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Bioprosthetic valve thrombosis may have implications for valve function and durability. Using a novel glycoprotein IIb/IIIa receptor radiotracer 18F-GP1, we investigated whether positron emission tomography (PET)-computed tomography (CT) could detect thrombus formation on bioprosthetic aortic valves. Ex vivo experiments were performed on human platelets and explanted bioprosthetic aortic valves. In a prospective cross-sectional study, patients with either bioprosthetic or normal native aortic valves underwent echocardiography, CT angiography, and 18F-GP1 PET-CT. Flow cytometric analysis, histology, immunohistochemistry, and autoradiography demonstrated selective binding of 18F-GP1 to activated platelet glycoprotein IIb/IIIa receptors and thrombus adherent to prosthetic valves. In total, 75 participants were recruited: 53 with bioprosthetic valves (median time from implantation 37 months [IQR: 12-80 months]) and 22 with normal native aortic valves. Three participants had obstructive valve thrombosis, and a further 3 participants had asymptomatic hypoattenuated leaflet thickening on CT angiography. All bioprosthetic valves, but none of the native aortic valves, demonstrated focal 18F-GP1 uptake on the valve leaflets: median maximum target-to-background ratio 2.81 (IQR: 2.29-3.48) vs 1.43 (IQR: 1.28-1.53) (P < 0.001). Higher 18F-GP1 uptake was independently associated with duration of valve implantation and hypoattenuated leaflet thickening. All 3 participants with obstructive valve thrombosis were anticoagulated for 3 months, leading to resolution of their symptoms, improvement in mean valve gradients, and a reduction in 18F-GP1 uptake. Adherence of activated platelets is a common and sustained finding on bioprosthetic aortic valves. 18F-GP1 uptake is higher in the presence of thrombus, regresses with anticoagulation, and has potential use as an adjunctive clinical tool. (18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis; NCT04073875) [Display omitted] [ABSTRACT FROM AUTHOR]

Time of day potentially impacts outcomes in cardiac surgery. Therefore, the goal of this study was to assess whether elective aortic valve replacement surgery performed in the morning versus the afternoon is associated with differences in risk-adjusted morbidity and mortality. We performed a propensity score–matched analysis on 2720 consecutive patients (1360 pairs) who underwent elective aortic valve replacement with or without coronary artery bypass grafting at our institution between July 2009 and December 2016. The primary endpoint was a composite of death, myocardial infarction, or heart failure up to a maximum follow-up of 500 days. Secondary endpoints were perioperative troponin concentrations and in-hospital mortality. The primary endpoint did not differ between the morning surgery group (8.5%; n = 113) and the afternoon surgery group (8.4%, n = 111), with a hazard ratio for the morning surgery group (reference: afternoon surgery group) of 1.01 (95% confidence interval, 0.78-1.32; P =.93). Event risks of the components of the primary endpoint were also similar between the study groups (all P >.05). The postoperative troponin decline was slightly more pronounced in the morning surgery group than in the afternoon surgery group (P <.001), whereas in-hospital mortality was similar between study groups (P >.99). In our propensity score–matched analysis on 2720 patients undergoing elective isolated aortic valve replacement or combined aortic valve replacement and coronary artery bypass grafting, time of day variation had no significant impact on clinical outcomes. Thus our study refutes the need to consider the timing of elective aortic valve surgery to improve clinical outcomes. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). Background Limited data are available about the “off-label” use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. Methods The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. Results A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m 2 , STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. Conclusions TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option. [ABSTRACT FROM AUTHOR]

Objectives This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry). Background Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population. Methods In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year. Results Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits. Conclusions TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the TAVR-TV group as compared to the TAVR-TA group. However, there was a sizable group of patients who did not derive any HrQoL benefits. Several independent pre- and post-operative factors were identified being predictive for less pronounced HrQoL benefits. [ABSTRACT FROM AUTHOR]

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MESP1 represents an essential transcription factor to guarantee coordinated cardiac development. The expression of MESP1 is thought to be the first sign that a cell has been committed to the cardiac lineage. We analyzed the coding sequence of MESP1 in 215 patients with congenital heart disease. Our results show that the sequence of exon 1 is highly variable with up to seven alterations in individual samples. Five base pair positions (c.157_G>C A53P, rs6496598; c.174_A>C P58P, rs28377352; c.182_T>G L61R, rs28368490; c.669_C>G F223L, rs2305440; c.687_T>G P229P, rs2305441) are particularly variable. In almost half of the samples a 12 base pair insertion after position 55 (c.165_166insGTGCCGAGCCCC P55insVPSP, rs71934166) coding for VPSP was detected which was strongly correlated with the appearance of further amino acid changes (c.157_G>C A53P, c.182_T>G L61R, c.669_C>G F223L). Two missense mutations (c.33_G>C E11D, rs190259690; c.528_A>T T176S) were detected in two patients but were absent in the controls. The assessment of the biological activity of altered MESP1 proteins in a luciferase reporter assay showed an enhanced activity of the c.33_G>C E11D mutation and a reduction of the insertion without an accompanying change of c.182_T>G L61R. The modified biological properties of mutated MESP1 proteins might be associated with the appearance of certain pathological phenotypes of congenital heart disease. [ABSTRACT FROM AUTHOR]

Recently, it has been demonstrated that transcatheter aortic valve implantation (TAVI) can result in significant improvement in patients'' quality of life (QOL) in the short term. At present, however, little is known about the long-term improvements in QOL after TAVI. Thus, our aim was to prospectively assess the 1-year QOL outcome of patients undergoing TAVI. We performed a prospective analysis of 186 patients with symptomatic severe aortic valve stenosis ineligible for conventional aortic valve replacement, who underwent TAVI with either the Medtronic CoreValve or Edwards Sapien device. A total of 106 patients completed the 1-year follow-up protocol. The QOL was measured using the Medical Outcomes Study 36-item short-form health survey questionnaire at baseline and at 3 months and 1 year of follow-up. At 1 year of follow-up, significant improvements in the Medical Outcomes Study 36-item short-form health survey questionnaire scores for physical functioning (baseline 34.6 ± 2.3 vs 1 year of follow-up 45.6 ± 2.7; p <0.001), role physical (20 ± 3.0 vs 34.2 ± 4.4; p <0.001), bodily pain (59.9 ± 3 vs 70 ± 2.7; p <0.01), general health (47.3 ± 1.5 vs 55.2 ± 2.1, p <0.001), vitality (35.9 ± 2 vs 48.5 ± 2; p <0.001), and mental health (62.2 ± 2.2 vs 67.3 ± 1.8; p <0.05) were observed compared to baseline. No significant improvement could be detected for social functioning (75.4 ± 2.5 vs 76.5 ± 2.6; p = 0.79) and role emotional (61.1 ± 4.3 vs 66.5 ± 4.7; p = 0.29). At 1 year of follow-up, the various physical and mental scores were comparable to an age-matched standard population. In conclusion, the present study has demonstrated that TAVI can improve the QOL status of high-surgical risk patients with severe aortic valve stenosis that can be maintained for ≤1 year postproceduraly in survivors. Although the mental subscales improved slightly, the mental component summary score failed to reach statistical significance in our study population. [Copyright &y& Elsevier]

Objectives: This study sought to review the acute procedural outcomes of patients who underwent transcatheter aortic valve (TAV)–in–surgical aortic valve (SAV) implantation at the German Heart Center, Munich, and to summarize the existing literature on TAV-in-SAV implantation (n = 47). Background: There are several case reports and small case series describing transcatheter aortic valve implantation for a failing surgical aortic valve bioprosthesis (TAV-in-SAV implantation). Methods: From January 2007 to March 2011, 20 out of 556 patients underwent a TAV-in-SAV implantation at the German Heart Center Munich. Baseline characteristics and clinical outcome data were prospectively entered into a dedicated database. Results: The mean patient age was 75 ± 13 years, and the mean logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons'' Risk Model scores were 27 ± 13% and 7 ± 4%, respectively. Of the 20 patients, 14 had stented and 6 had stentless surgical bioprostheses. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, California). Successful implantation of a TAV in a SAV with the patient leaving the catheterization laboratory alive was achieved in 18 of 20 patients. The mean transaortic valve gradient was 20.0 ± 7.5 mm Hg. None-to-trivial, mild, and mild-to-moderate paravalvular aortic regurgitation was observed in 10, 6, and 2 patients, respectively. We experienced 1 intraprocedural death following pre-implant balloon aortic valvuloplasty (“stone heart”) and 2 further in-hospital deaths due to myocardial infarction. Conclusions: TAV-in-SAV implantation is a safe and feasible treatment for high-risk patients with failing aortic bioprosthetic valves and should be considered as part of the armamentarium in the treatment of aortic bioprosthetic valve failure. [Copyright &y& Elsevier]

With an aging population, improvement in life expectancy, and significant increase in the use of bioprosthetic valves, structural valve deterioration will become more and more prevalent. The operative mortality for an elective redo aortic valve surgery is reported to range from 2% to 7%, but this percentage can increase to more than 30% in high-risk and nonelective patients. Because transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation represents a minimally invasive alternative to conventional redo surgery, it may prove to be safer and just as effective as redo surgery. Of course, prospective comparisons with a large number of patients and long-term follow-up are required to confirm these potential advantages. It is axiomatic that knowledge of the basic construction and dimensions, radiographic identification, and potential failure modes of SAV bioprostheses is fundamental in understanding key principles involved in TAV-in-SAV implantation. The goals of this paper are: 1) to review the classification, physical characteristics, and potential failure modes of surgical bioprosthetic aortic valves; and 2) to discuss patient selection and procedural techniques relevant to TAV-in-SAV implantation. [Copyright &y& Elsevier]

Background: Transcatheter aortic valve implantation (TAVI) has been introduced to offer a new treatment option for patients who are not eligible for conventional aortic valve replacement. Especially in this subset of patients, the expected improvement of quality of life (QoL) after valve implantation will be critical for decision-making for TAVI. Methods: We performed a prospective analysis of 99 patients (41 male) aged 82 years (range 57-94 years) who underwent TAVI. For assessment of QoL, the Short Form 36 Health Survey Questionnaire was used preoperatively and 3 months after TAVI. Results: Thirty-day mortality rate was 10.1%. The Short Form 36 Health Survey Questionnaire scores for physical functioning (34.7 ± 2.8 vs 48.5 ± 3.4, P < .001), bodily pain (61.7 ± 3.1 vs 73.2 ± 2.9, P < .01), general health (47.1 ± 1.9 vs 54.1 ± 2.3, P < .01), and vitality (37 ± 2.8 vs 46.1 ± 2.7, P < .01) increased significantly 3 months after TAVI compared with preoperative scores. No significant changes were found for role-physical (21.7 ± 4.1 vs 31.1 ± 5.1, P < .08), social functioning (74.6 ± 3.4 vs 74.6 ± 3.1, P = 1), and mental health (63 ± 2.9 vs 67.4 ± 2.2, P = .17) 3 months after TAVI. Only the score for role-emotional (69.3 ± 5.6 vs 51.7 ± 6, P = .02) decreased significantly 3 months after TAVI compared with the preoperative score. Corresponding to these results, the physical health summarized score (31.2 ± 1.2 vs 38.6 ± 1.6, P < .001) was significantly increased 3 months after TAVI compared with the preoperative score, whereas the mental health summarized score (48.5 ± 1.8 vs 47.3 ± 1.7, P = .5) showed no changes. Conclusion: In patients who are not eligible for conventional aortic valve replacement, TAVI leads to a considerable QoL improvement within 3 months after valve implantation. [ABSTRACT FROM AUTHOR]

Background: Proton pump inhibitors (PPIs) are often prescribed for gastrointestinal discomfort after heart transplantation (HTx). This study investigates the impact of PPI use on mycophenolate acid (MPA) pharmacokinetics in heart transplant recipients receiving mycophenolate mofetil (MMF) and tacrolimus (Tac). Methods: MPA post-dose plasma concentrations at 0 to 2 hours were obtained by high-performance liquid chromatography (HPLC) in 21 patients on pantoprazole 40 mg/day (PPI group) and 12 patients not on pantoprazole (control group). In a subgroup, MPA plasma concentrations at 0 to 12 hours were measured to evaluate full MPA area-under-the-curve (AUC) measurements. Results: In the PPI group, the mean daily MMF dose was 1,912 ± 1,023 mg with mean pre-dose serum concentrations (C0) of 1.9 ± 1.4 mg/liter, without a significant difference from controls. Mean post-dose MPA concentrations at 30 minutes (C0.5h) were significantly higher in the control group (control, 17.9 ± 11.5 mg/liter; PPI, 6.7 ± 4.6 mg/liter; p < 0.001). One- and 2-hour (C1h, 2h) MPA concentrations were persistently higher in the control group (1 hour: control, 13.8 ± 9.1 mg/liter; PPI, 7.7 ± 4.1 mg/liter; 2 hours: control, 7.6 ± 4.2; PPI, 5.0 ± 2.8 mg/liter; p < 0.05). In the subgroup with full AUC measurements, the control group had higher MPA levels 12 hours after dosing (C12h: control, 3.3 ± 2.4 mg/liter; PPI, 1.6 ± 1.3 mg/liter; p < 0.05) and a significantly higher dose-adjusted AUC C0–3h (control, 59.5 ± 20.7 mg/liter; PPI, 41.7 ± 23.4 mg/liter; p < 0.05). In the subgroup, the maximum plasma concentration of mycophenolic acid (MPA Cmax) in the PPI group was significantly lower (10.1 ± 4.7 mg/liter) than in the control group (45.5 ± 53.5 mg/liter, p < 0.0001), whereas tmax revealed no differences (control: 1.1 ± 0.77 hours; PPI: 1.1 ± 0.97 hours). Furthermore, a clear trend for more acute rejection episodes (AREs) and more transplant vasculopathy (TVP) was found in the PPI group. Conclusions: Patients with PPI co-medication show significantly lower MPA plasma concentrations, possibly due to decreased absorption. Therapeutic drug monitoring allows identification of patients with decreased MMF drug exposure who might be at risk for acute rejection. [Copyright &y& Elsevier]

Abstract: We report on a rare case of combined unilateral atresia of the proximal right pulmonary artery (PA) and left patent ductus arteriosus (PDA). A 46 year-old female patient with known PDA and associated advanced pulmonary arterial hypertension presented with progressive hemoptysis and increasing exertional dyspnea. Computed tomography of the chest proved the presence of the known PDA but surprisingly failed to demonstrate an extrapulmonary proximal right PA. We show the imaging features and discuss the embryological background of this rare congenital cardiovascular malformation. [Copyright &y& Elsevier]