Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document.

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

Propensity Score Matched Analysis of Mechanical vs. Bioprosthetic Valve Replacement in Patients With Previous Stroke.

BACKGROUND: This study compared the long-term outcomes of prosthetic heart valve replacement with mechanical or bioprosthetic valves in patients with prior stroke.Methods and Results:In total, 1,984 patients with previous stroke who had received valve replacement between 2000 and 2011 were identified using the Taiwan National Health Insurance Research Database. Propensity score matching analysis was used. Ultimately, 547 patients were extracted from each group and were eligible for analysis. On survival analysis, the risks of all-cause mortality and recurrence of stroke were similar. The incidence of major bleeding was greater in the mechanical valve group than in the bioprosthetic valve group (P=0.040), whereas no difference was observed in re-do valve surgery. On subgroup analysis, the bioprosthetic valve was favored for older age (≥60 years) and previous gastrointestinal (GI) bleeding patients. The mechanical valve, however, was favored for younger patients (<60 years). CONCLUSIONS: In patients with previous stroke, bioprosthetic valves had a lower incidence of complications connected to major bleeding than did the mechanical valves. Survival and stroke recurrence rates, however, did not differ between the 2 groups. We recommend bioprosthetic valves for patients >60 years or who have a history of GI bleeding.

Reducing Prosthesis-Patient Mismatch With Edwards Magna Prosthesis for Aortic Valve Replacement.

BACKGROUND: Prosthesis-patient mismatch (PPM) is associated with increased mid-term and long-term mortality rates after aortic valve replacement (AVR). This study aimed to evaluate the efficacy of the Carpentier-Edwards Perimount Magna and Magna Ease (CEPMs) aortic bioprostheses to reduce the incidence of PPM.Methods and Results:Altogether, 282 consecutive patients (113 women, mean age 69.9±9.9 years) underwent AVR with a CEPMs between 2008 and 2015. They were divided into 3 groups based on the risk of PPM as a result of their body surface area and aortic annular diameter (BSA/AnnD ratio): low-risk (LR) group: 0.64±0.05 m2/cm (n=94); medium-risk (MR) group: 0.73±0.02 m2/cm (n=94); high-risk (HR) group: 0.83±0.05 m2/cm (n=94). The 30-day mortality rate was 0.4%. The 5-year actuarial survival rates were 93.2%, 92.3%, and 94.8% for groups LR, MR, and HR, respectively. No explants as a result of structural valve deterioration occurred. No patients showed severe PPM, defined as a measured effective orifice area index (EOAI) <0.65 cm2/m2. Although there were significant (P<0.05) differences in EOAI (0.98±0.2, 0.90±0.21, and 0.88±0.1 cm2/m2among the LR, MR, and HR groups, respectively), the corresponding transvalvular mean pressure gradients (13.0±5.5, 12.3±4.0, 12.7±5.3 mmHg) and regression rates of the left ventricular mass (29.8%, 28.7%, 28.9%) were similar among groups. CONCLUSIONS: CEPMs provide low surgical risk and reduce the risks of PPM, even in HR patients, with excellent hemodynamics.

A Genomics-Based Model for Prediction of Severe Bioprosthetic Mitral Valve Calcification.

Severe bioprosthetic mitral valve calcification is a significant problem in cardiovascular surgery. Unfortunately, clinical markers did not demonstrate efficacy in prediction of severe bioprosthetic mitral valve calcification. Here, we examined whether a genomics-based approach is efficient in predicting the risk of severe bioprosthetic mitral valve calcification. A total of 124 consecutive Russian patients who underwent mitral valve replacement surgery were recruited. We investigated the associations of the inherited variation in innate immunity, lipid metabolism and calcium metabolism genes with severe bioprosthetic mitral valve calcification. Genotyping was conducted utilizing the TaqMan assay. Eight gene polymorphisms were significantly associated with severe bioprosthetic mitral valve calcification and were therefore included into stepwise logistic regression which identified male gender, the T/T genotype of the rs3775073 polymorphism within the TLR6 gene, the C/T genotype of the rs2229238 polymorphism within the IL6R gene, and the A/A genotype of the rs10455872 polymorphism within the LPA gene as independent predictors of severe bioprosthetic mitral valve calcification. The developed genomics-based model had fair predictive value with area under the receiver operating characteristic (ROC) curve of 0.73. In conclusion, our genomics-based approach is efficient for the prediction of severe bioprosthetic mitral valve calcification.

Longevity after aortic root replacement: is the mechanically valved conduit really the gold standard for quinquagenarians?

BACKGROUND: The choice of the best conduit for root/ascending disease and its impact on longevity remain controversial in quinquagenarians. METHODS AND RESULTS: A total of 205 patients (men=155) between 50 and 60 years (mean, 55.7 ± 2.9 years) received either a stentless porcine xenoroot (n=78) or a mechanically valved composite prosthesis (n=127) between February 1998 and July 2011. Of these, 166 patients underwent root replacement for aneurysmal disease (porcine: 39% [n=65]; mechanical: 61% [n=101]; P=0.5), 25 for acute type A aortic dissection (porcine: 32% [n=8]; mechanical: 68% [n=17]; P=0.51), and 14 for endocarditis/iatrogenic injury involving the aortic root (6.4% [n=5] versus 7.1% [n=9]; P=1.0). The predominant aortic valve pathology was stenosis in 19% (n=38), regurgitation in 50% (n=102), combined valvular dysfunction in 26% (n=54), and normal aortic valve function in 5% (n=11). Concomitant procedures included coronary artery bypass grafting (13%), mitral valve repair (7%), and partial/complete arch replacement (12%/4%), with no significant differences between porcine and mechanical root replacement. Overall hospital mortality was 7.3%, with no difference between the 2 types of valve prostheses (7.7% for porcine and 7.1% for mechanical root replacement; P=1.0). Follow-up averaged 5.4 ± 3.7 years (1096 patient-years) and was 100% complete. Freedom from aorta-related reoperation at 12 years was not statistically different between the groups (porcine: 94.9% versus mechanical: 96.1%; P=0.73). Survival was equivalent between both groups, with a 5-year survival of 86 ± 3% (porcine: 88 ± 4%; mechanical: 85 ± 3%; P=0.96) and a 10-year survival of 76% (porcine: 80 ± 7%; mechanical: 75 ± 5%; P=0.84). The linearized mortality rate was 3.1%/patient-year (porcine: 2.9%/patient-year; mechanical: 3.2%/patient-year). CONCLUSIONS: In quinquagenerians, long-term survival after stentless porcine xenograft aortic root replacement is equivalent to that after a mechanical Bentall procedure. These results bring into question the predominance of mechanical composite conduits for root replacement in quinquagenerians, particularly in the current era of transcatheter valve-in-valve procedures for structural valve deterioration.

Delayed perforation of posterior pharyngeal wall caused by dislodged bioresorbable interbody cage. Case report.

A 48-year-old man was admitted for the management of congenital anomalies: Arnold-Chiari type I malformation combined with odontoid upward migration. He also had degenerative stenosis of the spinal canal by spurs at C2/C3 and C3/C4 levels. Osseous deformities caused ischaemic changes of the brainstem as well as spinal cord compression. Authors used the Biocage - interbody cage covered by bioresorbable layer to fill the surgically created gap after removal of the right part of C3 vertebral body. Twenty-seven months after implantation, the implant was extruded through posterior pharyngeal wall. Authors describe this unusual case and discuss possible causes of Biocage extrusion.

True external diameter better predicts hemodynamic performance of bioprosthetic aortic valves than the manufacturers' stated size.

BACKGROUND AND AIM OF THE STUDY: Currently, there is no universal standard for sizing bioprosthetic aortic valves. Hence, a standardized comparison was performed to clarify this issue. METHODS: Every size of four commercially available bioprosthetic aortic valves marketed in the United States (Biocor Supra; Mosaic Ultra; Magna Ease; Mitroflow) was obtained. Subsequently, custom sizers were created that were accurate to 0.0025 mm to represent aortic roots 18 mm through 32 mm, and these were used to measure the external diameter of each valve. Using the effective orifice area (EOA) and transvalvular pressure gradient (TPG) data submitted to the FDA, a comparison was made between the hemodynamic properties of valves with equivalent manufacturer stated sizes and valves with equivalent measured external diameters. RESULTS: Based on manufacturer size alone, the valves at first seemed to be hemodynamically different from each other, with Mitroflow valves appearing to be hemodynamically superior, having a large EOA and equivalent or superior TPG (p < 0.05). However, Mitroflow valves had a larger measured external diameter than the other valves of a given numerical manufacturer size. Valves with equivalent external diameters were then compared, regardless of the stated manufacturer sizes. For truly equivalently sized valves (i.e., by measured external diameter) there was no clear hemodynamic difference. There was no statistical difference in the EOAs between the Biocor Supra, Mosaic Ultra, and Mitroflow valves, and the Magna Ease valve had a statistically smaller EOA (p < 0.05). On comparing the mean TPG, the Biocor Supra and Mitroflow valves had statistically equivalent gradients to each other, as did the Mosaic Ultra and Magna Ease valves. CONCLUSION: When comparing valves of the same numerical manufacturer size, there appears to be a difference in hemodynamic performance across different manufacturers' valves according to FDA data. However, comparing equivalently measured valves eliminates the differences between valves produced by different manufacturers.

[ESC guidelines on the management of valvular heart disease. What has changed and what is new?]. / ESC-Leitlinien zu Herzklappenerkrankungen. Was ist neu und anders?

In 2012 the new and collaborative "Guidelines on the management of valvular heart disease (version 2012)" were published by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). These guidelines emphasize that decision-making in patients with valvular heart disease should ideally be carried out by a"heart team" with particular expertise in valvular heart disease. In aortic regurgitation pathologies of the aortic root are frequent and in patients with Marfan syndrome, surgery is indicated when the maximal ascending aortic diameter is ≥50 mm, while the threshold for intervention should be lower in patients with risk factors for progression. Regarding aortic stenosis, transcatheter aortic valve implantation (TAVI) should be performed only in hospitals with on-site cardiac surgery and with a"heart team" available to assess patient risks. The TAVI procedure is indicated in patients with severe symptomatic aortic stenosis who are judged by the"heart team" to be unsuitable for surgery but have sufficient life expectancy. It should be considered for high-risk patients with severe symptomatic aortic stenosis based on the individual risk profile assessed by the"heart team". Furthermore, low flow - low gradient aortic stenosis with normal ejection fraction and the difficult topic of asymptomatic severe aortic stenosis and the indications for aortic valve replacement are discussed. With respect to mitral regurgitation, valve repair should be the preferred technique when it is expected to be durable. The topics of asymptomatic mitral regurgitation as well as percutaneous mitral valve repair using the edge to edge technique as an alternative for high risk patients are discussed. Tricuspid disease should not be forgotten and during left-sided valve surgery, tricuspid valve surgery should be considered in the presence of mild to moderate secondary regurgitation if there is significant annular dilatation. Last but not least, in patients with aortic bioprostheses the use of low-dose aspirin is now favored for a 3-month postoperative period.

[The mithral valve replacement with biological prostheses: early and long-term results].

442 patients underwent the mitral valve replacement (MVR) with KemCor and PeriCor stented bioprostheses. The study results justified the preference of the "totally biological" PeriCor valve in patients with active infectious endocarditis. The longest follow-up period was 11 years, the mean follow-up was 51±34 months. The risk of the structural valve disfunction was shown to be inversely proportional to the age (p=0.03). 38% of the operated women younger the 45, developed the structural valve disfunction in 79±27 months after surgery. Thus, MVR with stented bioprostheses proved to be clinically efficient early after the operation. Predictability of the results of KemCor and PeriCor valve implantation allows the theoretically substantiated approach to the rehabilitation, especially, considering the adverse event rate in different patient groups at certain follow-up periods.

Carpentier-Edwards Magna ease versus Magna valves: a comparison of in-vitro valve hydrodynamic performance.

BACKGROUND AND AIM OF THE STUDY: Previous studies have shown that the Carpentier-Edwards Magna (CEM) valve is an excellent bioprosthesis in terms of its systolic performance; indeed, it has been described as 'a stented valve with stentless performance'. However, valve performance is not only a matter of gradients; it is also necessary to evaluate the diastolic-phase performance. Previous in-vitro studies have shown that the CEM has an excessive total regurgitant volume. Hence, the study aim was to compare the hydrodynamics of the CEM, with the newly evolved version of this valve, the CEM Ease (CEME). METHODS: The CEM and CEME valves (both 21 mm) were tested in the aortic chamber (23 mm diameter) of the Sheffield pulse duplicator. The tests were carried out at increasing pulse rates (PR; 70-100 beats/min), and at each pulse rate the valve was tested at different stroke volumes (SVs; 45-65 ml). The forward-flow pressure drop, closing leakage volumes and effective orifice area (EOA) were recorded. RESULTS: The CEM and CEME valves showed a comparable systolic-phase performance, there being no significant differences in terms of transvalvular gradient, EOA and stroke work loss, regardless of the PR and SV. In fact, the new CEME exhibited a significantly improved diastolic performance, with the total regurgitant volume being significantly lower, due especially to a reduced leakage volume and, to a lesser extent, a reduced closing volume. CONCLUSION: The study results indicated that the new CEME valve would maintain the excellent systolic performance of the previous CEM model, but with a significantly improved diastolic performance.

Aortic valve re-replacement after Bentall procedure with a biological valved conduit in a sheep model.

BACKGROUND AND AIM OF THE STUDY: The Bentall procedure is the 'gold standard' for the repair of a combined pathology of ascending aorta and aortic valve. Because there is no need for long-term anticoagulation, biological-valved conduits have become increasingly popular; however, the possible need for reoperation due to valve degeneration is a major disadvantage. The aim of this animal-based study was to prove the feasibility of an isolated replacement of the aortic valve prosthesis six months after a previous implantation of a biological valved conduit (BioValsalva) in a sheep model. A total aortic root replacement, using the BioValsalva conduit, was performed in 10 juvenile sheep. After six months, the surviving sheep were reoperated on, and the stentless valve was replaced with a stented biological valve placed inside the previously implanted vascular conduit. RESULTS: Five animals survived the initial implantation of a BioValsalva conduit. During reoperation, the triple-layered vascular graft with polytetrafluoroethylene on the outside showed only slight adhesions with the surrounding tissue. The stentless valve was removed in one piece, after which a new stented valve was implanted inside the conduit. An X-radiographic examination of the explanted valve showed moderate calcification of the leaflet, and severe calcification of the aortic wall. CONCLUSION: The results of this animal study confirmed that a degenerated stentless biological valve inside the BioValsalva conduit could be replaced with a new valve, without having to remove the entire conduit.

Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: Expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.

The Ross procedure: a systematic review and meta-analysis.

BACKGROUND: Reports on outcome after the Ross procedure are limited by small study size and show variable durability results. A systematic review of evidence on outcome after the Ross procedure may improve insight into outcome and potential determinants. METHODS AND RESULTS: A systematic review of reports published from January 2000 to January 2008 on outcome after the Ross procedure was undertaken. Thirty-nine articles meeting the inclusion criteria were allocated to 3 categories: (1) consecutive series, (2) adult patient series, and (3) pediatric patient series. With the use of an inverse variance approach, pooled morbidity and mortality rates were obtained. Pooled early mortality for consecutive, adult, and pediatric patients series was 3.0% (95% confidence interval [CI], 1.8 to 4.9), 3.2% (95% CI, 1.5 to 6.6), and 4.2% (95% CI, 1.4 to 11.5). Autograft deterioration rates were 1.15% (95% CI, 1.06 to 2.06), 0.78% (95% CI, 0.43 to 1.40), and 1.38%/patient-year (95% CI, 0.68 to 2.80), respectively, and for right ventricular outflow tract conduit were 0.91% (95% CI, 0.56 to 1.47), 0.55% (95% CI, 0.26 to 1.17), and 1.60%/patient-year (95% CI, 0.84 to 3.05), respectively. For studies with mean patient age >18 years versus mean patient age < or =18 years, pooled autograft and right ventricular outflow tract deterioration rates were 1.14% (95% CI, 0.83 to 1.57) versus 1.69% (95% CI, 1.02 to 2.79) and 0.65% (95% CI, 0.41 to 1.02) versus 1.66%/patient-year (95% CI, 0.98 to 2.82), respectively. CONCLUSIONS: The Ross procedure provides satisfactory results for both children and young adults. Durability limitations become apparent by the end of the first postoperative decade, in particular in younger patients.

Effect of freeze-drying on the mechanical, physical and morphological properties of glutaraldehyde-treated bovine pericardium: evaluation of freeze-dried treated bovine pericardium properties.

PURPOSE: Biomaterials have been widely used in the field of regenerative medicine. Bovine pericardium tissue has been successfully used as a bioprosthetic material in manufacturing heart valves, but studies concerning the tissue are ongoing in order to improve its storage, preservation and transportation. This article provides an overview of the characteristics of bovine pericardium tissue chemically treated after the freeze-drying process. These characteristics are essential to evaluate the changes or damage to the tissue during the process. METHODS: The mechanical properties of the tissue were analyzed by three different methods due to its anisotropic characteristics. The physical properties were analyzed by a colorimetric method, while the morphological properties were evaluated by scanning electron microscopy (SEM). RESULTS: The freeze-dried bovine pericardium showed no significant change in its mechanical properties. There was no significant change in the elasticity of the tissue (p>0.05) and no color change. In addition, SEM analysis showed that the freeze-dried samples did not suffer structural collapse. CONCLUSIONS: It was concluded that glutaraldehyde-treated bovine pericardium tissue showed no significant change in its properties after the freeze-drying process.

Treatment of failed aortic bioprostheses: An evaluation of conventional redo surgery and transfemoral transcatheter aortic valve-in-valve implantation.

BACKGROUND: The use of bioprostheses for surgical aortic valve replacement increased substantially within the last years. In case of prosthesis failure, re-SAVR is standard of care, whereas valve-in-valve deployment of a transfemoral transcatheter aortic valve prosthesis (VinV-TFAVI) has recently emerged as an alternative. We sought to evaluate early safety, clinical efficacy, and all-cause 1-year-mortality of VinV-TFAVI and redo surgery for failing aortic bioprostheses (re-SAVR). METHODS AND RESULTS: Patients receiving either VinV-TFAVI (n = 147) or re-SAVR (n = 111) for a degenerated aortic bioprosthesis between 01/2006 and 05/2017 were included in this analysis. All-cause 1-year mortality was the primary outcome measure. Early safety and clinical efficacy according to VARC-2 endpoint definitions were evaluated at 30 days. Baseline characteristics differed significantly between both groups including age, STS-PROM, and incidence of relevant comorbidities. Re-stenosis was the predominant mode of failure in 45.9% of re-SAVR and 63.1% of VinV-TFAVI patients. The rate of "early safety" endpoints was lower with VinV-TFAVI (17.7% vs. 64.9%, p < 0.01), the rate of "clinical efficacy" endpoints was lower, e.g. better with re-SAVR (53.1% vs. 32.4%, p < 0.01). All-cause 1-year-mortality (VinV-TFAVI 8.8% vs re-SAVR 9.9%, p = 0.84) was not different. Treatment strategy was not associated with 1-year-mortality in a Cox regression analysis. The incidence of prosthesis-patient-mismatch was higher in VinV-TFAVI compared to re-SAVR. CONCLUSION: VinV-TFAVI represents a viable alternative for treatment of degenerated aortic bioprostheses in patients at increased surgical risk. However, in patients at low risk for reoperation, a better clinical efficacy and acceptable safety may favour re-SAVR.

4D Flow MRI hemodynamic benchmarking of surgical bioprosthetic valves.

PURPOSE: We exploited 4-dimensional flow magnetic resonance imaging (4D Flow), combined with a standardized in vitro setting, to establish a comprehensive benchmark for the systematic hemodynamic comparison of surgical aortic bioprosthetic valves (BPVs). MATERIALS AND METHODS: 4D Flow analysis was performed on two small sizes of three commercialized pericardial BPVs (Trifecta™ GT, Carpentier-Edwards PERIMOUNT Magna and Crown PRT®). Each BPV was tested over a clinically pertinent range of continuous flow rates within an in vitro MRI-compatible system, equipped with pressure transducers. In-house 4D Flow post-processing of the post-valvular velocity field included the quantification of BPV effective orifice area (EOA), transvalvular pressure gradients (TPG), kinetic energy and viscous energy dissipation. RESULTS: The 4D Flow technique effectively captured the 3-dimensional flow pattern of each device. Trifecta exhibited the lowest range of velocity and kinetic energy, maximized EOA (p < 0.0001) and minimized TPGs (p ≤ 0.015) if compared with Magna and Crown, these reporting minor EOA difference s (p ≥ 0.042) and similar TPGs (p ≥ 0.25). 4D Flow TPGs estimations strongly correlated against ground-truth data from pressure transducers; viscous energy dissipation proved to be inversely proportional to the fluid jet penetration. CONCLUSION: The proposed 4D Flow analysis pinpointed consistent hemodynamic differences among BPVs, highlighting the not negligible effect of device size on the fluidynamic outcomes. The efficacy of non-invasive 4D Flow MRI protocol could shed light on how standardize the comparison among devices in relation to their actual hemodynamic performances and improve current criteria for their selection.

The better substitute for tricuspid valve replacement in patients with severe isolated tricuspid regurgitation.

OBJECTIVE: The ideal alternative for tricuspid valve replacement (TVR) in patients with severe isolated tricuspid regurgitation remains unclear. The aim of the present study was to retrospectively investigate the outcomes of using bioprosthetic and mechanical valves at the tricuspid position. METHODS: A total of 98 consecutive patients without left-side cardiac disease or history of heart surgery who underwent first-time TVR between January 2010 and March 2017 at the West China Hospital, China were included in the study. Patient data, including all-cause death and need for tricuspid valve reoperation as the main end points, were retrospectively evaluated. RESULTS: A total of 76 patients were enrolled into the study. The mean follow-up period was 43.3±21.9 (10-87) months. The mean age of the patients was 45.7±13.4 years. The study comprised 32.9% of male patients. During the follow-up period, 4, 3, 12, and 3 cases of death, reoperation, prosthesis dysfunctions, and prosthesis-related thrombosis were noted, respectively. Biological and mechanical valves were used in 56.6% and 43.4% of the patients, respectively. However, there was no significant difference between mechanical and biological valves with respect to echocardiographic date and survival, reoperation, prosthetic valve dysfunction, and thromboembolism rate. CONCLUSION: TVR is not a very high-risk procedure in patients with isolated tricuspid regurgitation, and the decision for prosthesis implantation in TVR should be made on an individual basis according to suitable clinical judgment.

Subclinical thrombus formation in bioprosthetic pulmonary valve conduits.

OBJECTIVES: Bioprosthetic pulmonary valve conduits have been reported with an increased risk of endocarditis. Thrombus formation is considered as source of these serious and life-threatening infections. We reviewed a series of explanted valved pulmonary conduits for histological evidence for thrombus formation. MATERIALS AND METHODS: Explanted bioprosthetic pulmonary valves were fixed in formalin and embedded in paraffin or in methylmethacrylate. Standard staining as well as immunohistochemical staining techniques were applied. Native pulmonary valves of German domestic pigs served as controls. RESULTS: 47 valved pulmonary conduits (Hancock n = 23, Homograft n = 7, Contegra n = 7, Melody n = 7, other n = 3) were analyzed histologically. Average time of implantation had been 63 months (6 to 342 months). Indications for explantation included significant obstruction (n = 45), regurgitation (n = 7), and/or endocarditis (n = 6). In 44/47 (93%) specimen, we found accumulation of thrombotic material at the basis of the semilunar valve sinus to a variable degree. 11 patients had been treated with antiplatelet agents, 2 had received anticoagulants at the time of explantation. There was no suspicion of thrombus formation clinically or echocardiographically prior to explantation in any of the patients. Control porcine pulmonary valves (n = 5) did not show any evidence of accumulation of thrombotic material. CONCLUSIONS: In a large series of explanted valved pulmonary conduits, formation of subclinical, mostly non-infectious thrombotic material was an almost ubiquitous finding. We speculate that high incidence of endocarditis in bioprosthetic valves may in part be explained by thrombus apposition at the basis of conduit valve sinus.

Characteristics of surgical prosthetic heart valves and problems around labeling: A document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO), and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labeling of SHV size, in vivo and in vitro testing, and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard- setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labeling and identifies the most important elements where further standardization is necessary.