Publications by authors named "Pascal Defaye"

157 Publications

Impact of COVID-19 on the incidence of cardiac arrhythmias in implantable cardioverter defibrillator recipients followed by remote monitoring.

Arch Cardiovasc Dis 2021 May 24. Epub 2021 May 24.

Department of Cardiology and Vascular Diseases, CHU de Rennes, 35000 Rennes, France.

Background: The coronavirus disease 2019 (COVID-19) has been a fast-growing worldwide pandemic.

Aims: We aimed to investigate the incidence of cardiac arrhythmias among a large French cohort of implantable cardioverter defibrillator recipients over the first 5 months of 2020.

Methods: Five thousand nine hundred and fifty-four implantable cardioverter defibrillator recipients were followed by remote monitoring during the COVID-19 period (from 01 January to 31 May 2020). Data were obtained from automated remote follow-up of implantable cardioverter defibrillators utilizing the Implicity® platform. For all patients, the type of arrhythmia (atrial fibrillation, ventricular tachycardia or ventricular fibrillation), the number of ventricular arrhythmia episodes and the type of implantable cardioverter defibrillator-delivered therapy were recorded.

Results: A total of 472 (7.9%) patients presented 4917 ventricular arrhythmia events. An increase in ventricular arrhythmia incidence was observed after the first COVID-19 case in France, and especially during weeks #10 and #11, at the time of major governmental measures, with an increase in the incidence of antitachycardia pacing delivered therapy. During the 11 weeks before the lockdown order, the curve of the percentage of live-stream television coverage of COVID-19 information matched the ventricular arrhythmia incidence. During the lockdown, the incidence of ventricular arrhythmia decreased significantly compared with baseline (0.05±0.7 vs. 0.09±1.2 episodes per patient per week, respectively; P<0.001). Importantly, no correlation was observed between ventricular arrhythmia incidence and the curve of COVID-19 incidence. No changes were observed regarding atrial fibrillation/atrial tachycardia episodes over time.

Conclusions: An increase in ventricular arrhythmia incidence was observed in the 2 weeks before the lockdown order, at the time of major governmental measures. Ventricular arrhythmia incidence decreased dramatically during the lockdown.
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http://dx.doi.org/10.1016/j.acvd.2021.02.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141722PMC
May 2021

Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry.

Catheter Cardiovasc Interv 2021 May 29. Epub 2021 May 29.

Inserm, CIC 1430, Henri Mondor University Hospital, Creteil, France.

Objectives: The French left atrial appendage (LAA) closure registry (FLAAC) aimed to assess the safety and efficacy of LAA closure in daily practice.

Background: LAA closure has emerged as an alternative for preventing thromboembolic events (TE) in patients with non-valvular atrial fibrillation (NVAF). Clinical data in this field remains limited and few investigator-initiated, real-world registries have been reported.

Methods: This nationwide, prospective study was performed in 36 French centers. The primary endpoint was the TE rate after successful LAA closure.

Results: The FLAAC registry included 816 patients with a mean age of 75.5 ± 0.3 years, mean follow-up of 16.0 ± 0.3 months, high TE (CHA DS -VASc score: 4.6 ± 0.1) and bleeding risks (HAS-BLED score: 3.2 ± 0.05) and common contraindications to long-term anticoagulation (95.7%). Procedure or device-related serious adverse events occurred in 49 (6.0%) patients. The annual rate of ischemic stroke/systemic embolism was 3.3% (2.4-4.6). This suggests a relative 57% reduction compared to the risk of stroke in historical NVAF populations without antithrombotic therapy. By multivariate analysis, history of TE was the only factor associated with stroke/systemic embolism during follow-up (HR, 3.3 [1.58-6.89], p = 0.001). The annual mortality rate was 10.2% (8.4-12.3). Most of the deaths were due to comorbidities or underlying cardiovascular diseases and unrelated to the device or to TE.

Conclusions: Our study suggests that LAA closure can be an option in patients with NVAF. Long-term follow-up mortality was high, mostly due to comorbidities and underlying cardiovascular diseases, highlighting the importance of multidisciplinary management after LAA closure.

Registration: NCT02252861.
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http://dx.doi.org/10.1002/ccd.29795DOI Listing
May 2021

Impact of Pulmonary Valve Replacement on Ventricular Arrhythmias in Patients With Tetralogy of Fallot and Implantable Cardioverter-Defibrillator.

JACC Clin Electrophysiol 2021 Apr 21. Epub 2021 Apr 21.

Auxerre Hospital, Auxerre, France.

Objectives: This study aimed to assess the impact of pulmonary valve replacement (PVR) on ventricular arrhythmias burden in a population of tetralogy of Fallot (TOF) patients with continuous cardiac monitoring by implantable cardioverter-defibrillators (ICDs).

Background: Sudden cardiac death is a major cause of death in TOF, and right ventricular overload is commonly considered to be a potential trigger for ventricular arrhythmias.

Methods: Data were analyzed from a nationwide French ongoing study (DAI-T4F) including all TOF patients with an ICD since 2000. Survival data with recurrent events were used to compare the burden of appropriate ICD therapies before and after PVR in patients who underwent PVR over the study period.

Results: A total of 165 patients (mean age 42.2 ± 13.3 years, 70.1% male) were included from 40 centers. Over a median follow-up period of 6.8 (interquartile range: 2.5 to 11.4) years, 26 patients (15.8%) underwent PVR. Among those patients, 18 (69.2%) experienced at least 1 appropriate ICD therapy. When considering all ICD therapies delivered before (n = 62) and after (n = 16) PVR, the burden of appropriate ICD therapies was significantly lower after PVR (HR: 0.21; 95% confidence interval [CI]: 0.08 to 0.56; p = 0.002). Respective appropriate ICD therapies rates per 100 person-years were 44.0 (95% CI: 35.7 to 52.5) before and 13.2 (95% CI: 7.7 to 20.5) after PVR (p < 0.001). In the overall cohort, PVR before ICD implantation was also independently associated with a lower risk of appropriate ICD therapy in primary prevention patients (HR: 0.29 [95% CI: 0.10 to 0.89]; p = 0.031).

Conclusions: In this cohort of high-risk TOF patients implanted with an ICD, the burden of appropriate ICD therapies was significantly reduced after PVR. While optimal indications and timing for PVR are debated, these findings suggest the importance of considering ventricular arrhythmias in the overall decision-making process. (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator [DAI-T4F]; NCT03837574).
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http://dx.doi.org/10.1016/j.jacep.2021.02.022DOI Listing
April 2021

EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS).

Europace 2021 Apr 20. Epub 2021 Apr 20.

Department of Cardiology, Hospital Santa Marta, Rua Santa Marta, 1167-024 Lisbon, Portugal.

With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.
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http://dx.doi.org/10.1093/europace/euaa367DOI Listing
April 2021

Easily available ECG and echocardiographic parameters for prediction of left atrial remodeling and atrial fibrillation recurrence after pulmonary vein isolation: A multicenter study.

J Cardiovasc Electrophysiol 2021 Jun 5;32(6):1584-1593. Epub 2021 May 5.

Arrhythmia Unit, Department of Cardiology, Hospital Universitario Sant Pau, Barcelona, Spain.

Background: The assessment of noninvasive markers of left atrial (LA) low-voltage substrate (LVS) enables the identification of atrial fibrillation (AF) patients at risk for arrhythmia recurrence after pulmonary vein isolation (PVI).

Methods: In this prospective multicenter study, 292 consecutive AF patients (72% male, 62 ± 11 years, 65% persistent AF) underwent high-density LA voltage mapping in sinus rhythm. LA-LVS (<0.5 mV) was considered as significant at 2 cm  or above. Preprocedural clinical electrocardiogram and echocardiographic data were assessed to identify predictors of LA-LVS. The role of the identified LA-LVS markers in predicting 1-year arrhythmia freedom after PVI was assessed in 245 patients.

Results: Significant LA-LVS was identified in 123 (42%) patients. The amplified sinus P-wave duration (APWD) best predicted LA-LVS, with a 148-ms value providing the best-balanced sensitivity (0.81) and specificity (0.88). An APWD over 160 ms was associated with LA-LVS in 96% of patients, whereas an APWD under 145 ms in 15%. Remaining gray zones improved their accuracy by introduction of systolic pulmonary artery pressure (sPAP) of 35 mmHg or above, age, and sex. According to COX regression, the risk of arrhythmia recurrence 12 months following PVI was twofold and threefold higher in patients with APWD 145-160 and over 160 ms, compared to APWD under 145 ms. Integration of pulmonary hypertension further improved the outcome prediction in the intermediate APWD group: Patients with APWD 145-160 ms and normal sPAP had similar outcome than patients with APWD under 145 ms (hazard ratio [HR] 1.62, p = .14), whereas high sPAP implied worse outcome (HR 2.56, p < .001).

Conclusions: The APWD identifies LA-LVS and risk for arrhythmia recurrence after PVI. Our prediction model becomes optimized by means of integration of the pulmonary artery pressure.
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http://dx.doi.org/10.1111/jce.15013DOI Listing
June 2021

Leadless cardiac resynchronization therapy: a distant Utopia-Authors' reply.

Europace 2021 May;23(5):817-818

Department of Cardiology, Arrhythmias Unit, Grenoble University Hospital, CS 10217, 38043 Grenoble, France.

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http://dx.doi.org/10.1093/europace/euab058DOI Listing
May 2021

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

Arch Cardiovasc Dis 2021 Feb 19;114(2):140-149. Epub 2021 Jan 19.

Department of cardiology, Tours university hospital, 37000 Tours, France.

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.
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http://dx.doi.org/10.1016/j.acvd.2020.11.003DOI Listing
February 2021

European experience with a first totally leadless cardiac resynchronization therapy pacemaker system.

Europace 2021 May;23(5):740-747

Arrhythmias Unit, Department of Cardiology, Grenoble University Hospital, CS 10217, 38043 Grenoble Cedex 09, France.

Aims: Totally leadless cardiac resynchronization therapy (CRT) can be delivered with a combination of Micra and WiSE-CRT systems. We describe the technical feasibility and first insights into the safety and efficacy of this combination in European experience.

Methods And Results: Patients enrolled had indication for both Micra and WiSE-CRT systems because of heart failure related to high burden of pacing by a Micra necessitating system upgrade or inability to implant a conventional CRT system because of infectious or anatomical conditions. The endpoints of the study were technical success of WiSE-CRT implantation with right ventricle-synchonized CRT delivery, acute QRS duration reduction, and freedom from procedure-related major adverse events. All eight WiSE-CRT devices were able to detect the Micra pacing output and to be trained to deliver synchronous LV endocardial pacing. Acute QRS reduction following WiSE-CRT implantation was observed in all eight patients (mean QRS 204.38 ± 30.26 vs. 137.5 ± 24.75 mS, P = 0.012). Seven patients reached 6 months of follow-up. At 6 months after WiSE-CRT implantation, there was a significant increase in LV ejection fraction (28.43 ± 8.01% vs. 39.71 ± 11.89%; P = 0.018) but no evidence of LV reverse remodelling or improvement in New York Heart Association class.

Conclusion: The Micra and the WiSE-CRT systems can successfully operate together to deliver total leadless CRT to a patient. Moreover, the WiSE-CRT system provides the only means to upgrade the large population of Micra patients to CRT capability without replacing the Micra. The range of application of this combination could broaden in the future with the upcoming developments of leadless cardiac pacing.
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http://dx.doi.org/10.1093/europace/euaa342DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8139811PMC
May 2021

FRAGILE: FRench Attitude reGistry in case of ICD LEad replacement.

Europace 2021 Mar;23(3):389-394

CHU La Timone Marseille, France.

Aims: FRench Attitude reGistry in case of ICD LEad replacement (FRAGILE) registry was set-up to describe the attitude in different French institutions in case of implantable cardioverter-defibrillator (ICD) lead replacement, extraction, or abandonment and to compare outcomes in both groups.

Methods And Results: Prospective observational study comparing two attitudes in case of ICD lead replacement, extraction, or abandonment. Primary endpoint describes the attitude in different French centres, collect parameters that may influence the decision. Secondary endpoint compares early and mid-term (2 years) complications in both groups.Between April 2013 and April 2017, 552 patients were included in 32 centres. 434 (78.6%) were male, mean patient's age was 60.3 ± 14.4 years. In 56.9% of the cases, the decision was to explant the lead. Patients in the extraction group were younger than in the abandonment group (56.7 ± 14.5 vs. 65 ± 12.7 P < 0.0001) and less likely to have comorbidities (46.5% vs. 58.3% of the patients P = 0.022). The mean lead dwelling time was significantly longer in the abandonment group as compared with the extraction group (7.6 ± 3.9 vs. 5.2 ± 3.1 years, P < 0.0001). There was no statistical difference between both groups concerning early and 2 years complications.

Conclusion: In this registry, the strategy in case of non-infected ICD lead replacement was mainly influenced by patient's age and comorbidities and lead dwelling time. No difference was observed in outcomes in both strategies.
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http://dx.doi.org/10.1093/europace/euaa290DOI Listing
March 2021

Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study.

Europace 2021 Jan;23(1):73-81

Department of Cardiology, General Hospital of Cannes, 06150 Cannes, France.

Aims : We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability.

Methods And Results : Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37-97) days. Median daily wear time of WCD was 23.4 (22.2-23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95-0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%).

Conclusion: Our real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.
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http://dx.doi.org/10.1093/europace/euaa268DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7842091PMC
January 2021

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

J Electrocardiol 2020 Nov - Dec;63:6-11. Epub 2020 Sep 2.

Service de Rythmologie, Centre de Référence National des Troubles du Rythme Cardiaque d'Origine Héréditaire de Lyon, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Avenue du Doyen Jean Lépine, 69500 Bron, France; Université de Lyon, Lyon, France. Electronic address:

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 ± 11.5 years old, all males), while 70 (49.3 ± 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.
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http://dx.doi.org/10.1016/j.jelectrocard.2020.08.023DOI Listing
September 2020

Long-Term Follow-Up of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator: The DAI-T4F Nationwide Registry.

Circulation 2020 Oct 1;142(17):1612-1622. Epub 2020 Oct 1.

Annecy Hospital, France (D.I.).

Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce.

Methods: A Nationwide French Registry including all patients with tetralogy of Fallot with an ICD was initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event end point was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee.

Results: A total of 165 patients (mean age, 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (interquartile range) follow-up of 6.8 (2.5-11.4) years, 78 (47.3%) patients received at least 1 appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively; =0.03). Overall, 71 (43.0%) patients presented with at least 1 ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) patients in primary prevention, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with, respectively, 0, 1, 2, or ≥3 guidelines-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (hazard ratio, 3.47 [95% CI, 1.19-10.11]), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 (=0.006). Patients with congestive heart failure or reduced left ventricular ejection fraction had a higher risk of nonarrhythmic death or heart transplantation (hazard ratio, 11.01 [95% CI, 2.96-40.95]).

Conclusions: Patients with tetralogy of Fallot and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03837574.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.046745DOI Listing
October 2020

Quality indicators for the care and outcomes of adults with atrial fibrillation.

Europace 2021 Apr;23(4):494-495

First Department of Cardiology and Angiology, Silesian Centre for Heart Disease, Curie-Sklodowskiej Str 9, 41-800 Zabrze, Poland.

Aims: To develop quality indicators (QIs) that may be used to evaluate the quality of care and outcomes for adults with atrial fibrillation (AF).

Methods And Results: We followed the ESC methodology for QI development. This methodology involved (i) the identification of the domains of AF care for the diagnosis and management of AF (by a group of experts including members of the ESC Clinical Practice Guidelines Task Force for AF); (ii) the construction of candidate QIs (including a systematic review of the literature); and (iii) the selection of the final set of QIs (using a modified Delphi method). Six domains of care for the diagnosis and management of AF were identified: (i) Patient assessment (baseline and follow-up), (ii) Anticoagulation therapy, (iii) Rate control strategy, (iv) Rhythm control strategy, (v) Risk factor management, and (vi) Outcomes measures, including patient-reported outcome measures (PROMs). In total, 17 main and 17 secondary QIs, which covered all six domains of care for the diagnosis and management of AF, were selected. The outcome domain included measures on the consequences and treatment of AF, as well as PROMs.

Conclusion: This document defines six domains of AF care (patient assessment, anticoagulation, rate control, rhythm control, risk factor management, and outcomes), and provides 17 main and 17 secondary QIs for the diagnosis and management of AF. It is anticipated that implementation of these QIs will improve the quality of AF care.
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http://dx.doi.org/10.1093/europace/euaa253DOI Listing
April 2021

Atrial fibrillation detection by the subcutaneous defibrillator: real-world clinical performances and implications from a multicentre study.

Europace 2020 11;22(11):1628-1634

Department of Cardiology, Caen University Hospital, Normandie Univ, UniCaen, Avenue de la Côte de Nacre, F-14000 Caen, France.

Aims: No data exist concerning the clinical performances of the subcutaneous implantable cardioverter-defibrillator (S-ICD) atrial fibrillation (AF) detection algorithm. We aimed to study the performances and implications of the latter in a 'real-world' setting.

Methods And Results: Between July 2017 and August 2019, 155 consecutive S-ICD recipients were included. Endpoint of the study was the incidence of de novo or recurrent AF using a combined on-site and remote-monitoring follow-up approach. After a mean follow-up of 13 ± 8 months, 2531 AF alerts were generated for 55 patients. A blinded analysis of the 1950 subcutaneous electrocardiograms available was performed. Among them 47% were true AF, 23% were premature atrial contractions or non-sustained AF, 29% were premature ventricular contractions or non-sustained ventricular tachycardia, and 1% were misdetection. Fourteen percent (21/155) patients had at least one correct diagnosis of AF by the S-ICD algorithm. One patient presented symptomatic paroxysmal AF not diagnosed by the S-ICD algorithm (false negative patient). Patient-based sensitivity, specificity, positive, and negative predictive values were respectively 95%, 74%, 38%, and 99%. Among patients with at least one correct diagnosis of AF, 38% (8/21) had subsequent clinical implications (anticoagulation initiation or rhythm control therapies).

Conclusion: The S-ICD AF detection algorithm yields a high sensitivity for AF diagnosis. Low specificity and positive predictive value contribute to a high remote monitoring-notification workload and underline the necessity of a manual analysis. Atrial fibrillation diagnosis by the S-ICD AF detection algorithm might lead to significant therapeutic adjustments.
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http://dx.doi.org/10.1093/europace/euaa184DOI Listing
November 2020

Implantable cardiac defibrillator leads dysfunction after LVAD implantation.

Pacing Clin Electrophysiol 2020 11 24;43(11):1309-1317. Epub 2020 Jul 24.

Department of Cardiology and Cardiac Surgery, AP-HP CHU Henri Mondor, Créteil, France.

Background: Implantable cardioverter-defibrillator (ICD) lead dysfunction has been reported after left ventricular assist device (LVAD) implantation in limited single-center studies. We aimed at describing and characterizing the incidence of ICD lead parameters dysfunction after LVAD implantation.

Methods: Among the 652 patients enrolled in the ASSIST-ICD study, only patients with an ICD prior to LVAD were included (n = 401). ICD lead parameters dysfunction following LVAD implantation is defined as follows: (a) >50% decrease in sensing threshold, (b) pacing lead impedance increase/decrease by >100Ω, and (c) >50% increase in pacing threshold.

Results: One hundred twenty-two patients with an ICD prior to LVAD had available ICD interrogation reports prior and after LVAD. A total of 67 (55%) patients exhibited at least one significant lead dysfunction: 17 (15%) exhibited >50% decrease in right ventricular (RV) sensing, 51 (42%) had >100 Ω increase/decrease in RV pacing impedance, and 24 (20%) experienced >50% increase in RV pacing threshold. A total of 52 patients experienced ventricular arrhythmia during follow-up and all were successfully detected and treated by the device. All lead dysfunction could be managed conservatively.

Conclusion: More than 50% of LVAD-recipients may experience >1 significant change in lead parameters but none had severe clinical consequences.
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http://dx.doi.org/10.1111/pace.14004DOI Listing
November 2020

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.

Arch Cardiovasc Dis 2020 Jun - Jul;113(6-7):473-484. Epub 2020 May 27.

Clinique Pasteur, 31076 Toulouse, France.

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.
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http://dx.doi.org/10.1016/j.acvd.2020.03.015DOI Listing
September 2020

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

Arch Cardiovasc Dis 2020 Aug - Sep;113(8-9):492-502. Epub 2020 May 24.

Department of Cardiology, LIRYC Institute/Bordeaux University Hospital, 33600 Pessac, France.

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.
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http://dx.doi.org/10.1016/j.acvd.2020.02.002DOI Listing
September 2020

Subcutaneous implantable cardioverter defibrillator indication in prevention of sudden cardiac death in difficult clinical situations: A French expert position paper.

Arch Cardiovasc Dis 2020 May 22;113(5):359-366. Epub 2020 Apr 22.

Service de cardiologie, CHU de Rouen, 76000 Rouen, France.

The introduction of a new technology always raises questions about its place compared with the reference technology. The use of an implantable cardioverter defibrillator to prevent sudden cardiac death is now a widely proven technique, with a clear statement of its indication in the guidelines. More recently, a subcutaneous implantable cardioverter defibrillator has been introduced, and appears to be an attractive technique as it removes the need to implant a lead inside the right ventricle to treat the patient, which should dramatically decrease the risk of complications over time. Currently, only one model of subcutaneous implantable cardioverter defibrillator is available on the market; its indications are the same as for transvenous implantable cardioverter defibrillators, except for patients who need stimulation because of conduction disorders or ventricular tachycardias that can potentially be treated effectively by antitachycardia pacing. The different technical characteristics of transvenous versus subcutaneous implantable cardioverter defibrillators therefore raise the question of which to choose in different clinical settings. The experts who participated in the preparation of this manuscript had three meetings, organized by the company Boston Scientific. Each expert prepared the draft of a section corresponding to a clinical situation. The choice between transvenous versus subcutaneous implantable cardioverter defibrillator was then voted on by all the experts. The results of the votes are presented in this manuscript, as it seemed important to us to show the disparities of opinion that can exist in certain situations. The votes were cast independently and anonymously.
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http://dx.doi.org/10.1016/j.acvd.2020.03.011DOI Listing
May 2020

Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system.

Heart Rhythm 2020 08 9;17(8):1291-1297. Epub 2020 Mar 9.

Division of Imaging Sciences and Biomedical Engineering, King's College London, United Kingdom; Cardiology Department, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.

Background: Biventricular endocardial pacing (BiV ENDO) is a therapy for heart failure patients who cannot receive transvenous epicardial cardiac resynchronization therapy (CRT) or have not responded adequately to CRT. BiV ENDO CRT can be delivered by a new wireless LV ENDO pacing system (WiSE-CRT system; EBR Systems, Sunnyvale, CA), without the requirement for lifelong anticoagulation.

Objective: The purpose of this study was to assess the safety and efficacy of the WiSE-CRT system during real-world clinical use in an international registry.

Methods: Data were prospectively collected from 14 centers implanting the WiSE-CRT system as part of the WiCS-LV Post Market Surveillance Registry. (ClinicalTrials.gov Identifier: NCT02610673).

Results: Ninety patients from 14 European centers underwent implantation with the WiSE-CRT system. Patients were predominantly male, age 68.2 ± 10.5 years, left ventricular ejection fraction 30.6% ± 8.9%, mean QRS duration 180.7 ± 27.0 ms, and 40% with ischemic etiology. Successful implantation and delivery of BiV ENDO pacing was achieved in 94.4% of patients. Acute (<24 hours), 1- to 30-day, and 1- to 6-month complications rates were 4.4%, 18.8%, and 6.7%, respectively. Five deaths (5.6%) occurred within 6 months (3 procedure related). Seventy percent of patients had improvement in heart failure symptoms.

Conclusion: BiV ENDO pacing with the WiSE-CRT system seems to be technically feasible, with a high success rate. Three procedural deaths occurred during the study. Procedural complications mandate adequate operator training and implantation at centers with immediately available cardiothoracic and vascular surgical support.
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http://dx.doi.org/10.1016/j.hrthm.2020.03.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397503PMC
August 2020

Mortality during transvenous lead extraction: is there a difference between laser sheaths and rotating sheaths?

Europace 2020 06;22(6):989

Davidal Arrythmia Center, Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Israel.

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http://dx.doi.org/10.1093/europace/euaa032DOI Listing
June 2020

Impact of Type-2 Diabetes Mellitus on the Outcomes of Catheter Ablation of Atrial Fibrillation (European Observational Multicentre Study).

Am J Cardiol 2020 03 30;125(6):901-906. Epub 2019 Dec 30.

Clinic Pasteur of Toulouse, Toulouse, France.

Type-2 diabetes mellitus (DM) is associated with an increased risk of atrial fibrillation (AF). It is unclear whether DM is a risk factor for arrhythmia recurrence following catheter ablation of AF. We performed a nonrandomised, observational study in 7 high-volume European centres. A total of 2,504 patients who underwent catheter ablation of AF were included, and procedural outcomes were compared among patients with or without DM. Patients with DM (234) accounted for 9.3% of the sample, and were significantly older, had a higher BMI and suffered more frequently from persistent AF. Arrhythmia relapses at 12 months after AF ablation occurred more frequently in the DM group (32.0% vs 25.3%, p = 0.031). After adjusting for type of AF (i.e., paroxysmal vs persistent), during a median follow-up of 17 ± 16 months, atrial arrhythmia free-survival was lower in the diabetics with persistent AF (log-rank p = 0.003), and comparable for paroxysmal AF (log-rank p = 0.554). These results were confirmed in a propensity-matched analysis, and DM was also an independent predictor of AF recurrence on the multivariate analysis (hazard ratio 1.39; 95% confidence interval 1.07 to 1.88; p = 0.016). There was no significant difference in the rate of periprocedural complications among DM and non-DM patients (3.8% vs 6.3%, p = 0.128). Efficacy and safety of cryoballoon ablation were comparable to radiofrequency ablation in both DM and no-DM groups. In conclusion, catheter ablation of AF appears to be safe in patients with DM. However, DM is associated with higher rate of atrial arrhythmia relapse, particularly for patients with persistent AF.
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http://dx.doi.org/10.1016/j.amjcard.2019.12.037DOI Listing
March 2020

Factors influencing the use of leadless or transvenous pacemakers: results of the European Heart Rhythm Association Prospective Survey.

Europace 2020 04;22(4):667-673

School of Medicine, University of Belgrade, Belgrade, Serbia.

To study the proportion of leadless pacemaker (LL-PM) implants and the factors influencing the choice of LL-PM vs. transvenous pacemaker (TV-PM) across tertiary centres in Europe with routine availability of the LL-PM. A European Heart Rhythm Association (EHRA) prospective snapshot survey using electronically distributed questionnaire sent to participating centres. Participating tertiary cardiac pacing centres prospectively included consecutive patients implanted between November 2018 and January 2019. Questions covered standards of care and policies used for patient management, focusing particularly on the reasons for choosing LL-PM vs. TV-PM. Overall, 21 centres from four countries (France, Netherlands, Spain, and Italy) participated, with eventual data from 798 patients (n = 472, 59% male). With 69 implants, LL-PM represented only 9% of all implants and 36% of the single-chamber pacing group; double-chamber transvenous pacemakers were implanted in 528 patients and biventricular (cardiac resynchronization pacemaker) in 79. The two major reasons reported in favour of LL-PM implantation were an anticipated high risk of infection or low rate of ventricular pacing. Compared to TV-PM, LL-PM patients were more often male (74% vs. 54%, P = 0.009), with greater proportion of valvular heart disease (45% vs. 35%, P = 0.01) and atrial fibrillation (AF; 65% vs. 23%, P < 0.0001), with significantly more comorbidities (≥ one comorbidity, 66% vs. 52%, P = 0.02). This contemporary multicentre European survey shows that LL-PM constitutes a small proportion of all PM implants. Patients implanted with LL-PM were more likely to have AF and a high anticipated risk of infection.
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http://dx.doi.org/10.1093/europace/euz357DOI Listing
April 2020

A novel bimodal stethoscope for gastric collection of heart sounds: preliminary results.

Annu Int Conf IEEE Eng Med Biol Soc 2019 Jul;2019:4926-4929

Heart sound analysis is commonly used by physicians during auscultations to evaluate cardiac activity as a first line. These sounds originate from heartbeats and the resulting blood flow, and can provide important information about heart function and hemodynamics. The monitoring of heart sounds in patients suffering from chronic cardiac pathologies can be useful to detect or prevent cardiac events. For this purpose, a bimodal implanted gastric stethoscope was developed allowing home monitoring of electrophysiological and mechanical parameters.An in-vivo experiment in pigs was carried out to validate the feasibility of heart sound detection from an accelerometer embedded in a stethoscope prototype implanted in the submucosal layer of the gastric wall. Data recorded over several weeks validate the tolerance and the sensitivity of the device. These promising preliminary results confirm the interest of considering the stomach as a strategic implantation site for heart sound monitoring.
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http://dx.doi.org/10.1109/EMBC.2019.8857315DOI Listing
July 2019

Cryoablation for persistent and longstanding persistent atrial fibrillation: results from a multicentre European registry.

Europace 2020 03;22(3):375-381

Department of Arrhythmia Services, The Barts Heart Centre, St Bartholomew's Hospital, London, UK.

Aims: Although cryoballoon pulmonary vein isolation is a well-established treatment for paroxysmal atrial fibrillation (AF), it's role in persistent AF is unclear. We examined procedural success and long-term outcomes of cryoablation in persistent and longstanding persistent AF.

Methods And Results: International multicentre registry from three UK and eight European centres. Consecutive patients undergoing cryoablation for persistent AF included. Procedural data, complications, and follow-up were prospectively recorded. Patients were followed-up at 3, 6, and 12 months with an electrocardiogram with open access to arrhythmia nurses thereafter. Ambulatory monitoring was dictated by symptoms. Success was defined as freedom from AF or atrial tachycardia lasting >30 s off antiarrhythmic drugs (AADs). Six hundred and nine consecutive cryoablation procedures. Mean procedure and fluoroscopy times were 95 ± 65 and 13 ± 10 min. Single procedure success rates were 368/602 (61%) off AADs over a median of 2.4 (1.0-4.0) years. Arrhythmia-free survival off AADs was 64% and 57% for persistent and longstanding persistent AF at 24 months of follow-up (P = 0.02). Rate of repeat ablations was 20% in persistent and 32% in longstanding persistent AF (P = 0.006). Cox regression analyses showed a significant association between duration of AF and left atrial diameter and arrhythmia recurrence [hazard ratio (HR) 1.05, P-value 0.01 and HR 1.02, P-value 0.004].

Conclusion: Cryoablation for persistent AF is safe, fast and has good outcomes at long-term follow-up. Cryoablation is reasonable as a first line option for these patients. Short procedure times may help increase capacity of cardiac units to meet the rising demand for AF ablation. Randomised control trials are needed to compare outcomes with different techniques.
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http://dx.doi.org/10.1093/europace/euz313DOI Listing
March 2020

Early mortality after implantable cardioverter defibrillator: Incidence and associated factors.

Int J Cardiol 2020 02 30;301:114-118. Epub 2019 Oct 30.

AP-HP, CHU Bichat Claude Bernard and Université Paris Diderot, 75018, Paris, France. Electronic address:

Background: According to guidelines, implantable cardioverter defibrillator (ICD) candidates must have a "reasonable expectation of survival with a good functional status >1 year". Identifying risk for early mortality in ICD candidates could be challenging. We aimed to identify factors associated with a ≤1-year survival among patients implanted with ICDs.

Methods: The DAI-PP program was a multicenter, observational French study that included all patients who received a primary prevention ICD in the 2002-2012 period. Characteristics of patients who survived ≤1 year following the implantation were compared with those who survived >1 year, and predictors of early death determined.

Results: Out of the 5539 enrolled patients, survival status at 1 year was known for a total of 5,457, and overall 230 (4.2%) survived ≤1 year. Causes of death were similar in the two groups. Patients with ≤1-year survival had lower rates of appropriate (14 vs. 23%; P = 0.004) and inappropriate ICD therapies (2 vs. 7%; P = 0.009) than patients who lived >1 year after ICD implantation. In multivariate analysis, older age, higher NYHA class (≥III), and atrial fibrillation were significantly associated with ≤1-year survival. Presence of all 3 risk factors was associated with a cumulative 22.63% risk of death within 1 year after implantation.

Conclusions: This is the largest study determining the factors predicting early mortality after ICD implantation. Patients dying within the first year had low ICD therapy rates. A combination of clinical factors could potentially identify patients at risk for early mortality to help improve selection of ICD candidates.
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http://dx.doi.org/10.1016/j.ijcard.2019.09.033DOI Listing
February 2020

The European Society of Cardiology Cardiac Resynchronization Therapy Survey II: A comparison of cardiac resynchronization therapy implantation practice in Europe and France.

Arch Cardiovasc Dis 2019 Nov 6;112(11):713-722. Epub 2019 Nov 6.

Department of Cardiology and Vascular Diseases, CHU de Rennes, 2, rue Henri-Le-Guilloux, 35000 Rennes, France. Electronic address:

Background: The first European Cardiac Resynchronization Therapy (CRT) Survey, conducted in 2008-2009, showed considerable variations in guideline adherence and implantation practice. A second prospective survey (CRT Survey II) was then performed to describe contemporary clinical practice regarding CRT among 42 European countries.

Aim: To compare the characteristics of French CRT recipients with the overall European population of CRT Survey II.

Methods: Demographic and procedural data from French centres recruiting all consecutive patients undergoing either de novo CRT implantation or an upgrade to a CRT system were collected and compared with data from the European population.

Results: A total of 11,088 patients were enrolled in CRT Survey II, 754 of whom were recruited in France. French patients were older (44.7% aged≥75 years vs 31.1% in the European group), had less severe heart failure symptoms, a higher baseline left ventricular ejection fraction and fewer co-morbidities. Additionally, French patients had a shorter intrinsic QRS duration (19.1% had a QRS<130ms vs 12.3% in the European cohort). Successful implantation rates were similar, but procedural and fluoroscopy times were shorter in France. French patients were more likely to receive a CRT pacemaker than European patients overall. Of note, antibiotic prophylaxis was reported to be administered less frequently in France, and a higher rate of early device-related infection was observed. Importantly, French patients were less likely to receive optimal drugs for treating heart failure at hospital discharge.

Conclusion: This study highlights contemporary clinical practice in France, and describes substantial differences in patient selection, implantation procedure and outcomes compared with the other European countries participating in CRT Survey II.
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http://dx.doi.org/10.1016/j.acvd.2019.09.005DOI Listing
November 2019

Impact of Body Mass Index on the Outcomes of Catheter Ablation of Atrial Fibrillation: A European Observational Multicenter Study.

J Am Heart Assoc 2019 10 4;8(20):e012253. Epub 2019 Oct 4.

Clinic Pasteur of Toulouse Toulouse France.

Background Outcomes of catheter ablation of atrial fibrillation (AF) are variable and the predictors of success require further elucidation since the identification of correctable risk factors could help to optimize therapy. We aimed to assess the impact of body mass index (BMI) in the overall safety and efficacy of catheter ablation of AF, with emphasis on the use of cryoballoon ablation and novel oral anticoagulants. Methods and Results There were 2497 consecutive patients undergoing catheter ablation of AF in 7 European high volume centers were stratified according to BMI (normal weight <25 kg/m, pre-obese 25-30 kg/m, obesity 30-35 kg/m, and morbid obesity ≥35 kg/m) and comparisons of procedural outcomes evaluated. Pre-obese and obese patients presented more comorbidities (hypertension, diabetes mellitus, and sleep apnea), and had higher rates of non-paroxysmal AF ablation procedures. The rate of atrial 12-month arrhythmia relapse increased alongside with BMI (35.2%, 35.7%, 43.6%, and 48.0% <0.001). During a median follow-up of 18.8 months (interquartile range 11-28), after adjusting for all baseline differences, BMI was an independent predictor of relapse (hazard ratio=1.01 per kg/m; 95% CI 1.01-1.02; =0.002), adding incremental predictive value to obstructive sleep apnea. BMI was not a predictor for any of the reported complications. Using novel oral anticoagulants and cryoballoon ablation was safe and efficacy was comparable with vitamin-K antagonists and radiofrequency ablation. Conclusions Obese patients present with a more adverse comorbidity profile, more advanced forms of AF, and have lower chances of being free from AF relapse after ablation. Use of novel oral anticoagulants and cryoballoon ablation may be an option in this patient group.
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http://dx.doi.org/10.1161/JAHA.119.012253DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6818047PMC
October 2019