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4. Unintended Deformation of Stents During Bifurcation PCI

Author

Andreasen, Lene Nyhus, primary, Neghabat, Omeed, additional, Laanmets, Peep, additional, Kumsars, Indulis, additional, Bennett, Johan, additional, Olsen, Niels T., additional, Odenstedt, Jacob, additional, Burzotta, Francesco, additional, Johnson, Thomas W., additional, O’Kane, Peter, additional, Hartikainen, Juha E.K., additional, Spratt, James C., additional, Christiansen, Evald H., additional, and Holm, Niels R., additional

Published
2024
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5. Unintended Deformation of Stents During Bifurcation PCI: An OCTOBER Trial Substudy

Author

Andreasen, Lene Nyhu, Neghabat, Omeed, Laanmets, Peep, Kumsars, Induli, Bennett, Johan, Olsen, Niels T, Odenstedt, Jacob, Burzotta, Francesco, Johnson, Thomas W, O'Kane, Peter, Hartikainen, Juha E K, Spratt, James C, Christiansen, Evald H, Holm, Niels R, Burzotta, Francesco (ORCID:0000-0002-6569-9401), Andreasen, Lene Nyhu, Neghabat, Omeed, Laanmets, Peep, Kumsars, Induli, Bennett, Johan, Olsen, Niels T, Odenstedt, Jacob, Burzotta, Francesco, Johnson, Thomas W, O'Kane, Peter, Hartikainen, Juha E K, Spratt, James C, Christiansen, Evald H, Holm, Niels R, and Burzotta, Francesco (ORCID:0000-0002-6569-9401)

Abstract

Background: Unintended deformation of implanted coronary stents can lead to loss of coronary access, stent thrombosis and coronary events during follow-up. The incidence, mechanisms and clinical outcomes of unintended stent deformations (USD) during complex bifurcation stenting are not well characterized. Objectives: In a prespecified analysis of the OCTOBER (European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction) trial, we aimed to: 1) determine the incidence and characterize mechanisms of USD identified by optical coherence tomography (OCT); and 2) evaluate physician's detection and correction of accidental abluminal rewiring and USD. Methods: OCT scans were analyzed for accidental abluminal rewiring and USD. When USD was identified, the plausible mechanism was determined by analysis of all procedural OCT scans and the corresponding angiograms. Results: USD was identified by the core lab in 9.3% (55/589) of OCT-guided cases. Accidental abluminal rewiring was the cause in 44% (24/55), and guide catheter collision was the cause in 40% (22/55) of cases. USD was found in 18.5% of all cases with left main bifurcation percutaneous coronary intervention. The total incidence of abluminal rewiring was 33 in 32 OCT-guided cases (5.4%) and was corrected by physicians in 18 of 33 appearances (54.5%). The 2-year major adverse cardiac event rate for patients with untreated USD (n = 30) was 23.3%, whereas patients with confirmed or possibly corrected USD (n = 25) had no events during follow-up. Conclusions: USD was associated with adverse procedural complications and cardiac events during follow-up when not identified and corrected. The predominant mechanisms were undetected abluminal rewiring and guide catheter collision. Left main bifurcation percutaneous coronary intervention was a particular risk with USD detected in 18.5% of cases.

Published
2024

7. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

Author

Holm, Niels R., primary, Andreasen, Lene N., additional, Neghabat, Omeed, additional, Laanmets, Peep, additional, Kumsars, Indulis, additional, Bennett, Johan, additional, Olsen, Niels T., additional, Odenstedt, Jacob, additional, Hoffmann, Pavel, additional, Dens, Jo, additional, Chowdhary, Saqib, additional, O’Kane, Peter, additional, Bülow Rasmussen, Søren-Haldur, additional, Heigert, Matthias, additional, Havndrup, Ole, additional, Van Kuijk, Jan P., additional, Biscaglia, Simone, additional, Mogensen, Lone J.H., additional, Henareh, Loghman, additional, Burzotta, Francesco, additional, H. Eek, Christian, additional, Mylotte, Darren, additional, Llinas, Miquel S., additional, Koltowski, Lukasz, additional, Knaapen, Paul, additional, Calic, Slobodan, additional, Witt, Nils, additional, Santos-Pardo, Irene, additional, Watkins, Stuart, additional, Lønborg, Jacob, additional, Kristensen, Andreas T., additional, Jensen, Lisette O., additional, Calais, Fredrik, additional, Cockburn, James, additional, McNeice, Andrew, additional, Kajander, Olli A., additional, Heestermans, Ton, additional, Kische, Stephan, additional, Eftekhari, Ashkan, additional, Spratt, James C., additional, and Christiansen, Evald H., additional

Published
2023
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8. TCT-670 Suboptimal OCT Guiding and Association With 2-Year Clinical Outcomes: An OCTOBER Trial Substudy

Author

Neghabat, Omeed, primary, Andreasen, Lene, additional, Christiansen, Evald, additional, Laanmets, Peep, additional, Kumsars, Indulis, additional, Bennett, Johan, additional, Olsen, Niels, additional, Odenstedt, Jacob, additional, Hoffmann, Pavel, additional, Dens, Joseph, additional, Chowdhary, Saqib, additional, O'Kane, Peter, additional, Spratt, James, additional, and Holm, Niels, additional

Published
2023
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9. TCT-667 Patterns in Stent Failure After Bifurcation PCI: An OCTOBER Trial Substudy

Author

Neghabat, Omeed, primary, Andreasen, Lene, additional, Rasmussen, Søren-Haldur, additional, Laanmets, Peep, additional, Kumsars, Indulis, additional, Bennett, Johan, additional, Heigert, Matthias, additional, Havndrup, Ole, additional, Van Kuijk, Jan-Peter, additional, Biscaglia, Simone, additional, Spratt, James, additional, Christiansen, Evald, additional, and Holm, Niels, additional

Published
2023
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12. Long-term multimodality imaging follow-up of ST-segment elevation myocardial infarction patients treated with bioresorbable vascular scaffold:advantages and challenges

Author

Eriksen, Erlend, Neghabat, Omeed, Larsen, Terje H, Saeed, Sahrai, and Bleie, Øyvind

Abstract

BACKGROUND: Multislice computed tomography (MSCT) offers a non-invasive method of imaging bioresorbable scaffolds (BRS).OBJECTIVES: To investigate the advantages and challenges using MSCT in the follow-up after BRS implantation.METHOD: The BRS cohort consisting of 31 patients in the 'BRS in STEMI' trial was examined by multimodality imaging and followed long-term. Minimum lumen area (MLA) and average lumen area (ALA) were examined 12 and 36 months after BRS implantation with MSCT. Optical coherence tomography (OCT) at 12 months was used as a reference.RESULTS: Measured by MSCT, the mean MLA was 0.05 ± 1.32 mm² (P = 0.85), but ALA was 1.32 (±2.59 mm², P = 0.015) greater than by OCT. ALA and MLA did not change significantly from 12 to 36 months. MSCT identified all cases of restenosis but missed one patient with massive malapposition.CONCLUSION: Our data support using MSCT in the follow-up after BRS implantation. Invasive investigation should still be considered for patients with unexplained symptoms.

Published
2023

13. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

Author

Holm, Niels R, Andreasen, Lene N, Neghabat, Omeed, Laanmets, Peep, Kumsars, Induli, Bennett, Johan, Olsen, Niels T, Odenstedt, Jacob, Hoffmann, Pavel, Dens, Jo, Chowdhary, Saqib, O'Kane, Peter, Bülow Rasmussen, Søren-Haldur, Heigert, Matthia, Havndrup, Ole, Van Kuijk, Jan P, Biscaglia, Simone, Mogensen, Lone J H, Henareh, Loghman, Burzotta, Francesco, H Eek, Christian, Mylotte, Darren, Llinas, Miquel S, Koltowski, Lukasz, Knaapen, Paul, Calic, Slobodan, Witt, Nil, Santos-Pardo, Irene, Watkins, Stuart, Lønborg, Jacob, Kristensen, Andreas T, Jensen, Lisette O, Calais, Fredrik, Cockburn, Jame, Mcneice, Andrew, Kajander, Olli A, Heestermans, Ton, Kische, Stephan, Eftekhari, Ashkan, Spratt, James C, Christiansen, Evald H, Burzotta, Francesco (ORCID:0000-0002-6569-9401), Holm, Niels R, Andreasen, Lene N, Neghabat, Omeed, Laanmets, Peep, Kumsars, Induli, Bennett, Johan, Olsen, Niels T, Odenstedt, Jacob, Hoffmann, Pavel, Dens, Jo, Chowdhary, Saqib, O'Kane, Peter, Bülow Rasmussen, Søren-Haldur, Heigert, Matthia, Havndrup, Ole, Van Kuijk, Jan P, Biscaglia, Simone, Mogensen, Lone J H, Henareh, Loghman, Burzotta, Francesco, H Eek, Christian, Mylotte, Darren, Llinas, Miquel S, Koltowski, Lukasz, Knaapen, Paul, Calic, Slobodan, Witt, Nil, Santos-Pardo, Irene, Watkins, Stuart, Lønborg, Jacob, Kristensen, Andreas T, Jensen, Lisette O, Calais, Fredrik, Cockburn, Jame, Mcneice, Andrew, Kajander, Olli A, Heestermans, Ton, Kische, Stephan, Eftekhari, Ashkan, Spratt, James C, Christiansen, Evald H, and Burzotta, Francesco (ORCID:0000-0002-6569-9401)

Abstract

Background: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. Methods: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. Results: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. Conclusions: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).

Published
2023

15. Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction: a randomized controlled trial

Author

Eriksen, Erlend, primary, Neghabat, Omeed, additional, Saeed, Sahrai, additional, Herstad, Jon, additional, Nordrehaug, Jan Erik, additional, Tuseth, Vegard, additional, Holm, Niels Ramsing, additional, Holck, Emil Nielsen, additional, Sejr-Hansen, Martin, additional, Maule, Camilla Fox, additional, Barkholt, Trine Ørhøj, additional, Andreasen, Lene Nyhus, additional, Christiansen, Evald Høj, additional, and Bleie, Øyvind, additional

Published
2022
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19. A randomized clinical study using optical coherence tomography to evaluate the short‐term effects of high‐intensity interval training on cardiac allograft vasculopathy: a HITTS substudy

Author

Rafique, Muzammil, primary, Solberg, Ole Geir, additional, Gullestad, Lars, additional, Bendz, Bjørn, additional, Holm, Niels Ramsing, additional, Neghabat, Omeed, additional, Dijkstra, Jouke, additional, Nytrøen, Kari, additional, Rolid, Katrine, additional, and Lunde, Ketil, additional

Published
2021
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20. Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction: a randomized controlled trial.

Author

Eriksen, Erlend, Neghabat, Omeed, Saeed, Sahrai, Herstad, Jon, Nordrehaug, Jan Erik, Tuseth, Vegard, Holm, Niels Ramsing, Holck, Emil Nielsen, Sejr-Hansen, Martin, Maule, Camilla Fox, Barkholt, Trine Ørhøj, Andreasen, Lene Nyhus, Christiansen, Evald Høj, and Bleie, Øyvind

Published
2023
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23. A randomized clinical study using optical coherence tomography to evaluate the short‐term effects of high‐intensity interval training on cardiac allograft vasculopathy: a HITTS substudy.

Author

Rafique, Muzammil, Solberg, Ole Geir, Gullestad, Lars, Bendz, Bjørn, Holm, Niels Ramsing, Neghabat, Omeed, Dijkstra, Jouke, Nytrøen, Kari, Rolid, Katrine, and Lunde, Ketil

Subjects
HIGH-intensity interval training, OPTICAL coherence tomography, VASCULAR diseases, HOMOGRAFTS, HEART transplantation
Abstract

Cardiac allograft vasculopathy (CAV) remains a leading cause of long‐term mortality after heart transplantation. Both preventive measures and treatment options are limited. This study aimed to evaluate the short‐term effects of high‐intensity interval training (HIT) on CAV in de novo heart transplant (HTx) recipients as assessed by optical coherence tomography (OCT). The study population was a subgroup of the 81‐patient HITTS study in which HTx recipients were randomized to HIT or moderate intensity continuous training (MICT) for nine consecutive months. OCT images from baseline and 12 months were compared to assess CAV progression. The primary endpoint was defined as the change in the mean intima area. Paired OCT data were available for 56 patients (n = 23 in the HIT group and n = 33 in the MICT group). The intima area in the entire study population increased by 25% [from 1.8±1.4 mm2 to 2.3±2.0 mm2, P <.05]. The change was twofold higher in the MICT group (.6±1.2 mm2) than in the HIT group (.3±.6 mm2). However, the treatment effect of HIT was not significant (treatment effect = –.3 mm2, 95% CI [–.825 to.2 mm2] P =.29). These results suggest that early initiation of HIT compared with MICT does not attenuate CAV progression in de novo HTx recipients. [ABSTRACT FROM AUTHOR]

Published
2022
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27. Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study

Author

Simonsen, Jo Krogsgaard, primary, Holck, Emil Nielsen, additional, Carrié, Didier, additional, Frey, Norbert, additional, Lutz, Matthias, additional, Weber-Albers, Joachim, additional, Dudek, Dariusz, additional, Chevalier, Bernard, additional, Daemen, Joost, additional, Dijkstra, Jouke, additional, Fox Maule, Camilla, additional, Neghabat, Omeed, additional, Lassen, Jens Flensted, additional, Anderson, Jeffrey, additional, Christiansen, Evald Høj, additional, Abizaid, Alexandre, additional, and Holm, Niels Ramsing, additional

Published
2019
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29. Diagnostic Performance of In‐Procedure Angiography‐Derived Quantitative Flow Reserve Compared to Pressure‐Derived Fractional Flow Reserve: The FAVOR II Europe‐Japan Study

Author

Westra, Jelmer, primary, Andersen, Birgitte Krogsgaard, additional, Campo, Gianluca, additional, Matsuo, Hitoshi, additional, Koltowski, Lukasz, additional, Eftekhari, Ashkan, additional, Liu, Tommy, additional, Di Serafino, Luigi, additional, Di Girolamo, Domenico, additional, Escaned, Javier, additional, Nef, Holger, additional, Naber, Christoph, additional, Barbierato, Marco, additional, Tu, Shengxian, additional, Neghabat, Omeed, additional, Madsen, Morten, additional, Tebaldi, Matteo, additional, Tanigaki, Toru, additional, Kochman, Janusz, additional, Somi, Samer, additional, Esposito, Giovanni, additional, Mercone, Giuseppe, additional, Mejia‐Renteria, Hernan, additional, Ronco, Federico, additional, Bøtker, Hans Erik, additional, Wijns, William, additional, Christiansen, Evald Høj, additional, and Holm, Niels Ramsing, additional

Published
2018
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31. Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study.

Author

Krogsgaard Simonsen, Jo, Nielsen Holck, Emil, Carrié, Didier, Frey, Norbert, Lutz, Matthias, Weber-Albers, Joachim, Dudek, Dariusz, Chevalier, Bernard, Daemen, Joost, Dijkstra, Jouke, Fox Maule, Camilla, Neghabat, Omeed, Flensted Lassen, Jens, Anderson, Jeffrey, Høj Christiansen, Evald, Abizaid, Alexandre, and Ramsing Holm, Niels

Published
2019
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32. Diagnostic performance of in-procedure angiography-derived quantitative flow reserve compared to pressure-derived fractional flow reserve: The FAVOR II Europe-Japan study

Author

Javier Escaned, Niels Ramsing Holm, Gianluca Campo, Ashkan Eftekhari, Janusz Kochman, Lukasz Koltowski, Samer Somi, Omeed Neghabat, Holger Nef, Shengxian Tu, Toru Tanigaki, Morten Madsen, Birgitte Krogsgaard Andersen, Hernán Mejía-Rentería, Luigi Di Serafino, Christoph Naber, Marco Barbierato, Evald Høj Christiansen, William Wijns, Domenico Di Girolamo, Hitoshi Matsuo, Matteo Tebaldi, Jelmer Westra, Giuseppe Mercone, Giovanni Esposito, Tommy Liu, Federico Ronco, Hans Erik Bøtker, Westra, Jelmer, Andersen, Birgitte Krogsgaard, Campo, Gianluca, Matsuo, Hitoshi, Koltowski, Lukasz, Eftekhari, Ashkan, Liu, Tommy, Di Serafino, Luigi, Di Girolamo, Domenico, Escaned, Javier, Nef, Holger, Naber, Christoph, Barbierato, Marco, Tu, Shengxian, Neghabat, Omeed, Madsen, Morten, Tebaldi, Matteo, Tanigaki, Toru, Kochman, Janusz, Somi, Samer, Esposito, Giovanni, Mercone, Giuseppe, Mejia-Renteria, Hernan, Ronco, Federico, Bøtker, Hans Erik, Wijns, William, Christiansen, Evald Høj, and Holm, Niels Ramsing

Subjects
Male, media_common.quotation_subject, Fractional flow reserve, Diagnostic Testing, 030204 cardiovascular system & hematology, Coronary Angiography, Severity of Illness Index, NO, Imaging, Angina Pectoris, 03 medical and health sciences, 0302 clinical medicine, Imaging, Three-Dimensional, Japan, Predictive Value of Tests, Quantitative coronary angiography, Medicine, Contrast (vision), Humans, 030212 general & internal medicine, Prospective Studies, fractional flow reserve, media_common, Original Research, Aged, medicine.diagnostic_test, business.industry, Angiography, Coronary Stenosis, Reproducibility of Results, Coronary Vessels, Interventional Cardiology, Flow ratio, Europe, Fractional Flow Reserve, Myocardial, Flow velocity, Flow (mathematics), Cardiology and Cardiovascular Medicine, Feasibility Studies, Female, Nuclear medicine, business, quantitative coronary angiography, Follow-Up Studies
Abstract

Background Quantitative flow ratio ( QFR ) is a novel modality for physiological lesion assessment based on 3‐dimensional vessel reconstructions and contrast flow velocity estimates. We evaluated the value of online QFR during routine invasive coronary angiography for procedural feasibility, diagnostic performance, and agreement with pressure‐wire–derived fractional flow reserve ( FFR ) as a gold standard in an international multicenter study. Methods and Results FAVOR II E‐J (Functional Assessment by Various Flow Reconstructions II Europe‐Japan) was a prospective, observational, investigator‐initiated study. Patients with stable angina pectoris were enrolled in 11 international centers. FFR and online QFR computation were performed in all eligible lesions. An independent core lab performed 2‐dimensional quantitative coronary angiography (2D‐ QCA ) analysis of all lesions assessed with QFR and FFR . The primary comparison was sensitivity and specificity of QFR compared with 2D‐ QCA using FFR as a reference standard. A total of 329 patients were enrolled. Paired assessment of FFR , QFR, and 2D‐ QCA was available for 317 lesions. Mean FFR , QFR, and percent diameter stenosis were 0.83±0.09, 0.82±10, and 45±10%, respectively. FFR was ≤0.80 in 104 (33%) lesions. Sensitivity and specificity by QFR was significantly higher than by 2D‐ QCA (sensitivity, 86.5% (78.4–92.4) versus 44.2% (34.5–54.3); P P =0.002). Area under the receiver curve was significantly higher for QFR compared with 2D‐ QCA ( area under the receiver curve, 0.92 [0.89–0.96] versus 0.64 [0.57–0.70]; P QFR was significantly lower than median time to FFR (time to QFR, 5.0 minutes [ interquartile range , –6.1] versus time to FFR, 7.0 minutes [ interquartile range, 5.0–10.0]; P Conclusions Online computation of QFR in the catheterization laboratory is clinically feasible and is superior to angiographic assessment for evaluation of intermediary coronary artery stenosis using FFR as a reference standard. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifier: NCT 02959814.

Published
2018

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