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:Bicuspid aortic valve (BAV) stenosis presents specific challenges for transcatheter aortic valve implantation (TAVI). Several transcatheter heart valve (THV) sizing strategies have been proposed. The CASPER algorithm (Calcium Algorithm Sizing for bicusPid aortic valve Evaluation with Raphe) indicates whether and how much to downsize the THV based on anatomic characteristics. The aim of this study was to prospectively assess the CASPER algorithm in a multicenter cohort of BAV patients treated with a self-expandable THV. METHODS:Consecutive BAV patients undergoing TAVI were prospectively enrolled across 6 centers from 2022 to 2024. Preprocedural multislice computed tomography (MSCT) was used for THV sizing according to CASPER. Procedural features and clinical outcomes at 30 days and 1 year were recorded. Patients were compared based on whether CASPER recommended downsizing. RESULTS:A total of 101 patients were included, and THV downsizing was advised in 39 cases (38.6%). The mean post-TAVI transvalvular gradient was 8.3 ± 4.3 mmHg, and moderate paravalvular leak occurred in 6 patients (6%). No deaths or major structural complications were reported, whereas the 30-day permanent pacemaker implantation rate was 25%. No significant differences between downsizing and non-downsizing groups were observed regarding procedural characteristics, hemodynamic performance, or clinical outcomes. Postprocedural MSCT (available in 84/101 patients, 83%) showed comparable THV eccentricity in both groups. CONCLUSIONS:The CASPER algorithm offers a practical and reproducible sizing strategy for use in BAV anatomy and appears to support appropriate THV expansion while identifying cases requiring downsizing. However, in the absence of a comparator group, these findings should be considered hypothesis-generating and require validation in prospective comparative or randomized studies. CLINICAL TRIAL REGISTRATION:NCT04817735.

BACKGROUND:Valve durability is a key consideration as the patient population eligible for transcatheter aortic valve implantation (TAVI) expands to include lower-risk and younger individuals who are expected to live many years after the procedure. AIMS:This registry aimed to assess the incidence of long-term structural valve deterioration (SVD) beyond 5 years post-TAVI. METHODS:Consecutive living patients who underwent TAVI up until 2014 using any commercially available transcatheter heart valve (THV) at 22 participant centres were enrolled in the European Valve Durability TAVI Registry. All patients underwent comprehensive echocardiographic assessments (61% were evaluated independently by a central core laboratory) within 6 months of enrolment and at least 5 years post-TAVI; SVD was defined according to Valve Academic Research Consortium 3 definitions. RESULTS:A total of 597 patients (aged 79.6±7.1 years at the time of TAVI; 47.2% male, mean Society of Thoracic Surgeons score 5.0%) were included. At a median of 6.1 years of follow-up (interquartile range 5.2-7.3 years), the crude incidence of moderate/severe SVD was 9.5% (n=57; moderate: 6.2%, n=37; severe: 3.4%, n=20). Predictors of SVD identified by Cox regression analysis were use of an intra-annular THV (hazard ratio [HR] 38.44, 95% confidence interval [CI]: 10.8-136.3; p<0.001), a small THV size (HR 4.82, 95% CI: 2.42-9.60; p<0.001) and moderate/severe postprocedural paravalvular leak (HR 3.64, 95% CI: 1.59-8.32; p=0.002). CONCLUSIONS:The incidence of moderate/severe SVD during long-term follow-up after TAVI is low, with severe SVD being even rarer than moderate SVD. SVD occurs more frequently in patients treated with older-generation intra-annular valves and in those with small-sized THVs.

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.

BACKGROUND:Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. AIMS:We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. METHODS:Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. RESULTS:Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). CONCLUSIONS:One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.

Background The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. Objectives The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. Methods Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. Results Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). Conclusions In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

BACKGROUND:The self-expanding, supra-annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3-year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery. METHODS:The FORWARD PRO prospective, single-arm, multicentre, post-market clinical study enrolled 638 patients with native aortic valve stenosis or failed surgical bioprosthetic aortic valve undergoing TAVI, at intermediate or high risk, with the Evolut PRO valve. Clinical and serial echocardiographic outcomes were followed-up for 3 years. RESULTS:TAVI using Evolut PRO was attempted in 629 AS patients (implanted in 97%) (mean age 81.7 years; STS PROM score, 4.7%). At 3 years all-cause mortality was 25.0%, disabling stroke 6.5% (all-cause mortality or disabling stroke, 28.5%) and rate of new permanent pacemaker implantation 24.7%. Excellent valve haemodynamics were maintained (mean gradient 8.8 ± 4.7 mm Hg; mean effective orifice area 2.0 ± 0.5 cm2) at 3 years. In a paired analysis of patients with ≥ mild paravalvular leakage (PVL) at discharge, more than two-thirds demonstrated improved PVL at 3 years. Patients with ≥ mild PVL at discharge had higher median total calcium volume than those with no/trace PVL (p < 0.001). CONCLUSIONS:In clinical practice TAVI with the Evolut PRO valve is associated with favorable clinical outcomes and excellent haemodynamic performance out to 3 years. The observation of improvements in PVL over time warrants further research.

Background Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated “purpose-built” Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs. Objectives The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR. Methods We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate. Results Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355). Conclusions The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.

BACKGROUND AND AIMS:Transcatheter aortic valve replacement (TAVR) determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis but data on very long-term durability are lacking. We sought to evaluate the clinical and hemodynamic outcomes of the CoreValve porcine pericardial self-expanding bioprosthesis at 12-year follow-up. METHODS:882 inoperable or high-risk patients were treated with the CoreValve bioprosthesis in 8 Italian high-volume centers between 2007 and 2011. The endpoints were 12-year all-cause and cardiovascular mortality, and Cumulative Incidence Functions (CIFs) for severe Structural Valve Deterioration (SVD), Bioprosthetic Valve Dysfunction (BVD), Bioprosthetic Valve Failure (BVF), and severe Hemodynamic Valve Deterioration (HVD). VARC-3 definitions were applied. RESULTS:Baseline characteristics included a mean age of 83 ± 6 years, and NYHA class III or IV in 76.3 % of patients. The actuarial risk of death at 12 years after TAVR was 95.5 % (CI 93.5 %- 97.1 %). The actual risk of cardiovascular death, weighted against the risk of non-cardiac death at 12 years was 23.9 % (21.0 %-26.8 %). The 12-year actual risk of BVD was 7.0 % (5.3 %-8.9 %), of SVD was 3.6 % (2.5 %-5.2 %), of BVF was 3.12 % (2.02 %-4.57 %), and of severe HVD was 1.7 % (0.9 %-2.9 %). Mean transaortic gradient significantly decreased after the procedure (52 ± 15 mmHg vs 9 ± 5 mmHg, p < 0.001), and remained stable up to 12 years (12 ± 4 mmHg, P = 0.08 vs. discharge). CONCLUSIONS:The first-generation CoreValve bioprosthesis showed reassuring clinical and hemodynamic performance at 12-year follow-up.

BACKGROUND:Limited data are available on transcatheter heart valves (THVs) durability in bicuspid aortic valve (BAV) stenosis.AIMS:To evaluate evaluating 4-year clinical and echocardiographic outcomes of patients with BAV undergoing transcatheter aortic valve implantation (TAVI).METHODS:The bicuSpid TAvi duraBILITY (STABILITY) registry is an Italian multicentre registry including all consecutive patients with BAV and severe aortic stenosis (AS), treated by means of TAVI between January 2011 and December 2017. Outcomes of interest were all-cause death at 4-year, over time changes in echocardiographic measurements, and THV durability according to the valve aortic research consortium (VARC)-3 update definitions.RESULTS:Study population included 109 patients (50% females; mean age 78 ± 7.5 years) with a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.1 ± 4.3%. Median follow-up (FU) duration was 4.1 years [interquartile range: 2.8-5.1]. The overall cumulative incidence of all-cause death by Kaplan-Meier estimates at 4 years was 32%. Compared to baseline, a significant decrease in transprosthetic mean gradient was obtained after TAVI (54 ± 16 vs. 10 ± 5 mmHg; p < 0.001), whereas a significant increase was observed at 4-year (13 ± 6.4 mmHg, p = 0.03). Cumulative incidence of hemodynamic valve dysfunction (HVD) was 4%. Six patients met HVD criteria: three moderate and three severe HVD. All three cases of severe HVD were clinically relevant (bioprosthetic valve failure [BVF]) with two patients receiving a reintervention (TAVI in TAVI), and one patient experiencing a valve-related death due to endocarditis.CONCLUSIONS:The STABILITY registry suggests that in patients with severe AS and BAV undergoing TAVI, postprocedural clinical benefits might last, over time, up to 4-year FU. The low rates of severe HVD and BVF may support the hypothesis of good THV durability also in BAV recipient.

BACKGROUND:Balloon post-dilation (BPD) is a widely adopted strategy to optimize acute results of TAVI, with a positive impact on both paravalvular leak and mean gradients. On the other hand, the inflation of the balloon inside prosthetic leaflets may damage them increasing the risk of structural valve deterioration (SVD). Furthermore, the impact of BPD on long-term clinical outcomes and valve hemodynamics is yet unknown.AIMS:To evaluate the impact of BPD on valve durability and long-term clinical outcomes in patients undergoing self-expanding transcatheter valve implantation (TAVI).METHODS:Echocardiographic and clinical data from the ClinicalService (a nation-based data repository and medical care project) were analyzed. Patients were divided into two groups, those who underwent BPD after TAVI and those who did not. Coprimary endpoints were all-cause death and SVD. Cumulative incidence functions for SVD were estimated.RESULTS:Among 1835 patients included in the study, 417 (22.7%) underwent BPD and 1418 (77.3%) did not undergo BPD. No statistically significant differences at 6-year follow-up were found between groups in terms of all-cause mortality (HR: 1.05, 95% CI: 0.9-1.22; p = 0.557) and SVD (2.1% vs. 1.4%, p = 0.381). In addition, BPD did not predispose to higher risk of cardiovascular death, myocardial infarction, valve thrombosis, and endocarditis at 6-year follow-up.CONCLUSIONS:BPD following TAVI with a self-expanding prosthesis does not seem to be associated with an increased risk of adverse clinical outcomes or SVD at 6-year follow-up.

BACKGROUND:Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL). OBJECTIVES:Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA. METHODS:We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes. RESULTS:Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort. CONCLUSION:In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.

Limited data are available about the impact of permanent pacemaker (PPM) implantation on long-term survival in patients with a bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR). We aimed to evaluate the long-term clinical outcomes of patients with BAV with AS who underwent periprocedural PPM implantation after TAVR with a self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService-CoreValve Project were collected. Patients were categorized in 2 groups according to PPM implantation after TAVR ("PPM" group) or not ("no PPM" group). The coprimary end points were all-cause death and a composite of cardiac mortality, rehospitalization because of cardiac causes, stroke, and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between the groups in terms of follow-up and baseline characteristics. Patients in the PPM group were more likely to show baseline conduction abnormalities (p = 0.023). Patients in the PPM group were more often treated with older generation prosthesis than those in the no PPM group (28.1% vs 5.4%, respectively, p = 0.013). At 2 years of follow-up, all-cause death in the no PPM and PPM groups occurred in 20.0% and 10.0% of patients, respectively (hazard ratio 0.37, 95% confidence interval 0.08 to 1.67). Similarly, no difference was evident for the composite end point between the 2 groups (no PPM vs PPM: 8 [14.6%] vs 6 [19.3%], hazard ratio 1.67, 95% CI 0.58 to 4.81). In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at 2 years of follow-up.

To retrospectively compare a reduced dose (RD) (0.075 mmol/kg) of gadobenate dimeglumine (RD-gadobenate) with standard single dose (SSD) (0.1 mmol/kg) of gadoterate meglumine (SSD-gadoterate) for cranial MRI.Thirty-one patients (12 males; aged 52 ± 16 years) underwent cranial MRI with SSD-gadoterate and repeated the examination with RD-gadobenate after a median interval of 10 months. Signal-to-noise ratio (SNR) was obtained on contrast-enhanced images for enhancing lesions (n = 10) as well as for right and left transverse venous sinuses, internal carotid arteries, and parotid glands. Moreover, a consecutive series of 100 cranial MRI with SSD-gadoterate (49 males; aged 51 ± 19 years) was compared with a consecutive series of 100 cranial MRI with RD-gadobenate (45 males; aged 54 ± 18 years). Two blinded neuroradiologists (R1, R2) judged contrast enhancement as sufficient, good, or optimal. Wilcoxon, Mann–Whitney, χ2, and Cohen κ statistics were used.At intraindividual analysis, median SNR ranged 57–88 for SSD-gadoterate and 79–99 for RD-gadobenate, the latter being systematically higher, the difference being significant for both transverse venous sinuses (p ≤ 0.011), not significant for both internal carotid arteries and both parotid glands, and enhancing lesions (p ≤ 0.101). The two series of interindividual analysis were not significantly different for gender/age (p > 0.415). Contrast enhancement was optimal in 59% (R1) and 76% (R2) of patients using RD-gadobenate, in 39% (R1) and 49% (R2) of patients using SSD-gadoterate (p ≤ 0.016), with substantial reproducibility (κ ≥ 0.606).Both analyses showed an equal or better contrast enhancement when using RD-gadobenate compared to SSD-gadoterate for routine cranial MRI. The high relaxivity of gadobenate allowed for a 25% dose reduction.

BACKGROUND The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain. OBJECTIVES The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB). METHODS Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry. RESULTS Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HRunadj: 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HRunadj: 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HRadj: 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HRadj: 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock. CONCLUSIONS In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications. (C) 2022 by the American College of Cardiology Foundation.

Background: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing. Aims: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old. Methods: All patients patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 dune 2020 were stratified by age (>70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups. Results: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0 +/- 2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715). Conclusions: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications.

BACKGROUND:The first-generation ACURATE neo transcatheter heart valve (THV) (Boston Scientific) was associated with a non-negligible occurrence of moderate or greater paravalvular aortic regurgitation (AR) following transcatheter aortic valve replacement. To overcome this issue, the ACURATE neo2 iteration, which incorporates a taller outer skirt aimed at reducing the occurrence of paravalvular AR, has recently been developed. OBJECTIVES:The aim of this study was to assess the efficacy and safety of the ACURATE neo2 (Boston Scientific) THV in patients with severe aortic valve stenosis. METHODS:ITAL-neo was an observational, retrospective, multicenter registry enrolling consecutive patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo THVs, via transfemoral and trans-subclavian access, in 13 Italian centers. One-to-one propensity score matching was applied to account for baseline characteristics unbalance. The primary endpoint was the occurrence of moderate or greater paravalvular AR on predischarge echocardiographic assessment. Secondary endpoints included postprocedural technical success and 90-day device success and safety. RESULTS:Among 900 patients included in the registry, 220 received the ACURATE neo2 THV, whereas 680 were treated with the first-generation device. A total of 410 patients were compared after 1:1 propensity score matching. The ACURATE neo2 THV was associated with a 3-fold lower frequency of postprocedural moderate or greater paravalvular AR (11.2% vs 3.5%; P < 0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the 2 cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 at 90 days. CONCLUSIONS:Transfemoral transcatheter aortic valve replacement using the ACURATE neo2 was associated with a significant lower frequency of moderate or greater paravalvular AR compared with the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy.

AIMS:The aim of this study was to minimize the procedure, and reduce the length of hospital stay (LoS) is the future objective for transcatheter aortic valve replacement (TAVI).Aims of the study are to identify procedural and electrocardiographical predictors of fast-track discharge in patients who underwent TAVI. METHODS:Patients treated with TAVI included in the One Hospital ClinicalService project were categorized according to the LoS. 'Fast-Track' population, with a postprocedural LoS less than or equal to 3 days, was compared with the 'Slow-Track' population with a postprocedural LoS greater than 3 days. RESULTS:One thousand five hundred and one patients were collected. Despite single baseline characteristics being almost similar between the two groups, Slow-Track group showed a higher surgical risk (P < 0.001). Patients in the Slow-Track group were more frequently treated with general anaesthesia (P = 0.002) and less frequently predilated (P < 0.001) and received a lower amount of contrast media. No difference between Slow-Track and Fast-Track patients was observed at 30 days in death and in cardiovascular rehospitalization.In the multivariable analysis, STS score of at least 4% [odds ratio (OR): 1.64; P = 0.01], general anaesthesia (OR: 2.80; P = 0.03), predilation (OR: 0.45; P < 001), NYHA 3-4 at baseline (OR: 1.65; P = 0.01), AVB I/LBBB/RBBB onset (OR: 2.41; P < 0.001) and in-hospital new PM (OR: 2.63; P < 0.001) were independently associated with a higher probability of Slow-Track. CONCLUSION:Fast-Track patients were safely discharged home showing no difference in clinical outcomes after discharge up to 30 days compared with the Slow-Track group. The STS score, general anaesthesia, NYHA 3--4 at baseline, in-hospital onset of conduction disturbances and new PM implantation after TAVI turned out to be predictors of Slow-Track.

OBJECTIVES:We evaluated the acute and two-year safety and efficacy of using the Corevalve, Evolut R, and Evolut PRO valves for treating failed surgical bioprosthesis from the Italian CoreValve Clinical Service Project. BACKGROUND:Valve-in-valve (ViV) TAVR is an emerging treatment option for failed surgical bioprosthesis. Choice of transcatheter valve is an important determinant of procedural and clinical outcomes, however, longer-term data are lacking. METHODS:The Clinical Service Project is a national clinical data repository evaluating the use of implantable devices across Italy. The present multi-center analysis includes consecutive patients who underwent ViV-TAVR with the Medtronic CoreValve series between October 2008 to June 2019. Evaluated endpoints included rates of overall mortality, cardiovascular mortality, myocardial infarction, and cerebrovascular accidents at 2-year follow-up. Procedural success, complications, and echocardiographic outcomes were reported according to VARC-2 criteria. RESULTS:A total of 139 patients (mean age, 80 ± 7 years; 47.5% male; mean STS score, 10.0 ± 9.7%) underwent ViV-TAVR with CoreValve (28.5%), Evolut R (68.6%), and Evolut Pro (2.9%) valves. Device success was achieved in 68% and acute coronary obstruction requiring PCI was observed in 4 patients (2.9%). Moderate PVL was observed in 3.7% and 2.8% of patients at 30-day and 2-year follow-up and moderate structural valve degeneration seen only 5 patients (3.6%). All-cause and cardiovascular mortality were 3.6% and 2.9% at 30 days, respectively, and 20.6% and 10.2% at 2-year follow-up. CONCLUSIONS:This real-world nationwide analysis demonstrates the acute and longer-term safety and efficacy of using the self-expanding Medtronic THV for ViV-TAVR.