Nieves Gonzalo

Background: Frailty is common in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and portends worse outcomes. Whether the benefit of posttranscatheter aortic valve implantation dapagliflozin differs by frailty is uncertain. Methods: In this post hoc analysis, we investigated the efficacy of dapagliflozin according to frailty status in the DapaTAVI (Dapagliflozin in Patients Undergoing Transcatheter Aortic Valve Implantation) trial. Frailty was assessed through the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight scale (robust=0, prefrail=1–2, frail=3–5). The primary outcome was the composite of all‐cause death or worsening heart failure at 1 year. Results: Among 1222 patients with baseline frailty assessment, 47.2% were frail, 40.3% prefrail, and 12.4% robust. Over 12 months, 215 patients (17.6%) experienced the primary end point. Patients who were prefrail and frail had higher risk than robust patients (adjusted hazard ratios [HRs], 1.88 [95% CI, 1.05–3.38] and 2.29 [1.29–4.07], respectively; P =0.004). Dapagliflozin was associated with a lower risk of the primary end point in patients who were frail (HR, 0.53 [95% CI, 0.36–0.77]) but not in those who were prefrail (HR, 1.01 [95% CI, 0.66–1.55]) or robust patients (HR, 1.26 [95% CI, 0.42–3.75]); P for interaction=0.021. There was no evidence that frailty modified the safety profile of dapagliflozin. Conclusions: Frailty was common and independently associated with worse outcomes after transcatheter aortic valve implantation. Dapagliflozin appeared to confer greater relative benefit in patients with frailty.

Background: Most evidence for transcatheter aortic valve replacement (TAVR) for valve‐in‐valve procedures comes from balloon‐expandable and supra‐annular self‐expanding valves. However, data on intra‐annular self‐expanding valves remain limited. The objectives of this registry were to evaluate the short‐ and midterm outcomes of ViV‐TAVR using the intra‐annular self‐expanding valve Navitor platform in a real‐world setting. Methods: The NAViV (Navitor Valve‐in‐Valve) registry is a retrospective, multicenter study that included 200 patients who underwent valve‐in‐valve TAVR with the Portico/Navitor systems. The primary end point was 30‐day device success. Secondary outcomes included intraprocedural technical success, early safety, and all‐cause death and major adverse events at 2 years. Results: The cohort had a high‐risk profile and a high prevalence of small surgical bioprostheses (internal diameter ≤21 mm in 86% of the patients). Technical success was achieved in 96%, with an in‐hospital mortality rate of 2% and early safety at 30 days of 84%. Mean residual gradients after TAVR were low (14 [interquartile range, 10–20] mm Hg), and residual significant aortic regurgitation was rare (1%). Device success was 73.5%, with high residual gradients (≥20 mm Hg) being the main reason for device failure. Two‐year survival and major adverse events were 85.6% and 69.8%, respectively; with low residual gradients and baseline significant AR being independently associated with higher survival. Conclusions: Valve‐in‐valve TAVR using the Portico/Navitor intra‐annular self‐expanding valve demonstrates a favorable procedural safety profile, sustained valve performance, and encouraging midterm survival in intermediate‐ and high‐risk populations. Larger and comparative studies are warranted to confirm these findings.

Background: Rotational atherectomy (RA) has undergone considerable technical modernization in recent years. This study evaluated whether RA performed in the contemporary era was associated with superior cardiovascular outcomes compared with the traditional era. Aims: To compare the clinical characteristics and cardiovascular outcomes of patients treated with contemporary versus traditional rotational atherectomy, reflecting the evolution of clinical practice over time. Methods: We employed a registry including patients from April 2004 to December 2020. Group allocation was determined through a cluster analysis based on three variables reflecting temporal changes in RA practice: vascular access, sheath size, and burr diameter, yielding a traditional cohort ( n = 290; procedures before May 2011) and a contemporary cohort ( n = 279; procedures from May 2011). Comparisons between groups were performed to assess for statistically and clinically relevant prognostic differences. Multivariable analyses were performed to adjust for baseline imbalances. Results: Patients treated in the contemporary cohort exhibited lower left ventricular ejection fraction (LVEF) and worse Killip class. Their RA procedures were longer, required less contrast, and made substantially greater use of intracoronary imaging than those in the traditional cohort. Statin therapy and potent P2Y ₁₂ inhibitors were prescribed more frequently in the contemporary cohort. On follow‐up, contemporary practice yielded fewer reinfarctions and fewer target‐lesion and target‐vessel revascularizations, but a higher incidence of clinically relevant bleeding. Cardiovascular and all‐cause mortality were comparable between both eras. These differences persisted after multivariable adjustment for baseline imbalances. Conclusions: Contemporary RA was associated with fewer reinfarctions and revascularizations, which persisted after multivariable adjustment. Despite including patients with lower LVEF and a more critical status, no differences were detected in all‐cause mortality.

Aims: Sodium–glucose cotransporter 2 (SGLT2) inhibitors improve outcomes in heart failure (HF) across the left ventricular ejection fraction (LVEF) spectrum, but patients with severe valvular heart disease have been excluded from pivotal trials. We investigated the efficacy and safety of dapagliflozin across the full range of baseline LVEF in elderly patients undergoing transcatheter aortic valve implantation (TAVI). Methods and results: DapaTAVI was a pragmatic, multicentre, randomized, open-label trial with blinded endpoint adjudication conducted at 39 Spanish centres. Patients with severe aortic stenosis undergoing TAVI were randomized after the procedure to dapagliflozin 10 mg once daily or standard of care. The primary endpoint was a composite of all-cause death or worsening HF. Among 1223 patients with available baseline LVEF, 213 (17.4%) had LVEF ≤40% and 1010 (82.6%) had LVEF >40%. During 1-year follow-up, the primary endpoint occurred in 20.2% of patients with LVEF ≤40% and 17.0% of those with LVEF >40% (adjusted HR 1.28, 95% CI 0.91–1.80; P = .15). Dapagliflozin reduced the risk of the primary endpoint consistently across LVEF subgroups, with no significant interaction between treatment effect and baseline LVEF (P for interaction = .41). Analyses modelling LVEF as a continuous variable confirmed a homogeneous treatment effect across the entire LVEF spectrum. Dapagliflozin was well tolerated, with a safety profile comparable to control across all LVEF categories, although genitourinary infections were more frequent with dapagliflozin. Conclusion: In elderly patients undergoing TAVI, dapagliflozin reduced the risk of all-cause death or worsening HF irrespective of baseline LVEF and was safe across the full LVEF spectrum. These findings extend the benefits of SGLT2 inhibition to patients with severe aortic stenosis treated with TAVI, independent of systolic function.

Background/Objectives: Hypoattenuated leaflet thrombosis (HALT) is a frequent finding after transcatheter aortic valve replacement (TAVR). Although high residual platelet reactivity (HPR) increases thrombotic risk after coronary stent implantation, its role in HALT remains unclear. This study aimed to determine the incidence and predictors of HALT in TAVR patients treated with dual antiplatelet therapy, focusing on the impact of HPR. Methods: This was a prospective, multicenter observational study. Between June 2018 and February 2022 patients with symptomatic severe aortic stenosis undergoing successful TAVR and treated with dual antiplatelet therapy for 3 months were included. Platelet reactivity was assessed 1–3 months post-TAVR using either VerifyNow (72%) or the Multiplate Analyzer (28%). HALT was evaluated using contrast-enhanced multidetector computed tomography. Results: A total of 169 patients were included (mean age 81.5 ± 5 years; 51% female). The incidence of HALT was 22%. Independent predictors of HALT were self-expanding valve (OR 3.05; 95% CI, 1.30–7.14; p = 0.010). Protective factors included larger prosthesis size (OR 0.78; 95% CI, 0.65–0.93; p = 0.007), statin-treated dyslipidemia (OR 0.37; 95% CI, 0.16–0.88; p = 0.024), and higher creatinine clearance (OR 0.98; 95% CI, 0.96–1.00; p = 0.035). HALT incidence was similar in patients with and without HPR (23.7% vs. 33.6%; p = 0.29). No differences in clinical outcomes were observed at 1 year. Conclusions: HALT occurred in nearly one-quarter of TAVR patients treated with dual antiplatelet therapy and was unrelated to platelet reactivity. Valve characteristics, renal function, and statin-treated dyslipidemia were associated with HALT, highlighting the multifactorial nature of its development.

Background: Transcatheter aortic valve replacement (TAVR) has shown noninferiority to surgical aortic valve replacement (SAVR). However, patients with bicuspid aortic stenosis are often excluded from these studies. More insights between these procedures in this population is crucial for treatment selection. Methods: In this multicenter observational study, patients with bicuspid aortic stenosis undergoing TAVR or SAVR were analyzed using propensity score matching. The primary outcome was a composite of all‐cause mortality, stroke, rehospitalization, or valve dysfunction at 1 year. Results: A total of 997 patients with bicuspid aortic stenosis underwent TAVR or SAVR. In the matched cohort of 256 pairs, the median age was 75.0 years (interquartile range, 71.0–78.0), 234 (44.9%) were women, and the median EuroScore II was 1.83% (interquartile range, 1.34–2.86). One‐year cumulative incidence of the primary outcome was 15.0% in TAVR compared with 12.0% in SAVR (hazard ratio [HR], 1.35 [95% CI, 0.83–2.19], P =0.23). Mortality (4.3% versus 5.0%, P =0.72) and rehospitalization (4.8% versus 6.4%, P =0.45) were similar between groups. Although rates of valve dysfunction (2.9% versus 0.5%, P =0.06) and stroke (5.3% versus 2.3%, P =0.10) were numerically lower in the surgical group at 1 year, both the risk of stroke (subdistribution HR, 3.01, P =0.02) and valve dysfunction (subdistribution HR, 4.16, P =0.03) were significantly higher in the TAVR group at 2 years. Conclusions: TAVR in patients with bicuspid aortic stenosis showed a similar 1‐year primary outcome rate compared with SAVR, though TAVR exhibited higher rates of valve dysfunction and stroke. These findings underscore the need for randomized trials to define the optimal treatment strategy for this population.