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ZusammenfassungVorhofflimmern (VHF) und eine Herzinsuffizienz begünstigen sich gegenseitig und treten häufig in Kombination auf. Eine effektive Therapie des VHF inklusive der möglicherweise notwendigen Antikoagulation sollte zentraler Baustein bei Patienten mit eingeschränkter systolischer Funktion und VHF sein. Medikamentöse Therapieoptionen sind in der Regel wenig effektiv, sodass zunehmend Katheterablationsverfahren zur Behandlung dieser Patienten in den Vordergrund gestellt werden. Randomisierte Studien bei selektierten Patienten zeigen nicht nur einen symptomatischen Effekt auf die Herzinsuffizienz, sondern neben Verbesserung der LV-Funktion auch einen Letalitätsbenefit der effektiven Ablation von VHF. In der Zukunft gilt es, Patienten sinnvoll für die Katheterablation zu identifizieren. Ob das reine Vorhandensein von VHF oder eher die VHF-Last bei Patienten mit Herzinsuffizienz entscheidend für die Prognose ist, wird aktuell in weiteren Studien untersucht.

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.

It has been shown that endocardial occlusion of the left atrial appendage (LAA) is equally effective in preventing embolic events compared to oral anticoagulation in patients with nonvalvular atrial fibrillation. An 82-year-old female patient was admitted for LAA occlusion for repetitive GI bleeding. She had high CHADSVASC Score and HASBLED with long persistent atrial fibrillation with many comorbities. The preprocedural transesophageal echo revealed a great mass in the left atrium (Picture 1). Cardiac surgery was denied, we performed an epicardial only ligation for closing the LAA. For this approach we performed an epicardial puncture and contrast injection within the pericardial space to delineate the LAA. An epicardial wire with a suction mechanism at its distal end was attached to the anterior lobe of the LAA. Using this epicardial wire the snare could be advanced over the appendage and closed down. Complete exclusion of the LAA was achieved. There were no procedural complications and the patient is doing well after 3 months.

Atrial fibrillation (AF) is a highly prevalent comorbidity in patients with severe mitral valve regurgitation (MR) undergoing transcatheter mitral valve repair (TMVR) and has been shown to significantly worsen their outcome. However, data on the impact of AF treatment strategy in this rapidly growing cohort of patients is unknown. In a multicenter, observational cohort study, 542 consecutive patients undergoing TMVR were enrolled, and subsequently, comprehensive survival analyses according to AF status and therapy were performed using propensity score matching and Cox regression. In the analyzed cohort, 373 (73.3%) of the TMVR patients had concomitant AF. Of these patients, 212 (59%) were on rate control therapy and 161 (41%) were on rhythm control therapy. At 3 years, significantly reduced cumulative survival was observed for patients on rhythm compared to patients on rate control (46.7% (75/161) vs. 56.5% (91/161), p = 0.032). Amiodarone was used to a substantial extent for rhythm control and found to be an independent mortality predictor (Hazard Ratio 1.5, 95%CI 1.1–2.1, p = 0.04). The adverse outcome of concomitant AF in TMVR patients was confirmed (AF: 47.3% (126/266) vs. non-AF: 58.3% (78/133), p = 0.047). Rhythm control achieved almost exclusively pharmacologically is associated with an adverse outcome compared to the rate control of AF in TMVR. This raises awareness of the importance of AF and its treatment, as this seems to be a promising key point for improving the prognosis of TMVR patients.

Background: The PASCAL system (Edwards Lifescience, Irvine, CA, USA) is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of our study was to examine the functional and hemodynamic outcome after repair of functional (FMR) and degenerative mitral regurgitation (DMR) using the PASCAL system in a real-world setting. Methods: A total 92 consecutive patients with symptomatic MR 3+/4+ were treated in our institute using the PASCAL device. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days and 7 months. Results: 68.5% had a functional and 31.5% a degenerative etiology. Overall success rate was achieved in 97.8% patients (98.4% FMR, 96.6% DMR). At follow-up, 85.7% of the patients (89.2% FMR, 78.3% DMR) had MR grade ≤ 1. 96.4% (97.4% FMR, 94.4% DMR) were in New York Heart Association class I or II. Six-minute walking distance improved by 96 m (92 m FMR, 106 m DMR), Kansas City Cardiomyopathy Questionnaire improved by 19 points (19 points FMR, 19 points DMR). Pro-B-type natriuretic peptide (proBNP) levels decreased from 4673 to 2179 pg/dl (5239–2018 pg/ml FMR, 3418–2530 pg/ml DMR) and mean pulmonary capillary wedge pressure from 21 to 16 mmHg (21–17 mmHg FMR, 19–13 mmHg DMR). At 30 days, there was 1 cardiovascular death (1.2%) with DMR. At 1 year, Kaplan-Meier survival was 86% (86% FMR, 86% DMR). Conclusions: Severe MR can successfully and safely be treated with the PASCAL device regardless of etiologies. This interventional approach resulted in a sustained MR reduction, improvement in exercise capacity, quality of life, proBNP levels, and hemodynamics in FMR and DMR at follow-up.

Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4–8%) as well as in low-risk patients (STS-Score

Vorhofflimmern ist assoziiert mit einem erhohten Risiko fur Schlaganfall oder periphere Embolien. Das Herzohr des linken Atriums (LAA) gilt als der favorisierte Ort der Thrombogenese, da hier die Flussgeschwindigkeit des Blutes in Abhangigkeit von vielen Faktoren reduziert und somit die Thrombogenitat erhoht ist. Die Therapie mit oralen Antikoagulanzien (OAK) hat sich als Standardtherapie zur Verhinderung von thromboembolischen Ereignissen etabliert. Bei wiederholt auftretenden Blutungen unter OAK oder bei erhohtem Blutungsrisiko besteht eine zumindest relative Kontraindikation. Als Alternative kommt hier die mechanische und funktionelle Elimination des LAA (LAA-Okklusion, LAAO) ins Spiel. Technische Moglichkeiten beinhalten den endokardialen Herzohrverschluss, die epikardiale LAA-Ligatur oder den operativen Herzohrverschluss. Die meisten Studienergebnisse existieren fur den endokardialen Herzohrverschluss, der einer OAK-Therapie mit Vitamin-K-Antagonisten bezuglich Mortalitat und embolischen Ereignissen nicht unterlegen ist.

Aims We aimed to assess whether the level of aortic root calcification is associated with BAV performance/omission during transcatheter aortic valve implantation (TAVI), and to explore related outcomes. Methods and results EASE-IT TF was a prospective, observational, multicenter registry of patients undergoing TF-TAVI with the Edwards SAPIEN 3, with or without BAV predilation. Valvular calcification was quantified from pre-procedural multi-slice computed tomography images and compared between BAV and no BAV patients. Data for 178 patients (55 BAV; 123 no BAV) were analyzed. There were no significant differences between groups in terms of regional/leaflet sector calcification volumes, maximum asymmetry between the different leaflet sectors, or total calcification scores. Overall, a greater-than-average leaflet calcification volume was independently predictive of ≥mild PVL (OR: 5.116; 95% CI: 1.042-38.35) and the need for post-dilation (OR: 3.592; 95% CI: 1.173-12.14). The latter effect was abated in patients with BAV (OR: 1.837; 95% CI: 0.223-18.00) and intensified in those without BAV (OR: 5.575; 95% CI: 1.114-38.74). No other BAV-dependent effects of calcification on outcomes were observed. Conclusions In the majority of transfemoral valve implantations, calcification does not appear to be the main driving factor in the decision to perform/omit BAV. Predilation may be valuable for reducing post-dilation requirements in patients only with a greater degree of leaflet calcification.

To evaluate diagnostic impact of clinical use of coronary computed tomography angiography (CCTA) in patients with suspected stable coronary artery disease (CAD) and its consequences in daily practice for patient management, depending on stress test results in daily practice. Between 2009 and 2014 of a total population of 1352 patients of the German Cardiac Computed Tomography (CT) Registry who had previously undergone stress tests, CCTA visualizations were carried out on the coronary arteries with suspected stable CAD. Patients were divided into three groups according to stress test results: Group 1 with inconclusive (n = 178, 13.2%), Group 2 with ischemia in stress test (n = 372, 27.5%) and Group 3 without ischemia in stress test (n = 802, 59.3%). The test of preference was the stress electrocardiogram (ECG), which was performed more frequently in patients without ischemia in stress test as compared to those with ischemia (96.3% vs. 93.0%, p = 0.015). The incidence of detected obstructive CAD was lower in patients with suggested ischemia in stress test as compared to patients with inconclusive results (14.1% vs. 21.1%, p = 0.037). There was no difference in the incidence of an obstructive CAD in patients with and without ischemia in stress test (14.1% vs. 15.8%, p = 0.440). CCTA is a reliable, non-invasive option for ruling-out obstructive CAD irrespective of the stress test result.

Introduction: Since 2008, specialized chest pain units (CPUs) were implemented across Germany ensuring structured diagnostics in acute chest pain. This study aims to analyze the management of pulmonary embolism (PE) patients in such certified CPUs. Methods: Data were retrieved from 13,902 patients enrolled in the German CPU registry and analyzed for the diagnosis of PE including patient characteristics, critical time intervals, diagnostic workup, treatment, and prognosis. PE patients were compared to the overall CPU patient cohort. Only patients with a complete 3-month follow-up were included. Results: Overall, 1.1% of all CPU patients were diagnosed with PE. Chest pain and dyspnea were the leading symptoms. Patients with PE were older, presented with higher heart rates, and more frequently exhibited signs of heart failure, despite a normal left ventricular function. PE patients showed significantly longer time delays between symptom onset and the first medical contact, while PE patients with chest pain presented earlier than PE patients with dyspnea only. Whereas more PE patients had to be transferred to the intensive care unit, in-CPU mortality and event rates over 3 months were low. Discussion/Conclusion: This study suggests a certain risk for underdiagnosis and consecutive potential undertreatment of PE patients in German Cardiac Society (GCS)-certified CPUs, which is thought to result from an anticipated focus on patients with acute coronary syndrome (ACS). Public awareness for PE beyond chest pain should be improved. Certified CPUs should be urged to implement strategic pathways for a better simultaneous diagnostic workup of differential diagnosis beyond ACS.

To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system. Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, all in New York Heart Association (NYHA) class III–IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5 months, 70.4% of the patients had MR grade ≤ 1 (p

Objectives The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. Background The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformite Europeene mark in 2014, but only limited clinical data are available so far. Methods This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. Results Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. Conclusions Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

To compare image quality, observer confidence, radiation exposure in the standard-dose (SD-CCTA) and low-dose (LD-CCTA) protocols of coronary CT angiography (CCTA) in patients with atrial fibrillation (AF). CCTA was performed in 303 patients using a CT scanner with 16-cm coverage (111 scans during sinus rhythm (SR); 192 during AF). LD-CCTA was used in 218 patients; SD-CCTA in 85 patients suspected of having coronary artery disease (CAD). Image quality and observer confidence were evaluated on 5-point scales. Radiation doses were recorded. Image quality was superior in the SD-CCTA compared to the LD-CCTA (SR 1.45±0.40; AF 1.72±0.46; vs. SR 1.83±0.48; AF 1.92±0.50; p < 0.001). Observers were more confident with SD-CCTA than with LD-CCTA (SR 1.38±0.33; AF 1.61±0.43; vs. SR 1.70±0.45; AF 1.82±0.50; p < 0.001). Radiation doses in AF were significantly higher than in the SR (LD-CCTA, 1.68±0.71 mSv; SD-CCTA, 3.72±1.95 mSv; vs. LD-CCTA, 1.3 ±0.52 mSv; SD-CCTA, 2.67±1.47 mSv; p < 0.001). Using a low-dose protocol in AF, radiation exposure can be decreased by 50 % at the expense of 20 % impaired image quality. A low-dose CCTA protocol can be considered in young patients, whereas the standard-dose protocol is recommended for older patients and those suspected of having CAD. • Whole-heart CT allows visualization of the coronary arteries in atrial fibrillation. • Low-dose CT decreases radiation exposure by 50%, image quality by 20%. • Standard-dose CT seems advantageous when concomitant coronary artery disease is suspected.

Aims The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population. Methods and results From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak. Conclusions In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.

Objectives This study sought to investigate whether the percutaneous mitral regurgitation (MR) reduction with the MitraClip® system in end-stage heart failure patients with a left ventricular ejection fraction (LVEF) of

Background Aim of the study was to determine the impact of right- and left-ventricular systolic dysfunction on perioperative outcome and long-term survival after TAVR. Methods Study population consisted of 702 TAVRs between 2009 and 2014, 345 by TF, 357 by TA route. RV and LV function were determined by TAPSE and LVEF measurement during baseline echocardiography. Patients were divided according to TAPSE (>18 mm/14-18 mm/ 50%/30-50%/

AIMS In the absence of randomised data, we aimed to compare the transapical ACURATE and transfemoral ACURATE neo with the SAPIEN 3 prosthesis using propensity matching. METHODS AND RESULTS From 2012 to 2016, 1,306 patients at three German centres received either the ACURATE/ACURATE neo prosthesis (n=591) or the SAPIEN 3 prosthesis (n=715). Through nearest neighbour matching with exact allocation for access route and centre, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Patients were 81 years old on average and had a logistic EuroSCORE I of 19%. Predilatation and post-dilatation were more frequent in the ACURATE group (97.6% versus 52.1%, p

Background Nonagenarians are at increased risk for morbidity and mortality after transcatheter aortic valve replacement (TAVR) based solely on their age. The aim of our study was to evaluate survival of nonagenarians with severe aortic valve stenosis (AS) after TAVR as compared to an age- and sex-matched general population. Methods From 2009 to 2017, 1052 consecutive patients ≥80 years scheduled for TAVR were included. Patients were divided into three groups depending on their age at the time of the procedure: 80–84 (Group 1), 85–89 (Group 2) and ≥90 years (Group 3). Survival of patients treated with TAVR was compared to the life expectancy of an age- and sex-matched cohort in the general population. Results Nonagenarians were more likely to experience major access-site complications than their younger counterparts (7.6% Group 1 vs. 10.1% Group 2 vs. 17.6% Group 3, p = 0.016). One-year mortality in nonagenarians was higher as compared to the general population (27.8% vs. 20.0%). After two years, the mortality curves between the TAVR patients and the general population converged (39.2% vs. 37.5%) and were lower after five years. Conclusions During the observation period of five years, carefully selected nonagenarians treated with TAVR had at least the same mortality rate as an age- and sex-matched general population after two years despite procedure-associated complications. The negative prognostic impact of the severe AS was completely eliminated by TAVR.

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

Summary Background Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. Methods In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346 ) and is ongoing but not recruiting. Findings Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6–5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference −1·3 to −12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. Interpretation TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. Funding Boston Scientific (USA).

Objectives: We sought to determine the effects of experience on the Mitraclip® procedure steps as well as procedure safety and functional results. Background: MR has proven deleterious in heart failure. Mitraclip® therapy evolved an important option in patients with severely reduced left ventricular function (LVEF). Methods: Between 2011 and 2016, 126 consecutive patients were grouped in three groups and investigated in a prospective observational study. We evaluated the duration of procedural steps, safety endpoints, and functional results. Results: The median logistic EuroScore was 32% (7–40%). Ninety-five percent of patients were in NYHA-stage ≥III and 51% had a LVEF

OBJECTIVES Transapical transcatheter aortic valve implantation (TAVI) is associated with increased mortality as compared to the transfemoral (TF) access. Possible mechanisms include different patient risk profiles as well as an intrinsic injury caused by the access route itself. METHODS All consecutive patients scheduled for TAVI between January 2009 and June 2016 at a single centre were evaluated. A comparison of 30-day mortality and morbidity rates for patients undergoing TF or transapical (TA) TAVI was performed according to the criteria of the Valve Academic Research Consortium 2. RESULTS During the investigated period, 1130 patients (TF: n = 619, TA: n = 511) were scheduled for TAVI. TA patients had a higher operative risk profile (logistic EuroSCORE: 24% vs 17%; P

The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions.The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far.This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure.Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cmTransfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

Cardiac computed tomography permits quantification of coronary calcification as well as detection of coronary artery stenoses after contrast enhancement. Moreover, cardiac CT offers high-resolution morphologic and functional imaging of cardiac structures which is valuable for various structural heart disease interventions and electrophysiology procedures. So far, only limited data exist regarding the spectrum of indications, image acquisition parameters as well as results and clinical consequences of cardiac CT examinations using state-of-the-art CT systems in experienced centers. Twelve cardiology centers with profound expertise in cardiovascular imaging participated in the German Cardiac CT Registry. Criteria for participation included adequate experience in cardiac CT as well of the availability of a 64-slice or newer CT system. Between 2009 and 2014, 7061 patients were prospectively enrolled. For all cardiac CT examinations, patient parameters, procedural data, indication and clinical consequences of the examination were documented. Mean patient age was 61 ± 12 years, 63% were males. The majority (63%) of all cardiac CT examinations were performed in an outpatient setting, 37% were performed during an inpatient stay. 91% were elective and 9% were scheduled in an acute setting. In most examinations (48%), reporting was performed by cardiologists, in 4% by radiologists and in 47% of the cases as a consensus reading. Cardiac CT was limited to native acquisitions for assessment of coronary artery calcification in 9% of patients, only contrast-enhanced coronary CT angiography was performed in 16.6% and combined native and contrast-enhanced coronary CT angiography was performed in 57.7% of patients. Non-coronary cardiac CT examinations constituted 16.6% of all cases. Coronary artery calcification assessment was performed using prospectively ECG-triggered acquisition in 76.9% of all cases. The median dose length product (DLP) was 42 mGy cm (estimated effective radiation dose of 0.6 mSv). Coronary CT angiography was performed using prospectively ECG-triggered acquisition in 77.3% of all cases. Tube voltage was 120 kV in 67.8% of patients and 100 kV in 30.7% of patients, with a resultant median DLP of 256 mGy cm (estimated effective dose of 3.6 mSv). Clinical consequences of cardiac CT were as follows: in 46.8% of the cases, invasive coronary angiography could be avoided; ischemia testing was recommended in 4.7% of the cases, invasive coronary angiography was recommended in 16.4% of the cases and change in medication in 21.6% of the examinations. Cardiac CT is performed in the majority of patients for non-invasive evaluation of the coronary arteries. CT frequently resulted in medication change, and otherwise planned downstream testing including invasive angiography could be avoided in a high percentage of patients. Radiation exposure in experienced centers is relatively low.

Die elektrokardiographische Differenzialdiagnostik von Tachykardien mit breitem QRS-Komplex (Breitkomplex-Tachykardien, BKT) stellt eine Herausforderung an den befundenden Arzt dar, ist aber fur die weitere Differenzialtherapie und Risikoabschatzung entscheidend. Komplexe Algorithmen erhohen im Einzelfall zwar die Spezifitat der Diagnose, mussen aber oft einem pragmatischen Vorgehen zur schnellen EKG-Differenzialdiagnostik weichen. Finden sich unregelmasige R-R-Abstande und ist der Patient trotz (unregelmasiger) BKT hamodynamisch stabil, handelt es sich fast ausschlieslich um Vorhofflimmern, entweder mit Schenkelblockierung oder bei antegrad leitender akzessorischer Leitungsbahn. Polymorphe ventrikulare Tachykardien (VT) als Mechanismus der unregelmasigen BKT sind sehr selten und – wenn anhaltend – nicht hamodynamisch toleriert. Bei Vorliegen einer regelmasigen BKT muss differenzialdiagnostisch an eine VT, eine supraventrikulare Tachykardie (SVT) mit Schenkelblockierung (funktionell oder vorbestehend) oder eine SVT mit ventrikularer Uberleitung uber eine akzessorische Leitungsbahn (WPW-Syndrom) gedacht werden. Das Vorliegen einer strukturellen Herzerkrankung, insbesondere ein Z. n. Herzinfarkt, spricht fur eine VT. Zur genaueren EKG-Analyse ist die Anfertigung eines 12-Kanal-EKGs bei hamodynamischer Stabilitat essenziell. Die Dokumentation einer AV-Dissoziation oder eine negative Konkordanz der Brustwand-QRS ist beweisend fur eine VT. Ist der QRS-Komplex in V1 uberwiegend positiv (V1-positive, rechtsschenkelblockartige BKT), sprechen u. a. eine positive Konkordanz der QRS-Komplexe in den Brustwandableitungen, eine QRS-Breite > 140 ms, ein uberdrehter Linkstyp wahrend VT, ein mono- oder biphasischer QRS-Komplex in V1, eine tiefe S-Zacke in V6 fur eine VT. Bei V1-negativer BKT (linksschenkelblockartig) spricht eine QRS-Breite > 160 ms, ein nach rechts gerichteter Lagetyp, eine > 40 ms breite R-Zacke in V1/V2, ein zogerlicher S-Downstroke in V1/V2 und jede Q-Zacke in V6 fur das Vorliegen einer VT.

Clinically silent brain injury detected with cerebral magnetic resonance imaging (MRI) is well known after various cardiovascular interventions. Thus far, only one study has examined the periprocedural risk of cerebral ischemic events in patients undergoing percutaneous mitral valve reconstruction. The study aim was to examine the incidence and clinical impact of cerebral embolic events in patients undergoing percutaneous mitral valve reconstruction using the MitraClip® system.Thirteen eligible high-risk patients without contraindications for MRI underwent MitraClip treatment at the authors' institution. Neurological testing with the assessment of global cognitive function was performed three days before and two days after the procedure. All patients underwent cerebral diffusion-weighted MRI (DWI) two days after the procedure.In nine patients, post-interventional MRI revealed newly acquired microembolic cerebral lesions. At follow up MRI scans recorded at 307 ± 270 days after the procedure, ischemic scars were not detectable in any patient. Two patients with five or more new cerebral lesions in DW-MRI showed a significant decline in their test scores.The MitraClip procedure results in acute cerebral lesions in the vast majority of patients. All lesions seen on DWI post-procedure resolved completely, but the number of lesions may have had an impact on cognitive function.

Coronary computed tomography angiography (CTA) is increasingly used as a test to rule out coronary artery disease (CAD) in patients with a low to intermediate pre-test probability of the disease. We used the database of the German CT registry, collected between 2009 and 2014 in a broad patient population, to analyze contemporary radiation dose associated with coronary CTA in clinical practice. The prospective observational registry included a total of 7061 patients ≥18 years, referred to 12 participating centers for a clinically indicated cardiac CT examination. All centers were cardiology units well experienced in CTA and used multi-slice CT scanners with at least 64 rows. Coronary CTA was performed in a subset of 5001 patients, 59.6 ± 11.8 years, body mass index (BMI) 26.9 ± 4.5 kg/m2, 38% females. Three time periods with approximately equal numbers of patients were created (01/09–03/10, 04/10–03/11, 04/11–07/14). The dose–length product of all examinations and derived effective dose in mSv (conversion factor k = 0.014) as well as the influence of patient characteristics on dose were compared for the three time periods. BMI and proportion of female patients remained stable over time, and mean heart rate decreased from 60.3 ± 9.0 to 58.5 ± 9.3 bpm from the first to the last time period (p

AIMS We aimed to evaluate the effect of omitting predilation on feasibility, procedural results and safety in balloon-expandable TAVI. METHODS AND RESULTS We performed an analysis of all 680 patients scheduled for a balloon-expandable TAVI prosthesis between January 2011 and August 2016. Patients treated with or without predilation were compared. Procedure times decreased from 85.6±42.9 to 56.7±26.1 minutes (p

Background Observational studies suggest there are gender based differences in the treatment of coronary artery disease, with women receiving evidence based therapy less frequently than suggested by current guidelines. The aim of our study was to evaluate gender based differences in the use of DES. Methods We analysed prospectively collected data from 100704 stent implantations in the PCI registry of the ALKK between 2005 and 2009. Results The usage of DES increased from 16.0 to 43.9%. Although women had smaller vessel sizes, they received DES less often compared to men (28.2 vs. 31.3%), with an adjusted odds ratio of 0.93 (95% confidence interval 0.89-0.97) at the age of 75, and an adjusted odds ratio of 0.89 (95% confidence interval 0.84-0.94) at the age of 80. Conclusion Despite having smaller vessels than men, women were treated less often with DES. These findings apply to women above the age of 75 years. These findings support previous reports, that elderly women with coronary artery disease are treated differently to men.

Aims Long-term outcomes are available for first-generation transcatheter heart valves but data on second-generation devices are scarce. We aimed to provide an oversight of all patients implanted with a second-generation valve in our centre. Methods and results From April 2012 to July 2016, 219 patients were enrolled in this prospective single-centre experience; they received either the transapical ACURATE TA (n=99) or the transfemoral ACURATE neo (n=120) prosthesis. Data were collected during the hospital stay and telephone follow-ups were conducted at 30 days post procedure and annually thereafter. Patients were 80.9±4.4 years old with a mean logistic EuroSCORE I of 19.3±13.9%. Transapical patients had significantly more comorbidities at baseline. Post intervention, mean gradient was reduced to 10.6±9.2 mmHg, and 1.9% had moderate paravalvular regurgitation. Mean follow-up time, based on the last patient contact, was 217±188 days for the transfemoral and 525±413 days for the transapical group. Thirty-day mortality was 2.5% and 4.0%, and one-year Kaplan-Meier survival was 94.8% (95% CI: 87.5-97.9) and 81.9% (95% CI: 72.0-88.5), respectively. At two years, survival was 64.9% (95% CI: 52.6-74.7) for transapical patients. Conclusions This early single-centre experience showed very good safety and performance outcomes in patients treated with the ACURATE prostheses.

Background Silent cerebral events (SCE) have been identified on magnetic resonance imaging (MRI) in asymptomatic patients after atrial fibrillation (AF) ablation. Procedural determinants influencing the risk for SCE still remain unclear. Objective Comparing the risk for SCE depending on exchanges of catheters (ExCath) over a single transseptal sheath. Methods 88 Patients undergoing pulmonary vein isolation (PVI) only ablation using either single-tip or balloon-based technique underwent pre- and post-ablation cerebral MRI. Ablations were either performed with double transseptal access and without exchanging catheters over the transseptal sheaths (group 1: no ExCath) or after a single transseptal access and exchanges of therapeutic and diagnostic catheters (group 2: ExCath). Differences in regard to SCE rates were analyzed. Multivariate analysis was performed to identify factors related to the risk for SCE. Results Included patients underwent PVI using single tip irrigated radiofrequency in 41, endoscopic laser balloon in 27 and cryoballoon in 20 cases. Overall SCE were identified in 23 (26%) patients. In group 1 (no ExCath; N = 46) 6 patients (13%) and in group 2 (N = 42) 17 patients (40%) had documented SCE (p = 0.007). The applied ablation technology did not affect sCe rate. In multivariate analysis age (OR 1.1, p = 0.03) and catheter exchanges over a single transseptal sheath (OR 12.1, p = 0.007) were the only independent predictors of a higher risk for SCE. Conclusions Exchanging catheters over a single transseptal access to perform left atrial ablation is associated with a significantly higher incidence of SCE compared to an ablation technique using different transseptal accesses for therapeutic and diagnostic catheters.

Patienten mit einer strukturellen Herzerkrankung, die einen elektrischen Sturm erleiden, weisen besonders in den ersten 3 Monaten eine stark erhohte rhythmogene und nichtrhythmogene Mortalitat auf. Nach notfallmasiger Terminierung der ventrikularen Arrhythmie mussen, abhangig vom Ergebnis einer Analyse der zugrunde liegenden Art und Ursache der Arrhythmie, verschiedene Therapiepfade eingeschlagen werden, um eine dauerhafte Rhythmusstabilisierung zu erreichen. Eckpfeiler der Therapie sind Triggerausschaltung, Sympathikusblockade (initial mittels β-Blocker und Sedierung), antiarrhythmische Therapie mit Amiodaron und Katheterablation, aber auch eine Behandlung der Herzinsuffizienz bzw. kreislaufunterstutzende Masnahmen. Der dargestellte Algorithmus kann helfen, auch invasive Masnahmen, wie invasive Koronardiagnostik, Katheterablation oder invasive Kreislaufunterstutzung rechtzeitig in die Therapiestrategie zu integrieren. Durch ein strukturiertes Vorgehen bei der Behandlung von Patienten mit elektrischem Sturm kann eine hohe Effektivitat der Akuttherapie erreicht werden. Ob dies auch zu einer Verbesserung des Outcomes fuhrt, muss im Weiteren evaluiert werden.

Instrumentalspiel und Gesang gehen mit physiologischen Reaktionen und einer konditionellen Beanspruchung einher, die auch für das Herz-Kreislaufsystem relevant sind. Kardiologische Aspekte in der Musikermedizin sind bislang vergleichsweise wenig untersucht und werden in ihrer klinischen Bedeutung oft unterschätzt. Für Musiker mit gesundem Herz-Kreislaufsystem liegen die Effekte im Allgemeinen im physiologischen, belastungsabhängigen Bereich. Doch bei Vorliegen kardiovaskulärer Grunderkrankungen können während des Musizierens Herz-Kreislaufsymptome auftreten, die einer kardiologischen Diagnostik und Therapie unter Einbeziehung musikerbezogener Faktoren bedürfen. Eine besondere Rolle spielen bei Musikern in diesem Zusammenhang Stressfaktoren im spezifischen beruflichen Kontext. Bei der Betreuung von Instrumentalisten und Sängern mit kardiologischen Fragestellungen sind multidisziplinäre und multimodale Ansätze erforderlich, um den komplexen Wechselwirkungen von physischen, psychischen und musizierbezogenen Parametern gerecht zu werden.

Functional mitral regurgitation (FMR) is common in patients with advanced heart failure and impaired left ventricular function. The study aim was to examine functional and hemodynamic effects at three months after MitraClip® implantation in high-risk surgical patients with FMR.A group of 93 patients was rejected for surgical treatment by heart-team decisions due to an inacceptable risk for conventional mitral valve surgery. Between October 2011 and May 2015, 89 of these patients (96%) were treated successfully with MitraClip implantation. A subsequent complete follow up was performed over three months in 32 patients with FMR, including pro-brain natriuretic peptide (pro-BNP) measurements, six-minute walk test, echocardiography, and right heart catheterization.The patients (mean age 73 ± 7 years) presented with a mean left ventricular ejection fraction (LVEF) of 32 ± 13%, and mitral regurgitation (MR) grade ≥3 in 30 of 32 cases (93%). All patients suffered from severe FMR and were highly symptomatic (NYHA functional class III or IV). The mean logistic EuroSCORE was 33%. MitraClip implantation resulted in a significant clinical improvement and reverse cardiac remodelling with a decrease in LV end-diastolic and LV endsystolic diameters, while LVEF was unchanged. In addition, a statistically relevant reduction of systolic, diastolic and mean pulmonary artery pressures (PAPsystolic -7.2 mmHg, p = 0.011; PAPdiastolic -4.5 mmHg, p = 0.003; and PAPmean -5.3 mmHg, p = 0.007) were measured, while the cardiac index (+0.3 l/min/m2, p0.001) and cardiac output (+0.5 l/min, p0.001) were increased significantly. The 30-day mortality was 8.6% (n = 8).Among the study population, MitraClip implantation led to clinical improvement, reverse cardiac remodeling, and a sustained hemodynamic benefit during the three-month follow up period.

Background Transcatheter aortic valve implantation via the transfemoral route (TF-TAVI) is commonly performed as a treatment for severe aortic stenosis (AS) in patients at high surgical risk. Pre-deployment balloon aortic valvuloplasty (BAV) has generally been considered an essential step for preparing the valve landing zone for receipt of the prosthesis. However, there is little evidence supporting the clinical value of BAV, while several associated complications have been documented. This has provoked several groups to evaluate the feasibility and safety of omitting BAV form the TF-TAVI procedure (direct TF-TAVI), with encouraging results. However, studies comparing the clinical outcomes of direct TF-TAVI to standard TF-TAVI are lacking. Methods EASE-IT TF is a prospective, observational, two-armed, multicentre registry designed to gather data on procedural aspects, adverse events and survival rates associated with direct TF-TAVI using the Edwards SAPIEN 3 balloon-expandable prosthesis. Discussion EASE-IT-TF data will be analysed firstly to determine the risks and benefits associated with direct TF-TAVI vs. standard TF-TAVI, and secondly to identify associations between patient variables and specific outcomes. This may assist identification of patients who stand to benefit from direct TF-TAVI, therefore contributing to clinical reductions in TF-TAVI-associated morbidity and mortality rates in high-risk AS patients. Trial registrations Clinictrials.gov: NCT02760771 peerReviewed

Introduction “Single shot” ablation devices to treat symptomatic atrial fibrillation have been engineered over the last years. Safety and efficacy also includes subclinical complications only detected with esophageal endoscopy or cerebral MRI in asymptomatic patients. We studied the acute efficacy and safety profile of a novel multipolar irrigated RF ablation catheter (nMARQ™). Methods and Results Forty-three patients underwent pulmonary vein isolation (PVI) using the novel ablation device. Patient baseline and procedural characteristics were documented. Efficacy of PVI was identified using only the nMARQ™ catheter. All patients underwent postablation endoscopic evaluation of the esophagus to document thermal damage and cerebral MRI (diffusion weight imaging, attenuated diffusion coefficient-map) to document incidence and number of silent cerebral lesions (SCL). Effective PVI was achieved in 98% of targeted PVs in a mean procedure time of 133 minutes. A mean of 4.8, 60-second RF applications, per PV was needed for effective PVI. No clinical procedure-associated complications were noted. Esophageal temperature increase >40.5 °C was noted in 22 (51%) patients and 14 of these had thermal esophageal lesions on endoscopic evaluation. A total of 26 SCLs were noted in 14 patients (33%; 1.9/patient; mean diameter of 2.3 mm, 88% of lesions were ≤3 mm). Conclusions PVI using the novel irrigated RF multipolar ablation device (nMARQ™) appears to be acutely effective. No clinical complications were identified. A high incidence of SCL (33%) and thermal esophageal lesions (33%) bears caution and further studies on long-term efficacy and safety are needed.

Background— The prognostic significance of papillary muscle infarction (PapMI) on hard clinical outcomes has not been investigated in patients with reperfused ST-segment–elevation myocardial infarction. Noninvasive investigation by gadolinium-enhanced cardiac MRI enables the detection of PapMI with high spatial resolution. The aim of our study was (1) to assess the incidence, determinants, and clinical characteristics of PapMI in a large multicenter cohort of patients with ST-segment–elevation myocardial infarction and (2) to assess the prognostic significance of PapMI at 1-year follow-up. Methods and Results— We enrolled 738 patients with ST-segment–elevation myocardial infarction reperfused by primary angioplasty (P P P P =0.02). Patients with PapMI had a significantly higher mortality (8 [7.7%] versus 12 [1.9%]) and major adverse cardiac events (21 [20.2%] versus 31 [4.9%]) rate at 12-month follow-up ( P P Conclusions— The presence of PapMI is associated with decreased myocardial salvage, larger infarcts, and more pronounced reperfusion injury with subsequent significantly increased major adverse cardiac event rates. Consequently, our data underscore the importance of PapMI as a marker of poor outcome in patients with ST-segment–elevation myocardial infarction. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00712101.

Objectives Aim of this study was to analyze feasibility, efficacy, and safety of a double-ProGlide preclose technique for access site closure after transfemoral transcatheter aortic valve implantation (TAVI). Background An effective and safe transcutaneous closure device is advantageous in transfemoral TAVI to avoid surgical cut down of the large caliber sheath insertion site. The use of two ProGlide sutures has not been described in this context in a large patient cohort. Methods ProGlide closure was used between 2010 and 2012 in 162 patients. ProGlide sutures were deployed in a preclose technique prior to insertion of the large caliber sheath. Success of the closure technique was defined as effective hemostasis and no further access site-related vascular or bleeding complications during the index hospitalization. Results Patients were 82 ± 5 years old with a logistic EuroSCORE of 16.7 ± 12.5. Edwards SAPIEN valves were used in 81.5% and Medtronic CoreValves in 18.5%. The overall success rate of the double-ProGlide technique was 93.9%. Success rate was only 40.0% under circumstances of prolonged high-dose heparinization. Success rate was 96.8% among the patients on dual-antiplatelet therapy (DAPT). All 10 ProGlide failures could effectively be managed by either percutaneous angioplasty or surgical reconstruction. The rate of VARC major vascular complications was 4.3%. Thirty-day mortality was 5.6%. Conclusion The double-ProGlide preclose technique offers a simple, highly effective, and safe method for closure of the arterial access site after transfemoral TAVI. The double-ProGlide strategy results in low rates of major vascular complications and translates into favorable early outcome. © 2013 Wiley Periodicals, Inc.