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Background: To prevent complications, uncontrolled movement of the guidewire during a coronary intervention should be avoided. Unintentional withdrawal of the wire can result in the inability to recross a lesion with the risk of myocardial infarction. On the other hand, unintended forward pushing can lead to a coronary perforation. Thus, interventionalists in training should practice keeping the coronary guidewire in a stable position to prevent complications. For this purpose, a skill trainer has been developed, which provides the possibility of unlimited practice outside of the cath lab.The purpose of this study was to assess the effectiveness and the validity of this skills trainer., Methods: Ten novices and 10 participants with experience in diagnostic catheterization underwent training on the skills trainer consisting of 25 procedures. To assess the efficacy of the training module, the mean score of the first 3 procedures was compared with the final 3 procedures in the novice and the advanced group. To determine the construct validity of the simulator, a group of experts (E; performed >1000 percutaneous coronary interventions) also underwent evaluation on the skills trainer. For each procedure, the change in position of the guidewire as well as the time was determined and combined into a skills score with a maximum of 15 points., Results: The novice and the advanced group improved significantly throughout the training on the simulator (N: 7.1 ± 2.6 to 12.2 ± 2.0, P = 0.007; A: 8.3 ± 2.0 to 13.2 ± 1.0, P = 0.005, Wilcoxon).The experts scored significantly higher than novices or the advanced participants during their first 3 procedures (E: 12.9 ± 1.0; N: 7.1 ± 2.6, P = 0.001; A: 8.3 ± 2.0, P = 0.001; Mann-Whitney U )., Conclusions: This low-cost task trainer is a valid and effective tool to train adequate balloon/stent exchange while keeping the guidewire in a stable position. Whether the skills acquired on the task trainer can be transferred to procedures performed on patients needs further investigation., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 Society for Simulation in Healthcare.)

Background Long-term data on evolution and clinical impact of myocardial fibrosis in valvular heart disease are scarce. Methods and Results In this 10 years' extension of a prospective study in patients undergoing conventional aortic valve replacement because of symptomatic severe aortic valve stenosis, the impact of myocardial replacement fibrosis (MRF) on long-term outcome was assessed. Endomyocardial biopsies were acquired during aortic valve replacement in 58 consecutive patients. MRF was graded using the calculated percentage area of fibrosis and patients categorized as severe (n=21), mild (n=15), and no fibrosis (n=22). Echocardiography including strain imaging, as well as cardiovascular magnetic resonance, to assess late gadolinium enhancement was performed at baseline, 1, and 10 years after aortic valve replacement. Death of any cause occurred in 21 patients (38.9%): 3 (14.3%) in the group without MRF, 6 (42.9%) in the mild MRF group, and 12 (63.2%) in the severe MRF group ( P=0.006), resulting in the lowest cumulative survival for patients with severe MRF (log-rank P=0.003). In the group without MRF, none died of cardiovascular cause. MRF was found to be an independent predictor of survival (hazard ratio, 1.271; 95% CI, 1.032-1.564; P=0.024). Conclusions This 10-year follow-up study underlines the profound impact of replacement fibrosis with regard to cardiac and all-cause mortality in patients undergoing aortic valve replacement for severe aortic valve stenosis. Integrating cardiovascular magnetic resonance and echocardiographic functional imaging beyond ejection fraction quantification could help in clinical decision making to stratify patient prognosis with regard to myocardial longitudinal function and prevalence of replacement fibrosis.

Background: For the clinical assessment of patients with dyspnea, the inversion of the early (E) and late (A) transmitral flow during Valsalva maneuver (VM) frequently helps to distinguish pseudonormal from normal filling pattern. However, in an important number of patients, VM fails to reveal the change from dominant early mitral flow velocity toward larger late velocity., Methods and Results: From December 2009 to October 2010, we selected consecutive patients with abnormal filling with (n=25) and without E/A inversion (n=25) during VM. Transmitral, tricuspid, and pulmonary Doppler traces were recorded and the degree of insufficiency was estimated. After evaluating all standard echocardiographic morphological, functional, and flow-related parameters, it became evident that the failure to unmask the pseudonormal filling pattern by VM was related to the degree of the tricuspid insufficiency (TI). TI was graded as mild in 24 of 25 patients in the group with E/A inversion during VM, whereas TI was graded as moderate to severe in 24 of the 25 patients with pseudonormal diastolic function without E/A inversion during VM., Conclusions: Our data suggest that TI is a major factor to prevent E/A inversion during a VM in patients with pseudonormal diastolic function. This probably is due to a decrease in TI resulting in an increase in forward flow rather than the expected decrease during the VM. Thus, whenever a pseudonormal diastolic filling pattern is suspected, the use of a VM is not an informative discriminator in the presence of moderate or severe TI.

Purpose: Direct magnetic resonance imaging (MRI) planimetry of the maximal systolic aortic valve area does not consider temporal variations of the opening area during the ejection period. We evaluated an MRI-based methodology for the assessment of valvular dynamics in patients with severe aortic stenosis by measuring the systolic variability of the valvular blood stream, that is, the "vena contracta.", Materials and Methods: With institutional review board approval, we examined 22 patients (13 male, 9 female; mean age, 68 ±10 years) with severe aortic stenosis using 1.5 T MRI and a standardized scanning protocol consisting of gradient-echo phase-contrast velocity imaging and steady-state free precession-cine MRI before and after valve replacement therapy. Temporal changes of the aortic valve area, represented by systolic variations of the area of poststenotic turbulent flow at its smallest convergence, that is, the proximal vena contracta, were determined by MRI and quantified by a calculated parameter of temporal valve dynamics (T). T was defined as the period which the aortic valve spent over its maximal opening area (>85%) during systole. MRI was also used to determine left ventricular hypertrophy before (LVMI) and its regression (LVMR) after valve replacement. Findings were compared with transthoracic echocardiography and cardiac catheterization., Results: All patients had an echocardiographic effective orifice area, EOATTE, of <1.0 cm2. The comparison of T to LVMI and LVMR revealed significant correlations (LVMI: r = -0.62; P = 0.002; LVMR: r = 0.62; P = 0.002). Further significant correlations with aortic stenosis severity were observed in the comparison with manual planimetry, invasive measurements, and echocardiographic valve areas, as well as with pressure gradients., Conclusions: MRI can measure systolic variations of the aortic valve area. Quantitative parameters of the hemodynamic relevance of valve dynamics obtained by this method correlate with established parameters of aortic stenosis severity and LVMR.

Background: In this prospective follow-up study, the effect of myocardial fibrosis on myocardial performance in symptomatic severe aortic stenosis was investigated, and the impact of fibrosis on clinical outcome after aortic valve replacement (AVR) was estimated., Methods and Results: Fifty-eight consecutive patients with isolated symptomatic severe aortic stenosis underwent extensive baseline characterization before AVR. Standard and tissue Doppler echocardiography and cardiac magnetic resonance imaging (late-enhancement imaging for replacement fibrosis) were performed at baseline and 9 months after AVR. Endomyocardial biopsies were obtained intraoperatively to determine the degree of myocardial fibrosis. Patients were analyzed according to the severity of interstitial fibrosis in cardiac biopsies (severe, n=21; mild, n=15; none, n=22). The extent of histologically determined cardiac fibrosis at baseline correlated closely with New York Heart Association functional class and markers of longitudinal systolic function (all P<0.001) but not global ejection fraction or aortic valve area. Nine months after AVR, the degree of late enhancement remained unchanged, implying that AVR failed to reduce the degree of replacement fibrosis. Patients with no fibrosis experienced a marked improvement in New York Heart Association class from 2.8+/-0.4 to 1.4+/-0.5 (P<0.001). Only parameters of longitudinal systolic function predicted this functional improvement. Four patients with severe fibrosis died during follow-up, but no patient from the other groups died., Conclusions: Myocardial fibrosis is an important morphological substrate of postoperative clinical outcome in patients with severe aortic stenosis and was not reversible after AVR over the 9 months of follow-up examined in this study. Because markers of longitudinal systolic function appear to indicate sensitively both the severity of myocardial fibrosis and the clinical outcome, they may prove valuable for preoperative risk assessment in patients with aortic stenosis.

Background: Enzyme replacement therapy with recombinant alpha-galactosidase A reduces left ventricular hypertrophy and improves regional myocardial function in patients with Fabry disease during short-term treatment. Whether enzyme replacement therapy is effective in all stages of Fabry cardiomyopathy during long-term follow-up is unknown., Methods and Results: We studied 32 Fabry patients over a period of 3 years regarding disease progression and clinical outcome under enzyme replacement therapy. Regional myocardial fibrosis was assessed by magnetic resonance imaging late-enhancement technique. Echocardiographic myocardial mass was calculated with the Devereux formula, and myocardial function was quantified by ultrasonic strain-rate imaging. In addition, exercise capacity was measured by bicycle stress test. All measurements were repeated at yearly intervals. At baseline, 9 patients demonstrated at least 2 fibrotic left ventricular segments (severe myocardial fibrosis), 11 had 1 left ventricular segment affected (mild fibrosis), and 12 were without fibrosis. In patients without fibrosis, enzyme replacement therapy resulted in a significant reduction in left ventricular mass (238+/-42 g at baseline, 202+/-46 g at 3 years; P for trend <0.001), an improvement in myocardial function (systolic radial strain rate, 2.3+/-0.4 and 2.9+/-0.6 seconds(-1), respectively; P for trend=0.045), and a higher exercise capacity obtained by bicycle stress exercise (106+/-14 and 122+/-26 W, respectively; P for trend=0.014). In contrast, patients with mild or severe fibrosis showed a minor reduction in left ventricular hypertrophy and no improvement in myocardial function or exercise capacity., Conclusions: These data suggest that treatment of Fabry cardiomyopathy with recombinant alpha-galactosidase A should best be started before myocardial fibrosis has developed to achieve long-term improvement in myocardial morphology and function and exercise capacity.

As mitoxantrone is a recently approved immunosuppressant for managing multiple sclerosis, the number of patients treated with this effective but potentially cardiotoxic anthracenedione derivative will increase substantially. To detect subclinical mitoxantrone-induced cardiotoxicity, sensitive non-invasive diagnostic tools are required. Assuming that changes in myocardial high-energy phosphate metabolism and alterations in left ventricular (LV) diastolic performance might be early markers of mitoxantrone-induced cardiotoxicity we examined fifteen MS patients treated with mitoxantrone up to 100 mg/m2 compared with 15 matched control MS patients. 31P-magnetic resonance (MR) spectroscopy was employed to measure myocardial high-energy phosphate metabolism, MR imaging for morphometric evaluation of changes in LV geometry. Indices of diastolic performance were assessed by Doppler echocardiography. In this exploratory study, phosphocreatine/ATP ratios were comparable between mitoxantrone-treated and control patients (1.48 +/- 0.23 and 1.43 +/- 0.41). LV mass, LV end-diastolic and systolic volumes, wall motion score, EF and cardiac output did not differ between both groups. All parameters of diastolic performance (E/A-ratio, isovolumic relaxation time, and E-wave deceleration time) were not different and within normal limits.In conclusion, using advanced diagnostic methodology, including functional, morphometric, and biochemical measurements no cardiotoxic effect of mitoxantrone up to a cumulative dose range of 100 mg/m2 could be detected.

Background: Enzyme replacement therapy (ERT) has been shown to enhance microvascular endothelial globotriaosylceramide clearance in the hearts of patients with Fabry disease. Whether these results can be translated into an improvement of myocardial function has yet to be demonstrated., Methods and Results: Sixteen patients with Fabry disease who were treated in an open-label study with 1.0 mg/kg body weight of recombinant alpha-Gal A (agalsidase beta, Fabrazyme) were followed up for 12 months. Myocardial function was quantified by ultrasonic strain rate imaging to assess radial and longitudinal myocardial deformation. End-diastolic thickness of the left ventricular posterior wall and myocardial mass (assessed by magnetic resonance imaging, n=10) was measured at baseline and after 12 months of ERT. Data were compared with 16 age-matched healthy controls. At baseline, both peak systolic strain rate and systolic strain were significantly reduced in the radial and longitudinal direction in patients compared with controls. Peak systolic strain rate increased significantly in the posterior wall (radial function) after one year of treatment (baseline, 2.8+/-0.2 s(-1); 12 months, 3.7+/-0.3 s(-1); P<0.05). In addition, end-systolic strain of the posterior wall increased significantly (baseline, 34+/-3%; 12 months, 45+/-4%; P<0.05). This enhancement in radial function was accompanied by an improvement in longitudinal function. End-diastolic thickness of the posterior wall decreased significantly after 12 months of treatment (baseline, 13.8+/-0.6 mm; 12 months, 11.8+/-0.6 mm; P<0.05). In parallel, myocardial mass decreased significantly from 201+/-18 to 180+/-21 g (P<0.05)., Conclusions: These results suggest that ERT can decrease left ventricular hypertrophy and improve regional myocardial function.

Background: We studied whether lipid-lowering therapy with atorvastatin (target LDL cholesterol [LDL-C] <100 mg/dL) compared with a moderate treatment regimen that used other lipid-lowering drugs led to a lesser progression of atherosclerosis and to different changes in plaque echogenicity in patients with coronary artery disease., Methods and Results: This study was a 12-month, open-label, randomized, multicenter trial, which used serial 3D intracoronary ultrasound to calculate plaque volume and plaque echogenicity. After transcatheter therapy, 131 patients were randomized (atorvastatin n=65, usual care n=66). The target plaque had to be a minor lesion (ie, a diameter stenosis of <50% on angiography). After 12 months, mean LDL-C was reduced from 155 to 86 mg/dL in the atorvastatin group and from 166 to 140 mg/dL in the usual care group. Mean absolute plaque volume showed a larger increase in the usual care group compared with the atorvastatin group (usual care 9.6+/-28.1 mm(3), atorvastatin 1.2+/-30.4 mm(3); P=0.191). The hyperechogenicity index of the plaque increased to a larger extent for the atorvastatin group than for the usual care group, with a significant treatment effect for the percent change (atorvastatin 42.2%, usual care 10.1%; P=0.021)., Conclusions: One year of lipid-lowering therapy to <100 mg/dL LDL-C most likely led to a slowdown of plaque growth of minor lesions. The significantly larger increase in plaque hyperechogenicity is most likely due to a change in plaque composition.

Background: Valvular resistance and stroke work loss have been proposed as alternative measures of stenotic valvular lesions that may be less flow dependent and, thus, superior over valve area calculations for the quantification of aortic stenosis. The present in vitro study was designed to compare the impacts of valvular resistance, stroke work loss, and Gorlin valve area as hemodynamic indexes of aortic stenosis., Methods and Results: In a pulsatile aortic flow model, rigid stenotic orifices in varying sizes (0.5, 1.0, 1.5 and 2.0 cm2) and geometry were studied under different hemodynamic conditions. Ventricular and aortic pressures were measured to determine the mean systolic ventricular pressure (LVSPm) and the transstenotic pressure gradient (delta Pm). Transvalvular flow (Fm) was assessed with an electromagnetic flowmeter. Valvular resistance [VR = 1333.(delta Pm/Fm)] and stroke work loss [SWL = 100.(delta Pm/LVSPm)] were calculated and compared with aortic valve area [AVA = Fm/(50 square root of delta Pm)]. The measurements were performed for a large range of transvalvular flows. At low-flow states, flow augmentation (100-->200 mL/s) increased calculated valvular resistance between 21% (2.0 cm2 orifice) and 66% (0.5-cm2 orifice). Stroke work loss demonstrated an increase from 43% (2.0 cm2) to 100% (1.0 cm2). In contrast, Gorlin valve area revealed only a moderate change from 29% (2.0 cm2) to 5% (0.5 cm2). At physiological flow rates, increase in transvalvular flow (200-->300 mL/s) did not alter calculated Gorlin valve area, whereas valvular resistance and stroke work loss demonstrated a continuing increase. Our experimental results were adopted to interpret the results of three clinical studies in aortic stenosis. The flow-dependent increase of Gorlin valve area, which was found in the cited clinical studies, can be elucidated as true further opening of the stenotic valve but not as a calculation error due to the Gorlin formula., Conclusions: Within the physiological range of flow, calculated aortic valve area was less dependent on hemodynamic conditions than were valvular resistance and stroke work loss, which varied as a function of flow. Thus, for the assessment of the severity of aortic stenosis, the Gorlin valve area is superior over valvular resistance and stroke work loss, which must be indexed for flow to adequately quantify the hemodynamic severity of the obstruction.

A clinical study was conducted to evaluate the efficacy and safety of percutaneous coronary excimer laser angioplasty in 60 patients with coronary artery disease. Forty-nine patients had stable exertional angina, and 11 patients had unstable angina despite medical therapy. A novel 1.4-mm diameter catheter with 20 quartz fibers of 100-microns diameter each arranged concentrically around a central lumen suitable for a 0.014-in. flexible guide wire was coupled to an excimer laser. A commercial excimer laser emitting energy at a wavelength of 308 nm with a pulse duration of 60 nsec was used. The laser was operated at 20 Hz. Mean energy transmission was 30 +/- 5 mJ/mm2. In five of the 60 patients, laser angioplasty was not attempted. In 23 patients with laser ablation alone, percent stenosis decreased from 76 +/- 14% before to 27 +/- 17% after ablation and was 34 +/- 15% at the early follow-up angiogram. In 32 patients, additional balloon angioplasty was performed because of vessel closure after laser ablation in 11 and an insufficient qualitative result in 21 patients. Of the 11 patients with unstable angina, one patient died due to vessel closure 3 hours after intervention, and two patients developed a myocardial infarction. In 22 of 47 patients with late follow-up angiography, restenosis within the 6-month follow-up period occurred. Rate of restenosis was higher in patients treated with laser ablation and balloon angioplasty (16 of 28) than in patients treated with laser ablation alone (six of 19). These results suggest that coronary excimer laser angioplasty for ablation of obstructive lesions is feasible and safe in patients with stable angina. However, development of new catheter systems is necessary for an improved success rate.