[Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory].

On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure.

Mortality in STEMI Patients With Cardiogenic Shock: Results From a Nationwide PCI Registry and Focus on Left Main PCI.

Background: The study aims to assess real-life short- and long-term outcomes of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) complicated with cardiogenic shock (CS). Outcome after left main (LM) PCI is of particular interest.

Methods: Procedural, 30-day, and >30-day mortality rates were assessed in 2744 CS-STEMI patients enrolled between 2012 and 2019 in a nationwide registry involving 49 centers.

Typical dynamic electrocardiographic changes in Takotsubo syndrome.

Aims: Negative T waves and QTc prolongation often occur in patients with Takotsubo syndrome. Description of typical electrocardiographic changes could be a diagnosis element of this syndrome. This study aimed to clarify on the one hand the more preciously possible the typical electrocardiographic changes, and on the other hand, the timing of occurrence of these abnormalities compared to the trigger occurrence, the symptoms onset and the hospital admission.

Practice and long-term outcome of unprotected left main PCI: real-world data from a nationwide registry.

Background: Percutaneous coronary intervention (PCI) is increasingly performed in significant left main (LM) lesions. Left untreated, the prognosis is poor, but PCI and coronary bypass surgery (CABG) behold risks as well. Additional long-term outcome data might guide future treatment decisions.

Early prognosis and predictor analysis for positive coronary angiography after out-of-hospital cardiac arrest (OHCA).

Background: Key predictors of survival after OHCA have been described in the literature. Current guidelines recommend emergency angiography in patients without an obvious extra-cardiac cause of arrest. However, the value of this strategy is debated.

Case report: osteogenesis imperfecta, internal mammary artery graft & nitinol clips.

Background: Osteogenesis imperfecta is a genetic disorder of connective tissue causing mostly left-sided heart valves and aortic root pathologies, but a coronary artery involvement reflecting an increased sensitivity to cardiovascular risk factors is also suspected in this patient population.

Case Presentation: We report a 38-year-old patient with an osteogenesis imperfecta and a typical presentation of an acute myocardial infarction. The coronary angiogram showed a coronary 3-vessel disease.

Quality assessment in percutaneous coronary interventions: the QERMID Belgian PCI registry.

Background: The recent increase in the number of interventional cathlabs that followed a moratorium of several years has resulted in an abrupt increase in the number of PCI and a dilution of the experience per centre and per operator.

Methods: Based on data extracted from the national "Quality Oriented Electronic Registration of Medical Implant Devices" (QERMID) database, we compared the characteristics and outcome of patients treated in 2015 in the 21 newly (<3 years) approved PCI centres with those of patients treated in the 28 historical PCI centres.

Results: The proportion of acute coronary syndromes was slightly higher in new than in historical centres (48% vs.

Double guide double wrist 5F left coronary artery transradial percutaneous coronary intervention and the X-Kiss technique.

Percutaneous coronary intervention for bifurcated anatomy, particularly at the proximal left coronary artery site, requires guide catheters (GC) of at least 6 french and preferably larger in diameter. We describe a new trans-radial approach more suitable for small artery size: the simultaneous use of both radial arteries for double cannulation of the LMCA with 5F GC: each GC will target either the LM/LAD or the LM/CX artery (or LM-LAD/LM-LAD-1st diagonal branch) stenoses. The technique successfully was applied to 5 cases.

Usefulness of a Gentle and Short Hemostasis Using the Transradial Band Device after Transradial Access for Percutaneous Coronary Angiography and Interventions to Reduce the Radial Artery Occlusion Rate (from the Prospective and Randomized CRASOC I, II, and III Studies).

The study sought to evaluate the benefit of the reduction in intensity and duration of the hemostasis obtained with the transradial (TR) Band compression device on the radial artery occlusion (RAO) rate. RAO is the most frequent complication of TR access for cardiac catheterization and limits future use of this safe route. Its occurrence must be minimized.

Belgium: coronary and structural heart interventions from 2010 to 2015.

In a ranking of the gross domestic product per capita in 2015, Belgium ranked 19th in the world according to the International Monetary Fun1d and the World Bank. It has a Human Development Index of 0.890, in which it is preceded by only 20 other countries in the world.

Bilateral Internal Thoracic Artery Configuration for Coronary Artery Bypass Surgery: A Prospective Randomized Trial.

Background: Bilateral internal thoracic arteries (BITA) have demonstrated superior patency and improved survival in patients undergoing coronary artery bypass grafting. However, the optimal configuration for BITA utilization and its effect on long-term outcome remains uncertain.

Methods And Results: We randomly assigned 304 patients undergoing coronary artery bypass grafting using BITA to either in situ or Y grafting configurations.

Impact of gender difference in hospital outcomes following percutaneous coronary intervention. Results of the Belgian Working Group on Interventional Cardiology (BWGIC) registry.

Aims: To determine whether there are gender-based differences in in-hospital outcomes among patients undergoing percutaneous coronary intervention (PCI).

Methods And Results: We studied a large cohort using clinical data from a registry of 130,985 PCI procedures in Belgium, from January 2006 to February 2011. Compared to males, females were significantly older (70.

Elevation of biomarkers and long-term outcome after percutaneous coronary intervention.

Background/objectives: The impact of an elevation of cardiac biomarkers occurring after percutaneous coronary intervention (PCI) on long-term outcome remains controversial. Most available data are based on observational registries using multivariable analysis. In this study, a case-control approach was used to assess separately the impact of post-PCI elevation of CK-MB on the short-term in-hospital outcome and on the long-term outcome after hospital discharge.

Chronic competitive flow from a patent arterial or venous graft to the circumflex system does not impair the long-term patency of internal thoracic artery to left anterior descending grafts in patients with isolated predivisional left main disease: long-term angiographic results of 2 different revascularization strategies.

Objective: To compare 2 different surgical approaches to treatment of patients with isolated predivisional stenosis of the left main coronary artery (IOSLM) and to evaluate the effect of chronic competitive flow from a patent arterial or venous graft to the circumflex system on the long-term patency of internal thoracic artery (ITA) to left anterior descending grafts.

Methods: Thirty-two patients with IOSLM were treated at our institutions during a 9-year period: 14 patients received double ITA grafts, whereas 18 underwent ITA graft plus saphenous vein (SV) bypass. All patients were reviewed clinically and angiographically at long-term follow-up.

Five-year follow-up of drug-eluting stents implantation vs minimally invasive direct coronary artery bypass for left anterior descending artery disease: a propensity score analysis.

Objectives: The spread of drug-eluting stents (DES) has reduced the incidence of early restenosis following percutaneous coronary interventions (PCI). Meanwhile, development of minimally invasive coronary artery bypass surgery (MIDCAB) has offered a valuable alternative to conventional sternotomy with preservation of the benefit of the internal mammary artery use. Therefore, the revascularization of the left anterior descending (LAD) artery is suitable for both techniques.

Competitive flow in coronary bypass surgery: is it a problem?

Purpose Of Review: Competition flow is a common finding in arterial grafting. This phenomenon can lead to graft occlusion.

Recent Findings: Internal thoracic arteries are the best equipped arterial conduit to withstand the competition flow thanks to their endothelial function.

Angiographic predictors of 3-year patency of bypass grafts implanted on the right coronary artery system: a prospective randomized comparison of gastroepiploic artery, saphenous vein, and right internal thoracic artery grafts.

Objective: Saphenous vein, in situ right gastroepiploic artery, and right internal thoracic artery grafts are routinely used to revascularize the right coronary artery. Little is known about the predictive value of objective preoperative angiographic parameters on midterm graft patency.

Methods: We prospectively enrolled 210 consecutive patients undergoing coronary revascularization.

Endothelium-dependent and endothelium-independent vasodilator response of left and right internal mammary and internal thoracic arteries used as a composite Y-graft.

Objective: The manner in which a blood vessel is for used as a coronary graft may be important in maintaining a viable and functional endothelial lining. Composite internal thoracic arteries (ITAs) in a Y-graft configuration are characterized by the connection of an in situ left ITA with preserved innervation and lymphatics and of a free semi-skeletonized right ITA.

Methods: To determine whether endothelial function differs between left and right ITA segments in a Y-graft configuration, 11 patients were studied 3 years after surgery.

Comparison of fractional flow reserve of composite Y-grafts with saphenous vein or right internal thoracic arteries.

Background: Composite Y-grafts, using the left internal thoracic artery as the inflow, allow a more efficient use of conduits without the need to touch a diseased ascending aorta. Among other conduits, the saphenous vein graft may be an alternative to the radial artery in elderly patients.

Patients And Methods: We evaluated the hemodynamic characteristics of 17 composite Y-grafts made with the left internal thoracic artery anastomosed to the left anterior descending coronary artery in all cases and with either the free right internal thoracic artery (RITA group, n = 10) or a saphenous vein graft (SVG group, n = 7) implanted proximally to the left internal thoracic artery and distally to the circumflex territory 6 months after the operation.

Comparison of minimally invasive direct coronary artery bypass surgery with implantation of drug-eluting stentsin patients with left anterior descending coronary artery disease.

Objective: : Bypass surgery and percutaneous coronary interventions improve the clinical status of patients with left anterior descending coronary artery disease. However, these techniques differ in invasiveness and in the need for subsequent reinterventions. The development of minimally invasive direct coronary artery bypass (MIDCAB) surgery and of drug-eluting stents (DES) offers perspectives to close this gap.