[Vascularsurgical Long-term Outcome - Comparison of Orthotopic and Extraanatomic Reconstructions in Unilateral Occlusions of Iliac Artery over 10 Years]. / Gefäßchirurgische Langzeitergebnisse ­ Vergleich orthotoper und extraanatomischer Rekonstruktionen bei unilateralen Beckenachsenverschlüssen über 10 Jahre.

In PAOD, several vascular regions are usually affected, the pelvic axis in 35% of cases. Interventional-radiological/endovascular or hybrid interventions have been established for recanalization, so that bypass procedures are increasingly taking a back seat, but are not losing their importance.To study unilateral iliac artery occlusions (inclusion criterion) that were repaired either by implantation of an orthotopic or extraanatomic bypass (oBP/eaBP).Over a defined period of time, the rate of open vessel, complications (frequency, type, severity) to characterize morbidity and mortality as well as the extent of clinical improvement after BP implantation were analyzed in a clinical-systematic, single-center observational study (for vascular surgical quality assurance and contribution to vascular medical-clinical health care research). The study method was not explicitly based on the STROBE criteria, but essentially corresponds to them.Over 10 years, 122 PAOD patients (50% in stage IIb-stage III and IV equally distributed; mean age: 63 [range, 44-87] years; majority ASA III) were included with the same number of reconstructions: 71 patients received an eaBP ("crossover"), 51 patients an iliacofemoral (orthotopic - oBP) bypass (neither significant difference regarding frequency nor number of risk factors per patient).The oBP is not superior to eaBP with regard to the analysis parameters of openness, complication rate and mortality. Furthermore, extraanatomic revascularization does not have to be reserved for polymorbid patients only.

[Outpatient and "Admission-Substituting" Interventions in Vascular Surgery - What is Feasible and Where are the Limits? Previous and New Legal Requirements and their Implementation in Practice]. / Ambulante und stationsersetzende Eingriffe in der Gefäßchirurgie ­ was ist machbar und wo liegen die Grenzen? Bisherige und neue gesetzliche Vorgaben sowie deren Umsetzung in der Praxis.

INTRODUCTION: In vascular surgery too, more services and procedures will have to be shifted from the previous inpatient to the outpatient sector in the future. Therefore, the previous and new legal requirements as well as their implementation in vascular surgery will be explained and evaluated. MATERIAL AND METHODS: Professional policy analysis from a perspective of medical vascular surgery. RESULTS: The AOP catalog from 01.01.2023 was extended by 208 additional OPS codes. The inpatient performance of services which, according to the AOP contract, must be regularly performed on an outpatient basis, are now to be justified on the basis of context factors.A special sector-equivalent remuneration, which is independent of whether the remunerated service is performed on an outpatient or inpatient basis, is a prerequisite for a cost-covering expansion of outpatient operations and inpatient-replacing services. The rehabilitation of primary varicosis under outpatient conditions is undoubtedly the standard. The majority of AV shunt installations are performed as inpatient procedures. No new OPS codes were added to the 2023 AOP catalog for varicose vein, shunt and endovascular surgery. DISCUSSION: The shift of inpatient services to the outpatient sector can be a feasible path, based on the experience of other European countries. However, the structures, economic conditions and incentives should first be created to successfully promote transfer to outpatients. Integrated care offers the possibility for the health insurance funds to conclude contracts with the service providers named in § 140a of the Social Code, paragraph 3, for special care. The use of telemedicine in the sense of tele-premedication or tele-monitoring can be a way to expand outpatient surgery, especially in rural regions. In order to enable therapy concepts from one expert in vascular medicine, the outpatient service billing of interventional procedures must also be demanded by vascular surgeons and specialists. CONCLUSION: The potential to transform inpatient services into the outpatient setting of service provision is realisable in vascular surgery in the core areas of varicose vein surgery, shunt surgery and peripheral interventional procedures under specific conditions.

[Suture Aneurysms - Aetiopathogenesis, Symptomatology, Diagnostic Testing, Treatment, Outcome and Influencing Factors after Open Vascular Surgical and Image-guided Interventional Reconstruction]. / Nahtaneurysmen - Ätiopathogenese, Symptomatologie, Diagnostik, Therapie, Outcome und Einflussfaktoren nach offen gefäßchirurgischer und interventioneller Rekonstruktion.

AIM: To illustrate incidence, aetiopathogenesis, symptomatology, diagnostic testing, peri-interventional/-surgical management and outcome of SA based on selective references from the scientific medical literature and our own clinical experiences in diagnostic and therapeutic care. METHODS: Narrative overview RESULTS: CONCLUSION: SA as relevant quantity of care has become a substantial part of basic vascular surgical or image-guided radiology treatment. The vascular surgeon or radiologist (for image-guided interventions) needs to be adequately focused on the demanding diagnostic and therapeutic management, demanding her/his complete competence and expertise.

Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study.

INTRODUCTION: The purpose of this observational study is to report the 12-month clinical outcomes with the novel Multiple Stent Delivery System (MSDS) to treat complex femoropopliteal lesions. Previously, we reported the 6-month clinical outcomes of the all-comers LOCOMOTIVE study, which demonstrated the safety and efficacy of the MSDS with a favorable target lesion revascularization (TLR) rate of 5.3% and a 90.7% patency rate at 6 months in claudicants and critical limb ischemia patients. The 12-month outcomes of LOCOMOTIVE registry are presented in this report. ClinicalTrials.gov Identifier: NCT02531230. METHODS: The LOCOMOTIVE study (Multi-LOC for flOw liMiting Outcomes after POBA and/or DCB Treatment in the infrainguinal position with the objecIVE to implant multiple stent segments) investigates the efficacy and safety of the MSDS approach in an all-comers population. Clinical follow-ups at 6 and 12 months are scheduled to assess TLR, ABI, and vessel patency based on sonographic imaging. RESULTS: At 12 months, the primary unassisted patency was 85.7% and all-cause TLR rate was 9.3% in the overall cohort. Between baseline and 12 months, the target leg ABI increased from 0.62 ± 0.24 to 0.91 ± 0.38 (p < 0.001) and the mean Rutherford class improved from 3.5 to 1.9 (p < 0.001). CONCLUSIONS: Over a 12-month post-procedural period, MSDS for focal provisional stenting of complex femoropopliteal lesions demonstrated a promising primary patency and freedom from TLR after 12 months. In addition, significant improvements were observed in symptom classification and hemodynamics.

Vacuum-assisted closure (VAC) for postoperative secondary peritonitis: Effect on bacterial load as well as local and systemic cytokine response (initial results).

BACKGROUND: It is still a matter of debate what the best management of peritonitis is following eliminating the source of infection. This particularly concerns the amplitude of local and systemic inflammatory response as well as bacterial clearence at the infectious site. AIM: To investigate the effects of vacuum-assisted closure (VAC) vs. relaparotomy on demand (ROD) onto the i) severity and course of disease, ii) surgical outcome, iii) intraperitoneal bacterial load as well as iv) local and systemic inflammatory and immune response in postoperative secondary peritonitis. METHODS: Over a defined time period, all consecutive patients of the reporting surgical department with a secondary peritonitis (assessed by Mannheim's Peritonitis Index [MPI] and APPACHE II score) were enrolled in this systematic unicenter clinical prospective observational pilot study reflecting daily surgical practice and as a contribution to internal quality assurance. Patients were subclassified into VAC or ROD group according to surgeon's individual decision at the time point of primary surgical intervention with the intent to sanitize the source of infection. Early postoperative result was assessed by 30-d and in-hospital mortality. Bacterial load was characterized by microbiological culture of intraperitoneal fluid collection obtained on postoperative days (POD) 0 (primary surgical intervention), 1, 4, 7, 10, 13 and following description of the microbial spectrum including semiquantitative assessment of bacterial load. Local and systemic inflammatory and immune response was determined by ELISA-based analysis of CrP, PCT and the representative cytokines such as TNF-α, IL-1ß, IL-6, IL-8, and IL-10 of serum and peritoneal fluid samples. RESULTS: Over a 26-months investigation period, 18 patients (sex ratio, male:female=9:9) were eligible for study criteria: n=8 were enrolled in the VAC (m:f=4:4) and n=10 in the ROD group (m:f=5:5). With regard to early postoperative results represented by mortality, there is no significant difference between both patients groups. Despite the relatively low number of cases enrolled in this study, a trend for more severe findings associated with the VAC group could be detected based on MPI score. There was also a trend of higher APACHE II scores in the VAC group from the 7th POD on and, in addition, patients of this group had a longer hospital stay. For patients with persisting infection, there were no relevant differences comparing VAC therapy and ROD. Cytokines released, in particular, at the beginning of the inflammation cascade with proinflammatory characteristics, showed higher values within the peritoneal fluid whereas CrP and PCT were found to be higher within the serum samples. Summary & Conclusion: Comparing data of various local and systemic inflammatory and immune parameters, there were only a few correlations. This may indicate a compartimentation of the inflammatory process within the abdominal cavity. Based on the observed inter-individual variation of this pilot study data, the clinically applicable benefit appears questionable. In this context, a reliable effect of VAC therapy onto reduction of bacterial burden within the abdominal cavity could not clearly be detected.

Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound?

PURPOSE: The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel-resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment. The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany. MATERIALS AND METHODS: Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to drug-coated balloon (DCB, n = 78) or plain old balloon angioplasty (POBA, n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency and increase in walking distance were recorded. Based on the Kaplan-Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system. RESULTS: There were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the treatment groups (DCB: 19.1 vs. POBA 40.6%, p = 0.007). At 2 years, the patency rate was significantly higher in the DCB group (72.3 vs. 48.4%, p = 0.006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 vs. 52 ± 136 m, p = 0.001). We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA. CONCLUSIONS: The use of paclitaxel-resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency and substantial cost savings at 2 years. ClinicalTrials.gov Identifier NCT01970579.

Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter.

OBJECTIVES: Based on a novel paclitaxel-resveratrol drug matrix, the safety and efficacy to inhibit intimal hyperplasia were studied in symptomatic claudicants with morphologically challenging lesions. BACKGROUND: The treatment of peripheral artery occlusive disease (PAOD) with percutaneous transluminal angioplasty is limited by occurrence of vessel recoil and neointimal hyperplasia. Drug-coated balloons (DCB) deliver drugs to the arterial wall to potentially reduce the restenosis rate. A number of paclitaxel-coated balloon technologies are available to treat peripheral lesions. METHODS: In this randomized controlled trial, a total of 153 patients with symptomatic PAOD in femoro-popliteal lesions were randomized either to DCB or plain old balloon angioplasty (POBA). RESULTS: The mean lesion length was 13.2 ± 10.4 cm with target lesion total occlusions in 26.1% of all patients (40/153). The primary endpoint of in-lesion late lumen loss (LLL) at 6 months was significantly reduced in the DCB group as compared to the POBA group (0.35 mm CI [0.19; 0.79 mm] vs. 0.72 mm CI [0.68; 1.22 mm], p = 0.006). At 12 months, the TLR rate in the DCB group was significantly lower as compared to the POBA group (17.8 vs. 37.7% p = 0.008). The censored walking distance increase suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (12 months 165 ± 105 vs. 94 ± 136 m, p = 0.012). CONCLUSION: The use of paclitaxel-resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates. ClinicalTrials.gov identifier NCT01970579.

Surrogate and clinical endpoints for studies in peripheral artery occlusive disease: Are statistics the brakes?

BACKGROUND: The aim of this review is to present the available clinical and surrogate endpoints that may be used in future studies performed in patients with peripheral artery occlusive disease (PAOD). Importantly, we describe statistical limitations of the most commonly used endpoints and offer some guidance with respect to study design for a given sample size. The proposed endpoints may be used in studies using surgical or interventional revascularization and/or drug treatments. METHODS: Considering recently published study endpoints and designs, the usefulness of these endpoints for reimbursement is evaluated. Based on these potential study endpoints and patient sample size estimates with different non-inferiority or tests for difference hypotheses, a rating relative to their corresponding reimbursement values is attempted. RESULTS: As regards the benefit for the patients and for the payers, walking distance and the ankle brachial index (ABI) are the most feasible endpoints in a relatively small study samples given that other non-vascular impact factors can be controlled. Angiographic endpoints such as minimal lumen diameter (MLD) do not seem useful from a reimbursement standpoint despite their intuitiveness. Other surrogate endpoints, such as transcutaneous oxygen tension measurements, have yet to be established as useful endpoints in reasonably sized studies with patients with critical limb ischemia (CLI). CONCLUSIONS: From a reimbursement standpoint, WD and ABI are effective endpoints for a moderate study sample size given that non-vascular confounding factors can be controlled.

Results from the International Silver Graft Registry for high-risk patients treated with a metallic-silver impregnated vascular graft.

The purpose of this postmarket surveillance registry was to document the efficacy of a vascular prosthesis coated with metallic silver in high-risk patients undergoing vascular reconstructions. Patency (primary endpoint) and freedom from graft infection (secondary endpoint) data were assessed at a minimum of 12 months in patients with significant co-morbidity and/or confirmed graft infections or infected native vessels. Between November 2006 and December 2009, 230 patients with high-risk factors underwent aortic,peripheral and/or extra-anatomic reconstructions with Silver Graft® (SG) in six German, one French and one Polish vascular center.All participating centers used the metallic silver-coated polyester graft (SG) in various diameters and lengths including tubular and bifurcate vascular grafts. Doppler ultrasound follow-ups to determine graft patency were planned at 12 months or done at an earlier time in case the patient became symptomatic. A total of 230 patients were studied. Ten of these 230 patients had graft infections at baseline whereas the remaining 220 subjects had significant risk factors such as coronary artery disease (62.7%, 138/220), vascular access in scar tissue (27.3%, 60/220), Fontaine III/IV (38.2%, 84/220), chronic renal insufficiency (26.8%, 59/220) and diabetes (21.0%,46/220). The long-term follow-up at 15.5 ± 8.3 months revealed a secondary patency rate of 93.2% (205/220) and an 'all cause' mortality rate of 18.6% (41/220). There was a freedom from de novo graft infection rate of 95.9% (211/220) in the high-risk group without graft infections at baseline. One regraft infection occurred distal of the revisional reconstruction in the 10 patients with graft infection at baseline. The presence of perigraft fluid at follow-up and Fontaine III/IV at baseline were found to be predictors for graft patency whereas perigraft fluid presence was the only predictor for de novo graft infections. This registry revealed favorable patency and freedom from de novo infections rates in a 'high-risk' population with significant co-morbidities.

Superiority of transcutaneous oxygen tension measurements in predicting limb salvage after below-the-knee angioplasty: a prospective trial in diabetic patients with critical limb ischemia.

PURPOSE: To assess postprocedural angiograms, the ankle-brachial index (ABI), and transcutaneous oxygen tension (TcPO2) to predict outcome after infrageniculate angioplasty (PTA) in diabetic patients with critical limb ischemia (CLI) scheduled for amputation. MATERIALS AND METHODS: PTA was performed in 28 diabetic patients with CLI confined to infrapopliteal vessels. We recorded patency of crural vessels, including the vascular supply of the foot as well as the ABI and TcPO2 of the foot. RESULTS: Technical success rate was 92.9% (n = 26), and limb-salvage rate at 12 months was 60.7% (n = 17). The number of patent straight vessels above and below the level of the malleoli increased significantly in patients avoiding amputation. Amputation was unnecessary in 88.2% (n = 15) patients when patency of at least one tibial artery was achieved. In 72.7% (n = 8) of patients, patency of the peroneal artery alone was not sufficient for limb salvage. ABI was of no predictive value for limb salvage. TcPO2 values increased significantly only in patients not requiring amputation (P = 0.015). In patients with only one tibial artery supplying the foot or only a patent peroneal artery in postprocedural angiograms, TcPO2 was capable of reliably predicting the outcome. CONCLUSION: Below-the-knee PTA as an isolated part of therapy was effective to prevent major amputation in more than a half of diabetic patients with CLI. TcPO2 was a valid predictor for limb salvage, even when angiographic outcome criteria failed.

Detection of type II endoleak after endovascular aortic repair: comparison between magnetic resonance angiography and blood-pool contrast agent and dual-phase computed tomography angiography.

PURPOSE: This prospective study was designed to assess the diagnostic value of magnetic resonance angiography (MRA) with blood-pool contrast agent (gadofosveset) in the detection of type-II endoleak after endovascular aortic repair (EVAR). METHODS: Thirty-two patients with aortic aneurysms who had undergone EVAR were included in this study. All patients were examined by dual-phase computed tomography angiography (CTA) as well as MRA with gadofosveset in the first-pass and steady-state phases. Two independent readers evaluated the images of CTA and MRA in terms of endoleak type II, feeding vessel, and image quality. RESULTS: Median follow-up-time after EVAR was 22 months (range 4 to 59). Endoleak type II was detected by CTA in 12 of 32 patients (37.5%); MRA detected endoleak in all of these patients as well as in another 9 patients (n = 21, 65.6%), of whom the endoleaks in 6 patients showed an increasing diameter. Most endoleaks were detected in the steady-state phase (n = 14). The decrease in diameter of the aneurysmal sac was significantly greater in the patients without a visible endoleak that was visible on MRA (P = 0.004). In the overall estimation of diagnostic accuracy, MRA was judged superior to CTA in 66% of all examinations. CONCLUSION: MRA with gadofosveset appeared superior to CTA, and has higher diagnostic accuracy, in the detection of endoleak after EVAR.

Early postoperative results of surgery for rectal carcinoma as a function of the distance of the tumor from the anal verge: results of a multicenter prospective evaluation.

BACKGROUND: The problems associated with rectal surgery are frequently discussed with no reference being made to the distance of the tumor from the anal verge. This study examined the effect of the location of the tumor on early postoperative results. PATIENTS AND METHODS: This was a multicenter study involving 75 German hospitals and 3756 patients, of whom 1463 had rectal carcinoma. On the basis of the location of the tumor (distance from the anal verge), four groups were distinguished: <4, 4-7.9, 8-11.9, and 12-16 cm. RESULTS: Resection and abdominoperineal resection rates and the incidence of postoperative complications depended on the location of the tumor. Significantly higher resection rates and fewer specific complications, and a significant reduction in overall postoperative morbidity were found with tumor locations more than 8 cm from the anal verge. The highest anastomotic leak rate was observed with anastomoses less than 7 cm from the anal verge. The logistic regression showed that the distance of the tumor from the anal verge is an independent variable for the development of an anastomotic leak. CONCLUSIONS: Early results are greatly affected by the location of the rectal carcinoma. This applies to both abdominoperineal resection rates and specific postoperative complications, such as anastomotic leak rate and operation morbidity in general.