Meta-Analysis of Bioprosthetic Valve Thrombosis After Transcatheter Aortic Valve Implantation

https://doi.org/10.1016/j.amjcard.2020.10.018Get rights and content

Bioprosthetic valve thrombosis may complicate transcatheter aortic valve implantation (TAVI). This meta-analysis sought to evaluate the prevalence and clinical impact of subclinical leaflet thrombosis (SLT) and clinical valve thrombosis (CVT) after TAVI. We summarized diagnostic strategies, prevalence of SLT and/or CVT and estimated their impact on the risk of all-cause death and stroke. Twenty studies with 12,128 patients were included. The prevalence of SLT and CVT was 15.1% and 1.2%, respectively. The risk of all-cause death was not significantly different between patients with SLT (relative risk [RR] 0.77; p = 0.22) and CVT (RR 1.29; p = 0.68) compared with patients without. The risk of stroke was higher in patients with CVT (RR 7.51; p <0.001) as compared with patients without, while patients with SLT showed no significant increase in the risk of stroke (RR 1.81; p = 0.17). Reduced left ventricular function was associated with increased prevalence, while oral anticoagulation was associated with reduced prevalence of bioprosthetic valve thrombosis. Bioprosthetic valve thrombosis is frequent after TAVI, but does not increase the risk of death. Clinical valve thrombosis is associated with a significantly increased risk of stroke. Future studies should focus on prevention and treatment of bioprosthetic valve thrombosis.

Section snippets

Methods

Medline, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific session abstracts and other relevant websites (www.clinicaltrialresults.org, www.escardio.org, www.tctmd.com, www.theheart.org) were searched for studies dealing with the topic under investigation without restricting to language status. Each database was screened for studies published between January 2010 and December 2019. The references listed in all eligible studies were checked to identify further

Results

The flow diagram for the trial selection process is shown in the Supplemental Figure 1. After application of inclusion/exclusion criteria twenty studies (5 randomized controlled trials1,2,5,12,13 and 15 observational studies6, 7, 8,14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25) with a total of 12,128 patients who underwent TAVI were included. No disagreements required solution by the third reviewer. Nine studies selectively reported on CVT,1,2,7,8,21, 22, 23, 24, 25 5 studies investigated SLT,5

Discussion

This study summarizes the prevalence and clinical relevance of SLT or CVT after TAVI in a cohort of 12,128 patients. The results can be summarized as follows: (1) The pooled prevalence of SLT and CVT after TAVI was 15.1% and 1.2%, respectively; (2) the presence of either SLT or CVT does not significantly increase the risk of all-cause death after TAVI; (3) the risk of stroke is significantly and almost 8-fold higher in patients with CVT, whereas it was numerically higher without reaching

Contributions

SC, MJ and TR did the data analysis and wrote the first draft of the report. SC, MJ, TR, EX, NPM, MM and SS were involved in study conception and design. TR, CP, SS, MM and FA were involved in data acquisition. TR, TP, OH, SA, SW, SC and MJ revised the manuscript for important intellectual content. All authors approved the report for final submission.

Disclosures

M. Joner reports personal fees from Biotronik, personal fees from Orbus Neich, grants and personal fees from Boston Scientific, grants and personal fees from Edwards Lifesciences, personal fees from Astra Zeneca, personal fees from Recor and grants from Amgen. All other authors have no conflicts of interest to declare.

References (30)

  • MJ Mack et al.

    Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients

    N Engl J Med

    (2019)
  • JJ Popma et al.

    Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients

    N Engl J Med

    (2019)
  • RR Makkar et al.

    Five-year outcomes of transcatheter or surgical aortic-valve replacement

    N Engl J Med

    (2020)
  • D Capodanno et al.

    Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for CardioThoracic Surgery (EACTS)

    Eur Heart J

    (2017)
  • RR Makkar et al.

    Possible subclinical leaflet thrombosis in bioprosthetic aortic valves

    N Engl J Med

    (2015)
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