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.

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.

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.

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.

[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.

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.

Prediction of Rupture Sites in Abdominal Aortic Aneurysms After Finite Element Analysis.

PURPOSE: To associate regions of highest local rupture risk from finite element analysis (FEA) to subsequent rupture sites in abdominal aortic aneurysms (AAA). METHODS: This retrospective multicenter study analyzed computed tomography angiography (CTA) data from 13 asymptomatic AAA patients (mean age 76 years; 8 men) experiencing rupture at a later point in time between 2005 and 2011. All patients had CTA scans before and during the rupture event. FEA was performed to calculate peak wall stress (PWS), peak wall rupture risk (PWRR), rupture risk equivalent diameters (RRED), and the intraluminal thrombus volume (ILTV). PWS and PWRR locations in the prerupture state were compared with subsequent CTA rupture findings. Visible contrast extravasation was considered a definite (n=5) rupture sign, while a periaortic hematoma was an indefinite (n=8) sign. A statistical comparison was performed between the 13-patient asymptomatic AAA group before and during rupture and a 23-patient diameter-matched asymptomatic AAA control group that underwent elective surgery. RESULTS: The asymptomatic AAAs before rupture showed significantly higher PWRR and RRED values compared to the matched asymptomatic AAA control group (median values 0.74 vs 0.52 and 77 vs 59 mm, respectively; p<0.0001 for both). No statistical differences could be found for PWS and ILTV. Ruptured AAAs showed the highest maximum diameters, PWRR, and RRED values. In 7 of the ruptured AAAs (2 definite and 5 indefinite rupture signs), CTA rupture sites correlated with prerupture PWRR locations. CONCLUSION: The location of the PWRR in unruptured AAAs predicted future rupture sites in several cases. Asymptomatic AAA patients with high PWRR and RRED values have an increased rupture risk.

Single-center experience in the management of spontaneous isolated abdominal aortic dissection.

OBJECTIVE: This study aims to report the management of patients with spontaneous isolated dissection of the abdominal aorta (sIAAD). METHODS: A cohort of 18 consecutive patients (12 male, mean age 58 years) with sIAAD was treated between 1990 and 2009. Dissection was asymptomatic in ten and symptomatic in eight patients. Retrospective data analysis from patient charts was performed. Follow-up included clinical examination, ultrasound, and/or CT-angiography. Mean follow-up was 54 months (range 1-211). RESULTS: In total, eight out of 18 received invasive treatment. All asymptomatic patients initially underwent conservative treatment and surveillance. Spontaneous false lumen thrombosis occurred in four (40 %), and three patients showed relevant aneurysmatic progression and underwent elective invasive treatment (open n = 2, endovascular n = 1), representing a crossover rate of 30 %. Late mortality was 20 % (n = 2) in this group. In symptomatic patients, five underwent urgent treatment due to persistent abdominal or back pain (n = 4) or contained rupture (n = 1); one was treated for claudication. The remaining two patients presented with irreversible spinal cord ischemia and were treated conservatively. Three patients were treated by open surgery and three by endovascular interventions (two stentgrafts, one Palmaz XXL stent). Early and late morbidity and mortality was 0 % in this group. There were no reinterventions CONCLUSION: The majority of patients with sIADD require invasive treatment, with EVAR being the preferable treatment option today. In asymptomatic IADD, primary surveillance is justifiable, but close surveillance due to expansion is necessary.

Frequency of abdominal aortic expansion after thoracic endovascular repair of type B aortic dissection.

PURPOSE: To determine abdominal aortic expansion after thoracic endovascular aortic repair (TEVAR) in patients with aortic dissection type B and 36 months minimum follow-up. METHODS: Retrospective study of 18 TEVAR patients with follow-up >36 months. Abdominal aortic diameters at celiac trunk (location B) and infrarenal aorta (location C) were recorded on the first and last imaging after TEVAR. False lumen thrombosis was determined at level of endograft (A) and at B and C. Aortic expansion was defined as diameter increase of 5 mm or 15%. Correlation analyses were performed to investigate potential determinants of expansion. RESULTS: Median follow-up was 75.2 months. Sixteen of 18 patients (88.9%) demonstrated abdominal expansion. Mean expansion was 9.9 ± 6.1 mm at B and 11.7 ± 6.5 mm at C, without a difference between acute and chronic dissections. Critical diameters of 55 mm were reached in two patients treated for chronic dissection (11.1%). Annual diameter increase was significantly greater at locations with baseline diameters >30 mm (2.1 ± 1.1 mm vs. 1.0 ± 0.6 mm, p = 0.009). Baseline diameters were greater in patients with chronic dissections. CONCLUSION: Abdominal aortic expansion can be frequently recognized after TEVAR for aortic dissection type B and occurs independently from thoracic false lumen thrombosis. Clinical significant abdominal aortic expansion may occur more frequently in patients treated with TEVAR for chronic dissection.

Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial.

BACKGROUND: Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery, and triclosan-coated sutures were developed to reduce their occurrence. The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure, compared with non-coated PDS II sutures, in the prevention of surgical site infections. METHODS: This multicentre, randomised controlled group-sequential superiority trial was done in 24 German hospitals. Adult patients (aged ≥18 years) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion. Exclusion criteria were impaired mental state, language problems, and participation in another intervention trial that interfered with the intervention or outcome of this trial. A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures (PDS Plus) or uncoated sutures (PDS II) for abdominal fascia closure. The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation. Patients, surgeons, and the outcome assessors were masked to group assignment. Interim and final analyses were by modified intention to treat. This trial is registered with the German Clinical Trials Register, number DRKS00000390. FINDINGS: Between April 7, 2010, and Oct 19, 2012, 1224 patients were randomly assigned to intervention groups (607 to PDS Plus, and 617 to PDS II), of whom 1185 (587 PDS Plus and 598 PDS II) were analysed by intention to treat. The study groups were well balanced in terms of patient and procedure characteristics. The occurrence of surgical site infections did not differ between the PDS Plus group (87 [14·8%] of 587) and the PDS II group (96 [16·1%] of 598; OR 0·91, 95% CI 0·66-1·25; p=0·64). Serious adverse events also did not differ between the groups-146 of 583 (25·0%) patients treated with PDS Plus had at least one serious adverse event, compared with 138 of 602 (22·9%) patients treated with PDS II; p=0·39). INTERPRETATION: Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy. Innovative, multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections. FUNDING: Johnson & Johnson Medical Limited.

Finite element analysis of abdominal aortic aneurysms: predicted rupture risk correlates with aortic wall histology in individual patients.

PURPOSE: To evaluate a finite element analysis (FEA) model as a predictive tool for abdominal aortic aneurysm (AAA) rupture risk assessment. METHODS: FEA of asymptomatic infrarenal AAAs in 15 men (mean age 72 years) was performed preoperatively using semiautomatic finite element analysis software (A4clinics) to calculate peak wall stress (PWS) and regions of highest and lowest rupture risk index (RRI). The areas of high and low RRI identified on the preoperative FEA were sampled during open surgery; aortic wall specimens were prepared for histological analysis. A semiquantitative score compared the histological findings from high and low rupture risk samples. RESULTS: Significant correlation was found between histological AAA wall integrity and RRI in individual patients. AAA wall regions with highest RRI showed advanced histological disintegrity compared to regions with lower RRI within the same AAA: mean smooth muscle cells: 0.43 vs. 1.21, respectively (p=0.031); elastic fibers: 0.57 vs. 1.29, respectively (p=0.008); cholesterol plaque: 2.60 vs. 2.20, respectively (p=0.034); and calcified plaque: 2.27 vs. 1.40, respectively (p=0.017). The amount of calcified plaque was significantly correlated with PWS (r=0.528, p=0.043) by univariate regression analysis. However, there was no correlation between PWS or RRI and the histological findings between patients. CONCLUSION: These preliminary results show that high rupture risk regions estimated by FEA contain increased histopathological degeneration compared to low rupture risk samples within the same AAA. Until now, the role of FEA in predicting individual AAA rupture risk has not been established as a validated diagnostic tool. However, these data provide promising results for FEA model verification.

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.

Symptom Clusters in Acute SARS-CoV-2 Infection and Long COVID Fatigue in Male and Female Outpatients.

(1) Background: After an acute SARS-CoV-2 infection, patients are at risk of developing Long COVID, with fatigue as a frequent and serious health problem. Objectives: To identify symptom clusters in acute SARS-CoV-2 infections and investigate their associations with the development of Long COVID fatigue, and to examine sex-specific differences. (2) Methods: The analysis included a total of 450 COVID-19 outpatients, of whom 54.4% were female. The median ages of the men and women were 51 years (IQR 36.0; 60.0) and 48 years (IQR 33.0; 57.0), respectively. Data collection took place between November 2020 and May 2021, with a median time between acute SARS-CoV-2 infection and examination in the study center of 240 days (IQR 133; 326). The Fatigue Assessment Scale (FAS) was used to identify fatigue and its severity. A multiple correspondence analysis was used to group forty-two COVID-19 symptoms into seven symptom clusters. Logistic and log-linear regressions were used to investigate associations between acute symptom clusters and Long COVID fatigue as dichotomous and continuous outcome, respectively. (3) Results: Fatigue occurred more frequently in women than in men (45% vs. 25%) and the median FAS score, indicating severity of fatigue, was higher in women than in men. The comparison between men and women revealed notable differences in four out of seven clusters. The strongest associations between symptom clusters in infection and Long COVID fatigue were identified for the cluster "cognitive and mental symptoms". In the log-linear regression model, each additional symptom in this cluster was associated with an increase of the FAS score by 5.13% (95% CI: [0.04; 0.07]; p < 0.001). The results of the logistic regression models supported this finding. Each additional symptom in this symptom cluster increased the odds of fatigue by 42% (95% CI: [1.23; 1.66]; p < 0.001). (4) Conclusions: In our study in COVID-19 outpatients, a strong association was observed between the number of symptoms in the cluster "cognitive and mental symptoms" during acute SARS-CoV-2 infection and the risk of developing fatigue months later. The consequent use of preventive and therapeutic strategies is necessary to decrease the burden of fatigue in the context of Long COVID.

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.

Clinical significance of type II endoleaks after thoracic endovascular aortic repair.

BACKGROUND: To evaluate the clinical significance of type II endoleaks (ELII) after thoracic endovascular aortic repair (TEVAR). METHODS: From January 1997 to June 2012, a total of 344 patients received TEVAR in our institution. ELII was diagnosed in 30 patients (8.7%; 13 males; median age: 65 years, range: 24 to 84 years), representing the study population of this retrospective, single-center analysis. Mean follow-up was 29.5 months (range, 8 months to 9.5 years). RESULTS: Primary ELII was observed in all but two cases (28/30; 93.3%). The most common sources of ELII were the left subclavian artery (LSA; 13/30; 43.3%) and intercostal/bronchial vessels (13/30; 43.3%), followed by visceral arteries (4/30; 13.4%). Overall mortality was 33.3% (10/30). ELII-related death (secondary rupture) was observed in 20% (2/10). Reintervention (RI) procedures for ELII were performed in 9 of 30 patients (30.0%); 5 of 9 (55.6%) in cases with ELII via the LSA. Indications for RI were diameter expansion in five and extensive leakage in four cases. Treatment was successful in five patients (55.6%) but failed in four cases (44.4%). In 12 of 21 (57.1%) untreated patients, ELII sealed during follow-up. In conservatively treated patients, an increase in aortic diameter has been only observed in a patient with secondary ELII. CONCLUSIONS: The results presented herein suggest that the clinical impact of ELII after TEVAR must not be underestimated. Albeit a transient finding in most cases, ELII is associated with a relevant RI rate, particularly in cases involving the LSA. RI seems indicated in patients with increasing aortic diameter and/or extensive leakage. Careful surveillance of all patients with ELII is recommended.

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.

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.

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).