A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial.

The treatment of coronary artery disease (CAD) in patients with severe aortic valve stenosis (AVS) eligible for transcatheter aortic valve implantation (TAVI) is not supported by clinical evidence, and the role of physiology over anatomy as well as the timing of coronary intervention are not defined. FAITAVI (ClinicalTrials.gov: NCT03360591) is a nationwide prospective, open-label, multicentre, randomised controlled study comparing the angiography-guided versus the physiology-guided coronary revascularisation strategy in patients with combined significant CAD and severe AVS undergoing TAVI. Significant CAD will be defined as coronary stenosis ≥50%, as assessed by visual estimation in vessels ≥2.5 mm. Physiology will be tested by fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). The study will be conducted at 15 sites in Italy. In the angiography arm, percutaneous coronary intervention (PCI) will be performed either before TAVI, during the TAVI procedure - before or after the valve implantation - or within 1 month±5 days of the valve implantation, left to the operator's decision. In the physiology arm, FFR and iFR will be performed before TAVI, and PCI will be indicated for FFR ≤0.80, otherwise the intervention will be deferred. In case of borderline values (0.81-0.85), FFR and iFR will be repeated after TAVI, with PCI performed when needed. With a sample size of 320 patients, the study is powered to evaluate the primary endpoint (a composite of death, myocardial infarction, stroke, major bleeding, or ischaemia-driven target vessel revascularisation). TAVI indication, strategy and medical treatment will be the same in both groups. After discharge, patients will be contacted at 1, 6, 12 and 24 months after the procedure to assess their general clinical status, and at 12 months for the occurrence of events included in the primary and secondary endpoints. FAITAVI is the first randomised clinical trial to investigate "optimal" percutaneous coronary intervention associated with TAVI in patients with severe AVS and CAD.

Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.

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.

Sex-Related Outcomes of Transcatheter Aortic Valve Implantation With Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry.

Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation. Overall, 1,174 of 1,897 patients were matched based on valve type and compared according to gender, whereas 470 men and 630 women were matched and compared according to valve type. The 30-day and 1-year outcomes were evaluated. In the PRO and ULTRA groups, men had a higher co-morbidity burden, whereas women had smaller aortic root. The 30-day (device success [DS], early safety outcome, permanent pacemaker implantation, patient-prosthesis mismatch, paravalvular regurgitation, bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke, and heart failure hospitalization) did not differ according to gender in both valve groups. However, the male gender decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction = 0.047). A higher risk of 30-day permanent pacemaker implantation and 1-year stroke and a lower risk of patient-prosthesis mismatch was observed in PRO versus ULTRA, regardless of gender. In conclusion, gender did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, except for 30-day DS, which was decreased in men (vs women) who received ULTRA (vs PRO).

On the Material Constitutive Behavior of the Aortic Root in Patients with Transcatheter Aortic Valve Implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat patients with severe aortic valve stenosis. However, there is limited knowledge on the material properties of the aortic root in TAVI patients, and this can impact the credibility of computer simulations. This study aimed to develop a non-invasive inverse approach for estimating reliable material constituents for the aortic root and calcified valve leaflets in patients undergoing TAVI. METHODS: The identification of material parameters is based on the simultaneous minimization of two cost functions, which define the difference between model predictions and cardiac-gated CT measurements of the aortic wall and valve orifice area. Validation of the inverse analysis output was performed comparing the numerical predictions with actual CT shapes and post-TAVI measures of implanted device diameter. RESULTS: A good agreement of the peak systolic shape of the aortic wall was found between simulations and imaging, with similarity index in the range in the range of 83.7% to 91.5% for n.20 patients. Not any statistical difference was observed between predictions and CT measures of orifice area for the stenotic aortic valve. After TAVI simulations, the measurements of SAPIEN 3 Ultra (S3) device diameter were in agreement with those from post-TAVI angio-CT imaging. A sensitivity analysis demonstrated a modest impact on the S3 diameters when altering the elastic material property of the aortic wall in the range of inverse analysis solution. CONCLUSIONS: Overall, this study demonstrates the feasibility and potential benefits of using non-invasive imaging techniques and computational modeling to estimate material properties in patients undergoing TAVI.

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

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.

Parametric analysis of transcatheter aortic valve replacement in transcatheter aortic valve replacement: evaluation of coronary flow obstruction.

Transcatheter aortic valve replacement (TAVR) is increasingly being considered for use in younger patients having longer life expectancy than those who were initially treated. The TAVR-in-TAVR procedure represents an appealing strategy to treat failed transcatheter heart valves (THV) likely occurring in young patients. However, the permanent displacement of first THV can potentially compromise the coronary access and ultimately inhibit the blood flow circulation. The objective of this study was to use finite-element analysis (FEA) to quantify coronary flow in a patient who underwent TAVR-in-TAVR. A parametric investigation was carried out to determine the impact of both the implantation depth and device size on coronary flow for several deployment configurations. The FEAs consisted of first delivering the SAPIEN 3 Ultra THV and then positioning the Evolut PRO device. Findings indicates that high implantation depth and device undersize of the second THV could significantly reduce coronary flow to 20% of its estimated level before TAVR. Additionally, a positive correlation was observed between coronary flow and the valve-to-coronary distance (R = 0.86 and p = 0.032 for the left coronary artery, and R = 0.93 and p = 0.014 for the right coronary artery). This study demonstrated that computational modeling can provide valuable insights to improve the pre-procedural planning of TAVR-in-TAVR.

Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. AIMS: We sought to compare different PCI timing strategies in TAVI patients. METHODS: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. RESULTS: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. CONCLUSIONS: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Biomechanical performance of the Bicaval Transcatheter System for the treatment of severe tricuspid regurgitation.

Introduction: Tricuspid regurgitation (TR) is a relatively common valvular disease, which can result from structural abnormalities of any anatomic part of the tricuspid valve. Severe TR is linked to congestive heart failure and hemodynamic impairment, resulting in high mortality when repaired by elective surgery. This study was undertaken to quantify the structural and hemodynamic performance of the novel Transcatheter Bicaval Valves System (TricValve) percutaneously implanted in the superior vena cava (SVC) and inferior vena cava (IVC) of two patients with severe TR and venous congestion. Methods: After developing the SVC and IVC device models, the contact pressure exerted on the vena cava wall was obtained by computational analysis. Both smoothed-particle hydrodynamics (SPH) and computational fluid dynamics were carried out to quantify caval reflux in the right atrium and the pressure field of pre- and post-TricValve scenarios, respectively. Results: Analysis of contact pressure highlighted the main anchoring area of the SVC device occurring near the SVC device belly, while the IVC device exerted pronounced forces in the device's proximal and distal parts. SPH-related flow velocities revealed the absence of caval reflux, and a decrease in time-averaged pressure was observed near the SVC and IVC after TricValve implantation. Discussion: Findings demonstrated the potential of computational tools for enhancing our understanding of the biomechanical performance of structural tricuspid valve interventions and improving the way we design next-generation transcatheter therapies to treat the tricuspid valve with heterotopic caval valve implantation.

One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry.

BACKGROUND: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce. AIMS: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3). METHODS: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year. RESULTS: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups. CONCLUSIONS: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Feasibility of Ultra-Low Volume Contrast-Saline Mixture Injection With Dual-Flow Technique in a Pre-TAVI Computed Tomography Angiography.

BACKGROUND: To explore the feasibility and image quality of ultra-low volume contrast-saline mixture injection with dual-flow injection technique in a computed tomography angiography (CTA) protocol in patients scheduled for transcatheter aortic valve implantation (TAVI). METHODS: Forty (40) TAVI candidates underwent investigation with CTA using a third-generation dual-source CT scanner between September and November 2020. Different volumes of a monophasic contrast-saline mixture at an 80:20 ratio were administered at an infusion rate of 3 mL/s in 20 patients (group A). The injected volume was based on patient body mass index (BMI): 50 mL if BMI <29 kg/m2 and 63 mL if BMI >29 kg/m2. The other 20 patients (group B)-the control cases-received a total of 65 mL of contrast medium (CM), in multiphasic injections at different flow rates, followed by 10 mL of saline. The images that were obtained were prospectively evaluated for image quality, vessel attenuation (HU), signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and estimated radiation dose. RESULTS: Image quality of the aortic root and ilio-femoral vessels was diagnostic in all patients. Vascular attenuation was >200 HU and CNR >3 at any vessel level. CONCLUSIONS: Data from this study suggest that a monophasic ultra-low volume contrast-saline mixture injection with a dual-flow technique can provide clear visualisation of the aortic root and ilio-femoral vessels in pre-TAVI CTA, which is comparable with a standard multiphasic volume injection protocol.

Management of Myocardial Revascularization in Patients With Stable Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. METHODS: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. RESULTS: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio' 0.88 [95% CI, 0.66-1.18]; P=0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio' 0.97 [95% CI, 0.76-1.24]; P=0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10). CONCLUSIONS: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

Numerical simulation of transcatheter mitral valve replacement: The dynamic implication of LVOT obstruction in the valve-in-ring case.

Transcatheter mitral valve replacement (TMVR) has been used for "off-label" treatment when annuloplasty band ring for mitral repair fails. However, the complex anatomy and function of the mitral valve may lead to fatal complications as a result of the left ventricular outflow tract (LVOT) obstruction in TMVR. We report the structural and hemodynamic response of LVOT obstruction resulting from TMVR with the Edwards SAPIEN 3 Ultra (S3) device. We modified the original Living Heart Human Model (LHHM) to account for a failed mitral valve with an annuloplasty band ring and simulated the cardiac beating condition in the setting of S3 device implantation. Findings demonstrated a high dynamic behavior of the newly formed LVOT (neoLVOT) as confined by the displaced mitral valve and the interventricular septum. During the cardiac beat, the neoLVOT area oscillated from a maximum of 472.1 mm2 at early systole to the minimum of 183 mm2 at end-systole. The profile of both anchoring force and contact pressure revealed that the band ring serves as the anchoring zone while mitral valve is primally displaced by the deployed device. At early systole, computational flow dynamics highlighted hemodynamic disturbances associated with the LVOT obstruction, with a skewed flow towards the septum and a pressured drop of 4.5 mmHg between the left ventricular apex and the neoLVOT region. This study can lead to a more accurate assessment of the risk induced by the LVOT obstruction when stratifying patient anatomic suitability for TMVR.

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry.

BACKGROUND: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes. OBJECTIVES: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices. METHODS: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium-3 device success and early safety, respectively. RESULTS: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01). CONCLUSIONS: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium-3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

Review of Contemporary Invasive Treatment Approaches and Critical Appraisal of Guidelines on Hypertrophic Obstructive Cardiomyopathy: State-of-the-Art Review.

BACKGROUND: Hypertrophic obstructive cardiomyopathy (HOCM) is a heterogeneous disease with different clinical presentations, albeit producing similar dismal long-term outcomes if left untreated. Several approaches are available for the treatment of HOCM; e.g., alcohol septal ablation (ASA) and surgical myectomy (SM). The objectives of the current review were to (1) discuss the place of the standard invasive treatment modalities (ASA and SM) for HOCM; (2) summarize and compare novel techniques for the management of HOCM; (3) analyze current guidelines addressing HOCM management; and (4) offer suggestions for the treatment of complex HOCM presentations. METHODS: We searched the literature and attempted to gather the most relevant and impactful available evidence on ASA, SM, and other invasive means of treatment of HOCM. The literature search yielded thousands of results, and 103 significant publications were ultimately included. RESULTS: We critically analyzed available guidelines and provided context in the setting of patient selection for standard and novel treatment modalities. This review offers the most comprehensive analysis to-date of available invasive treatments for HOCM. These include the standard treatments, SM and ASA, as well as novel treatments such as dual-chamber pacing and radiofrequency catheter ablation. We also account for complex pathoanatomic presentations and current guidelines to offer suggestions for tailored care of patients with HOCM. Finally, we consider promising future therapies for HOCM. CONCLUSIONS: HOCM is a heterogeneous disease associated with poor outcomes if left untreated. Several strategies for treatment of HOCM are available but patient selection for the procedure is crucial.

Transcatheter Heart Valve Implantation in Bicuspid Patients with Self-Expanding Device.

Bicuspid aortic valve (BAV) patients are conventionally not treated by transcathether aortic valve implantation (TAVI) because of anatomic constraint with unfavorable outcome. Patient-specific numerical simulation of TAVI in BAV may predict important clinical insights to assess the conformability of the transcathether heart valves (THV) implanted on the aortic root of members of this challenging patient population. We aimed to develop a computational approach and virtually simulate TAVI in a group of n.6 stenotic BAV patients using the self-expanding Evolut Pro THV. Specifically, the structural mechanics were evaluated by a finite-element model to estimate the deformed THV configuration in the oval bicuspid anatomy. Then, a fluid-solid interaction analysis based on the smoothed-particle hydrodynamics (SPH) technique was adopted to quantify the blood-flow patterns as well as the regions at high risk of paravalvular leakage (PVL). Simulations demonstrated a slight asymmetric and elliptical expansion of the THV stent frame in the BAV anatomy. The contact pressure between the luminal aortic root surface and the THV stent frame was determined to quantify the device anchoring force at the level of the aortic annulus and mid-ascending aorta. At late diastole, PVL was found in the gap between the aortic wall and THV stent frame. Though the modeling framework was not validated by clinical data, this study could be considered a further step towards the use of numerical simulations for the assessment of TAVI in BAV, aiming at understanding patients not suitable for device implantation on an anatomic basis.

Feasibility of combined ECG-Gated and Helical acquisition mode in a pre-TAVI computed tomography angiography protocol using a fixed low-volume contrast medium injection.

BACKGROUND: To investigate the feasibility, image quality, and clinical implications of a combined ECG-gated and helical acquisition mode in a computed tomography angiography (CTA) protocol in patients scheduled for transcatheter aortic valve implantation (TAVI) using a fixed, low-volume, contrast medium injection. METHODS: Between July and October 2019, 43 TAVI candidates underwent investigation with CTA using a 64-slice CT scanner. Images obtained were prospectively evaluated. 65 mL of low iodine dose contrast medium (CM), followed by 25 mL of saline, were administered using a fixed multiphasic injection protocol in all patients. Patients were divided into three groups based on BMI: Group 1 (n = 9) with BMI < 22 kg/m2; Group 2 (n = 22) with BMI 22-29 kg/m2; Group 3 (n = 12) with BMI > 29 kg/m2. Images were evaluated for image quality, vessel attenuation (HU), Signal-to-Noise Ratio (SNR), Contrast-to-Noise Ratio (CNR) and estimated radiation dose. Image quality of the aortic root and iliac-femoral vessels was diagnostic in all patients. RESULTS: Vascular attenuation was > 200 HU and CNR > 3 at all vessel levels. CONCLUSION: Data from our study suggest that it is possible to image the aortic annulus and aorto-iliac anatomy and obtain high image quality in all patients by using a combined ECG-gated and helical acquisition mode in a computed tomography angiography (CTA) protocol with a fixed low-volume contrast medium injection (65 mL). This allows for accurate CT measurements of the aortic annulus, recruitment of patients for TAVI and facilitates pre-procedural planning in these high surgical risk patients.

Echocardiography to estimate high filling pressure in patients with heart failure and reduced ejection fraction.

AIMS: Echocardiographic assessment of left ventricular filling pressures is performed using a multi-parametric algorithm. Unselected sample of patients with heart failure with reduced ejection fraction (HFrEF) patients may demonstrate an indeterminate status of diastolic indices making interpretation challenging. We sought to test improvement in the diagnostic accuracy of standard and strain echocardiography of the left ventricle and left atrium (LA) to estimate a pulmonary capillary wedge pressure (PCWP) > 15 mmHg in patients with HFrEF. METHODS AND RESULTS: Out of 82 consecutive patients, 78 patients were included in the final analysis and right heat catheterization, and echocardiogram was performed simultaneously. According to the univariable analysis, E wave velocity, the ratio between E-wave/A-wave (E/A, area under the curve [AUC] = 0.81, respectively), isovolumic relaxation time (AUC = 0.83), pulmonary vein D wave (AUC = 0.84), pulmonary vein S/D Ratio (AUC = 0.85), early pulmonary regurgitation velocity (AUC = 0.80), and accelerationa time at right ventricular out-flow tract (RVOT AT, AUC = 0.84) identified with the highest accuracy PCWP > 15 mmHg. They were all tested in multivariate analysis, and they were not independently correlated with PCWP. Tricuspid regurgitation (TR) velocity was measurement with the highest predictive value in identifying PCWP > 15 mmHg (AUC = 0.89), compared with other established parameters such as the ratio between e-wave velocity divided by mitral annular e' velocity (E/e'), deceleration time, or LA indexed volume (LAVi), which all reached a lower accuracy level (AUC = 0.75; 0.78; 0.76). Among strain measures, global longitudinal strain in four chamber view (GLS 4ch), the ratio between e-wave velocity divided by mitral annular e' strain rate (E/e'sr), and LA longitudinal strain at the reservoir phase were helpful in estimating elevated PCWP (AUC = 0.77; 0.76; 0.75). According to multivariable analysis, the following two models had the greatest accuracy in detecting PCWP > 15 mmHg: (i) TR velocity, LAVi, and E wave velocity (receiver operating characteristic [ROC]-AUC = 0.98), (ii) AT RVOT, LAVi and GLS 4ch (ROC-AUC = 0.96). Neither E/A (ROC-AUC = 0.81) nor E/e' (ROC-AUC = 0.75) was an independent predictor when included in the model. The two MODELS were applicable to the entire population and demonstrated better agreement with the invasive reference (91% and 88%) than the guidelines algorithm (77%) regardless of the type of rhythm. CONCLUSIONS: Our suggested echocardiographic approach could be used to potentially reduce the frequency of "doubtful" classification and increase the accuracy in predicting elevated left ventricular filling pressure leading to a decrease in the number of invasive assessment made by right heart catheterization.

Simulation of left ventricular outflow tract (LVOT) obstruction in transcatheter mitral valve-in-ring replacement.

Left ventricular outflow tract (LVOT) obstruction is a feared complication of transcatheter mitral valve replacement (TMVR). This procedure leads to an elongation of LVOT in the left ventricle (namely, the neoLVOT), ultimately portending hemodynamic impairment and death. This study sought to understand the biomechanical implications of LVOT obstruction in two patients who underwent TMVR as an "off-label" application of the Edwards SAPIEN 3 (S3) Ultra transcatheter heart valve (THV). A computational framework of TMVR was developed to assess the neoLVOT area and quantify the sub-aortic flow structure. We observed that the annuloplasty ring serves as the key anchor zone of S3 Ultra THV. A good agreement was found between the numerically-predicted and CT-imaging measurements of neoLVOT area, with differences less than 10% in both patients. The pressure drop across the neoLVOT did not determine hemodynamic impairment in both patients. Quantification of structural and hemodynamic variables by computational modeling may facilitate more accurate predictions of the LVOT obstruction in TMVR, particularly for patients which are considered to have a borderline risk of obstruction.

Simulation study of transcatheter heart valve implantation in patients with stenotic bicuspid aortic valve.

Bicuspid aortic valve (BAV) anatomy has routinely been considered an exclusion in the setting of transcatheter aortic valve implantation (TAVI) because of the large dimension of the aortic annulus having a more calcified, bulky, and irregular shape. The study aims to develop a patient-specific computational framework to virtually simulate TAVI in stenotic BAV patients using the Edwards SAPIEN 3 valve (S3) and its improved version SAPIEN 3 Ultra and quantify stent frame deformity as well as the severity of paravalvular leakage (PVL). Specifically, the aortic root anatomy of n.9 BAV patients who underwent TAVI was reconstructed from pre-operative CT imaging. Crimping and deployment of S3 frame were performed and then followed by fluid-solid interaction analysis to simulate valve leaflet dynamics throughout the entire cardiac cycle. Modeling revealed that the S3 stent frame expanded well on BAV anatomy with an elliptical shape at the aortic annulus. Comparison of predicted S3 deformity as assessed by eccentricity and expansion indices demonstrated a good agreement with the measurement obtained from CT imaging. Blood particle flow analysis demonstrated a backward blood jet during diastole, whereas the predicted PVL flows corresponded well with those determined by transesophageal echocardiography. This study represents a further step towards the use of personalized simulations to virtually plan TAVI, aiming at improving not only the efficacy of the implantation but also the exploration of "off-label" applications as the TAVI in the setting of BAV patients. Graphical abstract Computational frameworks of TAVI in patients with stenotic bicuspid aortic valve.