心臓ペースメーカーおよびカーディオバーター・デフィブリレーターの超音波画像誘導による無造影implantation：ラジカル使用試験における複数術者の経験

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

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 would be met if the lower boundary of the one-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 would be met if the lower boundary of the one-sided 97.5% CI for percentage of patients free from procedural complications was >85%.

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 in <20 seconds of fluoroscopy was 87% (lower bound of one-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 one-sided 97.5% CI, P<0.01). One lead dislodgement and 3 lead-related worsening TR 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 (IQR=2-11) seconds.

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.