Publications by authors named "Michael Laule"

91 Publications

Prognostic value of noninvasive combined anatomic/functional assessment by cardiac CT in patients with suspected coronary artery disease - Comparison with invasive coronary angiography and nuclear myocardial perfusion imaging for the five-year-follow up of the CORE320 multicenter study.

J Cardiovasc Comput Tomogr 2021 May 12. Epub 2021 May 12.

Department of Nuclear Medicine and Cardiovascular Imaging, Brigham and Women's Hospital, Boston, MA, USA.

Background: Few data exist on long-term outcome in patients undergoing combined coronary CT angiography (CTA) and myocardial CT perfusion imaging (CTP) as well as invasive coronary angiography (ICA) and single photon emission tomography (SPECT).

Methods: At 16 centers, 381 patients were followed for major adverse cardiac events (MACE) for the CORE320 study. All patients underwent coronary CTA, CTP, and SPECT before ICA within 60 days. Prognostic performance according binary results (normal/abnormal) was assessed by 5-year major cardiovascular events (MACE) free survival and area under the receiver-operating-characteristic curve (AUC).

Results: Follow up beyond 2-years was available in 323 patients. MACE-free survival rate was greater among patients with normal combined CTA-CTP findings compared to ICA-SPECT: 85 vs. 80% (95% confidence interval [CI] for difference 0.1, 11.3) though event-free survival time was similar (4.54 vs. 4.37 years, 95% CI for difference: -0.03, 0.36). Abnormal results by combined CTA-CTP was associated with 3.83 years event-free survival vs. 3.66 years after abnormal combined ICA-SPECT (95% CI for difference: -0.05, 0.39). Predicting MACE by AUC also was similar: 65 vs. 65 (difference 0.1; 95% CI -4.6, 4.9). When MACE was restricted to cardiovascular death, myocardial infarction, or stroke, AUC for CTA-CTP was 71 vs. 60 by ICA-SPECT (difference 11.2; 95% CI -1.0, 19.7).

Conclusions: Combined CTA-CTP evaluation yields at least equal 5-year prognostic information as combined ICA-SPECT assessment in patients presenting with suspected coronary artery disease. Noninvasive cardiac CT assessment may eliminate the need for diagnostic cardiac catheterization in many patients.

Clinical Trial Registration: NCT00934037.
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http://dx.doi.org/10.1016/j.jcct.2021.04.005DOI Listing
May 2021

Clinical pre-test probability for obstructive coronary artery disease: insights from the European DISCHARGE pilot study.

Eur Radiol 2021 Mar 9;31(3):1471-1481. Epub 2020 Sep 9.

Dept. of Coronary and Structural Heart Diseases, Institute of Cardiology, Warsaw, Poland.

Objectives: To test the accuracy of clinical pre-test probability (PTP) for prediction of obstructive coronary artery disease (CAD) in a pan-European setting.

Methods: Patients with suspected CAD and stable chest pain who were clinically referred for invasive coronary angiography (ICA) or computed tomography (CT) were included by clinical sites participating in the pilot study of the European multi-centre DISCHARGE trial. PTP of CAD was determined using the Diamond-Forrester (D+F) prediction model initially introduced in 1979 and the updated D+F model from 2011. Obstructive coronary artery disease (CAD) was defined by one at least 50% diameter coronary stenosis by both CT and ICA.

Results: In total, 1440 patients (654 female, 786 male) were included at 25 clinical sites from May 2014 until July 2017. Of these patients, 725 underwent CT, while 715 underwent ICA. Both prediction models overestimated the prevalence of obstructive CAD (31.7%, 456 of 1440 patients, PTP: initial D+F 58.9% (28.1-90.6%), updated D+F 47.3% (34.2-59.9%), both p < 0.001), but overestimation of disease prevalence was higher for the initial D+F (p < 0.001). The discriminative ability was higher for the updated D+F 2011 (AUC of 0.73 95% confidence interval [CI] 0.70-0.76 versus AUC of 0.70 CI 0.67-0.73 for the initial D+F; p < 0.001; odds ratio (or) 1.55 CI 1.29-1.86, net reclassification index 0.11 CI 0.05-0.16, p < 0.001).

Conclusions: Clinical PTP calculation using the initial and updated D+F prediction models relevantly overestimates the actual prevalence of obstructive CAD in patients with stable chest pain clinically referred for ICA and CT suggesting that further refinements to improve clinical decision-making are needed.

Trial Registration: https://www.clinicaltrials.gov/ct2/show/NCT02400229 KEY POINTS: • Clinical pre-test probability calculation using the initial and updated D+F model overestimates the prevalence of obstructive CAD identified by ICA and CT. • Overestimation of disease prevalence is higher for the initial D+F compared with the updated D+F. • Diagnostic accuracy of PTP assessment varies strongly between different clinical sites throughout Europe.
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http://dx.doi.org/10.1007/s00330-020-07175-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880945PMC
March 2021

Impact of inferior caval valve implantation on severity of tricuspid regurgitation and right heart function.

Echocardiography 2020 07 14;37(7):999-1007. Epub 2020 Jun 14.

Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Aims: Severe tricuspid regurgitation (TR) is a common finding in heart failure patients and associated with increased mortality. New interventional therapeutic options are needed as many heart failure patients are unfit for surgery. The TRICAVAL study compared valve implantation into the inferior vena cava (CAVI) with optimal medical therapy (OMT) in patients with severe TR. Here, we report details on the impact of CAVI on TR severity as well as right heart function and morphology.

Methods And Results: We randomized 28 patients with severe TR to CAVI (n = 14) with transfemoral implantation of an Edwards Sapien XT valve into the inferior vena cava or OMT (n = 14). Inclusion and exclusion criteria were based on anatomical and clinical parameters. Echocardiographic measurements were performed at baseline, at the first postoperative day and one, three, and twelve months after randomization. As proof of concept of an effective sealing of the inferior vena cava, we detected a significant decrease in systolic hepatic vein reflux volume (11.0 [6.2-21.9] mL vs 3.5 [0.6-8.5] mL, P = .016) and hepatic vein diameter (11.5 [10.0-14.8] mm vs 10.0 [9.3-11.8] mm, P = .034) at thirty-day follow-up. However, CAVI had no significant impact on TR, cardiac function, and morphology.

Conclusions: Caval valve implantation significantly reduced systolic reflux into the hepatic veins but was not associated with an improvement in cardiac function, morphology, or TR severity.
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http://dx.doi.org/10.1111/echo.14760DOI Listing
July 2020

Treatment of Severe TRIcuspid Regurgitation in Patients with Advanced Heart Failure with CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL): a randomised controlled trial.

EuroIntervention 2020 Apr;15(17):1506-1513

Medizinische Klinik für Kardiologie und Angiologie, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Aims: The aim of our study was to compare the impact of implantation of a balloon-expandable transcatheter valve into the inferior vena cava (CAVI) on exercise capacity with optimal medical therapy (OMT) in patients with severe tricuspid regurgitation (TR) and high surgical risk.

Methods And Results: Twenty-eight patients were randomised to OMT (n=14) or CAVI (n=14). The primary endpoint was maximal oxygen uptake at the three-month follow-up. Secondary endpoints included six-minute walk test, NYHA class, NT-proBNP levels, right heart function, unscheduled heart failure hospitalisation, and quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Patients underwent follow-up examinations one, three, six, and twelve months after randomisation. Maximal oxygen uptake did not change significantly in either group after three months and there was no difference between the OMT and CAVI groups (-0.1±1.8 ml∙kg-1∙min-1 vs -1.0±1.6 ml∙kg-1∙min-1, p=0.4995). Compared to baseline, CAVI improved NYHA class, dyspnoea, and quality of life after three months. However, there were no statistically significant differences in the secondary endpoints between the groups. Four periprocedural complications occurred after CAVI, resulting in open heart surgery. Four patients in the OMT group and eight patients (including four after conversion to surgery) in the CAVI group died from right heart failure, sepsis or haemorrhage.

Conclusions: CAVI did not result in a superior functional outcome compared to OMT. Due to an unexpectedly high rate of valve dislocations, the study was stopped for safety reasons.
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http://dx.doi.org/10.4244/EIJ-D-19-00901DOI Listing
April 2020

Pilot study of the multicentre DISCHARGE Trial: image quality and protocol adherence results of computed tomography and invasive coronary angiography.

Eur Radiol 2020 Apr 16;30(4):1997-2009. Epub 2019 Dec 16.

Department of Cardiology, St. Vincent's University Hospital, Belfield Campus, 4, Dublin, Ireland.

Objective: To implement detailed EU cardiac computed tomography angiography (CCTA) quality criteria in the multicentre DISCHARGE trial (FP72007-2013, EC-GA 603266), we reviewed image quality and adherence to CCTA protocol and to the recommendations of invasive coronary angiography (ICA) in a pilot study.

Materials And Methods: From every clinical centre, imaging datasets of three patients per arm were assessed for adherence to the inclusion/exclusion criteria of the pilot study, predefined standards for the CCTA protocol and ICA recommendations, image quality and non-diagnostic (NDX) rate. These parameters were compared via multinomial regression and ANOVA. If a site did not reach the minimum quality level, additional datasets had to be sent before entering into the final accepted database (FADB).

Results: We analysed 226 cases (150 CCTA/76 ICA). The inclusion/exclusion criteria were not met by 6 of the 226 (2.7%) datasets. The predefined standard was not met by 13 of 76 ICA datasets (17.1%). This percentage decreased between the initial CCTA database and the FADB (multinomial regression, 53 of 70 vs 17 of 75 [76%] vs [23%]). The signal-to-noise ratio and contrast-to-noise ratio of the FADB did not improve significantly (ANOVA, p = 0.20; p = 0.09). The CTA NDX rate was reduced, but not significantly (initial CCTA database 15 of 70 [21.4%]) and FADB 9 of 75 [12%]; p = 0.13).

Conclusion: We were able to increase conformity to the inclusion/exclusion criteria and CCTA protocol, improve image quality and decrease the CCTA NDX rate by implementing EU CCTA quality criteria and ICA recommendations.

Key Points: • Failure to meet protocol adherence in cardiac CTA was high in the pilot study (77.6%). • Image quality varies between sites and can be improved by feedback given by the core lab. • Conformance with new EU cardiac CT quality criteria might render cardiac CTA findings more consistent and comparable.
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http://dx.doi.org/10.1007/s00330-019-06522-zDOI Listing
April 2020

Kidney Injury after Intravenous versus Intra-arterial Contrast Agent in Patients Suspected of Having Coronary Artery Disease: A Randomized Trial.

Radiology 2019 09 2;292(3):664-672. Epub 2019 Jul 2.

From the Department of Radiology, Charité-Universitätsmedizin Berlin, Humboldt-Universität and Freie Universität zu Berlin, Schumannstr 20/21, Berlin 10117, Germany (E.S., M.B., E.Z., R.T, M.L., M.D.); and Institute for Clinical Epidemiology and Applied Biometry, University of Tübingen, Tübingen, Germany (P.M.).

Background In the absence of randomized studies, it has been controversial whether the likelihood of acute kidney injury (AKI) differs between intravenous and intra-arterial contrast agent administration. Purpose To compare intravenous versus intra-arterial contrast agent administration in relationship to AKI and analyze the association between AKI and chronic kidney disease (defined as at least mildly decreased estimated glomerular filtration rates [eGFRs]). Materials and Methods This was a prospective study (: NCT00844220) that involved randomizing participants with atypical chest pain and suspected coronary artery disease (CAD) between February 2009 and August 2015 to undergo coronary CT angiography with intravenous contrast agent administration or cardiac catheterization angiography with intra-arterial contrast agent administration. This prespecified secondary analysis compared AKI (serum creatinine increase of ≥ 25% or 0.5 mg/dL after 18-24 or 46-50 hours) determined by blinded investigators using absolute differences and relative risks, including two-sided 95% confidence intervals (CIs). Results A total of 320 participants (163 [50.9%] women; mean age, 60 years ± 11) were included. Baseline eGFR did not differ between the CT angiography group (84.3 mL/min/1.73 m ± 17.2) and the catheterization group (87.1 mL/min/1.73 m ± 16.7) ( = .14). AKI occurred in nine of 161 participants in the CT angiography group (5.6%; 95% CI: 3%, 10%) and in 21 of 159 participants in the catheterization group (13.2%; 95% CI: 9%,19%) (relative risk, 2.4; 95% CI: 1.1, 5.0; = .02). Also in the subgroup of participants without obstructive CAD, in those not requiring coronary interventions, AKI was more common in the catheterization group (11.9%; 95% CI: 8%, 19%) than in the CT angiography group (4.3% [95% CI: 2%, 9%]; difference, 7.7% [95% CI: 1.3%, 14.1%]; relative risk, 2.8 [95% CI: 1.1, 7.0]; = .02). Obstructive CAD (odds ratio [OR]: 2.7 [95% CI: 1.1, 6.6]; = .02), femoral catheter access (OR: 2.5 [95% CI: 1.1, 5.6]; = .04), and cine ventriculography were associated with AKI (OR: 2.3 [95% CI: 1.0, 4.9]; = .03). In multivariable analysis, the presence of postcontrast AKI was associated with chronic kidney disease (hazard ratio: 12.4 [95% CI: 4.5, 34.6]; < .01). Conclusion Acute kidney injury was more common after cardiac catheterization than after CT angiography in this prospective randomized study of patients suspected of having coronary artery disease. © RSNA, 2019 See also the editorial by Einstein and Newhouse in this issue.
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http://dx.doi.org/10.1148/radiol.2019182220DOI Listing
September 2019

Diagnosis of obstructive coronary artery disease using computed tomography angiography in patients with stable chest pain depending on clinical probability and in clinically important subgroups: meta-analysis of individual patient data.

BMJ 2019 06 12;365:l1945. Epub 2019 Jun 12.

Department of Internal Medicine, University of Rome Tor Vergata, Rome, Italy.

Objective: To determine whether coronary computed tomography angiography (CTA) should be performed in patients with any clinical probability of coronary artery disease (CAD), and whether the diagnostic performance differs between subgroups of patients.

Design: Prospectively designed meta-analysis of individual patient data from prospective diagnostic accuracy studies.

Data Sources: Medline, Embase, and Web of Science for published studies. Unpublished studies were identified via direct contact with participating investigators.

Eligibility Criteria For Selecting Studies: Prospective diagnostic accuracy studies that compared coronary CTA with coronary angiography as the reference standard, using at least a 50% diameter reduction as a cutoff value for obstructive CAD. All patients needed to have a clinical indication for coronary angiography due to suspected CAD, and both tests had to be performed in all patients. Results had to be provided using 2×2 or 3×2 cross tabulations for the comparison of CTA with coronary angiography. Primary outcomes were the positive and negative predictive values of CTA as a function of clinical pretest probability of obstructive CAD, analysed by a generalised linear mixed model; calculations were performed including and excluding non-diagnostic CTA results. The no-treat/treat threshold model was used to determine the range of appropriate pretest probabilities for CTA. The threshold model was based on obtained post-test probabilities of less than 15% in case of negative CTA and above 50% in case of positive CTA. Sex, angina pectoris type, age, and number of computed tomography detector rows were used as clinical variables to analyse the diagnostic performance in relevant subgroups.

Results: Individual patient data from 5332 patients from 65 prospective diagnostic accuracy studies were retrieved. For a pretest probability range of 7-67%, the treat threshold of more than 50% and the no-treat threshold of less than 15% post-test probability were obtained using CTA. At a pretest probability of 7%, the positive predictive value of CTA was 50.9% (95% confidence interval 43.3% to 57.7%) and the negative predictive value of CTA was 97.8% (96.4% to 98.7%); corresponding values at a pretest probability of 67% were 82.7% (78.3% to 86.2%) and 85.0% (80.2% to 88.9%), respectively. The overall sensitivity of CTA was 95.2% (92.6% to 96.9%) and the specificity was 79.2% (74.9% to 82.9%). CTA using more than 64 detector rows was associated with a higher empirical sensitivity than CTA using up to 64 rows (93.4% 86.5%, P=0.002) and specificity (84.4% 72.6%, P<0.001). The area under the receiver-operating-characteristic curve for CTA was 0.897 (0.889 to 0.906), and the diagnostic performance of CTA was slightly lower in women than in with men (area under the curve 0.874 (0.858 to 0.890) 0.907 (0.897 to 0.916), P<0.001). The diagnostic performance of CTA was slightly lower in patients older than 75 (0.864 (0.834 to 0.894), P=0.018 all other age groups) and was not significantly influenced by angina pectoris type (typical angina 0.895 (0.873 to 0.917), atypical angina 0.898 (0.884 to 0.913), non-anginal chest pain 0.884 (0.870 to 0.899), other chest discomfort 0.915 (0.897 to 0.934)).

Conclusions: In a no-treat/treat threshold model, the diagnosis of obstructive CAD using coronary CTA in patients with stable chest pain was most accurate when the clinical pretest probability was between 7% and 67%. Performance of CTA was not influenced by the angina pectoris type and was slightly higher in men and lower in older patients.

Systematic Review Registration: PROSPERO CRD42012002780.
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http://dx.doi.org/10.1136/bmj.l1945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6561308PMC
June 2019

Patient Preferences for Coronary CT Angiography with Stress Perfusion, SPECT, or Invasive Coronary Angiography.

Radiology 2019 05 19;291(2):340-348. Epub 2019 Mar 19.

From the Department of Cardiology, Johns Hopkins Hospital and Health System, Baltimore, Md (A.M., A.L.V., M.R.O., M.M., C.C., P.M.); Departments of Radiology (M.D., M.L., M.R., S.F., M.P.) and Anesthesiology (E.S.), Charité-Universitätsmedizin Berlin, Humboldt-Universität and Freie Universität zu Berlin, Schumannstr 20/21, Berlin 10117, Germany; Department of Radiology, Keio University School of Medicine, Tokyo, Japan (Y.T.); Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil (C.E.R.); Department of Medicine, Division of Cardiology, St Luke's International Hospital, Tokyo, Japan (H.N.); Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (K.F.K.); Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands (J.G.); Department of Radiology, Mount Elizabeth Hospital, Singapore (J.H.); Laboratory of Cardiac Energetics, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md (M.Y.C.); Department of Radiology, Mie University Hospital, Tsu, Japan (K.K.); Department of Radiology, Albert Einstein Hospital, São Paulo, Brazil (C.N.); Department of Radiology, Beth Israel Deaconess Medical Center, Harvard University, Boston, Mass (M.E.C.); Department of Radiology, University of Ottawa Faculty of Medicine, Ottawa, Canada (F.J.R.); Department of Cardiology, National Heart Center Singapore, Singapore (S.Y.T.); and Department of Radiology, Toronto General Hospital, Toronto, Canada (N.P.).

Background Patient preference is pivotal for widespread adoption of tests in clinical practice. Patient preferences for invasive versus other noninvasive tests for coronary artery disease are not known. Purpose To compare patient acceptance and preferences for noninvasive and invasive cardiac imaging in North and South America, Asia, and Europe. Materials and Methods This was a prospective 16-center trial in 381 study participants undergoing coronary CT angiography with stress perfusion, SPECT, and invasive coronary angiography (ICA). Patient preferences were collected by using a previously validated questionnaire translated into eight languages. Responses were converted to ordinal scales and were modeled with generalized linear mixed models. Results In patients in whom at least one test was associated with pain, CT and SPECT showed reduced median pain levels, reported on 0-100 visual analog scales, from 20 for ICA (interquartile range [IQR], 4-50) to 6 for CT (IQR, 0-27.5) and 5 for SPECT (IQR, 0-25) ( < .001). Patients from Asia reported significantly more pain than patients from other continents for ICA (median, 25; IQR, 10-50; = .01), CT (median, 10; IQR, 0-30; = .02), and SPECT (median, 7; IQR, 0-28; = .03). Satisfaction with preparation differed by continent and test ( = .01), with patients from Asia reporting generally lower ratings. Patients from North America had greater percentages of "very high" or "high" satisfaction than patients from other continents for ICA (96% vs 82%, respectively; < .001) and SPECT (95% vs 79%, respectively; = .04) but not for CT (89% vs 86%, respectively; = .70). Among all patients, CT was preferred by 54% of patients, compared with 18% for SPECT and 28% for ICA ( < .001). Conclusion For cardiac imaging, patients generally favored CT angiography with stress perfusion, while study participants from Asia generally reported lowest satisfaction. © RSNA, 2019 See also the editorial by Woodard and Nguyen in this issue.
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http://dx.doi.org/10.1148/radiol.2019181409DOI Listing
May 2019

Correction to: Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

Eur Radiol 2018 11;28(11):4919-4921

Department of Medical Imaging and Radiological Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan.

The original version of this article, published on 19 March 2018, unfortunately contained a mistake. The following correction has therefore been made in the original: The names of the authors Philipp A. Kaufmann, Ronny Ralf Buechel and Bernhard A. Herzog were presented incorrectly.
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http://dx.doi.org/10.1007/s00330-018-5521-0DOI Listing
November 2018

Valve in valve implantation of the CoreValve Evolut R in degenerated surgical aortic valves.

Cardiol J 2018 23;25(3):301-307. Epub 2018 Mar 23.

Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany, Germany.

Background: The new CoreValve Evolut R has an improved design to minimize paravalvular leak-age and allows repositioning of the valve. For patients with degenerated bioprosthetic aortic valves, transcatheter aortic valve implantation (TAVI) represents a less invasive option. Herein reported are valve-in-valve (ViV) implantations of this new valve.

Methods: A total of 26 patients (mean age 79.4 ± 6.1 years, 17 males and 9 females) were treated for severe prosthesis stenosis (n = 9), severe regurgitation (n = 8) or severe combination of stenosis and regurgitation (n = 9). All patients underwent transthoracic echocardiography before and after ViV implantation.

Results: Valve-in-valve implantation of a CoreValve Evolut R was performed successfully in all pa-tients. The mean transaortic gradient for stenotic valves determined by transthoracic echocardiography was reduced significantly from 37.5 ± 15.3 mmHg in patients with prosthesis stenosis to 16.3 ± 8.2 mmHg (p < 0.001). In all cases with severe prosthesis regurgitation, regurgitation was reduced to none or mild. All-cause mortality after 30 days was 0%.

Conclusions: It was concluded that CoreValve Evolut R is well suited for ViV implantation.
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http://dx.doi.org/10.5603/CJ.a2018.0004DOI Listing
December 2018

Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

Eur Radiol 2018 Sep 19;28(9):4006-4017. Epub 2018 Mar 19.

Department of Medical Imaging and Radiological Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan.

Objectives: To analyse the implementation, applicability and accuracy of the pretest probability calculation provided by NICE clinical guideline 95 for decision making about imaging in patients with chest pain of recent onset.

Methods: The definitions for pretest probability calculation in the original Duke clinical score and the NICE guideline were compared. We also calculated the agreement and disagreement in pretest probability and the resulting imaging and management groups based on individual patient data from the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT).

Results: 4,673 individual patient data from the CoMe-CCT Consortium were analysed. Major differences in definitions in the Duke clinical score and NICE guideline were found for the predictors age and number of risk factors. Pretest probability calculation using guideline criteria was only possible for 30.8 % (1,439/4,673) of patients despite availability of all required data due to ambiguity in guideline definitions for risk factors and age groups. Agreement regarding patient management groups was found in only 70 % (366/523) of patients in whom pretest probability calculation was possible according to both models.

Conclusions: Our results suggest that pretest probability calculation for clinical decision making about cardiac imaging as implemented in the NICE clinical guideline for patients has relevant limitations.

Key Points: • Duke clinical score is not implemented correctly in NICE guideline 95. • Pretest probability assessment in NICE guideline 95 is impossible for most patients. • Improved clinical decision making requires accurate pretest probability calculation. • These refinements are essential for appropriate use of cardiac CT.
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http://dx.doi.org/10.1007/s00330-018-5322-5DOI Listing
September 2018

Interventional Treatment of Severe Tricuspid Regurgitation: Early Clinical Experience in a Multicenter, Observational, First-in-Man Study.

Circ Cardiovasc Interv 2018 02;11(2):e006061

From the Charité - Universitätsmedizin Berlin, Germany (A.L., H.D., D.L., B.A., U.L., K.S., M.L., V.F.); Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Berlin, Germany (A.L., H.D., D.L., B.A., U.L., K.S., M.L., A.U., V.F.); Friedrich-Schiller-Universitaet Jena, Germany (H.R.F., T.D., M.F.); Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Germany (A.S.); German Heart Center Berlin (A.U., V.F.); Division of Cardiology, St. Michaels Hospital, Toronto, Canada (N.F.); Albertinen Heart Center, Hamburg, Germany (J.S.); Medizinische Klinik und Poliklinik I, Ludwig-Maximilians-Universität München, Munich, Germany (J.H.); Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, University Düsseldorf, Germany (C.J.); and Berlin Institute of Health, Germany (U.L.).

Background: Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept.

Methods And Results: Twenty-five patients (mean age, 73.9±7.6 years; women, 52.0%) with severe symptomatic TR despite optimal medical treatment deemed unsuitable for surgery were treated with caval valve implantation under a compassionate clinical use program. Technical feasibility defined as procedural success, hemodynamic effect defined as venous pressure reduction, and safety defined as periprocedural adverse events were evaluated, with clinical follow-up at discharge and up to 12 months. The functional impact was evaluated by assessment of New York Heart Association class at the time of hospital discharge. The total number of valves implanted in the caval position was 31. Patients were treated with single (inferior vena cava-only; n=19; 76.0%) or bicaval valve implantation (inferior vena cava+superior vena cava; n=6; 24.0%). Either balloon-expandable valves (Sapien XT/3: n=18; 72.0%) or self-expandable valves (TricValve: n=6; 24.0%; Directflow: n=1; 4.0%) were used. Procedural success was achieved in 96% (n=24). Early and late valve migration requiring surgical intervention occurred in 1 patient each. Thirty-day and in-hospital mortality were 8% (2 of 25) and 16% (4 of 25). Causes of in-hospital mortality included respiratory (n=1) or multiple organ failure (n=3) and were not linked to the procedure. Mean overall survival in the study cohort was 316±453 days (14-1540 days).

Conclusions: Caval valve implantation for the treatment of severe TR and advanced right ventricular failure is associated with a high procedural success rate and seems safe and feasible in an excessive-risk cohort. The study demonstrates hemodynamic efficacy with consistent elimination of TR-associated venous backflow and initial clinical improvement. These results encourage further trials to determine which patients benefit most from this interventional approach.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.117.006061DOI Listing
February 2018

Levels of Circulating Intermediate Monocytes Decrease after Aortic Valve Replacement in Patients with Severe Aortic Stenosis.

Thromb Haemost 2017 12 6;117(12):2346-2355. Epub 2017 Dec 6.

Medizinische Klinik m.S. Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany.

Aortic valve stenosis (AS) is a chronic inflammatory disease. We have previously shown that severe AS is associated with increased levels of circulating intermediate monocytes. Haemodynamics are considered to influence levels of circulating monocyte subsets; we therefore hypothesized that aortic valve replacement may result in changes in the distribution of circulating monocyte subsets. In the present study, we evaluated levels of circulating monocyte subsets in patients with severe AS undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Levels of classical (CD14++CD16–), intermediate (CD14++CD16+), and non-classical (CD14+CD16++) CD86-positive monocytes were determined by flow cytometry in peripheral blood of patients with severe AS before (baseline) and at 3- and 6-month follow-ups (FUP) after SAVR (n = 25 patients) or TAVR (n = 44 patients). Absolute and relative levels of circulating intermediate monocytes decreased from median 39.9/µL (interquartile range [IQR]: 31.7–53.6/µL) and 6.7% (5.6–8.1%) at baseline to 31.6/µL (24.3–42.4/µL; p < 0.001) and 5.4% (4.4–6.7%; p < 0.001) at 6-month FUP after aortic valve replacement, respectively. The decrease in levels of circulating intermediate monocytes appeared earlier (between baseline and 3-month FUP) in the TAVR group compared with the SAVR group (between 3- and 6-month FUP). In conclusion, levels of circulating intermediate monocytes decrease after SAVR or TAVR in patients with severe AS.
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http://dx.doi.org/10.1160/TH17-05-0341DOI Listing
December 2017

Caval Valve Implantation.

Interv Cardiol Clin 2018 Jan 12;7(1):57-63. Epub 2017 Oct 12.

University Heart Center Jena, Erlanger Allee 101, 07747 Jena, Germany.

Recently, transcatheter therapy has expanded the treatment options for patients with heart valve disease. With the growing understanding of tricuspid regurgitation and its natural history, it becomes increasingly obvious that this patient population is a heterogeneous cohort presenting for treatment in different stages of a continuous disease process. It is still unclear which interventional approach will result in functional and clinical success and in which subtype of patient population. This article reviews the pathophysiologic background and current evidence for caval valve implantation and examines the potential role of this approach for the treatment of severe tricuspid regurgitation.
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http://dx.doi.org/10.1016/j.iccl.2017.08.008DOI Listing
January 2018

Coronary Artery Disease: Analysis of Diagnostic Performance of CT Perfusion and MR Perfusion Imaging in Comparison with Quantitative Coronary Angiography and SPECT-Multicenter Prospective Trial.

Radiology 2018 02 25;286(2):461-470. Epub 2017 Sep 25.

From the Departments of Radiology (M.R., B.K., E.Z., M.D.), Nuclear Medicine (M.P.), and Cardiology (M.L.), Charité-Universitätsmedizin Berlin, Medical School, Humboldt-Universität zu Berlin, Freie Universität Berlin, Charitéplatz 1, 10117 Berlin, Germany; Department of Health and Human Services, National Institutes of Health, Bethesda, Md (M.Y.C., W.P.B., A.E.A.); Department of Medicine, Johns Hopkins University, Baltimore, Md (A.L.V., J.M.M., R.T.G., J.L.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (C.C.); Departments of Radiology and Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass (M.D.C.); and Department of Medical Statistics, Informatics and Documentation, University Hospital Jena, Jena, Germany (P.S.).

Purpose To compare the diagnostic performance of stress myocardial computed tomography (CT) perfusion with that of stress myocardial magnetic resonance (MR) perfusion imaging in the detection of coronary artery disease (CAD). Materials and Methods All patients gave written informed consent prior to inclusion in this institutional review board-approved study. This two-center substudy of the prospective Combined Noninvasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Row Computed Tomography (CORE320) multicenter trial included 92 patients (mean age, 63.1 years ± 8.1 [standard deviation]; 73% male). All patients underwent perfusion CT and perfusion MR imaging with either adenosine or regadenoson stress. The predefined reference standards were combined quantitative coronary angiography (QCA) and single-photon emission CT (SPECT) or QCA alone. Results from coronary CT angiography were not included, and diagnostic performance was evaluated with the Mantel-Haenszel test stratified by disease status. Results The prevalence of CAD was 39% (36 of 92) according to QCA and SPECT and 64% (59 of 92) according to QCA alone. When compared with QCA and SPECT, per-patient diagnostic accuracy of perfusion CT and perfusion MR imaging was 63% (58 of 92) and 75% (69 of 92), respectively (P = .11); sensitivity was 92% (33 of 36) and 83% (30 of 36), respectively (P = .45); and specificity was 45% (25 of 56) and 70% (39 of 56), respectively (P < .01). When compared with QCA alone, diagnostic accuracy of CT perfusion and MR perfusion imaging was 82% (75 of 92) and 74% (68 of 92), respectively (P = .27); sensitivity was 90% (53 of 59) and 69% (41 of 59), respectively (P < .01); and specificity was 67% (22 of 33) and 82% (27 of 33), respectively (P = .27). Conclusion This multicenter study shows that the diagnostic performance of perfusion CT is similar to that of perfusion MR imaging in the detection of CAD. RSNA, 2017 Online supplemental material is available for this article.
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http://dx.doi.org/10.1148/radiol.2017162447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5790301PMC
February 2018

Are Sutureless Aortic Valves Suitable for Severe High-Risk Patients Suffering from Active Infective Aortic Valve Endocarditis?

Med Sci Monit 2017 Jun 8;23:2782-2787. Epub 2017 Jun 8.

Department of Cardiac Surgery, University Hospital Oldenburg, European Medical School Oldenburg-Groningen, Carl von Ossietzky University Oldenburg, Oldenburg, Germany.

BACKGROUND Sutureless aortic valves were introduced to facilitate minimally invasive aortic valve surgery. Since sutureless aortic valves are a feasible procedure, we evaluated if any benefits could be identified in severe high-risk patients with active infective endocarditis of the aortic valve. MATERIAL AND METHODS Between April 2014 and April 2015, a total of 42 patients received a sutureless Perceval® aortic valve (Sorin Biomedica Cardio Srl, Saluggia, Italy) for different indications. Nine of these patients (median age 71 years, range 47-83 years) suffered from active infective endocarditis, including four patients with prosthetic aortic valve endocarditis. Five patients underwent prior cardiac surgery, including transcatheter aortic valve implantation (TAVI). The median EuroSCORE II was 29.5% (range 16.8-87.7%). Post-operatively, data regarding mortality, operative results, and early operative morbidity were collected. RESULTS There were no cases of 30-day mortality. Four patients needed abscess closure with pericardium. Three patients underwent left atrial appendix closure: one left ventricular thrombectomy, one bypass grafting, and one arch replacement. Median aortic cross-clamp and cardiopulmonary bypass time was 35 minutes (range 26-88 minutes) and 52 minutes (range 40-133 minutes), respectively. The median intubation time was 14 hours (range 1-9 hours). In these high-risk patients, no postoperative morbidity was found except for one re-intubation due to extensive delirium and one re-exploration. No pacemaker implantation was needed. Echocardiographic evaluation showed no central or para-valvular regurgitation, and a median discharge mean gradient of 5.5 mm Hg (range 2.5-10.0 mm Hg). CONCLUSIONS Sutureless aortic valve replacement in very high-risk patients suffering from active infection endocarditis seems to be an option with limited morbidity and appropriate echocardiographic results, however, further studies are needed.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5472401PMC
http://dx.doi.org/10.12659/msm.902785DOI Listing
June 2017

A multicenter randomized trial comparing the effectiveness and safety of a novel vascular closure device to manual compression in anticoagulated patients undergoing percutaneous transfemoral procedures: The CELT ACD trial.

Catheter Cardiovasc Interv 2017 Nov 15;90(5):756-765. Epub 2017 Mar 15.

Division of Cardiology, Department of Medicine, Weill Cornell Medical College/New York Presbyterian Hospital, New York, NY, USA.

Objectives: This study compared the performance of Celt ACD , a novel stainless steel based vascular closure device versus manual compression (MC) for femoral arteriotomy site hemostasis in patients undergoing percutaneous coronary procedures.

Background: Optimal access site management after percutaneous transfemoral procedures remains controversial.

Methods: Patients enrolled in this multicenter, randomized open label trial underwent 6-F diagnostic or interventional procedures and were assigned 2:1 to Celt ACD versus MC. All patients were on full anticoagulation. The primary efficacy end point was time to hemostasis (TTH) and the primary safety end points were 30-day incidence of major procedural and access site related complications.

Results: The trial allocated 207 patients to Celt ACD (n = 148) versus MC (n = 59) at 5 investigational sites. Baseline characteristics of the two groups were similar. Median TTH was 0 (Interquartile range (IQR): 0, 0.33) in the Celt ACD compared to 8 min (IQR: 0, 20; P < 0.0001) in the MC group. Procedural success was 99.3% in the Celt ACD versus 98.1% in the MC group (P = NS). There was a single major adverse event due to device maldeployment and embolization with successful percutaneous retrieval. The 30-day major complication rate was 0.7% in the Celt ACD and 0% in the MC group (P = NS).

Conclusions: After 6-F percutaneous invasive procedures in fully anticoagulated patients, TTH was significantly reduced in patients assigned to Celt ACD compared to patients managed with MC. The 30-day rates of vascular complications were similarly low in both groups. (CELT ACD Trial; NCT01600482) © 2017 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.26991DOI Listing
November 2017

Prognostic Value of Combined CT Angiography and Myocardial Perfusion Imaging versus Invasive Coronary Angiography and Nuclear Stress Perfusion Imaging in the Prediction of Major Adverse Cardiovascular Events: The CORE320 Multicenter Study.

Radiology 2017 07 14;284(1):55-65. Epub 2017 Mar 14.

From the Laboratory of Cardiac Energetics, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Md (M.Y.C., A.E.A.); InCor Heart Institute, University of São Paulo Medical School, Brazil, São Paulo, Brazil (C.E.R.); Johns Hopkins Hospital and School of Medicine, 600 N Wolfe St, Blalock 524, Baltimore, MD 21287 (A.A., R.T.G., J.M.M., A.L.V., R.J.C., V.C.M., J.A.B., J.A.C.L.); Department of Radiology, Charité Medical School-Humboldt, Berlin, Germany (M.D., M.L.); Memorial Heart Center, Iwate Medical University, Morioka, Japan (H.N., K.Y.); Department of Radiology, St. Luke's International Hospital, Tokyo, Japan (H.N.); Department of Radiology, Mie University Hospital, Tsu, Japan (K.K., H.S.); Department of Radiology, Beth Israel Deaconess Medical Center, Harvard University, Boston, Mass (R.L., M.E.C.); and Radiology Sector, Hospital Israelita Albert Einstein, São Paulo, Brazil (C.N.); From the Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark (K.F.K.); Keio University School of Medicine, Tokyo, Japan (M.J., S.K.); Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands (A.J.S.); Department of Cardiology, National Heart Centre, Singapore (S.Y.T.); Medi-Rad Associates, CT Centre, Mount Elizabeth Hospital, Singapore (J.H.); Department of Medical Imaging, Toronto General Hospital, Toronto, Ontario, Canada (N.P.); Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada (F.J.R.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (M.B.M., C.C.); and Department of Nuclear Medicine and Cardiovascular Imaging, Brigham and Women's Hospital, Boston, Mass (M.F.D.C.).

Purpose To compare the prognostic importance (time to major adverse cardiovascular event [MACE]) of combined computed tomography (CT) angiography and CT myocardial stress perfusion imaging with that of combined invasive coronary angiography (ICA) and stress single photon emission CT myocardial perfusion imaging. Materials and Methods This study was approved by all institutional review boards, and written informed consent was obtained. Between November 2009 and July 2011, 381 participants clinically referred for ICA and aged 45-85 years were enrolled in the Combined Noninvasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Row Computed Tomography (CORE320) prospective multicenter diagnostic study. All images were analyzed in blinded independent core laboratories, and a panel of physicians adjudicated all adverse events. MACE was defined as revascularization (>30 days after index ICA), myocardial infarction, or cardiac death; hospitalization for chest pain or congestive heart failure; or arrhythmia. Late MACE was defined similarly, except for patients who underwent revascularization within the first 182 days after ICA, who were excluded. Comparisons of 2-year survival (time to MACE) used standard Kaplan-Meier curves and restricted mean survival times bootstrapped with 2000 replicates. Results An MACE (49 revascularizations, five myocardial infarctions, one cardiac death, nine hospitalizations for chest pain or congestive heart failure, and one arrhythmia) occurred in 51 of 379 patients (13.5%). The 2-year MACE-free rates for combined CT angiography and CT perfusion findings were 94% negative for coronary artery disease (CAD) versus 82% positive for CAD and were similar to combined ICA and single photon emission CT findings (93% negative for CAD vs 77% positive for CAD, P < .001 for both). Event-free rates for CT angiography and CT perfusion versus ICA and single photon emission CT for either positive or negative results were not significantly different for MACE or late MACE (P > .05 for all). The area under the receiver operating characteristic curve (AUC) for combined CT angiography and CT perfusion (AUC = 68; 95% confidence interval [CI]: 62, 75) was similar (P = .36) to that for combined ICA and single photon emission CT (AUC = 71; 95% CI: 65, 79) in the identification of MACE at 2-year follow-up. Conclusion Combined CT angiography and CT perfusion enables similar prediction of 2-year MACE, late MACE, and event-free survival similar to that enabled by ICA and single photon emission CT. RSNA, 2017 Online supplemental material is available for this article.
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http://dx.doi.org/10.1148/radiol.2017161565DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5495129PMC
July 2017

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol.

Cardiol J 2017 1;24(3):250-258. Epub 2017 Mar 1.

Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany, Germany.

Background: Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria.

Methods: A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19-27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation.

Results: The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days.

Conclusions: The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.
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http://dx.doi.org/10.5603/CJ.a2017.0024DOI Listing
April 2018

Severe Aortic Valve Stenosis in Adults is Associated with Increased Levels of Circulating Intermediate Monocytes.

J Cardiovasc Transl Res 2017 Feb 17;10(1):27-34. Epub 2017 Jan 17.

Medizinische Klinik m.S. Kardiologie und Angiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany.

Individual monocyte subsets have been associated with atherosclerotic disease, but their distribution has not been evaluated in aortic valve stenosis (AS) so far. In the present study, we have asked whether levels of the circulating intermediate monocyte subset are increased in AS. Classical (CD14++CD16-), intermediate (CD14++CD16+), and non-classical (CD14+CD16++) CD86-positive monocytes and monocyte activation (intensity of CD11b expression) were determined by flow cytometry in peripheral blood of patients with severe AS (n = 100) and matched AS-free controls (n = 75). AS patients exhibited significantly higher levels of circulating intermediate monocytes, while levels of circulating classical and non-classical monocytes or monocyte activation did not differ compared to controls. The difference in levels of intermediate monocytes between groups was independent of age, gender, BMI, LDL-C, NT-proBNP, NYHA functional class, or creatinine levels. The present pilot study provides evidence of an association of severe AS with increased levels of circulating intermediate monocytes. Further studies need to clarify whether this finding is related to the inflammatory status and hemodynamic disturbances associated with severe AS.
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http://dx.doi.org/10.1007/s12265-016-9726-9DOI Listing
February 2017

Redo procedures for degenerated stentless aortic xenografts and the role of valve-in-valve transcatheter techniques.

Eur J Cardiothorac Surg 2017 04;51(4):653-659

Department of Cardiology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Objectives: This study evaluates reinterventions for degenerated stentless aortic xenografts.

Methods: Between 2010 and 2015, 52 consecutive patients (age 72.3 ± 9.7 years, EuroSCORE II 11.1 ± 8.9%) underwent reintervention for failed stentless aortic valves (60% porcine, 40% pericardial, 87% sub-coronary, 81% isolated/combined regurgitation).

Results: Based on age, EuroSCORE II, the presence of pulmonary hypertension, renal failure, a patent internal mammary artery graft and required concomitant procedures, the heart team assigned 25 patients to reoperation and 27 to valve-in-valve transcatheter aortic valve implantation (ViV-TAVI). Valve implantation was successful in all surgical (24% root replacement) and in 24 transcatheter cases (93% trans-femoral, 56% balloon-expandable). Procedural complications were aortic dissection ( n  = 1) during reoperation and coronary obstruction ( n  = 4), device malpositioning ( n  = 3), deployment of >1 valve ( n  = 2) and vascular access site complications ( n  = 2) during ViV-TAVI. Thirty-day mortality (10%, three ViV-TAVI patients, two surgical patients, P  = 1.0) was associated with preoperative renal failure, >1 concomitant procedure, life-threatening bleeding, coronary obstruction and necessity for prolonged circulatory support. ViV-TAVI was beneficial regarding ventilation time, transfusion requirements and the incidence of sepsis. Overall, functional (94% New York Heart Association Class I/II) and echocardiographic results (indexed effective orifice area 0.95 ± 0.27 cm 2 /m 2 , mean transvalvular gradient 14 ± 6.8 mmHg) were favourable. After ViV-TAVI, aortic regurgitation was mild and moderate in two and three patients. One-year survival was 82.3 ± 5.4% and similar after surgery (83.1 ± 7.7%) and ViV-TAVI (81.5 ± 7.5%, P  = 0.76).

Conclusions: Reinterventions for degenerated stentless aortic valves are challenging. Although ViV-TAVI is appropriate in high-risk patients, limitations and potential complications must be considered. Redo surgery has its place in low-risk patients and if concomitant procedures are required.
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http://dx.doi.org/10.1093/ejcts/ezw397DOI Listing
April 2017

Sutureless Aortic Valve Replacement in a Patient with Transfemoral Aortic Valve Replacement and Left Ventricular Hypertrophy.

Thorac Cardiovasc Surg Rep 2016 Dec 10;5(1):21-23. Epub 2015 Jul 10.

Department of Cardiovascular Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.

 Transarterial valve intervention (TAVI) is valuable in high-risk patients, however, in case of left ventricular outflow tract (LVOT) obstruction, conventional surgery, including partial myectomy, is indicated.  An 84-year-old female patient presented with increasing fatigue after TAVI in 2012, demonstrated a narrowed LVOT. Conventional surgery was performed, including removal of the transcathether valve, partial septal myectomy, and implantation of a sutureless valve. The postoperative course was uncomplicated.  Aortic valve stenosis combined with severe left-ventricular hypertrophy is not ideal for TAVI. Conventional surgery, performing partial septal myectomy and implantation of sutureless aortic prosthesis, seems more appropriate.
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http://dx.doi.org/10.1055/s-0035-1554991DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5177443PMC
December 2016

Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial.

Eur Radiol 2017 Jul 18;27(7):2957-2968. Epub 2016 Nov 18.

Department of Cardiology, Lithuanian University of Health Sciences, Eivelniu 2, 50009, Kaunas, Lithuania.

Objectives: More than 3.5 million invasive coronary angiographies (ICA) are performed in Europe annually. Approximately 2 million of these invasive procedures might be reduced by noninvasive tests because no coronary intervention is performed. Computed tomography (CT) is the most accurate noninvasive test for detection and exclusion of coronary artery disease (CAD). To investigate the comparative effectiveness of CT and ICA, we designed the European pragmatic multicentre DISCHARGE trial funded by the 7th Framework Programme of the European Union (EC-GA 603266).

Methods: In this trial, patients with a low-to-intermediate pretest probability (10-60 %) of suspected CAD and a clinical indication for ICA because of stable chest pain will be randomised in a 1-to-1 ratio to CT or ICA. CT and ICA findings guide subsequent management decisions by the local heart teams according to current evidence and European guidelines.

Results: Major adverse cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction and stroke as a composite endpoint will be the primary outcome measure. Secondary and other outcomes include cost-effectiveness, radiation exposure, health-related quality of life (HRQoL), socioeconomic status, lifestyle, adverse events related to CT/ICA, and gender differences.

Conclusions: The DISCHARGE trial will assess the comparative effectiveness of CT and ICA.

Key Points: • Coronary artery disease (CAD) is a major cause of morbidity and mortality. • Invasive coronary angiography (ICA) is the reference standard for detection of CAD. • Noninvasive computed tomography angiography excludes CAD with high sensitivity. • CT may effectively reduce the approximately 2 million negative ICAs in Europe. • DISCHARGE addresses this hypothesis in patients with low-to-intermediate pretest probability for CAD.
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http://dx.doi.org/10.1007/s00330-016-4620-zDOI Listing
July 2017

Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial.

BMJ 2016 Oct 24;355:i5441. Epub 2016 Oct 24.

Charité-Universitätsmedizin Berlin, Humboldt-Universität and Freie Universität zu Berlin, Germany.

Objective:  To evaluate whether invasive coronary angiography or computed tomography (CT) should be performed in patients clinically referred for coronary angiography with an intermediate probability of coronary artery disease.

Design:  Prospective randomised single centre trial.

Setting:  University hospital in Germany.

Participants:  340 patients with suspected coronary artery disease and a clinical indication for coronary angiography on the basis of atypical angina or chest pain.

Interventions:  168 patients were randomised to CT and 172 to coronary angiography. After randomisation one patient declined CT and 10 patients declined coronary angiography, leaving 167 patients (88 women) and 162 patients (78 women) for analysis. Allocation could not be blinded, but blinded independent investigators assessed outcomes.

Main Outcome Measure:  The primary outcome measure was major procedural complications within 48 hours of the last procedure related to CT or angiography.

Results:  Cardiac CT reduced the need for coronary angiography from 100% to 14% (95% confidence interval 9% to 20%, P<0.001) and was associated with a significantly greater diagnostic yield from coronary angiography: 75% (53% to 90%) v 15% (10% to 22%), P<0.001. Major procedural complications were uncommon (0.3%) and similar across groups. Minor procedural complications were less common in the CT group than in the coronary angiography group: 3.6% (1% to 8%) v 10.5% (6% to 16%), P=0.014. CT shortened the median length of stay in the angiography group from 52.9 hours (interquartile range 49.5-76.4 hours) to 30.0 hours (3.5-77.3 hours, P<0.001). Overall median exposure to radiation was similar between the CT and angiography groups: 5.0 mSv (interquartile range 4.2-8.7 mSv) v 6.4 mSv (3.4-10.7 mSv), P=0.45. After a median follow-up of 3.3 years, major adverse cardiovascular events had occurred in seven of 167 patients in the CT group (4.2%) and six of 162 (3.7%) in the coronary angiography group (adjusted hazard ratio 0.90, 95% confidence interval 0.30 to 2.69, P=0.86). 79% of patients stated that they would prefer CT for subsequent testing. The study was conducted at a University hospital in Germany and thus the performance of CT may be different in routine clinical practice. The prevalence was lower than expected, resulting in an underpowered study for the predefined primary outcome.

Conclusions:  CT increased the diagnostic yield and was a safe gatekeeper for coronary angiography with no increase in long term events. The length of stay was shortened by 22.9 hours with CT, and patients preferred non-invasive testing.Trial registration ClinicalTrials.gov NCT00844220.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5076567PMC
http://dx.doi.org/10.1136/bmj.i5441DOI Listing
October 2016

Mid-regional pro-adrenomedullin (MR-proADM) and mid-regional pro-atrial natriuretic peptide (MR-proANP) in severe aortic valve stenosis: association with outcome after transcatheter aortic valve implantation (TAVI).

Clin Chem Lab Med 2017 Feb;55(2):275-283

Background: This study aimed to assess the association of mid-regional (MR) pro-adrenomedullin (MR-proADM) and MR-pro-A-type natriuretic peptide (MR-proANP) in comparison to N-terminal pro-natriuretic peptide (NT-proBNP) with outcome in patients with aortic stenosis (AS) treated with transcatheter aortic valve implantation (TAVI).

Methods: One hundred consecutive TAVI patients were included in this prospective study. Association of preinterventional levels of MR-proADM, MR-proANP, NT-proBNP, C-reactive protein (CrP), and high-sensitive cardiac Troponin T (hsTN) with 30-day and 1-year outcome was analyzed.

Results: There was no association with 30-day outcome, but all markers were associated with 1-year cardiovascular events and all-cause mortality. The combined biomarker analysis further improved risk prediction.

Conclusions: In TAVI patients MR-proADM, MR-proANP, and NT-proBNP are promising predictors of adverse events within 1 year. Integration of these biomarkers into decision pathways may help to identify patients at higher risk.
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http://dx.doi.org/10.1515/cclm-2015-0419DOI Listing
February 2017
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