Austrian Competence Centre of Food Safety

Diabetic patients with ST-segment elevation myocardial infarction (STEMI) are at an increased risk of cardiovascular events as compared to non-diabetic patients. This analysis investigated outcomes of diabetic patients presenting with multivessel disease (MVD) and STEMI in a contemporary trial and the relevance of an immediate versus staged multivessel PCI strategy in this high-risk population. Patients enrolled in the MULTISTARS AMI trial were stratified according to the presence/absence of diabetes. Baseline characteristics and outcomes of diabetic and non-diabetic patients were compared. The primary end point was a composite of all-cause death, non-fatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1year. In the MULTISTARS AMI trial, out of a total of 840 patients, 131 (15.6%) patients had diabetes. Patients with diabetes had a higher cardiovascular risk profile and worse kidney function. The occurrence of the primary end point was similar between patients with and without diabetes (HR, 1.14 (95% CI, 0.69-1.90), p-value = 0.60). Rates of non-cardiovascular death (HR, 6.53 (95% CI, 2.00-21.33)) and acute renal failure (HR, 3.23 (95% CI, 1.49-7.04)) were higher in diabetic patients as compared to non-diabetic patients. Comparing an immediate with a staged PCI strategy in diabetic patients, a numerically lower number of patients in the immediate PCI group experienced a primary end point event (10.6% vs. 16.9%, HR, 0.60 (95% CI, 0.23-1.53), p-value = 0.28). Among diabetic patients with STEMI and MVD, a strategy of immediate multivessel PCI may be safe and comparable to a strategy of staged multivessel PCI. Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.

The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries. Although device approval is currently executed by Notified Bodies in the EU, it will be advantageous in the mid-term to consider a single EU regulatory agency for devices. In the short term, steps can be taken to transform the current system into a more efficient, predictable, cost-effective, and user-friendly service. Key strategies include the following: enhancing predictability of the approval process through use of early scientific advice from regulators; establishing unique regulatory pathways for CV orphan, paediatric, and innovative devices; promoting more efficient (re)certification of essential legacy CV devices; improving transparency of sponsor interactions with Notified Bodies; expanding the roles of the Expert Panels to assist in the approval of CV devices; promoting global regulatory harmonization, considering streamlined authorization of CV medical technologies across selected jurisdictions; developing an efficient system to monitor device safety; and ensuring funding for data collection platforms. Some strategies that could help include considering a pilot programme for joint approval processes of selected devices in partnership with other regions (i.e. US Food and Drug Administration); developing priority pathways for accelerated access to innovative or orphan devices; and increasing recognition of the importance of early feasibility studies in the EU.

There is a spelling mistake in one of the authors listed in the published version of the paper: "Martin Otler" should be read "Martin Ortler" The original article is corrected.

Summary Many agroecosystems face nitrogen (N), phosphorus (P) or potassium (K) deficiencies due to imbalanced or insufficient nutrient replenishment after plant biomass harvest. How this affects the symbiosis between plants and arbuscular mycorrhizal fungi (AMF), and the abundance of exploration-based AMF guilds (i.e., rhizophilic, edaphophilic, ancestral) remains largely unknown. We studied a 70-year nutrient-deficiency experiment in a managed grassland in central Austria, where aboveground biomass was harvested three times annually. N, P and K were fully, partially, or not replenished, causing long-term nutrient deficiencies and imbalances. We analysed AMF communities in soil and roots by DNA/RNA amplicon sequencing and fatty-acid biomarkers, alongside soil and plant community properties. Soil AMF communities were affected by N and P deficiencies, while root AMF communities were most susceptible to K deficiency, showing a 50% biomass reduction. We observed distinct guild- and family-specific responses: The edaphophilic guild declined with N deficiency, while the rhizophilic guild decreased with P and K deficiencies. Families within each guild, particularly in the ancestral guild, showed differential responses, indicating complementary nutrient specializations at the family level. Our findings underscore the previously unrecognized role of K deficiency in AMF symbiosis and suggest the existence of nutrient-related functional subgroups within exploration-based AMF guilds.

Previous experimental and clinical studies suggested a beneficial effect of statins, metformin, angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers (RASi) on portal hypertension. Still, their effects on hard cirrhosis-related clinical endpoints, such as variceal bleeding and bleeding-related mortality, remain to be investigated. Thus, we recorded the use of statins, metformin and RASi in a large cohort of cirrhotic patients undergoing endoscopic band ligation (EBL) for primary (PP, n = 440) and secondary bleeding prophylaxis (SP, n = 480) between 01/2000 and 05/2020. Variceal (re-) bleeding and survival rates were compared between patients with vs. without these co-medications. A total of 920 cirrhotic patients with varices were included. At first EBL, median MELD was 13 and 515 (56%) patients showed ascites. Statins, metformin and RASi were used by 49 (5.3%), 74 (8%), and 91 (9.9%) patients, respectively. MELD and platelet counts were similar in patients with and without the co-medications of interest. Rates of first variceal bleeding and variceal rebleeding at 2 years were 5.2% and 11.7%, respectively. Neither of the co-medications were associated with decreased first bleeding rates (log-rank tests in PP: statins p = 0.813, metformin p = 0.862, RASi p = 0.919) nor rebleeding rates (log-rank tests in SP: statin p = 0.113, metformin p = 0.348, RASi p = 0.273). Similar mortality rates were documented in patients with and without co-medications for PP (log-rank tests: statins p = 0.630, metformin p = 0.591, RASi p = 0.064) and for SP (statins p = 0.720, metformin p = 0.584, RASi p = 0.118). In clinical practice, variceal bleeding and mortality rates of cirrhotic patients were not reduced by co-medication with statins, metformin or RASi. Nevertheless, we recommend the use of these co-medications by indication, as they may still exert beneficial effects on non-bleeding complications in patients with liver cirrhosis.