A comparison of transcatheter aortic valve implantation and surgical aortic valve replacement in 1,141 patients with severe symptomatic aortic stenosis and less than high risk.

OBJECTIVES: To assess outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement but with less than high risk. BACKGROUND: While there is abundant data for high risk patients there is insufficient data for reduced risk. METHODS: Patients undergoing TAVI or SAVR between 2007 and 2012 in Karlsruhe were considered. They were assessed by cardiac computed tomography, transoesophageal echocardiogram, and logistic EuroSCORE I (ES) and groups compared using Propensity Score Matching. RESULTS: The mean ES was 10.1±2.8 in the TAVI group (n = 419) and 5.7 ± 3.2 in the SAVR group (n = 722; P < 0.0001). Mean survival probability over 3 years was higher in patients undergoing surgery (P < 0.0001). A total of 432 patients were considered for the matched-pairs analysis based on propensity scores (216 in each group). Major vascular complications (10.6% vs. 0.0%; P < 0.0001), new pacemaker implantation (13.9% vs. 4.6%; P < 0.001) and moderate aortic insufficiency (3.2% vs. 0.5%; P = 0.03) were more frequent in patients undergoing TAVI. Major (20.8% vs. 4.2%; P < 0.0001) and life-threatening (14.5% vs. 2.3%; P < 0.0001) bleeding complications were more frequent in those undergoing surgery. Survival probability over 3 years in the propensity matched cohort was comparable between both groups (P = 0.16). CONCLUSIONS: In this large, single center, real world dataset there was no difference in mortality between patients undergoing TAVI or SAVR during a 3-year follow-up but there was a TAVI related increase in major vascular complications, new pacemaker implantation and aortic insufficiency and a SAVR related increased bleeding risk.

Generalized anxiety is a predictor of impaired quality of life in patients with atrial fibrillation: Findings from the prospective observational ARENA study.

OBJECTIVE: Atrial fibrillation (AF) is associated with impaired health-related quality of life (HRQoL), an increased risk of morbidity, and mortality. Traditional AF-related outcomes (e.g., AF recurrence) primarily demonstrate the physiological benefits of AF management but do not focus on the benefits experienced subjectively by the patient (i.e., patient-reported outcomes), which have been suggested as optimal endpoints in AF intervention studies. The aim of this study is to identify medical and psychological factors associated with impaired HRQoL at 1-year follow-up. METHODS: Using data from the prospective observational multicenter ARENA study in patients with AF, we analyzed associations between medical factors, anxiety, and HRQoL at 1-year follow-up assessed using 5-level EuroQoL-5D. RESULTS: In 1353 AF patients (mean age 71.4 ± 10.3 years, 33.8% female), none of the medical predictors (e.g., heart disease) or history of cardioversion were associated with HRQoL at the 1-year follow-up. Higher generalized anxiety (ß = -0.114, p < .001) but not cardiac anxiety (ß = -0.006, p = .809) at baseline predicted decreased HRQoL, independent of confounding variables and patients' medical status. Furthermore, the worsening of patients' generalized anxiety was associated with decreased HRQoL (ß = -0.091, p < .001). In contrast, the improvement of generalized anxiety over time predicted higher HRQoL (ß = 0.097, p < .001). Finally, the worsening of patients' cardiac anxiety over time was associated with decreased HRQoL (ß = -0.081, p < .001). CONCLUSION: Our results highlight the importance of anxiety as a predictor of future HRQoL in patients with AF. Additional studies to examine the impact of anxiety treatment on HRQoL in this population are needed. CLINICAL TRIAL REGISTRATION: The investigators registered on ClinicalTrials.gov (NCT02978248) on November 30, 2016 https://clinicaltrials.gov/ct2/show/NCT02978248.

Acute and late outcomes of Transcatheter Aortic Valve Implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in patients at high- and low-surgical risk.

BACKGROUND: This prospective study examines the impact of EuroSCORE and transfemoral (TF) or transapical (TA) delivery approach on mortality at 30 days and 1 year in patients with severe aortic stenosis implanted with either the Edwards SAPIEN Transcatheter Heart Valve (THV) or Medtronic CoreValve. METHODS AND RESULTS: TAVI was successfully performed in 293 (97.7%) of 300 patients (TF: 174, TA: 126, mean EuroSCORE 24.0). The mortality at 30 days and after 1 year was 6.0% and 17.3%. Mortality depends significantly on the logistic EuroSCORE with a 30-day odds ratio (OR) of 1.92 (95% CI 1.41 to 2.62, P < 0.001) and after 1 year of 1.67 (95% CI 1.34 to 2.08, P < 0.001). Mortality in patients with a logistic EuroSCORE <15 (n = 113) or ≥15 (n = 187) at 30 days was 0.9% versus 9.1% and after 1 year 7.1% versus 23.5% demonstrating significantly less mortality (P < 0.001) in patients with lower logistic EuroSCOREs. In this specific setup of our center there was no significant difference (P = 0.553) in mortality regarding the technical approach for TA (4.0% and 15.9%) and for TF (7.5% and 18.4%). Severe cardiac complications occurred in 20 patients (6.7%) with a 30-day mortality of 45.0%. CONCLUSION: The mortality in patients undergoing TAVI correlates significantly with the logistic EuroSCORE. Patients with a logistic EuroSCORE <15 can be implanted, with a low 30-day mortality and good long-term outcome over 1 year.

Impact of functional, morphological and clinical parameters on epicardial adipose tissue in patients with coronary artery disease.

BACKGROUND: Because a close relationship between epicardial adipose tissue (EAT) and coronary artery disease (CAD) has been shown, the impact of functional, morphological and clinical parameters to identify potential determinants of EAT was investigated. METHODS AND RESULTS: Clinical and cardiac magnetic resonance parameters were determined and correlated to the amount of EAT in 158 patients with CAD and 40 healthy subjects. Patients with CAD and left ventricular function (LVEF) ≥50% revealed significantly elevated EAT (36±11g/m²) compared to healthy controls (31±8g/m²) and to patients with LVEF <50% (26±8.0g/m²). In the whole study population, only LVEF (P=0.003), body mass index (BMI) (P=0.004) and left ventricular end diastolic diameter (LV-EDD) (P=0.004) remained significantly associated with EAT after multivariate analysis. Subgroup analysis in patients with CAD and LVEF ≥50% showed that BMI (P=0.03) was the only correlate of EAT. However, in patients with CAD and LVEF <50%, indexed LV end diastolic mass (LV-EDMI) (P=0.003) and the extent of late gadolinium enhancement (LGE %) (P=0.03) remained significantly correlated with EAT in multivariate analysis. CONCLUSIONS: The amount and the determinants of EAT differ according to the LVEF in patients with CAD. Thus, different amounts of EAT reflect different stages of CAD underlining the complex interaction of EAT in the pathogenesis and progression of ischemic cardiomyopathy.

Symptom Severity and Health-Related Quality of Life in Patients with Atrial Fibrillation: Findings from the Observational ARENA Study.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with impaired health-related quality of life (HRQoL), high symptom severity, and poor cardiovascular outcomes. Both clinical and psychological factors may contribute to symptom severity and HRQoL in AF. METHODS: Using data from the observational Atrial Fibrillation Rhine-Neckar Region (ARENA) trial, we identified medical and psychosocial factors associated with AF-related symptom severity using European Heart Rhythm Association symptom classification and HRQoL using 5-level EuroQoL- 5D. RESULTS: In 1218 AF patients (mean age 71.1 ± 10.5 years, 34.5% female), female sex (OR 3.7, p < 0.001), preexisting coronary artery disease (CAD) (OR 1.7, p = 0.020), a history of cardioversion (OR 1.4, p = 0.041), cardiac anxiety (OR 1.2; p < 0.001), stress from noise (OR 1.4, p = 0.005), work-related stress (OR 1.3, p = 0.026), and sleep disturbance (OR 1.2, p = 0.016) were associated with higher AF-related symptom severity. CAD (ß = -0.23, p = 0.001), diabetes mellitus (ß = -0.25, p < 0.001), generalized anxiety (ß = -0.30, p < 0.001), cardiac anxiety (ß = -0.16, p < 0.001), financial stress (ß = -0.11, p < 0.001), and sleep disturbance (ß = 0.11, p < 0.001) were associated with impaired HRQoL. CONCLUSIONS: Psychological characteristics, preexisting CAD, and diabetes may play an important role in the identification of individuals at highest risk for impaired HRQoL and high symptom severity in patients with AF.

Investigation of platelet adhesiveness in patients with coronary artery disease and acute myocardial infarction using the platelet adhesion assay (PADA).

BACKGROUND: Increased platelet reactivity may contribute to the development of coronary artery disease and myocardial infarction. The aim of the present study was to assess platelet adhesiveness in different stages of coronary artery disease using the platelet adhesion assay (PADA). In addition, the acute effect of coronary angiography and stent implantation on platelet adhesiveness was examined. METHODS: 85 patients with stable coronary artery disease (SAP - stable angina pectoris) and 19 patients with acute myocardial infarction (AMI) were enrolled in the study. 35 volunteers served as controls. Blood sampling in SAP and AMI patients was done before coronary angiography to measure the adhesion index (AI) using the PADA. In 33 patients additional blood was drawn at the end of coronary angiography. In 6 patients blood samples were drawn also after stent implantation. RESULTS: In blood samples from patients with an AMI the AI was significantly higher than in blood samples from the SAP group (p < 0.01) and the control group (p < 0.01). Coronary angiography and stent implantation did not result in significant acute changes in mean AI however results show an interindividual variability in initial values as well as in AI changes during procedures. CONCLUSIONS: This is the first study to show that PADA, a quick and simple laboratory method for the quantitative determination of platelet adhesiveness, is able to detect platelet hyper-adhesiveness in patients with AMI.

Epicardial adipose tissue in patients with heart failure.

PURPOSE: The aim of this study was to evaluate the extent of epicardial adipose tissue (EAT) and its relationship with left ventricular (LV) parameters assessed by cardiovascular magnetic resonance (CMR) in patients with congestive heart failure (CHF) and healthy controls. BACKGROUND: EAT is the true visceral fat deposited around the heart which generates various bioactive molecules. Previous studies found that EAT is related to left ventricular mass (LVM) in healthy subjects. Further studies showed a constant EAT to myocardial mass ratio in normal, ischemic and hypertrophied hearts. METHODS: CMR was performed in 66 patients with CHF due to ischemic cardiomyopathy (ICM), or dilated cardiomyopathy (DCM) and 32 healthy controls. Ventricular volumes, dimensions and LV function were assessed. The amount of EAT was determined volumetrically and expressed as mass indexed to body surface area. Additionally, the EAT/LVM and the EAT/left ventricular remodelling index (LVRI) ratios were calculated. RESULTS: Patients with CHF had less indexed EAT mass than controls (22 +/- 5 g/m2 versus 34 +/- 4 g/m2, p < 0.0001). In the subgroup analysis there were no significant differences in indexed EAT mass between patients with ICM and DCM (21 +/- 4 g/m2 versus 23 +/- 6 g/m2, p = 0.14). Linear regression analysis showed that with increasing LV end-diastolic diameter (LV-EDD) (r = 0.42, p = 0.0004) and LV end-diastolic mass (LV-EDM) (r = 0.59, p < 0.0001), there was a significantly increased amount of EAT in patients with CHF. However, the ratio of EAT mass/LV-EDM was significantly reduced in patients with CHF compared to healthy controls (0.54 +/- 0.1 versus 0.21 +/- 0.1, p < 0.0001). In CHF patients higher indexed EAT/LVRI-ratios in CHF patients correlated best with a reduced LV-EF (r = 0.49, p < 0.0001). CONCLUSION: Patients with CHF revealed significantly reduced amounts of EAT. An increase in LVM is significantly related to an increase in EAT in both patients with CHF and controls. However, different from previous reports the EAT/LVEDM-ratio in patients with CHF was significantly reduced compared to healthy controls. Furthermore, the LV function correlated best with the indexed EAT/LVRI ratio in CHF patients. Metabolic abnormalities and/or anatomic alterations due to disturbed cardiac function and geometry seem to play a key role and are a possible explanation for these findings.

A hole in the heart.

We present the case of a 91-year-old male whose percutaneous aortic valve replacement was complicated by perforation of the left ventricular (LV) apex caused by an extra-stiff guidewire. Although two-dimensional echocardiography was able to demonstrate a small hole at the LV apex and the presence of an LV pseudo-aneurysm, the exact size and shape of the hole could not be readily appreciated. Thus, three-dimensional (3D) echocardiography was performed and an oval-shaped hole of roughly 0.8 cm(2) could be clearly visualized. This case illustrates the unique value of 3D echocardiography in visualizing geometry and flow across LV rupture sites.

Effect of atorvastatin on cellular adhesion molecules on leukocytes in patients with normocholesterolemic coronary artery disease.

BACKGROUND: Expression of cellular adhesion molecules on leukocytes plays a key role in coronary artery disease (CAD). The aim of the present study was to assess whether atorvastatin therapy has an impact on the expression of cellular adhesion molecules on leukocytes in patients with normocholesterolemic CAD. PATIENTS AND METHODS: In 54 patients with CAD and atorvastatin treatment and 54 CAD patients without atorvastatin therapy, expression of CD40L, CD11a, CD11b, CD54, CD62L and CD41 on leukocytes was measured using flow cytometry. All patients were normocholesterolemic. RESULTS: Atorvastatin treatment led to a significantly lower expression of CD40L, CD11b and CD54 on monocytes (p<0.05) and neutrophils (p<0.05). Expression of CD11a was significantly lower on monocytes (p<0.05) in atorvastatin-treated patients. CONCLUSION: The present results indicate that atorvastatin apparently improves chronic inflammation and may have a beneficial effect on hemostasis by reducing the expression of cellular adhesion molecules on leukocytes.

Effect of atorvastatin on haemostasis, fibrinolysis and inflammation in normocholesterolaemic patients with coronary artery disease: a post hoc analysis of data from a prospective, randomized, double-blind study.

BACKGROUND: Treatment with HMG-CoA reductase inhibitors (statins) reduces the morbidity and mortality of coronary artery disease (CAD). In addition to their lipid-lowering actions, pleiotropic effects of statins have been demonstrated. OBJECTIVE: The aim of the present study was to assess if atorvastatin therapy has an impact on haemostasis, fibrinolysis and inflammation in normocholesterolaemic patients with CAD. METHODS: Fifty-four patients with CAD who had received atorvastatin treatment for at least 8 weeks (mean dosage 30 mg/day) and 54 patients with CAD who had not received atorvastatin therapy were selected from a larger prospective, randomized, double-blind study for inclusion in this post hoc analysis. Patients were matched by their total cholesterol levels. All patients were normocholesterolaemic. RESULTS: In the atorvastatin-treated patients significantly lower plasma levels of thrombin-antithrombin complexes (p < 0.05), plasminogen activator inhibitor-1 activity (PAI-1) [p < 0.05], soluble vascular cell adhesion molecule-1 (p < 0.05), soluble platelet selectin (p < 0.05) and high-sensitivity C-reactive protein (p < 0.05) were measured compared with patients not on atorvastatin therapy. Additionally, a strong trend towards lower soluble intercellular adhesion molecule-1 plasma levels was detected in patients treated with atorvastatin. No differences were found in tissue-type plasminogen activator antigen, plasmin-plasmin inhibitor complexes, fibrinogen, D-dimer and activated factor XII values. CONCLUSION: Atorvastatin appears to have an effect on coagulation activation, fibrinolysis and inflammation in patients with CAD. Reduction in PAI-1 and reduced thrombin formation may have an impact on cardiovascular morbidity and mortality in patients with CAD.

Use, Persistence, Efficacy, and Safety of Apixaban in Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany. Results of the Prospective Apixaban in Atrial Fibrillation (APAF) Registry.

INTRODUCTION: Apixaban has been shown to be superior to warfarin in patients with non-valvular atrial fibrillation in the randomized ARISTOTLE trial and its use is recommended in current guidelines. There are only scarce data about its use, efficacy, and safety in unselected patients in Germany. METHODS AND RESULTS: The APAF registry is a prospective non-interventional study enrolling 5015 patients with non-valvular atrial fibrillation. Of these, 1349 (26.9%) patients were initially treated with apixaban and followed up at 3 and 12 months. The dose of apixaban used was 1 × 2.5 mg in 1.6%, 2 × 2.5 mg in 30.4%, and 2 × 5 mg daily in 68.0% of patients, respectively. Inappropriate underdosing of apixaban was observed in 22.3%, mostly in elderly patients with higher HAS-BLED Score and a history of bleeding. Persistence to apixaban after 1 year was 88.6%, while the dose was changed in 3.7% of patients. Switching to other NOACs or VKAs occurred in 5.1%. After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively. CONCLUSIONS: In this prospective experience in unselected patients with atrial fibrillation, persistence to apixaban was high, and efficacy and safety were comparable to the results in clinical trials, supporting its use in clinical practice.

Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction.

BACKGROUND: Pilot trials suggest that the intracoronary administration of autologous progenitor cells may improve left ventricular function after acute myocardial infarction. METHODS: In a multicenter trial, we randomly assigned 204 patients with acute myocardial infarction to receive an intracoronary infusion of progenitor cells derived from bone marrow (BMC) or placebo medium into the infarct artery 3 to 7 days after successful reperfusion therapy. RESULTS: At 4 months, the absolute improvement in the global left ventricular ejection fraction (LVEF) was significantly greater in the BMC group than in the placebo group (mean [+/-SD] increase, 5.5+/-7.3% vs. 3.0+/-6.5%; P=0.01). Patients with a baseline LVEF at or below the median value of 48.9% derived the most benefit (absolute improvement in LVEF, 5.0%; 95% confidence interval, 2.0 to 8.1). At 1 year, intracoronary infusion of BMC was associated with a reduction in the prespecified combined clinical end point of death, recurrence of myocardial infarction, and any revascularization procedure (P=0.01). CONCLUSIONS: Intracoronary administration of BMC is associated with improved recovery of left ventricular contractile function in patients with acute myocardial infarction. Large-scale studies are warranted to examine the potential effects of progenitor-cell administration on morbidity and mortality.

CMR findings in patients with hypertrophic cardiomyopathy and atrial fibrillation.

OBJECTIVES: We sought to evaluate the relation between atrial fibrillation (AF) and the extent of myocardial scarring together with left ventricular (LV) and atrial parameters assessed by late gadolinium-enhancement (LGE) cardiovascular magnetic resonance (CMR) in patients with hypertrophic cardiomyopathy (HCM). BACKGROUND: AF is the most common arrhythmia in HCM. Myocardial scarring is also identified frequently in HCM. However, the impact of myocardial scarring assessed by LGE CMR on the presence of AF has not been evaluated yet. METHODS: 87 HCM patients underwent LGE CMR, echocardiography and regular ECG recordings. LV function, volumes, myocardial thickness, left atrial (LA) volume and the extent of LGE, were assessed using CMR and correlated to AF. Additionally, the presence of diastolic dysfunction and mitral regurgitation were obtained by echocardiography and also correlated to AF. RESULTS: Episodes of AF were documented in 37 patients (42%). Indexed LV volumes and mass were comparable between HCM patients with and without AF. However, indexed LA volume was significantly higher in HCM patients with AF than in HCM patients without AF (68 +/- 24 ml.m-2 versus 46 +/- 18 ml.m-2, p = 0.0002, respectively). The mean extent of LGE was higher in HCM patients with AF than those without AF (12.4 +/- 14.5% versus 6.0 +/- 8.6%, p = 0.02). When adjusting for age, gender and LV mass, LGE and indexed LA volume significantly correlated to AF (r = 0.34, p = 0.02 and r = 0.42, p < 0.001 respectively). By echocardiographic examination, LV diastolic dysfunction was evident in 35 (40%) patients. Mitral regurgitation greater than II was observed in 12 patients (14%). Multivariate analysis demonstrated that LA volume and presence of diastolic dysfunction were the only independent determinant of AF in HCM patients (p = 0.006, p = 0.01 respectively). Receiver operating characteristic curve analysis indicated good predictive performance of LA volume and LGE (AUC = 0.74 and 0.64 respectively) with respect to AF. CONCLUSION: HCM patients with AF display significantly more LGE than HCM patients without AF. However, the extent of LGE is inferior to the LA size for predicting AF prevalence. LA dilation is the strongest determinant of AF in HCM patients, and is related to the extent of LGE in the LV, irrespective of LV mass.

Global and regional myocardial function quantification by two-dimensional strain in Takotsubo cardiomyopathy.

AIMS: This study sought to characterize global and regional systolic function in Takotsubo cardiomyopathy (TC) using two-dimensional (2D) strain imaging. METHODS AND RESULTS: Twelve consecutive patients (11 women, 1 man) underwent 2D echocardiography on admission and on early follow-up (34 +/- 16 days). Two-dimensional images were analysed to measure longitudinal and radial strain and to calculate post-systolic shortening (PSS) and the post-systolic index (PSI). Mean age was 64 +/- 14 years. Upon presentation ejection fraction, average longitudinal and radial strains were 42 +/- 9%, -10.6 +/- 5.5%, and 20.1 +/- 17.3%, respectively. Values improved to 59 +/- 8%, -17.6 +/- 3.0%, and 50.2 +/- 17.0%, respectively (all P < 0.001). PSS was present in 69% of segments upon presentation and in 53% of segments upon follow-up. PSI was -0.16 at baseline and improved to -0.06 upon follow-up (P < 0.001). CONCLUSION: Patients with TC show abnormal global and regional strain patterns during the acute phase of the disease which improve over time. However, subtle abnormalities of regional LV function seem to persist into the early follow-up period as suggested by the presence of PSS in more than half of LV segments. Long-term follow-up studies are needed to clarify whether these subtle abnormalities will further improve.

Percutaneous treatment of a coronary aneurysm by stent graft and drug-eluting stent implantation: a potential method to reduce stent graft restenosis.

Coronary artery aneurysms (CAAs) can occur congenitally or secondary to specific disorders such as Kawasaki disease or atherosclerosis. Apart from a surgical approach, CAA can be treated by coronary stent graft (CSG) implantation. However, restenosis is frequent after CSG placement, precluding a wider use of this technique. We hypothesized that implantation of a drug-eluting stent (DES) within a CSG could be of use to avoid CSG restenosis. We report the case of a patient with a large aneurysm of the right coronary artery who underwent CSG implantation followed by DES placement. The immediate angiographic result showed complete exclusion of the aneurysm. Intravascular ultrasound confirmed good apposition of both the CSG and DES. Follow-up angiography after 23 weeks demonstrated a good long-term result without restenosis. The patient has remained asymptomatic during 12 months of follow-up. In conclusion, the present case suggests that CSG placement followed by DES implantation is a safe and effective approach to treat coronary aneurysms interventionally.

Effect of clopidogrel on adhesion molecules, hemostasis, and fibrinolysis in coronary heart disease.

BACKGROUND: The interaction among inflammation, Hemostasis, and fibrinolysis plays a major role in the genesis of coronary artery disease (CAD). The aim of the study was to compare the effect of clopidogrel plus aspirin versus aspirin alone on cellular adhesion molecules on leukocytes, soluble adhesion molecules, and molecular markers of coagulation and fibrinolysis in patients with CAD. METHODS: In this randomized, placebo-controlled, and double-blind study, 42 patients with chronic angina pectoris were included. All patients were treated with aspirin (ASA). Twenty-three patients received clopidogrel additionally (75 mg/day with a 300-mg loading dose) for 14 days. Nineteen patients received placebo additionally. Soluble adhesion molecules (sICAM-1, sVCAM-1, sP-selectin), surface expression of CD54, CD11a, CD11b, CD40, CD40L, CD41, CD42b, and CD62L on lymphocytes, monocytes, and neutrophils, and markers of hemostasis and fibrinolysis (TAT, PAP, D-dimers) were measured. RESULTS: In the ASA + clopidogrel group, no change in surface expression of cellular adhesion molecules on leukocytes and on plasma levels of sICAM-1, sVCAM-1, sP-selectin, TAT, PAP, and D-dimers was detectable. CONCLUSIONS: Clopidogrel plus aspirin for 2 weeks did not result in a detectable benefit versus sole aspirin therapy regarding cellular adhesion molecules on leukocytes, plasma markers of coagulation, fibrinolysis, and soluble adhesion molecules in patients with CAD.

Local paclitaxel delivery after coronary stenting in an experimental animal model.

The goal of this study was to test the safety and efficacy of local paclitaxel delivery via a newly designed application catheter in an experimental animal study. Drug-eluting stents reduce restenosis in comparison to bare-metal stents. The drug-eluting polymer, however, may exert potential thrombogenic and inflammatory effects. A catheter-based local paclitaxel delivery offers further advantages, particularly a homogenous drug transfer into the vessel wall and a pharmacotherapy of the stent edges. In 30 pigs, both bare-metal stent (3.0 x 13 mm) implantation and balloon angioplasty were performed. Ten pigs received subsequent local delivery of paclitaxel-solution via a newly designed catheter (Genie, ACROSTAK corp., Switzerland), 10 animals served as a sham group and received vehicle (0.9% NaCl solution) and 10 animals were used as a control group. All animals were treated with aspirin and clopidogrel to prevent stent thrombosis. After final angiography the vessels were excised 42 days after intervention and prepared for histological and histomorphometric analysis. All coronary arteries showed complete endothelialization 42 days following treatment. Paclitaxel treatment led to a marked reduction of neointimal proliferation either post stent implantation (neointimal area: 1.04 +/- 0.10 mm(2) vs. 2.37 +/- 0.23 mm(2), p < 0.001) or post balloon dilatation (neontimal area: 0.35 +/- 0.14 mm(2), vs. 0.68 +/- 0.24 mm(2), p < 0.01). There were no significant angiographic or histomorphometric differences between the control and the sham group. In both paclitaxel groups neither angiographic edge phenomena nor a significant histomorphometric inflammatory response were found in the treated vessel segments. In conclusion, the local application of paclitaxel via the Genie catheter is safe and effective to significantly reduce the proliferative response post-stent implantation or balloon dilatation in an experimental animal model.

Impact of mitral E/A ratio on the accuracy of different echocardiographic indices to estimate left ventricular end-diastolic pressure.

The objective was to determine the influence of left ventricular (LV) inflow pattern on the accuracy of different echocardiographic indices for estimation of LV end-diastolic pressure (LVEDP). Echocardiography with color tissue Doppler imaging (TDI) and LVEDP measurements using fluid-filled catheters were performed in 176 consecutive patients on the same day. Mitral peak diastolic velocities (E, A) and the difference in duration between pulmonary venous retrograde velocity and mitral A-velocity (PV(R)-A) were recorded by pulsed Doppler. Propagation velocity of the early mitral inflow (V(P)) was assessed using color M-mode. Early diastolic longitudinal (E'(lat)) and radial (E'(radial)) velocities of mitral annulus were measured by TDI. Area under ROC curve (AUC) for prediction of elevated LVEDP (> or =15 mm Hg) was computed for each parameter. For E/A > or =1 (98 patients, 46 with elevated LVEDP), the AUC values were: PV(R)-A: 0.914; E/E'(lat): 0.780; E/E'(radial): 0.729; E/V(P): 0.712 (p < 0.001). When E/A <1 (78 patients, 26 with elevated LVEDP), only PV(R)-A reached statistical significance (AUC = 0.893, p < 0.001). The conclusions were: PV(R)-A enabled the most accurate noninvasive estimation of LVEDP irrespective of LV filling profile and combined indices E/V(P), E/E'(lat) and E/E'(radial) represent more feasible alternatives for patients with mitral E/A-1.

Side branch occlusion after coronary stent implantation in patients presenting with ST-elevation myocardial infarction: clinical impact and angiographic predictors.

BACKGROUND: The aim of this study was to assess the incidence and clinical outcome of the occlusion of major (> 1 mm) side branches following coronary stenting in patients undergoing percutaneous coronary intervention for acute ST-elevation myocardial infarction (STEMI). METHODS: Among 276 consecutive patients presenting with STEMI, we found 80 patients (29%) with 101 stent-covered side branches. Clinical data and quantitative angiographic analysis were evaluated. Angiographic follow-up was available in 56 (70%) patients, and clinical follow-up could be completed in all patients. RESULTS: Acute side branch occlusion after stent implantation (SBO) was observed in 10 (12.5%) patients involving 11 (10.9%) side branches. Predictors for SBO were: (1) reference side branch diameter at baseline < or = 1.4 mm; (2) ostial side branch stenosis > 50%; and (3) minimal side branch diameter at baseline < or = 0.6 mm. During hospitalization, in the SBO group, 2 patients died in cardiogenic shock and 1 underwent bypass surgery; no events were causally related to SBO. During long-term follow-up, 1 patient with SBO developed repeat MI as opposed to 7 patients in the non-SBO group who developed major adverse cardiac events (1 death, 6 repeat revascularizations). CONCLUSIONS: The presence of a side branch originating from the target lesion in patients undergoing coronary stenting for acute STEMI is a frequent observation (29%) and is associated with a low incidence of side branch occlusion. Major predictors for SBO are the side branch size and the presence of an ostial side branch stenosis.

Takotsubo cardiomyopathy (acute left ventricular apical ballooning syndrome) occurring in the intensive care unit.

OBJECTIVE: Diagnosis of Takotsubo cardiomyopathy (also known as stress cardiomyopathy or acute left ventricular apical ballooning syndrome) can be challenging in patients who are being treated for other diseases in the intensive care unit, because symptoms could erroneously be attributed to the underlying disease or patients may not experience symptoms due to analgesia and sedation. The aim of our study was to assess clinical features of Takotsubo cardiomyopathy occurring in the intensive care unit. DESIGN: Prospective observational study. SETTING: University hospital. PATIENTS: Six consecutive patients diagnosed with Takotsubo cardiomyopathy who were being treated for other diseases in the intensive care unit. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Sudden hemodynamic deterioration (i.e., sudden hypotension, tachycardia or drop in monitored stroke volume) requiring vasopressor support was the presenting symptom in five of the six patients. Only one patient was able to report angina-like chest pain, all others were unable to experience symptoms due to analgesia and sedation. The electrocardiogram was abnormal in all patients upon diagnosis, demonstrating either ST-segment elevation (n=2) and/or T-wave inversion (n=5). Mild elevation of cardiac enzymes disproportionate to the extent of wall motion abnormalities on left ventriculography was present in all patients. All patients survived their acute event. CONCLUSIONS: Sudden hemodynamic deterioration requiring vasopressor support and/or ECG abnormalities consisting of ST-segment elevation, ST-segment depression or T-wave inversion may be the presenting symptom of Takotsubo cardiomyopathy in the intensive care unit and should be included in the diagnostic algorithm.