Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center

ObjectivesTo determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.DesignRetrospective cohort.SettingThree health systems in the USA.ParticipantsPatients receiving ablation with the two ablation catheters of interest at any of the three health systems.Main outcome measuresFeasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.ResultsOverall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.ConclusionsIt is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.

Fluid–Structure Interaction and Non-Fourier Effects in Coupled Electro-Thermo-Mechanical Models for Cardiac Ablation

In this study, a fully coupled electro-thermo-mechanical model of radiofrequency (RF)-assisted cardiac ablation has been developed, incorporating fluid–structure interaction, thermal relaxation time effects and porous media approach. A non-Fourier based bio-heat transfer model has been used for predicting the temperature distribution and ablation zone during the cardiac ablation. The blood has been modeled as a Newtonian fluid and the velocity fields are obtained utilizing the Navier–Stokes equations. The thermal stresses induced due to the heating of the cardiac tissue have also been accounted. Parametric studies have been conducted to investigate the effect of cardiac tissue porosity, thermal relaxation time effects, electrode insertion depths and orientations on the treatment outcomes of the cardiac ablation. The results are presented in terms of predicted temperature distributions and ablation volumes for different cases of interest utilizing a finite element based COMSOL Multiphysics software. It has been found that electrode insertion depth and orientation has a significant effect on the treatment outcomes of cardiac ablation. Further, porosity of cardiac tissue also plays an important role in the prediction of temperature distribution and ablation volume during RF-assisted cardiac ablation. Moreover, thermal relaxation times only affect the treatment outcomes for shorter treatment times of less than 30 s.