Treatment of end-stage peripheral artery disease by neuromodulation.

BACKGROUND: Neuromodulation is a therapeutic option to improve limb salvage in end-stage peripheral arterial disease (PAD), but there is no consensus on its indication for spinal cord stimulation (SCS) in PAD patients. OBJECTIVE: The aim of this study was to present the outcome of end-stage PAD patients treated with SCS. METHODS: This study is a retrospective analysis based on a local prospective registry. Neuromodulation was performed if there was: 1) no revascularisation option, 2) no septicemia, 3) and Rutherford stage 4-6. The primary endpoint of the study was limb salvage. Secondary endpoints were reduction in pain or simply pain reduction pain (assessed using a visual anlog scale/VAS) and improvement in walking distance. RESULTS: Limb salvage was reached in 30/34 patients (88%). Patients reported a significant reduction in pain on the 10-point VAS scale from baseline (median = 7.5, IQR = 7-8) to follow-up at 2 years (median = 0, IQR 0-2.75), p < 0.001. Walking distance also improved from preoperative (median = 50 m, IQR = 20-50 m) to follow-up at 2 years (median = 150 m, IQR 50-272 m), p < 0.001. RESULTS: SCS implantation in patients with end-stage PAD can enable limb salvage in a high percentage of cases and increase mobility due to pain reduction. The role of microcirculation in these improvements needs to be investigated in further studies.

Perioperative quality assessment of varicose vein surgery : Commission for quality assessment of the German Society for Vascular Surgery.

PURPOSE: An estimated 350,000 varicose vein (VV) surgical procedures are performed in Germany each year, with annual treatment costs amounting to about 800 million Euro. To evaluate the outcome quality of this treatment, we examined the intraoperative and postoperative complication rates on record in the VV surgery quality assessment (QA) registry of the German Society for Vascular Surgery (GSVS). METHODS: Data on 89,647 patients (27,463 men, 62,184 women; average age 52.8 years, range 15-96 years) collected in the GSVS varicose surgery QA registry between 2001 and 2009 were analyzed. In these patients, 95,214 surgical procedures were performed on 105,296 limbs. Complication rates were correlated with the type of VV surgical procedure, with whether surgery was performed on an inpatient or outpatient basis, and with the CEAP classification (C stage) and American Society of Anaesthesiologists' (ASA) stage at the time of surgery. Statistical analyses were performed using a chi-square test, a Cochrane-Armitage test, and an odds ratio calculation. RESULTS: Intraoperative and postoperative complication was low (0.18 and 0.43 %, respectively), being the lowest for radiofrequency ablation (0.25 %) but not differing significantly from those for endovenous laser therapy and high ligation and stripping. General complications occurred in 0.67 % of outpatients and in 0.25 % of inpatients, a highly significant statistical difference (p < 0.0001, chi-square test). With regard to C stage, the higher the stage, the higher the local complication rate. A clear correlation was also found between preoperative ASA stage and postoperative complication rates: for ASA stages I and II, the complication rates were 0.2 and 0.5 %, respectively, increasing for ASA stage III to 1.2 % and for ASA IV to 2.2 %. The differences between the ASA classes were highly statistically significant (p < 0.0001, Cochrane-Armitage test) CONCLUSIONS: Outcome quality as reflected in the intraoperative and postoperative complication rates was very good for all patients undergoing inpatient or outpatient VV surgery. Data from the GSVS QA registry shows that VV surgery is performed with very good perioperative results in specialized centers in Germany.

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.

[Diagnosis and treatment of varicose veins: part 2: therapeutic procedures and results]. / Diagnose und Therapie der primären Varikose: Teil 2: Therapieverfahren und Ergebnisse.

This is the second of two articles on the diagnosis and treatment of varicose veins. Primary varicosis is a congenital degenerative disease of the peripheral venous system of the lower extremities. Treatment is carried out according to an individualized concept which takes the incurability and progression of the disease into consideration. Conservative treatment with compression bandages is an option for all forms of varicosis and the accompanying complications. Veins can be specifically ablated by sclerotherapy of varices. In addition to high ligation and stripping mini-phlebectomy and subfascial endoscopic perforator surgery (SEPS) can also be performed. The indications in cases of SEPS should be extremely limited because of possible severe complications. Radiofrequency ablation (RFO) and endovenous laser therapy (ELT) are also available as endovenous therapy options. Information in the literature on recurrence rates of the various procedures is extremely variable and the reasons for recurrent varicosis are the subject of controversy. The data relating to the results of RFO and ELT are relatively good and both procedures show a significant improvement in quality of life and the venous clinical severity score (VCSS).

[Diagnosis and treatment of varicose veins. Part 1: definition, epidemiology, etiology, classification, clinical aspects, diagnostic and indications]. / Diagnose und Therapie der primären Varikose. Teil 1: Definition, Epidemiologie, Ätiologie, Klassifikation, Klinik, Diagnostik und Indikationsstellung.

This is the first of two articles on the diagnosis and treatment of varicose veins. Primary varicosis is a congenital degenerative disease of the peripheral venous system of the lower extremities. The realisation factors are age, female sex and pregnancy. Degeneration of the peripheral veins leads to dilatation of the lumen and insufficient closure of the valves resulting in a backflow of blood from deep to the superficial venous system. This leads to ambulatory hypertension in the superficial venous system and recirculation of noteworthy amounts of venous drainage blood in the affected leg. Without treatment this results in the long term in variable degrees of decompensation of the recirculation pathways and an increasing (volume-induced) secondary insufficiency of the deep venous system. The result corresponds to the clinical symptoms of chronic venous insufficiency (CVI). When treatment is started early enough the pathological course can be reduced or avoided. The various therapeutic measures will be described in the second article of this series.

[Treatment of primary varicosis]. / Therapie der primären Varikosis.

While the treatment of varicose veins has remained unchanged over the past 100 years based on the three principles of compression, sclerotherapy, and classic varicose vein surgery, alternative approaches and advancements in treatment have developed in the last 10 years such as foam sclerotherapy, endovenous laser therapy, and radiofrequency obliteration. In contrast to classic varicose vein surgery, prospective, randomized, comparative studies are available with respect to the modern treatment procedures. They clearly show that endovenous thermal techniques are not inferior to the classic operation regarding the perioperative complication rate. There appears to be a tendency toward considerably fewer perioperative complaints with endovenous laser therapy and in particular with radiofrequency obliteration. Foam sclerotherapy represents a minimally invasive alternative that is markedly cost-effective. Even though the occlusion rate of the root veins after foam sclerotherapy is not as good as after endovenous therapy, the method is initially very effective. Especially in cases of recurrent varicose veins from the saphenofemoral or popliteal junction, foam sclerotherapy should be considered as the ideal method. All procedures significantly improve the patients' quality of life and the symptom complaints related to varicose veins. They are not in competition, but rather partially complement each other so that a combination of several approaches is quite judicious.

The relationship between volume and outcome following elective open repair of abdominal aortic aneurysms (AAA) in 131 German hospitals.

OBJECTIVES: Several studies indicate that high-volume hospitals have better results in open repair of unruptured abdominal aortic aneurysms (AAA). Up to now no studies had addressed this question in German hospitals. DESIGN: Post-hoc-analysis from a prospective physician-led registry. MATERIAL AND METHODS: Since 1999, the German Society for Vascular Surgery has conducted a prospective registry for open and endovascular repair of AAAs. This study includes 131 hospitals who conducted n=10163 elective open repairs for unruptured AAA between 1999 to 2004. All perioperative variables including annual volume as a continuous variable were analysed in a step-wise logistic regression model. In order to define a threshold annual volume an additional logistic regression analysis was performed by use of annual volume groups (0-9, 10-19, 20-29, 30-39, 40-49, 50 or more). The relationship between annual volume and further outcome parameters (length of procedure, blood transfusion, length of stay) were also analyzed. RESULTS: The overall mortality rate was 3.2%. The stepwise logistic regression model identified the following predictors of an increased perioperative mortality: age (OR 1.084, 95% CI 1.066-1.102), AAA diameter (OR 1.008, 95% CI 1.001-1.016), length of procedure (OR 1.008, 95% CI 1.006-1.009), ASA-Score (OR 2.636, 95% CI 2.129-3.264), suprarenal clamping (OR 1.447, 95% CI 1.008-2,078), blood transfusion (OR 1.786, 95% CI 1.268-2.514). Annual volume was moderately predictive (OR 1.003, 95% CI 1-1.006) but failed to reach statistical significance (p=0.07). The analysis of volume groups identified a significantly higher risk for hospitals with an annual volume of 1-9 AAA-repairs by comparison to hospitals with an annual volume of 50 or more AAA-repairs (OR 1.903, 95% CI 1.124-3.222). Operations at low volume hospitals were also longer (p<0.001), with an extended postoperative stay (p<0.001) and a higher transfusion rate (p<0.001). CONCLUSIONS: Patient's age, ASA classification, AAA diameter, length of procedure, suprarenal clamping and blood transfusion are predictive variables for an increased perioperative mortality in elective open AAA repair. Mortality is also increased by a low annual volume. Further studies are needed to examine whether these data are applicable to all German hospitals.

[Primary varicosis]. / Primäre Varikose.

The classic varicose vein operation still represents the "gold standard" in the operative therapy of varicose veins. The results of this procedure in view of perioperative complications are very good, with the incidence of perioperative deep venous thrombosis varying between 0.05% and 0.1%. Recurrence rates between 6% and 60% are published. However, the true recurrence rate is unknown since an exact definition of recurrent varicosis is still lacking. In recurrent varices it is essential to distinguish between disease progression, including neorevascularisation, and technical errors. Endovascular procedures for elimination of the superficial venous system - radiofrequency obliteration and endovenous laser therapy - meanwhile have established themselves as alternative, minimally invasive procedures. The perioperative complication rate of endovenous procedures is very low and comparable to that of the classic operation. Good results, with occlusion rates of the treated vein around 87% to 93% up to 2 years postoperatively, have been published for both endovenous laser therapy and radiofrequency obliteration. For the latter, 5-year results were published, with occlusion of the treated vein in 87%. Results in the literature for radiofrequency are better documented than for endovenous laser treatment because there are now five prospective randomised trials for the former and most publications for endovenous laser treatment are single-center experiences. The advantage of endovenous procedures, especially radiofrequency obliteration, over the classic operation is the lower rate of perioperative pain and better quality of life. The spectrum of operative treatment methods of the superficial venous system has increased tremendously due to new technical developments. For the surgeon this implies the necessity of informing patients conscientiously about the pros and cons and available results of each procedure, and carefully weighing which methods are at the time best for the patient.

Certification of vascular centers - a project of the German Society for Vascular Surgery.

OBJECTIVES: Due to the progress vascular medicine has made in conventional vascular surgery, endovascular procedures, and conservative therapy close, interdisciplinary cooperation is required. In order to assure the contextual and structural quality of vascular centers, the German Society for Vascular Surgery established a list of criteria for certification of each interdisciplinary vascular center. MATERIAL AND METHODS: Between July 2002 and December 2005, 77 centers have submitted a written application and have been audited by the commission for quality assurance of the German Society for Vascular Surgery, 59 vascular centers were certified for a period of 3 years with one center in each in Austria and in Switzerland, 13 centers were not certified (16.8%), and the applications of 5 centers are still pending. This analysis is based on 57 German certified vascular centers. RESULTS: Each center treats a median of 1149 inpatients (11% of these are emergency admissions) and 2,159 outpatients per year. Sixty percent of the patients treated have an arterial disease. All centers have vascular surgery and radiology departments. In 11 out of 57 centers, angiology services are offered in cooperation with affiliated physicians. Each vascular center has an average of 4.2 vascular surgeons, 3 radiologists and 1 angiologist. All centers offer radiological and ultrasound diagnostics (CT angiography in 100%, MRT in 95%, duplex sonography in 100%). Each clinic executes a median of 521 (233-1436) arterial operations and 263 (37-1055) arterial interventions. In addition, they execute varicose surgeries (n=217), shunt applications/revisions (n=58), minor amputations (n=57) and major amputations (n=42). They conduct 338 (92-3606) conservative therapies per year (POAD, diabetic foot, phlebothrombosis, chronic venous insufficiency). CONCLUSIONS: The certification of interdisciplinary vascular centers is a new approach to assure the contextual and structural quality of interdisciplinary vascular centers.

[Results of the certification of vascular centers by the German Society for Vascular Surgery]. / Ergebnisse der Zertifizierung von Gefässzentren durch die Deutsche Gesellschaft für Gefässchirurgie.

INTRODUCTION: Advances in conventional vascular surgery, endovascular procedures and conservative treatment require close interdisciplinary cooperation. The term Vascular Centre indicates to patients and referring doctors optimal professional and organisational competence. METHODS: 73 applications by vascular centres for certification were made between June 2002 and December 2005, of which after audit 54 were successful for three years, including one centre each in Austria and Switzerland. 13 centres were not accepted and six are still under consideration. This analysis is based on the data of 52 certified centres in the Federal Republic of Germany. RESULTS: A mean of 1149 patients were hospitalized in these centres per year (12 % emergency admissions) and 2159 patients per year were treated as outpatients, 60 % with arterial vascular disease. All centres have vascular surgery and radiology department, 10 of the 52 centres cooperate with specialists in private practice to provide an angiology service. A mean of 460 arterial vascular operations and 239 arterial interventional procedures were performed at each centre annually. In addition there were operations for varicose veins (n = 217), shunt operations (n = 58) and major amputations (n = 42). Inpatient or outpatient conservative treatment (for peripheral vascular disease, diabetic foot syndrome, phlebothrombosis or chronic venous insufficiency) was given to a mean of 338 patients annually. CONCLUSIONS: Certification of interdisciplinary vascular centres provides structural and medical data and the beginnings of comparing such centres. A future task will be standardization of documentation and continuing assessment of the quality of results.

[Acute superficial thrombophlebitis--therapeutic strategies]. / Strategien zur Antikoagulation und Operation bei akuter Thrombophlebitis.

UNLABELLED: Thrombophlebitis (TP) of the superficial venous system is associated to a high percentage with deep venous thrombosis (DVT). References in literature vary between 5 and 65 %, pulmonary embolisms (LE) were described in up to 33 %. PATIENTS: In a retrospective study, 114 patients who had presented themselves with a TP of the superficial venous system between January 1 (st) and December 31 (st) 2004, were analysed in our institution. 50 % (n = 57) exhibited a TP in side branches of the superficial venous system. 19.3 % (n = 22) showed a TP of the great saphenous vein (GSV) of the calf or of the small saphenous vein (SSV) distally, in 28.1 % (n = 32) the GSV or SSV were affected at the thigh or proximally or in total length, 3 patients (2.6 %) exhibited a TP of the arm vein. 11 patients (9.6 %) showed a concomitant DVT. The frequency of DVT depended on the localisation and extension of the TP, and also on additional basic and acute risks for DVT. The incidence of a concomitant DVT was 5.2 % when side branches were affected and amounted to 15.6 % with TP in the area of the GSV or SSV. With varicosis as single risk factor, the frequency of a concomitant DVT was 6 %, varicosis combined with further risks showed a DVT frequency of 15.4 %. RESULTS: All patients were treated with low molecular weight heparin either with prophylactic or therapeutic dosage, depending on localisation, extension and concomitant diseases. 10.5 % of the patients (n = 12) had to undergo urgent surgery with ligation of the sapheno-femoral junction or popliteal junction, if the TP had reached the junction into the deep venous system. By this therapy, we had not to observe any additional DVT. In 9 cases, an extension, respectively a recurrence of the TP could be observed. In each of these cases the dosage of the LMWH had not been adapted to the concomitant risks or had been terminated too early. DISCUSSION: TP of the superficial venous system should be considered and treated as DVT. Consequent anticoagulation is needed, surgery should be performed when the TP reaches the junction into the deep venous system. The duration of the anticoagulation is not quite clear, but is carried out in our institution for three months with therapeutic intention.

[Current status of standard and endovascular varicosity surgery]. / Gegenwärtiger Stand der operativen und endovaskulären Varizenchirurgie.

The classical varicose vein operation represents the "gold standard" in the operative approach to this condition. The results of the standard procedure are very good especially with regard to complications. The recurrence rate is estimated between 6% and 60%, but the true rate is unknown, since there is no generally accepted definition of recurrent varicosities. Endovascular procedures for the elimination of the superficial venous system - radiofrequency obliteration and laser therapy - have established themselves as alternative, minimal invasive procedures. Good results up to 2 years post operatively have been documented; for radiofrequency obliteration, very good results 5 years after surgery are available. Less well-known procedures are available, such as the CHIVA method, which represents a totally different pathophysiological concept. Data on the efficacy of this method are limited, making an evaluation difficult. The spectrum of operative treatment methods of the superficial venous system and its side branches has increased tremendously because of new technical developments. The surgeon must inform the patient about the pros and cons of each procedure and the anticipated results, as well as making an accurate decision as to which methods are best suited for the patient.

[Results of standard varicose vein surgery]. / Ergebnisse nach klassischer Varizenchirurgie.

The principles of modern varicose vein surgery are based on the interruption of the cranial and distal points of venous insufficiency. Especially due to the rise of alternate surgery procedures, we have scrutinized our results of varicose vein surgery. In a retrospective analysis, the results of those patients (pat.) who underwent venous surgery in our institution in 1995 were analysed. In 1995 we performed 1 575 varicose vein operations (n = 1 019 pat., 16.8 % male, 83.2 % female). 63.5 % were on an outpatient basis. During a follow-up period of 4 to 66 months (av. 38 months) the patients were re-examined, 481 (47.2 %) by Duplex sonography, 94 (9.2 %) by clinical examination alone, from 103 (10.1 %) information was obtained through a written inquiry. 341 pat. (33.5 %) had just perioperative follow-ups. We didn't find any signs of varicosis in 301 pat. (33.3 %). Minor side branches could be detected in 515 pat. (56.8 %). In 90 pat. (9.9 %) a clearly visible varicosis could be seen. Based on the results of the Duplex examinations, 86 % of the pat. showed no recurrence after ligation of the sapheno-femoral junction and stripping of the LSV, the results after stripping of the short saphenous vein were similar. Analysis of the inquiry forms concluded that 62.3 % of the pat. were satisfied with surgery and the results. The results of the standard varicose vein surgery are satisfactory regarding recurrence rate and patient satisfaction. Our results are comparable to those published in prospective randomised studies. Alternate procedures, for example the CHIVA method, have still to proof their efficiency, especially in view of long-term results.