Single versus dual antiplatelet therapy following percutaneous left atrial appendage closure-A systematic review and meta-analysis.

BACKGROUND: In the last few years, percutaneous LAA occlusion (LAAO) has become a plausible alternative in atrial fibrillation (AF) patients with contraindications to anticoagulation therapy. Nevertheless, the optimal antiplatelet strategy following percutaneous LAAO remains to be defined. METHODS: Studies comparing single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following LAAO were systematically searched and screened. The outcomes of interest were ischemic stroke, device-related thrombus (DRT) and major bleeding. A random-effect meta-analysis was performed comparing outcomes in both groups. The moderator effect of baseline characteristics on outcomes was evaluated by univariate meta-regression analyses. RESULTS: Sixteen observational studies with 3255 patients treated with antiplatelet therapy (SAPT, n = 1033; DAPT, n = 2222) after LAAO were included. Mean age was 74.5 ± 8.3 years, mean CHA2DS2-VASc and HAS-BLED scores were 4.3 ± 1.5 and 3.2 ± 1.0, respectively. At a weighted mean follow-up of 12.7 months, the occurrence of stroke (RR 1.33; 95% CI 0.64-2.77; p =.44), DRT (RR 1.52; 95% CI 0.90-2.58; p =.12), and the composite of stroke and DRT (RR 1.26; 95% CI 0.67-2.37; p =.47) did not differ significantly between SAPT and DAPT groups. The rate of major bleedings was also not different between groups (RR 1.41; 95% CI 0.64-3.12; p =.39). CONCLUSIONS: Among AF patients at high bleeding risk undergoing percutaneous LAAO, a post-procedural minimalistic antiplatelet strategy with SAPT did not significantly differ from DAPT regimens regarding the rate of stroke, DRT and major bleeding.

Neural Stem Cells of the Subventricular Zone Contribute to Neuroprotection of the Corpus Callosum after Cuprizone-Induced Demyelination.

Myelin loss occurring in demyelinating diseases, including multiple sclerosis, is the leading cause of long-lasting neurological disability in adults. While endogenous remyelination, driven by resident oligodendrocyte precursor cells (OPCs), might partially compensate myelin loss in the early phases of demyelinating disorders, this spontaneous reparative potential fails at later stages. To investigate the cellular mechanisms sustaining endogenous remyelination in demyelinating disorders, we focused our attention on endogenous neural precursor cells (eNPCs) located within the subventricular zone (SVZ) since this latter area is considered one of the primary sources of new OPCs in the adult forebrain. First, we fate mapped SVZ-eNPCs in cuprizone-induced demyelination and found that SVZ endogenous neural stem/precursor cells are recruited during the remyelination phase to the corpus callosum (CC) and are capable of forming new oligodendrocytes. When we ablated SVZ-derived eNPCs during cuprizone-induced demyelination in female mice, the animals displayed reduced numbers of oligodendrocytes within the lesioned CC. Although this reduction in oligodendrocytes did not impact the ensuing remyelination, eNPC-ablated mice experienced increased axonal loss. Our results indicate that, in toxic models of demyelination, SVZ-derived eNPCs contribute to support axonal survival.SIGNIFICANCE STATEMENT One of the significant challenges in MS research is to understand the detrimental mechanisms leading to the failure of CNS tissue regeneration during disease progression. One possible explanation is the inability of recruited oligodendrocyte precursor cells (OPCs) to complete remyelination and to sustain axonal survival. The contribution of endogenous neural precursor cells (eNPCs) located in the subventricular zone (SVZ) to generate new OPCs in the lesion site has been debated. Using transgenic mice to fate map and to selectively kill SVZ-derived eNPCs in the cuprizone demyelination model, we observed migration of SVZ-eNPCs after injury and their contribution to oligodendrogenesis and axonal survival. We found that eNPCs are dispensable for remyelination but protect partially from increased axonal loss.

A novel balloon-expandable transcatheter aortic valve bioprosthesis: Myval and Myval Octacor.

INTRODUCTION: Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis. AREAS COVERED: This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs' performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures. EXPERT OPINION: Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both internal skirt and external reinforced cuff may also explain the low rate of moderate to severe PVL.

Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.

INTRODUCTION: Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. METHODS: A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). RESULTS: A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006]. CONCLUSION: Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal-free" strategy in this subset of CAD.

Performance of the Mammoth Balloon Catheter in Patients with Severe Aortic Valve Stenosis Undergoing Percutaneous Treatment.

Background: Balloon aortic valvuloplasty (BAV) is currently used as pre-treatment for patients undergoing trans-catheter aortic valve replacement (TAVR) as well as a stand-alone option for subjects with significant contraindications to TAVR. Mammoth is a newly available non-compliant balloon catheter (BC) included in the balloon-expandable Myval THV system (Meril Life Sciences Pvt. Ltd., India). As limited data on the performance of this BC are available, we here report the results following its use for BAV as pre-dilatation during TAVR or as a stand-alone procedure. Methods: A retrospective, single-center cohort analysis was performed on patients with severe aortic valve stenosis (AS) treated with the Mammoth BC at IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy. The primary endpoint was technical success defined as successful Mammoth BC advancement across the AS followed by its full and homogeneous inflation without major complications such as aortic root/left ventricular outflow tract injury and/or stroke. Results: A total of 121 patients were treated by BAV with Mammoth BC during the study period. Among these, 105 patients underwent BAV pre-dilatation before TAVR while 16 patients underwent a stand-alone BAV procedure. Mammoth BC was delivered and successfully inflated at the target site in all of the 121 cases without BC-related complications (100% technical success). However, in the BAV "stand-alone group", three patients required two different balloon sizes while in nine patients multiple rounds (two to three) of balloon inflation were needed to significantly lower the transvalvular gradient. No cases of aortic root injury or massive aortic regurgitation due to Mammoth BC-related aortic leaflet injury were reported while one major stroke occurred late after TAVR. No intra-procedural deaths occurred nor bleeding (BARC 3-4) or major vascular complication. Conclusions: Mammoth BC use in patients with severe AS proved safe and effective, either before TAVR or as a stand-alone procedure, expanding the range of available tools for structural operators.

Coronary Access and PCI after Transcatheter Aortic Valve Replacement With Different Self-Expanding Platforms in Failed Surgical Valves.

BACKGROUND: Coronary access (CA) and percutaneous coronary intervention (PCI) might be challenging after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) with supra-annular self-expanding valves (SS-TAVs) in surgical aortic valves (SAVs). Our study aim was to compare feasibility, predictors, and techniques of CA and PCI following ViV-TAVR with ACURATE neo2 (Boston Scientific, Marlborough, MA) and Evolut PRO+ (Medtronic, Minneapolis, MN). METHODS: Fifteen computed tomography (CT)-based patient-specific aortic models were 3-dimensionally (3D) printed and implanted with specific SAVs and with the 2 SS-TAVs with commissural alignment. Two operators attempted CA (n = 120) and PCI (n = 120) of each coronary artery in a pulsatile-flow-simulator, under real catheterization laboratory conditions. The primary endpoints were the rate of successful CA and PCI. Outcomes with different SS-TAVs were directly compared. An internally mounted borescope camera was used to assess procedures. CT of the models was obtained. RESULTS: ACURATE neo2 showed significantly higher rates of successful CA (96.7% vs 75%, P = 0.001) and PCI (98.3% vs 85%, P = 0.008) and was associated with a shorter procedural time compared with Evolut PRO+. Independent predictors of unsuccessful CA and PCI were smaller SAV size and Evolut PRO+. The advantage of ACURATE neo2 was mediated by a larger valve-to-anatomy distance at the top of the leaflet plane (11.3 mm vs 4.8 mm), facilitating more often an external cannulation approach for both CA (36.7% vs 15%, P < 0.001) and PCI (36.7% vs 21.7%, P = 0.013). CONCLUSIONS: The rate of successful CA and PCI following ViV-TAVR was higher with ACURATE neo2 compared with Evolut PRO+. The differences in SS-TAVs design affected the cannulation approach and subsequent procedural outcomes.

Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study.

Introduction: Limited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria. Material and methods: A multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (n = 128), Italy (n = 58), and Greece (n = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria. Results: Technical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%. Conclusions: In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.

Comparing two-year outcomes of balloon-expandable Myval and self-expanding Evolut R in severe aortic valve stenosis.

BACKGROUND: The new balloon-expandable (BE) Myval transcatheter heart valves (THV) has shown promising early results with low paravalvular leak (PVL) and permanent pacemaker implantation (PPI) rates. Limited data are available regarding its long-term performance. We aimed to compare the 2-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement (TAVR) using the self-expanding (SE) Evolut R and the BE Myval THVs. METHODS: The EVAL study included 166 patients with severe aortic valve stenosis who underwent TAVR either with SE Evolut R (n = 108) or BE Myval (n = 58) THV. Primary objectives include comparison on clinical efficacy (freedom from all-cause mortality, stroke, and cardiovascular hospitalization), echocardiographic performance and PPI rates between the two THVs. RESULTS: At 2-year the BE Myval group showed higher clinical efficacy (86% vs. 66%,HR:2.62, 95%CI 2.2-5.1;p = 0.006), with fewer cardiac hospitalizations (3.4% vs. 13.9%,p = 0.03). No significant differences in all-cause mortality, cardiovascular mortality, or stroke rates were observed. The proportion of patients with ≥moderate PVL was significantly lower in the BE Myval compared to the SE Evolut R group (4%vs. 22%,p = 0.008). The mean transvalvular gradient was significantly higher in the SE group compared to the BE group (9.5 ± 4.3 vs. 6.9 ± 2.2 mmHg,p < 0.001), however there was no difference in the percentage of patients with a mean gradient ≥20 mmHg between the two groups. CONCLUSIONS: Both THVs offer similar 2-year clinical outcomes. The BE Myval THV demonstrated advantages with higher clinical efficacy and lower PVL incidence. Longer follow-up and randomized trials are needed to validate these results and assess Myval's sustained performance and durability.

Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Atrial Functional Mitral Regurgitation from the GIOTTO Registry.

Atrial functional mitral regurgitation (aFMR) has a peculiar pathophysiology that may have distinctive outcomes. We investigated the impact of transcatheter edge-to-edge repair in aFMR compared with other FMR etiologies. The GIOTTO (GIse registry Of Transcatheter treatment of MR) is a multicenter, prospective study enrolling patients with symptomatic MR treated with MitraClip up to 2020. We categorized patients with FMR as aFMR, ischemic FMR (iFMR), and nonischemic ventricular FMR (niFMR). The clinical end points were defined according to the Mitral Valve Academic Research Consortium. Of 1,153 patients, 6% had aFMR, 47% iFMR, and 47% niFMR. Patients with aFMR were older, mostly women, and had a higher atrial fibrillation rate. They had better left ventricular ejection fraction and smaller left ventricular volumes, with no difference in mitral effective regurgitant orifice area. The acute device and procedural success rates were similar among the groups. At the longest available follow-up (median 478 days, interquartile range 91 to 741 days), the rate of MR ≥2+ was similar among the groups. Patients with aFMR had a lower rate of cardiovascular death and heart failure than patients with iFMR (hazard ratio [HR] 0.43, p = 0.02) and niFMR (HR 0.45, p = 0.03). The aFMR etiology remained independently associated with the composite outcome, together with postprocedural MR ≤1+ (HR 0.63, p <0.01) and peripheral arteriopathy (HR 1.82, p = 0.003). The results of this GIOTTO subanalysis suggested that aFMR is less prevalent and associated with better outcomes compared with other causes of FMR treated by transcatheter edge-to-edge repair. Postprocedural MR >1+, peripheral vasculopathy, non-aFMR were independent predictors of worse outcomes.

Percutaneous Coronary Intervention before or after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis Involving 1531 Patients.

Background: The optimal timing to perform percutaneous coronary interventions (PCIs) in patients undergoing transcatheter aortic valve replacement (TAVR) is not well established. In this meta-analysis, we aimed to compare the outcomes of patients undergoing PCI before versus after TAVR. Methods: A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to 5 April 2024 for studies that compared PCI before and after TAVR reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were mortality, stroke, and myocardial infarction (MI) at follow-up. Results: A total of 3 studies involving 1531 patients (pre-TAVR PCI n = 1240; post-TAVR PCI n = 291) were included in this meta-analysis following our inclusion criteria. Mortality was higher in the pre-TAVR PCI group (OR: 2.48; 95% CI: 1.19-5.20; p = 0.02). No differences were found between PCI before and after TAVR for the risk of stroke (OR: 3.58; 95% CI: 0.70-18.15; p = 0.12) and MI (OR: 0.66; 95% CI: 0.30-1.42; p = 0.29). Conclusions: This meta-analysis showed in patients with stable CAD undergoing TAVR that PCI after TAVR is associated with lower mortality compared with PCI before TAVR.

Comparison of ultrasound- versus fluoroscopy-guidEd femorAl access In tranS-catheter aortic valve replacement In the Era of contempoRary devices: The EASIER registry.

BACKGROUND: Vascular complications (VCs) still represent one of the principal concerns of trans-femoral trans-catheter aortic valve replacement (TF-TAVR). New-generation devices can minimize such complications but the arterial access management is left to the operator's choice. This study aims to describe the rate of VCs in a contemporary cohort of patients undergoing TAVR with new-generation devices and to determine whether an ultrasound-guided (USG) vs. a fluoroscopy-guided (FG) femoral access management has an impact on their prevention. METHODS: This is a prospective, observational, multicenter study. Consecutive patients undergoing TAVR with new-generation devices were analyzed from January 2022 to October 2022 in five tertiary care centers. Femoral accesses were managed according to the operator's preferences. All the patients underwent a pre-discharge peripheral ultrasound control. VCs and bleedings were the main endpoints of interest. RESULTS: A total of 458 consecutive patients were enrolled (274 in the USG group and 184 in the FG group). VCs occurred in 6.5 % of the patients (5.2 % minor and 1.3 % major). There was no difference between the USG and the FG groups in terms of any VCs (7.3 % vs. 5.4 %; p = 0.4), or any VARC-3 bleedings (6.9 % vs 6 %, p = 0.9). At logistic regression analysis, the two guidance strategies did not result as predictors of VCs (odds Ratio 0.8, 95 % Confidence Interval 0.46-1.4; P = 0.4). CONCLUSIONS: In a contemporary cohort of patients undergoing TAVR with new-generation devices, the occurrence of VCs is low and mostly represented by minor VCs. USG and FG modalities did not affect the rate of VCs.

Spontaneous coronary artery dissection: the emerging role of coronary computed tomography.

Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome and myocardial infarction, more frequent among young women. Invasive coronary angiography (ICA) is the gold standard for the diagnosis of SCAD, although the risk of propagating dissection flap is considerable. Therefore, coronary computed tomography angiography (CCTA) is an emerging alternative modality to diagnose SCAD with the advantage of being a non-invasive technique. Clinicians should be aware of the predisposing conditions and pathophysiology to raise the pre-test probability of SCAD and select the most appropriate diagnostic tools. In recent times, improvements in spatial and temporal resolution and the use of semi-automated software providing quantitative assessment make CCTA a valid alternative to ICA also for the follow-up. Moreover, CCTA may be helpful to screen and evaluate extra-coronary arteriopathies closely related to SCAD. In this review, we illustrate the current and the potential role of CCTA in the diagnosis of SCAD, highlighting advantages and disadvantages of this imaging modality compared to ICA.

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.

Added Value of CCTA-Derived Features to Predict MACEs in Stable Patients Undergoing Coronary Computed Tomography.

Clinical evidence has emphasized the importance of coronary plaques' characteristics, rather than lumen stenosis, for the outcome of cardiovascular events. Coronary computed tomographic angiography (CCTA) has a well-established role as a non-invasive tool for assessing plaques. The aim of this study was to compare clinical characteristics and CCTA-derived information of stable patients with non-severe plaques in predicting major adverse cardiac events (MACEs) during follow-up. We retrospectively selected 371 patients (64% male) who underwent CCTA in our center from March 2016 to January 2021 with Coronary Artery Disease­Reporting and Data System (CAD-RADS) 0 to 3. Of those, 198 patients (53% male) had CAD-RADS 0 to 1. Among them, 183 (49%) had normal pericoronary fat attenuation index (pFAI), while 15 (60% male) had pFAI ≥ 70.1 Hounsfield unit (HU). The remaining 173 patients (76% male) had CAD-RADS 2 to 3 and were divided into patients with at least one low attenuation plaque (LAP) and patients without LAPs (n-LAP). Compared to n-LAP, patients with LAPs had higher pFAI (p = 0.005) and had more plaques than patients with n-LAP. Presence of LAPs was significantly higher in elderly (p < 0.001), males (p < 0.001) and patients with traditional risk factors (hypertension p = 0.0001, hyperlipemia p = 0.0003, smoking p = 0.0003, diabetes p = <0.0001, familiarity p = 0.0007). Among patients with CAD-RADS 0 to 1, the ones with pFAI ≥ 70.1 HU were more often hyperlipidemic (p = 0.05) and smokers (p = 0.007). Follow-up (25,4 months, range: 17.6−39.2 months) demonstrated that LAP and pFAI ≥ 70.1 significantly and independently (p = 0.04) predisposed to outcomes (overall mortality and interventional procedures). There is an added value of CCTA-derived features in stratifying cardiovascular risk in low- to intermediate-risk patients with non-severe, non-calcified coronary plaques. This is of utmost clinical relevance as it is possible to identify a subset of patients with increased risk who need strengthening in therapeutic management and closer follow-up even in the absence of severe CAD. Further studies are needed to evaluate the effect of medical treatments on pericoronary inflammation and plaque composition.

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.

Impact of the "atherosclerotic pabulum" on in-hospital mortality for SARS-CoV-2 infection. Is calcium score able to identify at-risk patients?

BACKGROUND: Although the primary cause of death in COVID-19 infection is respiratory failure, there is evidence that cardiac manifestations may contribute to overall mortality and can even be the primary cause of death. More importantly, it is recognized that COVID-19 is associated with a high incidence of thrombotic complications. HYPOTHESIS: Evaluate if the coronary artery calcium (CAC) score was useful to predict in-hospital (in-H) mortality in patients with COVID-19. Secondary end-points were needed for mechanical ventilation and intensive care unit admission. METHODS: Two-hundred eighty-four patients (63, 25 years, 67% male) with proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection who had a noncontrast chest computed tomography were analyzed for CAC score. Clinical and radiological data were retrieved. RESULTS: Patients with CAC had a higher inflammatory burden at admission (d-dimer, p = .002; C-reactive protein, p = .002; procalcitonin, p = .016) and a higher high-sensitive cardiac troponin I (HScTnI, p = <.001) at admission and at peak. While there was no association with presence of lung consolidation and ground-glass opacities, patients with CAC had higher incidence of bilateral infiltration (p = .043) and higher in-H mortality (p = .048). On the other side, peak HScTnI >200 ng/dl was a better determinant of all outcomes in both univariate (p = <.001) and multivariate analysis (p = <.001). CONCLUSION: The main finding of our research is that CAC was positively related to in-H mortality, but it did not completely identify all the population at risk of events in the setting of COVID-19 patients. This raises the possibility that other factors, including the presence of soft, unstable plaques, may have a role in adverse outcomes in SARS-CoV-2 infection.

Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications.

Backgrounds: Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population. Methods: Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated. Results: Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure. Conclusions: In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.

Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study.

BACKGROUND: Coronary access (CA) after transcatheter aortic valve replacement (TAVR) with supra-annular transcatheter heart valves (THV) can be challenging. Specific Evolut R/Pro and Acurate Neo THVs orientations are associated with reduced neo-commissure overlap with coronary ostia, while SAPIEN 3 THV cannot be oriented. With the ALIGN-ACCESS study (TAVR With Commissural Alignment Followed by Coronary Access), we investigated the impact of commissural alignment on the feasibility of CA after TAVR. METHODS: We performed coronary angiography after TAVR with intra-annular SAPIEN 3, supra-annular Evolut R/Pro, and Acurate Neo THVs in 206 patients. Evolut THVs were implanted aiming for commissure alignment. Alignment of Acurate Neo was retrospectively assessed in 36, intentionally attempted in 26 cases. The primary end point was the rate of unfeasible and nonselective CA after TAVR. RESULTS: Thirty-eight percent of patients received SAPIEN 3, 31.1% Evolut Pro/R, 30.1% Acurate Neo THV. Final valve orientation was favorable to commissural alignment in 85.9% of Evolut and 69.4% of Acurate Neo cases (with intentional alignment successful in 88.5%). Selective CA was higher for SAPIEN 3 than for aligned and misaligned supra-annular THVs (95% versus 71% versus 46%, P<0.001). Cannulation of at least one coronary was unfeasible with 11% misaligned supra-annular, 3% aligned supra-annular, and 0% SAPIEN 3 THVs. Independent predictors of unfeasible/nonselective CA were implantation of a misaligned supra-annular THV (odds ratio, 4.59 [95% CI, 1.81-11.61]; P<0.01), sinus of Valsalva height (odds ratio, 0.83 [95% CI, 0.7-0.98]; P=0.03), and THV-sinus of Valsalva relation (odds ratio, 1.06 [95% CI, 1.02-1.1]; P<0.01). CONCLUSIONS: Commissural alignment improves the rate of selective CA after TAVR with supra-annular THVs. Nevertheless, aligned supra-annular THVs carry higher risk of unfeasible/nonselective CA than SAPIEN 3. Patients with a misaligned supra-annular THV, low sinus of Valsalva, and higher THV-sinus of Valsalva relation are at highest risk of impaired CA after TAVR.

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.

[High-risk percutaneous coronary intervention using hemodynamic support device eight years after transcatheter aortic valve implantation]. / Rivascolarizzazione coronarica ad alto rischio con dispositivo di supporto emodinamico otto anni dopo l'impianto transcatetere di bioprotesi aortica.

Coronary artery disease is a frequent comorbidity in patients with severe aortic stenosis undergoing trans-catheter aortic valve implantation (TAVI) and the need to ensure coronary access after TAVI is fundamental. This aspect is becoming increasingly relevant as TAVI indication expand to younger and lower-risk patients. Moreover, the longer life expectancy of subjects who are currently treated with TAVI could result in an increased need for TAVI-in-TAVI due to valve degeneration. As the implantation of a second transcatheter bioprosthesis might impair coronary access, TAVI-in-TAVI will be unfeasible in a significant proportion of cases, particularly if they received a tall-frame transcatheter heart valve at the time of the first intervention. Thus, patients might experience the paradox of needing surgical aortic valve replacement when they are older and frailer. Here we report the case of a patient with history of coronary artery disease and severe aortic stenosis treated with TAVI, presenting with an acute coronary syndrome 8 years after percutaneous aortic valve implantation. Thanks to the low frame height of the transcatheter aortic valve, it was possible to easily perform coronary angiography and high-risk percutaneous coronary intervention using hemodynamic support device (Impella CP). Moreover, this case highlights how the implantation of a low-frame transcatheter prosthesis can increase the possibility of achieving coronary access even after TAVI-in-TAVI, if needed.