Reprocessing of electrophysiology material in EHRA countries: an EHRA Young EP survey.

Data on reprocessing of electrophysiology (EP) materials are sparse. Reprocessing of catheters and other materials in daily routine varies through countries and may depend on specific material characteristics, supplier, or federal law. The aim of this study was to collect data on reprocessing usage through EHRA countries. An online survey consisting of 27 questions was distributed to EHRA Young EP members and members of national EP working groups. Two hundred and two participants from 34 EHRA countries completed the survey. One hundred and seven respondents (53.0%) reported having used and using reprocessed EP material, 30 (14.9%) respondents have used reprocessed EP material in the past but not at the time of the survey, 65 (32.2%) had never used reprocessed EP material. The most reprocessed EP materials include cables (70%), diagnostic EP catheters with deflectable (64%) or fixed curve (63%), non-irrigated ablation catheters (51%), and other conventional diagnostic catheters (41%). The most durable material was diagnostic EP catheters with a fixed curve (61%), the most sensitive material was ablation catheters with contact force sensors (21%). Important benefits were seen in reducing costs for the providing hospital (65%) and the healthcare provider (42%) and making EP procedures available for a greater number of patients (42%). Main concerns were on quality aspects (58%), contamination (52%), and loss of precision (47%). Reprocessing of EP materials is heterogeneously managed among EHRA countries. The present survey shows that European electrophysiologists consider the use of reprocessed EP material as generally safe and cost-effective.

Utilization and perception of same-day discharge in electrophysiological procedures and device implantations: an EHRA survey.

The aim of this European Heart Rhythm Association (EHRA) survey was to assess the utilization of same-day discharge (SDD) in electrophysiology (EP). An online-based questionnaire was shared with the EHRA community between 12 and 30 June 2020 and recorded institutional information, complication assessment, recent experiences, and opinions regarding possible advantages or concerns with SDD. In total, 218 responses from 49 countries provided information on current SDD management. Overall, SDD was implemented in 77.5%, whereas this proportion was significantly higher in tertiary and high-volume centres (83.8% and 85.3%, both P < 0.01). The concept of SDD was most commonly used following implantations of cardiac event recorders (97%), diagnostic EP procedures (72.2%), and implantations of pacemakers with one or two intracardiac leads (50%), while the lowest SDD utilization was observed after catheter ablations of left atrial or ventricular arrhythmias. Within SDD-experienced centres, ∼90% respondents stated that this discharge concept is recommendable or highly recommendable and reported that rates of increased rehospitalization and complication rates were low. Most respondents assumed a better utilization of hospital resources (78.2%), better cost effectiveness (77.3%), and an improved patients' comfort but were concerned about possible impairment of detection (72.5%) and management (78.7%) of late complications. In conclusion, >75% of respondents already implement SDD following EP interventions with a large heterogeneity with regard to specific procedures. Further research is needed to confirm or disprove existing and expected benefits and obstacles.

Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: results of the EU-CERT-ICD controlled multicentre cohort study.

AIMS: The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy. METHODS AND RESULTS: We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537-0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class

Present criteria for prophylactic ICD implantation: Insights from the EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope) project.

BACKGROUND: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. It is urgently needed to better identify patients who benefit from prophylactic ICD therapy. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) completed in 2019 will assess this issue. SUMMARY: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicenter observational cohort study done in 44 centers across 15 European countries. A total of 2327 patients with heart failure due to ischemic heart disease or dilated cardiomyopathy indicated for primary prophylactic ICD implantation were recruited between 2014 and 2018 (>1500 patients at first ICD implantation, >750 patients non-randomized non-ICD control group). The primary endpoint was all-cause mortality, and first appropriate shock was co-primary endpoint. At baseline, all patients underwent 12­lead ECG and Holter-ECG analysis using multiple advanced methods for risk stratification as well as documentation of clinical characteristics and laboratory values. The EU-CERT-ICD data will provide much needed information on the survival benefit of preventive ICD therapy and expand on previous prospective risk stratification studies which showed very good applicability of clinical parameters and advanced risk stratifiers in order to define patient subgroups with above or below average ICD benefit. CONCLUSION: The EU-CERT-ICD study will provide new and current data about effectiveness of primary prophylactic ICD implantation. The study also aims for improved risk stratification and patient selection using clinical risk markers in general, and advanced ECG risk markers in particular.

Sex differences in outcomes of primary prevention implantable cardioverter-defibrillator therapy: combined registry data from eleven European countries.

Aims: Therapy with an implantable cardioverter defibrillator (ICD) is established for the prevention of sudden cardiac death (SCD) in high risk patients. We aimed to determine the effectiveness of primary prevention ICD therapy by analysing registry data from 14 centres in 11 European countries compiled between 2002 and 2014, with emphasis on outcomes in women who have been underrepresented in all trials. Methods and results: Retrospective data of 14 local registries of primary prevention ICD implantations between 2002 and 2014 were compiled in a central database. Predefined primary outcome measures were overall mortality and first appropriate and first inappropriate shocks. A multivariable model enforcing a common hazard ratio for sex category across the centres, but allowing for centre-specific baseline hazards and centre specific effects of other covariates, was adjusted for age, the presence of ischaemic cardiomyopathy or a CRT-D, and left ventricular ejection fraction ≤25%. Of the 5033 patients, 957 (19%) were women. During a median follow-up of 33 months (IQR 16-55 months) 129 women (13%) and 807 men (20%) died (HR 0.65; 95% CI: [0.53, 0.79], P-value < 0.0001). An appropriate ICD shock occurred in 66 women (8%) and 514 men (14%; HR 0.61; 95% CI: 0.47-0.79; P = 0.0002). Conclusion: Our retrospective analysis of 14 local registries in 11 European countries demonstrates that fewer women than men undergo ICD implantation for primary prevention. After multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.

No Association Between T-peak to T-end Interval on the Resting ECG and Long-Term Incidence of Ventricular Arrhythmias Triggering ICD Interventions.

BACKGROUND AND OBJECTIVES: Potential of using the T-peak to T-end (TpTe) interval as an electrocardiographic parameter reflecting the transmural dispersion of ventricular repolarization (TDR) to identify patients (pts.) with higher risk of malignant ventricular arrhythmias (MVA) for better selection of candidates for implantable cardioverter-defibrillator (ICD) in primary prevention (PP) of sudden cardiac death (SCD) remains controversial. The primary objective of this study was to investigate the relationship between the TpTe interval in patient's preimplantation resting 12-lead electrocardiogram (ECG) and the incidence of MVA resulting in appropriate ICD intervention (AI). The secondary objective was to assess its relationship to overall mortality. METHODS: A total of 243 consecutive pts. with severe left ventricular (LV) systolic dysfunction after myocardial infarction (MI) with a single-chamber ICD for PP of SCD from one implantation center were included. Excluded were all pts. with any other disease that could interfere with the indication of ICD implantation. Primarily investigated intervals were measured manually in accordance with accepted methodology. Data on ICD interventions were acquired from device interrogation during regular outpatient visits. Survival data were collected from the databases of health insurance and regulatory authorities. RESULTS: We did not find a significant relationship between the duration of the TpTe interval and the incidence of MVA (71.5 ms in pts. with MVA vs. 70 ms in pts. without MVA; p = 0.408). Similar results were obtained for the corrected TpTe interval (TpTec) and the ratio of TpTe to QT interval (76.3 ms vs. 76.5 ms; p = 0.539 and 0.178 vs. 0.181; p = 0.547, respectively). There was also no significant difference between the duration of TpTe, TpTec and TpTe/QT ratio in pts. groups by overall mortality (71.5 ms in the deceased group vs. 70 ms in the survivors group; HR 1.01; 95% CI, 0.99-1.02; p = 0.715, 76.3 ms vs. 76.5 ms; HR 1.01; 95% CI, 0.99-1.02; p = 0.208 and 0.178 vs. 0.186; p = 0.116, respectively). CONCLUSION: This study suggests no significant association of overall or MVA-free survival with ECG parameters reflecting TDR (TpTe, TpTec) in patients with systolic dysfunction after MI and ICD implanted for primary prevention.

Appropriate Shocks and Mortality in Patients With Versus Without Diabetes With Prophylactic Implantable Cardioverter Defibrillators.

OBJECTIVE: Diabetes increases the risk of all-cause mortality and sudden cardiac death (SCD). The exact mechanisms leading to sudden death in diabetes are not well known. We compared the incidence of appropriate shocks and mortality in patients with versus without diabetes with a prophylactic implantable cardioverter defibrillator (ICD) included in the retrospective EU-CERT-ICD registry. RESEARCH DESIGN AND METHODS AND RESULTS: A total of 3,535 patients from 12 European EU-CERT-ICD centers with a mean age of 63.7 ± 11.2 years (82% males) at the time of ICD implantation were included in the analysis. A total of 995 patients (28%) had a history of diabetes. All patients had an ICD implanted for primary SCD prevention. End points were appropriate shock and all-cause mortality. Mean follow-up time was 3.2 ± 2.3 years. Diabetes was associated with a lower risk of appropriate shocks (adjusted hazard ratio [HR] 0.77 [95% CI 0.62-0.96], P = 0.02). However, patients with diabetes had significantly higher mortality (adjusted HR 1.30 [95% CI 1.11-1.53], P = 0.001). CONCLUSIONS: All-cause mortality is higher in patients with diabetes than in patients without diabetes with primary prophylactic ICDs. Subsequently, patients with diabetes have a lower incidence of appropriate ICD shocks, indicating that the excess mortality might not be caused primarily by ventricular tachyarrhythmias. These findings suggest a limitation of the potential of prophylactic ICD therapy to improve survival in patients with diabetes with impaired left ventricular function.