Table 2. Complication rates of immediate and long term safety outcomes of percutaneous mitral valve repair are listed according to a recent meta-analysis (18), two registries (7,13) and the EVEREST II trial (9).
| Complication rates | Meta-analysis [Vakil et al. (18)] (%) | ACCESS-EU [Maisano et al. (7)] (%) | TRAMI [Wiebe et al. (13) (Euo score ≥20%/EuroSCORE <20%)] (%) | EVEREST II [Whitlow et al. (9)] (%) |
|---|---|---|---|---|
| Procedural death | 0.1 | 0 | – | 0 |
| 30-day mortality | 4.2 | 3.4 | 4.3/1.1* (in hospital mortality) | 7.7 |
| All-cause mortality during follow-up | 15.8 (mean follow-up 310 days) | 17.3% (12–month follow-up) | 13.4/9.6 (mean follow-up of 72 days) | 24.4 (12–month follow-up) |
| Vascular complications needing intervention | 1.0§ | – | – | – |
| Major bleeding requiring transfusion | 9.7§ | – | 13.7/8.7* | 17.9¶ |
| Bleeding complications | – | 3.9¶ | – | – |
| Tamponade or significant pericardial effusion | 0.7§ | 1.1¶ | 1.1/1.6* | – |
| Emergent cardiac surgery | 0.7§ | 0.4¶ | – | 0.0¶ |
| Non-fatal myocardial infarction | 0.4§ | 0.7¶ | 0.0/0.2* | 2.6¶ |
| Chordal rupture | 0.8§ | – | – | – |
| Single leaflet clip detachement | 2.3§ | 4.8 (diagnosed within 6 months) | – | – |
| Clip embolism | 0.04§ | 0.0¶ | – | – |
| Hemorrhagic or ischemic stroke/TIA | 1.3§ | 0.7¶ | 0.7/0.0* | 2.6¶ |
| Acute renal failure | 4.2§ | 4.8¶ | 1.8/0.2* (dialysis at discharge) | 3.8¶ |
| Need for repeat MitraClip | 1.6§ | 3.4¶ | 1.8/1.6* | 0.0¶ |
§, immediate safety outcomes; ¶, data for 30-day follow up; *, data for in-hospital events. EVEREST II, Endovascular Valve Edge-to-Edge Repair Study II trial; TRAMI, transcatheter mitral valve interventions.