Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaboration.

INTRODUCTION: The purpose of this study is to assess the ability of two new ECG markers (Regional Repolarisation Instability Index (R2I2) and Peak Electrical Restitution Slope) to predict sudden cardiac death (SCD) or ventricular arrhythmia (VA) events in patients with ischaemic cardiomyopathy undergoing implantation of an implantable cardioverter defibrillator for primary prevention indication. METHODS AND ANALYSIS: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction is a prospective, open label, single blinded, multicentre observational study to establish the efficacy of two ECG biomarkers in predicting VA risk. 440 participants with ischaemic cardiomyopathy undergoing routine first time implantable cardioverter-defibrillator (ICD) implantation for primary prevention indication are currently being recruited. An electrophysiological (EP) study is performed using a non-invasive programmed electrical stimulation protocol via the implanted device. All participants will undergo the EP study hence no randomisation is required. Participants will be followed up over a minimum of 18 months and up to 3 years. The first patient was recruited in August 2016 and the study will be completed at the final participant follow-up visit. The primary endpoint is ventricular fibrillation or sustained ventricular tachycardia >200 beats/min as recorded by the ICD. The secondary endpoint is SCD. Analysis of the ECG data obtained during the EP study will be performed by the core lab where blinding of patient health status and endpoints will be maintained. ETHICS AND DISSEMINATION: Ethical approval has been granted by Research Ethics Committees Northern Ireland (reference no. 16/NI/0069). The results will inform the design of a definitive Randomised Controlled Trial (RCT). Dissemination will include peer reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries. TRIAL REGISTRATION NUMBER: NCT03022487.

Unexpected early complication of implantable-cardioverter defibrillator.

A 41-year-old woman was visiting Oxford, where she had a sudden cardiac arrest. Cardiopulmonary resuscitation was started by a bystander until the paramedics arrived, who found her in ventricular fibrillation, and delivered three shocks. After 28 min she had return of spontaneous circulation. Emergency coronary angiography revealed normal coronary arteries. Echocardiography followed by a cardiac MRI showed non-dilated left ventricles with no evidence of late gadolinium enhancement. She had a single-chamber implantable-cardioverter defibrillator (ICD). A chest CT showed sternal fracture and subsegmental pulmonary embolism, for which she was anticoagulated and was discharged.Several days later, the patient presented to another hospital with atypical chest pain and dizziness. She had haemodynamic instability and echocardiography showed the ICD lead perforating through the right ventricle, with a large pericardial effusion and tamponade, for which pericardiocentesis was done. Afterwards, the patient had repositioning of the ICD lead safely.

Complex cardiac pacing in the setting of a district general hospital: procedural success and complications.

BACKGROUND AND PURPOSE: Complex cardiac pacing with either an implantable cardiovertor defibrillator (ICD) or a biventricular pacemaker with pacing only (CRT-P) or biventricular pacemaker with implantable cardiovertor defibrillator (CRT-D) plays an important role in the management of patients with heart failure. However, device implantation is associated with rare but significant complications which may limit the number of centres offering this treatment. The aim of this study is to define procedural success and complication rates associated with implantation of complex implantable cardiac devices in a district general hospital. METHODS AND SUBJECTS: The pacing records of all the patients who underwent complex cardiac pacing (ICD, CRT-P and CRT-D) between January 2010 and December 2011 were reviewed. Information on clinical characteristics, pacing indications, venous access, implantation data, lead stability at follow-up, and procedure-related complications were obtained. RESULTS: A total of 151 devices (60 CRT-Ds, 55 CRT-Ps and 36 ICDs), were implanted between January 2010 and December 2011 with a median follow-up of 12 months. Overall transvenous procedural success rate was 99.3%. 14 (9.3%) out of the 151 patients suffered a complication. There were no procedure-related deaths, and lead displacement (5.3%) was the most common complication. Other complications included pocket haematoma and phrenic nerve stimulation (1.3% and 3.4%, respectively). There were no cases of pneumothorax, cardiac tamponade, device-related infection, symptomatic venous thrombosis and stroke. Lead thresholds, in particular that of the left ventricular lead, remained stable during the follow-up period indicating persistent delivery of cardiac resynchronisation therapy in the group receiving CRT systems. CONCLUSIONS: In the presence of necessary clinical expertise, complex cardiac devices can be implanted successfully and with a high degree of safety in the setting of a district general hospital.

Cardiovascular risks of COX inhibition: current perspectives.

BACKGROUND: NSAIDs are among the most commonly used pharmacotherapeutic agents worldwide. As the long-term use of these drugs is associated with serious gastrointestinal side effects, a new subgroup of COX-2 selective NSAIDs was developed. It was thought that the therapeutic strategy underlying the development of these newer compounds would enable them to provide the same analgesic and anti-inflammatory benefits as those of their traditional counterparts but perhaps offer a much safer gastrointestinal profile. Much scientific data has accumulated over the last few years, however, raising concerns regarding the increased cardiovascular complications associated with the use of COX-2 selective NSAIDs, and perhaps of the traditional NSAIDs as well. OBJECTIVE: To review current and emerging evidence related to the cardiovascular effects of COX inhibitors and examine the clinical implications. METHOD: We studied data from basic clinical research, non-randomized analyses, and randomized trials of COX inhibitors that investigated their cardiovascular effects. CONCLUSION: Both COX-2 selective and traditional NSAIDs are associated with a moderately increased risk of cardiovascular events.

Early management of ST elevation myocardial infarction: a review of practice.

The last two decades of the 20th century witnessed continuous evolution in the understanding of the pathophysiology of ST elevation myocardial infarction. In parallel, the management of these patients developed steadily throughout this time and into the early years of the 21st century. From humble beginnings involving oxygen therapy, bed rest and analgesia, the relative merits of different strategies to open 'infarct-related arteries' (IRAs) are now being debated: pharmacological reperfusion, mechanical reperfusion or a combination of both these modalities. The current understanding of the process of thrombotic occlusion of the coronary artery has led to the appreciation of the importance of not simply opening the IRA, but also maintaining its patency once opened. Considerable attention is now being afforded to the significant minority of patients who do not achieve early, complete myocardial reperfusion, despite restoration of adequate flow down the epicardial IRA. Those patients who fail to achieve myocardial reperfusion, either due to late presentation or failure of reperfusion therapy, and are left with permanent myocardial scarring can now be considered. This article critically appraises the recent and emerging evidence and clinical implications of the contemporary management of ST elevation myocardial infarction.