Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing

Quast, Anne‐Floor B.E.; Baalman, Sarah W.E.; Betts, Timothy R.; Boersma, Lucas V.A.; Bonnemeier, Hendrik; Boveda, Serge; Brouwer, Tom F.; Burke, Martin C.; Delnoy, Peter Paul H.M.; El‐Chami, Mikhael F.; Kuschyk, Juergen; Lambiase, Pier D.; Marquié, Christelle; Miller, Marc A.; Smeding, Lonneke; Wilde, Arthur A.M.; Knops, Reinoud E.

doi:10.1016/j.ahj.2019.05.002

Cited by 47 publications

(25 citation statements)

References 20 publications

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“…The combination of these and our findings support the call for the elimination of routine DT testing at S‐ICD implantation, making S‐ICD procedures more similar to TV‐ICD implantations and avoiding all the risks related to VF induction, especially in critically ill patients. We hope that results from RCTs may soon completely assess this topic 12 …”

Section: Discussionmentioning

confidence: 99%

“…A recent pivotal study from Quast et al 11 has shown the PRAETORIAN score being capable of predicting shock efficacy and of identifying patients at high risk of conversion failure, thus questioning DT necessity. This score may have the potential of replacing DT in clinical practice and its prospective validation is being performed in a dedicated randomized controlled trial (RCT) 12 …”

Section: Introductionmentioning

confidence: 99%

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Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

Ricciardi

Ziacchi

Gasperetti

et al. 2020

Cardiovasc electrophysiol

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Background Current guidelines recommend defibrillation testing (DT) performance in patients with a subcutaneous implantable cardioverter defibrillator (S‐ICD), theoretically to reduce the amount of ineffective shocks. DT, however, has been proven unnecessary in transvenous ICD and real‐world data show a growing trend in avoidance of DT after S‐ICD implantation. Methods All patients undergoing S‐ICD implant at nine associated Italian centers joining in the ELISIR registry (http://ClinicalTrials.gov Identifier: NCT04373876) were enrolled and classified upon DT performance. Long‐term follow‐up events were recorded and compared to report the long‐term efficacy and safety of S‐ICD implantations without DT in a real‐world setting. Results A total of 420 patients (54.0 ± 15.5 years, 80.0% male) were enrolled in the study. A DT was performed in 254 (60.5%) patients (DT+ group), while in 166 (39.5%) was avoided (DT− group). Over a median follow‐up of 19 (11–31) months, a very low rate (0.7%) of ineffective shocks was observed, and no significant differences in the primary combined arrhythmic outcome were observed between the two groups (p = .656). At regression analysis, the only clinical predictor associated with the primary combined outcome was S‐ICD placement for primary prevention (odds ratio: 0.42; p = .013); DT performance instead was not associated with a reduction in primary outcome (p = .375). Conclusion Implanting an S‐ICD without DT does not appear to impact the safety of defibrillation therapy and overall patients' survival.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

Ricciardi

Ziacchi

Gasperetti

et al. 2020

Cardiovasc electrophysiol

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“…Indeed, recent reports show that despite a class I recommendation, ventricular fibrillation termination testing is declining in clinical practice, owing to physician preference . However, definite data on the actual need for defibrillation testing will be yielded by the ongoing randomized Trial of S‐ICD implantation with and without defibrillation testing (PRAETORIAN‐DFT), which aims to prove the safety of withholding defibrillation verification when implantation optimization is based on the PRAETORIAN score …”

Section: Discussionmentioning

confidence: 99%

Serratus anterior plane block in subcutaneous implantable cardioverter defibrillator implantation: A case‐control analysis

Ziacchi

Bisignani²,

Palmisano³

et al. 2019

Cardiovasc electrophysiol

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Background: A two-incision technique, in association with inter-muscular positioning of the subcutaneous defibrillator (S-ICD), is now the most frequently adopted implantation approach in Europe. Ultrasound-guided serratus anterior plane block (SAPB) has been proposed to provide anesthesia/analgesia during S-ICD implantation.Objective: We performed a case-control analysis in which a standardized SAPB approach was compared with the typical local anesthesia and sedation approach.Methods: Ninety-one consecutive patients underwent implantation of an S-ICD with the SAPB approach for anesthesia/analgesia at 10 centers. The control group consisted of 55 consecutive patients who underwent S-ICD implantation with a standard local approach.Results: The mean procedure duration was 59 ± 15 minutes in the SAPB group and 76 ± 23 minutes in the control group (P < .001). No operative complications were reported in either group. During the procedure, 79 (87%) patients in the SAPB group and 25 (46%) patients in the control group (P < .001) remained awake. Lower values of pain intensity at the device pocket (P = .005) and the lateral tunneling site (P = .046) were reported in the SAPB group. The difference in static (P = .002) and dynamic (P = .007) pain intensity between the groups persisted at 1 hour, while no differences were observed 6 hours after the end of the procedure.Conclusions: SAPB is feasible and effective in providing anesthesia/analgesia during S-ICD implantation. The procedures were successfully accomplished and no complications occurred in either group. However, SAPB was associated with lower Correspondence

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“…Others came up with a method to assess implant position to identify patients who are likely to fail their DFT [35]. Currently, an ongoing randomised controlled trial is testing the hypothesis that S-ICD implantation is safe when these implant requirements are met: PRAETORIAN-DFT (NCT03495297) [36]. This trial, the results of which are expected in 2023, will be the first study to take the different factors that influence defibrillation success into account.…”

Section: Omission Of Dft In S-icd Implantsmentioning

confidence: 99%

Defibrillation testing during implantation of the subcutaneous implantable cardioverter-defibrillator: a necessary standard or becoming redundant?

2020

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Since the publication of the SIMPLE and NORDIC trials, defibrillation testing (DFT) is rarely performed during routine implantation of transvenous implantable cardioverter-defibrillators (ICD). However, the results of these trials cannot be extrapolated to the later introduced subcutaneous ICD (S-ICD) and a class I recommendation to perform DFT during the implantation of these devices remains in the current guidelines. Due to the high conversion success rate of DFT on one hand, and the risk of complications on the other, a significant number of physicians omit DFT in S-ICD recipients. Several retrospective analyses have assessed the safety of the omission of DFT and report contradicting results and recommendations. It is known that implant position, as well as device factors and patient characteristics, influence defibrillation success. A better comprehension of these factors and their relationship could lead to more reliable and safer alternatives to DFT. An ongoing randomised clinical trial, which is expected to end in 2023, is the first study to implement a method that assesses implant position to identify patients who are likely to fail their DFT.

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Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing

Cited by 47 publications

References 20 publications

Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

Serratus anterior plane block in subcutaneous implantable cardioverter defibrillator implantation: A case‐control analysis

Defibrillation testing during implantation of the subcutaneous implantable cardioverter-defibrillator: a necessary standard or becoming redundant?

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