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Background and Aims: To explore male-female differences in aneurysm growth and clinical outcomes in a two-centre retrospective Dutch cohort study of adult patients with ascending aortic aneurysm (AscAA)., Methods: Adult patients in whom imaging of an AscAA (root and/or ascending: ≥40 mm) was performed between 2007 and 2022 were included. Aneurysm growth was analysed using repeated measurements at the sinuses of Valsalva (SoV) and tubular ascending aorta. Male-female differences were explored in presentation, aneurysm characteristics, treatment strategy, survival, and clinical outcomes., Results: One thousand eight hundred and fifty-eight patients were included (31.6% female). Median age at diagnosis was 65.4 years (interquartile range: 53.4-71.7) for females and 59.0 years (interquartile range: 49.3-68.0) for males (P < .001). At diagnosis, females more often had tubular ascending aortic involvement (75.5% vs. 70.2%; P = .030) while males more often had SoV involvement (42.8% vs. 21.6%; P < .001). Maximum absolute aortic diameter, at any location, at diagnosis did not differ between females (45.0 mm) and males (46.5 mm; P = .388). In females, tubular ascending growth was faster (P < .001), whereas in males, SoV growth was faster (P = .005), corrected for covariates. Unadjusted 10-year survival was 72.5% [95% confidence interval (CI) 67.8%-77.6%] for females and 78.3% (95% CI 75.3%-81.3%) for males (P = .010). Twenty-three type A dissections occurred, with an incidence rate of 8.2/1000 patient-years (95% CI 4.4-14.1) in females and 2.4/1000 patient-years (95% CI 1.2-4.5) in males [incidence rate ratio females/males: 3.4 (95% CI 1.5-8.0; P = .004)]., Conclusions: In patients having entered a diagnostic programme, involvement of aortic segments and age- and segment-related growth patterns differ between women and men with AscAA, particularly at an older age. Unravelling of these intertwined observations will provide a deeper understanding of AscAA progression and outcome in women and men and can be used as an evidence base for patient-tailored clinical guideline development., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objectives: The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs. Our goal was to present the results from the fourth Paedi-EUROMACS report., Methods: All paediatric (<19 years) patients from the EUROMACS database supported by a VAD were included. Patients were stratified into a congenital heart disease (CHD) group and a group with a non-congenital aetiology. End points included mortality, a transplant and recovery. Cox proportional hazard models were used to explore associated factors for mortality, cerebrovascular accident and pump thrombosis., Results: A total of 590 primary implants were included. The congenital group was significantly younger (2.5 vs 8.0 years, respectively, P < 0.001) and was more commonly supported by a pulsatile flow device (73.5% vs 59.9%, P < 0.001). Mortality was significantly higher in the congenital group (30.8% vs 20.4%, P = 0.009) than in the non-congenital group. However, in multivariable analyses, CHD was not significantly associated with mortality [hazard ratio (HR) 1.285; confidence interval (CI) 0.8111-2.036, P = 0.740]. Pump thrombosis was the most frequently reported adverse event (377 events in 132 patients; 0.925 events per patient-year) and was significantly associated with body surface area (HR 0.524, CI 0.333-0.823, P = 0.005), CHD (HR 1.641, CI 1.054-2.555, P = 0.028) and pulsatile flow support (HR 2.345, CI 1.406-3.910, P = 0.001) in multivariable analyses., Conclusions: This fourth Paedi-EUROMACS report highlights the increasing use of paediatric VADs. The patient populations with congenital and non-congenital aetiologies exhibit distinct characteristics and clinical outcomes., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Hemocompatibility-related adverse events (HRAEs), particularly gastrointestinal bleeding, remain a frequent complication after left ventricular assist device (LVAD) implantation. The current study sought to describe and analyze whether early (<60 days) postoperative von Willebrand factor (VWF) activity assays predict the risk of gastrointestinal bleeding and stroke. A prospective single-center study including 74 HeartMate 3 device recipients between 2016 and 2023 was undertaken. The postoperative trajectory of the VWF profile was analyzed using linear mixed-effect models and Cox models were used to quantify associations between an early postoperative dip (≤0.7) in VWF activity assay measurements and late outcomes. Preoperatively, the mean VWF:Activity (Act)/Antigen (Ag) and VWF:Collagen Binding (CB)/Ag ratios were 0.94 (95% confidence interval [CI] = 0.81-1.02) and 0.95 (95% CI = 0.80-1.03), respectively, decreasing to 0.66 (95% CI = 0.57-0.73) and 0.67 (95% CI = 0.58-0.74) within 40 days (p < 0.05). In patients with VWF:CB/Ag and VWF:Act/Ag ratios ≤0.7 significantly more gastrointestinal bleeding (hazard ratio [HR]: 2.53; 95% CI = 1.1-5.8, and HR: 3.7; 95% CI = 1.5-9.2, respectively) and hemorrhagic stroke events (HR: 3.5; 95% CI = 1.6-7.6 and HR: 4.9; 95% CI = 2.1-11.7, respectively) were observed throughout the entire late (>60 days) postoperative period. In patients with VWF:Act/Ag ratio ≤0.7 less ischemic stroke events were observed (HR: 0.11; 95% CI = 0.01-0.85). In conclusion, VWF:Act/Ag and VWF:CB/Ag ratios ≤0.7 in the early postoperative phase can be used as biomarkers to predict HRAEs during long-term LVAD support., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

Treatment decisions in healthcare often carry lifelong consequences that can be challenging to foresee. As such, tools that visualize and estimate outcome after different lifetime treatment strategies are lacking and urgently needed to support clinical decision-making in the setting of rapidly evolving healthcare systems, with increasingly numerous potential treatments. In this regard, microsimulation models may prove to be valuable additions to current risk-prediction models. Notable advantages of microsimulation encompass input from multiple data sources, the ability to move beyond time-to-first-event analysis, accounting for multiple types of events and generating projections of lifelong outcomes. This review aims to clarify the concept of microsimulation, also known as individualized state-transition models, and help clinicians better understand its potential in clinical decision-making. A practical example of a patient with heart valve disease is used to illustrate key components of microsimulation models, such as health states, transition probabilities, input parameters (e.g. evidence-based risks of events) and various aspects of mortality. Finally, this review focuses on future efforts needed in microsimulation to allow for increasing patient-tailoring of the models by extending the general structure with patient-specific prediction models and translating them to meaningful, user-friendly tools that may be used by both clinician and patient to support clinical decision-making., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims: The prognostic value of functional tricuspid valve regurgitation (TR) in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (CTEPH) remains undetermined. This study primarily aims to quantify the prognostic role of TR in relation to right ventricle (RV) dysfunction on clinical outcomes and secondarily the evolution of TR and RV dysfunction over time., Methods: Adult PAH or CTEPH patients diagnosed by right heart catheterization were included. Exclusion criteria were prevalent patients and age < 18 years.The primary endpoint was a composite of death or lung transplantation. Longitudinal evolution of TR and RV dysfunction were modelled with generalized mixed-effect models, which were inserted in a cox model under the joint-modelling framework in order to investigate the association of TR and RV dysfunction with the endpoint., Results: We included 76 PAH and 44 CTEPH patients (median age:59, females:62 %), with a mean follow-up of 3.2 ± 2.1 years. 31 patients reached the endpoint (2 transplant, 29 mortality). On average the probability of moderate-to-severe TR decreased during follow-up, whereas the probability of moderate-to-severe RV dysfunction remained stable. The cumulative effect of moderate-to-severe TR (HR per day 1.01 95 %CI[1.00-1.01],P < 0.001) and moderate-to-severe RV dysfunction (HR per day : 1.01 95 %CI[1.00-1.01],P < 0.001) was associated with the endpoint in univariable joint-models. In a multivariable joint-model with both the evolutions of TR and RV dysfunction only TR remained significant (HR per day : 1.01 95 %CI[1.00-1.01],P < 0.001)., Conclusion: Persistent moderate-to-severe tricuspid valve regurgitation during follow-up predicts adverse outcomes and might be a better predictor of lung transplantation and mortality compared to right ventricle dysfunction., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Author(s).)

Importance: The Ross procedure as treatment for adults with aortic valve disease (AVD) has been the subject of renewed interest., Objective: To evaluate the long-term clinical and echocardiographic outcomes following the Ross procedure for the treatment of adults with AVD., Design, Setting, and Participants: This post hoc analysis of a randomized clinical trial included adult patients (age <69 years) who underwent a Ross procedure for the treatment of AVD, including those with active endocarditis, rheumatic AVD, decreased ejection fraction, and previous cardiac surgery. The trial, conducted from September 1, 1994, to May 31, 2001, compared homograft root replacement with the Ross procedure at a single center. Data after 2010 were collected retrospectively in November and December 2022., Exposure: Ross procedure., Main Outcomes and Measures: The primary end point was long-term survival among patients who underwent the Ross procedure compared with that in the age-, country of origin- and sex-matched general population. Secondary end points were freedom from any reintervention, autograft reintervention, or homograft reintervention and time-related valve function, autograft diameter, and functional status., Results: This study included 108 adults (92 [85%] male) with a median age of 38 years (range, 19-66 years). Median duration of clinical follow-up was 24.1 years (IQR, 22.6-26.1 years; 2488 patient-years), with 98% follow-up completeness. Of these patients, 9 (8%) had active endocarditis and 45 (42%) underwent reoperations. The main hemodynamic lesion was stenosis in 30 (28%) and regurgitation in 49 (45%). There was 1 perioperative death (0.9%). Twenty-five year survival was 83.0% (95% CI, 75.5%-91.2%), representing a relative survival of 99.1% (95% CI, 91.8%-100%) compared with the general population (83.7%). At 25 years, freedom from any reintervention was 71.1% (95% CI, 61.6%-82.0%); from autograft reintervention, 80.3% (95% CI, 71.9%-89.6%); and from homograft reintervention, 86.3% (95% CI, 79.0%-94.3%). Thirty-day mortality after the first Ross-related reintervention was 0% and after all Ross-related reinterventions was 3.8% (n = 1); 10-year survival after reoperation was 96.2% (95% CI, 89.0%-100%)., Conclusions and Relevance: This study found that the Ross procedure provided excellent survival into the third decade postoperatively that was comparable to that in the general population. Long-term freedom from reintervention demonstrated that the Ross procedure may be a durable substitute into late adulthood, showing a delayed but progressive functional decline., Trial Registration: isrctn.org Identifier: ISRCTN03530985.

Aims: To support decision-making in children undergoing aortic valve replacement (AVR), by providing a comprehensive overview of published outcomes after paediatric AVR, and microsimulation-based age-specific estimates of outcome with different valve substitutes., Methods and Results: A systematic review of published literature reporting clinical outcome after paediatric AVR (mean age <18 years) published between 1/1/1990 and 11/08/2021 was conducted. Publications reporting outcome after paediatric Ross procedure, mechanical AVR (mAVR), homograft AVR (hAVR), and/or bioprosthetic AVR were considered for inclusion. Early risks (<30d), late event rates (>30d) and time-to-event data were pooled and entered into a microsimulation model. Sixty-eight studies, of which one prospective and 67 retrospective cohort studies, were included, encompassing a total of 5259 patients (37 435 patient-years; median follow-up: 5.9 years; range 1-21 years). Pooled mean age for the Ross procedure, mAVR, and hAVR was 9.2 ± 5.6, 13.0 ± 3.4, and 8.4 ± 5.4 years, respectively. Pooled early mortality for the Ross procedure, mAVR, and hAVR was 3.7% (95% CI, 3.0%-4.7%), 7.0% (5.1%-9.6%), and 10.6% (6.6%-17.0%), respectively, and late mortality rate was 0.5%/year (0.4%-0.7%/year), 1.0%/year (0.6%-1.5%/year), and 1.4%/year (0.8%-2.5%/year), respectively. Microsimulation-based mean life-expectancy in the first 20 years was 18.9 years (18.6-19.1 years) after Ross (relative life-expectancy: 94.8%) and 17.0 years (16.5-17.6 years) after mAVR (relative life-expectancy: 86.3%). Microsimulation-based 20-year risk of aortic valve reintervention was 42.0% (95% CI: 39.6%-44.6%) after Ross and 17.8% (95% CI: 17.0%-19.4%) after mAVR., Conclusion: Results of paediatric AVR are currently suboptimal with substantial mortality especially in the very young with considerable reintervention hazards for all valve substitutes, but the Ross procedure provides a survival benefit over mAVR. Pros and cons of substitutes should be carefully weighed during paediatric valve selection., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objectives: To support clinical decision-making in children with aortic valve disease, by compiling the available evidence on outcome after paediatric aortic valve repair (AVr)., Methods: A systematic review of literature reporting clinical outcome after paediatric AVr (mean age at surgery <18 years) published between 1 January 1990 and 23 December 2021 was conducted. Early event risks, late event rates and time-to-event data were pooled. A microsimulation model was employed to simulate the lives of individual children, infants and neonates following AVr., Results: Forty-one publications were included, encompassing 2 623 patients with 17 217 patient-years of follow-up (median follow-up: 7.3 years; range: 1.0-14.4 years). Pooled mean age during repair for aortic stenosis in children (<18 years), infants (<1 year) or neonates (<30 days) was 5.2 ± 3.9 years, 35 ± 137 days and 11 ± 6 days, respectively. Pooled early mortality after stenosis repair in children, infants and neonates, respectively, was 3.5% (95% confidence interval: 1.9-6.5%), 7.4% (4.2-13.0%) and 10.7% (6.8-16.9%). Pooled late reintervention rate after stenosis repair in children, infants and neonates, respectively, was 3.31%/year (1.66-6.63%/year), 6.84%/year (3.95-11.83%/year) and 6.32%/year (3.04-13.15%/year); endocarditis 0.07%/year (0.03-0.21%/year), 0.23%/year (0.07-0.71%/year) and 0.49%/year (0.18-1.29%/year); and valve thrombosis 0.05%/year (0.01-0.26%/year), 0.15%/year (0.04-0.53%/year) and 0.19%/year (0.05-0.77%/year). Microsimulation-based mean life expectancy in the first 20 years for children, infants and neonates with aortic stenosis, respectively, was 18.4 years (95% credible interval: 18.1-18.7 years; relative survival compared to the matched general population: 92.2%), 16.8 years (16.5-17.0 years; relative survival: 84.2%) and 15.9 years (14.8-17.0 years; relative survival: 80.1%). Microsimulation-based 20-year risk of reintervention in children, infants and neonates, respectively, was 75.2% (72.9-77.2%), 53.8% (51.9-55.7%) and 50.8% (47.0-57.6%)., Conclusions: Long-term outcomes after paediatric AVr for stenosis are satisfactory and dependent on age at surgery. Despite a high hazard of reintervention for valve dysfunction and slightly impaired survival relative to the general population, AVr is associated with low valve-related event occurrences and should be considered in children with aortic valve disease., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: In complex double outlet right ventricle (DORV) patients, the optimal surgical approach may be difficult to assess based on conventional 2-dimensional (2D) ultrasound (US) and computed tomography (CT) imaging. The aim of this study is to assess the added value of 3-dimensional (3D) printed and 3D virtual reality (3D-VR) models of the heart used for surgical planning in DORV patients, supplementary to the gold standard 2D imaging modalities., Methods: Five patients with different DORV subtypes and high-quality CT scans were selected retrospectively. 3D prints and 3D-VR models were created. Twelve congenital cardiac surgeons and paediatric cardiologists, from 3 different hospitals, were shown 2D-CT first, after which they assessed the 3D print and 3D-VR models in random order. After each imaging method, a questionnaire was filled in on the visibility of essential structures and the surgical plan., Results: Spatial relationships were generally better visualized using 3D methods (3D printing/3D-VR) than in 2D. The feasibility of ventricular septum defect patch closure could be determined best using 3D-VR reconstructions (3D-VR 92%, 3D print 66% and US/CT 46%, P < 0.01). The percentage of proposed surgical plans corresponding to the performed surgical approach was 66% for plans based on US/CT, 78% for plans based on 3D printing and 80% for plans based on 3D-VR visualization., Conclusions: This study shows that both 3D printing and 3D-VR have additional value for cardiac surgeons and cardiologists over 2D imaging, because of better visualization of spatial relationships. As a result, the proposed surgical plans based on the 3D visualizations matched the actual performed surgery to a greater extent., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

In this study, we aim to elucidate the clinical impact and long-term course of tricuspid regurgitation (TR), taking into account its dynamic nature, after biatrial orthotopic heart transplant (OHT). All consecutive adult patients undergoing biatrial OHT (1984-2017) with an available follow-up echocardiogram were included. Mixed-models were used to model the evolution of TR. The mixed-model was inserted into a Cox model in order to address the association of the dynamic TR with mortality. In total, 572 patients were included (median age: 50 years, males: 74.9%). Approximately 32% of patients had moderate-to-severe TR immediately after surgery. However, this declined to 11% on 5 years and 9% on 10 years after surgery, adjusted for survival bias. Pre-implant mechanical support was associated with less TR during follow-up, whereas concurrent LV dysfunction was significantly associated with more TR during follow-up. Survival at 1, 5, 10, 20 years was 97% ± 1%, 88% ± 1%, 66% ± 2% and 23% ± 2%, respectively. The presence of moderate-to-severe TR during follow-up was associated with higher mortality (HR: 1.07, 95% CI (1.02-1.12), p = 0.006). The course of TR was positively correlated with the course of creatinine (R = 0.45). TR during follow-up is significantly associated with higher mortality and worse renal function. Nevertheless, probability of TR is the highest immediately after OHT and decreases thereafter. Therefore, it may be reasonable to refrain from surgical intervention for TR during earlier phase after OHT., (© 2023. Higher Education Press.)

Background: Current guidelines recommend valve-sparing aortic root replacement (VSRR) procedures over valve replacement for the treatment of root aneurysm. The reimplantation technique seems to be the most widely used valve-sparing technique, with excellent outcomes in mostly single-center studies. The aim of this systematic review and meta-analysis is to present a comprehensive overview of clinical outcomes after VSRR with the reimplantation technique, and potential differences for bicuspid aortic valve (BAV) phenotype., Methods: We conducted a systematic literature search of papers reporting outcomes after VSRR that were published since 2010. Studies solely reporting on acute aortic syndromes or congenital patients were excluded. Baseline characteristics were summarized using sample size weighting. Late outcomes were pooled using inverse variance weighting. Pooled Kaplan-Meier (KM) curves for time-to-event outcomes were generated. Further, a microsimulation model was developed to estimate life expectancy and risks of valve-related morbidity after surgery., Results: Forty-four studies, with 7,878 patients, matched the inclusion criteria and were included for analysis. Mean age at operation was 50 years and almost 80% of patients were male. Pooled early mortality was 1.6% and the most common perioperative complication was chest re-exploration for bleeding (5.4%). Mean follow-up was 4.8±2.8 years. Linearized occurrence rates for aortic valve (AV) related complications such as endocarditis and stroke were below 0.3% patient-year. Overall survival was 99% and 89% at 1- and 10-year respectively. Freedom from reoperation was 99% and 91% after 1 and 10 years, respectively, with no difference between tricuspid and BAVs., Conclusions: This systematic review and meta-analysis shows excellent short- and long-term results of valve-sparing root replacement with the reimplantation technique in terms of survival, freedom from reoperation, and valve related complications with no difference between tricuspid and BAVs., Competing Interests: Conflicts of Interest: The authors declare no conflicts of interest., (2023 Annals of Cardiothoracic Surgery. All rights reserved.)

Background: No clear guidelines exist for performing preventive surgery for ascending aortic (AA) aneurysm in elderly patients. This study aims to provide insights by: (1) evaluating patient and procedural characteristics and (2) comparing early outcomes and long-term mortality after surgery between elderly and non-elderly patients., Methods: A multicenter retrospective observational cohort-study was performed. Data was collected on patients who underwent elective AA surgery in three institutions (2006-2017). Clinical presentation, outcomes, and mortality were compared between elderly (≥70 years) and non-elderly patients., Results: In total, 724 non-elderly and 231 elderly patients were operated upon. Elderly patients had larger aortic diameters (57.0 mm (IQR 53-63) vs. 53.0 mm (IQR 49-58), p < 0.001) and more cardiovascular risk factors at the time of surgery than non-elderly patients. Elderly females had significantly larger aortic diameters than elderly males (59.5 mm (55-65) vs. 56.0 mm (51-60), p < 0.001). Short-term mortality was comparable between elderly and non-elderly patients (3.0% vs. 1.5%, p = 0.16). Five-year survival was 93.9% in non-elderly patients and 81.4% in elderly patients ( p < 0.001), which are both lower than that of the age-matched general Dutch population., Conclusion: This study showed that in elderly patients, a higher threshold exists to undergo surgery, especially in elderly females. Despite these differences, short-term outcomes were comparable between 'relatively healthy' elderly and non-elderly patients.

The correct positioning of nipple-areolar complexes (NAC) during gender-affirming mastectomies remains a particular challenge. Recently, a Dutch two-step algorithm was proposed predicting the most ideal NAC-position derived from a large cisgender male cohort. We aimed to externally validate this algorithm in a Belgian cohort. The Belgian validation cohort consisted of cisgender men. Based on patient-specific anthropometry, the algorithm predicts nipple-nipple distance (NN) and sternal-notch-to-nipple distance (SNN). Predictions were externally validated using the performance measures: R 2 -value, means squared error (MSE) and mean absolute percentage error (MAPE). Additionally, data were collected from a Belgian and Dutch cohort of transgender men having undergone mastectomy with free nipple grafts. The observed and predicted NN and SNN were compared and the inter-center variability was assessed. A total of 51 Belgian cisgender and 25 transgender men were included, as well as 150 Dutch cisgender and 96 transgender men. Respectively, the performance measures ( R 2 -value, MSE and MAPE) for NN were 0.315, 2.35 (95%CI:0-6.9), 4.9% (95%CI:3.8-6.1) and 0.423, 1.51 (95%CI:0-4.02), 4.73%(95%CI:3.7-5.7) for SNN. When applying the algorithm to both transgender cohorts, the predicted SNN was larger in both Dutch (17.1 measured ( ± 1.7) vs. 18.7 predicted ( ± 1.4), p= <0.001) and Belgian (16.2 measured ( ± 1.8) vs. 18.4 predicted ( ± 1.5), p = <0.001) cohorts, whereas NN was too long in the Belgian (22.0 measured ( ± 2.6) vs. 21.2 predicted ( ± 1.6), p  = 0.025) and too short in the Dutch cohort (19.8 measured ( ± 1.8) vs. 20.7 predicted ( ± 1.9), p  = 0.001). Both models performed well in external validation. This indicates that this two-step algorithm provides a reproducible and accurate clinical tool in determining the most ideal patient-tailored NAC-position in transgender men seeking gender-affirming chest surgery.

Mechanical device malfunction remains a known issue in left ventricular assist devices (LVADs). We investigated the incidence of mechanical device malfunction in the HeartMate II and HeartMate 3 LVADs. We conducted a retrospective study of all HeartMate II and HeartMate 3 LVADs implanted in our center. We evaluated major malfunction, potential major malfunction, minor malfunction, and need of device exchange. In total, 163 patients received an LVAD; in 63 (39%) a HeartMate II, and in 100 (61%) a HeartMate 3, median support time of respectively 24.6 months (interquartile range [IQR]: 32.4) and 21.1 months [IQR: 27.2]. Mechanical device malfunction, consisting of both major and potential major malfunction, occurred significantly less in the HeartMate 3 patients with a hazard ratio (HR) of 0.37 (95% confidence interval [CI]: 0.15-0.87, p = 0.022). Major malfunction alone occurred significantly less in HeartMate 3 patients with a HR of 0.18 (95% CI: 0.05-0.66, p = 0.009). HeartMate 3 patients had a significantly decreased hazard of a pump or outflow graft exchange (HR 0.13, 95% CI: 0.08-0.81, p = 0.008). System controller defects occurred significantly less in HM 3 patients ( p = 0.007), but battery-clips defects occurred significantly more in HM 3 patients ( p = 0.039). Major device malfunction including pump or outflow graft exchange occurred significantly less in HeartMate 3 compared to HeartMate II, while minor malfunctions were similar. Periodical assessment of the technical integrity of the device remains necessary during long-term LVAD support., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

Objectives: New temperature management concepts of moderate and mild hypothermic circulatory arrest during aortic arch surgery have gained weight over profound cooling. Comparisons of all temperature levels have rarely been performed. We performed direct and indirect comparisons of deep hypothermic circulatory arrest (DHCA) (≤20°C), moderate hypothermic circulatory arrest (MHCA) (20.1-25°C), and mild hypothermic circulatory arrest (mild HCA) (≥25.1°C) in a network meta-analysis., Methods: The literature was systematically searched for all papers published through February 2022 reporting on clinical outcomes after aortic arch surgery utilizing DHCA, MHCA and mild HCA. The primary outcome was operative mortality. The secondary outcomes were postoperative stroke and acute kidney failure (AKI)., Results: A total of 34 studies were included, with a total of 12,370 patients. DHCA was associated with significantly higher postoperative incidence of stroke when compared with MHCA (odds ratio [OR], 1.46, 95% confidence interval [CI], 1.19-1.78) and mild HCA: (OR, 1.50, 95% CI, 1.14-1.98). Furthermore, DHCA and MHCA were associated with higher operative mortality when compared with mild HCA (OR 1.71, 95% CI, 1.23-2.39 and OR 1.50, 95% CI, 1.12-2.00, respectively). Separate analysis of randomized and propensity score matched studies showed sustained increased risk of stroke with DHCA in contrast to MHCA and mild HCA (OR, 1.61, 95% CI, 1.18-2.20, p value = .0029 and OR, 1.74, 95% CI, 1.09-2.77, p value = .019)., Conclusions: In the included studies, the moderate to mild hypothermia strategies were associated with decreased operative mortality and the risk of postoperative stroke. Large-scale prospective studies are warranted to further explore appropriate temperature management for the treatment of aortic arch pathologies., (© 2022 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC.)

Objectives: In patients supported by a durable left ventricular assist device (LVAD), infections are a frequently reported adverse event with increased morbidity and mortality. The purpose of this study was to investigate the possible association between infections and thromboembolic events, most notable cerebrovascular accidents (CVAs), in LVAD patients., Methods: An analysis of the multicentre European Registry for Patients Assisted with Mechanical Circulatory Support was performed. Infections were categorized as VAD-specific infections, VAD-related infections and non-VAD-related infections. An extended Kaplan-Meier analysis for the risk of CVA with infection as a time-dependent covariate and a multivariable Cox proportional hazard model were performed., Results: For this analysis, 3282 patients with an LVAD were included with the majority of patients being male (83.1%). During follow-up, 1262 patients suffered from infection, and 457 patients had a CVA. Cox regression analysis with first infection as time-dependent covariate revealed a hazard ratio (HR) for CVA of 1.90 [95% confidence interval (CI): 1.55-2.33; P &lt; 0.001]. Multivariable analysis confirmed the association for infection and CVAs with an HR of 1.99 (95% CI: 1.62-2.45; P &lt; 0.001). With infections subcategorized, VAD-specific HR was 1.56 (95% CI: 1.18-2.08; P 0.002) and VAD-related infections [HR: 1.99 (95% CI: 1.41-2.82; P &lt; 0.001)] remained associated with CVAs, while non-VAD-related infections (P = 0.102) were not., Conclusions: Infection during LVAD support is associated with an increased risk of developing an ischaemic or haemorrhagic CVA, particularly in the setting of VAD-related or VAD-specific infections. This suggests the need of a stringent anticoagulation management and adequate antibiotic treatment during an infection in LVAD-supported patients., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: The emergence of big cardio-thoracic surgery datasets that include not only short-term and long-term discrete outcomes but also repeated measurements over time offers the opportunity to apply more advanced modelling of outcomes. This article presents a detailed introduction to developing and interpreting linear mixed-effects models for repeated measurements in the setting of cardiothoracic surgery outcomes research., Methods: A retrospective dataset containing serial echocardiographic measurements in patients undergoing surgical pulmonary valve replacement from 1986 to 2017 in Erasmus MC was used to illustrate the steps of developing a linear mixed-effects model for clinician researchers., Results: Essential aspects of constructing the model are illustrated with the dataset including theories of linear mixed-effects models, missing values, collinearity, interaction, nonlinearity, model specification, results interpretation and assumptions evaluation. A comparison between linear regression models and linear mixed-effects models is done to elaborate on the strengths of linear mixed-effects models. An R script is provided for the implementation of the linear mixed-effects model., Conclusions: Linear mixed-effects models can provide evolutional details of repeated measurements and give more valid estimates compared to linear regression models in the setting of cardio-thoracic surgery outcomes research., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: This retrospective study investigated the correlation between the angular position of the left ventricular assist device (LVAD) inflow cannula and relapsing low-flow alarms., Methods: Medical charts were reviewed of all patients with HeartMate 3 LVAD support for relapsing low-flow alarms. A standardized protocol was created to measure the angular position with a contrast-enhanced computed tomography scan. Statistics were done using a gamma frailty model with a constant rate function., Results: For this analysis, 48 LVAD-supported patients were included. The majority of the patients were male (79%) with a median age of 57 years and a median follow-up of 30 months (interquartile range: 19-41). Low-flow alarm(s) were experienced in 30 (63%) patients. Angulation towards the septal-lateral plane showed a significant increase in low-flow alarms over time with a constant rate function of 0.031 increase in low-flow alarms per month of follow-up per increasing degree of angulation (P = 0.048). When dividing this group using an optimal cut-off point, a significant increase in low-flow alarms was observed when the septal-lateral angulation was 28° or more (P = 0.001). Anterior-posterior and maximal inflow cannula angulation did not show a significant difference., Conclusions: This study showed an increasing number of low-flow alarms when the degrees of LVAD inflow cannula expand towards the septal-lateral plane. This emphasizes the importance of the LVAD inflow cannula angular position to prevent relapsing low-flow alarms with the risk of diminished quality of life and morbidity., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Heart transplantation (HTx) is, at present, the most effective therapy for end-stage heart failure patients; however, the number of patients on the waiting list is rising globally, further increasing the gap between demand and supply of donors for HTx. First studies using the Organ Care System (OCS) for normothermic machine perfusion show promising results yet are limited in sample size. This article presents a meta-analysis of heart donation either after brain death (OCS-DBD) or circulatory death (OCS-DCD) on using OCS versus static cold storage used for HTx., Methods: A systematic literature search was performed for articles discussing the use of normothermic ex situ heart perfusion in adult patients. Thirty-day survival outcomes were pooled, and odds ratios were calculated using random-effects models. Long-term survival was visualized with Kaplan-Meier curves, hazard ratios were calculated and pooled using fixed-effects models, and secondary outcomes were analyzed., Results: A total of 12 studies were included, with 741 patients undergoing HTx, of which 260 with the OCS (173 DBD and 87 DCD). No differences were found between the 3 groups for early and late survival outcomes or for secondary outcomes., Conclusions: OCS outcomes, for both DBD and DCD hearts, appeared similar as for static cold storage. Therefore, OCS is a safe and effective technique to enlarge the cardiac donor pool in both DBD and DCD, with additional benefits for long-distance transport and surgically complex procedures., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Consensus regarding optimal cerebral protection strategy in aortic arch surgery is lacking. We therefore performed a systematic review and meta-analysis to assess outcome differences between unilateral antegrade cerebral perfusion (ACP), bilateral ACP, retrograde cerebral perfusion (RCP) and deep hypothermic circulatory arrest (DHCA). A systematic literature search was performed in Embase, Medline, Web of Science, Cochrane and Google Scholar for all papers published till February 2021 reporting on early clinical outcome after aortic arch surgery utilizing either unilateral, bilateral ACP, RCP or DHCA. The primary outcome was operative mortality. Other key secondary endpoints were occurrence of postoperative disabling stroke, paraplegia, renal and respiratory failure. Pooled outcome risks were estimated using random-effects models. A total of 222 studies were included with a total of 43 720 patients. Pooled postoperative mortality in unilateral ACP group was 6.6% [95% confidence interval (CI) 5.3-8.1%], 9.1% (95% CI 7.9-10.4%), 7.8% (95% CI 5.6-10.7%), 9.2% (95% CI 6.7-12.7%) in bilateral ACP, RCP and DHCA groups, respectively. The incidence of postoperative disabling stroke was 4.8% (95% CI 3.8-6.1%) in the unilateral ACP group, 7.3% (95% CI 6.2-8.5%) in bilateral ACP, 6.4% (95% CI 4.4-9.1%) in RCP and 6.3% (95% CI 4.4-9.1%) in DHCA subgroups. The present meta-analysis summarizes the clinical outcomes of different cerebral protection techniques that have been used in clinical practice over the last decades. These outcomes may be used in advanced microsimulation model. These findings need to be placed in the context of the underlying aortic disease, the extent of the aortic disease and other comorbidities. Prospero registration number: CRD42021246372 METC: MEC-2019-0825., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: Multiple biomarkers have been investigated in the risk stratification of patients with pulmonary arterial hypertension (PAH). This systematic review and meta-analysis is the first to investigate the prognostic value of (NT-pro)BNP in patients with PAH., Methods: A systematic literature search was performed using MEDLINE, Embase, Web of Science, the Cochrane Library and Google scholar to identify studies on the prognostic value of baseline (NT-pro)BNP levels in PAH. Studies reporting hazard ratios (HR) for the endpoints mortality or lung transplant were included. A random effects meta-analysis was performed to calculate the pooled HR of (NT-pro)BNP levels at the time of diagnosis. To account for different transformations applied to (NT-pro)BNP, the HR was calculated for a 2-fold difference of the weighted mean (NT-pro)BNP level of 247 pmol/L, for studies reporting a HR based on a continuous (NT-pro)BNP measurement., Results: Sixteen studies were included, representing 6999 patients (mean age 45.2-65.0 years, 97.3% PAH). Overall, 1460 patients reached the endpoint during a mean follow-up period between 1 and 10 years. Nine studies reported HRs based on cut-off values. The risk of mortality or lung transplant was increased for both elevated NT-proBNP and BNP with a pooled HR based on unadjusted HRs of 2.75 (95%-CI: 1.86-4.07) and 3.87 (95% CI 2.69-5.57) respectively. Six studies reported HRs for (NT-pro)BNP on a continues scale. A 2-fold difference of the weighted mean NT-proBNP resulted in an increased risk of mortality or lung transplant with a pooled HR of 1.17 (95%-CI: 1.03-1.32)., Conclusions: Increased levels of (NT-pro)BNP are associated with a significantly increased risk of mortality or lung transplant in PAH patients., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Significant aortic regurgitation at the time of left ventricular assist device (LVAD) implantation, requires concomitant aortic valve (AoV) replacement or repair. However, the impact of concomitant AoV surgery on morbidity remains unknown. Therefore, our aim is to determine the impact of concomitant AoV surgery on thromboembolic and bleeding events., Methods: A retrospective IMACS registry study, including patients implanted from 2013 until September 2017. Differences between different concomitant AoV surgery modalities were analyzed., Results: In total, 785 (5.1%) out of 15.267 patients (median age 58 IQR 49-66 years, 79% male) underwent concomitant AoV surgery (median age 63 IQR 54-69 years, 84% male); 386 (49%) patients received biological prostheses, 71 (9%) mechanical prostheses and 328 (42%) AoV repairs. In total, 54 (8%) patients with AoV surgery experienced a thromboembolic event and 1016 (9%) patients with no AoV surgery. Furthermore, concomitant AoV surgery was associated with an increased rate of all and nonsurgical bleedings. Following a multivariable Cox regression, concomitant AoV surgery remained an independent predictor for bleeding events., Conclusions: In LVAD patients undergoing concomitant AoV surgery, thromboembolic event rates were not higher, however both all and nonsurgical bleeding event rates were higher., (Copyright © 2022. Published by Elsevier B.V.)

Objectives: In the third report of the European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery, outcomes of patients receiving mechanical circulatory support are reviewed in relation to implant era., Methods: Procedures in adult patients (January 2011-June 2020) were included. Patients from centres with <60% follow-ups completed were excluded. Outcomes were stratified into 3 eras (2011-2013, 2014-2017 and 2018-2020). Adverse event rates (AERs) were calculated and stratified into early phase (<3 months) and late phase (>3 months). Risk factors for death were explored using univariable Cox regression with a stepwise time-varying hazard ratio (<3 vs >3 months)., Results: In total, 4834 procedures in 4486 individual patients (72 hospitals) were included, with a median follow-up of 1.1 (interquartile range: 0.3-2.6) years. The annual number of implants (range: 346-600) did not significantly change (P = 0.41). Both Interagency Registry for Mechanically Assisted Circulatory Support class (classes 4-7: 23, 25 and 33%; P < 0.001) and in-hospital deaths (18.5, 17.2 and 11.2; P < 0.001) decreased significantly between eras. Overall, mortality, transplants and the probability of weaning were 55, 25 and 2% at 5 years after the implant, respectively. Major infections were mainly noted early after the implant occurred (AER<3 months: 1.44 vs AER>3 months: 0.45). Bilirubin and creatinine levels were significant risk factors in the early phase but not in the late phase after the implant., Conclusions: In its 10 years of existence, EUROMACS has become a point of reference enabling benchmarking and outcome monitoring. Patient characteristics and outcomes changed between implant eras. In addition, both occurrence of outcomes and risk factor weights are time dependent., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Atrial fibrillation (AF) is a risk factor for mortality and cerebrovascular accidents (CVAs) and is common in patients with heart failure. This study evaluated survival and adverse events in patients with a left ventricular assist device (LVAD) and a history of AF in the European Registry for Patients with Mechanical Circulatory Support., Methods: Patients with a continuous-flow LVAD, AF or sinus rhythm (SR) and a follow-up were included. Kaplan-Meier analyses for survival (including a propensity-scored matched analysis), freedom from CVA, pump thrombosis, bleeding and a composite of pump thrombosis/CVA were performed. To correct for covariate imbalance, a Kaplan-Meier (KM) analysis was performed after propensity score (PS) matching the groups. Finally, a Cox regression was performed for predictors of lower survival., Results: Overall, 1821 patients (83% male) were included, with a median age of 57 years and a median follow-up of 13.1 months (interquartile range: 4.3-27.7). Preoperative Electrocardiogram (ECG) rhythm was AF in 421 (23.1%) and SR in 1400 (76.9%) patients. Patients with pre-LVAD AF had a lower ≤90-day (81.9% vs 87.1%, P = 0.0047) and 4-year (35.4% vs 44.2%, P = 0.0083) survival compared to SR. KM analysis with PS matching groups revealed a trend (P = 0.087) towards decreased survival. Univariable analyses confirmed pre-LVAD AF as a predictor for mortality, but the multivariable analysis did not. No difference in the rate of adverse events was found. An analysis of patients at 24 months revealed a higher rate of CVAs for pre-LVAD AF patients (77% vs 94.3%, P < 0.0001)., Conclusions: Patients with pre-LVAD AF undergoing LVAD implantation had a worse survival. However, after performing a multivariate analysis, and PS matching analysis, AF was no longer significant, indicating a worser preoperative condition in these patients. Concerning thrombo-embolic events, only patients with pre-LVAD AF alive beyond 24 months have a higher risk of CVAs., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Introduction: To our knowledge, methylprednisolone pharmacokinetics and plasma concentrations have not been comprehensively investigated in children with congenital heart disease undergoing cardiac surgery with cardiopulmonary bypass. It is unknown whether there is a significant influence of cardiopulmonary bypass on the plasma concentrations of methylprednisolone and whether this may be an explanation for the limited reported efficacy of steroid administration in cardiac surgery with cardiopulmonary bypass. Methods: The study was registered in the Dutch Trial Register (NTR3579; https://www.trialregister.nl/trial/3428). Methylprednisolone 30 mg/kg was administered as an intravenous bolus after induction of anesthesia. Methylprednisolone concentration was measured with liquid chromatography tandem mass spectrometry and analyzed using linear mixed-effects modeling. Results: Thirty-nine patients were included in the study, of which three were excluded. There was an acute decrease in observed methylprednisolone plasma concentration on initiation of cardiopulmonary bypass (median = 26.8%, range = 13.9-48.14%, p < 0.001). We found a lower intercept ( p = 0.02), as well as a less steep slope of the model predicted methylprednisolone concentration vs. time curve for neonates ( p = 0.048). A lower intercept ( p = 0.01) and a less steep slope (p = 0.0024) if the volume of cell saver blood processed was larger than 91 ml/kg were also found. Discussion: We report similar methylprednisolone plasma concentrations as earlier studies performed in children undergoing cardiopulmonary bypass, and we confirmed the large interindividual variability in achieved methylprednisolone plasma concentrations with weight-based methylprednisolone administration. A larger volume of distribution and a lower clearance of methylprednisolone for neonates were suggested. The half-life of methylprednisolone in our study was calculated to be longer than 6 h for neonates, 4.7 h for infants, 3.6 h for preschool children and 4.7 h for school children. The possible influence of treatment of pulmonary hypertension with sildenafil and temperature needs to be investigated further., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 van Saet, Zeilmaker-Roest, Veen, de Wildt, Sorgel, Stolker, Bogers and Tibboel.)

Background: The ministernotomy approach is increasingly used in aortic valve surgery. However, the advantages are still a matter of discussion. The aim of this study was to compare the postoperative outcome in patients undergoing elective aortic valve operation, either through mini-sternotomy or conventional sternotomy., Methods: We included 317 patients who were treated for their aortic valve, 63 patients underwent a minimally invasive aortic valve replacement (mini-AVR) and 254 patients underwent a full-sternotomy AVR. Patients with endocarditis, those who underwent previous cardiac surgery and those who required a concomitant procedure were excluded from the analysis. The method of matching weights according to propensity score was used to adjust for differences between the two treatment groups, and outcomes were compared., Results: The mediastinal drainage was significantly lower at 6, 24 hours and total after mini-AVR procedure than after full-sternotomy AVR (median: 373 vs. 499 mL, P<0.001). However, the number of patients receiving packed red blood cells transfusion was similar. Overall, the hospital mortality was lower in the full-sternotomy group, 0% vs. 3.2%, P=0.039. No difference was found in the median hospital length of stay, perioperative myocardial infarction, postoperative incidence of new pacemaker implantation, stroke, prolonged mechanical ventilation and mediastinitis. No patients in the mini-AVR group experienced paravalvular leakage. Midterm survival resulted in no difference between the treatment groups at 4-year (90.5% vs. 95.2%), P=0.75., Conclusions: Although the minimally invasive surgery for AVR may increasingly be applied, our initial experience calls for a careful approach of adapting this procedure.

Background: In the treatment of gender dysphoria, appropriate nipple-areola complex (NAC) positioning is essential for achieving a natural appearing male chest after subcutaneous mastectomy. An accurate predictive model for the ideal personalized position of the NAC is still lacking. The aim of this study is to determine the anthropometry of the male chest to create individualized guidelines for appropriate NAC positioning in the preoperative setting., Materials and Methods: Cisgender male participants were recruited. Multiple chest measurements were manually recorded. Best subset regression using linear models was used to select predictors for the horizontal coordinate (nipple-nipple distance; NN) and vertical coordinate (sternal notch-nipple distance; SNN) of the NAC. Internal validation was assessed using bootstrapping. Furthermore, a cohort of transgender men who had received a mastectomy with replantation of nipples according to current practice was identified. Comparison testing between the algorithm and standard practice was performed to test the limitations of standard practice., Results: One hundred and fifty cis male participants were included (median age: 26, IQR: 22-34 years). Four predictors were found to predict NN (age, weight, chest circumference (CC), anterior-axillar fold to anterior-axillar fold (AUX-AUX)) and reads as follows: NN = 4.11 + 0.035*age + 0.041*weight + 0.093*CC + 0.140*AUX-AUX Two predictors were found to predict SNN (NN and weight), and reads as follows: SNN = 7.248 + 0.303*NN + 0.072*weight. Both models performed well (Bootstrapped R 2 : 0.63 (NN), 0.50 (SNN)) and outperformed previous models predicting NAC position. Ninety-six transgender men were eligible for evaluation of current practice and showed an average placement error of -0.9 cm for NN and +2.2 cm for SNN., Conclusion: The non-standardized approach of NAC repositioning results in a significant error of nipple placement. We suggest that the two predictive models for NN and SNN can be used to optimize NAC positioning on the masculinized chest wall., Supplemental data for this article is available online at https://doi.org/10.1080/26895269.2021.1884926., Competing Interests: The authors declare that they have no conflict of interest., (© 2021 The Author(s). Published with license by Taylor & Francis Group, LLC.)

Objectives: Data on the impact and course of uncorrected tricuspid regurgitation (TR) during left ventricular assist device (LVAD) implantation are scarce and inconsistent. This study explores the clinical impact and natural course of uncorrected TR in patients after LVAD implantation., Methods: The European Registry for Patients with Mechanical Circulatory Support was used to identify adult patients with LVAD implants without concomitant tricuspid valve surgery. A mediation model was developed to assess the association of TR with 30-day mortality via other risk factors. Generalized mixed models were used to model the course of post-LVAD TR. Joint models were used to perform sensitivity analyses., Results: A total of 2496 procedures were included (median age: 56 years; men: 83%). TR was not directly associated with higher 30-day mortality, but mediation analyses suggested an indirect association via preoperative elevated right atrial pressure and creatinine (P = 0.035) and bilirubin (P = 0.027) levels. Post-LVAD TR was also associated with increased late mortality [hazard ratio 1.16 (1.06-1.3); P = 0.001]. On average, uncorrected TR diminished after LVAD implantation. The probability of having moderate-to-severe TR immediately after an implant in patients with none-to-mild TR pre-LVAD was 10%; in patients with moderate-to-severe TR pre-LVAD, it was 35% and continued to decrease in patients with moderate-to-severe TR pre-LVAD, regardless of pre-LVAD right ventricular failure or pulmonary hypertension., Conclusions: Uncorrected TR pre-LVAD and post-LVAD is associated with increased early and late mortality. Nevertheless, on average, TR diminishes progressively without intervention after an LVAD implant. Therefore, these data suggest that patient selection for concomitant tricuspid valve surgery should not be based solely on TR grade., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: The aim of this study is to evaluate the effects of minimal access mitral valve surgery (MAMVS) versus conventional surgery with or without concomitant tricuspid valve plasty (TVP) in consecutive patients with mitral regurgitation (MR) on clinical and echocardiographic outcome., Methods: One-hundred-and-twenty patients operated for MR (91 conventional and 29 MAMVS) were followed by echocardiography and quality of life assessment before and 6 months after surgery., Results: Patients in the MAMVS group were younger, more often in NYHA functional class I-II and had lower NT-proBNP levels. Only four patients (all in the conventional group) underwent mitral valve replacement. There were no significant differences in complications between MAMVS and conventional surgery. At 6 months, comparable MR reduction and left ventricular remodeling data were seen, left atrial remodeling was most prominent in the MAMVS group, 71 [55-90] to 43 [35-58] versus 69 [53-89] to 49 [41-70] mL/m 2 in the conventional group (P<0.05). Significant improvement for all quality of life domains were seen, except for pain, with no intergroup differences. Twenty-seven (23%) patients underwent concomitant TVP, all in the conventional group. Tricuspid regurgitation decreased after concomitant TVP (P<0.001), whereas in patients with no TVP no significant changes occurred. At 6 months tricuspid regurgitation grade was comparable in patients with TVP versus patients without need for TVP., Conclusions: MR severity reduced significantly, with no difference between conventional surgery and MAMVS in reducing MR, with superior left atrial remodeling in the MAMVS group. In-hospital complications and NYHA class and quality of life assessment were not different between conventional surgery and MAMVS.

Purpose: With the increasing interest in treatment decision-making based on risk prediction models, it is essential for clinicians to understand the steps in developing and interpreting such models., Methods: A retrospective registry of 20 Dutch hospitals with data on patients treated for castration-resistant prostate cancer was used to guide clinicians through the steps of developing a prediction model. The model of choice was the Cox proportional hazard model., Results: Using the exemplary dataset several essential steps in prediction modelling are discussed including: coding of predictors, missing values, interaction, model specification and performance. An advanced method for appropriate selection of main effects, e.g. Least Absolute Shrinkage and Selection Operator (LASSO) regression, is described. Furthermore, the assumptions of Cox proportional hazard model are discussed, and how to handle violations of the proportional hazard assumption using time-varying coefficients., Conclusion: This study provides a comprehensive detailed guide to bridge the gap between the statistician and clinician, based on a large dataset of real-world patients treated for castration-resistant prostate cancer.

Background: Orthotopic heart transplantation (OHT) is the gold standard treatment in end-stage heart disease. Controversy remains whether bicaval OHT is superior to biatrial OHT in both early and late outcomes. This study aimed to provide an overview of the early and late outcomes in patients who underwent a bicaval or biatrial OHT., Methods: A systematic literature search was performed for articles published before December 2017. Studies comparing adult patients undergoing biatrial OHT and bicaval OHT were included. Early outcomes were pooled in odds ratios and late outcomes were pooled in rate ratios. Late survival was visualized by a pooled Kaplan-Meier curve., Results: A total of 36 publications were included in the meta-analysis, counting 3555 patients undergoing biatrial OHT and 3208 patients undergoing bicaval OHT. Early outcomes in mortality, tricuspid regurgitation, mitral regurgitation, and permanent pacemaker implantation differed significantly in favor of the bicaval OHT patients. Long-term survival was significantly better in patients undergoing bicaval vs biatrial OHT (hazard ratio, 1.32; 95% confidence interval, 1.1-1.6; P = .008). Also, late tricuspid regurgitation was less frequently seen in the bicaval OHT patients (rate ratio, 2.14; 95% CI, 1.17-3.94; P = .014)., Conclusions: This systematic review with meta-analysis shows that bicaval OHT results in more favorable early and late outcomes for patients undergoing a bicaval OHT compared with a biatrial OHT. Therefore, bicaval OHT should be considered as preferable technique for OHT., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study provides an overview of the change over a 45-year time period in the characteristics and outcome of patients with tricuspid valve disease undergoing surgical tricuspid valve replacement (TVR)., Methods: The characteristics and outcomes of all consecutive TVRs from November 1972 to November 2017 at Erasmus MC were collected retrospectively. A logistic regression analysis was conducted to identify the significant predictors of 30-day mortality. Multivariable Cox regression analysis was used to identify the potential risk factors of patient outcome and the effect of time on these factors., Results: Ninety-eight patients with tricuspid valve dysfunction underwent 114 consecutive TVRs at a mean age of 50.1 ± 17.2 years (68.5% female). Aetiology changed over time from predominantly functional regurgitation (42.9% in 1972-1985) to predominantly carcinoid heart disease (47.7% in 2001-2017). Early mortality declined significantly from 35% in 1972-1985 to 6.7% in 2001-2017 (P < 0.001). Over time, the hazard ratio of late mortality decreased for higher New York Heart Association class, lower preoperative haemoglobin, and high central venous pressure and increased for the presence of preoperative leg oedema, higher creatinine and alkaline phosphatase. The late survival was 43.8% ± 5.89% at 10 years and was comparable among eras (P = 0.44). The cumulative incidence of reoperation at 10 years was 14.1% (2.3-26.0) in biological valves and 4.9% (0.1-10.3) in mechanical valves (P = 0.25)., Conclusions: Patient characteristics, potential risk factors and patient outcome changed considerably over time in patients undergoing TVR. Notably, there was a shift in aetiology, completely altering the patient population and their characteristics., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Tricuspid regurgitation (TR) is a frequent and complex problem, commonly combined with left-sided heart disease, such as mitral regurgitation. Significant TR is associated with increased mortality if left untreated or recurrent after therapy. Tricuspid regurgitation was historically often disregarded and remained undertreated. Surgery is currently the only Class I Guideline recommended therapy for TR, in the form of annuloplasty, leaflet repair, or valve replacement. As growing experience of transcatheter therapy in structural heart disease, many dedicated transcatheter tricuspid repair or replacement devices, which mimic well-established surgical techniques, are currently under development. Nevertheless, many aspects of TR are little understood, including the disease process, surgical or interventional risk stratification, and predictors of successful therapy. The optimal treatment timing and the choice of proper surgical or interventional technique for significant TR remain to be elucidated. In this context, we aim to highlight the current evidence, underline major controversial issues in this field and present a future roadmap for TR therapy., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Objectives: We evaluated the impact of preoperative liver function on early and 1-year postoperative outcomes in patients supported with a left ventricular assist device (LVAD) and subsequent evolution of liver function markers., Methods: A retrospective multicentre cohort study was conducted, including all patients undergoing continuous-flow LVAD implantation. The Model for End-stage Liver Disease (MELD) score was used to define liver dysfunction., Results: Overall, 290 patients with an LVAD [78% HeartMate II, 15% HVAD and 7% HeartMate 3, mean age 55 (18), 76% men] were included. Over 40 000 measurements of liver function markers were collected over a 1-year period. A receiver operating characteristic curve analysis for the 1-year mortality rate identified the optimal cut-off value of 12.6 for the MELD score. Therefore, the cohort was dichotomized into patients with an MELD score of less than or greater than 12.6. The early (90-day) survival rates in patients with and without liver dysfunction were 76% and 91% (P = 0.002) and 65% and 90% at 1 year, respectively (P < 0.001). Furthermore, patients with preoperative liver dysfunction had more embolic events and more re-explorations. At the 1-year follow-up, liver function markers showed an overall improvement in the majority of patients, with or without pre-LVAD liver dysfunction., Conclusions: Preoperative liver dysfunction is associated with higher early 90-day and 1-year mortality rates after LVAD implantation. Furthermore, liver function improved in both patient groups. It has become imperative to optimize the selection criteria for possible LVAD candidates, since those who survive the first year show excellent recovery of their liver markers., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Many patients undergoing durable left ventricular assist device (LVAD) implantation suffer from chronic kidney disease (CKD). Therefore, we investigated the effect of LVAD support on CKD., Methods: A retrospective multicenter cohort study, including all patients undergoing LVAD (HeartMate II (n = 330), HeartMate 3 (n = 22) and HeartWare (n = 48) implantation. In total, 227 (56.8%) patients were implanted as bridge-to-transplantation; 154 (38.5%) as destination therapy; and 19 (4.7%) as bridge-to-decision. Serum creatinine measurements were collected over a 2-year follow-up period. Patients were stratified based on CKD stage., Results: Overall, 400 patients (mean age 53 ± 14 years, 75% male) were included: 186 (46.5%) patients had CKD stage 1 or 2; 93 (23.3%) had CKD stage 3a; 82 (20.5%) had CKD stage 3b; and 39 (9.8%) had CKD stage 4 or 5 prior to LVAD implantation. During a median follow-up of 179 days (IQR 28-627), 32,629 creatinine measurements were available. Improvement of kidney function was noticed in every preoperative CKD-stage group. Following this improvement, estimated glomerular filtration rates regressed to baseline values for all CKD stages. Patients showing early renal function improvement were younger and in worse preoperative condition. Moreover, survival rates were higher in patients showing early improvement (69% vs 56%, log-rank P = 0 .013)., Conclusions: Renal function following LVAD implantation is characterized by improvement, steady state and subsequent deterioration. Patients who showed early renal function improvement were in worse preoperative condition, however, and had higher survival rates at 2 years of follow-up., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: This study aims to provide a contemporary overview of outcomes after tricuspid valve (TV) surgery for functional tricuspid regurgitation (TR)., Methods and Results: The literature was systematically searched for papers published between January 2005 and December 2017 reporting on clinical/echocardiographic outcomes after TV surgery for functional TR. A random effects meta-analysis was conducted for outcome variables, and late outcomes are visualized by pooled Kaplan-Meier curves. Subgroup analyses were performed for studies with a within-study comparison of suture vs. ring repair and flexible vs. rigid ring repair. Eighty-seven publications were included, encompassing 13 184 patients (mean age: 62.1 ± 11.8 years, 55% females). A mitral valve procedure was performed in 92% of patients. Pooled mean follow-up was 4.0 ± 2.8 years. Pooled early mortality was 3.9% (95% CI: 3.2-4.6), and late mortality rate was 2.7%/year (95% CI: 2.0-3.5), of which approximately half was cardiac-related 1.2%/year (95% CI: 0.8-1.9). Pooled risk of early moderate-to-severe TR at discharge was 9.4% (95% CI: 7.0-12.1). Late moderate-to-severe TR rate after discharge was 1.9%/year (95% CI: 1.0-3.5). Late reintervention rate was 0.3%/year (95% CI: 0.2-0.4). Mortality and overall (early and late) TR rate were comparable between suture vs. ring annuloplasty (14 studies), whereas overall TR rate was higher after flexible ring vs. rigid ring annuloplasty (6 studies) (7.5%/year vs. 3.9%/year, P = 0.002)., Conclusion: This study shows that patients undergoing surgery for functional tricuspid regurgitation (FTR) have an acceptable early and late mortality. However, TR remains prevalent after surgery. The results of this study can be used to inform patients and clinicians about the expected outcome after surgery for FTR and can results serve as a benchmark for the performance of emerging transcatheter TV interventions., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Objectives: Tricuspid regurgitation (TR) is common in patients receiving a left ventricular assist device (LVAD). Controversy exists as to whether concomitant tricuspid valve surgery (TVS) is beneficial in currently treated patients. Therefore, our goal was to investigate the effect of TVS concomitant with a LVAD implant., Methods: The European Registry for Patients with Mechanical Circulatory Support was used to identify adult patients. Matched patients with and without concomitant TVS were compared using a propensity score matching strategy., Results: In total, 3323 patients underwent LVAD implantation of which 299 (9%) had TVS. After matching, 258 patients without TVS were matched to 258 patients with TVS. In the matched population, hospital deaths, days on inotropic support, temporary right ventricular assist device implants and hospital stay were comparable, whereas stay in the intensive care unit was higher in the TVS cohort (11 vs 15 days; P = 0.026). Late deaths (P = 0.17), cumulative incidence of unexpected hospital readmission (P = 0.15) and right heart failure (P = 0.55) were comparable between patients with and without concomitant TVS. In the matched population, probability of moderate-to-severe TR immediately after surgery was lower in patients with concomitant TVS compared to patients without TVS (33% vs 70%; P = 0.001). Nevertheless, the probability of moderate-to-severe TR decreased more quickly in patients without TVS (P = 0.030), resulting in comparable probabilities of moderate-to-severe TR within 1.5 years of follow-up., Conclusions: In matched patients, TVS concomitant with LVAD implant does not seem to be associated with better clinical outcomes. Concomitant TVS reduced TR significantly early after LVAD implant; however, differences in probability of TR disappeared during the follow-up period., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: This study aims to explore male-female differences in baseline and procedural characteristics, and outcomes of patients undergoing isolated or concomitant tricuspid valve (TV) surgery., Methods: All TV procedures registered between 2007 and 2016 in the database of the Netherlands Association for Cardio-Thoracic Surgery were analysed. Logistic regression analyses with interaction terms were used to determine whether sex was associated with hospital mortality., Results: Five thousand five hundred and eighty-two patients underwent TV surgery [isolated: N = 685 (49% male), TVrepair: N = 5286 (50% male) and TVreplacement: N = 250 (46% male)]. In the TVrepair group, females were significantly older, had less prior percutaneous/surgical coronary interventions, less extracardiac arteriopathies, a lower prevalence of renal impairment, less endocarditis, a lower prevalence of preoperative critical condition, less recent myocardial infarction, less concomitant coronary artery bypass grafting (CABG) and, in case of concomitant mitral valve surgery, less concomitant mitral valve repair compared to males. In the TVreplacement group, females more often had a history of prior valve surgery and less prior CABG. Hospital mortality for males and females was 7.0% (N = 183) and 6.1% (N = 163), P = 0.241 in the TVrepair group and 2.6% (N = 3) and 8.8% (N = 12), P = 0.074 in the TVreplacement group. Sex was not associated with hospital mortality (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.88-1.48; P = 0.322). Sex demonstrated a significant interaction with the parameter 'critical preoperative condition' (OR 0.44, 95% CI 0.22-0.90; P = 0.026)., Conclusions: Substantial differences in patient and procedural characteristics existed between male and female patients undergoing TV surgery, although sex was not a derterminant for hospital mortality. Nevertheless, sex interacted with a critical preoperative condition, indicating the usefulness of separate risk factor models for males and females requiring TV surgery., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Since 1988, our centre employs vertical plication repair with deattachment and reattachment of the tricuspid valve for Ebstein anomaly. This study describes the characteristics and long-term outcomes of our single-centre cohort., Methods: Data from all patients operated on between 1988 and 2016 were retrospectively collected. Kaplan-Meier analyses were done for survival data and mixed models were used to analyse longitudinally collected clinical and echocardiography data., Results: Thirty-six patients (mean age: 25.4 ± 15.9 years, 36% male) were operated on using the Carpentier-Chauvaud 21 (58%) or Cone repair 15 (42%). One patient (3%) died in hospital. Two late deaths were observed, yielding a survival of 97 ± 3% at 25 years. Reoperation was performed in 6 patients after a mean follow-up of 14.1 ± 10.3 years, resulting in a freedom of reoperation of 80 ± 8% at 25 years. During follow-up, predicted probability of being in New York Heart Association III/IV did not exceed 10%. Modelling longitudinal evolution of tricuspid regurgitation showed no major changes over time. Additionally, a rigid ring repair was associated with a higher probability of tricuspid regurgitation, especially after the first years after the operation. A full Cone repair was associated with less progression of tricuspid regurgitation over time., Conclusions: Repair of Ebstein abnomaly is associated with low mortality and morbidity, acceptable reoperation rate and excellent valve function over time, especially in patients with completed Cone repair. Therefore, we conclude that in our centre, repair of Ebstein abnomaly is a durable technique to treat patients.

Background & Aims: Low skeletal muscle mass and density have recently been discovered as prognostic and predictive parameters to guide interventions in various populations, including cancer patients. The gold standard for body composition analysis in cancer patients is computed tomography (CT). To date, the effect of contrast-enhancement on muscle composition measurements has not been established. The aim of this study was to determine the effect of contrast-enhancement on skeletal muscle mass and density measurements on four-phase CT studies., Design: In this observational study, two observers measured cross-sectional skeletal muscle area corrected for patients' height (skeletal muscle index [SMI]) and density (SMD) at the level of the third lumbar vertebra on 50 randomly selected CT examinations with unenhanced, arterial, and portal-venous phases. The levels of agreement between enhancement phases for SMI and SMD were calculated using intra-class correlation coefficients (ICCs)., Results: Mean SMI was 42.5 (±9.9) cm 2 /m 2 on the unenhanced phase, compared with 42.8 (±9.9) and 43.6 (±9.9) cm 2 /m 2 for the arterial and portal-venous phase, respectively (both p < 0.01). Mean SMD was lower for the unenhanced phase (30.9 ± 8.0 Hounsfield units [HU]) compared with the arterial (38.0 ± 9.9 HU) and portal-venous (38.7 ± 9.2 HU) phase (both p < 0.001). No significant difference was found between SMD in the portal-venous and arterial phase (p = 0.161). The ICCs were excellent (≥0.992) for all SMIs and for SMD between the contrast-enhanced phases (0.949). The ICCs for the unenhanced phase compared with the arterial (0.676) and portal-venous (0.665) phase were considered fair to good., Conclusions: Statistically significant differences in SMI were observed between different enhancement phases. However, further work is needed to assess the clinical relevance of these small differences. Contrast-enhancement strongly influenced SMD values. Studies using this measure should therefore use the portal-venous phase of contrast-enhanced CT examinations., (Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Objectives: Moderate-to-severe tricuspid regurgitation is common in end-stage heart disease and is associated with an impaired survival after left ventricular assist device (LVAD) surgery. Controversy remains whether concomitant tricuspid valve surgery (TVS) during LVAD implantation is beneficial. We aimed to provide a contemporary overview of outcomes in patients who underwent LVAD surgery with or without concomitant TVS., Methods: A systematic literature search was performed for articles published between January 2005 and March 2017. Studies comparing patients undergoing isolated LVAD implantation and LVAD + TVS were included. Early outcomes were pooled in risk ratios using random effects models, and late survival was visualized by a pooled Kaplan-Meier curve., Results: Eight publications were included in the meta-analysis, including 562 undergoing isolated LVAD implantation and 303 patients with LVAD + TVS. Patients undergoing LVAD + TVS had a higher tricuspid regurgitation grade, central venous pressure and bilirubin levels at baseline and were more often female. We found no significant differences in early mortality and late mortality, early right ventricular failure and late right ventricular failure, acute kidney failure, early right ventricular assist device implantation or length of hospital stay. Cardiopulmonary bypass time was longer in patients undergoing additional TVS [mean difference +35 min 95% confidence interval (16-55), P = 0.001]., Conclusions: Adding TVS during LVAD implantation is not associated with worse outcome. Adding TVS, nevertheless, may be beneficial, as baseline characteristics of patients undergoing LVAD + TVS were suggestive of a more progressive underlying disease, but with comparable short-term outcome and long-term outcome with patients undergoing isolated LVAD.