Pick Topic
Review Topic
List Experts
Examine Expert
Save Expert
  Site Guide ··   
Coronary Artery Disease: HELP
Articles by Evald Høj Christiansen
Based on 40 articles published since 2010
(Why 40 articles?)
||||

Between 2010 and 2020, Evald Høj Christiansen wrote the following 40 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Review Clinical outcomes with percutaneous coronary revascularization vs coronary artery bypass grafting surgery in patients with unprotected left main coronary artery disease: A meta-analysis of 6 randomized trials and 4,686 patients. 2017

Palmerini, Tullio / Serruys, Patrick / Kappetein, Arie Pieter / Genereux, Philippe / Riva, Diego Della / Reggiani, Letizia Bacchi / Christiansen, Evald Høj / Holm, Niels R / Thuesen, Leif / Makikallio, Timo / Morice, Marie Claude / Ahn, Jung-Min / Park, Seung-Jung / Thiele, Holger / Boudriot, Enno / Sabatino, Mario / Romanello, Mattia / Biondi-Zoccai, Giuseppe / Cavalcante, Raphael / Sabik, Joseph F / Stone, Gregg W. ·Polo Cardio-Toraco-Vascolare, Policlinico S. Orsola, Bologna, Italy. · International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. · Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. · Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada; Morristown Medical Center, Morristown, NJ. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. · Department of Cardiology, Oulu University Hospital, Oulu, Finland. · MC Moriec Ramsay Générale de Santé, ICPS, Massy, France. · The Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. · University Heart Center Lübeck and the German Center for Cardiovascular Research (DZHK), Lübeck, Germany. · Department of Internal Medicine/Cardiology, University Heart Center, Leipzig, Germany. · Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy. · Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. · The Cleveland Clinic Foundation, Cleveland, OH. · Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY. Electronic address: gs2184@columbia.edu. ·Am Heart J · Pubmed #28760214.

ABSTRACT: Some but not all randomized controlled trials (RCT) have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents may be an acceptable alternative to coronary artery bypass grafting (CABG) surgery for the treatment of unprotected left main coronary artery disease (ULMCAD). We therefore aimed to compare the risk of all-cause mortality between PCI and CABG in patients with ULMCAD in a pairwise meta-analysis of RCT. METHODS: Randomized controlled trials comparing PCI vs CABG for the treatment of ULMCAD were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. RESULTS: Six trials including 4,686 randomized patients were identified. After a median follow-up of 39 months, there were no significant differences between PCI vs CABG in the risk of all-cause mortality (hazard ratio [HR] 0.99, 95% CI 0.76-1.30) or cardiac mortality. However, a significant interaction for cardiac mortality (P CONCLUSIONS: In patients undergoing revascularization for ULMCAD, PCI was associated with similar rates of mortality compared with CABG at a median follow-up of 39 months, but with an interaction effect suggesting relatively lower mortality with PCI in patients with low SYNTAX score and relatively lower mortality with CABG in patients with high SYNTAX score. Both procedures resulted in similar long-term composite rates of death, myocardial infarction, or stroke, with PCI offering an early safety advantage and CABG demonstrating greater durability.

2 Review Calibration of intravascular optical coherence tomography as presented in peer reviewed publications. 2014

Hebsgaard, Lasse / Christiansen, Evald Høj / Holm, Niels Ramsing. ·Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. · Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. Electronic address: niels.holm@ki.au.dk. ·Int J Cardiol · Pubmed #24342409.

ABSTRACT: -- No abstract --

3 Clinical Trial Safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: three-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. 2020

Haude, Michael / Ince, Hüseyin / Toelg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Neumann, Franz-Josef / Eeckhout, Eric / Garcia-Garcia, Hector M / Waksman, Ron. ·Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. ·EuroIntervention · Pubmed #30803936.

ABSTRACT: AIMS: We aimed to evaluate the safety and performance of a magnesium-based sirolimus-eluting metal scaffold at three-year follow-up to assess vessel response two years beyond scaffold resorption. METHODS AND RESULTS: BIOSOLVE-II is an international, multicentre first-in-man study, including 123 patients with de novo lesions. Predilatation was mandatory and post-dilatation was left to the discretion of the investigators. Dual antiplatelet therapy was recommended for six months. At three years, 91.1% of patients were angina-free and 8.0% were on dual antiplatelet therapy. The target lesion failure rate was 6.8% (n=8: two cardiac deaths, one target vessel myocardial infarction and five target lesion revascularisations). No probable or definite scaffold thrombosis was observed. Imaging follow-up was voluntary and serial angiographic assessment at 6, 12, and 36 months was available in 25 patients. In these, a slight increase in in-segment and in-scaffold late lumen loss and diameter stenosis was observed between 12 and 36 months (by 0.11±0.28 mm and 0.13±0.30 mm for late lumen loss, and by 3.8±10.1% and 4.1±10.2% for diameter stenosis). CONCLUSIONS: Two years beyond the resorption period of a sirolimus-eluting bioresorbable metal scaffold built from a proprietary magnesium alloy, complication rates remained low. In the patients with serial angiographic assessment, late lumen loss and diameter stenosis did not increase substantially beyond the resorption period.

4 Clinical Trial Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial). 2019

Ozaki, Yuichi / Garcia-Garcia, Hector M / Hideo-Kajita, Alexandre / Kuku, Kayode O / Haude, Michael / Ince, Hüseyin / Abizaid, Alexandre / Tölg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Escaned, Javier / Waksman, Ron. ·Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia; MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, District of Columbia. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia; MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, District of Columbia. Electronic address: hector.m.garciagarcia@medstar.net. · MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, District of Columbia. · Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. · Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. · Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. · Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, the Netherlands. · Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia. ·Am J Cardiol · Pubmed #30683424.

ABSTRACT: Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is used for treating coronary lesions. However, the natural history of the jailed side-branch (SB) after DREAMS 2G implantation remains to be elucidated. The aim of this study is to investigate the effect of scaffold struts on jailed SBs as assessed by 3-dimensional (3D) optical coherence tomography (OCT) after implantation of DREAMS 2G. We enrolled the patients who received a DREAMS 2G implantation and where OCT was performed at postprocedure and 12-month follow-up in the BIOSOLVE-II trial. The area of the ostium of jailed SBs and number of compartments divided by scaffold struts were assessed by cut-plane analysis using 3D OCT. A total of 24 patients with 61 jailed SBs were analyzed in this study. The number of compartments was significantly decreased (postprocedure; 1.98 ± 0.84 vs 12 months; 1.10 ± 0.30, p <0.001) during the 12 months. Since most of the struts disappeared, the ostium area was increased in 62% of jailed SBs at 12 months, however, not significantly different from postprocedure (postprocedure; 0.74 [0.34 to 1.46] mm

5 Clinical Trial Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up: the FANTOM II study. 2018

van Zandvoort, Laurens J C / Dudek, Dariusz / Weber-Albers, Joachim / Abizaid, Alexandre / Christiansen, Evald Høj / Muller, David W M / Kochman, Janusz / Kołtowski, Łukasz / Lassen, Jens Flensted / Wojdyla, Roman / Wykrzykowska, Joanna J / Onuma, Yoshinobu / Daemen, Joost. ·Department of Cardiology, Erasmus MC, Rotterdam, the Netherlands. ·EuroIntervention · Pubmed #30222116.

ABSTRACT: AIMS: FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings. METHODS AND RESULTS: A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25% at six months, and 3.40±4.11% at nine months). CONCLUSIONS: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.

6 Clinical Trial Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III. 2018

Haude, Michael / Ince, Hüseyin / Kische, Stephan / Abizaid, Alexandre / Tölg, Ralph / Alves Lemos, Pedro / Van Mieghem, Nicolas M / Verheye, Stefan / von Birgelen, Clemens / Christiansen, Evald Høj / Barbato, Emanuele / Garcia-Garcia, Hector M / Waksman, Ron / Anonymous1941174. ·Medical Clinic I Städtische Kliniken Neuss Lukaskrankenhaus GmbH, Neuss, Germany. · Department of Cardiology Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. · Department of Cardiology, Universitätsmedizin Rostock, Germany. · Department of Cardiology, Vivantes Klinikum im Friedrichschain, Berlin, Germany. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. · Instituto do Coração - HCFMUSP University of Sao Paulo, São Paulo Brazil. · Thoraxcenter Erasmus Medical Center, Rotterdam, The Netherland. · Interventional Cardiology Middelheim Hospital, Antwerpen, Belgium. · Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, the Netherlands. · Aarhus University Hospital, Skejby Aarhus, Denmark. · OLV Hospital, Cardiovascular Research Center Aalst, Aalst, Belgium. · Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy. · Interventional Cardiology MedStar Washington Hospital Center, Washington, District of Columbia. ·Catheter Cardiovasc Interv · Pubmed #30079472.

ABSTRACT: OBJECTIVES: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data. BACKGROUND: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. METHODS: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III). RESULTS: Mean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in-segment and 0.39 ± 0.34 mm in-scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed. CONCLUSION: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.

7 Clinical Trial In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial. 2018

Garcia-Garcia, Hector M / Haude, Michael / Kuku, Kayode / Hideo-Kajita, Alexandre / Ince, Hüseyin / Abizaid, Alexandre / Tölg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Escaned, Javier / Dijkstra, Jouke / Waksman, Ron. ·Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: hector.m.garciagarcia@medstar.net. · Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. · Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. · Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. · Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. · Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, The Netherlands. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · LKEB, Leiden University, Leiden, The Netherlands. ·Int J Cardiol · Pubmed #29292064.

ABSTRACT: RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. CONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504.

8 Clinical Trial Donor-specific antibodies are associated with micro- and macrovascular coronary disease, restrictive myocardial damage, and poor outcome in heart-transplanted patients. 2017

Clemmensen, Tor Skibsted / Koefoed-Nielsen, Pernille / Jensen, Lis-Ann / Poulsen, Steen Hvitfeldt / Holm, Niels Ramsing / Løgstrup, Brian Bridal / Christiansen, Evald Høj / Dijkstra, Jouke / Valen, Kamilla Pernille Bjerre / Eiskjaer, Hans. ·Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. · Department of Cardiology, Horsens Regional Hospital, Horsens, Denmark. · Department of Clinical Immunology, Aarhus University Hospital, Skejby, Denmark. · Division of Image Processing, Leiden University Medical Center, Leiden, The Netherlands. ·Clin Transplant · Pubmed #28627046.

ABSTRACT: AIMS: We examined the relationship between donor-specific HLA antibody (DSA) presence and graft function, hemodynamics, cardiac allograft vasculopathy (CAV), and major adverse cardiac events (MACE) in stable long-term heart-transplanted (HTx) patients. METHODS: Sera from 79 patients (median 7.5 years after HTx) were analyzed for DSA presence. Graft function was evaluated by echocardiography and right heart catheterization. CAV burden was determined by coronary angiography, optical coherence tomography (OCT), and coronary flow velocity reserve (CFVR). Patients were prospectively followed after DSA assessment. MACE included significant CAV progression, heart failure, treated rejection, and cardiovascular death. RESULTS: Sixty patients had no DSA, and 19 patients were sensitized. The vasculopathy burden by angiography, OCT, and CFVR was more pronounced in DSA-positive patients than in DSA-negative patients. DSA-positive patients had higher pulmonary capillary wedge pressure (16 [8; 21] vs 9 mm Hg [7; 11], P<.05) and right atrial pressure (8 [6; 9] vs 4 mm Hg [2; 6], P<.01) and lower global longitudinal strain (-13% [-10; -15] vs -16% [-14; -17], P<.01) than DSA-negative patients. DSA presence was a strong MACE predictor (HR 4.7 (95% CI 2.0-11.4), P<.001). CONCLUSIONS: DSA-positive patients had higher vasculopathy burden, higher filling pressures, and lower longitudinal myocardial deformation than DSA-negative patients. The DSA presence was a strong MACE predictor.

9 Clinical Trial Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. 2016

Haude, Michael / Ince, Hüseyin / Abizaid, Alexandre / Toelg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Neumann, Franz-Josef / Kaiser, Christoph / Eeckhout, Eric / Lim, Soo Teik / Escaned, Javier / Onuma, Yoshinobu / Garcia-Garcia, Hector M / Waksman, Ron. ·Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Preussenstr. 84, 41464 Neuss, Germany mhaude@lukasneuss.de michael.haude@uni-due.de. · Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. · Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. · Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, The Netherlands. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany. · Department of Cardiology, University Hospital, Basel, Switzerland. · Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland. · Department of Cardiology, National Heart Center Singapore, Singapore, Singapore. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · Cardialysis BV, Rotterdam, The Netherlands. · Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. ·Eur Heart J · Pubmed #27190094.

ABSTRACT: AIMS: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. METHODS AND RESULTS: The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and-if subjects consented-at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis. CONCLUSION: The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months. CLINICALTRIALSGOV IDENTIFIER: NCT01960504.

10 Clinical Trial Comparison of outcomes in patients with versus without diabetes mellitus after revascularization with everolimus- and sirolimus-eluting stents (from the SORT OUT IV trial). 2012

Jensen, Lisette Okkels / Thayssen, Per / Junker, Anders / Maeng, Michael / Tilsted, Hans-Henrik / Kaltoft, Anne / Hansen, Knud Nørregaard / Christiansen, Evald Høj / Kristensen, Steen Dalby / Ravkilde, Jan / Madsen, Morten / Sørensen, Henrik Toft / Thuesen, Leif / Lassen, Jens Flensted. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk ·Am J Cardiol · Pubmed #22959714.

ABSTRACT: Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients.

11 Article Danish study of Non-Invasive testing in Coronary Artery Disease 2 (Dan-NICAD 2): Study design for a controlled study of diagnostic accuracy. 2019

Rasmussen, Laust Dupont / Winther, Simon / Westra, Jelmer / Isaksen, Christin / Ejlersen, June Anita / Brix, Lau / Kirk, Jane / Urbonaviciene, Grazina / Søndergaard, Hanne Maare / Hammid, Osama / Schmidt, Samuel Emil / Knudsen, Lars Lyhne / Madsen, Lene Helleskov / Frost, Lars / Petersen, Steffen E / Gormsen, Lars Christian / Christiansen, Evald Høj / Eftekhari, Ashkan / Holm, Niels Ramsing / Nyegaard, Mette / Chiribiri, Amedeo / Bøtker, Hans Erik / Böttcher, Morten. ·Department of Cardiology, Hospital Unit West, Gl. Landevej 61, Herning, Denmark. Electronic address: lausra@rm.dk. · Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus, Denmark. · Department of Radiology, Regional Hospital Central Jutland, Falkevej 1A, Silkeborg, Denmark. · Department of Nuclear Medicine, Hospital Unit West, Gl. Landevej 61, Herning, Denmark. · Department of Cardiology, Regional Hospital Central Jutland, Falkevej 1A, Silkeborg, Denmark. · Department of Cardiology, Regional Hospital Central Jutland, Heibergs Allé 4, Viborg, Denmark. · Department of Cardiology, Regional Hospital East Jutland, Skovlyvej 15, Randers, Denmark. · Department of Health Science and Technology, Aalborg University, Aalborg, Denmark. · Department of Cardiology, Hospital Unit West, Gl. Landevej 61, Herning, Denmark. · Barts Heart Centre, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London, United Kingdom; William Harvey Research Institute, NIHR Barts Biomedical Research Centre, Queen Mary University of London, Charterhouse Square, London, United Kingdom. · Department of Nuclear Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus, Denmark. · Department of Biomedicine, Aarhus University, Aarhus, Denmark. · Department of Cardiovascular Imaging, School of Biomedical Engineering and Imaging Sciences, King's College London, United Kingdom. · Department of Cardiology, Hospital Unit West, Gl. Landevej 61, Herning, Denmark. Electronic address: morboett@rm.dk. ·Am Heart J · Pubmed #31323454.

ABSTRACT: BACKGROUND: Coronary computed tomography angiography (CTA) is the preferred primary diagnostic modality when examining patients with low to intermediate pre-test probability of coronary artery disease (CAD). Only 20-30% of these have potentially obstructive CAD. Because of the relatively poor positive predictive value of coronary CTA, unnecessary invasive coronary angiographies (ICAs) are conducted with the costs and risks associated with the procedure. Hence, an optimized diagnostic CAD algorithm may reduce the numbers of ICAs not followed by revascularization. The Dan-NICAD 2 study has 3 equivalent main aims: (1) To examine the diagnostic precision of a sound-based diagnostic algorithm, The CADScor®System (Acarix A/S, Denmark), in patients with a low to intermediate pre-test risk of CAD referred to a primary examination by coronary CTA. We hypothesize that the CADScor®System provides better stratification prior to coronary CTA than clinical risk stratification scores alone. (2) To compare the diagnostic accuracy of 3T cardiac magnetic resonance imaging (3T CMRI), METHODS: Dan-NICAD 2 is a prospective, multicenter, cross-sectional study including approximately 2,000 patients with low to intermediate pre-test probability of CAD and without previous history of CAD. Patients are referred to coronary CTA because of symptoms suggestive of CAD, as evaluated by a cardiologist. Patient interviews, sound recordings, and blood samples are obtained in connection with the coronary CTA. If coronary CTA does not rule out obstructive CAD, patients will be examined by 3T CMRI DISCUSSION: The results of the Dan-NICAD 2 study are expected to contribute to the improvement of diagnostic strategies for patients suspected of CAD in 3 different steps: risk stratification prior to coronary CTA, diagnostic strategy after coronary CTA, and invasive wireless QFR analysis as an alternative to ICA-FFR.

12 Article Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions. 2019

Holck, Emil Nielsen / Fox-Maule, Camilla / Barkholt, Trine Ørhøj / Jakobsen, Lars / Tu, Shengxian / Maeng, Michael / Dijkstra, Jouke / Christiansen, Evald Høj / Holm, Niels Ramsing. ·Department of Cardiology, Aarhus University Hospital Skejby, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark. · Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Wenxuan Building, 800 Dongchuan RD, Minhang District, Shanghai, China. · Division of Image Processing, Department of Radiology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. · Department of Cardiology, Aarhus University Hospital Skejby, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark. niels.holm@clin.au.dk. ·Int J Cardiovasc Imaging · Pubmed #31053981.

ABSTRACT: We aimed to evaluate feasibility, early healing and self-correcting properties of the Desolve 150 bioresorbable scaffold (BRS) implanted in bifurcation lesions, using the simple, provisional side branch (SB) stenting technique. BIFSORB pilot was a proof-of-concept study enrolling 10 patients with stable angina pectoris and a bifurcation lesion with SB ≥ 2.5 mm and less than 50% diameter stenosis. Procedure and 1-month outcome was evaluated by optical coherence tomography (OCT) to assess scaffold performance and healing patterns. Nine patients were treated with Desolve 150 BRS and one delivery to the target bifurcation failed. Thrombus formation in the jailed SB ostium was seen in three cases, but was completely resolved at 1-month. OCT confirmed acute self-correcting properties. No clinical events were reported after six months. Scaffold diameter by OCT increased in the proximal main vessel from 3.09 ± 0.16 mm to 3.34 ± 0.18 mm (p = 0.01) and in distal main vessel from 2.82 ± 0.26 mm to 3.02 ± 0.29 mm (p < 0.01) at one-month follow-up. SB ostial diameter stenosis improved from 42 ± 15% to 34 ± 12% (p = 0.01). Malapposition was effectively reduced after 1 month from 4.1 (1.4; 6.1)% to 0.1 (0; 0.6)% (p = 0.002). Treatment of bifurcation lesions using Desolve 150 BRS was feasible except for a delivery failure and unsettling thrombus formation behind jailing SB struts, which was completely resolved at 1-month. Self-correcting and even self-expanding properties were confirmed.

13 Article Diagnostic performance of quantitative flow ratio in prospectively enrolled patients: An individual patient-data meta-analysis. 2019

Westra, Jelmer / Tu, Shengxian / Campo, Gianluca / Qiao, Shubin / Matsuo, Hitoshi / Qu, Xinkai / Koltowski, Lukasz / Chang, Yunxiao / Liu, Tommy / Yang, Junqing / Andersen, Birgitte Krogsgaard / Eftekhari, Ashkan / Christiansen, Evald Høj / Escaned, Javier / Wijns, William / Xu, Bo / Holm, Niels Ramsing. ·Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. · School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China. · Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona (FE), Italy. · Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy. · Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. · Department of Cardiovascular Medicine, Gifu Heart Center, Gifu City, Japan. · Huadong Hospital Affiliated to Fudan University, Shanghai, China. · 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland. · Department of Cardiology, Hagaziekenhuis, The Hague, The Netherlands. · Guangdong General Hospital, Guangzhou, China. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · The Lambe Institute for Translational Medicine and Curam, National University of Ireland Galway, Ireland. ·Catheter Cardiovasc Interv · Pubmed #30963676.

ABSTRACT: OBJECTIVES: We aimed to provide robust performance estimates for quantitative flow ratio (QFR) in assessment of intermediary coronary lesions. BACKGROUND: Angiography-based functional lesion assessment by QFR may appear as a cost saving and safe approach to expand the use of physiology-guided percutaneous coronary interventions. QFR was proven feasible and showed good diagnostic performance in mid-sized off-line and on-line studies with fractional flow reserve (FFR) as reference standard. METHODS: We performed a collaborative individual patient-data meta-analysis of all available prospective studies with paired assessment of QFR and FFR using the CE-marked QFR application. The main outcome was agreement of QFR and FFR using a two-step analysis strategy with a multilevel mixed model accounting for study and center level variation. RESULTS: Of 16 studies identified, four studies had prospective enrollment and provided patient level data reaching a total of 819 patients and 969 vessels with paired FFR and QFR: FAVOR Pilot (n = 73); WIFI II (n = 170); FAVOR II China (n = 304) and FAVOR II Europe-Japan (n = 272). We found an overall agreement (mean difference 0.009 ± 0.068, I CONCLUSIONS: Diagnostic performance of QFR was good with FFR as reference in this meta-analysis of high quality studies. QFR could provide an easy, safe, and cost-effective solution for functional evaluation of coronary artery stenosis.

14 Article One-year cost-effectiveness and safety of simultaneous hybrid coronary revascularization versus conventional coronary artery bypass grafting. 2019

Rimestad, Jesper Møller / Christiansen, Evald Høj / Modrau, Ivy Susanne. ·Danish Center for Healthcare Improvements, Department of Business and Management, Aalborg University, Aalborg, Denmark. · Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark. ·Interact Cardiovasc Thorac Surg · Pubmed #30903175.

ABSTRACT: OBJECTIVES: To evaluate the cost-effectiveness and safety of simultaneous hybrid coronary revascularization (sHCR) compared to conventional coronary artery bypass grafting (CABG) in elective patients with multivessel coronary artery disease. METHODS: Cost-utility analysis of a prospective cohort follow-up study comparing per protocol 50 sHCR patients to 50 contemporaneous matched patients undergoing CABG. Resource utilization data and health-related quality of life were collected prospectively, and the cumulative 1-year costs were assessed from the Danish health sector perspective. Effectiveness was measured by quality-adjusted life years using EuroQol-5D. Probabilistic sensitivity analyses using bootstrapping were conducted. Secondary safety measures including early clinical outcomes and freedom from major adverse cardiac or cerebrovascular events at 1 year were assessed. RESULTS: The clinical trial was discontinued prematurely due to safety reasons after inclusion of 50 patients (24 sHCR; 26 CABG), as the chest tube output and the risk of postoperative pleural effusions requiring thoracocentesis were significantly increased following sHCR compared with CABG. Based on 48 patients available for 1-year follow-up, both treatment strategies were similarly effective (quality-adjusted life year difference between the groups -0.019), with a net cost difference in favour of conventional CABG estimated to be €2173 per patient. Exclusion of 1 outlier patient with chronic renal failure and deep sternal wound infection in the sHCR group resulted in an equalization of the total 1-year costs. CONCLUSIONS: At 1 year, sHCR was less cost-effective than conventional CABG and associated with higher chest tube output and a higher risk of postoperative pleural effusions requiring thoracocentesis. CLINICAL TRIAL REGISTRATION: NCT01496664.

15 Article Impact of diabetes on clinical outcomes after revascularization with sirolimus-eluting and biolimus-eluting stents with biodegradable polymer from the SORT OUT VII trial. 2019

Ellert, Julia / Christiansen, Evald Høj / Maeng, Michael / Raungaard, Bent / Jensen, Svend Eggert / Kristensen, Steen Dalby / Veien, Karsten Tange / Junker, Anders Bo / Jakobsen, Lars / Aarøe, Jens / Terkelsen, Christian Juhl / Kahlert, Johnny / Villadsen, Anton Boel / Bøtker, Hans Erik / Jensen, Lisette Okkels. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. · Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark. · Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. · Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark. ·Catheter Cardiovasc Interv · Pubmed #30244533.

ABSTRACT: OBJECTIVES: In this substudy of the SORT OUT VII trial, the clinical outcomes among patient with diabetes mellitus treated with Orsiro sirolimus-eluting stent (O-SES; Biotronik, Bülach, Switzerland) or Nobori biolimus-eluting stent (N-BES; Terumo, Tokyo, Japan) were compared. BACKGROUND: Diabetes is associated with increased risk of target lesion failure (TLF) after percutaneous coronary intervention. METHODS: In total, 2525 patients were randomized to stent implantation with O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). The primary endpoint, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 2 years. RESULTS: At 2 year, TLF did not differ between O-SES vs N-BES in diabetic (9.3% vs 9.4%; RR 0.98, 95% CI 0.54-1.78) patients. The individual components of the primary endpoint did not differ among stent type. In diabetics, cardiac death occurred in 3% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.77, 95% CI 0.29-2.08), MI occurred in 3.0% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.76, 95% CI 0.28-2.06) and TLR occurred in 5,5% of O-SES-treated and in 6.0% of N-BES-treated patients (RR 0.91, 95% CI 0.43-1.95). CONCLUSION: TLF did not differ between O-SES- and N-BES-treated diabetic patients.

16 Article Ten-year clinical outcome of patients treated with a drug-eluting stent in the proximal left anterior descending artery segment compared with patients stented in other non-left main coronary segments. 2018

Kjøller-Hansen, Lars / Bligaard, Niels / Kelbæk, Henning / Christiansen, Evald Høj / Thuesen, Leif / Hansen, Peter R / Engstrøm, Thomas / Junker, Anders / Abildgaard, Ulrik / Lassen, Jens Flensted / Jensen, Jan S / Jeppesen, Jørgen L / Galløe, Anders M. ·Department of Cardiology, Zealand University Hospital, Roskilde, Denmark. ·EuroIntervention · Pubmed #29969425.

ABSTRACT: AIMS: The aim of the study was to determine whether patients treated with drug-eluting stents in the proximal left anterior descending artery (LAD) carried a different long-term prognosis from patients treated in other coronary artery segments. METHODS AND RESULTS: Ten-year clinical outcome expressed as all-cause mortality and major adverse cardiac events (MACE: cardiac death, acute myocardial infarction, or target vessel revascularisation) was determined for 1,479 patients with a single non-left main coronary stenosis treated with a first-generation drug-eluting stent in the SORT OUT II trial. The outcome of patients treated with stents in the proximal LAD (n=365) was compared with that of patients treated in a non-proximal LAD segment (n=1,114). Follow-up was 99.3% complete. All-cause mortality was 24.9% in the proximal LAD group vs. 26.3% in the non-proximal LAD group (p=0.60). MACE occurred less frequently in the proximal LAD group, 24.6% vs. 31.0% with a hazard ratio of 0.77 (95% confidence interval [CI]: 0.61-0.97, p=0.024). After multivariate analysis which included baseline characteristics that were unevenly distributed between the groups, the hazard ratio for MACE was 0.82 (95% CI: 0.65-1.03, p=0.09). CONCLUSIONS: Patients treated with a drug-eluting stent in the proximal LAD have similar, if not better, long-term clinical outcome compared with patients stented in other coronary artery segments.

17 Article Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). 2018

Westra, Jelmer / Tu, Shengxian / Winther, Simon / Nissen, Louise / Vestergaard, Mai-Britt / Andersen, Birgitte Krogsgaard / Holck, Emil Nielsen / Fox Maule, Camilla / Johansen, Jane Kirk / Andreasen, Lene Nyhus / Simonsen, Jo Krogsgaard / Zhang, Yimin / Kristensen, Steen Dalby / Maeng, Michael / Kaltoft, Anne / Terkelsen, Christian Juhl / Krusell, Lars Romer / Jakobsen, Lars / Reiber, Johan H C / Lassen, Jens Flensted / Bøttcher, Morten / Bøtker, Hans Erik / Christiansen, Evald Høj / Holm, Niels Ramsing. ·From the Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (J.W., S.W., M.-B.V., B.K.A., E.N.H., C.F.M., L.N.A., J.K.S., S.D.K., M.M., A.K., C.J.T., L.R.K., L.J., J.F.L., H.E.B., E.H.C., N.R.H.) · Med-X Research Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, China (S.T., Y.Z.) · Department of Cardiology, Hospitalsenheden Vest, Regionshospitalet Herning, Denmark (L.N., M.B.) · Department of Cardiology, Hospitalsenheden Midt, Regionshospitalet Silkeborg, Denmark (J.K.J.) · and Department of Radiology, Leiden University Medical Center, The Netherlands (J.H.C.R.). ·Circ Cardiovasc Imaging · Pubmed #29555835.

ABSTRACT: BACKGROUND: Quantitative flow ratio (QFR) is a novel diagnostic modality for functional testing of coronary artery stenosis without the use of pressure wires and induction of hyperemia. QFR is based on computation of standard invasive coronary angiographic imaging. The purpose of WIFI II (Wire-Free Functional Imaging II) was to evaluate the feasibility and diagnostic performance of QFR in unselected consecutive patients. METHODS AND RESULTS: WIFI II was a predefined substudy to the Dan-NICAD study (Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease), referring 362 consecutive patients with suspected coronary artery disease on coronary computed tomographic angiography for diagnostic invasive coronary angiography. Fractional flow reserve (FFR) was measured in all segments with 30% to 90% diameter stenosis. Blinded observers calculated QFR (Medis Medical Imaging bv, The Netherlands) for comparison with FFR. FFR was measured in 292 lesions from 191 patients. Ten (5%) and 9 patients (5%) were excluded because of FFR and angiographic core laboratory criteria, respectively. QFR was successfully computed in 240 out of 255 lesions (94%) with a mean diameter stenosis of 50±12%. Mean difference between FFR and QFR was 0.01±0.08. QFR correctly classified 83% of the lesions using FFR with cutoff at 0.80 as reference standard. The area under the receiver operating characteristic curve was 0.86 (95% confidence interval, 0.81-0.91) with a sensitivity, specificity, negative predictive value, and positive predictive value of 77%, 86%, 75%, and 87%, respectively. A QFR-FFR hybrid approach based on the present results enables wire-free and adenosine-free procedures in 68% of cases. CONCLUSIONS: Functional lesion evaluation by QFR assessment showed good agreement and diagnostic accuracy compared with FFR. Studies comparing clinical outcome after QFR- and FFR-based diagnostic strategies are required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02264717.

18 Article Detection of early changes in the coronary artery microstructure after heart transplantation: A prospective optical coherence tomography study. 2018

Clemmensen, Tor Skibsted / Holm, Niels Ramsing / Eiskjær, Hans / Jakobsen, Lars / Berg, Katrine / Neghabat, Omeed / Løgstrup, Brian Bridal / Christiansen, Evald Høj / Dijkstra, Jouke / Terkelsen, Christian Juhl / Maeng, Michael / Poulsen, Steen Hvitfeldt. ·Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark; Department of Cardiology, Horsens Regional Hospital, Horsens, Denmark. Electronic address: torskibstedclemmensen@gmail.com. · Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. · Division of Image Processing, Leiden University Medical Centre, Leiden, The Netherlands. ·J Heart Lung Transplant · Pubmed #29128426.

ABSTRACT: BACKGROUND: Optical coherence tomography (OCT) enables in-vivo cardiac allograft vasculopathy (CAV) microstructure characterization. Early coronary artery microstructure changes after heart transplantation (HTx) may provide valuable mechanistic information regarding CAV development. Our in this study was to describe and characterize changes in the coronary artery microstructure during the first year after HTx using serial OCT scans. METHODS: Twenty-six patients were enrolled at routine baseline coronary angiography 3 months after HTx. Coronary OCT scans were performed on all 3 major vessels at baseline and were repeated 12 months after HTx. We contoured the vessel layers for absolute and relative measurements. Lipid plaques, calcified plaques, layered fibrotic plaques (LFPs) and bright spots were analyzed by delineating circumferential borders and measuring angulation of total circumference. RESULTS: A total of 8,789 frames from 71 vessels were analyzed after 3 and 12 months (vessel length 79 ± 24 mm vs 82 ± 23 mm, respectively, p = 0.39). Mean intima area increased by 20% from 3 months to 12 months (1.6 [1.2 to 2.7] mm CONCLUSIONS: Early CAV formation during the first year after HTx is characterized by a pronounced intima layer thickening strongly associated with LFP progression. In contrast, the extent of lipid plaque and calcifications remained stable. LFP formation may be a key mechanism in CAV.

19 Article Diagnostic performance of an acoustic-based system for coronary artery disease risk stratification. 2018

Winther, Simon / Nissen, Louise / Schmidt, Samuel Emil / Westra, Jelmer Sybren / Rasmussen, Laust Dupont / Knudsen, Lars Lyhne / Madsen, Lene Helleskov / Kirk Johansen, Jane / Larsen, Bjarke Skogstad / Struijk, Johannes Jan / Frost, Lars / Holm, Niels Ramsing / Christiansen, Evald Høj / Botker, Hans Erik / Bøttcher, Morten. ·Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Cardiology, Hospital Unit West, Herning, Denmark. · Department of Health Science and Technology, Aalborg University, Aalborg, Denmark. · Department of Cardiology, Regional Hospital of Silkeborg, Silkeborg, Denmark. ·Heart · Pubmed #29122932.

ABSTRACT: OBJECTIVE: Diagnosing coronary artery disease (CAD) continues to require substantial healthcare resources. Acoustic analysis of transcutaneous heart sounds of cardiac movement and intracoronary turbulence due to obstructive coronary disease could potentially change this. The aim of this study was thus to test the diagnostic accuracy of a new portable acoustic device for detection of CAD. METHODS: We included 1675 patients consecutively with low to intermediate likelihood of CAD who had been referred for cardiac CT angiography. If significant obstruction was suspected in any coronary segment, patients were referred to invasive angiography and fractional flow reserve (FFR) assessment. Heart sound analysis was performed in all patients. A predefined acoustic CAD-score algorithm was evaluated; subsequently, we developed and validated an updated CAD-score algorithm that included both acoustic features and clinical risk factors. Low risk is indicated by a CAD-score value ≤20. RESULTS: Haemodynamically significant CAD assessed from FFR was present in 145 (10.0%) patients. In the entire cohort, the predefined CAD-score had a sensitivity of 63% and a specificity of 44%. In total, 50% had an updated CAD-score value ≤20. At this cut-off, sensitivity was 81% (95% CI 73% to 87%), specificity 53% (95% CI 50% to 56%), positive predictive value 16% (95% CI 13% to 18%) and negative predictive value 96% (95% CI 95% to 98%) for diagnosing haemodynamically significant CAD. CONCLUSION: Sound-based detection of CAD enables risk stratification superior to clinical risk scores. With a negative predictive value of 96%, this new acoustic rule-out system could potentially supplement clinical assessment to guide decisions on the need for further diagnostic investigation. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT02264717; Results.

20 Article Two-year outcome after biodegradable polymer sirolimus- and biolimus-eluting coronary stents (from the randomised SORT OUT VII trial). 2018

Jensen, Lisette Okkels / Maeng, Michael / Raungaard, Bent / Hansen, Knud Nørregaard / Kahlert, Johnny / Jensen, Svend Eggert / Hansen, Henrik Steen / Lassen, Jens Flensted / Bøtker, Hans Erik / Christiansen, Evald Høj. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. ·EuroIntervention · Pubmed #28870882.

ABSTRACT: -- No abstract --

21 Article Final five-year outcomes after implantation of biodegradable polymer-coated biolimus-eluting stents versus durable polymer-coated sirolimus-eluting stents. 2017

Jakobsen, Lars / Christiansen, Evald Høj / Maeng, Michael / Hansen, Knud N / Kristensen, Steen D / Bøtker, Hans E / Terkelsen, Christian J / Jensen, Svend Eggert / Raungaard, Bent / Madsen, Morten / Lassen, Jens Flensted / Jensen, Lisette Okkels. ·Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. ·EuroIntervention · Pubmed #28846543.

ABSTRACT: AIMS: Our aim was to report the long-term safety and efficacy of the biodegradable polymer-coated biolimus- eluting Nobori stent compared to the durable polymer-coated sirolimus-eluting CYPHER stent. METHODS AND RESULTS: SORT OUT V randomised 2,468 patients 1:1 to the Nobori (n=1,229) versus the CYPHER stent (n=1,239). Clinically driven event detection based on Danish registries was used. The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation). Individual components of the primary endpoint comprise the secondary endpoints. At five-year follow-up, the composite endpoint rate was found to be similar in patients treated with the two study stents (Nobori 182/1,229 [14.8%] vs. CYPHER 197/1,239 [15.8%]; odds ratio [OR] 0.93, 95% CI: 0.75-1.16; p=0.53). The rates of definite stent thrombosis were also found to be similar in patients treated with the two study stents (Nobori 23/1,229 [1.9%] vs. CYPHER 18/1,239 [1.5%]; OR 1.31, 95% CI: 0.70-2.47; p=0.40), as were the other secondary endpoints. CONCLUSIONS: At five-year follow-up, the Nobori stent with a biodegradable polymer coating provided a similar safety and efficacy profile when compared to the durable polymer first-generation CYPHER stent.

22 Article Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III. 2017

Haude, Michael / Ince, Hüseyin / Kische, Stephan / Abizaid, Alexandre / Tölg, Ralph / Alves Lemos, Pedro / Van Mieghem, Nicolas M. / Verheye, Stephan / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Garcia-Garcia, Hector M. / Waksman, Ron. ·Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany ·EuroIntervention · Pubmed #28504239.

ABSTRACT: AIMS: We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant. METHODS AND RESULTS: The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical follow-up was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis. CONCLUSIONS: The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.

23 Article Layered Fibrotic Plaques Are the Predominant Component in Cardiac Allograft Vasculopathy: Systematic Findings and Risk Stratification by OCT. 2017

Clemmensen, Tor Skibsted / Holm, Niels Ramsing / Eiskjær, Hans / Løgstrup, Brian Bridal / Christiansen, Evald Høj / Dijkstra, Jouke / Barkholt, Trine Ørhøj / Terkelsen, Christian Juhl / Maeng, Michael / Poulsen, Steen Hvitfeldt. ·Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. Electronic address: torclemm@rm.dk. · Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. · Division of Image Processing, Leiden University Medical Centre, Leiden, the Netherlands. ·JACC Cardiovasc Imaging · Pubmed #28330670.

ABSTRACT: OBJECTIVES: The aims of this study were to characterize cardiac allograft vasculopathy (CAV) phenotypes using optical coherence tomography (OCT) and to evaluate the prognostic significance of OCT-determined CAV severity. BACKGROUND: Intravascular OCT enables in vivo characterization of CAV microstructure after heart transplantation. METHODS: Sixty-two patients undergoing heart transplantation were enrolled at routine angiography from September 2013 through October 2015 and prospectively followed until censoring on May 27, 2016. Optical coherence tomographic acquisitions aimed for the longest possible pull-backs, including proximal segments of all 3 major vessels. Plaques and bright spots were analyzed by delineating circumferential borders and measuring the angulation of total circumference. Layers were contoured for absolute and relative estimates. Nonfatal CAV progression (NFCP) during follow-up was registered. NFCP included occluded vessels or severe (≥70%) new angiographic coronary stenosis or percutaneous coronary intervention. RESULTS: A total of 172 vessels were categorized as follows: no CAV, n = 111; mild to moderate CAV (<70% stenosis), n = 40; and severe CAV (≥70% stenosis), n = 21. Layered fibrotic plaque (LFP) was the most prevalent plaque component, and the extent increased with angiographic CAV severity (p < 0.01). During follow-up, 22 of 172 vessels (13%) experienced NFCP. Median follow-up was 633 days (interquartile range: 432 to 808 days). The extent of LFP (hazard ratio: 5.0; 95% confidence interval: 2.1 to 12.4; p < 0.0001) and the extent of bright spots (hazard ratio: 6.2; 95% confidence interval: 2.4 to 15.8, p < 0.001) were strong predictors of NFCP. By combining LFP and bright spots, a strong NFCP predictive model was obtained (hazard ratio: 8.9; 95% confidence interval: 2.6 to 29.9; p < 0.0001). CONCLUSIONS: OCT enables the detection of CAV-associated plaque compositions and allows early detection and differentiation of vessel wall disease not visible on angiography. LFP was the most prevalent plaque component, was strongly associated with NFCP, and may be associated with stepwise CAV progression caused by organizing mural thrombi. (The GRAFT Study: Evaluation of Graft Function, Rejection and Cardiac Allograft Vasculopathy in First Heart Transplant Recipients; NCT02077764).

24 Article Fractional flow reserve derived from coronary computed tomography angiography: diagnostic performance in hypertensive and diabetic patients. 2017

Eftekhari, Ashkan / Min, James / Achenbach, Stephan / Marwan, Mohamed / Budoff, Matthew / Leipsic, Jonathon / Gaur, Sara / Jensen, Jesper Møller / Ko, Brian S / Christiansen, Evald Høj / Kaltoft, Anne / Bøtker, Hans Erik / Jensen, Jens Flensted / Nørgaard, Bjarne Linde. ·Department of Cardiology, Aarhus University Hospital, Skejby, Palle Juul-Jensens Boulevard 99, 8200 Aarhus, Denmark. · Weill Cornell Medical College, Dalio Institute of Cardiovascular Imagaing, New York-Presbyterian Hospital, New York, NY, USA. · Department of Cardiology, University of Erlangen, Erlangen, Germany. · Department of Medicine, Los Angeles Biomedical Research Center, Torrance, CA, USA. · Division of Cardiology, Department of Radiology, St. Paul's Hospital, Vancouver, BC, Canada. ·Eur Heart J Cardiovasc Imaging · Pubmed #28013282.

ABSTRACT: Aims: Fractional flow reserve (FFR) derived from coronary computed tomography (FFRCT) has high diagnostic performance in stable coronary artery disease (CAD). The diagnostic performance of FFRCT in patients with hypertension (HTN) and diabetes (DM), who are at risk of microvascular impairment, is not known. Methods and results: We analysed the diagnostic performance of FFRCT, in patients (vessels) with DM (n = 16), HTN (n = 186), DM + HTN (n = 58) vs. controls (n = 107) with or with suspected CAD. Patients (vessels) were further divided according to left ventricular mass index (LVMI) tertiles. Reference standard was invasively measured FFR ≤0.80. Per-patient diagnostic accuracy (95% CI) in control patients was 71.7% (61.6-81.8) vs. 79.3 (74.0-85.0) (P = 0.12), 75.0% (47.6-92.7) (P = 0.52), and 75.9% (62.8-86.1) (P = 0.39) in patients with HTN, DM, and HTM + DM, respectively. There was no difference in discrimination of ischaemia by FFRCT between groups. On a per-vessel level, there was no significant difference in diagnostic performance or discrimination of ischaemia by FFRCT between groups. There was a decline in both per-patient and -vessel diagnostic specificity of FFRCT in the upper LVMI tertile when compared with lower tertiles; however, discrimination of ischaemia by FFRCT was unaltered across LVMI tertiles. Conclusion: The diagnostic performance of FFRCT is independent of the presence of HTN and DM. FFRCT is a robust method in a broad stable CAD population, including patients at high risk for microvascular disease.

25 Article Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial. 2016

Jensen, Lisette Okkels / Thayssen, Per / Maeng, Michael / Ravkilde, Jan / Krusell, Lars Romer / Raungaard, Bent / Junker, Anders / Terkelsen, Christian Juhl / Veien, Karsten Tange / Villadsen, Anton Boel / Kaltoft, Anne / Tilsted, Hans-Henrik / Hansen, Knud Nørregaard / Aaroe, Jens / Kristensen, Steen Dalby / Hansen, Henrik Steen / Jensen, Svend Eggert / Madsen, Morten / Bøtker, Hans Erik / Berencsi, Klára / Lassen, Jens Flensted / Christiansen, Evald Høj. ·From the Department of Cardiology, Odense University Hospital, Denmark (L.O.J., P.T., A.J., K.T.V., K.N.H., H.S.H.) · Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (M. Maeng, L.R.K., C.J.T., A.K., S.D.K., H.E.B., J.F.L., E.H.C.) · Department of Cardiology, Aalborg University Hospital, Denmark (J.R., B.R., A.B.V., H.-H.T., J.A., S.E.J.) · and Department of Clinical Epidemiology, Aarhus University, Denmark (M. Madsen, K.B.). ·Circ Cardiovasc Interv · Pubmed #27412869.

ABSTRACT: BACKGROUND: Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. METHODS AND RESULTS: The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, -0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05). CONCLUSIONS: The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358.

Next