Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: To identify the incidence, predictors, and clinical outcomes of PVR following TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with severe Sievers type 1 BAV stenosis undergoing TAVR with current generation transcatheter heart valves (THVs) in 24 international centres were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAE), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%): mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were larger virtual raphe ring (VRR) perimeter (ORadj 1.07, 95% CI 1.02-1.13), severe annular or left ventricular outflow tract (LVOT) calcification (ORadj 5.21, 95% CI 1.45-18.77), self-expanding valve (ORadj 9.01, 95% CI 2.09-38.86), and intentional supra-annular THV positioning (ORadj 3.31, 95% CI 1.04-10.54). At a median follow-up of 1.3 [IQR 0.5-2.4] years, moderate or severe PVR was associated with an increased risk of MAE (HRadj 2.52, 95% CI 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAE during follow-up.

Quality of life in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: tools and evidence.

Aortic stenosis is the most prevalent valvular heart disease requiring intervention, especially in the elderly population. Surgical aortic valve replacement and transcatheter aortic valve implantation (TAVI) are well established treatment options for symptomatic patients with severe aortic stenosis, as they provide a significant survival benefit. Aortic stenosis may have an important impact on patients' quality of life (QoL). However, advanced age, comorbidities and frailty may limit the beneficial effect of aortic stenosis interventions in terms of QoL. Current guidelines mention the importance of frailty and avoiding the futility of interventions, but lack specific indications about decision-making. Also, there are limited data on how to specifically assess QoL in aortic stenosis patients since the most used questionnaires are validated in different populations (i.e. heart failure). The aim of this review is to summarize all the available tools for QoL assessment in patients with aortic stenosis; to report current evidence on the impact of TAVI on QoL; and to discuss the role of frailty and comorbidities in this setting.

Eicosapentaenoic Acid: between Cardiovascular Benefits and the Risk of Atrial Fibrillation.

In recent years, scientific research has increasingly focused on the cardiovascular benefits of omega-3 polyunsaturated fatty acids (n-3 PUFAs) supplements. The most promising results emerged from the new trials on a high-dose eicosapentaenoic acid (EPA)-only approach, instead of the previously prescribed therapy with EPA + docosahexaenoic acid (DHA). The evidence of the reduction of cardiovascular events in patients at high cardiovascular risk with EPA is intriguing. However, physicians have expressed concern about the potential high risk of atrial fibrillation (AF) occurrence due to such an approach. This study aims to investigate the current evidence on the cardiovascular benefits of EPA and its association with atrial arrhythmogenesis. Current guidelines consider EPA (as IPE) treatment for selected patients but with no specific indication regarding AF risk evaluation. We propose a flowchart that could be a starting point for the future development of an algorithm to help clinicians to prescribe EPA safely and effectively, especially in patients at high risk of incipient AF.

Impact of Pacemaker Implantation After Transcatheter Aortic Valve Replacement on Long-Term Survival in Patients With Bicuspid Aortic Valve.

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.

Impact of Chronic Coronary Artery Disease and Revascularization Strategy in Patients with Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Implantation.

The prognostic impact of coronary artery disease (CAD) after transcatheter aortic valve implantation (TAVI) is controversial. The aim of this study is to investigate the impact of CAD and different revascularization strategies on clinical outcomes in patients who underwent TAVI with third generation devices. Patients enrolled in the national observational Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment II study were stratified according to the presence of CAD (CAD+, n = 1,130) versus no CAD (CAD-, n = 1,505), and compared using a propensity matched analysis. CAD+ group was further stratified according to the revascularization strategy: no revascularization (n = 331), revascularization performed >90 days before index-TAVI (n = 417) and coronary revascularization performed <90 days before index-TAVI or during TAVI (n = 382). In-hospital, 30-day and 1-year clinical outcomes were estimated. The mean age of the overall population was 81.8 years; 54.9% of patients were female. Propensity score matching yielded 813 pairs and their 30-day all-cause mortality was comparable (p = 0.480). Major periprocedural adverse events were also similar between the groups. At 1-year follow-up, the rate of major adverse cardiac and cerebrovascular events (MACCEs) and all-cause mortality were similar between the groups (p = 0.732 and p = 0.633, respectively). Conversely, patients with CAD experienced more often myocardial infarction and need for percutaneous coronary intervention at 1 year (p = 0.007 and p = 0.001, respectively). Neither CAD nor revascularization strategy were independent predictors of 1-year MACCE. About 40% of patients presenting with severe AS and who underwent TAVI had concomitant CAD. The presence of CAD had no impact on all-cause mortality and MACCE 1-year after TAVR. However, CAD carries a higher risk for acute myocardial infarction and need of percutaneous coronary intervention during follow-up.

Mid-term outcomes and hemodynamic performance of transcatheter aortic valve implantation in bicuspid aortic valve stenosis: Insights from the bicuSpid TAvi duraBILITY (STABILITY) registry.

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.

Transcatheter aortic valve replacement with the self-expanding ACURATE Neo2 in patients with horizontal aorta: Insights from the ITAL-neo registry.

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.

Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves.

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Incidence, predictors, and prognostic impact of new permanent pacemaker implantation after TAVR with self-expanding valves

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Coronary artery disease and TAVI: Current evidence on a recurrent issue.

Coronary artery disease (CAD) is a frequent finding in patients with aortic stenosis (AS). Concomitant coronary artery bypass and aortic valve replacement is considered the gold standard treatment in surgical candidates. However, limited evidence is available regarding the role of coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI). How to evaluate CAD severity in patients with AS, whether percutaneous coronary intervention (PCI) needs to be performed and what is the timing for revascularization to minimize procedural risks, remains matters of debate. The aim of this review is to summarize epidemiology, diagnostic tools and possible options for CAD management in patients undergoing TAVI with specific focus on the pros and the cons of the different timing of PCI.

Prediction of mortality and heart failure hospitalisations in patients undergoing M-TEER: external validation of the COAPT risk score.

BACKGROUND: A risk score was recently derived from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial. However, external validation of this score is still lacking. AIMS: We aimed to validate the COAPT risk score in a large multicentre population undergoing mitral transcatheter edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). METHODS: The Italian Society of Interventional Cardiology (GIse) Registry of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) population was stratified according to COAPT score quartiles. The performance of the COAPT score for 2-year all-cause death or heart failure (HF) hospitalisation was evaluated in the overall population and in patients with or without a COAPT-like profile. RESULTS: Among the 1,659 patients included in the GIOTTO registry, 934 had SMR and complete data for a COAPT risk score calculation. The incidence of 2-year all-cause death or HF hospitalisation progressively increased through the COAPT score quartiles in the overall population (26.4% vs 44.5% vs 49.4% vs 59.7%; log-rank p<0.001) and COAPT-like patients (24.7% vs 32.4% vs 52.3% vs. 53.4%; log-rank p=0.004), but not in those with a non-COAPT-like profile. The COAPT risk score had poor discrimination and good calibration in the overall population, moderate discrimination and good calibration in COAPT-like patients and very poor discrimination and poor calibration in non-COAPT-like patients. CONCLUSIONS: The COAPT risk score has a poor performance in the prognostic stratification of real-world patients undergoing M-TEER. However, after application to patients with a COAPT-like profile, moderate discrimination and good calibration were observed.

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries.

BACKGROUND: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. METHODS: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. RESULTS: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1-4, 4.1% [2.8-6.3%], 3.7% [2.6-5.3%], 3.3% [2.4-4.9%], 2.9% [2.2-4.3%]; P<0.001) and more moderate or heavy valve calcification (Q1-4, 80%, 80%, 82%, 88%; P=0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1-4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P=0.023) and early safety (Q1-4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P<0.001), with fewer permanent pacemaker implantations (Q1-4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P=0.023) and residual mild or greater paravalvular leaks (Q1-4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P<0.001). CONCLUSIONS: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

Deep learning to detect significant coronary artery disease from plain chest radiographs AI4CAD.

BACKGROUND: The predictive role of chest radiographs in patients with suspected coronary artery disease (CAD) is underestimated and may benefit from artificial intelligence (AI) applications. OBJECTIVES: To train, test, and validate a deep learning (DL) solution for detecting significant CAD based on chest radiographs. METHODS: Data of patients referred for angina and undergoing chest radiography and coronary angiography were analysed retrospectively. A deep convolutional neural network (DCNN) was designed to detect significant CAD from posteroanterior/anteroposterior chest radiographs. The DCNN was trained for severe CAD binary classification (absence/presence). Coronary angiography reports were the ground truth. Stenosis severity of ≥70% for non-left main vessels and ≥ 50% for left main defined severe CAD. RESULTS: Information of 7728 patients was reviewed. Severe CAD was present in 4091 (53%). Patients were randomly divided for algorithm training (70%; n = 5454) and fine-tuning/model validation (10%; n = 773). Internal clinical validation (model testing) was performed with the remaining patients (20%; n = 1501). At binary logistic regression, DCNN prediction was the strongest severe CAD predictor (p < 0.0001; OR: 1.040; CI: 1.032-1.048). Using a high sensitivity operating cut-point, the DCNN had a sensitivity of 0.90 to detect significant CAD (specificity 0.31; AUC 0.73; 95% CI DeLong, 0.69-0.76). Adding to the AI chest radiograph interpretation angina status improved the prediction (AUC 0.77; 95% CI DeLong, 0.74-0.80). CONCLUSION: AI-read chest radiographs could be used to pre-test significant CAD probability in patients referred for suspected angina. Further studies are required to externally validate our algorithm, develop a clinically applicable tool, and support CAD screening in broader settings.

Definition of trAnscatheter heart Valve orIeNtation in biCuspId aortic valve: The DA VINCI pilot study.

Objectives: To assess the impact of conventional transcatheter heart valve (THV) commissural alignment techniques on THV/coronary overlap and coronary access (CA) after transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV). Background: Specific Evolut Pro/Pro + and Acurate Neo2 THV orientations are associated with reduced neo-commissural overlap with coronary ostia in tricuspid aortic anatomy. Whether standard orientation techniques are effective also in the setting of BAV anatomy has not been studied. Methods: The DA VINCI (Definition of trAnscatheter aortic Valve orIeNtation in biCuspId aortic valve) pilot study is a prospective registry enrolling consecutive patients with severe BAV stenosis undergoing TAVR with last generation supra-annular tall-frame THVs implanted with a cusp overlap view-based commissural alignment. Patients underwent pre- and post-TAVR computed tomography (CT) and coronary angiography. The study endpoint was the rate of favorable THV/coronary overlap, defined as an angle > 40° between the THV commissural post and coronary ostia. Other endpoints were the rates of successful THV alignment with respect to the raphe and of selective CA after TAVR. Moreover, different virtual THV alignment models were tested to identify which one would produce the lower degree of THV/coronary overlap. Results: Thirty-four patients with type 1 BAV with right-left raphe undergoing TAVR (23 with Evolut Pro/Pro + and 11 with Acurate Neo2) were included. At pre-TAVR CT, moderate/severe cusp asymmetry was found in 50% of patients, severe coronary ostia eccentricity was observed in 47.1% for the RCA vs. 8.8% for the LCA (P < 0.007). Correct TVH orientation was achieved in 29 cases. At post-TAVR CT, optimal THV alignment/mild misalignment to the raphe was observed in 86.2%, but a moderate/severe overlap with the coronaries was seen in 13.7% for the RCA and 44.8% for the LCA (P = 0.019). After TAVR, selective RCA cannulation was possible in 82.8% vs. 75.9% for the LCA (P = 0.74), while combined selective CA of both coronaries was possible in less than two-thirds of the patients. Virtual THV alignment in the coronary ostia overlap view assuming a hypothetical circular THV expansion would produce an optimal THV/coronary overlap in almost 90% of cases. Conclusion: Given cusp asymmetry and coronary ostia eccentricity of BAV combined with potential THV asymmetrical expansion, conventional commissural alignment techniques are associated with higher rates of THV misalignment and of moderate/severe neo-commissure overlap with the coronary ostia as compared to tricuspid aortic stenosis, resulting in lower rates of selective CA after TAVR. A modified THV orientation technique based on the coronary ostia overlap view might be preferable in BAV patients.

Functional and metabolic frailty predicts mortality in patients undergoing TAVI: Insights from the OBSERVANT II study.

BACKGROUND/AIM: Despite the prognostic role of frailty among elderly patients undergoing transcatheter aortic valve implantation (TAVI) is known, its assessment still represents a challenge due to the multitude of scales proposed in literature. The aim of this study was to define the prognostic impact of a simple combined frailty model including both functional and metabolic parameters in a large cohort of patients undergoing TAVI with new generation devices. METHODS AND RESULTS: We examined 1-year survival of patients affected by aortic valve stenosis treated with new generation TAVI devices from the OBSERVANT II study. Frailty of patients undergoing TAVI was stratified in four groups according to a combination of functional (geriatric status scale - GSS) and metabolic (global nutritional risk index - GNRI) assessment. Among 1985 patients included in the analysis, 1008 (51%) had no significant frailty, 246 (12%) had only functional impairment, 522 (26%) had only metabolic impairment and 209 (11%) had both functional and metabolic impairment. The presence of combined functional and metabolic frailty was associated with a two-fold increased risk of 1-year all-cause mortality (HR 2.06 [95% CI 1.35-3.14]; p = 0.001). GNRI as a single parameter had a lower impact on mortality (HR 1.48 [95% CI 1.05 - 2.09]; p = 0.027), whereas GSS did not impact on mortality (HR 1.23 [95% CI 0.77-1.97]; p = 0.386). CONCLUSIONS: In a large real-world cohort of patients undergoing TAVI with new generation devices, combined functional and metabolic frailty had a significant and incremental impact on 1-year mortality.

10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance.

Background: The impact of transcatheter aortic valve replacement (TAVR) leaflet design on long-term device performance is still unknown. This study sought to compare the clinical and hemodynamic outcomes of intra- (IA) versus supra-annular (SA) TAVR designs up-to 10-years following implantation. Methods: Consecutive patients with at least 5-years follow-up following TAVR for severe symptomatic aortic stenosis from June 2007 to December 2016 were included. Bioprosthetic valve failure (BVF) and hemodynamic valve deterioration (HVD) were defined according to VARC-3 updated definitions and estimated using cumulative incidence function to account for the competing risk of death. Results: A total of 604 patients (82 years; 53% female) were analyzed and divided into IA (482) and SA (122) groups. Overall survival rates at 10-years were similar (IA 15%, 95%CI: 10-22; SA 11%, 95%CI: 6-20; p = 0.21). Compared to the SA TAVR, mean transaortic gradients were significantly higher and increased over time in the IA group. IA TAVRs showed higher 10-year cumulative incidences of BVF (IA 8% vs. SA 1%, p = 0.02) and severe HVD (IA 5% vs. SA 1%, p = 0.05). The occurrence of BVF and HVD in the IA group occurred primarily in the smallest TAVR devices (20-23-mm). After excluding these sizes, the cumulative incidences of BVF (IA 5% vs. SA 1%, p = 0.40) and severe HVD (IA 2% vs. SA 1%, p = 0.11) were similar. Conclusion: In this study, TAVR leaflet design had no impact on survival at 10-years. IA devices showed higher transaortic gradients and cumulative incidences of HVD and BVF predominantly occurring in the smallest valve sizes.

Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation. AIMS: The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices. METHODS: The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC-3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed. RESULTS: A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p<0.001), resulting in higher VARC-3 intended valve performance (96% vs 90%; p<0.001). Furthermore, more patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%; p<0.001). The reduction in paravalvular AR with neo2 was mainly observed with heavy aortic valve calcification. New pacemaker implantation and VARC-3 technical and device success rates were similar between the 2 groups; there were more frequent vascular and bleeding complications for the neo device. Similar 1-year survival was detected after TAVR (neo2: 90% vs neo: 87%; p=0.14). CONCLUSIONS: TAVR with the ACURATE neo2 device was associated with a lower prevalence of moderate or severe paravalvular AR and more patients with none/trace paravalvular AR. This difference was particularly evident with heavy aortic valve calcification.

Meta-Analysis of Relation Between Left Ventricular Dysfunction and Outcomes After Transcatheter Mitral Edge-to-Edge Repair.

Randomized controlled trials (RCTs) and observational studies provided conflicting results regarding the role of left ventricular (LV) function on outcomes after transcatheter edge-to-edge repair (TEER). The study aimed to provide a comprehensive assessment of the interplay between severe LV dysfunction and TEER outcomes. Multiple electronic databases, including PubMed, EMBASE, Scopus, Web of Science, and CENTRAL, were searched to identify studies on TEER for secondary mitral regurgitation reporting outcomes stratified for LV ejection fraction <30% and ≥30%. The prespecified primary end points were the composite of all-cause death or heart failure (HF) hospitalization and New York Heart Association (NYHA) class III/IV. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by random-effects models. Multiple sensitivity analyses accounting for baseline characteristics and study design were applied. A total of 6 studies (1,957 patients) with 1 year or 2 years of follow-up were available. Severe LV dysfunction was associated with an increased risk of death or HF hospitalization (OR 1.71, 95% CI 1.14 to 2.57). Conversely, comparable rates of NYHA class III/IV (OR 1.06, 95% CI 0.82 to 1.38) or secondary end points (reinterventions, recurrence of significant secondary mitral regurgitation) were found regardless of the baseline LV function. Subgroup meta-analysis found no difference in the composite primary end point between patients with LV ejection fraction <30% and ≥30% enrolled in RCTs. In conclusion, TEER seems to be associated with higher mortality or HF hospitalization rates in patients with severe LV dysfunction. However, RCTs found no differences between groups. No impact of LV function was found on the risk of NYHA class III/IV or other clinical outcomes.

Transcatheter Aortic Valve Replacement With Self-Expanding ACURATE neo2: Postprocedural Hemodynamic and Short-Term Clinical Outcomes.

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.