A Left-to-Right Shunt After Transfemoral TAVR Using Edwards SAPIEN 3.

Transcatheter aortic valve replacement (TAVR) is used for the treatment of aortic stenosis (AS). Besides major bleeding, conduction blocks, stroke or atrial fibrillation, complications include cardiac perforation with possible left-to-right-shunts. Herein is reported the sixth case of a left-to-right shunt in an 87-year-old man who underwent TAVR using a 29 mm Edwards SAPIEN S3 prosthesis to treat AS. Soon after the procedure, a small channel evolving from the right coronary cusp could be detected on echocardiography. The patient was managed medically.

Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.

BACKGROUND: In patients with acute pulmonary embolism, systemic thrombolysis improves right ventricular (RV) dilatation, is associated with major bleeding, and is withheld in many patients at risk. This multicenter randomized, controlled trial investigated whether ultrasound-assisted catheter-directed thrombolysis (USAT) is superior to anticoagulation alone in the reversal of RV dilatation in intermediate-risk patients. METHODS AND RESULTS: Fifty-nine patients (63±14 years) with acute main or lower lobe pulmonary embolism and echocardiographic RV to left ventricular dimension (RV/LV) ratio ≥1.0 were randomized to receive unfractionated heparin and an USAT regimen of 10 to 20 mg recombinant tissue plasminogen activator over 15 hours (n=30; USAT group) or unfractionated heparin alone (n=29; heparin group). Primary outcome was the difference in the RV/LV ratio from baseline to 24 hours. Safety outcomes included death, major and minor bleeding, and recurrent venous thromboembolism at 90 days. In the USAT group, the mean RV/LV ratio was reduced from 1.28±0.19 at baseline to 0.99±0.17 at 24 hours (P<0.001); in the heparin group, mean RV/LV ratios were 1.20±0.14 and 1.17±0.20, respectively (P=0.31). The mean decrease in RV/LV ratio from baseline to 24 hours was 0.30±0.20 versus 0.03±0.16 (P<0.001), respectively. At 90 days, there was 1 death (in the heparin group), no major bleeding, 4 minor bleeding episodes (3 in the USAT group and 1 in the heparin group; P=0.61), and no recurrent venous thromboembolism. CONCLUSIONS: In patients with pulmonary embolism at intermediate risk, a standardized USAT regimen was superior to anticoagulation with heparin alone in reversing RV dilatation at 24 hours, without an increase in bleeding complications. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01166997.

Distribution of coronary calcifications in patients with suspected coronary heart disease.

BACKGROUND: Coronary calcifications are a marker of coronary atherosclerosis. The role of coronary calcium scoring (CS) as part of the initial evaluation of patients with suspected coronary heart disease (CHD) is controversially discussed. The primary goal of this study was to characterize the coronary calcium distribution in this particular patient population. In a second step, we aimed to establish a possible clinical implication using CS for the diagnosis of CHD. METHODS: Calcium scoring procedure was performed by either using a multidetector or a dual-source computed tomographic scanner. All patients underwent invasive coronary angiography (ICA) as the current criterion standard for CHD detection. A total of 4,137 (2,780 men, mean age 60.5 ± 12.4 years) consecutive patients were included. RESULTS: Mean CS was 288 ± 446 (range 0-5,252). Overall coronary artery calcifications significantly increased with patients' age. In 2,048 patients (mean CS 101 ± 239, range 0-5252), significant CHD (≥50% stenosis) was excluded by ICA (1,939 patients without calcifications). In remaining 2,089 patients (51%, mean CS 607 ± 821, range 0-5,252), significant CHD was documented leading to intervention in 732 patients. A threshold of zero calcifications (existence of calcified tissue) had the best overall sensitivity and negative predictive value with 99%. Overall specificity with 34% and overall positive predictive value with 24% were rather low. CONCLUSION: Coronary calcium scoring is able to exclude significant CHD in patients with suspected CHD with a high negative predictive value and, therefore, possibly reduce the number of invasive diagnostic examinations. Because of the low specificity and positive predictive value, CS cannot be used to indicate ICA.

Immediate and 12 months follow up of function and lead integrity after cranial MRI in 356 patients with conventional cardiac pacemakers.

BACKGROUND: Conventional cardiac pacemakers are still often regarded as a contraindication to magnetic resonance imaging (MRI). We conducted this study to support the hypothesis that it is safe to scan patients with cardiac pacemakers in a 1.5 Tesla MRI, if close supervision and monitoring as well as adequate pre- and postscan programming is provided. METHODS: We followed up 356 patients (age 61.3 ± 9.1 yrs., 229 men) with single (n = 132) or dual chamber (n = 224) cardiac pacemakers and urgent indication for a cranial MRI for 12 months. The scans were performed at 1.5T. During the scan patients were monitored with a 3-lead ECG and pulse oximetry. Prior to the scan pacemakers were programmed according to our own protocol. RESULTS: All 356 scans were completed without complications. No arrhythmias were induced, programmed parameters remained unchanged. No pacemaker dysfunction was identified. Follow-up examinations were performed immediately, 2 weeks, 2, 6, and 12 months after the scan. There was no significant change of pacing capture threshold (ventricular 0.9 ± 0.4 V@0.4 ms, atrial 0.9 ± 0.3 V@0.4 ms) immediately (ventricular 1.0 ± 0.3 V@0.4 ms, atrial 0.9 ± 0.4 V@0.4 ms) or at 12 months follow-up examinations (ventricular 0.9 ± 0.2 V@0.4 ms, atrial 0.9 ± 0.3 V@0.4 ms). There was no significant change in sensing threshold (8.0 ± 4.0 mV vs. 8.1 ± 4.2 mV ventricular lead, 2.0 ± 0.9 mV vs. 2.1 ± 1.0 mV atrial lead) or lead impedance (ventricular 584 ± 179 Ω vs. 578 ± 188 Ω, atrial 534 ± 176 Ω vs. 532 ± 169 Ω) after 12 months. CONCLUSIONS: This supports the evidence that patients with conventional pacemakers can safely undergo cranial MRI in a 1.5T system with suitable preparation, supervision and precautions. Long term follow-up did not reveal significant changes in pacing capture nor sensing threshold.

Circulating concentrations of GLP-1 are associated with coronary atherosclerosis in humans.

BACKGROUND: GLP-1 is an incretine hormone which gets secreted from intestinal L-cells in response to nutritional stimuli leading to pancreatic insulin secretion and suppression of glucagon release. GLP-1 further inhibits gastric motility and reduces appetite which in conjunction improves postprandial glucose metabolism. Additional vasoprotective effects have been described for GLP-1 in experimental models. Despite these vasoprotective actions, associations between endogenous levels of GLP-1 and cardiovascular disease have yet not been investigated in humans which was the aim of the present study. METHODS: GLP-1 serum levels were assessed in a cohort of 303 patients receiving coronary CT-angiography due to typical or atypical chest pain. RESULTS: GLP-1 was found to be positively associated with total coronary plaque burden in a fully adjusted model containing age, sex, BMI, hypertension, diabetes mellitus, smoking, triglycerides, LDL-C (low density lipoprotein cholesterol), hsCRP (high-sensitive C-reactive protein), and eGFR (estimated glomerular filtration rate) (OR: 2.53 (95% CI: 1.12 - 6.08; p = 0.03). CONCLUSION: Circulating GLP-1 was found to be positivity associated with coronary atherosclerosis in humans. The clinical relevance of this observation needs further investigations.

Detection of significant coronary artery stenosis with cardiac dual-source computed tomography angiography in heart transplant recipients.

Present study evaluates clinical feasibility of cardiac dual-source computed tomography angiography (DSCTA) to detect significant coronary stenosis because of chronic allograft vasculopathy (CAV) after heart transplantation (HTX). An overall of 51 consecutive heart transplant recipients (43 men, 8 women, mean age: 52.3 ± 13.6 years) underwent DSCTA 1 ± 2 days before annual routine invasive coronary angiography (ICA). Three patients were excluded from further analysis. Total 714/717 (99.6%) segments in remaining 48 patients were depicted in diagnostic image quality by DSCTA with three vessel segments in two patients being additionally excluded because of motion artefacts. On a segment-based analysis, sensitivity, specificity, and diagnostic accuracy (DA) for detection of significant stenosis were calculated as 100%, 98.9% and 98.9% respectively. On a patient-based evaluation, sensitivity, specificity and DA were 100%, 86.0% and 93.0% respectively for remaining 46 patients. Negative predictive value (NPV) was 100%. DSCTA enables diagnosis and especially the exclusion of significant coronary artery stenosis in patients after HTX with a high NPV. The low rate of excluded vessel segments compared with former studies indicates improvement in image acquisition and robustness of latest scanner technology and thus may make subsequent annual invasive coronary angiography unnecessary.

Determination of pericardial adipose tissue increases the prognostic accuracy of coronary artery calcification for future cardiovascular events.

OBJECTIVES: Pericardial adipose tissue (PAT) is associated with coronary artery plaque accumulation and the incidence of coronary heart disease. We evaluated the possible incremental prognostic value of PAT for future cardiovascular events. METHODS: 145 patients (94 males, age 60 ± 10 years) with stable coronary artery disease underwent coronary artery calcification (CAC) scanning in a multislice CT scanner, and the volume of pericardial fat was measured. Mean observation time was 5.4 years. RESULTS: 34 patients experienced a severe cardiac event. They had a significantly higher CAC score (1,708 ± 2,269 vs. 538 ± 1,150, p < 0.01), and the CAC score was highly correlated with the relative risk of a future cardiac event: 2.4 (1.8-3.7; p = 0.01) for scores >400, 3.5 (1.9-5.4; p = 0.007) for scores >800 and 5.9 (3.7-7.8; p = 0.005) for scores >1,600. When additionally a PAT volume >200 cm(3) was determined, there was a significant increase in the event rate and relative risk. We calculated a relative risk of 2.9 (1.9-4.2; p = 0.01) for scores >400, 4.0 (2.1-5.0; p = 0.006) for scores >800 and 7.1 (4.1-10.2; p = 0.005) for scores >1,600. CONCLUSIONS: The additional determination of PAT increases the predictive power of CAC for future cardiovascular events. PAT might therefore be used as a further parameter for risk stratification.

SPECT myocardial perfusion imaging as an adjunct to coronary calcium score for the detection of hemodynamically significant coronary artery stenosis.

BACKGROUND: Coronary artery calcifications (CAC) are markers of coronary atherosclerosis, but do not correlate well with stenosis severity. This study intended to evaluate clinical situations where a combined approach of coronary calcium scoring (CS) and nuclear stress test (SPECT-MPI) is useful for the detection of relevant CAD. METHODS: Patients with clinical indication for invasive coronary angiography (ICA) were included into our study during 08/2005-09/2008. At first all patients underwent CS procedure as part of the study protocol performed by either using a multidetector computed tomography (CT) scanner or a dual-source CT imager. CAC were automatically defined by dedicated software and the Agatston score was semi-automatically calculated. A stress-rest SPECT-MPI study was performed afterwards and scintigraphic images were evaluated quantitatively. Then all patients underwent ICA. Thereby significant CAD was defined as luminal stenosis ≥ 75% in quantitative coronary analysis (QCA) in ≥ 1 epicardial vessel. To compare data lacking Gaussian distribution an unpaired Wilcoxon-Test (Mann-Whitney) was used. Otherwise a Students t-test for unpaired samples was applied. Calculations were considered to be significant at a p-value of <0.05. RESULTS: We consecutively included 351 symptomatic patients (mean age: 61.2 ± 12.3 years; range: 18-94 years; male: n=240) with a mean Agatston score of 258.5 ± 512.2 (range: 0-4214). ICA verified exclusion of significant CAD in 66/67 (98.5%) patients without CAC. CAC was detected in remaining 284 patients. In 132/284 patients (46.5%) with CS>0 significant CAD was confirmed by ICA, and excluded in 152/284 (53.5%) patients. Sensitivity for CAD detection by CS alone was calculated as 99.2%, specificity was 30.3%, and negative predictive value was 98.5%. An additional SPECT in patients with CS>0 increased specificity to 80.9% while reducing sensitivity to 87.9%. Diagnostic accuracy was 84.2%. CONCLUSIONS: In patients without CS=0 significant CAD can be excluded with a high negative predictive value by CS alone. An additional SPECT-MPI in those patients with CS>0 leads to a high diagnostic accuracy for the detection of CAD while reducing the number of patients needing invasive diagnostic procedure.

Detection of hemodynamically significant coronary artery stenosis: incremental diagnostic value of dynamic CT-based myocardial perfusion imaging.

PURPOSE: To determine the feasibility of computed tomography (CT)-based dynamic myocardial perfusion imaging for the detection of hemodynamically significant coronary artery stenosis, as defined with fractional flow reserve (FFR). MATERIALS AND METHODS: Institutional review board approval and informed patient consent were obtained before patient enrollment in the study. The study was HIPAA compliant. Subjects who were suspected of having or were known to have coronary artery disease underwent electrocardiographically triggered dynamic stress myocardial perfusion imaging. FFR measurement was performed within all main coronary arteries with a luminal narrowing of 50%-85%. Estimated myocardial blood flow (MBF) was derived from CT images by using a model-based parametric deconvolution method for 16 myocardial segments and was related to hemodynamically significant coronary artery stenosis with an FFR of 0.75 or less in a blinded fashion. Conventional measures of diagnostic accuracy were derived, and discriminatory power analysis was performed by using logistic regression analysis. RESULTS: Of 36 enrolled subjects, 33 (mean age, 68.1 years ± 10 [standard deviation]; 25 [76%] men, eight [24%] women) completed the study protocol. An MBF cut point of 75 mL/100 mL/min provided the highest discriminatory power (C statistic, 0.707; P <.001). While the diagnostic accuracy of CT for the detection of anatomically significant coronary artery stenosis (>50%) was high, it was low for the detection of hemodynamically significant stenosis (positive predictive value [PPV] per coronary segment, 49%; 95% confidence interval [CI]: 36%, 60%). With use of estimated MBF to reclassify lesions depicted with CT angiography, 30 of 70 (43%) coronary lesions were graded as not hemodynamically significant, which significantly increased PPV to 78% (95% CI: 61%, 89%; P = .02). The presence of a coronary artery stenosis with a corresponding MBF less than 75 mL/100 mL/min had a high risk for hemodynamic significance (odds ratio, 86.9; 95% CI:17.6, 430.4). CONCLUSION: Dynamic CT-based stress myocardial perfusion imaging may allow detection of hemodynamically significant coronary artery stenosis.

Increased Pericardial Adipose Tissue in Smokers.

BACKGROUND: Pericardial adipose tissue (PAT), a visceral fat depot directly located to the heart, is associated with atherosclerotic and inflammatory processes. The extent of PAT is related to the prevalence of coronary heart disease and might be used for cardiovascular risk prediction. This study aimed to determine the effect of smoking on the extent of PAT. METHODS: We retrospectively examined 1217 asymptomatic patients (490 females, age 58.3 ± 8.3 years, smoker n = 573, non-smoker n = 644) with a multislice CT scanner and determined the PAT volume. Coronary risk factors were determined at inclusion, and a multivariate analysis was performed to evaluate the influence of smoking on PAT independent from accompanying risk factors. RESULTS: The mean PAT volume was 215 ± 107 mL in all patients. The PAT volume in smokers was significantly higher compared to PAT volume in non-smokers (231 ± 104 mL vs. 201 ± 99 mL, p = 0.03). Patients without cardiovascular risk factors showed a significantly lower PAT volume (153 ± 155 mL, p < 0.05) compared to patients with more than 1 risk factor. Odds ratio was 2.92 [2.31, 3.61; p < 0.001] for elevated PAT in smokers. CONCLUSION: PAT as an individual marker of atherosclerotic activity and inflammatory burden was elevated in smokers. The finding was independent from metabolic risk factors and might therefore illustrate the increased inflammatory activity in smokers in comparison to non-smokers.

Association of inflammation of the left anterior descending coronary artery with cardiovascular risk factors, plaque burden and pericardial fat volume: a PET/CT study.

PURPOSE: Measurements of [(18)F]fluorodeoxyglucose (FDG) uptake as a potential marker of the inflammatory activity of the vessel wall could be useful to identify vulnerable atherosclerotic plaques. The purpose of this study was to correlate the FDG uptake in the left anterior descending coronary artery (LAD) with cardiovascular risk factors, pericardial fat volume (PFV) and calcified plaque burden (CPB). METHODS: A total of 292 consecutive tumour patients were examined by whole-body FDG PET and contrast-enhanced CT. The blood pool-corrected standardized uptake value (target to background ratio, TBR) was measured in the LAD, and the contrast-enhanced CT images were used to measure the PFV and the CPB. The Spearman correlation coefficient and the unpaired t test were used for statistical comparison between image-based results and cardiovascular risk factors. RESULTS: Vascular FDG uptake could be measured for 161 of 292 (55%) patients without myocardial uptake, but the vessel uptake could not be distinguished in the other patients, due to pervasive myocardial uptake. The TBR of the LAD showed significant correlations with hypertension (R = 0.18; p < 0.05), coronary heart disease (R = 0.19; p < 0.05), body mass index (BMI) (R = 0.19; p < 0.05), CPB (R = 0.36; p < 0.001) and PFV (R = 0.20; p < 0.05), but not with other risk factors. Patients with a TBR in the upper tertile had a larger CPB and a higher PFV than patients with a TBR in the lower tertile (9.1 vs 3.5; p < 0.001 for CPB and 92.2 vs 71.5 mm(3); p < 0.05 for PVF). CONCLUSION: FDG uptake measurement in the LAD correlates with hypertension, coronary heart disease, BMI, PFV and CPB. However, due to myocardial FDG uptake these measurements are only feasible in one half of the patients.

Pericardial adipose tissue determined by dual source CT is a risk factor for coronary atherosclerosis.

OBJECTIVES: Pericardial fat as a visceral fat depot may be involved in the pathogenesis of coronary atherosclerosis. To gain evidence for that concept we sought to investigate the relation of pericardial fat volumes to risk factors, serum adiponectin levels, inflammatory biomarkers, and the quantity and morphology of coronary atherosclerosis. METHODS AND RESULTS: Using Dual source CT angiography pericardial fat volume and coronary atherosclerosis were assessed simultaneously. Plaques were classified as calcified, mixed, and noncalcified, and the number of affected segments served as quantitative score. Patients with atherosclerotic lesions had significant larger PAT volumes (226 cm3+/-92 cm3) than patients without atherosclerosis (134 cm3+/-56 cm3; P>0.001). No association was found between BMI and coronary atherosclerosis. PAT volumes >300 cm3 were the strongest independent risk factor for coronary atherosclerosis (odds ratio 4.1; CI 3.63 to 4.33) also significantly stronger compared to the Framingham score. We furthermore demonstrated that elevated PAT volumes are significantly associated with low adiponectin levels, low HDL levels, elevated TNF-alpha levels, and hsCRP. CONCLUSION: In the present study we demonstrated that elevated PAT volumes are associated with coronary atherosclerosis, hypoadiponectinemia, and inflammation and represent the strongest risk factor for the presence of atherosclerosis and may be important for risk stratification and monitoring.

MMP-1 serum levels predict coronary atherosclerosis in humans.

BACKGROUND: Myocardial infarction results as a consequence of atherosclerotic plaque rupture, with plaque stability largely depending on the lesion forming extracellular matrix components. Lipid enriched non-calcified lesions are considered more instable and rupture prone than calcified lesions. Matrix metalloproteinases (MMPs) are extracellular matrix degrading enzymes with plaque destabilisating characteristics which have been implicated in atherogenesis. We therefore hypothesised MMP-1 and MMP-9 serum levels to be associated with non-calcified lesions as determined by CT-angiography in patients with coronary artery disease. METHODS: 260 patients with typical or atypical chest pain underwent dual-source multi-slice CT-angiography (0.6-mm collimation, 330-ms gantry rotation time) to exclude coronary artery stenosis. Atherosclerotic plaques were classified as calcified, mixed or non-calcified. RESULTS: In multivariable regession analysis, MMP-1 serum levels were associated with total plaque burden (OR: 1.37 (CI: 1.02-1.85); p < 0.05) in a model adjusted for age, sex, BMI, classical cardiovascular risk factors, hsCRP, adiponectin, pericardial fat volume and medication. Specification of plaque morphology revealed significant association of MMP-1 serum levels with non-calcified plaques (OR: 1.16 (CI: 1.0-1.34); p = 0.05) and calcified plaques (OR: 1.22 (CI: 1,03-1.45); p < 0.05) while association with mixed plaques was lost in the fully adjusted model. No associations were found between MMP9 serum levels and total plaque burden or plaque morphology. CONCLUSION: MMP-1 serum levels are associated with total plaque burden but do not allow a specification of plaque morphology.

Predictive value of coronary calcifications for future cardiac events in asymptomatic patients: underestimation of risk in asymptomatic smokers.

Coronary calcification (CAC) is an established marker for coronary atherosclerosis and has a highly specific predictive value for cardiovascular events. This study aimed to determine the predictive value in the specific group of asymptomatic smokers in comparison to non-smokers. We included 1432 asymptomatic individuals (575 women, 857 men, age 59.2 ± 7.7 years.) in this study. Coronary calcification was calculated by multi-slice computed tomography following a standardized protocol including calcium score (CS). Coronary risk factors were determined at inclusion. After mean observation time of 76.3 ± 8.5 months the patients were contacted and evaluated for cardiovascular events (myocardial infarction, cardiac death and revascularisation). Mean CS was 231 ± 175 in smokers and 239 ± 188 in non-smokers. Cardiovascular events were found in 14.9% of our patients and there were significantly more events in smokers (119 events, 8.3%) than in non-smokers (94 events, 6.6%, p = 0.001). CS > 400 showed a hazard ratio for future cardiac events of 5.1 (95% CI 4.3-7.6) in smokers and 4.4 (95% CI 3.4-6.2) in non-smokers, p = 0.01. Also in smokers determination of CAC is a valuable predictor of future cardiovascular events. In our study smokers showed throughout all score groups a significantly higher risk compared to non-smokers with equal CS. Therefore, CS may underestimate the risk for future cardiac events in smokers compared to non-smokers.

Emergency treatment of decompensated aortic stenosis.

OBJECTIVE: The optimal treatment of patients with acute and severe decompensation of aortic stenosis is unclear due to recent advances in transcatheter interventions and supportive therapies. Our aim was to assess the early outcome of emergency transcatheter aortic valve implantation (eTAVI) versus emergency balloon aortic valvuloplasty (eBAV) followed by TAVI under elective circumstances. METHODS: Emergency conditions were defined as: cardiogenic shock with requirement of catecholamine therapy, severe acute dyspnoea (NYHA IV), cardiac resuscitation or mechanic respiratory support. The data were collected according to the Valve Academic Research Consortium 2 (VARC-2) criteria. RESULTS: In five German centres, 23 patients (logistic Euroscore 37.7%±18.1) underwent eTAVI and 118 patients underwent eBAV (logistic Euroscore 35.3%±20.8). In the eTAVI group, immediate procedural mortality was 8.7%, compared with 20.3% for the eBAV group (p=0.19). After 30 days, cardiovascular mortality for the eTAVI group was 23.8% and for the eBAV group 33.0% (p=0.40). Analyses adjusting for potential confounders did not provide evidence of a difference between groups. Of note, the elective TAVI performed after eBAV (n=32, logistic Euroscore 25.9%±13.9) displayed an immediate procedural mortality of 9.4% and a cardiovascular mortality after 30 days of 15.6%. Major vascular complications were significantly more likely to occur after eTAVI (p=0.01) as well as stroke (p=0.01). CONCLUSION: In this multicentre cohort, immediate procedural and 30-day mortality of eTAVI and eBAV were high, and mortality of secondary TAVI subsequent to eBAV was higher than expected. Randomised study data are required to define the role of emergency TAVI in tertiary care centres with current device generations.

One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation.

AIMS: In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. METHODS AND RESULTS: From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p<0.001), closure device failure (0.8% vs. 2.3%, p=0.04), any bleeding (BARC: 36.8% vs. 53.9%, p<0.001; VARC-2: 30.8% vs. 34.9%, p=0.59). Furthermore, one-year mortality was significantly lower in the ProGlide SMCD group, 14.8% vs. 19.5% in the Prostar SMCD group, log-rank p=0.04. However, VARC-2 major vascular complications but not ProGlide use were identified as an independent predictor of one-year mortality (adjusted odds ratio 1.54, 95% CI: 1.01-2.34 and 1.01, 95% CI: 0.65-1.55, respectively). CONCLUSIONS: In this analysis, the use of ProGlide SMCD was associated with a reduced risk of vascular and bleeding complications following TAVI compared to Prostar SMCD usage. However, major vascular complications but not ProGlide use did independently predict long-term mortality.

Bivalirudin vs Heparin in Patients Who Undergo Transcatheter Aortic Valve Implantation.

BACKGROUND: We aimed to compare safety and efficacy of the direct thrombin inhibitor bivalirudin with unfractionated heparin (UFH) during transcatheter aortic valve implantation (TAVI). METHODS: In this retrospective analysis, 461 patients underwent TAVI between 2007 and 2012; 339 patients received bivalirudin, and 122 patients received UFH. In the bivalirudin group, the Sapien XT valve was implanted in 159 (46.9%) patients, and 180 (53.1%) received a Medtronic CoreValve. In the UFH group, only the Medtronic CoreValve was implanted. The primary outcome of interest was the incidence of any bleeding. Secondary outcomes of interest were all-cause mortality and cardiovascular mortality at 72 hours after the procedure and at 30 days. RESULTS: No significant difference between the groups was observed for life-threatening bleeding (2.4% for bivalirudin vs 3.3% for UFH; P = 0.59), major bleeding (8.3% vs 8.2%, respectively; P = 0.98) and minor bleeding (8.3% vs 7.4%, respectively; P = 0.76). At 72 hours after the procedure, all-cause mortality was 3.0% in the bivalirudin group and 3.3% for the UFH group (P = 0.88), whereas cardiovascular mortality was 3.0% in the bivalirudin group and 2.5% in the heparin group (P = 0.77). At 30 days, all-cause mortality was 5.3% vs 4.1% in the bivalirudin and heparin groups (P = 0.57) and cardiovascular mortality was 4.4% vs 2.5% (P = 0.33). Device success (Valve Academic Research Consortium 2 composite end point) was 94.0% in the bivalirudin-treated and 92.6% in the UFH-treated patients (P = 0.60). The early safety at 30 days was 85.3% in the bivalirudin-treated group compared with 83.6% in the UFH-treated group (P = 0.65). CONCLUSIONS: Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure.

Aortic regurgitation with second versus third-generation balloon-expandable prostheses in patients undergoing transcatheter aortic valve implantation.

AIMS: Our aim was to assess the incidence of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the second (SXT) versus third-generation (S3) balloon-expandable SAPIEN prosthesis in patients with symptomatic aortic stenosis (AS). METHODS AND RESULTS: Of 634 patients undergoing TAVI in our centre from May 2010 to July 2014, 354 were treated with the SXT and 100 with the S3 prosthesis. The primary outcome was the incidence of more-than-mild post-TAVI AR at discharge. Secondary outcomes were 30-day incidence of all-cause death, any bleeding complications and need for new pacemaker. The incidence of the primary outcome was 2.0% vs. 8.8%, p<0.01 with S3 compared to SXT, and S3 use was the only independent predictor of post-TAVI AR (odds ratio 0.54; 95% CI: 0.33 to 0.89). At 30 days, there were no differences in mortality (1.0% vs. 4.2%, p=0.13) and pacemaker rate (12.0% vs. 10.5%, p=0.59) between S3 and SXT. S3-treated patients less frequently had bleeding complications (24.0% vs. 41.8%, p<0.01) and more often had permanent new left bundle branch block (22.0% vs. 7.1%, p<0.001). CONCLUSIONS: Compared to the SXT, the use of the S3 prosthesis substantially reduces post-TAVI aortic regurgitation. Longer follow-up is needed to assess if this finding translates to better clinical outcomes.

Transcutaneous aortic valve replacement with the Edwards SAPIEN XT and Medtronic CoreValve prosthesis under fluoroscopic guidance and local anaesthesia only.

OBJECTIVE: To assess the feasibility of transcatheter aortic valve implantation (TAVI; Medtronic CoreValve and Edwards SAPIEN XT) under local anaesthesia with only mild analgesic medication and fluoroscopic guidance. METHODS: 461 patients underwent TAVI under local anaesthesia with lidocaine. The procedure was performed successfully in 459 of the cases. All patients were also treated with piritramide, metoclopramide hydrochloride and 62 mg dimenhydrinate. Monitoring consisted of a six-electrode, virtual 12-lead ECG, pulse oximetry, and invasive arterial pressure measurement. There was no continuous surveillance by an anaesthesiologist. RESULTS: There was no need for conversion to general anaesthesia except in four patients who required cardiopulmonary resuscitation. Conscious sedation with intravenous administration of midazolam for agitation or inotropic medication for prolonged hypotension was necessary in only seven of the 461 patients. The combined safety end point according to the Valve Academic Research Consortium consensus document was reached in 12.6%. CONCLUSIONS: Our results show that TAVI performed under local anaesthesia with only mild analgesic medication and under fluoroscopic guidance is feasible, with good outcome comparable to published data.

Use of multi-slice computed tomography in patients with chest-pain submitted to the emergency department.

This study evaluates calcium scoring (CS) and computed tomography angiography (MSCTA) in patients >50 years with chest-pain submitted to the emergency department utilising CS as a "diagnostic filter" upfront. Results of CS and MSCTA performed by a 64-slice CT scanner were compared to invasive coronary angiography (ICA). 289 consecutive symptomatic patients (185 men, mean age 71.3 ± 6.4 years) were included. In patients with CS = 0 (Group I; n = 60) or CS > 400 (Group III; n = 95) we refrained from MSCTA, whereas patients with CS 1-400 (Group II; n = 134) underwent subsequent MSCTA. ICA detected significant coronary artery disease (CAD) in 162 patients (56.1%; male 98). None of Group I-patients showed CAD, but in Group III CAD prevalence increased to 82.1%. In Group II, MSCTA correctly identified 177/190 significantly diseased vessel segments. Compared to CS alone, our approach increased sensitivity to 98.1% (+1.8%), specificity to 82.6% (+27.5%) and negative predictive value (NPV) to 97.2% (+5.1%) as well as positive predictive value to 87.8% (+14.6%), respectively. Overall DA was 91.3%. Stratification of symptomatic patients into three different risk groups according to CS results with concomitantly increasing disease prevalence is possible. Zero calcium was found to exclude significant CAD, but needs further evaluation. Still server calcifications impair image quality in MSCTA. Thus direct referral to ICA might be a reasonable approach in case of high CS. In patients with intermediate CS, MSCTA is able to rule out significant CAD with a high NPV.