Editor's Choice – The ENGAGE Registry Ten Year Outcomes with the Endurant Stent Graft System for Endovascular Abdominal Aortic Aneurysm Repair
Bibliographic record
Abstract
OBJECTIVE: Long term performance of endovascular aneurysm repair has not been well studied. The Endurant Stent Graft Natural Selection Global Post-market Registry (ENGAGE) observational, multicentre, non-randomised, prospective global registry was used to assess long term outcomes in patients treated with the Endurant stent graft system (Medtronic, Santa Rosa, CA, USA). METHODS: Inclusion criteria were minimal and included patients who fell outside of the instructions for use guidance. Exclusion criteria were high probability of non-adherence to follow up requirements, or concurrent participation in another trial that could confound results. Clinical and imaging data were collected continuously to evaluate treatment efficacy through ten years. RESULTS: There were 1 263 patients enrolled in the ENGAGE registry, of whom 390 re-consented for follow up from more than five through ten years and constituted the extended follow up (FU) cohort. The other 873 patients made up the non-extended FU cohort. For the extended FU cohort from more than five through ten years, Kaplan-Meier rates with 95% confidence intervals (95% CIs) were 97.3% (95% CI 95.5 - 99.1%) for freedom from site reported all cause mortality, 75.7% (95% CI 70.4 - 81.0%) for freedom from Clinical Event Committee adjudicated aneurysm related mortality, and 99.4% (95% CI 98.6 - 100%) for freedom from conversion to open surgical repair. From zero through to ten years, these rates were 96.2% (95% CI 94.0 - 98.4%) for aneurysm rupture and 71.4% (95% CI 66.3 - 76.5%) for aneurysm related re-interventions. For the extended FU cohort in the first five years, freedom estimates were 99.2% (95% CI 98.4 - 100%) for aneurysm rupture and 83.6% (95% CI 79.9 - 87.3%) for aneurysm related re-interventions. Late re-interventions (n = 72) were associated with type Ia endoleaks (18/72), type II endoleaks (18/72), and type Ib endoleaks (16/72). At ten years, 64.1% of patients exhibited sac regression, 19.2% were sac stable, and 16.8% had sac expansion. CONCLUSION: This is the first study to report long term outcomes in a real world, global cohort of patients with abdominal aortic aneurysm treated with the Endurant stent graft. Overall, long term efficacy and durability were observed in patients who survived beyond five years post-enrolment in the ENGAGE registry.
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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 | 0.008 | 0.039 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.005 | 0.005 |
| Insufficient payload (model declined to judge) | 0.011 | 0.004 |
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".