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Background: The parallel wire technique (PW) is a classic part of the antegrade strategy to open chronic total coronary occlusions (CTO)., Aims: With modern wires and dual-lumen catheters (DLC) the approach has evolved, but this progress had not been evaluated in a contemporary registry of CTO interventions., Method: This analysis is based on 26,589 CTO procedures performed by 36 operators with > 50 procedures annually between 2015 and 2022. The different strategies and techniques were analyzed with respect to clinical and lesion characteristics, procedural resource use and periprocedural complications. Within the antegrade approach, PW was compared to antegrade wire escalation (AWE) and antegrade-dissection re-entry (ADR)., Results: The primary antegrade approach was used in 65.9%, primary retrograde in 16.9% and a strategy change in 17.2% with a wide inter-operator variability. In primary antegrade approach, PW was applied in 10.8% and ADR in 5.3%. Lesion complexity was higher in AWE and PW than with single wire, and highest in ADR procedures, leading to more complex procedures with higher contrast and radiation usage. Complications increased with ADR, while they were similar with PW and AWE. Through the observation period PW adoption increased steadily from 6.7% to 10.7%, as the DLC use facilitating PW increased from 8.3% to 17.0% over the observation period., Conclusion: In this largest database of contemporary CTO PCI from Europe, PW adoption increased over time but remained low at about 10%. While there was a wide individual variety among the operators, it was a safe and successful technique., (© 2024 Wiley Periodicals LLC.)

For over a century, there was a major gap in our understanding of the evolution of the flying Mesozoic reptiles, the pterosaurs, with a major morphological gap between the early forms and the derived pterodactyloids. 1 Recent discoveries have found a cluster of intermediate forms that have the head and neck of the pterodactyloids but the body of the early grade, 2 yet this still leaves fundamental gaps between these intermediates and both earlier and more derived pterosaurs. Here, we describe a new and large Jurassic pterosaur, Skiphosoura bavarica gen. et sp. nov., preserved in three dimensions, that helps bridge the gap between current intermediate pterosaurs and the pterodactyloids. A new phylogeny shows that there is a general progression of key characteristics of increasing head size, increasing length of neck and wing metacarpal, modification to the fifth toe that supports the rear wing membrane, and gradual reduction in tail length and complexity from earlier pterosaurs into the first pterodactyloids. This also shows a clear evolution of the increasing terrestrial competence of derived pterosaurs. Furthermore, this closes gaps between the intermediates and their ancestors and descendants, and it firmly marks the rhamphorhynchines and ctenochasmatid clades as, respectively, being the closest earliest and latest groups to this succession of transitional forms., Competing Interests: Declaration of interests The authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) present as a main feature ≤50% stenosis upon angiography despite clinical symptoms and biomarker elevation related to acute coronary syndrome. Due to broad availability of high sensitivity troponin testing as well as invasive and non-invasive imaging, this clinical entity receives increasing clinical awareness., Objective: We aimed to investigate the in-hospital work flow and economic impact of MINOCA vs. MICAD (myocardial infarction with obstructive coronary artery disease) patients and related clinical outcomes in a single-center patient collective of a large university heart center in Germany., Methods: We retrospectively screened and analyzed all patients who were admitted to our hospital under the suspicion of an acute coronary syndrome within a 12-month period (2017-2018) for further diagnostics and treatment. All included patients showed a pathological troponin elevation and received invasive coronary angiography for acute coronary syndrome. Associated in-hospital costs, procedural and various clinical parameters as well as timelines and parameters of work-flow were obtained., Results: After screening of 3,021 patients, we included 660 patients with acute coronary syndrome. Of those, 118 patients were attributed to the MINOCA-group. 542 patients presented with a "classical" myocardial infarction (MICAD group). MINOCA patients were less frail, more likely female, but showed no relevant difference in age or other selected comorbidities except for fewer cases of diabetes. In-hospital mortality (11% vs. 0%; p  < 0.001) and 30-day mortality (17.3% vs. 4.2%; p  < 0.001) after the index event were significantly higher in the "classical" myocardial infarction group (MICAD)- Despite a shorter overall length of hospital stay (9.5 ± 8.7 days vs. 12.3 ± 10.5 days, p  < 0.01) with a significantly shorter duration of high care monitoring (intensive/intermediate care or chest pain units) (2.4 ± 2.1 days vs. 4.7 ± 3.3 days, p  < 0.01) MINOCA patients consumed a relevant contingent of hospital resources. Thus, in a 12-months period a total sum of almost 300 days was attributed to high care monitoring for MINOCA patients with a mean difference of approximately 50% compared to patients with classical myocardial infarction. With average and median costs of 50% less per index, MINOCA treatment costs were lower compared to the MICAD group in the hospital reimbursement system of Germany. Consequently, MINOCA treatment was not associated with a relevant profit for these expanses and a relevant share of nearly 40% of the total costs was generated due to high care monitoring., Conclusion: In light of lower mortality than MICAD and growing scarcity of staff, financial and capacity resources the clinical symptom complex of MINOCA should be put under particular consideration for refining care concepts and resource allocation., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Haertel, Montag, Kraeplin, Lauer, Memisevic, Moebius-Winkler, Schulze and Otto.)

The fossil record of chondrichthyans (chimaeras, sharks, rays and skates) consists largely of isolated teeth, with holomorphic specimens being extraordinary exceptions. However, numerous of these more or less completely preserved specimens are known from several Upper Jurassic deposits of Europe, enabling detailed analysis of their morphology. Batomorphs (rays and skates) resembling modern guitarfishes and wedgefishes (Rhinopristiformes) are among the most common Jurassic chondrichthyans found, but they have been only sporadically studied up to now, resulting in large knowledge gaps concerning their taxonomy and phylogeny. Here, we present the most detailed revision of Late Jurassic holomorphic batomorphs to date, quantitatively analysing body proportions of specimens from Germany (Solnhofen Archipelago), France (Cerin) and the UK (Kimmeridge), using both geometric and traditional morphometrics. Furthermore, we identify qualitative morphological characters for species discrimination, to clarify the taxonomic identity and diversity of Late Jurassic batomorphs based on holomorphic specimens. Our results support the validity of Belemnobatis sismondae, Kimmerobatis etchesi and Spathobatis bugesiacus , as well as that of the previously doubtful Asterodermus platypterus . Moreover, we describe Aellopobatis bavarica , a new taxon, which has hitherto been considered to be a large-sized morphotype of Spathobatis bugesiacus . Our results highlight that the diversity of holomorphic batomorphs during the Late Jurassic was greater than previously thought, and suggest that this group was already well-established and diverse by this time. This study thus provides vital information about the evolutionary history of Late Jurassic batomorphs and has direct implications for batomorph species that are based on isolated teeth only.

Introduction: Despite the prospective randomized controlled JAVELIN Bladder 100 trial, no real-world evidence exists regarding tumor characteristics, adverse events (AEs), and survival of avelumab maintenance (AVM)-treated patients with partial/complete response or stable disease after previous platinum-based chemotherapy for advanced/metastatic urothelial carcinoma (mUC)., Methods: We relied on our institutional database to identify mUC patients who received AVM between January, 2021 and December, 2023. The main outcomes consisted of overall survival (OS) and progression-free survival (PFS) and were computed by Kaplan-Meier estimates. Stratification was performed according to programmed death ligand 1 (PD-L1) status., Results: Overall, 24 AVM patients were identified at a median age of 71 (interquartile range [IQR]: 67-76) years, of which 67% were males. Of these, 63%, 21%, and 17% received AVM therapy for bladder cancer and upper tract urothelial carcinoma or both, respectively. PD-L1 status was positive in 45% of patients. During AVM treatment, AEs were observed in 33% of patients; however, they were limited to ≤2 grade AEs. At a median follow-up of eight (IQR 4-20) months, 71% of patients had progressed under AVM with median PFS of 6.2 months (confidence interval [CI]: 3.2-18.2). Median OS was 13.4 (CI: 6.9 - not reached [NR]) months. One-year OS after AVM was 52%. In PD-L1-positive patients, median PFS and OS were 6.4 (CI: 2.7 - NR) months and 13.4 (CI: 7.7 months - NR), respectively., Conclusion: AVM is associated with moderate AE rates. Despite similarities in baseline characteristics compared to trial-selected JAVELIN Bladder 100 mUC patients, AVM resulted in longer/similar PFS but significantly shorter OS in real-world setting., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Background: Percutaneous coronary intervention (PCI) for chronic total coronary occlusions (CTO) improves clinical symptoms and quality of life. The longer-term safety of PCI compared to optimal medical therapy (OMT) remains uncertain., Aims: We sought to evaluate the long-term safety of PCI for CTO in a randomised trial as compared to OMT., Methods: A total of 396 patients with a symptomatic CTO were enrolled into a randomised, multicentre clinical trial comparing PCI and OMT. Half of the patients had a single CTO; the others had multivessel disease. Non-CTO lesions were treated prior to randomisation (2:1 ratio). During follow-up, crossover from OMT to PCI occurred in 7.3% (1 year) and 17.5% (3 years) of patients., Results: At 3 years, the incidence of cardiovascular death or nonfatal myocardial infarction was not significantly different between the groups (OMT 3.7% vs PCI 6.2%; p=0.29). By per-protocol analysis, the difference remained non-significant (OMT 5.7% vs PCI 4.7%; p=0.67). Overall, major adverse cardiovascular events (MACE) were more frequent with OMT (OMT 21.2% vs PCI 11.2%), largely because of ischaemia-driven revascularisation. The rates of stroke or hospitalisation for bleeding were not different between the groups., Conclusions: At 3 years there was no difference in the rate of cardiovascular death or myocardial infarction between PCI or OMT among patients with a remaining single coronary CTO. The MACE rate was higher in the OMT group due largely to ischaemia-driven revascularisation. CTO PCI appears to be a safe option for patients with a single remaining significant coronary CTO. CinicalTrials.gov: NCT01760083.

Background and Aims: Currently, less than 20% of patients at very high-risk achieve ESC/EAS dyslipidemia guideline-recommended LDL-C target levels in Europe. "Jena auf Ziel-JaZ" is a prospective cohort study in which early combination therapy with atorvastatin 80 mg and ezetimibe 10 mg was initiated on admission in patients with ST-elevation myocardial infarction (STEMI) and lipid-lowering therapy was escalated during follow-up with bempedoic acid and PCSK9 inhibitors to achieve recommended LDL-C targets in all patients. Moreover, we evaluated side-effects of lipid-lowering therapy., Methods: Patients admitted with STEMI at Jena University Hospital were started on atorvastatin 80 mg and ezetimibe 10 mg on admission. Patients were followed for EAS/ESC LDL-C target achievement during follow-up., Results: A total of 85 consecutive patients were enrolled in the study. On discharge, 32.9% achieved LDL-C targets on atorvastatin 80 mg and ezetimibe 10 mg. After 4-6 weeks, 80% of all patients on atorvastatin 80 mg and ezetimibe started at the index event were on ESC/EAS LDL-C targets. In 20%, combined lipid-lowering therapy was escalated with either bempedoic acid or PCSK9 inhibitors. All patients achieved LDL-C levels of or below 55 mg/dL during follow-up on triple lipid-lowering therapy. Combined lipid-lowering therapy was well-tolerated with rare side effects., Conclusions: Early combination therapy with a high-intensity statin and ezetimibe and escalation of lipid-lowering therapy with either bempedoic acid or PCSK9 inhibitors gets potentially all patients with STEMI on recommended ESC/EAS LDL-C targets without significant side effects., (© 2023. The Author(s).)

Background: The aim of this study was to describe the mechanism of subintimal shift (SIS), standardise diagnostic criteria and sensitise the interventional community to this phenomenon. The treatment of chronic total occlusions (CTO) by means of percutaneous coronary intervention (PCI) is complicated by bifurcation lesions involved in the CTO segment or adjacent to it. Extraplaque expansion of intracoronary devices during CTO PCI may extend the dissection plane over the bifurcation with the consequential side or main branch compression by an intimo-medial flap. This phenomenon is hereby described for the first time and named subintimal shift., Methods: Experienced CTO operators from 3 international high volume centers for CTO PCI retrospectively searched their personal records for paradigmatic cases of SIS, summarising key features and proposing diagnostic criteria., Results: The series comprised 7 demonstrative cases, illustrating SIS by intravascular imaging (2 cases) or indirect angiographic signs during CTO PCI (5 cases). Five cases were triggered by stent expansion, 1 by balloon inflation and 1 case was aborted after angiographic warning signs. In 4 cases, SIS resulted in total occlusion of a branch, refractory to ballooning whenever attempted. Four cases required bailout intervention and in 2 cases the branch was left occluded, resulting in a rise of cardiac markers., Conclusions: Subintimal shift is a noteworthy complication in CTO bifurcations, potentially resulting in occlusion of the relevant side or even the main branch. Intracoronary imaging prior to stenting is recommended to understand the tissue planes. Some counterintuitive peculiarities of this phenomenon, like its refractoriness to ballooning, must be known by CTO operators for its efficient resolution.

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) in coronary bifurcation lesions (CBL) is undergoing substantial technical progress and standardization, paralleling the evolution of dedicated devices, tools, and techniques. A standard consensus to classify CTO-CBL might be instrumental to homogenize data collection and description of procedures for scientific and educational purposes. The Medina-CTO classification replicates the classical three digits in Medina classification for bifurcations, representing the proximal main vessel, distal main vessel, and side branch, respectively. Each digit can take a value of 1 if it concerns atherosclerosis and is anatomically stenosed, or 0 if it is not. In addition, the occluded segment(s) of the bifurcation are noted by a subscript, which describes key interventional features of the cap: t (tapered), b (blunt), or a (ambiguous). This approach results in 56 basic categories that can be grouped by means of different elements, depending on the specific needs of each study. Medina-CTO classification, consisting of adding a subscript describing the basic cap characteristics to the totally occluded segment(s) of the standard Medina triplet, might be a useful methodological tool to standardize percutaneous intervention of bifurcational CTO lesions, with interesting scientific and educational applications.

Objective: Chinese-American patients use CIH at high rates but disclosure of CIH use to clinicians is low. Further, the content of CIH talk between patients and their clinicians is not well described. We aimed to characterize CIH talk between Chinese-American patients and their primary care clinicians., Methods: Discourse analysis of 70 audio-recordings of language concordant and discordant-interpreted visits., Results: Nearly half of all visits (48.6%) had some form of CIH communication. 'Simple CIH talk' focused on a single CIH topic resulting in a positive, neutral, or negative response by clinicians. 'CIH-furthering talk' was characterized by clinicians and patients addressing more than one CIH topic or including a combination of orientations to CIH by both clinicians and patients. CIH-furthering talk characterized by clinician humility could enhance rapport, cultural understanding, and open communication. CIH-furthering talk also led to miscommunication and retreat toward biomedicine., Conclusion: CIH communication occurred frequently during language concordant and discordant-interpreted visits with Chinese-American patients. Both patients and clinicians used CIH-furthering talk as a conversational resource for managing care., Innovation: This discourse analysis of visits between Chinese-American patients and their clinicians advances understanding of CIH communication beyond disclosure, illustrating the complexity of linguistic and cultural nuances that affect patient care., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Leah Karliner reports financial support was provided by Patient-Centered Outcomes Research Institute. Leah Karliner reports financial support was provided by National Institutes of Health. Jane Jih reports financial support was provided by National Institutes of Health.

Introduction: Cardiogenic shock due to myocardial infarction or heart failure entails a reduction in end organ perfusion. Patients who cannot be stabilized with inotropes and who experience increasing circulatory failure are in need of an extracorporeal mechanical support system. Today, small, percutaneously implantable cardiac assist devices are available and might be a solution to reduce mortality and complications. A temporary, ventricular, continuous flow propeller pump using magnetic levitation (Impella ® ) has been approved for that purpose., Methods and Study Design: JenaMACS (Jena Mechanical Assist Circulatory Support) is a monocenter, proof-of-concept study to determine whether treatment with an Impella CP ® leads to improvement of hemodynamic parameters in patients with cardiogenic shock requiring extracorporeal, hemodynamic support. The primary outcomes of JenaMACS are changes in hemodynamic parameters measured by pulmonary artery catheterization and changes in echocardiographic parameters of left and right heart function before and after Impella ® implantation at different support levels after 24 h of support. Secondary outcome measures are hemodynamic and echocardiographic changes over time as well as clinical endpoints such as mortality or time to hemodynamic stabilization. Further, laboratory and clinical safety endpoints including severe bleeding, stroke, neurological outcome, peripheral ischemic complications and occurrence of sepsis will be assessed. JenaMACS addresses essential questions of extracorporeal, mechanical, cardiac support with an Impella CP ® device in patients with cardiogenic shock. Knowledge of the acute and subacute hemodynamic and echocardiographic effects may help to optimize therapy and improve the outcome in those patients., Conclusion: The JenaMACS study will address essential questions of extracorporeal, mechanical, cardiac support with an Impella CP ® assist device in patients with cardiogenic shock. Knowledge of the acute and subacute hemodynamic and echocardiographic effects may help to optimize therapy and may improve outcome in those patients., Ethics and Dissemination: The protocol was approved by the institutional review board and ethics committee of the University Hospital of Jena. Written informed consent will be obtained from all participants of the study. The results of this study will be published in a renowned international medical journal, irrespective of the outcomes of the study. Strengths and Limitations: JenaMACS is an innovative approach to characterize the effect of additional left ventricular mechanical unloading during cardiogenic shock via a minimally invasive cardiac assist system (Impella CP ® ) 24 h after onset and will provide valuable data for acute interventional strategies or future prospective trials. However, JenaMACS, due to its proof-of-concept design, is limited by its single center protocol, with a small sample size and without a comparison group.

Background: Percutaneous mitral valve (MV) clipping for mitral regurgitation (MR) revolutionized MV repair; however, valve anatomies and pathologies vary. Often multiple clips are required, and predicting this pre-procedurally would be useful. We evaluated pre-procedural predictors for multiple clips., Results: We retrospectively analyzed 127 severe MR patients treated by mitral clipping between January 2011 and August 2018. Patients were grouped according to the use of a single (group I) or multiple clips (group II) and pre-procedure echocardiographs compared. No demographic differences existed except group II had more males (68.1%) than group I (48.3%). Mean left atrial diameter was larger in group II, 51 ± 9 mm, than group I, 48 ± 5 mm, p = 0.026. Mean mitral annular diameter differed: 34 ± 4mm (group II) versus 33 ± 3 mm (group I), p = 0.017. The vena contracta was broader in group II than group I (6.6 ± 1 mm vs. 6 ± 0.9 mm, p = 0.001). Severe mitral annular calcification occurred more in group I (36.2%) than group II (10.1%), p = 0.0001. On multivariate analysis, vena contracta width correlated positively with multiple clips (B 0.125, p = 0.013), but severe annular calcification correlated inversely (B - 0.35, p = 0.002)., Conclusions: Vena contracta width and severe annular calcification are factors to consider when planning MV clipping., (© 2021. The Author(s).)

Background: Since January 2018 performance of urethroplasties is done on regular basis at the University Hospital Frankfurt (UKF). We aimed to implement and transfer an institutional standardized perioperative algorithm for urethral surgery (established at the University Hospital Hamburg-Eppendorf-UKE) using a validated Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM) in patients undergoing urethroplasty at UKF. Materials and Methods: We retrospectively analyzed all patients who underwent urethroplasty for urethral stricture disease between January 2018 and January 2020 at UKF. All patients were offered to revisit for clinical follow-up (FU) and completion of USS-PROM. Primary end point was stricture recurrence-free survival (RFS). Secondary endpoints were functional outcomes, quality of life (QoL), and patient satisfaction. Results: In total, 50 patients underwent urethroplasty and 74 and 24% had a history of previous urethrotomy or urethroplasty, respectively. A buccal mucosal graft urethroplasty was performed in 86% ( n = 43). After patient's exclusion due to lost of FU, FU <3 months, and/or a pending second stage procedure, 40 patients were eligible for final analysis. At median FU of 10 months (interquartile-range 5.0-18.0), RFS was 83%. After successful voiding trial, the postoperative median Qmax significantly improved (24.0 vs. 7.0 mL/s; p < 0.01). Conversely, median residual urine decreased significantly (78 vs. 10 mL; p < 0.01). Overall, 95% of patients stated that QoL improved and 90% were satisfied by the surgical outcome. Conclusions: We demonstrated a successful implementation and transfer of an institutional standardized perioperative algorithm for urethral surgery from one location (UKE) to another (UKF). In our short-term FU, urethroplasty showed excellent RFS, low complication rates, good functional results, improvement of QoL and high patient satisfaction. PROMs allow an objective comparison between different centers., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer SAh declared a past co-authorship with several of the authors RD, MV, MF, FK-HC, AB, and LK to the handling editor., (Copyright © 2020 Wenzel, Krimphove, Lauer, Hoeh, Müller, Mandel, Becker, Vetterlein, Mueller, Dahlem, Fisch, Chun, Kluth and for the Trauma and Reconstructive Urology Working Party of the European Association of Urology Young Academic Urologists (EAU YAU).)

Aims: To investigate the long-term prognostic value of aspiration thrombectomy in conjunction with primary percutaneous coronary intervention (PCI) compared to conventional PCI in patients with non-ST-elevation myocardial infarction (NSTEMI)., Methods: In the randomized TATORT-NSTEMI (Thrombus aspiration in thrombus containing culprit lesions in non-ST-elevation myocardial infarction) trial, NSTEMI patients with thrombus containing culprit lesions were randomized to either PCI with aspiration thrombectomy or conventional PCI. The endpoint was a combination of all-cause death, reinfarction and new congestive heart failure., Results: From 440 patients initially randomized, outcome data were available in 432 (98.2%) patients at a median follow-up of 4.9 (interquartile range [IQR] 4.4-5.0) years. Thrombectomy was associated with a significant reduction of the combined endpoint compared to conventional PCI (19.9% vs. 30.7%, p = 0.01). This finding was primarily driven by a reduced rate of reinfarction with thrombectomy (3.4% vs. 10.3%, p = 0.01). Thrombectomy was still independently associated with the combined endpoint after multivariable adjustment (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.30-0.76, p = 0.002). Findings were consistent across all analyzed subgroups (p values for interaction all > 0.05)., Conclusions: In NSTEMI, thrombus aspiration is associated with favorable clinical outcome during long-term follow-up., Clinical Trial Registration: NCT01612312.

Aims: Drug-coated balloons (DCB) may avoid stent-associated long-term complications. This trial compared the clinical outcomes of patients with non-ST-elevation myocardial infarction (NSTEMI) treated with either DCB or stents., Methods and Results: A total of 210 patients with NSTEMI were enrolled in a randomised, controlled, non-inferiority multicentre trial comparing a paclitaxel iopromide-coated DCB with primary stent treatment. The main inclusion criterion was an identifiable culprit lesion without angiographic evidence of large thrombus. The primary endpoint was target lesion failure (TLF; combined clinical endpoint consisting of cardiac or unknown death, reinfarction, and target lesion revascularisation) after nine months. Secondary endpoints included total major adverse cardiovascular events (MACE) and individual clinical endpoints. Mean age was 67±12 years, 67% were male, 62% had multivessel disease, and 31% were diabetics. One hundred and four patients were randomised to DCB, 106 to stent treatment. In the stent group, 56% of patients were treated with BMS, 44% with current-generation DES. In the DCB group, 85% of patients were treated with DCB only whereas 15% underwent additional stent implantation. During a follow-up of 9.2±0.7 months, DCB treatment was non-inferior to stent treatment with a TLF rate of 3.8% versus 6.6% (intention-to-treat, p=0.53). There was no significant difference between BMS and current-generation DES. The total MACE rate was 6.7% for DCB versus 14.2% for stent treatment (p=0.11), and 5.9% versus 14.4% in the per protocol analysis (p=0.056), respectively., Conclusions: In patients with NSTEMI, treatment of coronary de novo lesions with DCB was non-inferior to stenting with BMS or DES. These data warrant further investigation of DCB in this setting, in larger trials with DES as comparator (ClinicalTrials.gov Identifier: NCT01489449).

Introduction: There is still an ongoing debate whether a transrectal ultrasound (TRUS) approach for prostate biopsies is associated with higher (infectious) complications rates compared to transperineal biopsies. This is especially of great interests in settings with elevated frequencies of multidrug resistant organisms (MDRO). Materials and Methods: Between 01/2018 and 05/2019 230 patients underwent a TRUS-guided prostate biopsy at the department of Urology at University Hospital Frankfurt. Patients were followed up within the clinical routine that was not conducted earlier than 6 weeks after the biopsy. Among 230 biopsies, 180 patients took part in the follow-up. No patients were excluded. Patients were analyzed retrospectively regarding complications, infections and underlying infectious agents or needed interventions. Results: Of all patients with follow up, 84 patients underwent a systematic biopsy (SB) and 96 a targeted biopsy (TB) after MRI of the prostate with additional SB. 74.8% of the patients were biopsy-naïve. The most frequent objective complications (classified by Clavien-Dindo) lasting longer than one day after biopsy were hematuria (17.9%, n = 32), hematospermia (13.9%, n = 25), rectal bleeding (2.8%, n = 5), and pain (2.2%, n = 4). Besides a known high MDRO prevalence in the Rhine-Main region, only one patient (0.6%) developed fever after biopsy. One patient each (0.6%) consulted a physician due to urinary retention, rectal bleeding or gross hematuria. There were no significant differences in complications seen between SB and SB + TB patients. The rate of patients who consulted a physician was significantly higher for patients with one or more prior biopsies compared to biopsy-naïve patients. Conclusion: Complications after transrectal prostate biopsies are rare and often self-limiting. Infections were seen in <1% of all patients, regardless of an elevated local prevalence of MDROs. Severe complications (Clavien-Dindo ≥ IIIa) were only seen in 3 (1.7%) of the patients. Repeated biopsy is associated with higher complication rates in general., (Copyright © 2020 Wenzel, Theissen, Preisser, Lauer, Wittler, Humke, Bodelle, Ilievski, Kempf, Kluth, Chun, Mandel and Becker.)

Objective. We investigated the influence of functional impairment assessed by the Barthel index (BI) on the three-month outcomes after transfemoral-transcatheter aortic valve intervention (TF-TAVI) under general anesthesia. Design . We included retrospectively analyzed 336 patients undergoing TAVI between January 2017 and January 2018 in central hospital, Bad Berka, Germany. All patients were followed up at three-month in our center's outpatient clinic. We stratified the patients according to the BI. Results . At baseline, 76 patients had a BI <80. Patients with a BI <80 were characterized by advanced age (80.6 ± 5.6 vs. 83 ± 4.1 years. p  = .027), diabetes mellitus on insulin and higher surgical risk scores. A prior cerebral ischemic event was recorded more in patients with a BI ≥80. Regarding intermediate outcomes, three-month mortality was significantly higher in patients with a BI <80. Patients with a BI <80 developed significantly more postoperative cardiac decompensation, delirium and strokes. Patients with BI <80 had lower hemoglobin level preoperative and needed more blood transfusion postoperative. Other valve academic research consortiums (VARCs) complications were equally distributed in both groups. A BI <80 was associated with prolonged postoperative hospital stay and was an independent predictor of FT protocol failure (OR 4; CI 95% 1.3-11. p .02). Conclusions . A BI <80 is associated with increased mortality and risk of neurological events and cardiac decompensations after TF TAVI. A BI <80 is an independent predictor of failure in fast track TAVI.

Aims: In the absence of randomised data, we aimed to compare the transapical ACURATE and transfemoral ACURATE neo with the SAPIEN 3 prosthesis using propensity matching., Methods and Results: From 2012 to 2016, 1,306 patients at three German centres received either the ACURATE/ACURATE neo prosthesis (n=591) or the SAPIEN 3 prosthesis (n=715). Through nearest neighbour matching with exact allocation for access route and centre, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Patients were 81 years old on average and had a logistic EuroSCORE I of 19%. Predilatation and post-dilatation were more frequent in the ACURATE group (97.6% versus 52.1%, p<0.001 for predilatation and 40.4% versus 11.6%, p<0.001 for post-dilatation), but rapid pacing for implantation was used less frequently (37.1% versus 98.2%, p<0.001). More-than-mild aortic regurgitation at postoperative echocardiography was 12.0% for the ACURATE group and 3.1% for the SAPIEN group, p≤0.001). More-than-mild aortic regurgitation in the ACURATE group differed amongst the centres with 6.0% (3/50) in centre A, 34.1% (29/85) in centre B and 3.4% (6/181) in centre C. Patients in the ACURATE group less frequently had pacemaker implantation compared to the SAPIEN 3 group (11.9% versus 18.5%, p=0.020), 30-day mortality was 4.6% versus 2.1%, respectively, p=0.134, and one-year survival was 83.1% (95% CI: 77.6-87.4) versus 88.8% (95% CI: 84.0-92.2)., Conclusions: In this propensity score analysis, patients treated with the transapical ACURATE or transfemoral ACURATE neo prosthesis less frequently had pacemakers at 30 days but had more aortic regurgitation and lower one-year survival.

Background: It is known that patients with acute coronary syndromes (ACS) and diabetes mellitus (DM) are at higher risk for in-hospital adverse events. However, we hypothesized that the higher event rate is due to the patients' subgroup with renal failure (RF), a common sequel of DM., Methods and Results: We used data of the prospective ALKK-PCI registry including all consecutive percutaneous coronary interventions (PCI) for ACS of 48 hospitals between 2008 and 2013. We divided 69,651 patients in four groups according to their history of DM and RF (GFR < 60 ml/min). All-cause, in-hospital mortality of the following four groups: noDM/noRF, DM/noRF, DM/RF, RF/noDM, was: 3.5%, 6.6%, 21.9%, and 14.1% for STEMI and 1.5%, 2.1%, 7.2%, and 5.4% for NSTE-ACS. In a multivariate analysis we looked for independent mortality-predictors. Odds ratios with confidence intervals for the following variables: DM without RF, DM with RF, RF without DM were: 1.62 (1.37-1.90), 3.02 (2.43-3.76), and 2.13 (1.80-2.52) for STEMI and 1.20 (0.99-1.45), 2.72 (2.18-3.88), and 2.08 (1.69-2.56) for NSTE-ACS. We also calculated mortality in four groups (60-90, 45-60, 45-30, <30 ml/min) according to the estimated glomerular filtration rate (eGFR). Mortality rates were: 5.0%, 12.8%, 17.7%, and 31.5% for STEMI and 2.1%, 3.8%, 7.1%, and 12.0% for NSTE-ACS (p for trend <0.0001 for both)., Conclusions: In-hospital death after PCI in patients with ACS and DM is mainly observed in the subgroup with co-existing RF. In a multivariate analysis, DM without RF was a significant mortality-predictor in STEMI, but not in NSTE-ACS. RF, irrespective of co-existent DM, was a stronger predictor than DM alone for both ACS-types (OR > 3) and mortality increased with decreasing eGFR., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: The Heart Team (HT) discussion has been incorporated in the current guidelines for myocardial revascularization in order to optimize treatment decisions for patients with multivessel coronary disease (MVD). There are no data in the literature, whether hierarchical issues do have an impact on HT decisions. We aimed to analyze the therapeutic recommendations of the multidisciplinary "Heart Team" (HT) for coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) if: (a) The head of cardiovascular surgery (HOS) and the head of cardiology (HOC) were present during the HT meeting, (b) both directors were absent, (c) only HOS or HOC was present. Methods: Retrospective analysis of all HT discussions between 2012 and 2015 in patients with isolated MVD (without any other cardiac problems requiring surgery). Results: During the study period, we analyzed 209 HT discussions in patients with isolated MVD. If neither HOS nor HOC was present at the HT discussion, the therapeutic recommendation was in 69% CABG and 31% PCI. If HOS and HOC were present in 77% CABG and 23% PCI was recommended ( p = 0.34). If only HOS was present therapeutic recommendation was in 83% CABG and 17% PCI, and if only HOC was present the recommendation was in 54% CABG and 46% PCI ( p < 0.0001). This difference did not attenuate during the study period. Conclusions: The hierarchy of the participating physicians significantly impacts treatment recommendations of a multidisciplinary HT in patients with isolated MVD. This impact did not attenuate after several years of Heart Team interaction.

Objectives: The aim was to establish a contemporary scoring system to predict the outcome of chronic total occlusion coronary angioplasty., Background: Interventional treatment of chronic total coronary occlusions (CTOs) is a developing subspecialty. Predictors of technical success or failure have been derived from datasets of modest size. A robust scoring tool could facilitate case selection and inform decision making., Methods: The study analyzed data from the EuroCTO registry. This prospective database was set up in 2008 and includes >20,000 cases submitted by CTO expert operators (>50 cases/year). Derivation (n = 14,882) and validation (n = 5,745) datasets were created to develop a risk score for predicting technical failure., Results: There were 14,882 patients in the derivation dataset (with 2,356 [15.5%] failures) and 5,745 in the validation dataset (with 703 [12.2%] failures). A total of 20.2% of cases were done retrogradely, and dissection re-entry was performed in 9.3% of cases. We identified 6 predictors of technical failure, collectively forming the CASTLE score (Coronary artery bypass graft history, Age (≥70 years), Stump anatomy [blunt or invisible], Tortuosity degree [severe or unseen], Length of occlusion [≥20 mm], and Extent of calcification [severe]). When each parameter was assigned a value of 1, technical failure was seen to increase from 8% with a CASTLE score of 0 to 1, to 35% with a score ≥4. The area under the curve (AUC) was similar in both the derivation (AUC: 0.66) and validation (AUC: 0.68) datasets., Conclusions: The EuroCTO (CASTLE) score is derived from the largest database of CTO cases to date and offers a useful tool for predicting procedural outcome., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Context: With more cement augmentation procedures done, the occurrence of serious complications is also expected to rise. Symptomatic central cement embolization is a rare but very serious complication. Moreover, the pathophysiology and treatment of intrathoracic cement embolism remain controversial., Purpose: In this case series, we are trying to identify various presentations and suggest our emergent management scheme for symptomatic central cement embolization., Patient Sample: Retrospective case series of nine patients with symptomatic central cement embolism identified after vertebroplasty with 24 months of follow-up. Level IV., Outcome Measures: The degree of dyspnea measured by the New York Heart Association (NYHA) score and/or death related to cement embolism induced cardio/respiratory failure at the final follow-up at 24 months., Methods: The nine patients, eight females, and one male had a mean age of 70.25 years (range 65-78 years) and were operated between January 2004 and December 2014. They had percutaneous vertebroplasty for osteoporotic non-traumatic and malignant vertebral collapse of dorsal and lumbar vertebrae. Post-vertebroplasty dyspnea and stitching chest pain were striking in the nine patients. After exclusion of cardiac ischemia and medical pulmonary causes for dyspnea, we identified radiopaque lesions on the chest X-ray. Further echocardiography and high-resolution chest CT were performed for optimal localization. Emergent heart surgery was performed in two patients: interventional therapy was conducted in one patient, while the remaining six patients were conservatively treated by anticoagulation. The management decision was taken in the setting of an interdisciplinary meeting depending on localization, fragmentation, and clinical status., Results: All patients of this series showed gradual improvement and an uneventful hospital stay. During our 24-month follow-up phase, eight patients showed no subsequent cardiological and/or respiratory symptoms (NYHA I). However, one mortality due to advanced malignancy occurred. Preoperative anemia was the only common intersecting preoperative parameter among these nine patients., Conclusions: After cement augmentation, close clinical monitoring is mandatory. A chest CT is pivotal in determining the interdisciplinary management approach in view of the availability of necessary expertise, facilities and the location of the cement emboli whether accessible by cardiac or vascular surgical means. The clinical presentation and its timing may vary and the patient may be seen subsequently by other health care providers obligating a wide-spread awareness for this serious entity among health care providers for this age group as spine surgeons, family and emergency room doctors, and institutional or home-care nurses. Most symptomatic central cement emboli may be treated conservatively.

Background: The study focuses on the evolution of practice, procedural outcomes, and in-hospital complications of chronic total occlusion percutaneous coronary intervention in Europe., Methods and Results: Data from 17 626 procedures enrolled in European Registry of Chronic Total Occlusion between January 2008 and June 2015 were assessed. The mean patient age was 63.9±10.9 years; 85% were men. Procedural success increased from 79.7% to 89.3% through the study period. Patients enrolled during the years had increasing comorbidities and lesion complexity (J-CTO score [Multicenter CTO Registry of Japan] increased from 1.76±1.03 in 2008 to 2.17±0.91 in 2015; P for trend, <0.001). Retrograde approach utilization steadily increased from 10.1% in 2008 to 29.9% in 2015 ( P for trend, <0.001). Antegrade dissection reentry adoption was low, not exceeding 5.5%. In-hospital mortality decreased during the study period from 0.4% to 0.1% ( P for trend, <0.001), whereas in-hospital complication rates remained essentially unchanged, in the range 4.4% to 5.2% ( P for trend, 0.390)., Conclusions: Chronic total occlusion percutaneous coronary intervention has shown a steady increase in procedural success rate over time, with unchanged complication rates, despite the increasing complexity of the lesions attempted. The J-CTO score predictive value for procedural success was low for the entire registry and had no predictive ability for the retrograde approach.

Aims: The aim of this study was to analyze whether local application of 3% hydrogen peroxide (H2O2) additionally to standard antibiotic prophylaxis following implantation of cardiac implantable electronic devices (CIED) reduces the incidence of pocket infections (PI)., Methods: In this observational case-control study every patient from the group additionally treated with H2O2 was matched with two patients out of the control group for age, male-gender, body-mass-index and operation time. The incidence of PI within 365 days after device implantation was compared., Results: During the 5-year study period, 429 consecutive patients were additionally treated with H2O2 and matched with 858 patients undergoing standard treatment (mean age 69 ± 12 years, 876 males (67.4%), body-mass-index 28 ± 4.0 kg/m 2 and operation time 45 ± 23 min). Except for a more frequent use of dual-platelet-inhibition in the H2O2-group, clinical characteristics were otherwise similar. A total of 23 (1.78%) PIs occurred, most of them (14/23; 61%) during the first 45 days after implantation procedure. The use of H2O2 was associated with a significant reduction (3/429 = 0.69% versus 20/858 = 2.33%; p = 0.04), although patients of the H2O2 treated group received more complex procedures increasing the risk of PI., Conclusion: Intraoperative local application of 3% H2O2 seems to be associated with a significant reduced incidence of PI following implantation of CIED. Because of its non-randomized character this trial should be considered as a hypothesis generating study., (Copyright © 2018 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.)

Aims: Transcatheter valve-in-valve implantation (VinV) is established for the treatment of degenerated surgical bioprostheses in patients at high operative risk. Our aim was to report on the first large assessment of VinV with next-generation balloon-expandable transcatheter heart valves., Methods and Results: After SAPIEN XT or SAPIEN 3 VinV, 514 patients were analysed using an inverse probability of treatment weighting. Standardised clinical and haemodynamic outcomes were compared, and core laboratory evaluation of implantation depth was performed. Thirty-day all-cause mortality was 0.6% and 3.5% for SAPIEN 3 and SAPIEN XT (p=0.077). Residual transprosthetic gradient ≥20 mmHg was observed in 38.3% (SAPIEN 3) and 35.7% (SAPIEN XT) of patients (p=0.627) with increased rates in small bioprostheses (≤21 mm true ID). In SAPIEN 3 VinV, low implantation depth >20% THV stent frame length was associated with a higher rate of elevated transaortic gradients (p=0.048). Similarly, an implantation depth >5 mm was linked to more pacemaker implantations (p=0.01). Overall, a trend towards higher pacemaker implantation rates was observed after SAPIEN 3 VinV (6% vs. 2.5% in SAPIEN XT, p=0.071)., Conclusions: Transcatheter aortic VinV with the balloon-expandable SAPIEN XT or SAPIEN 3 was similarly safe and effective. However, residual stenosis remains a concern, particularly in smaller bioprostheses and with increasing implantation depth.

Aims: The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO., Method and Results: Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups., Conclusion: Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone., Trial Registration: NCT01760083.

Background: The decision for coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with multi-vessel coronary artery disease (mCAD) is currently made by a heart-team approach. Patients' preference is less well investigated., Methods: All consecutive patients with prior CABG and at least 2 PCI procedures were interviewed whether they would elect bypass surgery or staged PCI in case of a hypothetical scenario in which they had mCAD and CABG or PCI will equally improve symptoms and survival., Results: A total 213 patients were surveyed. About 21 (10%) patients had multiple CABG, and mean number of PCI per patient was 4.0 ± 2.7. Complications during CABG were reported in 19.7% and in 14% after PCI, respectively. About 15% experienced complications after both CABG and PCI, and 51% had no complications at all. Mean symptom-free period was 5.2 (following CABG) vs 1.8 years (following PCI); P<.001. Duration of recovery was significant shorter after PCI (mean 9.2 ± 1.2 vs 136.4 ± 57.9 days; P<.01). Based on their personal experience with both procedures, 15% of the participants elected CABG in the hypothetical scenario and 67% choose staged PCI, 18% were equally happy with either. More participants preferred PCI when age was ≥70, complications following CABG occurred, and when undergoing CABG first. Gender, number of CABG or PCI procedures per patient, and complications following PCI did not affect participants' preference., Conclusions: In our hypothetical scenario, the majority of participants preferred staged PCI over CABG. Preferences were related to age, complications following CABG, and whether CABG was performed first., (© 2018 John Wiley & Sons Ltd.)

We report on a transapical tricuspid valve-in-ring implantation performed via right ventricular apex using the Sapien-XT-prosthesis. A 57-year-old woman with recurrent episodes of right heart failure and three previous sternotomies, including tricuspid valve repair with a 32 mm Carpentier-Edwards-Classic annuloplasty ring was admitted due to recurrent severe tricuspid regurgitation. Given the excessive surgical risk, a 29 mm Sapien-XT-prosthesis was selected for valve-in-ring implantation. Transapical valve-in-ring implantation procedure was uneventful. Predischarge echocardiography showed only trace paravalvular tricuspid regurgitation in the septal region. Transapical approach via right ventricular apex is a viable alternative for tricuspid valve-in-ring implantation in selected high-risk patients. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Aims: Shock coil interaction in patients with multiple implantable cardioverter defibrillator (ICD) leads is occasionally observed. We aimed to evaluate the incidence of shock coil interaction and its clinical relevance., Methods and Results: All ICD patients (646 patients) who came to follow up control in our ICD ambulance between January 1, 2011, and December 31, 2011 in the department of cardiology in Bad Berka hospital were retrospectively evaluated in this study. All baseline demographic, clinical, and procedural characteristics and postoperative chest x ray in postero-anterior and lateral view as well as clinical and ICD follow up data were evaluated. Among 646 patients 42 had multiple ICD leads (6.5%) of whom 36 patients (5.5% of total cohort patients and 85.7% of patients with multiple ICD leads) had shock coil interaction and presented the study group (Group I). The control group (Group II) consisted of 610 patients without coil-coil interaction including patients with single shock lead (604 patients) or patients with multiple leads but without interaction between shock coils (6 patients). Inappropriate anti-tachycardia therapies and RV lead revisions were more frequent in patients with interaction between shock coils (Group I vs Group II: 27.7% and 5.7%; p = 0.049 and 30.6% vs 6.4; p = 0.0001, respectively)., Conclusions: Interaction between shock coils may be one of possible causes of lead failure and resulted in inappropriate therapies and subsequent lead revision., (Copyright © 2018 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) has been increasingly used in symptomatic patients with severe aortic stenosis who are at high risk for conventional open heart surgery. However, it might be associated with serious complications. We report a case with an iatrogenic ventricular septal defect as a rare complication following TAVI procedure. < Learning objective: To highlight a rare complication of iatrogenic ventricular septal defect (VSD) following transcatheter aortic valve implantation procedure and its treatment with percutaneous interventional VSD closure.>.

Background and Aim of the Study: Left ventricular (LV) perforation is one of the rare and most serious complications of transcatheter aortic valve implantation (TAVI). The study aim was to determine the pathophysiological factors associated with this serious complication., Methods: A retrospective study was conducted of pathophysiological factors shown in echocardiograms and computed tomography angiograms performed preoperatively in patients who developed LV perforation during transfemoral TAVI (study group) with regards to anatomic and functional variables. Results were then compared with data acquired from a randomly selected sample of patients without perforation (control group). Among 963 TAVI cases, LV perforation occurred in 11 patients (three males, eight females; mean age 79 years). These patients showed complications of LV perforation that required emergency sternotomy and repair of injury to the left ventricle. Ten patients were rescued by the procedure, but one patient died during surgery., Results: Focus on preoperative factors and intraoperative steps was established in favor to identify possible predictors of LV perforation. A LV cavity size <4.2 cm and a hypercontractile ventricle were identified in 10 patients (90%). Only one patient had a dilated cardiomyopathic left ventricle, with a cavity size of 6.1 cm and an ejection fraction of 10%. The present study results revealed other specific patient-related factors, namely a narrow aorto-mitral angle and a thin ventricular muscular wall despite long-standing aortic stenosis. All 11 patients had an average mid-LV muscular wall thickness of 5 mm. An inverse proportional relationship between the aorto-mitral angle and the incidence of perforation was noted, where in all 11 patients the wire had directed itself towards the anterior free wall of the left ventricle, where it induced injury., Conclusions: A small LV cavity, a hypercontractile state, a thin muscular wall, and a narrow aorto-mitral angle may be considered potential predictors of the occurrence of LV perforation during TAVI.

Background: In a number of coronary bifurcation lesions, both the main vessel and the side branch (SB) need stent coverage., Objectives: To analyze the procedural performance and the impact on radiation times (RT) and contrast medium consumption (CMC) of the Axxess™ stent system (Biosensors, Switzerland) treating de novo bifurcation lesions (DBL)., Methods: One hundred and ten consecutive prospectively enrolled cases (Axxess Group) and 110 age, sex, and lesion location matched controls undergoing mandatory (Group A, n = 56) or provisional (Group B, n = 54) SB intervention were analyzed., Results: Although more pre-dilatation was performed in the Axxess Group (92.7% vs. 46.4% [Group A] vs. 24.1% [Group B]), and more stents were used (2.4 vs. 1.2 vs. 1.05), RT and CMC were significantly lower in the Axxess Group [7.9 min/129 ml vs. 14.2 min/209 ml vs. 7.8 min/152 ml; P < 0.001]. Final Thrombolysis In Myocardial Infarction three flow in both branches was significantly more frequent in the Axxess Group (98.2% vs. 94.6% vs. 88.9%; P = 0.02), and post-interventional troponin T elevations were the lowest in the Axxess Group. Eighty one percent of the Axxess-stents could be implanted without technical difficulties. Difficult implantations procedures were mainly related to coronary anatomy. There was no safety concerns (cardiac death, stent-thrombosis) compared to controls. Cumulative 6-months MACE rates were 11% versus 23% versus 25%. TLR rates at 6-months were 5%, 18%, and 15%, respectively., Conclusions: Axxess bifurcation stent system procedures were associated with significantly less RT and CMC compared to conventional DBL therapy strategies. Difficult coronary anatomy may hinder successful implantation and a learning curve has to be considered. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

A literature on systematic treatment protocols for patients after resuscitation for cardiac arrest is lacking. We evaluated a systematic protocol, including ECG, echocardiogram, urgent cardiac catheterisation ("STEMI-like" workflow), CT scans, laboratory findings, IABP, hypothermia, and cMRI, prospectively over 5 years. The primary endpoint was the Cerebral Performance Category Scale (CPCS). During the period from January 2008 to December 2012, 212 patients were included. The mean age was 66.7 years, n = 151 (71.2 %) were male, mean time from the first medical contact to start of catheterisation was 76.6 min, and ventricular fibrillation (VF) was present in n = 99 (46.7 %). A significant coronary artery stenosis was seen in n = 130 (61.3 %), PCI was performed in n = 101 (47.6 %), an ACS was found in n = 100 (47.2 %), n = 91 patients (42.9 %) had another cardiac cause, an extra-cardiac cause was found in n = 12 (5.7 %, mostly a cerebral process), and in 9 patients (4.3 %), no cause was identifiable. A significant difference in mortality was found for patients with TIMI flow 2/3 vs. 0/1 (65.4 vs. 95.7 %, p < 0.01). The difference of intra-aortic balloon pumping vs. no pumping was not significant, performing hypothermia reduced mortality significantly (52.7 vs. 68.2 %, p = 0.04). The survival rate was n = 76 (35.9 %), a CPCS of 1/2 was reached in n = 68 pts (32.1 %), patients with ongoing resuscitation had a 100 % mortality (n = 41), and VF had a lower mortality (54.6 vs. 72.6 %, p < 0.01). A systematic algorithm may improve the outcome of patients after reanimation compared with classically reported outcomes. The data are hypothesis generating for further studies.

Background: In the randomised TATORT-NSTEMI trial routine thrombus aspiration in comparison with standard percutaneous coronary intervention (PCI) did not reduce the primary endpoint of microvascular obstruction assessed by cardiac magnetic resonance imaging in patients with non-ST-elevation myocardial infarction (NSTEMI). So far, no data on long-term outcome of head-to-head comparisons between both treatment strategies in NSTEMI patients have been reported., Methods: The prospective, controlled, multicentre, randomised, open-label TATORT-NSTEMI trial assigned patients with NSTEMI and thrombus-containing lesions to aspiration thrombectomy plus PCI ( n=221) or standard PCI only ( n=219). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events defined as the composite of death, myocardial reinfarction, target vessel revascularisation, and new congestive heart failure at 12-month follow-up. In addition, functional outcome and quality of life were assessed., Results: At one year, major adverse cardiac events occurred in 19 patients in the thrombectomy arm and 29 patients in the standard PCI group (8.7% vs. 13.4%, relative risk 0.63, 95% confidence interval 0.35-1.12, p=0.11). The individual components of the combined endpoint such as death ( p=0.20), myocardial reinfarction ( p=0.73), target vessel revascularisation ( p=0.42), and congestive heart failure ( p=0.18) were similar in both groups. Functional outcome and quality of life did not differ significantly between both groups (Canadian Cardiovascular Society class: p=0.68, New York Heart Association class: p=0.70 and EuroQol5D score: p=0.96). Post-hoc analyses revealed consistent results with regard to the occurrence of major adverse cardiac events across a wide range of subgroups (all p>0.05)., Conclusions: In this first randomised trial on thrombectomy in NSTEMI patients, routine thrombus aspiration before PCI did not improve clinical outcome at 12-month follow-up.

Background: There is growing evidence for beneficial prognostic and economic effects of FFR-guided treatment of stable coronary artery disease. We sought to evaluate the real-world use of FFR measurements in patients undergoing elective coronary angiography., Methods and Results: We analyzed the data of the prospective ALKK coronary angiography and PCI registry including data of 38 hospitals from January 2010 to December 2013. A total of 100,977 patients undergoing coronary angiography were included. In 3240 patients (3.2 %) intracoronary pressure measurement was performed. There was a wide range of use of FFR measurement in the different analyzed ALKK hospitals from 0.1 to 8.8 % in elective patients with suspected or known coronary artery disease (median 2.7 %, quartiles 0.9 and 5.3 %), with a successive increase of use over time during the study period. Overall, it was performed in 3.2 % of coronary angiographies. Use in patients with three-vessel disease (2.5 %) and recommendation for bypass surgery (1.6 %) was less frequent. In procedures without PCI, dose area product was higher in the FFR group (2641 cGy × cm 2 vs. 2368 cGy × cm 2 , p < 0.001), while it was lower in procedures with ad hoc PCI (4676 cGy × cm 2 vs. 5143 cGy × cm 2 , p < 0.001). The performing center turned out to be the strongest predictor., Conclusions: The use of FFR measurement was very heterogeneous between different hospitals and in general relatively low, in particular in patients with multivessel disease or recommendation for bypass surgery, but there was a positive trend during the study period. Technically, FFR measurement was not associated with an increased periprocedural complication rate.

Background: Elimination of cardiac autoantibodies, frequently detected in patients with dilated cardiomyopathy (DCM), with immunoadsorption (IA) improves functional capacity and left ventricular (LV) function. This study aimed to prospectively address this issue in a large cohort of unselected patients., Methods: Consecutive patients undergoing IA followed by IgG substitution were included. Clinical and echocardiographic parameters were assessed at baseline (BL) and 12-month follow-up (FU). Patients were classified as IA responders when ≥2 of the following criteria were achieved: improvement in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) ≥5 points, symptoms [≥1 New York Heart Association (NYHA) class], LV ejection fraction (EF) ≥10% or decrease in LV end-diastolic diameter (EDD) ≥10%, or N-terminal pro B-type natriuretic peptide (NT-pro-BNP) ≥50%., Results: 93 patients (median age 61 years, LVEF 30%, duration of symptoms 14 months, 87% in NYHA class III/IV, >90% treated with β-blocker/angiotensin-converting enzyme inhibitor) were included. When the entire cohort was analyzed, a significant improvement in MLHFQ (50 vs. 26 points), NYHA-class (median 3.0 vs. 2.0), LVEF (30% vs. 38%), LVEDD (62 vs. 59mm), NT-pro-BNP (892 vs. 523pg/ml) was observed at FU (p<0.05 for all). 48% (n=43) were classified as responders. Those were characterized by a shorter disease duration (11 vs. 22 months), larger BL LVEDD (64 vs. 60mm), presence of >1 viral genome, and higher values of mononuclear inflammatory cells at endomyocardial biopsy. Sixteen (17.2%) patients experienced IA related complications., Conclusions: A positive response is observed in 48% of inflammatory DCM patients undergoing IA, and this translates into a significant improvement in clinical and echocardiographic parameters., (Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Objectives: Perforation of the subannular left ventricular outflow tract (LVOT) represents an uncommon but almost invariably fatal transcatheter aortic valve implantation (TAVI)-associated complication. The risk factors to predict the occurrence of this devastating complication, particularly in relation to specific LVOT anatomy, have not yet been systematically analysed. We aimed to evaluate the pathophysiological background and possible risk factors for the occurrence of subannular LVOT perforation., Methods: A total of 6 (0.7%) consecutive patients (78.8 ± 3.3 years, 83% women) with subannular LVOT perforation complicating TAVI procedure were identified from our institutional TAVI registry, including 900 consecutive patients who underwent TAVI procedure at a single institution between January 2009 and July 2015. Only patients with an intraoperatively confirmed LVOT perforation were included., Results: The computed tomography (CT)-guided analysis of aortic root/LVOT morphology revealed subannular calcification in close proximity of the anatomically weakest region of muscular LVOT (i.e. in the region of the muscular LVOT between the left fibrous trigone and the left/right commissure) in 5/6 (83%) patients. Moreover, significant annular asymmetry >20% was present in 4/6 (67%) patients and was combined with a severe asymmetric hypertrophy of muscular LVOT., Conclusions: Subannular calcification in close proximity of the anatomically unprotected muscular LVOT might represent an important risk factor for the occurrence of subannular LVOT injury. Precise CT-based analysis of patient-specific aortic root anatomy/subannular calcification patterns may be helpful to predict this TAVI-associated complication preoperatively and hence to avoid it in future patients., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: A normal anatomy of coronary arteries is important to have adequate cardiac muscle blood supply especially during extraneous physical activities. This case report describes a rare coronary anomaly in which the accessory coronary artery arose from the right coronary artery, reentered the left anterior descending coronary artery, and then ran as a single vessel., Case Presentation: We present a case of a coronary anomaly in a 47-year-old white man who presented with atypical angina. Computed tomographic angiography and coronary angiography showed a variant of dual left anterior descending coronary artery not previously described. Our patient's accessory coronary artery arose from his right coronary artery. It took an intramuscular course beneath the right ventricular outflow tract in the interventricular septal area to the anterior interventricular sulcus, giving off septal perforators that reentered his medial left anterior descending coronary artery. Both vessels ran after the anastomosis in the anterior interventricular sulcus as a single vessel., Conclusions: We propose that this anomaly represents a new variant of coronary artery anomaly. This coronary artery anomaly does not cause ischemia. Recognition of this coronary anomaly is important in patients undergoing percutaneous coronary intervention or coronary artery bypass graft operations.

A 70-year-old woman with persistent atrial fibrillation underwent pulmonary vein isolation and linear ablation with a contact sensor catheter. During cavotricuspid isthmus ablation, a steam pop resulted in cardiac tamponade, and the patient developed severe hypotension despite successful pericardial puncture and minimal residual pericardial effusion. Right coronary artery angiography revealed extravasal contrast medium accumulation posterior of the Crux Cordis. Emergent cardiac surgery confirmed isolated disruption of the artery in the absence of additional heart perforation. Although contact sensor catheters may reduce complications, steam pops can still occur and result in dramatic complications., (© 2016 Wiley Periodicals, Inc.)

Aims: Inadvertent lead malposition (ILM) in the left heart is a potential cause of thromboembolism and, therefore, a complication of heart rhythm device implantation [HRDI: pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT)]. The aim of the study was to report the incidence and clinical outcome of ILM., Methods and Results: Postoperative lateral and posterior-anterior chest X-rays of all consecutive patients undergoing HRDI from 2007 through 2012 were retrospectively analysed. During the study period, 2579 patients underwent HRDI at our institution. ILM was present in six patients (0.34%, 50% male, mean age 71.5 ± 9.4 years). In one and four patients, malposition was in the left atrium and ventricle, respectively. In one case, the RV-lead was placed in a coronary sinus branch. In four patients, ILM was detected intra-operatively or in the early postoperative period. In the remaining two patients, malposition was not recognized and they suffered cerebral embolism 4 months and 1 year after implantation. ILM was corrected during the same hospital stay (four cases), or during follow-up by percutaneous extraction (two cases). Patients with ILM had significantly more scoliosis (16.7 vs. 0.17%; P = 0.01), congenital heart disease (CHD: 33.3 vs. 0.4%; P = 0.003), or prior surgery for CHD (16.7 vs. 0.5%; P = 0.03). The likelihood of ILM was also increased when HRDI was performed by an inexperienced operator (<100 HRDI; P < 0.01)., Conclusion: The incidence of ILM was 0.34% in our series. Scoliosis, CHD, prior correction of CHD, and limited operator experience were identified as risk factors., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

The purpose of this study was to assess (1) the incidence of safety margin testing <10 J (SMT) and (2) the efficacy/safety of routinely adding a subcutaneous array (SQA) (Medtronic 6996SQ) for these patients. Patients with SMT smaller than a 10-J safety margin from maximum output were considered to have very high readings and underwent SQA insertion. These patients were compared with the rest of the patients who had acceptable SMT (≥10 J). A total of 616 patients underwent ICD implantation during the analysis period. Of those, 16 (2.6%) had SMT <10 J. By univariate analysis, younger age, and non-ischemic cardiomyopathy, were all significant predictors of SMT <10 J (p < 0.05). In all 16 cases, other methods to improve SMT prior to array insertion were attempted but failed for all patients: reversing shock polarity (n = 15), removing the superior vena cava coil (n = 14), reprogramming shock waveform (n = 9), and repositioning right ventricular lead (n = 9). Addition of the SQA successfully increased SMT to within safety margin for all patients (32 ± 2 versus 21 ± 3 J; p < 0.001). Follow-up (mean 48.1 ± 21 months) was available for all patients with SQA, only 2 cases with inappropriate shocks due to atrial fibrillation had to be noted. None of the patients experienced complications due to SQA implantation. SMT <10 J occur in about 2.6% of patients undergoing ICD implantation. SQA insertion corrects this problem without procedural/mid-term complications., (Copyright © 2016 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.)

Background: The anticoagulation of biological heart valves remains a 'hot spot' of discussion in various domains due to the risk of developing valve thrombosis and arterial thromboembolism. The situation has always been controversial, especially during the early postoperative phase. The American College of Cardiology/ American Heart Association and European Society of Cardiology guidelines recommend the use of warfarin for the first three months after biological aortic valve replacement (BAVR), although the American College of Chest Physicians guidelines suggest that these recommendations are experience-based and that the risk/benefit is unclear. The aim of the present study was to compare the efficacy of aspirin and warfarin in patients after BAVR., Methods: A total of 863 patients who underwent BAVR between 2008 and 2015 was allocated to two groups. Each group was managed with a specific anticoagulation regimen, with 430 patients receiving warfarin during the first three postoperative months, and 433 receiving aspirin. The major study end points were bleeding, cerebral ischemic events, and survival., Results: In total, 10 and 15 postoperative cerebral ischemic events occurred between 24 h and three months after surgery in patients treated with aspirin and warfarin, respectively. After three months the incidence of cerebral ischemic events did not differ greatly between the two groups. The rate of major bleeding events and rates of stroke-free survival and overall survival were not statistically significant between the warfarin and aspirin groups., Conclusions: Plasma anticoagulation with warfarin during the early postoperative phase was shown statistically to be inferior to platelet aggregation inhibition by aspirin with regards to postoperative bleeding risk, cerebral ischemic events, and survival.

Background: Impedance cardiography (IC) is a noninvasive modality that utilizes changes in impedance across the thorax to assess hemodynamic parameters, including stroke volume (SV). This study compared aortic valve area (AVA) as assessed by a hybrid approach of transthoracic echocardiography (TTE) and impedance cardiography (IC) to AVA determined at cardiac catheterization using the Gorlin equation., Methods: A total of 30 patients with moderate to severe aortic stenosis underwent AVA measurement using two different approaches: using the continuity equation (CE) in a hybrid method combining IC and TTE (AVA = stroke by volume impedance cardiography/trans-aortic-VTI) and using the Gorlin equation. Patient age ranged from 37 to 82 years (mean 48); there were 21 men and 9 women. Twenty-five patients were in sinus rhythm, and five had atrial fibrillation., Results: There was no statistically significant difference for the mean AVA between the two methods (0.7 ± 0.24 cm(2) using the Gorlin equation versus 0.7 ± 0.23 cm(2) using the hybrid approach, p = 0.17; r = 0.76, p < 0.001). The mean difference was 0.004 cm(2), and the limits of agreement were -0.33 to 0.37., Conclusion: The hybrid method using impedance cardiography and TTE is a reasonable, clinically applicable approach to evaluate AVA and has significant correlation to invasive measurement using the Gorlin equation.

Background: Endomyocardial biopsy (EMB) is an important tool when patients with inflammatoric cardiomyopathy (DCMi) are evaluated. We aimed to assess the clinical profile of elderly patients with DCMi on EMB., Methods: Retrospective study of all consecutive patients hospitalized from January 2007 to December 2011 with clinical suspicion of DCMi undergoing EMB. Patients with evidence of DCMi on EMB (Group 1 ≥ 70 years, n = 85; Group 3 < 70 years; n = 418) were compared to patients of the same age group without evidence of DCMi on EMB (Group 2 ≥ 70 years, n = 45; Group 4 < 70 years; n = 147)., Results: Among 24,275 patients treated at our institution during the study period, 695 had clinical suspicion of DCMi and underwent EMB; 503 (2.1%) patients had DCMi on EMB. There were more male patients in Group 1, mean age was 74 ± 2.8 years, mean ejection fraction was 38% ± 14%. On presentation, signs of hemodynamic compromise (NYHA functional class III/IV, low cardiac output/index, and low cardiac power index) were more frequent in Group 1. EMB revealed viral genome in 78% of the patients, parvovirus B19 (PVB) was frequently encountered in both age groups (Group 1: 69.4% vs. Group 2: 59.6%); detection of more than one viral genome was more frequent in Group 1 (21.2% vs. 11.2%; P = 0.02) whereas the extent of immune response was significantly lower in individuals with advanced age., Conclusions: In patients ≥ 70 years with DCMi on EMB signs of hemodynamic compromise, detection of multiple viral genomes together with an overall lower extent of immune response were more frequently observed.

Background: Data about the impact of thrombectomy in primary percutaneous coronary intervention (PCI) are inconsistent. The aim of our study was an evaluation of both the real-world use of thrombectomy and the impact of thrombectomy on outcome in unselected patients treated with primary PCI for ST-elevation myocardial infarction (STEMI)., Methods and Results: We used the data of the prospective ALKK PCI-registry of 35 hospitals from January 2010 to December 2013. A total of 10,755 patients receiving single-vessel primary PCI for acute STEMI were included. In 2176 patients (20.2 %) thrombectomy was performed. There was a wide range of use of thrombectomy in the different ALKK hospitals from 1.1 to 61.7 % (median 18.6 %, quartiles 6.0 and 40.3 %) with a general increase of use over the first years of the study period. In patients with and without thrombectomy there was TIMI 0 flow present before PCI in 6010 patients, TIMI 1 in 1338, TIMI 2 in 2002, and TIMI 3 in 1405. Patients with acute heart failure or cardiogenic shock received significantly more often thrombectomy. Fluoroscopy time (8.1 vs. 7.3 min, p < 0.0001) and dose area product (5373 cGy × cm(2) vs. 4802 cGy × cm(2), p < 0.0001) were significantly higher in patients treated with thrombectomy. The subgroup of patients with TIMI 0 flow before PCI had significantly higher rates of TIMI 3 flow after PCI when treated with thrombectomy (87.1 vs. 84.1 %, p < 0.01), while there was no difference in post-PCI TIMI 3 flow in patients with TIMI 1, 2 or 3 flow before PCI. Rates of major adverse cardiac and cerebrovascular events were similar in both groups in general and in all subgroups of TIMI flow., Conclusions: The use of thrombectomy in patients with STEMI is heterogenous between hospitals. Overall, there was no impact of thrombectomy on TIMI 3 patency or mortality after PCI. In the subgroup of STEMI patients with TIMI 0 flow before PCI individualized thrombectomy had a positive impact on restoration of normal blood flow.

Background: A retrograde approach improves the success rate of percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs)., Objectives: The authors describe the European experience with and outcomes of retrograde PCI revascularization for coronary CTOs., Methods: Follow-up data were collected from 1,395 patients with 1,582 CTO lesions enrolled between January 2008 and December 2012 for retrograde CTO PCI at 44 European centers. Major adverse cardiac and cerebrovascular events were defined as the composite of cardiac death, myocardial infarction, stroke, and further revascularization., Results: The mean patient age was 62.0 ± 10.4 years; 88.5% were men. Procedural and clinical success rates were 75.3% and 71.2%, respectively. The mean clinical follow-up duration was 24.7 ± 15.0 months. Compared with patients with failed retrograde PCI, successfully revascularized patients showed lower rates of cardiac death (0.6% vs. 4.3%, respectively; p < 0.001), myocardial infarction (2.3% vs. 5.4%, respectively; p = 0.001), further revascularization (8.6% vs. 23.6%, respectively; p < 0.001), and major adverse cardiac and cerebrovascular events (8.7% vs. 23.9%, respectively; p < 0.001). Female sex (hazard ratio [HR]: 2.06; 95% confidence interval [CI]: 1.33 to 3.18; p = 0.001), prior PCI (HR: 1.73; 95% CI: 1.16 to 2.60; p = 0.011), low left ventricular ejection fraction (HR: 2.43; 95% CI: 1.22 to 4.83; p = 0.011), J-CTO (Multicenter CTO Registry in Japan) score ≥3 (HR: 2.08; 95% CI: 1.32 to 3.27; p = 0.002), and procedural failure (HR: 2.48; 95% CI: 1.72 to 3.57; p < 0.001) were independent predictors of major adverse cardiac and cerebrovascular events at long-term follow-up., Conclusions: The number of retrograde procedures in Europe has increased, with high percents of success, low rates of major complications, and good long-term outcomes., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Congenital left ventricular aneurysm (LVA) or diverticulum (LVD) is rare cardiac anomalies. We aimed to analyse the clinical characteristics and outcome in all ever published patients., Methods: MEDLINE, Web of science, Google and EMBASE, and reference lists of relevant articles were searched for publications reporting on LVA or LVD patients., Results: We identified 809 patients published since 1816 [354 (49.1%) LVA, 453 (50.6%) LVD, 2 (0.3%) both]. Mean age at diagnosis was 34.1±27 (LVA) and 29.7±27.6years (LVD; p=0.05). 48.9% were male. LVA was larger (38.7±22.5mm versus 31.4±21.2mm; p=0.002) and frequently found in submitral location (33% versus 4.9%; p<0.001), LVD was frequently located at the LV-apex (61.2% versus 28.7%; p<0.001). LVD was often associated with cardiac (34.2% versus 11%; p<0.001) or extracardiac anomalies (32.7% versus 3%; p<0.001). LVA patients presented more frequently with ventricular tachycardia/fibrillation (18.1% versus 13.1%; p=0.01), the incidences of rupture (4% versus 4.5%; p=0.9), syncope (8.3% versus 5.1%; p=0.1), and embolic events (4.9% versus 3.6%; p=0.4) at presentation were not different between LVA and LVD. Mean follow-up was 56.3±43months. Cardiac death occurred more frequently in the LVA group (11.5% versus 5.0%; p=0.05) at a median age of 0.8 [LVA] and 2.5 [LVD] years. The leading cause of cardiac death was congestive heart failure in the LVA-group (50.0% versus 0.0%; p=0.01), and rupture in the LVD-group (75.0% versus 27.3%; p=0.04)., Conclusions: LVA and LVD are distinct congenital anomalies with different clinical and morphological characteristics. The prognosis of LVA is significantly worse during long-term follow-up., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)