- Email: [email protected]
Day surgery versus Outpatient setting for endovenous laser ablation treatment. A prospective cohort study
International Journal of Surgery 51 (2018) 180–183
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.elsevier.com/locate/ijsu
Original Research
Day surgery versus Outpatient setting for endovenous laser ablation treatment. A prospective cohort study
T
Gianfranco Varetto, Lorenzo Gibello∗, Edoardo Frola, Alessandra Trevisan, Andrea Trucco, Luigi Contessa, Pietro Rispoli Division of Vascular Surgery (Chief. Prof. P. Rispoli), University of Turin, Department of Surgical Sciences, Azienda Ospedaliera Universitaria Città della Salute e delle Scienza, Molinette Corso Bramante 88, 10126 Torino, Italy
A R T I C L E I N F O
A B S T R A C T
Keywords: Endothermal laser ablation Varicose veins Outpatient treatment
Objectives: The traditional surgical approach to the treatment of the superficial venous insufficiency requires at least 12 h of post-operative monitoring and this often means the necessity of an overnight hospitalization. The introduction of new, less invasive techniques (i.e endovenous laser ablation) reduces the hospitalization stay in a Day Surgery setting. However, the increasing skills of the operators and the patient's selection, allows to propose endovenous laser ablation in an Outpatient setting. The aim of this study is to evaluate the activity of a single high-volume center. Method: We enrolled 112 consecutive patients with great sapehous vein insufficiency and indication to endothermal laser ablation, 57 operations (51%) were performed in Day Surgery setting and 55 (49%) in Outpatient setting according to endovascular laser ablation's criteria. Past medical history, CEAP classification, VCSS score, type of symptoms and intervention's data were collected. Post-operative results (success and complications rates, patient's functional and aesthetic satisfaction) were evaluated at 7 and 30 days after intervention. A QoL questionnaire (CIVIQ) was submitted to the patients 30 days after surgery. Results: We did not observe a statistically significant difference between the two groups concerning treatment results and complications onset. The QoL assessment did not differed significantly, except for over 65-year old patients undergoing outpatient treatment that showed a better QoL compared to those undergoing the same treatment in Day Surgery (p 0.05). Conclusions: The endothermal laser ablation technique allows a safe, comfortable and faster management of the venous disease in Outpatient setting. This would further reduce the costs of the treatment while preserving the functional and aesthetic results and the low complication rate of the Day Surgery setting.
1. Introduction Chronic venous insufficiency and varicose veins of the lower limbs represent a pathology with a great impact on the patient's quality of life (QoL) with a broad range of symptoms as discomfort, pain and disability [1,2]. Considering the high incidence in worker population, the disease carries also a not negligible socio-economic impact. In the last years, traditional surgery has been broadly replaced by endovenous techniques like endothermal laser or radiofrequency ablation which allow a lower invasiveness (i.e. the possibility to perform percutaneous access under local anesthesia) and pain and complications reductions with a consequent faster recovery time. NICE and the SIFSICVE 2016 guidelines lately confirmed that the endothermal ablation with laser or radiofrequency is, when suitable, to be preferred to the traditional surgery [3,4]. The principle of endothermal laser ablation ∗
(ELA) is explained with the convertion of 1470 nm laser energy into heat with water vaporization and consequent collapse and obliteration of the inner vessel wall [5]. This technique is extremely safe and reliable and data from literature confirm a success rate of 88–100% [6]. Moreover ELA has been recently extended to the treatment of the small saphenous vein (SSV) [7]. Another important advantage of ELA is the possibility to perform the entire intervention through a percutaneous access under local ultrasound-guided tumescence anesthesia. This peculiarity reduces the post-operative hospitalization stay and allows a faster and safe recovery of the patient that could be managed in a Day Surgery or even Outpatient setting. The aim of this prospective study is to compare the impact of Day Surgery versus Outpatient setting after ELA.
Corresponding author. Division of Vascular Surgery, Corso Bramante 88, 10126 Torino, Italy. E-mail address: [email protected] (L. Gibello).
https://doi.org/10.1016/j.ijsu.2018.01.039 Received 17 August 2017; Received in revised form 31 October 2017; Accepted 25 January 2018 Available online 02 February 2018 1743-9191/ © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
International Journal of Surgery 51 (2018) 180–183
G. Varetto et al.
2. Material and methods
drive as before the operation) as reported in Table 2. The 30-days follow-up confirmed the efficacy of the technique with an incomplete GSV occlusion reported in only 3 (2%) of cases (Table 2). Patient's satisfaction was evaluated both in aesthetic and functional results: in group A 87% of patients were fully satisfied while the remaining patients (13%) were only functionally satisfied; in group B 88% of patients were overall satisfied, 7% were functionally but not esthetically satisfied and 5% were esthetically but not functionally satisfied. The 30days CIVIQ questionnaire revealed a medium score in Day Surgery group of 20,45 ± 0,94 while in Outpatients group-B was 20,5 ± 0,93 (p 0,1). However, there was a statistical different perception of QoL in patients over 65 years: for this subgroup of patients there was a better perception of QoL for Outpatient setting compare to Day Surgery (p. 0,05).
Between October 2015 and July 2016 we enrolled 112 patients with great saphenous vein insufficiency and indication for ELA. They were randomly divided into two groups: 57 (51%) who underwent the operation in Day Surgery setting; 55 (49%) who underwent the operation in Outpatient setting. Primary endpoints were: the technical success (GSV obliteration at 30 days) and patient's quality of life (through the Chronic Venous Insufficiency quality of life -CIVIQ-questionnaire) [8] between the two groups. Secondary endpoints were: the post-operative complications (haematoma and ecchymosis, swelling, pain, paresthesia) between the two groups. Inclusion criteria were: CEAP (Clinical, Etiological, Anatomical, Pathophysiological) class > C1 (presence of varicose veins involving superficial venous system), GSV reflux, not tortuous vessel, GSV's calibre between 5 and 12 mm (horizontal posture). Exclusion criteria were double GSV or crosse's abnormalities, pregnancy/lactation, blood coagulation disorders or venous thrombosis, superficial GSV course (less than 4 mm). The work has been approved by the Ethic Committee and reported in line with the STROCSS criteria. All the patients underwent a pre-operative evaluation with an accurate interview and history taking and a Doppler Ultrasound to confirm the GSV dilatation and exclude an eccessive tortuosity of the vessel. ELA was performed in a sterile setting (operating theatre for Day Surgery, specialized ambulatory for Outpatient setting) with Eufoton 1470 nm diode laser fiber. After a Seldinger's cannulation of the GSV, the tip of the laser catheter is placed proximately to the origin of the epigastric vein. An US guided tumescence anesthesia is performed all along the saphenous eye (500 ml of 5 °C physiological solution with 30 ml 2% lidocaine and 5 ml 1,4% sodium bicarbonate). The ablation is obtained with an energy supply of 80 J/cm for the first 2 cm and then 40 J/cm with a power of 4–7 Watt. Post-operative follow-up consisted in a clinical (presence/absence of pain, swelling, ecchymosis, resumed daily activities) and ultrasonographic (presence/absence of DVT, GSV obliteration) controls at 7 and 30 days. The CIVIQ-20 QoL questionnaire was submitted to all the patients 30 days after surgery. It consists of 20 questions evaluating pain, sleep quality and the ability of doing everyday activities. Scores for each question ranges from 1 (no pain, no trouble) to 5 (severe pain, severe trouble). Questionnaire score ranges from 20 (best post-operative QoL) to 100 (worst post-operative QoL).
4. Discussion The first endovenous treatment of an incompetent GSV reported in literature was performed by Boné in 1998 [9]. Since then we assisted to a progressive widespread of this minimal invasive, but equally efficient, way to manage patients suffering from chronic vein insufficiency. In particular, ELA has proved to be comparable to the traditional stripping in terms of effectiveness and showed superiority in terms of complication rates and impact on the QoL [10,11]. This is partially related to the percutaneous access and the tumescence anesthesia (that guarantee a faster recovery and the absence of important wounds to heal) and partially related to the improvement of the diode laser systems and probes. In fact, in early years, diode laser systems had a wavelength ranging from 810 to 980 nm with a targeted action on the molecules of haemoglobin [12,13]. For this reason, the effect of the ablation was dependent to the presence and the amount of red blood cells. Moreover, the first-generation probes had the drawback of an inhomogeneous delivery of energy along the vessel walls provoking quite frequently spots of venous injury with consequent ecchymosis and pain for the patient [14]. The latest developments in laser technology however, increased the wavelength to 1470 nm acting on water molecules as a specific target and this improved the efficacy of obtaining durable endogenous ablation of the GSV without increasing the joules delivered [4,10,15,16]. The probes as well were ameliorated with the introduction of a double ring system for a circumferential delivery of energy into the vein lumen that guarantee a reduction of joules needed to obtain thrombosis and a reduction of pain and discomfort to the patients [17,18]. The reduced invasiveness of the procedure permitted to offer ELA in Outpatient Setting, as advocated in the latest NICE Guidelines, where non-thermal and non-tumescent venous ablation (i.e sclerotherapy) is already performed [3]. Another important aspect of this new technique is the reduction of the economical impact of the disease not only for the shortening of hospital stay (Day Surgery versus overnight stay) but also in terms of working days lost [3]. In the last years, the excellent technical results confirmed in Literature and the increasing knowledge and operator's skills, permitted to propose ELA in Outpatient setting [16,19–22]. According to our perspective randomized study we found no difference in terms of clinical success and peri-post operative complications, among patients treated in Day Surgery versus Outpatient setting. However, a slightly but significant difference was highlighted in terms of QoL: patients with more than 65 years preferred Outpatient Setting compared to Day Surgery setting. We did not find similar data in Literature to compare with but this could probably be explained with the lower emotional stress and less impact on the resumption of everyday life and a better patient's compliance in Outpatient Setting. One of the limits of this work is the relative small population size but, according to the perspective structure of the study, the ongoing collection of patients and data will probably allow us to better define the cohort of population that advantages most from one hospitalization
2.1. Statistical analysis All the data were collected and stored for statistical analysis. Continuous variables were expressed as mean and standard deviation and compared through nonparametric test of Student. Categorical variables were expressed as scores or as percentages. For their comparison were built contingency tables or matrices of cross-correlation RXC. Chi-square (with Yates correction test for 2 × 2 tables) were used. For all variables, the statistical significance was conventionally set at p < 0.05. Through the use of the Student t-test for independent samples a correlation (statistically significant) between the outcome of the procedure in the two groups was sought. 3. Results The prospective study is based on 112 consecutive patients treated with ELA with a mean age of 62 ± 13,2 and predominantly of female gender (79/112; 70%). They were randomly assigned to Day Surgery (57/112; 51%) or Outpatient (55/112; 49%) setting. Pre-operative characteristics of the general population and of the two subgroups are shown in Table 1. No difference between the two groups was highlighted for GSV length, joules delivered and post-operative complications rate nor for the time needed for a complete recovery (work, walk, 181
International Journal of Surgery 51 (2018) 180–183
G. Varetto et al.
Table 1 Preoperative characteristics of the study population. BMI: body mass index; GSV: great saphenous vein.
Age Gender F BMI GSV diameter CEAP classification
VCSS classification
Population
Day Surgery setting
Outpatient setting
p.value
62 ± 13,2 79/112 (70%) 24,9 ± 3,12 7,1 ± 1,27 C2: 38/112 (34%) C3: 63/112 (56%) C4: 11/55 (10%) C5: 0 C6: 0 V2: 17/112 (16%) V3: 29/112 (26%) V4: 25/112 (22%) V5: 24/112 (21%) > V5: 17/112 (15%)
59 ± 13,2 40/57 (70%) 25,2 ± 3,92 7,2 ± 1,48 C2: 19/57 (33%) C3: 33/57 (58%) C4: 5/57 (9%) C5: 0 C6: 0 V2: 9/57 (16%) V3:16/57 (27%) V4: 10/57 (18%) V5: 14/57 (24%) > V5: 8/57 (15%)
65 ± 13,2 39/55 (71%) 24,6 ± 1,93 7 ± 0,71 C2: 19/55 (34,5%) C3: 30/55 (54,5%) C4: 6/55 (11%) C5: 0 C6: 0 V2: 8/55 (15%) V3: 13/55 (24%) V4: 15/55 (27%) V5: 10/55 (18%) > V5: 9/55 (16%)
0,09 0,6 0,31 0,27 0,48
0,38
Table 2 Intraoperative characteristics and follow-up of the study population.* statistical significant result. ° complete recovery: work, walk, drive as before the intervention. Intra-operative
Population
Day Surgery setting
Outpatient setting
p.value
GSV length Delivered Joules Post-operative Hospital stay Superficial Ecchymosis Paresthesia Infection Complete recovery within 7 days° 30 days follow-up Incomplete GSV obliteration 30-days CEAP classification
35,5 ± 7,04 1668 ± 431,12
37,1 cm ± 9,02 cm 1689 ± 441,34
33,9 cm ± 6,86 cm 1647 ± 424,7
0,06 0,63
– 91/112 (80%) 1/112 (0,8%) 0/112 (0%) 97/112 (86%)
474 ± 12 min 47/57 (80%) 1/57 (1%) 0/57 (0%) 50/57 (87%)
106 ± 16 min 44/55 (80%) 0/55 (0%) 0/55 (0%) 47/55 (85%)
0,001* 0,6 0,08 – 0,27
3/112 (2%) C0: 90/112 (80%) C1: 7/112 (6%) C2: 11/55 (10%) C3: 3/112 (3%) C4: 1/112 (1%) V0: 82/112 (73%) V1: 21/112 (19%) V2: 9/112 (8%) 20,48 ± 0,94 –
1/57 (1%) C0: 46/57 (81%) C1: 4/57 (7%) C2: 6/57 (11%) C3: 1/57 (1%) C4: 0 V0: 42/57 (74%) V1: 11/57 (19%) V2: 4/57 (7%) 20,45 ± 0,94 20,7 ± 0,8
2/55 (3%) C0: 44/55 (80%) C1: 3/55 (5%) C2: 5/55 (9%) C3: 2/55 (4%) C4: 1/55 (2%) V0: 40/55 (72%) V1: 10/55 (19%) V2: 5/55 (9%) 20,5 ± 0,93 20,4 ± 0,81
0,12 0,53
30 days VCSS classification
QoL questionnaire QoL questionnaire over 65 years
0,38
0,6 0,05*
Author contribution
stay or the other. In fact, we believe that some other factors (i.e. the presence of concomitant important extrasaphenous varices, the patient's compliance and familiar setting) must be kept in consideration to define the best setting for each patient.
Gianfranco Varetto: study design, surgical procedure. Lorenzo Gibello: study design, writing, manuscript revision. Edoardo Frola: data analysis, writing. Alessandra Trevisan: data collection, data analysis. Andrea Trucco: data collection. Luigi Contessa: surgical procedure, manuscript revision. Pietro Rispoli: study design, manuscript revision.
5. Conclusions Endovenous laser ablation is a safe and reliable option for the treatment of varicose veins and it could be performed in Outpatient Setting with cost reduction and comparable results to those obtained in a conventional operating theatre. Moreover, patients with more than 65 years old showed an improvement of QoL and a better tolerance of the operation compared to Day Surgery hospitalization.
Conflicts of interest The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Ethical approval Research registration Unique Identifying Number (UIN) Ethical Approval was given by the Hospital Ethical Committee. researchregistry2879. Sources of funding Guarantor The author(s) received no financial support for the research, authorship, and/or publication of this article.
Lorenzo Gibello. 182
International Journal of Surgery 51 (2018) 180–183
G. Varetto et al.
References
[11] Health Quality Ontario, Endovascular laser therapy for varicose veins: an evidencebased analysis, Ont. Health Technol. Assess. Ser. 10 (2010) 1–92. [12] R.J. Min, N. Khilnani, S.E. Zimmet, et al., Endovenous laser treatment of saphenous vein reflux: long-term re- sults, J Vasc Interv Radiol 14 (8) (2003) 991–996. [13] F. Pannier, E. Rabe, Mid-term results following en- dovenous laser ablation (EVLA) of saphenous veins with a 980 nm diode laser, Int. Angiol. 27 (2008) 475–481. [14] R.A. Weiss, Comparison of endovenous radiofre- quency versus 810nm diode laser occlusion of large veins in an animal model, Dermatol. Surg. 28 (2002) 56–61. [15] N. O'Flynn, M. Vaughan, K. Kelley, Diagnosis and management of varicose veins in the legs: NICE guideline, Br. J. Gen. Pract. J. R. Coll. Gen. Pract. 64 (2014) 314–315. [16] G. Varetto, et al., Endovenous laser ablation for varicose veins: towards a personalized energy dose, J. Vasc. Diagn. 85 (2014) (2014 Sep). [17] K. Hartmann (Ed.), Endovenöse Verfahren, Minimalinvasive Therapie der Varikosis, Schattauer Verlag, Stuttgart, 2015. [18] F. Pannier, E. Rabe, J. Rits, A. Kadiss, U. Maurinus, Endovenous laser ablation of great saphenous veins using a 1470 nm diode laser and the radial fibre − follow-up after six months, Phlebology 26 (2011) 35. [19] L. Schuler, K. Hartmann, A review of endothermal laser ablative treatment of incompetent saphenous veins, Phlebologie 46 (2017) 131–135. [20] J.A. Park, et al., The 1,470-nm bare-fiber diode laser ablation of the great saphenous vein and small saphenous vein at 1-year follow-up using 8-12 W and a mean linear endovenous energy density of 72 J/cm, J. Vasc. Interv. Radiol. JVIR 25 (2014) 1795–1800. [21] C. Wittens, et al., Editor's choice - management of chronic Venous disease: clinical practice guidelines of the European society for vascular surgery (ESVS), Eur. J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. Vasc. Surg. 49 (2015) 678–737. [22] C. Hamel-Desnos, J.-L. Gérard, P. Desnos, Endovenous laser procedure in a clinic room: feasibility and side effects study of 1,700 cases, Phlebology 24 (2009) 125–130.
[1] P. Gloviczki, 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. 53 (2011) 2S–48S. [2] R.M. Kaplan, M.H. Criqui, J.O. Denenberg, J. Bergan, A. Fronek, Quality of life in patients with chronic venous disease: san Diego population study, J. Vasc. Surg. 37 (2003) 1047–1053. [3] National Clinical Guideline Centre (UK), Varicose Veins in the Legs: The diagnosis and Management of Varicose Veins, National Institute for Health and Care Excellence, UK, 2013. [4] H. Ebner, et al., Linee guida flebo-linfologiche SIF-SICVE 2016 della Società Italiana di Flebologia e della Società Italiana di Chirurgia Vascolare ed Endovascolare, Minerva Cardioangiol. 64 (2016) 1–80. [5] T.M. Proebstle, et al., Thermal damage of the inner vein wall during endovenous laser treatment: key role of energy absorption by intravascular blood, Dermatol. Surg. Off. Publ. Am. Soc. Dermatol. Surg. Al 28 (2002) 596–600. [6] L. Mundy, T.L. Merlin, R.A. Fitridge, J.E. Hiller, Systematic review of endovenous laser treatment for varicose veins, Br. J. Surg. 92 (2005) 1189–1194. [7] L.C. Huisman, R.M.G. Bruins, M. van den Berg, R.J. Hissink, Endovenous laser ablation of the small saphenous vein: prospective analysis of 150 patients, a cohort study, Eur. J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. Vasc. Surg. 38 (2009) 199–202. [8] R. Launois, J. Reboul-Marty, B. Henry, Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ), Qual. Life Res. Int. J. Qual. Life Asp. Treat. Care Rehabil. 5 (1996) 539–554. [9] C. Boné, et al., Tratamiento endoluminal de las varices con laser de Diodo. Estudio preliminary, Rev Pathol Vasc 5 (1999) 35–46. [10] D. Carradice, et al., Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins, Br. J. Surg. 98 (2011) 501–510.
183
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.elsevier.com/locate/ijsu
Original Research
Day surgery versus Outpatient setting for endovenous laser ablation treatment. A prospective cohort study
T
Gianfranco Varetto, Lorenzo Gibello∗, Edoardo Frola, Alessandra Trevisan, Andrea Trucco, Luigi Contessa, Pietro Rispoli Division of Vascular Surgery (Chief. Prof. P. Rispoli), University of Turin, Department of Surgical Sciences, Azienda Ospedaliera Universitaria Città della Salute e delle Scienza, Molinette Corso Bramante 88, 10126 Torino, Italy
A R T I C L E I N F O
A B S T R A C T
Keywords: Endothermal laser ablation Varicose veins Outpatient treatment
Objectives: The traditional surgical approach to the treatment of the superficial venous insufficiency requires at least 12 h of post-operative monitoring and this often means the necessity of an overnight hospitalization. The introduction of new, less invasive techniques (i.e endovenous laser ablation) reduces the hospitalization stay in a Day Surgery setting. However, the increasing skills of the operators and the patient's selection, allows to propose endovenous laser ablation in an Outpatient setting. The aim of this study is to evaluate the activity of a single high-volume center. Method: We enrolled 112 consecutive patients with great sapehous vein insufficiency and indication to endothermal laser ablation, 57 operations (51%) were performed in Day Surgery setting and 55 (49%) in Outpatient setting according to endovascular laser ablation's criteria. Past medical history, CEAP classification, VCSS score, type of symptoms and intervention's data were collected. Post-operative results (success and complications rates, patient's functional and aesthetic satisfaction) were evaluated at 7 and 30 days after intervention. A QoL questionnaire (CIVIQ) was submitted to the patients 30 days after surgery. Results: We did not observe a statistically significant difference between the two groups concerning treatment results and complications onset. The QoL assessment did not differed significantly, except for over 65-year old patients undergoing outpatient treatment that showed a better QoL compared to those undergoing the same treatment in Day Surgery (p 0.05). Conclusions: The endothermal laser ablation technique allows a safe, comfortable and faster management of the venous disease in Outpatient setting. This would further reduce the costs of the treatment while preserving the functional and aesthetic results and the low complication rate of the Day Surgery setting.
1. Introduction Chronic venous insufficiency and varicose veins of the lower limbs represent a pathology with a great impact on the patient's quality of life (QoL) with a broad range of symptoms as discomfort, pain and disability [1,2]. Considering the high incidence in worker population, the disease carries also a not negligible socio-economic impact. In the last years, traditional surgery has been broadly replaced by endovenous techniques like endothermal laser or radiofrequency ablation which allow a lower invasiveness (i.e. the possibility to perform percutaneous access under local anesthesia) and pain and complications reductions with a consequent faster recovery time. NICE and the SIFSICVE 2016 guidelines lately confirmed that the endothermal ablation with laser or radiofrequency is, when suitable, to be preferred to the traditional surgery [3,4]. The principle of endothermal laser ablation ∗
(ELA) is explained with the convertion of 1470 nm laser energy into heat with water vaporization and consequent collapse and obliteration of the inner vessel wall [5]. This technique is extremely safe and reliable and data from literature confirm a success rate of 88–100% [6]. Moreover ELA has been recently extended to the treatment of the small saphenous vein (SSV) [7]. Another important advantage of ELA is the possibility to perform the entire intervention through a percutaneous access under local ultrasound-guided tumescence anesthesia. This peculiarity reduces the post-operative hospitalization stay and allows a faster and safe recovery of the patient that could be managed in a Day Surgery or even Outpatient setting. The aim of this prospective study is to compare the impact of Day Surgery versus Outpatient setting after ELA.
Corresponding author. Division of Vascular Surgery, Corso Bramante 88, 10126 Torino, Italy. E-mail address: [email protected] (L. Gibello).
https://doi.org/10.1016/j.ijsu.2018.01.039 Received 17 August 2017; Received in revised form 31 October 2017; Accepted 25 January 2018 Available online 02 February 2018 1743-9191/ © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
International Journal of Surgery 51 (2018) 180–183
G. Varetto et al.
2. Material and methods
drive as before the operation) as reported in Table 2. The 30-days follow-up confirmed the efficacy of the technique with an incomplete GSV occlusion reported in only 3 (2%) of cases (Table 2). Patient's satisfaction was evaluated both in aesthetic and functional results: in group A 87% of patients were fully satisfied while the remaining patients (13%) were only functionally satisfied; in group B 88% of patients were overall satisfied, 7% were functionally but not esthetically satisfied and 5% were esthetically but not functionally satisfied. The 30days CIVIQ questionnaire revealed a medium score in Day Surgery group of 20,45 ± 0,94 while in Outpatients group-B was 20,5 ± 0,93 (p 0,1). However, there was a statistical different perception of QoL in patients over 65 years: for this subgroup of patients there was a better perception of QoL for Outpatient setting compare to Day Surgery (p. 0,05).
Between October 2015 and July 2016 we enrolled 112 patients with great saphenous vein insufficiency and indication for ELA. They were randomly divided into two groups: 57 (51%) who underwent the operation in Day Surgery setting; 55 (49%) who underwent the operation in Outpatient setting. Primary endpoints were: the technical success (GSV obliteration at 30 days) and patient's quality of life (through the Chronic Venous Insufficiency quality of life -CIVIQ-questionnaire) [8] between the two groups. Secondary endpoints were: the post-operative complications (haematoma and ecchymosis, swelling, pain, paresthesia) between the two groups. Inclusion criteria were: CEAP (Clinical, Etiological, Anatomical, Pathophysiological) class > C1 (presence of varicose veins involving superficial venous system), GSV reflux, not tortuous vessel, GSV's calibre between 5 and 12 mm (horizontal posture). Exclusion criteria were double GSV or crosse's abnormalities, pregnancy/lactation, blood coagulation disorders or venous thrombosis, superficial GSV course (less than 4 mm). The work has been approved by the Ethic Committee and reported in line with the STROCSS criteria. All the patients underwent a pre-operative evaluation with an accurate interview and history taking and a Doppler Ultrasound to confirm the GSV dilatation and exclude an eccessive tortuosity of the vessel. ELA was performed in a sterile setting (operating theatre for Day Surgery, specialized ambulatory for Outpatient setting) with Eufoton 1470 nm diode laser fiber. After a Seldinger's cannulation of the GSV, the tip of the laser catheter is placed proximately to the origin of the epigastric vein. An US guided tumescence anesthesia is performed all along the saphenous eye (500 ml of 5 °C physiological solution with 30 ml 2% lidocaine and 5 ml 1,4% sodium bicarbonate). The ablation is obtained with an energy supply of 80 J/cm for the first 2 cm and then 40 J/cm with a power of 4–7 Watt. Post-operative follow-up consisted in a clinical (presence/absence of pain, swelling, ecchymosis, resumed daily activities) and ultrasonographic (presence/absence of DVT, GSV obliteration) controls at 7 and 30 days. The CIVIQ-20 QoL questionnaire was submitted to all the patients 30 days after surgery. It consists of 20 questions evaluating pain, sleep quality and the ability of doing everyday activities. Scores for each question ranges from 1 (no pain, no trouble) to 5 (severe pain, severe trouble). Questionnaire score ranges from 20 (best post-operative QoL) to 100 (worst post-operative QoL).
4. Discussion The first endovenous treatment of an incompetent GSV reported in literature was performed by Boné in 1998 [9]. Since then we assisted to a progressive widespread of this minimal invasive, but equally efficient, way to manage patients suffering from chronic vein insufficiency. In particular, ELA has proved to be comparable to the traditional stripping in terms of effectiveness and showed superiority in terms of complication rates and impact on the QoL [10,11]. This is partially related to the percutaneous access and the tumescence anesthesia (that guarantee a faster recovery and the absence of important wounds to heal) and partially related to the improvement of the diode laser systems and probes. In fact, in early years, diode laser systems had a wavelength ranging from 810 to 980 nm with a targeted action on the molecules of haemoglobin [12,13]. For this reason, the effect of the ablation was dependent to the presence and the amount of red blood cells. Moreover, the first-generation probes had the drawback of an inhomogeneous delivery of energy along the vessel walls provoking quite frequently spots of venous injury with consequent ecchymosis and pain for the patient [14]. The latest developments in laser technology however, increased the wavelength to 1470 nm acting on water molecules as a specific target and this improved the efficacy of obtaining durable endogenous ablation of the GSV without increasing the joules delivered [4,10,15,16]. The probes as well were ameliorated with the introduction of a double ring system for a circumferential delivery of energy into the vein lumen that guarantee a reduction of joules needed to obtain thrombosis and a reduction of pain and discomfort to the patients [17,18]. The reduced invasiveness of the procedure permitted to offer ELA in Outpatient Setting, as advocated in the latest NICE Guidelines, where non-thermal and non-tumescent venous ablation (i.e sclerotherapy) is already performed [3]. Another important aspect of this new technique is the reduction of the economical impact of the disease not only for the shortening of hospital stay (Day Surgery versus overnight stay) but also in terms of working days lost [3]. In the last years, the excellent technical results confirmed in Literature and the increasing knowledge and operator's skills, permitted to propose ELA in Outpatient setting [16,19–22]. According to our perspective randomized study we found no difference in terms of clinical success and peri-post operative complications, among patients treated in Day Surgery versus Outpatient setting. However, a slightly but significant difference was highlighted in terms of QoL: patients with more than 65 years preferred Outpatient Setting compared to Day Surgery setting. We did not find similar data in Literature to compare with but this could probably be explained with the lower emotional stress and less impact on the resumption of everyday life and a better patient's compliance in Outpatient Setting. One of the limits of this work is the relative small population size but, according to the perspective structure of the study, the ongoing collection of patients and data will probably allow us to better define the cohort of population that advantages most from one hospitalization
2.1. Statistical analysis All the data were collected and stored for statistical analysis. Continuous variables were expressed as mean and standard deviation and compared through nonparametric test of Student. Categorical variables were expressed as scores or as percentages. For their comparison were built contingency tables or matrices of cross-correlation RXC. Chi-square (with Yates correction test for 2 × 2 tables) were used. For all variables, the statistical significance was conventionally set at p < 0.05. Through the use of the Student t-test for independent samples a correlation (statistically significant) between the outcome of the procedure in the two groups was sought. 3. Results The prospective study is based on 112 consecutive patients treated with ELA with a mean age of 62 ± 13,2 and predominantly of female gender (79/112; 70%). They were randomly assigned to Day Surgery (57/112; 51%) or Outpatient (55/112; 49%) setting. Pre-operative characteristics of the general population and of the two subgroups are shown in Table 1. No difference between the two groups was highlighted for GSV length, joules delivered and post-operative complications rate nor for the time needed for a complete recovery (work, walk, 181
International Journal of Surgery 51 (2018) 180–183
G. Varetto et al.
Table 1 Preoperative characteristics of the study population. BMI: body mass index; GSV: great saphenous vein.
Age Gender F BMI GSV diameter CEAP classification
VCSS classification
Population
Day Surgery setting
Outpatient setting
p.value
62 ± 13,2 79/112 (70%) 24,9 ± 3,12 7,1 ± 1,27 C2: 38/112 (34%) C3: 63/112 (56%) C4: 11/55 (10%) C5: 0 C6: 0 V2: 17/112 (16%) V3: 29/112 (26%) V4: 25/112 (22%) V5: 24/112 (21%) > V5: 17/112 (15%)
59 ± 13,2 40/57 (70%) 25,2 ± 3,92 7,2 ± 1,48 C2: 19/57 (33%) C3: 33/57 (58%) C4: 5/57 (9%) C5: 0 C6: 0 V2: 9/57 (16%) V3:16/57 (27%) V4: 10/57 (18%) V5: 14/57 (24%) > V5: 8/57 (15%)
65 ± 13,2 39/55 (71%) 24,6 ± 1,93 7 ± 0,71 C2: 19/55 (34,5%) C3: 30/55 (54,5%) C4: 6/55 (11%) C5: 0 C6: 0 V2: 8/55 (15%) V3: 13/55 (24%) V4: 15/55 (27%) V5: 10/55 (18%) > V5: 9/55 (16%)
0,09 0,6 0,31 0,27 0,48
0,38
Table 2 Intraoperative characteristics and follow-up of the study population.* statistical significant result. ° complete recovery: work, walk, drive as before the intervention. Intra-operative
Population
Day Surgery setting
Outpatient setting
p.value
GSV length Delivered Joules Post-operative Hospital stay Superficial Ecchymosis Paresthesia Infection Complete recovery within 7 days° 30 days follow-up Incomplete GSV obliteration 30-days CEAP classification
35,5 ± 7,04 1668 ± 431,12
37,1 cm ± 9,02 cm 1689 ± 441,34
33,9 cm ± 6,86 cm 1647 ± 424,7
0,06 0,63
– 91/112 (80%) 1/112 (0,8%) 0/112 (0%) 97/112 (86%)
474 ± 12 min 47/57 (80%) 1/57 (1%) 0/57 (0%) 50/57 (87%)
106 ± 16 min 44/55 (80%) 0/55 (0%) 0/55 (0%) 47/55 (85%)
0,001* 0,6 0,08 – 0,27
3/112 (2%) C0: 90/112 (80%) C1: 7/112 (6%) C2: 11/55 (10%) C3: 3/112 (3%) C4: 1/112 (1%) V0: 82/112 (73%) V1: 21/112 (19%) V2: 9/112 (8%) 20,48 ± 0,94 –
1/57 (1%) C0: 46/57 (81%) C1: 4/57 (7%) C2: 6/57 (11%) C3: 1/57 (1%) C4: 0 V0: 42/57 (74%) V1: 11/57 (19%) V2: 4/57 (7%) 20,45 ± 0,94 20,7 ± 0,8
2/55 (3%) C0: 44/55 (80%) C1: 3/55 (5%) C2: 5/55 (9%) C3: 2/55 (4%) C4: 1/55 (2%) V0: 40/55 (72%) V1: 10/55 (19%) V2: 5/55 (9%) 20,5 ± 0,93 20,4 ± 0,81
0,12 0,53
30 days VCSS classification
QoL questionnaire QoL questionnaire over 65 years
0,38
0,6 0,05*
Author contribution
stay or the other. In fact, we believe that some other factors (i.e. the presence of concomitant important extrasaphenous varices, the patient's compliance and familiar setting) must be kept in consideration to define the best setting for each patient.
Gianfranco Varetto: study design, surgical procedure. Lorenzo Gibello: study design, writing, manuscript revision. Edoardo Frola: data analysis, writing. Alessandra Trevisan: data collection, data analysis. Andrea Trucco: data collection. Luigi Contessa: surgical procedure, manuscript revision. Pietro Rispoli: study design, manuscript revision.
5. Conclusions Endovenous laser ablation is a safe and reliable option for the treatment of varicose veins and it could be performed in Outpatient Setting with cost reduction and comparable results to those obtained in a conventional operating theatre. Moreover, patients with more than 65 years old showed an improvement of QoL and a better tolerance of the operation compared to Day Surgery hospitalization.
Conflicts of interest The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Ethical approval Research registration Unique Identifying Number (UIN) Ethical Approval was given by the Hospital Ethical Committee. researchregistry2879. Sources of funding Guarantor The author(s) received no financial support for the research, authorship, and/or publication of this article.
Lorenzo Gibello. 182
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