|Year : 2020 | Volume
| Issue : 2 | Page : 154-157
Outcome of Re-Using radiofrequency ablation catheter for varicose veins treatment
Edwin Stephen1, Albert Abhinay Kota2, Deepak George John2, Vimalin Samuel2, Andrew Dheepak Selvaraj2, Prabhu Premkumar2, Sunil Agarwal2
1 Vascular Surgery Unit, Division of Surgery, Sultan Qaboos University Hospital, Muscat, Oman
2 Department of Vascular Surgery, Christian Medical College and Hospital, Vellore, Tamil Nadu, India
|Date of Submission||27-Mar-2020|
|Date of Decision||10-Apr-2020|
|Date of Acceptance||18-Apr-2020|
|Date of Web Publication||17-Jun-2020|
Dr. Andrew Dheepak Selvaraj
Department of Vascular Surgery, Christian Medical College and Hospital, Vellore, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Objective: The objective of the study is to evaluate the success of re-use by assessing the recanalization rates following radiofrequency ablation (RFA) with Closure Fast® catheter in patients with symptomatic varicose veins. Methods: This retrospective study approved by the institutional review board analyzed the occlusion rates of the great saphenous vein (GSV) in patients who underwent RFA between January 1, 2015, and December 31, 2016. A record of the number of times the RFA catheter was re-used was maintained. The catheter was used for a maximum of five systems. Follow-up was performed postoperatively at 1 week and 6 months with an ultrasound to assess failure by looking for recanalization. Results: In this study, 272 GSV endoablations (RFA) were performed in 238 patients. The mean age was 47.68 (standard deviation ± 13.05). Majority of the patients were male (76.9%). 27.3% (73 GSV) of the venous systems received a first fire with the RFA catheter. At the first follow-up on week 1, 97.7% (266 GSV systems) had complete occlusion, 2.3% (6 GSV systems) had partial recanalization, and none had complete failure. Recanalization rates at 1 week with 1st, 2nd, 3rd, 4th, and 5th re-use were 0%, 2%, 2%. 4.1%, and 3.8%, respectively. At 6-month postoperative follow-up, 96.5% (250) had complete occlusion, 2.7% (7) had partial recanalization, and 0.8% (2) had complete recanalization. Recanalization rates at 6 weeks with 1st, 2nd, 3rd, 4th, and 5th re-use were 1.4%, 2.1%, 2.3%. 6.4%, 5.9% respectively. There was no statistical significance with the recanalization rates at 1st week and at 6 weeks. 4.2% (10) of the patients were lost to follow-up. None of the patients had any complications. Conclusion: The results of GSV occlusion rates are encouraging when the RFA catheter was re-used and cut the cost of treatment substantially, thereby making RFA ablation more affordable to the common human.
Keywords: Ablation, Closure Fast, radiofrequency, radiofrequency ablation, varicose veins, VNUS
|How to cite this article:|
Stephen E, Kota AA, John DG, Samuel V, Selvaraj AD, Premkumar P, Agarwal S. Outcome of Re-Using radiofrequency ablation catheter for varicose veins treatment. Indian J Vasc Endovasc Surg 2020;7:154-7
|How to cite this URL:|
Stephen E, Kota AA, John DG, Samuel V, Selvaraj AD, Premkumar P, Agarwal S. Outcome of Re-Using radiofrequency ablation catheter for varicose veins treatment. Indian J Vasc Endovasc Surg [serial online] 2020 [cited 2020 Jul 4];7:154-7. Available from: http://www.indjvascsurg.org/text.asp?2020/7/2/154/286904
| Introduction|| |
Radiofrequency ablation (RFA) has been in vogue for the treatment of varicose veins and chronic venous insufficiency for over a decade in India. RFA has been proven to be an excellent alternative to open surgery with good outcomes. However, this treatment modality is not offered to a majority of the Indian patients due to the cost associated with it and the fact that these patients have to pay for the treatment “out of pocket.”
The 2017 Indian National Health Policy report says, “Around 35 crore individuals were covered under any insurance in 2015–2016. This amounts to 27% of the total population of India. Compared to other countries that have either universal health coverage or moving toward it, India's per capita public spending on health is low.”
At our institution, we have been offering RFA to patients with symptomatic varicose veins and chronic venous insufficiency since November 2009. Over 90% of these patients are uninsured. To make RFA affordable to the large subset of patients, we began re-using the RFA (VNUS®, Closure Fast®) catheter. As there are no published data to support our experience that the re-use of RFA catheter yielded good occlusion rates, we conducted this retrospective study.
| Methods|| |
This was a retrospective study conducted after approval by the institutional review board and ethics approval committee (IRB/EC number 10496) and included patients who underwent RFA of the great saphenous vein (GSV) between January 2015 and January 2016. It is hospital policy for patients undergoing surgical intervention to undergo blood-borne virus screening after they consent for it. RFA catheter was re-used in patients after their consent. In patients who were seropositive, RFA catheters were discarded after the first use. Only patients who were within a 100 km radius of our hospital were included, in an attempt to reduce the “lost to follow-up” group. Electronic medical records of the patient cohort and details of the RFA catheter use were stored in the hospital's intranet and accessed for the study. The RFA catheter once used is thoroughly cleaned and soaked in Dakin's solution for ½ h. Thereafter, it is sent for ethylene oxide sterilization with a mark placed on the cover indicating how many times it has been used. Once the catheter has been used five times or was damaged, whichever was earlier, it is discarded.
The cost of the RFA catheter was divided among the five end-users. The procedure was carried out in the setting of an operation theater under local or regional anesthesia. Patients were observed postoperatively for a minimum of 4 h and discharged on above knee Elastocrepe bandaging. They were followed up in the outpatient clinic at 1 week and 6 months postoperatively. The endoablated GSV was assessed with a portable ultrasound [Sonosite – Turbo®] for recanalization and any evidence of deep vein thrombosis (DVT). Recanalization was defined as a segment of the treated GSV >5 cm in length based on compression ultrasound.
| Results|| |
A total of 272 GSV endoablations (RFA) were performed in 238 patients. The mean age was 47.68 (standard deviation [SD] ± 13.05). Majority of the patients were male (76.9%). The mean size of the right GSV was 7.06 (SD ± 2.3) and the left GSV was 7.78 (SD ± 5.5) [Table 1]. 27.3% (65) of the systems received a first fire with the RFA catheter, 18% (49) were between second and fourth re-use, and 19% (52) had fifth re-use [Figure 1].
At the first follow-up on week 1, 97.7% (266 GSV systems) had complete occlusion, 2.3% (6 GSV systems) had partial recanalization, and none had complete failure. At 6-month postoperative follow-up, only 259 GSV systems were analyzed. 96.5% (250) had complete occlusion, 2.7% (7) had partial recanalization, and 0.8% (2) had complete recanalization [Figure 2]. 4.2% (10) of the patients were lost to follow-up. Recanalization rates at 1 week with 1st, 2nd, 3rd, 4th, and 5th re-use were 0%, 2%, 2%, 4.1%, and 3.8%, respectively, and at 6 weeks with 1st, 2nd, 3rd, 4th, and 5th re-use were 1.4%, 2.1%, 2.3%, 6.4%, and 5.9%, respectively [Figure 3]. There was no statistical significance with the recanalization rates at 1st week and at 6 weeks. The GSV had complete recanalization in the fourth and fifth re-use, respectively, and had no statistical significance.
|Figure 2: Rates of recanalization at follow-up. (a) Recanalization rate at first visit. (b) Recanalization rate at 6-month follow-up|
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|Figure 3: Recanalization rate with fiber use. (a) Radiofrequency ablation fiber use (272 systems in 238 patients) and recanalization at 1st week follow up. (b) Radiofrequency ablation fiber use (259 systems in 228 patients) and recanalization at 6-month follow-up|
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None of the patients had any complications such as retaining of the RFA catheter or getting stuck in the GSV during withdrawal, skin burn, blebs, necrosis, or DVT.
| Discussion|| |
There is sufficient evidence to support a conclusion that endovenous ablation when compared to conventional surgery (Trendelenburg, stripping of the GSV, and stab avulsions), and ultrasound-guided foam sclerotherapy is both clinically and economically beneficial.,,
Clinical benefits of minimally invasive surgery, leading to early recovery time with minimal complications and pain combined with the economic benefits, would make a good argument for making this treatment modality available for the Indian population.
Majority of the Indian population has no health insurance, and the public health system does not support the use of endovenous ablation in most hospitals due to the cost associated with it. Carroll et al. following a systematic review, network analysis, and exploratory cost-effectiveness model of randomized trials of minimally invasive techniques versus surgery for varicose veins concluded that there is little to choose between the two modalities based on efficacy and safety; however, the relative cost of treatment becomes a deciding factor.
To make newer modalities of treatment available and affordable to the common human, it is imperative that we look at ways in which costs can be reduced.
The RFA catheter is meant to be for single use, as per the company instructions for use. However, re-use has been in regular use and practiced by many users in developing countries. This requires the additional effort of cleaning, sterilizing, and gentler handling of the catheter. By taking this extra effort, patients are benefitted by the use of minimally invasive surgery and the family/nation economically.
The rate of recanalization seen in this study matched the international data, which is up to 10% at 1 year., Our partial recanalization was 2.3% at 1 week. The partial and complete recanalization rates at 6-month follow-up were 2.7% and 0.8%.
One factor that we noted while re-using the catheter was the target temperature reached. The temperature assessment (within the vein) was not accurate after the first use. There was always a temperature reading on the machine up to the fifth use. Hence, the operator would need to ensure that there is adequate tumescence to avoid thermal injury.
Our study is the first published literature on outcome and economic effectiveness and would encourage the re-using of RFA catheters in patients who cannot afford a new catheter. However, it is imperative that all efforts are made to clean and re-sterilize the RFA catheter well to negate possibility of transmission of blood-borne viruses.
| Conclusion|| |
Re-using the RFA (VNUS®, Closure Fast®) catheter provides internationally acceptable GSV occlusion rates at follow-up of up to 6 months.
A prospective double-blind study could be done following the encouraging results of this study and might help formulate the guidelines for reuse of catheters – endovenous laser ablation and RFA.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]