Publications by authors named "Henryk Dreger"

76 Publications

Detection of relevant extracardiac findings on coronary computed tomography angiography vs. invasive coronary angiography.

Eur Radiol 2021 Jun 15. Epub 2021 Jun 15.

Department of Radiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.

Objectives: To compare the detection of relevant extracardiac findings (ECFs) on coronary computed tomography angiography (CTA) and invasive coronary angiography (ICA) and evaluate the potential clinical benefit of their detection.

Methods: This is the prespecified subanalysis of ECFs in patients presenting with a clinical indication for ICA based on atypical angina and suspected coronary artery disease (CAD) included in the prospective single-center randomized controlled Coronary Artery Disease Management (CAD-Man) study. ECFs requiring immediate therapy and/or further workup including additional imaging were defined as clinically relevant. We evaluated the scope of ECFs in 329 patients and analyzed the potential clinical benefit of their detection.

Results: ECFs were detected in 107 of 329 patients (32.5%; CTA: 101/167, 60.5%; ICA: 6/162, 3.7%; p < .001). Fifty-nine patients had clinically relevant ECFs (17.9%; CTA: 55/167, 32.9%; ICA: 4/162, 2.5%; p < .001). In the CTA group, ECFs potentially explained atypical chest pain in 13 of 101 patients with ECFs (12.9%). After initiation of therapy, chest pain improved in 4 (4.0%) and resolved in 7 patients (6.9%). Follow-up imaging was recommended in 33 (10.0%; CTA: 30/167, 18.0%; ICA: 3/162, 1.9%) and additional clinic consultation in 26 patients (7.9%; CTA: 25/167, 15.0%; ICA: 1/162, 0.6%). Malignancy was newly diagnosed in one patient (0.3%; CTA: 1/167, 0.6%; ICA: 0).

Conclusions: In this randomized study, CTA but not ICA detected clinically relevant ECFs that may point to possible other causes of chest pain in patients without CAD. Thus, CTA might preclude the need for ICA in those patients.

Trial Registration: NCT Unique ID: 00844220 KEY POINTS: • CTA detects ten times more clinically relevant ECFs than ICA. • Actionable clinically relevant ECFs affect patient management and therapy and may thus improve chest pain. • Detection of ECFs explaining chest pain on CTA might preclude the need for performing ICA.
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http://dx.doi.org/10.1007/s00330-021-07967-xDOI Listing
June 2021

Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.

EuroIntervention 2021 05 18. Epub 2021 May 18.

University Hospital Bonn, Bonn, Germany.

Background: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality.

Aims: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system (Edwards Lifesciences, Irvine, CA, USA) from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study.

Methods: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team.

Results: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001).

Conclusions: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.
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http://dx.doi.org/10.4244/EIJ-D-21-00300DOI Listing
May 2021

Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial.

Lancet Digit Health 2020 01 12;2(1):e16-e24. Epub 2019 Dec 12.

Department of Cardiology, Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Background: The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial showed that, compared with usual care, a structured remote patient management (RPM) intervention done over 12-months reduced the percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause death. The aim of the study was to evaluate whether this clinical benefit seen for the RPM group during the initial 12 month follow-up of the TIM-HF2 trial would be sustained 1 year after stopping the RPM intervention.

Methods: TIM-HF2 was a prospective, randomised, multicentre trial done in 43 hospitals, 60 cardiology practices, and 87 general practitioners in Germany. Patients with heart failure, New York Heart Association functional class II or III, and who had been hospitalised for heart failure within 12 months before randomisation were randomly assigned to either the RPM intervention or usual care. At the final study visit (main trial), the RPM intervention was stopped and the 1 year extended follow-up period started, which lasted 1 year. The primary outcome was percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause mortality. Analyses were done using the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01878630.

Findings: Between Aug 13, 2013, and May 12, 2017, 1538 patients were enrolled (765 to the remote patient management group and 773 to the usual care group) in the main trial. 671 of 765 patients in the remote patient management group and 673 of 773 in the usual care group completed the main trial and started the extended follow-up period up to 1 year later. In the extended follow-up period, the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality did not differ significantly between groups weighted mean 5·95% [95% CI 4·59-7·31] in the RPM group vs 6·64% [95% CI 5·19-8·08] in the usual care group [rate ratio 0·79; 95% CI 0·78-1·21]). However, when data from the main trial and the extended follow-up period were combined, the percentage of days lost due to unplanned cardiovascular hospitalisation or all-cause death was significantly less in patients allocated to the RPM group (382 [50%] of 765; weighted mean 9·28%; 95% CI 7·76-10·81) than in the UC group (398 [51%] of 773; 11·78%; 95% CI 10·08-13·49; ratio of weighted average 0·79; 95% CI 0·62-1·00; p=0·0486).

Interpretation: The positive effect of our RPM intervention on morbidity and mortality over the course of the main trial was no longer observed 1 year after stopping the RPM intervention. However, because the TIM-HF2 trial was not powered to show significance during the extended follow-up period, our results are exploratory and require further research.

Funding: German Federal Ministry of Education and Research.
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http://dx.doi.org/10.1016/S2589-7500(19)30195-5DOI Listing
January 2020

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

Automated quantification of mitral valve tenting volume in functional mitral regurgitation by three-dimensional echocardiography.

Echocardiography 2020 07 12;37(7):1043-1048. Epub 2020 Jun 12.

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

Background: Tenting of the mitral leaflets is a major pathophysiological factor contributing to functional mitral regurgitation (FMR). A novel software tool allows automated quantification of the tenting volume (TnV) by 3D transesophageal echocardiography (TEE). The aims of this study are to investigate the correlations of biometric patient characteristics with the TnV and whether a threshold value for the diagnosis of a moderate or severe FMR can be calculated for the TnV.

Methods: This explorative and hypothesis-generating study analyzed the TnV of the mitral valve obtained by clinically indicated TEE. The mid-systolic, threefold calculated and averaged TnV from 80 patients with no or mild FMR and 27 patients with moderate or severe FMR was determined using the TomTec 4D MV Assessment tool.

Results: The TnV correlated significantly with the body size (r = 0.341), the weight (r = 0.272), and the body surface area (r = 0.320). After the adjustment to the body size, a threshold value of 1.25 cm /m was determined for the TnV by using a receiver-operating characteristic curve. This value distinguished moderate to severe from none to mild FMR with a sensitivity of 85% and a specificity of 71%. The intra-observer variability and inter-observer variability were determined to be 0.96 and 0.85, respectively.

Conclusions: Automated assessment of TnV has the potential to support the diagnostic evaluation of FMR. Further studies are needed to validate this result, detect additional factors influencing the size of the TnV, and determine further thresholds for any degree of FMR.
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http://dx.doi.org/10.1111/echo.14759DOI Listing
July 2020

Associations of 2D speckle tracking echocardiography-based right heart deformation parameters and invasively assessed hemodynamic measurements in patients with pulmonary hypertension.

Cardiovasc Ultrasound 2020 May 14;18(1):13. Epub 2020 May 14.

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

Background: We aimed to evaluate associations of right atrial (RA) and right ventricular (RV) strain parameters assessed by 2D speckle tracking echocardiography (2D STE) with invasively measured hemodynamic parameters in patients with and without pulmonary hypertension (PH).

Methods: In this study, we analyzed 78 all-comer patients undergoing invasive hemodynamic assessment by left and right heart catheterization. Standard transthoracic echocardiographic assessment was performed under the same hemodynamic conditions. RA and RV longitudinal strain parameters were analyzed using 2D STE. PH was defined as invasively obtained mean pulmonary arterial pressure (mPAP) ≥25 mmHg at rest and was further divided into pre-capillary PH (pulmonary capillary wedge pressure [PCWP] ≤ 15 mmHg), post-capillary PH (PCWP > 15 mmHg) and combined PH (PCWP > 15 mmHg and difference between diastolic PAP and PCWP of ≥7 mmHg). Correlation analyses between variables were calculated with Pearson's or Spearman's correlation coefficient as applicable.

Results: Out of 78 patients, 45 presented with PH. Within the PH group, 39 had post-capillary, five had combined pre- and post-capillary PH, and one had pre-capillary PH. Patients with PH had a significantly increased RA area (PH 22.0 ± 9.2 cm, non-PH 17.3 ± 10.7 cm; p = 0.003) and end-systolic RV area (PH 14.7 ± 6.1, non-PH 11.9 ± 4.8 cm; p = 0.022). RV mid strain was significantly reduced in PH (PH -17.4 ± 7.8, non-PH: - 21.6 ± 5.5; p = 0.019). Average peak systolic RA strain (RAS) and average peak systolic RV strain (RVS) showed a significant association with mPAP (r = - 0.470, p = 0.001 and r = 0.490, p = 0.001, respectively) and with PCWP (r = - 0.296, p = 0.048 and r = 0.365, p = 0.015, respectively) in patients with PH. Furthermore, RV apical, mid and basal strain as well as RV free wall strain showed moderate associations with mPAP. In patients without PH, there were no associations detectable between RA or RV strain parameters and mPAP and PCWP.

Conclusion: In an all-comer cohort, RA and RV strain parameters showed significant associations with invasively assessed mPAP and PCWP in patients with predominantly post-capillary PH. These associations may be useful in clinical practice to assess the impact of post-capillary PH on myocardial right heart function.
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http://dx.doi.org/10.1186/s12947-020-00197-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227096PMC
May 2020

Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain.

Health Qual Life Outcomes 2020 05 14;18(1):140. Epub 2020 May 14.

Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas, Lithuania.

Background: Health-related quality of life (HRQoL) is impaired in patients with stable angina but patients often present with other forms of chest pain. The aim of this study was to compare the pre-diagnostic HRQoL in patients with suspected coronary artery disease (CAD) according to angina type, gender, and presence of obstructive CAD.

Methods: From the pilot study for the European DISCHARGE trial, we analysed data from 24 sites including 1263 patients (45.9% women, 61.1 ± 11.3 years) who were clinically referred for invasive coronary angiography (ICA; 617 patients) or coronary computed tomography angiography (CTA; 646 patients). Prior to the procedures, patients completed HRQoL questionnaires: the Short Form (SF)-12v2, the EuroQoL (EQ-5D-3 L) and the Hospital Anxiety and Depression Scale.

Results: Fifty-five percent of ICA and 35% of CTA patients had typical angina, 23 and 33% had atypical angina, 18 and 28% had non-anginal chest discomfort and 5 and 5% had other chest discomfort, respectively. Patients with typical angina had the poorest physical functioning compared to the other angina groups (SF-12 physical component score; 41.2 ± 8.8, 43.3 ± 9.1, 46.2 ± 9.0, 46.4 ± 11.4, respectively, all age and gender-adjusted p < 0.01), and highest anxiety levels (8.3 ± 4.1, 7.5 ± 4.1, 6.5 ± 4.0, 4.7 ± 4.5, respectively, all adjusted p < 0.01). On all other measures, patients with typical or atypical angina had lower HRQoL compared to the two other groups (all adjusted p < 0.05). HRQoL did not differ between patients with and without obstructive CAD while women had worse HRQoL compared with men, irrespective of age and angina type.

Conclusions: Prior to a diagnostic procedure for stable chest pain, HRQoL is associated with chest pain characteristics, but not with obstructive CAD, and is significantly lower in women.

Trial Registration: Clinicaltrials.gov, NCT02400229.
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http://dx.doi.org/10.1186/s12955-020-01312-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7222590PMC
May 2020

Prevalence of left ventricular systolic dysfunction in a typical outpatient pacemaker cohort.

Herzschrittmacherther Elektrophysiol 2020 Jun 6;31(2):219-223. Epub 2020 May 6.

Herzschrittmacher- und ICD-Zentrum Berlin, Berlin, Germany.

Background: Right ventricular (RV) pacing is the standard treatment for symptomatic bradycardia. RV pacing is known to cause dyssyncrony. New treatment options like His bundle pacing enhance the focus on left ventricular dysfunction in patients with pacemakers.

Objectives: The aim of this cross-sectional study was to obtain a real-life picture of the patients in a representative cohort of outpatients with permanent pacemakers. The prevalence and causes of left ventricular dysfunction (LVD) were explored.

Methods: In total, 1869 patients of a pacemaker outpatient clinic were screened for left ventricular systolic dysfunction by transthoracic echocardiography. All patients were interviewed for symptoms and cardiologist care. Percentages of RV pacing and underlying cardiac disease were recorded.

Results: A left ventricular ejection fraction (LVEF) under 45% was found in 207 (11.1%) of all patients. Predictive factors for a reduced LVEF were a high pacing rate and long-term pacing. LVD due to RV pacing was diagnosed in 3.4% of all patients. Only 845 patients (45%) reported that they regularly visited a cardiologist.

Conclusion: There is a high prevalence of unknown LVD in a typical pacemaker cohort. Therefore, regular echocardiographic examinations should be performed in outpatients of pacemaker clinics.
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http://dx.doi.org/10.1007/s00399-020-00683-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7272385PMC
June 2020

Phasic left atrial strain analysis to discriminate cardiac amyloidosis in patients with unclear thick heart pathology.

Eur Heart J Cardiovasc Imaging 2021 May;22(6):680-687

Department of Cardiology and Angiology, Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117 Berlin, Germany.

Aims : Traditional echocardiographic parameters for the assessment of suspected cardiac amyloidosis (CA) are of limited diagnostic accuracy. We sought to explore differences and the discriminative value of phasic left atrial strain (LAS) reductions and of regional longitudinal left ventricular (LV) strain alterations (relative apical sparing; RELAPS) in CA and other causes of LV wall thickening (LVH).

Methods And Results : We included 54 patients with unclear LVH (mean septal diastolic wall thickness 17.8 ± 3.5 mm); CA was bioptically confirmed in 35 patients (8 mATTR, 6 wtATTR, 20 AL, and 1 AA amyloidosis) and LVH in 19 subjects. We analysed RELAPS as well as LA reservoir (LASr), conduit (LAScd), and contraction strain (LASct) using 2D speckle tracking echocardiography (EchoPAC software, GE). RELAPS was higher (1.37 ± 0.94 vs. 0.86 ± 0.29, P < 0.007), whereas atrial mechanics were significantly reduced in CA (LASr, LAScd, and LASct: 9.7 ± 5.2%, -6.5 ± 3.5%, and -5.0 ± 4.1% in CA; and 22.7 ± 7.8%, -13.9 ± 5.2%, and -13.0 ± 5.5% in LVH, respectively; P < 0.001 each). With an area under the curve (AUC) of 0.91 [95% confidence interval (CI) 0.82-0.99], LASr showed a higher diagnostic accuracy in discriminating CA than RELAPS (AUC 0.74, 95% CI 0.59-0.88). LASr and LAScd remained significantly associated with CA in a multivariate regression model.

Conclusion : Phasic LAS was significantly reduced in patients with CA and showed a higher diagnostic accuracy in discriminating CA than RELAPS. The additional assessment of phasic LAS may be useful to rule in the possible diagnosis of CA in patients with unclear LVH.
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http://dx.doi.org/10.1093/ehjci/jeaa043DOI Listing
May 2021

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

Sex-specific metabolic and functional differences in human umbilical vein endothelial cells from twin pairs.

Atherosclerosis 2019 12 10;291:99-106. Epub 2019 Oct 10.

Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Medizinische Klinik für Kardiologie und Angiologie, Campus Mitte, Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Germany. Electronic address:

Background And Aims: Gonadal hormones are mainly thought to account for sex and gender differences in the incidence, clinical manifestation and therapy of many cardiovascular diseases. However, intrinsic sex differences at the cellular level are mostly overlooked. Here, we assessed sex-specific metabolic and functional differences between male and female human umbilical vein endothelial cells (HUVECs).

Methods: Cellular metabolism was investigated by bioenergetic studies (Seahorse Analyser) and a metabolomic approach. Protein levels were determined by Western blots and proteome analysis. Vascular endothelial growth factor (VEGF)-stimulated cellular migration was assessed by gap closure. HUVECs from dizygotic twin pairs were used for most experiments.

Results: No sex differences were observed in untreated cells. However, sexual dimorphisms appeared after stressing the cells by serum starvation and treatment with VEGF. Under both conditions, female cells had higher intracellular ATP and metabolite levels. A significant decline in ATP levels was observed in male cells after serum starvation. After VEGF, the ratio of glycolysis/mitochondrial respiration was higher in female cells and migration was more pronounced.

Conclusions: These results point to an increased stress tolerance of female cells. We therefore propose that female cells have an energetic advantage over male cells under conditions of diminished nutrient supply. A more favourable energy balance of female HUVECs after serum starvation and VEGF could potentially explain their stronger migratory capacity.
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http://dx.doi.org/10.1016/j.atherosclerosis.2019.10.007DOI Listing
December 2019

Midregional pro-A-type natriuretic peptide as part of a dual biomarker strategy for the early rule out of non-ST segment elevation acute coronary syndrome - The WilCop study.

Int J Cardiol 2018 Dec 26;273:243-248. Epub 2018 Sep 26.

Wilhelminen Hospital, Department of Cardiology and Internal Emergency Medicine, Vienna, Austria; Sigmund Freud University, Medical School, Vienna, Austria.

Background: Mr-proANP is a biomarker produced in atrial and left ventricular myocardium. We investigated the effect of combined measurement of mr-proANP and high-sensitive cardiac Troponin I assay of the penultimate generation (s-cTnI) for an early type-1 and type-2 NSTE-ACS rule-out with emphasis on the very early presenters' subgroup with symptom onset time (SOT) ≤ 2 h.

Methods: This was a prospective cohort study of 311 consecutive patients admitted to ER with symptoms suggestive of an acute coronary syndrome (ACS). All patients had baseline mr-proANP and s-cTnI measurements.

Results: Of the total cohort, 17.6% (n = 55) had final diagnosis of NSTE-ACS: 9.6% (n = 30) had an angiographically-confirmed type-1 infarction and 8.0% (n = 25) had type-2 infarction. In the subgroup of very early presenters (SOT ≤ 2 h) the negative predictive value (NPV) of s-cTnI for type-1 NSTE-ACS was 96.7% (95%-CI: 87.5-99.4) and the NPV of mr-proANP was 100% (95%-CI: 87.1-100). The dual biomarker strategy yielded an NPV of 100% (95%-CI: 86.7-100). In the same time-related subgroup, the NPV of s-cTnI alone for type-2 was 98.3% (95%-CI: 89.8-99.9) and the NPV of mr-proANP was 97.0% (95%-CI: 82.5-100). The combination of biomarker increased the NPV to 100% (95%-CI: 86.7-100).

Conclusions: Our study demonstrated an immediate release pattern of mr-proANP in NSTE-ACS that may bridge the silent troponin time phenomenon when highest-sensitivity cardiac troponin assays are not used. This concept performed best in the very early presenters' subgroup with an excellent NPV of 100% and might result in an early rule-out of NSTE-ACS thus accelerating the diagnostic work-up.
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http://dx.doi.org/10.1016/j.ijcard.2018.09.084DOI Listing
December 2018

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.

Lancet 2018 09 25;392(10152):1047-1057. Epub 2018 Aug 25.

Department of Cardiology and Angiology, Campus Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany; German Centre for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany.

Background: Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population.

Methods: The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed.

Findings: Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55-5·23) in the remote patient management group and 6·64% (6·19-7·13) in the usual care group (ratio 0·80, 95% CI 0·65-1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6-19·1) per year compared with 24·2 days (22·6-26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14-10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21-13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50-0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45-1·01; p=0·0560).

Interpretation: The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality.

Funding: German Federal Ministry of Education and Research.
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http://dx.doi.org/10.1016/S0140-6736(18)31880-4DOI Listing
September 2018

Normative reference data, determinants, and clinical implications of right atrial reservoir function in women assessed by 2D speckle-tracking echocardiography.

Echocardiography 2018 10 1;35(10):1542-1549. Epub 2018 Jul 1.

Department of Cardiology and Angiology, Charité - Universitätsmedizin, Berlin, Germany.

Aim: We aim to determine normative reference data of phasic right atrial (RA) strain and to investigate determinants, possible clinical implications as well as feasibility and reproducibility of RA strain analysis.

Methods And Results: Right atrial strain was analyzed in 266 participants of the cross-sectional Berlin Female Risk Evaluation (BEFRI) study using 2D speckle-tracking echocardiography (2D STE). To determine reference values, phasic RA strain was determined in a subgroup of 123 individuals without known cardiovascular diseases or risk factors. Mean RA reservoir strain (RAS), RA conduit, and contraction strain in this reference group were 44.9 ± 11.6%, 27.1 ± 9.5%, and 17.0 ± 5.9%, respectively. Regarding possible clinical implications, RAS was significantly reduced in women with a BMI ≥ 25, compared with women with a BMI < 25 (35.5 ± 11.1% vs 43.4 ± 11.6%, P < 0.0001). RA strain analysis showed a good feasibility (92.7%); intra- and inter-observer variability was low (<5%). BMI, global longitudinal peak systolic LV strain (LVGLS%), RA area, TAPSE, and early diastolic myocardial relaxation velocity of the RV (RV-e') were significantly associated with RA mechanics in a multivariate logistic regression analysis.

Conclusion: In this cross-sectional trial, we determined reference values, feasibility and reproducibility, clinical and echocardiographic determinants, and possible clinical implications of RA strain analysis. Our data may help to introduce the analysis of RA mechanics into future echocardiographic routine use.
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http://dx.doi.org/10.1111/echo.14092DOI Listing
October 2018

Percutaneous biventricular Impella support in therapy-refractory cardiogenic shock.

Heart Lung 2018 May - Jun;47(3):250-252. Epub 2018 Apr 5.

Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Department of Cardiology and Angiology, Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.

Introduction: Percutaneous mechanical circulatory support systems have increasingly been adopted as a bail out strategy in patients with cardiogenic shock. Since studies showed mostly mixed results, however, the use of support systems remains a case by case decision.

Case: Here, we report on a case of therapy-refractory cardiogenic shock due to acute myocardial infarction treated with percutaneous right and left ventricular assist devices (Impella RP and CP).

Conclusion: Due to myocardial stunning, even patients with fulminant cardiogenic shock have the potential for full recovery. In the present case, we demonstrate the feasibility of biventricular Impella support in therapy-refractory cardiogenic shock facilitating bridge to recovery.
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http://dx.doi.org/10.1016/j.hrtlng.2018.03.009DOI Listing
January 2019

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

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

Right heart function in impaired left ventricular diastolic function: 2D speckle tracking echocardiography-based and Doppler tissue imaging-based analysis of right atrial and ventricular function.

Echocardiography 2018 01 6;35(1):47-55. Epub 2017 Nov 6.

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

Aim: The aim of our study was to describe right atrial (RA) and right ventricular (RV) function, assessed by Doppler tissue imaging and 2D speckle tracking echocardiography (2DSTE), in women with signs of early impaired left ventricular diastolic function (DD).

Methods And Results: In a cross-sectional trial, standard parameters of diastolic and right heart function were investigated in 438 women of the Berlin Female Risk Evaluation (BEFRI) study. In a subset of women, average peak systolic RA strain (RAS), as well as the average peak systolic RV strain of the free wall (RVS free wall) and of all RV segments (average RV strain; RVS Avg), was analyzed using 2DSTE. Compared to women with normal diastolic function (DD0), RAS, RVS free wall and RVS Avg were significantly reduced in DD (43.1% ± 11.9%, -26.7% ± 5.6%, and -23.3% ± 3.5% in DD0; vs 35.1% ± 10.4%, -23.9% ± 5.5%, and -20.6% ± 3.8% in DD; P < .01). Peak RV myocardial velocity (RV-IVV) and acceleration during isovolumetric contraction (RV-IVA) were markedly higher in DD (15.0 ± 3.9 cm/s and 3.1 ± 1.0 m/s² in DD vs 11.9 ± 3.2 cm/s and 2.8 ± 0.8 m/s² in DD0; P < .05). RAS and RV-IVV were significantly associated with DD after adjustment to age, BMI, and left atrial strain in multivariate regression analysis.

Conclusion: Systolic right heart function is significantly altered in DD. DTI as well as 2DSTE constitute sensitive echocardiographic tools that enable the diagnosis of impaired right heart mechanics in early-staged DD.
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http://dx.doi.org/10.1111/echo.13745DOI Listing
January 2018

Lipoprotein apheresis in patients with peripheral artery disease and lipoprotein(a)-hyperlipoproteinemia: 2-year follow-up of a prospective single center study.

Atheroscler Suppl 2017 Nov 1;30:174-179. Epub 2017 Jun 1.

Helios Klinikum Emil von Behring, Klinik für Gefäßmedizin, Walterhöferstraße. 11, 14165 Berlin, Germany. Electronic address:

Objective: Elevated plasma levels of lipoprotein(a) [Lp(a)], referred to as lipoprotein(a)-hyperlipoproteinemia [Lp(a)-HLP], are an independent risk factor for atherosclerosis. Lipoprotein apheresis (LA) enables an effective reduction of Lp(a) plasma levels. The present study investigates the effects of LA in patients with Lp(a)-HLP and peripheral artery disease (PAD).

Methods: Ten patients with isolated Lp(a)-HLP and severe PAD and who had recently undergone a revascularization (index procedure) were prospectively included in this observational single center study. All patients received weekly LA. Ankle-brachial-index (ABI), transcutaneous partial oxygen pressure (tcpO), pain level, and walking distance were assessed at baseline and at the follow ups scheduled 1, 3, 6, 12, and 24 months after initiation of LA. The number of revascularizations within 12 months prior and within 24 months after the index procedure was determined.

Results: As early as 1 month after initiation of LA, all investigated parameters had improved significantly compared to baseline. This improvement was further substantiated under LA throughout the entire follow-up period. Comparing baseline results with the 24-month follow-up, the average ABI increased from 0.53 ± 0.15 to 0.97 ± 0.08 (P < 0.001). The mean tcpO also increased from 42.9 ± 2.3 mmHg to 61 ± 4.6 mmHg (P < 0.001). The improved perfusion led to a reduction of the mean pain level from 7.0 ± 1.5 to 1.1 ± 0.4 (P < 0.001) on a visual analogue scale (VAS) and an extension of the mean walking distance from 87 ± 60 m to 402 ± 119 m (P < 0.001). All patients suffered from severe PAD with a high number of revascularizations in the 12 months prior to the index procedure (35 procedures in 120 patient-months). Since initiation of LA, the number of revascularizations dropped significantly and remained very low during the entire follow-up period (2 procedures in 229 patient-months, P < 0.001).

Conclusion: In patients with Lp(a)-HLP and severe PAD, LA results in sustained improvement of circulation, pain level and walking distance. The number of repeat revascularizations is strongly reduced under LA treatment.
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http://dx.doi.org/10.1016/j.atherosclerosissup.2017.05.007DOI Listing
November 2017
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