Longitudinal course and predictors of health-related quality of life, mental health, and fatigue, in non-hospitalized individuals with or without post COVID-19 syndrome.

BACKGROUND: Long-term information on health-related quality of life (HRQOL) and mental health of non-hospitalized individuals with "post COVID-19 syndrome" (PCS) is scarce. Thus, the objectives of the present study were to compare HRQOL and mental health of individuals with and without PCS in a German sample of non-hospitalized persons after SARS-CoV-2 infection, to characterize the long-term course up to 2 years and to identify predictors for post COVID-19 impairments. METHODS: Individuals with past SARS-CoV-2 infection were examined at the University Hospital of Augsburg from November 2020 to May 2021 and completed a postal questionnaire between June and November 2022. Participants who self-reported the presence of fatigue, dyspnea on exertion, memory problems or concentration problems were classified as having PCS. HRQOL was assessed using the Veterans RAND 12-Item Health Survey, mental health was measured by the Patient Health Questionnaire and the Fatigue Asessment Scale was used to assess fatigue severity. Multivariable linear regression models with inverse probability weighting were used to determine the association between PCS and health outcomes. RESULTS: From the 304 participants (58.2% women, median age 52 years), 210 (69.1%) were classified as having PCS in median 26 months after SARS-CoV-2 infection. Persons with PCS showed significantly more often depressive and anxiety disorders. PCS was independently and significantly associated with higher levels of depression, post-traumatic stress and fatigue, as well as poorer physical and mental HRQOL in median 9 months as well as 26 months after SARS-CoV-2 infection. A large number of acute symptoms and a prior diagnosis of depression were independently associated with poor mental health and HRQOL. While post-traumatic stress and mental HRQOL improved from 9 months to 26 months post infection onset, depressiveness, fatigue and physical HRQOL remained stable in both, persons with and without PCS. CONCLUSIONS: PCS in non-hospitalized persons after SARS-CoV-2 infection is often associated with long-term impairments of mental health and HRQOL outcomes.

A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery.

BACKGROUND: Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower limb peripheral arterial disease (LLPAD). However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-the-knee (BK) surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing BK surgical bypass. METHODS: Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back 2 years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage, and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95% CI), using a random-effects model. RESULTS: Following deduplication, 10,263 records were identified and 261 were assessed as full texts. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from 9 individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing BK surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2-85.7%] at 1 year, 68.2% [95% CI: 62.8-73.6%] at 2 years, decreasing to 48.0% [95% CI: 27.3-68.7%] at 5 years. The secondary patency rate was 84.8% [95% CI: 77.0-92.5%] at 1 year and 68.9% [95% CI: 43.0-94.9%] at 3 years; the 1-year limb salvage rate was 88.3% [95% CI: 79.6-97.1%] at 1 year and 79.0% [95% CI: 56.7-100%] at 3 years. CONCLUSIONS: In patients undergoing BK bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low, and well-performed randomized clinical trials are needed to inform clinical decision-making on the choice of synthetic graft.

Can inflammatory plasma proteins predict Long COVID or Fatigue severity after SARS-CoV-2 infection?

OBJECTIVE: To investigate whether specific immune response plasma proteins can predict an elevated risk of developing Long COVID symptoms or fatigue severity after SARS-CoV-2 infection. METHODS: This study was based on 257 outpatients with test-confirmed SARS-CoV-2 infection between February 2020 and January 2021. At least 12 weeks after the acute infection, 92 plasma proteins were measured using the Olink Target 96 immune response panel (median time between acute infection and venous blood sampling was 38.8 [IQR: 24.0-48.0] weeks). The presence of Long COVID symptoms and fatigue severity was assessed 115.8 [92.5-118.6] weeks after the acute infection by a follow-up postal survey. Long COVID (yes/no) was defined as having one or more of the following symptoms: fatigue, shortness of breath, concentration or memory problems. The severity of fatigue was assessed using the Fatigue Assessment Scale (FAS). In multivariable-adjusted logistic and linear regression models the associations between each plasma protein (exposure) and Long COVID (yes/no) or severity of fatigue were investigated. RESULTS: Nine plasma proteins were significantly associated with Long COVID before, but not after adjusting for multiple testing (FDR-adjustment): DFFA, TRIM5, TRIM21, HEXIM1, SRPK2, PRDX5, PIK3AP1, IFNLR1 and HCLS1. Moreover, a total of 10 proteins were significantly associated with severity of fatigue before FDR-adjustment: SRPK2, ITGA6, CLEC4G, HEXIM1, PPP1R9B, PLXNA4, PRDX5, DAPP1, STC1 and HCLS1. Only SRPK2 and ITGA6 remained significantly associated after FDR-adjustment. CONCLUSIONS: This study demonstrates that certain immune response plasma proteins might play an important role in the pathophysiology of Long COVID and severity of fatigue after SARS-CoV-2 infection.

A rare case of an acute type B aortic dissection contained infrarenal rupture of the false lumen after prior endovascular abdominal aneurysm repair.

New-onset acute type B aortic dissection after prior endovascular aneurysm repair is extremely rare. Extension of an aortic dissection can cause destabilization of the previously implanted stent graft, thrombosis of the stent graft, and rupture of the aneurysmal sac, with high mortality without therapy. This report describes the case of a 66-year-old patient complaining of sudden abdominal pain radiating to both flanks. Computed tomography angiography of the aorta revealed acute type B aortic dissection with infrarenal rupture of the false lumen after endovascular abdominal aneurysm repair 5 years prior. The patient underwent infrarenal open surgical conversion with suprarenal aortic clamping and implantation of a bifurcated Dacron graft. Postoperatively, no serious complications resulted from the treatment, except for fascial dehiscence. In such cases, the patients can be treated in an emergency situation with open repair, despite the high risk of complications and mortality.

Revascularization with BYCROSS atherectomy device- protocol of a prospective multicenter observational study.

BACKGROUND: The BYCROSS™ device is a novel device intended for use in atherectomy of the peripheral arterial disease (PAD). With the BYCROSS™ atherectomy system, also prolonged calcifying lesions can be treated in a minimally invasive manner, which was previously reserved for bypass surgery. The aim of this study is to collect additional clinical data on safety and performance of the BYCROSS™ from patients undergoing revascularization of severely stenotic or occluded peripheral arterial vessels with the BYCROSS™. METHODS AND DESIGN: This is an investigator-initiated national prospective multicenter observational study in patients with PAD. Sixty patients (20 per center) with PAD with stenosis higher than 80% or complete occlusion (de novo or recurrent stenosis) of vessels below the aortic bifurcation (min 3 mm vessel diameter) will be recruited. Three vascular surgery centers are participating in the study. The primary efficacy endpoint is procedural success, defined as passage of the occlusion through the BYCROSS device, and safety outcomes, explicated as freedom from device-related serious adverse events (SADEs). Secondary endpoints include primary and secondary patency rates, change in Rutherford classification, and freedom from amputation at 3 and 12 months. DISCUSSION: The BYCROSS atherectomy system may be a novel device for the minimally invasive treatment of prolonged calcified lesions previously reserved for bypass surgery. This national prospective multicenter observational study could represent another step in demonstrating the efficancy and safety of this device for treatment of PAD. TRIAL REGISTRATION: #DRKS00029947 (who.int). PROTOCOL APPROVAL ID: #22-0047(Ethics Committee at Ludwig-Maximilians-University Munich).

Valvulotomy of the great saphenous vein in ex situ non-reversed and in situ setting: a multicenter post-market study to assess the safety and efficacy of the AndraValvulotome™".

PURPOSE: To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft. METHODS: This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy. RESULTS: Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46-91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20-70 cm) with a median diameter of 5.0 mm (range 3-6 mm) and 4.0 mm (range 2-6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection). CONCLUSION: The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD.

Post-COVID-19 Syndrome in Non-Hospitalized Individuals: Healthcare Situation 2 Years after SARS-CoV-2 Infection.

Although "post-COVID-19 syndrome" (PCS) is reported to be common even in non-hospitalized individuals, long-term information on symptom burden, healthcare needs, utilization, and satisfaction with healthcare is scarce. The objectives of this study were to describe symptom burden, healthcare utilization and experiences with the healthcare offered for PCS in a German sample of non-hospitalized persons 2 years after SARS-CoV-2 infection. Individuals with past COVID-19 confirmed by positive polymerase chain reaction testing were examined at the University Hospital of Augsburg from 4 November 2020 to 26 May 2021 and completed a postal questionnaire between 14 June 2022 and 1 November 2022. Participants who self-reported the presence of fatigue, dyspnea on exertion, memory problems or concentration problems were classified as having PCS. Of the 304 non-hospitalized participants (58.2% female, median age 53.5), 210 (69.1%) had a PCS. Among these, 18.8% had slight to moderate functional limitations. Participants with PCS showed a significantly higher utilization of healthcare and a large proportion complained about lacking information on persistent COVID-19 symptoms and problems finding competent healthcare providers. The results indicate the need to optimize patient information on PCS, facilitate access to specialized healthcare providers, provide treatment options in the primary care setting and improve the education of healthcare providers.

The association between the number of symptoms and the severity of Post-COVID-Fatigue after SARS-CoV-2 infection treated in an outpatient setting.

BACKGROUND: Post-COVID-Fatigue (PCF) is one of the most reported symptoms following SARS-CoV-2 infection. Currently, research on persistent symptoms focuses mainly on severe infections, while outpatients are rarely included in observations. OBJECTIVE: To investigate whether the severity of PCF is related to the number of acute and persistent symptoms due to mild-to-moderate COVID-19 and to compare the most common symptoms during acute infection with the persistent symptoms in PCF patients. METHODS: A total of 425 participants were examined after COVID-19 treated as an outpatient (median 249 days [IQR: 135; 322] after acute disease) at the site of University Hospital Augsburg, Germany. The Fatigue Assessment Scale (FAS) was used to quantify the severity of PCF. The number of symptoms (maximum 41) during acute infection and persistent symptoms (during the last 14 days before examination) were added up to sum scores. Multivariable linear regression models were used to show the association between the number of symptoms and PCF. RESULTS: Of the 425 participants, 37% (n = 157) developed PCF; most were women (70%). The median number of symptoms was significantly higher in the PCF group than in the non-PCF group at both time points. In multivariable linear regression models, both sum scores were associated with PCF (acute symptoms: ß-estimate per additional symptom [95%-CI]: 0.48 [0.39; 0.57], p < 0.0001); persistent symptoms: ß-estimate per additional symptom [95%-CI]: 1.18 [1.02; 1.34], p < 0.0001). The acute symptoms strongest associated with PCF severity were difficulty concentrating, memory problems, dyspnea or shortness of breath on exertion, palpitations, and problems with movement coordination. CONCLUSION: Each additional symptom that occurs in COVID-19 increases the likelihood of suffering a higher severity of PCF. Further research is needed to identify the aetiology of PCF. TRIAL REGISTRATION: Nr. NCT04615026. Date of registration: November 4, 2020.

Strategies for Avoiding Typical Drug-Drug Interactions and Drug-Related Problems in Patients with Vascular Diseases.

Background and objectives: Drug-drug interactions and drug-related problems in patients with vascular diseases are common. To date, very few studies have focused on these important problems. The aim of the present study is to investigate the most common drug-drug interactions and DRPs in patients with vascular diseases. Materials and Methods: The medications of 1322 patients were reviewed manually in the time period from 11/2017 to 11/2018; the medications of 96 patients were entered into a clinical decision support system. Potential drug problems were identified, and a read-through consensus was reached between a clinical pharmacist and a vascular surgeon during the clinical curve visits; possible modifications were implemented. The focus was on additional dose adjustment and drug antagonization on drug interactions. Interactions were classified as contraindicated/high-risk combination (drugs must not be combined), clinically serious (interaction can be potentially life-threatening or have serious, possibly irreversible consequences), or potentially clinically relevant and moderate (interaction can lead to therapeutically relevant consequences). Results: A total of 111 interactions were observed. Of these, 6 contraindicated/high-risk combinations, 81 clinically serious interactions, and 24 potentially clinically relevant and moderate interactions were identified. Furthermore, 114 interventions were recorded and categorized. Discontinued use of the drug (36.0%) and drug dose adjustment (35.1%) were the most common interventions. Mostly, antibiotic therapy was continued unnecessarily (10/96; 10.4%), and the adjustment of the dosage to kidney function was overlooked in 40/96; 41.7% of the cases. In the most common cases, a dose reduction was not considered necessary. Here, unadjusted doses of antibiotics were found in 9/96, 9.3% of the cases. Notes for medical professionals summarized information that did not require direct intervention but rather increased attention on the part of the ward doctor. It was usually necessary to monitor laboratory parameters (49/96, 51.0%) or the patients for side effects (17/96, 17.7%), which were expected with the combinations used. Conclusions: This study could help identify problematic drug groups and develop prevention strategies for drug-related problems in patients with vascular diseases. A multidisciplinary collaboration between the different professional groups (clinical pharmacists and surgeons) might optimize the medication process. Collaborative care could have a positive impact on therapeutic outcomes and make drug therapy safer for patients with vascular diseases.

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients.

PURPOSE: Technical aspects are crucial for planning and performing endovascular arteriovenous fistula (AVF) creation. The Ellipsys® Vascular Access System represents a minimal invasive method for the creation of a proximal forearm fistula. This report summarizes the essential elements for AVF creation with the Ellipsys® Vascular Access System and investigates feasibility, efficacy, and safety procedures conducted on 16 patients. MATERIALS AND METHODS: We performed a retrospective analysis of patients who underwent endovascular AVF creation with the Ellipsys® Vascular Access System between May 2020 and March 2022 at a tertiary referral center. RESULTS: The median age was 67.5 years (47-86 years). The mean BMI was 31.4 kg/m2. AV fistula was created on 15/16 patients on their left arm. The technical success was 100%. The mean operation time was 24.2 min. There were no complications associated with the procedure. All patients were examined after 30 days (± 5 days). Primary patency after 30 days was 94% (15/16). The mean fistula flow was 681.1 mL/min and the mean AVF diameter was 6.1 mm. Thirteen out of 15 patients met the criteria for potential hemodialysis. CONCLUSION: With the Ellipsys Vascular Access System exist an additional possibility of an AV fistula creation. Based on above findings, the Ellipsys® Vascular Access System represents a feasible, safe, and effective method for AVF creation.

Subjective and Objective Cognitive Impairments in Non-Hospitalized Persons 9 Months after SARS-CoV-2 Infection.

Studies on cognitive problems of persons with mild COVID-19 courses are still lacking. This study aimed to determine the frequency and associated factors of subjective and objective cognitive problems after COVID-19 in non-hospitalized persons. Study participants were examined at the University Hospital of Augsburg from 04/11/2020 to 26/05/2021. The Wechsler Adult Intelligence Scale (WAIS) IV digit span, Stroop Color and Word Test (SCWT), Regensburger verbal fluency test (RWT) and, subjective ratings of memory and concentration were applied. Of the 372 participants (mean age 46.8 ± 15.2 years, 54.3% women, median time after infection 9.1 months), 24.9% reported concentration and 21.9% memory problems. Overall, 55.6% of the participants had at least a mild negative alteration in any cognitive test. The strongest impairments were found regarding memory functions (41.1% mild alterations, 6.2% distinct impairments) and verbal fluency (12.4% mild alterations, 5.4% distinct impairments). SCWT showed negative alterations in no more than 3.0% of the participants. Level of school education, age, and depressiveness emerged as significantly related to the cognitive tests. The number of complaints and depressiveness were significantly associated with subjective memory and concentration problems. It is important to identify mild cognitive impairment in non-hospitalized COVID-19 patients early to offer them effective interventions.

Elevated Plasma D-Dimer Concentrations in Adults after an Outpatient-Treated COVID-19 Infection.

Elevated D-dimer plasma concentrations are common in hospitalized COVID-19 patients and are often associated with a worse prognosis, but it is not yet clear whether this also applies to outpatient cases. The present cross-sectional study evaluated D-dimer levels and their association with clinical parameters and inflammation biomarkers after a COVID-19 disease in individuals treated as outpatients. The study included 411 individuals (43.3% men) with an average age of 46.8 years (SD 15.2). Study participants who had acute COVID-19 disease at a median of 235 days (120; 323) ago were examined at the University Hospital Augsburg, Southern Germany, between 11/2020 and 05/2021. Plasma D-dimers were measured by a particle-enhanced immunoturbidimetric assay. Sixty-one subjects (15%) showed increased D-dimer concentrations (≥500 µg/L). Study participants with elevated D-dimer levels in comparison to subjects with levels in the reference range were significantly older, and more frequently reported a history of cardiovascular disease, hypertension, venous thromboembolism, and chronic venous insufficiency. In multivariable logistic regression analysis, CRP levels (OR 5.58 per mg/dL, 95% CI 1.77-17.60) and white blood cell count (OR 1.48 per nL, 95% CI 1.19-1.83) were significantly related to elevated D-dimers even after adjustment for multiple testing. However, acute or persistent symptoms were not significantly associated with increased D-dimers. Elevated D-dimer levels months after an acute COVID-19 disease seems to be associated with markers of inflammation. Further studies are needed to investigate the underlying pathophysiological mechanisms and consequences of prolonged D-dimer elevation in these patients.

Post-COVID-19 Fatigue and SARS-CoV-2 Specific Humoral and T-Cell Responses in Male and Female Outpatients.

Background: Information on the clinical characteristics and pathophysiological mechanisms underlying post-COVID-19 fatigue are scarce. The main objective of this study was to evaluate sex-specific humoral and T-cell responses associated with post-COVID-19 fatigue in a sample of individuals treated as outpatients. Methods: At a median time of 279 (179;325) days after the acute infection, a total of 281 individuals (45.9% men) aged 18-87 years old were included in the analysis. The participants were examined at the University Hospital of Augsburg, Southern Germany. Fatigue was assessed using the Fatigue Assessment Scale (FAS). Levels of anti-SARS-CoV2-spike IgG antibodies were measured by an enzyme-linked immunosorbent assay (ELISA), and for exploration of the SARS-CoV2-specific T-cell response, ex vivo ELISpot/FLUOROspot assays were conducted using an interferon-γ (IFN-γ) and interleukin-2 (IL-2) SARS-CoV-iSpot kit. Results: Women more significantly suffered from post-COVID-19 fatigue in comparison to men (47.4% versus 25.6%, p=0.0002). Females but not males with fatigue showed a significantly lower number of T-cells producing IFN-γ, IL-2 or both IL-2 and IFNγ in comparison with females without fatigue. In both sexes, serum levels of anti-SARS-CoV2-spike IgG antibodies did not differ significantly between participants with or without fatigue. Conclusions: Development of fatigue after acute COVID-19 disease might be associated with SARS-CoV-2-specific T-cell responses in women, but not men after a mild infection course treated outpatient.

Comparison of the Development of SARS-Coronavirus-2-Specific Cellular Immunity, and Central Memory CD4+ T-Cell Responses Following Infection versus Vaccination.

Memory T-cell responses following infection with coronaviruses are reportedly long-lived and provide long-term protection against severe disease. Whether vaccination induces similar long-lived responses is not yet clear since, to date, there are limited data comparing memory CD4+ T-cell responses induced after SARS-CoV-2 infection versus following vaccination with BioNTech/Pfizer BNT162b2. We compared T-cell immune responses over time after infection or vaccination using ELISpot, and memory CD4+ T-cell responses three months after infection/vaccination using activation-induced marker flow cytometric assays. Levels of cytokine-producing T-cells were remarkably stable between three and twelve months after infection, and were comparable to IFNγ+ and IFNγ+IL-2+ T-cell responses but lower than IL-2+ T-cell responses at three months after vaccination. Consistent with this finding, vaccination and infection elicited comparable levels of SARS-CoV-2 specific CD4+ T-cells after three months in addition to comparable proportions of specific central memory CD4+ T-cells. By contrast, the proportions of specific effector memory CD4+ T-cells were significantly lower, whereas specific effector CD4+ T-cells were higher after infection than after vaccination. Our results suggest that T-cell responses-as measured by cytokine expression-and the frequencies of SARS-CoV-2-specific central memory CD4+T-cells-indicative of the formation of the long-lived memory T-cell compartment-are comparably induced after infection and vaccination.

[Deep Vein Thrombosis in Intensive Care Patients with COVID-19 Infection - Impact of a Standardised Therapeutic Regimen]. / Tiefe Beinvenenthrombosen bei Intensivpatienten mit COVID-19-Infektion ­ Einfluss eines standardisierten Therapieregimes.

BACKGROUND AND OBJECTIVES: It has been reported that the risk of deep vein thrombosis is greater in patients with COVID-19 infection. We have now investigated whether a standardised therapy can reduce the risk of DVT. MATERIALS AND METHODS: After establishing standard therapy with anticoagulation, steroids and convalescent plasma, we screened 20 patients with COVID-19 pneumonia for DVT by ultrasound examination. The comparison group contained 20 COVID patients with inconsistent therapy, who were examined for the presence of thrombosis during the first wave. RESULTS: In the current patient population with standard therapy, we could not detect any thrombosis, and in the prior patients group only 25% of patients developed DVT. Pulmonary embolism was found in one patient in the first cohort and two in the second. CONCLUSION: The risk of DVT could be reduced through anticoagulation, and administration of steroids and convalescent plasma. The specific significance of the individual components has not yet been clarified. Since bleeding is a rarely observed in SARS-CoV-2 infections, a generous indication for anticoagulation seems to be justified.

Results of endovascular aortic arch repair using the Relay Branch system.

OBJECTIVES: Our goal was to evaluate results of endovascular aortic arch repair using the Relay Branch system. METHODS: Forty-three patients with thoracic aortic pathology involving the aortic arch have been treated with the Relay Branch system (Terumo Aortic, Sunrise, FL, USA) in 10 centres. We assessed in-hospital mortality, neurological injury, treatment success according to current reporting standards and the need for secondary interventions. In addition, outcome was analysed according to the underlying pathology: non-dissective disease versus residual aortic dissection (RAD) (defined as remaining dissection after previous type A repair, chronic type B aortic dissections). RESULTS: In-hospital mortality was 9% (0% in patients with RAD). Disabling stroke occurred in 7% (0% in patients with RAD); non-disabling stroke occurred in 19% (7% in patients with RAD). Early type IA and B endoleak formation occurred in 4%. Median follow-up was 16 ± 18 months. During the follow-up period, 23% of the patients died. Aortic-related deaths were low (3% in patients with RAD). CONCLUSIONS: The results of endovascular aortic arch repair using the Relay Branch system in a selected patient population with regard to technical success are good. In-hospital mortality is acceptable, the number of disabling strokes is low and technical success is high. Non-disabling stroke is a major concern, and every effort has to be taken to reduce this to a minimum. The best outcome is seen in patients with underlying RAD. Finally, more data are needed.

[Resuscitative endovascular balloon occlusion of the aorta (REBOA) : Current aspects of material, indications and limits: an overview]. / "Resuscitative endovascular balloon occlusion of the aorta" (REBOA) : Aktuelles zu Material, Indikationen und Grenzen: ein Überblick.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) describes an endovascular procedure in which a blocking balloon is introduced into the aorta to reduce bleeding situated distal to the balloon and simultaneously to improve cardiac and cerebral oxygenation. OBJECTIVE: Presentation of the REBOA technique, the possible indications, the required material and possible complications of the procedure. MATERIAL AND METHODS: Non-systematic review of the currently available literature. RESULTS: The REBOA procedure is an adjunct to achieve hemodynamic stabilization in patients with traumatic hemorrhage and ruptured aortic aneurysms. The complication rate of the procedure is approximately 5%, whereby access complications are the most common; however, fatal complications are also possible. CONCLUSION: A balloon block of the aorta is well established in the treatment of ruptured aortic aneurysms. There is growing evidence that REBOA is a minimally invasive alternative to open surgical cross-clamping of the aorta by thoracotomy for the treatment of patients with polytrauma and hemorrhagic shock due to abdominal or visceral bleeding. Due to the development of new balloon catheters, which can be placed without stiff guidewires and require smaller sheath diameters, REBOA is also discussed for treatment of postoperative abdominal or gynecological bleeding or as a possible adjunct to cardiopulmonary resuscitation for nontraumatic cardiac arrest.

Continuous wound infiltration versus epidural analgesia for midline abdominal incisions - a randomized-controlled pilot trial (Painless-Pilot trial; DRKS Number: DRKS00008023).

OBJECTIVES: To test the feasibility of a randomized controlled study design comparing epidural analgesia (EDA) with continuous wound infiltration (CWI) in respect to postoperative complications and mobility to design a future multicentre randomized controlled trial. DESIGN, SETTING, PARTICIPANTS: CWI has been developed to address drawbacks of EDA. Previous studies have established the equivalent analgesic potential of CWI compared to EDA. This is a single centre, non-blinded pilot randomized controlled trial at a tertiary surgical centre. Patients undergoing elective non-colorectal surgery via a midline laparotomy were randomized to EDA or CWI. Endpoints included recruitment, feasibility of assessing postoperative mobility with a pedometer and morbidity. No primary endpoint was defined and all analyses were explorative. INTERVENTIONS: CWI with local anaesthetics (experimental group) vs. thoracic EDA (control). RESULTS: Of 846 patients screened within 14 months, 71 were randomized and 62 (31 per group) included in the intention-to-treat analysis. Mobility was assessed in 44 of 62 patients and revealed no differences within the first 3 postoperative days. Overall morbidity did not differ between the two groups (measured via the comprehensive complication index). Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day. Duration of preoperative induction of anaesthesia was shorter with CWI than with EDA. Of 17 serious adverse events, 3 were potentially related to EDA, while none was related to CWI. CONCLUSION: This trial confirmed the feasibility of a randomized trial design to compare CWI and EDA regarding morbidity. Improvements in the education and training of team members are necessary to improve recruitment. TRIAL REGISTRATION: DRKS00008023.

Influence of the Revised Nellix Instructions for Use on Outcomes After Endovascular Aneurysm Sealing.

PURPOSE: To evaluate the impact of the revised Nellix instructions for use (IFU) from 2016 on clinical outcomes and anatomic applicability by retrospectively applying them to a cohort treated with endovascular aneurysm sealing according to the original IFU 2013. METHODS: A single-center study was conducted of 100 consecutive patients (mean age 72±8 years, range 46-91; 89 men) treated electively with standard bilateral EVAS from July 2013 to August 2015 and followed through December 2017. Procedures previously classified within and outside the original IFU from 2013 (75 and 25, respectively) were reclassified according to the revised IFU 2016 (34 and 66, respectively). Stepwise backward logistic regression analysis was performed to evaluate the prognostic value of specific anatomic features for the development of endoleak and/or migration. RESULTS: The single most important morphologic feature disqualifying patients from being within IFU 2016 was a thrombus ratio >1.4 (36 of 41 reclassified patients). Overall technical success was 98% (100% within vs 97% outside IFU 2016, p=0.323) and 30-day mortality was 3% (0% within vs 5% outside IFU 2016, p=0.251). During a median follow-up of 31 months (range 0-53), overall mortality was 21% (15% within vs 24% outside IFU 2016, p=0.469); aneurysm-related mortality was 8% (3% within vs 11% outside IFU 2016, p=0.533). Twenty-six patients developed an endoleak (6 within vs 20 outside IFU 2016, p=0.172) and 23 had migration (4 within vs 19 outside IFU 2016, p=0.088). Both proximal neck length <10 mm and neck angulation >60° were positive predictors for the development of endoleak and/or migration. A reintervention was performed in 26 patients (7 within vs 19 outside IFU 2016, p=0.376). While a significant difference was found between the within vs outside IFU 2016 groups with regard to freedom from migration (p=0.026) and the composite freedom from endoleak and/or migration (p=0.021), there were no significant differences in survival (p=0.201) or freedom from reintervention (p=0.505), suggesting a limited effectiveness of the new IFU 2016. CONCLUSION: The IFU 2016 reduced the anatomic applicability to 34% from 75% for the original IFU 2013. The lack of significant intergroup differences in terms of survival and reinterventions suggests a limited effectiveness of the new IFU 2016.