Feasibility, safety, and efficacy of transcatheter aortic valve replacement without balloon predilation: A systematic review and meta‐analysis
Bibliographic record
Abstract
OBJECTIVES: To evaluate the feasibility, safety, and efficacy of direct transcatheter aortic valve replacement (TAVR), that is, TAVR without balloon predilation (BPD), by performing a systematic review and meta-analysis of available evidence. BACKGROUND: Avoiding BPD during TAVR was shown to be feasible in previous studies but the risks and benefits of this technique are unknown owing to the limited number of patients included in these studies. METHODS: We performed a systematic search for studies comparing direct TAVR vs TAVR performed with BPD. Crude risk ratios (RRs) or mean differences and 95% confidence intervals (CI) for each endpoint were calculated using random effects models. RESULTS: Twenty studies including 3586 patients (1606 undergoing direct TAVR) were selected for the analysis. Mean device success with direct TAVR was 88% with <5% of bail-out techniques. There were no differences between direct and BPD-TAVR in short-term (in-hospital or 30-day) mortality (RR: 1.06; 95% CI: 0.78-1.43) or cerebrovascular events (RR: 0.92; 95% CI: 0.58-1.46). Direct TAVR associated with reduced moderate or severe paravalvular leak post-TAVR (RR: 0.59; 95% CI: 0.36-0.98) but not with a reduced risk of permanent pacemaker implantation (RR: 0.85, 95% CI: 0.71-1.02). A slight increase in postdilation was observed in direct transfemoral-TAVR recipients (RR: 1.2; 95% CI: 1.00-1.44). CONCLUSION: Direct TAVR is feasible and safe. However, given the unadjusted nature of our results, uncertainties remain regarding the independent effect of direct TAVR on outcomes post-TAVR. Randomized studies are warranted to determine the potential benefits of direct TAVR. © 2017 Wiley Periodicals, Inc.
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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 | 0.011 | 0.028 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.017 | 0.037 |
| Bibliometrics | 0.005 | 0.006 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".