EARLY TAVR trial Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis NCT03042104 The article examines a trial on transcatheter aortic-valve replacement (TAVR) for patients with asymptomatic severe aortic stenosis (AS). Typically, clinical guidelines recommend monitoring asymptomatic patients with severe AS rather than intervening early. However, the EARLY TAVR trial, a multicenter, randomized study involving 901 patients across the United States and Canada, aimed to determine if early TAVR could benefit patients by lowering risks of death, stroke, or hospitalization compared to standard clinical surveillance. Methods Patients aged 65 or older with severe AS but no symptoms were randomized to receive either early TAVR with a balloon-expandable valve or clinical surveillance. The trial’s primary composite endpoint included all-cause death, stroke, and unplanned cardiovascular hospitalization, with the intention-to-treat analysis applied. Results The findings demonstrated a significant advantage for early TAVR: • Primary Outcome: The early TAVR group had a 26.8% incidence of primary endpoint events (death, stroke, hospitalization) versus 45.3% in the surveillance group. • Specific Events: TAVR recipients saw lower rates of stroke (4.2% vs. 6.7%) and unplanned cardiovascular hospitalizations (20.9% vs. 41.7%) than those under surveillance. • Procedure-Related Adverse Events: No significant difference in procedure-related adverse events was observed between the two groups. The median follow-up period of 3.8 years highlighted that 87% of patients initially assigned to clinical surveillance eventually required aortic-valve replacement. Secondary Endpoints Secondary outcomes also favored TAVR: • Quality of Life (Kansas City Cardiomyopathy Questionnaire Score): 86.6% of TAVR patients maintained a score of ≥75 at two years, compared to 68% in the surveillance group. • Cardiac Health Indicators: Integrated cardiac health measures (e.g., left ventricular and left atrial function) were better preserved in the TAVR group at two years. Conclusions The trial results indicate that early TAVR is superior to clinical surveillance for asymptomatic severe AS patients, significantly reducing serious adverse outcomes and improving cardiac health indicators. This suggests that for some patients, early intervention may be beneficial and could lead to a re-evaluation of current AS management guidelines. Limitations of the study 1. Lack of Blinding: The study was open-label, meaning both patients and clinicians were aware of treatment allocations. This could introduce bias, especially in subjective assessments of outcomes like quality of life (Kansas City Cardiomyopathy Questionnaire scores) and decisions to convert patients in the surveillance group to TAVR. 2. Limited Generalizability: • Low Surgical Risk Patients: The trial primarily included low-risk patients, as defined by a Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of around 1.8%. These findings may not apply to higher-risk groups or younger patients who might have different long-term risks from valve replacement. • Specific Valve Type: Only balloon-expandable valves (SAPIEN 3 or SAPIEN 3 Ultra) were used, so results may not generalize to other valve types used in TAVR. • Demographic Homogeneity: The trial’s predominantly White patient population may limit the applicability of results to racially or ethnically diverse populations, where outcomes could differ due to variability in disease progression or response to TAVR. 3. Follow-Up Duration: Although the median follow-up was nearly four years, the study does not fully address long-term outcomes of TAVR in asymptomatic patients, particularly the durability of the valve over decades, which is a critical consideration given the non-progressive nature of symptoms in this cohort. 4. Risk of Over-Treatment in Surveillance Group: Given that nearly 87% of the surveillance group eventually underwent aortic-valve replacement, it’s possible that the trial’s design encouraged early crossover to intervention, perhaps due to a lower threshold for elective TAVR. This may not reflect real-world practice, where intervention is often deferred until symptom onset or disease progression. 5. Bias Due to Adverse Events Reporting: The adjudication of primary endpoints (death, stroke, unplanned cardiovascular hospitalization) was unblinded, potentially affecting the objectivity in reporting events. Awareness of treatment assignment could have influenced decisions to hospitalize or report events, impacting outcome measures. 6. Pandemic Influence: The COVID-19 pandemic overlapped with part of the trial, potentially affecting follow-up care, patient health, and TAVR decision-making. For instance, changes in healthcare delivery and patient behavior during the pandemic could impact generalizability. 7. Absence of Quality-of-Life Adjustment in Surveillance Group: While TAVR patients had planned procedures and postoperative recovery plans, the surveillance group’s conversions were more variable. Delays in transitioning symptomatic patients to TAVR could affect outcomes like quality of life and cardiac health, skewing comparisons between groups. Anyhow this is a big step forward in the improvement of prognosis of patients with Asymptomatic Severe Aortic Stenosis. Article at: nejm.org/doi/full/10.1056/NE…

Results from the individual patient data Collaborative Meta-Analysis of Cardiac CT (COME-CCT) The study titled “The effectiveness of coronary computed tomography angiography and functional testing for the diagnosis of obstructive coronary artery disease: results from the individual patient data Collaborative Meta-Analysis of Cardiac CT (COME-CCT)” by Schlattmann et al. aims to evaluate the effectiveness of coronary computed tomography angiography (CTA) compared to functional stress testing methods (exercise electrocardiography (ECG) and single-photon emission computed tomography (SPECT)) in diagnosing obstructive CAD. Key Findings: 1.Sample and Methodology: 2920 symptomatic stable chest pain pts from the Collaborative Meta-Analysis of Cardiac CT consortium. Patients underwent CTA, exercise-ECG, or SPECT, with invasive coronary angiography (ICA) as the reference standard. The study employed generalized linear mixed models to calculate the diagnostic accuracy of these non-invasive tests. 2.Diagnostic Accuracy: •CTA demonstrated superior diagnostic performance, with a sensitivity of 94.6% and specificity of 76.3%. •Exercise-ECG had a much lower sensitivity (54.9%) and specificity (60.9%). •SPECT also performed lower than CTA, with a sensitivity of 72.9% and specificity of 44.9%. 3.Positive Predictive Value (PPV): •CTA had a PPV ≥ 50% in patients with a clinical pretest probability of 10% or more. •For exercise-ECG, a PPV ≥ 50% was achieved only at pretest probabilities of 40% or more. •SPECT showed a PPV ≥ 50% at pretest probabilities of 28% or more. 4.Negative Predictive Value (NPV): •CTA reliably excluded obstructive CAD with an NPV of less than 15% in pts with a pretest probability up to 74%. This indicates that CTA is particularly useful for ruling out CAD in patients with intermediate pretest probability. •For exercise-ECG and SPECT, this exclusion was effective only at much lower pretest probabilities (7% and 11%, respectively). 5.Conclusion: •CTA is more effective than functional testing (exercise-ECG and SPECT) in diagnosing and reliably excluding obstructive CAD, particularly in pts with intermediate pretest probability. •Given the superior diagnostic accuracy and its ability to exclude obstructive CAD, CTA should be more widely used in clinical practice for diagnosing CAD in symptomatic pts. 6.Recommendations: •The study advocates for the broader adoption of CTA as a diagnostic tool for obstructive CAD, especially for pts with intermediate pretest probability, and highlights its potential to improve clinical decision-making compared to functional testing. Conclusions - CTA outperforms traditional stress testing for diagnosing obstructive coronary artery disease. - findings are consistent across multiple centers and patient populations, supporting the wider use of CTA in clinical guidelines. PDF open access at: insightsimaging.springeropen… #PCCT #photoncounting #QuantumHD #CT #computedtomography #yesCCT #coronaryarterydisease #ischemia #naeotomalpha

2024 ESC Guidelines for the management of chronic coronary syndromes A focused analysis on the role of Cardiac CT. In the 2024 ESC Guidelines for the management of chronic coronary syndromes (CCS), Coronary Computed Tomography Angiography (CCTA) is emphasized as a pivotal diagnostic and prognostic tool, reflecting a significant shift in contemporary clinical practice. The role of CCTA has expanded substantially, while the use of other functional imaging modalities has become more selective and complementary rather than central. Below is a detailed breakdown of the key points surrounding CCTA’s role and the reduced reliance on functional imaging modalities. 1. CCTA as the First-Line Diagnostic Tool • First-Line Recommendation: CCTA is now recommended as the preferred initial test for patients with a low to moderate pre-test likelihood (5–50%) of obstructive coronary artery disease (CAD). This recommendation underscores a major shift from traditional reliance on functional tests like stress echocardiography or myocardial perfusion imaging (MPI) as the first diagnostic step. • Diagnostic Accuracy: CCTA offers high-resolution, non-invasive imaging of the coronary arteries, providing an unparalleled view of both obstructive and non-obstructive atherosclerosis. Its ability to detect even subclinical plaques makes it an essential tool for both diagnosis and risk stratification . Compared to functional imaging tests, CCTA is more effective in identifying patients without significant CAD, helping to avoid unnecessary invasive procedures like coronary angiography . • Efficiency and Safety: The non-invasive nature of CCTA, combined with its widespread availability and reduced need for ionizing radiation compared to earlier CT technologies, makes it a safer, more accessible option for a broader range of patients. Its ability to quickly rule out significant coronary disease in patients with chest pain symptoms reduces the need for more invasive and costly procedures . 2. Prognostic Value of CCTA • Plaque Characterization: One of CCTA’s significant advantages over traditional functional tests is its ability to detect and characterize high-risk plaque features. These include positive remodeling, low-attenuation plaques, and napkin-ring signs, all of which are associated with an increased risk of major adverse cardiovascular events (MACE). This ability to visualize plaque characteristics helps clinicians identify patients who are at higher risk for future cardiac events, even when stenosis is not severe . • Long-Term Risk Stratification: CCTA’s comprehensive imaging capabilities allow for a detailed assessment of the total atherosclerotic burden, making it valuable for long-term risk stratification. Patients with non-obstructive plaques or diffuse atherosclerosis, identified through CCTA, are still at considerable risk of adverse outcomes. CCTA’s role in uncovering this hidden risk is particularly important in guiding preventive strategies, even in patients with minimal or no symptoms . 3. Diminishing Role of Functional Imaging Modalities • Functional Testing Relegated to Secondary Use: While functional imaging modalities like stress echocardiography, single-photon emission computed tomography (SPECT), and cardiac magnetic resonance imaging (CMR) remain useful, their role is now more secondary and specific. The guidelines recommend functional imaging primarily for patients with a moderate to high pre-test likelihood (15–85%) of obstructive CAD or when additional functional information is needed following anatomical assessment by CCTA . • Less Emphasis on Stress Testing as First-Line: The broad use of CCTA as a primary diagnostic tool has led to a decline in the reliance on stress testing for the initial evaluation of coronary artery disease. Functional imaging tests are now more commonly used to complement anatomical findings rather than as standalone diagnostic modalities . • Invasive Functional Testing Now Secondary: Invasive coronary angiography (ICA), traditionally the gold standard for diagnosing obstructive CAD, has now become more of a secondary option, often guided by CCTA findings. Techniques such as fractional flow reserve (FFR) are now employed after CCTA reveals intermediate stenoses, allowing for more targeted and efficient use of invasive tests . This approach reduces the number of unnecessary catheterizations, improving patient safety and healthcare efficiency. 4. Use of CCTA in Non-Obstructive CAD • Ruling Out CAD: CCTA plays a critical role in ruling out obstructive CAD, particularly in patients with low to moderate likelihoods of significant coronary disease. It offers a reliable and non-invasive method to determine whether further functional or invasive tests are necessary . • Non-Obstructive Disease and Diffuse Atherosclerosis: One of the strengths of CCTA is its ability to detect diffuse atherosclerosis and non-obstructive coronary disease. Unlike functional imaging, which primarily identifies ischemia, CCTA provides direct visualization of the atherosclerotic plaques themselves, allowing for a more comprehensive understanding of a patient’s coronary health . • Intermediate Stenosis and FFR-CT: For patients with intermediate stenoses detected by CCTA, fractional flow reserve computed tomography (FFR-CT) can be used to assess the functional significance of these lesions. This non-invasive alternative to invasive FFR allows for the assessment of hemodynamic impact without the need for a catheterization lab, offering a more patient-friendly option . 5. Integration of CCTA and Risk Stratification Tools • CACS Integration: CCTA is often performed alongside coronary artery calcium scoring (CACS), especially in asymptomatic individuals or those with equivocal symptoms. CACS helps stratify patients by providing a measure of atherosclerotic burden, which can further guide the intensity of preventive therapy . • Risk Stratification and MACE Prediction: CCTA’s role in detecting both obstructive and non-obstructive CAD, combined with its ability to evaluate high-risk plaque features, makes it a powerful tool for predicting major adverse cardiovascular events (MACE). This predictive capability is especially important for long-term management, where early intervention could prevent the progression of disease . 6. Functional Imaging as a Complement to CCTA • Functional Imaging for Higher Risk Patients: Functional tests like stress echocardiography, SPECT, and CMR still hold value, particularly in patients with moderate to high pre-test likelihood of CAD, or in those where CCTA results are inconclusive. These tests can provide additional insights into myocardial perfusion and ischemia, particularly when more detailed functional information is needed . • Complementary Role of FFR-CT: FFR-CT complements CCTA by providing a non-invasive evaluation of coronary artery physiology. This approach is particularly valuable for assessing intermediate stenoses and helping clinicians decide whether revascularization is necessary . 7. Revascularization Decisions Guided by CCTA • Guiding PCI and CABG: In cases where revascularization is being considered, CCTA helps identify the severity and location of stenosis, guiding the decision between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). For borderline cases, functional tests such as FFR may still play a role in determining the need for and type of revascularization . Conclusion The 2024 ESC Guidelines reflect a significant shift toward CCTA as the cornerstone of diagnostic and prognostic evaluation in patients with chronic coronary syndromes. CCTA’s ability to provide comprehensive anatomical and prognostic information makes it a critical first-line tool, reducing the role of traditional functional imaging tests in many scenarios. Functional modalities, while still valuable, are now more likely to be used as complementary tools rather than primary diagnostic methods. This shift toward CCTA not only improves diagnostic accuracy but also streamlines patient management, offering safer, more efficient pathways to guide clinical decision-making. PDF open access at: doi.org/10.1093/eurheartj/eh… #CardiacCT #CoronaryImaging #ESC2024 #HeartHealth #CoronarySyndromes #CTAngiography #MedicalGuidelines #CCTA #HeartDisease #CardiacCare #CardiacRisk #NonInvasiveImaging #PlaqueDetection #CoronaryArteryDisease #CardiacDiagnostics PCCT is changing the game, the field, the language, the priorities and in the end it will change the entire infrastructure of diagnostic medicine. Stay tuned and follow updates on the fine tuning and applications of Advanced Imaging within the "Expert Network of DECT, DSCT/Photon Counting CT and Advanced Imaging". #PCCT #photoncounting #QuantumHD #CT #computedtomography #yesCCT #coronaryarterydisease #ischemia #naeotomalpha