Abstract 14753: A Novel Quadripolar Lead with a Narrow-Spaced Bipole Allows for Effective LV Pacing While Avoiding Phrenic Nerve Stimulation - Attain Performa LV Lead Study Primary Results
Bibliographic record
Abstract
Introduction: The Medtronic Attain Performa™ Model 4298 Quadripolar left ventricular (LV) Lead has 4 electrodes, provides 16 different polarities & includes a short bipole (1.3 mm between 2nd & 3rd electrodes). A prospective clinical study was conducted to investigate the safety and effectiveness of this new lead in 20 countries worldwide. Methods: Cardiac resynchronization therapy defibrillator (CRT-D) patients were enrolled & implanted with the Model 4298 LV lead & a Quad CRT-D device. All implanted subjects(SUB) were followed at 1, 3, 6 and every 6 months (M) post-implant. Pacing capture thresholds (PCTs) were measured manually or with automated testing methods. Adverse events (AEs) were reported upon occurrence & reviewed by an independent committee. Events requiring invasive intervention or resulting loss of CRT were considered to be complications. Results: Of 499 SUB (68 + 11 yr, 71% male) who underwent an LV lead implant attempt, 487 (97.6%) had an LV lead implanted, Most (73%) had NYHA Class III or IV symptoms, average LV ejection fraction was 25 ± 7%, QRS duration was 155 ± 24ms & most (71%) had LBBB. There were 20 LV lead related complications in 19 SUB over 6M (LV lead related complication free survival rate = 96%). Phrenic nerve stimulation (PNS) occurred in 31 SUB (6.3%) & resolved with no treatment (N=1) or noninvasive reprogramming (N=29). The average PCT at 6M was 1.1 + 0.7 V at the programmed vector and 93.9% of SUB had a PCT≤ 2.5V. The vast majority (97.7%) of SUB had > 1 additional selectable pacing vector with a PCT ≤ 4V and no PNS. Non-standard pacing polarities (i.e., vectors other than LV1 [LV tip] to right ventricular coil [RVC], LV2 to RVC & LV1 to LV2) were utilized in 56% of SUB. LV1 was not used in the final vector in 46% of SUB. The LV1 to RVC was utilized in 19%, LV1 to LV2 in 18% & the short bipole (LV2 to LV3) in 12%. Conclusions: This large multicenter study demonstrated that implantation of the Model 4298 LV quadripolar lead is associated with a low complication rate and no unanticipated complications. PNS can be readily resolved with reprogramming & that PCT values are low & stable over time. Moreover, At least 1 back-up LV pacing vector was available in the vast majority of SUB. Non-standard vectors, including the short bipole (LV2-LV3) were used in 56% of subjects.
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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 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 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 | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".