Zentralklinik Bad Berka

Patients with tricuspid regurgitation (TR) are at high risk for morbidity and mortality, with poorer outcomes associated with increasing TR severity. Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a promising treatment option. TriCLASP is a prospective, single-arm, European post-market study evaluating the safety and effectiveness of T-TEER with the PASCAL system to treat patients with ≥severe TR. The TriCLASP study enrolled 300 patients to evaluate the safety and performance of T-TEER. Major adverse events (MAE), reduction in TR grade, and clinical, functional, and quality-of-life outcomes were assessed at 1 year. Enrolled patients had a mean age of 80.1 years, 52.0% were female, and 75.8% had ≥severe TR. Tricuspid regurgitation was reduced to ≤moderate in 87.7% of patients (p<0.001). The composite MAE rate was 1.7% at 30 days and 12.7% at 1 year. Kaplan-Meier estimates for survival and freedom from heart failure hospitalisation (HFH) were 88.3±1.9% and 83.2±2.3%, respectively. Annualised HFH rates decreased by 72.2% in the 12 months pre- versus post-procedure (p<0.001). Significant functional and quality-of-life improvements were observed from baseline to 1 year, including 74.5% of patients in New York Heart Association Class I/II, a 29.4-metre increase in the 6-minute walk distance, and an 8.3-point increase in the Kansas City Cardiomyopathy Questionnaire score (p<0.001). The 1-year results of the TriCLASP study confirm the safety and effectiveness of T-TEER with the PASCAL system in patients with ≥severe TR. Patients experienced significant TR reduction, low mortality, high freedom from HFH, and significant improvements in symptoms, functional capacity, and quality of life.

The ablation index (AI) standardizes lesions in radiofreqency ablation (RF) of atrial fibrillation (AF). High-power, short-duration ablation (HPSD) shortens procedures, but AI is histologically unvalidated in HPSD. We evaluated esophageal safety with voltage-adapted AF ablation using an optimized, AI-guided HPSD (AI-HPSD) protocol. Consecutive AF patients undergoing AI-HPSD at 50 W (AI = 400-450 for posterior left atrium (LA); AI ≥ 500 anteriorly) were compared with a recent AF cohort treated by AI-guided low-power, long-duration ablation (AI-LPLD). Esophageal endoscopy was performed 1-3 days postablation. Posterior wall lesion characteristics and endoscopically-detected esophageal lesions (EDEL) were compared. AI-LPLD (n = 100) and AI-HPSD (n = 100) groups had similar baselines, except AI-LPLD had slightly larger LA-area. VISITAG numbers were comparable, but total posterior wall RF time was shorter with AI-HPSD versus AI-LPLD [4.1 (2.1-12.7) vs. 10.9 (5.1-26.6), p < 0.001]. Mean AI and mean impedance drop were higher in AI-HPSD [449 (394-487) vs. 399 (329-485), p < 0.001 and 8.7 (3.9-15.7) vs. 7.4 (3.6-18.2), p = 0.004]. AI standard deviation was lower with AI-HPSD [25 (9-79) vs. 48 (19-100), p < 0.001]. Although Max AI values were higher in AI-HPSD [514 (435-662) vs. 492 (404-644), p = 0.003), maximum impedance drop did not differ significantly. EDEL rate was comparably low at 2% (AI-HPSD) and 4% (AI-LPLD), but AI > 520 occurred more with AI-HPSD (3.5 ± 5.5% vs. 2.5 ± 5.2%; p = 0.048). Optimized AI-HPSD at 50 W with posterior LA target AI = 400-450 was not associated with more EDEL. However, a signal for more unacceptable Max AI values existed. We recommend limiting AI to 400 and developing an automatic, AI-guided ablation stop.

Pivotal clinical trials have assessed the efficacy and safety of fixed-dose upadacitinib 15 mg (UPA15) and 30 mg (UPA30) once daily in atopic dermatitis (AD). To assess the efficacy and safety of dose escalation to UPA30 and dose reduction to UPA15 based on a clinical response [90% reduction in Eczema Area and Severity Index (EASI 90)] after 12 weeks of treatment in adults with moderate-to-severe AD enrolled in a randomized blinded treat-to-target multicentre phase IIIb/IV study. A total of 461 patients were randomized in a 1 : 1 ratio to receive oral doses of UPA15 (n = 229) or UPA30 (n = 232) once daily during the 12-week double-blinded period. At week 12, patients on UPA15 not achieving EASI 90 were dose escalated to UPA30 (UPA15/30); patients achieving ≥ EASI 90 continued on UPA15 (UPA15/15). Patients on UPA30 not achieving EASI 90 at week 12 continued on UPA30 (UPA30/30); patients achieving ≥ EASI 90 received a reduced dose of UPA15 (UPA30/15) for 12 additional weeks. The primary efficacy endpoint was EASI 90 achievement at week 24. Results were reported descriptively as observed. Safety outcomes were assessed. At week 24, of patients who received dose escalation (UPA15/30), 48.1% [n = 64/133; 95% confidence interval (CI) 39.6-56.6] achieved EASI 90; of patients who received a dose reduction (UPA30/15), 68.5% (n = 89/130; 95% CI 60.5-76.4) maintained EASI 90. Of patients who continued on their initial dose, 29.3% (n = 24/82; 95% CI 19.4-39.1) on UPA30/30 achieved EASI 90 and 74.6% (n = 53/71; 95% CI 64.5-84.8) on UPA15/15 maintained EASI 90. At week 24, 32.5% (n = 27/83; 95% CI 22.5-42.6) and 38.0% (n = 38/100; 95% CI 28.5-47.5) of patients on UPA15/30 and UPA30/15, respectively, achieved a worst pruritus numerical rating scale score of 0 or 1 (WP-NRS 0/1), and 20.7% (n = 17/82; 95% CI 12.0-29.5) and 35.0% (n = 35/100; 95% CI 25.7-44.3), respectively, achieved combined EASI 90 and WP-NRS 0/1. At week 24, treatment emergent adverse events were reported in 43.1% (n = 31/72; UPA15/15), 54.2% (n = 78/144; UPA15/30), 61.5% (n = 56/91; UPA30/30) and 48.9% (n = 65/133; UPA30/15) of patients. No malignancies, adjudicated venous thromboembolic events or deaths were reported. Treatment of moderate-to-severe AD with UPA15 or UPA30, with dose escalation or dose reduction based on achievement of the optimal treatment target of EASI 90 at week 12, demonstrated that both approaches support the achievement and maintenance of EASI 90 at week 24. Overall safety findings were consistent with the known UPA safety profile, with no new safety signals identified.

The parallel wire technique (PW) is a classic part of the antegrade strategy to open chronic total coronary occlusions (CTO). With modern wires and dual-lumen catheters (DLC) the approach has evolved, but this progress had not been evaluated in a contemporary registry of CTO interventions. This analysis is based on 26,589 CTO procedures performed by 36 operators with > 50 procedures annually between 2015 and 2022. The different strategies and techniques were analyzed with respect to clinical and lesion characteristics, procedural resource use and periprocedural complications. Within the antegrade approach, PW was compared to antegrade wire escalation (AWE) and antegrade-dissection re-entry (ADR). The primary antegrade approach was used in 65.9%, primary retrograde in 16.9% and a strategy change in 17.2% with a wide inter-operator variability. In primary antegrade approach, PW was applied in 10.8% and ADR in 5.3%. Lesion complexity was higher in AWE and PW than with single wire, and highest in ADR procedures, leading to more complex procedures with higher contrast and radiation usage. Complications increased with ADR, while they were similar with PW and AWE. Through the observation period PW adoption increased steadily from 6.7% to 10.7%, as the DLC use facilitating PW increased from 8.3% to 17.0% over the observation period. In this largest database of contemporary CTO PCI from Europe, PW adoption increased over time but remained low at about 10%. While there was a wide individual variety among the operators, it was a safe and successful technique.