The Canadian journal of cardiology · 2025
Fluoroless Implantation of Pacemaker and Cardioverter-Defibrillator Using Ultrasound As An Imaging Tool: A Multi-Operator Experience in Radical Use Study.
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Khan Habib Rehman, Triemstra Samuel, Pardo Abbie, Moustafa Ahmed T, Mokhtar Ahmed T, Antiperovitch Pavel, Saravu Saketh, Mtwesi Viwe, Gula Lorne J, Leong-Sit Peter, Manlucu Jaimie, Yee Raymond, Tang Anthony
Аннотация
BACKGROUND: Cardiac implantable electronic device (CIED) implantation requires fluoroscopy and is associated with procedural complications, including pneumothorax, lead dislodgement, cardiac perforation, lead-associated tricuspid regurgitation, and radiation risk for patients and operators. The efficacy and safety of ultrasound-guided CIED implantation need to be determined.
METHODS: A prospective, nonrandomized, multioperator, single-centre study enrolled patients requiring a single-chamber CIED. The primary efficacy endpoint was successful single-chamber CIED implantation with < 20 seconds of fluoroscopy time. The efficacy objective is met if the lower boundary of the 1-sided 97.5% confidence interval (CI) for percentage of patients with successful implantation is > 75%. The primary safety endpoint was freedom from procedural complications at 12 months and was met if the lower boundary of the 1-sided 97.5% CI for percentage of patients free from procedural complications was > 85%.
RESULTS: A total of 69 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 in < 20 seconds of fluoroscopy was 87% (lower bound of 1-sided 97.5% CI = 77.5, P = 0.01). The Kaplan-Meier estimate of percentage of patients free from complications was 94.2% (lower bound of 86.8% for the 1-sided 97.5% CI, P < 0.01). One lead dislodgement and 3 cases of lead-related worsening tricuspid regurgitation occurred during 12 months of follow-up. The mean procedural time was 64.3 ± 20.3 (95% CI = 59.4-69.2) minutes. The median fluoroscopic duration was 6 seconds (interquartile range = 2-11).
CONCLUSIONS: In this 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.
CLINICAL TRIAL REGISTRATION: NCT04858698.
METHODS: A prospective, nonrandomized, multioperator, single-centre study enrolled patients requiring a single-chamber CIED. The primary efficacy endpoint was successful single-chamber CIED implantation with < 20 seconds of fluoroscopy time. The efficacy objective is met if the lower boundary of the 1-sided 97.5% confidence interval (CI) for percentage of patients with successful implantation is > 75%. The primary safety endpoint was freedom from procedural complications at 12 months and was met if the lower boundary of the 1-sided 97.5% CI for percentage of patients free from procedural complications was > 85%.
RESULTS: A total of 69 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 in < 20 seconds of fluoroscopy was 87% (lower bound of 1-sided 97.5% CI = 77.5, P = 0.01). The Kaplan-Meier estimate of percentage of patients free from complications was 94.2% (lower bound of 86.8% for the 1-sided 97.5% CI, P < 0.01). One lead dislodgement and 3 cases of lead-related worsening tricuspid regurgitation occurred during 12 months of follow-up. The mean procedural time was 64.3 ± 20.3 (95% CI = 59.4-69.2) minutes. The median fluoroscopic duration was 6 seconds (interquartile range = 2-11).
CONCLUSIONS: In this 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.
CLINICAL TRIAL REGISTRATION: NCT04858698.