Patients with Acute Limb Ischemia Might Benefit from Endovascular Therapy—A 17-Year Retrospective Single-Center Series of 985 Patients

Acute lower limb ischemia (ALI) is a common vascular emergency, requiring urgent revascularization by open or endovascular means. The aim of this retrospective study was to evaluate patient demographics, treatment and periprocedural variables affecting the outcome in ALI patients in a consecutive cohort in a tertiary referral center. Primary outcome events (POE) were 30-day (safety) and 180-day (efficacy) combined mortality and major amputation rates, respectively. Secondary outcomes were perioperative medical and surgical leg-related complications and the 5-year combined mortality and major amputation rate. Statistical analysis used descriptive and uni- and multivariable Cox regression analysis. In 985 patients (71 ± 9 years, 56% men) from 2004 to 2020, the 30-day and 180-day combined mortality and major amputation rates were 15% and 27%. Upon multivariable analysis, older age (30 d: aHR 1.17; 180 d: 1.27) and advanced Rutherford ischemia stage significantly worsened the safety and efficacy POE (30 d: TASC IIa aHR 3.29, TASC IIb aHR 3.93, TASC III aHR 7.79; 180 d: TASC IIa aHR 1.97, TASC IIb aHR 2.43, TASC III aHR 4.2), while endovascular treatment was associated with significant improved POE after 30 days (aHR 0.35) and 180 days (aHR 0.39), respectively. Looking at five consecutive patient quintiles, a significant increase in endovascular procedures especially in the last quintile could be observed (17.5% to 39.5%, p < 0.001). Simultaneously, the re-occlusion rate as well as the number of patients with any previous revascularization increased. In conclusion, despite a slightly increasing early re-occlusion rate, endovascular treatment might, if possible, be favorable in ALI treatment

Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany

Background Beyond a certain threshold diameter, abdominal aortic aneurysms (AAA) are to be treated by open surgical or endovascular aortic aneurysm repair (EVAR). In a quarter of patients who undergo EVAR, inversion of blood flow in the inferior mesenteric artery or lumbar arteries may lead to type II endoleak (T2EL), which is associated with complications (e.g. AAA growth, secondary type I endoleak, rupture). As secondary interventions to treat T2EL often fail and may be highly invasive, prevention of T2EL is desirable. The present study aims to assess the efficacy of sac embolization (SE) with metal coils during EVAR to prevent T2EL in patients at high risk. Methods Over a 24-month recruitment period, a total of 100 patients undergoing EVAR in four vascular centres (i.e. Klinikum rechts der Isar of the Technical University of Munich, University Hospital Augsburg, University Hospital Dresden, St. Joseph’s Hospital Wiesbaden) are to be included in the present study. Patients at high risk for T2EL (i.e. ≥ 5 efferent vessels covered by endograft or aneurysmal thrombus volume <40%) are randomized to one group receiving standard EVAR and another group receiving EVAR with SE. Follow-up assessments postoperatively, after 30 days, and 6 months involve contrast-enhanced ultrasound scans (CEUS) and after 12 months an additional computed tomography angiography (CTA) scan. The presence of T2EL detected by CEUS or CTA after 12 months is the primary endpoint. Secondary endpoints comprise quality of life (quantified by the SF-36 questionnaire), reintervention rate, occurrence of type I/III endoleak, aortic rupture, death, alteration of aneurysm volume, or diameter. Standardized evaluation of CTA scans happens through a core lab. The study will be terminated after the final follow-up visit of the ultimate patient. Discussion Although preexisting studies repeatedly indicated a beneficial effect of SE on T2EL rates after EVAR, patient relevant outcomes have not been assessed until now. The present study is the first randomized controlled multicentre study to assess the impact of SE on quality of life. Further unique features include employment of easily assessable high-risk criteria, a contemporary follow-up protocol, and approval to use any commercially available coil material. Overcoming limitations of previous studies might help SE to be implemented in daily practice and to enhance patient safety. Trial registration ClinicalTrials.gov NCT05665101. Registered on 23 December 2022

Surveys about the long-term course of the hearing in children with a cleft lip and palate

Die Hauptfragestellung der hier vorgelegten Studie bezieht sich auf die langfristige Entwicklung des Hörvermögens der nach dem Münchner Konzept behandelten Kinder mit einer Lippen-Kiefer-Gaumenspalte. Beeindruckend ist, dass 94 % der 34 untersuchten Kinder subjektiv von einem guten Hörvermögen berichteten. Damit ist das Hauptziel für den Patienten erreicht, nämlich eine so gute Hörfähigkeit, dass sie offensichtlich für alle entscheidenden Hörsituationen eines Kindes ausreicht. Die subjektiv angegebene Hörfähigkeit und die Audiogramm-Ergebnisse liegen sogar etwas über denen anderer Autoren. Entscheidende Vorraussetzung für diese guten Ergebnisse ist die enge Zusammenarbeit zwischen Kieferchirurg und Otologen. Dieses Konzept ist damit auch einem breiteren Anwenderkreis zu empfehlen.The main question of the study submitted here refers to the long-term development of the hearing of children with a cleft lip and palate, treated according to the Munich concept. It is impressing that 94 % of the 34 examined children reported subjectively of a good hearing. So the principal purpose for the patient is reached, even a so good hearing ability that it is sufficient obviously for all crucial hearing situations of a child. The subjectively indicated hearing ability and the audiogram results lie even somewhat over those of other authors. Crucial precondition for these good results is the close cooperation between oral surgeon and otologist. So this concept is also recommended to a broader group of users

Diagnostic performance of quantitative and qualitative parameters for the diagnosis of aortic graft infection using [18F]-FDG PET/CT

Purpose The aim of this study was the evaluation of quantitative and qualitative parameters for the diagnosis of aortic graft infection (AGI) using [F-18]-FDG PET/CT. Methods PET/CT was performed in 50 patients with clinically suspected AGI. 12 oncological patients with aortic repair but without suspicion of AGI were included in the analysis to serve as control cohort. The [F-18]-FDG uptake pattern around the graft was assessed using (a) a five-point visual grading scale (VGS), (b) SUV(max)and (c) different graft-to-background ratios (GBRs). The diagnostic performance of VGS, SUV(max)and GBRs was assessed and compared by ROC analysis. Results 28 infected and 34 uninfected grafts were identified by standard of reference. SUV(max)and VGS were the most powerful predictors for the diagnosis of AGI according to the area under the curve (AUC 0.988 and 0.983, respectively) without a significant difference compared to GBRs. SUV(max)and VGS showed congruent and accurate findings in 54 patients (i.e. either both positive or negative), yielding sensitivity and specificity (100%) in this subgroup of patients. Conclusion Quantitative analysis by SUV(max)and qualitative analysis by VGS are highly effective in the diagnosis of AGI and should be tested as an outcome measure in prospective trials

The "Intermediate" CD14++^{++}CD16+^{+} monocyte subset increases in severe peripheral artery disease in humans

Monocytes are key players in atherosclerotic. Human monocytes display a considerable heterogeneity and at least three subsets can be distinguished. While the role of monocyte subset heterogeneity has already been well investigated in coronary artery disease (CAD), the knowledge about monocytes and their heterogeneity in peripheral artery occlusive disease (PAOD) still is limited. Therefore, we aimed to investigate monocyte subset heterogeneity in patients with PAOD. Peripheral blood was obtained from 143 patients suffering from PAOD (Rutherford stage I to VI) and three monocyte subsets were identified by flow cytometry: CD14$^{++}$CD16$^{-}$ classical monocytes, CD14$^{+}$CD16$^{++}$ non-classical monocytes and CD14$^{++}$CD16$^{+}$ intermediate monocytes. Additionally the expression of distinct surface markers (CD106, CD162 and myeloperoxidase MPO) was analyzed. Proportions of CD14$^{++}$CD16$^{+}$ intermediate monocyte levels were significantly increased in advanced stages of PAOD, while classical and non-classical monocytes displayed no such trend. Moreover, CD162 and MPO expression increased significantly in intermediate monocyte subsets in advanced disease stages. Likewise, increased CD162 and MPO expression was noted in CD14$^{++}$CD16$^{-}$ classical monocytes. These data suggest substantial dynamics in monocyte subset distributions and phenotypes in different stages of PAOD, which can either serve as biomarkers or as potential therapeutic targets to decrease the inflammatory burden in advanced stages of atherosclerosis