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Aims Identification of high-risk patients and individualized decision support based on objective criteria for rapid discharge after transcatheter aortic valve implantation (TAVI) are key requirements in the context of contemporary TAVI treatment. This study aimed to predict 30-day mortality following TAVI based on machine learning (ML) using data from the German Aortic Valve Registry. Methods and results Mortality risk was determined using a random forest ML model that was condensed in the newly developed TAVI Risk Machine (TRIM) scores, designed to represent clinically meaningful risk modelling before (TRIMpre) and in particular after (TRIMpost) TAVI. Algorithm was trained and cross-validated on data of 22 283 patients (729 died within 30 days post-TAVI) and generalisation was examined on data of 5864 patients (146 died). TRIMpost demonstrated significantly better performance than traditional scores [C-statistics value, 0.79; 95% confidence interval (CI)] [0.74; 0.83] compared to Society of Thoracic Surgeons (STS) with C-statistics value 0.69; 95%-CI [0.65; 0.74]). An abridged (aTRIMpost) score comprising 25 features (calculated using a web interface) exhibited significantly higher performance than traditional scores (C-statistics value, 0.74; 95%-CI [0.70; 0.78]). Validation on external data of 6693 patients (205 died within 30 days post-TAVI) of the Swiss TAVI Registry confirmed significantly better performance for the TRIMpost (C-statistics value 0.75, 95%-CI [0.72; 0.79]) compared to STS (C-statistics value 0.67, CI [0.63; 0.70]). Conclusion TRIM scores demonstrate good performance for risk estimation before and after TAVI. Together with clinical judgement, they may support standardised and objective decision-making before and after TAVI.

Background: Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce. Aims: The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems. Methods: Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05/2012 to 09/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations. Results: Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299). Conclusions: The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes.

Background Patients with severe aortic stenosis (AS) frequently presented mitral regurgitation (MR), which may interfere with the standard echocardiographic measurements of mean pressure gradient (MPG), flow velocity, and aortic valve area (AVA). Aims Herein we investigated the prevalence and severity of MR in patients with severe AS and its role on the accuracy of the standard echocardiographic parameters of AS quantification. Methods Of all patients with severe AS undergoing transcatheter or surgical aortic valve replacement enrolled in the German Aortic Registry from 2011 to 2017, 119,641 were included in this study. The population was divided based on the values of left ventricular ejection fraction ([LVEF] > 50%, LVEF 31–50%, and LVEF ≤ 30%] and AVA (0.80 to ≤ 1.00 cm2, 0.60 to 2, 0.40 to 2, and 0.20 to 2). Results Overall, 77,890 (65%) patients with mild to-moderate and 4262 (4%) with severe MR were compared with 37,489 (31%) patients without MR. Patients with mild-to-moderate and severe MR presented significantly lower mPG (ΔmPG [95%CI] − 1.694 mmHg [− 2.123 to − 1.265], p p 2 [− 0.023 to 0.009], p = 0.973). Increasing MR severity was associated with significant mPG reduction throughout all AVA strata, causing a low-gradient pattern, that manifested since the early stages of severe AS (LVEF > 50%: AVA 0.80 to 1.00 cm2; LVEF 31–50%: AVA 0.60 to 0.80 cm2). Conclusions In patients with severe AS, concomitant MR is common, contributes to the onset of a low-gradient AS pattern, and affects the diagnostic accuracy of flow-dependent AVA measurements. In this setting, a multimodality, AVA-centric approach should be implemented. Graphical abstract In patients with severe aortic stenosis, concomitant mitral regurgitation contributes to the onset of a low-gradient pattern, warranting a multimodality, and AVA-centric diagnostic approach.

BackgroundRobotically assisted remote-controlled PCI (rPCI) was introduced in the past decade as one of the latest enhancements in this rapidly evolving field. The use of a second-generation rPCI system in ST-elevation myocardial infarction (STEMI) is an effort to couple immediate revascularization with the accuracy of newer robotic assistance and software support.Case summaryHere we report on the safety and efficacy of rPCI applied to a 74-year-old female STEMI patient with persistent acute chest pain as well as regional wall motion abnormalities in the echocardiogram. The first medical contact-to-device time was 76 min, and door-to-balloon time was 33 min. The impatient course was uneventful, so the patient was discharged from hospital after 5 days. To the best of our knowledge, this is the first report of the successful application of second-generation rPCI in STEMI.DiscussionIn the case presented, rPCI was feasible and safe even in acute coronary syndrome based on a single-centre experience. rPCI is a revolutionary new technique that may be applied to various types of clinical presentations.

RESUMEN Introducción y objetivos: Entre las potenciales complicaciones del implante percutáneo de válvula aórtica (TAVI) se encuentran las complicaciones vasculares. Los dispositivos de sutura son los más utilizados para el cierre vascular, pero algunos sistemas de cierre con colágeno (MANTA, Essential Medical Inc., Estados Unidos) ofrecen una solución de rescate cuando los de sutura fallan. Para la correcta implantación de este dispositivo es necesario conocer la profundidad exacta de la arteria femoral antes de la inserción del introductor del TAVI. El objetivo de este estudio fue validar 2 técnicas diferentes de medida, la tomografía computarizada con multidetector (TCMD) y una técnica alternativa que emplea el dispositivo Angio-Seal (Terumo Medical Corporation, Estados Unidos), en comparación con el sistema específico de medida del dispositivo MANTA. Métodos: En pacientes que recibieron TAVI, se midió la profundidad de la arteria femoral mediante TCMD antes y durante el procedimiento con un dispositivo Angio-Seal. Ambas medidas se correlacionaron con la real obtenida tras la punción mediante el medidor del dispositivo MANTA. Resultados: En 168 pacientes a quienes se realizó TAVI transfemoral, se midió la profundidad de la arteria femoral antes y durante el procedimiento. La medida con TCMD previa al procedimiento mostró una correlación moderada con las medidas durante el procedimiento (r = 0,64; p < 0,001). La medida con el dispositivo Angio-Seal mostró una alta correlación con la herramienta de medición (r = 0,99; p < 0,001). En total, 10 pacientes necesitaron rescate con dispositivo MANTA por fracaso de los dispositivos de sutura. Conclusiones: En caso de fracaso de los dispositivos de sutura tras TAVI, el dispositivo de tapón de colágeno MANTA puede actuar como técnica de rescate. Sin embargo, la medida antes del procedimiento obtenida con TCMD no es precisa para implantar correctamente el dispositivo MANTA. La medición con un dispositivo Angio-Seal antes de la inserción del introductor del TAVI puede ser una solución sencilla para conocer las medidas con exactitud y para la inserción de rescate de un dispositivo MANTA, cuando fracasan los dispositivos de cierre por sutura.

Introduction and objectives: Vascular complications remain a potential problem after transcatheter aortic valve implantation (TAVI). Although suture-based vascular closure devices are most often used for vascular closure purposes, alternative plug-based vascular closure devices like the MANTA (Essential Medical Inc., United States) stand as a bail-out option for patients with failed suture-based closure devices. Since knowing the exact vessel depth is essential to use this device correctly before inserting the large introducer, we aimed to validate 2 different measurement techniques including preoperative multidetector computer tomography (MDCT) plus an alternative technique with the Angio-Seal device (Terumo Medical Corporation, United States) compared to a vendor specific measuring tool. Methods: In patients eligible for TAVI, the depth of the femoral artery was measured preoperatively using MDCT, and then perioperatively with the Angio-Seal device. Both measurements were associated with the actual depth after puncture using the vendor-specific tool of the MANTA device. Results: In a total of 168 patients treated with transfemoral TAVI, the depth of the vessel was measured both pre and perioperatively. The measurements obtained from the preoperative MDCT revealed the existence of a moderate correlation compared to the preoperative measurements obtained (r = 0.64; P < .001). Measurements obtained with the Angio-Seal device revealed a high correlation with the measuring tool included (r = 0.99; P < .001). Overall, 10 patients required the bail-out option with the MANTA device due to failed suture-based vascular closure devices. Conclusions: In case of a failed suture-based vascular closure device after TAVI, the plug-based MANTA device can be used as a bail-out strategy. However, the measurement of the vessel depth obtained from preoperative MDCTs is not accurate enough for safe MANTA insertions. Measurements with the Angio-Seal device before inserting the large TAVI sheath stand as a simple solution to obtain exact measurements facilitating the use of the bail-out MANTA in case of failed suture-based closure vascular devices after TAVI.

Background: Severe calcification of the ascending aorta increases the peri-operative risk for neurological complications in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) seems to be an optimal treatment option in these patients. However, the impact of the extent of aortic calcification on procedural and neurological outcomes during TAVI is unclear. Methods: Data from 3010 patients with severe native aortic valve stenosis treated with ACURATE neo/neo2 from May 2012 to July 2022 were evaluated and matched by 2-to-1 nearest-neighbor matching to identify one patient with porcelain aorta (PA) (n = 492) compared with two patients without PA (n = 984). PA was additionally subdivided into circumferential (classic PA) (n = 89; 3.0%) and non-circumferential (partial PA) (n = 403; 13.4%) calcification. We compared outcomes according to VARC-3 criteria among patients with and without PA and identified predictors for occurrence of stroke in the overall population. Results: Technical success (88.5% vs. 87.4%, p = 0.589) and device success at 30 days (82.3% vs. 81.5%, p = 0.755) after transcatheter ACURATE neo/neo2 implantation according to VARC-3 definition was high and did not differ between non-calcified aortas or PA. The rate of in-hospital complications according to VARC-3-definitions was low in both groups. Rates of all stroke (3.2% (n = 31) vs. 2.6% (n = 13), p = 0.705) or transitory ischemic attacks (1.1% vs. 1.2%, p = 1.000) did not differ significantly. Thirty-day all-cause mortality did not differ (3.0% vs. 3.2%, RR 1.1; p = 0.775). Overall device migration/embolization (OR 5.0 [2.10;11.87]), severe bleeding (OR 1.79 [1.11;2.89]), and major structural cardiac complications (OR 3.37 [1.32;8.57]) were identified as independent predictors for in-hospital stroke in a multivariate analysis after implantation of ACURATE neo/neo2. Conclusion: A porcelain aorta does not increase the risk of neurological complications after transfemoral ACURATE neo/neo2 implantation. Based on these findings, transfemoral ACURATE neo/neo2 implantation is safe in these particularly vulnerable patients.

BACKGROUND The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. METHODS We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. RESULTS A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P���=���0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P���=���0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). CONCLUSIONS In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.).

Background Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. Aims We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system (Edwards Lifesciences, Irvine, CA, USA) from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. Methods Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. Results Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (pl0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all pl0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (pl0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (pl0.001) with improvements in overall KCCQ score by 17 points (pl0.001). Conclusions In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.

Background Percutaneous coronary intervention (PCI) is the standard-of-care treatment for left main stenosis as an alternative to bypass surgery. In addition, severe coronary lesion calcification can be modified by intravascular lithotripsy (IVL). However, with PCI and debulking treatment options, there are inherent limitations. PCI poses an increased health burden for the treating physician that is associated with wearing a heavy, lead-lined apron and being exposed to radiation. To overcome these issues, a robotically assisted angioplasty system (rPCI) was established that enables the operator to perform PCI remotely in routine clinical procedures. Furthermore, IVL have not been used remotely. Case summary Here, we report the use of this technique for treating a heavily calcified left main stenosis in an 82-year-old male with previously diagnosed two-vessel coronary artery disease, progressive symptoms of dyspnoea at high cardio-vascular risk profile. The decision of the local heart team declined surgery. To the best of our knowledge, this is the first report of successful rPCI combined with IVL. Discussion In the case presented, rPCI was feasible and safe even in a complex lesion of the left main coronary artery requiring IVL. rPCI is a revolutionary new technique that may be applied to various types of coronary artery lesions.

Few data exist on immediate outcomes of the next-generation Acurate neo2 prosthesis (Boston Scientific), which is distinguished by an active sealing mechanism. We sought to determine procedural outcomes of transfemoral transcatheter aortic valve replacement using the neo2 in comparison with its predecessor, the Acurate neo.In this retrospective analysis, consecutive neo2 and neo cases were compared from 2 high-volume centers. The primary outcome of interest was the rate of relevant paravalvular regurgitation (PVR), defined as PVR ≥ moderate, or valve-in-valve and/or surgical aortic valve replacement for PVR ≥ moderate. Secondary outcomes of interest were assessed according to Valve Academic Research Consortium (VARC)-3 criteria. Logistic regression analysis was used to identify predictors of relevant PVR.A total of 810 neo2 and 2055 neo cases comprised the study cohort. The rate of relevant PVR was significantly lower in the neo2 group (2.7% vs 4.5%; P=.04). The technical success rate was numerically higher in the neo2 group (91.5% vs 89.3%; P=.10) and the rate of device success at 30 days was significantly higher (86.5% vs 82.9%; P=.02). In the neo group, a greater amount of aortic valve calcification (AVC), the presence of eccentric AVC, less oversizing, and a higher sinotubular junction annulus index were predictors of relevant PVR, whereas in the neo2 population only the presence of eccentric AVC, less oversizing, and a higher sinotubular junction annulus index was predictive.The neo2 valve shows superior outcomes over the neo valve, with a lower burden of PVR and a higher device success rate at 30 days.

We aimed to develop and validate an effective prediction model for 1-year mortality risk in elective transfemoral transcatheter aortic valve replacement (TAVR), ie, the TAVR-Risk (TARI) model.TAVR is the primary treatment for patients with symptomatic severe aortic valve stenosis; however, risk assessment tools for longer-term outcomes after TAVR remain scarce.This retrospective cohort study used logistic regression to test univariate and multivariate associations. The German Aortic Valve Registry (GARY) was the derivation (n = 20,704) and the Swedish SWEDEHEART TAVR Registry (SWENTRY) was the validation cohort (n = 3982). The main outcome was the area under the curve (AUC) in the prediction of 1-year mortality. The final model included 12 parameters that were associated with 1-year mortality in a multivariate analysis.The TARI model (AUC, 0.66; 95% confidence interval [CI] 0.65-0.67) performed better as compared with the Society of Thoracic Surgeons (STS) score (AUC, 0.63; 95% CI, 0.62-0.64; P.001) and logistic EuroSCORE I (AUC, 0.60; 95% CI, 0.59-0.61; P.001) in the GARY derivation cohort, and discriminated the risk for 1-year mortality better than logistic EuroSCORE I in the SWENTRY validation cohort (AUC, 0.62; 95% CI, 0.60-0.64 vs AUC, 0.59; 95% CI, 0.57-0.61; P=.04).This novel TARI score provides a relatively easy-to-use risk model and offers a superior prediction for 1-year mortality in European TAVR patients.

Die perkutane Koronarintervention (PCI) von chronischen Koronarverschlussen (CTO-PCI) hat sich in der letzten Dekade stetig weiterentwickelt und geht mittlerweile mit Erfolgsraten von uber 85 % einher. Die Ausbildung zum selbststandigen CTO-Operateur dauert oft mehrere Jahre und Bedarf neben institutionellen Voraussetzungen eines hohen Eigenengagements zur standigen Weiterbildung. Randomisierte Daten konnten zwar eine symptomatische Verbesserung, aber bisher keine Mortalitatssenkung nach erfolgreicher Koronarintervention zeigen. Umso entscheidender ist die richtige Patientenauswahl verbunden mit einer niedrigen periinterventionellen Komplikationsrate. Um dies zu gewahrleisten, hat sich die Deutsche Gesellschaft fur Kardiologie (DKG) entschieden, ein Positionspapier fur alle in Praxen und Krankenhausern tatigen Kardiologen, insbesondere aber auch fur alle interventionellen Kardiologen zu verfassen. Zielfuhrend erscheint eine bundesweite Etablierung von spezialisierten CTO-Zentren. Nur dadurch konnen diese hochkomplexen Prozeduren dem Patienten gegenuber mit einem niedrigen und somit vertretbaren Risiko angeboten werden.

OBJECTIVES The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR). BACKGROUND Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences. METHODS In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included. RESULTS Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P��=��0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P��=��0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P��=��0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement. CONCLUSIONS CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality.

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe aortic stenosis and is now standard of care for high surgical risk patients and a valid alternative strategy in intermediate risk patients. Recently, TAVR has shown excellent results in low-risk patients, indicating an imminent extension toward this population. Improvements in procedural outcomes are the result of increasing operator experience, sophisticated imaging for procedural planning but also due to the continuous evolution of transcatheter heart valves developed to minimize procedural complications. ‘Next-generation’ valves are currently available, among them the self-expanding ACURATE neo. Here, the technical details and clinical outcomes of the ACURATE neo are reviewed, comparative data with other ‘next-generation’ valves and potential advantages and disadvantages are discussed.

Objectives Computed tomography angiography (CTA) is performed routinely in the work-up for transcatheter aortic valve implantation (TAVI), and could potentially replace invasive coronary angiography (ICA) to rule out left main (LM) and proximal coronary stenosis. The objectives were to assess the diagnostic yield and accuracy of pre-TAVI CTA to detect LM and proximal coronary stenosis of ≥ 50% and ≥ 70% diameter stenosis (DS). Methods The DEPICT CTA database consists of individual patient data from four studies with a retrospective design that analyzed the diagnostic accuracy of pre-TAVI CTA to detect coronary stenosis, as compared with ICA. Pooled data were used to assess diagnostic accuracy to detect coronary stenosis in the left main and the three proximal coronary segments on a per-patient and a per-segment level. We included 1060 patients (mean age: 81.5 years, 42.7% male). Results On ICA, the prevalence of proximal stenosis was 29.0% (≥ 50% DS) and 15.7% (≥ 70% DS). Pre-TAVI CTA ruled out ≥ 50% DS in 51.6% of patients with a sensitivity of 96.4%, specificity of 71.2%, PPV of 57.7%, and NPV of 98.0%. For ≥ 70% DS, pre-TAVI CTA ruled out stenosis in 70.0% of patients with a sensitivity of 96.7%, specificity of 87.5%, PPV of 66.9%, and NPV of 99.0%. Conclusion CTA provides high diagnostic accuracy to rule out LM and proximal coronary stenosis in patients undergoing work-up for TAVI. Clinical application of CTA as a gatekeeper for ICA would reduce the need for ICA in 52% or 70% of patients, using a threshold of ≥ 50% or ≥ 70% DS, respectively. Key Points • Clinical application of CTA as a gatekeeper for ICA would reduce the need for ICA in 52% or 70% of TAVI patients, using a threshold of ≥ 50% or ≥ 70% diameter stenosis. • The diagnostic accuracy of CTA to exclude proximal coronary stenosis in these patients is high, with a sensitivity of 96.4% and NPV of 98.0% for a threshold of ≥ 50%, and a sensitivity of 96.7% and NPV of 99.0% for a threshold of ≥ 70% diameter stenosis. • Atrial fibrillation and heart rate did not significantly affect sensitivity and NPV. However, a heart rate of < 70 b/min during CTA was associated with a significantly improved specificity and PPV.

Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract

Background: During the last years, several transcatheter aortic heart valves entered the clinical market and are commercially available. The prostheses differ regarding several technical and functional aspects. However, little is known regarding head-to-head comparative data of the ACURATE neo and the PORTICO valve prostheses. Objectives: The aim of this study was to compare two self-expanding transcatheter aortic heart valves (THV), the ACURATE neo and the PORTICO, with regard to in-hospital and 30-day outcomes, as well as early device failures. Methods: A total of 1591 consecutive patients with severe native aortic valve stenosis from two centers were included in the analyses and matched by 1:1 nearest neighbor matching to identify one patient treated with PORTICO (n = 344) for each patient treated with ACURATE neo (n = 344). Results: In-hospital complications were comparable between both valves, including any kind of stroke (ACURATE neo = 3.5% vs. PORTICO = 3.8%; p = 1.0), major vascular complications (ACURATE neo = 4.5% vs. PORTICO = 5.4%; p = 0.99) or life-threatening bleeding (ACURATE neo = 1% vs. PORTICO = 2%; p = 0.68). The rate of device failure defined by the VARC-2 criteria were comparable, including elevated gradients and moderate-to-severe paravalvular leakage (ACURATE neo = 7.3% vs. PORTICO = 7.6%; p = 1.0). However, the need for permanent pacemaker implantation (PPI) was significantly more frequent after the use of PORTICO THV (9.5% vs. 18.7%; p = 0.002). Conclusions: In this two-center case-matched comparison, short-term clinical and hemodynamic outcomes showed comparable results between PORTICO and ACURATE neo prostheses. However, PORTICO was associated with a significant higher incidence of PPI.

Background: Self-expanding transcatheter valves (THV) seem superior to balloon-expanding valves in regard to the incidence of prosthesis–patient mismatch (PPM). Data on the occurrence of PPM with the ACURATE neo/neo2 system as a representative of self-expanding prostheses in very small annuli, even below the applicable instructions for use (IFU), are scarce. Methods: Data from 654 patients with severe native aortic stenosis treated with the smallest size ACURATE neo/neo2 valve (size S, 23 mm) at two German high-volume centers from 06/2012 to 12/2021 were evaluated. We compared clinical and hemodynamic outcomes among patients with implantation in adherence to the recommended sizing (on-label n = 529) and below the recommended sizing range (off-label n = 125) and identified predictors for PPM in the overall population. BMI-adjusted PPM was defined according to VARC-3 recommendations. Results: Post-procedure, the mean gradient (10.0 mmHg vs. 9.0 mmHg, p = 0.834) and the rate of paravalvular leakage (PVL) ≥ moderate (3.2% vs. 2.8%, p = 0.770) were similar between on-label and off-label implantations. The rate of moderate to severe PPM (24%) was comparably low in ACURATE neo/neo2 S, with a very low proportion of severe PPM whether implanted off- or on-label (4.9% vs. 3.8%, p = 0.552). Thirty-day all-cause mortality was higher among patients with off-label implantations (6.5% vs. 2.3%, p = 0.036). In the subgroup of these patients, no device-related deaths occurred, and cardiac causes did not differ (each 5). Besides small annulus area and high BMI, a multivariate analysis identified a greater cover index (OR 3.26), deep implantation (OR 2.25) and severe calcification (OR 2.07) as independent predictors of PPM. Conclusions: The ACURATE neo/neo2 S subgroup shows a convincing hemodynamic outcome according to low mean gradient even outside the previous IFUs without a relevant increase in the rate of PVL or PPM. In addition to known factors such as annulus area and BMI, potential predictors for PPM are severe annulus calcification and implantation depth. Nevertheless, the ACURATE neo/neo2 system seems to be a reliable option in patients with very small annuli.

In den letzten 18 Jahren hat sich die Therapie der Aortenklappenstenose rasant weiterentwickelt. Im Jahr 2019 wurden beispielsweise in Deutschland 3‑mal so viele TAVI(kathetergestutzte Aortenklappenimplantation)-Prozeduren gegenuber dem isolierten chirurgischen Aortenklappenersatz durchgefuhrt. Grundlage hierfur sind die Ergebnisse verschiedener randomisierter Multicenterstudien sowie Registerdaten. Ein Beispiel hierfur sind die Publikationen aus dem Deutschen Aortenklappenregister (GARY). Im Jahr 2020 wurden die Themen Patientencharakteristika, der Einfluss eines postoperativen Herzschrittmachers und ein Vergleich der chirurgischen Sutureless-Aortenklappenprothesen mit den TAVI-Prothesen analysiert. Internationale Publikationen aus der CHOICE- und PARTNER 2-Studie beschaftigten sich unter anderem mit dem Thema der 5‑Jahres-Haltbarkeit von TAVI-Prothesen. Mit der wachsenden Anzahl an TAVI-Prozeduren erlangt auch das Thema einer erneuten TAVI im Verlauf moglicherweise Bedeutung. Hierzu gab es ebenso im letzten eine interessante Arbeit. Weitere Publikationen beschaftigten sich mit dem Thema bikuspide Aortenklappenstenose sowie der medikamentosen Begleittherapie nach einer TAVI. Die vorliegende Arbeit soll die relevanten Studien zum Thema Aortenklappenstenose aus dem Jahr 2020 zusammenfassen.

Die im August 2020 publizierten Leitlinien der European Society of Cardiology (ESC) zum Management des akuten Koronarsyndroms ohne persistierende ST-Strecken-Hebungen (NSTE-ACS) ersetzen die zuletzt 2015 veroffentlichten Leitlinien. Diese aktualisierte Leitlinie hat einige bedeutsame Veranderungen fur die klinische Praxis, die die Diagnostik, Risikostratifizierung, medikamentose antithrombotische Therapie, das weitere Management mit invasiver Diagnostik oder nichtinvasiver Diagnostik und die Langzeittherapie beinhalten. Neue Abschnitte befassen sich mit der spontanen Koronararteriendissektion (SCAD), dem Myokardinfarkt mit nichtobstruktiven Koronararterien (MINOCA) und auch neu eingefuhrten Qualitatsindikatoren in der Therapie. Eine Betonung erfahrt die Diagnostik mit hochsensitivem kardialem Troponin (hs-cTn) mit Algorithmen, die ein fruhes Rule-in oder auch Rule-out in der Notaufnahme oder Chest-Pain-Unit ermoglichen. Bei der Risikostratifizierung wurde die fruhere intermediare Risikogruppe gestrichen und neu betont, dass Patienten mit niedrigem Risiko weitgehend wie Patienten mit einem chronischen Koronarsyndrom behandelt werden sollten. Bei der Antiplattchentherapie erfolgt eine starkere Individualisierung der Dauer, basierend auf dem ischamischen und dem Blutungsrisiko. Fur die invasive Diagnostik und den Zeitpunkt der invasiven Diagnostik wurden einige neue Aspekte eingefuhrt. Es bleibt aber bei der Gruppe mit sehr hohem Risiko, die sofort invasiv untersucht werden sollte, und der Gruppe mit hohem Risiko, die innerhalb von 24 h eine invasive Diagnostik bekommen sollte.

OBJECTIVES Chronic kidney disease (CKD) is a key risk factor in patients undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). We analysed the impact of estimated glomerular filtration rate (eGFR) and CKD stages on their mid-term survival. METHODS Data from 29 893 patients enrolled in the German Aortic Valve registry from January 2011 to December 2015 receiving TAVI (n = 12 834) or SAVR (n = 17 059) at 88 sites were included. The impact of renal impairment, as measured by eGFR and CKD stages, was investigated. The primary end-point was 1-year cumulative all-cause mortality. RESULTS Higher CKD stages were significantly associated to lower in-hospital, 30-day- and 1-year survival rates. Both TAVI- and SAVR-treated patients in CKD 3a, 3b, 4 and 5 stages showed significant and gradually increasing HR values for 1-year all-cause mortality. The same trend persisted in multivariable analysis, although HR values for CKD 3a and 5 did not reach significance in TAVI patients, whereas CKD 4 + 5 did not reach statistical significance in SAVR. Likewise, eGFR as a continuous variable was a significant predictor for 1-year mortality, with the best cut-off points being 47.4 ml/min/1.73 m2 for TAVI and 59.8 ml/min/1.73 m2 for SAVR. Significant 8.6% and 9.0% increases in 1-year mortality were observed for every 5-ml reduction in eGFR for TAVI and SAVR, respectively. CONCLUSIONS CKD ≥3b and CKD ≥3a are the independent major risk factors for mortality in patients undergoing TAVI and SAVR, respectively. In the overall population of patients with severe aortic stenosis, an appropriate stratification based on CKD substage may contribute to a better selection of patients suitable for such therapies.

Both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are established options to treat aortic valve stenosis. We present the outcome of the complete cohort of all patients undergoing SAVR or TAVI in Germany during the calendar year 2019. Data concerning all isolated aortic valve procedures performed in Germany in 2019 were retrieved from the mandatory nationwide quality control program: 22,973 transvascular (TV)-TAVI procedures, 7905 isolated SAVR (iSAVR), and 1413 transapical (TA)-TAVI. Data was complete in 99.9% (n = 32,156). In-hospital mortality after TV-TAVI (2.3%) was significantly lower when compared with iSAVR (2.8%, p = 0.007) or TA-TAVI (6.3%; p

In den letzten Jahren finden strukturelle kardiale Interventionen zunehmend Anwendung in der klinischen Routine. Trotz der raschen Einfuhrung und Weiterentwicklung dieser Techniken, ist die Evidenz fur die optimale antithrombotische Therapie nach solchen Interventionen limitiert, da randomisierte Studien zum Vergleich verschiedener antithrombotischer Therapien fur die meisten Einsatzgebiete fehlen. Diese Empfehlung fasst den gegenwartigen Erkenntnisstand zusammen. Basierend auf den zur Verfugung stehenden Daten, werden Behandlungsempfehlungen formuliert, die Arzten und ihren Patienten die Entscheidungsfindung erleichtern sollen.

The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system.The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture.Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE).Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%).Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status.

Data are lacking regarding the outcomes of balloon postdilation (BPD) for the Acurate neo and neo2 devices. The aim of this study was to assess the impact of BPD in a large, single-center cohort of patients treated with the Acurate platform.For this retrospective analysis, we included all patients with severe aortic stenosis who underwent transfemoral transcatheter aortic valve replacement (TAVR) with the Acurate neo or neo2 prosthesis at our institution.Among 1417 Acurate recipients, BPD was required in 521 cases (36.8%) for relevant paravalvular regurgitation (PVR) (n = 418) and incomplete prosthesis expansion or increased transprosthetic gradients (n = 103). Overall, BPD was successful in 87.9% and led to a significant reduction of more-than-mild PVR from 32.0% to 7.5% (P.001). In the BPD group, prosthesis-patient mismatch (PPM) was less common. Prosthetic leaflet damage or valve dislodgment due to BPD occurred in 6 cases (1.2%). All other outcomes were similar between groups with and without BPD, including rates of aortic root injury, stroke, acute kidney injury, permanent pacemaker implantation, and all-cause 30-day mortality. Independent predictors of the need for BPD were higher mean transaortic gradients, severe aortic valve calcification, less prosthesis oversizing, and the use of larger prosthesis sizes.For transfemoral TAVR using the Acurate neo/neo2, BPD effectively reduces relevant PVR and decreases the risk of PPM without increasing adverse events. Transcatheter heart valve damage associated with BPD is rare, commonly avoidable, and does not jeopardize the net benefit of BPD.