0328: Assessment of radiation exposure during cardiac device implantation: lessons learned from a multicenter registry

BackgroundFew data exist about radiation exposure during implantation of cardiac electrical device. No dose reference levels (DRLs) were reported.Purpose to define DRLs and to analyze factors related to an increased radiation dose delivered to patients and medical staff.Methods the Raypace study is a multicenter, prospective observational registry. Using a national database, patient demographic, procedural and radiation data were collected. Fluoroscopy time (FT) and dose-area product (DAP) were registered. Physician/staff exposure was measured using 2 real-time personal dosimeters, one worn under the lead apron and the other one worn outside the apron. Statistical analysis used log-transformation of DAP, FT and DAP/FT ratio.ResultsA total of 657 procedures from 9 institutions were reviewed. Pacemaker (PM) and cardioverter-defibrillator (ICD) implantation was performed in 481 and 176 patients, respectively. A cardiac resynchronization device was implanted in 153 patients. Fluoroscopy time was similar for PM and ICD implantations. Median fluoroscopy time was 836, 117 and 101 second and median DAP was 1410, 150 and 129 cGy.cm2 for biventricular, dual chamber and ventricular device implantation, respectively. LAO projection, in addition to AP projection, was used in 47% of the procedures. Five centers out of 9 used collimation. The median Hp (10) effective dose measured outside the lead apron was 4.6 µSv and 0.1 µSv under the lead apron.Regarding CRT implant procedures, four systems out of 6 were responsible for an increased exposure (p<0.001). DRLs were 2600, 338 and 332 cGy.cm2 for biventricular, dual chamber and ventricular device implantation, respectively.ConclusionsDAP reduction was improved with the use of latest generators but needed customized settings. Biventricular device implantation was responsible for the highest radiation exposure. However, radiation exposure during those procedures have decreased as compared to previously reported values

Comparaison de l'angioplastie primaire et de la thrombolyse pré-hospitalière à la phase aiguë de l'infarctus du myocarde (analyse médico-économique)

GRENOBLE1-BU Médecine pharm. (385162101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study.

BACKGROUND: Inappropriate shocks (IS) continue to have a major negative impact on patients implanted with defibrillators. OBJECTIVE: The purpose of this study was to assess IS reduction with the PARAD+ discrimination algorithm in a general population implanted for primary or secondary prevention. METHODS: ISIS-ICD (Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator) was a 2-year international, interventional study in patients implanted with a dual implantable cardioverter-defibrillator (ICD) or triple-chamber defibrillator (cardiac resynchronization therapy-defibrillator [CRT-D]) featuring PARAD+. IS (shocks not delivered for ventricular tachycardia or fibrillation) were independently adjudicated. The primary endpoint was percentage of IS-free patients at 24 months. Primary and worst-case analyses of annual incidence rates of patients with ≥1 IS, overall and per defibrillator type, were conducted. RESULTS: In total, 1013 patients (80.7% male; age 67.1 ± 11.4 years; 68%/30%/2% primary/secondary/other indication) were enrolled and followed for a median of 552 days (interquartile range 354; 725). Of 993 analyzed patients programmed with PARAD+, 14 had ≥1 IS, corresponding to a percentage free from IS of 98.1% (95% confidence interval [CI] 96.8%- 98.9%). Annual incidence rates (per 100 person-years) of patients with IS were 1.0 (95% CI 0.59-1.69) and 2.1 (95% CI 1.46-3.02) in the primary and worst-case analyses, respectively. In ICD patients, rates were 1.2 (95% CI 0.68-2.23) and 2.3 (95% CI 1.47-3.53), and in CRT-D patients 0.59 (95% CI 0.19-1.83) and 1.8 (95% CI 0.93-3.44) per 100 person-years. CONCLUSION: The annual rate of defibrillator patients with IS using the enhanced PARAD+ discrimination algorithm alone ranged from 1.0 to 2.1 per 100 person-years in a general population implanted for primary or secondary prevention

FRAGILE: FRench Attitude reGistry in case of ICD LEad replacement

International audienceAimsFRench 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 resultsProspective 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.ConclusionIn 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

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

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

Les sciences de gouvernement

Depuis le début du XIXe siècle, ce n'est plus le secret qui légitime les « arts de gouvernement > en Europe. C'est la science. Élections, colonies, propagande, état civil, hygiène, risques naturels : les territoires de cette revendication, promue nouveau Graal de la raison bureaucratique, ont donné naissance à des savoirs de plus en plus professionnalisés. Ce sont d'eux que viennent en droite ligne les « expertises » qui aujourd'hui encore trament l'administration du politique. S'intéresser, comme y invite cet ouvrage, à ces savoirs mais aussi à ces figures, revues, théories ou disciplines aujourd'hui sans sépulture, ce n'est pas céder à une passion érudite. C'est oeuvrer à une histoire sociale : celle des registres de scientificité dont s'est continûment enorgueillie la conduite du pouvoir politique. C'est se donner les moyens d'interroger les instruments de connaissance et de légitimation par lesquels se font puis se défont les modèles d'action gouvernementale, ceux qui ont accompagné l'extension des interventions de l'État. Car ces « sciences de gouvernement », qu'elles soient oubliées ou toujours actuelles, décriées ou pourvues de titres académiques, n'ont cessé d'apporter de la majesté au politique. Un éclat d'objectivité dont se targuent toujours les pratiques du gouvernement de la Cité

Les sciences de gouvernement

Depuis le début du XIXe siècle, ce n'est plus le secret qui légitime les « arts de gouvernement > en Europe. C'est la science. Élections, colonies, propagande, état civil, hygiène, risques naturels : les territoires de cette revendication, promue nouveau Graal de la raison bureaucratique, ont donné naissance à des savoirs de plus en plus professionnalisés. Ce sont d'eux que viennent en droite ligne les « expertises » qui aujourd'hui encore trament l'administration du politique. S'intéresser, comme y invite cet ouvrage, à ces savoirs mais aussi à ces figures, revues, théories ou disciplines aujourd'hui sans sépulture, ce n'est pas céder à une passion érudite. C'est oeuvrer à une histoire sociale : celle des registres de scientificité dont s'est continûment enorgueillie la conduite du pouvoir politique. C'est se donner les moyens d'interroger les instruments de connaissance et de légitimation par lesquels se font puis se défont les modèles d'action gouvernementale, ceux qui ont accompagné l'extension des interventions de l'État. Car ces « sciences de gouvernement », qu'elles soient oubliées ou toujours actuelles, décriées ou pourvues de titres académiques, n'ont cessé d'apporter de la majesté au politique. Un éclat d'objectivité dont se targuent toujours les pratiques du gouvernement de la Cité