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Eur Heart J Cardiovasc Imaging. 2018 Feb 1;19(2):225-233. doi: 10.1093/ehjci/jex019.

Patient-prosthesis mismatch in new generation trans-catheter heart valves: a propensity score analysis.

Author information

1
Department of Cardiac Surgery, La Timone Hospital, La Timone Hospital 264, rue saint Pierre 13005 Marseille, France.
2
APHM, Hôpital de la Timone, Service Biostatistique et Technologies de l'Information et de la Communication, Marseille, France.
3
Department of Cardiology, La Timone Hospital, Marseille, France.
4
Aix-Marseille Université, UMR_S 912 (SESSTIM), IRD, 13385 Marseille, France.
5
INSERM, UMR_S 912 (SESSTIM), 13385 Marseille, France.
6
Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France.

Abstract

Aims:

When compared with the former Sapien XT (XT-THV), the Sapien 3 trans-catheter heart valve (S3-THV) embeds an outer annular sealing cuff to prevent para-valvular regurgitation (PVR). The consequences of this new feature on valve haemodynamics have never been evaluated. We aimed to compare both types of prostheses regarding patient-prosthesis mismatch (PPM).

Methods and results:

Patients who underwent a TAVR for aortic stenosis were retrospectively included. Regression adjustment for the propensity score was used to compare 50 XT-THV patients with 71 S3-THV. At the 1-month follow-up, the mean indexed effective orifice area (iEOA) was 1.12 ± 0.34 cm2/m2 with XT-THV and 0.96 ± 0.27 cm2/m2 with S3-THV. The mean gradient was 11 ± 5 mmHg and 13 ± 5 mmHg, respectively. Nine patients had moderate PPM, and two exhibited severe PPM with XT-THV. Nineteen patients had moderate PPM, and seven demonstrated severe PPM with S3-THV. There was a five-fold increased risk of PPM with S3-THV (OR = 4.98; [1.38-20.94], P = 0.019). S3-THV decreased the iEOA by 0.21 cm2/m2 [-0.21; (-0.38 to - 0.05); P = 0.012] and increased the mean gradient by 4.95 mmHg [4.95; (2.27-7.64); P < 0.001]. The risk of PPM was increased 15.24-fold with 23 mm S3-THV [15.24; (2.92-101.52); P = 0.002] in comparison with the 23 mm XT-THV. PVR were reduced by 98% with S3-THV.

Conclusion:

There is an increased risk of PPM with 23mm S3-THV in comparison with 23 mm XT-THV. This may be attributable to the additional sub-annular cuff that avoids the risk of PVR. Regarding the increased vulnerability of younger patients to PPM, we provide essential information on the extension of TAVR indication to the younger population.

PMID:
28329317
DOI:
10.1093/ehjci/jex019
[Indexed for MEDLINE]

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