Fluoroless Implantation of Pacemaker and Cardioverter-Defibrillator Using Ultrasound As An Imaging Tool: A...

Area of Science:

• Cardiology
• Medical Imaging
• Interventional Procedures

Background:

• Cardiac implantable electronic devices (CIEDs) implantation traditionally relies on fluoroscopy, posing risks like pneumothorax, lead dislodgement, cardiac perforation, tricuspid regurgitation, and radiation exposure.
• The need for safer and more effective CIED implantation techniques is critical to mitigate procedural complications and radiation risks for patients and healthcare providers.

Purpose of the Study:

• To determine the efficacy and safety of utilizing ultrasound guidance for the implantation of single-chamber CIEDs.
• To evaluate if ultrasound-guided CIED implantation meets predefined success criteria for reduced fluoroscopy time and minimal procedural complications.

Main Methods:

• A prospective, nonrandomized, multioperator, single-center study involving patients requiring single-chamber CIED implantation.
• Primary efficacy endpoint: successful CIED implantation with less than 20 seconds of fluoroscopy.
• Primary safety endpoint: freedom from procedural complications at 12 months post-implantation.

Main Results:

• Successful CIED implantation in 87% of patients using <20 seconds of fluoroscopy (lower bound of 97.5% CI = 77.5%).
• 94.2% of patients remained free from procedural complications at 12 months (lower bound of 97.5% CI = 86.8%).
• Low rates of complications observed: one lead dislodgement and three cases of lead-related worsening tricuspid regurgitation.

Conclusions:

• Ultrasound guidance is an efficacious and safe method for implanting single-chamber CIEDs.
• The findings support ultrasound guidance as a viable alternative to traditional fluoroscopy-based implantation.
• Further validation through larger randomized controlled trials is recommended to confirm these promising results.