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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 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.

ZusammenfassungIn den vergangenen Jahren hat der Einsatz mechanischer Unterstützungssysteme für Patienten mit Herz- und Kreislaufversagen kontinuierlich zugenommen, sodass in Deutschland mittlerweile jährlich etwa 3000 ECLS/ECMO-Systeme implantiert werden. Vor dem Hintergrund bislang fehlender umfassender Leitlinien bestand ein dringlicher Bedarf an der Formulierung evidenzbasierter Empfehlungen zu den zentralen Aspekten der ECLS/ECMO-Therapie.Im Juli 2015 wurde daher die Erstellung einer S3-Leitlinie durch die Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG) bei der zuständigen Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF) angemeldet. In einem strukturierten Konsensusprozess mit Einbindung von Experten aus Deutschland, Österreich und der Schweiz, delegiert aus 11 AWMF-Fachgesellschaften, 5 weiteren Fachgesellschaften sowie der Patientenvertretung, entstand unter Federführung der DGTHG die Leitlinie „Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen“, die im Februar 2021 publiziert wurde.Die Leitlinie fokussiert auf klinische Aspekte der Initiierung, Fortführung, Entwöhnung und Nachsorge und adressiert hierbei auch strukturelle und ökonomische Fragestellungen. Dieser Artikel präsentiert eine Übersicht zu der Methodik und den konsentierten Empfehlungen.

Background: The importance of pulmonary artery pressure recovery (PR) in patients with Ross procedures in whom a homograft substitutes the resected pulmonary valve, is unknown. The aim of the study was to evaluate the occurrence and extent of PR in the pulmonary artery in 65 asymptomatic patients with pulmonary homograft after Ross surgery during rest and exercise. Methods: Stress echocardiography was performed in 65 pulmonary homograft patients and 31 controls with native pulmonary valves up to 75 watts (W). Right ventricular systolic pressure (RVSP), transvalvular flow, mean pressure gradient (P ), valve resistance and RV stroke work were determined in the exercise (max. 75 W) and recovery phases in increments of 25W each. Results: Pulmonary homografts demonstrated significantly elevated P compared to controls at all stages. When considering pressure recovery (absolute and relative PR at rest 3.8+/-1.8 mmHg, 42.6+/-7.2%, respectively) and transvalvular energy loss (EL; at rest 4.5+/-4.3 mmHg) the homograft hemodynamics reached the level of controls. In a subgroup of patients with tricuspid regurgitation, resting RVSP was the same in homograft patients and controls (21.3 +/- 6.1 vs. 20.4 +/- 6.3, p=0.62), despite significant different P values. Conclusions: Ross patients with pulmonary homograft showed systematically increased hemodynamic parameters compared to normal pulmonary valves. These differences were abolished when PR was considered for homograft patients. The equality of RVSP values at rest in both groups shows non-invasive evidence for PR in the pulmonary system after homograft implantation. Therefore, PR appears to be an important measure in calculating the actual hemodynamics in pulmonary homografts.

Vor allem im Rahmen der COVID-19-Pandemie wird die ECLS/ECMO-Therapie noch häufiger in der Intensivmedizin eingesetzt und oft auch in den allgemeinen Medien genannt. Seit Februar 2021 ist die S3-Leitlinie „Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen“ bei der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) online abrufbar. Die Autorenschaft fasst die Inhalte in der Leitlinie zusammen und legt dabei einen Schwerpunkt auf die Intensivpflege und Physiotherapie.

The treatment of aortic valve disease in young patients is still a major clinical challenge, as the pre-eminent emphasis is on durability and long-term outcomes beyond 10 to 15 years, sometimes >20 to 30 years. The Ross procedure uses the autologous pulmonary valve as an aortic valve substitute and aims to improve valve durability while avoiding anticoagulation and therefore achieve a sustained long-term result with regard to survival, valve functionality, and quality of life. However, this procedure is technically demanding and only performed at a low frequency. Data investigating the Ross procedure are mostly limited to observational studies from single expert centers, while sufficient randomized data are almost completely lacking. Therefore, to create a clinically relevant database of this therapy, the multicenter Ross Registry was founded in 2001. New patients were included, follow-up of past patients continuously updated, and outcomes regularly reported. Throughout recent years, numerous analyses have been performed to characterize this patient population, surgical techniques, risk factors for morbidity and mortality, and most importantly survival outcomes. Currently, more than 2500 patients are included, and the long-term follow-up has reached >25 years in the very first patients who were included. In the most recent study, 2444 adult patients with a mean age of 44.1 ± 11.7 years were analyzed, and it showed that excellent mid-term survival is maintained after 25 years. In addition, the rate of reintervention was lower than reported in patients with xenografts and anticoagulation-related morbidity lower than reported in patients with mechanical valves. In the absence of robust randomized controlled trials, registry data are very important to monitor outcomes and mirror the quality of current practice. Therefore, the Ross Registry provides a unique and important data base regarding treatment of aortic valve disease in young patients.

Currently, it is unclear whether transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI; d-TAVI) or with preimplantation balloon valvuloplasty (b-TAVI) provides similar clinical safety and efficacy. Therefore, we analyzed patients undergoing d-TAVI or b-TAVI for severe aortic stenosis (AS) with either self-expanding or balloon-expandable transcatheter heart valves (THVs) from the German Aortic Valve Registry (GARY).Between 2011 and 2017, a total of 44,783 TAVI patients were collected, with 25,717 (57.4%) receiving a balloon-expandable THV and 19,066 (42.6%) receiving a self-expanding THV. A propensity-score weighted model was used to compare d-TAVI vs b-TAVI regarding differences in outcome.B-TAVI was performed in 71% and d-TAVI was performed in 29% of patients. In the investigated time interval, frequency of b-TAVI declined from 88.4% to 58.2%, accompanied by a constant rate of postdilation. After propensity weighting of patients receiving balloon-expandable THV, d-TAVI vs b-TAVI was associated with more frequent postoperative transvalvular mean pressure gradients (mPG)15 mm Hg (20.7% vs 18.4%; P.001), similar rates of paravalvular leakage (PVL) ≥ moderate (18.0% vs 16.9%; P=.08), fewer postdilations (13.4% vs 15.5%; P.001), and fewer complications (permanent pacemaker implantation, 10.2% vs 11.9% [P=.01]; vascular complications, 1.9% vs 2.6% [P.01]; pericardial tamponade, 0.5% vs 0.9% [P.01]; and stroke, 0.9% vs 1.3% [P=.02]). In patients receiving self-expanding THVs, d-TAVI vs b-TAVI was associated with more frequent postimplantation mean PG ≥ 15 mm Hg (12.7% vs 10.4%; P.01), higher rates of PVL ≥ moderate (24.8% vs 16.5%; P.001), and similar complication rates including permanent pacemaker implantation.The safety and efficacy of d-TAVI vs b-TAVI depends on the type of THV implanted. For balloon-expandable valves, d-TAVI provides an advantage, while self-expanding valves offer a similar safety profile for d-TAVI compared with b-TAVI. However, increased mPG post intervention with both valve types and more significant PVL in self-expanding THVs emphasize the importance of proper patient selection and evaluation of valve anatomy to identify suitable cases for d-TAVI.

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.

In recent years, the use of mechanical support for patients with cardiac or circulatory failure has continuously increased, leading to 3,000 ECLS/ECMO (extracorporeal life support/extracorporeal membrane oxygenation) implantations annually in Germany. Due to the lack of guidelines, there is an urgent need for evidence-based recommendations addressing the central aspects of ECLS/ECMO therapy. In July 2015, the generation of a guideline level S3 according to the standards of the Association of the Scientific Medical Societies in Germany (AWMF) was announced by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS). In a well-structured consensus process, involving experts from Germany, Austria and Switzerland, delegated by 16 scientific societies and the patients' representation, the guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" was created under guidance of the GSTCVS, and published in February 2021. The guideline focuses on clinical aspects of initiation, continuation, weaning and aftercare, herein also addressing structural and economic issues. This article presents an overview on the methodology as well as the final recommendations.In den vergangenen Jahren hat der Einsatz mechanischer Unterstützungssysteme für Patienten mit Herz- und Kreislaufversagen kontinuierlich zugenommen, sodass in Deutschland mittlerweile jährlich etwa 3000 ECLS-/ECMO-Systeme implantiert werden. Vor dem Hintergrund bislang fehlender umfassender Leitlinien bestand ein dringlicher Bedarf an der Formulierung evidenzbasierter Empfehlungen zu den zentralen Aspekten der ECLS-/ECMO-Therapie. Im Juli 2015 wurde daher die Erstellung einer S3-Leitlinie durch die Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG) bei der zuständigen Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF) angemeldet. In einem strukturierten Konsensusprozess mit Einbindung von Experten aus Deutschland, Österreich und der Schweiz, delegiert aus 11 AWMF-Fachgesellschaften, 5 weiteren Fachgesellschaften sowie der Patientenvertretung, entstand unter Federführung der DGTHG die Leitlinie „Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen“, die im Februar 2021 publiziert wurde. Die Leitlinie fokussiert auf klinische Aspekte der Initiierung, Fortführung, Entwöhnung und Nachsorge und adressiert hierbei auch strukturelle und ökonomische Fragestellungen. Dieser Artikel präsentiert eine Übersicht zu der Methodik und den konsentierten Empfehlungen.

OBJECTIVES Selection of a surgical aortic valve (SAV) bioprosthesis model for the treatment of aortic valve disease remains controversial. The aim of this study was to characterize the functional performance of 8 SAV models in a standardized in vitro setting. METHODS The hydrodynamic performance of 8 SAVs with labelled size 21 mm (Avalus™, Hancock® II, Mosaic® Ultra™, Perimount®, Perimount® Magna Ease, Epic™ Supra, Trifecta™ GT; Freestyle®), was investigated in a pulse duplicator. Transvalvular pressure gradients and effective orifice area (EOA) were recorded. The geometrical orifice area and physical dimensions of the valves were determined, and new functional dimensions were introduced. RESULTS Mean pressure gradient (MPG) and EOA differed significantly between the analysed SAVs. The Epic presented with the lowest EOA and highest MPG, while the Trifecta showed the highest EOA and the lowest MPG. We introduce a useful way to determine the minimal internal diameter and a new measure termed ‘relative orifice area’ to characterize a valve’s performance. CONCLUSIONS SAVs showed significant differences in their hydrodynamic performance despite the same label size. This finding was related to the construction of the valves. We introduce a new measure that characterizes the functional performance of a valve model and size for the treatment of an aortic annulus of a specific size. Our data emphasize that SAV selection should carefully be done using an individual patient approach and that future research is necessary to improve the current generation of SAVs.

The aim of this study was to investigate the degree of functional improvement of a transcatheter heart valve (THV) for valve-in-valve after bioprosthetic valve fracture (BVF) of three small surgical aortic valve bioprostheses (SAVBP) using high-pressure balloon aortic valvuloplasty (HP-BAV) under standardized ex-vivo-conditions.A THV 26 mm (Evolut R) and SAVBP 21 mm (Perimount Magna Ease, Trifecta, and Epic supra [n = 4] were used. Mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area (GOA), minimal internal diameter (MID), and pinwheeling index (PWI) were analyzed before and after HP-BAV of the SAVBP using a noncompliant balloon. Fracturing of the SAVBP was done before implantation of the THV and the balloon pressures at the point of fracture were recorded.The Magna Ease and Epic fractured at balloon pressures of 18 and 8 atm, respectively. The Trifecta did not fracture up to a balloon pressure of 30 atm but was dilated. HP-BAV led to increased THV expansion as evident by straightened coaptation lines of the Evolut R 26 mm with reduced PWI, increased MID, and increased GOA in all 21 mm SAVBP. Evolut R showed significantly lower MPG and higher EOA as ViV in all prostheses after HP-BAV (p lt; 0.001). MPG and EOA of Evolut R differed regarding the SAVBP. Evolut R presented the lowest MPG and highest EOA in Magna Ease and the highest MPG and lowest EOA in Epic supra.The degree of function improvement of the same THV as ViV after HP-BAV depends on the surgical valve model. Functional improvement can also be achieved without valve fracture.

OBJECTIVES We investigated the hydrodynamic performance and cusp kinematics of the Ozaki neocuspidized aortic valve in comparison with the native aortic and prosthetic valves in an ex vivo study. METHODS Native aortic valves of swine hearts were replaced by aortic valve substitutes, and their hydrodynamic performance (effective orifice area and mean pressure gradient) was evaluated in a mock circulation under defined conditions. The following aortic valve substitutes were investigated: native aortic valve, Ozaki valve, Perimount Magna Ease, Trifecta and St. Jude Medical Masters. All prosthetic valves had a labelled size of 21 mm. RESULTS The Ozaki valve and native aortic valve showed a similar and significantly larger orifice area than all investigated prosthetic valves particularly at high flow rates. There was no significant difference between the Ozaki valve and the native aortic valve. The native aortic valve and Ozaki valve showed a similar increase in orifice area with increasing flow through the valve while prosthetic valves showed a markedly weaker increase. Similarly, the native and Ozaki valve showed a similar increase in mPG with forward flow which was weaker than prosthetic valves. Cusp kinematics were similar between the native and Ozaki valve, whilst prosthetic valves were clearly distinguishable from them. CONCLUSIONS The Ozaki procedure showed excellent hydrodynamic performance compared to prosthetic valves and showed similar cusp motion characteristics to the native aortic valve. Our results suggest that the Ozaki neocuspidized valve behaves physiologically in many aspects, which may contribute to beneficial clinical outcomes.

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.

OBJECTIVES Transcatheter aortic valve-in-valve (ViV) procedures are increasingly performed for the treatment of degenerated surgical aortic valves with a high risk for a redo operation. For an optimal functional result, precise positioning of the transcatheter heart valve (THV) inside the SHV is crucial. The aim of this study was to systematically investigate the impact of implantation depth on the functional result after a ViV procedure in a standardized in vitro setting. METHODS A THV 23 mm (Evolut PRO) and 3 SHV 21 mm (Perimount Magna Ease, Trifecta and Hancock II) were used for hydrodynamic testing with a constant heartbeat 64/min and a range of 55–105 ml of stroke volume in 5 different positions of the THV. The following parameters were analysed: mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area, minimal internal diameter and pin-wheeling index. RESULTS MPG and EOA differed significantly regarding the position of the THV in the same SHV. The highest EOA and the lowest MPG were recorded for Evolut PRO with significance for both parameters in Hancock II at 4 vs 5 mm (P < 0.001), in Magna Ease at 2 mm (vs 3 mm and vs 6 mm, P < 0.001) and in Trifecta at 4 mm (vs 5 and 6 mm, P < 0.001). Leaflet coadaptation, minimal internal diameter and maximal geometric orifice area of the same TAV differ regarding the position of the TAV. CONCLUSIONS The optimal position for hydrodynamic performance of the THV as ViV differs among specific SHV models. The findings may be useful for planning a ViV procedure using the Evolut PRO THV.

Objectives This study sought to compare patient characteristics, procedural outcomes, and valve hemodynamics of surgical aortic valve replacement (SAVR) with current-generation rapid-deplo...

The aim of this study was to compare outcomes of transcatheter and surgical aortic valve implantation in chronic dialysis patients with aortic valve stenosis (AS). Chronic dialysis patients undergoing heart valve surgery are at higher risk for morbidity and mortality. Whether interventional techniques can reduce this risk is unclear because dialysis patients have thus far been excluded from randomized trials. Chronic dialysis patients with AS enrolled in the German Aortic Valve Registry (GARY) between 2012 and 2015 were analyzed to compare transcatheter aortic valve implantation (TAVI n = 661) with surgical aortic valve replacement (SAVR n = 457). Propensity scores for inverse probability of treatment weighting (IPTW) were used to adjust the comparison of the two treatment groups for potential confounders. TAVI patients were older (78 ± 7.3 vs. 69 ± 10.2 years, p

ZUSAMMENFASSUNGDie kathetergestützte Behandlung hat sich bei Patienten unterschiedlicher Risikoprofile mit hochgradiger symptomatischer Aortenklappenstenose als ein sehr sicheres Verfahren mit guten funktionellen Ergebnissen etabliert und ist für viele Patienten zur Behandlung der Wahl geworden. Insbesondere bei Patienten mit niedrigem operativem Risiko zeigten sich im kurzfristigen Verlauf einige Vorteile gegenüber dem operativen Aortenklappenersatz. Allerdings fielen in der mittelfristigen Nachbeobachtung kürzlich erstmals erhöhte Ereignisraten des kathetergestützten Verfahrens auf. Bei limitierten Daten zur Langzeit-Haltbarkeit der Transkatheter-Herzklappenprothesen steht insbesondere bei jüngeren Patienten die ausgewogene Diskussion der Therapieoptionen im interdisziplinären Heart Team mit dem Ziel eineslangfristigen Behandlungsplans im Vordergrund.

The aim of this study was to compare the outcome of nonagenarians (≥ 90 years) with that of younger ( 90 years) patients undergoing transcatheter aortic valve implantation (TAVI) in current practice.Data are collected from the German Aortic Valve Registry (GARY), which was designed to evaluate current practice in the invasive treatment of patients with aortic valve diseases in Germany. Data were analyzed regarding procedural outcome, 30-day, and 1-year outcomes of nonagenarians in comparison to that of younger patients.Between 2011 and 2015, 2436/33,051 (7.3%) nonagenarians underwent TAVI and were included in GARY. Nonagenarians were significantly more often male (45.2% vs. 40.0%, p 0.001), frail (38.7% vs. 34.7%, p 0.001), and had higher EuroSCORE scores than younger patient group (23.2% vs. 17.0%). Nonagenarians were significantly less often treated via transapical access (16.3% vs. 22.3%, p 0.001). Procedure was performed significantly less often in general anesthesia (58.2% vs. 60.7%, p = 0.02) in nonagenarians, while necessity of pacemaker implantation was significantly higher in nonagenarians (27.2% vs. 24.8%, p 0.001). The incidence of other typical postprocedural complications such as severe bleeding events and vascular complications were comparable between groups. However, 30-day (5.2% vs. 3.9%) and 1-year (22.7% vs. 17.7%) mortality rates were significantly higher among nonagenarians and age ≥ 90 years could be identified as an isolated risk factor for mortality.TAVI is a highly standardized procedure that can be performed safely with high procedural success even in very old patients. Although mortality is significantly higher in these patients-most probably due to the intrinsic higher risk profile of the very old patients-the results are still acceptable. To optimize outcome, especially elderly patients seem to profit from a procedure under local anesthesia or conscious sedation, to minimize the rate of postoperative delirium and the length of stay and to facilitate early mobilization.

Objective We compared TAVI vs. SAVR in patients with moderate-to-severe chronic kidney disease (eGFR 15–60 ml/min/1.73 m2) for whom both procedures could possibly be considered (age ≤ 80 years, STS-score 4–8). Background According to both ACC/AHA and ESC/EACTS recent guidelines, aortic stenosis may be treated with either transcatheter (TAVI) or surgical (SAVR) aortic valve replacement in a subgroup of patients. A shared therapeutic decision is made by a heart team based on individual factors, including chronic kidney disease (CKD). Methods Data from the large nationwide German Aortic Valve Registry were used. A propensity score method was used to select 704 TAVI and 374 SAVR matched patients. Primary endpoint was 1-year survival. Secondary endpoints were clinical complications, including pacemaker implantation, vascular complications, myocardial infarction, bleeding, and the need for new-onset dialysis. Results One-year survival was similar (HR [95% CI] for TAVI 1.271 [0.795, 2.031], p = 0.316), with no divergence in Kaplan–Meier curves. In spite of post-procedural short-term survival being numerically higher for TAVI patients and 1-year survival being numerically higher for SAVR patients, such differences did not reach statistical significance (96.4% vs. 94.2%, p = 0.199, and 86.2% vs. 81.2%, p = 0.316, respectively). In weighted analyses, pacemaker implantation, vascular complications, and were significantly more common with TAVI; whereas myocardial infarction, bleeding requiring transfusion, and longer ICU-stay and overall hospitalization were higher with SAVR. Temporary dialysis was more common with SAVR (p Conclusion Both TAVI and SAVR led to comparable and excellent results in patients with moderate-to-severe CKD in an intermediate-risk population of patients with symptomatic severe aortic stenosis for whom both therapies could possibly be considered.

OBJECTIVES Aortic valve (AV) repair is an evolving surgical strategy in the treatment of young patients with aortic regurgitation (AR) and/or aortic root aneurysm. We aimed to determine the clinical outcome following AV repair/AV-sparing root surgery using real-world data from the German Aortic Valve Registry. METHODS A total of 2327 patients with AR (mean age 55.2 ± 15.0 years, 76% men), who underwent AV repair/AV-sparing root surgery between 2011 and 2015 (i.e. 5% of 42 868 AV surgery patients enrolled in the German Aortic Valve Registry during the same period) were included. Study cohort was subdivided according to the technique of AV repair: isolated AV repair without root surgery (group I) (n = 914), AV-sparing root surgery (i.e. reimplantation or remodelling) without cusp repair (group II) (n = 1077) and AV-sparing root surgery (i.e. reimplantation or remodelling) with simultaneous cusp repair (group III) (n = 336). Primary end point was 1-year survival after AV repair/AV-sparing root surgery. Secondary end points were freedom from cardiac adverse events and freedom from AV reinterventions at 1-year follow-up. RESULTS Thirty-day mortality was 19 (0.8%) in the whole study cohort without significant differences in the 3 subgroups [4 (0.4%) patients in group I vs 14 (1.3%) patients in group II vs 1 (0.3%) patient in group III (P = 0.054)]. Postoperatively, 1445 (74%) patients had no residual AR, 474 (24%) patients had mild AR and 40 (2%) patients had moderate/severe AR at the time of hospital discharge. One-year survival (95% confidence interval) was 97.7% (97.1–98.3) in the whole study cohort and without significant difference among the 3 subgroups. One-year cardiac adverse event-free survival (95% confidence interval) was 85.7% (84.2–87.1) and was similar in all 3 study groups in propensity score-weighted analysis. A total of 38 (1.6%) patients required AV reintervention during a 1-year follow-up, without significant difference among subgroups (P = 0.11). CONCLUSIONS AV repair/AV-sparing root surgery is performed in 5% of patients requiring AV surgery in Germany. Our data demonstrate very satisfactory periprocedural and 1-year survival and cardiac event-free survival after AV repair surgery. Implementation of specific surgical techniques during the index procedure seems to result in comparable outcomes.

In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF). Although the clinical application of ECMO/ECLS represents the main focus, the presented guideline also addresses structural and economic issues. Experts from 17 German, Austrian and Swiss scientific societies and a patients' organization, guided by the GSTCVS, completed the project in February 2021. In this report, we present a summary of the methodological concept and tables displaying the recommendations for each chapter of the guideline.Seit einigen Jahren ist eine stetige Zunahme des Einsatzes von mechanischen extrakorporalen Herz-Kreislauf- und Lungenunterstützungssystemen (ECLS/ECMO) zu verzeichnen. So wurden seit 2015 in Deutschland jährlich bei etwa 3000 Patienten ECLS/ECMO-Systeme implantiert. Trotz dieser häufigen Anwendung der passageren Unterstützungssysteme existieren zurzeit national und international nur Leitlinien zum Einsatz der ECMO/ECLS, die erkrankungsbezogene Teilaspekte komplexer Therapiekaskaden adressieren. Vor diesem Hintergrund erschien es notwendig, evidenzbasierte Empfehlungen zur ECLS/ECMO-Therapie im Hinblick auf Indikationen und das komplexe Patientenmanagement zu verfassen, in denen personelle, prozessuale und infrastrukturelle Anforderungen definiert werden. Aus diesem Grund erfolgte im Juli 2015 durch die Deutsche Gesellschaft für Thorax‑, Herz- und Gefäßchirurgie (DGTHG) die Anmeldung einer diesbezüglichen S3-Leitlinie bei der zuständigen Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF). Im Mittelpunkt der Leitlinie steht die klinische Anwendung der ECLS/ECMO-Therapie; ergänzend werden auch strukturelle und ökonomische Aspekte adressiert. Unter Federführung der DGTHG wurde mit Einbindung von Experten aus Deutschland, Österreich und der Schweiz, delegiert aus 11 AWMF-Fachgesellschaften, 5 weiteren Fachgesellschaften sowie der Patientenvertretung, die S3-Leitlinie im Februar 2021 publiziert. Dieser Artikel stellt eine kurze Zusammenfassung des methodischen Konzepts sowie aller konsentierten Empfehlungen für jede bearbeitete Fragestellung der Leitlinie dar.

Aims The present study aims to characterize the genetic risk architecture of bicuspid aortic valve (BAV) disease, the most common congenital heart defect. Methods and results We carried out a genome-wide association study (GWAS) including 2236 BAV patients and 11 604 controls. This led to the identification of a new risk locus for BAV on chromosome 3q29. The single nucleotide polymorphism rs2550262 was genome-wide significant BAV associated (P = 3.49 × 10−08) and was replicated in an independent case–control sample. The risk locus encodes a deleterious missense variant in MUC4 (p.Ala4821Ser), a gene that is involved in epithelial-to-mesenchymal transformation. Mechanistical studies in zebrafish revealed that loss of Muc4 led to a delay in cardiac valvular development suggesting that loss of MUC4 may also play a role in aortic valve malformation. The GWAS also confirmed previously reported BAV risk loci at PALMD (P = 3.97 × 10−16), GATA4 (P = 1.61 × 10−09), and TEX41 (P = 7.68 × 10−04). In addition, the genetic BAV architecture was examined beyond the single-marker level revealing that a substantial fraction of BAV heritability is polygenic and ∼20% of the observed heritability can be explained by our GWAS data. Furthermore, we used the largest human single-cell atlas for foetal gene expression and show that the transcriptome profile in endothelial cells is a major source contributing to BAV pathology. Conclusion Our study provides a deeper understanding of the genetic risk architecture of BAV formation on the single marker and polygenic level.

Patients presenting with severe aortic stenosis and large aortic annuli are challenging to treat because of the size limitations of available transcatheter heart valves. In this study, we aimed to determine clinical and hemodynamic outcomes in patients presenting with large aortic annuli who underwent transcatheter aortic valve implantation (TAVI). Patients from the German Aortic Valve Registry who underwent TAVI either with the Edwards Sapien (ES) or Medtronic CoreValve (MCV) systems from 2011 to 2017 were included. They were further stratified into a large (aortic annulus diameter 26 to 29 mm for ES; 26 to 30 mm for MCV) and extra-large (aortic annulus diameter >29 mm for ES; >30 mm for MCV) group and analyzed using propensity score adjustment. Extra-large was set beyond the sizing limitations according to the manufacturer's instructions for use. Patients in the large (n = 5,628) and extra-large (n = 509) groups were predominantly male (large: 92.6% vs extra-large: 91.9%). The 30-day mortality was comparable (large: 3.9% vs extra-large: 5.0%, p = 0.458). Procedure duration (large: 78.9 minutes ± 0.82 vs extra-large: 86.4 minutes ± 1.9, p

AIMS The aim of this study was to evaluate transcatheter aortic valve-in-valve (ViV) implantation performance in rapid deployment (ViVr) vs. conventional (ViVc) surgical heart valves. METHODS AND RESULTS A multicentre registry was developed as part of the VIVID international registry. A total of 30 ViVr patients (Perceval, n=24, ATS 3f Enable™, n=5, and the INTUITY, n=1) were evaluated and compared with 2,288 ViVc patients. Propensity score (PS) matching was performed to adjust further for bias. Compared with ViVc, ViVr patients presented twice as early after surgical heart valve (SHV) implantation (55.2±36.1 vs. 118.4±57.7 months, p

Item does not contain fulltext BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17 [95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68-1.20], pinteraction=0.019). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0.66) and no linear trend across SYNTAX score tertiles (ptrend=0.30). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).

Background: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. Methods: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%–8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. Results: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P P P P P =0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P P =0.59). Conclusions: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): This work was supported by German Cardiac Society, German Society for Thoracic and Cardiovascular Surgery, and German Heart Foundation. Statistical funding support by the German Center for Cardiovascular Research/Deutsches Zentrum für Herz-Kreislauf Forschung (DZHK). Background Patients with severe aortic stenosis (AS) frequently present concomitant mitral regurgitation (MR), which may interfere with echocardiographic measurement of mean pressure gradient (MPG), maximal flow velocity and aortic valve area (AVA). Purpose We therefore, aimed to investigate the impact of different grades of MR on parameters of AS severity in a large cohort of all-comer patients with severe AS, prospectively included in the national German Aortic Registry (GARY). Methods All patients undergoing transcatheter or surgical aortic valve replacement for severe AS enrolled in GARY between 2011 and 2017 were considered for this analysis. After excluding cases with mitral stenosis and unknown causes of MR, 119,641 patients were considered for the present study. Based on LVEF, the study population was divided into the following subgroups: group 1 (LVEF 50%, n = 81,980). Differences in the values of the mPG were explored in each group and in relation to the decremental values of aortic valve area (AVA). Results Overall, 37,489 (31.3%) patients had no MR, 77,890 (65.1%) had MR grade I-II, and 4262 (3.6%) had MR grade III-IV. In group 1, 2 and 3, no MR was reported in 1339 (17.7%), 7612 (25.3%) and 28,538 (34.8%) patients respectively. MR grade I-II was more frequently observed (group 1 5621 [74.5%] vs. group 2 20,972 [69.6%] vs. group 3 51,297 [62.6%]), whereas MR grade III-IV was observed less frequently and present only in 585 (7.7%), 1532 (5.1%) and 2145 (2.6%) patients in subgroups 1, 2 and 3, respectively. The aortic mPG was significantly lower in subgroup 1 compared to 2 and 3 (33.74 ± 14.93 versus 41.4 ± 16.47 and 46 ± 16.19mmHg respectively, p Conclusions In patients with severe AS, concomitant MR may potentially affect diagnostic accuracy of echocardiographic AS evaluation. In this first GARY analysis of patients with severe AS and concomitant MR, we observed that increasing MR severity affects transvalvular aortic mPG and results in a low-gradient AS pattern. In contrast, AVA is a robust diagnostic parameter for the diagnosis of true severe AS that maintains its validity independently of LVEF and severity of concomitant MR. Abstract Figure 1

OBJECTIVES We investigated the Ozaki procedure using a single interrupted suture technique (SST) and compared this with the standard continuous suture technique (CST) with regard to hydrodynamic valve performance. In addition, both techniques were compared with the native aortic valve (NAV). METHODS Effective orifice area, mean pressure gradient and leakage volume were evaluated in the NAV as well as after an Ozaki procedure using SST or CST in fresh swine aortic roots using a mock circulation loop. The NAV, SST and CST were evaluated under 4 defined hydrodynamic conditions. RESULTS Both suture techniques resulted in a similar effective orifice area under all conditions [for stroke volume of 70 ml: SST: 1.50 (1.35–1.87) vs CST: 1.57 (1.41–1.72) cm2, P = 0.8] and there were no significant differences between both suture techniques and the NAV (P > 0.05). Regarding mean pressure gradient, the Ozaki procedure with SST and CST showed no significant differences [7.23 (5.53–8.91) vs 7.04 (6.65–7.60) mmHg, P = 0.72] and there was no significant difference between both suture techniques and the NAV (P > 0.1). In leakage volume, there was no significant difference between SST and CST [4.49 (3.91–4.99) vs CST: 4.23 (3.58–4.87) ml/stroke, P = 0.34]. CONCLUSIONS The Ozaki procedure with SST performed similarly to that with CST with regard to hydrodynamic performance. Our results suggest that the Ozaki procedure can be performed with SST instead of CST, which may be useful in patients with limited surgical exposure, such as a small annulus.

OBJECTIVES To determine the 5-year outcome in patients treated by isolated transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (sAVR)—a prospective observational cohort study. METHODS A total of 18 010 patients were included (n = 8942 TAVI and n = 9068 sAVR) in the German Aortic Valve Registry (GARY) who were treated in 2011 and 2012 at 92 sites in central Germany. Eligible patients with TAVI and sAVR were matched using propensity scores in a nearest-neighbour approach. Patients with repeat procedures or unequivocal indication for one treatment option (e.g. frailty) were excluded (n = 4785 for TAVI and n = 2 for sAVR). This led to 13 223 patients (4157 TAVI and 9066 sAVR) as an unmatched subcohort. The main outcome measure was the 5-year all-cause mortality. RESULTS TAVI patients were significantly older (80.9 ± 6.1 vs 68.5 ± 11.1 years, P CONCLUSIONS The 5-year follow-up data show that TAVI patients were significantly older and had a higher STS score than sAVR patients. After propensity score matching, TAVI with early-generation prosthesis was associated with significantly higher 5-year all-cause mortality than sAVR.

Objectives The aim of the study was to analyse LV systolic function and mechanical energetics in asymptomatic patients with severe aortic regurgitation (AR) to seek a new hemodynamic concept for timing for surgery. Background Current guidelines suggest surgery for patients with severe AR including clinical symptoms, subnormal LV ejection fraction (EF), or markedly abnormal left ventricular dimensions. However, the optimal measure to detect intrinsic myocardial systolic dysfunction in the presence of normal LVEF remains elusive. Methods Strain and echo-derived single beat pressure-volume analyses were performed in cohorts with severe AR without indication for surgery (ARNS; LVEDD 50%, n=41), with indication for surgery (ARS; n=19) and in healthy, age-matched controls (C; n=20). Additionally, end-systolic elastance (Ees=LV contractility), stroke work (SW) and total energy (PVA) were calculated. Results Patients with ARNS demonstrated significant depression of LV contractility vs. C: Ees (1.5mmHg/ml ±0.7 vs. 2.25mmHg/ml ±0.7; p Conclusion Patients with severe AR and normal LVEF showed depressed LV contractility and waste of energy when assessed by Ees and GLS, both correlating well with each other. Hence, GLS may outperform LV dimensions for predicting timing for surgery and clinical outcomes in AR patients. Funding Acknowledgement Type of funding source: None

Background Chronic kidney disease (CKD) is a key risk factor in patients undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). Purpose We analyzed the impact of eGFR and different stages of chronic kidney disease (CKD), on short- and mid-term survival in patients undergoing TAVI or SAVR. Methods Data from 29893 patients enrolled in the German Aortic Valve registry (GARY) from January 2011 to December 2015 receiving TAVI (n=12834) or SAVR (n=17059) at 88 sites were included. The impact of renal impairment, as measured by eGFR and CKD stages, was investigated. The primary endpoint was 1-year cumulative all-cause mortality. A propensity score method was used to compare TAVI vs. SAVR in patients with intermediate risk and mild-to-moderate renal disease being eligible for both therapies. 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. No significant differences in survival were found between TAVI and SAVR in a matched group of intermediate-risk patients potentially eligible for both therapies (HR [(95% CI] for TAVI vs SAVR 1.24 [0.76, 2.02], p=0.240). Conclusions CKD≥3b and CKD≥3a is an independent major risk factor 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. TAVI and SAVR appear to achieve similar survival rates in intermediate-risk patients with moderate-to-severe renal dysfunction. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Unrestricted grants by medical device companies (Edwards Lifesciences, JenaValve Technology, Medtronic, Sorin, St. Jude Medical, Symetis S.A.). Unrestricted support by funding statisticians by the DZHK (Deutsches Zentrum für Herz-Kreislaufforschung).

This study sought to compare patient characteristics, procedural outcomes, and valve hemodynamics of surgical aortic valve replacement (SAVR) with current-generation rapid-deployment valves (RDVs) versus transcatheter aortic valve replacement (TAVR) with current-generation transcatheter heart valves (THVs).The patient population currently treated with RDVs may have potential similarities with the current TAVR population, but comparative studies in a large patient population remain scarce.A total of 16,473 patients who underwent isolated SAVR using current-generation RDVs or isolated transfemoral TAVR with current-generation THVs between 2011 and 2017 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for RDVs and THVs before and after 1:1 propensity score matching. Furthermore, RDVs and THVs with similar design characteristics were compared with each other.A total of 1,743 patients received SAVR with an RDV, whereas 14,730 patients were treated with transfemoral TAVR. Patients treated with TAVR were significantly older and had higher surgical risk scores. Following valve replacement, patients treated with an RDV had a significantly higher rate of disabling stroke (1.7% vs. 1.1%; p = 0.03), need for transfusion of4 red blood cell units (8.5% vs. 1.4%; p 0.001), and new onset renal replacement therapy (1.9% vs. 1.2%; p = 0.01), whereas the need for a new permanent pacemaker was lower (8.4% vs. 14.9%; p 0.001). In-hospital mortality was similar (1.6% vs. 1.8%; p = 0.62). These findings persisted after 1:1 propensity score matching, but in-hospital mortality was significantly higher after RDVs (1.7% vs. 0.6%; p = 0.003). Balloon-expandable (BE) RDVs had significantly lower residual gradients compared with BE-THVs, while self-expanding (SE)-RDVs had significantly higher residual gradients compared with SE-THVs.In a large all-comers' registry, TAVR with current-generation THVs was associated with improved in-hospital outcomes compared with SAVR with current-generation RDVs. The pacemaker rate is significantly higher with TAVR. Post-procedural hemodynamic function varied between individual RDVs and THVs.

According to the Valve Academic Resortium, underweight is one parameter in the definition of frailty, which is associated with increased mortality after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). Aims of our study were (1) to examine the impact of underweight on mortality after TAVI and SAVR and (2) to determine the effect of intervention mode (TAVI vs SAVR) on mortality in underweight patients from the German Aortic Valve Registry. Overall, 35,109 patients treated with TAVI or SAVR were studied. Outcomes of underweight (body mass index [BMI]20 kg/m