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.

[Mutation in factor II and factor V gene in patients with peripheral arterial occlusive disease]. / Chronisch-arterielle Verschlusskrankheit der Beine im Stadium IIb-IV: Molekulargenetische Diagnostik von Mutationen im Faktor-II-und Faktor-V-Gen.

Mutations in factor-V- and factor-II-genes are correlated with an increased risk for venous thrombosis according to the literature. The significance of the mutations in factor- II- and factor-V-genes for the development of the peripheral arterial occlusive disease is not known. Therefore, we investigated the presence of these mutations in 152 patients with documented peripheral arterial occlusive disease and 318 controls without peripheral arterial occlusive disease with polymerase chain reaction (PCR). There was no association between factor-II-mutation and peripheral arterial occlusive disease. The factor-V-mutation, however, was increased in patients with peripheral arterial occlusive disease double fold (12 positive cases in 318 controls, 12 positive cases in 152 patients with peripheral arterial occlusive disease). The significance level was reached (p = 0.05) in statistical analysis but the result did not fall below the significance level as necessary to reach statistical significance (odds ratio 2.19). Nevertheless, from these data we have to discuss a biological relevance of factor-V-mutation in the pathogenesis of peripheral arterial occlusive disease.

Infrainguinal ePTFE vascular graft with bioactive surface heparin bonding. First clinical results.

AIM: The ultimate aim of improved expanded polytetrafluoroethylene (ePTFE) vascular graft design is to achieve patency rates in femoropopliteal bypass grafting comparable with autologous saphenous vein grafts. Enhanced thromboresistance of the ePTFE material by bioactive surface heparin bonding is one conceivable path toward this goal. This retrospective study was performed to collect the first clinical data for a new ePTFE graft with bioactive surface heparin immobilization. METHODS: Between March 2003 and February 2004, 43 femoropopliteal or femorocrural ePTFE vascular prostheses with bioactive end-point immobilized heparin (Gore-Tex Propaten Vascular Graft), using the Car-meda BioActive Surface technology, were implanted in 40 patients. Twelve prostheses were implanted in above-knee and 31 in below-knee position. The indication for bypass grafting was limb-threatening ischemia in 88% of the patients. The mean follow-up was 16.6 months. RESULTS: The primary 1-year patency was 91% for above-knee bypass grafts and 92% for below-knee bypass grafts. The 2-year primary patency rate for above-knee bypass grafts was 68% and 81% for below-knee bypass grafts. Limb salvage was achieved in 98%. The perioperative mortality was 0%, but during follow-up 22% of the patients died with patent bypass grafts. CONCLUSIONS: While conventional ePTFE grafts, particularly in the below-knee position, have shown poor results even in the short-term, the bioactive heparinized ePTFE graft evaluated in this study provides patency rates comparable with autologous vein grafts. Because the influence of luminal heparin bonding is not only limited to thromboresistance but has impact on, amongst other elements, protein adsorption (thereby improving hemocompatibility), a continuous effect for long-term patency could also be expected.

Early and long-term results of replacement of the descending aorta.

OBJECTIVES: The aim of this analysis was to evaluate our results of open surgery on the descending thoracic aorta as benchmark to define indications for endovascular treatment. METHODS: Between January 1981 and December 2000, 115 patients underwent replacement of the descending or thoraco-abdominal aorta. Follow-up to 20 years was complete in 98%. RESULTS: Early mortality was 19% and paraplegia rate was 7%. Surgery before 1990 and coronary artery disease were independent predictors for early mortality. Thoraco-abdominal repair and normothermia were independent predictors for paraplegia. Ten years survival rate was 63%. CONCLUSIONS: Our results confirm that replacement of the descending aorta can be performed today with acceptable low mortality and morbidity and with consistent exclusion of the aneurysm or dissection. Long-term results of endovascular stent-grafts in the descending aorta are unclear. In our opinion endovascular stent-grafts should be reserved for high risk patients, acute dissection or acute aortic rupture.

[First clinical results in a study of contrast enhanced magnetic resonance angiography with the 1.0 molar gadobutrol in peripheral arterial occlusive disease--comparison to intraarterial DSA]. / Erste klinische Erfahrungen zur Wertigkeit der kontrastverstärkten Magnetresonanzangiographie der Becken-Bein-Strombahn mit dem 1,0 molaren Gadobutrol--Vergleich zur i. a. DSA.

PURPOSE: To assess the value of contrast enhanced (CE)-MR angiography (MRA) with 1.0 molar Gadobutrol (Schering, Germany) in comparison to intraarterial DSA in peripheral arterial occlusive disease (PAOD). MATERIALS AND METHODS: Within 48 hours, 30 symptomatic patients with PAOD were examined by CE-MRA (Gadobutrol dose 0.2-0.3 mmol/kg body weight) and DSA. For CE-MRA, a 1.5 T magnet (Vision, Siemens, Germany) was used (FA 35 degrees, TR/TE 4.6/1.8 ms, FOV 400 mm, matrix 230 x 512, total acquisition time 81 sec). Two radiologists evaluated a total of 600 vessel segments for stenotic lesions and image quality (1 = not visible to 5 = excellent). Treatment was independently planned on the basis of the MRA and DSA findings. RESULTS: The Kendall's tau-b coefficient was 0.92 for overall stenotic grading, and 0.92, 0.93 and 0.92, respectively, for the vascular flow in the iliac, femoropopliteal and crural arteries. Sensitivity, specificity, negative and positive predictive value, and accuracy were, respectively, 94, 97, 98 and 92, 96 % for > 50 % stenoses, 95, 99, 99, 95 and 99 % for iliac arteries, 96, 98, 98%, 94 and 97 % for femoropopliteal arteries, and 92, 94, 96, 89 and 94 % for crural arteries. Therapy planning by MRA and DSA coincided in 51 of 54 cases. No relevant adverse event occurred. CONCLUSION: CE-MRA with 1.0 molar Gadobutrol is highly efficient in diagnosing peripheral arterial occlusive disease and correlates excellently with DSA.

Severe obesity does not adversely affect perioperative mortality and morbidity in coronary artery bypass surgery.

OBJECTIVE: Obese patients are usually thought to have an increased risk for complications in coronary artery bypass surgery. METHODS: Therefore, the data of 500 consecutive patients undergoing coronary artery bypass grafting at our department in 1998 by use of cardiopulmonary bypass were analyzed. Severe obesity was defined as body mass index (BMI) > or = 30.0 kg/m(2). Obese patients (n=100; group O) were compared to the remaining 400 patients (group C). Both groups were comparable with respect to sex, history of prior myocardial infarction, chronic obstructive pulmonary disease, previous stroke, duration of cardiopulmonary bypass, aortic cross-clamp time and number of distal anastomoses performed. Obese patients were slightly younger and diabetes and hypertension were more common in these patients. RESULTS: Survival and potential complications including perioperative myocardial infarction, sternal wound infection, wound infection at the leg, renal failure, stroke, prolonged mechanical ventilation, pneumonia, reexploration for bleeding, and atrial arrhythmias were analyzed. No significant differences between obese and non-obese patients were detected. CONCLUSION: Severe obesity does not necessarily adversely affect perioperative mortality and morbidity in patients undergoing coronary artery bypass grafting in this study.

Percutaneous endoluminal stent and stent-graft placement for the treatment of femoropopliteal aneurysms: early experience.

PURPOSE: To determine the efficacy of percutaneous endoluminal stents and stent-grafts for the treatment of isolated femoropopliteal aneurysms. METHODS: Seven men (age 51-69 years) with femoropopliteal occlusions (n = 6) related to aneurysms and a patent femoropopliteal aneurysm (n = 1) were treated percutaneously. In two patients uncovered Wallstents and in five patients polyester-covered nitinol stents were implanted. Assessment was performed with Doppler ultrasound and duplex ultrasonography 24 hr, 1, 3, 6, 12, and 24 months after the intervention. Additionally, intraarterial angiography was performed at 6 months. RESULTS: Stent placement succeeded in all cases. No immediate adjunctive surgical treatment was necessary. Ankle-brachial index (ABI) improved from 0.29 +/- 0. 29 (SD) before to 0.78 +/- 0.23 (SD) 24 hr after the intervention. One patient was lost to follow-up. Stent-graft occlusion occurred in four patients: after 2 days (n = 1), 1 month (n = 2), and 3 months (n = 1). One of the patients, whose stent occluded at 1 month, underwent successful recanalization with local fibrinolysis therapy. Three of the seven, all with three-vessel run-off, demonstrated patency of the stent, which was assessed by duplex ultrasonography at 29, 31, and 34 months. Breaking of the stent struts or significant stent migration was not observed. CONCLUSIONS: These results in a small number of patients warrant further investigation to evaluate the role of percutaneous stents in femoropopliteal aneurysms. Until further data of clinical studies are available, this method cannot be recommended, and it cannot replace surgical treatment.

Influence of bicaval anastomoses on late occurrence of atrial arrhythmia after heart transplantation.

BACKGROUND: The standard technique for orthotopic heart transplantation includes right and left atrial anastomoses, which potentially disturb the integrity of the donor atria. Consequently, electrophysiologic abnormalities such as atrial flutter and fibrillation may occur even late after heart transplanation. METHODS: Over a 3-year period, 39 heart transplantations were performed using a standard right atrial anastomosis (group A), and 40 were done using bicaval anastomoses (group B). In each group, data of 30 consecutive patients with a minimum follow-up of 9 months were reviewed retrospectively to assess the incidence of atrial arrhythmia after hospital discharge. RESULTS: Early postoperatively, there was no difference in the duration of temporary pacemaker requirement and incidence of permanent pacemaker implantation (group A, 7%; group B, 7%; not significant) between the two groups. In 12 patients in group A (40%), 16 episodes of atrial flutter and fibrillation were detected 20 to 205 days after heart transplantation. In group B, 1 patient (4%) suffered from atrial fibrillation on day 116 after the operation (p < 0.001). CONCLUSIONS: Preservation of the integrity of the right donor atrium by construction of bicaval anastomoses results in a significantly decreased incidence of atrial flutter and fibrillation after heart transplantation when compared with the standard technique.

[Minimal invasive therapy of aneurysms of the superficial femoral artery and the popliteal artery]. / Minimal-invasive Therapie von Aneurysmen der A. femoralis superficialis und der A. poplitea.

Percutaneous stent placement has been described for treatment of aneurysms as an alternative to surgical therapy. Literature reports of percutaneous minimal invasive therapy of peripheral aneurysms shall be reviewed and compared with our own results. Six male patients (51-69 years) with femoropopliteal occlusions related to aneurysms were treated percutaneously. In two cases Wallstents and in four cases polyester-covered nitinol stents were applicated. A clinical investigation including doppler-ultrasound was performed 24 hrs, 1, 3, 6, 12 and 24 months after the intervention. Stent placement succeeded in all cases. No adjunctive surgical treatment was necessary. Ankle-brachial-index (ABI) improved from 0.22 +/- 0.2 before to 0.74 +/- 0.2 24 hours after the intervention. One patient was lost for follow-up (Wallstent). A decrease of ABI and additional intraarterial angiography revealed stent-graft occlusion within one month (n = 2) and within three months (n = 1). One of these cases was successfully recanalized with local fibrinolysis therapy. In three patients patency of the stent persisted for 24 (+/- 2) months follow-up with three-vessel-supply of the calf. These results warrant further investigations for this minimal invasive method of percutaneous stent deployment as an alternative to surgical bypass treatment of femoropopliteal aneurysms. Time of hospitalization was reduced. At this time, surgical treatment of peripheral vascular aneurysms is gold standard.

[Modified manual rt-PA pulse-spray lysis in occlusions of leg arteries and femoro-popliteal bypasses]. / Modifizierte manuelle rt-PA Puls-Sprüh-Lyse bei Beinarterien- und femoropoplitealen Bypass-verschlüssen.

PURPOSE: The evaluation of local rt-PA pulse-spray-lysis (PSL) by the Katzen infusion wire for treatment of thrombosed leg arteries and bypass grafts. MATERIAL AND METHOD: 21 patients (mean age 64.4 years) with either occluded leg arteries (n = 19) or femorocrural bypass grafts (n = 2) were treated with PSL. Mean length of occlusion was 13.2 +/- 11.6 cm. Time of occlusion ranged from less than one week to 6 months. RESULTS: In 71.43% (15/21) the occlusions could be successfully recanalized with PSL. The mean rt-PA dose was 10.7 +/- 4.9 mg. Remaining stenoses were handled with PTA (n = 9) and additional stent implantation (n = 3). Additional long-time-lysis with 17.5 mg rt-PA was necessary in two cases, the success rate increased to 81% (17/21). The anlde-brachial-index increased from 0.38 +/- 0.29 to 0.83 +/- 0.32 within 24 hours after intervention. In 4 cases bleeding complications occurred. 5 patients showed reocclusions during 6 months follow-up. CONCLUSIONS: Local fibrinolysis with rt-PA in PSL technique using the Katzen infusion wire is a feasible and promising treatment of thrombosed leg arteries and grafts. Even careful and dosage-minimized rt-PA application cannot prevent bleeding complications.

Improved endothelial cell attachment on ePTFE vascular grafts pretreated with synthetic RGD-containing peptides.

OBJECTIVES: To assess endothelial cell (EC) attachment in seeding of expanded polytetrafluoroethylene (ePTFE) vascular prostheses by application of a new technique of coupling synthetic RGD-containing peptides with the graft surface. DESIGN: Prospective, open study. SETTING: University Department of Cardiovascular Surgery and Institute of Biochemistry. MATERIALS AND METHODS: ePTFE vascular grafts (group 1) uncoated (group 2) coated with fibronectin (group 3) coated with a RGD-containing peptide or (group 4) coated in a similar way to group 3 but without application of a RGD-peptide, were incubated for 30 min with adult human saphenous vein endothelial cells. After seeding, grafts were exposed to shear stress in an artificial flow circuit. EC attachment after seeding and retention after perfusion was assessed by scanning electron microscopy and image analysis. MAIN RESULTS: Both EC attachment and retention were significantly increased by coating with fibronectin in comparison to uncoated ePTFE. Graft coating with an RGD-peptide lead to the highest increase in EC attachment (30.6% +/- 2.1%) and retention after shear stress (62.9% +/- 7.5%) compared to fibronectin coated (26.0% +/- 3.3%/45.5% +/- 2.1%), uncoated (14.9% +/- 3.1%/13.9% +/- 7.9%) and similar coated ePTFE grafts without application of a RGD-peptide (10.5% +/- 1.1%/6.6% +/- 1.5%). CONCLUSIONS: EC attachment on uncoated ePTFE vascular prostheses is very weak. Our technique of coupling the ePTFE graft surface with cell adhesion promoting RGD-containing synthetic peptides significantly improved this decisive step in endothelial cell seeding of ePTFE grafts.

Endothelial cell seeding of de-endothelialised human arteries: improvement by adhesion molecule induction and flow-seeding technology.

OBJECTIVES: To assess re-endothelialisation of denuded human arteries by two different seeding techniques using adhesion molecule induction and a dynamic flow-seeding. DESIGN: Prospective, open study. SETTING: University Department of Cardiovascular Surgery. MATERIALS AND METHODS: In the first group (I) segments of human common carotid arteries (n = 4) were balloon-denuded, short-time seeded with cultured adult human venous endothelial cells (EC) and exposed to a mock circulation. In the second group (II) (n = 4), EC were incubated with a synthetic RGD peptide (arginine-glycine-aspartate) prior to seeding with the aim of upregulating the cellular adhesion molecules and increasing EC attachment. In the third group (III) (n = 4), EC were seeded not using the common technique of instillating cells and sequentially rotating the graft but by a dynamic flow application. The percentage of EC-covered luminal surface was assessed by image analysis of scanning electron micrographs. RESULTS: EC attachment was significantly increased in groups II (73%) and III (94%) compared with group I (34%). In group III, a preconfluent monolayer could be established immediately after seeding. One hour of artificial perfusion resulted in no significant EC loss in any of the study groups. CONCLUSIONS: RGD-peptide preincubation improves EC seeding of biological surfaces. Because of accelerated seeding times it may have good potential for clinical applications. The flow-seeding technology may be indispensable if EC seeding of the vascular surface of complete organ systems is required.