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

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.

STACCATO (Assessment of Stent sTrut Apposition and Coverage in Coronary ArTeries with Optical coherence tomography in patients with STEMI, NSTEMI and stable/unstable angina undergoing everolimus vs. biolimus A9-eluting stent implantation): a randomised controlled trial.

AIMS: To compare tissue coverage in coronary lesions stented with durable fluoropolymer-coated everolimus-eluting stents (EES) vs. biodegradable polymer-coated biolimus A9-eluting stents (BES). METHODS AND RESULTS: Sixty-four patients (64 lesions) with de novo coronary artery lesions were randomised to percutaneous treatment with XIENCE EES (Abbott Vascular, Santa Clara, CA, USA) vs. BioMatrix BES (Biosensors, Morges, Switzerland). The primary endpoint was the percentage of uncovered struts, as assessed with OCT, at nine months. The average percentage of uncovered struts was significantly lower with EES (4.3±4.8% vs. 8.7±7.8% with BES, p=0.019). There was no difference in the average percentage of malapposed struts at baseline (6.8±6.9% vs. 6.9±7.0%, respectively, p=0.974) and at follow-up (0.1±0.3% vs. 0.6±1.3%, p=0.143). Neointimal thickness at nine months was 109±43 µm in EES vs. 64±18 µm in BES (p<0.001), and angiographic LLL was 0.15 mm in EES vs. 0.10 mm in BES (p=0.581). We did not observe differences in the incidence of MACE and ST. CONCLUSIONS: A significantly higher percentage of uncovered struts was detected in the BioMatrix BES compared with the XIENCE EES at nine-month follow-up. Our findings do not support a preferential use of stents with biodegradable polymer-based biolimus elution to reduce the risk for ST.

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.

The apical nipple sign: a useful tool for discriminating between anterior infarction and transient left ventricular ballooning syndrome.

AIMS: Even after coronary angiography, transient left ventricular ballooning syndrome (TLVBS) can be misdiagnosed as ST-elevation myocardial infarction (STEMI) caused by transient thrombotic occlusion of the left anterior descending artery, as the appearance of the left ventricular angiograms is often very similar. As prognosis and antithrombotic treatment of these two conditions differ widely, it is desirable to make a correct diagnosis as early as possible. METHODS: Between January 1998 and August 2012, we identified 145 patients diagnosed with TLVBS in a single tertiary hospital, based on the Mayo criteria and (near) normalization of left ventricular function over weeks. For 119 of these patients, coronary and left ventricular angiograms were available for detailed study. RESULTS: In 27 (22.7%) patients, mid-ventricular ballooning was observed, with preserved contractility of the apex, while in 92 (77.3%) typical apical ballooning was seen, with extensive akinesis of the apex. In 28 of the patients with typical apical ballooning (30.4%), we observed the presence of a very small zone with preserved contractility in the most apical portion of the left ventricle. We coined this phenomenon 'apical nipple sign'. For comparison, we reviewed the left ventricular angiograms of 405 patients who had been treated for anterior STEMI by emergency percutaneous intervention on the left anterior descending artery in our hospital between February 2007 and October 2012. On careful review, the apical nipple sign was not seen in any of these. CONCLUSION: While discrimination between TLVBS and anterior STEMI is warranted as early as possible after admission, this is very difficult, especially in the majority of cases presenting with the classical apical ballooning phenotype. By observing the herein-described apical nipple sign, the attending physician can make the diagnosis of TLVBS with virtual certainty in almost one-third of cases.

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.

Prospective evaluation of clinical outcomes in all-comer high-risk patients with aortic valve stenosis undergoing medical treatment, transcatheter or surgical aortic valve implantation following heart team assessment.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has been proposed as a treatment alternative for patients with aortic valve stenosis (AS) at high or prohibitive risk for surgical aortic valve replacement (AVR). We aimed to assess real-world outcomes after treatment according to the decisions of the multidisciplinary heart team. METHODS: At a tertiary centre, all high-risk patients referred between 1 March 2008 and 31 October 2011 for symptomatic AS were screened and planned to undergo AVR, TAVI or medical treatment. We report clinical outcomes as defined by the Valve Academic Research Consortium. RESULTS: Of 163 high-risk patients, those selected for AVR had lower logistic EuroSCORE and STS scores when compared with TAVI or medical treatment (median [interquartile range] 18 [12-26]; 26 [17-36]; 21 [14-32]% (P = 0.015) and 6.5 [5.1-10.7]; 7.6 [5.8-10.5]; 7.6 [6.1-15.7]% (P = 0.056)). All-cause mortalities at 1 year in 35, 73 and 55 patients effectively undergoing AVR, TAVI and medical treatment were 20, 21 and 38%, respectively (P = 0.051). Cardiovascular death and major stroke occurred in 9, 8 and 33% (P < 0.001) and 6, 4 and 2% (P = 0.62), respectively. For patients undergoing valve implantation, device success was 91 and 92% for AVR and TAVI, respectively. The combined safety endpoint at 30 days was in favour of TAVI (29%) vs AVR (63%) (P = 0.001). In contrast, the combined efficacy endpoint at 1 year tended to be more favourable for AVR (10 vs 24% for TAVI, P = 0.12). CONCLUSIONS: Patients who are less suitable for AVR can be treated safely and effectively with TAVI with similar outcomes when compared with patients with a lower-risk profile undergoing AVR. Patients with TAVI or AVR have better survival than those undergoing medical treatment only.

Healing responses after bifurcation stenting with the dedicated TRYTON Side-Branch Stent™ in combination with XIENCE-V™ stents: a clinical, angiography, fractional flow reserve, and optical coherence tomography study: the PYTON (Prospective evaluation of the TRYTON Side-Branch Stent™ with an additional XIENCE-v™ everolimus-eluting stent in coronary bifurcation lesions) study.

OBJECTIVES: We evaluated healing responses with optical coherence tomography (OCT), and clinical and angiographic outcome after bifurcation stenting with the TRYTON Side-Branch Stent™. BACKGROUND: Dedicated bifurcation stents have been proposed as a potential alternative for treatment of true coronary bifurcation lesions. METHODS: We treated 20 consecutive patients with coronary bifurcation lesions and significant involvement of the side-branch (SB) with the TRYTON Stent and an additional XIENCE-V™ everolimus-eluting stent. At 9 months, we assessed the ratio of uncovered to total stent struts (RUTSS) with OCT, angiographic late luminal loss (LLL), and in-stent and in-segment restenosis. Clinical endpoints at 1 year included major adverse cardiac events (MACE) and their components [target lesion revascularization (TLR), myocardial infarction (MI), and cardiac death]. RESULTS: LLL (N = 16) was 0.34 (0.17-0.46), 0.29 (0.24-0.48) and 0.57 (0.29-0.73) mm in the proximal main vessel (MV), distal MV and SB, respectively. In-bifurcation binary in-stent restenosis occurred in four patients (25%), in-segment restenosis in five (31.25%). The RUTSS (N = 13) was 4.0 ± 5.8, 0.7 ± 1.3, 0, and 2.5 ± 3.6% in the proximal MV, distal MV, SB, and polygon of confluence, respectively. At 1 year, MACE occurred in 5 (25%) [4 TLR (20%), 3 MI (15%)]. CONCLUSION: The homogeneous stent strut coverage and the low LLL in the MV reflect proper healing characteristics of the TRYTON Stent in combination with the XIENCE-V™ stent. However, proximal MV edge and ostial SB restenoses together with overall clinical outcomes do not fulfill expectations of a dedicated bifurcation stent. © 2012 Wiley Periodicals, Inc.

Risk assessment for percutaneous coronary intervention of the unprotected left main coronary artery in a real-world population.

BACKGROUND: Available clinical and angiographic scoring systems fail to predict clinical outcomes in real-world patients undergoing revascularization of the unprotected left main coronary artery (ULMCA). METHODS: We prospectively assessed major adverse cardiac and cerebrovascular events (MACCE) in a real-world population undergoing percutaneous coronary intervention (PCI) for ULMCA disease. Cumulative risk-adjusted mortality in our patients was compared with expected mortality at 30 days based on logistic EuroSCORE and SYNTAX SCORE. Similarly, we plotted cumulative risk-adjusted MACCE at 1 year based on SYNTAX SCORE. Finally, both scores were combined in 1 year Global Risk Charts, including the use of drug-eluting stents (DES), diabetic status, and several factors precluding coronary surgery. RESULTS: Over a 12-year period, 240 patients underwent elective (76%) or urgent (24%) PCI of the ULMCA. Median logistic EuroSCORE and SYNTAX SCORE were 8.7% (3.5; 21) and 23% (14; 31). During the first year of follow-up, 89 patients presented MACCE (37.1%) (46 deaths [19.2%], 18 acute myocardial infarctions [7.5%], 45 revascularizations [18.8%] and 4 strokes [1.7%]). Cumulative risk-adjusted mortality based on individual logistic EuroSCORE and SYNTAX SCORE pointed towards significant overestimation (+19 deaths) and underestimation (-35 deaths) of risk by these respective scoring systems. Similarly, the anatomic SYNTAX SCORE largely underestimated cumulative risk-adjusted MACCE (-60 MACCE). The Global Risk Charts provided a more balanced view on 1-year clinical outcome. CONCLUSION: An integrated risk evaluation combining EuroSCORE, SYNTAX SCORE, diabetic status, stent type and general condition, may predict outcomes more accurately awaiting validation in a larger and multicentre setting.

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.

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.

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.

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.

Symptomatic atraumatic dissection of a left internal mammary artery graft five years after coronary artery bypass graft surgery.

The case of a spontaneous dissection of a left internal mammary artery grafted on to the diagonal branch and the left anterior descending artery is reported. The clinical and diagnostic features of this condition are discussed. Despite an extensive literature search, no such case was found. The present case is the first to be reported. It was speculated that extensive kinking of the left internal mammary artery contributed to the pathogenesis of this syndrome.