The burden of radiation exposure in congenital heart disease: the Italian cohort profile and bioresource collection in HARMONIC project.

BACKGROUND: The European-funded Health Effects of Cardiac Fluoroscopy and Modern Radiotherapy in Pediatrics (HARMONIC) project aims to improve knowledge on the effects of medical exposure to ionizing radiation (IR) received during childhood. One of its objectives is to build a consolidated European cohort of pediatric patients who have undergone cardiac catheterization (Cath) procedures, with the goal of enhancing the assessment of long-term radiation-associated cancer risk. The purpose of our study is to provide a detailed description of the Italian cohort contributing to the HARMONIC project, including an analysis of cumulative IR exposure, reduction trend over the years and an overview of the prospective collection of biological samples for research in this vulnerable population. METHODS: In a single-center retrospective cohort study, a total of 584 patients (323 males) with a median age of 6 (2-13) years, referred at the Pediatric Cardiology in Niguarda Hospital from January 2015 to October 2023, were included. Biological specimens from a subset of 60 patients were prospectively collected for biobanking at baseline, immediately post-procedure and after 12 months. RESULTS: Two hundred fifty-nine (44%) patients were under 1 year old at their first procedure. The median KAP/weight was 0.09 Gy·cm2/kg (IQR: 0.03-0.20), and the median fluoroscopy time was 8.10 min (IQR: 4.00-16.25). KAP/weight ratio showed a positive correlation with the fluoroscopy time (Spearman's rho = 0.679, p < 0.001). Significant dose reduction was observed either after implementation of an upgraded technology system and a radiation training among staff. The Italian cohort includes 1858 different types of specimens for Harmonic biobank, including blood, plasma, serum, clot, cell pellet/lymphocytes, saliva. CONCLUSIONS: In the Italian Harmonic cohort, radiation dose in cardiac catheterization varies by age and procedure type. An institution's radiological protection strategy has contributed to a reduction in radiation dose over time. Biological samples provide a valuable resource for future research, offering an opportunity to identify potential early biomarkers for health surveillance and personalized risk assessment.

Congenital Heart Disease and the Risk of Cancer: An Update on the Genetic Etiology, Radiation Exposure Damage, and Future Research Strategies.

Epidemiological studies have shown an increased prevalence of cancer in patients with congenital heart disease (CHD) as compared with the general population. The underlying risk factors for the acquired cancer risk remain poorly understood, and shared genetic anomalies and cumulative radiation exposure from repeated imaging and catheterization procedures may be contributing factors. In the present review, we provide an update on the most recent literature regarding the associations between CHD and cancer, with a particular focus on genetic etiology and radiation exposure from medical procedures. The current evidence indicates that children with CHD may be a high-risk population, already having the first genetic "hit", and, consequently, may have increased sensitivity to ionizing radiation from birth or earlier. Future research strategies integrating biological and molecular measures are also discussed in this article.

X-ray management in electrophysiology: a survey of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC).

AIMS: Radiation use in medicine has significantly increased over the last decade, and cardiologists are among the specialists most responsible for X-ray exposure. The present study investigates a broad range of aspects, from specific European Union directives to general practical principles, related to radiation management among a national cohort of cardiologists. METHODS AND RESULTS: A voluntary 31-question survey was run on the Italian Arrhythmology and Pacing Society (AIAC) website. From June 2019 to January 2020, 125 cardiologists, routinely performing interventional electrophysiology, participated in the survey. Eighty-seven (70.2%) participants are aware of the recent European Directive (Euratom 2013/59), although only 35 (28.2%) declare to have read the document in detail. Ninety-six (77.4%) participants register the dose delivered to the patient in each procedure, in 66.1% of the cases both as fluoroscopy time and dose area product. Years of exposition (P = 0.009) and working in centers performing pediatric procedures (P = 0.021) related to greater degree of X-ray equipment optimization. The majority of participants (72, 58.1%) did not recently attend radioprotection courses. The latter is related to increased awareness of techniques to reduce radiation exposure (96% vs. 81%, P = 0.022), registration of the delivered dose in each procedure (92% vs. 67%, P = 0.009), and X-ray equipment optimization (50% vs. 36%, P = 0.006). CONCLUSION: Italian interventional cardiologists show an acceptable level of radiation awareness and knowledge of updated European directives. However, there is clear space for improvement. Comparison to other health professionals, both at national and international levels, is needed to pursue proper X-ray management and protect public health.

Radiation awareness in an Italian multispecialist sample assessed with a web-based survey.

INTRODUCTION: The awareness of radiation doses and risks, also during interventional cardiology procedures, is essential today in order to apply the risk-benefit assessment and to reinforce the principles of justification and optimisation in clinical practice. METHODS: A voluntary survey with 10 questions and multiple-choice answers was run on a popular cardiology website (www.cardiolink.it) independently by a scientific publisher, in order to evaluate the contemporary level of radiation awareness in a multi-speciality sample of physicians in Italy. RESULTS: One thousand eight hundred and sixty-one physicians completed the test. The survey showed good results since both prescribers and practitioners (mostly cardiologists) working in Italy are largely aware of the cancer and non-cancer risks of medical radiation use, regardless of their subspecialty background. CONCLUSION: Physicians are largely aware of the cancer and non-cancer risks of medical radiation use, regardless of their subspecialty background. However, there is still broad space for improvement; in the future, the awareness of radiation risk is a prerequisite to create a culture of respect for radiation hazard and a commitment to minimise exposure and maximise protection.

A New Era in Zero X-ray Ablation.

In this article, the authors focus on the importance of the zero X-ray ablation approach in electrophysiology. Radiation exposure related to conventional transcatheter ablation carries small but non-negligible stochastic and deterministic effects on health. Non-fluoroscopic mapping systems can significantly reduce, or even completely avoid, radiological exposure. The zero X-ray approach determines potential clinical benefits in terms of reduction of ionising radiation exposure, as well as safe technical advantages. The use of this method can result in similar outcomes when compared to the conventional fluoroscopic technique. These results are achieved without altering the duration, or compromising the effectiveness and safety, of the procedure. The zero X-ray ablation approach is a feasible and safe alternative to fluoroscopy, which is often only used in selected cases for troubleshooting. The non-fluoroscopic approach is considered a milestone for cancer prevention in ablation procedures.

Long-term outcomes after "Zero X-ray" arrhythmia ablation.

PURPOSE: Radiation exposure related to conventional tachyarrhythmia radiofrequency catheter ablation (RFCA) carries small but definite risk for both patients and operators. Today, non-fluoroscopic mapping systems enable to perform catheter ablation with minimal or zero fluoroscopy. The purpose of this study was to evaluate the long-term outcome of patients who had undergone "Zero X-ray" ablation, since no information is available on the very long-term benefits. METHODS: A total of 272 arrhythmias in 266 patients have been treated with catheter ablation by means of a zero-ray approach guided only by a nonconventional mapping system (EnSite NavX™, Ensite™ Velocity™ mapping system; subsequently Ensite™ Precision™ Abbott, St. Paul, MN). Fluoroscopy was never used. RESULTS: Over a period of 6 years, patients were followed up for an average of 2.9 ± 1.6 years. A 100% rate of acute success was observed in the study population, with a complication rate of 0.8%. Chronic success was achieved in 90.8% of the total number of procedures (272). Patients in whom the same arrhythmia recurred during follow-up underwent to a redo catheter ablation procedure in 60.0% of cases, while the remaining 40.0% underwent pharmacological treatment. A new post-ablation arrhythmia occurred in 7.7% of the sample. CONCLUSIONS: The non-fluoroscopic approach is a feasible and safe alternative to fluoroscopy for arrhythmias ablation. This method ensures low complications rates, high acute procedural success rates, and comparable long-term outcomes with clinical benefits for both patients and physicians. The complete elimination of fluoroscopy during catheter ablation is advantageous and does not reduce patient safety.

Ablation of recurrent malignant idiopathic ventricular tachycardia: When proper diagnosis and success is a matter of contact.

Effective and stable contact between the catheter tip and the tissue is crucial for both mapping and lesion formation during cardiac ablation procedures. Contact force catheter may be not only a therapeutic approach to arrhythmias, but also a tool for achieving accurate characterization of the arrhythmic substrate.

Zero x-ray cardiac resynchronization therapy device implantation guided by a nonfluoroscopic mapping system: A pilot study.

BACKGROUND: Fluoroscopic guidance is the standard tool used in device implantation. This means that both the patient and the operator are exposed to radiation, which may sometimes be high. The possibility of single-lead permanent pacemaker implantation without fluoroscopy has already been demonstrated. OBJECTIVE: The aim of our study was to investigate the feasibility and reliability of biventricular device implantation guided only by an electroanatomic navigation system. METHODS: Sixty-one patients with heart failure underwent implantation of a cardiac resynchronization therapy (CRT) device with or without defibrillator (CRT-D; CRT-P). The procedure was performed with or without fluoroscopy guidance (Rx+; Rx0). In the latter case, the EnSite Velocity system was used; this system is able to reconstruct the anatomy and activation of the cardiac chambers by simultaneously collecting a "cloud" of anatomical points from multiple electrodes. RESULTS: Lead positioning was achieved in 24 of 26 patients undergoing CRT implantation without fluoroscopy (92% success). No complications were observed during the procedure and no catheter dislodgment occurred the day after the implantation or during 1-month follow-up. Procedure time progressively decreased from 136 minutes in the first case to 59 minutes in the last one, suggesting that operators gradually gained confidence while using the new technique. CONCLUSION: Our study demonstrates the feasibility, efficacy, and safety of lead positioning guided only by the nonfluoroscopic EnSite Velocity mapping system without the use of fluoroscopy in CRT-P or CRT-D implantation. The benefits in terms of significantly reduced fluoroscopy exposure are associated with technical and clinical advantages.

Near-zero x-ray in arrhythmia ablation using a 3-dimensional electroanatomic mapping system: A multicenter experience.

BACKGROUND: Radiation exposure related to conventional tachyarrhythmia radiofrequency catheter ablation (RFCA) carries small but not negligible stochastic and deterministic effects on health. These effects are cumulative and potentially more harmful in younger individuals. Nonfluoroscopic mapping systems can significantly reduce the radiological exposure and in some cases it can completely eliminate it. OBJECTIVE: The aim of this study was to assess the safety, feasibility, and efficacy of a complete nonfluoroscopic approach for RFCA compared with ablation procedures performed under fluoroscopic guidance. METHODS: RFCA was performed in 442 consecutive patients (mean age 58 ± 19 years). The first 145 patients (group 1) were treated only under fluoroscopic guidance, and the following 297 patients (group 2) were treated using a nonfluoroscopic electroanatomic mapping system (EnSite Velocity). RFCA was completely performed without fluoroscopy in 255 of 297 patients in group 2 (86%). RESULTS: The acute success rate did not differ between group 1 and group 2 (97% vs 96%; P = .46), and there were no differences in either procedure time (87 ± 57 minutes vs 91 ± 52 minutes; P = .41) or complication rate. Fluoroscopic exposure in group 2 was significantly reduced in comparison with group 1 (14 ± 6 seconds vs 1159 ± 833 seconds; P < .0001). CONCLUSION: Compared with the conventional fluoroscopic technique, the near-zero radiation (RX) approach provides similar outcomes and may significantly reduce or eliminate ionizing radiation exposure in RFCA. These reductions are achieved without altering the duration or compromising the safety and effectiveness of the procedure.

Postacute rehabilitation after coronary surgery: the effect of preoperative physical activity on the incidence of paroxysmal atrial fibrillation.

OBJECTIVE: Postoperative atrial fibrillation (AF) is a frequent complication after cardiac surgery. AF may also occur after hospital discharge during postacute rehabilitation. Several studies have addressed the AF that occurs in the hospital after surgery, and predictors have already been identified. Postoperative AF that occurs after hospital discharge has not been investigated thoroughly, and predictors are still unknown. In this study, we hypothesized that moderate-intensity physical activity in the year before surgery might favorably affect the incidence of AF during postacute rehabilitation. DESIGN: We tested our hypothesis in a cohort of 158 older patients admitted to a medical rehabilitation facility for postacute inpatient rehabilitation after coronary surgery and continuously monitored by telemetry for the duration of the rehabilitation. RESULTS: Independent of potential confounders, patients who reported low-intensity physical activity in the year before surgery showed a significantly higher incidence of AF during postacute rehabilitation when compared with those who reported moderate-intensity physical activity (32.1% vs. 8.1%; P = 0.029). Other independent predictors of AF during postacute rehabilitation were the occurrence of AF during the patients' stay in hospital, larger left atrial volume, and lower left atrial emptying fraction. CONCLUSIONS: These findings confirm our hypothesis that physical activity in the year before surgery affects the incidence of postoperative AF during postacute rehabilitation. The results also provide information regarding possible predictors that may assist in identifying patients who could benefit from preventive treatments.