Transdisciplinary transformative change: an analysis of some best practices and barriers, and the potential of critical social science in getting us there

Biodiversity experts now widely acknowledge that transformative change is best supported through transdisciplinary collaborations. Yet, such collaborations rarely successfully occur in major biodiversity research institutions and those that do rarely achieve the paradigmatic effects they aim to deliver. To gain some insight into this global phenomenon, we surveyed Swiss-based researchers and non-academic stakeholders addressing global change and biodiversity. In this article, we connect our findings to global patterns in transdisciplinary transformative change initiatives (TTCIs) and heuristically divide collaboration barriers into two categories: lack of resources and lack of vital functional elements. Two of the major themes that emerged from this research were the continued difficulties with (1) establishing a common ‘language’, understanding, and goals, and (2) meaningful pluralization of knowledge in transdisciplinary collaborations aimed at addressing global change and biodiversity loss. The former is widely cited in the literature as contributing to the failure of TTCIs in the form of incoherent problem-framing, while the latter is often identified as contributing to the lack of structural transformative change (e.g., paradigmatic shifts) in completed initiatives. Another major theme reflected in TTCI literature was limited time. Moreover, based on our own extensive inter- and transdisciplinary experience, we agree with other experts that there is a persistent lack of understanding of the potential contributions of critical social science (CSS) to TTCIs. We thus argue that enhancing resource availability for TTCIs, especially tools for improving CSS literacy, could save time and support both problem-framing alignment and delivery of the structural/paradigmatic changes we aspire to

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system

BACKGROUND: Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking. METHODS AND RESULTS: We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years. CONCLUSIONS: The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings

One-year clinical outcomes following Edwards INSPIRIS RESILIA aortic valve implantation in 487 young patients with severe aortic stenosis: a single-center experience

IntroductionThe use of an aortic bioprosthesis is on the rise in younger patients with severe aortic stenosis despite the risk of accelerated structural valve degeneration (SVD). In the search for an optimal valve substitute that would not be prone to SVD, the INSPIRIS bioprosthesis represents a promising solution to lowering the risk of SVD. Here, we report the 1-year outcomes of the INSPIRIS RESILIA aortic bioprosthesis in a population of young patients who underwent aortic valve replacement.MethodsIn this prospective single-center study, we included all consecutive patients receiving INSPIRIS RESILIA bioprosthesis between June 2017 and July 2021. Patients with isolated severe aortic regurgitation were excluded. Clinical assessment and transthoracic echocardiography were performed preoperatively and at 1 year post-operatively. The primary outcome was overall mortality at one year.ResultsA total of 487 patients were included. The mean age was 58.2 ± 11.5 years, 75.2% were men. Most of the interventions were elective, with a mean EuroSCORE II of 4.8 ± 7.9. The valve annulus size in most cases was either 23 mm or 25 mm. Overall mortality at 1-year was 4.1%. At 1-year, 7 patients (1.4%) had a stroke, 4 patients (0.8%) had a myocardial infarction, and 20 patients (4.1%) were hospitalized for congestive heart failure. The Kaplan-Meier estimated survival rates and survival without major adverse cardiac events at 1-year were 96.4% and 96.7%, respectively. At 1-year follow-up, 10 patients (2.1%) had endocarditis and 1 patient (0.2%) had partial prosthetic thrombosis. Pacemaker implantation at 1-year post-operative was necessary in 27 patients (5.5%). Severe patient prosthesis mismatch and severe intra valvular regurgitation were 1.2% and 0.6%, respectively. The Kaplan-Meier estimated survival rates at 1-year of no infective endocarditis preoperative and infective endocarditis preoperative were 97.9 ± 0.7% and 89.5 ± 3.3%, respectively (P < 0.001). Excluding endocarditis-related complication, no structural valve deterioration and no valve failure requiring redo surgery were reported.ConclusionThis is the largest single-center descriptive study of the 1-year outcomes after INSPIRIS RESILIA bioprosthesis implantation. The EDWARDS INSPIRIS RESILIA bioprosthesis provides encouraging clinical outcomes with an excellent 1- year survival rates and good hemodynamic performance. Long-term studies are mandatory to assess valve durability

Transcatheter Aortic Valve Replacement Using Transaortic Access

OBJECTIVES The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431). BACKGROUND TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published. METHODS ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates. RESULTS A total of 301 patients with a mean age of 81.7 +/- 5.9 years and an Society of Thoracic Surgeons score of 9.0 +/- 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation. CONCLUSIONS TAo access for TAVR seems to be a safe alternative to the transapical procedure. (C) 2016 by the American College of Cardiology Foundation.Peer reviewe

Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation

Objective: It has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation. Methods: Patients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (thorn balloon aortic valvuloplasty) versus direct (-balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation. Results: Of the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55). Conclusions: For many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.Peer reviewe

Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry

OBJECTIVES: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. METHODS: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA-and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. RESULTS: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (>= moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% (P = 0.76), rates of stroke 2% vs. 0% (P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% (P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. CONCLUSIONS: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation.Peer reviewe

Prespecified Risk Criteria Facilitate Adequate Discharge and Long‐Term Outcomes After Transfemoral Transcatheter Aortic Valve Implantation

Background Despite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which impact on the mean duration of postprocedure hospitalization. Methods and Results This was a prospective, multicenter registry of 502 patients to validate the appropriateness of discharge timing after transfemoral TAVI, using prespecified risk criteria from FAST‐TAVI (Feasibility and Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation), based on hospital events within 1‐year after discharge. The end point—a composite of all‐cause mortality, vascular access–related complications, permanent pacemaker implantation, stroke, cardiac rehospitalization, kidney failure, and major bleeding—was reached in 27.0% of patients (95% CI, 23.3–31.2) within 1 year after intervention; 7.5% (95% CI, 5.5–10.2) had in‐hospital complications before discharge and 19.6% (95% CI, 16.3–23.4) within 1 year after discharge. Overall mortality within 1 year after discharge was 7.3% and rates of cardiac rehospitalization 13.5%, permanent pacemaker implantation 4.2%, any stroke 1.8%, vascular‐access–related complications 0.7%, life‐threatening bleeding 0.7%, and kidney failure 0.4%. Composite events within 1 year after discharge were observed in 18.8% and 24.3% of patients with low risk of complications/early (≤3 days) discharge and high risk and discharged late (>3 days) (concordant discharge), respectively. Event rate in patients with discordant discharge was 14.3% with low risk but discharged late and increased to 50.0% in patients with high risk but discharged in ≤3 days. Conclusions The FAST‐TAVI risk assessment provides a tool for appropriate, risk‐based discharge that was validated with the 1‐year event rate after transfemoral TAVI. Registration URL: https://www.ClinicalTrials.gov ; Unique identifier: NCT02404467

Impact of selected comorbidities on the presentation and management of aortic stenosis

Background: Contemporary data regarding the impact of comorbidities on the clinical presentation and management of patients with severe aortic stenosis (AS) are scarce. Methods Prospective registry of severe patients with AS across 23 centres in nine European countries. Results Of the 2171 patients, chronic kidney disease (CKD 27.3%), left ventricular ejection fraction (LVEF) = 2 of these). The decision to perform aortic valve replacement (AVR) was taken in a comparable proportion (67%, 72% and 69%, in patients with 0, 1 and >= 2 comorbidities;p=0.186). However, the decision for TAVI was more common with more comorbidities (35.4%, 54.0% and 57.0% for no, 1 and >= 2;p= 2 comorbidities than in those without (8.7%, 10.0% and 15.7%;p= 2 comorbidities (30.8 days) than in those without (35.7 days;p=0.012). Patients with reduced LVEF tended to be offered an AVR more frequently and with a shorter delay while patients with CKD were less frequently treated. Conclusions: Comorbidities in severe patients with AS affect the presentation and management of patients with severe AS. TAVI was offered more often than SAVR and performed within a shorter time period

Negation as a means for emotion regulation? Startle reflex modulation during processing of negated emotional words

This study investigated startle reflex modulation in 33 healthy student participants during the processing of negated emotional items. To build upon previous research, our particular interest was to find out whether processing of negated emotional items modulates emotional responding in line with the logical meaning of the negated expression, or instead leads to paradox emotional effects that point in the direction opposite the one logically implied by the negation. Startle reflex modulation was assessed during silent reading of pleasant and unpleasant nouns. The nouns were either paired with the possessive pronoun my or with the negation word no. The startle eyeblink amplitude was enhanced during processing of the unpleasant pronoun-noun phrases and attenuated during processing of the pleasant phrases. Negation attenuated the startle eyeblink for negated unpleasant nouns and enhanced it for negated pleasant nouns. In line with this finding, negation decreased arousal ratings for unpleasant nouns and reversed the valence ratings for pleasant nouns. Our results are the first to show an effect of negation on both peripheral physiological and subjective indices of affective responding. Our results suggest that negation may be an effective strategy for spontaneous down-regulation of emotional responses to unpleasant, but not to pleasant, stimuli.status: publishe