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. 2020 Dec;11(6):769-782.
doi: 10.1007/s13239-020-00499-3. Epub 2020 Nov 18.

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  4 , Dimitra Dodou  4
Affiliations

First Expert Evaluation of a New Steerable Catheter in an Isolated Beating Heart

Awaz Ali et al. Cardiovasc Eng Technol. 2020 Dec.

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: Beating heart; Catheter design; Evaluation; Expert opinion; Steerable catheter.

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Figures

Figure 1
Figure 1
Overview of limitations, clinical effects, and mechanical challenges that were identified and solved in previous research. Figure adopted and modified from Ref. .
Figure 2
Figure 2
The concept of catheter steering with multiple segments explained in DOF, with (a) 1 DOF steering with one steerable segment, (b) 2 DOF steering with one steerable segment, and c) 4 DOF steering with two steerable segments. Image adopted from Ref. .
Figure 3
Figure 3
Prototypes of (a) the Sigma catheter with joystick control through thumb and index finger and (b) the Epsilon catheter with a handle that is an enlarged version of the tip.
Figure 4
Figure 4
Preparation of the passive beating heart setup: (a) passive beating heart prepared by connection of a pulsatile dynamic fluid system with a saline solution to a porcine heart (b) handle of the steerable Sigma catheter used in the experiment.
Figure 5
Figure 5
Preparation of the active beating heart setup by cannulating a porcine heart and mounting it in a circulation platform with porcine blood.
Figure 6
Figure 6
Flowchart representing both experiments.
Figure 7
Figure 7
Endoscopic views of the Sigma catheter tip in the passive beating heart in various positions in the ventricle.
Figure 8
Figure 8
(a and b) Echocardiography views of the Sigma catheter tip in the active beating heart, (c) cardiac fibrillation to start the cardiac beating motion.
Figure 9
Figure 9
Task performance scores for (a) conventional steerable catheters from previous experience, (b) the Sigma catheter in the passive beating heart experiment, (c) the Sigma catheter in the active beating heart experiment, and (d) the Epsilon catheter in air.
Figure 10
Figure 10
Overview of NASA TLX raw data for each of the catheters. MD mental demand, PD physical demand, TD temporal demand, P performance, E effort, F frustration.
Figure 11
Figure 11
Catheter characteristics of the Sigma compared to conventional catheters.
Figure 12
Figure 12
Prediction of effects for the Sigma catheter in comparison with conventional catheters.
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