Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369

Tissue factor pathway inhibitor, natural coagulation inhibitors and hemostatic activation markets in patients with acute coronary syndromes

Departments of Cardiology (Al-Nozha, Arafah, Al-Harthi), Physiology (Abdel-Gader), Endocrinology (Al-Maatouq), College of Medicine, King Khalid University HospitalThis study aims at characterizing the hemostatic changes, in a large cohort of Saudi Arab patients with acute coronary syndromes. Methods: We consecutively enrolled 389 patients (unstable angina [UA]: n=181; myocardial infarction [MI]: n=208) in this study at King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia in the period from April 2000 to November 2001. We collected blood samples before coronary angiography. Controls (n=101) were healthy males and females. All hemostatic assays were undertaken using enzyme linked immunosorbent assay based techniques and commercial kits. Results: The mean plasma levels of both bound and free tissue factor pathway inhibitors (TFPI) were significantly higher and to comparable levels, in patients with MI and UA, than in healthy control levels. Markers of thrombin generation: the mean levels of prothrombin fraction 1+2, thrombin antithrombin complexes, and D-Dimer were very significantly elevated in the 2 patients groups than in controls. Proteins C and antithrombin III showed statistically significant reduction especially in patients with MI. Plasminogen activator inhibitor levels were significantly elevated in the 2 patient groups, but were higher in MI patients. The mean levels of fibrinogen and D-Dimer as well thrombin antithrombin complex were higher and the levels of free tissue factor pathway inhibitor were lower in patients with 3-vessel coronary artery disease than those with single and double vessel disease. Conclusion: The results of this study confirm the existence, and to a similar extent, of a hypercoagulable state in Saudi patients with MI than UA and in those with 3-vessel coronary artery disease than those with one or 2-vessel disease

Smoking in Saudi Arabia and its relation to coronary artery disease

AbstractObjectivesThe health hazards related to smoking are well known. Smoking is a recognized risk factor for coronary artery disease (CAD). Despite rejection of smoking by the Saudi community, we are still seeing smokers in our population. This study is designed to determine the prevalence of smoking in the Kingdom of Saudi Arabia (KSA), and to find out its relation to CAD. This study is part of the Coronary Artery Disease In Saudis (CADIS) study.MethodsThis health survey was conducted by collecting data regarding smoking status among adult Saudis aged between 30 and 70 years of both sexes in KSA over a five year period from 1995 up to 2000. The study sample was of normal distribution and representative of all regions of KSA. The data were analyzed to provide the prevalence of smoking and its relation with CAD.ResultsThe total number of subjects was 17,350, and current smokers were 2217; accordingly the overall prevalence of smoking among Saudis was 12.8%. Males (1555) were significantly smoking more than females (662) with a prevalence of 18.7% and 7.3%, respectively (P<0.0001). Smoking is more prevalent among Saudis living in urban, northern, western, and eastern regions compared to other regions of KSA. Smokers are more likely to develop CAD compared to non-smokers (P<0.0001).ConclusionsSmoking is a prevalent health problem among Saudis that requires intervention for eradication. We found clear association between cigarettes smoking and CAD particularly among males. Persistent education of the health hazards related to smoking is recommended particularly at early age in-order to prevent initiation of smoking