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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.

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.

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.

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.

The coronavirus disease 2019 (COVID-19) pandemic poses an unprecedented challenge to healthcare worldwide. The infection can be life threatening and require intensive care treatment. The transmission of the disease poses a risk to both patients and healthcare workers. The number of patients requiring hospital admission and intensive care may overwhelm health systems and negatively affect standard care for patients presenting with conditions needing emergency interventions. This position statements aims to assist cardiologists in the invasive management of acute coronary syndrome (ACS) patients in the context of the COVID-19 pandemic. To that end, we assembled a panel of interventional cardiologists and acute cardiac care specialists appointed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and from the Acute Cardiovascular Care Association (ACVC) and included the experience from the first and worst affected areas in Europe. Modified diagnostic and treatment algorithms are proposed to adapt evidence-based protocols for this unprecedented challenge. Various clinical scenarios, as well as management algorithms for patients with a diagnosed or suspected COVID-19 infection, presenting with ST- and non-ST-segment elevation ACS are described. In addition, we address the need for re-organization of ACS networks, with redistribution of hub and spoke hospitals, as well as for in-hospital reorganization of emergency rooms and cardiac units, with examples coming from multiple European countries. Furthermore, we provide a guidance to reorganization of catheterization laboratories and, importantly, measures for protection of healthcare providers involved with invasive procedures.

Aims Paravalvular leakage (PVL) after transcatheter aortic valve replacement (TAVR) is a common complication in patients with bicuspid aortic valve (BAV). However, predictors and mechanisms of PVL are not well understood in this subset. The aim of this study was to analyse determinants and mechanisms of PVL in BAV and tricuspid aortic valve (TAV). Methods and results Of the 2394 consecutive patients undergoing transfemoral TAVR using new-generation valves at our centre, we identified 242 cases with BAV. To adjust for baseline differences, we performed 3 : 1 propensity score matching (TAVPS n = 726). We analysed the aortic root anatomy and calcification as well as the number, circumferential distribution, and predilection sites of PVL using pre-procedural multidetector computed tomography and post-TAVR echocardiography. In the matched cohort, the incidence of PVL ≥mild (BAV 51.9% vs. TAVPS 51.7%; P = 0.955) and PVL ≥moderate (BAV 5.0% vs. TAVPS 3.7%; P = 0.393), the circumferential distribution, and independent predictors were similar between BAV and TAVPS. Both the presence of peri-annular calcium chunks or LVOT calcification were highly associated with PVL in BAV and TAVPS patients, whereas in BAV patients neither the presence of a calcium bridge nor the volume of its calcification was related to PVL. Notably, the spatial localization of these lesions did not necessarily match the circumferential leak position. Conclusion The incidence, circumferential distribution, predilection sites, and predictors of PVL were similar in matched population of BAV and TAVPS patients undergoing transfemoral TAVR using new-generation devices. These novel findings suggest a common underlying mechanism of PVL in both entities.

Aims Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic valve stenosis at high surgical risk and may be considered for patients with intermediate risk. During the last few years, an increasing number of patients with low surgical risk have been treated with TAVI. In this study, low-risk patients undergoing isolated TAVI or surgical aortic valve replacement (SAVR) were analysed using data from the German Aortic Valve Registry (GARY). Methods and results All patients with a Society of Thoracic Surgeons Score of Conclusion In this first GARY analysis of low-risk patients, weighted comparison showed similar 1-year survival for TAVI and SAVR and higher in-hospital survival for TAVI patients.

Objectives Due to increasing clinical experience with transcatheter aortic valve implantation (TAVI) procedures, sophisticated imaging and advanced device technology, TAVI complication rates are low; however, patients requiring conversion to surgery are confronted with an increased mortality risk. In this retrospective study, we evaluated the predictors for conversion and the outcomes of these patients. Methods We analysed the records of all patients undergoing TAVI in our centre from 2011 to 2016 and focused on cases that required conversion to sternotomy. We investigated reasons and risk factors for conversion as well as 30-day and 1-year outcomes. Results During the study period, 32 (2.1%) of 1775 patients undergoing TAVI required immediate conversion to sternotomy. Annular rupture (5 of 32; 16%), device embolization (9 of 32; 28%) and pericardial tamponade (15 of 32; 47%) were the most common reasons for conversion. Usage of a self-expandable valve showed to be the only predictor for conversion (odds ratio 0.38, 95% confidence interval 0.16-0.90; P = 0.03). Survival at 30 days and 1 year was 56% and 41%, respectively. Patients who survived 30 days after conversion showed higher preoperative ejection fraction, shorter duration of surgery and shorter perfusion time. Conclusions In this high-volume, single-centre experience, conversion to sternotomy during TAVI occurred in about 2%, with annular rupture, device embolization and pericardial tamponade being the most common causes. Complications requiring conversion showed to be unpredictable. However, in view of these life-threatening complications, the 30-day survival rate exceeding 50% emphasizes the importance of an experienced and well-attuned heart team providing immediate access to surgical bailout procedures.

Surgical aortic valve replacement (sAVR) is coming under close scrutiny with the recent upswing in the use of less invasive approaches. The aim of this analysis was to identify current trends in patient selection, procedural characteristics and outcomes after sAVR in Germany.We analysed data from 42 776 patients included in the German Aortic Valve Registry who underwent sAVR with and without coronary artery bypass surgery (CABG) between 2011 and 2015. Baseline, procedural and short-term outcome parameters were analysed.Of all registered patients, 26 618 (62.2%) underwent isolated sAVR and 16 158 (37.8%) sAVR + CABG. The median age was 72 years, and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) was 2.3%. From 2011 to 2015, there was a decline in STS PROM (2.4-2.2%, P 0.001) and a decline in risk factors, such as pulmonary hypertension (9.1-3.2%, P 0.001), occlusive arterial disease (19.6-17.7%, P = 0.003), mitral regurgitation ≥2° (10.6-7.6%, P 0.001) and New York Heart Association Class III/IV (65.3-59.2%, P 0.001). In-hospital mortality was 2.3%, 1.3% had disabling stroke, 0.4% residual aortic regurgitation ≥2°, and the incidence of new-onset pacemaker/implantable cardioverter-defibrillator implantation was 3.9%. There was an increase in the use of biological valves in patients65 years (50.1-65.7%, P 0.001), and the proportion of rapid deployment valves increased significantly (1.5-8.4%, P 0.001) over the investigated time period.Both isolated sAVR as well as sAVR + CABG resulted in excellent in-hospital outcomes based on 42 000 patients treated between 2011 and 2015. The implementation of alternative treatment strategies has resulted in palpable changes in patient and device selection.

OBJECTIVES: Transapical aortic valve implantation (TA-AVI) using the Edwards SAPIEN™ prosthesis has evolved into a routine procedure for selected high-risk elderly patients. The recently introduced SAPIEN™ delivery system (Ascendra II+™) with an added nose cone seems to facilitate direct valve implantation without prior balloon valvuloplasty (BAV). Here, we report our initial experience with this device. METHODS: A total of 128 patients were enrolled in the study in 2012 and 2013 and were designated Cohort I. For a subset of 79 patients, exact cardio- computed tomography-based measurements were available; these patients were assigned to Cohort II. All patients received SAPIEN XT™ valves using the TA approach. TA-AVI without pre-ballooning was performed in 31.2% (Cohort I) and 31.6% (Cohort II) of patients. To adjust for baseline variables, propensity score (PS)-based pair matching was used. RESULTS: All valves were implanted successfully. The use of PS matching resulted in bias reduction for both cohorts. For Cohort I, there were no significant differences in the primary end points, which were aortic valve incompetence ≥2+, Pmean postimplantation, major stroke, transient ischaemic attack (TIA), requirement for post-dilatation and necessity for new pacemaker implantation. As expected, fluoroscopy time was significantly lower in no-BAV patients. In Cohort II, the 30-day TIA rate was lower in the no-BAV group. CONCLUSIONS: Direct TA implantation of the SAPIEN valve without pre-ballooning is feasible, safe, does not seem to compromise functional outcomes and may be associated with fewer neurological events.

OBJECTIVES: Precise measurements of aortic annulus dimensions are crucial for prosthesis size selection in patients undergoing transcatheter aortic valve implantation (TAVI). The so-called effective diameter (derived from area) measured in multislice computed tomography (MSCT) images has evolved to be the most precise measurement tool. Usually, the operator must manually adjust the aortic annular plane. Syngo Aortic ValveGuide (Siemens Healthcare) is a new software tool that allows for automatic aortic root reconstruction and annular plane detection. The aim of this study was to compare the effective diameter measured in automatically detected and manually adjusted annular plane. METHODS: Seventy-three raw image datasets of preoperative TAVI MSCT scans were analysed using our institutional gold standard (3Mensio Valves™) with manual annular plane adjustment and using Aortic ValveGuide with automatic annular plane detection. The aortic annular circumference was manually marked for both software tools, and the effective diameter was calculated using the formula: effective diameter = 2 × √(circumferential area/π). RESULTS: Automatic annulus plane detection using Syngo Aortic ValveGuide worked well in all MSCT scans. Minor manual adjustment of the detected plane was necessary in only 3 patients. The mean effective aortic annulus diameter was 23.1 ± 2.4 mm for 3Mensio and 23.3 ± 2.4 mm for Syngo Aortic ValveGuide. Bland-Altman analysis of both imaging software tools showed good agreement (mean difference of 0.16 mm and limits of agreement of -0.48 to 0.80 mm). CONCLUSIONS: Effective aortic annulus diameter measured with Syngo Aortic ValveGuide, as a new imaging software that allows for automatic aortic annular plane detection, shows good agreement to gold standard measurements. Automatic annulus plane detection might reduce the effort for MSCT analysis and may lead to more reproducible aortic annulus measurements. Aortic ValveGuide is part of the DynaCT and in future aortic annulus dimension measurements may be feasible during intraoperatively acquired DynaCT.

Aims Aortic stenosis causes cardiac hypertrophy and fibrosis, which often persists despite pressure unloading after aortic valve replacement. The persistence of myocardial fibrosis in particular leads to impaired cardiac function and increased mortality. We investigated whether granulocyte colony-stimulating factor (G-CSF) beneficially influences cardiac remodelling after pressure unloading. Methods and results Left ventricular hypertrophy was induced by transverse aortic constriction in C57bl6 mice followed by debanding after 8 weeks. This model closely mimics aortic stenosis and subsequent aortic valve replacement. After debanding, mice were treated with either G-CSF or saline injection. Granulocyte colony-stimulating factor treatment significantly improved systolic (ejection fraction 70.48 ± 1.17 vs. 58.41 ± 1.56%, P < 0.001) and diastolic ( E / E ′ 26.0 ± 1.0 vs. 32.6 ± 0.8, P < 0.05) function. Furthermore, cardiac fibrosis was significantly reduced in G-CSF-treated mice (collagen-I area fraction 7.96 ± 0.47 vs. 11.64 ± 1.22%, P < 0.05; collagen-III area fraction 10.73 ± 0.99 vs. 18.46 ± 0.71%, P < 0.001). Direct effects of G-CSF on cardiac fibroblasts or a relevant transdifferentiation of mobilized bone marrow cells could be excluded. However, a considerable infiltration of neutrophils was observed in G-CSF-treated mice. This sterile inflammation was accompanied by a selective release of interleukin-1 β (IL-1β) in the absence of other proinflammatory cytokines. In vitro experiments confirmed an increased expression of IL-1β in neutrophils after G-CSF treatment. Interleukin-1β directly induced the expression of the gelatinases matrix metalloproteinase-2 (MMP-2) and MMP-9 in cardiac fibroblasts thereby providing the regression of cardiac fibrosis. Conclusion Granulocyte colony-stimulating factor treatment improves the cardiac function and leads to the regression of myocardial fibrosis after pressure unloading. These findings reveal a previously unknown mechanism of fibrosis regression. Granulocyte colony-stimulating factor might be a potential pharmacological treatment approach for patients suffering from congestive heart failure after aortic valve replacement, although further basic research and clinical trials are required in order to prove beneficial effects of G-CSF in the human organism.

This editorial refers to ‘Similar outcome with an invasive strategy in men and women with non-ST-elevation acute coronary syndromes’, by J. Alfredsson et al. , doi:10.1093/eurheartj/ehr349 Over many years, gender differences in medical care have been reported, particularly in the context of cardiovascular disease (CVD). Across the industrialized world, CVD shows a continuous increase over the last decades and is the major cause of morbidity and mortality for men as well as for women.1 Moreover, the impact of CVD on overall mortality rates in Europe is even higher for women than it is for men. Nonetheless, women today outlive men by ∼5–10 years,2 a fact that may be explained by different arguments. One reason for women's longevity is the delay in onset of CVD. Women developing coronary artery disease (CAD) are usually 10 years older than men, who typically develop CAD at the age of 50–60. The risk factors for CAD are well established and do not differ between genders. However, given the older age of onset of clinically relevant CAD, women presenting with acute coronary syndrome (ACS) have a higher frequency of diabetes, hypertension, heart failure, and other co-morbidities.3 Women with ACS are more likely to have had prior episodes of angina pectoris or congestive heart failure, whereas men with ACS are more likely to have had prior myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting.4,5 Differences between women and men with ACS in terms of diagnostic work-up, treatment, and outcome have been reported, but available data are conflicting.6,7 While ACS is quite …

The objective of this study was to identify electrocardiographic (ECG) and further predictors for atrioventricular (AV) block with a need for pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI). Pre- and post-procedural ECGs of patients with severe aortic stenosis and ongoing TAVI were investigated in a prospective study. From 50 consecutive patients enrolled in the study (mean age 80 +/- 6 years, 46% men), 17 (34%) experienced an AV block with subsequent requirement of a permanent PM [16 of 36 (44.4%) with CoreValve System and 1 of 14 (7.1%) with Edwards Sapiens System]. In patients with right bundle branch block (RBBB), PM implantation had to be performed more frequently [6 of 6 (100%) with CoreValve System and none with Edwards Sapiens System], P = 0.005. An AV block (Mobitz II second degree and third degree) occurred mostly within the first 24 h (range: Days 0-13) after the index procedure. No recovery of AV conduction with a change in PM indication occurred in a mean follow-up time of 13 +/- 6 days. Our data demonstrate that patients with pre-operative RBBB and those receiving CoreValve prosthesis are at a significantly higher risk for PM implantation after TAVI. Therefore, patients with the presence of RBBB before TAVI may be at lower risk for PM implantation using the Edwards Sapiens System.

This editorial refers to ‘ISAR-REACT 3A: a study of reduced dose of unfractionated heparin in biomarker negative patients undergoing percutaneous coronary intervention’[†][1], by S. Schulz et al. , on page 2482 Since the first days of percutaneous coronary interventions (PCI), it has been a common understanding to treat patients with a combination of antiplatelet and anticoagulant drugs to prevent thrombotic complications.1 Numerous anticoagulants have been tested during elective PCI.2 Nonetheless, aspirin and unfractionated heparin (UFH) have survived more than 30 years as the standard regimen, particularly in patients with stable angina. After the introduction of stents, the antiplatelet regimen was supplemented by thienopyridines. The administration of glycoprotein IIb/IIIa antagonists did not render additional benefits in the setting of elective interventions.3 Bivalirudin as a direct antithrombin was shown to be safer and effective in patients with acute coronary syndromes.4,5 However, the anticoagulation management during elective procedures gained only limited attention. Tradition and habits may influence the selection of anticoagulants and especially the dose of heparin.6 This is even more surprising, since PCI technique and material improved considerably and bleeding complications moved in our focus. Much of the data regarding heparin administration during PCI were obtained before introduction of coronary stenting and potent antiplatelet agents. Was there no need to address this question … [1]: #fn-2

We appreciate very much the distinctive comments regarding the hypothesis of an altered calcium-regulatory system in Tako-Tsubo cardiomyopathy.1 Once again, the points raised by Nikus et al. emphasize the central role of catecholamines in an oestrogen-deficient situation. Moreover, the shown cardioregulatory role of the female sex hormones might contribute to the sudden occurrence of this disorder after an emotional or physical stress event and its unexplained disappearance after several days, which has aroused great …

OBJECTIVES: Precise measurements of aortic annulus dimensions are crucial for prosthesis size selection in patients undergoing transcatheter aortic valve implantation (TAVI). The so-called effective diameter (derived from area) measured in multislice computed tomography (MSCT) images has evolved to be the most precise measurement tool. Usually, the operator must manually adjust the aortic annular plane. Syngo Aortic ValveGuide (Siemens Healthcare) is a new software tool that allows for automatic aortic root reconstruction and annular plane detection. The aim of this study was to compare the effective diameter measured in automatically detected and manually adjusted annular plane. METHODS: Seventy-three raw image datasets of preoperative TAVI MSCT scans were analysed using our institutional gold standard (3Mensio Valves™) with manual annular plane adjustment and using Aortic ValveGuide with automatic annular plane detection. The aortic annular circumference was manually marked for both software tools, and the effective diameter was calculated using the formula: effective diameter = 2 × √(circumferential area/π). RESULTS: Automatic annulus plane detection using Syngo Aortic ValveGuide worked well in all MSCT scans. Minor manual adjustment of the detected plane was necessary in only 3 patients. The mean effective aortic annulus diameter was 23.1 ± 2.4 mm for 3Mensio and 23.3 ± 2.4 mm for Syngo Aortic ValveGuide. Bland–Altman analysis of both imaging software tools showed good agreement (mean difference of 0.16 mm and limits of agreement of −0.48 to 0.80 mm). CONCLUSIONS: Effective aortic annulus diameter measured with Syngo Aortic ValveGuide, as a new imaging software that allows for automatic aortic annular plane detection, shows good agreement to gold standard measurements. Automatic annulus plane detection might reduce the effort for MSCT analysis and may lead to more reproducible aortic annulus measurements. Aortic ValveGuide is part of the DynaCT and in future aortic annulus dimension measurements may be feasible during intraoperatively acquired DynaCT.