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Article Citation - WoS: 1Citation - Scopus: 1Outcomes of Transcatheter Aortic Valve Implantation in Patients With and Without Diabetes Mellitus(Soc Brasil Cirurgia Cardiovasc, 2024) Ayhan, Huseyin; Guney, Murat Can; Keles, Telat; Bozkurt, EnginIntroduction: Diabetes mellitus (DM) in patients undergoing cardiac transcatheter or surgical interventions usually is correlated with poor outcomes. Transcatheter aortic valve implantation (TAVI) has been developed as a therapy choice for inoperable, high-, or intermediate-risk surgical patients with severe aortic stenosis (AS). Objective: To evaluate the impact of DM and hemoglobin A1c (HbA1c) on outcomes and survival after TAVI. Methods: Five hundred and fifty-two symptomatic severe AS patients who underwent TAVI, of whom 164 (29.7%) had DM, were included in this retrospective study. Follow-up was performed after 30 days, six months, and annually. Results: The device success and risks of procedural-related complications were similar between patients with and without DM, except for acute kidney injury, which was more frequent in the DM group (2.4% vs. 0%, P=0.021). In-hospital and first-year mortality were similar between the groups (4.9% vs. 3.6%, P=0.490 and 15.0% vs. 11.2%, P=0.282, respectively). There was a statistical difference between HbA1c >= 6.5 and HbA1c <= 6.49 groups in total mortality (34.4% vs. 15.8%, P<0.001, respectively). The only independent predictors were Society of Thoracic Surgeons score (hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.09-1.51; P=0.003) and HbA1c level >= 6.5 (HR 10.78, 95% CI 2.58-21.50; P=0.003) in multivariable logistic regression analysis. Conclusion: In this study, we conclude that DM was not correlated with an increased mortality risk or complication rates after TAVI. Also, it was shown that mortality was higher in patients with HbA1c >= 6.5, and it was an independent predictor for long-term mortality.Article Randomized Controlled Trials in Europe: A Call to Action to Protect National Healthcare Systems from the Upcoming Tsunami of Kidney Failure(Oxford University Press, 2026) Ortiz, Alberto; Arici, Mustafa; Goumenos, Dimitrios S.; Adamczak, Marcin; Eller, Kathrin; Ferreira, Ana Carina; Torra, RoserKidney diseases are among the fastest-growing global health burdens, with chronic kidney disease projected to become the third leading cause of death by 2050. Despite this, therapeutic innovation remains limited: no European Medicines Agency-approved treatment exists for acute kidney injury, and no drugs have demonstrated survival benefits in patients on dialysis. Randomized controlled clinical trials, although pivotal for advancing care, face persistent challenges in nephrology, including patient heterogeneity, multimorbidity, high dropout rates and small populations in rare diseases. In Europe, these intrinsic obstacles are compounded by fragmented implementation of the Clinical Trials Regulation (536/2014), excessive safety reporting demands and lack of nephrology-specific guidance, discouraging academic-led initiatives and limiting pragmatic research. The Coalition for Reducing Bureaucracy in Clinical Trials, a broad alliance of medical societies and patient advocates, has recently published the 'Clinical research in Europe: putting quality and patient safety first' recommendations calling for regulatory harmonization, simplified safety reporting and patient-centred consent. The European Renal Association, a member of the Coalition and contributor to the report, fully supports these recommendations. Implementing such measures is critical to fostering efficient, high-quality nephrology trials in Europe and delivering urgently needed, evidence-based, life-saving and safe therapies for patients with kidney disease.
