Author + information
- Jan-Malte Sinning1,
- Anja Stundl1,
- Fritz Mellert2,
- Armin Welz2,
- Eberhard Grube3,
- Nikos Werner4 and
- Georg Nickenig3
More than mild paravalvular aortic regurgitation (pAR) negatively impacts prognosis after trans catheter aortic valve implantation (TAVI). Next generation transcatheter heart valves (THVs) promise to improve outcome by reducing the rate of TAVI-related issues such as pAR by specific design features such as paravalvular sealing mechanisms and repositionability/recapturing. The aim of the present study was to evaluate and compare the hemodynamic performance of next generation THVs.
In 805 patients undergoing TAVI, the degree of pAR was compared using imaging modalities (angiography, echocardiography) and hemodynamics (aortic regurgitation index, diastolic pressure time index). Severity of pAR and outcome were assessed in accordance with the VARC-2 criteria.
805 patients (mean age 80.9 ± 6.3 years, 50.8% male, mean left-ventricular ejection fraction 52.6 ± 14.0%, median STS PROM 5.2 (3.4-8.3)) underwent TAVI with use of the Medtronic Core Valve (n=400), Edwards SAPIEN XT (n=48), Direct Flow Medical (n=38), Medtronic Evolut R (n=114), Boston Lotus (n=104), and Edwards SAPIEN 3 (n=101). 30-day, 1-year and 3-year all-cause mortality were 4.8% (39/805), 19.9% (160/805), and 30.2% (243/805), respectively. Trans thoracic echocardiography post TAVI revealed that 326/805 (40.5%) of the patients had no relevant pAR, 420/805 (52.2%) trace or mild pAR, whereas 59/805 (7.3%) of the patients suffered from moderate/severe pAR.
More than mild pAR occurred significantly less frequently in patients undergoing TAVI with next generation THVs (p<0.001): Medtronic Core Valve (10.8%), Edwards SAPIEN XT (12.5%), Direct Flow Medical (5.3%), Medtronic Evolut R (4.4%), Boston Lotus (0.0%), and Edwards SAPIEN 3 (0.0%). The post-procedural AR index was significantly higher (p<0.001) with use of the Boston Lotus (34.2 ± 8.7), and the Direct Flow Medical (30.8 ± 6.9) THV compared with the Medtronic Core Valve (28.1 ± 8.3), Edwards SAPIEN XT (27.7 ± 7.2), Medtronic Evolut R (29.6 ± 9.2), and Edwards SAPIEN 3 (28.4 ± 6.9). Furthermore, the diastolic pressure time index (DPTI) after TAVI also differed significantly: Core Valve: 23.2 ± 9.2, Edwards SAPIEN XT: 25.1 ± 9.5, Direct Flow Medical: 28.5 ± 10.4, Medtronic Evolut R: 25.1 ± 8.4, Boston Lotus: 32.2 ± 11.3, Edwards SAPIEN 3: 26.7 ± 8.5, p<0.001).
TAVI with the use of next generation trans catheter heart valves significantly reduces pAR. Improved outcome might also be explained by more beneficial hemodynamics as assessed with the aortic regurgitation index (AR index) and diastolic pressure time index (DPTI).