Background: Studies of survivorship of primary total ankle replacements (TARs) beyond 5 years have shown varying results among early and modern designs. National cohorts give valuable insights about TAR outcomes, revision risk factors, and specific designs. The purpose of this study was to investigate implant survivorship and risk factors for revision of contemporary TARs using our national database. Methods: This observational study included patients identified in the national PMSI (Programme médicalisé des systèmes d’information) database as having undergone TAR from 2010 to 2019. Demographics, discharge data, concomitant procedures, and type of implant were extracted. Kaplan-Meier estimations were performed to determine time to revision using metal component revision for implant failure and revision for deep infection as end points. Weighted Cox models were used for risk factor analysis, including risks of early revision (within the first 2 years). The adjusted hazard ratios (HR _adj ) were reported with 95% confidence intervals. Results: A cohort of 4,748 patients was extracted. The mean age at surgery was 63 years; 43% of the patients were female. The mean follow-up was 5 years (range, 1 to 10 years). Revisions were noted in 817 cases (17%), including 734 with metal component revision and 83 with revision due to deep infection. The 1-year, 2-year, 5-year, and 10-year survivorship free of metal component revision was 95%, 90%, 84%, and 78%, respectively. Younger age, implants derived from second-generation designs, and an institutional volume of ≤10 TARs per year were found to be independent predictors of revision for any cause. In addition to the above factors (except for implant generation), male sex and concomitant osteotomies and/or fusion were found to be significant predictors for any early revision. Conclusions: The 10-year survivorship free of metal component revision after TAR was 78%, which was consistent with other national registries. Revisions were associated with young age, associated arthritis or deformities requiring concomitant fusion or osteotomy, and implants derived from second-generation designs. Institutions where >10 procedures were performed per year were associated with better TAR survivorship. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Backgrounds: To explain the excess cardiovascular mortality observed in the SERVE-HF study, it was hypothesized that the high-pressure ASV default settings used lead to inappropriate ventilation, cascading negative consequences (i.e. not only pro-arrythmogenic effects through metabolic/electrolyte abnormalities, but also lower cardiac output). The aims of this study are: i) to describe ASV-settings for long-term ASV-populations in real-life conditions; ii) to describe the associated minute-ventilations (MV) and therapeutic pressures for servo-controlled-flow versus servo-controlled-volume devices (ASV-F Philips®-devices versus ASV-V ResMed®-devices). Methods: The OTRLASV-study is a cross-sectional, 5-centre study including patients who underwent ASV-treatment for at least 1 year. The eight participating clinicians were free to adjust ASV settings, which were compared among i) initial diagnosed sleep-disordered-breathing (SBD) groups (Obstructive-Sleep-Apnea (OSA), Central-Sleep-Apnea (CSA), Treatment-Emergent-Central-Sleep-Apnea (TECSA)), and ii) unsupervised groups (k-means clusters). To generate these clusters, baseline and follow-up variables were used (age, sex, body mass index (BMI), initial diagnosed Obstructive-Apnea-Index, initial diagnosed Central-Apnea-Index, Continuous-Positive-Airway-Pressure used before ASV treatment, presence of cardiopathy, and presence of a reduced left-ventricular-ejection-fraction (LVEF)). ASV-data were collected using the manufacturer’s software for 6 months. Results: One hundred seventy-seven patients (87.57% male) were analysed with a median (IQ_25–75) initial Apnea-Hypopnea-Index of 50 (38–62)/h, an ASV-treatment duration of 2.88 (1.76–4.96) years, 61.58% treated with an ASV-V. SDB groups did not differ in ASV settings, MV or therapeutic pressures. In contrast, the five generated k-means clusters did (generally described as follows: (C1) male-TECSA-cardiopathy, (C2) male-mostly-CSA-cardiopathy, (C3) male-mostly-TECSA-no cardiopathy, (C4) female-mostly-elevated BMI-TECSA-cardiopathy, (C5) male-mostly-OSA-low-LVEF). Of note, the male-mostly-OSA-low-LVEF-cluster-5 had significantly lower fixed end-expiratory-airway-pressure (EPAP) settings versus C1 (p = 0.029) and C4 (p = 0.007). Auto-EPAP usage was higher in the male-mostly-TECSA-no cardiopathy-cluster-3 versus C1 (p = 0.006) and C2 (p < 0.001). MV differences between ASV-F (p = 0.002) and ASV-V (p < 0.001) were not homogenously distributed across clusters, suggesting specific cluster and ASV-algorithm interactions. Individual ASV-data suggest that the hyperventilation risk is not related to the cluster nor the ASV-monitoring type. Conclusions: Real-life ASV settings are associated with combinations of baseline and follow-up variables wherein cardiological variables remain clinically meaningful. At the patient level, a hyperventilation risk exists regardless of cluster or ASV-monitoring type, spotlighting a future role of MV-telemonitoring in the interest of patient-safety. Trial registration: The OTRLASV study was registered on ClinicalTrials.gov (Identifier: NCT02429986). 1 April 2015.

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure. This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.