Background:The 30-day Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) has been used to risk-stratify patients undergoing transcatheter aortic valve replacement (TAVR). Whether surgical mortality risk predicts stroke and neurocognitive outcomes following TAVR is unknown. We evaluated the association between STS-PROM and clinical outcomes, including stroke, acute brain injury on diffusion-weighted magnetic resonance imaging (DW-MRI), and cognitive decline in patients undergoing TAVR. Methods:Patient-level data were pooled from 4 prospective trials: (1) DEFLECT III (N = 87), (2) NeuroTAVR (N = 44), (3) REFLECT I (N = 214), and (4) REFLECT II (N = 258). All studies included patients undergoing TAVR with a protocol-mandated predischarge DW-MRI and serial cognitive and neurologic assessments. All patients were evaluated by a board-certified neurologist at baseline, postprocedure, and 30 days. Clinical outcomes, including stroke, cognitive decline (Montreal Cognitive Assessment score), death, myocardial infarction, vascular, and bleeding complications were adjudicated by the same clinical events committee. Imaging analysis was performed by a single core laboratory using identical methods. The DW-MRI measures included total lesion number, individual lesion volume, and total lesion volume. Outcomes were compared between low (STS <4), intermediate (STS 4-8), and high (STS >8) risk groups. Results:In total, 537 of 603 patients with DW-MRI and complete STS assessment undergoing transfemoral TAVR were included in this pooled analysis, of which 253 (47%) were low risk, 198 (37%) intermediate risk, and 86 (16%) high risk patients. At 30 days, high risk patients had higher rates of all-cause and cardiovascular mortality, myocardial infarction, acute kidney injury, bleeding, and vascular complications. Rates of stroke, disabling stroke, DW-MRI measures of brain injury, and cognitive decline were similar across risk categories. Conclusions:This pooled analysis demonstrates that the STS score does not predict stroke, cognitive decline, or acute brain injury after TAVR.
Acute brain infarction detected by diffusion-weighted magnetic resonance imaging (DW-MRI) is common after transcatheter aortic valve replacement (TAVR), but its clinical relevance is uncertain. The authors investigated the relationship between DW-MRI total lesion number (TLN), individual lesion volume (ILV), and total lesion volume (TLV) and clinical stroke outcomes after TAVR. Patient-level data were pooled from 4 prospective TAVR embolic protection studies, with consistent predischarge DW-MRI acquisition and core laboratory analysis. C-statistic was used to determine the best DW-MRI measure associated with clinical stroke. A total of 495 of 603 patients undergoing TAVR completed the predischarge DW-MRI. At 30 days, the rate of clinical ischemic stroke was 6.9%. Acute ischemic brain injury was seen in 85% of patients with 5.5 ± 7.3 discrete lesions per patient, mean ILV of 78.2 ± 257.1 mm3, and mean TLV of 555 ± 1,039 mm3. The C-statistic was 0.84 for TLV, 0.81 for number of lesions, and 0.82 for maximum ILV in predicting ischemic stroke. On the basis of the TLV cutpoint as defined by receiver operating characteristic (ROC), patients with a TLV >500 mm3 (vs TLV ≤500 mm3) had more ischemic stroke (18.2% vs 2.3%; P < 0.0001), more disabling strokes (8.8% vs 0.9%; P < 0.0001), and less complete stroke recovery (44% vs 62.5%; P = 0.001) at 30 days. Our study confirms that the number, size, and total volume of acute brain infarction defined by DW-MRI are each associated with clinical ischemic strokes, disabling strokes, and worse stroke recovery in patients undergoing TAVR and may have value as surrogate outcomes in stroke prevention trials. (A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI [DEFLECT III]; NCT02070731) (A Study to Evaluate the Neuro-embolic Consequences of TAVR [NeuroTAVR]; NCT02073864) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT I]; NCT02536196) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT II]; NCT02536196)
Accurate measurement and interpretation of serum levels of troponin (Tn) is a central part of the clinical workup of a patient presenting with chest pain suspicious for acute coronary syndrome (ACS). Knowledge of the molecular characteristics of the troponin complex and test characteristics of troponin measurement assays allows for a deeper understanding of causes of false positive and false negative test results in myocardial injury. In this review, we discuss the molecular structure and functions of the constituent proteins of the troponin complex (TnT, TnC, and TnI); review the different isoforms of Tn and where they are from; survey the evolution of clinical Tn assays, ranging from first-generation to high-sensitivity (hs); provide a primer on statistical interpretation of assay results based on different clinical settings; and discuss potential causes of false results. We also summarize the advances in technologies that may lead to the development of future Tn assays, including the development of point of care assays and wearable Tn sensors for real-time continuous measurement.
BackgroundApproximately 30% to 50% of patients who are referred for diagnostic coronary angiography are found to have no obstructive coronary artery disease (CAD). Ischemia and nonobstructive coronary arteries (INOCA) is increasingly recognized and encompasses coronary microvascular dysfunction, vasospastic angina, symptomatic myocardial bridging, and other vasomotor disorders. However, the prevalence of these disorders and whether underlying atherosclerotic plaque burden and morphology affect the long-term outcomes of each physiologic phenotype is unknown.Trial DesignThe DISCOVER INOCA registry is ongoing at 8 centers in the United States and plans to enroll 500 patients with ischemic heart disease referred for angiography undergoing coronary function testing (CFT). All participants will complete patient-reported outcome measures and undergo protocol-guided angiography, acetylcholine provocation, coronary thermodilution, and intravascular imaging. Follow-up assessments occur at 30 days, 6 months, 1 year, and annually for 5 years. The primary short-term end point is the prevalence of INOCA phenotypes based on physiology and the degree of atherosclerosis based on intravascular ultrasound or optical coherence tomography (intravascular imaging). The primary long-term end point is the incidence of major adverse cardiovascular events, defined as a composite of cardiovascular death, myocardial infarction, hospitalization for cardiovascular causes, or coronary revascularization at a follow-up of 5 years. At the time of this publication, 100 participants have been enrolled.ConclusionsDISCOVER INOCA is the first prospective study of INOCA patients to integrate anatomic and physiologic measures of disease and correlate them with long-term outcomes. DISCOVER INOCA will report on the prevalence of INOCA phenotypes, the safety of comprehensive invasive CFT, and the impact of testing on diagnoses and medical therapy. Symptoms and cardiovascular adverse events at long-term follow-up will be determined in patients with no obstructive CAD undergoing angiography.
Background Acute brain infarction detected by diffusion-weighted magnetic resonance imaging (DW-MRI) is common after transcatheter aortic valve replacement (TAVR), but its clinical relevance is uncertain. Objectives The authors investigated the relationship between DW-MRI total lesion number (TLN), individual lesion volume (ILV), and total lesion volume (TLV) and clinical stroke outcomes after TAVR. Methods Patient-level data were pooled from 4 prospective TAVR embolic protection studies, with consistent predischarge DW-MRI acquisition and core laboratory analysis. C-statistic was used to determine the best DW-MRI measure associated with clinical stroke. Results A total of 495 of 603 patients undergoing TAVR completed the predischarge DW-MRI. At 30 days, the rate of clinical ischemic stroke was 6.9%. Acute ischemic brain injury was seen in 85% of patients with 5.5 ± 7.3 discrete lesions per patient, mean ILV of 78.2 ± 257.1 mm3, and mean TLV of 555 ± 1,039 mm3. The C-statistic was 0.84 for TLV, 0.81 for number of lesions, and 0.82 for maximum ILV in predicting ischemic stroke. On the basis of the TLV cutpoint as defined by receiver operating characteristic (ROC), patients with a TLV >500 mm3 (vs TLV ≤500 mm3) had more ischemic stroke (18.2% vs 2.3%; P < 0.0001), more disabling strokes (8.8% vs 0.9%; P < 0.0001), and less complete stroke recovery (44% vs 62.5%; P = 0.001) at 30 days. Conclusions Our study confirms that the number, size, and total volume of acute brain infarction defined by DW-MRI are each associated with clinical ischemic strokes, disabling strokes, and worse stroke recovery in patients undergoing TAVR and may have value as surrogate outcomes in stroke prevention trials. (A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI [DEFLECT III]; NCT02070731) (A Study to Evaluate the Neuro-embolic Consequences of TAVR [NeuroTAVR]; NCT02073864) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT I]; NCT02536196) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT II]; NCT02536196)
Neurocognitive dysfunction is common in heart failure (HF), with 30% to 80% of patients experiencing some degree of deficits in one or more cognitive domains, including memory, attention, learning ability, executive function, and psychomotor speed. Although the mechanism is not fully understood, reduced cardiac output, comorbidities, chronic cerebral hypoperfusion, and cardioembolic brain injury leading to cerebral hypoxia and brain damage seem to trigger the neurocognitive dysfunction in HF. Cognitive impairment is independently associated with worse outcomes including mortality, rehospitalization, and reduced quality of life. Patients with poorer cognitive function are at an increased risk of severe disease as they tend to have greater difficulty complying with treatment requirements. Coronary revascularization in patients with ischemic HF has the potential to improve cardiovascular outcomes but risks worsening neurocognitive dysfunction even further. Revascularization by coronary artery bypass grafting carries inherent risks for delirium, cognitive impairment, neurologic injury, and stroke, which are known to exacerbate the risk of neurocognitive dysfunction. Alternatively, percutaneous coronary intervention, as a less-invasive approach, has the potential to minimize the risk of cognitive impairment but has not yet been evaluated as an alternative to coronary artery bypass grafting in patients with ischemic HF. Therefore, it is paramount to raise awareness of the neurocognitive consequences in ischemic HF and devise strategies for recognition and prevention as an important target of patient management and personalized decision making that contributes to patient outcomes.
Purpose of Review Digital tools have emerged to assist clinicians in decision-making across the spectrum of coronary artery disease (CAD), from risk stratification to the assessment of acute coronary syndrome (ACS) and delivery of percutaneous coronary intervention (PCI) in the catheterization lab (CCL). However, despite the continued proliferation of novel digital aids, clinical uptake has been gradual and heterogenous. In this review, we aim to summarize tools available across 3 domains: the primary prevention of CAD, the triage and diagnosis of patients with ACS, and execution of PCI. Recent Findings Smartphone- and web-based digital aids can bring evidence-based risk estimation models to the point of care. Digital tools augment traditional methods by incorporating biomarkers, imaging data, and electrocardiographic patterns into automated risk stratification for ACS, and inform the planning and execution of PCI. Summary The development of digital tools for clinical decision-making is fundamentally changing the ways we prevent, diagnose, and treat CAD. These tools increasingly allow clinicians to synthesize multiple sources of data efficiently.
Transcatheter aortic valve replacement (TAVR) generates significant debris, and strategies to mitigate cerebral embolization are needed. The novel Emboliner embolic protection catheter (Emboline, Inc., Santa Cruz, California) is designed to capture all particles generated during TAVR. This first-in-human study sought to assess the safety and feasibility of the device and to characterize the distribution and histopathology of the debris generated during TAVR. The SafePass 2 study was a prospective, nonrandomized, multicenter, single-arm investigation of the Emboliner device. Primary end points included 30-day major adverse cardiac and cerebrovascular events (MACCE) and technical performance. Computed tomography angiography was analyzed by an independent core laboratory, and filters were sent for histopathology of captured debris. Predictors of particle number were identified using >150 p.m and >500 p.m size thresholds. Of 31 subjects enrolled, technical success was 100%, and 30-day MACCE was 6.5% (2 cerebrovascular accidents, with 1 attributed to subtherapeutic dosing of rivaroxaban along with atrial fibrillation and the other to possible previous small ischemic strokes on magnetic resonance imaging; neither MACCE event had a causal relation to the Emboliner). All filters contained debris, with a median of 191.0 particles >150 p.m and 14.0 particles >500 p.m. Histopathology revealed mostly acute thrombus and valve or arterial tissue with lesser amounts of calcified tissue. A history of atrial fibrillation predicted a greater number of particles >500 p.m (p = 0.0259) and its presence on admission was associated with 4.1 times more particles >150 p.m (p = 0.0130) and 8.1 times more particles >500 p.m (p = 0.0086). Self-expanding valves were associated with twice the number of particles >150 p.m (p = 0.0281). TASK score was positively correlated with number of particles >500 p.m (p = 0.0337). The Emboliner device was safe and feasible. Emboli after TAVR appear more numerous than previously documented. Atrial fibrillation, higher TASK score, and self-expanding valve use conferred higher embolic burden. Notably, none of the tested computed tomography angiography features were able to identify with higher embolic risk. Larger-scale studies are needed to identify high-risk patients for selective embolic protection device use. (c) 2023 Elsevier Inc. All rights reserved. (Am J Cardiol 2023;207:28-34)
Despite recent advances in drug-eluting stent (DES) technology, late adverse events remain concerns after percutaneous coronary intervention. The persistence of polymer material on DES has been suggested as a trigger for chronic inflammation. The Firehawk, a novel DES, has a unique design with recessed abluminal grooves, to which sirolimus and biodegradable polymer are applied. The Firehawk stent is designed to minimize polymer volume and antiproliferative drug concentration to reduce inflammation and hypersensitivity reactions. Several recent trials have reported the clinical outcomes of this device. This article provides a review of the current clinical evidence concerning the Firehawk stent.
Drug-eluting stents have become the mainstay of percutaneous coronary interventions, but late and very late stent thrombosis remain a concern. Drug-coated balloons (DCBs) have the advantage of preserving the antirestenotic benefits of drug-eluting stents while minimizing potential long-term safety