P897Complication rates with a fibre-optic contact force sensing ablation catheter in Europe and North America
Bibliographic record
Abstract
Introduction: Contact force measurement allows feedback on tissue contact during lesion formation. An ablation catheter with fibre-optic contact force sensing was introduced in 2014. With the introduction of new technology comes a need for real-world outcomes data in multiple geographies. Purpose: This analysis compares user-reported complication rates for a contact force sensing catheter by country and year. Methods: Data used were unit volumes of the ablation catheter by country and year from January 2014-July 2017, and a company database of reports on any complications attributed to the catheter. Events recorded included atrioesophageal fistula and cardiac perforation or tamponade. Results are presented for individual countries in Europe and North America, combined as necessary to ensure no groups of fewer than 10 events. Multivariable logistic regression was used to determine the effect of time and region on event rates. Results: Of 99,357 units in Europe, the U.S. and Canada, there were 217 perforations or tamponades (0.22%). There were 11 fistulas observed in North America (0.02%) and fewer than 10 in Europe. Event rates declined over time (P<0.001 for both types). In multivariable regression, there was a significant association of year of ablation with perforations (0.26% in 2014-5 vs. 0.17% in 2016-7). The difference between geographic regions (0.30% in Europe vs. 0.16% in North America) became non-significant when year of ablation was included as a covariate. Rates by country are shown in the table. Conclusion: Fistula and perforation rates for the contact force sensing catheter are lower than historical complication rates. A more complete analysis could consider additional types of procedural complications, as well as those attributed to other tools used during ablation. Event rates by country.
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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 | 0.002 | 0.008 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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".