Background
There is a lack of data on outcomes in classical (C-LFLG) and paradoxical low-flow, low-gradient aortic stenosis (P-LFLG) patients undergoing TAVR.
Purpose
We aim to compare baseline characteristic and procedural outcomes between C-LFLG, P-LFLG and high-gradient aortic stenosis (HG-AS) patients undergoing TAVR.
Methods
Patients included in the Transcatheter RegistrY of aorTic valve biOprosthesis in Latin-AMerica (TRYTOM Registry) were divided in 3 groups: 1) HG-AS: mean transaortic gradient (MG) ≥40 mmHg; 2) P-LFLG: MG <40 mmHg and left ventricular ejection fraction (LVEF) ≥50%; 3) C-LFLG: MG <40 mmHg and LVEF <50%. The outcomes were evaluated at 30-days and 1-year and were classified according to definitions of the VARC-2.
Results
1040 patients were included, 677 (65%) classified as HG-AS, 223 (21%) as P-LFLG and 140 (14%) as C-LFLG. Median follow-up was 16 months (range 0–109). There were baseline differences between HG-AS, P-LFLG and C-LFLG regarding age (80±7 vs 80±5 vs 78±8 years, respectively; p=0.017), NYHA FC III and IV (61.0 vs 72.6 vs 83.6%, respectively; p<0.001), coronary artery disease (44.1 vs 47.1 vs 57.9%, respectively; p=0.012), EuroSCORE II (7.2±6.3 vs 7.5±5.0 vs 12.9±10.4%, respectively; p<0.001), LVEF (56±11 vs 61±7 vs 32±9%, respectively; p<0.001), MG (53±13 vs 30±6 vs 27±7 mmHg, respectively; p<0.001), aortic valve area (0.65±0.16 vs 0.74±0.15 vs 0.70±0.16 cm2, respectively; p<0.001) and creatinine (1.2±0.7 vs 1.1±0.5 vs 1.5±1.3 mg/dl, respectively; p<0.001). Despite these significant baseline differences, we found similar outcomes after TAVR between HG-AS, P-LFLG and C-LFLG regarding device success (89.8 vs 95.1 vs 90.7%, respectively; p=0.057), in-hospital mortality (6.1 vs 5.9 vs 11.8%, respectively; p=0.144) and all other VARC-2 major outcomes, including major bleeding, major vascular complication and disabling stroke. In addition, female sex (OR 2.13, 95% CI 1.16–3.92, p=0.014), LVEF (OR 1.02, 95% CI 1.00–1.04, p=0.039) and MG (OR 0.97, 95% CI 0.95–0.99, p=0.004) were the only predictor of device success by multivariate analysis. Furthermore, 1-year mortality was similar among the groups (9.5 vs 8.3 vs 14.3%, respectively; p=0.358; Figure 1), and by multivariate analysis, diabetes (HR 2.44, 95% CI 1.10–5.41, p=0.028), creatinine (HR 1.65, 95% CI 1.17–2.33, p=0.004), conversion to general anesthesia (HR 7.93, 95% CI 2.08–30.20, p=0.002) and post-procedure disabling stroke (HR 12.84, 95% CI 3.09–53.40, p<0.001) predicted increased 1-year mortality, irrespective on the LVEF and MG.
Conclusions
Apart from baseline differences, TAVR in P-LFLG and C-LFLG was feasible and with similar clinical outcomes when compared to HG-AS. Mid-term mortality rates was associated with diabetes, creatinine and procedure complications.