of person days, especially when our serving soldiers are concerned. At present, the main limiting factors to its widespread use seem to be the high cost of treatment and limited availability of expertise.
| Conclusion|| |
Results are on par with world literature. It is a easy and safe procedure with least or almost nil deleterious affects and minimal post op complications.
It is also evident to have least hospitalization and early to work with tremendous improvement in QoL.
Hence it holds immense promise as a safe & effective modality for treatment of primary varicose veins of lower limbs.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4]