PATHFINDER-CHD: prospective registry on adults with congenital heart disease, abnormal ventricular function, and/or heart failure as a foundation for establishing rehabilitative, prehabilitative, preventive, and health-promoting measures: rationale, aims, design and methods.

BACKGROUND: Adults with congenital heart defects (ACHD) globally constitute a notably medically underserved patient population. Despite therapeutic advancements, these individuals often confront substantial physical and psychosocial residua or sequelae, requiring specialized, integrative cardiological care throughout their lifespan. Heart failure (HF) is a critical challenge in this population, markedly impacting morbidity and mortality. AIMS: The primary aim of this study is to establish a comprehensive, prospective registry to enhance understanding and management of HF in ACHD. Named PATHFINDER-CHD, this registry aims to establish foundational data for treatment strategies as well as the development of rehabilitative, prehabilitative, preventive, and health-promoting interventions, ultimately aiming to mitigate the elevated morbidity and mortality rates associated with congenital heart defects (CHD). METHODS: This multicenter survey will be conducted across various German university facilities with expertise in ACHD. Data collection will encompass real-world treatment scenarios and clinical trajectories in ACHD with manifest HF or at risk for its development, including those undergoing medical or interventional cardiac therapies, cardiac surgery, inclusive of pacemaker or ICD implantation, resynchronization therapy, assist devices, and those on solid organ transplantation. DESIGN: The study adopts an observational, exploratory design, prospectively gathering data from participating centers, with a focus on patient management and outcomes. The study is non-confirmatory, aiming to accumulate a broad spectrum of data to inform future hypotheses and studies. PROCESSES: Regular follow-ups will be conducted, systematically collecting data during routine clinical visits or hospital admissions, encompassing alterations in therapy or CHD-related complications, with visit schedules tailored to individual clinical needs. ASSESSMENTS: Baseline assessments and regular follow-ups will entail comprehensive assessments of medical history, ongoing treatments, and outcomes, with a focus on HF symptoms, cardiac function, and overall health status. DISCUSSION OF THE DESIGN: The design of the PATHFINDER-CHD Registry is tailored to capture a wide range of data, prioritizing real-world HF management in ACHD. Its prospective nature facilitates longitudinal data acquisition, pivotal for comprehending for disease progression and treatment impacts. CONCLUSION: The PATHFINDER-CHD Registry is poised to offer valuable insights into HF management in ACHD, bridging current knowledge gaps, enhancing patient care, and shaping future research endeavors in this domain.

Prognostic value of negative stress cardiac magnetic resonance imaging in patients with moderate-severe coronary artery stenosis.

Objective: This study aims to evaluate the prognostic value of stress cardiac magnetic resonance (CMR) without inducible ischemia in a real-world cohort of patients with known severe coronary artery stenosis. Background: The prognosis of patients with severe coronary artery stenosis and without inducible ischemia using stress CMR remains uncertain, even though its identification of functionally significant coronary artery disease (CAD) is excellent. Materials and methods: Patients without inducible ischemia and known CAD who underwent stress CMR between February 2015 and December 2016 were included in this retrospective study. These patients were divided into two groups: group 1 with stenosis of 50%-75% and group 2 with stenosis of >75%. The primary endpoint was defined as the occurrence of a major adverse cardiovascular event (MACE) [cardiac death, non-fatal myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)]. Results: Real-world data collected from 169 patients with a median age of 69 (60-75) years were included. The median follow-up was 5.5 (IQR 4.1-6.6) years. Events occurred after a mean time of 3.0 ± 2.2 years in group 1 and 3.7 ± 2.0 years in group 2 (p = 0.35). Sixteen (18.8%) patients in group 1 and 23 (27.4%) patients in group 2 suffered from MACE without a significant difference between the two groups (p = 0.33). In group 2, one cardiac death (1.2%), seven non-fatal MI (8.3%), 15 PCI (17.9%), and one CABG (1.2%) occurred. Conclusion: The findings of this pilot study suggest that long-term outcomes in a real-world patient cohort with known severe and moderate coronary artery stenosis but without inducible ischemia were similar. Stress CMR may provide valuable risk stratification in patients with angiographically significant but hemodynamically non-obstructive coronary lesions.

Plasma levels of thrombin and activated protein C in patients with acute myocardial Infarction: An observational study.

Introduction: Activation of the plasmatic coagulation system is a major contributor to acute myocardial infarction (AMI). Markers of plasmatic coagulation and thrombin activation are correlated with clinical, laboratory and outcome parameters. In this study, we sought to evaluate if the catalytically active coagulation factors thrombin and activated protein C (APC) can be measured in patients with AMI and whether there are associations with laboratory or clinical parameters. Methods: Thrombin and APC was quantified using oligonucleotide-enzyme-capture assays (OECAs) in 132 patients presenting with AMI immediately before and 24 h after percutaneous coronary intervention (PCI). Results: APC was measured above the lower limit of quantification (LLOQ) in 43 (32.6%) patients before PCI (day 0) and in 55 (41.7%) patients on the following day (day 1). Thrombin was measured in 62 (47.0%) patients on day 0 and 60 (45.5%) on day 1. Both APC and thrombin were correlated with markers of thrombin generation including F1 + 2 and TAT. Additionally, APC values correlated with CK and CK-MB while thrombin correlated with CK and troponin I after PCI. APC levels above a cutoff of 0.141 ng/ml after PCI, but not thrombin, predicted 30 day major adverse cerebrovascular events. Conclusion: Both thrombin and APC were elevated above the LLOQ in a subset of patients with AMI before and after PCI and correlated with surrogate markers of myocardial injury. Our results indicate that enzymatically active APC and thrombin are present in the circulation of patients with AMI.

Serial Changes in Coronary Plaque Formation Using CT Angiography in Patients Undergoing PCSK9-Inhibitor Therapy With 1-year Follow-up.

PURPOSE: Previous studies have shown positive effects of intensive low-density lipoprotein (LDL)-lowering therapy on atheroma volume using invasive intravascular ultrasound. This study describes the changes in coronary plaque composition on coronary computed tomography angiography in patients treated with proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. MATERIALS AND METHODS: In this prospective study, coronary plaques were analyzed using third-generation dual-source computed tomography before and after 1 year of PCSK9-inhibitor treatment. Plaque markers included total plaque volume (TPV), calcified plaque volume (CPV), noncalcified plaque volume (NCPV), lumen volume and vessel volume (VV), minimal luminal area (MLA), minimal lumen diameter (MLD), corrected coronary opacification, eccentricity, remodeling index, and functional plaque parameters. Primary endpoint was defined as change in TPV; the secondary endpoint was TPV or CPV regression or nominal change in plaque parameters. RESULTS: We analyzed 74 coronary plaques in 23 patients (60±9 y, 65% male). After 1 year of PCSK9-inhibitor treatment, LDL was reduced from 148 to 66 mg/dL ( P <0.0001). Significant changes were found for VV (196 to 215 mm 3 , P =0.0340), MLA (3.1 to 2.6 mm 2 , P =0.0413), and MLD (1.7 to 1.4 mm, P =0.0048). TPV, CPV, NCPV, lumen volume, and functional plaque parameters did not change significantly ( P >0.05). CONCLUSIONS: Coronary artery plaque analysis by coronary computed tomography angiography highlights that LDL lowering therapy affects plaque composition. The primary endpoint of TPV change was not reached; however, VV, MLA, and MLD changed significantly.

Stable patients with suspected myocardial ischemia: comparison of machine-learning computed tomography-based fractional flow reserve and stress perfusion cardiovascular magnetic resonance imaging to detect myocardial ischemia.

BACKGROUND: Machine-Learning Computed Tomography-Based Fractional Flow Reserve (CT-FFRML) is a novel tool for the assessment of hemodynamic relevance of coronary artery stenoses. We examined the diagnostic performance of CT-FFRML compared to stress perfusion cardiovascular magnetic resonance (CMR) and tested if there is an additional value of CT-FFRML over coronary computed tomography angiography (cCTA). METHODS: Our retrospective analysis included 269 vessels in 141 patients (mean age 67 ± 9 years, 78% males) who underwent clinically indicated cCTA and subsequent stress perfusion CMR within a period of 2 months. CT-FFRML values were calculated from standard cCTA. RESULTS: CT-FFRML revealed no hemodynamic significance in 79% of the patients having ≥ 50% stenosis in cCTA. Chi2 values for the statistical relationship between CT-FFRML and stress perfusion CMR was significant (p < 0.0001). CT-FFRML and cCTA (≥ 70% stenosis) provided a per patient sensitivity of 88% (95%CI 64-99%) and 59% (95%CI 33-82%); specificity of 90% (95%CI 84-95%) and 85% (95%CI 78-91%); positive predictive value of 56% (95%CI 42-69%) and 36% (95%CI 24-50%); negative predictive value of 98% (95%CI 94-100%) and 94% (95%CI 90-96%); accuracy of 90% (95%CI 84-94%) and 82% (95%CI 75-88%) when compared to stress perfusion CMR. The accuracy of cCTA (≥ 50% stenosis) was 19% (95%CI 13-27%). The AUCs were 0.89 for CT-FFRML and 0.74 for cCTA (≥ 70% stenosis) and therefore significantly different (p < 0.05). CONCLUSION: CT-FFRML compared to stress perfusion CMR as the reference standard shows high diagnostic power in the identification of patients with hemodynamically significant coronary artery stenosis. This could support the role of cCTA as gatekeeper for further downstream testing and may reduce the number of patients undergoing unnecessary invasive workup.

Prediction of cardiac events with non-contrast magnetic resonance feature tracking in patients with ischaemic cardiomyopathy.

AIMS: The aim of this study was to evaluate the prognostic value of feature tracking (FT) derived cardiac magnetic resonance (CMR) strain parameters of the left ventricle (LV)/right ventricle (RV) in ischaemic cardiomyopathy (ICM) patients treated with an implantable cardioverter-defibrillator (ICD). Current guidelines suggest a LV-ejection fraction ≤35% as major criterion for ICD implantation in ICM, but this is a poor predictor for arrhythmic events. Supplementary parameters are missing. METHODS AND RESULTS: Ischaemic cardiomyopathy patients (n = 242), who underwent CMR imaging prior to primary and secondary implantation of ICD, were classified depending on EF ≤ 35% (n = 188) or >35% (n = 54). FT parameters were derived from steady-state free precession cine views using dedicated software. The primary endpoint was a composite of cardiovascular mortality (CVM) and/or appropriate ICD therapy. There were no significant differences in FT-function or LV-/RV-function parameters in patients with an EF ≤ 35% correlating to the primary endpoint. In patients with EF > 35%, standard CMR functional parameters, such as LV-EF, did not reveal significant differences. However, significant differences in most FT parameters correlating to the primary endpoint were observed in this subgroup. LV-GLS (left ventricular-global longitudinal strain) and RV-GRS (right ventricular-global radial strain) revealed the best diagnostic performance in ROC curve analysis. The combination of LV-GLS and RV-GRS showed a sensitivity of 85% and a specificity of 76% for the prediction of future events. CONCLUSIONS: The impact of FT derived measurements in the risk stratification of patients with ICM depends on LV function. The combination of LV-GLS/RV-GRS seems to be a predictor of cardiovascular mortality and/or appropriate ICD therapy in patients with EF > 35%.

Coronary Computed Tomography vs. Cardiac Magnetic Resonance Imaging in the Evaluation of Coronary Artery Disease.

Coronary artery disease (CAD) represents a widespread burden to both individual and public health, steadily rising across the globe. The current guidelines recommend non-invasive anatomical or functional testing prior to invasive procedures. Both coronary computed tomography angiography (cCTA) and stress cardiac magnetic resonance imaging (CMR) are appropriate imaging modalities, which are increasingly used in these patients. Both exhibit excellent safety profiles and high diagnostic accuracy. In the last decade, cCTA image quality has improved, radiation exposure has decreased and functional information such as CT-derived fractional flow reserve or perfusion can complement anatomic evaluation. CMR has become more robust and faster, and advances have been made in functional assessment and tissue characterization allowing for earlier and better risk stratification. This review compares both imaging modalities regarding their strengths and weaknesses in the assessment of CAD and aims to give physicians rationales to select the most appropriate modality for individual patients.

Short-Time Changes in Coronary Artery Plaques Assessed by Follow-Up Coronary CT Angiography-Characteristics and Impact on Patient Management.

Background: Coronary artery disease (CAD) shows a chronic but heterogeneous clinical course. Coronary CT angiography (CTA) allows for the visualization of the entire coronary tree and the detection of early stages of CAD. The aim of this study was to assess short-time changes in non-calcified and mixed plaques and their clinical impact using coronary CTA in a real-world setting. Methods: Between 11/2014 and 07/2019, 6,701 patients had a coronary CTA with a third-generation dual-source CT, of whom 77 patients (57 males, 63.8 ± 10.8 years) with a chronic CAD received clinically indicated follow-up CTA. Non-calcified and mixed plaques were analyzed in 1,211 coronary segments. Patients were divided into groups: stable, progressive, or regressive plaques. Results: Within the follow-up period of 22.3 ± 10.4 months, 44 patients (58%) showed stable plaques, 27 (36%) showed progression, 5 (7%) showed regression. One patient was excluded due to an undetermined CAD course showing both, progressive and regressive plaques. Age did not differ significantly between groups. Patients with plaque regression were predominantly female (80 vs. 20%), whereas patients showing progression were mainly male (85 vs. 15%; p < 0.01 for both). Regression was only observed in patients with mild CAD or one-vessel disease. The follow-up CTA led to changes in patient management in the majority of subjects (n = 50; 66%). Conclusions: Changes in coronary artery plaques can be observed within a short period resulting in an adjustment of the clinical management in the majority of CAD patients. Follow-up coronary CTA renders the non-invasive assessment of plaque development possible and allows for an individualized diagnostics and therapy optimization.

Prognostic Value of Coronary Computed Tomography Angiography-derived Morphologic and Quantitative Plaque Markers Using Semiautomated Plaque Software.

PURPOSE: In this study, we analyzed the prognostic value of coronary computed tomography angiography-derived morphologic and quantitative plaque markers and plaque scores for major adverse cardiovascular events (MACEs). MATERIALS AND METHODS: We analyzed the data of patients with suspected coronary artery disease (CAD). Various plaque markers were obtained using a semiautomated software prototype or derived from the results of the software analysis. Several risk scores were calculated, and follow-up data concerning MACE were collected from all patients. RESULTS: A total of 131 patients (65±12 y, 73% male) were included in our study. MACE occurred in 11 patients within the follow-up period of 34±25 months.CAD-Reporting and Data System score (odds ratio [OR]=11.62), SYNTAX score (SS) (OR=1.11), Leiden-risk score (OR=1.37), segment involvement score (OR=1.76), total plaque volume (OR=1.20), and percentage aggregated plaque volume (OR=1.32) were significant predictors for MACE (all P≤0.05). Moreover, the difference of the corrected coronary opacification (ΔCCO) correlated significantly with the occurrence of MACE (P<0.0001). The CAD-Reporting and Data System score, SS, and Leiden-risk score showed substantial sensitivity for predicting MACE (90.9%). The SS and Leiden-risk score displayed high specificities of 80.8% and 77.5%, respectively. These plaque markers and risk scores all provided high negative predictive value (>90%). CONCLUSION: The coronary computed tomography angiography-derived plaque markers of segment involvement score, total plaque volume, percentage aggregated plaque volume, and ΔCCO, and the risk scores exhibited predictive value for the occurrence of MACE and can likely aid in identifying patients at risk for future cardiac events.

Comparison of Machine Learning Computed Tomography-Based Fractional Flow Reserve and Coronary CT Angiography-Derived Plaque Characteristics with Invasive Resting Full-Cycle Ratio.

BACKGROUND: The aim is to compare the machine learning-based coronary-computed tomography fractional flow reserve (CT-FFRML) and coronary-computed tomographic morphological plaque characteristics with the resting full-cycle ratio (RFRTM) as a novel invasive resting pressure-wire index for detecting hemodynamically significant coronary artery stenosis. METHODS: In our single center study, patients with coronary artery disease (CAD) who had a clinically indicated coronary computed tomography angiography (cCTA) and subsequent invasive coronary angiography (ICA) with pressure wire-measurement were included. On-site prototype CT-FFRML software and on-site CT-plaque software were used to calculate the hemodynamic relevance of coronary stenosis. RESULTS: We enrolled 33 patients (70% male, mean age 68 ± 12 years). On a per-lesion basis, the area under the receiver operating characteristic curve (AUC) of CT-FFRML (0.90) was higher than the AUCs of the morphological plaque characteristics length/minimal luminal diameter4 (LL/MLD4; 0.80), minimal luminal diameter (MLD; 0.77), remodeling index (RI; 0.76), degree of luminal diameter stenosis (0.75), and minimal luminal area (MLA; 0.75). CONCLUSION: CT-FFRML and morphological plaque characteristics show a significant correlation to detected hemodynamically significant coronary stenosis. Whole CT-FFRML had the best discriminatory power, using RFRTM as the reference standard.

Additional Value of Machine-Learning Computed Tomographic Angiography-Based Fractional Flow Reserve Compared to Standard Computed Tomographic Angiography.

Background: Machine-learning-based computed-tomography-derived fractional flow reserve (CT-FFRML) obtains a hemodynamic index in coronary arteries. We examined whether it could reduce the number of invasive coronary angiographies (ICA) showing no obstructive lesions. We further compared CT-FFRML-derived measurements to clinical and CT-derived scores. Methods: We retrospectively selected 88 patients (63 ± 11years, 74% male) with chronic coronary syndrome (CCS) who underwent clinically indicated coronary computed tomography angiography (cCTA) and ICA. cCTA image data were processed with an on-site prototype CT-FFRML software. Results: CT-FFRML revealed an index of >0.80 in coronary vessels of 48 (55%) patients. This finding was corroborated in 45 (94%) patients by ICA, yet three (6%) received revascularization. In patients with an index ≤ 0.80, three (8%) of 40 were identified as false positive. A total of 48 (55%) patients could have been retained from ICA. CT-FFRML (AUC = 0.96, p ≤ 0.0001) demonstrated a higher diagnostic accuracy compared to the pretest probability or CT-derived scores and showed an excellent sensitivity (93%), specificity (94%), positive predictive value (PPV; 93%) and negative predictive value (NPV; 94%). Conclusion: CT-FFRML could be beneficial for clinical practice, as it may identify patients with CAD without hemodynamical significant stenosis, and may thus reduce the rate of ICA without necessity for coronary intervention.

Characterization of circulating thrombin in patients with septic shock: a prospective observational study.

Septic shock is characterized by a dysregulated response to infection, hypotension and activation of the coagulation system. Markers of coagulation activation are commonly used to diagnose and monitor ensuing coagulopathies. In this study, we sought to determine levels of circulating thrombin in patients with septic shock. To characterize levels of circulating, active thrombin in patients with septic shock. 48 patients with septic shock were included in this prospective, observational study. Blood samples were obtained on admission, day 1, day 3 and day 6. Levels of active thrombin were measured using a standardized, clinically applicable oligonucleotide (aptamer)-based enzyme-capture assay (OECA). Thrombin levels were correlated with established indirect thrombin parameters, conventional coagulation tests, laboratory parameters, patient characteristics and outcome. Elevated levels of thrombin were detected in 27 patients (56.3%) during the course of the study. Thrombin levels were positively correlated with thrombin-antithrombin complexes (r = 0.30, p < 0.05) and negatively associated with FVII levels (r = - 0.28, p < 0.05). Thrombin levels on admission did not predict 30-day mortality (OR 0.82, 95% CI 0.23-2.92, p = 0.77). Circulating levels of active thrombin can be measured in a subset of patients with septic shock. Although thrombin levels are correlated with established markers of coagulation, they do not provide additional prognostic information.

Coronary CT angiography derived plaque markers correlated with invasive instantaneous flow reserve for detecting hemodynamically significant coronary stenoses.

PURPOSE: The study aimed to compare morphological and anatomic plaque markers derived from coronary computed tomography angiography (cCTA) for the detection of lesion specific ischemia with invasive instantaneous wave free ratio (iFR®) as the reference standard. METHODS: In our prospective study, we enrolled patients with suspected coronary artery disease (CAD), who had undergone cCTA, using a low-dose third-generation dual-source CT and invasive coronary angiography (ICA) with iFR® measurement. Various plaque markers were assessed on cCTA. Discriminatory power of these markers for the detection of ischemia-inducing coronary artery disease was evaluated against invasive iFR®. RESULTS: Our study cohort included 39 patients (66.6 ± 12.0 years, 72 % male). Among 54 vessel-specific lesions, 15 lesions (28 %) were characterized as hemodynamically significant by iFR® ≤0.89. The area under the curve (AUC) of lesion length/ minimal luminal diameter4 (LL/MLD4) (0.84) was greater than the AUC of minimal luminal area (MLA) (0.82), MLD (0.81), the degree of luminal diameter stenosis (0.81), corrected coronary opacification (CCO) (0.79), remodeling index (RI) (0.75), and percentage aggregate plaque volume (%APV) (0.72). LL, vessel volume (VV), total plaque volume (TPV), calcified and non-calcified plaque volume (CPV and NCPV) did not reach statistical significance and were unable to discriminate between vessels with and without ischemia-inducing coronary stenosis. CONCLUSION: LL/MLD4, MLA, MLD, the degree of luminal diameter stenosis, CCO, RI, and %APV derived from cCTA can support the detection of hemodynamically significant coronary stenosis as compared with iFR®, with LL/MLD4 showing the greatest discriminatory power.

Correlation of machine learning computed tomography-based fractional flow reserve with instantaneous wave free ratio to detect hemodynamically significant coronary stenosis.

BACKGROUND: Fractional flow reserve based on coronary CT angiography (CT-FFR) is gaining importance for non-invasive hemodynamic assessment of coronary artery disease (CAD). We evaluated the on-site CT-FFR with a machine learning algorithm (CT-FFRML) for the detection of hemodynamically significant coronary artery stenosis in comparison to the invasive reference standard of instantaneous wave free ratio (iFR®). METHODS: This study evaluated patients with CAD who had a clinically indicated coronary computed tomography angiography (cCTA) and underwent invasive coronary angiography (ICA) with iFR®-measurements. Standard cCTA studies were acquired with third-generation dual-source computed tomography and analyzed with on-site prototype CT-FFRML software. RESULTS: We enrolled 40 patients (73% males, mean age 67 ± 12 years) who had iFR®-measurement and CT-FFRML calculation. The mean calculation time of CT-FFRML values was 11 ± 2 min. The CT-FFRML algorithm showed, on per-patient and per-lesion level, respectively, a sensitivity of 92% (95% CI 64-99%) and 87% (95% CI 59-98%), a specificity of 96% (95% CI 81-99%) and 95% (95% CI 84-99%), a positive predictive value of 92% (95% CI 64-99%), and 87% (95% CI 59-98%), and a negative predictive value of 96% (95% CI 81-99%) and 95% (95% CI 84-99%). The area under the receiver operating characteristic curve for CT-FFRML on per-lesion level was 0.97 (95% CI 0.91-1.00). Per lesion, the Pearson's correlation between the CT-FFRML and iFR® showed a strong correlation of r = 0.82 (p < 0.0001; 95% CI 0.715-0.920). CONCLUSION: On-site CT-FFRML correlated well with the invasive reference standard of iFR® and allowed for the non-invasive detection of hemodynamically significant coronary stenosis.

One-year clinical outcome of angiography, fractional flow reserve and instantaneous wave-free ratio guided percutaneous coronary intervention: A PRISMA-compliant meta-analysis.

The present study aimed to compare the clinical outcome of patients with coronary artery disease (CAD) who underwent a revascularization using conventional coronary angiography or a physiologically guided revascularization with Fractional Flow Reserve (FFR). Furthermore, outcomes in FFR guided percutaneous coronary intervention (PCI) and instantaneous wave-free ratio (iFR) guided PCI were compared. The analysis was performed for reported outcomes at a 1-year follow-up. After searching PubMed, EMBASE, and Web of Science for suitable publications, a total of 15,880 subjects were included. Comparing angiography guided and FFR guided PCI showed no significant difference in major adverse cardiac events [odds ratio (OR), 0.78; 95% confidence interval (CI), 0.59-1.04; P=0.09; I2=73%], death from any cause (OR, 0.74; 95% CI, 0.46-1.18; P=0.20; I2=74%), myocardial infarction (OR, 0.93; 95% CI, 0.81-1.07; P=0.31; I2=0%) or unplanned revascularization (OR, 0.71; 95% CI, 0.41-1.23; P=0.22; I2=79%). In addition, no significant difference could be found between iFR and FFR guided PCI for major adverse cardiac events (OR, 0.97; 95% CI; 0.76-1.23; P=0.81; I2=0%), death from any cause (OR, 0.66; 95% CI, 0.40-1.11; P=0.12; I2=0%), myocardial infarction (OR, 0.83; 95% CI, 0.56-1.24; P=0.37) or unplanned revascularization (OR, 1.16; 95% CI, 0.85-1.58; P=0.34; I2=16%). Overall, there was a tendency towards better outcomes of FFR in all four clinical endpoints compared with angiography guiding of PCI, and furthermore iFR showed no significant inferiority when compared to FFR in said clinical endpoints. When conducting a network meta-analysis, the results confirmed a non-inferiority of iFR compared to angiography guided revascularization.

Comparison of peri and post-procedural complications in patients undergoing revascularisation of coronary artery multivessel disease by coronary artery bypass grafting or protected percutaneous coronary intervention with the Impella 2.5 device.

BACKGROUND: While coronary artery bypass grafting remains the standard treatment of complex multivessel coronary artery disease, the advent of peripheral ventricular assist devices has enhanced the safety of percutaneous coronary intervention. We therefore evaluated the safety in terms of inhospital outcome comparing protected high-risk percutaneous coronary intervention with the Impella 2.5 device and coronary artery bypass grafting in patients with complex multivessel coronary artery disease. METHODS: This retrospective study included patients with complex multivessel coronary artery disease (SYNTAX score >22) undergoing either coronary artery bypass grafting before the implementation of a protected percutaneous coronary intervention programme with a peripheral ventricular assist device or protected percutaneous coronary intervention with the Impella 2.5 device following the start of the programme. The primary endpoint consisted of inhospital major adverse cardiac and cerebrovascular events. The combined secondary endpoint included peri and post-procedural adverse events. RESULTS: A total of 54 patients (mean age 70.1±9.9 years, 92.6% men) were enrolled in the study with a mean SYNTAX score of 34.5±9.8. Twenty-six (48.1%) patients underwent protected percutaneous coronary intervention while 28 (51.9%) patients received coronary artery bypass grafting. The major adverse cardiac and cerebrovascular event rate was numerically higher in the coronary artery bypass grafting group (17.9 vs. 7.7%; P=0.43) but was not statistically significant. The combined secondary endpoint was not different between the groups; however, patients undergoing coronary artery bypass grafting experienced significantly more peri-procedural adverse events (28.6 vs. 3.8%; P<0.05). CONCLUSION: Patients with complex multivessel coronary artery disease undergoing protected percutaneous coronary intervention with the Impella 2.5 device experience similar intrahospital major adverse cardiac and cerebrovascular event rates when compared to coronary artery bypass grafting. Protected percutaneous coronary intervention represents a safe alternative to coronary artery bypass grafting in terms of inhospital adverse events.

Association of Serum Lipid Profile With Coronary Computed Tomographic Angiography-derived Morphologic and Functional Quantitative Plaque Markers.

PURPOSE: Recent advances in image quality of coronary computed tomographic angiography (cCTA) have enabled improved characterization of coronary plaques. Thus, we investigated the association between quantitative morphological plaque markers obtained by cCTA and serum lipid levels in patients with suspected or known coronary artery disease. MATERIALS AND METHODS: We retrospectively analyzed data of 119 statin-naive patients (55±14 y, 66% men) who underwent clinically indicated cCTA between January 2013 and February 2017. Patients were subdivided into a plaque and a no-plaque group. Quantitative and morphologic plaque markers, such as segment involvement score, segment stenosis score, remodeling index, napkin-ring sign, total plaque volume, calcified plaque volume, and noncalcified plaque volume (NCPV) and plaque composition, were analyzed using a semiautomated plaque software prototype. Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein, low-density lipoprotein/high-density lipoprotein ratio, and triglycerides were determine in both groups. RESULTS: Higher age (61±11 y vs. 52±14 y, P<0.0001) and a higher likelihood of male gender (77% vs. 56%, P<0.0001) were observed in the plaque group. Differences in lipid levels were neither observed for differentiation between plaque presence or absence, nor after subcategorization for plaque composition. LDL serum levels >160 mg/dL correlated with higher NCPV compared with patients with LDL between 100 and 160 mg/dL (112 vs. 27 mm, P=0.037). Other markers were comparable between the different groups. CONCLUSION: Statin-naive patients with known or suspected coronary artery disease did not show differences in lipid levels related to plaque composition by cCTA. Patients with plaques tended to be men and were significantly older. High LDL levels correlated with high NCPV.

Unprotected versus protected high-risk percutaneous coronary intervention with the Impella 2.5 in patients with multivessel disease and severely reduced left ventricular function.

Selecting a revascularization strategy in patients with multivessel disease (MVD) and severely reduced left ventricular ejection fraction (LVEF) remains a challenge. PCI with Impella 2.5 may facilitate high-risk PCI, however long-term results comparing unprotected versus protected PCI are currently unknown. We sought to evaluate the outcome of patients undergoing protected compared to unprotected percutaneous coronary intervention (PCI) in the setting of MVD and severely reduced LVEF.We included patients with MVD and severely reduced LVEF (≤35%) in this retrospective, single-centre study. Patients that underwent unprotected PCI before the start of a dedicated protected PCI program with Impella 2.5 were compared to patients that were treated with protected PCI after the start of the program. The primary endpoint was defined as major adverse cardiac and cerebrovascular events (MACCE) during a 1-year follow-up. The secondary endpoints consisted of in-hospital MACCE and adverse events.A total of 61 patients (mean age 70.7 ±â€Š10.9 years, 83.6% male) were included in our study, of which 28 (45.9%) underwent protected PCI. The primary endpoint was reached by 26.7% and did not differ between groups (P = .90). In-hospital MACCE (P = 1.00) and in-hospital adverse events (P = .12) also demonstrated no significant differences. Multivariate logistic regression identified procedural success defined as complete revascularization and absence of in-hospital major clinical complications as protective parameter for MACCE (OR 0.17, 95% CI 0.04-0.70, P = .02).Patients with MVD and severely depressed LVEF undergoing protected PCI with Impella 2.5 demonstrate similar in-hospital and one-year outcomes compared to unprotected PCI.