Predictive value of the PRAETORIAN score for defibrillation test success in patients with subcutaneous ICD: A subanalysis of the PRAETORIAN-DFT trial

Background: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events. Objective: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias. Methods: This multicenter investigator-initiated trial randomized 965 patients between DFT and PRAETORIAN score calculation after de novo S-ICD implantation. Successful DFT was defined as conversion of induced ventricular arrhythmia in <5 seconds from shock delivery within 2 attempts. Bidirectional chest radiographs were obtained after implantation. The predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm. Results: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 (95%) underwent DFT according to protocol, of whom 445 (97%) had successful DFT and 12 (3%) had failed DFT. A PRAETORIAN score of ≥90 had a positive predictive value of 25% for failed DFT, and a PRAETORIAN score of <90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score of ≥90 was the strongest independent predictor for failed DFT (odds ratio 33.77; confidence interval 6.13–279.95; P <.001). Conclusion: A PRAETORIAN score of <90 serves as a reliable indicator for DFT success in patients with S-ICD, and a PRAETORIAN score of ≥90 is a strong predictor for DFT failure

The predictive value of the PRAETORIAN score for defibrillation test success in subcutaneous ICD patients:a sub-analysis of the PRAETORIAN-DFT trial

BACKGROUND: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter defibrillator (S-ICD) therapy, using generator and lead positioning on bidirectional chest radiographs. The PRAETORIAN-DFT trial investigates whether PRAETORIAN score calculation is non-inferior to defibrillation testing (DFT), with regard to first shock efficacy in spontaneous events.OBJECTIVE: This pre-specified sub-analysis assesses the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias.METHODS: This multicenter investigator initiated trial randomized 965 patients between DFT or PRAETORIAN score calculation after de novo S-ICD implant. Successful DFT was defined as conversion of an induced ventricular arrhythmia in less than five seconds from shock delivery, within two attempts. Bidirectional chest radiographs were obtained after implantation. Predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm.RESULTS: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 underwent DFT according to protocol, of whom 445 had a successful DFT and 12 had a failed DFT. A PRAETORIAN score ≥ 90 had a positive predictive value of 25% for failed DFT and a PRAETORIAN score &lt; 90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score ≥ 90 was the strongest independent predictor for failed DFT (OR 33.77; CI 6.13-279.95, p&lt;0.001).CONCLUSION: A PRAETORIAN score &lt;90 serves as a reliable indicator for DFT success in S-ICD patients and a PRAETORIAN score ≥90 is a strong predictor for DFT failure.</p

P6539Automated detection of atrial fibrillationb based on vocal features analysis

Abstract Background Early identification of atrial fibrillation (AF) has been a long-standing clinical challenge and an unmet need. AF may be present without the patient being aware of any symptoms, leading to a delay in or failure of diagnosis. ESC guidelines recommend opportunistically screening patients &gt;65 years of age using pulse palpation or an ECG rhythm strip, however these methods have limited effectivity. Analysis of natural speech signals has been used as a monitoring tool for various medical conditions and has recently been reported to enable estimation of heart rate. In this study we evaluated the efficacy of vocal features analysis in the detection of AF and in discriminating between sinus rhythm (SR) and episodes of AF. Methods In this prospective multicenter study, patients with persistent AF admitted for cardioversion were enrolled. A total of 86 patients in 2 centers were included. Prior to cardioversion, the patients spoke specific vowels and words according to a pre-specified protocol; an ECG tracing was simultaneously recorded. Following successful cardioversion and recovery from sedation, these recordings were repeated in SR. The recordings of the first 34 patients were used to develop an algorithm of AF detection based on analysis of acoustic features in SR and AF conditions. The algorithm was then validated in all of the patients (n=86) in the following manner: 25% of SR recordings were used to train the algorithm while the remaining 75% of SR and 100% of AF data from every patient were tested with the algorithm to distinguish between AF and SR. Results A total of 513 recordings from 86 patients were analyzed. Classification of the recordings as AF or SR was performed using varying cutoff values of the separation parameter. The resulting curve showing the specificity and sensitivity of the developed algorithm for distinguishing AF from SR is presented. Two specific examples of working points are a specificity of 92% and sensitivity of 83%, and a specificity of 82% and sensitivity of 92%. Conclusions This study demonstrates the feasibility of detecting AF and discriminating it from SR using analysis of acoustic features extracted from spoken vowels. The potential use of this method for wider population screening should be further evaluated. </jats:sec

Impact of the Covid-19 related lockdown on physical activity, heart rate and arrhythmia burden in a large prospective cohort of CHF patients

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): BIOTRONIK SE &amp; Co. KG OnBehalf BIO|STREAM.HF Background At the beginning of the Covid-19 pandemic in spring 2020, governments around the world issued curfews and other stay at home orders (‘lockdown’) to limit the spread of the SARS-CoV19 virus. This may have forced people to decrease their physical activity. Physical inactivity as well as social stress is known to be especially deleterious for heart failure (HF) patients. The BIO|STREAM.HF study enrolled such HF patients into a prospective registry with Home Monitoring. Purpose We aimed to evaluate the impact of the lockdown during the first Covid-19 pandemic wave on physical activity and arrhythmia burden of heart failure patients. Methods We analysed daily transmitted data of patients enrolled into a large international registry (BIO|STREAM.HF) being implanted with a cardiac resynchronization therapy (CRT) devices. Patients with NYHA ≥ II and LVEF ≤ 40% before CRT implantation were selected. Intra-individual weekly mean and median values were calculated for the following daily transmitted parameters: physical activity (measured as % of the day during which the patient moves), atrial arrhythmia burden, mean heart rate (at rest), PP variability, PVC burden, and rate of biventricular pacing. Values were calculated for 12 weeks before and 12 weeks after the country-specific effective date of most rigorous restrictions in spring 2020 to visualize the general trend of parameter changes. Moreover, values for intra-individual changes between three 28-days periods (before, during, and after the lockdown) were calculated. Results Of 444 patients, 76% were male. They had a mean age of 69 ± 10 years and LVEF of 28.2 ± 6.7%. HF was of ischemic etiology in 42% of cases and they were in NYHA class II (47.5%), III (50.0%) or IV (2.5%). On average, patients were active for 9% of the day (2 h 10 min). The physical activity decreased by approx. 10% with the onset of the lockdown (figure 1) and recovered within the following eight weeks. Comparison of the 28-days periods before, during and after the lockdown showed a statistically significant intra-individual decrease in physical activity (mean decrease 9 min per day) during the lockdown compared to pre- and post-lockdown values and a trend toward reduced mean heart rates. In parallel, a significant increase in device detected atrial arrhythmia burden (mean increase 17 min per day) was observed. All other parameters did not change significantly. Conclusion  Our results show that patients reduced their physical activity during the Covid-19 related lockdown in spring 2020. This was associated with an increase in atrial arrhythmia burden and a reduction of the mean heart rate. Prognostic implications of these results will further be analysed. Abstract Figure. </jats:sec