Actor roles in transition: Insights from sociological perspectives

AbstractTo date, the field of transition research lacks a suitable vocabulary to analyse the (changing) interactions and relations of actors as part of a sustainability transition. This article addresses this knowledge gap by exploring the potential of the concept of ‘roles’ from social interaction research. The role concept is operationalized for transition research to allow the analysis of (changing) roles and relations between actor roles as indicative of changes in the social fabric and shared values, norms and beliefs. It also allows considering the use of roles as a transition governance intervention. This includes creating new roles, breaking down or altering existing ones and explicitly negotiating or purposefully assigning roles, as well as the flexible use of roles as resources

Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry

Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed. In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing. Findings from this landmark registry will provide important information regarding procedural success rates and early mortality in patients undergoing TAo-TAVI. Identifier: NCT0199143

Aortic valve replacement: validation of the Toronto Aortic Stenosis Quality of Life Questionnaire

Reemplaçament de la vàlvula aòrtica; Qualitat de vida; QüestionariReemplazo de la válvula aórtica; Calidad de vida; CuestionarioAortic valve replacement; Quality of life; QuestionnaireAims There is no quality of life tool specifically developed for patients with severe aortic stenosis (AS) to assess how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) has been developed to overcome this gap. The results of the validation of the TASQ in patients undergoing treatment for severe AS are presented. Methods and results Prospective study at 10 centres in Europe and Canada, which enrolled 274 patients with severe symptomatic AS undergoing surgical or transcatheter aortic valve replacement. Mean TASQ score at baseline was 71.2 points and increased to 88.9 three months after aortic valve implantation (P < 0.001). Increases were seen for the emotional impact (32.0 to 39.0; P < 0.001), physical limitations (14.8 to 22.0; P < 0.001), and physical symptoms (8.5 vs. 11.0; P < 0.001) domains. Internal consistency was good/excellent for overall TASQ score (α = 0.891) and for the physical limitation, emotional impact, and social limitation domains (α = 0.815–0.950). Test–retest reliability was excellent or strong for the overall TASQ (intraclass correlation coefficient of 0.883) and for the physical symptoms, physical limitation, emotional impact, and social limitation domains (intraclass correlation coefficient of 0.791–0.895). Responsiveness was medium overall (Cohen's d = 0.637) and medium/large for physical symptoms, emotional impact, and physical limitations (0.661–0.812). Sensitivity to change was significant for physical symptoms, physical limitations (both P < 0.001), emotional impact (P = 0.003), and social limitations (P = 0.038). Conclusions The TASQ is a new, brief, self‐administered, and clinically relevant health‐specific tool to measure changes in quality of life in patients with AS undergoing an intervention.This work was supported by a research grant provided by Edwards Lifesciences (Nyon, Switzerland) to the Institute for Pharmacology and Preventive Medicine (Cloppenburg, Germany)

Procedural outcomes in patients with dual versus single antiplatelet therapy prior to transcatheter aortic valve replacement

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

Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry

Aortic stenosis; Aortic valve replacement; Quality of lifeEstenosi aòrtica; Reemplaçament de la vàlvula aòrtica; Qualitat de vidaEstenosis aórtica; Reemplazo de la válvula aórtica; Calidad de vidaPatients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency. METHODS: The present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS. DISCUSSION: Validation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients.A research grant provided by Edwards Lifesciences (Nyon, Switzerland) to the Institute for Pharmacology and Preventive Medicine (Cloppenburg, Germany)

Transcatheter aortic valve resection: new mechanical devices

Background To improve periprocedural outcomes of transcatheter aortic valve implantation (TAVI), transcatheter mechanical resection devices were tested for prior ablation of the aortic cusps. Methods Three mechanical transcatheter resection devices were tested in a series of native porcine (n=30) and reassembled calcified human valves (n=54). The resection time, the resected valve area, the number of released cusps, and the degree of surrounding tissue damage were measured. Afterwards, postmortem transapical-transcatheter-resections of the aortic valve in two humans were performed. Results In the native porcine hearts, the Aesculap II device demonstrated significantly shorter resection time compared to the R&R II and the Randstad devices (6.5±2.0 vs. 28.6±24.1 vs. 23.3±14.4 sec; P=0.001). However, it created more lesions in the surrounding tissue (P=0.002). The R&R II achieved a smaller number of resected cusps than the other two devices (2.7±0.7 vs. 1.1±0.7 vs. 2.4±0.5; P<0.001, respectively). It also resected a smaller area of the aortic valve (306.5±149.2 vs. 106.7±29.6 vs. 256.8±81.3 mm2; P=0.09) but a larger mean area of the resected fragments (110.3±41.5 vs. 160.7±29.6 vs. 111.5±43.9 mm2; P=0.01). The resection of the reassembled human valves demonstrated the same results between the devices regarding resection time (P=0.001) and resected area (P=0.016), but not fragment sizes (P=0.610). Finally, transapical-transcatheter-resection of aortic valve was performed in two cadavers. Conclusions Transcatheter aortic valve resection is feasible with variable aortic leaflet resection times and mild risk of lesions of the surrounding tissue

Active Infective Native and Prosthetic Valve Endocarditis: Short- and Long-Term Outcomes of Patients after Surgical Treatment

BackgroundActive infective endocarditis (IE) is a serious disease associated with high mortality. The current study represents our experience over 18 years with surgical treatment for active infective native and prosthetic valve endocarditis (INVE, IPVE).MethodAnalysis of 413 patients (171 with IPVE vs. 242 with INVE) who underwent cardiac surgery due to IE between 2002 and 2020.ResultsPatients with IPVE were significantly older (64.9 ± 13.2 years vs. 58.3 ± 15.5 years; p < 0.001) with higher EuroSCORE II (21.2 (12.7; 41.8) vs. 6.9 (3.0; 17.0); p < 0.001)) and coronary heart disease (50.6% vs. 38.0%; p < 0.011). Preoperative embolization was significantly higher within INVE (35.5% vs. 16.4%; p < 0.001) with high incidence of cerebral embolization (18.6% vs. 7.6%; p = 0.001) and underwent emergency curative surgery than the IPVE group (19.6% vs. 10.6%; p < 0.001). However, patients with IPVE were significantly represented with intracardiac abscess (44.4% vs.15.7%; p < 0.001). Intraoperatively, the duration of surgery was expectedly significantly higher in the IPVE group (356 min vs. 244 min.; p = 0.001) as well as transfusion of blood (4 units (0-27) vs. 2 units (0-14); p < 0.001). Post-operatively, the incidence of bleeding was markedly higher within the IPVE group (700 mL (438; 1163) vs. 500 mL (250; 1075); p = 0.005). IPVE required significantly more permanent pacemakers (17.6% vs. 7.5%: p = 0.002). The 30-day mortality was higher in the IPVE group (24.6% vs. 13.2%; p < 0.003).ConclusionPatients with INVE suffered from a higher incidence of cerebral embolization and neurological deficits than patients with IPVE. Surgical treatment in INVE is performed mostly as an emergency indication. However, patients with IPVE were represented commonly with intracardiac abscess, and had a higher indication of pacemaker implantation. The short- and long-term mortality rate among those patients was still high

Is total arch replacement associated with an increased risk after acute type A dissection?

Background The surgical strategy for acute type A aortic dissection (AADA) usually consists of reconstruction of the tear-lesion in the affected part of the ascending aorta. The optimal strategy either to replace the ascending aorta (AAR) or to replace the ascending aorta and the total aortic arch (TAAR) is still under debate. Our study compares the 30-day mortality between AAR and TAAR in AADA surgery. Results In 292 (86.1%) patients AAR and in 47 (13.9%) patients TAAR was performed for emergent AADA. Patients were older (P=0.049) in the AAR group. The median log Euro-SCORE was 25.5% (12.7; 41.7) for AAR and 19.7% (11.7; 32.2) for the TAAR patient cohort (P=0.12). Operative time, cardiopulmonary bypass- (CPB), cross-clamp- and ischemic time were significantly longer in the TAAR group (P<0.001). The overall 30-day mortality-rate was 17.7% (n=60) but was not significantly different between the two groups (P=0.27). Forty-nine (16.8%) patients died in the AAR and 11 patients (23.4%) in the TAAR group. After propensity-score matching, no difference in mortality was seen between the subgroups as well (P=0.44). Multivariable analysis identified the Euro-SCORE, long operation-time, postoperative dialysis and arrhythmia and administration of red blood cell concentrates as risk factors for 30-day mortality, but not for TAAR versus AAR. Conclusions The therapeutic goal in AADA surgery should be the complete restoration of the aorta to avoid further long-term complications and re-operations. Though 30-day mortality and postoperative co-morbidity for AAR are comparable to those in TAAR after treatment of AADA in our analysis, decision-making for the surgical strategy should weigh the operative risk of TAAR against the long-term outcome

Improvement of renal function after transcatheter aortic valve replacement and its impact on survival

Background Chronic kidney disease as well as acute kidney injury are associated with adverse outcomes after transcatheter aortic valve replacement (TAVR). However, little is known about the prognostic implications of an improvement in renal function after TAVR. Methods Renal improvement (RI) was defined as a decrease in postprocedural creatinine in μmol/l of ≥1% compared to its preprocedural baseline value. A propensity score representing the likelihood of RI was calculated to define patient groups which were comparable regarding potential confounders (age, sex, BMI, NYHA classification, STS score, log. EuroSCORE, history of atrial fibrillation/atrial flutter, pulmonary disease, previous stroke, CRP, creatinine, hsTNT and NT-proBNP). The cohort was stratified into 5 quintiles according to this propensity score and the survival time after TAVR was compared within each subgroup. Results Patients in quintile 5 (n = 93) had the highest likelihood for RI. They were characterized by higher creatinine, lower eGFR, higher NYHA class, higher NT-proBNP, being mostly female and having shorter overall survival time. Within quintile 5, patients without RI had significantly shorter survival compared to patients with RI (p = 0.002, HR = 0.32, 95% CI = [0.15-0.69]). There was no survival time difference between patients with and without RI in the whole cohort (p = 0.12) and in quintiles 1 to 4 (all p > 0.16). Analyses of specific subgroups showed that among patients with NYHA class IV, those with RI also had a significant survival time benefit (p < 0.001, HR = 0.15; 95%-CI = [0.05-0.44]) compared to patients without RI. Conclusions We here describe a propensity score-derived specific subgroup of patients in which RI after TAVR correlated with a significant survival benefit

Outcome of Unilateral Pulmonary Edema after Minimal-Invasive Mitral Valve Surgery: 10-Year Follow-Up

The study was approved by the institutional review board (IRB) at the University Medical Center Campus Kiel, Kiel, Germany (reference number: AZ D 559/18) and registered at the German Clinical Trials Register (reference number: DRKS00022222). Objective Unilateral pulmonary edema (UPE) is a complication after minimally invasive mitral valve surgery (MIMVS). We analyzed the impact of this complication on the short- and long-term outcome over a 10-year period. Methods We retrospectively observed 393 MIMVS patients between 01/2009 and 12/2019. The primary endpoint was a radiographically and clinically defined UPE within the first postoperative 24 h, secondary endpoints were 30-day and long-term mortality and the percentage of patients requiring ECLS. Risk factors for UPE incidence were evaluated by logistic regression, and risk factors for mortality in the follow-up period were assessed by Cox regression. Results Median EuroSCORE II reached 0.98% in the complete MIMVS group. Combined 30-day and in-hospital mortality after MIMVS was 2.0% with a 95, 93 and 77% survival rate after 1, 3 and 10 years. Seventy-two (18.3%) of 393 patients developed a UPE 24 h after surgery. Six patients (8.3%) with UPE required an extracorporeal life-support system. Logistic regression analysis identified a higher creatinine level, a worse LV function, pulmonary hypertension, intraoperative transfusion and a longer aortic clamp time as predictors for UPE. Combined in hospital mortality and 30-day mortality was slightly but not significantly higher in the UPE group (4.2 vs. 1.6%; p = 0.17). Predictors for mortality during follow-up were age ≥ 70 years, impaired RVF, COPD, drainage loss ≥ 800 mL and length of ventilation ≥ 48 h. During a median follow-up of 4.6 years, comparable survival between UPE and non-UPE patients was seen in our analysis after 5 years (89 vs. 88%; p = 0.98)