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BACKGROUND Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation. AIMS The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices. METHODS The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC-3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed. RESULTS A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p

Cerebrovascular accidents (CVAs) can complicate the follow-up of patients with acute myocardial infarction (AMI). Intracavitary blood stasis evaluation can be useful to stratify cardioembolic risk and optimize medical therapy. Cardiac magnetic resonance (CMR) imaging is increasingly used in AMI patients for prognostic purposes. Slow-flow artefact is common on T2-weighted images in presence of left ventricular (LV) blood stasis.In this observational retrospective study, all patients with AMI undergoing CMR in our hospital were included. T2-weighted images were used to assess the presence of LV blood stasis. Among the 209 patients enrolled (males 72%, mean age 61 ± 12 years), LV blood stasis was detected in 48 (23%) and was significantly more prevalent in patients with extensive anterior or antero-apical AMI, lower LV ejection fraction, greater infarct size and microvascular obstruction. During follow-up (54 months, IQR 41-70), 8 CVAs and 6 cardiovascular deaths occurred. LV blood stasis emerged as a significant risk factor for both endpoints (logRank p 0.001 and p = 0.008, respectively) and remained independent predictor of CVAs (HR 9.819, 95% CI 1.733-55.617, p = 0.010).LV blood stasis identified with CMR predicts the occurrence of CVAs in patients with AMI. These results may be helpful to personalize antithrombotic therapy for prevention strategies.

Randomized controlled trials (RCTs) and observational studies provided conflicting results regarding the role of left ventricular (LV) function on outcomes after transcatheter edge-to-edge repair (TEER). The study aimed to provide a comprehensive assessment of the interplay between severe LV dysfunction and TEER outcomes. Multiple electronic databases, including PubMed, EMBASE, Scopus, Web of Science, and CENTRAL, were searched to identify studies on TEER for secondary mitral regurgitation reporting outcomes stratified for LV ejection fraction30% and ≥30%. The prespecified primary end points were the composite of all-cause death or heart failure (HF) hospitalization and New York Heart Association (NYHA) class III/IV. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by random-effects models. Multiple sensitivity analyses accounting for baseline characteristics and study design were applied. A total of 6 studies (1,957 patients) with 1 year or 2 years of follow-up were available. Severe LV dysfunction was associated with an increased risk of death or HF hospitalization (OR 1.71, 95% CI 1.14 to 2.57). Conversely, comparable rates of NYHA class III/IV (OR 1.06, 95% CI 0.82 to 1.38) or secondary end points (reinterventions, recurrence of significant secondary mitral regurgitation) were found regardless of the baseline LV function. Subgroup meta-analysis found no difference in the composite primary end point between patients with LV ejection fraction30% and ≥30% enrolled in RCTs. In conclusion, TEER seems to be associated with higher mortality or HF hospitalization rates in patients with severe LV dysfunction. However, RCTs found no differences between groups. No impact of LV function was found on the risk of NYHA class III/IV or other clinical outcomes.

The coronary sinus (CS) Reducer is a novel device designed for the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. Aim of this study was to investigate the efficacy and the safety of the CS Reducer device in a real-world, multicenter, and country-level cohort of patients presenting with refractory angina pectoris. The study included patients affected by refractory angina pectoris who underwent CS Reducer implantation in 16 centers. Clinical follow-up was carried as per each center's protocol. One hundred eighty-seven patients were included. Technical and procedural success were achieved in 98% and 95%, respectively. Minor peri-procedural complications were recorded in 8 patients. During a median follow-up of 18.4 months, 135 (82.8%) patients demonstrated at least 1 CCS class reduction after Reducer implantation, and 80 (49%) patients at least 2 CCS class reduction. Mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Treatment benefit was also reflected in a significant improvement in quality of life scores and in a reduction of the mean number of anti-ischemic drugs prescribed for patient. In conclusion, in this multicenter, country-level study, the implantation of CS Reducer in patients with refractory angina pectoris resulted to be safe and effective in reducing of angina pectoris and improving quality of life.

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

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

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

Background Transcatheter pulmonary valve implantation (TPVI) is an effective treatment for right ventricular outflow tract (RVOT) dysfunction. Patients affected by congenital heart disease requiring TPVI may have difficult anatomies, thus making the intervention technically demanding. Case summary We report a case series of two patients affected by RVOT dysfunction. Both the cases were characterized by difficulty to advance the valve over the wire, which was successfully overcome by the application of the snared wire technique (SWT) to TPVI. Discussion Various technical pitfalls and tips have been described to facilitate the delivery of the transcatheter Edwards Sapien valve in the pulmonary position. The SWT described by the authors may be a helpful tool to gain supportiveness and stability of the guidewire during the procedure.

Coronary sinus Reducer is a current therapeutic treatment for patients with persistent refractory angina. We report a case of successful implantation of the device in the middle cardiac vein of a 65 years old female patient. The singular and unusual site for the Reducer was planned after a careful assessment of the venous drainage of the ischemic territory.

Transcatheter aortic valve replacement (TAVR) is a well-established procedure which shares common features with percutaneous coronary intervention and surgical aortic valve replacement. Technical and clinical aspects influence the appropriate antithrombotic strategy. Anticoagulation management is a priority in patients with atrial fibrillation and may have a role in preventing bioprosthetic valve thrombosis. In this chapter, we will offer a summary of published studies, current recommendations, and future perspectives on optimal medical therapy after TAVR.

Even considering the great strides made in cardiovascular therapy during the past 10 years, intraventricular thrombosis still represents a clinical challenge. An accurate detection of left ventricular thrombosis (LVT) and early initiation of a proper antithrombotic therapy are of absolute importance in preventing potentially life-threatening complications. There are no high-quality studies that address the issue of the optimal anticoagulant regimen in patients with left ventricular thrombosis; moreover, the role of new potent antiplatelet drugs has not been evaluated in randomized trials. Warfarin remains the most commonly used oral anticoagulant while DOACs should be taken under consideration due to convenience in dosing and achieving therapeutic anticoagulation so long as there is no specific indication for warfarin.

Atrial fibrillation (AF) is the most common cardiac rhythm disorder and often requires oral anticoagulation (OAC) in order to decrease the risk of thromboembolic complications, such as stroke and systemic embolic events. Unless contraindicated, current guidelines suggest that direct oral anticoagulants (DOAC) should be preferred over vitamin K antagonists. Of note, nearly 30% of AF patients also present with concomitant coronary artery disease requiring percutaneous coronary intervention (PCI) as well as dual antiplatelet therapy (DAPT) to prevent adverse cardiac events. So, a sizeable proportion of patient’s needs to be treated with a combination of OAC and DAPT, a regimen also known as triple antithrombotic treatment, which in turns will substantially increase the risk of major and fatal bleedings.

Background: Conduction disturbances after transcatheter aortic valve replacement (TAVR) are often transient. Limited data exist on anatomic factors predisposing to pacemaker dependency after TAVR. We sought to assess the rate and the possible predictors of pacemaker dependency after TAVR. Methods: Consecutive patients undergoing pacemaker implantation up to 30 days after TAVR between May 2014 and September 2019 were included. Baseline electrocardiographic, computed tomography, and procedural characteristics were collected, including valve implantation depth and membranous septum length, an anatomic surrogate of the distance between the aortic annulus and the His bundle. Pacemaker dependency at 30 days and 1 year and all-cause mortality during follow-up were evaluated. Results: Of 728 TAVR patients, 112 (53.5% men; median age, 81 years) underwent pacemaker implantation after TAVR. Of these, 44.6% (50 of 112) were pacemaker dependent at 30 days and 46.7% (36 of 77) at 1 year. By multivariate analysis, independent predictors of 30-day pacemaker dependency included left ventricular outflow tract calcifications under the left coronary cusp (odds ratio, 5.69 [95% CI, 1.45–22.31]; P =0.013) and a difference between membranous septum length and implantation depth (ΔMSID) ≥3 mm (odds ratio, 7.58 [95% CI, 2.07–27.78]; P =0.002). Conversely, membranous septum length and implantation depth alone were not associated with pacemaker dependency (odds ratio, 0.79 [95% CI, 0.60–1.05]; P =0.11 and odds ratio, 1.11 [95% CI, 0.99–1.24]; P =0.08). At a median follow-up of 28.1 (11.7–48.6) months, pacemaker-dependent patients did not show a worse survival ( P =0.26). Conclusions: Less than half of the patients undergoing pacemaker implantation after TAVR are pacemaker-dependent at midterm follow-up. ΔMSID ≥3 mm and the presence of left ventricular outflow tract calcifications under the left coronary cusp, but not membranous septum length nor implantation depth alone, are predictive of long-term pacemaker dependency after TAVR, thus influencing device selection and programming.

Transcatheter therapies have progressively assumed a major role in the treatment of valve heart disease. The major drivers have been population ageing, the high prevalence of valve disease in the elderly, and the consequent need of less invasive treatments for this fragile patient population. While transcatheter aortic valve implantation (TAVI) has achieved a central role in the treatment of severe aortic stenosis across any surgical risk category, transcatheter treatment of mitral valve disease is still the object of intense debate and investigation. The reasons are that the mitral valve apparatus anatomy is more complex, involving valve leaflets, subvalvular apparatus and the left ventricle. Further, the most frequent mitral valve disease, i.e. mitral regurgitation, has different etiologies and is frequently a consequence rather than the cause of left ventricular dysfunction and heart failure. Hence, clinical efficacy of its correction is uncertain. Beyond the varying clinical scenarios, there are a miriad of devices under developement or at different stages of clinical investigations. This book describes the state of the art in the filed of percutaneous treatment of mitral valve disease. It provides a comprehensive review including anatomical basis, in-depth diagnostics, patophysiology, summary of available evidence for transcatheter treatments, state-of-the art of cardiac surgery,description of devices commercially available or under investigation, and clinical examples.

Background Transcatheter aortic valve replacement (TAVR)‐in‐TAVR is a possible treatment for transcatheter heart valve ( THV ) degeneration. However, the displaced leaflets of the first THV will create a risk plane ( RP ) under which the passage of a coronary catheter will be impossible. The aim of our study was to evaluate the potential risk of impaired coronary access ( CA ) after TAVR ‐in‐ TAVR . Methods and Results We prospectively performed coronary angiography after TAVR with different THV s in 137 consecutive patients, looking where the catheter crossed the valve frame. If coronary cannulation was achieved from below the RP , the distance between valve frame and aortic wall was measured by aortic angiography. CA after TAVR ‐in‐ TAVR was defined as feasible if the catheter passed above the RP , as theoretically feasible if passed under the RP with valve‐to‐aorta distance >2 mm, and as unfeasible if passed under the RP with valve‐to‐aorta distance ≤2 mm. Seventy‐two patients (53%) received a Sapien 3 THV, 26 (19%) received an Evolut Pro/R THV, and 39 (28%) received an Acurate Neo THV . CA after TAVR ‐in‐ TAVR was considered feasible in 40.9% (68.1%, 19.2%, and 5.1%, respectively; P P P =0.116). Independent predictors of impaired CA after TAVR ‐in‐ TAVR were female sex (odds ratio [OR], 3.99; 95% CI , 1.07–14.86; P =0.040), sinotubular junction diameter (OR, 0.62; 95% CI , 0.48–0.80; P THV (OR, 6.61; 95% CI , 1.98–22.03; P =0.002). Conclusions CA after TAVR ‐in‐ TAVR might be unfeasible in >30% of patients currently treated with TAVR . Patients with a small sinotubular junction and those who received a supra‐annular THV are at highest risk of potential CA impairment with TAVR ‐in‐ TAVR .

BACKGROUND Stroke is a feared complication of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). OBJECTIVES With this meta-analysis we aimed to evaluate the incidence of 30-day stroke with TAVR and SAVR focusing on its possible correlation with surgical risk. METHODS Major electronic databases were searched for studies published between January 2002 and October 2019 reporting the rates of 30-day stroke after TAVR and SAVR. Data were pooled using fixed- and random-effects models. The primary outcome of the study was stroke rate within 30-day from TAVR or SAVR. Results were stratified according to surgical risk score (high, intermediate and low). RESULTS A total of 23 studies were identified (TAVR: 14,589 patients; SAVR: 11,681 patients). Regardless of the model used, in the overall population TAVR was associated with a significant reduction in the risk of stroke compared with SAVR (fixed effect: OR 0.78, 95% CI 0.66-0.92, p = .003; random-effects: OR 0.80, 95% CI 0.64-1.00, p = .045). Rates of 30-day stroke after TAVR and SAVR were not significantly different in the high- (OR 1.01, 95% CI 0.44-1.98, p = .105) and intermediate-risk groups (OR 0.92, 95% CI 0.63-1.36, p = .319), while low-risk patients had a lower rate of 30-day stroke after TAVR than SAVR (OR 0.65, 95% CI 0.50-0.83, p

Left ventricular thrombosis (LVT) is a major risk factor for systemic thromboembolism and might complicate both the acute and the chronic phase of ischaemic heart disease after myocardial infarction and, less frequently, non-ischaemic cardiomyopathies. The pathophysiology of thrombus formation is complex and involves the three aspects of Virchow’s triad: blood stasis, prothrombotic state, and tissue injury. Advances in technology have improved the detection rate of intracardiac thrombi, but several uncertainties still remain regarding the optimal treatment strategy within daily clinical practice. Of note, anticoagulation therapy with heparin and vitamin K antagonists decreases the risk of embolic stroke though exposing patients to an undeniable risk of bleeding complications. Although limited data on the off-label use of direct oral anticoagulants have reported safety and efficacy for LVT resolution, yet more evidence is needed to justify their use in clinical practice.

Background Incidence of coronary access (CA) after transcatheter aortic valve replacement (TAVR) at long-term follow-up remains unknown. CA and percutaneous coronary intervention (PCI) after TAVR might present technical challenges, particularly with supra-annular devices. Methods Patients undergoing CA after being treated with TAVR at our institution were included in the study. Coronary interventions for coronary obstruction during TAVR procedure were excluded. Incidence, feasibility and outcomes of CA after TAVR were analyzed. Results Out of 912 patients aged 80 ± 7 years treated with TAVR at our institution between 2007 and 2018, 48 (5.3%) underwent CA at a median follow up of 769 [363-1,471] days. Twenty-one had received a SAPIEN XT, 15 a SAPIEN 3, 6 Corevalve, 2 Evolut Pro, 2 JenaValve, and 2 Lotus valve. PCI was indicated in 26 (54%) cases. Seventeen (35%) procedures were performed for acute coronary syndromes (ACS). Independent predictors of CA after TAVR were younger age, previous PCI, and CABG. CA of both vessels was feasible in all patients with an intra-annular device, while the right coronary artery was not engaged in two patients with a supra-annular valve. PCI was successful in all but one case. All-cause mortality was similar between patients needing CA for ACS and those who had other clinical indications. Conclusions In this high-risk AS population, incidence of CA after TAVR at long-term follow-up was rather low. CA and PCI were safe and successful in most cases, with a lower rate of selective CA for supra-annular devices.

A 47-year-old woman has been suffering from intermittent claudication since she was 33 years old. The symptoms have slowly worsened during the following years and the patient was unable to walk more than 200 m without leg pain (Leriche-Fontain IIb) at admission. She had a history of hydroxyapatite