Medium-Term Follow-Up of Early Leaflet Thrombosis After Transcatheter Aortic Valve Replacement

Objectives

The aim of this study was to investigate medium-term outcomes in patients with leaflet thrombosis (LT).

Long-Term Follow-Up of Hypoattenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement

BackgroundEarly hypoattenuated leaflet thickening (HALT) occurs in at least 10% of all transcatheter aortic valve replacement (TAVR) patients. The long-term prognostic impact of HALT is uncertain.ObjectivesThe aim of this study was to assess the long-term risk of early HALT post-TAVR.MethodsWe report outcome data from our prospective observational registry with post-TAVR computed tomography angiography performed between May 2012 and December 2017. The outcomes were survival, cardiovascular mortality, ischemic cerebrovascular events, and symptomatic hemodynamic valve deterioration.ResultsEarly HALT was diagnosed in 115 (16.0%) of 804 patients. During a median follow-up of 3.25 years, survival rates did not differ significantly between patients with and without HALT (Kaplan-Meier 3-year estimates for survival 70.1% vs 74.0%, P = 0.597). The 3-year cardiovascular mortality rate was 13.2% versus 11.3% (with vs without HALT, P = 0.733). The 3-year event rate for cerebrovascular events was 2.0% versus 4.4% (with vs without HALT, P = 0.246), and the 3-year event rate of symptomatic hemodynamic valve deterioration was 9.4% versus 1.5% (with vs without HALT, P < 0.001). Multivariable analysis revealed the following predictors of symptomatic hemodynamic valve deterioration: HALT (HR: 6.10; 95% CI: 2.59-14.29; P < 0.001), the mixed valve–type group (HR: 6.51; 95% CI: 2.38-17.81; P < 0.001), and prosthesis diameter (HR valve size per 3 mm [HR: 0.37; 95% CI: 0.17-0.79]; P = 0.011).ConclusionsDuring a median follow-up of more than 3 years, HALT was not associated with mortality or cerebrovascular events. However, we observed an association of HALT with symptomatic hemodynamic valve deterioration.     

Subclinical Leaflet Thrombosis After Transcatheter Aortic Valve Replacement: A Meta-Analysis

This meta-analysis and systematic review was performed to evaluate the clinical relevance of subclinical leaflet thrombosis (SLT) following transcatheter aortic valve replacement. PubMed, Web of Science, and CENTRAL were searched for eligible randomized and nonrandomized studies until November 2020. Risk ratios (RRs) or odds ratios and 95% CIs were calculated, using a random-effects model. Overall, 25 studies were eligible for the analysis and comprised a total of 11,098 patients. The median incidence of SLT was 6% at a median follow-up of 30 days. Use of intra-annular valves was associated with 2-fold greater risk for the development of SLT compared with use of supra-annular valves. There was no difference in the risk for SLT (RR: 0.97; 95% CI: 0.72-1.29; P = 0.83) between single-antiplatelet therapy (SAPT) and dual-antiplatelet therapy (DAPT), whereas oral anticoagulation (OAC) was associated with a 58% relative risk reduction for SLT (RR: 0.42; 95% CI: 0.29-0.61; P < 0.00001) compared with SAPT and DAPT. In patients with diagnosed leaflet thrombosis at follow-up, the risk for stroke or transient ischemic attack was increased by 2.6-fold (RR: 2.56; 95% CI: 1.60-4.09; P < 0.00001) compared with patients without leaflet thrombosis. In patients diagnosed with SLT, the odds of SLT resolution increased by 99% after switch from antiplatelet agents to OAC (odds ratio: 0.01; 95% CI: 0.00-0.06; P < 0.00001). To summarize, indication-based use of OAC after transcatheter aortic valve replacement is associated with a lower risk for SLT compared with SAPT and DAPT. Switching to OAC seems to be effective for SLT resolution. As SLT increased the odds of stroke or transient ischemic attack in the included population, further studies are needed to investigate whether screening tests for SLT and appropriate antithrombotic therapy improve long-term valve functionality and clinical prognosis.     

Biodegradable-Polymer Versus Polymer-Free Drug-Eluting Stents for the Treatment of Coronary Artery Disease

Background/purposeBiodegradable-polymer (BP) and polymer-free (PF) drug eluting stents (DES) were developed to reduce the risk of delayed arterial healing observed with durable-polymer (DP) platforms. Although trials demonstrate BP-DES and PF-DES are non-inferior to DP-DES, there is limited data directly comparing these technologies. We performed a meta-analysis to assess the efficacy and safety of BP-DES versus PF-DES for the treatment of coronary artery disease.Methods/materialsElectronic searches were performed identifying randomized trials comparing BP-DES with PF-DES. Co-primary efficacy endpoints were target vessel revascularization (TVR), target lesion revascularization (TLR) and angiographic in-stent late lumen loss (LLL). Co-secondary safety endpoints were all-cause death, myocardial infarction (MI) and stent thrombosis (ST).ResultsOf 208 studies, 5 met inclusion criteria including 1975 patients. At mean follow-up (14 ± 5 months), BP-DES were associated with significantly reduced rates of TVR (OR 0.58, 95%CI 0.37–0.92, p = 0.02), TLR (4.7% vs 9.5%) (OR 0.48, 95%CI 0.31–0.75, p = 0.001) and in-stent LLL (pooled mean difference ?0.20 mm, 95%CI ?0.24 to ?0.16, p < 0.001). There was no difference in safety, including all-cause death (OR 1.24, 95%CI 0.68–2.28, p = 0.48), MI (OR 0.92, 95%CI 0.54–1.56, p = 0.75) or ST (OR 1.58, 95%CI 0.67–3.73, p = 0.30).ConclusionsThese data suggests that BP-DES are more efficacious when compared with PF-DES for the treatment of CAD.     

Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy

BackgroundSubclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact.ObjectivesThe aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography.MethodsThe randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5 mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with ≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population.ResultsSeven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95% CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95% CI: 0.62-5.25) (P_interaction = 0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n = 9 of 84) and 7.1% (n = 48 of 178) of patients with and without subclinical valve thrombosis at 90 days, respectively (HR: 1.68; 95% CI: 0.82-3.44).ConclusionsApixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649)     

Feasibility and Safety of Same-Day Discharge Following Transfemoral Transcatheter Aortic Valve Replacement

ObjectivesThis study evaluated the feasibility and safety of same-day discharge (SDD) following transfemoral transcatheter aortic valve replacement (TF-TAVR) compared with next-day discharge (NDD).BackgroundReducing hospital length of stay is an important goal for patients and hospitals. Cleveland Clinic implemented a post-TAVR SDD pathway beginning in March 2020.MethodsThe study retrospectively analyzed patients who underwent “minimalist” outpatient TF-TAVR in 2019 to 2020. SDD was applied to patients who met the predefined criteria. Outcomes included in-hospital and 30-day events and were compared between SDD and NDD (during and prior to availability of the SDD pathway).ResultsIn 2020, SDD and NDD accounted for 22.1% (n = 114 of 516) and 63.8% (n = 329 of 516) of outpatient TF-TAVR, respectively. SDD patients in 2020, compared with NDD patients in 2019 (n = 481), were younger, were more often male, and had a lower surgical risk. There were no significant differences in in-hospital events and 30-day readmissions (cardiovascular readmission: 3.5% vs 6.2%; P = 0.37; noncardiovascular readmission: 2.6% vs 4.0%; P = 0.78), and there were no deaths after SDD. These outcomes remained consistent after propensity score matching. Only 1 (0.9%) patient required pacemaker implantation after SDD (post-TAVR day 25). As expected based on SDD criteria, multivariable logistic regression analysis identified procedure end-time as the strongest predictor of SDD (adjusted OR: 7.74; 95% CI: 4.39-13.63), while male sex and baseline hemoglobin level were also associated with SDD.ConclusionsSDD after TF-TAVR was feasible in this early experience without impairing post-discharge safety. Our SDD pathway may serve as a useful strategy to improve bed utilization and reduce hospital stay for TAVR recipients.