TCT-545 Angiographic Features, Lesion, and Procedural Characteristics in Patients With Chronic Kidney Disease Undergoing Protected High-Risk Percutaneous Coronary Intervention

Background: Patients with chronic kidney disease (CKD) are at risk for accelerated atherosclerosis. There is a paucity of data regarding coronary lesion characteristics and procedural details of CKD patients, especially those on dialysis, undergoing high-risk percutaneous coronary intervention (HRPCI) with left ventricular support. Methods: We analyzed patients from the PROTECT III study who underwent Impella-supported HRPCI, stratified into 3 groups according to kidney function status based on history: 1) normal kidney function; 2) CKD not on dialysis; and 3) CKD on dialysis. Baseline characteristics, angiographic features, and procedural details were assessed. Results: The study population included 3,702 treated lesions in 1,223 patients with a mean age of 71 ± 11 years; 73% (893) were male, 68% (834) had normal kidney function (serum creatinine = 1 mg/dL [IQR: 0.9-1.2]), 23% (278) had CKD not on dialysis (serum creatinine = 1.6 mg/dL [IQR: 1.3-1.9]), and 9% (111) were on dialysis. Patients on dialysis were significantly younger and had more comorbidities, as well as a greater incidence of acute myocardial infarction as an indication for HRPCI compared with the other 2 groups (45.0 [dialysis] vs 30.1 [CKD not on dialysis] vs 36.0 [normal kidney function]; P = 0.03). There was no difference between groups in prevalence of 3-vessel disease (P = 0.63). Patients on dialysis had greater prevalence of severely calcified lesions and higher use of rotational and orbital atherectomy with greater number of passes (Table 1). Despite this, no significant differences were observed in post-PCI Thrombolysis In Myocardial Infarction flow, incidence of no-reflow, or dissection/perforation. Conclusion: In contrast to patients with normal kidney function, patients with CKD with or without dialysis treated with Impella had more comorbidities, higher prevalence of severely calcified lesions, and greater use of atherectomy with more passes. Despite the complexity of PCI, no significant differences in complications were observed. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-99 Short- and Long-Term Outcomes of Patients With Chronic Kidney Disease Undergoing Protected High-Risk Percutaneous Coronary Intervention

Background: Patients with chronic kidney disease (CKD) and concomitant multivessel coronary artery disease (CAD) with or without left ventricular dysfunction often have high surgical risk and are declined for coronary artery bypass grafting. There is little data regarding clinical outcomes in these patients undergoing high-risk PCI (HRPCI) using Impella. Methods: We analyzed patients from the PROTECT III Study who underwent Impella-supported HRPCI and stratified them into 3 groups by kidney function status based on history: 1) normal kidney function, 2) CKD without dialysis, and 3) CKD with dialysis. We compared the composite incidence of major adverse cardiac and cerebrovascular events (MACCE) rate, defined as all-cause death, myocardial infarction (MI), stroke/transient ischemic attack (TIA), and repeat revascularization at 30 and 90 days. Results: We included 1,223 patients, aged 71 ± 11 years; 73% (893) were men, 68% (834) had normal kidney function (serum creatinine [Cr] 1.1 mg/dL, IQR 0.9-1.2), 23% (278) had CKD without dialysis (Cr 1.7 mg/dL, IQR 1.3-1.9), and 9% (111) were on dialysis. Patients on dialysis were younger with more comorbidities such as diabetes, heart failure, anemia, PVD and prior stroke. HRPCI status (urgent or elective), proportion of acute MI, and mean SYNTAX scores were similar. No significant differences in MACCE were shown between groups at 30 days or 90 days (Table). Patients with normal kidney function had comparable risks of 30-day and 90-day MACCE compared with CKD patients without dialysis with Cox proportional hazards analysis, and lower risk of 90-day MACCE compared to CKD patients with dialysis. Notably, CKD patients with or without dialysis also had similar 90-day MACCE risk (Table). Conclusion: Patients with CKD and dialysis undergoing HRPCI exhibit higher risk for 90-day MACCE compared to patients with normal kidney function. CKD patients without dialysis also had higher risk of MI at 90 days. Further research is needed. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

Pathophysiology of Takotsubo syndrome - a joint scientific statement from the Heart Failure Association Takotsubo Syndrome Study Group and Myocardial Function Working Group of the European Society of Cardiology - Part 2: vascular pathophysiology, gender and sex hormones, genetics, chronic cardiovascular problems and clinical implications

While the first part of the scientific statement on the pathophysiology of Takotsubo syndrome was focused on catecholamines and the sympathetic nervous system, in the second part we focus on the vascular pathophysiology including coronary and systemic vascular responses, the role of the central and peripheral nervous systems during the acute phase and abnormalities in the subacute phase, the gender differences and integrated effects of sex hormones, genetics of Takotsubo syndrome including insights from microRNA studies and inducible pluripotent stem cell models of Takotsubo syndrome. We then discuss the chronic abnormalities of cardiovascular physiology in survivors, the limitations of current clinical and preclinical studies, the implications of the knowledge of pathophysiology for clinical management and future perspectives and directions of research

Pathophysiology of Takotsubo syndrome - a joint scientific statement from the Heart Failure Association Takotsubo Syndrome Study Group and Myocardial Function Working Group of the European Society of Cardiology - Part 1 : overview and the central role for catecholamines and sympathetic nervous system

Acknowledgements S.H. acknowledges the support from the Netherlands Cardiovascular Research Initiative, an initiative with support of the Dutch Heart Foundation, CVON2016-Early HFPEF, 2015-10, and CVON She-PREDICTS, grant 2017-21, CVON-Arena-PRIME, European Union Commission’s Seventh Framework programme under grant agreement n. 305507 (HOMAGE) and n. 602904 (FIBROTAR-GETS). D.D. acknowledges support from the British Heart Foundation grants PG/15/108/31928 and FS/16/39/32174, the Josephine Lansdell British Medical Association 2015Award and Tenovus Scotland, G13.10. A.R.L. is supported by the Leducq Foundation Cardio-Oncology Network. Conflict of interest: none declaredPeer reviewedPublisher PD

Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints.

Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options

Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints.

Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options

Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction: Rationale and Methodology

Background: Individual randomized controlled trials (RCTs) of periprocedural anticoagulation with bivalirudin versus heparin during percutaneous coronary intervention (PCI) have reported conflicting results. Study-level meta-analyses lack granularity to adjust for confounders, explore heterogeneity, or identify subgroups that may particularly benefit or be harmed. Objective: To overcome these limitations, we sought to develop an individual patient-data pooled database of RCTs comparing bivalirudin versus heparin. Methods: We conducted a systematic review to identify RCTs in which ≥1,000 patients with acute myocardial infarction (AMI) undergoing PCI were randomized to bivalirudin versus heparin. Results: From 738 identified studies, 8 RCTs met the prespecified criteria. The principal investigators of each study agreed to provide patient-level data. The data were pooled and checked for accuracy against trial publications, with discrepancies addressed by consulting with the trialists. Consensus-based definitions were created to resolve differing antithrombotic, procedural, and outcome definitions. The project required 3.5 years to complete, and the final database includes 27,409 patients (13,346 randomized to bivalirudin and 14,063 randomized to heparin). Conclusion: We have created a large individual patient database of bivalirudin versus heparin RCTs in patients with AMI undergoing PCI. This endeavor may help identify the optimal periprocedural anticoagulation regimen for patient groups with different relative risks of adverse ischemic versus bleeding events, including those with ST-segment and non-ST-segment elevation MI, radial versus femoral access, use of a prolonged bivalirudin infusion or glycoprotein inhibitors, and others. Adherence to standardized techniques and rigorous validation processes should increase confidence in the accuracy and robustness of the results