First Expert Evaluation of a New Steerable Catheter in an Isolated Beating Heart
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Cardiovascular Engineering and Technology (Ó 2020) https://doi.org/10.1007/s13239-020-00499-3
Original Article
First Expert Evaluation of a New Steerable Catheter in an Isolated Beating Heart AWAZ ALI
,1 TAMAS SZILI-TOROK,2 MARCO STIJNEN,3 PAUL BREEDVELD,1 and DIMITRA DODOU1
1
BioMechanical Engineering, Delft University of Technology, Delft, Zuid-Holland, The Netherlands; 2Erasmus Medical Center, Electrophysiology, Rotterdam, Zuid-Holland, The Netherlands; and 3LifeTec Group, Eindhoven, The Netherlands (Received 24 December 2019; accepted 5 November 2020) Associate Editor Hwa Liang Leo oversaw the review of this article.
Abstract Purpose—In previous studies we developed two mechanical prototypes of steerable catheters: the Sigma, which uses joysticks to actuate two steerable tip segments, and the Epsilon, which has a handle that is an enlarged version of the tip. In this study, we present a first performance evaluation of the prototypes in the cardiac environment. The evaluation was carried out by an expert user, an electrophysiologist with over 20 years of experience, to obtain insight in clinically relevant factors. Methods—Two experiments were conducted. In the first experiment, the Sigma was used in a passive beating heart setup connected to pumps with a saline solution and camera visualization, and compared with the expert’s past experience with conventional steerable catheters. In the second experiment, the Sigma was used in an active beating heart setup with blood perfusion through the coronary arteries and echo visualization, and compared with the Epsilon prototype. The prototype was evaluated through questionnaires on task performance, catheter usability, and workload. After each of the experiments, the catheter characteristics were evaluated via a survey and followed by an in-depth interview. Results & Conclusions—The expert user found the passive beating heart setup to more successful than the active beating heart setup for the purpose of this experiment, with insightful visualization while the heart was in beating condition. The steerability of the prototypes was experienced as useful and clinically relevant. Based on the questionnaires and interview we were able to identify future design improvements and developments for the steerable catheter prototypes. Keywords—Expert opinion, Evaluation, Steerable catheter, Beating heart, Catheter design.
Address correspondence to Awaz Ali, BioMechanical Engineering, Delft University of Technology, Delft, Zuid-Holland, The Netherlands. Electronic mail: [email protected]
INTRODUCTION Catheters and sheaths are used to treat and diagnose disorders in the majority of cardiac interventions. Interventions include, for example, radiofrequency ablation to treat cardiac arrhythmia, replacement of calcified or leaking heart valves, and obtaining samples from the heart tissue during endo-mycoardial biopsy. Precise manipulation of cardiac catheters remains a complicated task, due to the dynamic cardiac environment and the limited freedom of catheter movement.5,13 Mal-posit
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