Cardinale Giovanni Panico General Hospital

Abstract Background As ablation and electroanatomical mapping technology evolve, workflows change to maximize the impact on procedural efficacy, safety, and efficiency. In a magnetic-primary navigation mode, optimization of the magnetic-impedance field links (VoXels) must be considered to provide accurate environments for anatomic modeling, mapping, and lesion placement. To achieve this accuracy and optimize speed of data collection, many operators have adopted the strategy of collecting VoXels using an ablation catheter prior to introduction of a multipolar mapping catheter. However, the impact of this workflow on procedural metrics has not yet been quantified in a multicenter, international cohort. Objective Assess the impact of optimizing the magnetic navigation field using an ablation catheter prior to collecting left atrial (LA) data using a high-density diagnostic tool on acute outcomes in de novo atrial fibrillation (AF) ablation procedures. Methods Acute observational data from 199 de novo pulmonary vein isolation (PVI) cases was prospectively collected from 56 operators at 42 centers in Europe, the US, and Australia. Procedural metrics, modeling workflow, ablation technology used, and acute outcomes were collected. Results Of 199 de novo AF (62.3% PAF) ablation procedures, VoXels were collected with an ablation catheter prior to LA map collection with a multipolar catheter in 65/199 (32.7%) cases; the remainder collected with multipolar catheter first. An irrigated, contact force sensing RF ablation catheter was used in all procedures. Mean procedure duration was similar in procedures in which VoXels were collected prior to map collection (VC) compared to those that did not (nVC) (107.0±46.8 min and 115.4±59.2 min, respectively (p=0.28)). Mean fluoroscopy time was significantly reduced in VC cases compared to nVC cases (3.0±4.5 min and 5.3±5.6 min, respectively (p=0.002)). Total RF duration was significantly reduced in VC cases compared to nVC cases (904±444s and 1063±632s, respectively (p=0.04)). There was also a significant reduction in fluid delivered through the ablation catheter in VC cases, 369±159mL, compared to nVC cases, 520±243mL (p<0.001). Acute success rates were similar between groups: 98.5% for VC cases and 99.2% for nVC cases (p=0.64). Conclusion In this international cohort, cases where VoXels were collected prior to map and model collection had significantly reduced fluoroscopy times, RF durations, and fluid volumes delivered through the ablation catheter, potentially as a result of improved model quality. Despite the introduction of an additional step to the workflow, there was a trend toward shorter procedures when VoXels were collected prior to map and model collection, although it did not achieve statistical significance. Better quantification of the impact of this workflow on model quality, along with analysis of long-term patient outcomes, is warranted.Procedure Duration Comparison_VC vs. nVCFluoroscopy Comparison_VC vs. nVC

Abstract Background Antiarrhythmic drugs, class I are widely used for prevention of atrial fibrillation recurrence. However, previous studies found that these drugs could affect pacing thresholds among pacemaker recipients. Aim of the study: evaluate short -term effect on myocardial pacing following therapy with oral flecainide (200 mg/daily). Methods 45 consecutive pacemaker recipients were prospectively enrolled in a multicenter registry. These patients had preserved left ventricular ejection fraction, a dual chamber pacemaker with symptomatic sustained high-rate atrial fibrillation episodes and stable output atrial and ventricular thresholds. Patients were followed with ambulatory and/or remote monitoring. Results mean age was 74±1 years, 48% pts were male and AF burden was 8±16%. Pacemaker implantation was performed 3.9±0.3 year before study enrollment. Three (6%) out of 45 patients were excluded due to drug sided effects including dyspnea (n=1), diplopia (n=1) and toxicity during acute renal insufficiency (n=1). Flecainide treatment was associated with a significant reduction of atrial fibrillation burden (from 8±16% to 5±12%, p<0.01). At 30 days follow-up since Flecainide starting therapy both atrial and ventricular sensing significantly decreased (3.6 ± 2.2 vs 3.4 ± 2.1mV p=0.01; 12.5±6.6 vs 11.8±6.3 mV p=0.01), while there was a slight increase of both atrial and ventricular capture thresholds (0.77±0.61V@0.4ms vs 0.80±0.42V@0.4ms p=0.01; 0.80±0.53V @0.4ms vs 0.83±0.33V @0.4ms p=0.01). No patient required pacemaker parameters reprogramming. Conclusions oral flecainide therapy among pacemaker recipients at 30 days follow-up seems to be safe and do not affect device function. Further studies with additional follow-up data are warranted.

Background: it is unclear if patients implanted with an implantable cardioverter defibrillator (ICD) after an out-of-hospital cardiac arrest (OHCA) have a higher risk of appropriate device therapy than patients implanted for primary and other secondary prevention. Aims: to assess if appropriate device interventions (ATP/shocks) are higher in patients implanted after OHCA compared to patients implanted for primary and secondary prevention other than OHCA. To verify also if mortality, implantation-related complications (pneumothorax, hemothorax, hematoma, cardiac tamponade), device-related complications (lead displacement and fracture, infections) and inappropriate shocks/ATP are higher in OHCA patients. Methods: a retrospective multicenter international study. We included all the patients implanted with an ICD in 2015 and 2016 in the centers. Follow-up was concluded if death or at the last follow-up available until 12/2023. Patients were divided according to ICD indication (secondary prevention after OHCA, other secondary prevention, primary prevention). Results: 1386 patients (79% males; median age 67, IQR 59-74) from 15 centers were included (median follow-up 83 months): 111 patients in OHCA group, 134 in other secondary prevention group and 1141 in primary prevention group. Considering the first appropriate intervention, a significant difference among the three groups was observed (Fig.1A) and, at post-hoc comparison, the OHCA group was at higher risk than primary prevention (HR 1.51, 95%CI 1.06-2.17, p=0.02), but was at similar risk than other secondary prevention (HR 0.79, 95%CI 0.51-1.23, p=0.3). This was confirmed also after correction for age, gender, history of atrial fibrillation, aetiology and multi-comorbidity (Fig.2A). Considering the number of appropriate interventions during follow-up, the risk of OHCA group was lower than other secondary prevention (IRR 0.28, 95%CI 0.11-0.68, p<0.01) and similar to primary prevention (IRR 0.97, 95%CI 0.47-1.96, p=0.93), also after correction for the other predictors (Fig.2B). The three groups showed no differences in survival (Fig.1B), implantation-related complication, device-related complications (Fig.1C) and inappropriate shocks/ATP. Conclusion: Our study highlights how OHCA patients represents a peculiar population with the same chance of survival and rate of complications compared to primary and other secondary prevention patients suggesting the need of more studies to improve their long-term treatment.

Background: Previous studies on oocyte extract supplementation showed benefits in patients with liver tumours. In this trial, we hypothesized that the oocyte extract supplement impacted the QoL after hepatectomy for hepatocellular carcinoma and intrahepatic cholangiocarcinoma. Methods: This was a multicentre, double-blind, randomized clinical trial designed to assess the QoL of patients receiving a supplement of oocyte extract or placebo postoperatively. QoL was assessed using the Short Form-36 questionnaire in participants randomly assigned to treatment (Synchrolevels) or placebo. All study personnel and participants were masked to treatment assignment. The endpoint was the change in the QoL score. Results: Between June 2018 and September 2022, 66 of 128 expected patients were considered as per interim analysis, of which 33 were assigned to the treatment and 33 to the placebo group. Baseline and clinicopathological characteristics were similar between the two groups. In the treatment group, the health, mental and psychological status improved for many of the items considered, reaching statistical significance, while in the placebo group, those items either did not change or were impaired in comparison with the corresponding baseline. Conclusions: Supplementation with oocyte extract modifies QoL after liver surgery by enhancing functional recovery. Further in-depth studies are required to confirm this evidence.

Abstract Funding Acknowledgements Type of funding sources: None. Background The recent Avoiding Transvenous Leads in Appropriate Subjects (ATLAS) Trial demonstrated that the subcutaneous implantable cardioverter–defibrillator (S-ICD) reduces lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain. Purpose To assess the perioperative and postoperative pain during S-ICD implantation in current clinical practice and evaluate the influence of implantation techniques. Methods We analyzed 255 consecutive patients (84% male, 52±16 years, body mass index 26±4 Kg/m², ejection fraction 42±16%) who had undergone S-ICD implantation from 2017 to 2022. The primary endpoint was pain during S-ICD placement. The secondary outcome measure included static and dynamic pain intensity 6 hours after the end of the procedure. Patients were asked to rate pain intensity on a 10-point visual analogue scale from 0 (no pain) to 10 (worst imaginable pain). Results The mean procedure duration was 62±22 minutes. The serratus anterior plane block (SAPB) was performed in 161 (63%) patients for anesthesia/analgesia, and 161 (63%) patients underwent the defibrillation testing. Implantation success was reported in all patients with no operative complications. In the overall group, the pain intensity was 2 [range: 1-8] during the implantation procedure, and 1 [1-7] for both static and dynamic pain, 6 hours after the end of the procedure. Significantly lower values were recorded during implantation in the SAPB group (p=0.010) and among those who did not undergo the defibrillation testing (p=0.008). The adoption of the SAPB (coefficient: -0.54, p=0.047) and the omission of defibrillation testing (coefficient: -0.70, p=0.028) remained associated with less pain during implantation after correction for age, sex, body habitus, ejection fraction. Six hours after the end of the procedure the static and dynamic pain intensity remained lower among those with omitted testing (p=0.018 and 0.004, respectively). Conclusions In current clinical practice, S-ICD implantation is associated with very little discomfort. The adoption of novel anesthetic techniques and the omission of defibrillation testing is associated with lower pain levels.