A novel tool to evaluate the implant position and predict defibrillation success of the subcutaneous implantable cardioverter-defibrillator: The PRAETORIAN score

Abstract

Background: Suboptimal positioning of the subcutaneous implantable cardioverter-defibrillator (S-ICD) increases the defibrillation threshold and risk of conversion failure.

Objective: Our objective is to develop a tool to evaluate the implant position and predict defibrillation success of the S-ICD: the PRAETORIAN score.

Methods: The PRAETORIAN score is based on clinical and computer modeling knowledge of determinants affecting the defibrillation threshold: subcoil fat, subgenerator fat, and anterior positioning of the S-ICD generator. The score evaluates these determinants on the postoperative anterior-posterior and lateral chest radiographs and has 3 categories: 30-<90 points representing a low risk, 90-<150 points representing an intermediate risk, and ≥150 points representing a high risk of conversion failure. The score was developed using 2 separate S-ICD data sets for derivation and validation. The performance metrics are the positive and negative predictive values.

Results: The development data set consisted of 181 patients with S-ICD, and the validation cohort consisted of 321 patients from the S-ICD Investigational Device Exemption trial. The distribution of scores was 93%-98% low risk (<90 points), 2%-5% intermediate risk (90-<150 points), and 1% high risk (≥150 points). The positive predictive value for an intermediate or high PRAETORIAN score for a failed conversion test was 51%, while a low PRAETORIAN score predicted a successful conversion in 99.8% of patients.

Conclusion: The PRAETORIAN score allows the identification of patients with high defibrillation thresholds by using the routine chest radiograph and provides feedback to implanters on S-ICD positioning. The PRAETORIAN-DFT trial will prospectively validate the score by randomizing to standard conversion testing vs using the score without conversion testing.

Keywords: Conversion testing; Defibrillation testing; Implantation; Subcutaneous implantable cardioverter-defibrillator.