Methods: In a retrospective study we examined postprocedural complications in patients undergoing TMTVR and the association with frailty and outcome. We assessed frailty according to Fried criteria. Postprocedural acute kidney injury (AKI), access site vascular complications and bleeding complications were recorded according to the Mitral Valve Academic Research Consortium (MVARC), and clinically manifest infections were identified from charts.
Results: Of 626 patients included (median age 79 (73-83) years, 56% male), 46.6% were classified as frail. During a median follow-up of 560 days, mortality was significantly higher in frail patients, and length of stay in hospital and in intermediate/intensive care unit was significantly longer (table 1, figure 1).
Frail patients suffered more bleeding complications, received blood transfusion more often and had higher risk of pneumonia and total infections compared to non-frail patients. Frequency of AKI and access site vascular complications was similar between groups (table 1).
AKI, access site vascular complications, and bleeding complications, were associated with reduced survival in both frail and non-frail patients (table 2). Total infections and pneumonia were of particular prognostic relevance in frail patients with a borderline significant test for interaction (p=0.061 and p=0.081, respectively) (table 2).
Loss of hemoglobin within 48 hours was associated with mortality only in frail patients (table 2).
Conclusion: Frail patients have more bleeding and infectious complications after TMTVR, and the prognostic relevance of these complications is more pronounced in frail compared to non-frail patients. These findings might explain the overall increased risk of mortality in frail patients.
Table 1: Postprocedural complications and outcomes by frailty status
| Non frail (N=334) | Frail (N=292) |
p-value | |
| Bleeding complication (MVARC) (any) | 25 (8) |
45 (16) | 0.001 |
| Loss of hemoglobin within 48h after the procedure, g/dl | 1.9 (1.3 – 2.5) | 1.8 (1.3 – 2.5) | 0.500 |
| Bleeding necessitating blood transfusion | 9 (3) | 27 (9) | <0.001 |
| Access site vascular complication (MVARC) (any) | 18 (6) | 21 (8) | 0.326 |
| Infection (any) | 33 (10) | 50 (18) | 0.006 |
| Pneumonia | 11 (3) | 30 (11) | <0.001 |
| Acute kidney injury (MVARC) | 66 (20) | 57 (20) | 1.000 |
| Stay on ICU (nights) | 1 (1-2) | 2 (1-3) | 0.003 |
| Stay at hospital (nights) | 6 (4-7) | 6 (4-8) | <0.001 |
| Death at 1 year | 36 (12) | 79 (30) | <0.001 |
Table 2: Hazard ratios of mortality associated with postprocedural complications, in the overall population and by frailty
| Overall (n=626) | Non frail (N=334) | Frail (N=292) |
Interaction | ||
| HR (95% CI) | p-value | HR (95% CI) | HR (95% CI) | p-value | |
| Bleeding complication (MVARC) (any) | 1.5 (1.06-2.29) | 0.023 | 1.7 (0.92-3.29) | 1.2 (0.76-1.98) | 0.397 |
| Loss of hemoglobin within 48h after the procedure, g/dl | 1.0 (0.97-1.03) | 0.761 | 0.9 (0.93-1.05) | 1.1 (1.02-1.39) | 0.025 |
| Access site vascular complication (MVARC) (any) | 1.5 (0.95-2.58) | 0.078 | 1.1 (0.44-2.71) | 1.8 (0.99-3.27) | 0.370 |
| Infection (any) | 2.1 (1.53-3.06) | <0.001 | 1.3 (0.67-2.53) | 2.6 (1.73-3.98) | 0.061 |
| Pneumonia | 3.0 (1.96-4.70) | <0.001 | 1.4 (0.52-3.86) | 3.4 (2.11-5.78) | 0.081 |
| Acute kidney injury (MVARC) | 2.2 (1.63-2.98) | <0.001 | 2.3 (1.51-3.78) | 2.2 (1.48-3.32) | 0.930 |
Figure 1: Kaplan-Meier Survival Plots for mortality by frailty status
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