scholarly journals Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction—UK multicentre collaboration

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e059527
Author(s):  
G Andre Ng ◽  
Amar Mistry ◽  
Michelle Newton ◽  
Fernando Soares Schlindwein ◽  
Craig Barr ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Ventricular Arrhythmia ◽  
Implantable Cardioverter Defibrillator ◽  
Controlled Trial ◽  
Ethics Committees ◽  
Risk Markers ◽  
Open Label ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Ischaemic Cardiomyopathy

IntroductionThe purpose of this study is to assess the ability of two new ECG markers (Regional Repolarisation Instability Index (R2I2) and Peak Electrical Restitution Slope) to predict sudden cardiac death (SCD) or ventricular arrhythmia (VA) events in patients with ischaemic cardiomyopathy undergoing implantation of an implantable cardioverter defibrillator for primary prevention indication.Methods and analysisMulticentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction is a prospective, open label, single blinded, multicentre observational study to establish the efficacy of two ECG biomarkers in predicting VA risk. 440 participants with ischaemic cardiomyopathy undergoing routine first time implantable cardioverter-defibrillator (ICD) implantation for primary prevention indication are currently being recruited. An electrophysiological (EP) study is performed using a non-invasive programmed electrical stimulation protocol via the implanted device. All participants will undergo the EP study hence no randomisation is required. Participants will be followed up over a minimum of 18 months and up to 3 years. The first patient was recruited in August 2016 and the study will be completed at the final participant follow-up visit. The primary endpoint is ventricular fibrillation or sustained ventricular tachycardia >200 beats/min as recorded by the ICD. The secondary endpoint is SCD. Analysis of the ECG data obtained during the EP study will be performed by the core lab where blinding of patient health status and endpoints will be maintained.Ethics and disseminationEthical approval has been granted by Research Ethics Committees Northern Ireland (reference no. 16/NI/0069). The results will inform the design of a definitive Randomised Controlled Trial (RCT). Dissemination will include peer reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries.Trial registration numberNCT03022487.

Worldwide differences in primary prevention implantable cardioverter defibrillator utilization and outcomes in hypertrophic cardiomyopathy

2021 ◽  
Author(s):  
Victor Nauffal ◽  
Peter Marstrand ◽  
Larry Han ◽  
Victoria N Parikh ◽  
Adam S Helms ◽  
...  
Keyword(s):  
Hypertrophic Cardiomyopathy ◽  
Primary Prevention ◽  
Implantable Cardioverter Defibrillator ◽  
Cox Proportional Hazards ◽  
Icd Implantation ◽  
Icd Therapy ◽  
Cardioverter Defibrillator ◽  
Significant Difference ◽  
Implantation Rates ◽  
The Impact

Abstract Aims  Risk stratification algorithms for sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM) and regional differences in clinical practice have evolved over time. We sought to compare primary prevention implantable cardioverter defibrillator (ICD) implantation rates and associated clinical outcomes in US vs. non-US tertiary HCM centres within the international Sarcomeric Human Cardiomyopathy Registry. Methods and results We included patients with HCM enrolled from eight US sites (n = 2650) and five non-US (n = 2660) sites and used multivariable Cox-proportional hazards models to compare outcomes between sites. Primary prevention ICD implantation rates in US sites were two-fold higher than non-US sites (hazard ratio (HR) 2.27 [1.89–2.74]), including in individuals deemed at high 5-year SCD risk (≥6%) based on the HCM risk-SCD score (HR 3.27 [1.76–6.05]). US ICD recipients also had fewer traditional SCD risk factors. Among ICD recipients, rates of appropriate ICD therapy were significantly lower in US vs. non-US sites (HR 0.52 [0.28–0.97]). No significant difference was identified in the incidence of SCD/resuscitated cardiac arrest among non-recipients of ICDs in US vs. non-US sites (HR 1.21 [0.74–1.97]). Conclusion  Primary prevention ICDs are implanted more frequently in patients with HCM in US vs. non-US sites across the spectrum of SCD risk. There was a lower rate of appropriate ICD therapy in US sites, consistent with a lower-risk population, and no significant difference in SCD in US vs. non-US patients who did not receive an ICD. Further studies are needed to understand what drives malignant arrhythmias, optimize ICD allocation, and examine the impact of different ICD utilization strategies on long-term outcomes in HCM.

5968Adherence to driving restrictions among patients with an implantable cardioverter defibrillator: insights from a nationwide register-linked survey study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Bjerre ◽  
S M Rosenkranz ◽  
M Schou ◽  
C Jons ◽  
B T Philbert ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Primary Prevention ◽  
Secondary Prevention ◽  
Implantable Cardioverter Defibrillator ◽  
Survey Study ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Driving Restrictions ◽  
Driver's License ◽  
Icd Shock

Abstract Background Patients with an implantable cardioverter defibrillator (ICD) are restricted from driving following initial implantation or ICD shock. It is unclear how many patients are aware of, and adhere to, these restrictions. Purpose To investigate knowledge of, and adherence to, private and professional driving restrictions in a nationwide cohort of ICD patients. Methods A questionnaire was distributed to all living Danish residents ≥18 years who received a first-time ICD between 2013 and 2016 (n=3,913). During this period, Danish guidelines recommended 1 week driving restriction following ICD implantation for primary prevention, and 3 months following either ICD implantation for secondary prevention or appropriate ICD shock, and permanent restriction of professional driving and driving of large vehicles (>3.5 metric tons). Questionnaires were linked with relevant nationwide registries. Logistic regression was applied to identify factors associated with non-adherence. Results Of 2,741 questionnaire respondents, 92% (n=2,513) held a valid private driver's license at time of ICD implantation (85% male; 46% primary prevention indication; median age: 67 years (IQR: 59–73)). Of these, 7% (n=175) were actively using a professional driver's license for truck driving (n=73), bus driving (n=45), taxi driving (n=22), large vehicle driving for private use (n=54), or other purposes (n=32) (multiple purposes allowed). Only 42% of primary prevention patients, 63% of secondary prevention patients, and 72% of patients who experienced an appropriate ICD shock, recalled being informed of any driving restrictions. Only 45% of professional drivers recalled being informed about specific professional driving restrictions (Figure). Most patients (93%, n=2,344) resumed private driving after ICD implantation, more than 30% during the driving restriction period: 34% of primary prevention patients resumed driving within 1 week, 43% of secondary prevention patients resumed driving within 3 months, and 30% of patients who experienced an appropriate ICD shock resumed driving within 3 months. Professional driving was resumed by 35%. Patients who resumed driving within the restricted periods were less likely to report having received information about driving restrictions (all p<0.001) (Figure). In a multiple logistic regression model, non-adherence was predicted by reporting non-receipt of information about driving restrictions (OR: 3.34, CI: 2.27–4.03), as well as male sex (OR: 1.53, CI: 1.17–2.01), age ≥60 years (OR: 1.20, CI: 1.02–1.64), receipt of a secondary prevention ICD (OR: 2.2, CI: 1.80–2.62), and being the only driver in the household (OR: 1.29, CI: 1.05–1.57). Conclusion In this nationwide survey study, many ICD patients were unaware of the driving restrictions, and many ICD patients, including professional drivers, resumed driving within the restricted periods. More focus on communicating driving restrictions might improve adherence. Acknowledgement/Funding Danish Heart Foundation, Arvid Nilsson Foundation, Fraenkels Mindefond

scholarly journals Risk of subsequent ventricular arrhythmia is higher in primary prevention patients with implantable cardioverter defibrillator than in secondary prevention patients

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
You Zhou ◽  
Shuang Zhao ◽  
Keping Chen ◽  
Wei Hua ◽  
Yangang Su ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Ventricular Arrhythmia ◽  
Secondary Prevention ◽  
Implantable Cardioverter Defibrillator ◽  
Incidence Rate ◽  
Home Monitoring ◽  
Icd Therapy ◽  
Cardioverter Defibrillator ◽  
All Cause Mortality

Abstract Background Because of previous ventricular arrhythmia (VA) episodes, patients with implantable cardioverter-defibrillator (ICD) for secondary prevention (SP) are generally considered to have a higher burden of VAs than primary prevention (PP) patients. However, when PP patients experienced VA, the difference in the prognosis of these two patient groups was unknown. Methods The clinical characteristics and follow-up data of 835 ICD patients (364 SP patients and 471 PP patients) with home monitoring feature were retrospectively analysed. The incidence rate and risk of subsequent VA and all-cause mortality were compared between PP patients after the first appropriate ICD therapy and SP patients. Results During a mean follow-up of 44.72 ± 20.87 months, 210 (44.59%) PP patients underwent appropriate ICD therapy. In the Kaplan-Meier survival analysis, the PP patients after appropriate ICD therapy were more prone to VA recurrence and all-cause mortality than SP patients (P<0.001 for both endpoints). The rate of appropriate ICD therapy and all-cause mortality in PP patients after the first appropriate ICD therapy was significantly higher than that in SP patients (for device therapy, 59.46 vs 20.64 patients per 100 patient-years; incidence rate ratio [IRR] 2.880, 95% confidence interval [CI]: 2.305–3.599; P<0.001; for all-cause mortality, 14.08 vs 5.40 deaths per 100 patient-years; IRR 2.607, 95% CI: 1.884–3.606; P<0.001). After propensity score matching for baseline characteristics, the risk of VA recurrence in PP patients with appropriate ICD therapy was still higher than that in SP patients (41.80 vs 19.10 patients per 100 patient-years; IRR 2.491, 95% CI: 1.889–3.287; P<0.001), but all-cause mortality rates were similar between the two groups (12.61 vs 9.33 deaths per 100 patient-years; IRR 1.352, 95% CI: 0.927–1.972; P = 0.117). Conclusions Once PP patients undergo appropriate ICD therapy, they will be more prone to VA recurrence and death than SP patients.

scholarly journals Mortality and readmission in non-ischemic compared with ischemic cardiomyopathies after implantable cardioverter-defibrillator implantation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Freeman ◽  
J Bjerre ◽  
C Parzynski ◽  
K Minges ◽  
T Ahmad ◽  
...  
Keyword(s):  
Heart Failure ◽  
Primary Prevention ◽  
Implantable Cardioverter Defibrillator ◽  
The United States ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Icd Implantation ◽  
Ventricular Ejection Fraction ◽  
Cardioverter Defibrillator ◽  
Risk Of Death

Abstract Background/Introduction Uncertainty remains regarding the benefit of primary prevention ICDs overall in contemporary practice, and particularly in those with NICM compared with ICM. Purpose To evaluate the contemporary risk of death and readmission following following implantable cardioverter-defibrillator (ICD) implantation in patients with non-ischemic cardiomyopathies (NICM) compared with ischemic cardiomyopathies (ICM) in a large nationally representative cohort in the United States. Methods We used data from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ICD Registry linked with Medicare claims from April 1, 2010 to December 31, 2013 to establish a cohort of NICM and ICM patients with a left ventricular ejection fraction ≤35% who received a de novo, primary prevention ICD. We compared mortality, all-cause readmission, and heart failure readmission using Kaplan-Meier curves and Cox proportional hazard regressions models. We also evaluated temporal trends in mortality. Results Among 31,044 NICM and 68,458 ICM patients with a median follow up of 2.4 years, one-year mortality was significantly higher in ICM patients (12.3%) compared with NICM (7.9%, p&lt;0.001). The higher mortality in ICM patients remained significant after adjustment for covariates (hazard ratio (HR) 1.40; 95% confidence interval (CI) 1.36 to 1.45), and was consistent in subgroup analyses. These findings were consistent across the duration of the study. ICM patients were also significantly more likely to be readmitted for all causes (adjusted HR 1.15, CI 1.12 to 1.18) and for heart failure (adjusted HR 1.25, CI 1.21 to 1.31). Conclusions The risks of mortality and hospital readmission after primary prevention ICD implantation were significantly higher in patients with ICM compared with NICM, and these findings were consistent across all patient subgroups tested and over the duration of the study. Funding Acknowledgement Type of funding source: None

Sign in / Sign up

Export Citation Format

Share Document