Federico De Marco

Background: The Evolut and the Navitor transcatheter heart valves (THVs) represent the most widely used self‐expanding implanted valves. Despite a similar implant concept, they markedly differ in design and hemodynamic performance. In both THVs, conduction disturbances following transcatheter aortic valve replacement (TAVR) are reported higher than in balloon‐expandable devices. Nevertheless, to date, no direct comparative studies have analyzed their real difference rates. Aim: Aim of the present study was to directly compare the self‐expanding Evolut PRO+ and Navitor THVs, with specific focus on the incidence of new permanent pacemaker implantation (PPI) and post‐procedural hemodynamic performance. Methods: The CONNAVIPRO registry is an international, multicenter, retrospective study including 880 consecutive patients with severe aortic stenosis treated with Evolut PRO+ ( n = 451) or Navitor ( n = 429) between May 2022 and December 2024. The primary endpoint was new PPI within 30 days among pacemaker‐naïve patients. Secondary endpoints included technical and device success, transprosthetic gradients, and paravalvular leak (PVL). Inverse probability weighting (IPW) was applied to adjust for baseline differences. Results: Procedural success was high with both valves (97.6%), and early safety outcomes were comparable. At 30 days, the Navitor group showed a higher PPI rate than Evolut (23.2% vs. 17.6%), reaching statistical significance after IPW adjustment (OR 1.53, 95% CI 1.08–2.17; p = 0.018). Mean transprosthetic gradients were slightly higher with Navitor (8 vs. 7 mmHg; p = 0.002), whereas moderate or greater PVL was less frequent (2.8% vs. 7.7%; p < 0.001). Variables independently associated with PPI were hypertension, and pre‐existing right bundle branch block. Conclusions: Both Evolut PRO+ and Navitor THVs provided excellent safety and hemodynamic outcomes. Navitor may be associated with a higher 30‐day PPI rate, a lower incidence of moderate or greater PVL, and clinically non‐significant higher gradients. These associations should be interpreted as hypothesis‐generating and warrant confirmation in prospective studies.

BACKGROUND: The best management of coronary artery disease in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) is debated. We investigated the clinical impact of the residual extent of myocardium at risk in patients undergoing TAVI. METHODS: Patients enrolled in the REVASC-TAVI (Management of Myocardial Revascularization in Patients Undergoing TAVI With Coronary Artery Disease) international multicenter registry were stratified according to the myocardium jeopardized by coronary artery disease using the British Cardiovascular Intervention Society Jeopardy Score (BCIS-JS) after a planned coronary revascularization. A planned revascularization included percutaneous coronary interventions performed before TAVI, during TAVI, or within 1 month after TAVI. The study population was divided according to the residual BCIS-JS (rBCIS-JS): patients with extensive residual myocardial at risk (rBCIS-JS >4 group) and patients without extensive residual myocardial at risk (rBCIS-JS ≤4 group). The primary study end point was the composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 2 years. RESULTS: Among the 2407 patients enrolled, 294 pairs of patients were selected by propensity matching and compared. At 2-year follow-up, the incidence of the primary end point was higher in patients with rBCIS-JS >4 compared with patients with rBCIS-JS ≤4 (37.5% versus 23.0%, P =0.004). A significantly lower rate of myocardial infarction was reported in patients with BCIS-JS ≤4 (8.2% versus 2.6%, P =0.011). At multivariate analysis, rBCIS-JS >4 (hazard ratio, 1.43 [95% CI, 1.11–1.84]; P =0.005) independently predicted 2-year major adverse cardiac and cerebrovascular events. CONCLUSIONS: In patients with concomitant coronary artery disease and severe aortic stenosis, the residual myocardial risk significantly affects TAVI outcomes. In particular, a rBCIS-JS >4 is associated with higher rates of major adverse cardiac and cerebrovascular events at 2 years.

Background: Among patients treated for severe aortic stenosis, a small aortic annulus could have a different impact on outcomes according to body size. We aimed to compare forward‐flow hemodynamics and clinical outcomes after transcatheter aortic valve replacement in patients with small annuli according to aortic annular area (AAA) index, defined as computed tomography‐derived AAA divided by body surface area. Methods: The TAVI‐SMALL 2 (International Multicenter Registry to Evaluate the Performance of Self‐Expandable Valves in Small Aortic Annuli 2) observational, retrospective, international cohort study enrolled patients with severe aortic stenosis and small annuli in 16 high‐volume centers between 2011 and 2020. Analyses comparing patients with low (ie, ≤2 cm ² /m ² ) and high AAA index (ie, >2 cm ² /m ² ) were conducted adopting propensity score methodology. Primary end points were predischarge device forward‐flow composite (including mean aortic gradient ≥20 mm Hg or severe prosthesis–patient mismatch), and clinical efficacy composite (including all‐cause death, transient ischemic attack/stroke, or hospitalization for heart failure) at 1‐year follow‐up. Results: A total of 1256 patients were included in the analysis. In the 1:1 propensity score–matched population (n=688), the primary predischarge forward‐flow composite end point occurred in 48 patients (7.5%) overall and was more common in low versus high AAA index (9.7% versus 5.3%, P =0.034). The primary composite clinical efficacy end point occurred in 95 patients (18.1%), and no difference between groups was observed at 1‐year follow‐up (11.5% [95% CI, 7.8%–16.8%] versus 14.4% [95% CI, 10.4%–19.9%], hazard ratio, 0.89 [95% CI, 0.59–1.33]; P _log‐rank =0.842). Conclusions: Among patients with small aortic annuli undergoing transcatheter aortic valve replacement, the novel AAA index further identifies patients at increased risk of predischarge suboptimal forward‐flow hemodynamics. No difference in clinical efficacy at 1‐year follow‐up was observed according to the AAA index.