Comparative Effectiveness of TAVI Platforms and Surgical Aortic Valve Replacement: A Network Meta-Analysis of Randomized Controlled Trials
Bibliographic record
Abstract
BACKGROUND: Evidence informing clinical guidelines assumes that all transcatheter aortic valve implantation (TAVI) devices have similar effectiveness, in other words, displaying a class effect across TAVI valves. We aimed to assess the comparative effectiveness of different TAVI platforms relative to other TAVI counterparts or surgical aortic valve replacement (SAVR). METHODS: MEDLINE/Embase/CENTRAL were searched from inception until April 2025, for randomized controlled trials comparing outcomes with different commercially available TAVI devices relative to other TAVI counterparts or SAVR. The certainty of the evidence was assessed following the Grading of Recommendations, Assessment, Development, and Evaluations approach. We performed a frequentist network meta-analysis to generate treatment effect estimates. All-cause, cardiovascular mortality, and stroke were considered critically important patient-centered outcomes. RESULTS: We identified 11 randomized controlled trials with 9946 participants and reporting outcomes between 1 to 10 years. TAVI with CoreValve-Evolut was associated with a similar risk of all-cause (absolute risk difference [ARD], 31/1000 from -12 to 79), and cardiovascular mortality (ARD, -8/1000 from -39 to 28) compared with SAVR (moderate certainty). Compared with SAVR, TAVI with SAPIEN and ACURATE neo were associated with an increased risk of all-cause (ARD, 109/1000 from 56 to 169, high certainty and ARD, 123/1000 from 9 to 277, moderate certainty, respectively) and cardiovascular mortality (ARD, 58/1000 from 18 to 105, high certainty and ARD, 105 from 7 to 247, moderate certainty, respectively). Moderate and high-certainty evidence showed that all TAVI platforms were associated with an increased risk of reinterventions and pacemaker implant versus SAVR. Compared with TAVI with CoreValve-Evolut, SAPIEN was associated with higher all-cause (ARD, 75/1000 from 13 to 147, high certainty) and cardiovascular mortality (ARD, 66/1000 from 15 to 130, high certainty), same scenario for ACURATE neo (ARD 113/1000 from 13 to 259, high certainty). CONCLUSIONS: TAVI with CoreValve-Evolut is probably associated with similar mortality to SAVR. TAVI with SAPIEN and ACURATE neo were associated with increased risk of mortality compared with SAVR and CoreValve-Evolut. The current body of evidence from randomized controlled trials goes against the hypothesis of a class effect across TAVI valves. REGISTRATION: URL: https://www.crd.york.ac.uk; Unique identifier: CRD42024512026.
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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 | 0.071 | 0.141 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.019 | 0.052 |
| Bibliometrics | 0.008 | 0.006 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.005 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".