ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy
Bibliographic record
Abstract
AIMS: The ALternate Site Cardiac ResYNChronization (ALSYNC) study evaluated the feasibility and safety of left ventricular endocardial pacing (LVEP) using a market-released pacing lead implanted via a single pectoral access by a novel atrial transseptal lead delivery system. METHODS AND RESULTS: ALSYNC was a prospective clinical investigation with a minimum of 12-month follow-up in 18 centres of cardiac resynchronization therapy (CRT)-indicated patients, who had failed or were unsuitable for conventional CRT. The ALSYNC system comprises the investigational lead delivery system and LVEP lead. Patients required warfarin therapy post-implant. The primary study objective was safety at 6-month follow-up, which was defined as freedom from complications related to the lead delivery system, implant procedure, or the lead ≥70%. The ALSYNC study enrolled 138 patients. The LVEP lead implant success rate was 89.4%. Freedom from complications meeting the definition of primary endpoint was 82.2% at 6 months (95% CI 75.6-88.8%). In the study, 14 transient ischaemic attacks (9 patients, 6.8%), 5 non-disabling strokes (5 patients, 3.8%), and 23 deaths (17.4%) were observed. No death was from a primary endpoint complication. At 6 months, the New York Heart Association class improved in 59% of patients, and 55% had LV end-systolic volume reduction of 15% or greater. Those patients enrolled after CRT non-response showed similar improvement with LVEP. CONCLUSIONS: The ALSYNC study demonstrates clinical feasibility, and provides an early indication of possible benefit and risk of LVEP. CLINICAL TRIAL: NCT01277783.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".