Position paper on sustainability in cardiac pacing and electrophysiology from the Working Group of Cardiac Pacing and Electrophysiology of the French Society of Cardiology.

Sustainability in healthcare, particularly within the domain of cardiac electrophysiology, assumes paramount importance for the near future. The escalating environmental constraints encountered necessitate a proactive approach. This position paper aims to raise awareness among physicians, spark critical inquiry and identify potential solutions to enhance the sustainability of our practice. Reprocessing of single-use medical devices has emerged as a potential solution to mitigate the environmental impact of electrophysiology procedures, while also offering economic advantages. However, reprocessing remains unauthorized in certain countries. In regions where it is possible, stringent regulatory standards must be adhered to, to ensure patient safety. It is essential that healthcare professionals, policymakers and manufacturers collaborate to drive innovation, explore sustainable practices and ensure that patient care remains uncompromised in the face of environmental challenges. Ambitious national/international programmes of disease prevention should be the cornerstone of the strategy. It is equally vital to implement immediate actions, as delineated in this position paper, to bring about tangible change quickly.

Using technology to improve reconnection to remote monitoring in cardiac implantable electronic device patients.

Background: Remote monitoring (RM) of cardiac implantable electronic device (CIED) patients is now considered standard of care. However, a fundamental requirement of RM is continuous connectivity between the patient's implanted device and the CIED manufacturer's central server. This study examined the rate of RM disconnections in CIED recipients and the impact of short message service (SMS) to facilitate reconnections. Methods: Using a platform that collects RM data from CIED manufacturers, we retrospectively examined the disconnection and reconnection events in 6085 patients from 20 medical centers. Each medical center reported their usual practice regarding RM disconnections, which consisted of either an automatic SMS from the platform to patients who were disconnected for 2 weeks or the standard of care (SC) of a phone call to patients. Results: During a 1-year period, 43% of patients had at least 1 disconnection. Half of these patients experienced multiple disconnections. The use of SMS reduced the time to reconnection by 43% in comparison to SC. The median time to reconnect a disconnected patient was 11.0 [3.2, 29.0] days for SC vs 6.3 [1.3, 22.0] days for SMS (P < .0001). Furthermore, there was a high rate of reconnections within the first 48 hours of the SMS message, which was nearly double that in the SC arm. Conclusion: This study demonstrates the feasibility of an automatic system to deliver an SMS to patients with a disconnected CIED to facilitate early reconnection to RM.

ATE Score Diagnostic Accuracy for Predicting the Absence of Intra-Atrial Thrombi Before AF Ablation.

BACKGROUND: In a preliminary study in patients hospitalized for catheter ablation of atrial fibrillation (AF), the atrial thrombus exclusion (ATE) score (stroke, hypertension, heart failure, and D-dimers >270 ng/mL) was developed to rule out the diagnosis of intra-atrial thrombus, with a negative predictive value (NPV) of 100%, and to avoid performing transesophageal echocardiography (TEE). OBJECTIVES: The present study was designed to prospectively confirm the NPV of the ATE score in an independent population. METHODS: Consecutive patients hospitalized for catheter ablation of AF or left atrial tachycardia (LAT) were prospectively enrolled in a multicenter study. D-dimer levels were measured within 48 hours before ablation. An ATE score of 0 was considered predictive of no thrombus. TEE was routinely performed at the beginning or just before the ablation procedure. The primary endpoint was the presence of atrial thrombus diagnosed by TEE. RESULTS: The analysis included 3,072 patients (53.3% paroxysmal AF, 36.7% persistent AF, and 10% LAT). A thrombus was detected in 29 patients (0.94%; 95% CI: 0.63%-1.35%), all on appropriate anticoagulant therapy. An ATE score of 0 was observed in 818 patients (26.6%), and the sensitivity, specificity, positive predictive value, and NPV were 93.1%, 26.8%, 1.2%, and 99.8%, respectively. Follow-up of the 2 false negative patients revealed the persistence of chronic organized thrombi. CONCLUSIONS: In patients hospitalized for catheter ablation of AF or LAT, the ATE score identifies a population at very low risk for atrial thrombus. In consultation with the patient, the cardiologist may consider not performing a preoperative TEE in case of an ATE score of 0.

[Rythmology activity in France and consequences of new thresholds approvals]. / État de l'activité de rythmologie interventionnelle en France et conséquences des réformes des seuils sur les autorisations d'activité.

BACKGROUND: Interventional rhythmology activity (electrophysiology and pacing) has progressed in France during the last decade. The objective of this article is to assess the distribution of this activity depending on the type of centre (public, university or non-university, private). As the French government issued a new regulation regarding rhythmology activity in 2022, the impact of this regulation on activity distribution has been evaluated. METHODOLOGY: All French data activity can be evaluated after accessing to a national database called PMSI [Programme de Médicalisation des Systèmes d'Information]. Based on data collected in year 2021, the level of activity of the different centres, and the impact of the new criteria of the French regulation regarding rhythmology activity have been analysed. RESULTS: About 200,000 arrhythmias interventions have been done in France in 2021 in 382 centres. According to the new criteria of the French regulation, 66% responded to level A (diagnostic electrophysiology, single- and dual-chamber pacing), 68% for level B (A+ right atrial ablation, implantable automatic defibrillator, cardiac resynchronisation therapy) and 70% for level C (B + left atrial and ventricular ablation). 1/4 of the centres do not meet criteria for level A activity, and 1/5 of them for levels B and C CONCLUSIONS: This work showed that immediat and systematic application of new threshold could be threatening for 1/4 of A center and 1/5 of B or C center. The priority will be to reinforce existing centres before allowing new centres to perform arrhythmias management activity in France.

Survey on the paramedical role in the remote monitoring of cardiac implantable electronic devices in France.

Remote monitoring of cardiac implantable electronic devices (CIEDs) has become an expansive priority in many European countries, with nurses playing a central role in it. In France, a national survey for paramedics was set up to assess the organization of remote monitoring in the different institutions and to determine the paramedical role. A self-administered questionnaire (supplementary material), developed and validated by the College of Paramedics in partnership with the Working Group of Pacing and Electrophysiology of the French Society of Cardiology (SFC).

[Where are done electrophysiology procedures in France and what is the expected evolution ?] / Où se fait l'activité de rythmologie interventionnelle en France et quelle est son évolution ?

INTRODUCTION: Interventional rhythmology activity (electrophysiology and pacing) has progressed in France during the last decade. The objective of this article was to assess the distribution of this activity depending on the type of centre (public, university or non-university, private). As the French government issued a new regulation regarding rhythmology activity in 2022, the impact of this regulation on activity distribution has been evaluated. METHODOLOGY: All French data activity can be evaluated after accessing to a national database called PMSI [Programme de médicalisation des systèmes d'information]. Based on data collected in year 2019, the level of activity of the different centres, and the impact of the new criteria of the French regulation regarding rhythmology activity have been analysed. RESULTS: About 180,000 arrhythmias interventions have been done in France in 2019 in 377 centres. According to the new criteria of the French regulation, only 76% responded to level A (diagnostic electrophysiology, single- and dual-chamber pacing), 52% for level B (A+ right atrial ablation, implantable automatic defibrillator, cardiac resynchronisation therapy) and 54% for level C (B + left atrial and ventricular ablation). CONCLUSIONS: This work showed that approximately a quarter of the centres do not meet criteria for level A activity, and approximately half of them for levels B and C. The priority will be to reinforce existing centres before allowing new centres to perform arrhythmias management activity in France.

[False positive troponinemia in patient with pneumothorax : a case report]. / Troponinémie faussement positive chez un patient présentant un pneumothorax : cas clinique.

A 20-year-old patient is admitted to the emergency room for chest pain occurring in the context of recurrent left complete pneumothorax. Ultrasensitive troponinemia is elevated to 20 times normal. Myocardial distress is attributed to pneumothorax following the negativity of cardiological examinations (EKG, TTE, cardiac MRI). The pneumothorax is drained with a favorable evolution. This is the first reported case of pneumothorax associated with a significant elevation of troponin without ECG change, TakoTsubo syndrome, or myocardial inflammation. Several mechanisms are considered: rotation of the myocardium around its axis, increase in pulmonary vascular resistance with overload of right ventricular pressure, disturbance of coronary blood flow on significant mediastinal compression with decrease in systolo-diastolic myocardial perfusion.

[Hypnosis rhythmology practice : Results of a French survey]. / Pratiques d'hypnose en rythmologie en France : résultats d'une enquête de pratique.

This survey evaluated hypnosis practice in French centres in June 2020. The survey was sent via email to different rhythmology centres in France and responses from cardiologists and nurses were obtained. We present here the preliminary results of this survey. Hypnosis was used on a regular basis in 7.5% of the centres and 13% of the participants received education on hypnosis. 75% of the participants were interested to have an education of hypnosis. The survey points the different possibilities of improvement of management of patients while having the different procedures.

Heart rate distribution in paced and non-paced patients with severe recurrent reflex syncope and tilt-induced asystole: Findings from the BIOSync CLS study.

BACKGROUND: Undiagnosed sinus or atrioventricular node dysfunction may bias estimation of the real efficacy of cardiac pacing in preventing vasovagal reflex syncope. We assessed this hypothesis in the BIOSync CLS trial which showed that dual-chamber pacing with closed loop stimulation (CLS) remarkably reduced recurrences of syncope. METHODS AND RESULTS: In the study patients aged 40 years or older with ≥2 episodes of loss of consciousness in the last year and an asystolic response to Tilt-Table test were randomized to pacing ON (DDD-CLS mode) or pacing OFF (ODO mode). We utilized the available pacemaker diagnostic data in a total of 103 patients (52 pacing ON, 51 pacing OFF) to generate cumulative distribution charts for heart rate (HR) and percentage of pacing. At 12 months, we did not find evidence of suspected sinus or atrioventricular node dysfunction. Beats were similarly distributed between groups (p = 0.96), with an average HR of 76 ± 8 bpm (pacing ON) versus 77 ± 7 bpm (pacing OFF). In the active group, the median percentage of atrial and ventricular pacing was 47% and 0%, respectively. Intolerance to high pacing rates was reported in only one patient (1.6%) and was easily resolved by reprogramming the maximum CLS pacing rate. CONCLUSIONS: We did not find evidence of suspected sinus or atrioventricular node dysfunction in the BIOSync CLS patients. The benefit of pacing should be ascribed to pacing prevention of pure vasovagal episodes. CLS algorithm modulated pacing rates over a wide frequency range, consistently competing with sinus node.

Focus on stereotactic radiotherapy: A new way to treat severe ventricular arrhythmias?

Ventricular tachycardia has a significant recurrence rate after ablation for several reasons, including inaccessible substrate. A non-invasive technique to ablate any defined areas of myocardium involved in arrhythmogenesis would be a potentially important therapeutic improvement if shown to be safe and effective. Early feasibility studies of single-fraction stereotactic body radiotherapy have demonstrated encouraging results, but rigorous evaluation and follow-up are required. In this document, the basic concepts of stereotactic body radiotherapy are summarized, before focusing on stereotactic arrhythmia radioablation. We describe the effect of radioablation on cardiac tissue and its interaction with intracardiac devices, depending on the dose. The different clinical studies on ventricular tachycardia radioablation are analysed, with a focus on target identification, which is the key feature of this approach. Our document ends with the indications and requirements for practicing this type of procedure in 2020. Finally, because of the limited number of patients treated so far, we encourage multicentre registries with long-term follow-up.

Prognostic significance of a low T/R ratio in Brugada syndrome.

OBJECTIVES: To determine the prognostic value of a low T/R ratio, defined as the amplitude ratio between the T waves and the R waves, in patients (pts) with a spontaneous type-1 Brugada pattern (SBT1). BACKGROUND: Abnormalities of myocardial repolarization may play a key role in the initiation of ventricular fibrillation (VF) in Brugada syndrome (BrS). Recent studies have shown that the height of the T waves and the T/R ratio are inversely proportional to sudden cardiac arrest (SCA) risk in early repolarization syndrome and hypertrophic cardiomyopathy. METHODS: In an international retrospective study, we reviewed 115 pts. (105 males, 91.3%). 45 had VF and/or SCA (38.7 ±â€¯11.5 years old, all males), while 70 (49.3 ±â€¯12.0 years, 10 women) remained free of ventricular arrhythmia. 6 ECG markers plus the T/R ratio in leads V5 & II were studied. RESULTS: The T/R ratio among leads II & V5 was significantly lower in the VF/SCA group (0.24 [0.14; 0.38]vs. 0.34 [0.24; 0.45]; p = 0.006). 44.4% of pts. in the VF/SCA group had a lowest T/R ratio among leads II & V5 ≤ 0.17 compared to 11.4% in the non-VF/SCA group (p < 0.001). In multivariate analysis, a lowest T/R ratio among leads II & V5 ≤ 0.17 was independently associated with VF/SCA (OR 6.10, 95% CI 1.92-19.40; p = 0.002). Type 1 Brugada pattern in the peripheral leads (OR 10.78) and early repolarization (OR 3.60) were other independent markers of VF/SCA. CONCLUSION: A low T/R ratio among leads II & V5 is an independent marker for VF/SCA risk in patients with type-1 Brugada pattern.

Joint Position Paper of the Working Group of Pacing and Electrophysiology of the French Society of Cardiology and the French Society of Diagnostic and Interventional Cardiac and Vascular Imaging on magnetic resonance imaging in patients with cardiac electronic implantable devices.

Magnetic resonance imaging (MRI) has become the reference imaging technique for the management of a large number of diseases. The number of MRI examinations increases every year, simultaneously with the number of patients receiving a cardiac electronic implantable device (CEID). The presence of a CEID was considered an absolute contraindication for MRI for many years. The progressive replacement of conventional pacemakers and defibrillators by "magnetic resonance (MR)-conditional" CEIDs and recent data on the safety of MRI in patients with "MR-non-conditional" CEIDs have gradually increased the demand for MRI in patients with a CEID. However, some risks are associated with MRI in CEID carriers, even with MR-conditional devices, because these devices are not "MR safe". Specific programming of the device in "MR mode" and monitoring patients during MRI remain mandatory for all patients with a CEID. A standardized patient workflow based on an institutional protocol should be established in each institution performing such examinations. This joint position paper of the Working Group of Pacing and Electrophysiology of the French Society of Cardiology and the French Society of Diagnostic and Interventional Cardiac and Vascular Imaging describes the effect of and risks associated with MRI in CEID carriers. We propose recommendations for patient workflow and monitoring and CEID programming in MR-conditional, "MR-conditional non-guaranteed" and MR-non-conditional devices.

Position paper concerning the competence, performance and environment required for the practice of ablation in children and in congenital heart disease.

The population of patients with congenital heart disease (CHD) is continuously increasing, and a significant proportion of these patients will experience arrhythmias because of the underlying congenital heart defect itself or as a consequence of interventional or surgical treatment. Arrhythmias are a leading cause of mortality, morbidity and impaired quality of life in adults with CHD. Arrhythmias may also occur in children with or without CHD. In light of the unique issues, challenges and considerations involved in managing arrhythmias in this growing, ageing and heterogeneous patient population and in children, it appears both timely and essential to critically appraise and synthesize optimal treatment strategies. The introduction of catheter ablation techniques has greatly improved the treatment of cardiac arrhythmias. However, catheter ablation in adults or children with CHD and in children without CHD is more technically demanding, potentially causing various complications, and thus requires a high level of expertise to maximize success rates and minimize complication rates. As French recommendations regarding required technical competence and equipment are lacking in this situation, the Working Group of Pacing and Electrophysiology of the French Society of Cardiology and the Affiliate Group of Paediatric and Adult Congenital Cardiology have decided to produce a common position paper compiled from expert opinions from cardiac electrophysiology and paediatric cardiology. The paper details the features of an interventional cardiac electrophysiology centre that are required for ablation procedures in adults with CHD and in children, the importance of being able to diagnose, monitor and manage complications associated with ablations in these patients and the supplemental hospital-based resources required, such as anaesthesia, surgical back-up, intensive care, haemodynamic assistance and imaging. Lastly, the need for quality evaluations and French registries of ablations in these populations is discussed. The purpose of this consensus statement is therefore to define optimal conditions for the delivery of invasive care regarding ablation of arrhythmias in adults with CHD and in children, and to provide expert and - when possible - evidence-based recommendations on best practice for catheter-based ablation procedures in these specific populations.

Radiation exposure during cardiac device implantation: Lessons learned from a multicenter registry.

BACKGROUND: Little data are available about radiation exposure during cardiac electrical device implantation, and no dose reference levels have been published. This multicenter, prospective, observational study assesses patient and staff radiation exposure during cardiac device implantations, and aims at defining dose reference levels. METHODS: Patient demographic, procedural, and radiation data were obtained for 657 procedures from nine institutions. Physician and staff exposure were measured using real-time dosimeters worn beneath and above lead apron. Statistical analysis included fluoroscopy time (FT), dose-area product (DAP), and DAP adjusted for FT and body mass index. RESULTS: Pacemakers and cardioverter defibrillators were implanted in 481 and 176 patients, respectively. Of these, 152 were treated with cardiac resynchronization therapy (CRT). Median FTs were 837s (interquartile range [IQR]: 480-1323), 117s (IQR: 69-209), and 101s (IQR: 58-162), and median DAPs were 1410 (IQR: 807-2601), 150 (IQR: 72-338), and 129 (IQR: 72-332) cGy.cm² for biventricular, dual chamber, and ventricular device implantation, respectively. Dose reference levels correspond to the third quartile values. During CRT, higher exposure was observed with four X-ray systems than with the two newer and customizable ones (adjusted DAP of 0.90 [IQR: 0.26-1.01] and 0.29 [IQR: 0.23-0.39], respectively; P < .001). CONCLUSION: Based on real-life measurements, this multicenter registry provides dose reference levels and may help centers assess radiation exposure. Although biventricular device implantation was responsible for the highest radiation exposure, FT was meaningfully shortened compared to previously reported values. For a same FT, the use of new generators and custom settings has significantly reduced DAP.

Prediction of ventricular arrhythmias in patients with a spontaneous Brugada type 1 pattern: the key is in the electrocardiogram.

AIMS: There is currently no reliable tool to quantify the risks of ventricular fibrillation or sudden cardiac arrest (VF/SCA) in patients with spontaneous Brugada type 1 pattern (BrT1). Previous studies showed that electrocardiographic (ECG) markers of depolarization or repolarization disorders might indicate elevated risk. We aimed to design a VF/SCA risk prediction model based on ECG analyses for adult patients with spontaneous BrT1. METHODS AND RESULTS: This retrospective multicentre international study analysed ECG data from 115 patients (mean age 45.1 ± 12.8 years, 105 males) with spontaneous BrT1. Of these, 45 patients had experienced VF/SCA and 70 patients did not experience VF/SCA. Among 10 ECG markers, a univariate analysis showed significant associations between VF/SCA and maximum corrected Tpeak-Tend intervals ≥100 ms in precordial leads (LMaxTpec) (P < 0.001), BrT1 in a peripheral lead (pT1) (P = 0.004), early repolarization in inferolateral leads (ER) (P < 0.001), and QRS duration ≥120 ms in lead V2 (P = 0.002). The Cox multivariate analysis revealed four predictors of VF/SCA: the LMaxTpec [hazard ratio (HR) 8.3, 95% confidence interval (CI) 2.4-28.5; P < 0.001], LMaxTpec + ER (HR 14.9, 95% CI 4.2-53.1; P < 0.001), LMaxTpec + pT1 (HR 17.2, 95% CI 4.1-72; P < 0.001), and LMaxTpec + pT1 + ER (HR 23.5, 95% CI 6-93; P < 0.001). Our multidimensional penalized spline model predicted the 1-year risk of VF/SCA, based on age and these markers. CONCLUSION: LMaxTpec and its association with pT1 and/or ER indicated elevated VF/SCA risk in adult patients with spontaneous BrT1. We successfully developed a simple risk prediction model based on age and these ECG markers.

Management of acute cardiac tamponade by direct autologous blood transfusion in interventional electrophysiology.

AIMS: Acute cardiac tamponade (ACT) is the most common life-threatening complication of interventional electrophysiology. Urgent drainage by percutaneous pericardiocentesis and anticoagulation reversal are required. Immediate direct transfusion of the blood volume aspirated from the pericardial space to the patient has been rarely described. This study was designed to assess the efficacy and safety of immediate direct autologous blood transfusion (AutoBT). METHODS: A retrospective case series of direct AutoBT performed for ACT was collected. Urgent drainage by percutaneous pericardiocentesis and immediate direct AutoBT were performed to achieve hemodynamic stabilization without a cell-saver system. RESULTS: Twenty-two electrophysiology centers were contacted to participate in the case series. Fourteen centers reported not to use direct AutoBT. Three centers reported using direct AutoBT with the cell-saver system. Fourteen cases of immediate direct AutoBT without cell-saver system were included from the five remaining centers. Electrophysiological procedures were performed for ventricular tachycardia (n = 5), atrial fibrillation (n = 5), atrial tachycardia (n = 2), left accessory pathway (n = 1), and premature ventricular contraction (n = 1) with transseptal (n = 9), retroaortic (n = 4), and/or epicardial access (n = 4). Pericardial drainage was performed by percutaneous pericardiocentesis for 13 patients and via the transseptal sheath for one patient. Surgical hemostasis was required for seven patients. The mean volume of autologous blood directly transfused was 1207 ± 963 mL. Direct AutoBT permitted to resume the procedure in four patients. No major complication related to the use of AutoBT occurred. CONCLUSION: Direct AutoBT without a cell-saver system is a feasible, safe, and useful technique for salvage therapy in ACT in interventional electrophysiology.

How is Contact Force implemented in routine clinical practice? Results from a French National and Monaco Survey.

BACKGROUND: Combination of elementary parameters (force, time, power, impedance drop) has been proposed to optimize radiofrequency (RF) delivery. They have been partially validated in clinical studies. AIMS: The aim of this study was to assess contact-force (CF) implementation into clinical practice. METHODS: A 36-question electronic form was sent to 105 electrophysiologists (EP) including some general questions concerning the practice of catheter atrial fibrillation ablation and items concerning the parameters used for CF-guided ablation. RESULTS: Answers from 98 EP were collected (93% response rate). The CF-catheters used were Smart Touch, Biosense (52%), Tacticath, Saint-Jude Medical (12%), or both (27%) and no CF (9%). The power applied on the left atrial (LA) anterior (LAAW) and posterior (LAPW) wall was, respectively, 26-34 W (for 73% of the EP) and below 25 W (88% of the EP). Forty percent of the Visitag® users mostly used the nominal parameters. Seventy-five percent of the users did not use automatic display of the impedance drop. For the Tacticath users, 57% used a target value of 400 gs on the LAAW and 300 to 400 gs on the LAPW. Lesion Size Index was exceptionally used. CONCLUSIONS: The parameters used for CF-guided ablation are widely variable among the different operators. Further prospective studies are needed to validate the targets for automatic annotation of the RF applications.