Mark Coosemans

Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial

AIMS Little is known about the respective healing responses and clinical efficacy and safety of drug-eluting balloons (DEB) and the second generation of drug-eluting stents (DES) when used to treat in-stent restenosis (ISR). In this study, we set out to compare prospectively the healing characteristics, as assessed by optical coherence tomography (OCT), of DEB versus DES after treatment of ISR in bare metal stents (BMS). METHODS AND RESULTS Fifty patients with BMS ISR were randomised to treatment with a paclitaxel-eluting balloon vs. an everolimus-eluting stent (EES). The primary endpoint was the percentage of uncovered struts, assessed with OCT at nine months, as a marker of vessel wall healing. A mean of 366±135 and 636±184 struts were analysed per patient in the DEB and EES groups, respectively. The percentage of uncovered struts per patient was significantly lower with DEB vs. EES (1.4% vs. 3.1%, p=0.025). Mean neointimal hyperplasia area was 2.4±1.08 mm in DEB vs. 1.92±0.67 mm in EES (p=0.1806), while the percentage of malapposed struts per patient was very low in both groups (0.2% vs. 0.3%, p=0.699). At nine months, angiographic in-stent MLD (minimum lumen diameter) was lower (2.13 vs. 2.54 mm, p=0.006), while diameter stenosis (26.4 vs. 11.4%, p=0.002), and LLL (0.28 vs. 0.07 mm, p=0.1) were higher after DEB compared to EES. During one-year follow-up, we did not observe differences in the rates of death, TLR (target lesion revascularisation) or stent thrombosis. CONCLUSIONS DEB appears to be associated with better healing characteristics, as assessed by stent strut coverage with OCT, but tended to be slightly less effective compared to EES. These findings give support to the use of either DEB or EES as valuable treatment options for ISR. CLINICAL TRIAL REGISTRATION http://www.clinicaltrials.gov. Unique identifier: NCT 01065532.

Time course of electrocardiographic changes in transient left ventricular ballooning syndrome.

BACKGROUND We sought to describe, for the first time, in detail the time course of electrocardiographic (ECG) changes in transient left ventricular ballooning syndrome (TLVBS) from acute onset until 1 year after presentation. METHODS The serial ECGs of all patients identified with TLVBS who presented to our cardiology department from August 1998 to August 2012 were analyzed, from admission to 1-year follow-up, with respect to time from onset of symptoms. RESULTS In total, 145 TLVBS episodes were identified in 139 patients. In 53% of patients, ST segment elevation was present in the first 3h after symptom onset, after which there was a steady decline with complete resolution in all patients by 1 month. The presence of T wave inversion (TWI), with or without ST segment depression, was most prevalent between day 1 (60%) and day 30 (71%) from symptom onset, with 17% of patients still exhibiting TWI after 6 to 12 months. At 1 year, approximately 80% of patients had no significant residual ST-T wave changes. In 86% of patients, there was prolongation of the corrected QT (QTc) interval in the acute phase, with normalization of all QTc intervals by day 14. CONCLUSIONS During the early phase, ECG mimics acute ST elevation myocardial infarction with initial regional ST segment elevation progressing to T wave inversion with or without ST depression. In the majority of patients, significant QTc interval prolongation occurs in the early phase, normalizing by day 14.

Clinical outcome of coronary stenting after thoracic radiotherapy: a case-control study

Objective Patients with lymphoma, lung or breast neoplasia show significant improvement in their disease-specific survival after radiotherapy (RT), but these benefits may be offset by delayed effects of irradiation of the heart. We compared clinical outcome after coronary stenting in patients with neoplastic disease and previous thoracic RT with matched patients without previous RT. Design Single-centre retrospective case-control study. Patients and methods Each patient with former thoracic RT undergoing coronary stenting between June 1998 and June 2005 was matched to two control patients according to several known prognostic factors (gender, age, available follow-up, stented vessel, drug-eluting stent use, unstable coronary disease, renal insufficiency, diabetes, bifurcational disease, stent length and size and ejection fraction). Main outcome measures Major adverse cardiac events (MACE) were defined as the composite of cardiac death, acute myocardial infarction (AMI) and target lesion revascularisation (TLR) and were assessed at latest follow-up and compared using Cox regression analyses. Results 41 patients underwent coronary stenting at 6±4 years after RT. Clinical outcome at 5±2 years after stenting was compared with outcome in 82 matched patients. For all-cause mortality, the hazard ratio for RT versus no RT was 4.2 (95% CI 1.8 to 9.5; p=0.0006). For cardiac mortality, the estimated hazard ratio was 4.2 (95% CI 1.0 to 17.0; p=0.0451). No significant differences were detected in terms of AMI, TLR, MACE or stent thrombosis. Conclusions Our findings suggest an increased risk of all-cause and cardiac mortality in patients who underwent coronary stent implantation after previous thoracic RT. Verification in larger patient populations is warranted.

Automatic three-dimensional registration of intravascular optical coherence tomography images

Intravascular optical coherence tomography (IV-OCT) is a catheter-based high-resolution imaging technique able to visualize the inner wall of the coronary arteries and implanted devices in vivo with an axial resolution below 20 μm. IV-OCT is being used in several clinical trials aiming to quantify the vessel response to stent implantation over time. However, stent analysis is currently performed manually and corresponding images taken at different time points are matched through a very labor-intensive and subjective procedure. We present an automated method for the spatial registration of IV-OCT datasets. Stent struts are segmented through consecutive images and three-dimensional models of the stents are created for both datasets to be registered. The two models are initially roughly registered through an automatic initialization procedure and an iterative closest point algorithm is subsequently applied for a more precise registration. To correct for nonuniform rotational distortions (NURDs) and other potential acquisition artifacts, the registration is consecutively refined on a local level. The algorithm was first validated by using an in vitro experimental setup based on a polyvinyl-alcohol gel tubular phantom. Subsequently, an in vivo validation was obtained by exploiting stable vessel landmarks. The mean registration error in vitro was quantified to be 0.14 mm in the longitudinal axis and 7.3-deg mean rotation error. In vivo validation resulted in 0.23 mm in the longitudinal axis and 10.1-deg rotation error. These results indicate that the proposed methodology can be used for automatic registration of in vivo IV-OCT datasets. Such a tool will be indispensable for larger studies on vessel healing pathophysiology and reaction to stent implantation. As such, it will be valuable in testing the performance of new generations of intracoronary devices and new therapeutic drugs.

Very late bare metal stent thrombosis due to neoatherosclerotic plaque rupture: an optical coherence tomography finding

Very late stent thrombosis (VLST) is a rare but potentially catastrophic complication occurring after percutaneous coronary intervention. The mechanisms involved in VLST in bare metal stents (BMS) are poorly understood. A 50-year-old man presented with an inferior ST-elevation myocardial infarction

Optical coherence tomography (OCT) in PCI for in-stent restenosis (ISR): rationale and design of the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) study.

BACKGROUND The optimal treatment of bare metal stent restenosis is still not defined. The most employed contemporary option is the implantation of a drug-eluting stent (DES). However, this procedure implies the addition of a second metal layer in the vessel wall, which is linked to delayed healing. Furthermore, there may be a increased risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stent. These phenomena may give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) have been proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising. OBJECTIVES To compare healing processes after treatment of bare metal stent (BMS) in-stent restenosis (ISR) with balloon dilatation using DEB versus implantation of DES. STUDY DESIGN This is a prospective, multicentre (University Hospitals Leuven and ZOL Hospital Genk, Belgium) randomised clinical trial with clinical, angiographic and OCT follow-up at nine months. Patients with bare metal stent restenosis and an indication for repeat PCI are randomised to treatment with a paclitaxel-eluting balloon (SeQuent Please, B-Braun, Melsungen, Germany) versus a Xience V/ Xience Prime everolimus-eluting stent (Abbott Vascular, Santa Clara, CA, USA). The primary objective of this study is to evaluate the vascular healing response of the vessel wall after balloon angioplasty with a paclitaxel-eluting balloon versus implantation of a drug-eluting stent in patients with in-stent restenosis in a coronary artery. The primary endpoint of the study is stent strut coverage and stent strut apposition at nine months, as assessed with OCT. CONCLUSIONS Currently no prospectively collected data on vessel wall healing after treatment of in-stent restenosis, whether with DES or with DEB, are available. Therefore, the SEDUCE trial will yield pivotal insights on this important topic and guide further optimisation of the interventional treatment for this condition.

Automated volumetric stent analysis of in-vivo intracoronary optical coherence tomography three-dimensional datasets

Intra-vascular Optical Coherence Tomography (IV-OCT) is an appropriate imaging modality for the evaluation of stent struts apposition and coverage in the coronary arteries. Most often, image analysis is performed by a time-consuming manual contour tracing process. Recently, we proposed an algorithm for fully automated lumen morphology and individual stent struts apposition/coverage quantification. In this manuscript further developments allowing for automatic segmentation of the stent contour are presented. As such, quantification of in-stent area, malapposition cross-sectional area (i.e. the area representing the space from the stent surface to the vessel wall) and coverage cross-sectional area (i.e. the area of the tissue covering the stent surface) are automatically obtained. Volumetric measurements of malapposition and coverage are then achieved through the analysis of equally-spaced consecutive IV-OCT cross-sectional images. In addition, uncovered and malapposed struts are automatically clustered through consecutive slices according to their three-dimensional spatial position. Finally, properties of each cluster (e.g. malapposition/coverage volumes and struts spatial location and distribution) are quantified allowing for a volumetric analysis of the implanted device. Validation of the algorithm was obtained taking as a reference manual measurements performed by an expert cardiologist. 102 in-vivo images, taken at random from 8 different patients, were both automatically and manually analyzed quantifying lumen and stent area. High Pearsons correlation coefficients (Rarea = 0.99) and Bland-Altman statistics, showing no significant bias and good limits of agreement, proved that the presented algorithm provides a robust and fast tool to automatically estimate apposition and coverage of stent through an entire in-vivo IV-OCT pullback. Such a tool will be important for the integration of this technology in clinical routine and large clinical trials.

A right ventricular infarction disguised as an anterior infarction due to an occluded isolated right ventricular branch

We report a case of abrupt closure of the right ventricular branch of the right coronary artery due to stenting. This closure caused marked ST-elevations in the precordial leads suggesting a problem in the left coronary artery. This phenomenon is scarcely reported in the literature.We discuss the typical electrocardiographic features of an isolated right ventricular infarction and we also give an anatomical model to elucidate them.

Assessing the landscape of percutaneous coronary chronic total occlusion treatment in Belgium and Luxembourg: the Belgian Working Group on Chronic Total Occlusions (BWGCTO) registry

Abstract Background: Important developments in materials, devices, and techniques have improved outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI), and resulted in a growing interest in CTO-PCI. The Belgian Working Group on Chronic Total Occlusions (BWGCTO) working group aims to assess the evolution within the CTO-PCI landscape over the next years. Methods: From May 2016 onwards, patients undergoing CTO-PCI were included in the BWGCTO registry by 15 centres in Belgium and Luxemburg. Baseline, angiographic, and procedural data were collected. Here, we report on the one-year in-hospital outcomes. Results: Over the course of one year, 411 procedures in 388 patients were included with a mean age of 64 ± 11 years. The majority were male (81%). Relatively complex CTOs were treated (Japanese CTO score =2.2 ± 1.2) with a high procedure success rate (82%). Patient- and lesion-wise success rates were 83 and 85%, respectively. Major adverse in-hospital events were acceptably low (3.4%). Antegrade wire escalation technique was applied most frequently (82%). On the other hand, antegrade dissection and re-entry and retrograde strategies were more frequently applied in higher volume centres and successful for lesions with higher complexity. Conclusion: Satisfactory procedural outcomes and a low rate of adverse events were obtained in a complex CTO population, treated by operators with variable experience levels. Antegrade wire escalation was the preferred strategy, regardless of operator volume.

Cancer in the Left Anterior Descending Artery: A Therapeutic Aspect of Thrombus Aspiration?

A 49-year-old male was admitted for surgical resection of a solitary pulmonary metastasis. A mixed germ cell testis tumor (mature teratoma and seminoma) was diagnosed 1 year before and treated with orchidectomy and adjuvant chemotherapy. Surgical resection of regional retroperitoneal disease