Sensing and detection performance of the novel, small-diameter omniasecure defibrillation lead: leadr trial analysis
Bibliographic record
Abstract
Abstract Introduction The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the small-diameter (4.7Fr), integrated bipolar OmniaSecure defibrillation lead. The trial exceeded primary safety and efficacy endpoint thresholds, demonstrating favorable performance and zero fractures through ~12 mo; patients remain in ongoing follow-up. Purpose To report on chronic electrical performance of the OmniaSecure lead through midterm follow-up of the LEADR trial. Methods Patients with indication for de novo ICD/CRT-D were implanted with the OmniaSecure lead in standard RV locations and followed at prespecified intervals along with CareLink. Results As reported, a total of 643 patients were implanted with the OmniaSecure lead; the lead continues to show favorable safety, efficacy, and reliability with zero fractures through midterm follow-up (18.2 ± 5.5 mo). Electrical measurements (Pacing capture threshold, pacing impedance, and R-wave amplitude) were chronically stable through follow-up; average R-wave amplitudes were >10mV throughout (Figure 1). Nineteen patients had reports of P-wave oversensing (PWOS), however there were zero inappropriate shocks due to PWOS. Among those with associated adverse events, 3 resulted in system modification and 1 in reprogramming. The remaining 15 patients had instances of PWOS noted by physicians via monitoring that were not associated with an adverse event; resolved via repositioning at implant (1) and reprogramming (14). Thirty-eight patients had reports of T-wave oversensing (TWOS). Among these, 1 patient had a system modification and 3 patients had reprogramming after inappropriate shock after which no further IAS was reported. The remaining 34 patients had instances of TWOS noted by physicians at device checks that were not associated with an adverse event; 1 resulted in unsuccessful implant and 1 had no action taken for lack of clinical concern, the others were resolved via repositioning at implant (1) and reprogramming (31). Additionally, 1 patient reported both TWOS and PWOS; both resolved via reprogramming with no further reports of TWOS/PWOS. During induced VF sensing at implant, 98% (119/122) of patients showed appropriate detection at the least sensitive setting (1.2mV) and the remaining were successful at more sensitive settings. There were 670 ambulatory VT/VF episodes appropriately treated in 94 patients, all of which were successfully detected across a variety of programmed sensitivities (Table 1) with no reported undersensing. Conclusion Chronic sensing performance of the OmniaSecure defibrillation lead demonstrated R-wave stability with a low rate of PWOS and TWOS, predominantly resolved by reprogramming RV sensitivity. Furthermore, VT/VF detection was successful in all patients and was not impacted when reprogrammed to less sensitive settings. The OmniaSecure lead shows a robustness of sensing and detection performance and programmability.Figure 1:Chronic electrical stability o Table 1:Proportion of successfully trea
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".