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.

Device-detected atrial sensing amplitudes as a marker of increased risk for new onset and progression of atrial high-rate episodes.

BACKGROUND: Atrial high-rate episodes (AHREs) are frequent in patients with cardiac implantable electronic devices. A decrease in device-detected P-wave amplitude may be an indicator of periods of increased risk of AHRE. OBJECTIVE: The objective of this study was to assess the association between P-wave amplitude and AHRE incidence. METHODS: Remote monitoring data from 2579 patients with no history of atrial fibrillation (23% pacemakers and 77% implantable cardioverter-defibrillators, of which 40% provided cardiac resynchronization therapy) were used to calculate the mean P-wave amplitude during 1 month after implantation. The association with AHRE incidence according to 4 strata of daily burden duration (≥15 minutes, ≥6 hours, ≥24 hours, ≥7 days) was investigated by adjusting the hazard ratio with the CHA2DS2-VASc score. RESULTS: The adjusted hazard ratio for 1-mV lower mean P-wave amplitude during the first month increased from 1.10 (95% confidence interval [CI], 1.05-1.15; P < .001) to 1.18 (CI, 1.09-1.28; P < .001) with AHRE duration strata from ≥15 minutes to ≥7 days independent of the CHA2DS2-VASc score. Of 871 patients with AHREs, those with 1-month P-wave amplitude <2.45 mV had an adjusted hazard ratio of 1.51 (CI, 1.19-1.91; P = .001) for progression of AHREs from ≥15 minutes to ≥7 days compared with those with 1-month P-wave amplitude ≥2.45 mV. Device-detected P-wave amplitudes decreased linearly during the 1 year before the first AHRE by 7.3% (CI, 5.1%-9.5%; P < .001 vs patients without AHRE). CONCLUSION: Device-detected P-wave amplitudes <2.45 mV were associated with an increased risk of AHRE onset and progression to persistent forms of AHRE independent of the patient's risk profile.

The European TauroPace™ Registry.

BACKGROUND: Cardiac implantable electronic device (CIED) placement comes with certain complications. CIED infection is a severe adverse event related to CIED placement. In randomised controlled trials, the preoperative intravenous administration of antibiotics and the adjunctive use of an antibiotic mesh envelope resulted in significant reduction in infections related to cardiac implantable electronic devices. The adjunctive use of taurolidine for this purpose is relatively novel and not considered in the guidelines. The required evidence may consist of a set of clinical studies. METHODS: The European TauroPaceTM registry (ETPR) prospectively evaluates every consecutive invasive procedure involving any CIED with adjunct TauroPace™ use in the contributing centres. As the estimation of the infection rate needs to be defensible, only interventions registered prior to the procedure will be followed-up. The endpoint is a major cardiac implantable electronic device infection according to the novel CIED infection criteria (1). Secondary endpoints comprise all-cause mortality, complications, adverse events of all grades, and major CIED infections during all follow-up examinations. The follow-up times are three months, twelve months, and eventually 36 months, as acute, subacute, and long-term CIED infections are of interest. RESULTS: As the rate of CIED infections is expected to be very low, this registry is a multicentre, international project that will run for several years. Several reports are planned. The analyses will be included in the case number calculations for future randomised controlled trials. CONCLUSIONS: The ETPR will accumulate large case numbers to estimate small event rates more precisely; we intend to follow up on participants for years to reveal possible late effects.

ANMCO position paper: guide to the appropriate use of the wearable cardioverter defibrillator in clinical practice for patients at high transient risk of sudden cardiac death.

Extended risk stratification and optimal management of patients with a permanently increased risk of sudden cardiac death (SCD) are becoming increasingly important. There are several clinical conditions where the risk of arrhythmic death is present albeit only transient. As an example, patients with depressed left ventricular function have a high risk of SCD that may be only transient if there will be a significant recovery of function. It is important to protect the patients while receiving and titrating to the optimal dose the recommended drugs that may lead to an improved left ventricular function. In several other conditions, a transient risk of SCD can be observed even if the left ventricular function is not compromised. Examples are patients with acute myocarditis, during the diagnostic work-up of some arrhythmic conditions or after extraction of infected catheters while eradicating the associated infection. In all these conditions, it is important to offer a protection to these patients. The wearable cardioverter defibrillator (WCD) is of particular importance as a temporary non-invasive technology for both arrhythmia monitoring and therapy in patients with increased risk of SCD. Previous studies have shown the WCD to be an effective and safe therapy for the prevention of SCD caused by ventricular tachycardia/fibrillation. The aim of this ANMCO position paper is to provide a recommendation for clinical utilization of the WCD in Italy, based upon current data and international guidelines. In this document, we will review the WCD functionality, indications, clinical evidence, and guideline recommendations. Finally, a recommendation for the utilization of the WCD in routine clinical practice will be presented, in order to provide physicians with a practical guidance for SCD risk stratification in patients who may benefit from this device.

[ANMCO Position paper: Wearable cardioverter defibrillator appropriate use guidance for the management of patients at high transient risk of sudden cardiac death]. / Position paper ANMCO: Guida all'uso appropriato del defibrillatore indossabile nella pratica clinica per i pazienti ad elevato rischio transitorio di morte improvvisa.

Extended risk stratification and optimal management of patients with a permanently increased risk of sudden cardiac death (SCD) is becoming increasingly important. There are several clinical conditions where the risk of arrhythmic death is present albeit only transient. As an example, patients with depressed left ventricular function have a high risk of SCD that may be only transient when there is a significant recovery of function. It is important to protect the patients while receiving the recommended measures and drugs that may either lead or not to an improved left ventricular function. In several other conditions a transient risk of SCD can be observed even if the left ventricular function is not compromised. Examples are patients with acute myocarditis, during the diagnostic work-up of some arrhythmic conditions or after extraction of infected catheters while eradicating the associated infection. In all these conditions it is important to offer a protection to these patients. The wearable cardioverter-defibrillator (WCD) is of particular importance as a temporary non-invasive technology for both arrhythmia monitoring and therapy in patients with increased risk of SCD. Previous studies have shown the WCD to be an effective and safe therapy for the prevention of SCD caused by ventricular tachycardia/fibrillation. The aim of this ANMCO position paper is to provide a recommendation for clinical utilization of the WCD in Italy, based upon current data and international guidelines. In this document we will review the WCD functionality, indications, clinical evidence as well as guideline recommendations. Finally, a recommendation for the utilization of the WCD in routine clinical practice will be presented, in order to provide physicians with a practical guidance for SCD risk stratification in patients who may benefit from this device.

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.

[Indications for leadless VVI and VDD pacing in clinical practice]. / Indicazioni all'utilizzo di pacemaker leadless VVI e VDD nella pratica clinica.

Leadless, intracardiac pacemakers are a major innovation in the management of bradyarrhythmia. Both safety and feasibility of leadless pacing have been assessed in acute settings and mid-term follow-up showing a significant reduction of pacing-related complications as compared with standard transvenous pacemakers. There are many advantages of the leadless approach including a reduction of infection risk and malfunction due to the absence of transvenous leads and the pacemaker pocket. Patients at high risk of endocarditis or pocket failure, with compromised venous access, can benefit from the leadless approach. In this review article, the relevant implant indications for leadless pacemaker and patient populations are described.

Salvage of Cardiac Implantable Electronic Device Pocket Infection with Skin Erosion in Frail 92-Year-Old.

We reported the novel use of a taurolidine-containing antimicrobial solution in the successful salvage of a partially exposed and polymicrobially infected cardiac implantable electronic device pulse generator in a frail patient unfit for lead extraction. The old, salvaged device was entirely internalized, and there were no signs of recurrent infection at 9 months follow-up.

[The wearable cardiac defibrillator: the meeting point between the latest scientific evidence and clinical applicability]. / Il defibrillatore indossabile: punto di incontro tra ultime evidenze scientifiche ed applicabilità clinica.

The use of the wearable cardioverter-defibrillator, already widely used in the United States and other European countries, is rapidly spreading in Italy. The population of patients who may benefit from this type of device is very heterogeneous, but they share the transient risk of sudden cardiac death, for which temporary, automatic and non-invasive protection is required. By interpreting the latest scientific evidence and clinical experiences reported in the registries, it is clear that this type of tool is safe, effective and could have an important impact on the reduction of arrhythmic and total mortality in certain patient subsets. Starting from the clinical conditions for which even the guidelines have recognized the usefulness of the device, new opportunities open up where the wearable cardiac defibrillator can be used with the double benefit of protecting the patient from the risk of sudden cardiac death in safety and allows clinicians to have the right time to make the most appropriate long-term therapeutic decisions.

Prolonged care delivery time and reduced rate of electrophysiological procedures during the lockdown period due to Covid-19 outbreak.

OBJECTIVES: The aim of this study is to demonstrate how Electrophysiology activity has been impacted by the pandemic Coronavirus disease 2019 (COVID-19). METHODS: In this multicenter retrospective study, we analyze all consecutive patients admitted for electrophysiological procedures during the COVID-19 lockdown in the Tuscany region of Italy, comparing them to patients hospitalized in the corresponding period of the previous year. RESULTS: The impact of COVID-19 on cardiac arrhythmia management was impressive, with a reduction of more than 50% in all kinds of procedures. A gender gap was observed, with a more relevant reduction for female patients. Arrhythmic urgencies requiring a device implant showed a reduced time from symptoms to first medical contact but the time from first medical contact to procedure was significantly prolonged. CONCLUSION: Hospitals need to consider how outbreaks may affect health systems beyond the immediate infection. Routine activity should be based on a risk assessment between the prompt performance of procedure and its postponement. Retrospective observational analysis such as this study could be decisive in evidence-based medicine of any future pathogen outbreak.Nonstandard Abbreviations and Acronyms PM= pacemakerICD= implantable cardioverter defibrillatorECV= electrical cardioversionEPS= electrophysiological studyAP= ablations proceduresCIED= cardiac implantable electronic devicesWCD= wearable cardioverter defibrillatorEP Lab= Electrophysiology LaboratoriesAVNRT =atrioventricular nodal reentry tachycardiaAVRT= atrioventricular reentry tachycardiaAFL= atrial flutterAF= atrial fibrillationVT= ventricular tachycardiaAT= atrial tachycardia.

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.

Frequent Ventricular Premature Beats in Children and Adolescents: Natural History and Relationship with Sport Activity in a Long-Term Follow-Up.

Premature ventricular complexes (PVCs) are frequently documented in children. To date, few studies report long-term follow-up in pediatric cohorts presenting with frequent PVCs. The aim of this study is to assess the clinical relevance and long-term outcomes of frequent PVCs (≥ 500/24 h) in a large pediatric cohort. From 1996 to 2016, we enrolled all consecutive patients evaluated at Anna Meyer Children Hospital for frequent PVCs. Symptomatic children were excluded together with those patients with known underlying heart diseases; thus, our final cohort of study included 103 patients (male 66%; mean age 11 ± 3.4 years), with a mean follow-up of 9.5 ± 5.5 years. All patients were submitted to complete non-invasive cardiologic evaluation. The mean number of PVCs at Holter Monitoring (HM) was 11,479 ± 13,147/24 h; couplets and/or triplets were observed in 5/103 (4.8%) cases; 3 patients (2.9%) presented runs of non-sustained ventricular tachycardia (NSVT). High-burden PVCs (> 30,000/24 h) was confirmed in 11/103 (10.6%) patients. During the follow-up, only five patients (4.8%) developed clinical symptoms (3 for palpitations, 1 myocardial dysfunction due to frequent PVCs and NTSV; 1 arrhythmogenic cardiomyopathy); no deaths occurred. Basal PVCs were still present in 45/103 (43.7%) patients. Our data suggest that frequent PVCs may be addressed as a benign condition and should not preclude sport participation if not associated with cardiac malformations, heart dysfunction, or cardiomyopathy. This seems to be true also in presence of very frequent/high-burden PVCs. Otherwise, a careful follow-up is mandatory since sport eligibility should be reconsidered in case of onset of symptoms and/or ECG/echocardiographic changes.

Sleep-disordered breathing and effectiveness of cardiac resynchronization therapy in heart failure patients: gender differences?

OBJECTIVES: This study evaluated heart failure (HF) patients who underwent cardiac resynchronization therapy (CRT) and who had device-documented sleep-disordered breathing (SDB). We found gender differences in acute changes in SDB due to CRT impact. BACKGROUND: SDB typically occurs in HF patients. However, the role of SDB and its response to CRT in HF patients, as well as the relation with gender are currently not fully researched. METHODS: Among 63 consecutive patients who received CRT with an SDB algorithm, 23 patients documented SDB at one-month cardiac device interrogation and represented our population. We defined a Sleep apnoea Severity SCore(SSSC), and consequently, patients were categorized to have mild, moderate, and severe sleep apnoea syndrome divided into two groups: Group-1: 18 males (78%); Group-2: 5 females (22%). We evaluated the variation of apnoea burden and CRT response based on gender differences. RESULTS: A significantly higher proportion of patients in the male group were non-responders to CRT at 12-months follow-up (p = 0.076) while in the female population 5/5 patients (100%) were responders to CRT at the same follow-up time (p = 0.021). Among Group-2 subjects, we documented a significant linear decrease in SSSC(p > 0,01) while in Group-1 the CRT effect on SSSC was variable. At 12-months follow-up, the difference in SSSC between the two groups was statistically significant (p < 0.001). CONCLUSIONS: Our study reports a correlation between CRT response and sleep apnoea burden considering gender differences. In particular, HF-women responders to CRT demonstrate a significant linear decrease in sleep apnoea burden determined through a device algorithm, when compared to a similar male population. Further research is needed to confirm these findings.

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.