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BACKGROUND: Primary percutaneous coronary intervention with implantation of a metallic drug-eluting stent (DES) is the standard treatment for patients presenting with ST-elevation myocardial infarction (STEMI). Implantation of a bioresorbable scaffold (BRS) during STEMI represents a novel strategy without intravascular metal.OBJECTIVE: The aim of the study was to investigate 12-month healing response in an STEMI population after implantation of either the Absorb BRS or Xience DES (Abbott Vascular, USA).METHODS: The present trial was a prospective, randomized, controlled, nonblinded, noninferiority study with planned inclusion of 120 patients with STEMI. Patients were randomly assigned 1:1 to treatment with Absorb BRS or Xience DES. Implantation result and healing response were evaluated by angiography and optical coherence tomography (OCT) at baseline and 12-month follow-up. The primary endpoint was minimum flow area (MFA) assessed at 12 months. Coronary stent healing index (CSHI) was calculated from OCT images.RESULTS: Out of 66 included patients, 58 had follow-up OCT after 12 months, and 49 entered matched analysis. One death occurred in each group; none were stent-related. MFA was 5.13 ± 1.70 mm2 (95% CI, 4.44-5.82) in the BRS group compared with 6.30 ± 2.49 mm2 (95% CI, 5.22-7.37) (P = 0.06) in the DES group. Noninferiority could not be evaluated. CSHI for both groups had a median score of 3.CONCLUSION: The DES group performed numerically better in primary and secondary endpoints, but the CSHI showed good stent healing in both groups.

Mechanical assist devices in refractory cardiac arrest are increasingly employed. We compared the hemodynamics and organ perfusion during cardiac arrest with either veno-arterial extracorporeal membrane oxygenation (ECMO) or biventricular assisted circulation combining left- and right-sided impeller devices (BiPella) in an acute experimental setting. Twenty pigs were randomized in two equal groups receiving circulatory support either by ECMO or by BiPella during 40 minutes of ventricular fibrillation (VF) followed by three attempts of cardioversion, and if successful, 60 minute observation with spontaneous, unsupported circulation. Hemodynamic variables were continuously recorded. Tissue perfusion was evaluated by fluorescent microsphere injections. Cardiac function was visualized by intracardiac echocardiography. During VF device output, carotid flow, kidney perfusion, mean aortic pressure (AOPmean), and mean left ventricular pressure (LVPmean) were all significantly higher in the ECMO group, and serum-lactate values were lower compared with the BiPella group. No difference in myocardial or cerebral perfusion was observed between groups. In 15 animals with sustained cardiac function for 60 minutes after return of spontaneous circulation, left ventricular subendocardial blood flow rate averaged 0.59 ± 0.05 ml/min/gm during VF compared with 0.31 ± 0.07 ml/min/gm in five animals with circulatory collapse (p = 0.005). Corresponding values for the midmyocardium was 0.91 ± 0.06 vs. 0.65 ± 0.15 ml/min/gm (p = 0.085). Both BiPella and ECMO could sustain vital organ function. ECMO provided a more optimal systemic circulatory support related to near physiologic output. Myocardial tissue perfusion and sustained cardiac function were related to coronary perfusion pressure during VF, irrespective of mode of circulatory support.

Background There is increasing concern and focus in the interventional cardiology community on potential long term health issues related to radiation exposure and heavy wearable protection. Optimized shielding measures may reduce operator dose to levels where lighter radioprotective garments can safely be used, or even omitted. X-ray blankets (XRB) are commercially available but suffer from small size and lack of stability. Purpose The aim of this study is to assess shielding effect of an optimized XRB during cardiac catheterization and estimate the potential reduction in annual operator dose based on DICOM Radiation Dose Structured Report (RDSR) data reflecting everyday clinical practice. Methods Data accumulated from 7681 procedures over three years in our RDSR repository was used to identify projection angles and radiation doses during cardiac catheterization. Using an anthropomorphic phantom and a scatter radiation detector, radiation dose to the operator (mSv) and patient (dose area product – DAP) was measured for each angiographic projection for three different shielding setups. Relative operator dose (mSv/DAP) was calculated and multiplied by DAP per projection to estimate effect on operator dose. Results Adding an optimized XRB to a standard shielding setup comprising a table- and ceiling-mounted shield resulted in a 94.9% reduction in estimated operator dose. The largest shielding effect was observed in left and cranial projections where the ceiling-mounted shield offered less protection. Conclusions An optimized XRB is a simple shielding measure that has the potential to reduce operator dose. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Grieg Foundation

This study evaluated the effects of extracorporeal membrane oxygenation (ECMO) in combination with a percutaneous adjunctive left ventricular assist device (LVAD) in a porcine model during 60 minutes of refractory cardiac arrest (CA). Twenty-four anesthetized swine were randomly allocated into three groups given different modes of circulatory assist: group 1: ECMO 72 ml/kg/min and LVAD; group 2: ECMO 36 ml/kg/min and LVAD; and group 3: ECMO 72 ml/kg/min. During CA and extracorporeal cardiopulmonary resuscitation (ECPR), mean left ventricular pressure (mLVP) was lower in group 1 (p = 0.013) and in group 2 (p = 0.003) versus group 3. Mean aortic pressure (mAP) and coronary perfusion pressure (CPP) were higher in group 1 compared with the other groups. In group 3, mean pulmonary artery flow (mPAf) was lower versus group 1 (p = 0.003) and group 2 (p = 0.039). If the return of spontaneous circulation (ROSC) was achieved after defibrillation, up to 180 minutes of unsupported observation followed. All subjects in groups 1 and 3, and 5 subjects in group 2 had ROSC. All subjects in group 1, five in group 2 and four in group 3 had sustained cardiac function after 3 hours of spontaneous circulation. Subjects that did not achieve ROSC or maintained cardiac function post-ROSC had lower mAP (p < 0.001), CPP (p= 0.002), and mPAf (p = 0.004) during CA and ECPR. Add-on LVAD may improve hemodynamics compared with ECMO alone during refractory CA but could not substitute reduced ECMO flow. Increased mAP and CPP could be related to ROSC rate and sustained cardiac function. Increased mLVP was related to poor post-ROSC cardiac function.

Aims To assess characteristics and outcome of patients treated with Impella for acute myocardial infarction (AMI) complicated by severe cardiogenic shock (CS) or cardiac arrest (CA). Methods and results From 2008 through 2017, 92 patients with AMI complicated by CS were treated with Impella. Survival varied according to clinical presentation. Patients in cardiogenic shock without CA had a 75% 30-day survival. Patients with CA and return of spontaneous circulation (ROSC) had a 43% survival and those with CA and ongoing cardio-pulmonary resuscitation (CPR) had a 6% 30-day survival. Age, pre-existing hypertension, coronary disease, ventilatory support and use of adrenergic agents were associated with worse prognosis. Complications were predominantly access site related. Conclusions In this registry of patients with AMICS treated with Impella, hypertension and older age were found to be negatively predictive for survival. Patients without CA had the highest 30-day survival. In patients with ROSC, survival was strongly related to age and comorbidity. Patients with ongoing CPR had very high mortality.

Background. Percutaneous coronary intervention exposes patient and staff to ionizing radiation. Although staff only receive a small fraction of patient dose through scatter radiation, there are concerns about the potential health effects of repeated exposure. Minimizing both patient and occupational exposure is needed. Objective. This article investigates patient and operator X-ray exposure over time in coronary intervention in relation to upgraded X-ray equipment, improved shielding, and enhanced operator awareness. Materials and Methods. Data regarding irradiation time, patient dose, and patient characteristics were extracted from the Norwegian Registry for Invasive Cardiology (NORIC) for procedures performed from 2013 to mid-2019. Personal operator dosimetry records were provided by the Norwegian Radiation and Nuclear Safety Authority. Improved operator shielding and awareness measures were introduced in 2018. Results. In the period 2013 through June 2019, 21499 procedures were recorded in our institution. Mean dose area product (DAP) for coronary angiography decreased 37% from 2981 μGy·m2 in 2013 to 1891 μGy·m2 in 2019 (p<0.001). For coronary intervention, DAP decreased 39% from 8358 μGy·m2 to 5055 μGy·m2. Personal dosimetry data indicate a 70% reduction in operator dose per procedure in 2019 compared to 2013. The most pronounced reduction occurred after improved radiation protection measures were implemented in 2018 (−48%). Conclusions. This study shows a temporal trend towards considerable reduction in X-ray doses received by the patient and operator during cardiac catheterization. Upgraded X-ray equipment, improved shielding, and enhanced operator awareness are likely contributors to this development.

Background In 10% to 15% of patients with ST-segment elevation myocardial infarction (STEMI), concurrent coronary chronic total occlusion (CTO) in a non–infarct-related artery is present and is associated with increased morbidity and mortality. Objectives The EXPLORE (Evaluating Xience and Left Ventricular Function in Percutaneous Coronary Intervention on Occlusions After ST-Elevation Myocardial Infarction) trial evaluated whether patients with STEMI and concurrent CTO in a non–infarct-related artery benefit from additional percutaneous coronary intervention (PCI) of CTO shortly after primary PCI. Methods From November 2007 through April 2015, we enrolled 304 patients with acute STEMI who underwent primary PCI and had concurrent CTO in 14 centers in Europe and Canada. A total of 150 patients were randomly assigned to early PCI of the CTO (CTO PCI), and 154 patients were assigned to conservative treatment without PCI of the CTO (no CTO PCI). Primary outcomes were left ventricular ejection fraction (LVEF) and left ventricular end diastolic volume (LVEDV) on cardiac magnetic resonance imaging after 4 months. Results The investigator-reported procedural success rate in the CTO PCI arm of the trial was 77%, and the adjudicated success rate was 73%. At 4 months, mean LVEF did not differ between the 2 groups (44.1 ± 12.2% vs. 44.8 ± 11.9%, respectively; p = 0.60). Mean LVEDV at 4 months was 215.6 ± 62.5 ml in the CTO PCI arm versus 212.8 ± 60.3 ml in the no–CTO PCI arm (p = 0.70). Subgroup analysis revealed that patients with CTO located in the left anterior descending coronary artery who were randomized to the CTO PCI strategy had significantly higher LVEF compared with patients randomized to the no–CTO PCI strategy (47.2 ± 12.3% vs. 40.4 ± 11.9%; p = 0.02). There were no differences in terms of 4-month major adverse coronary events (5.4% vs. 2.6%; p = 0.25). Conclusions Additional CTO PCI within 1 week after primary PCI for STEMI was feasible and safe. In patients with STEMI and concurrent CTO, we did not find an overall benefit for CTO PCI in terms of LVEF or LVEDV. The finding that early CTO PCI in the left anterior descending coronary artery subgroup was beneficial warrants further investigation. (Evaluating Xience and Left Ventricular Function in Percutaneous Coronary Intervention on Occlusions After ST-Segment Elevation Myocardial Infarction; NTR1108)

Maintaining adequate organ perfusion during cardiac arrest remains a challenge, and various assist techniques have been evaluated. We assessed whether a right ventricular impeller assist device (RVAD) in adjunct to a left ventricular impeller assist device (LVAD) is beneficial. Twenty anesthetized pigs were randomized to maximized circulatory support by percutaneously implanted left- or biventricular assist device(s) during 30 minutes of electrically induced ventricular fibrillation followed by three attempts of cardioversion. Continuous hemodynamic variables were recorded. Cardiac output and myocardial, cerebral, renal, and ileum mucosa tissue perfusion were measured with fluorescent microspheres, and repeated blood gas analyses were obtained. With biventricular support, an increased LVAD output was found compared with left ventricular (LV) support; 3.2 ± 0.2 (SEM) vs. 2.0 ± 0. 2 L/minute just after start of ventricular fibrillation, 3.2 ± 0.1 vs. 2.0 ± 0.1 L/minute after 15 minutes, and 3.0 ± 0.1 vs. 2.1 ± 0.1 L/minute after 30 minutes of cardiac arrest (pg < 0.001). Biventricular support also increased aortic and LV pressure, in addition to end-tidal CO2. Tissue blood flow rates were increased for most organs with biventricular support. Blood gas analyses showed improved oxygenation and lower s-lactate values. However, myocardial perfusion was degraded with biventricular support and return of spontaneous circulation less frequent (5/10 vs. 10/10; p = 0.033). Biventricular support was associated with high intraventricular pressure and decreased myocardial perfusion pressure, correlating significantly with flow rates in the LV wall. A transmural flow gradient was observed for both support modes, with better maintained subepicardial than midmyocardial and subendocardial perfusion.

Persistent cardiac arrest is often caused by coronary ischemia. Urgent revascularization during on-going resuscitation with the support of percutaneous left ventricular assist devices (PVAD) may be feasible and can have the potential to improve the prognosis. Transport during resuscitation is a challenge that may be overcome with the use of cardiopulmonary resuscitation devices. In the catheterization laboratory, rapid deployment of PVAD may reduce ischemia, contribute to electrical stabilization of the heart, and facilitate definite treatment with percutaneous coronary intervention. After revascularization, PVAD therapy may promote myocardial recovery and improve vital organ perfusion in a critical phase.

Objectives: In the MITOCARE study, reperfusion injury was not prevented after administration of the mitochondrial permeability transition pore (mPTP) opening inhibitor, TRO40303, in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI). The effects of TRO40303 on pro-inflammatory cytokines and acute-phase proteins were assessed. Methods: STEMI patients (n = 163, mean age 62 years) with chest pain within 6 h before admission for pPCI were randomized to intravenous bolus of TRO40303 (n = 83) or placebo (n = 80) prior to reperfusion. We tested whether the groups differed in levels of IL-1β, IL-6, IL-10, TNF, and high-sensitive C-reactive protein at various time points (0, 12, and 72 h) after PCI. Further, potential differences between groups in the change of biomarker levels between 0 and 72 h, 0 and 12 h, and 12 and 72 h were tested. Results: There were no statistically significant differences between the two groups, neither in levels of pro-inflammatory cytokines nor in levels of acute-phase proteins, and there were no statistically significant differences in the change of biomarker levels between the groups considering the time intervals from 0 to 72 h, from 0 to 12 h, and from 12 to 72 h. Conclusion: The administration of the mPTP, TRO40303, prior to reperfusion does not alter the pharmacokinetics of pro-inflammatory cytokines or acute-phase proteins during the first 72 h after PCI.

Insulin given at immediate reperfusion reduces myocardial infarct size in the in vitro and the ex vivo rat heart. In vivo, insulin may cause hypoglycaemia, hypokalaemia and elevation of catecholamines, potentially harmful during an acute myocardial infarction. The purpose of this study was to evaluate tolerance and safety of intracoronary insulin infusions in a porcine model applying percutaneous intervention techniques.

Percutaneous left ventricular assist devices improve hemodynamics in acute heart failure. The devices can be deployed rapidly and with a low risk of complications, and may thereby offer potential advantages compared with surgical assist systems in the critically ill. Cerebral hypoperfusion with cerebral injury is a major challenge in acutely ill cardiac patients, especially when cardio–pulmonary resuscitation is performed. There is no indication that catheter-based left ventricular assist devices confer more cerebrovascular complications than current percutaneous angiographic and interventional procedures. Recent data suggest that microcirculation in the head may be improved during percutaneous assist device support in cardiogenic shock. Specific assessment of the effect of a percutaneous device during cardiac arrest and impaired cerebral circulation has been performed in newly published experimental protocols. The available data indicate that a percutaneous intracardiac impeller device may be able to sus...

A percutaneous left ventricular assist device has been shown to be able to perfuse cardiac and cerebral tissues during cardiac arrest and may be a useful supplement to current methods in resuscitation. We wished to assess device-assisted circulation during cardiac arrest with microspheres injections and continuous end-tidal CO(2) monitoring, and used cerebral microdialysis to detect ischaemia in the brain.12 anaesthetised pigs had microdialysis and pressure catheters implanted via craniotomy. The percutaneous assist device was deployed transfemorally. Ventricular fibrillation was induced by angioplasty-balloon occlusion of the left coronary artery. Cerebral microdialysis samples representing 0-20 and 20-40 min of cardiac arrest with assisted circulation were analysed for markers of cerebral injury (glucose, pyruvate, lactate, and glycerol).Microdialysis showed no ischaemic changes after 20 min of cardiac arrest (P=NS to Baseline for glucose, glycerol, lactate, pyruvate and lactate/pyruvate ratio) in subjects with maintained end-tidal CO(2) values above 1.3 kPa (10 mmHg). After 40 min only lactate showed a significant change compared to Baseline (P0.05). Microspheres flow to the brain was 57% and myocardial flow was 72% compared to Baseline after 15 min (P0.05). After 45 min flow declined to 22% and 40% of Baseline, respectively (P=NS vs. 15 min).A percutaneous left ventricular assist device may prevent ischaemic cerebral injury during cardiac arrest for a limited time. Cerebral injury and tissue perfusion were indicated by end-tidal CO(2).

AIM: The MITOCARE study evaluated the efficacy and safety of TRO40303 for the reduction of reperfusion injury in patients undergoing revascularization for ST-elevation myocardial infarction (STEMI).METHODS: Patients presenting with STEMI within 6 h of the onset of pain randomly received TRO40303 (n = 83) or placebo (n = 80) via i.v. bolus injection prior to balloon inflation during primary percutaneous coronary intervention in a double-blind manner. The primary endpoint was infarct size expressed as area under the curve (AUC) for creatine kinase (CK) and for troponin I (TnI) over 3 days. Secondary endpoints included measures of infarct size using cardiac magnetic resonance (CMR) and safety outcomes.RESULTS: The median pain-to-balloon time was 180 min for both groups, and the median (mean) door-to-balloon time was 60 (38) min for all sites. Infarct size, as measured by CK and TnI AUCs at 3 days, was not significantly different between treatment groups. There were no significant differences in the CMR-assessed myocardial salvage index (1-infarct size/myocardium at risk) (mean 52 vs. 58% with placebo, P = 0.1000), mean CMR-assessed infarct size (21.9 g vs. 20.0 g, or 17 vs. 15% of LV-mass) or left ventricular ejection fraction (LVEF) (46 vs. 48%), or in the mean 30-day echocardiographic LVEF (51.5 vs. 52.2%) between TRO40303 and placebo. A greater number of adjudicated safety events occurred in the TRO40303 group for unexplained reasons.CONCLUSION: This study in STEMI patients treated with contemporary mechanical revascularization principles did not show any effect of TRO40303 in limiting reperfusion injury of the ischaemic myocardium.

Treatment of acute ST-elevation myocardial infarction (STEMI) by reperfusion using percutaneous coronary intervention (PCI) or thrombolysis has provided clinical benefits; however, it also induces considerable cell death. This process is called reperfusion injury. The continuing high rates of mortality and heart failure after acute myocardial infarction (AMI) emphasize the need for improved strategies to limit reperfusion injury and improve clinical outcomes. The objective of this study is to assess safety and efficacy of TRO40303 in limiting reperfusion injury in patients treated for STEMI. TRO40303 targets the mitochondrial permeability transition pore, a promising target for the prevention of reperfusion injury. This multicenter, double-blind study will randomize patients with STEMI to TRO40303 or placebo administered just before balloon inflation or thromboaspiration during PCI. The primary outcome measure will be reduction in infarct size (assessed as plasma creatine kinase and troponin I area under the curve over 3 days). The main secondary endpoint will be infarct size normalized to the myocardium at risk (expressed by the myocardial salvage index assessed by cardiac magnetic resonance). The study is being financed under an EU-FP7 grant and conducted under the auspices of the MITOCARE research consortium, which includes experts from clinical and basic research centers, as well as commercial enterprises, throughout Europe. Results from this study will contribute to a better understanding of the complex pathophysiology underlying myocardial injury after STEMI. The present paper describes the rationale, design and the methods of the trial. Copyright (c) 2012 S. Karger AG, Basel (Less)

Insulin given at immediate reperfusion reduces myocardial infarct size in the in vitro and the ex vivo rat heart. In vivo, insulin may cause hypoglycaemia, hypokalaemia and elevation of catecholamines, potentially harmful during an acute myocardial infarction. The purpose of this study was to evaluate tolerance and safety of intracoronary insulin infusions in a porcine model applying percutaneous intervention techniques.

A percutaneous left ventricular assist device can maintain blood flow to vital organs during ventricular fibrillation and may improve outcomes in ischaemic cardiac arrest. We compared haemodynamic and clinical effects of a percutaneous left ventricular assist device with a larger device deployed via endovascular prosthesis and with open-chest cardiac massage during ischaemic cardiac arrest.Eighteen swine were randomised into three groups. After thoracotomy, coronary ischaemia and ventricular fibrillation was induced. Cardiac output was measured with transit-time flowmetry. Tissue perfusion was measured with microspheres. Defibrillation was performed after 20 min.Cardiac output with cardiac massage was 1129 mL min⁻¹ vs. 1169 mL min⁻¹ with the percutaneous- and 570 mL min⁻¹ with the surgical device (P0.05 surgical vs. others). End-tidal CO₂ was 3.3 kPa with cardiac massage vs. 3.2 kPa with the percutaneous- and 2.3 kPa with the surgical device (P0.05 surgical vs. others). Subepicardial perfusion was 0.33 mL min⁻¹ g⁻¹ with cardiac massage vs. 0.62 mL min⁻¹ g⁻¹ with both devices (P0.05 devices vs. massage), cerebral perfusion was comparable between groups (all reported values after 3 min cardiac arrest, all P0.05 vs. baseline, all P = NS for 3 min vs. 15 min). Return of spontaneous circulation was achieved in 5/6 subjects with cardiac massage vs. 6/6 with the percutaneous- and 4/6 with the surgical device (P = NS).The percutaneous device improved myocardial perfusion, maintained cerebral perfusion and systemic circulation with similar rates of successful defibrillation vs. cardiac massage. Increased delivery was not obtained with the surgical device during cardiac arrest.

Cardiogenic shock has a poor prognosis with established treatment strategies. We report a 62 years old man with heart failure exacerbating into refractory cardiogenic shock successfully treated with the combination of a percutaneous left ventricular assist device (LVAD) and subacute cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator device (CRT-D).

Ischemic cardiac arrest represents a challenge for optimal emergency revascularization therapy. A percutaneous left ventricular assist device (LVAD) may be beneficial.To determine the effect of a percutaneous LVAD during cardiac arrest without chest compressions and to assess the effect of fluid loading.Totally, 16 pigs randomized to either conventional or intensive fluid with LVAD support during ventricular fibrillation (VF).Acute experimental trial with pigs under general anesthesia.Farm pigs of both sexes.After randomization for fluid infusion, VF was induced by balloon occlusion of the proximal left anterior descending artery. LVAD and fluid were started after VF had been induced.Brain, kidney, myocardial tissue perfusion, and cardiac index were measured with the microsphere injection technique at baseline, 3, and 15 minutes. Additional hemodynamic monitoring continued until 30 minutes.At 15 minutes, vital organ perfusion was maintained without significant differences between the two groups. Mean cardiac index at 3 minutes of VF was 1.2 L x min(-1) x m2 (29% of baseline, p0.05). Mean perfusion at 3 minutes was 65% in the brain and 74% in the myocardium compared with baseline (p0.05), then remained unchanged during the initial 15 minutes. At 30 minutes, LVAD function was sustained in 11 of 16 animals (8 of 8 intensified fluid vs. 3 of 8 conventional fluid) and was associated with intensified fluid loading (p0.001).During VF, a percutaneous LVAD may sustain vital organ perfusion. A potential clinical role of the device during cardiac arrest has yet to be established.