BACKGROUND:Ischaemic cerebrovascular events (CVEs) are a major complication of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis. PURPOSE:We aimed to determine the incidence and risk factors for CVE at 30 days and 1 year after TAVI in a large, real-world patient cohort and evaluate the association of these events with all-cause mortality at 1 year. METHODS:All consecutive patients undergoing TAVI at a single centre between April 2008 and February 2024 were included in the analysis. CVE were defined as a composite of stroke and transient ischaemic attack. RESULTS:One thousand and three patients (mean age 81.8 ± 7.0 years, 52.6% male, median EuroSCORE II 6% [Q1 = 3.51%; Q3 = 10.9%]) underwent TAVI with a self-expandable valve (SEV) (n = 275; 27.4%) or balloon-expandable valve (BEV) (n = 728; 72.6%). The cumulative incidence of CVE was 3.6% (95% confidence interval (95% CI) = [2.6%; 4.9%], n = 36) at 30 days (77.8% within 48 h) and 6.2% (95% CI = [4.8%; 7.8%], n = 62) at 1 year. Risk factors associated with a lower risk of CVE at 30 days included BEV vs. SEV (OR 0.32 [0.16-0.63], p = 0.0009) and larger baseline aortic valve area (AVA) (ORUnit = 0.1 cm2 0.74 [0.61-0.91], p = 0.0035), while the risk was higher in the case of new-onset atrial fibrillation (AF) (OR 3.19 [1.18-8.59], p = 0.0218), diabetes (OR 2.00 [1.01-3.97], p = 0.0484), and conversion to sternotomy (OR 16.57 [4.62-59.48], p < 0.0001). Analysis at 1-year follow-up identified the same associations. Finally, the occurrence of CVE significantly increased 1-year all-cause mortality (OR 2.44 [1.32-4.50], p = 0.0045). CONCLUSIONS:CVE after TAVI were associated with double the odds of 1-year all-cause mortality. Risk factors associated with CVE include the use of a SEV, new-onset AF, diabetes, conversion to sternotomy, and a smaller AVA.
BACKGROUND:Since its introduction in clinical practice, patient selection and procedural technique for transcatheter aortic valve implantation (TAVI) have continued to evolve. METHODS:We investigated temporal trends in patient profiles, procedural, 30-day and 1-year clinical outcomes in all consecutive patients undergoing TAVI at our centre from March 2008 to February 2024 (n = 1000). Patients were stratified into eight consecutive 2-year calendar cohorts. Outcomes were reported according to VARC-III criteria. RESULTS:Median age was 82 y (53% male). Over the consecutive cohorts, we observed significant decreases in STS score (8.1 ± 3.1 to 4.4 ± 2.6%) and EuroSCORE II (10.2 ± 8.0 to 6.4 ± 7.0; p < 0.001 for both). In-hospital death rates decreased significantly (9.4% to 1.3%; p = 0.030). The incidence of major vascular complications, life-threatening bleeding, and cardiac tamponade decreased significantly over time (p < 0.05 for all). Enhanced learning and a shift to a minimalist approach resulted in reduced need for intensive care (from 4 [3-5] to 0 days) and shorter hospital stay (from 13 [8-19] to 2 [2-4] days) (p < 0.001 for both). Overall 30-day survival was 96.4%, with significant improvement across cohorts (93.4% to 98.7%), while 1-year survival was 88.1% with a similar gradual increase (81.3% to 90.2%). Composite VARC-III endpoints demonstrated high technical success and significant improvements in device success and early safety across the eight 2-year cohorts. CONCLUSIONS:Over 15 years we observed a shift from very high-risk towards predominantly intermediate- to high-risk patients, together with substantial procedural simplification and a marked reduction in in-hospital complications and length of stay. These improvements translated into a significant increase in 30-day and 1-year survival.
BACKGROUND & AIMS:Secondary loss of response to ustekinumab is observed in patients with Crohn's disease (CD). Multiple dose-intensification regimens have been proposed. We aimed to test prospectively 2 different dose-intensification regimens with ustekinumab in patients with CD experiencing secondary loss of response. METHODS:This was an investigator-initiated, multicenter, randomized, placebo-controlled trial conducted at 15 hospitals in Belgium. Eligible patients were adults with CD treated with ustekinumab on maintenance dosing of 90 mg subcutaneous every 8 weeks and experiencing a secondary loss of response (Patient-Reported Outcomes 2: abdominal pain score >1 and liquid or very soft stool frequency >3 and an objective documentation of disease). Patients were randomized 1:1 to receiving a single intravenous reinduction with ustekinumab ≈6 mg/kg followed by either subcutaneous ustekinumab 90 mg every 4 weeks or every 8 weeks until week 48. The primary endpoint was the proportion of patients with steroid-free clinical remission at week 48, defined as Patient-Reported Outcomes 2 remission: (abdominal pain ≤ 1 and stool frequency ≤3) and fecal calprotectin <250 μg/g and no steroids in the 90 days before week 48. RESULTS:Between March 2020 and October 2023, 108 patients were randomized. Steroid-free clinical remission at week 48 was reached in 15% vs 19% of patients in the every 4 weeks vs the every 8 weeks group (difference 4%; P = 0.5). Serious adverse events occurred in 17% vs 13% of patients. CONCLUSIONS:In patients with CD and secondary loss of response to ustekinumab, dose intensification with a single intravenous administration and followed by 4 weekly subcutaneous dosing of ustekinumab was not more effective than 1 intravenous administration followed by 8 weekly subcutaneous dosing of ustekinumab. (ClinicalTrials.gov, Number: NCT04245215).
BACKGROUND:5-Aminosalicylic acid (5-ASA) remains the first-line therapy for mild-to-moderate ulcerative colitis (UC). Modern treatment goals extend beyond symptom control to include steroid-free remission, endoscopic healing, and biomarker normalization. Real-world evidence on 5-ASA's ability to achieve these targets is limited. This study assessed remission levels and associated factors in Belgian UC patients in clinical remission on 5-ASA. METHODS:This cross-sectional, multicenter, phase 4 study included UC patients in clinical remission (PRO-2 ≤ 1, no rectal bleeding) treated with 5-ASA for ≥6 months. Patients receiving corticosteroids, immunomodulators, or advanced therapies were excluded. Outcomes were complete clinical remission (PRO-2 = 0, no urgency), endoscopic remission (MES ≤ 1, UCEIS ≤ 1), complete endoscopic remission (MES = 0), histological remission (Geboes 0-1), biological remission (fecal calprotectin <150 µg/g), and deep remission (clinical, endoscopic, and histological). Adherence was assessed using MARS-5. RESULTS:In total, 198 patients were enrolled (median age 50 years; 41% female). Treatment was oral 5-ASA only (n = 134, 68%), rectal only (n = 19, 9%), or combination (n = 45, 23%). Biological remission was observed in 78%, endoscopic remission in 87%, complete endoscopic remission in 70%, and histological remission in 80%. Deep remission occurred in 24%, limited by persistent urgency (63%). Adherence was high (median MARS-5: 24). Oral 5-ASA only was significantly associated with endoscopic remission (P < .001). CONCLUSION:In this real-world Belgian cohort, patients in clinical remission on 5-ASA achieved high rates of objective remission, while deep remission was low because of persistent urgency. These findings confirm 5-ASA's continued relevance in mild-to-moderate UC and highlight the importance of addressing residual symptoms despite mucosal healing.
Introduction: Aspiration of foreign bodies is relatively uncommon in adults but may cause significant morbidity because of the formation of granulation tissue. This granulation tissue can cause complications, for example, airway obstruction, hemoptysis, and post-obstructive infections. Case Report: We present the case of a 63-year-old man with dyspnoea and hemoptysis. Computed tomography (CT) thorax showed a foreign body in the bronchus intermedius. Upon removal of the foreign body, extensive granulation tissue was found, causing bronchial obstruction. The granulation tissue was successfully treated with cryotherapy and coagulation. After cryotherapy, the patient was admitted because of a post-obstructive pneumonia caused by airway obstruction due to necrotic tissue. This necrotic tissue was removed during repeat bronchoscopy. Conclusion: Granulation tissue should only be removed when bronchial obstruction occurs. A stepwise approach is advised after removal of a foreign body when residual granulation tissue is present. Our case highlights this stepwise approach of conservative management with active follow-up. When bronchial obstruction is present, the granulation tissue should be removed. Interventional techniques such as cryotherapy or coagulation are effective. Cryotherapy causes necrotic tissue that will heal over time. However, this necrotic tissue can cause airway obstruction which can lead to post-obstructive pneumonia. This is a known delayed complication of cryotherapy and needs immediate re-intervention to clear the airways. Our case highlights the potential delayed complication of cryotherapy as well.
