Luis Nombela-Franco

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: Data on the long-term incidence and clinical impact of bioprosthetic valve failure (BVF) after transcatheter aortic valve replacement remain limited. This study aimed to assess the incidence, predictors, and clinical impact of BVF following transcatheter aortic valve replacement. METHODS: We analyzed data from an international, multicenter registry including consecutive patients undergoing transcatheter aortic valve replacement at 13 centers. The primary outcome was BVF according to Valve Academic Research Consortium-3 criteria. The cumulative incidence of BVF was estimated using a competing-risk approach. The association between BVF and clinical outcomes was assessed using competing-risk models with BVF as a time-dependent covariate. RESULTS: Among 7501 patients, BVF occurred in 380 (5.1%) patients over a median follow-up of 4 (interquartile range, 2–5) years. The cumulative incidence of BVF increased over time, reaching 1.4% at 1 year, 4.6% at 5 years, and 8.3% at 10 years. Independent predictors of BVF included younger age, smoking, balloon-expandable valve, prosthesis size P P P =0.043), and heart failure hospitalization (adjusted hazard ratio, 1.43 [95% CI, 1.03–1.98]; P =0.032). Consistent findings were observed in different sensitivity analyses. CONCLUSIONS: BVF is a clinically relevant event associated with adverse long-term outcomes. These findings support the implementation of tailored surveillance and preventive strategies to mitigate BVF-related risk.

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.