波士顿科学

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: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.).

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).

Among patients with pancreatic cancer and biliary obstruction planned for pancreaticoduodenectomy, preoperative biliary drainage (PBD) may be considered during surgical delays. Higher complication rates have been reported for PBD using plastic stents versus early surgery. PBD with a self-expanding metal stent (SEMS) has not been compared with early surgery in a randomized controlled trial (RCT). We conducted a noninferiority RCT comparing PBD using a SEMS versus early surgery at 11 centers in 9 countries. We enrolled patients with resectable pancreatic or periampullary cancer and serum total bilirubin level ≥ 5.8 mg/dL, scheduled for primary resection. Primary endpoint was the proportion of patients reporting ≥ 1 serious adverse event (SAE) 120 days post-randomization. Secondary endpoints included rate of SEMS insertion, rate of curative-intent resection, and all-cause mortality. Among 284 patients, 144 were randomized to PBD and 140 to early surgery. In the modified intention-to-treat primary endpoint analysis, ≥ 1 SAE(s) occurred in 29.0

Background ADVANTAGE AF examined the safety and efficacy of pulsed field ablation (PFA) to treat persistent atrial fibrillation (AF). During AF ablation, typical atrial flutter (AFL) is commonly treated with cavotricuspid isthmus (CTI) ablation. Objectives Adjunctive CTI ablation in ADVANTAGE AF was performed with radiofrequency ablation (RFA; phase 1) or bipolar linear PFA (phase 2). Here, we compared lesion characteristics, CTI ablation efficacy, and safety between the ablation modalities. Methods A preclinical study assessed lesion dimensions with a novel 2.0 kV bipolar linear PFA catheter. In ADVANTAGE AF, after AF ablation with a pentaspline PFA catheter, CTI ablation was performed: in phase 1 with irrigated RFA, and in phase 2 with the linear PFA catheter (Farapoint). Before PFA CTI ablation ,patients were treated with a vasopressor bolus followed by high-dose intravenous nitroglycerin. Results Preclinical assessment showed lesion depth increasing at higher field strength and plateauing after 2 applications. In ADVANTAGE AF, 50 and 141 patients received CTI ablation with RFA and PFA, respectively. Patient characteristics across the 2 cohorts were similar (RFA vs PFA). Acute CTI conduction block was similar between techniques (50 of 50 RFA [100%] vs 139 of 141 PFA [98.6%]; P = 1.00). PFA was associated with a shorter CTI ablation time (median: RFA 5 min [Q1-Q3: 4-8 min] vs 14 min [Q1-Q3: 9-19 min]; P = 0.001). RFA and PFA had similar safety event rates (RFA 2.0% vs PFA 2.1%; P = 0.96). With the use of nitroglycerin pretreatment, there was no clinical manifestation of coronary artery spasm with PFA. Conclusions This subanalysis of ADVANTAGE AF extends the primary results by allowing comparison of bipolar linear PFA and RF ablation for CTI, integrating preclinical lesion modeling with clinical dosing, and establishing a standardized reliable coronary safety protocol. Although not randomized comparisons, these findings suggest that CTI ablation with a linear PFA catheter is associated with safety and efficacy similar to RF ablation and greater efficiency. (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation [ADVANTAGE AF; NCT05443594])