Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins.

BACKGROUND: This was the long-term follow-up of a previously reported randomized clinical trial comparing endovenous laser ablation (EVLA) with cryostripping for great saphenous varicose veins. METHODS: A total of 120 patients with great saphenous varicose veins were randomized 1:1 to EVLA or cryostripping. Principal outcome measures were freedom from incompetence or neovascularization on duplex imaging, and improvement in Venous Clinical Severity Score (VCSS) and Aberdeen Varicose Vein Severity Score (AVVSS) 5 years after treatment. RESULTS: Life-table analysis showed freedom from duplex-derived incompetence and neovascularization at 5 years in 62 (95 per cent confidence interval 50 to 76) per cent after EVLA and in 51 (39 to 66) per cent after cryostripping (P = 0.246). Neovascularization was more common after cryostripping, but incompetent tributaries were more common after EVLA. VCSS and AVVSS values improved significantly after treatment in both groups, and were maintained for 5 years, but with no significant difference between the groups. CONCLUSION: In this study, no significant difference was demonstrated in late outcome after EVLA or cryostripping in patients with great saphenous varicose veins.

Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction.

OBJECTIVE: To evaluate whether ligation of the saphenofemoral junction (SFL) improves the results of endovenous laser ablation (EVLA) of the great saphenous vein (GSV) in a 5-year randomised clinical trial (RCT). METHODS: Forty-three symptomatic patients (86 limbs) with bilateral incompetent GSVs were randomised so that one limb underwent EVLA without SFL and the other limb underwent EVLA with SFL. Eleven patients were lost to follow-up and two patients died, leaving 30 patients (60 limbs) for analysis. Duplex-confirmed groin varicose vein recurrence and venous clinical severity score (VCSS) were investigated at 6, 12, 24 and 60 months after treatment. RESULTS: Five-year life table analysis showed freedom from groin varicose vein recurrence in 79% of limbs (95% confidence interval (CI); 67-92%) in the EVLA without SFL group and in 65% of limbs (95%; CI; 51-82) in the EVLA with SFL group (P = 0.36). Groin varicose vein recurrence was due to neo-vascularisation (0%), re-canalisation (9%) and incompetent tributaries in 14% in the EVLA without SFL group, and to neo-vascularisation (33%), re-canalisation (0%) and incompetent tributaries (0%) in the EVLA with SFL group. The VCSS improved significantly and was comparable in both groups. CONCLUSION: The rate of varicose vein recurrence was similar in both study groups. There was less neo-vascularisation in the EVLA without SFL group, but more incompetent tributaries and early re-canalisation at 5-year follow-up than in the EVLA with SFL group. REGISTRATION NUMBER: ISRCTN60300873 (http://www.clinical-trials.com).

Randomised comparison of costs and cost-effectiveness of cryostripping and endovenous laser ablation for varicose veins: 2-year results.

BACKGROUND: Although endovenous laser ablation for varicose veins is replacing surgical stripping, proper economic evaluation with adequate follow-up in a randomised clinical trial is important for considered policy decisions regarding the implementation of new techniques. METHODS: Data from a randomised controlled trial comparing cryostripping and endovenous laser ablation in 120 patients were combined to study Short Form (SF) 6D outcome, costs and cost-effectiveness 2 years after treatment. Incremental cost per quality-adjusted life year (QALY) gained 2 years after treatment was calculated using different strategies, and uncertainty was assessed with bootstrapping. RESULTS: Over the total study period, mean SF-6D scores improved slightly from 0.78 at baseline to 0.80 at 2 years for patients who underwent cryostripping and from 0.77 to 0.79 for patients who underwent endovenous laser. QALY (SF-6D) was 1.59 in patients who underwent cryostripping and 1.60 in patients who underwent endovenous laser 2 years after treatment. The costs of cryostripping and endovenous laser per patient were euro 2651 and euro 2783, respectively. Bootstrapping indicated that cryostripping was associated with an incremental cost-effectiveness ratio of euro 32 per QALY gained. With regard to different strategies, outpatient cryostripping was less costly and more effective 2 years after treatment. CONCLUSION: In this study, in terms of costs per QALY gained, outpatient cryostripping appeared to be the dominant strategy, but endovenous laser yielded comparable outcomes for a relatively little additional cost.

Randomized clinical trial comparing endovenous laser ablation of the great Saphenous vein with and without ligation of the sapheno-femoral junction: 2-year results.

OBJECTIVE: To evaluate whether ligation of the sapheno-femoral junction (SFJ) improves the 2-year results of endovenous laser ablation (EVA). METHODS: Forty-three symptomatic patients with bilateral varicose veins were studied in which one limb was randomly assigned to receive EVA without SFJ ligation, and the other limb received EVA with SFJ ligation. Recurrence of varicose veins and abolition of great saphenous vein (GSV) reflux on duplex ultrasound imaging, and venous clinical severity score (VCSS) were investigated at 6, 12, and 24 months after treatment. RESULTS: Two-year life table analysis showed freedom from groin varicose vein recurrence in 83% of 43 limbs (95% CI; 67-95%) in the EVA without ligation group and in 87% of 43 limbs (95%; CI 73-97) of limbs in the EVA with ligation group (P=0.47). Thirty-eight (88%) treated GSV segments were ablated completely in the EVA without ligation group and 42 (98%) in the EVA with ligation group (N.S.). Groin recurrence was due to an incompetent SFJ/GSV (9%) and to incompetent tributaries (7%) in the EVA without ligation group and due to neovascularisation (12%) in the EVA with ligation group. The VCSS improved significantly and was comparable in both groups. CONCLUSION: The addition of SFJ ligation to EVA makes no difference to the short-term outcome of varicose veins treatment. Establishing whether SFJ ligation results in a poorer long-term outcome because of neovascularisation needs to be studied in larger populations with longer follow-up.

Randomized clinical trial comparing endovenous laser with cryostripping for great saphenous varicose veins.

BACKGROUND: The aim of this randomized single-centre trial was to compare the 2-year results of endovenous laser ablation (EVLA) and cryostripping for varicose veins. METHODS: A total of 120 patients with uncomplicated great saphenous varicose veins were randomized equally to one of the two treatments. Principal outcomes measures were: freedom from recurrent varicose veins on duplex imaging, and improvement in Venous Clinical Severity Score (VCSS) and Aberdeen Varicose Vein Severity Score (AVVSS) 6, 12 and 24 months after treatment. RESULTS: Life-table analysis showed overall freedom from recurrent incompetence at 2 years in 77 (95 per cent confidence interval (c.i.) 72 to 78) per cent of patients after EVLA and in 66 (95 per cent c.i. 60 to 67) per cent after cryostripping (P = 0.253). VCSS and AVVSS values improved significantly after treatment, but the differences between the treatments were not significant. EVLA provided significantly more favourable results than cryostripping with respect to duration of operation, postprocedural pain, induration and resumption of normal activity. CONCLUSION: EVLA and cryostripping were similarly effective in patients with varicose veins, but patients favoured EVLA because of less pain and postoperative morbidity, and quicker return to normal activity. REGISTRATION NUMBER: ISRCTN33832691 (http://www.controlled-trials.com).

Endovenous laser ablation: an experimental study on the mechanism of action.

OBJECTIVES: The aim of this experimental study was to investigate the mechanism of action of endovenous laser ablation (EVLA) using an 810-nm diode laser. METHODS: We compared intermittent and continuous delivery of laser energy and studied the absorption of laser light by blood, intravascular temperatures in ex vivo human vein segments using an intravascular thermography catheter and heat dissipation in a model tissue using the Schlieren technique. RESULTS: Laser light is absorbed by blood and converted to heat leading to coagulation, vaporization and carbonization, and forming an isolating layer at the fibre tip. Laser energy is then absorbed into the isolating layer forming black patches that burned on the laser fibre. Intravascular temperature increased rapidly above carbonization temperatures (300 degrees C) after the fibre tip reached the thermocouple, stayed at this temperature for a few seconds and decreased gradually to around 30 degrees C, 10 s after the fibre tip passed the thermocouple. Schlieren techniques revealed that heat spread from the laser was locally distributed and closely around the laser fibre tip while heat dissipation is minimal and comparable for both exposures. Compared with intermittent exposure, continuous exposure results in more carbonization, higher mean maximum intravascular temperature (128 +/- 7 vs. 75 +/- 4 degrees C), and long-lasting temperature of 100 degrees C (1.2 +/- 0.4 vs. 0.1 +/- 0.1 s). CONCLUSION: In this experimental study, application of endovenous laser shows to be dominated by carbonization at the fibre tip. Although intraluminal laser-induced heat was heterogeneously distributed, with laser tip temperatures up to 1200 degrees C, heat dissipation was minimal. Continuous exposure of laser light appears to be better suited in EVLA than intermittent.

Is there a risk for lymphatic complications after endovenous laser treatment versus cryostripping of the great saphenous vein? A prospective study.

OBJECTIVE: To investigate whether lymphatic complications occur after endovenous laser treatment (EVLT) versus cryostripping. METHODS: A prospective analysis of patients who underwent lymphoscintigraphy before and six months after treatment of primary varicose veins. RESULTS: Of 120 patients randomized in a clinical trial comparing EVLT and cryostripping, 33 agreed to participate in this study. Six months after treatment, none of the 17 patients treated with EVLT and one (6.3%) of the 16 patients treated with cryostripping had clinical grade 1 lymphoedema, with marked disruption of the lymphatics around the knee. This patient also showed an abnormal uptake of radioactive tracer at the groin, 120 min after injection. CONCLUSION: This study demonstrated that no lymphatic complications occurred six months after EVLT, whereas one lymphatic complication occurred after cryostripping, however not in the groin but at the knee.

Impact of low frequency transcutaneous electrical nerve stimulation on symptomatic diabetic neuropathy using the new Salutaris device.

In a double blind, randomised study, 19 patients suffering from mild-to-moderate symptomatic diabetic neuropathy (Total Symptom Score, NTSS 4-16) received either treatment with the new transcutaneous electrical nerve stimulation (TENS) device "Salutaris" (verum group) or a placebo treatment with an identical but electrically inactive device (placebo group). Stimulation pads were placed at the anatomical localisation of the peroneal nerve and stimulation was performed using a low frequency mode. At baseline (V1), after 6 (V2), and 12 (V3) wk of treatment, the patients' symptoms were registered using the new total symptom score (NTSS-6) and a visual analogue scale (VAS). In addition, sensory nerve thresholds (temperature, vibration, pain) and microvascular function were measured at the lower limb at baseline and after 12 wk of treatment. Active TENS-treatment resulted in a significant improvement in NTSS-6 score after 6 wk (-42%) and after 12 wk (-32%) of treatment (baseline: 10.0+/-3.3, 6 wk: 5.8+/-5.0, p<0.05; 12 wk: 6.8+/-3.9, p=0.05; placebo group: baseline: 7.6+/-3.1; 6 wk: 8.1+/-5.1, n.s.; 12 wk: 6.5+/-6.1, n.s.). Subanalysis of the different qualities of the NTSS-score revealed an improvement in numbness (2.2+/-1.0 to 1.6+/-1.3; p<0.03); lancinating pain (1.6+/-1.1 to 0.6+/-0.9; p<0.02) and allodynia (1.4+/-1.6 to 0.5+/-1.0; p<0.05). Also, a significant improvement in the VAS rating was found after 6 wk of TENS therapy (19.8+/-5.0 to 14.4+/-9.6; p<0.05), while no change was observed in the placebo arm. In conclusion, our study indicates that the new TENS device "Salutaris" is a convenient, non-pharmacological option for primary or adjuvant treatment of painful diabetic neuropathy.

[Postoperative transcutaneous electrical nerve stimulation (TENS) in shoulder surgery (randomized, double blind, placebo controlled pilot trial)]. / Postoperative transkutane elektrische Nervenstimulation (TENS). Randomisierte, doppelblinde, plazebokontrollierte Pilotstudie bei Eingriffen im Schultergelenkbereich.

BACKGROUND: The aim of this study was to determine whether 3 days of TENS therapy postoperatively after shoulder operations would result in better pain relief and/or reduced analgesic intake when compared to placebo. METHOD: The study was carried out randomized, double-blind and placebo controlled. Thirty patients were randomized to two groups. The verum group received TENS SM1AKS 80 Hz 6 mA and the placebo group received TENS SM1AKS 80 Hz 0 mA. The pain was assessed pre-operatively using the Hamburg Pain Adjective List. Premedication and Anaesthesia were standardized. TENS was applied to the patients immediately postoperatively for 8 hours and then on the following days 5 times daily for 45 minutes. The effectiveness was evaluated postoperatively using a visual analogue scale (rest, activity), the Hamburg Pain Adjective List and postoperative analgesic consumption. RESULTS: The visual analogue scale at rest and on activity showed no significant difference between the groups. Postoperative analgesic consumption of morphine hydrochloride in the first 24 hours was at time 8 hours postoperative significantly and at all other time points markedly less in the verum group compared to the placebo group. The sensory secondary scale score of the "Hamburg Pain Adjective List" was significantly lower postoperatively compared to preoperatively in the verum group. CONCLUSION: We were able to show in this study that TENS applied postoperatively after shoulder surgery clearly reduced analgesic consumption in the first 72 hours. Furthermore there was a significant difference in the pain scores using the "Hamburg Pain Adjective List" in favour of the verum group. TENS applied postoperatively is a effective, simple modality with few side-effects.

Color-flow duplex criteria for grading stenosis in infrainguinal vein grafts.

Color-flow duplex scanning of infrainguinal vein bypasses was used to identify failing grafts. Several duplex parameters were compared to determine their value in identifying and quantifying the degree of stenosis. Intraarterial digital subtraction angiography was used as the "gold standard" to determine the severity of the stenosis. The goal of this study was to identify specific color-flow duplex criteria for grading stenotic lesions. After a retrospective analysis some of these parameters were prospectively validated. The surveillance protocol required a color-flow duplex scan every 3 months for the first year and every 6 months during the second year. One hundred sixteen vein grafts in 112 patients were studied. Forty-three stenoses were identified and classified into categories from 30% to 49%, 50% to 69%, and 70% to 99% diameter reduction. These stenoses were identified in either the bypass graft or adjacent inflow or outflow arteries. Failing grafts were evaluated further by intraarterial digital subtraction angiography. Patients with normal appearing bypasses (without suspected stenotic lesions) had intravenous digital subtraction angiography. The five duplex parameters that were studied included the following: (1) graft peak systolic velocity (PSV-graft), (2) the maximum peak systolic velocity (at the site of a stenosis or in normal grafts at the narrowest segment of the bypass) (PSV-max), (3) the ratio between PSV-graft and PSV-max, (PSV-index), (4) end-diastolic velocity (EDV) at a stenosis or from narrowest graft segment, (5) color-flow image diameter measurements. For discrimination of different degrees of stenosis, threshold values of these parameters were calculated by receiver operating characteristic analysis. Diameter reduction measured by color-flow imaging was best to identify all stenotic lesions greater than 29% (sensitivity 88%, specificity 99%). Peak systolic velocity-index proved optimal identification of stenoses greater than 49% (sensitivity 89%, specificity 92%), and 70% to 99% stenoses were associated with increased EDV (sensitivity 91%, specificity 100%). The PSV-index criteria were then validated prospectively in a separate group of vein grafts. The data support the value of surveillance of femorodistal vein grafts and demonstrate that calculation of the degree of graft stenosis is feasible.

[Results of bypass surgery for imperiled leg]. / Resultaten van bypass-operaties wegens bedreigd been.

Femoropopliteal and crural bypass operations are performed frequently, but the results of operations for intermittent claudication and severe ischaemia are often reported jointly. However, the importance of the latter category for the quality of life is of a different order, so that its results should be studied separately. In a period of over eight years 199 bypass operation were performed. The cumulative proportion of preserved legs after three years was 82% for femoropopliteal and 68% for femorocrural transplantations. Factors such as presence of gangrene, diabetes mellitus and a systolic ankle blood pressure below 40 mm Hg were associated with a significantly smaller proportion of saved legs. The five-year survival rate for the group of patients as a whole was 42%, far lower than the 79% that applies to a comparable group of healthy persons. Cardiopathy was the main cause of death. Even if the number of remaining years of life is less, saving the leg by a bypass operation performed in time should be considered of major importance.

Early detection of stenosis of femoro-distal grafts. A surveillance study using colour-duplex scanning.

The development of stenoses following femoro-distal bypass procedures may jeopardise graft function. In a prospective study serial assessment of femoro-distal grafts in 77 patients was performed over a period of 13 months. Forty-eight of the bypasses were in situ, 18 were reversed veingrafts and 11 were modified sheep collagen grafts. Colour coded duplex scanning of all grafts was performed in addition to physical examination, ankle systolic pressure measurements and pulse volume recordings. Stenotic areas were detected in the graft in 16 cases and at the site of the proximal anastomosis in one case. In one graft a residual valve leaflet was found. In addition eleven arterio-venous communications were observed in in situ veingrafts and one aneurysmal degeneration in a collagen graft was noted. All stenoses were detected by colour duplex scanning and confirmed by arteriography or operative exploration. Only 38% of the stenoses over 50% was associated with recurrent symptoms or could be detected by diminished palpable pulses. Ankle blood-pressure measurements and pulse volume recordings indicated the presence of a stenosis over 50% in only 46% of the cases. Twelve of 13 patients with graft stenosis over 50% were revised by vein patch plasty with a good result in all cases. The primary and secondary two year cumulative patency rates of all in situ bypasses were 63% and 79% respectively. Close surveillance of femoro-distal grafts appears justified by this study. Colour duplex scanning was superior to systolic ankle pressure measurements and pulse volume recording in detecting the development of graft stenosis.