Fluoroless Implantation of Pacemaker and Cardioverter-Defibrillator Using Ultrasound As An Imaging Tool: A Multi-Operator Experience in Radical Use Study
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".