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Application of the DILEMMA score to improve lesion selection for invasive physiological assessment.

ABSTRACT: OBJECTIVES:We sought to assess the validity of the DILEMMA score against instantaneous wave-free ratio (iFR) and evaluate its utility in rationalizing the number of patients referred for invasive physiological assessment. BACKGROUND:The DILEMMA score is a validated angiographic scoring tool incorporating minimal lumen diameter, lesion length and subtended myocardial area that has been shown to predict the functional significance of lesions as assessed by fractional flow reserve (FFR). METHODS:Patients in the DEFINE-FLAIR study who had coronary stenosis of intermediate severity were randomized to either FFR or iFR. DILEMMA score was calculated retrospectively on a subset of this cohort by operators blinded to FFR or iFR values. RESULTS:Three hundred and forty-six lesions (181 assessed by FFR; 165 by iFR) from 259 patients (mean age 66.0 years, 79% male) were included. A DILEMMA score???2 had a negative predictive value of 96.3% and 95.7% for identifying lesions with FFR >0.80 and iFR >0.89, respectively. A DILEMMA score???9 had a positive predictive value of 88.9% and 100% for identifying lesions with FFR ?0.80 and iFR ?0.89, respectively. The receiver operating characteristic area under the curve values for DILEMMA score to predict FFR ?0.80 and iFR ?0.89 were 0.83 (95% CI 0.77-0.90) and 0.82 (0.75-0.89) respectively. A DILEMMA score???2 or ?9 occurred in 172 of the 346 lesions (49.7%). CONCLUSIONS:Using DILEMMA score in patients with coronary stenosis of intermediate severity may reduce the need for pressure wire use, offering potential cost-savings and minimizing the risks associated with invasive physiological lesion assessment.

SUBMITTER: Michail M

PROVIDER: S-EPMC6824904 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Application of the DILEMMA score to improve lesion selection for invasive physiological assessment.

Michail Michael M Dehbi Hakim-Moulay HM Nerlekar Nitesh N Davies Justin E JE Sharp Andrew S P ASP Talwar Suneel S Cameron James D JD Brown Adam J AJ Wong Dennis T DT Mathur Anthony A Hughes Alun D AD Narayan Om O

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20190102 3

<h4>Objectives</h4>We sought to assess the validity of the DILEMMA score against instantaneous wave-free ratio (iFR) and evaluate its utility in rationalizing the number of patients referred for invasive physiological assessment.<h4>Background</h4>The DILEMMA score is a validated angiographic scoring tool incorporating minimal lumen diameter, lesion length and subtended myocardial area that has been shown to predict the functional significance of lesions as assessed by fractional flow reserve (F ...[more]

PMID: 30604558

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Project description:Physiological closed-loop controlled (PCLC) medical devices are complex systems integrating one or more medical devices with a patient's physiology through closed-loop control algorithms; introducing many failure modes and parameters that impact performance. These control algorithms should be tested through safety and efficacy trials to compare their performance to the standard of care and determine whether there is sufficient evidence of safety for their use in real care setting. With this aim, credible mathematical models have been constructed and used throughout the development and evaluation phases of a PCLC medical device to support the engineering design and improve safety aspects. Uncertainties about the fidelity of these models and ambiguities about the choice of measures for modeling performance need to be addressed before a reliable PCLC evaluation can be achieved. This research develops tools for evaluating the accuracy of physiological models and establishes fundamental measures for predictive capability assessment across different physiological models. As a case study, we built a refined physiological model of blood volume (BV) response by expanding an original model we developed in our prior work. Using experimental data collected from 16 sheep undergoing hemorrhage and fluid resuscitation, first, we compared the calibration performance of the two candidate physiological models, i.e., original and refined, using root-mean-squared error (RMSE), Akiake information criterion (AIC), and a new multi-dimensional approach utilizing normalized features extracted from the fitting error. Compared to the original model, the refined model demonstrated a significant improvement in calibration performance in terms of RMSE (9%, P = 0.03) and multi-dimensional measure (48%, P = 0.02), while a comparable AIC between the two models verified that the enhanced calibration performance in the refined model is not due to data over-fitting. Second, we compared the physiological predictive capability of the two models under three different scenarios: prediction of subject-specific steady-state BV response, subject-specific transient BV response to hemorrhage perturbation, and leave-one-out inter-subject BV response. Results indicated enhanced accuracy and predictive capability for the refined physiological model with significantly larger proportion of measurements that were within the prediction envelope in the transient and leave-one-out prediction scenarios (P < 0.02). All together, this study helps to identify and merge new methods for credibility assessment and physiological model selection, leading to a more efficient process for PCLC medical device evaluation.

Dataset Information

Application of the DILEMMA score to improve lesion selection for invasive physiological assessment.

Publications

Application of the DILEMMA score to improve lesion selection for invasive physiological assessment.

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