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The impact of uninterrupted dual antiplatelet therapy (DAPT) on bleeding events among patients undergoing transcatheter aortic valve replacement (TAVR) has not been well studied. We conducted an analysis of 529 patients who underwent transfemoral TAVR in our centre and were receiving either DAPT or single antiplatelet therapy (SAPT) prior to the procedure. Accordingly, patients were grouped into a DAPT or SAPT group. Following current guidelines, patients in the SAPT group were switched to DAPT for 90 days after the procedure. The primary endpoint of our analysis was the incidence of bleeding events at 30 days according to the VARC-2 classification system. Any VARC-2 bleeding complications were found in 153 patients (28.9%), while major/life-threatening or disabling bleeding events occurred in 60 patients (11.3%). Our study revealed no significant difference between the DAPT vs. SAPT group regarding periprocedural bleeding complications. Based on multivariable analyses, major bleeding (HR 4.59, 95% CI 1.64-12.83, p = 0.004) and life-threatening/disabling bleeding (HR 8.66, 95% CI 3.31-22.65, p < 0.001) events were significantly associated with mortality at 90 days after TAVR. Both pre-existing DAPT and SAPT showed a comparable safety profile regarding periprocedural bleeding complications and mortality at 90 days. Thus, DAPT can be safely continued in patients undergoing transfemoral TAVR., (© 2021. The Author(s).)

The risk of left ventricular (LV) and right ventricular (RV) maladaptation after surgery for isolated primary mitral regurgitation (PMR) is poorly defined. We aimed to evaluate LV and RV contractile function using speckle-tracking analysis alongside with quantification of exercise tolerance in patients with PMR after mitral valve surgery. All consecutive patients with symptomatic PMR undergoing mitral valve surgery between July 2015 and May 2017 were prospectively enrolled. Sequential echocardiographic studies along with clinical assessment were performed before and three months after surgery. Mean age in 138 patients was 65.8 ± 12.7 years, 48.2% (66) of whom were female. Mean LV ejection fraction decreased from 57 ± 12% to 50 ± 11% (p < 0.001), LV global longitudinal strain deteriorated from -19.2 ± 4.1% to -15.7 ± 3.8% (p < 0.001), and mechanical strain dispersion increased from 88 ± 12 to 117 ± 115 ms (p = 0.004). There was a reduction in tricuspid annulus plane systolic excursion from 22 ± 5 mm to 18 ± 4 mm (p < 0.001), as well as a slight deterioration of RV free wall mean longitudinal strain from -16.9 ± 5.6% to -15.7 ± 4.1% (p = 0.05). The rate of moderate to severe tricuspid regurgitation significantly decreased (p < 0.005). Regarding exercise tolerance, the New York Heart Association class improved (p < 0.001) and the walking distance increased (p < 0.001). During mid-term follow up after surgery for PMR, a deterioration of LV and RV contractile function measures could be observed. However, the clinical status, LV dimensions, and concomitant tricuspid regurgitation improved which in particular imply more effective RV contractile pattern.

Background: Elevated pre-procedural high-sensitivity troponin T (hs-TnT) levels predict adverse outcomes in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). It is unknown whether elevated troponin levels still provide prognostic information during follow-up after successful TAVR. We evaluated the long-term implications of elevated hs-TnT levels found at 1-year post-TAVR., Methods and Results: The study included 349 patients who underwent TAVR for severe AS from 2010-2019 and for whom 1-year hs-TnT levels were available. Any required percutaneous coronary interventions were performed > 1 week before TAVR. The primary endpoint was survival time starting at 1-year post-TAVR. Optimal hs-TnT cutoff for stratifying risk, identified by ROC analysis, was 39.4 pg/mL. 292 patients had hs-TnT < 39.4 pg/mL (median 18.3 pg/mL) and 57 had hs-TnT ≥ 39.4 pg/mL (median 51.2 pg/mL). The high hs-TnT group had a higher median N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, greater left ventricular (LV) mass, higher prevalence of severe diastolic dysfunction, LV ejection fraction < 35%, severe renal dysfunction, and more men compared with the low hs-TnT group. All-cause mortality during follow-up after TAVR was significantly higher among patients who had hs-TnT ≥ 39.4 pg/mL compared with those who did not (mortality rate at 2 years post-TAVR: 12.3% vs. 4.1%, p = 0.010). Multivariate analysis identified 1-year hs-TnT ≥ 39.4 pg/mL (hazard ratio 2.93, 95% CI 1.91-4.49, p < 0.001), NT-proBNP level > 300 pg/mL, male sex, an eGFR < 60 mL/min/1.73 m 2 and chronic obstructive pulmonary disease as independent risk factors for long-term mortality after TAVR., Conclusions: Elevated hs-TnT concentrations at 1-year after TAVR were associated with a higher long-term mortality.

Gene therapeutic approaches to aortic diseases require efficient vectors and delivery systems for transduction of endothelial cells (ECs) and smooth muscle cells (SMCs). Here, we developed a novel strategy to efficiently deliver a previously described vascular-specific adeno-associated viral (AAV) vector to the abdominal aorta by application of alginate hydrogels. To efficiently transduce ECs and SMCs, we used AAV9 vectors with a modified capsid (AAV9SLR) encoding enhanced green fluorescent protein (EGFP), as wild-type AAV vectors do not transduce ECs and SMCs well. AAV9SLR vectors were embedded into a solution containing sodium alginate and polymerized into hydrogels. Gels were surgically implanted around the adventitia of the infrarenal abdominal aorta of adult mice. Three weeks after surgery, an almost complete transduction of both the endothelium and tunica media adjacent to the gel was demonstrated in tissue sections. Hydrogel-mediated delivery resulted in induction of neutralizing antibodies but did not cause inflammatory responses in serum or the aortic wall. To further determine the translational potential, aortic tissue from patients was embedded ex vivo into AAV9SLR-containing hydrogel, and efficient transduction could be confirmed. These findings demonstrate that alginate hydrogel harboring a vascular-targeting AAV9SLR vector allows efficient local transduction of the aortic wall., Competing Interests: O.J.M. has previously filed a patent application on the vascular-targeted AAV9SLR capsid variant. The other authors declare no competing interests., (© 2021 The Author(s).)

Background: Transcatheter aortic valve replacement (TAVR) in combination with a valve-in-valve (V-i-V) transcatheter mitral valve replacement (TMVR) is a rare procedure in comparison to surgical therapy especially in young patients. We report on a young patient at high surgical risk, receiving a double valve implantation with two S3 transcatheter heart valves., Case Summary: A 59-year-old female patient with two previous mitral valve replacements due to endocarditis and re-endocarditis experienced a new onset of severe mitral valve stenosis in combination with progredient aortic stenosis. She was admitted to the hospital with severe dyspnoea and intermittent non-invasive ventilation [New York Heart Association (NYHA) III-IV]. An interventional transapical transcatheter double valve implantation was planned and carried out due to cardiac decompensation and high comorbidity preoperatively (STS score of 6.92). At 6-month follow-up, the patient presented herself in an improved condition with reduced symptoms (NYHA I-II), a good functional status of both valves and an advanced right and left ventricular function in the echocardiogram., Discussion: Even in younger patients at high risk, a combined native TAVR and V-i-V TMVR procedure can be performed. In this case, a transcatheter SAPIEN 3 valve was transapically implanted with good clinical mid-term outcome at 6 months., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Although gender-related disparities in cardiovascular surgery have been investigated extensively in the past decades, knowledge about the impact of gender on outcomes after surgery for acute aortic dissection type A (AADA) is sparse. This study investigated the impact of gender on early morbidity and mortality and follow-up outcome in patients after surgery for AADA and to analyze gender-related risk factors for 30-day mortality., Methods: This retrospective study included 368 consecutive patients (male 65.8% vs. female 34.2%) undergoing surgery for AADA between 2001 and 2016 at our department. Survival was estimated by Kaplan-Meier curves. Risk factors for 30-day mortality were assessed by multivariable logistic regression and interaction analysis., Results: Women were older (70.7 years vs. 60.6 years; p <  0.001) and showed a higher logistic EuroSCORE I (31.0% vs. 19.7%, p <  0.001). In the male group, a higher portion of smokers (27.6% vs. 16.0%, p = 0.015) and intraoperatively, more complex procedures and longer cardiopulmonary bypass (CPB) (171 min vs. 149 min, p = 0.001) and cross-clamping times (94 min vs. 85 min, p = 0.018) occurred. 30-day mortality was 19.0% in the female and 16.5% in the male group (p = 0.545). Predictive for 30-day mortality in both genders was intraoperative blood transfusion, while in the female group chronic obstructive pulmonary disease (COPD), peripheral arterial disease and preoperative intubation were predictive. Preoperative cardiopulmonary resuscitation and duration of CPB time were predictors only in males. Averaged follow-up time was 5.2 years and survival did not differ between genders, even if it was stratified by age over 70 years., Conclusions: This analysis demonstrated a similar and satisfactory survival in both genders after surgical treatment of AADA. Women and men differed significantly in age, unadjusted and adjusted risk factors and complexity of surgical treatment, but gender itself was no risk factor for mortality. These results suggest that the decision-making for surgical treatment should not depend on gender, but that accounting for sex-specific risk factors rather than common risk factors may help to improve the outcome in both genders.

Objective: To compare the percutaneous Rotarex and Angiojet thrombectomy devices with regard to effectiveness and in vitro safety., Methods: The Rotarex and Angiojet devices were evaluated in an established in vitro pulsatile flow model with a human femoropopliteal vessel phantom. First pass recanalisation and thrombus weight were assessed after thrombectomy, as well as micro- and macro-emboli. Further, histological evaluation of the vascular phantom was performed to analyse vascular injuries., Results: Thrombus weight did not differ significantly prior to the thrombectomy between the groups, but the Rotarex showed slight advantages in thrombus removal vs. the Angiojet regarding first pass recanalisation. Micro- and macro-emboli occurred in most of the endovascular manoeuvres performed; however, significantly more macro-emboli (2.37 ± 1.51 vs. 0.87 ± 0.83; p = .048) were observed using the Rotarex than the Angiojet. Macroscopic dissections were detected in the Rotarex group (n = 3) but not in the Angiojet group. Microscopic vascular injuries were detected significantly more often in the Rotarex group (Rotarex: 531.61 μm ± 102.81 μm; Angiojet: 705.42 μm ± 61.68 μm [p = .001])., Conclusion: Both devices showed a comparable performance, with a slight advantage for the Rotarex regarding first pass recanalisation. Significantly more thrombo-emboli, and vascular injuries were observed in the Rotarex group with the latter being obviously the more tissue preserving procedure but potentially with a lower rate of recanalisation. Based on the present results, clinical randomised trials, including long term follow up, are needed to optimise and improve the use of catheter based procedures, taking into account the thrombus entity, localisation, and clinical history., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: Various studies evaluated the relationship between hypothermic circulatory arrest and neurological outcome in patients undergoing replacement of ascending aorta. The current analysis focuses on the effect of moderate hypothermic circulatory arrest (MHCA) on elderly patients. The aim of our study was to evaluate the impact of MHCA on neurological outcomes in elderly patients undergoing replacement of the ascending aorta., Results: We retrospectively analyzed 905 consecutive patients, who underwent elective replacement of ascending aorta in MHCA (24 ± 2 °C, nasopharyngeal) between 2001 and 2015. Patients with acute aortic dissection were excluded from this study. Patients were divided into two groups: those aged 75 years and older (elderly group 22.4%, n = 203) and those younger than 75 years (younger group 77.6%, n = 702). The average age was 63.2 ± 10.2 in the young group vs. 78.7 ± 3.0 years in elderly group (p < 0.001). The elderly group had a significantly higher EuroSCORE II [26.7% (18.1, 36.3) vs. 11.6% (7.4, 19.9); p < 0.001)]. The incidence of coronary heart disease (49.8% vs. 35.6%, p < 0.001) and chronic renal failure (17.2% vs. 9.1%, p = 0.001) was significantly higher in the elderly group. Intraoperatively, the time of MHCA [14 min (12, 17) vs. 15 min (12, 18); p = 0.42], cardiopulmonary bypass [139 min (110, 183) vs. 144 min (113, 189); p = 0.225], and cross-clamping [91 min (63, 116) vs. 92 min (65, 127); p = 0.348] was similar in both groups. Postoperatively, a higher incidence of delirium was significantly reported in the elderly group (24.1% vs. 9.0%, p < 0.001). However, there was no significant difference regarding neurological complications between both groups. A 30-day mortality was acceptable for the elderly group, but significantly higher compared with the younger group (7.1% vs. 3.5%, p = 0.031)., Conclusions: Our study suggests that surgical replacement of the ascending aorta in MHCA can also be applied safely in elderly patients without increasing the risk of severe neurological complications.

Background: Motor and cognitive deficits and consequently mobility problems are common in geriatric patients. The currently available methods for diagnosis and for the evaluation of treatment in this vulnerable cohort are limited. The aims of the ComOn (COgnitive and Motor interactions in the Older populatioN) study are (i) to define quantitative markers with clinical relevance for motor and cognitive deficits, (ii) to investigate the interaction between both motor and cognitive deficits and (iii) to assess health status as well as treatment outcome of 1000 geriatric inpatients in hospitals of Kiel (Germany), Brescia (Italy), Porto (Portugal), Curitiba (Brazil) and Bochum (Germany)., Methods: This is a prospective, explorative observational multi-center study. In addition to the comprehensive geriatric assessment, quantitative measures of reduced mobility and motor and cognitive deficits are performed before and after a two week's inpatient stay. Components of the assessment are mobile technology-based assessments of gait, balance and transfer performance, neuropsychological tests, frailty, sarcopenia, autonomic dysfunction and sensation, and questionnaires to assess behavioral deficits, activities of daily living, quality of life, fear of falling and dysphagia. Structural MRI and an unsupervised 24/7 home assessment of mobility are performed in a subgroup of participants. The study will also investigate the minimal clinically relevant change of the investigated parameters., Discussion: This study will help form a better understanding of symptoms and their complex interactions and treatment effects in a large geriatric cohort.

Aim of this study was to establish a simple and highly reproducible physiological circulation model to investigate endovascular device performance. The developed circulation model included a pneumatically driven pulsatile pump to generate a flow rate of 2.7 L/min at 70 beats per minute. Sections from the superficial femoral arteries were used in order to simulate device/tissue interaction and a filter was integrated to analyze periinterventional thromboembolism of white, red and mixed thrombi. The working fluid (3 L) was a crystalloid solution constantly tempered at 36.5 °C. To evaluate the model, aspiration thrombectomy, stent-implantation and thrombectomy with the Fogarty catheter were performed. Usability of the model was measured by the System Usability Scale (SUS) - Score. Histological specimens were prepared and analyzed postinterventional to quantify tissue/device interaction. Moreover, micro- and macroembolism were evaluated for each thrombus entity and each device. Results were tested for normality using the D'Agostino-Pearson test. Statistical comparisons of two groups were performed using the Student's t-test. All devices were able to remove the occlusions after a maximum of 2 attempts. First-pass-recanalization was not fully achieved for aspiration thrombectomy of mixed thrombi (90.6%), aspiration thrombectomy of red thrombi (84.4%) and stent-implantation in occlusions of red thrombi (92.2%). Most micro- and macroembolism were observed using the Fogarty catheter and after stent-implantation in occlusions of white thrombi. Histological examinations revealed a significant reduction of the vascular layers suggesting vascular damage after use of the Fogarty catheter (327.3 ± 3.5 μm vs. 440.6 ± 3.9 μm; p = 0.026). Analysis of SUS rendered a mean SUS-Score of 80.4 which corresponds to an excellent user acceptability of the model. In conclusion, we describe a stable, easy to handle and reproducible physiological circulation model for the simulation of endovascular thrombectomy including device performance and thromboembolism.

Advanced heart failure is an increasing problem worldwide. Nowadays, mechanical circulatory support devices (MSCD) are an established therapeutic option for terminal heart failure after exhaustion of medical and conventional surgical treatment, and are becoming a realistic alternative to heart transplantation (HTX). There are a number of different treatment options for these patients, such as bridge to transplantation (BTT), bridge to candidacy (BTC), bridge to recovery (BTR) and the destination therapy (DT) option. The latter option has become more frequent throughout the last years, due to a donor organ shortage and an increasing number of older patients with terminal heart failure who are not eligible for HTX. These factors have led to a rapidly increasing number of LVAD implantations as well as centers which perform these procedures. This has also been due to improved LVAD survival rates and quality of life following the introduction of smaller, intrapericardial and more durable continuous flow left ventricular devices. The most common complications for these patients are device-related problems, such as coagulation disorders, gastrointestinal bleeding, device related infection, pump thrombosis or cerebrovascular accidents. However, some questions still remain unanswered or under debate, such as the exact time-point for LVAD implantation. In addition, aspects such as better biocompatibility for LVADs remain a major challenge. This review will concentrate on DT for terminal heart failure and provide an overview of the current evidence for LVAD implantation in this patient group, with particular emphasis on indication and time-point of implantation, choice of LVADs, and long term outcomes and quality of life.

Background: Chronic rejection (CR) after lung transplantation (LTX) manifests pathologically by fibrotic airway remodelling and bronchiolitis obliterans (BO). The role of the mammalian target of rapamycin inhibitor everolimus in preventing this process is poorly understood., Methods: A rat model of left lung allo-transplantation (Fisher 344 to Wistar Kyoto) was used to analyze the effect of everolimus (2.5 mg/kg/day) on the development of CR. Drug therapy began on postoperative day (POD) 0, 7 and 14 characterizing different grade of acute rejection (AR) of the allograft before drug treatment., Results: Non-treated recipients developed severe acute rejection (AR) and first signs of CR on POD 20 and a pronounced CR on POD 60. On POD 20, only application of everolimus from POD 0 to 60 significantly reduced acute inflammatory infiltration (p<0.001). Independent of treatment scheme, everolimus suppressed the development of early signs of chronic alterations (POD 20). However, neither early (POD 7-60) nor late (POD 14-60) application of everolimus affected the progression of CR (POD 60). Only its initial treatment (POD 0-60) inhibited the development of BO and vasculopathy (p<0.001). An additional finding was a decrease in body weight after drug application., Conclusion: The effectiveness of everolimus after rat LTX depended on the grade of inflammation of the allograft before initiation of drug treatment. Only allografts with no or low grade AR benefit from long-term treatment with everolilmus in the prevention of BO after LTX. It could be speculated that conversion to an everolimus-based immunosuppression after LTX might only be successful in patients free of BO., (Copyright © 2011 Elsevier GmbH. All rights reserved.)