P116 - FLUOROLESS IMPLANTATION OF PACEMAKER AND CARDIOVERTER-DEFIBRILLATOR USING ULTRASOUND AS THE PRIMARY IMAGING TOOL: A MULTI-OPERATOR EXPERIENCE IN RADICAL USE STUDY

Background: Conventional cardiac implantable electronic devices (CIEDs) implantation requires fluoroscopy and is associated with procedural complications including pneumothorax, lead dislodgement, perforation of the right ventricle, worsening tricuspid regurgitation, and radiation risk for patients and operators. The efficacy and safety of ultrasound-guided, with minimal fluoroscopy CIED implantation needs to be determined.

METHODS AND RESULTS:

Methods: We conducted a prospective, single-centre, nonrandomized, multi-operator, clinical study involving patients requiring a single-chamber CIED. The primary efficacy endpoint was successful single-chamber CIED implantation with < 20 seconds of fluoroscopy time, inclusive of 5 seconds of fluoroscopy to confirm the slack and lead position as mandated by ethics. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful implantation was greater than 75%. The primary safety endpoint was freedom from pneumothorax, lead dislodgement, cardiac perforation, and worsening tricuspid regurgitation (TR) at 12 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from procedural complications was greater than 85%.

Results: Sixty-nine patients received CIEDs with a mean age of 80.4 ± 13.4 years (95% CI = 76.4 – 83.0). The percentage of patients with successful device implantation with < 20 seconds of fluoroscopy was 87% (lower bound of one-sided 97.5% CI = 77.5, P value = 0.01, for comparison with the performance goal of 75%. The Kaplan-Meier estimate of the percentage of patients free from acute complications and lead-associated worsening TR up to 12 months was 94.2, lower bound of one-sided 97.5% = 86.8%, P< 0.01, for comparison with the performance goal of 85%. At 12 months, there were no pneumothorax or cardiac perforation; one patient had micro lead dislodgement (1.4%) and three patients had worsening TR (4.3%). The mean procedural time, including ultrasound setup, was 64.3 ± 20.3 (95% CI = 59.4 - 69.2) minutes. The median fluoroscopic duration was 6 (IQR = 2-11) seconds, and the change in tricuspid regurgitation was 1.8 ± 11.6 (-1.9 – 5.4) mmHg. One lead was revised due to microdislodgement at 4 months.

Conclusion: In this prospective, single-centre, cohort study, we found that ultrasound guidance for implanting single-chamber CIEDs is efficacious and safe. Larger randomized controlled trials are needed to substantiate these observations.