The prospective GermanVasc cohort study.

Background: Previous observational studies reported a wide variation and possible room for improvement in the treatment of patients suffering from symptomatic peripheral artery disease (PAD). Yet, systematic assessment of everyday clinical practice is lacking. A General Data Protection Regulation (GDPR) compliant registry was developed and used to collect comprehensive data on clinical treatment and outcomes regarding PAD in Germany. Here, we report baseline characteristics of patients prospectively enrolled until the end of 2020. Methods: The GermanVasc registry study is a prospective longitudinal multicentre cohort study. Between 1st May 2018 and 31st December 2020, invasive endovascular, open-surgical, and hybrid revascularisations of patients suffering from chronic symptomatic PAD were prospectively included after explicit informed consent (NCT03098290). For ensuring high quality of the data, we performed comprehensive risk-based and random-sample external and internal validation. Results: In total, 5608 patients from 31 study centres were included (34% females, median 69 years). On-site monitoring visits were performed at least once in all centres. The proportion of chronic limb-threatening ischaemia was 30% and 13% were emergent admissions. 55% exhibited a previous revascularisation. Endovascular techniques made 69% among all documented invasive procedures (n=6449). Thirty-five percent were classified as patients with severe systemic disease, and 3% exhibited a constant threat to life according to the American Society of Anaesthesiologists classification. The risk profile comprised of 75% former or current smokers, 36% diabetes mellitus, and in 30% a current ischemic heart disease was present. At discharge, 93% of the patients received antiplatelets and 77% received statins. Conclusions: The GermanVasc registry study provides insights into real-world practice of treatment and outcomes of 5,608 patients with symptomatic PAD in Germany. The cohort covers a broader range of disease severity and types of interventions than usually found in trials. In future studies, comparative outcomes will be analysed in more detail.

Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany.

OBJECTIVE: The objective of this study was to assess the early and midterm outcomes of endovascular repair of complex aortic aneurysm cases using the Multilayer Flow Modulator (MFM; Cardiatis, Isnes, Belgium) endograft in Germany. METHODS: A retrospective study including patients presenting with abdominal aortic aneurysm (AAA), thoracic aortic aneurysm, or thoracoabdominal aortic aneurysm treated with the MFM was conducted in Germany. Mortality and morbidity (in terms of spinal cord ischemia, visceral ischemia, and stroke) at 30 days postoperatively were evaluated. In addition, during follow-up, freedom from reintervention, rupture, and failure mode were also assessed. RESULTS: Between 2009 and 2014, a total of 61 patients with AAA, thoracoabdominal aortic aneurysm, or thoracic aortic aneurysm were treated with the MFM endograft in 29 hospitals around Germany. However, data of 40 patients with a mean age of 73.4 ± 11.2 years (72.5% male; 29/40) and mean aortic aneurysm diameter of 60.3 ± 16.6 mm from 14 hospitals were available for this retrospective study. Thirty-seven (93%) patients were treated urgently. In 12 cases (12/40 [30%]), patients were treated outside instructions for use because of aortic aneurysm diameter >65 mm. A total of 69 MFM stents were used (1.7/patient). The technical success rate was 95% (38/40). Postoperatively, no patient presented with spinal cord ischemia, renal function deterioration, stroke, or intestinal ischemia, except for one patient who developed multiorgan failure because of early stent migration. The intraoperative and 30-day mortality rate was 0% and 2.5%, respectively. The mean follow-up was 12.9 months (±14.9 months), with a survival rate at 1 month, 6 months, and 12 months of 97%, 78%, and 70%, respectively. Freedom from failure mode (type I or II) at 1 month, 6 months, and 12 months was 97.5%, 88%, and 86%, respectively, and visceral vessel patency was 99.3% (155/156 available). During follow-up, 4 patients (4/39 [10%]) had an aneurysm sac rupture and 10 (10/39 [25%]) underwent a reintervention. Freedom from rupture and freedom from reintervention at 1 month, 6 months, and 12 months were 97.5% and 100%, 96% and 84%, and 86% and 75%, respectively. CONCLUSIONS: The use of the MFM for endovascular treatment of complex aortic aneurysm in urgent cases appears to be technically feasible in terms of mortality and morbidity, with moderate 30-day and acceptable midterm outcomes. Reinterventions may be needed to expand the utility of outcomes.

Pharmacokinetics and penetration of moxifloxacin into infected diabetic foot tissue in a large diabetic patient cohort.

OBJECTIVES: Physiological changes occurring in patients with diabetes may affect the pharmacokinetics and penetration of antimicrobial agents into peripheral tissue. We examined the pharmacokinetics and the penetration of moxifloxacin into perinecrotic tissue of diabetic foot lesions in patients with diabetic foot infections (DFI). PATIENTS AND METHODS: Adult patients suffering from type 2 diabetes mellitus and hospitalized for DFI (Texas classification of at least B2) were treated with 400 mg moxifloxacin intravenously (IV) or orally (PO) once daily. The pharmacokinetics of moxifloxacin and its concentration 3 h after administration in samples of perinecrotic tissue resected from infected diabetic foot wounds were determined at steady state (days 4-8). RESULTS: A total of 53 patients with diabetes mellitus type 2 (mean age 69.4 ± 10.8 years) were included in the study, of whom 28 received PO and 25 IV moxifloxacin therapy for a median of 8 days. In the PO and IV subgroups, the mean maximum observed plasma concentration (C (max)) in plasma was 2.69 and 4.77 mg/l at a median of 2 [time to reach C (max) (T (max)) range 1.0-8.0 h] and 1 h after administration, respectively. A mean area under the plasma concentration-time curve from time 0 until the last quantifiable plasma concentration (AUC(0-24 h)) of 29.36 mg h/l (PO) and 27.09 mg h/l (IV) was achieved. Mean moxifloxacin concentrations in perinecrotic tissue of infected diabetic foot wounds following PO or IV administration were 1.79 ± 0.82 and 2.20 ± 1.54 µg/g, thus exceeding the MIC(90) (minimum inhibitory concentration required to inhibit growth of 90% of organisms) for Staphylococcus aureus (0.25 mg/l) by seven- and eightfold and the MIC(90) for Escherichia coli (0.06 mg/l) by 29-fold and 36-fold, respectively. The mean tissue-to-plasma ratios of moxifloxacin concentration 3 h after administration were 1.01 ± 0.57 (PO) and 1.09 ± 0.69 (IV). Significant differences between the routes of administration were observed for T (max) and C (max) (P < 0.01), but not for other clinically relevant parameters (AUC(0-24); moxifloxacin DFI tissue concentration). CONCLUSIONS: The plasma concentration-time curve of moxifloxacin in diabetic patients is similar to that of healthy volunteers. We also observed a good penetration of moxifloxacin into inflamed DFI tissue which taken together with the possibility of sequential IV/PO therapy suggest that moxifloxacin 400 mg once daily is a therapeutic option in the treatment of DFI caused by susceptible organisms.

AMS INSIGHT--absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis.

Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.

Midterm results of endovascular stent graft treatment for descending aortic aneurysms including high-risk patients.

METHODS: 21 patients (17 men, 4 women; mean age 66.1 years, range 29-90 years) with 15 true aneurysms, and 6 type B-dissections were treated by implantation of a Talent Endoluminal Stentgraft System from February 2000 to July 2003. In 3 cases it was necessary to overstent the left subclavian artery, in 1 case to overstent the left common carotid. RESULTS: 2 patients (9.5%) died during the first 30 days (1 myocardial infarction, 1 pneumonia). Two patients (9.5%) suffered from cerebral ischemia and needed revascularisation. No paraplegia, no stroke occurred. One endoleak required additional stenting. No patient needed conversion. Follow-up, average 25.4 months (range 0-39), was 100% complete. During this another two patients died of myocardial infarction i.e. 9.5% (the above mentioned endoleak, but no late migration were detected in the remaining patients). In all cases the graft lumen stayed patent. CONCLUSIONS: Treatment of descending thoracic aortic aneurysm with an endovascular approach has acceptable mortality and morbidity-rates even in high risk patients. Procedural overstenting of the subclavian artery requires subclavian revascularisation in a minority of cases.

[Stent graft implantation for aneurysm of thoracic aorta with involvement of the origin of left subclavian and carotid arteries]. / Bal arteria subclavia és carotis szájadékot involváló aneurysma megoldása stentgrafttal.

Development in endovascular surgery made it possible to treat thoracic and abdominal aortic aneurysm by using catheter techniques. In 1990, Parodi performed the first unilateral stentgraft implantation after which a rapid progress commenced in this field. Since middle nineties, bifurcated stentgrafts have been brought into general use. In Hungary, stentgraft implantations have been performed in certain centers since 1999. The authors demonstrate a case operated on at the Department of Vascular Surgery, University of Pécs for aneurysm of thoracic aorta with involvement of the origin of left subclavian and carotid arteries. In order to maintain the flow in left carotid artery, right to left carotico-carotid interposition was shaped, then stentgraft implantation was carried out for the thoracic aneurysm. Preoperative investigations, surgical technique and postoperative follow up are discussed in this case report.