Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial.

BACKGROUND: A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis. METHODS: The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months. DISCUSSION: Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04470934.

["Prioritization and triage" in the context of cardiovascular diseases : Rational organization of safe care during and outside the corona pandemic]. / "Priorisierung und Triage" im Kontext kardiovaskulärer Erkrankungen : Rationale Organisation einer sicheren Versorgung während und außerhalb der Coronapandemie.

Since the beginning of 2020 the coronavirus disease 2019 (COVID-19) pandemic has extensively impacted medical care in Germany and worldwide. Germany is currently facing the so-called third wave of the COVID-19 pandemic. This is exacerbated by emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mutants with increased virus transmission and severe courses of disease. Rising numbers of SARS-CoV­2 infections translate into an increasing number of severe COVID-19 cases requiring intensive care, which interacts with limited structural and personnel resources for COVID-19 and non-COVID-19 critically ill patients. Therefore, prioritization and triage for critically ill patients with allocation of intensive care capacities becomes necessary, as with all situations with higher strain on capacities. Both strategies are meaningful forms of organization and are not to be equated with a collapse of medical care. Cardiovascular comorbidities and cardiac involvement in COVID-19 are of particular importance for disease severity and the clinical course. In addition to the medical care of patients with SARS-CoV­2 infections due to the pandemic, other patients with acute sometimes life-threatening diseases must also continue to receive high-quality treatment. This article provides a current overview of proposed restructuring measures in German hospitals as well as the accompanying triage and prioritization algorithms. Moreover, it is necessary to adapt existing treatment algorithms to the pandemic situation. Due their special importance this is sketched using cardiovascular diseases as an example.

Immediate unselected coronary angiography versus delayed triage in survivors of out-of-hospital cardiac arrest without ST-segment elevation: Design and rationale of the TOMAHAWK trial.

Patients experiencing out-of-hospital cardiac arrest (OHCA) without ST-segment elevation are a heterogenic group with a variety of underlying causes. Up to one-third of patients display a significant coronary lesion compatible with myocardial infarction as OHCA trigger. There are no randomized data on patient selection and timing of invasive coronary angiography after admission. METHODS AND RESULTS: The TOMAHAWK trial randomly assigns 558 patients with return of spontaneous circulation after OHCA with no obvious extracardiac origin of cardiac arrest and no ST-segment elevation/left bundle-branch block on postresuscitation electrocardiogram to either immediate coronary angiography or initial intensive care assessment with delayed/selective angiography in a 1:1 ratio. The primary end point is 30-day all-cause mortality. Secondary analyses will be performed with respect to initial rhythm, electrocardiographic patterns, myocardial infarction as underlying cause, neurological outcome, as well as clinical and laboratory markers. Clinical follow-up will be performed at 6 and 12 months. Safety end points include bleeding and stroke. CONCLUSION: The TOMAHAWK trial will address the unresolved issue of timing and general indication of angiography after OHCA without ST-segment elevation.

Endothelial progenitor cells and plaque burden in stented coronary artery segments: an optical coherence tomography study six months after elective PCI.

BACKGROUND: Endothelial progenitor cells (EPC) are involved in neovascularization and endothelial integrity. They might be protective in atherosclerosis. Optical coherence tomography (OCT) is a precise intracoronary imaging modality that allows assessment of subintimal plaque development. We evaluated the influence of EPC on coronary plaque burden in stable disease and implemented a novel computational plaque analysis algorithm using OCT. METHODS: Forty-three patients (69.8% males, 69.6 ± 7.7 years) were investigated by OCT during re-angiography 6 months after elective stent implantation. Different subpopulations of EPCs were identified by flow cytometry according to their co-expression of antigens (CD34+, CD133+, kinase domain receptor, KDR+). An algorithm was applied to calculate the underlying total plaque burden of the stented segments from OCT images. Plaque morphology was assessed according to international consensus in OCT imaging. RESULTS: A cumulative sub-strut plaque volume of 10.87 ± 12.7 mm3 and a sub-stent plaque area of 16.23 ± 17.0 mm2 were found within the stented vessel segments with no significant differences between different stent types. All EPC subpopulations (mean of EPC levels: CD34+/CD133+: 2.66 ± 2.0%; CD34+/KDR+: 7.50 ± 5.0%; CD34+/CD133+/KDR+: 1.12 ± 1.0%) inversely correlated with the identified underlying total plaque volume and plaque area (p ≤ 0.012). CONCLUSIONS: This novel analysis algorithm allows for the first time comprehensive quantification of coronary plaque burden by OCT and illustration as spread out vessel charts. Increased EPC levels are associated with less sub-stent coronary plaque burden which adds to previous findings of their protective role in atherosclerosis.

Cryptogenic left main thrombosis: successful mechanical clot retrieval with a self-expanding trapping device.

We present the case of a 52-year-old male with ST-segment elevation myocardial infarction due to a spontaneous large left main thrombosis, without any angiographic evidence for coronary artery disease. After multiple unsuccessful attempts of thrombaspiration the large clot was mechanically retrieved by a flow restoration device that was primarily made for intracranial interventions. Intravascular ultrasound revealed marginal lumen narrowing after the intervention, but the final coronary angiogram showed a patent left main and there was no relevant stenosis remaining.

Subintimal shift as mechanism for side-branch occlusion in percutaneous treatment of chronic total occlusions with bifurcation lesions.

BACKGROUND: The aim of this study was to describe the mechanism of subintimal shift (SIS), standardise diagnostic criteria and sensitise the interventional community to this phenomenon. The treatment of chronic total occlusions (CTO) by means of percutaneous coronary intervention (PCI) is complicated by bifurcation lesions involved in the CTO segment or adjacent to it. Extraplaque expansion of intracoronary devices during CTO PCI may extend the dissection plane over the bifurcation with the consequential side or main branch compression by an intimo-medial flap. This phenomenon is hereby described for the first time and named subintimal shift. METHODS: Experienced CTO operators from 3 international high volume centers for CTO PCI retrospectively searched their personal records for paradigmatic cases of SIS, summarising key features and proposing diagnostic criteria. RESULTS: The series comprised 7 demonstrative cases, illustrating SIS by intravascular imaging (2 cases) or indirect angiographic signs during CTO PCI (5 cases). Five cases were triggered by stent expansion, 1 by balloon inflation and 1 case was aborted after angiographic warning signs. In 4 cases, SIS resulted in total occlusion of a branch, refractory to ballooning whenever attempted. Four cases required bailout intervention and in 2 cases the branch was left occluded, resulting in a rise of cardiac markers. CONCLUSIONS: Subintimal shift is a noteworthy complication in CTO bifurcations, potentially resulting in occlusion of the relevant side or even the main branch. Intracoronary imaging prior to stenting is recommended to understand the tissue planes. Some counterintuitive peculiarities of this phenomenon, like its refractoriness to ballooning, must be known by CTO operators for its efficient resolution.

Effect of Hemolysis Regarding the Characterization and Prognostic Relevance of Neuron Specific Enolase (NSE) after Cardiopulmonary Resuscitation with Extracorporeal Circulation (eCPR).

BACKGROUND: Hemolysis, a common adverse event associated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO), may affect neuron-specific enolase (NSE) levels and potentially confound its prognostic value in predicting neurological outcomes in resuscitated patients without return of spontaneous circulation (ROSC) that require extracorporeal cardiopulmonary resuscitation (eCPR). Therefore, a better understanding of the relationship between hemolysis and NSE levels could help to improve the accuracy of NSE as a prognostic marker in this patient population. METHODS: We retrospectively analyzed the records of patients who received a VA-ECMO for eCPR between 2004 and 2021 and were treated in the medical intensive care unit (ICU) of the University Hospital Jena. The outcome was measured clinically by using the Cerebral Performance Category Scale (CPC) four weeks after eCPR. The serum concentration of NSE (baseline until 96 h) was analyzed by enzyme-linked immunosorbent assay (ELISA). To evaluate the ability of individual NSE measurements to discriminate, receiver operating characteristic (ROC) curves were calculated. Serum-free hemoglobin (fHb, baseline until 96 h) served as a marker for identifying a confounding effect of parallel hemolysis. RESULTS: 190 patients were included in our study. A total of 86.8% died within 4 weeks after ICU admission or remained unconscious (CPC 3-5), and 13.2% survived with a residual mild to moderate neurological deficit (CPC 1-2). Starting 24h after CPR, NSE was significantly lower and continued to decrease in patients with CPC 1-2 compared to the group with an unfavorable outcome of CPC 3-5. In addition, when evaluating on the basis of receiver operating characteristic curves (ROC), relevant and stable area under the curve (AUC) values for NSE could be calculated (48 h: 0.85 // 72 h: 0.84 // 96 h: 0.80; p < 0.01), and on the basis of a binary logistic regression model, relevant odds ratios for the NSE values were found even after adjusting for fHb regarding the prediction of an unfavorable outcome of CPC 3-5. The respective adjusted AUCs of the combined predictive probabilities were significant (48 h: 0.79 // 72 h: 0.76 // 96 h: 0.72; p ≤ 0.05). CONCLUSIONS: Our study confirms NSE as a reliable prognostic marker for poor neurological outcomes in resuscitated patients receiving VA-ECMO therapy. Furthermore, our results demonstrate that potential hemolysis during VA-ECMO does not significantly impact NSE's prognostic value. These findings are crucial for clinical decision making and prognostic assessment in this patient population.

Intensive lipid-lowering therapy for early achievement of guideline-recommended LDL-cholesterol levels in patients with ST-elevation myocardial infarction ("Jena auf Ziel").

BACKGROUND AND AIMS: Currently, less than 20% of patients at very high-risk achieve ESC/EAS dyslipidemia guideline-recommended LDL-C target levels in Europe. "Jena auf Ziel-JaZ" is a prospective cohort study in which early combination therapy with atorvastatin 80 mg and ezetimibe 10 mg was initiated on admission in patients with ST-elevation myocardial infarction (STEMI) and lipid-lowering therapy was escalated during follow-up with bempedoic acid and PCSK9 inhibitors to achieve recommended LDL-C targets in all patients. Moreover, we evaluated side-effects of lipid-lowering therapy. METHODS: Patients admitted with STEMI at Jena University Hospital were started on atorvastatin 80 mg and ezetimibe 10 mg on admission. Patients were followed for EAS/ESC LDL-C target achievement during follow-up. RESULTS: A total of 85 consecutive patients were enrolled in the study. On discharge, 32.9% achieved LDL-C targets on atorvastatin 80 mg and ezetimibe 10 mg. After 4-6 weeks, 80% of all patients on atorvastatin 80 mg and ezetimibe started at the index event were on ESC/EAS LDL-C targets. In 20%, combined lipid-lowering therapy was escalated with either bempedoic acid or PCSK9 inhibitors. All patients achieved LDL-C levels of or below 55 mg/dL during follow-up on triple lipid-lowering therapy. Combined lipid-lowering therapy was well-tolerated with rare side effects. CONCLUSIONS: Early combination therapy with a high-intensity statin and ezetimibe and escalation of lipid-lowering therapy with either bempedoic acid or PCSK9 inhibitors gets potentially all patients with STEMI on recommended ESC/EAS LDL-C targets without significant side effects.

Anatomical classification of chronic total occlusions in coronary bifurcations.

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) in coronary bifurcation lesions (CBL) is undergoing substantial technical progress and standardization, paralleling the evolution of dedicated devices, tools, and techniques. A standard consensus to classify CTO-CBL might be instrumental to homogenize data collection and description of procedures for scientific and educational purposes. The Medina-CTO classification replicates the classical three digits in Medina classification for bifurcations, representing the proximal main vessel, distal main vessel, and side branch, respectively. Each digit can take a value of 1 if it concerns atherosclerosis and is anatomically stenosed, or 0 if it is not. In addition, the occluded segment(s) of the bifurcation are noted by a subscript, which describes key interventional features of the cap: t (tapered), b (blunt), or a (ambiguous). This approach results in 56 basic categories that can be grouped by means of different elements, depending on the specific needs of each study. Medina-CTO classification, consisting of adding a subscript describing the basic cap characteristics to the totally occluded segment(s) of the standard Medina triplet, might be a useful methodological tool to standardize percutaneous intervention of bifurcational CTO lesions, with interesting scientific and educational applications.

Impact of a VA-ECMO in Combination with an Extracorporeal Cytokine Hemadsorption System in Critically Ill Patients with Cardiogenic Shock-Design and Rationale of the ECMOsorb Trial.

BACKGROUND: Cardiogenic shock and arrest present as critical, life-threatening emergencies characterized by severely compromised tissue perfusion and inadequate oxygen supply. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) serves as a mechanical support system for patients suffering shock refractory to conventional resuscitation. Despite the utilization of VA-ECMO, clinical deterioration due to systemic inflammatory response syndrome (SIRS) resulting from the underlying shock and exposure of blood cells to the artificial surfaces of the ECMO circuit may occur. To address this issue, cytokine adsorbers offer a valuable solution by eliminating blood proteins, thereby controlling SIRS and potentially improving hemodynamics. Consequently, a prospective, randomized, blinded clinical trial will be carried out with ECMOsorb. METHODS AND STUDY DESIGN: ECMOsorb is a single-center, controlled, randomized, triple-blinded trial that will compare the hemodynamic effects of treatment with a VA-ECMO in combination with a cytokine adsorber (CytoSorb®, intervention) to treatment with VA-ECMO only (control) in patients with cardiogenic shock (with or without prior cardiopulmonary resuscitation (CPR)) requiring extracorporeal, hemodynamic support. Fifty-four patients will be randomized in a 1:1 fashion to the intervention or control group over a 36-month period. The primary endpoint of ECMOsorb is the improvement of the Inotropic Score (IS) 72 h after the intervention. Prognostic indicators, including mortality rates, hemodynamic parameters, laboratory findings, echocardiographic assessments, quality of life measurements, and clinical parameters, will serve as secondary outcome measures. The safety evaluation encompasses endpoints such as air embolisms, allergic reactions, peripheral ischemic complications, vascular complications, bleeding incidents, and stroke occurrences. CONCLUSIONS: The ECMOsorb trial seeks to assess the efficacy of a cytokine adsorber (CytoSorb®; CytoSorbents Europe GmbH, Berlin, Germany) in reducing SIRS and improving hemodynamics in patients with cardiogenic shock who are receiving VA-ECMO. We hypothesize that a reduction in cytokine levels can lead to faster weaning from inotropic and mechanical circulatory support, and ultimately to improved recovery.

Microembolization and myonecrosis during elective percutaneous coronary interventions in diabetic patients: an intracoronary Doppler ultrasound study with 2-year clinical follow-up.

Elevation of cardiac troponin I (cTnI) is a well-known complication after percutaneous coronary interventions (PCI). The aims of this study were to quantify the extent of coronary microembolization during elective PCI, to identify predisposing anatomical and procedural factors, and to evaluate its impact on long-term outcome in diabetic patients with a high cardiovascular risk. 48 patients (pts, median 66.7 years) with type 2 diabetes and coronary artery disease underwent elective PCI with stenting to treat single-vessel lesions. Real-time microembolization during PCI ("HITS") was detected by an intracoronary Doppler guide wire. Peak levels of cTnI were measured within 24 h after PCI. Pts were followed for 2 years to record major cardiac events (MACE: death, myocardial infarction, revascularization of target and non-target vessels). In 47 patients microemboli were detected during PCI. Nineteen patients showed pathologic cTnI elevation (0.13-28.9, median 0.39 µg/l). The amount of HITS correlated with cTnI levels (r = 0.43, p = 0.003), but not with other clinical or angiographic data. Within 2 years MACE were detected in 9 patients, who had significantly more microemboli (15.4 ± 11.8 vs. 28.2 ± 16.0 HITS; p = 0.009, OR 1.07; 95 % CI 1.011-1.13) during PCI. HITS >23, but not cTnI elevation, predicted later MACE (ROC analysis, p = 0.025). A high amount of microembolization during elective PCI in diabetic patients appears to be an indicator of greater atherosclerotic burden and accelerated coronary artery disease progression, associated with acute biomarker elevation and adverse long-term outcomes.

Detection of coronary microembolization by Doppler ultrasound in patients with stable angina pectoris during percutaneous coronary interventions under an adjunctive antithrombotic therapy with abciximab: design and rationale of the High Intensity Transient Signals ReoPro (HITS-RP) study.

BACKGROUND: Embolization of atherosclerotic debris from the rupture of a vulnerable atherosclerotic plaque occurs iatrogenically during percutaneous coronary interventions (PCI) and can induce myocardial necrosis. These microembolizations are detected as high intensity transient signals (HITS) using intracoronary Doppler technology. PRESENTATION OF THE HYPOTHESIS: In the presented study we will test if abciximab (ReoPro®) infusion reduces high intensity transient signals in patients with stable angina pectoris undergoing PCI in comparison to standard therapy alone. TESTING THE HYPOTHESIS: The High Intensity Transient Signals ReoPro® (HITS-RP) study will enroll 60 patients. It is a prospective, single center, randomized, double-blinded, controlled trial. The study is designed to compare the efficacy of intravenous abciximab administration for reduction of microembolization during elective PCI. Patients will be randomized in a 1:1 fashion to abciximab or placebo infusion. The primary end point of the HITS-RP-Study is the number of HITS during PCI measured by intracoronary Doppler wire. Secondary endpoints are bleeding complications, elevation of cardiac biomarkers or ECG changes after percutaneous coronary interventions, changes in coronary flow velocity reserve, hs-CRP elevation, any major adverse cardio-vascular event during one month follow-up. IMPLICATIONS OF THE HYPOTHESIS: The HITS-RP-Study addresses important questions regarding the efficacy of intravenous abciximab administration in reducing microembolization and periprocedural complications in stable angina pectoris patients undergoing PCI. TRIAL REGISTRATION: The trial is registered under http://www.drks-neu.uniklinik-freiburg.de/drks_web/:DRKS00000603.

Increased cholesterol absorption is associated with In-stent-restenosis after stent implantation for stable coronary artery disease.

BACKGROUND AND AIMS: Blood cholesterol levels are regulated by competing mechanisms of cholesterol synthesis, absorption and excretion. Plant sterols are natural constituents of plants, are not synthesized in humans, and serve as markers for cholesterol absorption. Ezetimibe lowers the intestinal absorption of cholesterol and plant sterols. We analyzed the associations of differences in cholesterol metabolism, in particular increased cholesterol absorption, and the occurrence of in-stent restenosis (ISR) in patients with stable coronary artery disease. METHODS: Elective stent implantation of de novo stenosis was conducted in 59 patients (74.6 % males, 67.2 ± 9.6 years). Cholesterol and non-cholesterol sterols were quantified in serum samples by gas chromatography or mass spectrometry. ISR was assessed by optical coherence tomography (OCT) and quantitative angiography (QCA) after six months. RESULTS: Markers for cholesterol absorption (e.g. campesterol-to-cholesterol) were positively associated with ISR measured by QCA (%diameter stenosis, late lumen loss) and OCT (proliferation volume, %area stenosis), whereas markers for cholesterol synthesis (e.g. lathosterol-to-cholesterol) were negatively associated with ISR (%area stenosis: r = -0.271, p = 0.043). There was no association between ISR and total cholesterol, LDL, HDL, triglycerides. Markers for cholesterol absorption (e.g. campesterol-to-cholesterol) were significantly lower in ezetimibe-treated patients compared to patients on a statin only (1.29 ± 0.69 vs. 2.22 ± 1.23; p = 0.007). Combined lipid-lowering with ezetimibe plus statin reduced ISR compared to statin only (13.7 ± 10.4 vs. 22.5 ± 12.1 %diameter stenosis, p = 0.015). CONCLUSIONS: Differences in cholesterol metabolism, more specifically increased cholesterol absorption, are associated with ISR.

Rationale and Design of JenaMACS-Acute Hemodynamic Impact of Ventricular Unloading Using the Impella CP Assist Device in Patients with Cardiogenic Shock.

INTRODUCTION: Cardiogenic shock due to myocardial infarction or heart failure entails a reduction in end organ perfusion. Patients who cannot be stabilized with inotropes and who experience increasing circulatory failure are in need of an extracorporeal mechanical support system. Today, small, percutaneously implantable cardiac assist devices are available and might be a solution to reduce mortality and complications. A temporary, ventricular, continuous flow propeller pump using magnetic levitation (Impella®) has been approved for that purpose. METHODS AND STUDY DESIGN: JenaMACS (Jena Mechanical Assist Circulatory Support) is a monocenter, proof-of-concept study to determine whether treatment with an Impella CP® leads to improvement of hemodynamic parameters in patients with cardiogenic shock requiring extracorporeal, hemodynamic support. The primary outcomes of JenaMACS are changes in hemodynamic parameters measured by pulmonary artery catheterization and changes in echocardiographic parameters of left and right heart function before and after Impella® implantation at different support levels after 24 h of support. Secondary outcome measures are hemodynamic and echocardiographic changes over time as well as clinical endpoints such as mortality or time to hemodynamic stabilization. Further, laboratory and clinical safety endpoints including severe bleeding, stroke, neurological outcome, peripheral ischemic complications and occurrence of sepsis will be assessed. JenaMACS addresses essential questions of extracorporeal, mechanical, cardiac support with an Impella CP® device in patients with cardiogenic shock. Knowledge of the acute and subacute hemodynamic and echocardiographic effects may help to optimize therapy and improve the outcome in those patients. CONCLUSION: The JenaMACS study will address essential questions of extracorporeal, mechanical, cardiac support with an Impella CP® assist device in patients with cardiogenic shock. Knowledge of the acute and subacute hemodynamic and echocardiographic effects may help to optimize therapy and may improve outcome in those patients. ETHICS AND DISSEMINATION: The protocol was approved by the institutional review board and ethics committee of the University Hospital of Jena. Written informed consent will be obtained from all participants of the study. The results of this study will be published in a renowned international medical journal, irrespective of the outcomes of the study. Strengths and Limitations: JenaMACS is an innovative approach to characterize the effect of additional left ventricular mechanical unloading during cardiogenic shock via a minimally invasive cardiac assist system (Impella CP®) 24 h after onset and will provide valuable data for acute interventional strategies or future prospective trials. However, JenaMACS, due to its proof-of-concept design, is limited by its single center protocol, with a small sample size and without a comparison group.

Echocardiographic evaluation of left ventricular filling pressures validated against an implantable left ventricular pressure monitoring system.

BACKGROUND: Aim of this study was to assess the ability of different echocardiographic indices to evaluate left ventricular (LV) filling pressures in patients with reduced LV function. METHODS: In 5 patients scheduled for aortocoronary bypass surgery, a telemetric intraventricular pressure sensor was implanted. Over 6 months, these patients underwent a total of 21 echocardiographic examinations with a simultaneous recording of left ventricular mean (LVMDP) and end-diastolic pressure (LVEDP). The following echocardiographic parameters were extracted from the transmitral flow profile: early (E) and late (A) diastolic flow velocity, deceleration time of the E-wave (DT) and the isovolumic relaxation time (IVRT). Early diastolic velocity of the mitral ring (E') was recorded using pulsed-wave tissue Doppler echocardiography. RESULTS: All patients were in NYHA class III and mean ejection fraction was 30%. E correlated only moderately with LVMDP (r =-0.60, P = 0.003), but revealed the highest area under the receiver operating characteristic curve for the prediction of an elevated LVMDP > 12 mmHg (AUC = 0.94, sensitivity of 92% and specificity of 86%, cut-off value 7.5 cm/s). E/A > 1 predicted LVEDP > 15 mmHg with a sensitivity of 87% and a specificity of 80%. E/E' was not correlated with LVMDP or LVEDP. CONCLUSION: Although linear correlation between echocardiographic parameters and diastolic LV pressures reached statistical significance, the correlation coefficients were low. However, in these patients with severely reduced LV function due to ischemic heart disease conventional echocardiographic parameters of transmitral flow showed higher predictive values for elevated LV filling pressures than E/E'.

The impact of tricuspid annular geometry on outcome after percutaneous edge-to-edge repair for severe tricuspid regurgitation.

BACKGROUND: Percutaneous tricuspid repair using the edge-to-edge technique is a novel treatment option. More data are needed to better understand which aspects predict a favorable outcome. METHODS: Twenty high-risk patients (78.6 ± 8.3 years, EuroScore II 9.1 ± 7.7%, STS score 8.8 ± 4.3) with severe symptomatic tricuspid regurgitation (TR) were treated with the MitraClip® system. All patients underwent standardized pre-, peri-, and post-procedural evaluation. Acute success was defined as successful edge-to-edge repair with TR reduction of ≥ 1 grade and survival until hospital discharge. RESULTS: Fifteen (75%) patients showed acute success until discharge and 12 (60%) at 30-day followup. In 5 (25%) patients repair failed due to either unsuccessful clip implantation (n = 2), single leaflet device attachment (n = 1), TR reduction < 1 grade (n = 1), or in-hospital death (n = 1). Comparing patients with successful procedure versus those with failed repair revealed similar comorbidities but more severe right heart failure, lower left ventricular ejection fraction, worse renal function, and higher diuretic equivalent doses in the failed repair group. No differences in conventional echocardiographic parameters for TR severity but more dilated tricuspid annulus geometry (tricuspid valve annulus, coaptation depth, tenting area) in the failed repair group were observed. The success rate of non-central/non-anteroseptal jet location was only 25%. CONCLUSIONS: Tricuspid annulus geometry assessment may be of crucial importance and seems to impact procedural outcomes in patients undergoing edge-to-edge tricuspid valve repair. Further investigations including advanced imaging are needed to better understand and treat this complex valve disease.

Vena contracta area for severity grading in functional and degenerative mitral regurgitation: a transoesophageal 3D colour Doppler analysis in 500 patients.

Aims: Vena contracta area (VCA3D), derived by 3D colour Doppler echocardiography, has already been validated against cardiac magnetic resonance imaging, but the number of clinical studies to define cut-off values for grading of mitral regurgitation (MR) is limited. Aim of the study was to assess VCA3D in a large population of patients with functional (FMR) and degenerative MR (DMR). Methods and results: Transoesophageal echocardiography was performed in 500 patients with MR. The following 2D parameters were assessed for grading of MR: vena contracta width, effective regurgitant orifice area (EROAPISA), and regurgitation volume (RVPISA). VCA3D and the corresponding regurgitation volume (RVVCA) were quantified using 3D colour Doppler loop and CW Doppler tracing of the regurgitant jet. In 104 patients a 3D dataset of the left ventricle (LV) and the left ventricular outflow tract (LVOT) was acquired. As a reference method, regurgitation volume (RV3D) was calculated as difference between LV overall and LVOT stroke volumes. For prediction of severe MR, VCA3D yielded higher values of area under the ROC curve compared to EROAPISA (overall patient group 0.98 for VCA3D vs. 0.90 for EROAPISA, P < 0.001; FMR group 0.97 for VCA3D vs. 0.92 for EROAPISA, P = 0.002). RVVCA correlated closer with RV3D compared to RVPISA (r = 0.96 for RVPISA, r = 0.79 for RVPISA). Conclusion: This study delivers cut-off values for VCA3D in patients with different types of MR. VCA3D is a robust parameter for quantification of MR, showing a good correlation with the reference method using 3D datasets of LV.

Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography.

BACKGROUND: Percutaneous coronary interventions (PCI) with drug-coated balloons (DCB) might be a promising trade-off between balloon angioplasty and drug-eluting stents, since DCB inhibit neointimal proliferation and limit duration of dual antiplatelet therapy. We investigated the safety, feasibility, and 6-month results of fractional flow reserve (FFR)-guided use of the paclitaxel-coated SeQuent Please® balloon without stenting for elective PCI of de novo lesions. METHODS AND RESULTS: In 46 patients (54 lesions) with stable symptomatic coronary artery disease (CAD), a FFR-guided POBA (plain old balloon angioplasty) was performed. In case of a sufficient POBA result with residual stenosis < 40 %, FFR > 0.8 and no severe dissection, the target lesion was finally dilated using the DCB. Quantitative coronary angiography (QCA) was performed before and after the index procedure and at 6-month follow-up (f/u) to calculate late lumen loss (LLL) and net luminal gain (NLG). Optical coherence tomography (OCT) was performed at f/u to assess vascular remodeling. DCB-only treatment was applied to 43 patients (51 lesions), while 3 patients (3 lesions) needed provisional stenting. Invasive f/u was completed in 39 patients (47 lesions). At the stenotic site, the lumen diameter showed a trend toward progressive increase at f/u (LLL: -0.13 ± 0.44 mm, n.s.; NLG: 1.10 ± 0.53 mm, p < 0.001) without aneurysm formation or restenosis after DCB-only treatment. CONCLUSIONS: FFR-guided DCB-only PCI of de novo lesions appeared feasible and safe in stable CAD with clopidogrel discontinuation after 4 weeks, showing a trend toward positive vessel remodeling without lumen loss at 6 months. Clinical trial registration http://www.clinicaltrials.gov . Unique identifier: NCT02120859.