Objectives: The study aim was to assess the long-term results (up to 18 years) of mitral balloon valvuloplasty (MBV) and to identify predictors of restenosis and event-free survival. Methods: The immediate and long-term results for 531 consecutive patients (mean age 31 ± 11 years) who underwent successful MBV and were followed up for a mean of 8.5 ± 4.8 years (range: 1.5–18 years) are reported. Results: The mitral valve area (MVA) increased from 0.92 ± 0.17 to 1.95 ± 0.29 cm² (p < 0.0001). Restenosis was 31 and 19% in patients with mitral echocardiographic score (MES) ≤8. Actuarial freedom from restenosis at 10, 15 and 18 years was 77 ± 2, 46 ± 3 and 18 ± 4% and 86 ± 2, 62 ± 4 and 31 ± 7% for MES ≤8, respectively (p < 0.001). Event-free survival (death, redo MBV, mitral valve replacement, NYHA class III or IV) at 10, 15 and 18 years was 88 ± 1, 53 ± 4, and 21 ± 5% and 93 ± 2, 65 ± 5 and 38 ± 8% for MES ≤8, respectively (p < 0.001). Multivariable Cox regression analysis identified MES >8 (p < 0.0001) and previous surgery (p = 0.043) as predictors of restenosis, and MES >8 (p < 0.0001) and baseline atrial fibrillation (p = 0.03) as predictors of combined events. Conclusion: MBV provides excellent long-term results. The baseline clinical and MES characteristics are predictors of outcome.

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Background To evaluate the effect of screening for sepsis using an electronic sepsis alert vs. no alert in hospitalized ward patients on 90-day in-hospital mortality. Methods The SCREEN trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 45 wards, constituting clusters in this design) are randomized to have active alert vs. masked alert, 5 wards at a time, with each 5 wards constituting a sequence. The study consists of ten 2-month periods with a phased introduction of the intervention. In the first period, all wards have a masked alert for 2 months. Afterwards the intervention (alert system) is implemented in a new sequence every 2-month period until the intervention is implemented in all sequences. The intervention includes the implementation of an electronic alert system developed in the hospital electronic medical records based on the quick sequential organ failure assessment (qSOFA). The alert system sends notifications of “possible sepsis alert” to the bedside nurse, charge nurse, and primary medical team and requires an acknowledgment in the health information system from the bedside nurse and physician. The calculated sample size is 65,250. The primary endpoint is in-hospital mortality by 90 days. Discussion The trial started on October 1, 2019, and is expected to complete patient follow-up by the end of October 2021. Trial registration ClinicalTrials.gov NCT04078594. Registered on September 6, 2019