Endovenous laser ablation with and without high ligation compared to high ligation and stripping for treatment of great saphenous varicose veins: Results of a multicentre randomised controlled trial with up to 6 years follow-up.

OBJECTIVES: High ligation and stripping was compared to endovenous laser ablation for the therapy of great saphenous vein varicosity. Long-term efficacy was assessed in terms of avoidance of inguinal reflux and mechanisms of recurrence were investigated. DESIGN: Multicentre, randomised, three-arm, parallel trial. MATERIALS AND METHODS: A total of 449 patients were randomised into three different treatment groups: high ligation and stripping group (n = 159), endovenous laser ablation group (n = 142; 980 nm, 30 W continuous mode, bare fibre) or a combination of laser ablation with high ligation (endovenous laser ablation group/ high ligation group, n = 148). Patients were examined clinically and by duplex ultrasound once a year.The primary end point of this study is inguinal reflux at the saphenofemoral junction after 2 years. This paper presents secondary data on sonographically determined inguinal reflux and clinical recurrences in the treated area after up to 6 years of follow-up. RESULTS: Median time to follow-up was 4.0 years; the mean time follow-up 3.6 years. Follow-up rates were: 2 years 74%, 3 years 47%, 4 years 39%, 5 years 36% and 6 years 31%. Most reflux into the great saphenous vein appeared in the endovenous laser ablation group (after 6 years: high ligation/stripping versus endovenous laser ablation p = 0.0102; high ligation/endovenous laser ablation vs. endovenous laser ablation p < 0.0002). Furthermore, more refluxive side branches were also observed in the endovenous laser ablation group (after 6 years high ligation/stripping vs. endovenous laser ablation p = 0.0569; high ligation/endovenous laser ablation vs. endovenous laser ablation p = 0.0111). In terms of clinical recurrence during the 6 years post therapy, no significant differences between the three treatment groups were observed (p values from log-rank test: high ligation/stripping vs. endovenous laser ablation p = 0.5479; high ligation/stripping vs. high ligation/endovenous laser ablation p = 0.2324; high ligation/endovenous laser ablation vs. endovenous laser ablation p = 0.0848).The postoperative decline and later development in Class C (clinical etiological anatomical pathological) went parallel in all groups. CONCLUSIONS: Clinical recurrence appears with the same frequency in all three treatment groups, but the responsible pathological mechanisms seem to differ. Most reflux into the great saphenous vein and side branches appears after endovenous laser ablation, whereas more saphenofemoral junction-independent recurrences are seen after high ligation/stripping.

[Two-year results of a prospective randomised controlled multicenter trial to compare open operative therapy vs. endoluminal venous laser therapy with and without high ligation for the therapy of varicose greater saphenous veins]. / Zweijahresergebnisse einer prospektiv-randomisierten kontrollierten Multicenterstudie zum Vergleich der offen operativen Therapie vs. der lasergestützten endoluminalen Therapie mit und ohne Crossektomie zur Therapie der Varikose der V. saphena magna.

INTRODUCTION: Therapeutic options for the treatment of varicosis of the great saphenous vein (gsv) include endoluminal laser therapy, crossectomy/stripping and a combination of both. In this paper we present data for clinical and sonographic inguinal recurrencies up to two years post operation. MATERIAL AND METHODS: In an open multicentre, randomised three-arm trial, sonographic and clinical parameters were compared perioperatively, after 2, 6, 12 and 24 months between endoluminal venous laser therapy, high ligation and invaginating stripping and a combination of both (laser: 980 nm, continuous mode, 30 W, Biolitec®, Jena, Germany). Data of 449 patients were available for the perioperative and 2 months examination. 388 patients were followed up until 6, 380 patients for 12 and 332 patients for 24 months. We compared clinical recurrences, sonographic reflux findings, and reflux side branches in the inguinal region at the saphenofemoral junction. RESULTS: We found significantly more inguinal reflux and reflux side branches in the laser groups (p < 0.0001), however, there was no statistically significant relation between clinical recurrences and sonographic reflux. Over time, there were no intraindividual constant refluxes. Regarding the secondary endpoints oedema, lymphatic oedema, local disturbances of sensibility and irritations of the saphenous nerve, lymphatic oedema and irritations of the saphenous nerve were significantly more present in the two laser groups. After two years pain and restrictions in professional life were no longer relevant in all groups. DISCUSSION: Clinical recurrences developed both in the C/S and in the laser group but reflux into the gsv and into proximal side branches developed significantly more often in the laser group. In a long-term follow-up we have to investigate the importance of reflux side branches for the development of clinical recurrences to reveal differences between the three therapeutic strategies.

Endovenous laser ablation with and without high ligation compared with high ligation and stripping in the treatment of great saphenous varicose veins: initial results of a multicentre randomized controlled trial.

OBJECTIVES: To compare reflux recurrences at the saphenofemoral junction after endovenous laser ablation (EVLA) with or without high ligation with high ligation and stripping (HL/ST) of the great saphenous vein (GSV) in patients with varicosity of the GSV. Design Multicentre, randomized, three-arm, parallel trial. Material and Methods Patients with varicosity of the GSV were randomized to one of three groups: HL/ST, laser ablation (980 nm) or a combination of laser ablation with high ligation (EVLA/HL). Patients were examined clinically and by ultrasound pre- and postoperatively and after two months. The primary endpoint of this ongoing study is the inguinal venous reflux (IVR) in the proximal section of the GSV after two years. We present data after two months. Secondary endpoints include postoperative ecchymosis, pain or discomfort, saphenous syndrome. Groups were compared by chi-squared test. RESULTS: A total of 449 patients were randomized; mean age 48 years and 71.2% were women. Postoperative ecchymosis developed among 69.2% in the HL/ST group, in 50.4% of the EVLA group and in 50.3% of the EVLA/HL group (P = 0.0007). Postoperative pain after one day occurred in 32.7% in the HL/ST group. Discomfort occurred after surgery in 37.3% in the EVLA group, and in 50.0% in the EVLA/HL group (P = 0.0069). Early postoperative nervus saphenous syndrome developed in 0.6% in the HL/ST group, in 3.7% in the EVLA group and in 6.1% in the EVLA/HL group (P = 0.0341). After two months, IVR persisted in 38 cases (8.5%) in the laser group, in 10 (2.2%) in the EVLA/HL group and none in the HL/ST group (P = 0.6800). CONCLUSIONS: After two months IVR was more often seen in both EVLA groups compared with the HL/ST group. There were significantly more postoperative ecchymosis in the HL/ST. Postoperative pain occurred significantly more often in the EVLA/HL group. Peri- and postoperative data showed significant differences between the three groups. For definitive results concerning the primary endpoint of IVR the later follow-up has to be waited for.

[Obesity in vascular surgery]. / Adipositas in der Gefäßchirurgie.

The average weight of the Western population increases year by year. As a consequence there are new surgical challenges concerning changing medical risks, an increase of technical expenditure and economic costs. This development creates problems also for vascular surgery. These concern those patients' co-morbidities. On the other hand for this part of surgery the "obesity paradox" was proved as well. These problems, explanations and clinical results for different fields of vascular surgery as reported in the literature are discussed. Furthermore, we want to contribute to the acceptance of technical alternatives by describing our experiences in avoiding risks in obese patients.

Secondary medical prevention in patients with peripheral arterial disease - prescriptions of vascular surgeons and medical doctors (angiologists) in a multidisciplinary vascular centre.

BACKGROUND: We compared medical secondary prevention in patients with peripheral arterial disease stage II (Fontaine) located in the femoro-popliteal artery managed by vascular surgeons and medical doctors / angiologists in our multidisciplinary vascular center. PATIENTS AND METHODS: We retrospectively analyzed demission protocols of in-hospital treatments between 01.01.2007 and 20.06.2008. RESULTS: We surveyed 264 patients (54.2 % women; mean age 67.52 +/- 8.98 yrs), 179 (67.8 %) primarily treated by medical doctors / angiologists and 85 (32.2 %) primarily managed by vascular surgeons. Medical doctors / angiologists treated more women (n = 109) than men (n = 34), (p = 0.002) and documented smoking and diabetes mellitus more often (p < 0.001) than vascular surgeons. Besides, patients had similar cardiovascular risk profiles and concomitant diseases, vascular surgeons prescribed 5.47 +/- 2.26 drugs, medical doctors / angiologists 6.37 +/- 2.67 (p = 0.005). Overall, 239 (90.5 %) patients were on aspirin, 180 (68.2 %) on clopidogrel, and 18 (6.9 %) on oral anticoagulants. Significantly more patients treated by medical doctors / angiologists received clopidogrel (169 versus 11; p < 0.001), significantly more surgical patients received oral anticoagulants (11 versus 7; p = 0.016). The number of patients without prescriptions for any antithrombotic therapy was 6 (6.9 %) in patients treated by vascular surgeons and 0 (0 %) in patients managed by medical doctors / angiologists (p = 0.001). Prescription-rates of beta-blockers, ACE-inhibitors, Angiotensin II-antangonists, calcium channel blockers, and diuretics were statistically not different between the two disciplines, but statins were prescribed significantly more often by medical doctors / angiologists (139 versus 49; p < 0001). With the exceptions of Clopidogrel (women > men) and diuretics (men > women) we observed no gender-specific prescriptions. CONCLUSIONS: We observed high prescriptions rates of secondary medical prevention in patients primarily treated by medical doctors / angiologists and vascular surgeons. We believe that this result is highly influenced by our multidisciplinary approach. Nevertheless, efforts have to be made to raise vascular surgeons awareness of statin use and complete prescription of antithrombotic and antiplatelet drugs.

Proximal deep venous thrombosis following PTA of the superficial femoral artery--an obligation to disclose a complication that is rarely taken into account.

We report two cases of femoral vein thrombosis after arterial PTA and subsequent pressure stasis. We discuss the legal consequences of these complications for information policies. Because venous thrombembolism following an arterial PTA might cause serious sequel or life threatening complications, there is a clear obligation for explicit information of the patients about this rare complication.

[Strategic risk reduction in the operative therapy for abdominal aortic aneurysms]. / Operative Risikoreduktion in der Therapie des abdominellen Aortenaneurysmas.

Advances in early diagnosis of abdominal aortic abnormalities, enhanced pre-and post-surgical care and improved pharmacological treatment, as well as new interventional strategies and surgical techniques have led to a considerable increase of those patients, who undergo surgical therapy, either using classical trans-abdominal open or endovascular techniques. These patients, as a result of their often underlying multi-morbidity, are prone to secondary complications that often require individual solutions. We present and discuss two cases of post-surgical complications that required individual strategies for risk reduction. The first case demonstrates the endovascular approach to a complication following open aortic surgery, the second describes a surgical intervention to solve a problem following endovascular therapy.

[A lost Seldinger technique guide wire as the cause of deep venous thrombosis]. / Der Führungsdrahtverlust bei Seldinger-Technik als Auslöser einer Phlebothrombose.

Five months after the initial abdominal surgery, a female patient presented with a deep venous thrombosis of the right leg. A guide wire, lost during perisurgical insertion of a central venous catheter using Seldinger's technique, was identified and surgically removed. The guide wire had previously remained undetected despite regular radiological controls. The article presents details of the case together with a review of the literature regarding potential complications of Seldinger's technique. Common reasons and possible options for preventive and therapeutic strategies will be discussed.

[Biodegradation of a PTFE prosthesis]. / Biodegradation einer PTFE-Prothese.

Processes of biodegradation of PTFE--as they were not seen before for this type of graft--are demonstrated by clinical examples. As it is possible to subsume these results to regularly described processes of incorporation of alloplastic material, it is to be expected that there will be more cases than those observed by us up to now.