Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins.

BACKGROUND: This was a prospective study of radiofrequency segmental thermal ablation (RFA) for the treatment of incompetent varicose great saphenous veins (GSVs). The present report describes long-term follow-up at 5 years. METHODS: The 5-year follow-up of this multicentre European study included assessment of the Venous Clinical Severity Score (VCSS), and GSV occlusion and reflux on duplex imaging. RESULTS: A total of 225 patients had 295 GSVs treated by RFA, achieving an initial vein occlusion rate of 100 per cent. With 80·0 per cent compliance, Kaplan-Meier analyses showed a GSV occlusion rate of 91·9 per cent and a reflux-free rate of 94·9 per cent at 5 years. Among the 15 GSVs noted with reflux during follow-up, only three showed full recanalization of the GSV at 1 week, 6 months and 3 years. Of the 12 legs with partial recanalization, reflux originated at the saphenofemoral junction in ten, with a mean length of the patent segment of 5·8 (range 3·2-10) cm; only six patients were symptomatic. Mean(s.d.) VCSS scores improved from 3·9(2·1) at baseline to 0·6(1·2), 0·9(1·3) and 1·3(1·7) at 1, 3 and 5 years. CONCLUSION: At 5 years RFA proved to be an efficient endovenous treatment for incompetent GSVs in terms of sustained clinical and anatomical success for the vast majority of treated patients.

[Cellulite]. / Zellulitis.

Cellulite is a condition affecting the dermal and subdermal compartment and developing on thighs and buttocks of almost every woman. Macroscopically, cellulite is characterized by dimpling, visible either spontaneously or after provoking maneuvers. While published concepts on the pathophysiology of cellulite are in parts inconclusive or contradictory, there are at least some recent studies describing or confirming structural and anatomic changes on dermal and subdermal tissues: (1) A gender specific dimorphism with subdermal septae oriented orthogonally towards the skin surface as well as protrusion of fat tissue into the dermis. (2) These intradermal fat protrusions additionally correlate with the presence of cellulite. (3) There is also a correlation between the thickness of the subdermal fat layer and the presence of cellulite. (4) Cellulite also correlates with focal hypertrophic subcutaneous septae and a reduced density of septae in general. Treatment of cellulite aims at (1) the reduction of the subcutaneous fat layer, (2) increase in dermal thickness and elasticity and (3) dissection of hypertrophic connective tissue septae, responsible for the most pronounced dermal indentions. A variety of treatment options have evolved ranging from topical retinol to interstitial laser.

Radiofrequency-powered segmental thermal obliteration carried out with the ClosureFast procedure: results at 1 year.

This prospective and multicenter study shows the results at 1 year of radiofrequency-powered segmental thermal obliteration (RSTO) carried out with the ClosureFast procedure. The RSTO clinical and duplex ultrasound imaging results were evaluated at 3 days, 3 months, 6 months, and 1 year. All procedures were carried out on outpatients under tumescent local anesthesia. Among the 295 members who were treated, 289 were reexamined at 3 days, 290 at 3 months, 289 at 6 months, and 220 at 1 year. Occlusion scores were 99.7%, 99.3%, 98.6%, and 96.9% at, respectively, 3 days, 3 months, 6 months, and 1 year. At 3 cm below the saphenofemoral junction, before the procedure, the greater saphenous vein (GSV) diameter was 5.4+/-2 mm (range 2-18). It decreased to 4.5+/-1.7 mm at 3 days, 2.4+/-1.5 mm at 6 months, and 1.3+/-0.9 mm at 1 year. In members reexamined at 1 year, the decrease in diameter of the treated vein compared with the preprocedural measurement was 79% (p<0.001, t-test). At 1 year, in 58% of the cases, duplex ultrasound imaging at mid-thigh level could not show the GSV trunk. Preprocedural pain that was present in 57.5% of the cases decreased to 10.8% of the cases at 3 days and 2% of the cases at 1 year (p<0.001, chi2 test). Among the treated limbs, 70.1% did not present with any postprocedural pain at any time of the follow-up. On the third day, the patients evaluated the mean pain intensity at 0.7+/-1.6 on a visual analog scale of 0-10. During the follow-up, no painful indurations were noticed in 67.7% of the legs. No thromboembolic complications were reported. Paresthesias were observed in 3.4% of the cases. Invalidity clinical score, evaluated at 3.9+/-2 before the procedure, decreased to 3.5+/-1.2 on the third day, 0.9+/-1.5 at 3 months, 0.7+/-1.2 at 6 months, and 0.5+/-1.1 at 1 year. This study confirms the efficacy of RSTO when using ClosureFast, which allows obliteration of the GSV trunk in 97% of cases at 1 year with few side effects and almost no postprocedural pain.

Infrequent early recanalization of greater saphenous vein after endovenous laser treatment.

OBJECTIVE: The frequency of recanalization of the greater saphenous vein (GSV) after endovenous laser treatment (ELT) is unclear. This study was undertaken to establish the incidence of early recanalization after ELT and to study the histopathologic features of reperfused and excised GSV. METHODS: One hundred nine GSV in 85 consecutive patients with clinical stage C(2-6) E(P,S) A(S,P,D) P(R) disease were treated with ELT. Twelve months of follow-up with duplex scanning at regular intervals was possible in 104 treated veins (95.4%) in 82 patients (96.5%). Recanalized vessels were removed surgically and examined at histopathology. RESULTS: ELT-induced occlusion proved permanent at duplex scanning over 12 months of follow-up in 94 of 104 GSV (90.4%) in 73 patients. In 4 patients, 5 GSV (4.8%) were recanalized completely after 1 week, after 3 months (n = 3), or after 12 months. Another 5 GSV (4.8%) in 5 patients exhibited incomplete proximal recanalization over the 12 months of follow-up. Finally, 9 recanalized vessels (8.6%) required further treatment with high ligation and stripping. Histopathologic analysis of recanalized GSV revealed a multiluminal pattern, as commonly noted in reperfusion after spontaneous thromboplebotic occlusion of the GSV. During follow-up, secondary incompetency of untreated lateral accessory saphenous veins was observed in two legs (1.9%). CONCLUSION: Early recanalization requiring retreatment is observed in less than 10% of GSV after ELT. The histopathologic pattern mimics recanalization after thrombophlebotic occlusion.

[Surgical therapy of venous leg ulcers]. / Operative Ulkustherapie.

Surgical treatment of venous leg ulcers is a domain of dermatology. Special knowledge of differential diagnosis considerations and various treatment options are necessary to develop complex, sometimes interdisciplinary treatment plans together with angiologists,vascular surgeons and interventional radiologists. Besides surgical treatment options aiming towards normalization of venous hemodynamics, local options such as shave or total ulcer excision are well established. Additionally, new surgical techniques such as subfascial endoscopic perforator surgery (SEPS) or implantation of iliac stents now have their place in the surgical treatment of venous ulcer disease.

Gravimetrically controlled efficacy of subcorial curettage: a prospective study for treatment of axillary hyperhidrosis.

BACKGROUND: Botulinum toxin A (BTX-A) proved to be effective for the treatment of axillary hyperhidrosis by means of gravimetry. Quantitatively controlled studies for surgical treatment are lacking so far. OBJECTIVE: To prospectively test the efficacy of subcorial axillary curettage by gravimetric evaluation of pre- and postsurgical sweat rates. METHODS: Conservatively pretreated patients received subcorial curettage under tumescent local anesthesia using a sharp spoon. Sweat rates of each axilla were determined gravimetrically before and 4-8 weeks after surgery. Evaluation was performed with respect to baseline sweat rates greater than 50 mg/min (group A), greater than 25 and less than 50 mg/min (group B), and less than 25 mg/min (group C). Side effects and patients' ratings were also recorded. RESULTS: Of 42 treated patients, 38 could be evaluated completely. In 29 axillae of group A (high sweat rates), an average reduction from the baseline of 85.6 mg/min to 21.6 mg/min could be achieved (P <.0001). Corresponding values for 22 axillae of group B (medium sweat rates) were 36.8 mg/min and 16.5 mg/min (P <.0001). In 25 axillae with low sweat rates (group C), a significant reduction in sweat rates could not be achieved. The results remained almost stable during a median follow-up of 11 months (range 4-24 months). Only minor side effects were observed and patient satisfaction was high in groups A and B. CONCLUSION: Subcorial curettage is an effective treatment of axillary hyperhidrosis for patients with baseline sweat rates greater than 25 mg/min.

Subfascial endoscopic perforator surgery with tumescent local anesthesia.

BACKGROUND: Subfascial endoscopic perforator surgery (SEPS) has become an established procedure. OBJECTIVE: To evaluate SEPS with tumescent local anesthesia (TLA) using an single-port device originally designed for that purpose. METHODS: Patients selected for SEPS received subcutaneous infiltration of TLA into the medial aspect of the calf 20 minutes before surgery. Bipolar coagulation and dissection were used to treat incompetent perforators. RESULTS: Fifty-one patients with 67 legs of CEAP stages C3-C6 underwent SEPS with TLA. In 40 patients or 53 legs (79.1%) TLA alone allowed successful completion of the SEPS procedure. Five patients with 7 legs (10.4%) required additional intravenous analgesics during surgery. In 4 patients or 4 legs (6.0%) with marked dermatoliposclerosis, pain control with TLA was so inadequate that SEPS had to be stopped. CONCLUSION: SEPS with TLA is feasible in patients with CEAP stage C3-C6. However, patients with pronounced dermatoliposclerosis are likely to need more invasive analgesic measures.

Thermal damage of the inner vein wall during endovenous laser treatment: key role of energy absorption by intravascular blood.

BACKGROUND: Despite the clinical efficacy of endovenous laser treatment (EVLT), its mode of action is incompletely understood. OBJECTIVE: To evaluate the role of intravascular blood for the effective transfer of thermal damage to the vein wall through absorption of laser energy. METHODS: Laser energy (15 J/pulse, 940 nm) was endovenously administered to explanted greater saphenous vein (GSV) segments filled with blood (n = 5) or normal saline (n = 5) in addition to GSVs under in vivo conditions immediately prior to stripping. Histopathology was performed on serial sections to examine specific patterns of damage. Furthermore, in vitro generation of steam bubbles by different diode lasers (810, 940, and 980 nm) was examined in saline, plasma, and hemolytic blood. RESULTS: In saline-filled veins, EVLT-induced vessel wall injury was confined to the site of direct laser impact. In contrast, blood-filled veins exhibited thermal damage in more remote areas including the vein wall opposite to the laser impact. Steam bubbles were generated in hemolytic blood by all three lasers, while no bubbles could be produced in normal saline or plasma. CONCLUSION: Intravascular blood plays a key role for homogeneously distributed thermal damage of the inner vein wall during EVLT.

Endovenous treatment of the greater saphenous vein with a 940-nm diode laser: thrombotic occlusion after endoluminal thermal damage by laser-generated steam bubbles.

PURPOSE: Despite a rapid spread of the technique, very little is known about the laser-tissue interaction in endovenous laser treatment (EVLT). We evaluated EVLT of the incompetent greater saphenous vein (GSV) for efficacy, treatment-related adverse effects, and putative mechanisms of action. METHODS: Twenty-six patients with 31 limbs of clinical stages C(2-6), E(P), A(S,P), P(R) with incompetent GSV proven by means of duplex scanning were selected for EVLT in an outpatient setting. A 600-microm fiber was entered into the GSV via an 18-gauge needle below the knee and proceeded to the saphenofemoral junction (SFJ). After infiltration of tumescent local anesthesia, multiple laser pulses of 15 J energy and a wavelength of 940 nm were administered along the vein in a standardized fashion. D-dimers were determined in peripheral blood samples 30 minutes after completion of EVLT in 16 patients and on postoperative day 1 in 20 patients. One GSV that was surgically removed after EVLT was examined by means of histopathology. Additionally, an experimental in vitro set-up was constructed as a means of investigating the mechanism of laser action within a blood-filled tube. RESULTS: A median of 80 laser pulses (range, 22-116 laser pulses) were applied along the treated veins. On days 1, 7, and 28, all limbs except one (97%) showed a thrombotically occluded GSV. In one patient, the vessel showed incomplete occlusion. The distance of the proximal end of the thrombus to the SFJ was a median 1.1 cm (range, 0.2-5.9 cm) in the remaining patients. Adverse effects in all 26 patients were ecchymoses and palpable induration along the thrombotically occluded GSV that lasted for 2 to 3 weeks. In two limbs (6%), thrombophlebitis of a varicose tributary required oral treatment with diclofenac. D-dimers in peripheral blood were tested with normal results in 14 of 16 patients 30 minutes after completion of the procedure and elevated results in 7 of 20 patients at day 1 after EVLT. However, an increase of D-dimers from day 0 to day 1 was observed in 15 of the 16 patients undergoing tests 30 minutes after EVLT and on day 1. The 940-nm laser was demonstrated by means of in vitro experiments and the histopathological examination of one explanted GSV to act by means of indirect heat damage of the inner vein wall. CONCLUSION: EVLT of the GSV with a 940-nm diode laser is effective in inducing thrombotic vessel occlusion and is associated with only minor adverse effects. Laser-induced indirect local heat injury of the inner vein wall by steam bubbles originating from boiling blood is proposed as the pathophysiological mechanism of action of EVLT.

Efficacy of ultrasound B-scan compared with physical examination in follow-up of melanoma patients.

BACKGROUND: The value of ultrasound B-scan for routine follow-up of melanoma patients still is not generally accepted. Therefore, the authors compared the efficacy of physical examination (PE) with ultrasound B-scan (UBS) for detection of regional tumor recurrence in melanoma patients. The aim of the current study was to evaluate whether early detection of metastases improves relapse-free and overall survival. METHODS: For a period of 4 years, 829 consecutive melanoma patients were followed prospectively. Physical examination of 3011 patients and concomitant UBS of in-transit routes and regional lymph node basins were performed. Suspicious lesions were diagnosed by fine-needle aspiration cytology and pathology. RESULTS: During the study period, 242 (90.6%) of 267 patients with melanoma recurrences were first recognized by PE or UBS within the routine follow-up program. The sensitivities of both methods differed significantly (P = 0.001). Metastases were detected by PE in only 61 of 242 recurrences (25.2%, 95% confidence interval [CI]: 19.9-31.2%), whereas UBS revealed 240 recurrences (99.2%, 95% CI: 97.3-99.6%). The specificity was 98.4% (95% CI: 97.8-98.8%) and 98.3% (95% CI: 97.7-98.7%), respectively. Survival of 103 patients who presented with a first nodal melanoma recurrence was followed and analyzed by multiple Cox regression. Overall survival was affected by the diameter of the largest metastasis (P = 0.001) and the number of metastatic lesions (P = 0.012). CONCLUSION: The study found that ultrasound B-scan was highly effective in the early detection of regional melanoma metastases compared with physical examination. Earlier detection of such metastases seemed to result in improved overall survival.

Presurgical ultrasound-guided anchor-wire marking of soft tissue metastases in stage III melanoma patients.

BACKGROUND: Due to increased sensitivity of diagnostic procedures, soft tissue metastases in melanoma patients are frequently detected very early. However, small sizes, deep location, or position close to vulnerable structures could render subsequent surgery quite difficult. OBJECTIVE: To test the feasibility and effectiveness of presurgical ultrasound-guided anchor-wire marking of melanoma metastases. METHODS: We selected melanoma patients with cytologically proven metastases in clinical stage III which were either unfavorably located or which have failed removal by previous surgery. Anchor-wire marking was performed ultrasound guided and free-hand style without the use of local anesthesia. RESULTS: Twelve procedures in nine patients were well tolerated without any complications. In 11 cases the wire tip proved to be located within the tumor lesion; in one case the wire tip missed the target by less than 5 mm and thus was close enough to support appropriate surgery. Earlier, 3 of the 12 study lesions had undergone unsuccessful surgery. The median diameter of the removed metastases was 18.5 mm (range 7-30 mm). CONCLUSION: Ultrasound-guided anchor-wire marking of unfavorably located melanoma metastases is feasible and might facilitate subsequent surgery.

Ultrasound-guided fine-needle aspiration cytology in the early detection of melanoma metastases.

BACKGROUND: The early detection and treatment of tumor recurrences in melanoma patients is dependent on reliable, sensitive, and specific techniques to verify suspected tumor metastases. As of now, fine-needle aspiration cytology (FNAC) has yet to establish itself in the routine follow-up of melanoma patients. METHODS: FNAC procedures were performed in melanoma patients with palpable tumors or nonpalpable, ultrasonically suspicious lesions. Cytodiagnostic evaluation of fine-needle samples obtained from suspicious lesions was performed morphologically. Findings were validated either by histopathologic diagnosis or prolonged clinical follow-up. RESULTS: The cytologic examination of 739 FNACs from 330 melanoma patients was conducted within 1 day of sampling. Complications were not observed. This study showed a sensitivity of 97.9% and a specificity of 100.0%. Moreover, in 158 FNACs derived from lesions with a diameter less than 1 cm a sensitivity of 94.6% was achieved. Diagnosis of metastatic melanoma with unknown primary tumor was established in 20 cases. CONCLUSIONS: FNAC is very reliable for the early detection of melanoma metastases. FNAC is a swift method free of complications and is able to replace diagnostic surgery completely for nonmalignant lesions in a large number of patients. Moreover, FNAC is especially useful in combination with ultrasound in melanoma follow-up and can enable diagnosis of lesions smaller than 1 cm without impairment of sensitivity or specificity.

Correlation of positive RT-PCR for tyrosinase in peripheral blood of malignant melanoma patients with clinical stage, survival and other risk factors.

The clinical value of the reverse transcription polymerase chain reaction (RT-PCR) assay for tyrosinase in peripheral blood of melanoma patients is still under debate. A total of 212 blood samples from 212 melanoma patients in all clinical stages (AJCC) were examined. Erythrocytes were lysed prior to RNA extraction by phenol precipitation from 2.7 ml of blood. cDNA for tyrosinase PCR was synthesized using random hexamers. Positive tyrosinase RT-PCR results were obtained in 11% of 106 stage I patients, 18% of 56 stage II patients, 31% of 26 stage III patients and 67% of 24 stage IV patients. After a median follow-up of 36 months (range 26-41), stage III patients with positive RT-PCR for tyrosinase had a shortened disease-free interval as compared to negative patients (P < 0.01). In stage IV patients, median overall survival was 8 months in case of a positive RT-PCR in contrast to 12 months in case of a negative test. While univariate analysis showed sex and primary tumour location associated with positive RT-PCR, multiple regression analysis revealed clinical stage and detection of tyrosinase transcripts in peripheral blood as best prognostic factors. Hazard ratios for disease-free survival were 19.7 (confidence interval (CI) 8.53-45.5, P = 0.0001) for metastatic vs primary disease and 2.96 (CI 1.49-5.89, P = 0.002) for positive vs negative tyrosinase RT-PCR. The corresponding hazard ratios for overall survival were 97.0 (CI 12.7-741, P = 0.0001) and 4.33 (CI 1.69-11.1, P= 0.002). Our results emphasize the importance of tyrosinase RT-PCR testing in peripheral blood.

[Endoscopic fasciotomy and subfascial perforator division for chronic stasis ulcers]. / Die endoskopische Fasziotomie mit und ohne Perforansdiszision bei chronischem Ulcus cruris venosum.

Chronic venous ulcer disease is often refractory to conservative treatment modalities. After surgery of the superficial vein system, endoscopic methods can be used for division of incompetent perforators or to perform paratibial fasciotomy in cases of chronic functional compartment syndromes. We report on 13 endoscopically performed paratibial fasciotomies with or without concomitant endoscopic subfascial division of perforators (ESDP) in patients with stasis ulcers present for a median duration of 15 years. In all patients we observed immediate reduction of pain and edema. In 8 of 13 cases the ulcers healed within 3 months, another ulcer healed within 6 months and the remaining 4 ulcers showed a reduction in size of more than 75%. We conclude that endoscopically performed fasciotomy with or without ESDP is highly effective and has its place in the treatment of chronic venous ulcer disease.

Detection of regional melanoma metastases by ultrasound B-scan, cytology or tyrosinase RT-PCR of fine-needle aspirates.

Physical examination and ultrasound B-scan screening are important follow-up procedures in melanoma patients with regional disease. However, they do not allow definite diagnosis of suspicious lesions. Fine-needle aspiration cytology (FNAC) enhances the diagnostic accuracy in such patients but, unfortunately, reaches its technical limits, particularly when very small or necrotic lesions are examined. We therefore tested whether tyrosinase reverse transcription polymerase chain reaction (RT-PCR) of fine-needle aspirates (FNA-PCR) could help to increase diagnostic sensitivity. With clinical follow-up in 69 melanoma patients 81 regional lymph nodes were detected by ultrasound B-scan examination, nine of whom appeared to be palpable. Technically, FNAC was successful in all 81 lymph nodes, while FNA-PCR failed to obtain RNA at detectable levels in two lymph nodes of two patients. Of 79 lesions which have been completely evaluated by B-scan, FNAC and FNA-PCR, 44 proved to be melanoma metastases by histopathology, while the remaining 35 lesions were finally classified as non-specific lymph nodes. Of the 44 melanoma metastases 80% (n = 35) have been detected by B-scan, 90% (n = 39) by FNAC and 100% (n = 44) by FNA-PCR (P < 0.05 vs FNAC, P < 0.005 vs B-scan). In the subclass of lesions with diameters below 10 mm the sensitivities were 72% (n = 13), 78% (n = 14) and 100% (n = 18) respectively. In 35 regional lymph nodes classified as benign lesions, FNAC was always negative while FNA-PCR produced one positive result. Neither of these methods did produce false positive results in 15 control lymph nodes of non-melanoma patients. We conclude, that FNA-PCR might have superior sensitivity as compared to FNAC or ultrasound B-scan, particularly in melanoma lesions with diameters below 10 mm.

Light reflection rheography and clinical course of patients with advanced venous disease before and after endoscopic subfascial division of perforating veins.

BACKGROUND: Endoscopic subfascial division of perforating veins (ESDP) has been shown to cause fewer surgical complications than classic techniques. OBJECTIVE: To evaluate the efficacy of ESDP based on patients' symptoms, rheographic data, and ulcer healing. METHODS: Thirty-two subsequent patients underwent 40 ESDP procedures. Fifteen limbs presented with a postthrombotic syndrome (PTS), and 16 cases had an active venous ulcer. Data were recorded before and 2 months after ESDP. Stripping or high ligation procedures had been previously performed. RESULTS: The symptoms of pain and edema improved in 80% (PTS) and 74% (venous ulcer) of patients. Only one case did not show improvement of either pain or edema. Fifty-eight percent of patients showed hemodynamic improvement by light reflection rheography (LRR), while 32% did not change and 10% of patients had a worsened LRR after ESDP. The LRR refilling times increased by a median factor of 1.69, reaching at least 20 seconds in nine of 40 limbs. Venous ulcers that had been active for a median of 12 years (range, 0.5-21) healed in nine of 16 cases within 14-50 days (median, 21 days). CONCLUSION: ESDP reduces disease-related symptoms, improves hemodynamics in almost 60%, and facilitates healing of long lasting venous ulcers.