Scientific Review Protocol
Topic: Amplatzer Amulet vs Watchman FLX in Percutaneous LAAO
| PICO Domain | Specifications |
|---|---|
| Population | |
| Intervention | |
| Comparison | |
| Primary Outcomes | |
| Analysis Plan |
LAAO Device Context
"AMULET IDE compared Amulet vs Watchman 2.5 (legacy), NOT Watchman FLX. This introduces indirectness. GRADE will be downgraded automatically for indirect comparisons."
"Preferred evidence: head-to-head Amulet vs Watchman FLX trials (SWISS-APERO, etc.)."
Living Update Monitor
Evidence Acquisition
Real-time polling of ClinicalTrials.gov + OpenAlex for LAAO device trials.
Extraction & Source Verification
Interactive data capture with highlighted registry denominators.
| Trial | NCT ID | Year | Phase | Comparator | N (Total) | Source |
|---|
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Study Characteristics
| Trial | Year | Phase | Comparator | N (Amulet) | N (Watchman) | ER Amulet% | ER Watchman% | RoB |
|---|
ER = Event Rate for selected outcome. Values from registry records — verify against published manuscripts.
LAAO Analytics Suite
1. Forest Plot (DL Random-Effects)
2. Subgroup Synthesis (Comparator Type)
3. Cumulative Meta-Analysis
4. Cumulative Z-Score
5. Leave-One-Out Sensitivity
6. L'Abbe Plot (Event Rates)
7. Galbraith Plot (Heterogeneity)
8. Clinical Utility (NNT Curve)
9. Funnel Plot (Publication Bias)
10. Baujat Plot (Influence x Heterogeneity)
11. Cook's Distance (Influence on tau²)
9. Risk of Bias (RoB 2.0)
10. GRADE Evidence Certainty
Sensitivity Comparison (DL vs REML vs FE)
R Validation Script (Metafor DL)
WebR Reviewer Validation
Runs the current included-trial dataset through `metafor::rma()` in-browser so reviewers can compare RR, CI, I² and tau² against an R reference calculation.
Scientific Synthesis
Visual Abstract + PRISMA Flow
Amplatzer Amulet vs Watchman FLX
Living Meta-Analysis of Percutaneous LAAO Trials
PRISMA 2020 Flow Diagram
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Duplicates / Ineligible
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Summary of Findings
| Outcome | No. Trials | Total N | Effect (RR) | 95% CI | I² | GRADE |
|---|
SoF table follows GRADE Working Group recommendations. Verify values against R validation script.
Version Timeline
CI Comparison (DL vs HKSJ vs Prediction)
HKSJ uses t-distribution (df = k-1) and is recommended for small k. Prediction interval shows expected range for a future study.
Annotated Forest Plot (Publication Quality)
Evidence Narrative
Patient-Friendly Summary
This summary is for shared decision-making. Always discuss with your doctor. Results may change as new trials report.
NNT/NNH Calculator
Device Benchmarks (Single-Arm Reference Data)
| Study | Device | N | Stroke/SE (ann.) | Major Bleeding (ann.) | DRT (%) | Procedure Success |
|---|---|---|---|---|---|---|
| PINNACLE FLX (2yr) | Watchman FLX | 400 | 1.7% | 5.1% | 0.0% | 100% |
| Amulet Obs. (1.8yr) | Amulet | 1,088 | 2.4% | 6.3% | 1.6% | 99.0% |
| AMULET IDE (5yr) | Amulet vs W2.5 | 1,878 | ~2.8% | 14.5% | 3.3% vs 4.5% | >98% |
Single-arm studies cannot be pooled in head-to-head meta-analysis but provide device-specific safety benchmarks.
PRISMA 2020 Checklist
| Item | Section | Status |
|---|
PROSPERO Registration Info
Register at crd.york.ac.uk/prospero. Living reviews should indicate update frequency in the protocol.
Reviewer Transparency Pack
Directly exposes search strings, eligibility rules, record excerpts, structured-demographics coverage, RoB completion, and published-meta comparators.