Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections.

Aims: The number of transcatheter aortic valve implantation (TAVI) procedures is rapidly increasing. This has a major impact on health care resource planning. However, the annual numbers of TAVI candidates per country are unknown. The aim of this study was to estimate current and future number of annual TAVI candidates in 27 European countries, the USA and Canada. Methods and results: Systematic literature searches and meta-analyses were performed on aortic stenosis (AS) epidemiology and decision-making in severe symptomatic AS. The incidence rate of severe AS was determined. Findings were combined with population statistics and integrated into a model employing Monte Carlo simulations to predict the annual number of TAVI candidates. Various future scenarios and sensitivity analyses were explored. Data from 37 studies (n = 26 402) informed the model. The calculated incidence rate of severe AS was 4.4‰/year [95% confidence interval (95% CI) 3.0-6.1‰] in patients ≥65 years. AS-related symptoms were present in 68.3% (95% CI 60.8-75.9%) of patients with severe AS. Despite having severe symptomatic AS, 41.6% (95% CI 36.9-46.3%) did not undergo surgical aortic valve replacement. Of the non-operated patients, 61.7% (95% CI 42.0-81.7%) received TAVI. The model predicted 114 757 (95% CI 69 380-172 799) European and 58 556 (95% CI 35 631-87 738) Northern-American TAVI candidates annually. Conclusion: Currently, approximately 180 000 patients can be considered potential TAVI candidates in the European Union and in Northern-America annually. This number might increase up to 270 000 if indications for TAVI expand to low-risk patients. These findings have major implications for health care resource planning in the 29 individual countries.

Comparative study of male and female patients undergoing surgical aortic valve replacement.

BACKGROUND: Sex does have an effect on disease perception and outcomes after cardiac surgery. OBJECTIVES: The aim of this study was to quantify the differences in cardiovascular risk profiles within an age-matched cohort and assess the long-term survival differences in males and females who underwent surgical aortic valve replacement (SAVR) with or without concomitant coronary artery bypass surgery. METHODS: All-comers patients who underwent SAVR with or without coronary artery bypass surgery were included. Characteristics, clinical features and survival up to 30 years were compared between female and male patients. Propensity matching and age matching using propensity scores were used to compare both groups. RESULTS: During the total study period between 1987 and 2017, there were 3462 patients {mean age 66.8 [standard deviation (SD): 11.1] years, 37.1% female} who underwent SAVR with or without coronary artery bypass surgery at our institution. In general, female patients were older than male patients (69.1 (SD : 10.3) versus 65.5 (SD : 11.3), respectively). In the age-matched cohort, female patients were less likely to have multiple comorbidities and undergo concomitant coronary artery bypass surgery. Twenty-year survival following the index procedure was higher in age-matched female patients (27.1%) compared to male patients (24.4%) in the overall cohort (P = 0.018). CONCLUSIONS: Substantial sex differences in cardiovascular risk profile exist. However, when SAVR with or without coronary artery bypass surgery is performed, extended long-term mortality is comparable between males and females. More research regarding sex-dimorphic mechanisms of aortic stenosis and coronary atherosclerosis would promote more awareness in terms of sex-specific risk factors after cardiac surgery and contribute to more guided personalized surgery in the future.

Outcomes of surgical aortic valve replacement over three decades.

OBJECTIVE: The study objective was to analyze temporal changes in baseline and procedural characteristics and long-term survival of patients undergoing surgical aortic valve replacement over a 30-year period. METHODS: A retrospective analysis of patients undergoing surgical aortic valve replacement between 1987 and 2016 in the Erasmus Medical Center (Rotterdam, The Netherlands) was conducted. Patient baseline and procedural characteristics were analyzed in periods according to the date of surgical aortic valve replacement (period A: 1987-1996; B: 1997-2006; C: 2007-2016). Survival status was determined using the Dutch National Death Registry. Relative survival was obtained by comparing the survival after surgical aortic valve replacement with the survival of the age-, sex-, and year-matched general population. RESULTS: Between 1987 and 2016, 4404 patients underwent SAVR. From period A to C, the mean age increased from 63.9 ± 11.2 years to 66.2 ± 12.3 years (P < .001), and the prevalence of diabetes mellitus, hypertension, hypercholesterolemia, previous myocardial infarction, and previous stroke at baseline increased (P values for trend for all < .001). The prevalence of concomitant procedures increased from 42.4% in period A to 48.3% in period C (P = .004). Bioprosthesis use increased significantly (18.8% in period A vs 67.1% in period C, P < .001). Mean survival after surgical aortic valve replacement was 13.8 years. Relative survival at 20 years in the overall cohort was 60.4% (95% confidence interval, 55.9-65.2) and 73.8% (95% confidence interval, 67.1-81.1) in patients undergoing isolated primary surgical aortic valve replacement. CONCLUSIONS: Patient complexity has been continuously increasing over the last 30 years, yet long-term survival after surgical aortic valve replacement remains high compared with the age-, sex-, and year-matched general population.

Weaning from cardiopulmonary bypass, decannulation, and closure.

In 1952, John Gibbon performed the first successful cardiac procedure using cardiopulmonary bypass, which turned out to be one of the most important clinical advances of that year. Cardiopulmonary bypass has also been described as "One of the most impressive evidences of the role of investigative surgery in the history of medicine in the persevering efforts of Dr. Gibbon for more than 20 years, which finally culminated in a practical heart-lung machine," at the first John H. Gibbon, Jr, Lecture at the annual meeting of the American College of Surgeons [1]. Due to the subsequent advancement of cardiopulmonary bypass, many patients with complex heart disease requiring surgical care undergo cardiac surgery while the other organs remain adequately oxygenated and perfused.

Surgical setup for cardiopulmonary bypass through central cannulation.

The introduction of cardiopulmonary bypass was one of the most important clinical advances of 1952. In that year, John Gibbon performed the first successful cardiac surgery using cardiopulmonary bypass. The procedure has been described as "One of the most impressive evidences of the role of investigative surgery in the history of medicine in the persevering efforts of Dr. Gibbon for more than 20 years, which finally culminated in a practical heart-lung machine", at the first John H. Gibbon, Jr. Lecture at the annual meeting of the American College of Surgeons. Due to on-going advancements in cardiopulmonary bypass, many patients with complex heart disease requiring surgical care undergo cardiac surgery while the other organs remain adequately oxygenated and perfused. This tutorial discusses the access, surgical technique, and initiation of cardiopulmonary bypass through central cannulation and describes the safeguards and pitfalls.

Differences in baseline characteristics and outcomes of bicuspid and tricuspid aortic valves in surgical aortic valve replacement.

OBJECTIVES: Patients with bicuspid aortic valve (BAV) comprise a substantial portion of patients undergoing surgical aortic valve replacement (SAVR). Our goal was to quantify the prevalence of BAV in the current SAVR ± coronary artery bypass grafting (CABG) population, assess differences in cardiovascular risk profiles and assess differences in long-term survival in patients with BAV compared to patients with tricuspid aortic valve (TAV). METHODS: Patients who underwent SAVR with or without concomitant CABG and who had a surgical report denoting the relevant valvular anatomy were eligible and included. Prevalence, predictors and outcomes for patients with BAV were analysed and compared to those patients with TAV. Matched patients with BAV and TAV were compared using a propensity score matching strategy and an age matching strategy. RESULTS: A total of 3723 patients, 3145 of whom (mean age 66.6 ± 11.4 years; 37.4% women) had an operative report describing their aortic valvular morphology, underwent SAVR ± CABG between 1987 and 2016. The overall prevalence of patients with BAV was 19.3% (607). Patients with BAV were younger than patients with TAV (60.6 ± 12.1 vs 68.0 ± 10.7, respectively). In the age-matched cohort, patients with BAV were less likely to have comorbidities, among others diabetes (P = 0.001), hypertension (P < 0.001) and hypercholesterolaemia (P = 0.003), compared to patients with TAV. Twenty-year survival following the index procedure was higher in patients with BAV (14.8%) compared to those with TAV (12.9%) in the age-matched cohort (P = 0.015). CONCLUSIONS: Substantial differences in the cardiovascular risk profile exist in patients with BAV and TAV. Long-term survival after SAVR in patients with BAV is satisfactory.

Asymptomatic Patients with Severe Aortic Stenosis and the Impact of Intervention.

Objectives the exact timing of aortic valve replacement (AVR) in asymptomatic patients with severe aortic stenosis (AS) remains a matter of debate. Therefore, we described the natural history of asymptomatic patients with severe AS, and the effect of AVR on long-term survival. Methods: Asymptomatic patients who were found to have severe AS between June 2006 and May 2009 were included. Severe aortic stenosis was defined as peak aortic jet velocity Vmax ≥ 4.0 m/s or aortic valve area (AVA) ≤ 1 cm2. Development of symptoms, the incidence of AVR, and all-cause mortality were assessed. Results: A total of 59 asymptomatic patients with severe AS were followed, with a mean follow-up of 8.9 ± 0.4 years. A total of 51 (86.4%) patients developed AS related symptoms, and subsequently 46 patients underwent AVR. The mean 1-year, 2-year, 5-year, and 10-year overall survival rates were higher in patients receiving AVR compared to those who did not undergo AVR during follow-up (100%, 93.5%, 89.1%, and 69.4%, versus 92.3%, 84.6%, 65.8%, and 28.2%, respectively; p < 0.001). Asymptomatic patients with severe AS receiving AVR during follow-up showed an incremental benefit in survival of up to 31.9 months compared to conservatively managed patients (p = 0.002). Conclusions: The majority of asymptomatic patients turn symptomatic during follow-up. AVR during follow-up is associated with better survival in asymptomatic severe AS patients.

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 haemodynamic 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.

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.

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.

Challenges and satisfaction in Cardiothoracic Surgery Residency Programmes: insights from a Europe-wide survey.

OBJECTIVES: The increasing complexity of surgical patients and working time constraints represent challenges for training. In this study, the European Association for Cardio-Thoracic Surgery Residents' Committee aimed to evaluate satisfaction with current training programmes across Europe. METHODS: We conducted an online survey between October 2018 and April 2019, completed by a total of 219 participants from 24 countries. RESULTS: The average respondent was in the fourth or fifth year of training, mostly on a cardiac surgery pathway. Most trainees follow a 5-6-year programme, with a compulsory final certification exam, but no regular skills evaluation. Only a minority are expected to take the examination by the European Board of Cardiothoracic Surgery. Participants work on average 61.0 ± 13.1 h per week, including 27.1 ± 20.2 on-call. In total, only 19.7% confirmed the implementation of the European Working Time Directive, with 42.0% being unaware that European regulations existed. Having designated time for research was reported by 13.0%, despite 47.0% having a postgraduate degree. On average, respondents rated their satisfaction 7.9 out of 10, although 56.2% of participants were not satisfied with their training opportunities. We found an association between trainee satisfaction and regular skills evaluation, first operator experience and protected research time. CONCLUSIONS: On average, residents are satisfied with their training, despite significant disparities in the quality and structure of cardiothoracic surgery training across Europe. Areas for potential improvement include increasing structured feedback, research time integration and better working hours compliance. The development of European guidelines on training standards may support this.

Tissue Engineered Materials in Cardiovascular Surgery: The Surgeon's Perspective.

In cardiovascular surgery, reconstruction and replacement of cardiac and vascular structures are routinely performed. Prosthetic or biological materials traditionally used for this purpose cannot be considered ideal substitutes as they have limited durability and no growth or regeneration potential. Tissue engineering aims to create materials having normal tissue function including capacity for growth and self-repair. These advanced materials can potentially overcome the shortcomings of conventionally used materials, and, if successfully passing all phases of product development, they might provide a better option for both the pediatric and adult patient population requiring cardiovascular interventions. This short review article overviews the most important cardiovascular pathologies where tissue engineered materials could be used, briefly summarizes the main directions of development of these materials, and discusses the hurdles in their clinical translation. At its beginnings in the 1980s, tissue engineering (TE) was defined as "an interdisciplinary field that applies the principles of engineering and the life sciences toward the development of biological substitutes that restore, maintain, or improve tissue function" (1). Currently, the utility of TE products and materials are being investigated in several fields of human medicine, ranging from orthopedics to cardiovascular surgery (2-5). In cardiovascular surgery, reconstruction and replacement of cardiac and vascular structures are routinely performed. Considering the shortcomings of traditionally used materials, the need for advanced materials that can "restore, maintain or improve tissue function" are evident. Tissue engineered substitutes, having growth and regenerative capacity, could fundamentally change the specialty (6). This article overviews the most important cardiovascular pathologies where TE materials could be used, briefly summarizes the main directions of development of TE materials along with their advantages and shortcomings, and discusses the hurdles in their clinical translation.

Technique of surgical aortic valve implantation using single interrupted annular sutures.

The introduction of the first surgical prosthetic heart valves in the early 1960s made effective treatment of aortic valve disease possible. The goal of surgical aortic valve replacement is to replace the diseased aortic valve with a properly functioning, sufficiently large prosthesis while avoiding intraoperative complications such as conduction disturbances, coronary artery occlusion, or paravalvular leaks. Although most commonly, non-everting pledgeted mattress sutures are used to implant the prosthesis during surgical aortic valve replacement , interrupted single sutures without pledgets can be a useful alternative, especially in patients with a small tissue annulus, because they theoretically maximize the orifice available for flow. This tutorial discusses the surgical technique of surgical aortic valve replacement using interrupted single annular sutures.

Mortality in low-risk patients with aortic stenosis undergoing transcatheter or surgical aortic valve replacement: a reconstructed individual patient data meta-analysis.

OBJECTIVES: Although the standard of care for patients with severe aortic stenosis at low-surgical risk has included surgical aortic valve replacement (SAVR) since the mid-1960s, many clinical studies have investigated whether transcatheter aortic valve implantation (TAVI) can be a better approach in these patients. As no individual study has been performed to detect the difference in mortality between these 2 treatment strategies, we did a reconstructive individual patient data analysis to study the long-term difference in all-cause mortality. METHODS: Randomized clinical trials and propensity score-matched studies that included low-risk adult patients with severe aortic stenosis undergoing either SAVR or TAVI and with reports on the mortality rates during the follow-up period were considered. The primary outcome was all-cause mortality of up to 5 years. RESULTS: In the reconstructed individual patient data analysis, there was no statistically significant difference in all-cause mortality between TAVI and SAVR at 5 years of follow-up [30.7% vs 21.4%, hazard ratio (HR) 1.19, 95% confidence interval (CI) 0.96-1.48; P = 0.104]. However, landmark analyses in patients surviving up to 1 year of follow-up showed significantly higher all-cause mortality at 5 years of follow-up (27.5% vs 17.3%, HR 1.77, 95% CI 1.29-2.43; P < 0.001) in patients undergoing TAVI compared to patients undergoing SAVR, respectively. CONCLUSIONS: This reconstructed individual patient data analysis in low-risk patients with severe aortic stenosis demonstrates that the 5-year all-cause mortality rates are higher after TAVI than after SAVR, driven by markedly higher mortality rates between 1 and 5 years of follow-up in the TAVI group. The present results call for caution in expanding the TAVI procedure as the treatment of choice for the majority of all low-risk patients until long-term data from contemporary randomized clinical trials are available.

Coronary revascularization after surgical aortic valve replacement.

Objective: It remains unclear how often coronary revascularization is necessary after aortic valve interventions, either by surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement. However, these data are relevant for treatment and prosthesis choice. The authors sought to analyze the incidence and characteristics of coronary revascularization after SAVR during follow-up. Methods: Of 2256 patients undergoing isolated SAVR between 1987 and 2015, 420 patients (mean age 56.9 ± 15.5 years, 66.9% male) were followed at the Erasmus Medical Center. Incidence, predictors, and characteristics of coronary revascularization were analyzed. Cumulative incidence of revascularization was assessed using a competing risk approach. Results: Mean follow-up after SAVR was 17.2 years (total of 4541 patient-years). A total of 24 patients underwent 28 procedures of revascularization. The cumulative incidence of revascularization after SAVR was 0.5%, 2.2%, 4.1%, and 6.9% at 1, 5, 10, and 20 years, respectively. The linearized rate of revascularization was 6.2 per 1000 patient-years. Percutaneous coronary intervention was the most common revascularization method (64%; N = 18/28). Revascularization before SAVR (N = 36/420; of whom 27 percutaneous coronary intervention) was an independent predictor of revascularization during follow-up (hazard ratio, 6.6; 95% confidence interval, 2.6-17.1; P < .001). Conclusions: After SAVR, the rate of coronary revascularization was 6.9% (N = 24/420) at 20-year follow-up. Patients were at particular risk if they had undergone previous revascularization before SAVR. These data may furthermore be relevant to the transcatheter aortic valve replacement population.

How to construct and use a low-fidelity coronary anastomosis simulator.

This Core Skills tutorial shows how a low-fidelity coronary anastomosis simulator can be constructed out of materials available in a normal hospital environment and used to practice various peripheral coronary anastomoses in a realistic-depth environment with limited working space.

Extended pleurectomy decortication for the treatment of malignant pleural mesothelioma.

Malignant pleural mesothelioma is a cancer of the mesothelial cells lining the pleural sac. Surgery for malignant pleural mesothelioma should be part of a multimodality treatment approach and the aim of surgery should be macroscopic complete tumor resection. Lung-sparing operations, such as extended pleurectomy decortication, have gained increasing popularity in the past decade.  This video tutorial illustrates the main steps of extended pleurectomy decortication for the treatment of malignant pleural mesothelioma.

Standards of reporting in open and endovascular aortic surgery (STORAGE guidelines).

The number of patients undergoing surgery on the thoracic and thoraco-abdominal aorta has been steadily increasing over the past decade. This document aims to give guidance to authors reporting on results in aortic surgery by clarifying definitions of aortic pathologies, open and endovascular techniques and by listing clinical parameters that should be provided for full presentation of patients' clinical profile and in particular, their outcome. The aim is to help find a common language in the treatment of aortic disease and to contribute to a better understanding of this patient population.

Characteristics of Surgical Prosthetic Heart Valves and Problems Around Labelling: 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 labelling 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 labelling 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 labelling and identifies the most important elements where further standardization is necessary.

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.