Background: Minimally invasive tricuspid transcatheter edge-to-edge repair (T-TEER) is increasingly used for treatment of tricuspid regurgitation (TR) in patients with prohibitive surgical risk.
Methods: Incidence and impact of in-hospital safety events (death, myocardial infarction, stroke, leaflet detachment, bleeding, acute kidney injury, infection, pacemaker implantation) on outcome were analyzed in 284 consecutive patients undergoing T-TEER.
Results: Incidence of safety events (SE) was 21.8% (n=62), including 3.9% (n=11) of patients with major safety events. Patients with SE were comparable regarding age (80.5{75.0-84.3} vs. 80.5{75.0-84.0} years, p=0.46) and gender distribution (female 48.4 vs. 55.9%, p=0.30). Progressed chronic kidney disease (CKD stage ≥G3b 45.9 vs. 26.1%, p<0.01) as well as anemia (Hb 11.0{9.3-13.2} vs. 12.3{9.0-12.3}g/dl, p<0.01) were more frequent in patients with SE, resulting in overall higher interventional risk (TriScore: 6.0{5.0-7.0} vs. 4.0{3.0-6.0}, p<0.01). Initial grade of TR (≥IV: 66.1 vs. 60.1%, p=0.51) as well as procedural TR reduction (residual TR ≤II: 83.9 vs. 88.3%, p=0.26) were similar.
Most frequent SE were acute kidney injury (10.9%), infections (7.7%) and blood transfusions (5.3%). Leaflet detachment occurred in 1.1%, conduction disturbances and pacemaker implantation in 0.4%. Major bleedings (1.8%) were the most common major safety events, followed by death (1.4%). Stroke (0.7%) and new-onset dialysis (0.4%) were rare, while no case of myocardial infarction was observed.
During follow-up, in-hospital SE did not independently affect (HR: 0.99, CI: 0.58-1.71; p=0.98) long-term outcome (all-cause death, unplanned rehospitalisation/reintervention, stroke, myocardial infarction or major bleeding events) after adjusting for covariates. However, the unadjusted probability of event-free survival was significantly lower in patients with in-hospital SE (39.1 vs. 55.5%, log-rank p=0.02).
Conclusion: Although SE occurred in roughly one in five patients, they were mostly non-major events and did not independently impact long-term clinical outcome.
