Arkadiusz Pietrasik

Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation.

OBJECTIVES The purpose of this document is to make the output of the International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT) Standardization and Validation available to medical and scientific communities, through a peer-reviewed publication, in the interest of improving the diagnosis and treatment of patients with atherosclerosis, including coronary artery disease. BACKGROUND Intravascular optical coherence tomography (IVOCT) is a catheter-based modality that acquires images at a resolution of ~10 μm, enabling visualization of blood vessel wall microstructure in vivo at an unprecedented level of detail. IVOCT devices are now commercially available worldwide, there is an active user base, and the interest in using this technology is growing. Incorporation of IVOCT in research and daily clinical practice can be facilitated by the development of uniform terminology and consensus-based standards on use of the technology, interpretation of the images, and reporting of IVOCT results. METHODS The IWG-IVOCT, comprising more than 260 academic and industry members from Asia, Europe, and the United States, formed in 2008 and convened on the topic of IVOCT standardization through a series of 9 national and international meetings. RESULTS Knowledge and recommendations from this group on key areas within the IVOCT field were assembled to generate this consensus document, authored by the Writing Committee, composed of academicians who have participated in meetings and/or writing of the text. CONCLUSIONS This document may be broadly used as a standard reference regarding the current state of the IVOCT imaging modality, intended for researchers and clinicians who use IVOCT and analyze IVOCT data.

Access for percutaneous coronary intervention in ST segment elevation myocardial infarction: radial vs. femoral ??? a prospective, randomised clinical trial (OCEAN RACE)

BACKGROUND Percutaneous treatment of patients with ST segment elevation myocardial infarction (STEMI) has become the standard and default mode of management as recommended by the European Society of Cardiology guidelines for managing acute myocardial infarction in patients presenting with STEMI. The choice of vascular access is made by the operator and has a potential impact on the safety and efficacy of the procedure and outcomes. AIM To understand the influence of a radial approach on bleeding complications and angiographic success, we performed a prospective, controlled randomised trial. METHODS Patients were allocated to radial (TR) or femoral (TF) vascular access. The primary endpoints were major bleeding by the REPLACE-2 scale and minor bleeding by the EASY scale (TR arm) or the FEMORAL scale (TF arm). Other outcomes included procedural data, in-hospital and long-term survival. RESULTS There were 103 patients analysed in total, 52 in the TR arm and 51 in the TF arm. The demographic and clinical baseline characteristics were well matched between the two study groups. The frequency of the primary endpoint was the same in both arms (TR: 25.0% vs. TF: 33.3%, p = 0.238). In per protocol analysis, there was a significant benefit of the TR approach among independent operators (17.4% vs. 36.8%, p = 0.038). Major bleeding by the REPLACE-2 scale occurred in 4.2% of patients (TR: 5.8% vs. TF: 3.9%, p = 0.509). There were no differences in terms of the rate of major cardiac adverse events, which happened in 10.7% of the study population (TR: 9.6% vs. TF: 11.8%, p = 0.48). In the TF arm, there was a trend towards a higher risk of local bleedings (TR: 22.4% vs. TF: 37.7%, p = 0.081) and a significantly higher frequency of local haematoma (class III, EASY/FEMORAL) (TR: 0% vs. TF: 9.8%, p = 0.027). CONCLUSIONS There were no significant differences between the TR and TF approaches in terms of clinical efficacy and patient safety. However, patients treated by independent operators might benefit from TR access. The overall complication risk of percutaneous coronary intervention treatment of STEMI patients remains low.

Cost-effectiveness of radial vs. femoral approach in primary percutaneous coronary intervention in STEMI – Randomized, control trial

INTRODUCTION AND OBJECTIVES Primary percutaneous coronary intervention infarction became the preferred method of treatment for myocardial ST segment elevation. Improved safety was reported in transradial access (radial) compared to transfemoral access (femoral). The aim of this study was to compare the cost between the two access points in ST segment elevation myocardial infarction. METHODS This is a subanalysis of the OCEAN RACE trial in which 103 myocardial infarction patients were randomized to either the radial (n=52) or femoral (n=51) groups. The clinical safety and efficacy were recorded during the hospital stay. The procedural metrics were meticulously logged, and costs were evaluated using the micro-cost method. The indirect costs were estimated using the human capital approach. RESULTS Clinical success was numerically higher in the radial group (90.4 vs. 80.4%, p=0.123). There were no differences in major adverse cardiac events (9.6% vs. 11.8%, p=0.48) and death (2.0% vs. 6.0%, p=0.31). The average in-hospital cost per patient was 2,740 ± 1,092 EUR. The cost of therapeutic success was lower in the radial group at 3,060 EUR vs. 3,374 EUR. The indirect costs related to absence at work were 138 EUR per patient, which were lower in the radial group compared to the femoral group. CONCLUSIONS The total in-hospital costs were similar between the study groups. The indirect costs were lower in the radial group. Introduction of radial access as the default approach in all centers may significantly reduce the overall financial burden from a social perspective.

A 12–month angiographic and optical coherence tomography follow-up after bioresorbable vascular scaffold implantation in patients with ST-segment elevation myocardial infarction

The aim of the study was to evaluate the healing process at 12 months after ABSORB™ bioresorbable vascular scaffold (BVS) implantation in patients with ST‐segment elevation myocardial infarction (STEMI).

Improvement in Quality of Life and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension Treated With Balloon Pulmonary Angioplasty

BACKGROUND The effect of balloon pulmonary angioplasty (BPA) on improvement in functional and hemodynamic parameters in chronic thromboembolic pulmonary hypertension (CTEPH) is known, but the quality of life (QoL) of patients treated with BPA has never been studied before.Methods and Results:Twenty-five patients with inoperable or persistent CTEPH were enrolled in the study and filled out the 36-item Short Form (SF-36v2) questionnaire twice: prior to commencement of BPA treatment and after ≥3 BPA sessions. In addition WHO functional class, distance on the 6-min walk test (6MWT) and hemodynamic parameters such as right atrial pressure (RAP), mean pulmonary artery pressure (mPAP), cardiac index (CI) and pulmonary vascular resistance (PVR) were assessed. QoL improved significantly in all domains, except for physical pain. Improvement in RAP (10.5±3.4 vs. 6.2±2.2 mmHg; P<0.05), mPAP (51.7±10.6 vs. 35.0±9.1 mmHg; P<0.05), CI (2.2±0.5 vs. 2.5±0.4 L/min·m2; P=0.04), PVR (10.4±3.9 vs. 5.5±2.2 Wood units; P<0.05), functional class (96% vs. 20% in WHO class III and IV, P<0.05) and improvement in 6MWT distance (323±135 vs. 410±109 m; P<0.05) was observed. The only significant correlation was between the mental component summary score of QoL after completion of treatment and percentage improvement in the 6MWT (-0.404, P<0.05). CONCLUSIONS Alongside improvement in functional and hemodynamic parameters, BPA also provides significant improvement in QoL.

The oldest patient with takotsubo cardiomyopathy

Takotsubo cardiomyopathy (TTC) is a rare condition that affects mainly aging women. According to a retrospective review, patients with TTC accounted for approximately 2% of all the patients with suspected acute coronary syndrome (ACS). A few reports indicated that the average age of TTC patients was 68 years, although children or young adults may also be affected. In US and Europe, a number of contemporary TTC studies report that 90% of patients with TTC are women aged 65–70 years. Meta analysis showed that the age ranged from 10 to 89 years. [1] There was also one case study of a 90-year-old patient with TTC ― the oldest patient known so far. In that case, the patient died during the course of treatment from severe multi-organ failure. [2] In the present case report, we present a 98-years old woman with TTC admitted to our clinic. A 98-years old patient was admitted to our clinic because of significant chest pain and general weakness accompanied by hypotension that required catecholamine administration with ST-segment elevation in the anterolateral leads in ECG. The patient suffered from hypertension and third stage of chronic kidney disease. Urgent cardiac catheterization and ventriculography confirmed the absence of any critical coronary disease, but also the presence of a typical apical ballooning and midventricular hypokinesis. Troponin I (TnI) at admission was 5.555 ng/mL and creatine kinase soenzyme MB (CK-MB) mass was 14.5 ng/mL. Inflammatory parameters were not elevated, whereas N-terminal pro brain natriuretic peptide (NT-proBNP) concentration was markedly elevated, at 18,623 pg/mL. NT-proBNP/TnI ratio was 3352.48 on the first day and even higher after 24 h, at 7113.36. This markers profile is characteristic of TTC. There is a relatively small increase in creatine kinase and troponin concentrations in relation to the extent of wall motion abnormalities. BNP is always elevated in patients with TTC and is higher than in patients with ST-segment elevation myocardial infarction. Some researchers suggest that TTC can be distinguished from ACS on the basis of the characteristic profile of cardiac markers consisting of a sudden increase in the concentration of NT-proBNP in the first few days when there is only a small increase in markers of myocardial necrosis (the ratio of NT-pro BNP/troponin). [3]

A prospective randomised comparison of minor bleedings in transradial vs. transfemoral access percutaneous coronary interventions for STEMI: a new FEMORAL bleeding classification

BACKGROUND Local bleedings related to vascular access site in percutaneous procedures are relatively common complications. However, no uniform definitions exist to classify them. AIM To compare minor bleedings related to transradial (TR) and transfemoral (TF) percutaneous coronary intervention (PCI) approaches in ST elevation myocardial infarction (STEMI). In addition, a new classification of TF access-related bleeding - the FEMORAL scale - was proposed. METHODS OCEAN RACE is a prospective, randomised, open-label, clinical trial performed in STEMI patients treated with primary PCI. Patients were randomly assigned to the TR or TF arm. Bleedings related to the TR approach were assessed by the EASY scale, whereas bleedings related to the TF approach were classified according to the new FEMORAL scale. A combined analysis of all bleedings was performed using the TIMI scale. RESULTS There were 103 patients analysed, including 52 in the TR arm and 51 in the TF arm. Analysis of demographic and clinical baseline characteristics revealed no significant differences between the two study groups. In-hospital bleedings related to the access site were observed in 29.8% of patients. In the TR group, a trend towards lower risk of local bleedings was observed compared to the TF group (TR: 22.4% vs. TF: 37.7%, p = 0.081). Analysis of each class of access site bleeding according to EASY/FEMORAL scales showed that patients in the TR group had a significantly lower risk of class III local haematoma compared to the TF group (TR: 0% vs. TF: 9.8%, p = 0.027). The risk of bleeding in other classes was comparable in both groups. A trend towards less frequent minimal bleedings according to the TIMI scale was observed in the TR group (HR: 0.41, 95% CI: 0.152-1.112, p = 0.059). CONCLUSIONS TF patients had a higher risk of access-related bleedings than TR patients. The FEMORAL scale was effective in the classification of TF access-related bleedings. Although the popularity of TF access in PCI decreases, this approach is increasingly used in transcatheter aortic valve implantation, renal denervation and closure of paravalvular leaks. Therefore a scale accessing local bleeding in the TF approach may be useful.

Tissue coverage of paclitaxel and sirolimus eluting stents in long term follow-up: optical coherence tomography study.

BACKGROUND Implantation of drug eluting stents (DES) has become a standard treatment of patients undergoing percutaneous coronary intervention (PCI). Incomplete strut coverage is a potential risk factor for late stent thrombosis. Optical coherence tomography (OCT) enables in vivo identification of incomplete neointimal coverage. METHODS Study included 62 patients after sirolimus eluting stents (SES) or paclitaxel eluting stents (PES) implantation. OCT examination was performed at least 24 months after the initial procedure (35.4± 9.4 months). In cross-sectional still frames selected from each 1 mm of analyzed stents a total number of visible struts and number of struts with or without complete neointimal coverage was assessed. Measurements of neointimal coverage, presented as a mean thickness of tissue, were performed. Patients were followed up for 3 years and the frequency ofmajor adverse cardiac events was recorded. RESULTS In the analyzed 28 SES and 37 PES 9998 struts were identified. Complete neointimalcoverage was observed in 83.5% and 79.2% of SES and PES struts respectively (p = 0.48).There was no difference in incidence of not covered or malapposed struts between SES and PES groups. Mean thickness of the tissue covering SES struts was 0.165 ± 0.095 mm, and 0.157 ± 0.121 mm for PES. The mean neointimal thickness difference (SES vs. PES) was notstatistically significant. In a 36 months follow-up 1 death was observed - potentially attributed to stent thrombosis. CONCLUSIONS A long term OCT follow-up after DES implantation shows high incidence ofuncovered struts regardless of the stent type. Clinical significance of this finding remains questionable and requires further large scale trials.

Comparison between optical coherence tomography and intravascular ultrasound in detecting neointimal healing patterns after stent implantation

BACKGROUND The amount of data comparing intravascular ultrasound (IVUS) and optical coherence tomography (OCT) for the detection of stent coverage in clinical settings is limited. AIM To make a qualitative and quantitative assessment of the vascular healing patterns in patients after stent implantations visualised by both IVUS and OCT. METHODS Images were obtained in patients with clinical symptoms of angina, who had had a bare metal stent implanted in the previous 12 months. Angiography, IVUS and OCT were performed in 14 coronary arteries. Measurements of stent, lumen and neo-intima areas and dimensions were performed in stented regions and in both 10 mm references. IVUS, OCT, and angiographic data were compared in matched regions. Off-line analyses were performed by an independent core lab. RESULTS 14 stents were imaged without any procedural complications. The nominal stent length was 28 ± 4.5 mm. OCT was the most accurate technique for assessing stent length (28.12 ± 6.8 mm), while QCA underestimated length due to foreshortening (22.16 ± 6.39 mm) and IVUS was vulnerable to random error due to discontinuous pullbacks and vessel movements (24.21 ± 7.90 mm). Minimum lumen area (MLA) and minimum lumen diameter (MLD) in reference sites were comparable in IVUS and OCT, whereas there were significant differences between these two modalities for MLA (3.30 ± 1.49 vs. 2.19 ± 1.30 mm², p = 0.0046) and for MLD (2.42 ± 0.51 vs. 1.58 ± 0.56 mm², p = 0.0023) in stented segments. There was a slight overestimation of lumen volume (130.18 ± 70.61 vs. 117.82 ± 67.02 mm³, p = 0.7256),a marked overestimation of stent volume (179.29 ± 97.58 vs. 226.46 ± 108.76 mm³, p = 0.0544) and a statistically significant difference in the neointima volume (49.11 ± 39.70 vs. 108.64 ± 43.77 mm³, p = 0.0060) by IVUS compared to OCT. Mean neointima burden in IVUS was much smaller than in OCT (20.79 ± 14.27% vs. 58.16 ± 18.25%, p = 0.0033). CONCLUSIONS OCT can precisely quantify struts coverage and is more accurate than IVUS in the assessment of vascular healing in patients after stent implantation.

Delayed neointimal healing pattern after bioresorbable scaffold implantation

Fig. 1 a (Baseline) Optical coherence tomography (OCT) directly after implantation of the bioresorbable scaffold (BVS). Adequate BVS expansion and focally malapposed struts in the distal 3-mm scaffold segment (white arrow) into right coronary artery. b (1-year follow-up) Uncovered stent struts (blue arrows) at 12 months after the intervention. c (2-year follow-up) 24-month OCT revealed complete coverage of all struts with a homogeneous, bright neointimal layer and resolved malapposition in the distal segment