Modular and Cost-Effective Computed Tomography Design.

We present a modular and cost-effective gamma ray computed tomography system for multiphase flow investigations in industrial apparatuses. It mainly comprises a 137Cs isotopic source and an in-house-assembled detector arc, with a total of 16 scintillation detectors, offering a quantum efficiency of approximately 75% and an active area of 10 × 10 mm2 each. The detectors are operated in pulse mode to exclude scattered gamma photons from counting by using a dual-energy discrimination stage. Flexible application of the computed tomography system, i.e., for various object sizes and densities, is provided by an elaborated detector arc design, in combination with a scanning procedure that allows for simultaneous parallel beam projection acquisition. This allows the scan time to be scaled down with the number of individual detectors. Eventually, the developed scanner successfully upgrades the existing tomography setup in the industry. Here, single pencil beam gamma ray computed tomography is already used to study hydraulics in gas-liquid contactors, with inner diameters of up to 440 mm. We demonstrate the functionality of the new system for radiographic and computed tomographic scans of DN110 and DN440 columns that are operated at varying iso-hexane/nitrogen liquid-gas flow rates.

[Psychiatric symptoms of Huntington's disease]. / Psychiatrische Symptome der Huntington-Krankheit.

Huntington's disease (HD) is an autosomal dominant inherited disease, which leads to motor, cognitive and psychiatric symptoms. The diagnosis can be confirmed by genetic testing for extended CAG repeats in the Huntingtin gene. Mental and behavioral symptoms are common in HD and can appear several years before the onset of motor symptoms. The psychiatric symptoms include apathy, depression, anxiety, obsessive-compulsive symptoms and, in some cases, psychoses and aggression. These are currently restricted to symptomatic treatment as disease-modifying treatment approaches are still under investigation. The current clinical practice is based on expert opinions as well as experience with the treatment of similar symptoms in other neurological and mental health diseases. This article provides an overview of the complex psychiatric manifestations of HD, the diagnostic options and the established pharmacological and nonpharmacological treatment approaches.

Safety and acute efficacy of cryoballoon ablation for atrial fibrillation at community hospitals.

AIMS: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is an established procedure for treating symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI performed at community hospitals are unknown. We aimed to determine the safety and acute efficacy of PVI using CBA performed at community hospitals with limited annual case numbers. METHODS AND RESULTS: This registry study included 1004 consecutive patients who had PVI performed for symptomatic paroxysmal (n = 563) or persistent AF (n = 441) from January 2019 to September 2020 at 20 hospitals. Each hospital performed fewer than 100 CBA-PVI procedures/year according to local standards. Procedural data, efficacy, and complication rates were determined. The mean number of CBA procedures performed/year at each centre was 59 ± 25. The average procedure time was 90.1 ± 31.6 min and the average fluoroscopy time was 19.2 ± 11.4 min. Isolation of all pulmonary veins was documented in 97.9% of patients. The most frequent reason for not achieving complete isolation was development of phrenic nerve palsy. No hospital deaths were observed. Two patients (0.2%) suffered a clinical stroke. Pericardial effusion occurred in six patients (0.6%), two of whom (0.2%) required pericardial drainage. Vascular complications occurred in 24 patients (2.4%), two of whom (0.2%) required vascular surgery. Phrenic nerve palsy occurred in 48 patients (4.8%) and persisted up to hospital discharge in six patients (0.6%). CONCLUSION: Pulmonary vein isolation procedures for paroxysmal or persistent AF using CBA can be performed at community hospitals with high acute efficacy and low complication rates.

Aborted sudden cardiac death due to ventricular fibrillation in a female patient with mitral valve prolapse.

BACKGROUND: Mitral valve prolapse is the most frequent valvular defect associated with a wide range of electro-hemodynamic abnormalities, leading to heart failure, arrhythmias and sudden cardiac death. Mitral valve prolapse, first described from Barlow in the 1960s, is defined as displacement of mitral leaflet tissue into the left atrium past the mitral annular plane during systole. The correlation between mitral valve prolapse and sudden cardiac death has been investigated and clarified by various studies in recent years. However, identifying patients at risk and applying measures to prevent those from sudden cardiac death is challenging. CASE PRESENTATION: We report on a 61-year-old female patient who had undergone an aborted sudden cardiac death. An arrythmogenic mitral valve prolapse was diagnosed. In addition, electrocardiographically and morphologically risk markers for sudden cardiac death were found in this case. We performed an ICD implantation as secondary prophylaxis and intended to reconstruct the mitral valve. CONCLUSION: This article examines the association of mitral valve prolapse with sudden cardiac death, the underlying pathophysiological mechanisms and the strategies leading to identify the risk group.

Quantification of tricuspid regurgitation area by 3-dimensional color Doppler echocardiography considering different clinical settings.

PURPOSE: The precise assessment of tricuspid regurgitation (TR) using 2D imaging techniques may be associated with significant difficulties due to the nonround regurgitation area. Direct analysis of the regurgitation area by 3D color Doppler echocardiography at the vena contracta (3D VCA) has the potential to adequately quantify even complex TR. This study compared 3D VCA for quantification of the TR with the regurgitant area determined by proximal isovolumetric convergence method (PISA-EROA) considering different clinical settings. METHODS: In 95 patients with TR of different severity, the regurgitant orifice area was determined by 3D color Doppler echocardiography and by PISA-EROA. Using 3D color Doppler echocardiography, the regurgitant orifice area was determined three times in each patient considering 3 datasets. RESULTS: Mean 3D VCA was 0.27 ± 0.14, 0.27 ± 0.13, and 0.29 ± 0.14 cm2 , respectively, as determined by three separate measurements in each of the 95 patients. There was a mean relative deviation between the three measurements in each patient of 12.4 ± 14.9%. The regurgitant orifice area using the PISA method was 0.28 ± 0.14 cm2 . There was a mean difference of 0.07 cm2 (95% CI -0.124 to 0.138 cm2 ) between 3D VCA and PISA-EROA. The correlation between 3D VCA and PISA-EROA was r = .88 (P < .001). Considering a grading of TR severity in grade I (regurgitant area < 0.2 cm2 ), grade II (area 0.2-0.4 cm2 ), and grade III (area > 0.4 cm2 ), there was a good agreement between severity grade determined by 3D VCA and severity grade determined by PISA-EROA (kappa 0.71). CONCLUSION: The analysis of the VCA of a TR using 3D color Doppler echocardiography is an alternative method to determine the regurgitant severity with good agreement to the PISA method.

Screening for Hazardous Drinking in Nursing Home Residents: Evaluating the Validity of the Current Cutoffs of the Alcohol Use Disorder Identification Test-Consumption Questions by Using Ethyl Glucuronide in Hair.

BACKGROUND: Because of physiological changes, elderly people are much more exposed to the adverse effects of alcohol. Therefore, hazardous drinking is defined at lower levels as compared to younger adults. This work aimed to evaluate the validity of the current cutoff levels of the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) questions to detect hazardous drinking in the elderly by using ethyl glucuronide in hair (HEtG). METHODS: In a border region between Austria and Germany, 344 nursing home residents were included from 33 of the 107 nursing homes. Residents were asked to answer the AUDIT-C questions, hair samples were obtained, and nursing staff members were asked for their assessments of the residents' alcohol consumption. Hair samples were analyzed for HEtG using gas chromatography-mass spectrometry. Receiver-operating characteristic (ROC) curve analysis was performed to determine the validity of cutoff values for the AUDIT-C to detect an alcohol consumption of ≥10 g of alcohol/d. RESULTS: A total of 11.3% of the nursing home residents (n = 344) drank ≥10 g of alcohol/d (4.9% >60 g of alcohol/d, 6.4% 10 to 60 g of alcohol/d, 88.7% <10 g of alcohol/d)). For the drinking limit of ≥10 g of alcohol/d, ROC curve analysis showed a balanced sensitivity and specificity, with an AUDIT-C cutoff of ≥4 for men (sensitivity: 70%, specificity: 83.6%; AUC = 0.823, CI = 0.718 to 0.928, p < 0.001) and ≥2 for women (sensitivity: 73.7%, specificity: 81.9%; AUC = 0.783, CI = 0.653 to 0.914, p < 0.001). Nursing staff (n = 274) underestimated alcohol consumption and evaluated 40% of the chronic-excessive alcohol consumers (>60 g of alcohol/d) as being abstinent. CONCLUSIONS: Our data suggest that an AUDIT-C cutoff of ≥4 for men and ≥2 for women can be recommended to detect the consumption of ≥10 g of alcohol/d in the elderly. Because the nursing staff to a large extent underestimates the alcohol consumption among nursing home residents, further teaching of the staff, improvement of screening instruments for the elderly, and the use of objective biomarkers might be helpful for recognizing hazardous drinking and can thus help improve the quality of life of the elderly.

Image noise reduction technology allows significant reduction of radiation dosage in cardiac device implantation procedures.

BACKGROUND: Novel x-ray systems with real-time image noise reduction technology (INRT) to reduce radiation dose during fluoroscopy and cine acquisition have become available. This study evaluated the reduction of radiation dose in device implantation with INRT. METHODS: Radiation dose data from 132 consecutive new device implantation procedures (102 pacemaker [PM] or implantable cardioverter defibrillator [ICD] and 30 cardiac resynchronization therapy [CRT] devices) performed between January 2015 and December 2015 on an angiography system with INRT (Allura ClarityIQ) were collected. For comparison, radiation dose data from 147 consecutive device implantation procedures (121 PM/ICDs and 26 CRT devices) performed between June 2013 and September 2014 on a C-arm system with continuous and pulsed fluoroscopy option (4 frames/second) were evaluated. Total dose area product (DAP), fluoroscopy DAP, and cine DAP were evaluated. RESULTS: Patient age, gender and body weight, procedure, and fluoroscopy times were similar between systems. In PM/ICD cases, DAP of INRT and C-arm system was similar (423 ± 381 cGycm2  vs 417 ± 517 cGycm) due to pulsed fluoroscopy with the C-arm system (78% of time) and sparse use of cine. In CRT procedures requiring higher image quality (82% use of continuous fluoroscopy with C-arm system), DAP of INRT was significantly lower (1,544 ± 834 cGycm vs 7,252 ± 6,431 cGycm, P < 0.001) due to less fluoroscopy DAP (1,414 ± 757 cGycm vs 5,854 ± 6,767 cGycm) and less cine DAP (130 ± 106 cGycm vs 1,399 ± 1,342 cGycm). Considering all procedures, total DAP was reduced by 60% using INRT. CONCLUSION: Novel INRT results in a substantial lowering of radiation dose in device implantation, in particular, in complex CRT implantation procedures requiring high image quality.

Echogenicity of basal ganglia structures in different Huntington's disease phenotypes.

In Huntington's disease (HD), a neurodegenerative-inherited disease, chorea as the typical kind of movement disorder is described. Beside chorea, however, all other kinds of movement disturbances, such as bradykinesia, dystonia, tremor or myoclonus can occur. Aim of the current study was to investigate alterations in the echogenicity of basal ganglia structures in different Huntington's disease phenotypes. 47 patients with manifest and genetically confirmed HD were recruited. All participants underwent a thorough neurological examination. According to a previously described method, classification into predominantly choreatic, mixed or bradykinetic-rigid motor phenotypes was performed depending on subscores of the Unified Huntington's Disease Rating Scale. In addition, findings in juvenile HD were compared to adult HD. Transcranial sonography was performed by investigators blinded to clinical classification. There were no significant differences in basal ganglia echogenicities between the three phenotypes. Size of echogenic area of substantia nigra (SN) correlated positively with CAG repeat and bradykinesia subscore, and negatively with age of onset and chorea subscore. Comparing juvenile and adult HD subtypes, SN hyperechogenicity was significantly more often detectable in the juvenile form (100 vs. 29.3 %, p = 0.002). Regarding echogenicity of caudate or lentiform nuclei, no significant differences were detected. HD patients with the juvenile variant exhibit marked hyperechogenicity of substantia nigra. No significant differences in basal ganglia echogenicities between predominantly choreatic, mixed or bradykinetic-rigid motor phenotypes were detected.

Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study.

AIM: Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres. METHODS AND RESULTS: Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively. CONCLUSION: The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.

Progressive hepatic mitochondrial dysfunction in premanifest Huntington's disease.

BACKGROUND: A subclinical, hepatic involvement in manifest and premanifest Huntington's disease (HD) was recently demonstrated by using the (1) (3) C-methionine breath test (MeBT). In this longitudinal pilot study, we investigated whether there is evidence for progressive hepatic mitochondrial dysfunction in premanifest HD. METHODS: The MeBT was performed within a group of 25 well-characterized premanifest HD mutation carriers at baseline and in a 14.5-month follow-up. RESULTS: The total group of mutation carriers (P = 0.033; Cohen's d = 0.6) and the subgroup of mutation carriers from our PreHD-B subgroup (nearer to disease onset; P = 0.030; Cohen's d = 1.12) revealed a lower amount of exhaled (13) CO2 in the follow-up. CONCLUSIONS: This study demonstrates in vivo progressive, subclinical, hepatic involvement in premanifest HD. Limitations of the study, such as high variance in breath test results, are discussed.

Paclitaxel-eluting balloon versus everolimus-eluting stent for treatment of drug-eluting stent restenosis.

OBJECTIVE: Drug-eluting stent (DES) implantation is a very effective treatment of bare-metal stent-in-stent restenosis (BMS-ISR). Therapeutic options for drug-eluting stent-in-stent restenosis (DES-ISR) are less well defined, as there are only few data on safety and effectiveness of interventional modalities. This study compared the 1-year clinical outcome after the use of drug-eluting balloon (DEB) to second-generation everolimus-eluting stent (EES) for treatment of DES-ISR. METHODS: This observational study included 86 patients with 86 DES-ISR. Forty patients were treated by repeat percutaneous coronary intervention (PCI) using an EES. Forty-six patients were treated by repeat PCI using a DEB. Follow-up periods were 22 ± 11 and 25 ± 19 months, respectively. The primary endpoint of the study was survival free of major adverse cardiac events (MACEs) at 1 year. Secondary endpoints were needed for target lesion revascularization (TLR), definite stent thrombosis (ST) at 1 year, and MACE rate during total follow-up period. RESULTS: Baseline clinical and angiographic parameters were comparable between the two groups. EES were associated with a higher MACE rate at 1 year compared to DEB (27.5 vs. 8.6%, respectively; P = 0.046). TLR rates for EES and DEB were 22.5% versus 4.3%, respectively, P = 0.029, while rates of definite ST at 1 year follow-up were comparable (2.5% vs. 0%, respectively; P = 0.945). There were no differences in myocardial infarction rates between the two groups (5% vs. 2%, respectively; P = 0.595) and in mortality. Considering the complete follow-up periods, DEB were associated with significantly less MACE compared to EES (log-rank test, P = 0.045). Furthermore, comparison of TLR rates showed a strong trend in favor of DEB compared to EES (P = 0.074). CONCLUSIONS: Treatment of DES-ISR using a DEB is associated with favorable rates of MACE and TLR at 1-year follow-up compared to the implantation of an EES.

Optical coherence tomography derived differences of plaque characteristics in coronary culprit lesions between type 2 diabetic patients with and without acute coronary syndrome.

OBJECTIVE: To compare optical coherence tomography (OCT)-derived plaque characteristics of coronary target lesions between diabetic patients with acute coronary syndrome (ACS) versus stable angina pectoris (SAP). BACKGROUND: In vivo assessment of plaque composition of coronary culprit lesions in a cardiovascular high-risk population with diabetes mellitus is incompletely elucidated. METHODS: 102 diabetic patients with coronary de novo lesions were enrolled and categorized into an ACS-group (40 patients) and a SAP-group (62 patients) according to their clinical presentation. Assessment of clinical data, angiographic, and OCT imaging including the analysis of plaque composition and lipid content of the target lesions were performed prior to percutaneous coronary intervention and compared between the two groups. RESULTS: Plaque characteristics of patients in the ACS-group compared with the SAP-group showed a higher incidence of lipid-rich plaque [33 (82.5%) vs. 25 (40.3%)], thin-capped fibroatheroma [29 (72.5%) vs. 10 (16.1%)], macrophage infiltration [32 (80.0%) vs. 21 (33.9%)], thrombus [23 (57.5%) vs. 2 (3.2%)], and plaque rupture [27 (67.5%) vs. 2 (3.2%)] (all P < 0.001). Moreover, there was a wider lipid arc (174.5 ± 33.8° vs. 122.9 ± 43.9°), a longer lipid plaque length (6.52 ± 2.04 mm vs. 3.73 ± 2.16 mm), a greater lipid volume index (1117.2 ± 349.9 vs. 504.8 ± 379.3), and a smaller minimal fibrous cap thickness (51.52 ± 9.14 µm vs. 80.33 ± 26.71 µm) within lipid-rich lesions of ACS patients (all P < 0.001). CONCLUSION: Diabetic patients with ACS exhibit more vulnerable plaque features in coronary culprit lesions compared with diabetic patients with SAP. This may provide rationale for a specific therapeutic strategy either by pharmacological plaque stabilization or coronary intervention in any lesion with vulnerable plaque morphology in patients with diabetes.

Impaired motor speech performance in Huntington's disease.

Dysarthria is a common symptom of Huntington's disease and has been reported, besides other features, to be characterized by alterations of speech rate and regularity. However, data on the specific pattern of motor speech impairment and their relationship to other motor and neuropsychological symptoms are sparse. Therefore, the aim of the present study was to describe and objectively analyse different speech parameters with special emphasis on the aspect of speech timing of connected speech and non-speech verbal utterances. 21 patients with manifest Huntington's disease and 21 age- and gender-matched healthy controls had to perform a reading task and several syllable repetition tasks. Computerized acoustic analysis of different variables for the measurement of speech rate and regularity generated a typical pattern of impaired motor speech performance with a reduction of speech rate, an increase of pauses and a marked disability to steadily repeat single syllables. Abnormalities of speech parameters were more pronounced in the subgroup of patients with Huntington's disease receiving antidopaminergic medication, but were also present in the drug-naïve patients. Speech rate related to connected speech and parameters of syllable repetition showed correlations to overall motor impairment, capacity of tapping in a quantitative motor assessment and some score of cognitive function. After these preliminary data, further investigations on patients in different stages of disease are warranted to survey if the analysis of speech and non-speech verbal utterances might be a helpful additional tool for the monitoring of functional disability in Huntington's disease.

Speech Biomarkers in Huntington's Disease: A Longitudinal Follow-Up Study in Premanifest Mutation Carriers.

Speech alterations have been reported in manifest Huntington's disease (HD) and premanifest mutation carriers (preHD). The aim of our study was to explore these alterations in preHD and whether they can be used as biomarkers. 13 preHD mutation carriers performed reading task, sustained phonation task and syllable repetition tasks at baseline and after 21 months, as well as clinical examination and MRI. Syllable repetition capacity and self-chosen velocity of single syllable repetition differed significantly between time points. There were no changes in clinical ratings or MRI volumetry. Measurements of speech might be sensitive tools for monitoring subclinical changes in preHD.

Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial.

OBJECTIVES: PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). BACKGROUND: Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. METHODS: Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. RESULTS: A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm(2) or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m (P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm(2) (P = .001) and less prior history of myocardial infarction (P = .02), coronary artery bypass surgery (P = .03), and ischemic MR (P = .04). CONCLUSIONS: Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.

Transcatheter aortic valve-in-valve implantation of a CoreValve in a degenerated stenotic Sapien heart valve prosthesis.

Treatment options for re-stenotic aortic valve prosthesis implanted by transcatheter technique have not been evaluated systematically. We describe the case of a 75-year-old dialysis patient who was treated by transcatheter aortic valve implantation 3.5 years ago and now presented with severe stenosis of the percutaneous heart valve. The patient was initially treated with a trans-apical implantation of an Edwards Sapien 26 mm balloon expandable valve. The patient remained asymptomatic for 3 years when he presented with increasing shortness of breath and significant calcification of the valve prosthesis on transesophageal echocardiography. Valve-in-valve percutaneous heart valve implantation using a 26-mm CoreValve prosthesis was performed under local anesthesia. The prosthesis was implanted without prior valvuloplasty. Pacing with a frequency of 140/min was applied during placement of the valve prosthesis. Positioning was done with great care using only fluoroscopic guidance with the aim to have the ventricular strut end of the CoreValve prosthesis 5 mm higher than the ventricular strut end of the Edwards Sapien prosthesis. After placement of the CoreValve prosthesis within the Edwards Sapien valve additional valvuloplasty with rapid pacing was performed in order to further expand the CoreValve prosthesis. The final result was associated with a remaining mean gradient of 5 mm Hg and no aortic regurgitation. In conclusion, implantation of a CoreValve prosthesis for treatment of a restenotic Edwards Sapien prosthesis is feasible and is associated with a good functional result.

Impact of aortic valve calcification severity and impaired left ventricular function on 3-year results of patients undergoing transcatheter aortic valve replacement.

OBJECTIVES: To evaluate clinical pre-interventional predictors of 3-year outcome and mortality in high-risk patients with severe aortic valve stenosis treated with transcatheter aortic valve implantation (TAVI). METHODS: Among 367 patients included in the Aachen TAVI registry, 76 patients with baseline dual-source computed tomography (DSCT) for the quantification of aortic valve calcification (AVC) and a 3-year follow-up were identified. RESULTS: Survival at 30 days was 91 %, and it was 75 %, 66 % and 64 % at 1, 2 years and 3 years, respectively. Non-survivors at 3 years showed a significantly higher Agatston AVC score (2,854 ± 1,651) than survivors (1,854 ± 961, P = 0.007). Multivariate analysis including age, logistic EuroScore, glomerular filtration rate, Agatston AVC score, ejection fraction < 40 %, NYHA class, baseline medication, chronic lung disease and aortic regurgitation revealed that only the Agatston AVC score (P = 0.03) and impaired left ventricular function (P = 0.001) was significantly associated with mortality. Patients with Agatston AVC scores >2,000 had a significantly lower 3-year survival rate compared with patients with scores <2,000 (47 % vs 79 %, P = 0.004). CONCLUSIONS: In patients referred for TAVI, aortic valve calcification severity and impaired left ventricular function may serve as a predictor of long-term mortality. Therefore, AVC scores easily determined from pre-procedural CT datasets may be used for patient risk stratification.

Two-year mortality after transcatheter aortic valve implantation versus medical therapy for high-surgical risk or inoperable aortic stenosis patients.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for the treatment of high-risk or inoperable patients with symptomatic severe aortic stenosis. The study aim was to compare the two-year mortality of high-risk or inoperable patients treated by TAVI compared to medical therapy, in a single-center setting. METHODS: A total of 135 consecutive patients (58 males, 77 females; mean age 80 +/- 6 years; logistic EuroSCORE 21 +/- 13%) who had undergone TAVI was compared to 135 patients (60 males, 75 females; mean age 79 +/- 3 years; logistic EuroSCORE 21 +/- 19%) who had undergone medical treatment before TAVI became available. The one- and two-year follow up mortalities were recorded for each group. In the TAVI group, the patient characteristics were analyzed for predictors of mortality. RESULTS: Sixteen patients (12%) in the TAVI group and 10 (7%) in the medically treated group died within 30 days of intervention or presentation (p = 0.303). At the one-year follow up, 28 TAVI patients (21%) and 69 medically treated patients (41%) died (p < 0.001). At the two-year follow up, 41 TAVI patients (30%) and 80 medically treated patients (59%) died (p < 0.001). Log-rank analysis demonstrated a significant survival benefit after TAVI compared to medical treatment during the total follow up period. Univariate predictors of death at the two-year follow up included medical therapy, logistic EuroSCORE, and pulmonary hypertension. Medical therapy remained the only independent predictor of two-year mortality in a multivariate analysis (OR 3.343; 95% CI 2.021-6.234, p < 0.001). CONCLUSION: In high-surgical risk or inoperable symptomatic aortic stenosis patients, the one- and two-year follow up mortalities of patients treated with TAVI was significantly lower than after medical therapy. Predictors of mortality, in addition to treatment strategy, were pulmonary hypertension and EuroSCORE.

Development and characterization of a coronary polylactic acid stent prototype generated by selective laser melting.

In-stent restenosis is still an important issue and stent thrombosis is an unresolved risk after coronary intervention. Biodegradable stents would provide initial scaffolding of the stenosed segment and disappear subsequently. The additive manufacturing technology Selective Laser Melting (SLM) enables rapid, parallel, and raw material saving generation of complex 3- dimensional structures with extensive geometric freedom and is currently in use in orthopedic or dental applications. Here, SLM process parameters were adapted for poly-L-lactid acid (PLLA) and PLLA-co-poly-ε-caprolactone (PCL) powders to generate degradable coronary stent prototypes. Biocompatibility of both polymers was evidenced by assessment of cell morphology and of metabolic and adhesive activity at direct and indirect contact with human coronary artery smooth muscle cells, umbilical vein endothelial cells, and endothelial progenitor cells. γ-sterilization was demonstrated to guarantee safety of SLM-processed parts. From PLLA and PCL, stent prototypes were successfully generated and post-processing by spray- and dip-coating proved to thoroughly smoothen stent surfaces. In conclusion, for the first time, biodegradable polymers and the SLM technique were combined for the manufacturing of customized biodegradable coronary artery stent prototypes. SLM is advocated for the development of biodegradable coronary PLLA and PCL stents, potentially optimized for future bifurcation applications.

Whole-heart dynamic three-dimensional magnetic resonance perfusion imaging for the detection of coronary artery disease defined by fractional flow reserve: determination of volumetric myocardial ischaemic burden and coronary lesion location.

AIMS: Dynamic three-dimensional-cardiac magnetic resonance (3D-CMR) perfusion proved highly diagnostic for the detection of angiographically defined coronary artery disease (CAD) and has been used to assess the efficacy of coronary stenting procedures. The present study aimed to relate significant coronary lesions as assessed by fractional flow reserve (FFR) to the volume of myocardial hypoenhancement on 3D-CMR adenosine stress perfusion imaging and to define the inter-study reproducibility of stress inducible 3D-CMR hypoperfusion. METHODS AND RESULTS: A total of 120 patients with known or suspected CAD were examined in two CMR centres using 1.5 T systems. The protocol included cine imaging, 3D-CMR perfusion during adenosine infusion, and at rest followed by delayed enhancement (DE) imaging. Fractional flow reserve was recorded in epicardial coronary arteries and side branches with ≥2 mm luminal diameter and >40% severity stenosis (pathologic FFR < 0.75). Twenty-five patients underwent an identical repeat CMR examination for the determination of inter-study reproducibility of 3D-CMR perfusion deficits induced by adenosine. Three-dimensional CMR perfusion scans were visually classified as pathologic if one or more segments showed an inducible perfusion deficit in the absence of DE. Myocardial ischaemic burden (MIB) was measured by segmentation of the area of inducible hypoenhancement and normalized to left ventricular myocardial volume (MIB, %). Three-dimensional CMR perfusion resulted in a sensitivity, specificity, and diagnostic accuracy of 90, 82, and 87%, respectively. Substantial concordance was found for inter-study reproducibility [Lin's correlation coefficient: 0.98 (95% confidence interval: 0.96-0.99)]. CONCLUSION: Three-dimensional CMR stress perfusion provided high diagnostic accuracy for the detection of functionally significant CAD. Myocardial ischaemic burden measurements were highly reproducible and allowed the assessment of CAD severity.