Background: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR.Methods: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014).Results: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all).Conclusions: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.
1 August 2020 in JACC: Cardiovascular Interventions
Background: The potential benefit of using larger or smaller transcatheter heart valves (THV) in patients with borderline aortic annulus measurement (BAM) remains uncertain. The objective of this study was to evaluate the clinical outcomes associated with the selection of larger or smaller THV in the context of BAM. Methods: This was a multicenter observational study including patients who underwent transcatheter aortic valve replacement with the SAPIEN 3 or SAPIEN 3 Ultra-valve systems (Edwards Lifesciences, Irvine, CA) from April 2014 to June 2021. BAM was defined according to the manufacturer sizing chart and included the following annulus areas: 314 to 346, 400 to 430, 500 to 546 mm 2 . A 1:1 propensity score matching was used to compare outcomes of patients with larger or smaller THV. Results: From a total of 2467 patients, BAM was identified in 852 patients (34.5%). A larger and smaller THV was selected in 338 (39.7%) and 514 patients (60.3%) patients, respectively. The choice of a larger THV was associated (before and after propensity matching) with a higher risk of new-onset left bundle branch block (HR, 2.25 [95% CI, 1.39–3.65; P =0.001) and permanent pacemaker implantation (HR, 1.86 [95% CI, 1.11–3.09]; P =0.016) without any impact on gradients or the risk of moderate or severe paravalvular regurgitation at discharge (HR, 0.78 [95% CI, 0.41–1.45]; P =0.427). The risk of periprocedural complications such as aortic rupture and tamponade was low (<1%) and similar between groups. Conclusions: In patient with BAM, selecting a larger SAPIEN 3/Ultra THV increased the risk of conduction disturbances without any benefit on valve hemodynamics and clinical outcomes.
1 November 2020 in Circulation: Cardiovascular Imaging
Aims: Valve durability becomes a major issue as transcatheter aortic valve implantation (TAVI) is expanding to populations with longer life expectancy. We sought to (i) determine the incidence of structural valve deterioration (SVD), (ii) compare the incidence of SVD between balloon-expandable (BE) and self-expandable (SE) valves, and (iii) analyse the impact of SVD. Methods and results: 2040 patients who underwent TAVI (2007–2020) from 9 centres were included. After inverse probability treatment weighting (IPTW), 1848 patients were selected (973 BE and 875 SE). SVD was defined using recent echocardiographic definitions according to VARC-3 criteria: Median follow-up was 4.2 (IQR: 2.5–5.7) years. The estimated incidence of SVD and bioprosthetic valve failure (BVF) at 8 years follow-up for the overall cohort were 13.3% [95% confidence interval (CI) 9.8–18%] and 11.5% (95% CI 8.9–14.8%), respectively. After IPTW and a median follow-up of 4 years, the risk of SVD (5.25% vs. 1.19%; HR 10.25, 95% CI 3.79–27.71, P < 0.001), and all-cause BVF (6.41% vs. 3.2%; HR 2.1, 95% CI 1.27–3.47 P = 0.004), was significantly higher for BE compared with SE recipients. Patients developing SVD had a trend towards a higher incidence of cardiovascular death (P = 0.06), as well as a significantly higher risk of heart failure rehospitalization (P = 0.048). After IPTW, there were no differences between BE and SE recipients in the combined endpoint of cardiovascular death, heart failure rehospitalization and valve reintervention (P = 0.46). Conclusion: In this real-world registry, the incidence of SVD at 8 years after TAVI was relatively low. The risk of SVD was higher among BE compared with SE valve recipients. SVD was associated with an increased risk of heart failure rehospitalization and a trend towards a higher risk of cardiovascular death.
1 January 2025 in Circulation: Cardiovascular Interventions
BACKGROUND: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population. METHODS: Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding. RESULTS: Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04–1.70] and 1.97 [95% CI, 1.53–2.53], respectively). CONCLUSIONS: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.