Table 1.
Adverse events associated with left atrial ablation procedures with product codes LPB, OAD, and OAE denoting the ablation products from 2015 to 2022
| Product code by ablation | Fistula (n, %) | Other oesophageal injury (n) | Total oesophageal injury (n, %) | Total adverse events | Protective device used | |||
|---|---|---|---|---|---|---|---|---|
| Oesophageal monitoring probe | Oesophageal temperature control device | Retractor | No details | |||||
| LPB | 282 (2.3) | 56 | 338 (2.8) | 12 260 | 73 | 0 | 3 | 206 |
| OAD | 58 (1.6) | 20 | 78 (2.1) | 3676 | 5 | 0 | 0 | 53 |
| OAE | 81 (1.1) | 30 | 111 (1.6) | 7153 | 2 | 0 | 1 | 78 |
| Total | 421 (1.8) | 106 | 527 (2.3) | 23 089 | 80 | 0 | 4 | 337 |
| Device detailsa | S-Cath- Circa Scientific, Level 1 and ER 400-9 made by Smiths Medical; Esotherm/Sensitherm, Fiab | ensoETM, Attune Medical | DV8, EsoSure | |||||
A search was conducted for the number of atrio-oesophageal fistulas within that time period and if additional devices were used for oesophageal protection in these fistula cases. An attempt was made to review for which specific devices were used within the reported fistula cases, but results were limited.
Most fistula cases reported in these databases lacked in-depth clinical information including the protective method used, whether that was limitation of ablation power or contact force or if a protective device was used. Of the oesophageal monitoring probes specified in the reports, only S-Cath by Circa Scientific was linked to six cases of fistulas. The rest were linked to other oesophageal injury; most remain unknown. There was no other device apart from the ensoETM, used for oesophageal temperature control. The listed deviation devices, DV8, EsoSure are the only devices known to have been available during 2015–2022, but these are not specifically described in the reports.