Abstract Introduction Multiple catheter systems have been developed in the field of cardiac electrophysiology, each featuring distinct technological characteristics. These design differences may substantially impact clinical outcomes, particularly in terms of safety and procedural efficiency. In 2024, a novel integrated pulsed-field ablation (PFA) platform was introduced for atrial fibrillation (AF) ablation. Purpose This registry aimed to assess the early multicentre Italian experience with the variable-loop circular catheter (VLCC), focusing on procedural workflow, safety, and efficiency in AF ablation. The primary endpoint was to evaluate the safety of the new VLCC. Secondary endpoints included measures of procedural efficiency -total procedure time, left atrial (LA) dwell time, mapping time, and fluoroscopy time- and subgroup comparisons between paroxysmal versus persistent AF and pulmonary vein isolation (PVI)-only versus non–PVI-only ablation strategies. Methods We conducted a retrospective–prospective, observational, multicentre study to describe real-world initial experiences using the PFA VLCC for AF ablation. Nine Italian electrophysiology centres participated. Data from 361 patients undergoing AF ablation with the commercially approved VLCC were analysed for safety, efficacy, and procedural parameters. Comparisons were performed between paroxysmal (n=215) and persistent AF (n=146), and between PVI-only (n=190) and non–PVI-only (n=171) procedures. Results Baseline clinical and echocardiographic characteristics are summarized in Table 1. Procedural data for the overall cohort and the subgroups are summarized in Table 2. Among the 361 patients, 8 minor (2%) and 1 major (0.2%) complications were observed. Minor complications included 6 vascular events, 1 coronary spasm, and 1 transient ischemic attack; none required surgical intervention. The major complication was a post-procedural ischemic stroke, likely procedure related. PVI was successfully achieved in all patients, with additional extrapulmonary ablation performed in selected cases. Posterior wall ablation was performed in 120 patients (33%), significantly more often in persistent than in paroxysmal AF (76% vs. 4%; p<0.001). In persistent AF, additional targets included the mitral isthmus, anterior wall, left atrial appendage, superior vena cava, and cavotricuspid isthmus. The total median number of PFA applications was 63 [54–84], higher in persistent than paroxysmal AF (84 [66–105] vs. 57 [54–69]; p<0.001) and in non–PVI-only compared with PVI-only procedures (85 [72–105] vs. 56.5 [51–63]; P<0.001). Conclusion In this early multicentre Italian experience, AF ablation using the VLCC PFA platform demonstrated a favourable safety profile and high procedural efficiency across a broad spectrum of clinical settings. These findings support the feasibility and safety of the VLCC system in both paroxysmal and persistent AF, warranting further long-term follow-up.Table_1Table_2
Anastomotic leakage (AL) remains one of the most feared complications after rectal surgery for cancer, with stable incidence rates despite advances in surgical technique and perioperative care. Multiple anastomotic reinforcement strategies have been proposed, yet evidence remains heterogeneous and no clear consensus exists regarding their routine use. A structured expert position panel process was conducted. Eleven clinical scenarios based on AL risk factors and twenty thematic items addressing indications, devices, timing, contraindications, surgical approach, stoma use, costs, and expected outcomes were developed. A panel of experts evaluated each statement using a five-point Likert scale through a two-round process. Consensus was assessed using median scores and interquartile ranges (IQR). Consensus was not reached for most individual or combined preoperative risk factors. Most reinforcement techniques did not receive clear endorsement because of inconsistent and heterogeneous evidence. Strong agreement emerged regarding the central role of intraoperative assessment: tissue perfusion, mechanical tension, tissue quality, and unexpected technical difficulty were identified as key determinants. The panel agreed that reinforcement may still be appropriate in the presence of a diverting stoma, as diversion reduces clinical severity but does not prevent leakage or long-term sequelae. Surgical approach and material cost were not considered influent factors. This position statement highlights the lack of robust evidence supporting routine, indication-driven, or device-specific anastomotic reinforcement in rectal cancer surgery. The main shared recommendation was to base reinforcement on intraoperative surgical judgment, including tissue perfusion, tension, tissue quality, and unexpected technical difficulty.Keywords: anastomotic leakage, rectal cancer surgery, anastomotic reinforcement.
Chronic inflammation and immune remodeling are key features of colorectal cancer (CRC) development and progression, particularly because of the high level of microbiome presence. Among inflammatory mediators, CCL2 has been implicated in the recruitment of monocytes and tumor-associated macrophages, supporting its potential role as a marker of CRC-associated inflammatory remodeling. Therefore, we evaluated nine circulating inflammatory mediators, including CCL2, to assess their potential diagnostic value in patients with CRC. The study included 96 individuals, comprising 52 CRC patients and 44 healthy controls. Plasma cytokine levels were measured using the ProteinSimple Ella microfluidic immunoassay platform, and analyses were also stratified according to sex and BMI category (BMI < 25 vs. ≥25 kg/m2). Patients with CRC had significantly higher levels of CCL2 and IL-6 than healthy controls (p-value < 0.001), regardless of gender or overweight or obesity, confirming a chronic pro-tumor inflammatory profile. Among all markers, CCL2 showed strong exploratory diagnostic performance with an AUC of 0.918, 90.4% sensitivity, and 90.9% specificity (cut-off 436.5 pg/mL). This study highlights the central role of CCL2 as a candidate marker of systemic chronic inflammation associated with colorectal cancer.
To assess preoperative ocular surface findings in consecutive cataract surgery candidates without a prior dry eye diagnosis using a standardized battery of device-based and conventional tests, and to explore associations with age-, sex-, and menopausal status–related factors. A multicenter prospective clinical study was conducted across 12 centers, enrolling consecutive cataract patients scheduled for phacoemulsification surgery with intraocular lens implantation. Patients were studied preoperatively using a combination of non-invasive tests and traditional diagnostic tools. Test results were classified as physiological or non-physiological based on established cut-off values. A total of 1,482 patients were enrolled. Despite no preoperative diagnosis of dry eye, 20
Diabetic patients undergoing percutaneous coronary intervention (PCI) frequently have complex coronary artery disease (CAD) and suboptimal outcomes with drug-eluting stents (DES). Sirolimus-coated balloons (SCB) have recently been introduced, but comparative data versus DES in diabetic patients with de novo CAD are lacking. The SIMPLE-DM study is a pooled analysis of five observational registries including all-comer diabetic patients undergoing PCI for de novo CAD. Patients in the SCB cohort were treated with the phospholipid nanocarrier Magic Touch SCB, while those in the DES cohort received current-generation DES. Propensity score (PS) adjustment was used to balance clinical and angiographic characteristics. The primary endpoint was the 2-year cumulative incidence of target lesion failure (TLF), defined as the composite of cardiac death, target vessel MI (TV-MI), or target lesion revascularization (TLR). A total of 1838 patients were included, 599 treated with SCB-based PCI and 1239 with DES-only PCI. At 2 years, TLF occurred in 9.1
