Mauro Massussi

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: A bicuspid aortic valve (BAV) presents unique challenges for transcatheter aortic valve implantation (TAVI), and evidence on long-term bioprosthetic durability in an BAV compared to a tricuspid aortic valve (TAV) remains limited. We aimed to compare the 5-year durability and hemodynamic performance of self-expandable TAVI in patients with BAV versus TAV stenosis, using propensity score-matched data from a large, real-world, multicentre registry. Methods: This retrospective, multicentre analysis included patients treated with self-expandable TAVI (2009–2020) from the Medtronic One Hospital ClinicalService registry. Patients with at least one echocardiographic follow-up were matched 1 : 1 ( n = 106 BAV; n = 106 TAV) based on key clinical and procedural characteristics. Primary endpoints were structural valve deterioration (SVD) and bioprosthetic valve failure (BVF), defined by VARC-3 criteria, analysed as cumulative incidence functions accounting for competing risk of death. All-cause mortality was analysed using Kaplan–Meier estimates. Results: At 5 years, the cumulative incidence of SVD was 1.07% [95% confidence interval (CI): 0.09–5.26] in BAV and 1.79% (95% CI: 0.14–8.50) in TAV ( P = 0.829). BVF occurred in 2.38% (95% CI: 0.44–7.62) of BAV and 2.8% (95% CI: 0.47–9.19) of TAV patients ( P = 0.782). Hemodynamic performance remained stable over time, with no statistically significant differences between the mean gradients at 5 years (7.8 ± 2.8 mmHg BAV versus 9.5 ± 11.7 mmHg TAV, P = 0.304). All-cause mortality at 5 years was 41.7% (BAV) versus 51.5% (TAV, P = 0.09). Conclusion: In this propensity-matched, real-world multicentre cohort, BAV and TAV patients treated with self-expandable TAVI showed no statistically significant differences in 5-year durability and hemodynamic performance. These findings are hypothesis-generating and suggest TAVI may be a reasonable option for selected BAV patients, pending further validation from randomized controlled trials.

BACKGROUND: Evidence regarding prosthesis–patient mismatch (PPM), measured (mPPM), and predicted (pPPM), after transcatheter aortic valve replacement in bicuspid aortic valve stenosis remains limited. This study sought to evaluate the incidence, predictors, and prognostic implications of mPPM and pPPM in patients with Sievers type 1 bicuspid aortic valve undergoing transcatheter aortic valve replacement. METHODS: The AD-HOC registry is a retrospective, multicenter study including 781 patients with severe aortic stenosis and bicuspid aortic valve treated with transcatheter aortic valve replacement between 2016 and 2023 across 24 centers. PPM was defined according to Valve Academic Research Consortium-3 criteria. The primary outcome was all-cause mortality. RESULTS: Moderate-to-severe mPPM was more frequent than pPPM (22% versus 8%; P 2 ; n=145), pPPM occurrence was significantly higher (19% versus 5.5%; P <0.001) and was associated with increased all-cause mortality, but not with cardiovascular mortality. CONCLUSIONS: In patients with Sievers type 1 bicuspid aortic valve undergoing transcatheter aortic valve replacement, pPPM occurred less frequently than mPPM and was predominantly driven by anatomic characteristics and sizing strategies. Although pPPM was associated with increased all-cause mortality among patients with small annuli, this association did not extend to cardiovascular mortality and should be considered hypothesis-generating. Further prospective investigations are warranted to better delineate the impact of anatomic constraints on clinical outcomes in this anatomically challenging subset.

Background: With the progressively increasing number of low‐risk patients undergoing transcatheter aortic valve replacement (TAVR), the number of those who will be long‐time pacemaker (PM) carriers is expected to increase. To date, conflicting data is available regarding the association between PM and mortality following TAVR. Aims: To investigate the association between PM and mortality in patients undergoing TAVR with self‐expandable bio‐prosthesis. Methods: Patients undergoing TAVR between 2007 and 2014 in 10 Italian centers were considered. Two analyses were performed: one comparing patients with and without pre‐TAVR PM (primary) and one comparing those with and without post‐TAVR PM (secondary). The primary endpoint was all‐cause mortality; the secondary endpoint was re‐hospitalization to the cardiac ward. Clinical outcomes were assessed at the longest available follow‐up. Results: Overall, 1779 patients were included in the primary analysis and 1465 in the secondary one. Pre‐TAVR PM implantation was not associated with an increased risk of all cause death in both the primary (adj. HR 0.93, 95% CI 0.76−1.13; p = 0.475) and secondary analysis (adj. HR 0.83, 95% CI 0.71−0.98; p = 0.029). Regarding hospitalization to cardiac ward, pre‐TAVR PM was not associated with the outcome (adj. HR 1.10, 95% CI 0.85−1.42, p = 0.254), while post‐TAVR PM implantation was related with an increased risk (adj. HR 1.94, 95% CI 1.56−2.41; p < 0.001). Conclusions: PM implantation is not associated with an increased risk of mortality in patients undergoing TAVR.

2025 ESC/EACTS guidelines for valvular heart disease reflect the rapid evolution of transcatheter technologies and multidisciplinary care. In primary mitral regurgitation, surgical repair remains the gold standard, with a new Class I recommendation for asymptomatic patients and refined timing incorporating indexed left ventricular end-systolic dimension. Transcatheter edge-to-edge repair (TEER) is upgraded to Class IIa for symptomatic high-risk patients. In secondary mitral regurgitation (SMR), the guidelines distinguish between atrial and ventricular phenotypes. Transcatheter edge-to-edge repair has now a Class I [Level of Evidence (LOE) A] recommendation for very selected patients with ventricular SMR symptomatic despite guideline-directed medical therapy. For atrial SMR, surgery—often involving concomitant atrial fibrillation ablation—is preferred in suitable candidates, while TEER is reserved to high-risk patients. Regarding tricuspid regurgitation, the guidelines emphasize early referral and structured evaluation of right ventricular function and pulmonary pressures (Class I). Transcatheter tricuspid valve interventions are upgraded to Class IIa (LOE A) for symptomatic high-risk patients, provided severe right ventricular dysfunction or precapillary pulmonary hypertension are absent. These updates redefine atrio-ventricular valve management by promoting earlier and personalized intervention. They solidify the role of transcatheter therapies as evidence-based, outcome-modifying options within a Heart Valve Centre framework, while precisely delineating the continued priority of surgery in lower-risk populations and complex anatomies.

Tricuspid regurgitation (TR) is a common yet often overlooked valvular disorder that carries a substantial impact on morbidity and mortality. It is increasingly recognized as a heterogeneous entity with different phenotypes identified (primary, atrial secondary, ventricular secondary, CIED-related). Contemporary population studies and disease-specific registries reveal that secondary TR is highly prevalent in elderly patients, those with heart failure (HF) of any phenotype, and in candidates for transcatheter aortic or mitral interventions. Prognosis varies widely according to etiology, with atrial secondary TR consistently associated with better survival than ventricular secondary TR. Across diverse settings, TR severity is an independent predictor of mortality, and several clinical scores, including the TRI-SCORE, Wang score, and TRIO score, have been developed to refine risk stratification. Recent staging models integrating ventricular function, renal status, and biomarkers suggest that intervention during an intermediate disease phase, before irreversible end-organ damage, may optimize outcomes. Together, these advances underscore the need for accurate phenotyping, structured prognostic assessment, and timely intervention to improve the care of patients with TR.

Background: Self-expanding transcatheter heart valves (SEVs) are often used to treat Sievers type 1 bicuspid aortic valve (BAV) stenosis. It remains unclear, however, if different SEVs yield similar outcomes in BAV stenosis, a class effect, or if the unique design features of different SEVs produce disparate clinical results. Objectives: This is a “proof-of-concept” study that compares procedural and clinical outcomes of Acurate neo2 and Evolut Pro/Pro+/Fx platforms in Sievers type 1 BAV stenosis. Methods: The CLASS effect is a retrospective, multicenter registry that enrolls patients with raphe-type 1 BAV stenosis undergoing TAVI at 29 international centers, who received Acurate neo2 and Evolut Pro/Pro+/Fx devices. An inverse probability of treatment weighting (IPTW) analysis was performed to adjust for baseline imbalances. Primary endpoints included VARC-3 technical success, 30-day device success, and early safety according to VARC-3. Results: Among 389 eligible patients, 155 and 234 patients were treated with Acurate neo2 and Evolut platforms, respectively. A higher rate of technical success was observed in the Evolut group (Acurate neo2 vs. Evolut: 93.4% vs. 97.1%, OR 0.41, 95% CI 0.19–0.83, and p = 0.017). At 30 days, device success was comparable (90.1% vs. 89.4%, OR 1.09, 95% CI 0.68–1.75, and p = 0.733), whereas Acurate neo2 was associated with a higher rate of early safety (84.1% vs. 70.4%, OR 2.22, 95% CI 1.56–3.17, and p < 0.001), which was mainly driven by a lower risk of new permanent pacemaker implantation (PPI) (6.3% vs. 19.5%, OR 0.28, 95% CI 0.16–0.46, and p < 0.001). Conclusions: Acurate neo2 and Evolut Pro/Pro+/Fx platforms provide similarly effective procedural and short-term outcomes in Sievers type 1 BAV stenosis. However, Evolut was associated with a higher technical success, while Acurate neo2 demonstrated a lower incidence of new PPI.

In-stent restenosis (ISR) remains a significant complication of percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease, with potentially severe consequences. This study aimed to evaluate the incidence and predictors of ISR and highlight the role of systematic angiographic follow-up in optimizing patient outcomes. We conducted a retrospective cohort study including 229 patients who underwent LMCA PCI between 2013 and 2023 at ASST Spedali Civili di Brescia. All patients underwent systematic angiographic follow-up at 8 months. Data on clinical, angiographic, and procedural characteristics were collected and analyzed using univariate and multivariate logistic regression to identify predictors of ISR. Kaplan–Meier survival analysis was employed to assess outcomes. ISR was identified in 24 patients (10.5%) during angiographic follow-up, with 29.2% being symptomatic. Chronic kidney disease (CKD; odds ratio: 3.84, P = 0.003) and diabetes (odds ratio: 3.18, P = 0.008) emerged as independent predictors of ISR. Multivariate analysis confirmed these associations. Survival rates were high, with 97.7% at 1 year, 92.2% at 2 years, and 81.5% at 4 years. Subanalyses showed trends toward higher mortality among patients with CKD or diabetes but no significant differences between patients with acute and chronic coronary syndromes. In conclusion, ISR remains a clinically significant challenge after LMCA PCI, with CKD and diabetes as key predictors. Systematic angiographic follow-up is essential for early ISR detection, especially in high-risk populations, as the majority of cases are asymptomatic. These findings emphasize the need for tailored surveillance strategies to improve outcomes.