What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Severe aortic stenosis (n=6846). Intervention: High quantity of aortic valve calcification vs. Low quantity of aortic valve calcification. Primary outcome: Significant paravalvular leakage (≥2/4) (RR 3.79, 95% CI 2.29-6.28, p=<0.001).

May 24, 2023Open Access

Quantity and location of aortic valve calcification predicts paravalvular leakage after transcatheter aortic valve replacement: a systematic review and meta-analysis

Q: What are the key findings of this study?

A high quantity of aortic valve calcification significantly increased the risk of significant paravalvular leakage after transcatheter aortic valve replacement (RR 3.79).

Q: What does this research mean for the field?

A high quantity of aortic valve calcification significantly increases the risk of significant paravalvular leakage after transcatheter aortic valve replacement. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

Key Result

A high quantity of aortic valve calcification significantly increased the risk of significant paravalvular leakage after transcatheter aortic valve replacement (RR 3.79).

Study Design

Type

Meta-Analysis (n=6,846)

Structured PICO

Does a high quantity of aortic valve calcification increase the risk of paravalvular leakage after TAVR in patients with severe aortic stenosis?

Population

6,846 patients from 24 observational studies undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis with moderate-to-high surgical risk.

Intervention

High quantity of aortic valve calcification (assessed by MDCT) in the aortic valve complex and left ventricular outflow tract

Comparator

Low quantity of aortic valve calcification

Outcome

Significant paravalvular leakage (PVL ≥2/4) after TAVRsurrogate

A high quantity of aortic valve calcification significantly increases the risk of paravalvular leakage after TAVR, though the use of newer generation valves with sealing skirts may mitigate this effect.

Main Result

Effect estimate: RR 3.79 (95% CI 2.29-6.28)

p-value: p=<0.001

Limitations

All selected studies were retrospective, most being single-center observational studies.
Subgroup analysis was performed for a small number of studies, which may induce bias.
Lack of available data to perform a pooled analysis of the effect of the more specific location of calcification on PVL according to a more detailed classification of the valves.

Abstract

Introduction: Transcatheter aortic valve replacement (TAVR) is the first-line treatment for patients with moderate-to-high surgical risk of severe aortic stenosis. Paravalvular leakage (PVL) is a serious complication of TAVR, and aortic valve calcification contributes to the occurrence of PVL. This study aimed to investigate the effect of location and quantity of calcification in the aortic valve complex (AVC) and left ventricular outflow tract (LVOT) on PVL after TAVR. Method: We performed a systematic review and meta-analysis to evaluate the effect of quantity and location of aortic valve calcification on PVL after TAVR using observational studies from PubMed and EMBASE databases from inception to February 16, 2022. Results: Twenty-four observational studies with 6, 846 patients were included in the analysis. A high quantity of calcium was observed in 29. 6% of the patients; they showed a higher risk of significant PVL. There was heterogeneity between studies (I2 = 15%). In the subgroup analysis, PVL after TAVR was associated with the quantity of aortic valve calcification, especially those located in the LVOT, valve leaflets, and the device landing zone. A high quantity of calcium was associated with PVL, regardless of expandable types or MDCT thresholds used. However, for valves with sealing skirt, the amount of calcium has no significant effect on the incidence of PVL. Conclusion: Our study elucidated the effect of aortic valve calcification on PVL and showed that the quantity and location of aortic valve calcification can help predict PVL. Furthermore, our results provide a reference for the selection of MDCT thresholds before TAVR. We also showed that balloon-expandable valves may not be effective in patients with high calcification, and valves with sealing skirts instead of those without sealing skirts should be applied more to prevent PVL from happening. Systematic Review Registration: https: //www. crd. york. ac. uk/PROSPERO/displayᵣecord. php? RecordID=354630, identifier: CRD42022354630.

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