Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

BACKGROUND: Coronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries. OBJECTIVE: The aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia. METHODS: We will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis. RESULTS: In this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022. CONCLUSIONS: This study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of PCI in this limited-income region. TRIAL REGISTRATION: Clinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/24595.

[Clinical characteristics, management and prognostic evolution of patients admitted within six hours of symptom onset with st-segment elevation acute myocardial infarction complicated by cardiogenic shock : twenty year monocentric study]. / Évolution des caractéristiques cliniques, de la prise en charge et du pronostic des patients admis en choc cardiogénique au cours des six premières heures d'un infarctus du myocarde. Vingt ans d'expérience monocentrique.

BACKGROUND: Cardiogenic shock is one of the most serious complications of the acute myocardial infarction. Advances in interventional cardiology and early reperfusion strategy improved its management. AIM: Analysis of the clinical characteristics, management and prognostic evolution of patients admitted within 6 hours onset with ST-segment elevation acute myocardial infarction complicated by cardiogenic shock. METHODS: Follow-up study based on 2200 consecutive patients admitted with STEMI within 6 hours of symptom onset from 1988 to 2008. Among them 114 matched the criteria of cardiogenic shock. These were divided in two groups, according to the period: group 1 (N=57, among the first 1100 STEMI from 1988 to 1998) and group 2 (N=57, among the following 1100 STEMI from 1999 to 2008). RESULTS: This trial shows a similar rate of cardiogenic shock in STEMI (5%) in both 1100 patients groups. There is no overall change in patient's clinical characteristics, but improvements in earlier management, prehospital fibrinolysis and ventricular fibrillation treatment have been detected. Primary percutaneous coronary intervention was the most common revascularisation strategy. The proportion of patients achieving acute TIMI-3 flow in the infarct related artery increased (61% vs 80%, p= 0.11) but the mortality was still high (74% vs 63%, p= 0.22). CONCLUSION: The clinical characteristics of cardiogenic shock remain unchanged; its management is more successful with more often early reperfusion. The decline of mortality is unfortunately not significant. More aggressive treatment should probably be considered to improve outcomes.

Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: incidence and impact on outcome.

AIMS: Vascular complications remain the main limitation of transfemoral aortic valve implantation. Based on a single-centre experience, we aim to detail the type, management and impact of those vascular complications. METHODS AND RESULTS: From October 2006 to January 2009, 54 transfemoral aortic valve implantations were performed using the Edwards SAPIEN prosthesis. Nine patients (16.7%) developed vascular complications. Five patients (9.3%) had ruptures which necessitated a surgical bypass. Four patients (7.4%) had dissection necessitating repair using stenting in all four patients and associated bypass in two of them. Vascular complications led to death in one patient (1.9%), reintervention in one (1.9%), and transfusions in seven (13%). Five vascular complications occurred in the first 20 patients (25%), and only four in the last 34 (12%). CONCLUSIONS: Vascular complications of transfemoral aortic valve implantation are frequent and seem to be influenced by experience. They are associated with a high need for transfusion and could lead to major events such as death or reintervention. These findings highlight the importance of a multidisciplinary approach for patient selection and management of the procedure.