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Background Transcatheter aortic valve implantation (TAVI) is the procedure of choice for aortic stenosis in high surgical risk patients, but it is no free from complications. Case summary A 86-year-old patient with severe aortic stenosis underwent TAVI 3 years ago with an Edwards Sapiens valve by femoral access. In the echocardiography follow-up, an aorta–right ventricular (Ao-RV) fistula was noted with restrictive flow and no significant shunt and it was treated conservatively. Three years after TAVI, the patient underwent cardiac surgery because of worsening heart failure due to a severe degenerative mitral regurgitation with tethering of P2 due to left ventricular remodelling, a posterior jet of severe regurgitation, and left ventricular dilatation. Surgical replacement of the TAVI and aortic root with a bioprosthesis (Medtronic Freestyle) and direct closure of the fistula was performed along with the mitral valve replacement. The patient was discharged with a good clinical result and no evidence of remaining Ao-RV fistula at transthoracic echocardiography. Discussion Aorta–right ventricular fistula is a rare entity. Most reported cases arise after rupture of a congenital coronary sinus aneurism, endocarditis, trauma, and aortic valve or aortic root surgery. This is the 10th reported case after TAVI (9 after an Edwards Sapiens TAVI). Non-significant shunt can be treated conservatively but development of heart failure and death are described in significant shunts. Balloon post-dilatation and the absence of surgical calcium debridement inherent to TAVI may theoretically contribute to the development of the fistula. Surgical replacement and closure of the fistula is a therapeutic option for this entity even in high-risk patients.

Background: Several mortality prediction models (MPM) are used for predicting early (30-day) mortality following transcatheter aortic valve implantation (TAVI). Little is known about their predictive performance in external TAVI populations. We aim to externally validate established MPMs on a large TAVI dataset from the Netherlands Heart Registration (NHR). Methods: We included data from NHR-patients who underwent TAVI during 2013–2017. We calculated the predicted mortalities per MPM. We assessed the predictive performance by discrimination (Area Under Receiver Operating-characteristic Curve, AU-ROC); the Area Under Precision-Recall Curve, AU-PRC; calibration (using calibration-intercept and calibration-slope); Brier Score and Brier Skill Score. We also assessed the predictive performance among subgroups: tertiles of mortality-risk for non-survivors, gender, and access-route. Results: We included 6177 TAVI-patients with an observed early-mortality rate of 4.5% (n = 280). We applied seven MPMs (STS, EuroSCORE-I, EuroSCORE-II, ACC-TAVI, FRANCE-2, OBSERVANT, and German-AV) on our cohort. The highest AU-ROCs were 0.64 (95%CI 0.61–0.67) for ACC-TAVI and 0.63 (95%CI 0.60–0.67) for FRANCE-2. All MPMs had a very low AU-PRC of ≤0.09. ACC-TAVI had the best calibration-intercept and calibration-slope. Brier Score values ranged between 0.043 and 0.063. Brier Skill Score ranged between −0.47 and 0.004. ACC-TAVI and FRANCE-2 predicted high mortality-risk better than other MPMs. ACC-TAVI outperformed other MPMs in different subgroups. Conclusion: The ACC-TAVI model has relatively the best predictive performance. However, all models have poor predictive performance. Because of the poor discrimination, miscalibration and limited accuracy of the models there is a need to update the existing models or develop new TAVI-specific models for local populations.

We present the case of a severely symptomatic patient with a malfunctioning aortic bioprosthesis and severe multidistrict atherosclerosis that was addressed to our unit for transcatheter valve-in-valve implantation. The imaging and clinical assessment that led to the selection of the access route is discussed.

Transcatheter aortic valve implantation (TAVI) is currently an established therapy for elderly patients with symptomatic severe aortic valve stenosis across all surgical risk categories. Access is an important aspect when planning for and performing TAVI. The superiority of a transfemoral (TF) approach compared to a transthoracic (transapical, direct aortic) approach has been demonstrated in several studies. Recently, the introduction of intravascular lithotripsy (IVL) has made it possible to treat patients with calcified iliofemoral disease by TF approach. This article aimed to provide a comprehensive overview on the following aspects: (1) preprocedural planning for IVL-assisted TF-TAVI; (2) procedural aspects in IVL-assisted TF-TAVI; (3) outcomes of IVL-assisted TF-TAVI in an experienced TAVI center; and (4) literature review and discussion of this new emerging approach.

Selecting patients with a high chance of endured benefit from transcatheter aortic valve implantation (TAVI) is becoming relevant with changing indications and increasing number of TAVI being performed. The aim of our study was to investigate the association of the multidimensional prognostic index (MPI) based on a comprehensive geriatric assessment (CGA) on survival. The TAVI Care &amp, Cure program is a prospective, observational registry of patients referred for TAVI at the Erasmus MC University Medical Center. Consecutive patients who underwent a complete CGA and TAVI were included. CGA components were used to calculate the MPI score. The impact of the MPI score on survival was evaluated using Cox regression. Furthermore, 376 patients were included, 143 (38.0%) patients belonged to the MPI-1 group and 233 (61.9%) patients to the MPI-2–3 group. After 3 years, 14.9% of the patients in the MPI-1 group and 30.5% of the patients in the MPI-2–3 group died (p = 0.001). Patients in MPI-1 had increased chances of overall survival in comparison with patients in MPI group 2–3 Hazard Ratio (HR) 0.57, (95% Confidence Interval (CI) 0.33–0.98)). In this study we found that the MPI tool could be useful to assess frailty and to predict which patient will have a higher chance of enduring benefit from a TAVI procedure.

International audience; Purpose: To assess myocardial extracellular volume fraction (ECV) measurement provided by a single-source dual-energy computed tomography (SSDE-CT) acquisition added at the end of a routine CT examination before transcatether aortic valve implantation (TAVI) compared to cardiac magnetic resonance imaging (MRI).Materials and methods: Twenty-one patients (10 men, 11 women; mean age, 86±4.9 years [SD]; age range: 71-92 years) with severe aortic stenosis underwent standard pre-TAVI CT with additional cardiac SSDE-CT acquisition 7minutes after intravenous administration of iodinated contrast material and myocardial MRI including pre- and post-contrast T1-maps. Myocardial ECV and standard deviation (σECV) were calculated in the 16-segments model. ECV provided by SSDE-CT was compared to ECV provided by MRI, which served as the reference. Analyses were performed on a per-segment basis and on a per-patient involving the mean value of the 16-segments.Results: ECV was slightly overestimated by SSDE-CT (29.9±4.6 [SD] %; range: 20.9%-48.3%) compared to MRI (29.1±3.9 [SD] %; range: 22.0%-50.7%) (P

Cerebral embolic protection (CEP) devices aim to reduce the risk of periprocedural cerebrovascular events during transcatheter aortic valve implantation (TAVI). Here, the authors describe the first-in-human experience with the ProtEmbo Cerebral Protection System (Protembis), a next-generation CEP device, during TAVI. This case is part of a larger European trial evaluating the safety and performance of this device. After deployment of the ProtEmbo in the aortic arch, a first transcatheter heart valve was implanted. Despite postdilatation, moderate to severe aortic regurgitation persisted. The operating team decided to perform a valve-in-valve procedure using a second transcatheter heart valve. The ProtEmbo demonstrated good coverage of all three head vessels and no interaction with TAVI catheters in the aortic arch throughout the entire procedure. No adverse events were observed during hospitalisation or follow-up, and there was a significant reduction in aortic regurgitation at follow-up echocardiography. Despite a challenging overall procedure with presumably high embolic burden, diffusion-weighted MRI at follow-up showed a low number (n=3) and volume (156 mm3) of new hyperintense lesions. The first-in-human use of the ProtEmbo was safe and feasible, despite a challenging TAVI valve-in-valve procedure.

The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), and acute kidney injury (0.6 vs. 8.2%, p &lt, 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, p &lt, 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, p &lt, 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p &lt, 0.001), and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33–0.71), in females (HR 0.57, 0.38–0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32–0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR.

Background: Machine learning models have been developed for numerous medical prognostic purposes. These models are commonly developed using data from single centers or regional registries. Including data from multiple centers improves robustness and accuracy of prognostic models. However, data sharing between multiple centers is complex, mainly because of regulations and patient privacy issues.Objective: We aim to overcome data sharing impediments by using distributed ML and local learning followed by model integration. We applied these techniques to develop 1-year TAVI mortality estimation models with data from two centers without sharing any data.Methods: A distributed ML technique and local learning followed by model integration was used to develop models to predict 1-year mortality after TAVI. We included two populations with 1,160 (Center A) and 631 (Center B) patients. Five traditional ML algorithms were implemented. The results were compared to models created individually on each center.Results: The combined learning techniques outperformed the mono-center models. For center A, the combined local XGBoost achieved an AUC of 0.67 (compared to a mono-center AUC of 0.65) and, for center B, a distributed neural network achieved an AUC of 0.68 (compared to a mono-center AUC of 0.64).Conclusion: This study shows that distributed ML and combined local models techniques, can overcome data sharing limitations and result in more accurate models for TAVI mortality estimation. We have shown improved prognostic accuracy for both centers and can also be used as an alternative to overcome the problem of limited amounts of data when creating prognostic models.

Background Transcatheter aortic valve replacement (TAVR) is increasingly used to treat patients with severe aortic stenosis (AS). Cardiovascular magnetic resonance imaging (CMR) provides reliable and reproducible estimates for assessment of cardiac structure and function after TAVR. The goal of this study was to conduct a systematic review and meta-analysis of the literature to assess left ventricular (LV) volumes, mass and function by CMR after TAVR. Methods Using Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines, we searched PubMed and Embase for studies reporting CMR findings before and at least 1 month after TAVR. Main factors of interest were LV end-diastolic volume index (LVEDVi), LV end-systolic volume index (LVESVi), LV mass index (LVMi), and left ventricular ejection fraction (LVEF). Standardized mean differences (SMD) were pooled by random effects meta-analytic techniques. Results Of 453 screened publications, 10 studies (published between 2012 and 2018) were included. A total of 305 patients completed pre- and post-TAVR follow-up CMR (mean age range 78.6–85.0 years, follow-up range 6–15 months). Random effects analysis showed TAVR resulted in reduced LVEDVi (SMD: -0.25, 95% CI: − 0.43 to − 0.07, P = 0.006), LVESVi (SMD: -0.24, 95% CI: − 0.44 to − 0.05, P = 0.01), LVMi (SMD: -0.82, 95% CI: − 1.0 to − 0.63, P P = 0.006). Heterogeneity across studies was low (I2: 0%, Pheterogeneity > 0.05 for all). The median reduction was 4 ml/m2 (IQR: 3.1 to 8.2) for LVEDVi, 5 ml/m2 (IQR: 3.0 to 6.0) for LVESVi, and 15.1 g/m2 (IQR: 11.8 to 18.3) for LVMi. The median increase for LVEF was 3.4% (IQR 1.0 to 4.6%). Conclusions CMR demonstrates reverse LV remodeling occurrs within 6–15 months after TAVR, with reductions in LVEDVi, LVESVi and LVMi, and increased LVEF.

Background The aim of this study was to evaluate the impact of transcatheter aortic valve implantation (TAVI) on mitral valve geometry and function. Methods Eighty‐four patients underwent TAVI. Forty‐four (52%) patients received a balloon‐expandable valve and 40 (48%) were implanted with a self‐expandable valve. All patients underwent three‐dimensional‐volumetric transesophageal echocardiography of the mitral valve before and immediately after TAVI. A dedicated software was used for assisted semiautomatic measurement of mitral annular geometry. Results During systole, the anterior to posterior (AP) diameter was significantly reduced after the procedure (3.4 ± 0.5 cm vs 3.2 ± 0.5 cm; P, Journal of Cardiac Surgery, 35 (9), ISSN:0886-0440, ISSN:1540-8191

Transcatheter aortic valve implantation (TAVI) is nowadays a popular alternative technique to surgical valve replacement for critical patients. Biological valve tissue has been used in these devices for over a decade now with over 100,000 implantations. However, material degradations due to crimping for catheter insertion purpose have been reported, and with only 6-year follow-up, no information is available about the long-term durability of biological tissue. Moreover, expensive biological tissue harvesting and chemical treatment procedures tend to promote the development of synthetic valve leaflet materials. Textile polyester (PET) material is characterized by outstanding folding and strength properties combined with proven biocompatibility and could therefore be considered as a candidate to replace biological valve leaflets in TAVI devices. Nevertheless, the material should be preferentially partly elastic in order to limit water hammer effects at valve closing time and prevent exaggerated stress from occurring into the stent and the valve. The purpose of the present work is to study in vitro the mechanical as well as the hydrodynamic behavior of a hybrid elastic textile valve device combining non-deformable PET yarn and elastic polyurethane (PU) yarn. The hybrid valve properties are compared with those of a non-elastic textile valve. Testing results show improved hydrodynamic properties with the elastic construction. However, under fatigue conditions, the interaction between PU and PET yarns tends to limit the valve durability.

Objective A comparative study of manual and automated post processing software tools to measure CT parameters before Transcatheter Aortic Valve Implantation (TAVI). Patients and methods 51 patients were included; all admitted to the Cardiology Department with clinically established severe aortic stenosis, in whom TAVI was the treatment of choice. All patients underwent CT angiography (CTA) pre-TAVI. The CT images were post processed and the needed CT parameters were calculated using both manual and automated methods. The results were compared for statistical analysis. Results Only 43 patients completed the study, with mean age 65 years old. The automated software provided accurate almost similar results as the manual method, especially for aortic annulus area and aortic circumference measurements (p-value = 1 and 0.548) and was accepted for left and right coronary artery ostium height (p-value = 0.191 and 0.635). However, there was a statistically significant difference for the minor diameter axis and mean annular diameter (p-value = 0.001 and 0.021). Conclusion The automated software introduced rapid, accurate and reliable measurements for the aortic annulus in cases prepared for TAVI and can be used as a standard method. Also, it can be performed by junior staff with avoidable human errors.

Aims: Videodensitometric assessment of aortography provides a periprocedural quantitation of prosthetic valve regurgitation (PVR) after transcatheter aortic valve implantation. We sought to compare the videodensitometric parameters of PVR severity to the regurgitation fraction (RF) in a controlled in vitro setting. Methods and results: In a mock circulation system, a transcatheter balloon-expandable valve inserted at the aortic valve position was gradually deformed to induce different grades of paravalvular leakage and the RF was measured with a transonic flow probe. Contrast aortography was performed and the following videodensitometric parameters were generated: left ventricle aortic regurgitation (LV-AR), LV outflow tract AR (LVOT-AR), quantitative regurgitation assessment (qRA) index, relative maximum density (relative max), and maximum upslope of the LV time-density curve. The correlation was substantial between videodensitometric parameters (LV-AR, LVOT-AR, qRA index, relative max, and maximum upslope) and RF (r 2=0.96, 0.96, 0.93, 0.87, and 0.93; p2=0.99) with a mean difference of 1.92% (95% limits of agreement: ±2.83). The correlations of LV-AR and LVOT-AR with RF were stronger when more than one cardiac cycle was included in the analysis (one cycle: r 2=0.85 and r 2=0.83; four cycles: r 2=0.96 and r 2=0.96, for LV-AR and LVOT-AR, respectively). Including more cycles beyond four did not improve accuracy. Conclusions: Quantitative assessment of PVR by videodensitometry of aortograms strongly correlates with the actual RF in a controlled in vitro setting. Accuracy is improved by including more than one cardiac cycle in the analysis.

BACKGROUND Transcatheter heart valve thrombosis (THV-t) and endocarditis (THV-e) are relevant complications after transcatheter aortic valve implantation (TAVI). Transcatheter heart valve (THV) dysfunction definition is mostly based on Doppler (stenosis/regurgitation) without considering leaflets characteristics. PURPOSE To evaluate the additional diagnostic value of leaflets echocardiographic features over Doppler when prosthetic valve complication is suspected. METHODS Among 621 post-TAVI patients, 128 cases with probable valve complication were identified. THV-t was finally diagnosed in 13 patients (10%) and THV-e in 8 (6%), while the remaining 107 (84%) had no definitive diagnosis of thrombosis/endocarditis (THV-no). We analyzed at 2 time points (baseline and follow-up) both traditional Doppler parameters and leaflets morpho-functional features. RESULTS Both Doppler and leaflets parameters showed high sensitivity (sensitivity 92%) and low specificity (ranging from specificity 32% to 74%) in detecting THV-t. Interestingly, the combination of mean aortic pressure gradient ≥20 mm Hg and leaflet thickening significantly improved the specificity of echocardiography for diagnosis of THV thrombosis (specificity 94%). On the other hand, echocardiographic diagnosis of THV endocarditis remained limited by very low sensitivity despite showing high specificity. CONCLUSIONS The combination of Doppler and leaflets parameters can improve the echocardiographic diagnosis of THV thrombosis in post-TAVI patients with suspicious symptoms, via a significant increase in the overall test specificity. This would potentially allow more rational gatekeeping to more expensive/invasive diagnostic examinations (eg, CT scan) or therapeutic trials (eg, unnecessary anticoagulation).

Aims: In the minimalist transcatheter aortic valve implantation (TAVI) era, the usage of transoesophageal echocardiography has become restricted. Conversely, aortography has gained clinical ground in quantifying prosthetic valve regurgitation (PVR) during the procedure. In a mock circulation system, we sought to compare the contrast volume required and the accuracy of aortographic videodensitometric PVR assessment using a synchronised diastolic and standard (non-synchronised) injection aortography. Methods and results: Synchronised diastolic injection triggered by the signal stemming from the mock circulation was compared with standard non-synchronised injection. A transcatheter heart valve was implanted and was deformed step by step by advancing a screw perpendicularly to the cage of the valve in order to create increasing PVR. Quantitative measurement of PVR was derived from time-density curves of both a reference area (aortic root) and a region of interest (left ventricle) developed by a videodensitometric software. The volume of contrast required for the synchronised diastolic injection was significantly less than in the non-synchronised injection (8.1 [7.9-8.5] ml vs. 19.4 [19.2-19.9] ml, p

AIMS The safety and efficacy of single vs. dual antiplatelet therapy (DAPT) in patients undergoing TAVI remain to be addressed. The aim of our study was to evaluate the usefulness of a DAPT compared to a single platelet therapy in patients undergoing TAVI with a balloon-expandable prosthesis. METHODS AND RESULTS All consecutive patients enrolled in the ITER registry were included. Patients undergoing TAVI discharged with aspirin alone were compared to those taking DAPT before and after selection using propensity score with matching. Subgroup analysis was performed for those on OAT. Prosthetic heart valve dysfunction at follow-up was the primary endpoint, whereas all-cause death, cardiovascular death, bleedings, vascular complications and cerebrovascular accidents were the secondary ones. From 1,364 patients, after propensity score with matching, 605 were selected for each group (aspirin alone vs. DAPT). At 30 days, rates of VARC mortality were lower in patients with aspirin alone (1.5% vs. 4.1%, p=0.003), mainly driven by a reduction of major vascular complications (5.3% vs. 10.7%, p

Aims: The aim of this study was to investigate whether minimising trauma to the aortic annulus and left ventricular outflow tract reduces the occurrence of new conduction disorders and the need for permanent pacemakers. Methods and results: A total of 175 patients (58% female, mean age 83±6 years) underwent transfemoral TAVI with the Boston Scientific ACURATE neo at three centres in Europe. Prosthesis size selection was based on perimeter-derived annular diameter. Predilatation was performed in all with a balloon 1.9±0.9 mm smaller than the perimeter-derived annular diameter. Post-dilatation was performed in 46 (26.3%) with a balloon 1.2±0.9 mm smaller than the perimeter-derived annular diameter. Eighteen patients (10.3%) developed a new left bundle branch block, 13 (7%) a new first-degree AV block, and four (2.3%) received a new permanent pacemaker. Paravalvular regurgitation was none/trace in 66 (37.7%), mild in 101 (57.7%) and moderate in eight (4.6%). At 30 days, the rate of any stroke was 1.7% (3/175), and one patient (0.6%) had died. Conclusions: With careful selection of the balloon and the ACURATE neo prosthesis size, very low rates of new conduction disorders and permanent pacemaker implantation may be achieved without increasing the amount of paravalvular regurgitation.

The present study aimed to analyze sleep quality and quality of Life (QoL) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI). It was conducted at the Interventional Cardiology Unit of the Department of Cardiac, Thoracic, Vascular Sciences and Public Health of the University of Padova on 27 adult patients who underwent TAVI via the transfemoral approach. Patients completed two validated instruments, i.e., the Pittsburgh Sleep Quality Index (PSQI) and the EuroQoL (EQ-5D-5L), on the day of discharge and one month after the hospital discharge. Twenty-seven patients were enrolled with a severe aortic stenosis diagnosis, treated with transfemoral TAVI procedure. The study population included seventeen poor sleepers and ten good sleepers with a median age of 81.92 years overall. The global PSQI evaluation revealed a small significant improvement at follow-up (p-value 0.007). Small positive changes were detected in the Self-care and Usual activity domains of the EQ-5D-5L and the EQ-VAS. No correlation was detected between EQ-5D-5L and sleep quality. The present study confirms the importance of sleep quality monitoring in patients who undergo TAVI procedure for aortic stenosis treatment.

BackgroundPredilation of the native valve has long been deemed necessary in transfemoral transcatheter aortic valve implantation (TF-TAVI), despite little trial evidence to support its clinical use. As most evidence is derived from retrospective analyses of observational studies, we conducted a two-armed, prospective multicentre registry.MethodsPatients undergoing TF-TAVI with the Edwards SAPIEN 3 valve, with or without balloon aortic valvuloplasty (BAV), were included and their procedural characteristics, short-term safety and short-term efficacy outcomes compared. We hypothesised that BAV may be safely omitted in many patients and omission could be associated with procedural benefits.ResultsOverall, 196 consecutive patients underwent TF-TAVI, 56 with BAV and 140 without. The mean age was 81.2±6.2 years, and the mean logistic EuroSCORE I was 17.1±13.6. Device success according to Valve Academic Research Consortium-2 (VARC-2) was achieved in 96.4%. The median procedural duration was shorter without BAV (56 min vs 90 min; p=0.001), as was fluoroscopy time (10 min vs 13 min; p=0.001). The need for balloon postdilation was less frequent in patients without BAV (15.7% vs 30.4%, p=0.029). There was no difference in the proportion of patients meeting the VARC-2 defined composite safety endpoint at 30 days (9.3% without vs 8.9% with BAV; adjusted OR (adjOR) 2.55; 95% CI 0.56 to 18.84) and at 6 months (15.2% without vs 16.4% with BAV; adjOR 1.66; 95% CI 0.49 to 6.55).ConclusionsIn the majority of patients, BAV can be safely omitted from the TAVI procedure without adverse effects. The omission of BAV is associated with shorter procedural duration and could be advantageous for the majority of patients.Trial registration numberNCT02760771.

This review provides a comprehensive overview of the available data on antithrombotic therapy after transcatheter aortic valve implantation (TAVI). In the absence of large randomised clinical trials, clinical practice is leaning towards evidence reported in other populations. Due to the greater risk of major bleeding associated with oral anticoagulation using a vitamin-K antagonist (VKA), antiplatelet therapy (APT) may be considered as the first-line treatment of patients undergoing TAVI. Overall, single rather than dual APT is preferred. However, dual APT should be considered in patients with a recent acute coronary syndrome (ie, within 6 months), complex coronary stenting, large aortic arch atheromas or previous non-cardioembolic stroke. Monotherapy with VKA should be considered if concomitant atrial fibrillation or any other indication for long-term oral anticoagulation is present. APT on top of VKA seems only reasonable in patients with recent acute coronary syndrome, extensive or recent coronary stenting or large aortic arch atheromas. A direct-acting oral anticoagulant may be considered if oral anticoagulation is indicated in the absence of contraindications. Initiation of VKA is indicated in clinical valve thrombosis, for example, with high transvalvular gradient, whereas the role of VKA in the case of subclinical leaflet thrombosis is currently uncertain.

This is a post-peer-review, pre-copyedit version of an article published in Cardiovascular engineering and technology. The final authenticated version is available online at: http://dx.doi.org/10.1007/s13239-019-00427-0 Purpose Transcatheter aortic valve replacement (TAVR) is a minimally invasive treatment for high-risk patients with aortic diseases. Despite its increasing use, many influential factors are still to be understood and require continuous investigation. The best numerical approach capable of reproducing both the valves mechanics and the hemodynamics is the fluid–structure interaction (FSI) modeling. The aim of this work is the development of a patient-specific FSI methodology able to model the implantation phase as well as the valve working conditions during cardiac cycles. Methods The patient-specific domain, which included the aortic root, native valve and calcifications, was reconstructed from CT images, while the CAD model of the device, metallic frame and pericardium, was drawn from literature data. Ventricular and aortic pressure waveforms, derived from the patient’s data, were used as boundary conditions. The proposed method was applied to two real clinical cases, which presented different outcomes in terms of paravalvular leakage (PVL), the main complication after TAVR. Results The results confirmed the clinical prognosis of mild and moderate PVL with coherent values of regurgitant volume and effective regurgitant orifice area. Moreover, the final release configuration of the device and the velocity field were compared with postoperative CT scans and Doppler traces showing a good qualitative and quantitative matching. Conclusion In conclusion, the development of realistic and accurate FSI patient-specific models can be used as a support for clinical decisions before the implantation.

This study aims at achieving a proof-of-concept for a novel device designed to occlude the orifices that may form between transcatheter valves and host tissues after TAVI. The device effect on the performance of a SAPIEN XT with a paravalvular gap was assessed into an in vitro and ex vivo pulse duplicator. The in vitro tests were performed complying with the standard international regulations, measuring the trasvalvular pressure and regurgitant volumes with and without the paravalvular gap, and with the occluder correctly positioned into the gap. In the second series of tests, the leakage reduction due to the presence of the occluder was assessed for the same setup, into a beating swine heart. The occluder implantation decreased the regurgitant fraction of about 50% for the in vitro assessment and 75% for the ex vivo test, under rest operating conditions. These results suggest that suitably designed occluders can lead to important benefit in the PVL treatment.

Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade. Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017. Results: The annual number of treated patients increased three-fold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR (p = .011) and from 4.1% to 1.8% for SAVR (p = .048). Two-year survival improved from 71.4% to 83.9% for TAVR (p

Cerebrovascular events following transcatheter aortic valve implantation (TAVI) is one of the most devastating complications. Several studies with magnetic resonance or cerebral filters have demonstrated the universal brain embolization after TAVI, in the majority of patients clinically silent. Embolic protection devices (EPD) have been developed as a mechanical barrier to prevent these emboli to reach cerebral vasculature and potentially reduce neurological events. We review the current evidence about EPD in relation to histopathological and cerebral imaging findings and neurological events.

Background: The predictive performance of the models FRANCE-2 and ACC-TAVI for early-mortality after Transcatheter Aortic Valve Implantation (TAVI) can decline over time and can be enhanced by updating them on new populations. We aim to update and internally and temporally validate these models using a recent TAVI-cohort from the Netherlands Heart Registration (NHR).Methods: We used data of TAVI-patients treated in 2013-2017. For each original-model, the best update-method (model-intercept, model-recalibration, or model-revision) was selected by a closed-testing procedure. We internally validated both updated models with 1000 bootstrap samples. We also updated the models on the 2013-2016 dataset and temporally validated them on the 2017-dataset. Performance measures were the Area-Under ROC-curve (AU-ROC), Brier-score, and calibration graphs.Results: We included 6177 TAVI-patients, with 4.5% observed early-mortality. The selected update-method for FRANCE-2 was model-intercept-update. Internal validation showed an AU-ROC of 0.63 (95%CI 0.62-0.66) and Brier-score of 0.04 (0.04-0.05). Calibration graphs show that it overestimates early-mortality. In temporal-validation, the AU-ROC was 0.61 (0.53-0.67).The selected update-method for ACC-TAVI was model-revision. In internal-validation, the AU-ROC was 0.63 (0.63-0.66) and Brier-score was 0.04 (0.04-0.05). The updated ACC-TAVI calibrates well up to a probability of 20%, and subsequently underestimates early-mortality. In temporal-validation the AU-ROC was 0.65 (0.58-0.72).Conclusion: Internal-validation of the updated models FRANCE-2 and ACC-TAVI with data from the NHR demonstrated improved performance, which was better than in external-validation studies and comparable to the original studies. In temporal-validation, ACC-TAVI outperformed FRANCE-2 because it suffered less from changes over time.

Leaflet thrombosis has been suggested as the reason for the reduced leaflet motion in cases of hypoattenuated leaflet thickening of bioprosthetic aortic valves. This work aimed to estimate the risk of leaflet thrombosis in two post-valve-in-valve (ViV) configurations, using five different numerical approaches. Realistic ViV configurations were calculated by modelling the deployments of the latest version of transcatheter aortic valve devices (Medtronic Evolut PRO, Edwards SAPIEN 3) in the surgical Sorin Mitroflow. Computational fluid dynamics simulations of blood flow followed the dry models. Lagrangian and Eulerian measures of near-wall stagnation were implemented by particle and concentration tracking, respectively, to estimate the thrombogenicity and to predict the risk locations. Most of the numerical approaches indicate a higher leaflet thrombosis risk in the Edwards SAPIEN 3 device because of its intra-annular implantation. The Eulerian approaches estimated high-risk locations in agreement with the wall sheer stress (WSS) separation points. On the other hand, the Lagrangian approaches predicted high-risk locations at the proximal regions of the leaflets matching the low WSS magnitude regions of both transcatheter aortic valve implantation models and reported clinical and experimental data. The proposed methods can help optimizing future designs of transcatheter aortic valves with minimal thrombotic risks.

AIMS Our aim was to assess one-year outcomes of patients enrolled in the pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation (TAVI). METHODS AND RESULTS One-year outcomes of 4,571 patients (81.4±7.2 years, 2,291 [50.1%] male) receiving TAVI with the SAPIEN XT (57.3%) or CoreValve prosthesis at 137 European centres were analysed using Kaplan-Meier and Cox proportional hazards regression techniques. At one year, 3,341 patients were alive, 821 had died, and 409 were lost to follow-up. Of 2,125 patients who underwent functional assessment, 1,916 (90%) were in New York Heart Association (NYHA) Class I/II at one year, with functional improvement from baseline noted in 1,682 patients (88%). One-year survival based on 4,564 patients was estimated at 79.1%. Independent baseline predictors of mortality were increasing age and logistic EuroSCORE, the presence of NYHA III/IV, chronic obstructive pulmonary disease, and atrial fibrillation. Female gender was associated with a 4% survival benefit at one year. Vascular access routes other than transfemoral were associated with poorer survival. Procedural failure and major periprocedural complications had an adverse impact on survival. CONCLUSIONS Contemporary European experience attests to the effectiveness of routine TAVI in unselected elderly patients.

The transfemoral (TF) route constitutes the undisputed default access for transcatheter aortic valve implantation (TAVI). In patients in whom anatomical constraints preclude a TF approach, several alternative access routes have been used. Transthoracic (transapical and transaortic) access routes show higher mortality and bleeding complication rates than the TF approach, which is attributable to the higher baseline risk of the selected patients and the more invasive nature of these procedures. Alternative transarterial approaches (transaxillary, transcarotid, transinnominate) have demonstrated high technical success rates and a favourable safety profile in selected patients and are particularly valuable in the presence of poor respiratory function or previous cardiothoracic surgery. The transcaval approach is an innovative fully percutaneous approach that allows the introduction of large-bore sheaths and shows promising results in high-risk patients. Diligent procedural planning, appropriate patient selection and the expertise of the Heart Team allow the achievement of an adequate safety and efficacy profile of TAVI performed via alternative access. Future studies incorporating standardised and independent outcome assessment are required to gain further knowledge on the risk/benefit relation pertaining to the specific approaches and improve selection of the appropriate access route for the individual patient.

Background Although transcatheter aortic valve implantation (TAVI) can successfully correct aortic narrowing, pre-existing pathophysiological alterations in the left ventricle are still a concern in terms of long-term mortality. This study aimed to examine the predictive role of fQRS morphology on long-term prognosis in patients undergoing TAVI due to severe aortic stenosis. Methods A total of 117 patients undergoing TAVI due to severe aortic stenosis were included in this retrospective cohort study. Patients were assigned into two groups based on the presence (n = 36) or absence (n = 81) of fQRS. Predictors of long-term survival were estimated. Results In-hospital mortality was higher in fQRS group (5.5% vs. 1.2%, p = 0.0224). In the long-term, fQRS (OR: 3.06, 95% CI 1.29–7.27, p: 0.01), LVEF

Rupture of the “device landing zone” is a rare but severe complication of transcatheter aortic valve implantation (TAVI). Recently, the small segment of muscular left ventricular outflow tract (LVOT) located between the left–right commissure and left fibrous trigone was identified as the most vulnerable region at risk of external rupture. We here provide the first pictures of a rupture adjacent to this vulnerable area, inducing a connection between the LVOT and the left atrium. We also report a case of supra-annular rupture, a less usual location of rupture. These illustrations may help pathologists and clinicians to get familiar with early rare complications of TAVI, an important new field of interest of autopsy in cardiovascular pathology.

Background to determine reliability and reproducibility of measurements of aortic annulus in 3D models printed from cardiovascular computed tomography (CCT) images. Methods Retrospective study on the records of 20 patients who underwent aortic valve replacement (AVR) with pre-surgery annulus assessment by CCT and intra-operative sizing by Hegar dilators (IOS). 3D models were fabricated by fused deposition modelling of thermoplastic polyurethane filaments. For each patient, two 3D models were independently segmented, modelled and printed by two blinded “manufacturers”: a radiologist and a radiology technician. Two blinded cardiac surgeons performed the annulus diameter measurements by Hegar dilators on the two sets of models. Matched data from different measurements were analyzed with Wilcoxon test, Bland-Altmann plot and within-subject ANOVA. Results No significant differences were found among the measurements made by each cardiac surgeon on the same 3D model (p = 0.48) or on the 3D models printed by different manufacturers (p = 0.25); also, no intraobserver variability (p = 0.46). The annulus diameter measured on 3D models showed good agreement with the reference CCT measurement (p = 0.68) and IOH sizing (p = 0.11). Time and cost per model were: model creation ∼10–15 min; printing time ∼60 min; post-processing ∼5min; material cost ∼1€. Conclusion 3D printing of aortic annulus can offer reliable, not expensive patient-specific information to be used in the pre-operative planning of AVR or transcatheter aortic valve implantation (TAVI).

BACKGROUND In older patients with aortic stenosis (AS) undergoing TAVI, the potential role of prior CGA is not well established. To explore the value of comprehensive geriatric assessment (CGA) for predicting mortality and/or hospitalisation within the first 3 months after transcatheter aortic valve implantation (TAVI). METHODS An international, multi-centre, prospective registry (CGA-TAVI) was established to gather data on CGA results and medium-term outcomes in geriatric patients undergoing TAVI. Logistic regression was used to evaluate the predictive value of a multidimensional prognostic index (MPI); a short physical performance battery (SPPB); and the Silver Code, which was based on administrative data, for predicting death and/or hospitalisation in the first 3 months after TAVI (primary endpoint). RESULTS A total of 71 TAVI patients (mean age 85.4 years; mean log EuroSCORE I 22.5%) were enrolled. Device success according to VARC criteria was 100%. After adjustment for selected baseline characteristics, a higher (poorer) MPI score (OR: 3.34; 95% CI: 1.39-8.02; p = 0.0068) and a lower (poorer) SPPB score (OR: 1.15; 95% CI: 1.01-1.54; p = 0.0380) were found to be associated with an increased likelihood of the primary endpoint. The Silver Code did not show any predictive ability in this population. CONCLUSIONS Several aspects of the CGA have shown promise for being of use to physicians when predicting TAVI outcomes. While the MPI may be useful in clinical practice, the SPPB may be of particular value, being simple and quick to perform. Validation of these findings in a larger sample is warranted. TRIAL REGISTRATION The trial was registered in ClinicalTrials.gov on November 7, 2013 ( NCT01991444 ).

Introduction Patients undergoing structural heart interventions often require large-sized sheath insertion into femoral arteries and veins. Clinical outcome data on the use of suture-mediated devices for large femoral arterial access in structural heart interventions is limited. We assessed the efficacy of the Perclose™ (Abbott Vascular Devices, Santa Clara, CA, USA) suture-mediated device using the pre-closure technique in achieving hemostasis in femoral arterial access sites following large sheath insertion (≥8 Fr). Methods One hundred consecutive patients underwent 101 femoral artery access sites closures with the Perclose device using the pre-closure technique. Sixty-two percent of the patients were male and their mean (SD) age was 52 (±26) years. All patients received heparin. Results Mean arterial access site sheath diameter was 13 ± 2 Fr. Immediate hemostasis was achieved in 96/101 (96%) procedures (≤2 min). Two patients (2%) had access site-related complications requiring further interventions. On clinical follow up [mean (SD) follow-up of 24 (±12) months and median follow-up of 8.5 months], no complications were seen in the arterial access sites. Conclusion Pre-closure of large-size femoral arterial access sheath sites using the suture-mediated Perclose device is efficacious in achieving rapid hemostasis in patients undergoing structural interventions. On 1-year follow-up, there were no arterial access site complications requiring further investigations or interventions. Electronic supplementary material The online version of this article (doi:10.1007/s40119-014-0034-7) contains supplementary material, which is available to authorized users.

Aims We sought to assess eventual changes in iFR measurements in patients with aortic stenosis (AS) before and after TAVI in coronary lesions with different degrees of angiographic severity. Methods and results The functional relevance of 145 coronary lesions was assessed by online iFR and FFR measurement in 66 patients with severe AS before and after TAVI, during the same procedure. The iFR-FFR classification agreement was calculated for pre-TAVI and post-TAVI measurements. Mean iFR values remained identical before and after TAVI, irrespective of the angiographic severity of the coronary stenosis (0.89±0.12 vs. 0.89±0.12, p=0.66). However, individual iFR values varied widely after TAVI and the 0.89 iFR threshold was crossed by 15% of the investigated coronary lesions. Higher iFR variation was related to a higher transaortic gradient drop after valve intervention. The diagnostic accuracy of iFR in predicting an FFR ≤0.8 was poor (65%) in lesions with severe obstructions, and tended to increase post TAVI. Conclusions Although overall values did not change after TAVI, iFR presented significant and mostly erratic individual variations after valve replacement. Delta iFR was influenced by the extent of the transaortic gradient drop induced by TAVI. Therefore, caution is advisable in the interpretation of iFR in the presence of AS.

BACKGROUND: An 80-year-old man with symptomatic severe aortic valve stenosis, haemodynamic instability, important comorbidities and a high surgical risk. Following bridgeballoon aortic valvuloplasty to recover from the unstable haemodynamics he was deemed suitable for transcatheter aortic valve implantation (TAVI) via the femoral access route. INVESTIGATION: Fluoroscopy. DIAGNOSIS: During TAVI, while the operators were preparing for prosthesis deployment (Edwards SAPIEN 3), the extra-stiff guidewire was accidentally withdrawn from the left ventricle (LV) to the ascending aorta. MANAGEMENT: Valve orifice was re-crossed from the contralateral access, a snare was introduced through the AL1 catheter and pushed anterogradely through the valve. The extra-stiff wire was then captured in the ascending aorta and pulled back into the LV to complete the procedure.

Background: Transcatheter aortic valve implantation (TAVI) is an exciting new technology that was launched in South Africa in October 2009 for the treatment of aortic stenosis in patients at high risk for conventional surgery. We report our initial experience with TAVI in the Western Cape, South Africa. Methods: 70 patients with severe symptomatic aortic stenosis underwent TAVI with the Edwards SAPIEN device (26 via transapical approach and 44 via transfemoral) at Panorama and Vergelegen Mediclinic hospitals in the Western Cape. All implants were performed by a team consisting of 2 cardiothoracic anaesthesiologists, 2 cardiothoracic surgeons, 2 cardiologists and an echo expert. Results: Patients were at high risk with a mean age of 80 years and a mean logistic EuroSCORE of 26. The acute procedural success rate was 97% with two acute deaths. At 30 days, there were a total of 5 deaths. Major vascular complications were seen in 6 cases (9%). Only one stroke was seen during the follow-up period. Conclusions: With a multidisciplinary team approach and careful patient selection, TAVI can be performed by a high volume centre in South Africa with results comparable to international published outcomes.

Annular rupture presents a rare but potentially fatal complication of transcatheter aortic valve implantation (TAVI). Although it can be subtle and subclinical in presentation, most severe forms present with hemodynamic instability and represent true emergencies requiring a more invasive treatment, even conventional surgery. We present a case of successful treatment of annular rupture by left ventricular outflow tract patch and surgical aortic valve replacement.

AIMS The aim of the study was to evaluate the prognostic utility of right heart catheterisation (RHC)-derived measures among patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS Data of 469 patients included in the Bern TAVI Registry between August 2007 and December 2012 and undergoing preoperative RHC were analysed. The relationship between haemodynamic parameters and survival was evaluated with Cox proportional hazards models. At two-year follow-up, 118 patients had died (25.1%). At multivariable analysis, diabetes (hazard ratio [HR] 1.95, 95% confidence interval [CI]: 1.28-2.96, p=0.001), transapical access (HR 1.66, 95% CI: 1.07-2.56, p=0.02), and moderate or severe mitral regurgitation (HR 1.55, 95% CI: 1.00-2.39, p=0.04) were independent predictors of two-year mortality, whereas no correlation between RHC-derived measures and mortality was found. Furthermore, the addition of haemodynamic variables did not significantly improve the prognostic power of a model incorporating clinical and echocardiographic data (Harrell's C-index: 0.667, 95% CI: 0.615-0.719 vs. 0.662, 95% CI: 0.612-0.713, p=0.47). CONCLUSIONS On the basis of a comprehensive clinical and echocardiographic evaluation, RHC performed prior to TAVI does not add incremental prognostic value.

textabstractAims: Transcatheter aortic valve implantation (TAVI) is frequently complicated by new left bundle branch block (LBBB). We investigated the development and persistence of LBBB during follow-up and its clinical consequences. Methods and results: ECGs at baseline, within 24 hours, before discharge and at 12 months after TAVI were assessed in 476 patients without pre-existing LBBB and/or pacemaker before or after TAVI. TAVI-induced new LBBB was categorised based on the timing of the occurrence (within 24 hours [acute], after 24 hours but before discharge [subacute], and after discharge [late]), in addition to persistence (transient or persistent). A total of 175 patients (36.8%) developed new LBBB of which 85.7% occurred within 24 hours after TAVI, 12.0% before and 2.3% after hospital discharge, and was persistent in 111 patients (63.4%). Implantation of the Medtronic CoreValve System (MCS) more frequently led to new LBBB than the balloon-expandable Edwards SAPIEN valve (ES) (53.8% versus 21.7%) with less recovery during follow-up (39.0% versus 9.5%). Late new LBBB was only seen in four patients (0.8%). During a median follow-up of 915 (578-1,234) days, persistent LBBB was associated with a significant increase in mortality as compared to no LBBB and temporary LBBB combined (hazard ratio 1.49, 95% confidence interval, 1.10-2.03; p=0.01). Conclusions: TAVI-induced new LBBB occurs in almost 40% of patients, almost all before hospital discharge. It occurs three times more frequently after MCS than after ES valve implantation and has a twofold lower tendency to resolve during follow-up. Persistent LBBB is associated with a higher mortality.

Background Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. Methods/design The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure. Discussion This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. Trial registration ClinicalTrials.gov identifier: NCT02729519. Registered on 15 July 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2036-y) contains supplementary material, which is available to authorized users.

Aims Several studies have suggested good procedural and similar clinical outcomes between everolimus-eluting Absorb bioresorbable stents (BRS) versus conventional drug-eluting stents (DES), but the evidence is not definitive. Our aim was to perform a systematic review and meta-analysis to investigate the effects of BRS versus conventional drug-eluting and bare metallic stents on the cardiovascular endpoints and all-cause mortality. Methods and results The follow-up in the included studies was up to 13 months. The following endpoints were evaluated: all-cause mortality, cardiac death, patient-oriented major adverse cardiac events (POCE), device-oriented major adverse cardiac events (DOCE), any-cause myocardial infarction (MI), target vessel MI (TVMI), target vessel revascularisation (TVR) and target lesion revascularisation (TLR). The results of 10 studies with 5,773 subjects showed a statistically significant increase in the risk of TVMI between BRS and conventional stents (odds ratio [OR]: 1.45, 95% confidence interval [CI]: 1.03-2.05, p=0.032). None of the other differences reached statistical significance: all-cause mortality (OR: 0.67, 95% CI: 0.30-1.49, p=0.333), cardiac death (OR: 1.00, 95% CI: 0.47-2.12, p=0.996), POCE (OR: 0.91, 95% CI: 0.68-1.22, p=0.546), DOCE (OR: 1.12, 95% CI: 0.86-1.46, p=0.387), any-cause MI (OR: 1.34, 95% CI: 0.98-1.82, p=0.064), TVR (OR: 0.99, 95% CI: 0.73-1.33, p=0.934) and TLR (OR: 0.92, 95% CI: 0.66-1.29, p=0.641). Similar results were observed after restricting the meta-analysis to the comparison of BRS vs. EES. Conclusions Our meta-analysis suggests a significantly higher risk of TVMI with BRS compared with conventional stents and no significant differences in the rates of occurrence of the other outcomes during one-year follow-up. Further studies with larger samples sizes, longer follow-up, different clinical scenarios and more complex lesions are required to confirm or refute our findings.

SummaryIt is two decades since the first report of transcatheter implantation of a stented aortic valve in an animal. The first implantation of a transcatheter aortic valve in a human was accomplished just one decade ago dramatically demonstrating the promise and feasibility of this new therapy. Over the past 10 years, there have been rapid developments in valves, delivery systems and technical approaches. Today, transcatheter valve implantation is a technical possibility for the great majority of patients with aortic stenosis. The next 10 years may well see this become the dominant therapy for aortic stenosis.

SummaryBackgroundA new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex™ delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis.AimsTo evaluate periprocedural and 30-day clinical outcomes using the Edwards SAPIEN XT compared with the first-generation Edwards SAPIEN prosthesis.MethodsBetween May 2006 and October 2011, consecutive high-risk or non-operable patients with severe aortic stenosis had TAVI using an Edwards SAPIEN or SAPIEN XT prosthesis. Valve Academic Research Consortium endpoints were used.ResultsOf 250 patients who underwent TAVI, 190 were performed transfemorally (78 SAPIEN and 112 SAPIEN XT). Transfemoral access was possible more often using SAPIEN XT (112/123 [91.1%] vs 78/127 [61.4%]; P

Objectives The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California). Background The SXT has been recently commercialized in Europe, but there are no studies analyzing the efficacy and safety of SXT, compared with ESV. Methods All consecutive patients (n = 120) who underwent transcatheter aortic valve implantation in our center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54). Valve Academic Research Consortium endpoints were used. Results Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were 3-fold lower in the SXT group (11.1% vs. 33.3%, relative risk: 0.40, 95% confidence interval: 0.28 to 0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; relative risk: 0.44, 95% confidence interval: 0.24 to 0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild-to-moderate in 70.2% of SXT and 76.3% of ESV. Conclusions The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application.

Aortic stenosis (AS) is the most commonly acquired valvular heart disease in the Western world (2-7% of the population aged >65 years) and the mortality for untreated symptomatic severe AS is up to 50-60% at 2 years in high-risk patients. This review summarizes laboratory and recent clinical investigations concerning AS and current best treatment. Particular emphasis will be placed on pathophysiology and on the concept of afterload mismatch and preload reserve in which left ventricular function is proportionately matched to level of left ventricular pressure, mainly because such studies carry important implications for both treatment with transcatheter aortic valve implantation (TAVI) and prognosis. Surgical aortic valve replacement is currently the gold-standard treatment for patients with severe symptomatic AS. Without surgery, the prognosis is extremely poor, with a 3-year survival rate

The clinical and demographic characteristics of patients undergoing TAVI pose unique challenges for developing and implementing optimal antithrombotic therapy. Ischaemic and bleeding events in the periprocedural period and months after TAVI still remain a relevant concern to be faced with optimised antithrombotic therapy. Moreover, the antiplatelet and anticoagulant pharmacopeia has evolved significantly in recent years with new drugs and multiple possible combinations. Dual antiplatelet therapy (DAPT) is currently recommended after TAVI with oral anticoagulation (OAC) restricted for specific indications. However, atrial fibrillation (which is often clinically silent and unrecognised) is common after the procedure and embolic material often thrombin-rich. Recent evidence has therefore questioned this approach, suggesting that DAPT may be futile compared with aspirin alone and that OAC could be a relevant alternative. Future randomised and appropriately powered trials comparing different regimens of antithrombotic therapy, including new antiplatelet and anticoagulant agents, are warranted to increase the available evidence on this topic and create appropriate recommendations for this frail population. Meanwhile, it remains rational to adhere to current guidelines, with routine DAPT and recourse to OAC when specifically indicated, whilst always tailoring therapy on the basis of individual bleeding and thromboembolic risk.

AIMS Transcatheter aortic valve-in-valve implantation is an emerging alternative to conventional surgical aortic valve replacement (SAVR) in patients with degenerated aortic bioprostheses. This procedure presents a high risk of coronary occlusion, especially during treatment of patients implanted with a bioprosthesis with a lower distance between the leaflets and the coronary ostia, such as the Mitroflow valve (Sorin S.p.A., Milan, Italy). In this report we aim to describe the safety and feasibility of transfemoral valve-in-valve implantation of a new-generation Lotus™ Aortic Valve Replacement System (Boston Scientific, Marlborough, MA, USA) in a case of degenerated Mitroflow bioprostheses. METHODS AND RESULTS We describe a case of degenerated Sorin Mitroflow bioprostheses successfully treated with the transfemoral new-generation Lotus valve-in-valve system. During the procedure no coronary protection was required and the patient had no MACE at 30-day follow-up. To our knowledge, this is the first report of a Lotus valve implant in a degenerated Mitroflow prosthesis. CONCLUSIONS The transcatheter valve-in-valve procedure using the new-generation Lotus Valve System is a safe and feasible alternative to repeat cardiac surgery in high-risk patients with surgical degenerated Mitroflow bioprostheses.

Aims The aim of this study was to compare outcomes with the use of two haemostasis strategies after transfemoral transcatheter aortic valve implantation (TAVI) - one Prostar® vs. two ProGlide® devices (Abbott Vascular Inc., Santa Clara, CA, USA). Methods and results This was a retrospective study enrolling consecutive patients undergoing fully percutaneous transfemoral TAVI in our centre (Ferrarotto Hospital, Catania, Italy) from January 2012 to October 2014. All patients were dichotomised according to the vascular closure device (VCD) used for common femoral artery haemostasis (Prostar vs. ProGlide). All outcomes were defined according to VARC-2 criteria. The study population encompassed a total of 278 patients. Of these, 153 (55.1%) underwent TAVI using the Prostar, and 125 (44.9%) using two ProGlide devices. Vascular complications occurred in 48 patients (17.3%), being more frequent in the ProGlide group (11.8% vs. 24.0%, p=0.007). Patients who had TAVI using the ProGlide were also more likely to have a higher rate of percutaneous closure device failure (4.6% vs. 12.8%, p=0.013). Percutaneous peripheral intervention was performed in 13.7% and 28.0% of Prostar and ProGlide cases, respectively (p=0.003). Conclusions Patients undergoing transfemoral TAVI had significantly lower rates of vascular complications and percutaneous closure device failures when the Prostar was used compared with two ProGlide devices.