波士顿科学

BACKGROUND:Guidelines recommend a trial of antiarrhythmic drugs before catheter ablation for persistent atrial fibrillation. Whether pulsed field ablation (PFA) may be a preferred initial treatment is unclear. METHODS:We conducted an international, randomized trial involving patients with previously untreated persistent atrial fibrillation. The patients were randomly assigned in a 2:1 ratio to receive PFA performed with a pentaspline catheter or to receive antiarrhythmic-drug therapy. An additional group of patients (PFA-assigned) underwent PFA for the analysis of the primary safety end point alone. All the patients received an insertable cardiac monitor. The primary effectiveness end point was the short-term and long-term success of treatment through 12 months. Short-term success was defined as procedural success in the PFA group and the absence of ablation during the blanking period (90 days after treatment initiation) in the antiarrhythmic-drug group. Long-term success was defined as freedom from recurrence of atrial arrhythmias, repeat ablation, or need for antiarrhythmic drugs from 90 days through 12 months (in the PFA group) and freedom from amiodarone use at any time. The primary safety end point was device- and procedure-related serious adverse events. RESULTS:At 12 months, treatment success was observed in 128 of 207 patients (Kaplan-Meier estimate, 56%; 95% confidence interval [CI], 48 to 63) in the PFA group and in 40 of 103 patients (Kaplan-Meier estimate, 30%; 95% CI, 21 to 40) in the antiarrhythmic-drug group (hazard ratio for composite treatment failure [a lack of short- and long-term success], 0.46; 95% CI, 0.33 to 0.65; P<0.001). A primary safety end-point event occurred in 13 of 257 patients (5.1%) in the combined PFA group (both randomized and PFA-assigned groups). At 12 months, serious adverse events had occurred in 45 patients (25%) in the PFA group and in 20 patients (21%) in the antiarrhythmic-drug group. CONCLUSIONS:Among patients with persistent atrial fibrillation, the risk of recurrence of atrial arrhythmia was significantly lower among those who received PFA as first-line treatment than among those who received antiarrhythmic-drug therapy. (Funded by Boston Scientific; AVANT GUARD ClinicalTrials.gov number, NCT06096337.).

BACKGROUND:Prophylactic complete closure of mucosal defects after resection of gastrointestinal lesions is key to reducing delayed bleeding, but complete closure for large defects can be challenging with conventional through-the-scope clips (TTSC). The introduction of a TTSC with anchor prongs offers ability to approximate margins of larger defects. OBJECTIVE:The study objective was to evaluate prophylactic complete closure after polypectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD) in large (≥ 20 mm) nonpedunculated colorectal lesions (LNPCLs). METHODS:We conducted a multicenter, single-arm prospective cohort study of the TTSC with anchor prongs for prophylactic closure after EMR/polypectomy or ESD for LNPCLs. Patients were followed for 30 days after the index procedure. The primary outcome was the rate of complete closure of the defect. Other outcomes were the rate of delayed (postprocedural) bleeding, and rate of serious adverse events (SAEs). RESULTS:One hundred five eligible patients were enrolled. Ninety-nine (94.3%) defects had complete closure, with rates of 93.0% (80/86) for EMR/polypectomy and 100.0% (19/19) for ESD procedures. Delayed bleeding occurred in 2 (1.9%) patients by 30 days after the index procedure. Eight (7.6%) patients had ≥ 1 SAE, including bleeding (2 patients), perforation (1), microperforation (1), aspiration (1), nausea (1), and post-polypectomy syndrome (1). CONCLUSION:Prophylactic use of the TTSC with anchor prongs achieved a 94% rate of complete defect closure after EMR/polypectomy or ESD for LNPCLs. The rate of delayed bleeding after closure in this cohort was 1.9%. A prospective RCT is ongoing to further evaluate the clinical outcomes of a TTSC with anchor prongs used for prophylactic closure. TRIAL REGISTRATION:ClinicalTrials.gov number, NCT05653843.

Background Deep learning (DL) models for quantifying plaques at coronary CT angiography (CCTA) are rarely used in routine clinical care. Purpose To develop a fully automated DL model for coronary plaque quantification and to evaluate its prognostic value. Materials and Methods Patients who underwent CCTA were retrospectively enrolled from 17 Chinese hospitals between June 2009 and May 2024. The imaging data of these patients were randomly split into training and validation sets at a 7:3 ratio to develop a fully automated DL model for quantifying plaque volume (PV), PlaqueSegNet, which was subsequently externally tested with four independent datasets: a paired CCTA and intravascular US (IVUS) dataset, a subset of the China CT-derived fractional flow reserve (CT-FFR) study 3 dataset collected with different CT scanners, a serial CCTA dataset within a 3-month interval, and a photon-counting CT dataset. The prognostic value of PlaqueSegNet was evaluated using the Harrell C-index in three cohorts: China CT-FFR study 2, China CT-FFR study 1.1, and a serial CCTA cohort. Results The training dataset included 1409 patients (mean age, 63 years ± 10 [SD]; 795 male), and the internal validation dataset included 604 patients (mean age, 63 years ± 10; 329 male). PlaqueSegNet demonstrated excellent agreement and reproducibility for quantifying PV against IVUS and expert readers across the four external datasets (all intraclass correlation coefficients, >0.90), albeit with wide limits of agreement in Bland-Altman analysis. The C-index of PlaqueSegNet for predicting major adverse cardiac events (MACEs) was 0.64 (95% CI: 0.62, 0.67) in the China CT-FFR study 2 (median follow-up, 2.3 years), 0.65 (95% CI: 0.60, 0.69) in the China CT-FFR study 1.1 (median follow-up, 5.3 years), and 0.74 (95% CI: 0.66, 0.84) in the serial CCTA cohort (median follow-up, 3.6 years). Conclusion PlaqueSegNet provided fully automated measurements of PV from CCTA that closely agreed with expert readers and IVUS and carried prognostic value for future MACEs. Clinical trial registration no. NCT06025305 © RSNA, 2026 Supplemental material is available for this article. See also the editorial by Williams in this issue.

Intravascular ultrasound (IVUS)-guided revascularization offers clinical benefits compared to angiography-guided revascularization in patients with femoropopliteal occlusive disease. This study evaluates the cost-effectiveness of IVUS-guided versus angiography-guided revascularization from a Spanish payer perspective. A cost-effectiveness model combining a short-term decision tree and a long-term semi-Markov structure was developed to simulate clinical outcomes and costs over a lifetime horizon from the Spanish perspective. Transition probabilities, costs, and utility weights for health states including reintervention, amputation and death were derived from published literature and Spanish national databases. Health outcomes were measured in quality-adjusted life-years (QALYs), and costs were reported in 2025 Euros. One-way and probabilistic sensitivity analyses were conducted to assess model robustness. IVUS-guided revascularization was associated with improved clinical outcomes and reduced lifetime costs, dominating angiography-guided revascularization. In the base case, IVUS yielded 0.29 additional lifetime QALYs and €3,289 in lifetime cost savings per patient compared with angiography, resulting in a dominance of IVUS. Scenario analysis assuming equal amputation risk still favored IVUS. One-way sensitivity analysis identified the reintervention risk and costs as key drivers, and probabilistic sensitivity analysis confirmed that IVUS dominated in over 90

Heart failure (HF) represents a growing clinical and socioeconomic burden worldwide, placing increasing pressure on health care systems in both high- and low-resource settings. Remote patient care (RPC), encompassing telemonitoring and other digitally enabled strategies, has emerged as a promising adjunct to conventional follow-up by enabling continuous physiological assessment and early detection of clinical deterioration. Such proactive surveillance facilitates timely therapeutic adjustments and may improve patients' outcomes. A broad range of monitoring approaches is currently available or under development, including patient-directed home measurements, wearable technologies, and sensor-based solutions integrated into therapeutic cardiac implantable electronic devices (CIEDs). Among these, the HeartLogic multisensory algorithm offers a pragmatic and scalable solution, leveraging data from existing CIEDs without the need for additional procedures. It is a multiparametric, implant-based algorithm that detects early signs of HF decompensation by integrating sensor data, including heart sounds, intrathoracic impedance, respiratory rate, heart rate, and patient activity. Growing evidence supports its clinical use. DANLOGIC-HF (Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes) is the first randomized controlled trial designed to provide robust outcome data about whether HeartLogic-guided management reduces HF-related events. In this article, we discuss the current evidence for HeartLogic, as well as ongoing and planned clinical trials, with particular emphasis on the pragmatic randomized controlled trial DANLOGIC-HF (Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure).