[Electrical storm in patients with Automatic Implantable Defibrillator : A single Center study]. / Orage rythmique chez les patients porteurs de défibrillateurs automatiques implantables : une expérience monocentrique.

BACKGROUND: Electrical storms (ES) are serious cardiac emergencies associated with increased short-term mortality. The true incidence of ES in patients with an implantable cardioverter defibrillator (ICD) is still difficult to estimate because of the heterogeneous definition. The clinical presentation is variable and its management is multidisciplinary. OBJECTIVE: The aim of the study was to analyze the epidemiological profile and evolution of a group of patients implanted with an ICD who had electrical storms detected by a home monitoring system. METHODS: This is a single-center retrospective observational study, which included 14 patients who were implanted with ICDs, for primary or secondary prevention between 2008 and 2021. All of them were followed by home monitoring. All these patients had an ES detected by home monitoring and authenticated by ECG. RESULTS: The mean age of the patients at the time of onset of the electrical storm was 75.4 ± 14.5 years, with extremes ranging from 49 to 101 years. Most of patients (n = 11) were male. The majority of them had underlying ischaemic cardiomyopathy (n = 12). In a third of cases (n = 5) patients were implanted for secondary prevention. The electrical storm was related to recurrent episodes of VT. No cases of VF were detected. Syncope was the most frequent clinical presentation (four patients). Nine patients received internal shocks, with an average of four shocks per patient. The triggering factor was myocardial ischaemia in four cases. Majority of patients were managed in the cardiac intensive care unit. Two patients were admitted to the intensive care unit. In addition to anti-arrhythmic treatment with amiodarone and beta blockers. Nine patients underwent ablation of ventricular tachycardia focus. Mortality was high (in half of the cases) mainly due to a cardiogenic shock. CONCLUSION: This study shows that OR remain rare, but are still associated with high mortality. Home monitoring makes it possible to manage them earlier.

[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.

Perceptions and satisfaction of patients with chronic heart failure when using a remote monitoring web application named Satelia® Cardio.

INTRODUCTION: The use of telehealth, such as remote patient monitoring (RPM), for chronic heart failure (CHF) impacts patient pathways. Patient-centricity in chronic disease management is valuable. Even though RPM is recommended in practice, the evaluation of patient satisfaction has been limited to date. The objective of this study was to assess the perceptions and satisfaction of patients with CHF when using RPM. METHODS: A voluntary declarative survey was conducted with users of Satelia® Cardio, an RPM web application which was included in an experimental model program in France funded by the ETAPES program initiative sponsored by the French Ministry of Health. Monitoring was based on patient-reported outcomes (seven questions on symptoms, one question on weight) which were answered online (digitally literate patients) or by phone with a nurse (patients with poor digital literacy). The survey included questions on perceived usefulness, ease of use and impact on quality of life (QoL). RESULTS: Overall, 87% of the 825 patients were satisfied with having their CHF digitally monitored. Patients found that the application was easy to use (94%), problem free (95%), provided well-timed notifications (98%), easily accessible (96.5%), understandable (89%), and did not require an unreasonable amount of time to answer questions (99%). Most patients felt that RPM helped physicians provide better care during their follow-ups (70%, mean score: 7.98/10) and 45% of the digitally literate patients indicated an improved QoL. CONCLUSION: Poor digitally literate patients may need human-based or assisted RPM. Patients monitored daily for CHF through RPM expressed strong satisfaction and acceptance.

Impact of peri-procedural management of direct oral anticoagulants on pocket haematoma after cardiac electronic device implantation: the StimAOD multicentre prospective study.

AIMS: The study aims to investigate the impact of direct oral anticoagulant (DOAC) management on the incidence of pocket haematoma in patients undergoing pacemaker or implantable cardioverter-defibrillator implantation. METHODS AND RESULTS: All consecutive patients receiving DOAC and undergoing cardiac electronic device implantation were included in a large multicentre prospective observational study (NCT03879473). The primary endpoint was clinically relevant haematoma within 30 days after implantation. Overall, 789 patients were enrolled [median age 80 (IQR 72-85) years old, 36.4% women, median CHA2DS2-VASc score 4 (IQR 0-8)], of which 632 (80.1%) received a pacemaker implantation. Antiplatelet therapy was combined with DOAC in 146 patients (18.5%). Direct oral anticoagulants (DOACs) were interrupted 52 (IQR 37-62) h before the procedure and resumed 31 (IQR 21-47) h later. Ninety-six percent of the patients had at least 12 h DOAC interruption before the procedure, and 78% had at least 12 h DOAC interruption after the procedure. Overall, anticoagulation was interrupted for 72 (IQR 48-96) h. Pre- or post-procedural heparin bridging was used in 8.2% and 3.9%, respectively. Timing of DOAC interruption of resumption was not associated with clinically relevant haematoma. Clinically relevant haematoma occurred in 26 patients (3.3%), and thromboembolic events occurred in 5 patients (0.6%). CONCLUSION: In this large real-life registry where most patients had DOAC interruption, clinically relevant haematoma was rare. Despite DOAC interruption and high CHA2DS2-VASc score, thromboembolic events occurred seldomly, highlighting that bleeding exceeds thromboembolic risk in this peri-procedural period. Future research is needed to identify risk factors for clinically relevant haematoma and meaningfully guide clinicians in optimizing DOAC management.

[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.

[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.

The Importance of Appropriate Dosing of Nonvitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients with Atrial Fibrillation.

Preventing thromboembolic events, while minimizing bleeding risks, remains challenging when managing patients with atrial fibrillation (AF). Several factors contribute to current dosing patterns of nonvitamin K antagonist oral anticoagulants (NOACs), including patient characteristics, comorbidities, and physician judgment. Application of NOAC doses inconsistent with the drug labels may cause patients to receive either subtherapeutic (increasing stroke risk) or supratherapeutic (increasing bleeding risk) anticoagulant levels. In clinical practice, under- or over-dosing of NOACs in patients with AF is not uncommon. This analysis of prospective and retrospective registry and database studies on NOAC use in patients with AF (with at least 250 patients in each treatment arm) showed that under-dosing may be associated with reduced effectiveness for stroke prevention, with similar or even increased bleeding than with the standard dose. This may reflect underlying conditions and patient factors that increase bleeding despite NOAC dose reduction. Such factors could drive the observed overuse of reduced NOAC dosages, often making the prescription of reduced-dose NOAC an intentional label deviation. In contrast, over-dosing more likely occurs accidentally; instead of providing benefits, it may be associated with worse safety outcomes than the standard dose, including increased bleeding risk and higher all-cause mortality rates. This review summarizes the main findings on NOAC doses usually prescribed to patients with AF in clinical practice.

Lack of efficacy of hydroxychloroquine and azithromycin in patients hospitalized for COVID-19 pneumonia: A retrospective study.

BACKGROUND: Hydroxychloroquine combined with azithromycin (HCQ/AZI) has initially been used against coronavirus disease-2019 (COVID-19). In this retrospective study, we assessed the clinical effects of HCQ/AZI, with a 28-days follow-up. METHODS: In a registry-study which included patients hospitalized for COVID-19 between March 15 and April 2, 2020, we compared patients who received HCQ/AZI to those who did not, regarding a composite outcome of mortality and mechanical ventilation with a 28-days follow-up. QT was monitored for patients treated with HCQ/AZI. Were excluded patients in intensive care units, palliative care and ventilated within 24 hours of admission. Three analyses were performed to adjust for selection bias: propensity score matching, multivariable survival, and inverse probability score weighting (IPSW) analyses. RESULTS: Overall, 203 patients were included: 60 patients treated by HCQ/AZI and 143 control patients. During the 28-days follow-up, 32 (16.3%) patients presented the primary outcome and 23 (12.3%) patients died. Propensity-score matching identified 52 unique pairs of patients with similar characteristics. In the matched cohort (n = 104), HCQ/AZI was not associated with the primary composite outcome (log-rank p-value = 0.16). In the overall cohort (n = 203), survival and IPSW analyses also found no benefit from HCQ/AZI. In the HCQ/AZI group, 11 (18.3%) patients prolonged QT interval duration, requiring treatment cessation. CONCLUSIONS: HCQ/AZI combination therapy was not associated with lower in-hospital mortality and mechanical ventilation rate, with a 28-days follow-up. In the HCQ/AZI group, 18.3% of patients presented a prolonged QT interval requiring treatment cessation, however, control group was not monitored for this adverse event, making comparison impossible.

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.

Early Detection and Treatment of Atrial Arrhythmias Alleviates the Arrhythmic Burden in Paced Patients: The SETAM Study.

BACKGROUND: Remote monitoring (RM) can remotely detect atrial tachyarrhythmias (ATAs). The benefit of RM compared to conventional follow-up in the detection and management of ATA was assessed in recipients of dual-chamber pacemakers. METHODS: The multicenter randomized SETAM study enrolled 595 patients in sinus rhythm with a CHA2 DS2 -VASc score ≥2, without ATA history and untreated with antiarrhythmics and antithrombotics, randomly assigned to RM (RM-ON; n = 291) versus ambulatory follow-up (RM-OFF; n = 304) during 12.8 ± 3.3 months. ATA occurrence, burden, and management were analyzed together with adverse clinical events. RESULTS: Patients were 79 ± 8 years old, 63% men, with a CHA2 DS2 -VASc score of 3.7± 1.2. ATA were detected in 83 patients (28%) in the RM-ON versus 66 (22%) in the RM-OFF group (P = 0.06). The median time between the pacemaker implantation and the first treated ATA was 114 days [44; 241] in the RM-ON versus 224 days [67; 366] in the RM-OFF group (hazard ratio [HR] = 0.56; 95% confidence interval [CI]: 0.37-0.86; P = 0.01). Therapies for ATA were initiated in 92 patients and the time to treatment of ATA was shortened by 44% in the RM-ON group (HR = 0.565; 95% CI: 0.37-0.86; P = 0.01). Over the last 4 months of follow-up, the mean ATA burden was alleviated by 4 hours/day (18%) in the RM-ON group. The rate of adverse clinical events was similar in both groups. CONCLUSION: Remotely monitored patients were diagnosed and treated earlier for ATA, and subsequently had a lower ATA burden.

Perioperative management of antithrombotic treatment during implantation or revision of cardiac implantable electronic devices: the European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI).

The European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI) was a prospective European survey of consecutive adults who had undergone implantation/surgical revision of a cardiac implantable electronic device (CIED) on chronic antithrombotic therapy (enrolment March-June 2015). The aim of the survey was to investigate perioperative treatment with oral anticoagulants and antiplatelets in CIED implantation or surgical revision and to determine the incidence of complications, including clinically significant pocket haematomas. Information on antithrombotic therapy before and after surgery and bleeding and thromboembolic complications occurring after the intervention was collected at first follow-up. The study population comprised 723 patients (66.7% men, 76.9% aged ≥66 years). Antithrombotic treatment was continued during surgery in 489 (67.6%) patients; 6 (0.8%) had their treatment definitively stopped; 46 (6.4%) were switched to another antithrombotic therapy. Heparin bridging was used in 55 out of 154 (35.8%) patients when interrupting vitamin K antagonist (VKA) treatment. Non-vitamin K oral anticoagulant (NOAC) treatment was interrupted in 88.7% of patients, with heparin bridging in 25.6%, but accounted for only 25.3% of the oral anticoagulants used. A total of 108 complications were observed in 98 patients. No intracranial haemorrhage or embolic events were observed. Chronic NOAC treatment before surgery was associated with lower rates of minor pocket haematoma (1.4%; P= 0.042) vs. dual antiplatelet therapy (13.0%), VKA (11.4%), VKA + antiplatelet (9.2%), or NOAC + antiplatelet (7.7%). Similar results were observed for bleeding complications (P= 0.028). Perioperative management of patients undergoing CIED implantation/surgical revision while on chronic antithrombotic therapy varies, with evidence of a disparity between guideline recommendations and practice patterns in Europe. Haemorrhagic complications were significantly less frequent in patients treated with NOACs. Despite this, the incidence of severe pocket haematomas was low.

Differences in attitude, education, and knowledge about oral anticoagulation therapy among patients with atrial fibrillation in Europe: result of a self-assessment patient survey conducted by the European Heart Rhythm Association.

The purpose of this patient survey was to analyse the knowledge about blood thinning medications relative to gender, age, education, and region of residence in patients with atrial fibrillation (AF). A total of 1147 patients with AF [mean age 66 ± 13 years, 529 (45%) women] from eight European countries responded to this survey. Most patients understood that the indication for anticoagulation therapy was to 'thin the blood', but 8.1% responded that the purpose of the medication was to treat the arrhythmia. Patients with college or university grades reported less frequent deviations from their target INR range compared with those without schooling (2.8% vs. 5.1%, P < 0.05). The awareness of anticoagulation-related risk of bleedings was lowest in patients without schooling (38.5%) and highest in those with college and university education (57.0%), P < 0.05. The same pattern was also observed regarding patient's awareness of non-vitamin K antagonist oral anticoagulants (NOACs): 56.5% of the patients with university education and only 20.5% of those without schooling (P < 0.05) knew about NOACs, indicating that information about new anticoagulation therapies remains well below the target. Bleeding events were statistically less frequent in patients on NOACs compared with vitamin K antagonists. The education level and patients' knowledge have a direct influence on the global management of the anticoagulation.

Benefits of once-daily dosing with non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation.

Atrial fibrillation (AF) is the most prevalent clinically relevant arrhythmia, affecting millions of individuals in Europe and the USA. Atrial fibrillation increases the risk of stroke; the long-term standard of care for prevention of AF-related stroke is anticoagulation. The use of anticoagulants should be based on the absolute risks of stroke and bleeding and the relative benefit-risk profile of the individual patient. Treatment options include vitamin K antagonists (VKAs) such as warfarin, whose use is long-established but associated with drawbacks, including regular coagulation monitoring requirements and many food and drug interactions. The non-VKA oral anticoagulants are gaining widespread use as alternatives to VKAs, and are supported in treatment guidelines for patients with AF at moderate to high risk of stroke. Adherence to medication is important for the long-term efficacy of any therapy; however, relatively low levels of medication adherence are to be expected in 'real-world' AF patients compared with clinical trials. Experience across several therapy areas, including cardiovascular disease, shows that poor adherence to chronic medication is common. However, simple dosing schedules may be advantageous in this respect, and because long-term outcomes in AF are likely to be influenced by adherence, once-daily dosing has the potential to improve rates of stroke prevention in patients with AF.

Once-daily rivaroxaban for long-term stroke prevention in patients with atrial fibrillation.

Oral anticoagulation is the long-term standard of care for preventing stroke in patients with atrial fibrillation (AF). However, anticoagulation is associated with an increased risk of bleeding, such that its use should be based on the absolute risks of stroke and bleeding, and the relative benefit-risk profile of the individual patient. Non-vitamin K antagonist oral anticoagulants, including rivaroxaban, are alternatives to vitamin K antagonists such as warfarin in this setting, and are supported in treatment guidelines as the optimal choice for patients with AF at moderate to high risk of stroke. Rivaroxaban can be given in fixed doses without routine coagulation monitoring, and phase III studies have demonstrated its safety profile and efficacy in patients with non-valvular AF, including the elderly and those with co-morbidities. Moreover, rivaroxaban is administered once daily, which has advantages for optimal patient adherence to medication over the long term. The established efficacy and safety profile of rivaroxaban, together with its convenient once-daily dosing schedule, may contribute to improved patient outcomes and lead to sustained benefits for patients with non-valvular AF at risk of stroke.

Patients' attitude and knowledge about oral anticoagulation therapy: results of a self-assessment survey in patients with atrial fibrillation conducted by the European Heart Rhythm Association.

The purpose of this European Heart Rhythm Association survey was to assess the attitude, level of education, and knowledge concerning oral anticoagulants (OACs) among patients with atrial fibrillation (AF) taking vitamin K antagonists (VKAs), non-VKA oral anticoagulants (NOACs) or antiplatelets. A total of 1147 patients with AF [mean age 66 ± 13 years, 529 (45%) women] from 8 selected European countries responded to this survey. The overall use of OACs and antiplatelets was 77 and 15.3%, respectively. Of the patients taking OACs, 67% were on VKAs, 33% on NOACs, and 17.9% on a combination of OACs and antiplatelets. Among patients on VKAs, 91% correctly stated the target international normalized ratio (INR) level. The proportion of patients on VKA medication who were aware that monthly INR monitoring was required for this treatment and the proportion of patients on NOAC who knew that renal function monitoring at least annually was mandatory for NOACs was 76 and 21%, respectively. An indirect estimation of compliance indicated that 14.5% of patients temporarily discontinued the treatment, and 26.5% of patients reported having missed at least one dose. The survey shows that there is room for improvement regarding education and adherence of patients taking OACs, particularly regarding monitoring requirements for NOACs.

New oral anticoagulants in patients undergoing atrial flutter radiofrequency catheter ablation: an observational study.

AIM: Atrial flutter (AFL) ablation requires optimal periprocedural anticoagulation in order to minimize thromboembolic events/bleeding risk. This study describes the characteristics of patients receiving new oral anticoagulants before AFL ablation and assesses complications. METHODS: This multicenter, retrospective study reports ischemic and hemorrhagic predischarge, postprocedural complications. RESULTS: We evaluated 60 patients (62.3% male; mean age: 69.2 ± 9.7 years; CHA2DS2-VASc score: 2.44 ± 1.46, HAS-BLED score: 1.14 ± 0.7). Twenty-one (35.0%) and 23 patients (38.3%) received twice-daily dabigatran 110 or 150 mg; 16 patients (26.6%) received once-daily rivaroxaban (15 mg [n = 5] or 20 mg [n = 11]). Four cases of postprocedural minor bleeding were reported. CONCLUSION: This is the first study assessing new oral anticoagulants for periprocedural anticoagulation, specifically in patients undergoing AFL ablation. No major bleeding was reported. Further prospective investigation is warranted.

Role of patient education in the perception and acceptance of home monitoring after recent implantation of cardioverter defibrillators: the EDUCAT study.

BACKGROUND: Much attention is being paid to the education of and provision of medical information to patients, to optimize their understanding and acceptance of their disease. AIMS: To ascertain the impact of educating recent recipients of an implantable cardioverter defibrillator (ICD) on their perception and acceptance of a home monitoring (HM) system. METHODS: Questionnaire 1, completed one month after ICD implantation, was designed to assess: the quality of patient preparation for HM; patient comprehension of HM; and patient anxiety experienced during its installation. The comprehension questions were assigned a score of -2 for an incorrect answer, +1 for a correct answer and 0 for neither (total score ranging from -40 to +20). Questionnaire 2, completed six months after ICD implantation, assessed patient acceptance of and anxiety about HM. RESULTS: The registry included 571 patients (mean age 63.9±12.8 years; 83% men; 76% of ICDs implanted for primary prevention) followed by HM for 6.2±1.2 months. Questionnaire 1 was completed by 430 (75.3%) patients and questionnaire 2 by 398 (69.7%) patients. Younger patients had a better comprehension of HM than older patients. High-quality training conditions improved the comprehension score, and a positive association was observed between anxiety and acceptance levels and the comprehension score. The 80±20% mean data transmission rate (days of transmission/days of follow-up ratio) was unrelated to the comprehension scores. CONCLUSION: A clear understanding was associated with a higher acceptance of HM, although it was unrelated to the data transmission rate.