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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.

Human pluripotent stem cells (hPSCs) hold great promise for applications in cell therapy and drug screening in the cardiovascular field. Bone morphogenetic protein 4 (BMP4) is key for early cardiac mesoderm induction in hPSC and subsequent cardiomyocyte derivation. Small‐molecular BMP4 mimetics may help to standardize cardiomyocyte derivation from hPSCs. Based on observations that chalcones can stimulate BMP4 signaling pathways, we hypothesized their utility in cardiac mesoderm induction. To test this, we set up a two‐tiered screening strategy, (1) for directed differentiation of hPSCs with commercially available chalcones (4’‐hydroxychalcone [4’HC] and Isoliquiritigen) and 24 newly synthesized chalcone derivatives, and (2) a functional screen to assess the propensity of the obtained cardiomyocytes to self‐organize into contractile engineered human myocardium (EHM). We identified 4’HC, 4‐fluoro‐4’‐methoxychalcone, and 4‐fluoro‐4’‐hydroxychalcone as similarly effective in cardiac mesoderm induction, but only 4’HC as an effective replacement for BMP4 in the derivation of contractile EHM‐forming cardiomyocytes., Have a little heart: A screen for mesoderm inducing chalcones in human pluripotent stem cell cultures identified 4’‐hydroxychalcone (4’HC) as an effective replacement for bone‐morphogenetic protein 4 (BMP4) in supporting the derivation of engineered heart muscle (EHM)‐formation competent cardiomyocytes.

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.

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

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.

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.

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.

Treatment of aortic-valve disease in young patients still poses challenges. The Ross procedure offers several potential advantages that may translate to improved long-term outcomes.This study reports long-term outcomes after the Ross procedure.Adult patients who were included in the Ross Registry between 1988 and 2018 were analyzed. Endpoints were overall survival, reintervention, and major adverse events at maximum follow-up. Multivariable regression analyses were performed to identify risk factors for survival and the need of Ross-related reintervention.There were 2,444 adult patients with a mean age of 44.1 ± 11.7 years identified. Early mortality was 1.0%. Estimated survival after 25 years was 75.8% and did not statistically differ from the general population (p = 0.189). The risk for autograft reintervention was 0.69% per patient-year and 0.62% per patient-year for right-ventricular outflow tract (RVOT) reintervention. Larger aortic annulus diameter (hazard ratio [HR]: 1.12/mm; 95% confidence interval [CI]: 1.05 to 1.19/mm; p 0.001) and pre-operative presence of pure aortic insufficiency (HR: 1.74; 95% CI: 1.13 to 2.68; p = 0.01) were independent predictors for autograft reintervention, whereas the use of a biological valve (HR: 8.09; 95% CI: 5.01 to 13.08; p 0.001) and patient age (HR: 0.97 per year; 95% CI: 0.96 to 0.99; p = 0.001) were independent predictors for RVOT reintervention. Major bleeding, valve thrombosis, permanent stroke, and endocarditis occurred with an incidence of 0.15% per patient-year, 0.07% per patient-year, 0.13%, and 0.36% per patient-year, respectively.The Ross procedure provides excellent survival over a follow-up period of up to 25 years. The rates of reintervention, anticoagulation-related morbidity, and endocarditis were very low. This procedure should therefore be considered as a very suitable treatment option in young patients suffering from aortic-valve disease. (Long-Term Follow-up After the Autograft Aortic Valve Procedure [Ross Operation]; NCT00708409).

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.

The goal is to inform in depth on transcatheter aortic valve replacement (TAVR) prosthesis mechanical behavior, depending on frame type, design, and size, and how it crucially impacts the oversizing issue in clinical use, and ultimately the procedure outcome. Transcatheter aortic valve replacement is an established therapy for high-risk patients suffering from aortic stenosis, and the indication for TAVR is progressively expanding to intermediate-risk patients. Choosing the optimal oversizing degree is crucial to safely anchor the TAVR valve-which involves limiting the risks for embolism, aortic regurgitation, conductance disturbance, or annulus rupture-and to increase the valve prosthesis performance. The radial force (RF) profiles of five TAVR prostheses were measured in vitro: the CoreValve 23 and 26 (Medtronic, Minneapolis, MN), the Acurate neo S (Symetis, Écublens, Vaud, Switzerland), and the SAPIEN XT 23 and 26 (Edwards Lifesciences, Irvine, CA). Measurements were run with the RX Machine equipment (Machine Solutions Inc., Flagstaff, AZ), which is used in ISO standard tests for intravascular stents. Test protocols were adapted for TAVR prostheses. With the prostheses RF profiles' results, mechanical behavior differences could be described and discussed in terms of oversizing strategy and clinical impact for all five valves. Besides, crossing the prostheses' RF profiles with their recommended size windows made the assessment of borderline size cases possible and helped analyze the risks when accurate measurement of patient aortic annulus proves difficult. The prostheses' RF profiles bring new support in clinical decision-making for valve type and size in patients.

Background Surgical aortic valve replacement using conventional biological valves (CBVs) is the standard of care for treatment of old patients with aortic valve disease. Recently, rapid deployment valves (RDVs) have been introduced. Objectives The purpose of this study was to report the nationwide German experience concerning RDVs for treatment of aortic valve stenosis and provide a head-to-head comparison with CBVs. Methods A total of 22,062 patients who underwent isolated surgical aortic valve replacement using CBV or RDV between 2011 and 2015 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for CBVs and RDVs using 1:1 propensity score matching. Furthermore, 3 RDVs were compared with each other. Results A total of 20,937 patients received a CBV, whereas 1,125 patients were treated with an RDV. Patients treated with an RDV presented with significantly reduced procedure (160 min [25th to 75th percentile: 135 to 195 min] vs. 150 min [25th to 75th percentile: 127 to 179 min]; p Conclusions In this large, all-comers database, the incidence of pacemaker implantation and disabling stroke was higher with RDVs, whereas no beneficial effect on in-hospital mortality was seen. The 3 RDVs presented different complication profiles with regard to pacemaker implantation and transvalvular gradients. (German Aortic Valve Registry [GARY]; NCT01165827)

Objectives The aims of this study were to report on the use of local anesthesia or conscious sedation (LACS) and general anesthesia in transcatheter aortic valve replacement and to analyze the impact on outcome. Background Transcatheter aortic valve replacement can be performed in LACS or general anesthesia. Potential benefits of LACS, such as faster procedures and shorter hospital stays, need to be balanced with safety. Methods A total of 16,543 patients from the German Aortic Valve Registry from 2011 to 2014 were analyzed, and propensity-matched analyses were performed to correct for potential selection bias. Results LACS was used in 49% of patients (8,121 of 16,543). In hospital, LACS was associated with lower rates of low-output syndrome, respiratory failure, delirium, cardiopulmonary resuscitation, and death. There was no difference in paravalvular leakage (II+) between LACS and general anesthesia in the entire population (5% vs. 4.8%; p = 0.76) or in the matched population (3.9% vs. 4.9%, p = 0.13). The risk for prolonged intensive care unit stay (≥3 days) was significantly reduced with LACS (odds ratio: 0.82; 95% confidence interval [CI]: 0.73 to 0.92; p = 0.001). Thirty-day mortality was lower with LACS in the entire population (3.5% vs. 4.9%; hazard ratio [HR]: 0.72; 95% CI: 0.60 to 0.86; p Conclusions Use of LACS in transcatheter aortic valve replacement is safe, with fewer post-procedural complications and lower early mortality, suggesting its broad application.

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

AIMS The aim of this study was to determine the best functional position of a transcatheter heart valve (THV) implanted as a valve-in-valve (ViV) procedure in small rapid deployment valves (RDV) in an in vitro model. METHODS AND RESULTS A 21 mm Perceval, Enable or INTUITY RDV was mounted into a pulse duplicator and a 23 mm balloon-expandable or a self-expanding THV was deployed (valve-in-valve) in two different positions. Under physiological hydrodynamic conditions, the performance of the THV was characterised by mean transvalvular pressure gradient (MPG), effective orifice area (EOA) and regurgitation volume (RV). Leaflet kinematics were assessed with high-speed video recordings, and X-ray images were acquired. All THV/RDV combinations met ISO requirements regarding hydrodynamic performance. In most cases, the higher position of the THV performed better than the lower one in terms of a lower MPG and increased EOA. Leaflet motion of the implanted THV was impaired in the lower position. In contrast, regurgitation volumes were relatively small and similar, regardless of the THV position. CONCLUSIONS ViV implantation of a THV in a small RDV yielded satisfactory hydrodynamic results. In most cases, a high implantation position achieved lower MPG, higher EOA and a reduced risk of impaired THV leaflet function. Fluoroscopy images of the best functional ViV positions are presented as a blueprint for patient procedures.

Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR).This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR.From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices.A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001).Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.

Background and aim of the study Aortic hemodynamics influence the integrity of the vessel wall and cardiac afterload. The aim of this study was to compare hemodynamics distal to biological (BV) and mechanical aortic valve (MV) replacements by in vitro 4D Flow MRI excluding confounding factors of in-vivo testing potentially influencing hemodynamics. Methods Two BV (Perimount MagnaEase [Carpentier-Edwards], Trifecta [Abbott]) and two MV (On-X [CryoLife], prototype trileaflet valve) were scanned in a flexible aortic phantom at 3T using a recommended 4D Flow MR sequence. A triphasic aortic flow profile with blood-mimicking fluid was established. Using GTFlow (Gyrotools), area and velocity of the ejection jet were measured. Presence and extent of sinus vortices and secondary flow patterns were graded on a 0 to 3 scale. Results A narrow, accelerated central ejection jet (Area = 27 ± 7% of vessel area, Velocity = 166 ± 13 cm/s; measured at sinotubular junction) was observed in BV as compared to MV (Area = 53 ± 13%, Velocity = 109 ± 21 cm/s). As opposed to MV, the jet distal to BV impacted the outer curvature of the ascending aorta and resulted in large secondary flow patterns (BV: n = 4, grades 3, 3, 2, 1; MV: n = 1, grade 1). Sinus vortices only formed distal to MV. Although physiologically configured, they were larger than normal (grade 3). Conclusions In contrast to mechanical valves, biological valve replacements induced accelerated and increased flow patterns deviating from physiological ones. While it remains speculative whether this increases the risk of aneurysm formation through wall shear stress changes, findings are contrasted by almost no secondary flow patterns and typical, near-physiological sinus vortex formation distal to mechanical valves.

Mitral valve annuloplasty has been the gold standard for treatment of functional mitral valve regurgitation. However, annuloplasty for functional mitral regurgitation may cause augmented posterior leaflet tethering, which results in functional anterior prolapse. Herein we added papillary muscle heads focalization for such patients. All separated papillary muscle heads are sutured together, and the roots of chordae at each papillary muscle are unifocalized on both sides. Stitches are positioned at the same distances from corresponding leaflet edges to adjust the height of leaflet edges in each segment. This is a simple and effective technique to correct for functional anterior prolapse after annuloplasty.

Aims We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P

OBJECTIVESThe purpose of this study was to evaluate the incidence of new pacemaker implantation (NPMI) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), and investigate its influence on 1-year mortality.METHODSPatients who were enrolled in ‘The German Aortic Valve Registry’ undergoing isolated TAVR or SAVR between 2011 and 2015 were analysed. The rate of NPMI was analysed for both groups and multivariable Cox regression analysis was performed to investigate the possible independent association between NPMI and 1-year mortality.RESULTSTwenty thousand eight hundred and seventy-two patients who underwent TAVR and 17 750 patients who received SAVR were included in this study. The rate of NPMI was 16.6% after TAVR and 3.6% after SAVR. In the TAVR group, NPMI was associated with significantly increased 1-year mortality in univariable Cox regression analysis [hazard ratio (HR) 1.29, confidence interval (CI) 1.18–1.41; P CONCLUSIONSThe rate of NPMI was markedly higher after TAVR compared with SAVR and was independently associated with 1-year mortality after TAVR, whereas this was not significant after SAVR. As 30-day mortality was not different for TAVR and SAVR, the subsequent procedure of an NPMI itself seems not to increase the risk of mortality.

Allein in Europa leiden uber 15 Mio. Menschen an den Folgen einer chronischen Herzinsuffizienz mit einer Pravalenz von 1–2 % pro Jahr. Langzeitergebnisse der SYNTAX-Studie zeigen klare Vorteile bei Patienten mit einer koronaren Herzerkrankung und besonders komplexen Stenosen fur die aortokoronare Bypassoperation. Beim operativen Vorgehen war insbesondere die Re-Interventionsrate im Vergleich zur Intervention deutlich niedriger, und bei Patienten mit hohem SYNTAX-Score (≥ 33) ist dieser Vorteil noch nach 5 Jahren evident. Ohne eine langfristig suffiziente Revaskularisierung kann es zur Ausbildung einer ischamischen Kardiomyopathie (ICM) kommen. Bei diesen Patienten ist eine optimale medizinische Therapie (OMT) mit Diuretika, Angiotensin-Converting-Enzyme- und β-Blockern obligat, und es zeigten sich hier sowohl positive Effekte auf das Remodeling des Myokards als auch die Sterblichkeit der Patienten. Aufgrund der schlechten Prognose der ICM ist es nach wie vor nicht klar, ob die Patienten in diesem Stadium noch von einer Myokardrevaskularisation profitieren. In dieser Hinsicht konnte die multizentrisch-prospektiv randomisierte STICH-Studie in der Langzeitauswertung zeigen, dass eine zur OMT gleichzeitige operative Revaskularisierung die Letalitat reduziert und eine positive Auswirkung auf die Angina-pectoris-Symptomatik hat. Nach Ausschopfung samtlicher konventioneller Therapiestrategien ist die Herztransplantation immer noch der Goldstandard in der Therapie der terminalen Herzinsuffizienz. Weltweit wurden mittlerweile 85 000 Eingriffe dieser Art erfolgreich durchgefuhrt. Bei standig sinkenden Organspenderaten hat sich in den letzten Jahren die Implantation von miniaturisierten Linksherz-Unterstutzungssystemen als akzeptable und jederzeit verfugbare Therapiealternative in der akuten Behandlung der terminalen Herzinsuffizienz etabliert. Bei stark zunehmenden Implantationszahlen bleibt abzuwarten, ob diese Therapiestrategie in der Behandlung der terminalen Herzinsuffizienz auch den gewunschten nachhaltigen und langerfristigen Erfolg zeigt.

Aims New-onset conduction disturbances still represent a considerable problem after transcatheter aortic valve implantation (TAVI). The aim of this study was to identify calcification patterns with an elevated risk for permanent pacemaker implantation (PPI) after TAVI and investigate underlying mechanisms in an ex vivo setting. Methods and results One hundred and sixty-two patients who underwent TAVI with the Edwards SAPIEN XT® or Medtronic CoreValve® at our institution were analysed. The calcium load of the device landing zone was quantified with 3mensio®, and calcium patterns with an elevated risk for PPI were identified. Ex vivo simulations of balloon valvuloplasty were performed in 3D-printed silicone annuli of patients matching the identified risk profile. Patients with a calcium load of the left coronary cusp (LCC) above 209 mm3 had a higher rate of PPI than patients below this threshold (16.7 vs. 2.6%, P = 0.003). Multivariate regression revealed pre-existing right bundle branch block (RBBB) and increased LCC calcification as independent predictors for PPI. Simulation of the TAVI procedure in a silicone annulus revealed an off-centreline shift of the valvuloplasty balloon and transcatheter heart valve away from the LCC towards the commissure between right- and non-coronary cusp. Conclusion Pre-existing RBBB and elevated LCC calcification were identified as independent predictors for PPI. These two risk factors enabled us to distinguish between patients according to their risk for PPI after TAVI. Ex vivo simulations suggested an off-centreline shift of the balloon as a possible explanation.

Red cell distribution width was shown to reliably predict mortality and morbidity in numerous clinical settings, including patients hospitalized on surgical intensive care units (ICU). Patients hospitalized on an ICU usually comprise a very heterogeneous patient population. The aim of this analysis was to investigate whether (1) RDW is related to survival outcomes in patients hospitalized on a medical ICU and (2) the prognostic value of RDW is dependent on the diagnosis that led to ICU admission.829 patients hospitalized on the medical ICU of a tertiary care hospital were retrospectively investigated. Patients were divided in two groups according to the main diagnosis that led to ICU admission. Group 1: non-infectious cardiac disease and group 2: other. The prognostic value of RDW for ICU- and long-term mortality was investigated for the entire patient cohort as well as for the two subgroups.The median RDW of the whole study population was 16.1%. Patients with an RDW above this threshold were exposed to an increased risk for ICU mortality (34.4% vs. 17.2%, p0.001) and long-term mortality (log-rank p0.001). Similarly, this cut-off was able to distinguish patients with an elevated risk for death in subgroup 2 (ICU mortality: 37.9% vs. 19.2%, p0.001; long-term mortality: log-rank p0.001). In subgroup 1, this value was not able to identify patients with an increased risk for ICU-mortality (17.6% vs. 11.8%, p=0.26) as well as long-term mortality (log-rank p=0.3).Data of this analysis revealed that (1) RDW is a powerful predictor for ICU- and long-term mortality in patients hospitalized on a medical ICU and (2) RDW cut-offs to assess risk for death differ according to the main diagnosis that led to ICU admission.

Purpose The aim of this study was to analyze short and long-term outcomes in patients who were treated with veno-arterial extracorporeal membrane oxygenation (vaECMO) for treatment of perioperative low-output-syndrome (LOS) and identify risk factors for in-hospital mortality. Methods All consecutive patients who received vaECMO during or after cardiac surgery at a high volume center between 01/2008 and 12/2017 were identified. This patient cohort was characterized and long-term survival (9 years) was analyzed. Furthermore, a regression analysis was performed to identify risk factors for in-hospital mortality. Results n=576 patients were treated with vaECMO. The mean age was 65±12 years and 37.2% were female. 46.9% underwent elective surgery. Patients underwent isolated coronary bypass in 21.5%, aortic valve replacement in 7.3%, mitral valve replacement or repair in 5%, tricuspid replacement or repair in 2.2% and heart transplantation in 13%. The median logistic EuroSCORE was 23.9% (IQR 10.3-46.2). vaECMO was implanted peripherally through femoral vessels in 56.4% and centrally in 34.9%. 43% could be weaned off vaECMO, while 4.6% were switched to a durable ventricular assist device and 0.4% underwent heart transplantation. In 42%, treatment was terminated at the time of vaECMO explantation. In-hospital and 1-year mortality were 66% and 79.9%, respectively. In univariable analysis, age, severe aortic valve stenosis and EuroSCORE II emerged as risk factors for in-hospital mortality. After multivariable adjustment, age and EuroSCORE II persisted as independent risk factors for in-hospital mortality. Estimated 9-year survival was 8%. For patients who were discharged alive, estimated 9-year survival was 24.8%. Conclusion After treatment of perioperative LOS using vaECMO, 34% of patients could be discharged alive. Overall, in-hospital and long-term mortality were high but acceptable for patients who survived the in-hospital period. In multivariable regression, we found age and EuroSCORE II to be associated with in-hospital death but could not identify more specific risk factors.

Background Although low (but increasing) rates of lung/lung-heart transplantations of scleroderma (systemic sclerosis [SSc]) patients have been reported, exclusive heart transplantation is a rare approach for treatment of heart failure due to SSc. Cases We report on 2 cases of SSc patients receiving a heart transplantation (HTx) due to severe and progressive right heart failure without pulmonary artery hypertension. One patient received a hepatitis C virus (HCV)-positive donor heart and recovered excellently from viral transmission after administration of a direct-acting antiviral (DAA) regimen. This is the first published case of an SSc patient who underwent HTx using an HCV-positive donor heart. The clinical course of both patients was monitored by different serum SSc biomarkers. Only xylosyltransferase activity proved to be a promising biomarker for disease stage determination and therapeutic monitoring, precisely reflecting fibrotic remodeling and successful organ recovery. Conclusions Successful implementation of the 2 cases described here demonstrates that HTx is a safe and effective therapeutic option for defined SSc sub-patient groups despite the progressive character of the underlying disease. In the future, xylosyltransferase activity might be conducive to simplify the identification of patients with low systemic involvement but a strong indication for single heart transplantation. Finally, we demonstrate that treatment of HCV viral transmission from HCV-positive donor to organ recipient using DAA gives us new opportunities to consider HCV-positive donor organs for HTx and might reveal new possibilities to ease the lack of donor organs.

The current state-of-the-art treatment for heart failure patients is aimed at delaying disease progression, relieving symptoms, reducing morbidity and improving survival. Cardiac regeneration of the injured heart, however, is not achieved. Currently, numerous alternative treatment approaches aiming at cardiac regeneration are under investigation. Myocardial tissue engineering strategies follow the idea of in vitro generation of myocardium-like structures for epicardial transplantation. Recently, this field has made tremendous advances regarding in vitro optimization of tissue-engineered constructs, and valuable data have been generated in small animal models. This review summarizes the technical aspects of engineered human myocardium generation, lessons learned from preclinical in vitro and in vivo studies and the current state of this approach on its way to clinical translation.