Impact of coronary artery disease on clinical outcomes after TAVR: Insights from the BRAVO-3 randomized trial.

OBJECTIVE: To determine the prognostic impact of coronary artery disease (CAD) in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND: CAD is a common comorbidity among patients undergoing TAVR and studies provide conflicting data on its prognostic impact. METHODS: The Bivalirudin on Aortic Valve Intervention Outcomes-3 (BRAVO-3) randomized trial compared the use of bivalirudin versus UFH in 802 high-surgical risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence or absence of history of CAD as well as periprocedural anticoagulation. The coprimary endpoints were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding) and major Bleeding Academic Research Consortium (BARC) bleeding ≥3b at 30 days postprocedure. RESULTS: Among 801 patients, 437 (54.6%) had history of CAD of whom 223 (51.0%) received bivalirudin. There were no significant differences in NACE (adjusted odds ratio [OR]: 1.04; 95% confidence interval [CI]: 0.69-1.58) or BARC ≥ 3b bleeding (adjusted OR: 0.84; 95% CI: 0.51-1.39) in patients with vs without CAD at 30 days. Among CAD patients, periprocedural use of bivalirudin was associated with similar NACE (OR: 0.80; 95% CI: 0.47-1.35) and BARC ≥ 3b bleeding (OR: 0.64; 95% CI: 0.33-1.25) compared with UFH, irrespective of history of CAD (p-interaction = 0.959 for NACE; p-interaction = 0.479 for major bleeding). CONCLUSION: CAD was not associated with a higher short-term risk of NACE or major bleeding after TAVR. Periprocedural anticoagulation with bivalirudin did not show any advantage over UFH in patients with and without CAD.

Performance of the academic research consortium high-bleeding risk criteria in patients undergoing PCI for acute myocardial infarction.

Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) are at increased risk for thrombotic and bleeding complications compared to patients with chronic coronary syndrome (CCS). The academic research consortium (ARC) recently suggested a set of criteria to identify patients at high bleeding risk (HBR). We sought to evaluate the performance of the ARC-HBR criteria among patients undergoing PCI according to clinical presentation. We included all consecutive patients undergoing PCI at a tertiary-care center. Patients were deemed at HBR if they fulfilled ≥ 1 major or ≥ 2 minor ARC-HBR criteria. The primary bleeding endpoint was a composite of in-hospital or post-discharge bleeding at 1-year follow-up. Secondary outcomes included all-cause death and myocardial infarction. Out of 6068 patients, 1391 (22.9 %) presented with AMI and were more often at HBR than those with CCS (46.9 % vs. 43.0 %, p = 0.01). HBR patients had a higher risk for the primary bleeding endpoint than non-HBR, irrespective of the clinical indication for PCI (AMI: 19.5 % vs. 5.5 %; HR 3.86, 95 % CI 2.63-5.69; CCS: 6.8 % vs. 2.6 %; HR 2.65, 95 % CI 1.92-3.68; p-interaction = 0.11). Secondary outcomes followed a similar trend. After multivariable adjustment, AMI presentation remained significantly associated with increased risk for bleeding at 1 year (HR 1.64, 95 % CI 1.13-2.38, p = 0.01). The ARC-HBR criterion associated with the highest bleeding risk was severe/end-stage chronic kidney disease in AMI and moderate/severe anemia in CCS. The ARC-HBR framework successfully identified AMI and CCS patients with increased risk for bleeding complications at 1 year post-PCI. Figure prepared with BioRender.

Impact of anemia on short-term outcomes after TAVR: A subgroup analysis from the BRAVO-3 randomized trial.

OBJECTIVES: To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND: Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown. METHODS: The BRAVO-3 trial compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels <13 g/dl in men and <12 g/dl in women) or absence of anemia. The primary outcomes were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or bleeding) and major bleeding (Bleeding Academic Research Consortium ≥3b) at 30 days. RESULTS: Among 798 patients with available baseline hemoglobin levels, 427 (54%) were anemic of whom 221 (52%) received bivalirudin. There were no significant differences in NACE and major bleeding at 30 days between patients with and without anemia, irrespective of the type of anticoagulant used (pinteraction  = 0.71 for NACE, pinteraction  = 1.0 for major bleeding). However, anemic patients had a higher risk of major vascular complications (adjusted OR 2.43, 95% CI 1.42-4.16, p = 0.001), and acute kidney injury (adjusted OR 1.74, 95% CI 1.16-2.59, p = 0.007) compared to non-anemic patients at 30 days. CONCLUSIONS: Anemia was not associated with a higher risk of NACE or major bleeding at 30 days after TAVR without modification of the treatment effects of periprocedural anticoagulation with bivalirudin versus UFH.

Impact of target vessel choice on outcomes following percutaneous coronary intervention in patients with a prior coronary artery bypass graft.

OBJECTIVES: To evaluate and compare characteristics and clinical outcomes of percutaneous coronary intervention (PCI) among target vessel types in patients with a prior coronary artery bypass graft (CABG) surgery. BACKGROUND: Patients with a prior CABG often require repeat revascularization with PCI. Graft PCI has been associated with worse outcomes compared to native vessel PCI, yet the optimal PCI strategy in prior CABG patients remains unknown. METHODS: We stratified prior CABG patients who underwent PCI at a tertiary-care center between 2009 and 2017 by target vessel type: native vessel, venous graft, and arterial graft. The primary outcome of major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, stent thrombosis, or target vessel revascularization up to 1 year post-PCI. RESULTS: Prior CABG patients (n = 3983) represented 19.5% of all PCI interventions during the study period. PCI was most frequently performed on native vessels (n = 2928, 73.5%) followed by venous (n = 883, 22.2%) and arterial grafts (n = 172, 4.3%). Procedural success and complications were similar among the groups; however, slow- and no-reflow phenomenon was more common in venous graft PCI compared to native vessel PCI (OR 4.78; 95% CI 2.56-8.95; p < 0.001). At 1 year, there were no significant differences in MACE or in its individual components. CONCLUSIONS: Target vessel choice did not appear to affect MACE at 1 year in a large cohort of patients with prior CABG undergoing PCI. Whether PCI of surgical grafts versus native arteries truly results in similar outcomes warrants further investigation in randomized controlled trials.

In-Hospital Outcomes in Patients With Non-ST Segment Elevation Myocardial Infarction and Concomitant Neurodevelopmental Disorders in the United States: Insights From the National Inpatient Sample 2011-2020.

Patients with neurodevelopmental disorders (NDDs) encounter significant barriers to receiving quality health care, particularly for acute conditions such as non-ST segment elevation myocardial infarction (NSTEMI). This study addresses the critical gap in knowledge regarding in-hospital outcomes and the use of invasive therapies in this demographic. By analyzing data from the National Inpatient Sample database from 2011 to 2020 using the International Classification of Diseases, Ninth Edition (ICD-9) and Tenth Edition (ICD-10) codes, we identified patients with NSTEMI, both with and without NDDs, and compared baseline characteristics, in-hospital outcomes, and the application of invasive treatments. The analysis involved a weighted sample of 7,482,216 NSTEMI hospitalizations, of which 30,168 (0.40%) patients had NDDs. There were significantly higher comorbidity-adjusted odds of in-hospital mortality, cardiac arrest, endotracheal intubation, infectious complications, ventricular arrhythmias, and restraint use among the NDD cohort. Conversely, this group exhibited lower adjusted odds of undergoing left heart catheterization, percutaneous coronary intervention, or coronary artery bypass graft surgery. These findings underscore the disparities faced by patients with NDDs in accessing invasive cardiac interventions, highlighting the need for further research to address these barriers and improve care quality for this vulnerable population.

SGLT-2 inhibitors and cardiovascular outcomes in patients with and without a history of heart failure: a systematic review and meta-analysis.

AIMS: Sodium-glucose cotransporter 2 (SGLT-2) inhibitors have cardiovascular (CV) benefits in patients with heart failure with reduced ejection fraction (HFrEF). Whether these medications improve CV outcomes irrespective of heart failure history or left ventricular ejection fraction (LVEF) in HFrEF remains unknown. METHODS AND RESULTS: All randomized, placebo-controlled trials of SGLT-2 inhibitors reporting similar CV outcomes were searched in PubMed from 1 January 2010 to 1 October 2021. The primary outcome was the composite of hospitalization for heart failure or CV death. Secondary outcomes included all-cause mortality. Pooled hazard ratios (HRs) and 95% confidence intervals (CIs) were used as effect estimates and calculated with a random-effects model. Data from 11 trials and a total of 66 957 patients (n = 36 758 SGLT-2 group, n = 30 199 placebo group) were included. SGLT-2 inhibitors reduced the risk of hospitalization for heart failure or CV death in patients with (HR 0.76, 95% CI 0.71-0.80) and without (HR 0.76, 95% CI 0.68-0.86; Pinteraction = 0.69) heart failure. Patients with (HR 0.87, 95% CI 0.80-0.95) and without (HR 0.84, 95% CI 0.73-0.95; Pinteraction = 0.67) heart failure treated with SGLT-2 inhibitors had a reduction in all-cause mortality. Reduction in the primary outcome was consistently observed in HFrEF patients with (HR 0.68, 95% CI 0.59-0.78) and without (HR 0.84, 95% CI 0.71-0.99; Pinteraction = 0.13) severely reduced LVEF, and in heart failure with preserved ejection fraction patients (HR 0.80, 95% CI 0.70-0.92; Pinteraction = 0.65). CONCLUSION: SGLT-2 inhibitors improved CV outcomes irrespective of heart failure history or type, and severity of LVEF reduction.

Prognostic Value of Baseline Inflammation in Diabetic and Nondiabetic Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: There is a paucity of data on the prognostic value of high-sensitivity C-reactive protein (hsCRP) levels in diabetic and nondiabetic patients undergoing percutaneous coronary intervention (PCI). METHODS: All patients with known baseline hsCRP undergoing PCI at a single tertiary care centre from 2010 to 2017 were included. High hsCRP was defined as > 3 mg/L. Known causes of elevated hsCRP levels and hsCRP > 10 mg/L represented exclusion criteria. The 1-year primary outcome was major adverse cardiovascular events (MACE), including all-cause mortality, myocardial infarction (MI), and target-vessel revascularisation (TVR). RESULTS: Among a total of 11,979 patients included, high hsCRP levels were observed in 24.7% of patients without diabetes and 29.8% of patients with diabetes (P < 0.001). Both diabetics and nondiabetics with high hsCRP levels had increased rates of MACE compared with their counterparts with low hsCRP (diabetics: adjusted hazard ratio [aHR] 1.58, 95% CI 1.27-1.96; nondiabetics: aHR 1.45, 95% CI 1.13-1.86; P interaction = 0.981) primarily driven by increased rates all-cause deaths (diabetics: aHR 2.32, 95% CI 1.42-3.80; nondiabetics: aHR 3.14, 95% CI 1.74-5.65; P interaction = 0.415). Although high hsCRP levels were associated with increased rates of TVR (aHR 1.35, 95% CI 1.04-1.75) and MI (aHR 1.86, 95% CI 1.18-2.93) only in patients with diabetes, no significant interactions were observed between inflammation and diabetes (P interaction = 0.749 and 0.602, respectively). CONCLUSIONS: Patients undergoing PCI with high levels of hsCRP, defined as > 3 mg/L, have worse ischemic outcomes regardless of diabetes status.

Current state-of-the-art antiplatelet and anticoagulation therapy in diabetic patients with coronary artery disease.

Diabetes mellitus is a complex disease that leads to long-term damage to various organ systems. Among the numerous cardiovascular disease-related complications, thrombotic events frequently occur in patients with diabetes. Although guidelines exist for treating and preventing most diabetes-related co-morbidities, the evidence on antithrombotic therapy in primary and secondary prevention is limited due to the scarcity of randomized trials dedicated to patients with diabetes mellitus. Most of the available data are derived from studies that only included a small proportion of patients with diabetes. The present review provides an overview of the status of knowledge on antiplatelet and anticoagulation therapy in patients with diabetes, focusing on the risk-benefit balance of these therapies and future treatment strategies.

Lay abstract Patients with diabetes are at increased risk for heart diseases. In fact, heart attacks often occur silently in diabetic patients. Other complications, such as acute decrease in brain or limb perfusion, are also common especially in high-risk diabetic patients. Over the last decade, several drugs for the treatment of diabetes and its associated complications have emerged. Among these therapies, antithrombotic drugs play a pivotal role in preventing these accidents. However, the evidence on antithrombotic drugs use in prevention is limited due to the scarcity of studies dedicated to patients with diabetes. In this review, we provide an aerial view of the latest evidence on the optimal use of antithrombotic drugs in patients with diabetes and heart disease.

Coronary Dissection and Right Heart Failure Salvaged by PCI With Percutaneous Intraluminal Microaxial RV-Assist Support.

Right heart failure is a dreaded sequelae of proximal right coronary artery occlusion that can complicate an angiogram or percutaneous coronary intervention. This case illustrates the use of a percutaneous intraluminal microaxial right ventricular assist device for high-risk percutaneous coronary intervention of an ostial right coronary artery dissection in refractory right heart failure. (Level of Difficulty: Advanced.).

Characterization of Myocardial Injury in Patients With COVID-19.

BACKGROUND: Myocardial injury is frequent among patients hospitalized with coronavirus disease-2019 (COVID-19) and is associated with a poor prognosis. However, the mechanisms of myocardial injury remain unclear and prior studies have not reported cardiovascular imaging data. OBJECTIVES: This study sought to characterize the echocardiographic abnormalities associated with myocardial injury and their prognostic impact in patients with COVID-19. METHODS: We conducted an international, multicenter cohort study including 7 hospitals in New York City and Milan of hospitalized patients with laboratory-confirmed COVID-19 who had undergone transthoracic echocardiographic (TTE) and electrocardiographic evaluation during their index hospitalization. Myocardial injury was defined as any elevation in cardiac troponin at the time of clinical presentation or during the hospitalization. RESULTS: A total of 305 patients were included. Mean age was 63 years and 205 patients (67.2%) were male. Overall, myocardial injury was observed in 190 patients (62.3%). Compared with patients without myocardial injury, those with myocardial injury had more electrocardiographic abnormalities, higher inflammatory biomarkers and an increased prevalence of major echocardiographic abnormalities that included left ventricular wall motion abnormalities, global left ventricular dysfunction, left ventricular diastolic dysfunction grade II or III, right ventricular dysfunction and pericardial effusions. Rates of in-hospital mortality were 5.2%, 18.6%, and 31.7% in patients without myocardial injury, with myocardial injury without TTE abnormalities, and with myocardial injury and TTE abnormalities. Following multivariable adjustment, myocardial injury with TTE abnormalities was associated with higher risk of death but not myocardial injury without TTE abnormalities. CONCLUSIONS: Among patients with COVID-19 who underwent TTE, cardiac structural abnormalities were present in nearly two-thirds of patients with myocardial injury. Myocardial injury was associated with increased in-hospital mortality particularly if echocardiographic abnormalities were present.

Results of a Hepatitis C Virus Screening Program of the 1945-1965 Birth Cohort in a Large Emergency Department in New Jersey.

BACKGROUND: Persons born between 1945 and 1965 account for an estimated 81% of those infected with hepatitis C virus (HCV) in the United States. However, up to 60% remain undiagnosed. Prior studies have reported HCV screening results from large urban emergency departments. METHODS: This is a retrospective cohort study of patients in the 1945-1965 birth cohort tested for HCV in a large emergency department (ED) in New Jersey from June 1, 2016, through December 31, 2016. The purpose was to report HCV antibody and viral load results of this testing program located in a small urban/suburban area and to analyze specific characteristics associated with positive results, such as race/ethnicity and insurance status. Descriptive statistics were performed, and, using a multivariate logistic regression model, adjusted odds ratios and 95% confidence intervals were calculated. RESULTS: A total of 3046 patients were screened: 55.8% were white, and 17.9% were black; 52.1% had private insurance, 33.4% Medicare, 3.9% Medicaid. One hundred ninety-two were antibody positive (6.3%). Of 167 with HCV viral load testing results, 43% had a positive viral load. On multivariate analysis, black race and Medicaid were independently associated with a positive HCV viral load. CONCLUSIONS: HCV antibody seropositivity was above 6% and twice as high as the Centers for Disease Control and Prevention estimated prevalence in this birth cohort. These results indicate that EDs outside of large urban cities are also important sites for routine HCV screening. Other findings of interest include 43% with chronic HCV infection and the persistent association between black race and positive HCV viral load even when adjusted for insurance status.

Dois anos de pandemia da COVID-19: implicações para as salas de hemodinâmica e suas práticas atuais / Two years into the COVID-19 pandemic: implications for the cardiac catheterization laboratory and its current practices

A COVID-19 continua a sobrecarregar os sistemas de saúde. No auge da pandemia, os serviços de hemodinâmica do mundo todo tiveram redução significativa no volume de procedimentos devido a vários motivos, incluindo redistribuição de recursos médicos, alocação dos cardiologistas intervencionistas em alas da COVID-19 e preocupações dos médicos e pacientes com a transmissão viral. Em especial, as intervenções para doença cardíaca estrutural tiveram queda importante ­ de mais de 90% do volume. Para enfrentar esses desafios, os sistemas de saúde empregaram novas medidas de segurança e protocolos, incluindo pré-teste com reação em cadeia da polimerase para COVID-19, Equipamentos de Proteção Individuais e exigência de vacinação para garantir a segurança de pacientes e trabalhadores da saúde. Embora tais medidas tenham abordado parcialmente as questões de segurança, o diagnóstico e o tratamento da injúria miocárdica aguda permaneceram desafiadores durante a pandemia. Enquanto os mecanismos fisiopatológicos que causam injúria miocárdica não estão completamente elucidados, a maioria dos estudos sugere que a COVID-19 seja uma doença pró-inflamatória, associada a um estado de hipercoagulabilidade. Os estudos randomizados em andamento avaliam a eficácia de regimes antitrombóticos mais agressivos na COVID-19. Além disso, a apresentação de síndrome coronariana aguda junto da COVID-19 é variável, mais provavelmente atípica, tardia e está associada a altas taxas de eventos cardiovasculares adversos e óbito. É necessário implementar protocolos para agilizar diagnóstico, triagem e tratamento de pacientes com síndrome coronariana aguda, e também minimizar o risco de transmissão viral para os funcionários do hospital. A intervenção coronariana percutânea robótica oferece uma solução em potencial para as diversas questões de segurança enfrentadas pelos cardiologistas intervencionistas na era da COVID-19. Porém, ela também se apresenta com seu conjunto de limitações.

COVID-19 continues to overwhelm healthcare systems. During the peak of the pandemic, cardiac catheterization labs across the world observed a significant decrease in procedure volumes due to several reasons, including reallocation of medical resources, deployment of interventional cardiologists to the COVID-19 wards, and physician and patient concerns about viral transmission. In particular, structural heart disease interventions experienced a significant reduction in volume by more than 90%. To address these challenges, healthcare systems employed new safety measures and protocols, including COVID-19 rapid polymerase chain reaction pretesting, Personal Protective Equipment, and vaccination mandates to ensure safety of patients and healthcare workers. Although these measures partly addressed safety concerns, diagnosis and management of acute myocardial injury remained challenging throughout the pandemic. While the pathophysiological mechanisms leading to myocardial injury is not fully elucidated, most studies have suggested COVID-19 is a pro-inflammatory disease associated with a hypercoagulable state. Ongoing randomized studies are evaluating the efficacy of more aggressive antithrombic regimens in COVID-19. In addition, the presentation of acute coronary syndrome with concomitant COVID-19 infection is variable, more likely atypical, delayed, and is associated with higher rates of adverse cardiovascular events and death. It was necessary to implement protocols to expedite diagnosis, triage and management of patients with acute coronary syndrome, while minimizing the risk of viral transmission to hospital staff. Robotic percutaneous coronary intervention may offer in the future a potential solution to many of the safety concerns faced by interventional cardiologists during the COVID-19 era; however, it has its own set of limitations.