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Mitral regurgitation (MR) is a broadly diffuse valvular heart disease (VHD) with a significant impact on the healthcare system and patient prognosis. Transcatheter mitral valve interventions (TMVI) are now well-established techniques included in the therapeutic armamentarium for managing patients with mitral regurgitation, either primary or functional MR. Even if the guidelines give indications regarding the correct management of this VHD, the wide heterogeneity of patients' clinical backgrounds and valvular and heart anatomies make each patient a unique case, in which the appropriate device's selection requires a multimodal imaging evaluation and a multidisciplinary discussion. Proper pre-procedural evaluation plays a pivotal role in judging the feasibility of TMVI, while a cooperative work between imagers and interventionalist is also crucial for procedural success. This manuscript aims to provide an exhaustive overview of the main parameters that need to be evaluated for appropriate device selection, pre-procedural planning, intra-procedural guidance and post-operative assessment in the setting of TMVI. In addition, it tries to give some insights about future perspectives for structural cardiovascular imaging.

Patients with the complex congenital heart disease (CHD) are usually associated with right ventricular outflow tract dysfunction and typically require multiple surgical interventions during their lives to relieve the right ventricular outflow tract abnormality. Transcatheter pulmonary valve replacement was used as a non-surgical, less invasive alternative treatment for right ventricular outflow tract dysfunction and has been rapidly developing over the past years. Despite the current favorable results of transcatheter pulmonary valve replacement, many patients eligible for pulmonary valve replacement are still not candidates for transcatheter pulmonary valve replacement. Therefore, one of the significant future challenges is to expand transcatheter pulmonary valve replacement to a broader patient population. This review describes the limitations and problems of existing techniques and focuses on decellularized tissue engineering for pulmonary valve stenting.

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence (⨁⨁⨁Ο).This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold.The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient's values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation., Competing Interests: Competing interests: FSB: proctoring fees from Edwards LifeSciences, Medtronic and Boston Scientific. CA, MA, FC: proctoring fees from Edwards LifeSciences and Boston Scientific. Participants without voting rights: PL: proctoring fees from Edwards LifeSciences, Medtronic, Boston Scientific (significant); consulting fees Boston Scientific (not significant). HR: proctoring fees from Edwards LifeSciences, Boston Scientific and Medtronic, and research grants from Edwards LifeSciences, Boston Scientific and Medtronic. Clinical external reviewers: MT: Nothing to declare. OM: Consulting honoraria from Medtronic, Boston Scientific and Philips. CR: Nothing to declare., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Mitral repair for asymptomatic (New York Heart Association [NYHA] class I) degenerative mitral regurgitation (MR) is supported by the guidelines, but is not performed often. We sought to determine outcomes for asymptomatic patients when compared with those with symptoms., Methods: Between 2004 and 2018, 1027 patients underwent mitral replacement (22) or repair with or without other cardiac surgery (1005), the latter being grouped by NYHA class: I (n = 470; 47%), II (n = 408; 40%), or III/IV (n = 127; 13%). Statistical analyses included propensity score matching and weighting, and multistate models., Results: The proportion of patients designated as NYHA class I undergoing surgery increased steadily during this period (P < .001). Overall, 30-day mortality was 0.4%, and zero for patients designated NYHA class I. Unadjusted 10-year survival was significantly greater in patients designated NYHA class I compared with II and III/IV (P < .001). Freedom from reoperation at 10 years was 99.8% overall, and 100% for patients designated NYHA class I. In patients designated as NYHA class I, predischarge and 10-year moderate MR were 0.7% and 20.1%, whereas more than moderate was zero and 0.6%. Preoperative ejection fraction less than 60% was associated with late mortality (P = .025). After covariate-adjustments, freedom from MR and tricuspid regurgitation were not statistically significantly different by NYHA class. However, overall survival was significantly worse in patients with NYHA class III/IV, compared with class II., Conclusions: Mitral repair in asymptomatic patients is safe and durable. Careful monitoring until class II symptoms is appropriate. However, repair before ejection fraction decreases below 60% is important for late overall survival., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Use of transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves in clinical practice is limited to patients with failing bioprostheses and rings or mitral valve disease associated with severe mitral annulus calcification. Whereas the use of valve-in-valve TMVR appears to be a reasonable alternative to surgery in patients at high surgical risk, much less evidence supports valve-in-ring and valve-in-mitral annulus calcification interventions. Data on the results of TMVR in these settings are derived from small case series or voluntary registries. This review summarizes the current evidence on TMVR using transcatheter aortic valves in clinical practice from the characteristics of the TMVR candidates, screening process, performance of the procedure, and description of current results and future perspectives. TMVR using dedicated devices in native noncalcified mitral valve diseases is beyond the scope of the article.

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., (Copyright © 2021 Jointly between The Society of Thoracic Surgeons, the American Association for Thoracic Surgery, and the European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Mitral regurgitation (MR) is a complex valve lesion that can pose significant management challenges. This expert consensus decision pathway emphasizes that recognition of MR should prompt an assessment of its etiology, mechanism, and severity, as well as consideration of the indications for treatment. The document is a focused update of the 2017 ACC Expert Consensus Decision Pathway on the Management of Mitral Regurgitation, with some sections updated and others added in light of the publication of new trial data related to secondary MR, among other developments. A structured approach to evaluation based on clinical findings, accurate echocardiographic imaging, and, when necessary, adjunctive testing can help clarify decision making. Treatment goals include timely intervention by an experienced multidisciplinary heart team to prevent left ventricular dysfunction, heart failure, reduced quality of life, and premature death., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background and objectives : Plasma arginine vasopressin (P-AVP) is regulated by the non-osmotic pathway in patients with heart failure (HF) and reduced ejection fraction. However, the regulation of P-AVP in patients with severe aortic stenosis (AS) remains unknown. Materials and Methods : Consecutive patients with severe AS who received trans-catheter aortic valve implantation (TAVI) between Apr 2016 and Apr 2019 were enrolled in this prospective study. Clinical data including P-AVP were obtained just before TAVI, and the correlation between P-AVP and other variables was investigated. Results : In total, 159 patients with severe AS (85.3 ± 4.6 years, male 26%) were enrolled. P-AVP was 1.45 ± 1.13 ng/mL and cardiac index was relatively preserved (2.76 ± 0.54 L/min/m 2 ). There was no significant correlation between cardiac index and P-AVP ( p > 0.05), whereas plasma osmolality had a moderate positive correlation with P-AVP (r = 0.35, p < 0.01), predominantly due to blood urea nitrogen (r = 0.27, p < 0.01). Patients with diuretics had significantly higher P-AVP than those without diuretics (1.65 ± 1.43 vs. 1.22 ± 0.57 pg/mL, p < 0.01). Two-year survivals free from HF readmission were statistically comparable irrespective of the level of pre-procedural P-AVP ( p = 0.44). Conclusion : In patients with severe high-gradient AS who received TAVI, the P-AVP level was dominantly regulated by plasma osmolality instead of arterial underfilling. The clinical implication of elevated P-AVP in the TAVI candidates is the next concern.

Minimally invasive cardiac surgery options, which originated with off-pump coronary artery bypass grafting and aortic valve procedures, continue to evolve in order to address complex conditions, including those requiring mitral and tricuspid valve repair. Although these procedures are primarily indicated for high-risk patient populations, favorable patient outcomes have resulted in recommendations being expanded to include intermediate-risk groups. This article increases nursing-related knowledge of minimally invasive cardiac procedures, providing an overview of current minimally invasive cardiac surgeries and their associated risks and benefits., (©2020 American Association of Critical-Care Nurses.)

Objectives: The present study examines whether improvements have reduced the negative impact of guideline triggers on postoperative outcomes., Background: European and American guidelines for the management of severe aortic regurgitation (AR) define the triggers for AR surgery. These triggers are based on the results of studies performed in the 1990s analyzing outcomes of patients who underwent AR surgery in the 1980s. Although these triggers are used to indicate surgery, they have all been associated with poorer postoperative outcomes. In the meantime, innovations in operative techniques, including aortic valve repair, have allowed reducing the risk of surgery., Methods: A total of 356 consecutive patients undergoing surgical correction of severe AR were included in this study. Among them, 204 were operated on for a Class I, 17 for a Class IIa, 49 for a Class IIb, and 86 without any guideline triggers. Cox proportional hazards regression models and Kaplan-Meier survival curves were used to compare postoperative outcomes in the different groups. Inverse probability weighing was used to adjust for mismatched baseline characteristics., Results: Adjusted 10-year survival was better among patients without operative triggers (89 ± 4%) or with Class II triggers (85 ± 6%) than in patients with Class I triggers (71 ± 4%, p = 0.010). Similar results were obtained for cardiovascular survival and hospitalizations for heart failure. Spline function analyses indicated that mortality started to increase for left ventricular (LV) ejection fraction <55% and LV end-systolic dimensions >20 to 22 mm/m 2 . LV end-diastolic dimensions did not influence outcomes., Conclusions: Guideline-based Class I triggers for AR surgery carry major risks for long-term outcomes. This suggests that patients with severe AR should be operated on before the onset of these triggers; that is, at an asymptomatic stage, before LV ejection fraction falls below 55% or LV end-systolic dimensions exceeds 20 to 22 mm/m 2 ., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The benefits of tricuspid valve (TV) repair in patients with moderate tricuspid regurgitation (TR) during left-sided valve surgery are under debate. We investigated independent predictors for reduction in TR severity following left-sided valve surgery in patients with moderate TR., Methods: In this study, we included 106 patients (male: 33%) with a mean age of 4.23 ± 12.61 years who had moderate TR and underwent mitral or aortic valve surgery between March 2012 and November 2016. Concomitant tricuspid annuloplasty was done for one group of patients based on surgeon's decision. Transthoracic echocardiography was done before and at a median followup of 4.71 months for all patients. The patients were divided into improved and unimproved TR groups, with the term "improved" signifying a reduction of at least one grade in TR severity., Results: Tricuspid annuloplasty was performed on 65 (61.3%) patients. TR improvement was observed in 87.7% of patients in the TV repair group and 56.1% of patients in the no-TV repair group, indicating a significant difference (P < 0.001). Tricuspid annulus diameter was not significantly different between the two groups (32.41 ± 4.68 mm in no-TV repair group and 33.87 ± 4.34 mm in TV repair group, P = 0.128). At follow-up with echocardiography, 80 (75.5%) patients were placed in the improved group and the majority of patients (71.3% vs. 30.8%; P < 0.001) underwent tricuspid repair in the improved group. TV annuloplasty was correlated with reduced TR severity following left-sided valve surgery (odds ratio [OR]: 5.19, 95% CI: 1.70-15.85, P < 0.001). TR changed from moderate to severe in 17 (17.1%) patients with no concomitant tricuspid repair, while only one patient (1.5%) with tricuspid repair showed an increased TR severity., Conclusion: Tricuspid annuloplasty may be useful in patients who have moderate TR undergoing left-sided valve surgery regardless of the tricuspid annulus diameter, and it can play an effective role in the improvement of TR at mid-term follow-up., (© 2019 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

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., (Copyright © 2019 The Society of Thoracic Surgeons, The American Association for Thoracic Surgery, and the European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

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.

Objective: To investigate whether minimally invasive mitral valve repair (MIMVR) can be transferred from a high-volume center into a very small volume center and to clarify how many cases are necessary for maintenance of this program, early outcomes of MIMVR in Asahikawa Medical University were compared with those results in patients operated by a single surgeon in Duesseldorf University Hospital., Methods: Sixty-five patients who underwent MIMVR in Asahikawa Medical University (group A) between May 2014 and July 2018 and 134 patients who underwent MIMVR in Duesseldorf University Hospital (group D) between September 2009 and January 2014 by a surgeon who started MIMVS later in Asahikawa were retrospectively analyzed., Results: In group D, there were more patients with ischemic mitral valve regurgitation and with annular calcification than in group A. Survival rate at 6 months and 1 year was 98.5% and 98.5% in group A and 92.9% and 91.3% in group D, respectively. EuroSCORE II was significantly higher in patients dead within 30 days and within the first year., Conclusions: The present study demonstrated that MIMVR programs can be transferred with acceptable early results into very low volume centers, if the team is developed by surgeons who are well trained and experienced in MIMVR. Moreover, the present study suggested that case number for maintenance of acceptable results may be obviously less than the previous recognition that this kind of specialized surgery could be maintained with at least 50 cases annually. However, meticulous preparations for surgery are essential for satisfactory surgical outcomes.

Objective: Evaluate the accuracy and trending ability of the fourth-generation FloTrac/EV1000 (Edwards Lifesciences, Irvine, CA) system in patients with severe aortic valve stenosis by comparing FloTrac/EV1000-derived cardiac output (CCO-FT) with continuous thermodilution pulmonary artery catheter (CCO-PAC) measurements before and after surgical valve replacement., Design: Prospective clinical study., Setting: Anesthesia for cardiac surgery, operating room, single-center university hospital., Participants: Twenty-five patients were included. After exclusion, 20 patients undergoing elective aortic valve replacement were analyzed., Interventions: After induction of general anesthesia, CCO-FT and CCO-PAC values were recorded every 30 seconds before and after aortic valve replacement with a bioprosthesis under cardiopulmonary bypass (CPB)., Measurements and Main Results: Data were analyzed separately from skin incision to last suture and before and after CPB. Regression analyses, Bland-Altman analyses, and trending analyses (4-quadrant plot, polar plot) were performed. The percentage errors of the FloTrac/EV1000 were 69.7% and 59.3% before and after CPB, respectively. The concordance rates (CRs) and angular CRs of the FloTrac/EV1000 were 50.9% and 57.1%, and 48.7% and 61.9% before and after CPB, respectively., Conclusion: This study revealed a low level of agreement and poor trending ability of the FloTrac/EV1000 system compared to continuous thermodilution pulmonary artery catheter in patients with severe aortic stenosis. Although there was a slight improvement after surgical valve replacement and CPB, the results were not within acceptable limits to replace CCO-PAC in this patient population., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Chronic mitral regurgitation (MR) is the most prevalent valvular lesion in the adult US population. Appropriate patient selection for mitral intervention and selection of the appropriate interventional strategy and optimal periprocedural management rely on thorough clinical evaluation, accurate echocardiographic input, and in-depth understanding of chronic MR pathophysiology on the part of the cardiac anesthesiologist. The recently published Expert Consensus Decision Pathway on the management of MR was designed to provide tools to help the clinician with broad clinical decision-making, including patient referral, and the present review focuses and elaborates on the key aspects relevant to the cardiac anesthesiologist in the peri-interventional setting., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Public reporting of cardiac surgery ratings has been advocated to inform patient selection of hospitals. Although Society of Thoracic Surgeons (STS) ratings are based on audited risk-adjusted patient outcomes, other rating systems rely on administrative databases. In this study, we evaluate correlation among 4 widely used hospital rating systems for coronary artery bypass grafting (CABG) and aortic valve replacement (AVR)., Study Design: We identified an initial cohort of 602 hospitals from US News & World Report's (USN) listing of the 2016-2017 "Best Hospitals for Cardiology & Heart Surgery." From this cohort, current publicly available CABG and AVR ratings were collected from the STS, USN, Centers for Medicare & Medicaid Services, and Healthgrades. All 4 rating systems rated hospitals as high, average, or below average performers for each procedure. We then determined the match rate between rating systems for individual hospitals and assessed interrater reliability with Cohen's κ., Results: Rating systems had different distributions of high and low performing ratings assigned. USN rated hospitals as high performing for both CABG and AVR more frequently compared with STS, Healthgrades, and Centers for Medicare & Medicaid Services. For CABG, the match rate between systems varied from 50% to 85%, with the best match between STS and Centers for Medicare & Medicaid Services. Similarly for AVR, the match rate varied from 50% to 73%, with the best match between STS and Healthgrades. Interrater reliability was poor among the 4 rating systems (κ < 0.2) and consistent with no agreement for CABG and AVR ratings., Conclusions: Publicly reported cardiac surgery ratings have significant discrepancy and poor correlation. This might confuse instead of clarify public perception of hospital quality for cardiac surgery., (Copyright © 2018 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The durability of TAVR prostheses has come under major scrutiny since the move towards lower risk patients. We sought to compare the rate of structural valve deterioration (SVD) over time between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR)., Methods: We included all TAVR and SAVR patients (age ≥ 75 years) that were performed in our centre from 2005 until 2015. Applying the internationally "agreed on" definitions of SVD, we surveyed all available serial echocardiographic follow-ups., Results: We included 269 TAVR and 174 SAVR cases. Post-intervention, TAVR patients had lower mean and peak gradients but higher rate of mild aortic regurgitation. SAVR patients had longer follow-up (in months, SAVR: 53 (30, 85) Vs TAVR: 33.4 (23, 52)). SVD as per Valve Academic Research Consortium-2 (VARC-2) was similar between the two groups (TAVR 28% Vs SAVR 31%; P = 0.593) but moderate haemodynamic SVD (European Association of Percutaneous Cardiovascular Intervention (EAPCI) criteria) was more common among SAVR cases (TAVR 11.5% Vs SAVR 20.7%; P = 0.007). Using Kaplan-Meier estimates, the rate of SVD over time was not different between the two groups as per VARC-2 criteria but different when moderate haemodynamic SVD criteria were applied (Log Rank P = 0.022) in favour of TAVR. The mean gradient rose steadily over time but more so post-SAVR (β = 0.52 ± 0.24 in comparison to TAVR at every given time point; P = 0.032)., Conclusion: Structural valve deterioration is common on long-term follow-up post-TAVR. The rate is similar to post-SAVR cases according to VARC-2 criteria but less according to the moderate haemodynamic SVD criteria., (Copyright © 2018 Elsevier B.V. All rights reserved.)

The governing international standard for the development of prosthetic heart valves is International Organization for Standardization (ISO) 5840. This standard requires the assessment of the thrombus potential of transcatheter heart valve substitutes using an integrated thrombus evaluation. Besides experimental flow field assessment and ex vivo flow testing, computational fluid dynamics is a critical component of this integrated approach. This position paper is intended to provide and discuss best practices for the setup of a computational model, numerical solving, post-processing, data evaluation and reporting, as it relates to transcatheter heart valve substitutes. This paper is not intended to be a review of current computational technology; instead, it represents the position of the ISO working group consisting of experts from academia and industry with regards to considerations for computational fluid dynamic assessment of transcatheter heart valve substitutes.

Transcatheter Mitral Valve Replacement (TMVR) is currently under clinical investigation as a viable treatment option for mitral regurgitation (MR). Therefore, it is important to outline the key functional requirements of a TMVR prosthesis in order to provide an overall approach to assessing mitral valve replacement devices utilizing a combination of in vitro and preclinical methods. This article provides a review of the mitral valve disease as well as general considerations and guidance for developing a TMVR device based on International Industry Standards. Specific details pertaining to the mitral valve apparatus, morphology of mitral valve disease, assessment of specific patient population as well as hazard analysis to evaluate and develop a TMVR device to treat a specific patient population have been included. The details contained within this report are not all inclusive or explicate for every technology being developed but rather thought of as a general guide on how a TMVR technology could be developed in alignment with International Industry Standards. Key learnings from the Transcatheter Aortic Valve Replacement (TAVR) experience has also been considered and taken into account when outlining this general guidance for TMVR. Key learning points from the TAVR development experience included the following: quantification of acceptable levels of paravalvular leak, valve migration potential using various anchoring methods and overall implant frame failure modes when treating the native aortic valve. It should be noted that TAVR is over a decade further along in development and clinical experience compared to TMVR. These key learnings from the early experience with TAVR should be considered with all transcatheter development projects.

Experimental flow field characterization is a critical component of the assessment of the hemolytic and thrombogenic potential of heart valve substitutes, thus it is important to identify best practices for these experimental techniques. This paper presents a brief review of commonly used flow assessment techniques such as Particle image velocimetry (PIV), Laser doppler velocimetry, and Phase contrast magnetic resonance imaging and a comparison of these methodologies. In particular, recommendations for setting up planar PIV experiments such as recommended imaging instrumentation, acquisition and data processing are discussed in the context of heart valve flows. Multiple metrics such as residence time, local velocity and shear stress that have been identified in the literature as being relevant to hemolysis and thrombosis in heart valves are discussed. Additionally, a framework for uncertainty analysis and data reporting for PIV studies of heart valves is presented in this paper. It is anticipated that this paper will provide useful information for heart valve device manufacturers and researchers to assess heart valve flow fields for the potential for hemolysis and thrombosis.

Objective: Currently, there are no large-scale studies that compare differences in case duration of aortic valve replacements (AVRs). The primary objective of this study was to determine associations of hospital facility type, geographic location, case volume per year, and time of day with duration of valve replacement surgery., Design: Retrospective., Setting: Data from the National Anesthesia Clinical Outcomes Registry., Participants: National data from university and non-university hospitals., Interventions: No interventions., Measurements and Main Results: All AVRs from the National Anesthesia Clinical Outcomes Registry were identified from 2010 to 2014. Mean case duration for all AVRs was 360.8 ± 95.8 minutes and was presented based on facility type (university hospital, large community hospital, medium-sized community hospital, and other); US geographic region; time of day (cases performed after 5 pm and before 7 am v day shift); and case volume per year. A multivariable linear regression model was built to determine the association of various patient, procedural, and facility characteristics with case duration. University hospitals were associated with increased case duration for AVRs (p < 0.0001)., Conclusions: With this large national database, the authors demonstrated that academic hospitals, time of day of the surgery, US region, and case volume per year for a facility are related to the case duration of AVRs., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: The aims of this study were to evaluate the intraoperative transesophageal echocardiographic (iTEE) characteristics and Doppler flow profile of aortic Chitra heart valve prosthesis (CHVP) under stable hemodynamic and loading conditions, and to compare and correlate the iTEE data with the postoperative transthoracic echocardiography (TTE) data obtained at 48 hours (TTE 1 ) and 3 months (TTE 2 ) after the surgery., Design: Prospective, observational study., Setting: University-level tertiary referral hospital., Participants: Forty patients between 18 years and 65 years of age undergoing elective aortic valve replacement (AVR) using CHVP during the period January 2015 to August 2016., Interventions: After obtaining permission from institutional ethics committee, 40 patients undergoing elective AVR were studied prospectively. The iTEE examination was performed in the pre-cardiopulmonary bypass (CPB) and post-CPB period in all the study subjects. CHVP was subjected to iTEE two-dimensional (2D) echo, color Doppler, and spectral Doppler evaluation under stable hemodynamic and loading condition in the post-CPB period after the administration of protamine. The CHVP were re-evaluated using TTE in all the patients 48 hours after the surgery (TTE 1 ) and 3 months after the surgery (TTE 2 ). The iTEE and postoperative TTE Doppler values were compared and correlated., Measurements and Main Results: The CHVP could be imaged adequately and interrogated with Doppler in all the patients. None of the patients had restriction of occluder mobility or unstable seating of the valve. The intraoperative flow dependent (peak velocity [PV] and mean pressure gradient [MPG]) and less flow dependent (Doppler velocity index, acceleration time, acceleration time/ejection time, effective orifice area [EOA] and indexed EOA) Doppler parameters of CHVP were measured as per the American Society of Echocardiography recommendations. The PV and MPG of CHVP measured by iTEE showed no statistical difference (p > 0.05) and were in limits of agreement when compared with TTE 1 and TTE 2 data., Conclusion: The iTEE features of CHVP were found compliant with the criteria set by the ASE defining normal functioning of an aortic valve prosthesis. The iTEE Doppler parameters obtained under stable loading conditions strongly predicted the postoperative values of Doppler parameters on TTE examination. The iTEE Doppler values can be used as the reference values for the postoperative follow up studies., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose of Review: Despite the proven superiority of mitral repair over replacement for degenerative mitral disease, mitral valve replacement remains common. Guidelines now recommend referral of patients, particularly those whom are asymptomatic, to valve centers of excellence, although criteria that define such centers remain to be established. The purpose of this review is to define the structure of a mitral center of excellence and to review current clinical outcomes which are possible in such a center., Recent Findings: Recently, American College of Cardiology/American Heart Association as well as the European Society of Cardiology/European Association of Cardiothoracic Surgery guidelines define mitral centers of excellence as either centers in which the likelihood of successful and durable repair exceeds 95% and with an operative mortality risk of less than 1% (American College of Cardiology/American Heart Association definition) or centers with high repair rates, low operative mortality, and a record of durable results (European Society of Cardiology/European Association of Cardiothoracic Surgery definition). There is however less clarity about the structure and function of a center that achieves these outcomes., Summary: The importance of centers of excellence in mitral valve surgery are now well recognized, and this review will highlight the key components and outcomes of an established mitral valve reference center.

Objectives: Current sizing strategies suggest valve selection based on annulus diameter despite supra-annular placement of biological prostheses potentially allowing placement of a larger size. We assessed the frequency of selecting a larger prosthesis if prosthesis size was selected using a replica (upsizing) and evaluated its impact on haemodynamics., Methods: We analysed all discharge echocardiograms between June 2012 and June 2014, where a replica sizer was used for isolated aortic valve replacement (Epic Supra: 266 patients, Trifecta: 49 patients)., Results: Upsizing was possible in 71% of the Epic Supra valves (by 1 size: 168, by 2 sizes: 20) and in 59% of the Trifectas (by 1 size: 26, by 2 sizes: 3). Patients for whom upsizing was possible had the lowest pressure gradients within their annulus size groups. The difference was significant in annulus diameters of 21-22 or 25-26 mm (Epic Supra) and 23-24 mm (Trifecta). Trifecta gradients were the lowest. However, the ability to upsize the Epic Supra by 2 sizes eliminated the differences between Epic Supra and Trifecta. Upsizing did not cause intraoperative complications., Conclusions: Using replica sizers for aortic prosthesis size selection allows the implantation of bigger prostheses than recommended in most cases and reduces postoperative gradients, specifically for Epic Supra., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Mitral regurgitation is a common valvular heart disease and its prevalence is expected to increase with population ageing. In the recent years we have witnessed the evolution of several transcatheter devices to correct mitral regurgitation in patients at high-risk for surgery. Most of the evidence of the safety and efficacy of this new therapy comes from MitraClip studies. However, new alternatives have emerged with promising results. The aim of this position paper is to review the current evidence regarding patient selection, expected results and timing for transcatheter mitral valve interventions from the perspective of three European interventional societies., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objectives: Any aortic valve (AoV) operation in children (repair, Ross or mechanical replacement) is a palliation and reinterventions are frequent. AoV repair is a temporary solution primarily aimed at allowing the patient to grow to an age when more definitive solutions are available. We retrospectively analysed AoV repair effectiveness across the whole age spectrum of children, excluding neonates and AoV disease secondary to congenital heart disease., Methods: From 2003 to 2015, 193 consecutive patients were included. The mean age was 9.2 ± 6.9 years (22% <1 year); 86 (45%) had a preceding balloon valvuloplasty. The indications for the procedure were stenotic (n = 123; 64%), regurgitant (n = 63; 33%) or combined (n = 7; 4%) disease. The procedures performed were commissurotomy shaving (n = 74; 38%), leaflet replacement (n = 78; 40%), leaflet extension (n = 21; 11%) and neocommissure creation (n = 21; 11%). Post-repair geometry was tricuspid in 137 (71%) patients., Results: The 10-year survival rate was 97.1%. Freedom from reoperation and replacement at 7 years was, respectively, 57% (95% confidence interval, 47-66) and 68% (95% confidence interval, 59-76). In multivariate analysis, balloon dilatation before 6 months, the absence of a developed commissure, a non-tricuspid post-repair geometry and cross-clamp duration were predictors for reoperation and replacement. After a mean follow-up period of 5.1 ± 3.0 years, 145 (75%) patients had a preserved native valve, with undisturbed valve function (peak gradient <40 mmHg, regurgitation ≤mild) in 113 (58%)., Conclusions: Aortic valve repair in children is safe and effective in delaying the timing for more definitive solution. Surgical strategy should be individualized according to the age of the patient. Avoidance of early balloon dilatation and aiming for a tricuspid post-repair arrangement may improve outcomes., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)