Restricted accessResearch articleFirst published online 2022-12
Pilot single-arm study to investigate the efficacy and safety of endovenous Microwave ablations for treatment of varicose veins in Singapore – one year results of the MAESTRO registry
Aim was to report a prospective two-centre Singaporean experience using Endovenous Microwave Ablation (EMA) to treat symptomatic primary great saphenous vein reflux. We evaluated 1-year safety, efficacy and patient satisfaction.
Methods
50 patients (63 limbs; 29 females; mean age 58.0 ± 12.1 years) were included. Patients were reviewed at 2-weeks, 3-, 6- and 12-months and underwent Duplex ultrasound assessment. Three quality of life (QoL) questionnaires were completed.
Results
The truncal closure rates at 2-weeks, 3-, 6- and 12-months were 63/63 (100%), 59/59 (100%), 58/58 (100%) and 59/60 (98.3%), respectively. There was 100% technical success and no serious adverse events. There were sustained improvement of QoL questionnaire scores from 2 weeks to 12 months.
Conclusion
EMA is a safe and efficacious venous ablative technology at 12 months and is associated with a high rate of target vein occlusion and sustained QoL improvement.
MarsdenGPerryMKelleyK, et al.Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ2013; 347: f4279.
2.
GloviczkiPComerotaAJDalsingMC, 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 Vascular Surgery2011; 53: 2S–48S.
3.
KanwarAHansraniMLeesT, et al.Trends in varicose vein therapy in England: radical changes in the last decade. Ann R Coll Surg Engl2010; 92: 341–346.
4.
van den BosRArendsLKockaertM, et al.Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg2009; 49: 230–239.
5.
WhiteleyMSShiangoliIDos SantosSJ, et al.Fifteen year results of radiofrequency ablation, using VNUS closure, for the abolition of truncal venous reflux in patients with varicose veins. Eur J Vasc Endovasc Surg2017; 54: 357–362.
6.
AlmeidaJIKaufmanJGockeritzO, et al.Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol2009; 20: 752–759.
7.
KempeneersAIBechter-HuglBThomisS, et al.A prospective multicentre randomized clinical trial comparing endovenous laser ablation, using a 1470 nm diode laser in combination with a Tulip-TipTM fiber versus radiofrequency (Closure FAST VNUS(R)), in the treatment of primary varicose veins. Int Angiol2022.
8.
KabnickLSSadekM. Fiber type as compared to wavelength may contribute more to improving postoperative recovery following endovenous laser ablation. J Vasc Surg Venous Lymphat Disord2016; 4: 286–292.
9.
NyamekyeIKDattaniNHayesW, et al.A randomised controlled trial comparing three different radiofrequency technologies: short-term results of the 3-RF trial. Eur J Vasc Endovasc Surg2019; 58: 401–408.
10.
SichlauMJRyuRK. Cutaneous thermal injury after endovenous laser ablation of the great saphenous vein. J Vasc Interv Radiol2004; 15: 865–867.
11.
Van Den BosRRNeumannMDe RoosKP, et al.Endovenous laser ablation-induced complications: review of the literature and new cases. Dermatol Surg2009; 35: 1206–1214.
12.
TangTYRathnaweeraHPKamJW, et al.Endovenous cyanoacrylate glue to treat varicose veins and chronic venous insufficiency-Experience gained from our first 100+ truncal venous ablations in a multi-ethnic Asian population using the Medtronic VenaSeal Closure System. Phlebology2019; 34: 543–551.
13.
TangTYKamJWGauntME. ClariVein(R) - Early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins. Phlebology2017; 32: 6–12.
14.
TangTYTiwariA. The VenaSeal abnormal red skin reaction: looks like but is not phlebitis. Eur J Vasc Endovasc Surg2018; 55: 841.
15.
SumarliSALeeQWSYapHY, et al.Exit site complications following cyanoacrylate glue endovenous ablation of incompetent truncal veins for chronic venous insufficiency. J Vasc Surg Cases Innov Tech2020; 6: 500–504.
16.
KhorSNLeiJKamJW, et al.ClariVein - One year results of mechano-chemical ablation for varicose veins in a multi-ethnic Asian population from Singapore. Phlebology2018; 33: 687–694.
17.
LubnerMGBraceCLZiemlewiczTJ, et al.Microwave ablation of hepatic malignancy. Semin Intervent Radiol2013; 30: 56–66.
18.
YangLWangXWeiZ, et al.The clinical outcomes of endovenous microwave and laser ablation for varicose veins: A prospective study. Surgery2020; 168: 909–914.
19.
YangLWangXPSuWJ, et al.Randomized clinical trial of endovenous microwave ablation combined with high ligation versus conventional surgery for varicose veins. Eur J Vasc Endovasc Surg2013; 46: 473–479.
20.
MaoJZhangCWangZ, et al.A retrospective study comparing endovenous laser ablation and microwave ablation for great saphenous varicose veins. Eur Rev Med Pharmacol Sci2012; 16: 873–877.
21.
TangTYYapCSoonS, et al.Re: "Do we need another modality for truncal vein ablation?" - What about microwave as an endothermal device?Phlebology2021; 36: 414–415.
22.
van RuijvenPWPoluektovaAAvan GemertMJ, et al.Optical-thermal mathematical model for endovenous laser ablation of varicose veins. Lasers Med Sci2014; 29: 431–439.
23.
RutherfordRBPadbergFTJr.ComerotaAJ, et al.Venous severity scoring: an adjunct to venous outcome assessment. J Vasc Surg2000; 31: 1307–1312.
24.
LabropoulosNTiongsonJPryorL, et al.Definition of venous reflux in lower-extremity veins. J Vasc Surg2003; 38: 793–798.
25.
ChanYCLawYCheungGC, et al.Cyanoacrylate glue used to treat great saphenous reflux: measures of outcome. Phlebology2017; 32: 99–106.
26.
VasquezMARabeEMcLaffertyRB, et al.Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American venous forum Ad Hoc outcomes working group. J Vasc Surg2010; 52: 1387–1396.
27.
GarrattAMMacdonaldLMRutaDA, et al.Towards measurement of outcome for patients with varicose veins. Qual Health Care1993; 2: 5–10.
28.
KuetMLLaneTRAnwarMA, et al.Comparison of disease-specific quality of life tools in patients with chronic venous disease. Phlebology2014; 29: 648–653.
29.
KarnabatidisDPapageorgiouCKitrouP, et al.One-year duplex ultrasound-assessed closure outcomes of percutaneous endovenous microwave ablation for the treatment of varicose veins of the lower limbs. Vascular2022: 17085381221099115.
30.
HjermstadMJFayersPMHaugenDF, et al.Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage2011; 41: 1073–1093.
31.
TangTYYapCJQChanSL, et al.Early results (3 months) of an Asian prospective multicenter VenaSeal real-world postmarket evaluation to investigate the efficacy and safety of cyanoacrylate endovenous ablation for varicose veins. J Vasc Surg Venous Lymphat Disord2020.
32.
TangTYRathnaweeraHPKamJW, et al.Endovenous cyanoacrylate glue to treat varicose veins and chronic venous insufficiency-Experience gained from our first 100+ truncal venous ablations in a multi-ethnic Asian population using the Medtronic VenaSeal Closure System. Phlebology2019: 268355519826008.
33.
RCT. R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing. https://www.R-project.org/
34.
SubwongcharoenSPraditpholNChitwisetS. Endovenous microwave ablation of varicose veins: in vitro, live swine model, and clinical study. Surg Laparosc Endosc Percutan Tech2009; 19: 170–174.
35.
RasmussenLHLawaetzMBjoernL, et al.Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg2011; 98: 1079–1087.
