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Leaflet thrombosis not related to mortality, stroke after TAVR
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The rates of mortality, stroke and transient ischemic attack after about 1 year did not differ significantly between patients who developed leaflet thrombosis after TAVR compared with those who did not, according to data from a single-center, observational study.
Of 754 patients who received a transcatheter heart valve and underwent CT angiography at a median 5 days after TAVR, 15.9% developed leaflet thrombosis.
No differences in outcomes
During a median follow-up period of 406 days, the mortality rate per year was 11.1% in patients with leaflet thrombosis and 11.2% in those without leaflet thrombosis. Kaplan-Meier 18-month estimates for survival were comparable between the two groups (thrombosis group, 86.4%; no thrombosis group, 85.4%; P = .912).
In univariate analysis, leaflet thrombosis was not linked to an increased risk for all-cause mortality (HR = 0.88; 95% CI, 0.97-1.67). Predictors of all-cause mortality included atrial fibrillation (HR = 1.84; 95% CI, 1.29-2.62), more than mild paravalvular leakage (HR = 3.71; 95% CI, 1.35-10.16) and male sex (HR = 1.5; 95% CI, 1.05-2.13) — all of which remained associated with all-cause mortality in multivariate analysis.
Stroke occurred in 0.8% of patients with leaflet thrombosis and 2.1% of those without leaflet thrombosis (P = .32). Similarly, TIA occurred in no patients with leaflet thrombosis and 0.5% of patients without leaflet thrombosis (P = .594). Kaplan-Meier estimates for 18-month stroke- and TIA-free survival were 98.5% for patients with leaflet thrombosis and 96.8% for those without leaflet thrombosis (P = .331).
Leaflet thrombosis was also not predictive of stroke or TIA in univariate analysis (HR = 0.38; 95% CI, 0.05-2.88), and meaningful multivariate analysis could not be performed because of the low incidence of stroke and TIA. Other variables, including age, male sex and AF were also not predictors of stroke or TIA in univariate analysis.
The researchers found that patients with leaflet thrombosis were less likely to be men (36.7% vs. 47%; P = .045) and had a lower rate of AF (28.3% vs. 41.5%; P = .008). In the cohort, 80.1% received balloon-expandable valves (Sapien 3 or Sapien XT, Edwards Lifesciences) 14.5% received self-expandable valves (CoreValve or Evolut R, Medtronic) and 5.4% received other valve types.
There were no significant differences between procedural and periprocedural characteristics between patients with leaflet thrombosis and those without leaflet thrombosis.
Additionally, 16 patients received temporary anticoagulation therapy for 3 to 6 months from 2012 to 2015 because of leaflet findings on routine CT angiography, but the researchers noted there were no differences in all-cause mortality or stroke and TIA after exclusion of those patients.
Differences in definitions
In an accompanying editorial, Cardiology Today’s Intervention Editorial Board Member Raj Makkar, MD, and Tarun Chakravarty, MD, both from the Smidt Heart Institute at Cedars-Sinai Medical Center, highlighted several important limitations of the study.
For instance, the definition of leaflet thrombosis — hypoattenuated leaflet thickening, with or without rigidity, or reduced leaflet motion of at least one leaflet segment — in this study differs from that used in previous studies, they wrote. The researchers also did not differentiate between periprocedural neurological events and those that occurred after CT angiography, and events were not independently adjudicated by a stroke neurologist. Makkar and Chakravarty also noted that CT angiography was performed early after TAVR, whereas it was performed 1 to 3 months after the procedure in other subclinical leaflet thrombosis studies.
However, these findings are somewhat reassuring, according to Makkar and Chakravarty.
“Given the lack of an association between clinical outcomes and leaflet thrombosis in this and other studies and the clinical benefits of TAVR, it is reasonable not to be alarmed by this finding,” they wrote. “Nonetheless, it is equally important to not neglect or prematurely consider this a ‘benign’ finding.” – by Melissa Foster
Disclosure: One author reports he is a consultant for Edwards Lifesciences. All other authors and Makkar report no relevant financial disclosures. Chakravarty reports he is a consultant and proctor for Edwards Lifesciences and Medtronic.
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