Efficacy and User Experience of a Novel X-Ray Shield on Operator Radiation Exposure During Cardiac Catheterization: A Randomized Controlled Trial.

BACKGROUND: Radiation shielding is mandatory during cardiac catheterization, but there is a need to improve efficacy and ease of use. METHODS: The aim of the study was to assess the shielding effect and user feedback for a novel flexible multiconfiguration x-ray shield (FMX). The 0.5-mm Pb equivalent FMX can be selectively configured to accommodate for variations in patient morphology, access site, and type of procedure with maintained visualization, vascular access, and shielding. To evaluate efficacy, relative operator dose (operator dose indexed for given dose) was measured during 103 consecutive procedures randomized in a 1:1 proportion to the current routine setup or FMX+routine. User feedback was collected on function, relevance, and likelihood of adoption into clinical practice. RESULTS: Median relative operator dose was 3.63 µSv/µGy·m2×10-3 (IQR, 2.62-6.37) with routine setup and 0.57 µSv/µGy·m2×10-3 (IQR, 0.27-1.06) with FMX+routine, which amounts to an 84.4% reduction (P<0.001). For 500 procedures/year, this corresponds to an estimated yearly dose reduction from 3.6 to 0.7 mSv. User feedback regarding size, functionality, ease of use, likely to use, critical issues, shielding, draping, procedure time, vascular access, patient discomfort, and risk was 99% positive. No critical issues were identified. There was no significant difference in patient radiation exposure. CONCLUSIONS: The FMX reduces radiation exposure considerably. The FMX represents an effective and attractive solution for radiation protection that can easily be implemented in existing workflow. FMX has potential for general use with maintained visualization, vascular access, and shielding in routine cardiac catheterization.

Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction: a randomized controlled trial.

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.

Effect of an optimized X-ray blanket design on operator radiation dose in cardiac catheterization based on real-world angiography.

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. A larger XRB may reduce operator dose but could hamper vascular access and visualization. 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.

Thrombus characteristics evaluated by acute optical coherence tomography in ST elevation myocardial Infarction.

AIMS: ST elevation myocardial infarction (STEMI) is caused by an occlusive thrombosis of a coronary artery. We wanted to assess if the thrombus can be characterized according to erythrocyte content and age using intravascular optical coherence tomography (OCT) in a clinical setting. METHODS AND RESULTS: We performed manual thrombus aspiration in 66 STEMI patients. OCT was done of the thrombus remnants after aspiration. A light intensity ratio was measured through the thrombus. Forty two of the aspirates had thrombus which could be analyzed histomorphologically for analysis of erythrocyte and platelet content, and to determine the age of thrombus as fresh, lytic or organized. There were 11 red, 21 white and 10 mixed thrombi. Furthermore, 36 aspirates had elements of fresh, 7 of lytic and 8 of organized thrombi. There was no correlation between colour and age. OCT appearance could not predict erythrocyte or platelet content. The light intensity ratios were not significantly different in fresh, lytic or organized thrombi. CONCLUSION: OCT could not differentiate between red and white thrombi, nor determine thrombus age.

Effects of Add-On Left Ventricular Assist Device to Extracorporeal Membrane Oxygenation During Refractory Cardiac Arrest in a Porcine Model.

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.

Balanced Biventricular Assist Versus Extracorporeal Membrane Oxygenation in Cardiac Arrest.

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.

Temporal Trends in X-Ray Exposure during Coronary Angiography and Percutaneous Coronary Intervention.

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.

Impella use in acute myocardial infarction complicated by cardiogenic shock and cardiac arrest: Analysis of 10 years registry data.

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.

Left Versus Biventricular Assist Devices in Cardiac Arrest.

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.

Administration of the Mitochondrial Permeability Transition Pore Inhibitor, TRO40303, prior to Primary Percutaneous Coronary Intervention, Does Not Affect the Levels of Pro-Inflammatory Cytokines or Acute-Phase Proteins.

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-1ß, 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.

Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: MITOCARE study results.

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.

Percutaneous Assist Device for Cardiopulmonary Resuscitation.

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.

Percutaneous catheter-based intracoronary infusion of insulin--a dose finding study in the porcine model.

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.

Rationale and design of EXPLORE: a randomized, prospective, multicenter trial investigating the impact of recanalization of a chronic total occlusion on left ventricular function in patients after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction.

BACKGROUND: In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events. METHODS/DESIGN: The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years. DISCUSSION: The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome. TRIAL REGISTRATION: trialregister.nl NTR1108.

Treatment of cardiogenic shock with left ventricular assist device combined with cardiac resynchronization therapy: a case report.

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).

Percutaneous left ventricular assist in ischemic cardiac arrest.

BACKGROUND: Ischemic cardiac arrest represents a challenge for optimal emergency revascularization therapy. A percutaneous left ventricular assist device (LVAD) may be beneficial. OBJECTIVE: To determine the effect of a percutaneous LVAD during cardiac arrest without chest compressions and to assess the effect of fluid loading. DESIGN: Totally, 16 pigs randomized to either conventional or intensive fluid with LVAD support during ventricular fibrillation (VF). SETTING: Acute experimental trial with pigs under general anesthesia. SUBJECTS: Farm pigs of both sexes. INTERVENTIONS: 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. MEASUREMENTS: 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. MAIN RESULTS: 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, p < 0.05). Mean perfusion at 3 minutes was 65% in the brain and 74% in the myocardium compared with baseline (p < 0.05), 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 (p < 0.001). CONCLUSIONS: 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.