Description

Robotic systems for minimally invasive operations.

Domain

Surgical support

Leader

SERMAS Hospital (Spain)

Background

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in adults and one of the 3 cardiovascular pandemics of the XXI century according to the World Health Organization. Most treatments are aimed to reduce the complications of this disease, like anticoagulation to prevent stroke. However, pharmacological therapies to prevent AF episodes or the progression of the disease have shown disappointing results with minor or neutral effects in major outcomes. Catheter ablation has shown to be more effective than drugs to keep patients without this arrhythmia, preventing its progression and reducing follow-up events.

 

Problems

  • The procedure depends on the operator’s dexterity and experience, which results in a heterogeneity of clinical practice and an important barrier to offer the therapy to many patients.
  • The learning curve for manual catheter use is slow.
  • EP laboratories and physicians are not available in all hospitals.
  • Already developed robotic mechanical navigation systems have no impact on safety, operator dependency and procedure time.

 

Objectives

Facilitate the ablation procedure, either for the physician and the patient, by developing a remote magnetic navigation (RMN) approach.

  • Improve the procedure efficacy.
  • Reduce complications.
  • Make the procedure less operator dependent and more automatized.
  • Reduce the learning curve for the operator.
  • Allow to perform ablation remotely.
  • Demonstrate that the combination of RMN can reduce the total procedure time.
  • Prepare the path to allow future ventures to automatize part of an ablation procedure.
  • Review and archive data during EP procedures to create a database that can be leveraged for further research.

 

The solution

Our solution employs state-of-the-art RMN. Within the workspace of a Magnetic Navigation System (MNS), a magnetic catheter is positioned. The MNS allows for the generation of magnetic fields in arbitrary directions. By adjusting the MNS’s magnetic field, we gain the ability to manipulate the magnetic catheter, ensuring it aligns with the generated field. Consequently, the operator can directly steer the catheter tip by changing the external magnetic fields produced by the MNS.

This method has been proven to significantly enhance the operator’s dexterity, streamlining the learning process. Moreover, the robotic nature of RMN enables remote control by an operator from a distance, paving the way for sharing expertise to more remote regions.

Figure 1: The GUI shows the surgeon the status of the ablation targets and the location of the catheter tip.
Figure 2: Heart phantom used for the in-vitro experiments. (A) The ablation catheter is advanced from the femoral vein to the right atrium and into the left atrium through a transseptal puncture. (B) The two endoscopic cameras track the position of the catheter tip. (C) The triggers causing atrial fibrillation often lie in the pulmonary veins. In pulmonary vein isolation, the operator ablates points around these veins to electrically isolate the triggers and restore the normal heartbeat.
Figure 3: Evaluation setup for assessing the performance of manual catheter navigation. Manual navigation represents the current gold standard for catheter manipulation, providing a comprehensive framework for data collection and analysis.
Figure 4: Telesurgery experiments between Madrid and Zurich. An electrophysiologist in Madrid remotely controls a Magnetic Navigation System located in Zurich. The objective of the operator is to navigate the catheter to all defined ablation targets accurately and efficiently.

Value proposition

Our RMN-based approach represents a significant advancement in the treatment of AF. By facilitating precise AF ablations from a distance, our goal is to enhance procedural efficacy, minimize complications and automate aspects of the procedure. We prioritize offering healthcare professionals a practical and efficient tool, reducing the learning curve, allowing remote ablation and preparing the way for the automation of AF ablation procedures.