Results
Baseline characteristics are shown in Table 1. The median age of the
patients was 79 (74 – 83) years, 33% of patients (n = 25) were female,
and the STS SCORE was 11.0 (5.3 – 16.0)%. The mechanism of MR was
secondary in 55 (71%) patients and primary in 22 (29%) patients.
During a median of 221 (99 – 447) days of follow-up, 13% of patients
in the entire cohort had CV events (event group). The event group,
compared to the no-event group, had lower estimated glomerular
filtration rate (eGFR) (25.2 (IQR: 19.9 – 31.5)
mL/min/1.73m2 vs. 41.7 (IQR: 29.8 – 56.6)
mL/min/1.73m2, p = 0.006), higher N-terminal pro-brain
natriuretic peptide (4042 (IQR: 2794 – 7114) pg/mL vs. 1760 (IQR; 870
– 4955) pg/mL, p = 0.039), and lower TAPSE (12 (IQR: 7 – 14) mm vs. 16
(IQR: 13 – 22) mm, p = 0.009).
Procedural and clinical outcomes
One clip was implanted in 44 (57%) patients and two clips were
implanted in the remaining patients (Table 2). All patients experienced
technical success according to the Mitral Valve Academic Research
Consortium (MVARC) criteria.(16) During a median of 221 (99 – 447) days
of follow-up after TMVr, 5 patients died due to CV events and 8 patients
had HF hospitalization. The event group, compared to the no-event group,
had a higher prevalence of moderate residual MR at discharge (p = 0.012)
and longer length of hospital stay post-TMVr (p = 0.003) (Table 2). On
univariate Cox regression analysis (Table 3), CV events were associated
with eGFR (HR: 0.960, 95%CI; 0.926 – 0.995, p = 0.027), TAPSE (HR:
0.874, 95%CI; 0.789 – 0.968, p = 0.010), and significant residual MR
(HR: 11.652, 95%CI; 3.257 – 41.691, p <0.001).
On multivariate Cox regression
analysis, CV events were independently associated with TAPSE (HR: 0.788,
95%CI; 0.788 – 0.987, p = 0.029) and significant residual MR (HR:
9.373, 95%CI; 2.581 – 34.033, p = 0.001).
TAPSE did not significantly change
mean 4days after the procedure (15 (12 – 22) mm to 16 (12 – 21) mm, p
= 0.708). Figure 2 shows the ROC analysis of TAPSE to predict CV events.
TAPSE had the largest AUC compared to RV-FAC (0.793 vs. 0.681) and RV-S’
(0.793 vs. 0.626). TAPSE <11 mm was the best cut-off value for
predicting CV events (Sensitivity 0.839; Specificity 0.556).
Kaplan-Meier analysis showed that no RV functional parameters, except
for TAPSE, had a significant prognostic power for predicting CV events
(Figure 3).