BACKGROUND: The Heart Team approach has become an integral part of modern cardiovascular medicine. To evaluate current opinions and real-world practice among lead extraction practitioners, an online survey was created and distributed among a pool of lead extraction specialists participating in the International Lead Extraction Expert Meeting (ILEEM) 2018. METHODS: The online survey consisted of 10 questions and was performed using an online survey tool (www.surveymonkey.com). The collector link was sent to 48 lead extraction experts via email. RESULTS: A total of 43 answers were collected (89% return rate) from lead extraction experts in 16 different countries. A great majority (83.7%) of the respondents performed more than 30 lead extraction procedures per year. The most common procedural environment in this survey was the hybrid operating room (67.4%). Most procedures were performed by electrophysiologists and cardiologists (80.9%). Important additional members of the current lead extraction teams were cardiac surgeons (79.1%), anesthesiologists (95.3%) and operating room scrub nurses (76.7%). An extended Heart Team is regarded beneficial for patient care by 86.0%, with potential further members being infectious diseases specialists, intensivists and radiologists. Team training activities are performed in 48.8% of participating centers. CONCLUSIONS: This survey supports the importance of establishing lead extraction Heart Teams in specialized lead extraction centers to potentially improve patient outcomes. The concept of a core and an extended Heart Team approach in lead extraction procedures is introduced.

• MeSH
• Cardiologists * MeSH
• Physicians * MeSH
• Humans MeSH
• Surveys and Questionnaires MeSH
• Patient Care Team MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH

AIMS: Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent. METHODS AND RESULTS: Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group. CONCLUSIONS: Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.

• MeSH
• Transplantation, Autologous MeSH
• Ventricular Function, Left * MeSH
• Myocardial Infarction * therapy   MeSH
• Bone Marrow MeSH
• Humans MeSH
• Stroke Volume MeSH
• Bone Marrow Transplantation MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Observational Study MeSH
• Research Support, Non-U.S. Gov't MeSH
• Randomized Controlled Trial MeSH

Over the past 13 years bone marrow-derived mononuclear cells (BM-MNCs) have been widely investigated for clinical efficacy in patients following acute myocardial infarction (AMI). These early phase II trials have used various surrogate markers to judge efficacy and, although promising, the results have been inconsistent. The phase III BAMI trial has therefore been designed to demonstrate that intracoronary infusion of BM-MNCs is safe and will significantly reduce the time to first occurrence of all-cause death in patients with reduced left ventricular ejection fraction after successful reperfusion for ST-elevation AMI (powered with the aim of detecting a 25% reduction in all-cause mortality). This is a multinational, multicentre, randomized, open-label, controlled, parallel-group phase III study aiming to enrol approximately 3000 patients in 11 European countries with at least 17 sites. Eligible patients who have impaired left ventricular ejection (≤45%) following successful reperfusion for AMI will be randomized to treatment or control group in a 1:1 ratio. The treatment group will receive intracoronary infusion of BM-MNCs 2-8 days after successful reperfusion for AMI added on top of optimal standard of care. The control group will receive optimal standard of care. The primary endpoint is time from randomization to all-cause death. The BAMI trial is pivotal and the largest trial to date of BM-MNCs in patients with impaired left ventricular function following AMI. The aim of the trial is to provide a definitive answer as to whether BM-MNCs reduce all-cause mortality in this group of patients.

• MeSH
• Echocardiography MeSH
• Ventricular Function, Left physiology   MeSH
• ST Elevation Myocardial Infarction diagnosis   mortality   therapy   MeSH
• Humans MeSH
• Survival Rate trends   MeSH
• Cause of Death trends   MeSH
• Bone Marrow Transplantation methods   MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase III MeSH
• Multicenter Study MeSH
• Research Support, Non-U.S. Gov't MeSH
• Randomized Controlled Trial MeSH
• Geographicals
• Europe epidemiology   MeSH

AIMS: Patient access to reperfusion therapy and the use of primary percutaneous coronary intervention (p-PCI) or thrombolysis (TL) varies considerably between European countries. The aim of this study was to obtain a realistic contemporary picture of how patients with ST elevation myocardial infarction (STEMI) are treated in different European countries. METHODS AND RESULTS: The chairpersons of the national working groups/societies of interventional cardiology in European countries and selected experts known to be involved in the national registries joined the writing group upon invitation. Data were collected about the country and any existing national STEMI or PCI registries, about STEMI epidemiology, and treatment in each given country and about PCI and p-PCI centres and procedures in each country. Results from the national and/or regional registries in 30 countries were included in this analysis. The annual incidence of hospital admission for any acute myocardial infarction (AMI) varied between 90-312/100 thousand/year, the incidence of STEMI alone ranging from 44 to 142. Primary PCI was the dominant reperfusion strategy in 16 countries and TL in 8 countries. The use of a p-PCI strategy varied between 5 and 92% (of all STEMI patients) and the use of TL between 0 and 55%. Any reperfusion treatment (p-PCI or TL) was used in 37-93% of STEMI patients. Significantly less reperfusion therapy was used in those countries where TL was the dominant strategy. The number of p-PCI procedures per million per year varied among countries between 20 and 970. The mean population served by a single p-PCI centre varied between 0.3 and 7.4 million inhabitants. In those countries offering p-PCI services to the majority of their STEMI patients, this population varied between 0.3 and 1.1 million per centre. In-hospital mortality of all consecutive STEMI patients varied between 4.2 and 13.5%, for patients treated by TL between 3.5 and 14% and for patients treated by p-PCI between 2.7 and 8%. The time reported from symptom onset to the first medical contact (FMC) varied between 60 and 210 min, FMC-needle time for TL between 30 and 110 min, and FMC-balloon time for p-PCI between 60 and 177 min. CONCLUSION: Most North, West, and Central European countries used p-PCI for the majority of their STEMI patients. The lack of organized p-PCI networks was associated with fewer patients overall receiving some form of reperfusion therapy.

• MeSH
• Angioplasty, Balloon, Coronary statistics & numerical data   MeSH
• Time Factors MeSH
• Residence Characteristics MeSH
• Health Services Accessibility MeSH
• Hospitalization statistics & numerical data   MeSH
• Incidence MeSH
• Myocardial Infarction epidemiology   therapy   MeSH
• Humans MeSH
• Hospital Mortality MeSH
• Needs Assessment MeSH
• Myocardial Reperfusion methods   statistics & numerical data   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Europe MeSH