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Information about several papers discussed at the 2016 U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel Meeting held on March 16, 2016 is presented. Topics include presentations on AngelMed for Early Recognition and Treatment of STEMI (ALERTS) trial, early trial termination, and Bayesian framework. The meeting featured speakers from the FDA.

Introduction: Transcatheter aortic valve replacement (TAVR) is now standard of care for patients with symptomatic severe aortic stenosis who are extreme, high or intermediate risk for surgical aortic valve replacement (SAVR). However, safety and effectiveness of TAVR in low risk patients remains untested. Hypothesis: To test the safety and effectiveness of TAVR in low risk patients. Methods: The Low Risk TAVR (LRT) trial was the first FDA-approved Investigational Device Exemption (IDE) trial to enroll in the United States (US). This investigator-led trial was a prospective, multicenter, unblinded, non-randomized, feasibility study at 11 centers in the US. Subjects determined to be low risk by the enrolling center multidisciplinary Heart Team and by an independent Case Review Committee underwent TAVR using a commercially available balloon-expandable or self-expandable TAVR device. All imaging studies were analyzed by an independent Core Lab and endpoints were adjudicated by an independent Clinical Events Committee using Valve Academic Research Consortium (VARC 2) definitions. Results: A total of 200 subjects with symptomatic severe aortic stenosis were enrolled. Interim short-term results have been reported previously. Mean age was 74.6±5.7 years, and mean Society of Thoracic Surgeons (STS) score was 1.9±0.5%. There was no mortality or disabling stroke at 30 days. The permanent pacemaker implantation rate was 4.8% at 30 days. No patients had ≥moderate paravalvular leak at 30 days. We will present 6-month and 1-year clinical outcomes and echocardiographic findings at the American Heart Association 2018 Scientific Sessions. Conclusions: LRT was the first FDA-approved prospective multicenter clinical trial of TAVR in low risk patients in the US. Interim short-term results demonstrated excellent safety and effectiveness at 30-days. We will present the 6-month and 1-year clinical outcomes and echocardiographic findings at the American Heart Association 2018 Scientific Sessions. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 51-year-old man with ST segment elevation myocardial infarction. The man collapsed in an Internet cafe while eating and received bystander cardiopulmonary resuscitation. A foreign body, later confirmed to be a dental bridge, was retrieved during a cardiothoracic surgery done on the patient. The collapse was said to be caused by primary respiratory arrest leading to hypoxia-induced ST segment elevation and ventricular fibrillation.

Introduction: Cardiovascular disease is the leading cause of death in men and women, blacks and whites. Women are underrepresented in clinical studies. African-American women have a higher coronary heart disease mortality risk than their white counterparts. However, there exists limited outcomes data for black women (BW) compared to white women (WW) after percutaneous coronary intervention (PCI). Hypothesis: The aim of this retrospective analysis was to evaluate the 1 year major cardiovascular events (MACE) in patients undergoing PCI based on gender and race Methods: Within our PCI database we identified 4776 patients who underwent PCI from 2003 to 2016. Of those 1,916 were BW and 2,860 were WW. MACE/target vessel revascularization (TVR) at 30 days and 1 year were assessed and proportional Cox hazard model analyses was performed to assess outcomes after adjustment for confounding factors (i.e. age, BMI, presentation with acute M, diabetes, smoking, history of CAD, family history of CAD, hyperlipidemia, hypertension, prior coronary intervention, chronic kidney disease (CKD)). Results: Characteristics of the patient population is shown in the table. BW presented at younger age and had significantly higher rate of risk factors. BW were significantly sicker than WW. Periprocedural and in-hospital were similar between the 2 groups except for vascular complications more likely in WW (4.3% vs 2.6%; p=0.003). At 30 days and 1 year, the rate of MI, TVR and stent thrombosis (ST) was significantly higher in BW (Figure). There was a large difference in median income, $102,250 for WW vs. $80,150 for BW, but it had no effect on the outcome (HR = 1.00, p = 0.362). After adjusting for confounding factors BW were 1.6 times more likely to experience MI at 1 year than WW (HR 1.6, 05%CI 1.04-2.49, p= 0.03). Conclusions: In this large cohort of women with coronary artery disease undergoing PCI we observed significant race disparities in MI rate at 1 year even after adjustment for clinical presentation and cardiovascular risk factors [ABSTRACT FROM AUTHOR]

Introduction: It is estimated that in the United States, each year, >780,000 persons will experience an acute coronary syndrome (ACS). Approximately 70% of these will have non ST elevation-myocardial infarction (NSTEMI). Optimal timing of angiography in NSTEMI is matter of debate. Hypothesis: The aim of this retrospective analysis was to evaluate the 1 year major cardiovascular events (MACE) in patients presenting with NSTEMI and undergoing percutaneous intervention (PCI) Methods: Within our PCI database we identified 1550 patients who underwent PCI for NSTEMI. We then divided the population into 3 groups based on door to balloon time (D2BT) (group 1= D2BT<90 min; group 2 = D2BT >90 min <24h; group 3 = D2BT >24 h). Primary outcome was MACE/target vessel revascularization (TVR) (composite of MI, death and TVR) at 1 year Results: Characteristics of the patient population is reported in the table. Patients with D2BT<90 min were more likely to present with cardiogenic shock and had higher baseline and peak troponin level, indicating a significant bias related to the operator choice. In-hospital, 6 months and 1 year outcomes are reported in the figure. Overall the group with D2BT>90 min and <24h had better outcomes. Conclusions: In this large cohort of patients presenting with NSTEMI, patients undergoing PCI between 90 min to 24 h from presentation had better 1 year outcomes. However, treatment selection bias makes causal inference concerning rapid revascularization and outcome unreliable. Randomized clinical trials are warranted to assess outcome of rapid revascularization in patients presenting with NSTEMI [ABSTRACT FROM AUTHOR]