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Background: Inappropriate therapy (IAT) is an undesirable side effect of implantable cardiac defibrillator (ICD) therapy. Early studies with the subcutaneous ICD (S-ICD) showed relatively high inappropriate shock (IAS) rates. The PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial demonstrated that the S-ICD is noninferior to the transvenous ICD (TV-ICD) with regard to the combined end point of IAS and complications. This secondary analyses evaluates all IAT in the PRAETORIAN trial., Methods: This international, multicenter trial randomized 849 patients with an indication for ICD therapy between S-ICD (n=426) and TV-ICD therapy (n=423). ICD programming was mandated by protocol. All analysis were performed in the modified intention-to-treat population., Results: In both groups 42 patients experienced IAT (48-month Kaplan-Meier estimated cumulative incidence, 9.9% and 10.1%, respectively; hazard ratio (HR), 0.99 [95% CI, 0.65-1.52]; P =0.97). There was no significant difference in patients experiencing IAS between both groups ( P =0.14). In the S-ICD group, 81 IAT episodes with 124 IAS and 1 inappropriate antitachycardia pacing occurred versus 89 IAT episodes with 130 IAS and 124 inappropriate antitachycardia pacing in the TV-ICD group. IAT episodes were most frequently caused by supraventricular tachycardias in the TV-ICD group (n=83/89) versus cardiac oversensing in the S-ICD group (n=40/81). In the TV-ICD group, a baseline heart rate >80 bpm (HR, 1.99 [95% CI, 1.05-3.76]; P =0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41-5.02]; P =0.003), and smoking (HR, 2.46 [95% CI, 1.31-4.09]; P =0.005) were independent predictors for IAT. A QRS duration >120 ms was an independent predictor for IAT caused by cardiac oversensing in the S-ICD group (HR, 3.13 [95% CI, 1.34-7.31]; P =0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups ( P =0.046)., Conclusions: There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022., Competing Interests: Dr Knops reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cardiac, and has stock options from AtaCor Medical, Inc. Dr El Chami reports consultancy fees from Boston Scientific and Medtronic. Dr Mittal reports consultancy fees from Boston Scientific and Medtronic.Dr Neuzil reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. K.M. Kooiman reports consultancy fees from Boston Scientific. Dr Lambiase reports educational and research grants from and is in the research board of Boston Scientific, and reports research grants from Abbott. Dr Vernooy reports consultancy fees from Medtronic and Abbott. M.C. Burke is a consultant, receives honoraria, as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. Dr Wright has consultancy arrangements with Boston Scientific and Medtronic and a research grant from Boston Scientific. Dr Nordbeck reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. Dr Miller reports consultancy fees from Boston Scientific. Dr Whinnett is an advisor for Boston Scientific, on the advisory board for Medtronic and Abbot, and reports speaker fees from Medtronic. The other authors report no conflicts.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life., Methods: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time., Results: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning ( P =0.008) and role limitations due to emotional problems ( P =0.001) than patients without a shock, but this effect did not differ between treatment arms., Conclusions: In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022., Competing Interests: Dr Knops reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical, Inc. Dr El Chami reports consultancy fees from Boston Scientific and Medtronic. Dr Mittal reports consultancy fees from Boston Scientific and Medtronic. K.M. Kooiman reports consultancy fees from Boston Scientific. Dr Lambiase reports educational and research grants from and is in the research board of Boston Scientific, and reports research grants from Abbott. Dr Vernooy reports consultancy fees from Medtronic and Abbott. M.C. Burke is a consultant and receives honoraria, as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. Dr Wright has consultancy arrangements with Boston Scientific and Medtronic and iRhythm and a research grant from Boston Scientific. Dr Nordbeck reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. Dr Miller reports consultancy fees from Boston Scientific. Dr Whinnett is an advisor for Boston Scientific and is on the advisory board for Medtronic and Abbot and reports speaker fees from Medtronic. The other authors report no conflicts.

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., Competing Interests: Disclosures Dr Knops reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cardiac and has stock options from AtaCor Medical Inc. Dr El-Chami reports consultancy fees from Medtronic and Boston Scientific. Dr Marquie reports consultancy fees from Boston Scientific.Dr Tilz reports consultancy fees from Boston Scientific, Biotronik, Biosense Webster, and Abbott Medical; speaker’s honoraria from Boston Scientific, Biotronik, Biosense Webster, Abbott Medical, and LifeTech; and research grants from Abbott, Biosense Webster, and LifeTech. Dr Lambiase reports research contracts with Boston Scientific and is a member of the advisory board of Boston Scientific. Dr Manyam reports consultancy fees from Janssen and Abbott. Dr Betts received honoraria for speaking and proctoring from Boston Scientific. Dr Bijsterveld presented at a conference of Abbott and gave a presentation sponsored by AstraZeneca. Dr Field reports being a speaker and proctor for Boston Scientific. Dr Golovchiner reports being a proctor for Boston Scientific. Dr de Jong reports consultancy fees from Medtronic. Dr Lewis reported to receive travel grants and honoraria from Abbott, Boston Scientific, and Medtronic. Dr Martin reported to receive research grants, honoraria, and speaker’s fees from Boston Scientific and honoraria and speaker’s fees from Medtronic and Biosense Webster. Dr Miller reported to receive consultancy fees from Boston Scientific. Dr Shaik reported to receive consultancy fees from Boston Scientific, Medtronic, and Biotronik. Dr Kuschyk reported to receive consultancy fees and honoraria from Boston Scientific, consultancy fees from Impulse Dynamics, and honoraria fees from Medtronic. Dr Boveda reported to receive consultancy fees from Medtronic, Boston Scientific, MicroPort, and Zoll. Dr Kaiser is a proctor for Boston Scientific. Dr Maass reported to receive consultancy fees from Boston Scientific and Medtronic, with all fees going to the department of Cardiology of the University Medical Center Groningen. Dr Wilde is a consultant for ARMGO and Thyrvv Therapeutics. The rest of the authors report no conflicts of interest., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial., Methods and Results: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047)., Conclusion: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice., Competing Interests: Conflict of interest: R.E.K reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical Inc. S.M. reports consultancy fees from Boston Scientific. K.V. reports consultancy fees from Medtronic and Abbott. M.C.B. is a consultant and receives honoraria, as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. D.J.W. has consultancy arrangements with Boston Scientific and Medtronic and a research grant from Boston Scientific. P.N. reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. M.A.M. reports consultancy fees from Boston Scientific. Z.I.W. is an advisor for Boston Scientific and on the advisory board for Medtronic and Abbot and reports speaker fees from Medtronic. The other authors report no conflicts., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.)

Background: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks., Methods: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population., Results: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P =0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P =0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group ( P =0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group ( P =0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group ( P =0.05)., Conclusions: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Aims: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation., Methods and Results: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality., Conclusion: Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)