Publications by authors named "Rodrigue Garcia"

48 Publications

The use of social media for professional purposes by healthcare professionals: the #intEHRAct survey.

Europace 2021 Oct 9. Epub 2021 Oct 9.

Hannover Heart Rhythm Center, Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.

Social media (SoMe) represents a medium of communication in everyday life and has gained importance for professional use among clinicians. In the #intEHRAct survey, we aimed to describe the use of SoMe by the healthcare community in a professional setting. The EHRA e-Communication Committee and the Scientific Initiatives Committee prepared a questionnaire and distributed it via newsletters, Twitter, LinkedIn, and Facebook. The survey consisted of 19 questions made on an individual basis and collected anonymously. Two hundred and eighty-five responders from 35 countries (72.3% male, age 49 ± 11 years old) completed the survey. Most respondents (42.7%) declared to use SoMe as passive users while 38.3% and 19.0% declared to share content on a non-daily and daily basis, respectively. The respondents estimated they spent a median of 5 (Q1-Q3: 2-10) h per week on SoMe. The most widely used SoMe was LinkedIn (60.8%), but the use of each platform was heterogeneous between countries. Among the advantages of SoMe, respondents indicated the chance of being updated on recent publications (66.0%), networking (48.5%), and the availability of rare or interesting cases (47.9%) as the most useful. Regarding the disadvantages of SoMe, the respondents underlined the loss of personal contact (40.7%), the inability to get 'hands-on' training (38.7%), and the lack of control regarding quality of scientific evidence (37.1%). Social media is increasingly used for professional purposes for scientific updating, networking, and case-based learning. The results of this survey encourage scientific societies, journals, and authors to enhance the quality, reach and impact of scientific content provided through SoMe.
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http://dx.doi.org/10.1093/europace/euab244DOI Listing
October 2021

Independent factors of low radiation dose during atrial fibrillation ablation with cryoballoon or radiofrequency: Results from the "Go for zero fluoroscopy" registry.

Pacing Clin Electrophysiol 2021 Sep 26. Epub 2021 Sep 26.

Rhythmology Department, Helios Clinic Koethen, Koethen, Germany.

Aims: Atrial fibrillation (AF) catheter ablation is a common procedure requiring in most cases the use of fluoroscopy. We aimed to evaluate the factors associated with a lower dose of fluoroscopy used during AF ablation with cryoballoon or radiofrequency.

Methods: In this prospective European registry, centers were requested to provide procedural characteristics of consecutive AF ablation cases. Lower doses of fluoroscopy were defined as those with dose-area-product (DAP) under the median dose used in the radiofrequency and the cryoballoon ablation groups.

Results: A total of 638 AF ablation procedures were collected (n = 492 for radiofrequency and n = 146 for cryoballoon ablation groups) in 25 centers. The median [IQR] DAP were 926 [349;2092] and 1516 [418;3408] cGy*cm in the radiofrequency and cryoballoon groups, respectively. Main factors associated with lower DAP in cryoballoon ablation group were electrophysiology dedicated laboratory (OR 6.04, 95%CI 1.16-31.54; P = .03) and frequent dosimetry report (OR 21.39, 95%CI 5.43-98.54; P = .03). Main factors associated with lower DAP in the radiofrequency ablation group were the use of a chest dosimeter (OR 12.57, 95% CI 2.88-54.90; P = .01), biplane X-ray equipment (OR 3.12, 95%CI 1.89-5.16; P < .01), university hospital (OR 2.10, 95%CI 1.35-3.25; P = .01), electrophysiology dedicated laboratory (OR 2.45, 95%CI 1.48-4.05; P < .01) and use of contact force enabled catheter (OR 22.60, 95%CI 6.82-74.88; P < .01).

Conclusion: This real-life study of fluoroscopy use during AF ablation provides new data about current practices across European countries. Technological advances and quality of the fluoroscopic environment were the main factors associated with lower radiation dose during AF ablation.
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http://dx.doi.org/10.1111/pace.14366DOI Listing
September 2021

Worldwide sedation strategies for atrial fibrillation ablation: current status and evolution over the last decade.

Europace 2021 Jul 19. Epub 2021 Jul 19.

Department of Cardiology and Angiology, Hannover Heart Rhythm Center, Hannover Medical School, Hannover, Germany.

Catheter ablation for atrial fibrillation (AF) has become one of the most common procedures in the electrophysiology lab with rapidly increasing volumes. Peri-procedural anaesthesia for AF ablation varies between centres, from general anaesthesia to deep or conscious sedation. The aim of this survey was to assess current sedation practices for AF ablation worldwide and its evolution over the last decade. Centres regularly performing AF ablation responded to an online survey. A total of 297 centres participated in the survey. Overall, the median (interquartile range) number of AF ablation procedures increased from 91 (43-200) to 200 (74-350) per year (P < 0.001) between 2010 and 2019. The proportion of cryoablation also increased from 17.0% to 33.2% (P < 0.001). In 2019, the most used sedation technique was general anaesthesia (40.5%), followed by conscious sedation (32.0%) and deep sedation (27.5%). Between 2010 and 2019, the proportion of procedures performed under general anaesthesia (+4.4%; P = 0.02) and deep sedation (+4.8%; P < 0.01) increased, whereas the use of conscious sedation decreased (-9.2%; P < 0.001). The most commonly used hypnotic drugs were propofol and midazolam, whereas the most commonly used opioid drugs were remifentanyl and fentanyl. This worldwide survey shows that the number of AF ablation procedures has more than doubled over the last decade and general anaesthesia remains most commonly used. Studies comparing outcomes between different sedation strategies are needed to guide optimal decision-making.
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http://dx.doi.org/10.1093/europace/euab154DOI Listing
July 2021

Radiation Safety and Electrophysiologists: Radiation Protection Status - Go for Zero Fluoroscopy European Heart Rhythm Association Registry.

Cardiology 2021 2;146(5):600-606. Epub 2021 Jul 2.

1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

Background: The purpose of this study was to analyze electrophysiologists' radiation-protective devices for occupational exposure across European countries.

Methods: Data reported herein were gathered from the international, multicenter prospective Go for Zero Fluoroscopy registry performed in years 2018-2019. The registry encompassed 25 European electrophysiological centers from 14 countries and up to 5 operators from each center.

Results: The analysis included 95 operators (median age: 39 years, 85% of male, median training time: 5 years). The most frequently used X-ray protection tools (used by ≥80% of the group) were lead aprons, thyroid shields, screens below the table, glass in the laboratory, and least often (<7%) protective gloves and cabin. No statistically significant differences regarding the number of procedures performed monthly, electrophysiologists' experience and gender, and radiation exposure dose or radiation protection tools were observed, except lead thyroid shields and eyeglasses, which were more often used in case of fewer electrophysiological procedures performed (<20 procedures per month). Operators who were protected by >4 X-ray protection tools were exposed to lower radiation levels than those who were protected by ≤4 X-ray protection tools (median radiation exposure: 0.6 [0.2-1.1] vs. 0.2 [0.1-0.2] mSv per month, p < 0.0001; 1.1 [0.1-12.0] vs. 0.5 [0.1-1.1] mSv per year, p < 0.0001), respectively.

Conclusions: Electrophysiologists' radiation-protective devices for occupational exposure are similar across European centers and in accordance with the applicable X-ray protection protocols, irrespective of the level of experience, number of monthly performed EP procedures, and gender.
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http://dx.doi.org/10.1159/000517000DOI Listing
July 2021

Virtual Reality for Sedation During Atrial Fibrillation Ablation in Clinical Practice: Observational Study.

J Med Internet Res 2021 05 27;23(5):e26349. Epub 2021 May 27.

Department of Anesthesia and Critical Care, University Hospital of Poitiers, Poitiers, France.

Background: Connected devices are dramatically changing many aspects in health care. One such device, the virtual reality (VR) headset, has recently been shown to improve analgesia in a small sample of patients undergoing transcatheter aortic valve implantation.

Objective: We aimed to investigate the feasibility and effectiveness of VR in patients undergoing atrial fibrillation (AF) ablation under conscious sedation.

Methods: All patients who underwent an AF ablation with VR from March to May 2020 were included. Patients were compared to a consecutive cohort of patients who underwent AF ablation in the 3 months prior to the study. Primary efficacy was assessed by using a visual analog scale, summarizing the overall pain experienced during the ablation.

Results: The AF cryoablation procedure with VR was performed for 48 patients (mean age 63.0, SD 10.9 years; n=16, 33.3% females). No patient refused to use the device, although 14.6% (n=7) terminated the VR session prematurely. Preparation of the VR headset took on average 78 (SD 13) seconds. Compared to the control group, the mean perceived pain, assessed with the visual analog scale, was lower in the VR group (3.5 [SD 1.5] vs 4.3 [SD 1.6]; P=.004), and comfort was higher in the VR group (7.5 [SD 1.6] vs 6.8 [SD 1.7]; P=.03). On the other hand, morphine consumption was not different between the groups. Lastly, complications, as well as procedure and fluoroscopy duration, were not different between the two groups.

Conclusions: We found that VR was associated with a reduction in the perception of pain in patients undergoing AF ablation under conscious sedation. Our findings demonstrate that VR can be easily incorporated into the standard ablation workflow.
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http://dx.doi.org/10.2196/26349DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8193475PMC
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

Twitter for professional use in electrophysiology: practical guide for #EPeeps.

Europace 2021 08;23(8):1192-1199

Hannover Heart Rhythm Center, Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Straße 1, D-30625 Hannover, Germany.

Social media (SoMe) becomes more and more popular in the cardiological community. Among them, Twitter is an emerging and dynamic medium to connect, communicate and educate academic and clinical cardiologists. However, in contrast to traditional scientific communications, the content provided through SoMe is not peer-reviewed and may not necessarily always represent scientific evidence or may even be used to unjustifiably promote therapies for commercial purposes. For the unintended, this means of communication might be appear difficult to handle. This article aims to provide a practical guide on how to use Twitter efficiently for professional use to keep yourself up-to-date about new techniques, the latest study results and news presented at national or international conferences. Additionally, important limitations will be discussed.
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http://dx.doi.org/10.1093/europace/euab048DOI Listing
August 2021

Impact of the atrial lead pacing site regarding atrial fibrillation onset in patients with sinus node dysfunction.

Int J Cardiol 2021 06 1;332:85-86. Epub 2021 Apr 1.

University Hospital of Poitiers, Cardiology Department, 2 rue de la Milétrie, F-86021 Poitiers, France; Univ Poitiers, Faculté de Médecine et Pharmacie, F-86021 Poitiers, France. Electronic address:

Symptomatic sinus node disease (SND) most frequently requires the implantation of a dual chamber pacemaker of which the right atrial lead is generally implanted in the right atrial appendage (RAA) or the lateral wall (LW).The aim of this retrospective study was to evaluate the impact of the right atrial lead pacing site regarding the onset of AF in patients with SND. RESULTS: 126 patients were included (53% males; 76 yo). 64 (51%) patients were implanted in the RAA and 62 (49%) in the LW. The two groups were not different in terms of CHADS-VASc score and indexed left atrial volume. Forty-eight months after implantation, AF occurred in 17 (26.6%) of the RAA group and 6 (9.7%) in the lateral group. In the multivariate models, RAA site was the only factor associated with AF onset, with an Hazard Ratio of 2.5 (95%CI 1.1; 5.7; P=0.03). CONCLUSION: In our study, RAA pacing was associated with 2.5 higher risk of AF onset in patients with SND. Further larger randomized studies are needed to confirm these findings.
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http://dx.doi.org/10.1016/j.ijcard.2021.03.074DOI Listing
June 2021

[Screening and diagnosis of atrial fibrillation].

Rev Prat 2020 Oct;70(8):899-902

Unité de rythmologie, centre cardio-vasculaire, CHU de Poitiers, Poitiers, France.

Screening and diagnosis of atrial fibrillation. Screening for atrial fibrillation (AF) is crucial as this arrhythmia is asymptomatic in a third of patients and 5% of patients present a stroke as the first manifestation of their AF. The European Society of Cardiology recommends opportunistic screening of AF in patients over 65 years of age and systematically in patients over 75 years of age. The simplest way is pulse taking, but the number of connected devices for AF screening allows to multiply the frequency of screening and thus increase sensitivity, with another advantage of a digitalized transmission of the tracing. However many questions remain. No scientific evidence has demonstrated a benefit for AF screening. We do not know what duration and frequency of screening is relevant. The burden of AF which increases thromboembolic risk is not known. What population should be screened and how to consider subclinical AF? We will obtain answers to our questions in the coming years thanks to the results of the various studies in progress.
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October 2020

Use and misuse of instant messaging in clinical data sharing: the EHRA-SMS survey.

Europace 2021 08;23(8):1326-1330

Department of Cardiology and Angiology, Hannover Heart Rhythm Center, Hannover Medical School, Hannover, Germany.

Instant messaging (IM) enables medical professionals to quickly share clinical data to their peers for counselling. Purpose of this survey is to assess the habits related to IM, their application in clinical practice and the perceived pros and cons. An online survey was distributed to the medical community via newsletters, Twitter, LinkedIn, and Facebook. The survey consisted of 22 questions made on an individual-basis and collected anonymously on SurveyMonkey. A total of 287 subjects from 33 countries responded to the survey (mean age 43 years, 74.8% male). Of all respondents, 88.3% routinely send and 90.3% receive clinical data through IM which was second only to face-to-face contact as the preferred method for sharing clinical data. Twelve-lead electrocardiograms (88.6%), medical history (61.4%), and echo loops (55.7%) were the data shared most often. Nearly half of the clinical data that are sent (43%) or received (44%) are not anonymized. In the same way, 29.3% of the respondents were not aware of the European General Data Protection Regulation (GDPR) at the time of the survey. IM apps are used by medical professionals worldwide to share and discuss clinical data and are preferred to many other methods of data sharing, being second only to face-to-face contact. IM are often used to share many different types of clinical data, being perceived as a fast and easy way of communication. Medical professionals should be aware of the appropriate use of IM to prevent legal and privacy issues.
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http://dx.doi.org/10.1093/europace/euab063DOI Listing
August 2021

Sudden Cardiac Arrest in Young Women.

Circulation 2021 Feb 15;143(7):758-760. Epub 2021 Feb 15.

University of Paris, Paris-Cardiovascular Research Center, Institut National de la Santé et de la Recherche Médicale, France (O.W., A.S., N.T., N.K., F.D., V.W., L.L., K.W., O.V., A.C., X.J., E.M.).

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.052219DOI Listing
February 2021

Time to revisit implantable cardioverter-defibrillator implantation criteria in women.

Eur Heart J 2021 03;42(11):1110-1112

University of Paris, PARCC, INSERM, F-75015 Paris, France.

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http://dx.doi.org/10.1093/eurheartj/ehaa970DOI Listing
March 2021

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

Europace 2021 01;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

Fluoroscopy usage in contemporary interventional electrophysiology: Insights from a European registry.

Clin Cardiol 2021 Jan 21;44(1):36-42. Epub 2020 Nov 21.

Cardiovascular Center, OLV Hospital, Aalst, Belgium.

Background: Fluoroscopy has been an essential part of every electrophysiological procedure since its inception. However, till now no clear standards regarding acceptable x-ray exposure nor recommendation how to achieve them have been proposed.

Hypothesis: Current norms and quality markers required for optimal clinical routine can be identified.

Methods: Centers participating in this Europe-wide multicenter, prospective registry were requested to provide characteristics of the center, operators, technical equipment as well as procedural settings of consecutive cases.

Results: Twenty-five centers (72% university clinics, with a mean volume of 526 ± 348 procedures yearly) from 14 European countries provided data on 1788 cases [9% diagnostic procedures (DP), 38% atrial fibrillation (AF) ablations, 44% other supraventricular (SVT) ablations, and 9% ventricular ablations (VT)] conducted by 95 operators (89% male, 41 ± 7 years old). Mean dose area product (DAP) and time was 304 ± 608 cGy*cm , 3.6 ± 4.8 minutes, 1937 ± 608 cGy*cm , 15.3 ± 15.5 minutes, 805 ± 1442 cGy*cm , 10.6 ± 10.7 minutes, and 1277 ± 1931 cGy*cm , 10.4 ± 12.3 minutes for DP, AF, SVT, and VT ablations, respectively. Seven percent of all procedures were conducted without any use of fluoroscopy. Procedures in the lower quartile of DAP were performed more frequently by female operators (OR 1.707, 95%CI 1.257-2.318, P = .001), in higher-volume center (OR 1.001 per one additional procedure, 95%CI 1.000-1.001, P = .002), with the use of 3D-mapping system (OR 2.622, 95%CI 2.053-3.347, P < .001) and monoplane x-ray system (OR 2.945, 95%CI 2.149-4.037, P < .001).

Conclusion: Exposure to ionizing radiation varies widely in daily practice for all procedure. Significant opportunities for harmonization of exposure toward the lower range has been identified.
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http://dx.doi.org/10.1002/clc.23411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803367PMC
January 2021

Hypnosis Versus Placebo During Atrial Flutter Ablation: The PAINLESS Study: A Randomized Controlled Trial.

JACC Clin Electrophysiol 2020 11 12;6(12):1551-1560. Epub 2020 Aug 12.

Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France.

Objectives: The aim of this study was to assess the superiority of hypnosis versus placebo on pain perception and morphine consumption during typical atrial flutter (AFL) ablation.

Background: AFL ablation commonly requires intravenous opioid for analgesia, which can be associated with adverse outcomes. Hypnosis is an alternative technique with rising interest, but robust data in electrophysiological procedures are lacking.

Methods: This single center, randomized controlled trial compared hypnosis and placebo during AFl ablation. In addition to the randomized intervention, all patients were treated according to the institution's standard of care analgesia protocol (administration of 1 mg of intravenous morphine in case of self-reported pain ≥5 on an 11-point numeric rating scale or on demand). The primary endpoint was perceived pain quantified by patients using a visual analog scale.

Results: Between October 2017 and September 2019, 113 patients (mean age 70 ± 12 years, 21% women) were randomized to hypnosis (n = 56) or placebo (n = 57). Mean pain score was 4.0 ± 2.2 in the hypnosis group versus 5.5 ± 1.8 in the placebo group (p < 0.001). Pain perception, assessed every 5 min during the whole procedure, was consistently lower in the hypnosis group. Patients' sedation scores were also better in the hypnosis group than in the placebo group (8.3 ± 2.2 vs. 5.4 ± 2.5; p < 0.001). Finally, morphine requirements were significantly lower in the hypnosis group (1.3 ± 1.3 mg) compared with the placebo group (3.6 ± 1.8 mg; p < 0.001).

Conclusions: In this first randomized trial, hypnosis during AFL ablation was superior to placebo for alleviating pain and reducing morphine consumption.
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http://dx.doi.org/10.1016/j.jacep.2020.05.028DOI Listing
November 2020

Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy.

J Interv Card Electrophysiol 2020 Oct 30. Epub 2020 Oct 30.

Department of Electrophysiology and Pacing, Centre Médico-Chirurgical Ambroise Paré, 27 Boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France.

Purpose: Cardiac resynchronization therapy (CRT) devices have multiple programmable pacing parameters. The purpose of this study was to determine the best pacing mode, i.e., associated with the greatest acute hemodynamic response, in each patient.

Methods: Patients in sinus rhythm and intact atrioventricular conduction were included within 3 months of implantation of devices featuring SyncAV and multipoint pacing (MPP) algorithms. The effect of nominal biventricular pacing using the latest activated electrode (BiV-Late), optimized atrioventricular delay (AVD), nominal and optimized SyncAV, and anatomical MPP was determined by non-invasive measurement of systolic blood pressure (SBP). CRT response was defined as SBP increase > 10% relative to baseline.

Results: Thirty patients with left bundle branch block (LBBB) were included. BiV-Late increased SBP compared to intrinsic rhythm (128 ± 21 mmHg vs. 121 ± 22 mmHg, p = 0.0002). The best pacing mode further increased SBP to 140 ± 19 mmHg (p < 0.0001 vs. BiV-Late). The proportion of CRT responders increased from 40% with BiV-Late to 80% with the best pacing mode (p = 0.0005). Compared to BiV-Late, optimized AVD and optimized SyncAV increased SBP (to 134 ± 21 mmHg, p = 0.004, and 133 ± 20 mmHg, p = 0.0003, respectively), but nominal SyncAV and MPP did not. The best pacing mode was variable between patients and was different from nominal BiV-Late in 28 (93%) patients. Optimized AVD was the most frequent best mode, in 14 (47%) patients.

Conclusion: In patients with LBBB, the best pacing mode was patient-specific and doubled the magnitude of acute hemodynamic response and the proportion of acute CRT responders compared to nominal BiV-Late pacing.

Trial Registration: ClinicalTrials.gov : NCT03779802.
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http://dx.doi.org/10.1007/s10840-020-00908-6DOI Listing
October 2020

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

Circulation 2020 10 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

Prognostic value of Charlson Comorbidity Index in the elderly with a cardioverter defibrillator implantation.

Int J Cardiol 2020 09 26;314:64-69. Epub 2020 Mar 26.

CHU Poitiers, Service de Cardiologie, 2 rue de la Milétrie, F-86021 Poitiers, France; Univ Poitiers, Faculté de Médecine et Pharmacie, F-86021 Poitiers, France; INSERM CIC 1402, CHU Poitiers, 2 rue de la Milétrie, F-86021 Poitiers, France. Electronic address:

Background: Elderly patients are often underrepresented in implantable cardioverter defibrillator (ICD) trials, and ICD implantation in patients ≥75 years consequently remains controversial. We aimed to evaluate mortality, appropriate ICD therapy rates and survival gain in an elderly population after risk stratification according to the Charlson Comorbidity Index (CCI).

Methods: This monocentric retrospective study included elderly ICD patients ≥75 years. They were subdivided according to their CCI score into 3 categories (0-1, 2-3 or ≥4 points). Elderly patients were matched 1:2 with younger control ICD patients on gender, type of prevention (primary or secondary) and type of device (associated cardiac resynchronization therapy or not).

Results: Between January 2009 and July 2017, 121 elderly patients (mean age 78 ± 3; 83% male) matched with 242 controls (mean age 66 ± 5) were included. At 5 year follow-up after ICD implantation, overall survival was 78%, 57%, and 29% (P = 0.002) in the elderly with a CCI score of 0-1, 2-3 and ≥4 respectively, and 72% in controls. There was no significant difference regarding ICD appropriate therapy between the 3 subgroups despite a trend towards lower rates of therapy in CCI ≥ 4 points patients (34.2%, 39.7% and 22.8% respectively; P = 0.45). Median potential survival gain after an appropriate therapy was >5, 4.7 and 1.4 years, with a CCI score of 0-1, 2-3 and ≥4 respectively (P = 0.01).

Conclusion: Elderly patients with CCI score ≥ 4 had the lowest survival after ICD implantation and little survival gain in case of appropriate defibrillator therapy. More than age alone, the burden of comorbidities assessed by the CCI could be helpful to better select elderly patients for ICD implantation.
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http://dx.doi.org/10.1016/j.ijcard.2020.03.060DOI Listing
September 2020

High Risk of Sustained Ventricular Arrhythmia Recurrence After Acute Myocarditis.

J Clin Med 2020 Mar 20;9(3). Epub 2020 Mar 20.

Cardiology Department, Dijon Bourgogne University Hospital, 21000 Dijon, France.

Acute myocarditis is associated with cardiac arrhythmia in 25% of cases; a third of these arrhythmias are ventricular tachycardia (VT) or ventricular fibrillation (VF). The implantation of a cardiac defibrillator (ICD) following sustained ventricular arrhythmia remains controversial in these patients. We sought to assess the risk of major arrhythmic ventricular events (MAEs) over time in patients implanted with an ICD following sustained VT/VF in the acute phase of myocarditis compared to those implanted for VT/VF occurring on myocarditis sequelae. Our retrospective observational study included patients implanted with an ICD following VT/VF during acute myocarditis or VT/VF on myocarditis sequelae, from 2007 to 2017, in 15 French university hospitals. Over a median follow-up period of 3 years, MAE occurred in 11 (39%) patients of the acute myocarditis group and 24 (60%) patients of the myocarditis sequelae group. Kaplan-Meier MAE rate estimates at one and three years of follow-up were 19% and 45% in the acute group, and 43% and 64% in the sequelae group. Patients who experienced sustained ventricular arrhythmias during acute myocarditis had a very high risk of VT/VF recurrence during follow-up. These results show that the risk of MAE recurrence remains high after resolution of the acute episode.
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http://dx.doi.org/10.3390/jcm9030848DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141537PMC
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

Time trends in sudden cardiac death risk in heart failure patients with cardiac resynchronization therapy: a systematic review.

Eur Heart J 2020 06;41(21):1976-1986

Paris Cardiovascular Research Center (Inserm U970), Cardiovascular Epidemiology Unit, 56 Rue Leblanc, 75015 Paris, France.

Aims: While data from randomized trials suggest a declining incidence of sudden cardiac death (SCD) among heart failure patients, the extent to which such a trend is present among patients with cardiac resynchronization therapy (CRT) has not been evaluated. We therefore assessed changes in SCD incidence, and associated factors, in CRT recipients over the last 20 years.

Methods And Results: Literature search from inception to 30 April 2018 for observational and randomized studies involving CRT patients, with or without defibrillator, providing specific cause-of-death data. Sudden cardiac death was the primary endpoint. For each study, rate of SCD per 1000 patient-years of follow-up was calculated. Trend line graphs were subsequently constructed to assess change in SCD rates over time, which were further analysed by device type, patient characteristics, and medical therapy. Fifty-three studies, comprising 22 351 patients with 60 879 patient-years of follow-up and a total of 585 SCD, were included. There was a gradual decrease in SCD rates since the early 2000s in both randomized and observational studies, with rates falling more than four-fold. The rate of decline in SCD was steeper than that of all-cause mortality, and accordingly, the proportion of deaths which were due to SCD declined over the years. The magnitude of absolute decline in SCD was more prominent among CRT-pacemaker (CRT-P) patients compared to those receiving CRT-defibrillator (CRT-D), with the difference in SCD rates between CRT-P and CRT-D decreasing considerably over time. There was a progressive increase in age, use of beta-blockers, and left ventricular ejection fraction, and conversely, a decrease in QRS duration and antiarrhythmic drug use.

Conclusion: Sudden cardiac death rates have progressively declined in the CRT heart failure population over time, with the difference between CRT-D vs. CRT-P recipients narrowing considerably.
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http://dx.doi.org/10.1093/eurheartj/ehz773DOI Listing
June 2020

[Prevention of sudden cardiac death and implantable cardioverter defibrillators: Understanding the competitive risk!]

Presse Med 2019 Dec 4;48(12):1401-1405. Epub 2019 Nov 4.

Hôpital européen Georges-Pompidou, département de cardiologie, unité de rythmologie, 20, rue Leblanc, 75908 Paris cedex 15, France. Electronic address:

Sudden cardiac death represents a major public health issue, with up to 50% of the cardiovascular mortality. Coronary artery disease and dilated cardiomyopathy both represent almost 90% of sudden cardiac death burden. Primary prevention using implantable cardioverter defibrillator relies, in this population, on the left ventricle ejection fraction simple measurement. In this paper, we aim to discuss in which extent a better understanding of competing risk situation may help for a better patient selection and eventually for optimizing primary prevention using implantable cardioverter defibrillator.
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http://dx.doi.org/10.1016/j.lpm.2019.09.010DOI Listing
December 2019

Glucagon-like Peptide 1 Receptor Agonists, Diabetic Retinopathy and Angiogenesis: The AngioSafe Type 2 Diabetes Study.

J Clin Endocrinol Metab 2020 04;105(4)

Center for Interdisciplinary Research in Biology (CIRB), College de France - Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Paris Sciences et Lettres (PSL) Research University, Paris, France.

Aims: Recent trials provide conflicting results on the association between glucagon-like peptide 1 receptor agonists (GLP-1RA) and diabetic retinopathy (DR). The aim of the AngioSafe type 2 diabetes (T2D) study was to determine the role of GLP-1RA in angiogenesis using clinical and preclinical models.

Methods: We performed two studies in humans. In study 1, we investigated the effect of GLP-1RA exposure from T2D diagnosis on the severity of DR, as diagnosed with retinal imaging (fundus photography). In study 2, a randomized 4-week trial, we assessed the effect of liraglutide on circulating hematopoietic progenitor cells (HPCs), and angio-miRNAs.We then studied the experimental effect of Exendin-4, on key steps of angiogenesis: in vitro on human endothelial cell proliferation, survival and three-dimensional vascular morphogenesis; and in vivo on ischemia-induced neovascularization of the retina in mice.

Results: In the cohort of 3154 T2D patients, 10% displayed severe DR. In multivariate analysis, sex, disease duration, glycated hemoglobin (HbA1c), micro- and macroangiopathy, insulin therapy and hypertension remained strongly associated with severe DR, while no association was found with GLP-1RA exposure (o 1.139 [0.800-1.622], P = .47). We further showed no effect of liraglutide on HPCs, and angio-miRNAs. In vitro, we demonstrated that exendin-4 had no effect on proliferation and survival of human endothelial cells, no effect on total length and number of capillaries. Finally, in vivo, we showed that exendin-4 did not exert any negative effect on retinal neovascularization.

Conclusions: The AngioSafe T2D studies provide experimental and clinical data confirming no effect of GLP-1RA on angiogenesis and no association between GLP-1 exposure and severe DR.
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http://dx.doi.org/10.1210/clinem/dgz069DOI Listing
April 2020

Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: Results of the observational RESPIRE study.

Heart Rhythm 2020 02 4;17(2):195-202. Epub 2019 Sep 4.

Cardiology Division, Hôpitaux Universitaires de Genève, Geneva, Switzerland.

Background: Patients with atrial fibrillation (AF) often have sleep apnea (SA), but diagnosis of SA with polysomnography is costly. SA monitoring is a pacemaker feature that measures respiratory disturbance index, the sum of abnormal respiratory events divided by sleep duration.

Objective: The purpose of this study was to evaluate the incidence and severity of SA and its association with AF in an unselected population fitted with pacemakers.

Methods: RESPIRE (REgistry of Sleep APnea monItoring and Atrial Fibrillation in pacemakeR patients) was a multicenter, international, observational, open-label study following adult subjects for 18 months after implantation with an SA monitoring-enabled dual-chamber pacemaker. Severe SA was defined as average respiratory disturbance index ≥20 from implantation to follow-up visit. The first co-primary end point was the difference in significant AF (cumulative AF episodes lasting ≥24 hours over 2 consecutive days) between subjects with severe and those nonsevere SA at 12 months in the full analysis set (N = 553). The second co-primary end point was the rate of major serious adverse events at 18 months in the modified intention-to-treat set (N = 1024).

Results: Severe SA was detected in 31.1% (172 of 553). A higher incidence of significant AF was reported in patients with severe SA than in patients with nonsevere SA (25.0% vs 13.9%; difference 11.1%; 95% confidence interval 3.7%-18.4%; P = .002). Significant AF increased with time in both groups, but at a faster rate in the severe SA group. No intergroup difference in the overall rate of major serious adverse events was observed (P = .065).

Conclusion: SA screening over 12 months identified severe SA in almost one-third of unselected patients fitted with pacemakers. Severe SA was associated with a higher incidence of significant AF.
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http://dx.doi.org/10.1016/j.hrthm.2019.09.001DOI Listing
February 2020

Implantable cardioverter defibrillator therapy for primary prevention of sudden cardiac death in the real world: Main findings from the French multicentre DAI-PP programme (pilot phase).

Arch Cardiovasc Dis 2019 Aug - Sep;112(8-9):523-531. Epub 2019 Aug 27.

Clinique Pasteur, 31076 Toulouse, France; CHU de Poitiers, 86021 Poitiers, France; Université de Poitiers, 86073 Poitiers, France; CHU de Grenoble, 38700 La Tronche, France; Centre cardiologique du Nord, 93200 Saint-Denis, France; Paris Cardiovascular Research Centre (Inserm U970), 75015 Paris, France; Maxcure Hospitals, 500081 Hyderabad, Telangana, India; Royal Papworth Hospital NHS Foundation Trust, Cambridge University Health Partners, CB2 0AY Cambridge, UK; Hospital da Luz Arrabida, 4400-346 Vila Nova de Gaia, Portugal; Hopital privé du Confluent, 44000 Nantes, France; Barts Heart Centre, Barts Health NHS Trust, EC1A 7BE London, UK; Hôpital Bichat-Claude-Bernard, 75018 Paris, France; IRSN, 92260 Fontenay aux Roses, France; CHU Haut Lévêque, 33600 Pessac, France; CHU Trousseau, 37170 Chambray-lès-Tours, France; CHRU de Lille, 59000 Lille, France; CHU Pontchaillou, 35033 Rennes, France; CHU Brabois, 54500 Vandœuvre-lès-Nancy, France; Hôpital de La Timone, 13005 Marseille, France; Unité de Rythmologie, Hôpital européen Georges Pompidou, 20-40, rue Leblanc, 75908 Paris cedex 15, France; Paris Descartes University, 75006 Paris, France.

This review summarizes the main findings of the French multicentre DAI-PP pilot programme, and discusses the related clinical and research perspectives. This project included retrospectively (2002-2012 period) more than 5000 subjects with structural heart disease who received an implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death, and were followed for a mean period of 3 years. The pilot phase of the DAI-PP programme has provided valuable information on several practical and clinically relevant aspects of primary prevention ICD implantation in the real-world population, which are summarized in this review. This pilot has led to a prospective evaluation that started in May 2018, assessing ICD therapy in primary and secondary prevention in patients with structural and electrical heart diseases, with remote monitoring follow-up using a dedicated platform. This should further enhance our understanding of sudden cardiac death, to eventually optimize the field of preventative actions.
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http://dx.doi.org/10.1016/j.acvd.2019.05.005DOI Listing
November 2019

Very long-term survival and late sudden cardiac death in cardiac resynchronization therapy patients.

Eur Heart J 2019 07;40(26):2121-2127

Cardiology Department, Clinique Pasteur, Toulouse, France.

Aims: The very long-term outcome of patients who survive the first few years after receiving cardiac resynchronization therapy (CRT) has not been well described thus far. We aimed to provide long-term outcomes, especially with regard to the occurrence of sudden cardiac death (SCD), in CRT patients without (CRT-P) and with defibrillator (CRT-D).

Methods And Results: A total of 1775 patients, with ischaemic or non-ischaemic dilated cardiomyopathy, who were alive 5 years after CRT implantation, were enrolled in this multicentre European observational cohort study. Overall long-term mortality rates and specific causes of death were assessed, with a focus on late SCD. Over a mean follow-up of 30 months (interquartile range 10-42 months) beyond the first 5 years, we observed 473 deaths. The annual age-standardized mortality rates of CRT-D and CRT-P patients were 40.4 [95% confidence interval (CI) 35.3-45.5] and 97.2 (95% CI 85.5-109.9) per 1000 patient-years, respectively. The adjusted hazard ratio (HR) for all-cause mortality was 0.99 (95% CI 0.79-1.22). Twenty-nine patients in total died of late SCD (14 with CRT-P, 15 with CRT-D), corresponding to 6.1% of all causes of death in both device groups. Specific annual SCD rates were 8.5 and 5.8 per 1000 patient-years in CRT-P and CRT-D patients, respectively, with no significant difference between groups (adjusted HR 1.0, 95% CI 0.45-2.44). Death due to progressive heart failure represented the principal cause of death (42.8% in CRT-P patients and 52.6% among CRT-D recipients), whereas approximately one-third of deaths in both device groups were due to non-cardiovascular death.

Conclusion: In this first description of very long-term outcomes among CRT recipients, progressive heart failure death still represented the most frequent cause of death in patients surviving the first 5 years after CRT implant. In contrast, SCD represents a very low proportion of late mortality irrespective of the presence of a defibrillator.
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http://dx.doi.org/10.1093/eurheartj/ehz238DOI Listing
July 2019

VEGF-A plasma levels are associated with microvascular obstruction in patients with ST-segment elevation myocardial infarction.

Int J Cardiol 2019 09 6;291:19-24. Epub 2019 Mar 6.

Center for Interdisciplinary Research in Biology (CIRB), College de France, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Paris Sciences et Lettres (PSL) Research University, 11, place Marcelin Berthelot, Paris F-75005, France. Electronic address:

Background: Microvascular obstruction (MVO) is associated with poor outcome after ST-segment elevation myocardial infarction (STEMI). Vascular endothelial growth factor-A (VEGF-A) is a vascular permeability inducer playing a key role in MVO pathogenesis. We aimed to assess whether VEGF-A levels are associated with MVO, when evaluated by magnetic resonance imaging (MRI) in STEMI patients.

Methods: The multicenter prospective PREGICA study included a CMR substudy with all consecutive patients with a first STEMI who had undergone cardiac MRI at baseline and at 6-month follow-up. Patients with initial TIMI flow >1 were excluded. VEGF-A levels were measured in blood samples drawn at inclusion.

Results: Between 2010 and 2017, 147 patients (mean age 57 ± 10 years; 84% males) were included. MVO was present in 65 (44%) patients. After multivariate analysis, higher troponin peak (OR 1.005; 95% CI 1.001-1.008; p = 0.007) and VEGF-A levels (OR 1.003; 95% CI 1.001-1.005; p = 0.015) were independently associated with MVO. When considering only patients with successful percutaneous coronary intervention (final TIMI flow 3, n = 130), higher troponin peak (p = 0.004) and VEGF-A levels (p = 0.03) remained independently predictive of MVO. Moreover, MVO was associated with adverse left ventricular (LV) remodeling and VEGF-A levels were significantly and inversely correlated with LV ejection fraction (EF) at 6-month follow-up.

Conclusion: Our results show that VEGF-A levels were independently associated with MVO during STEMI and correlated with mid-term LVEF alteration. VEGF-A could therefore be considered as a biomarker of MVO in STEMI patients and be used to stratify patient prognosis.
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http://dx.doi.org/10.1016/j.ijcard.2019.02.067DOI Listing
September 2019

Prophylactic implantable cardioverter-defibrillator in the very elderly.

Europace 2019 Jul;21(7):1063-1069

Paris Cardiovascular Research Center, Paris, France.

Aims: Current guidelines do not propose any age cut-off for the primary prevention implantable cardioverter-defibrillator (ICD). However, the risk/benefit balance in the very elderly population has not been well studied.

Methods And Results: In a multicentre French study assessing patients implanted with an ICD for primary prevention, outcomes among patients aged ≥80 years were compared with <80 years old controls matched for sex and underlying heart disease (ischaemic and dilated cardiomyopathy). A total of 300 ICD recipients were enrolled in this specific analysis, including 150 patients ≥80 years (mean age 81.9 ± 2.0 years; 86.7% males) and 150 controls (mean age 61.8 ± 10.8 years). Among older patients, 92 (75.6%) had no more than one associated comorbidity. Most subjects in the elderly group got an ICD as part of a cardiac resynchronization therapy procedure (74% vs. 46%, P < 0.0001). After a mean follow-up of 3.0 ± 2 years, 53 patients (35%) in the elderly group died, including 38.2% from non cardiovascular causes of death. Similar proportion of patients received ≥1 appropriate therapy (19.4% vs. 21.6%; P = 0.65) in the elderly group and controls, respectively. There was a trend towards more early perioperative events (P = 0.10) in the elderly, with no significant increase in late complications (P = 0.73).

Conclusion: Primary prevention ICD recipients ≥80 years in the real world had relatively low associated comorbidity. Rates of appropriate therapies and device-related complications were similar, compared with younger subjects. Nevertheless, the inherent limitations in interpreting observational data on this particular competing risk situation call for randomized controlled trials to provide definitive answers. Meanwhile, a careful multidisciplinary evaluation is needed to guide patient selection for ICD implantation in the elderly population.
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http://dx.doi.org/10.1093/europace/euz041DOI Listing
July 2019
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