Towards a Standardized Classification of the Hepatobiliary Manifestations in Cystic Fibrosis (CFHBI): A Joint ESPGHAN/NASPGHAN Position Paper.

The broad spectrum of hepatobiliary involvement in cystic fibrosis (CF) has been commonly referred to as cystic fibrosis liver disease (CFLD). However, differences in the definitions of CFLD have led to variations in reported prevalence, incidence rates, and standardized recommendations for diagnosis and therapies. Harmonizing the description of the spectrum of hepatobiliary involvement in all people with CF (pwCF) is deemed essential for providing a reliable account of the natural history, which in turn supports the development of meaningful clinical outcomes in patient care and research. Recognizing this necessity, The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) commissioned and tasked a committee to develop and propose a systematic classification of the CF hepatobiliary manifestations to increase uniformity, accuracy, and comparability for clinical, registry, and research purposes. This report describes the committee's combined expert position statement on hepatobiliary involvement in CF, which has been endorsed by NASPGHAN and ESPGHAN. We recommend using CFHBI (Cystic Fibrosis Hepato-Biliary Involvement) as the updated term to describe and classify all hepatobiliary manifestations in all pwCF. CFHBI encompasses the current extensive spectrum of phenotypical, clinical, or diagnostic expressions of liver involvement observed in pwCF. We present a schematic categorization of CFHBI, which may also be used to track and classify the changes and development of CFHBI in pwCF over time. The proposed classification for CFHBI is based on expert consensus and has not been validated for clinical practice and research purposes. Achieving validation should be an important aim for future research.

Antibacterial copper-filled TiO2 coating of cardiovascular implants to prevent infective endocarditis-A pilot study.

BACKGROUND: Infective endocarditis (IE) poses a significant health risk, especially in patients with prosthetic heart valves. Despite advances in treatment, mortality rates remain high. This study aims to investigate the antibacterial properties of a copper titanium dioxide (4× Cu-TiO2) coating on cardiovascular implants against Staphylococcus aureus, a common causative agent of IE. METHODS: Titanium oxide carriers functionalized with copper ions were employed as an antibacterial coating for heart and vascular prostheses. The coating's antibacterial efficacy was assessed using S. aureus ATCC 29213. Microscopic evaluations were conducted on both biological and artificial materials. Antibacterial activity was qualitatively assessed via a modified disc diffusion method and quantitatively measured through colony counts in NaCl suspensions. RESULTS: The coating process was successfully applied to all tested cardiovascular prosthetic materials. Qualitative assessments of antibacterial effectiveness revealed an absence of bacterial growth in the area directly beneath the coated valve. Quantitative evaluations showed a significant reduction in bacterial colonization on coated mechanical valves, with 2.95 × 104 CFU per valve, compared to 1.91 × 105 CFU in control valves. CONCLUSIONS: The 4× Cu-TiO2 coating demonstrated promising antibacterial properties against S. aureus, suggesting its potential as an effective strategy for reducing the risk of bacterial colonization of cardiovascular implants. Further studies are needed to assess the longevity of the coating and its efficacy against other pathogens.

Left ventricular assist device implantation and concomitant mitral valve surgery: A systematic review and meta-analysis.

BACKGROUND: The management of concomitant valvular lesions in patients undergoing left ventricular assist device (LVAD) implantation remains a topic of debate. This systematic review and meta-analysis aimed to evaluate the existing evidence on postoperative outcomes following LVAD implantation, with and without concomitant MV surgery. METHODS: A systematic database search was conducted as per PRISMA guidelines, of original articles comparing LVAD alone to LVAD plus concomitant MV surgery up to February 2023. The primary outcomes assessed were overall mortality and early mortality, while secondary outcomes included stroke, need for right ventricular assist device (RVAD) implantation, postoperative mitral valve regurgitation, major bleeding, and renal dysfunction. RESULTS: The meta-analysis included 10 studies comprising 32 184 patients. It revealed that concomitant MV surgery during LVAD implantation did not significantly affect overall mortality (OR:0.83; 95% CI: 0.53 to 1.29; p = 0.40), early mortality (OR:1.17; 95% CI: 0.63 to 2.17; p = 0.63), stroke, need for RVAD implantation, postoperative mitral valve regurgitation, major bleeding, or renal dysfunction. These findings suggest that concomitant MV surgery appears not to confer additional benefits in terms of these clinical outcomes. CONCLUSION: Based on the available evidence, concomitant MV surgery during LVAD implantation does not appear to have a significant impact on postoperative outcomes. However, decision-making regarding MV surgery should be individualized, considering patient-specific factors and characteristics. Further research with prospective studies focusing on specific patient populations and newer LVAD devices is warranted to provide more robust evidence and guide clinical practice in the management of valvular lesions in LVAD recipients.

Hostile Hemodynamics in Distal Stent Graft-Induced New Entry Prior to Aortic Rupture: A Comparison of Transient versus Steady-State CFD Simulations.

BACKGROUND: Computational fluid dynamics (CFD) simulations model blood flow in aortic pathologies. The aim of our study was to understand the local hemodynamic environment at the site of rupture in distal stent graft-induced new entry (dSINE) after frozen elephant trunk with a clinically time efficient steady-flow simulation versus transient simulations. METHODS: Steady-state simulations were performed for dSINE, prior and after its development and prior to aortic rupture. To account for potential turbulences due geometric changes at the dSINE location, Reynolds-averaged Navier-Stokes equations with the realizable k-ε model for turbulences were applied. Transient simulations were performed for comparison. Hemodynamic parameters were assessed at various locations of the aorta. RESULTS: Post-dSINE, jet-like flow due to luminal narrowing was observed which increased prior to rupture and resulted in focal neighbored regions of high and low wall shear stress (WSS). Prior to rupture, aortic diameter at the rupture site increased lowering WSS at the entire aortic circumference. Concurrently, WSS and turbulence increased locally above the entry tear at the inner aortic curvature. Turbulent kinetic energy and WSS elevation in the downstream aorta demonstrated enhanced stress on the native aorta. Results of steady-state simulations were in good qualitative agreement with transient simulations. CONCLUSION: Steady-flow CFD simulations feasible at clinical time scales prior to aortic rupture reveal a hostile hemodynamic environment at the dSINE rupture site in agreement with lengthy transient simulations. Consequently, our developed approach may be of value in treatment planning where a fast assessment of the local hemodynamic environment is essential.

Development and evaluation of a novel combined perfusion decellularization heart-lung model for tissue engineering of bioartificial heart-lung scaffolds.

BACKGROUND: Bioengineered transplantable heart-lung scaffolds could be potentially lifesaving in a large number of congenital and acquired cardiothoracic disorders including terminal heart-lung disease. METHODS: We decellularized heart-lung organ-blocks from rats (n = 10) by coronary and tracheal perfusion with ionic detergents in a modified Langendorff circuit. RESULTS: In the present project, we were able to achieve complete decellularization of the heart-lung organ-block. Decellularized heart-lung organ-blocks lacked intracellular components but maintained structure of the cellular walls with collagen and elastic fibers. CONCLUSIONS: We present a novel model of combined perfusion and decellularization of heart-lung organ-blocks. This model is the first step on the pathway to creating bioengineered transplantable heart-lung scaffolds. We believe that further development of this technology could provide a life-saving conduit, significantly reducing the risks of heart-lung failure surgery and improving postoperative quality of life.

Prognostic value of mitral regurgitation in patients undergoing left ventricular assist device deployment: A systematic review and meta-analysis.

BACKGROUND: Left ventricular assist devices (LVADs) represent an important therapeutic option for patients progressing to end-stage heart failure. LVAD has previously been shown to have a promising role in improving mitral regurgitation (MR). Nevertheless, the prognostic value of preoperative uncorrected MR in this population remains unclear. METHODS: A systematic database search with meta-analysis was conducted of comparative original articles of patients with preoperative mild MR (Grade 0-I) versus moderate-severe MR (Grade II-III) undergoing LVAD implantation, in EMBASE, MEDLINE, Cochrane database, and Google Scholar, from inception to June 2022. Primary outcomes were overall and operative mortality. Secondary outcomes were neurological dysfunction, gastrointestinal bleeding, right heart failure, LVAD thrombosis, and driveline infection. RESULTS: Our search yielded 2228 relevant studies. A total of 19 studies met the inclusion criteria with a total of 11 873 patients. LVAD caused a statistically significant decrease of 35.9% in the number of patients with moderate-severe MR (grade II-III) postoperatively. No significant difference was observed in terms of overall mortality, operative mortality, GI bleeding, LVAD thrombosis, and driveline infection rates between mild and moderate-severe MR. An increased rate of right heart failure was seen among patients with moderate-severe MR, while lower rates of neurological events were also observed. CONCLUSION: LVAD improves the haemodynamics of the left ventricle, to promote resolution of MR. Nevertheless, the severity of preoperative mitral regurgitation in patients undergoing LVAD deployment does not seem to affect mortality.

Sex disparities in left ventricular assist device implantation outcomes: A systematic review and meta-analysis of over 50 000 patients.

BACKGROUND: Left ventricular assist devices (LVAD) represent an important therapeutic option for patients progressing to end-stage heart failure. Women have been historically underrepresented in LVAD studies, and have been reported to have worse outcomes despite technological optimisation. We aimed to systematically explore the evidence on sex disparities in the use and outcomes of LVAD implantation. METHODS: A systematic database search with meta-analysis was conducted of comparative original articles of men versus women undergoing LVAD implantation, in EMBASE, MEDLINE, Cochrane database and Google Scholar, from inception to July 2022. Primary outcomes were stroke (haemorrhagic and ischaemic) and early/overall mortality. Secondary outcomes were LVAD thrombosis, right VAD implantation, major bleeding, kidney dysfunction, and device/driveline infection. RESULTS: Our search yielded 137 relevant studies, including 22 meeting the inclusion criteria with a total of 53 227 patients (24.2% women). Overall mortality was higher in women (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.05-1.62, p = 0.02), as was overall stroke (OR 1.32, 95%CI 1.06-1.66, p = 0.01), including ischemic (OR 1.80, 95%CI 1.22-2.64, p = 0.003) and haemorrhagic (OR 1.72, 95%CI 1.09-2.70, p = 0.02). Women had more frequent right VAD implantation (OR 2.11, 95%CI 1.24-3.57, p = 0.006) and major bleeding (OR 1.40, 95%CI 1.06-1.85, p = 0.02). Kidney dysfunction, LVAD thrombosis, and device/driveline infections were comparable between sexes. CONCLUSIONS: Our analysis suggests that women face a greater risk of adverse events and mortality post-LVAD implantation. Although the mechanisms remain unclear, the difference in outcomes is thought to be multifactorial. Further research, that includes comprehensive pre-operative characteristics and post-operative outcomes, is encouraged.

Sutureless Aortic Valve Prosthesis in Redo Procedures: Single-Center Experience.

Background and Objectives: Sutureless aortic valve prostheses have presented favorable hemodynamic performance while facilitating minimally invasive access approaches. As the population ages, the number of patients at risk for aortic valve reoperation constantly increases. The aim of the present study is to present our single-center experience in sutureless aortic valve replacement (SU-AVR) in reoperations. Materials and Methods: The data of 18 consecutive patients who underwent SU-AVR in a reoperation between May 2020 and January 2023 were retrospectively analyzed. Results: The mean age of the patients was 67.9 ± 11.1 years; patients showed a moderate-risk profile with a median logistic EuroSCORE II of 7.8 (IQR of 3.8-32.0) %. The implantation of the Perceval S prosthesis was technically successful in all patients. The mean cardiopulmonary bypass time was 103.3 ± 50.0 min, and the cross-clamp time was 69.1 ± 38.8 min. No patients required a permanent pacemaker implantation. The postoperative gradient was 7.3 ± 2.4 mmHg, and no cases of paravalvular leakage were observed. There was one case of intraprocedural death, while the thirty-day mortality was 11%. Conclusions: Sutureless bioprosthetic valves tend to simplify the surgical procedure of a redo AVR. By maximizing the effective orifice area, sutureless valves may present an important advantage, being a safe and effective alternative not only to traditional surgical prostheses but also to transcatheter valve-in-valve approaches in select cases.

Expanding the Minimally Invasive Approach towards the Ascending Aorta-A Practical Overview of the Currently Available Techniques.

Minimally invasive techniques have gained immense importance in cardiovascular surgery. While minimal access strategies for coronary and mitral valve surgery are already widely accepted and often used as standard approaches, the application of minimally invasive techniques is currently expanded towards more complex operations of the ascending aorta as well. In this new and developing field, various techniques have been established and reported ranging from upper hemisternotomy approaches, which allow even extensive operations of the ascending aorta to be performed through a minimally invasive access to sternal sparing thoracotomy strategies, which completely avoid sternal trauma during ascending aorta replacements. All of these techniques place high demands on patient selection, preoperative planning, and practical surgical implementation. Application of these strategies is currently limited to high-volume centers and highly experienced surgeons. This narrative review gives an overview of the currently available techniques with a special focus on the practical execution as well as the advantages and disadvantages of the currently available techniques. The first results demonstrate the practicability and safety of minimally invasive techniques for replacement of the ascending aorta in a well-selected patient population. With success and complication rates comparable to classic full sternotomy, the proof of concept for minimally invasive replacement of the ascending aorta is now achieved.

Present and future of machine learning in breast surgery: systematic review.

BACKGROUND: Machine learning is a set of models and methods that can automatically detect patterns in vast amounts of data, extract information, and use it to perform decision-making under uncertain conditions. The potential of machine learning is significant, and breast surgeons must strive to be informed with up-to-date knowledge and its applications. METHODS: A systematic database search of Embase, MEDLINE, the Cochrane database, and Google Scholar, from inception to December 2021, was conducted of original articles that explored the use of machine learning and/or artificial intelligence in breast surgery in EMBASE, MEDLINE, Cochrane database and Google Scholar. RESULTS: The search yielded 477 articles, of which 14 studies were included in this review, featuring 73 847 patients. Four main areas of machine learning application were identified: predictive modelling of surgical outcomes; breast imaging-based context; screening and triaging of patients with breast cancer; and as network utility for detection. There is evident value of machine learning in preoperative planning and in providing information for surgery both in a cancer and an aesthetic context. Machine learning outperformed traditional statistical modelling in all studies for predicting mortality, morbidity, and quality of life outcomes. Machine learning patterns and associations could support planning, anatomical visualization, and surgical navigation. CONCLUSION: Machine learning demonstrated promising applications for improving breast surgery outcomes and patient-centred care. Neveretheless, there remain important limitations and ethical concerns relating to implementing artificial intelligence into everyday surgical practices.

Early and late outcomes of surgical aortic valve replacement with sutureless and rapid-deployment valves versus transcatheter aortic valve implantation: Meta-analysis with reconstructed time-to-event data of matched studies.

Sutureless/rapid-deployment (SURD) valves are options different from the stented prostheses included in the pivotal trials comparing surgical aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI). We performed a meta-analysis with reconstructed time-to-event data of matched studies published by November 2021 to compare SURD-AVR and TAVI. Primary endpoints were 30-day mortality and overall survival in the follow-up. Secondary endpoints included: 30-day stroke, acute kidney injury (AKI), major bleeding, permanent pacemaker implantation (PPI), paravalvular leak (PVL), prosthesis-patient mismatch (PPM), postoperative aortic valve area (AVA), and mean gradients. Ten studies met our eligibility criteria, including a total of 5134 patients (2567 underwent SURD-AVR and 2567 underwent TAVI). Pooled risk of 30-day mortality did not favor any group (odds ratio [OR]: 0.69; 95% confidence interval [CI]: 0.31-1.53; p = 0.360). Patients undergoing SURD-AVR had lower risk of PVL (OR: 0.09; 95% CI: 0.05-0.17; p < 0.001). No statistically significant differences were observed for 30-day stroke, AKI, major bleeding, PPI, PPM, and postoperative AVA. In the follow-up, we observed a higher risk of mortality (hazard ratio: 1.74; 95% CI: 1.26-2.40; p < 0.001) with TAVI. Patients who underwent SURD-AVR experienced better survival, however, the interpretation of these results warrant caution due to the fact that SURD-AVR patients tended to be younger than TAVI patients. Structural heart surgeons and interventional cardiologists should consider initial risk and life expectancy when referring patients for one approach over the other.

Early experience with the Impella pump: Single-center registry.

BACKGROUND: With the rapid development of mechanical circulatory support technologies, patients presenting with cardiogenic shock have gained access to various treatment opportunities which were not until recently available. The Impella® pump (Abiomed, Danvers, USA) is a minimally invasive device which provides excellent left ventricular unloading and full circulatory support. The aim of the study was to review our center's experience with Impella® and to analyze the major adverse events associated with the device. METHODS: From January 2020 to January 2022, a total of 32 patients underwent Impella® implantation at our center for various indications. RESULTS: The mean age at surgery was 60.3 ± 12.4 years and 9.4% were female. All patients presented with acute cardiogenic shock in INTERMACS Class I (53.1%) and INTERMACS Class II (46.9%). Twenty-six patients (81.25%) out of the whole cohort have been mobilized on Impella® support. Seventeen patients (53.1%) have been weaned from the Impella® support and 10 patients (31.3%) have been bridged to durable LVAD. The median time on Impella® was 7 days (IQR 5.0-11.0). 30-day mortality was 37.5%, with 56.25% survival until hospital discharge. Only one patient developed vascular complications consisting of arm hypoperfusion. There were no cases of stroke on Impella® support. CONCLUSION: The Impella® axial-flow pump seems an appropriate therapeutic option for patients with acute cardiogenic shock requiring partial or full hemodynamic support. It also provides sufficient left ventricular unloading to allow full mobilization and neurological assessment of the patients. Furthermore, Impella® offers a high rate of myocardial recovery.

Impact of severe mitral regurgitation on postoperative outcome after durable left-ventricular assist device implantation.

BACKGROUND: Mitral valve regurgitation (MR) is a common finding in patients with end-stage heart failure. The aim of the study was to analyze the impact of preoperative moderate-to-severe MR on postoperative outcomes and survival after durable left-ventricular assist device (LVAD) implantation. METHODS: From August 2010 to May 2021, 246 patients underwent a durable LVAD implantation. We stratified the patients into two groups: Group A (n = 109) presented with MR 0-I°, and Group B presented with MR II-III° (n = 137). MR II-III° was defined according to the current recommendations (i.e., vena contracta ≥ 7 mm, regurgitation volume ≥ 30 ml or effective regurgitation orifice area ≥ 20 mm2 ). RESULTS: Significantly more patients in Group B suffered from pulmonary hypertension and presented with chronic obstructive lung disease. We observed significantly higher rates of tricuspid regurgitation (TR) II-III° in Group B (76.1%) versus Group A (14.8%) (p < 0.001) and TR III° in Group B (30.4%) versus Group A (3.7%) (p < 0.001). There was no difference in the incidence of right heart failure between the groups. Within our cohort, the in-hospital, 1-year, 3-year, and 5-year mortality was 22.4%, 32.1%, 50.7%, and 64.4%, respectively. Group B showed significantly worse overall survival (p = 0.05). Patients with preoperative TR II-III° had a significantly worse survival than those with TR 0-I° (p = 0.048). In patients presenting with MR II-III°, we discovered that TR III° seems to predict both in-hospital and mid-term mortality. CONCLUSION: MR II-III° negatively affects the outcomes in patients requiring LVAD implantation. Persisting MR II-III° is an independent predictor of mortality. Patients with concomitant preoperative TR II-III° are at increased risk of developing postoperative major adverse events. Addressing the MR might be considered for these patients.

Initial experience with CytoSorb therapy in patients receiving left ventricular assist devices.

BACKGROUND: The use of left ventricular assist devices (LVAD) in patients with advance heart failure is still associated with an important risk of immune dysregulation and infections. The aim of this study was to determine whether extracorporeal blood purification using the CytoSorb device benefits patients after LVAD implantation in terms of complications and overall survival. MATERIALS AND METHODS: Between August 2010 and January 2020, 207 consecutive patients underwent LVAD implantation, of whom 72 underwent CytoSorb therapy and 135 did not. Overall survival, major adverse events, and laboratory parameters were compared between 112 propensity score-matched patients (CytoSorb: 72 patients; non-CytoSorb: 40 patients). RESULTS: WBC (p = .033), CRP (p = .001), and IL-6 (p < .001), significantly increased with LVAD implantation, while CytoSorb did not influence this response. In-hospital mortality and overall survival during follow-up were similar with CytoSorb. However, patients treated with CytoSorb were more likely to develop respiratory failure (54.2% vs. 30.0%, p = .024), need mechanical ventilation for longer than 6 days post-implant (50.0% vs. 27.5%, p = .035), and require tracheostomy during hospitalization (31.9% vs. 12.5%, p = .040). No other significant differences were observed with regard to major adverse events during follow-up. CONCLUSIONS: Overall, our results showed that CytoSorb might not convey a significant morbidity or mortality benefit for patients undergoing LVAD implantation.

Special issues regarding redo mitral valve procedures in the developing countries.

Redo mitral valve replacement remains the standard treatment for recurrent mitral valve disease. Most patients referred for a redo surgery in the western world are older and present with multiple comorbidities. With the successful broad implementation of anti-infective treatment, rheumatic mitral valve disease has become highly uncommon. Nonetheless, rheumatic heart disease is still thriving in developing countries causing the most severe mitral valve conditions. The guidelines are there to help us in our decision-making process, but the actual decision has to be made based on each patients' individual criteria.

Articulation is essential: First in cardiovascular surgery implementation of 360° surgeon-powered robotic instruments.

Since the development of endoscopic vision in the late 1970s, the implementation of minimally invasive surgical methods has been rapidly progressing throughout a wide range of surgical disciplines, including cardiovascular surgery. The benefits of minimally invasive procedures including a reduction in operative trauma and postoperative morbidity, have been well-documented and compared to open-heart procedures, eventually becoming the preferred modality of treatment by many centers. Due to the cost ineffectiveness of the robotic systems for numerous institutions, new technologies have been developed to provide the advantages of robotic surgical systems at a lower price, thus making them more widely available. In this paper, we aimed to share our first experiences with Artisential® surgeon-powered robotic instruments and review their general advantages compared to conventional and robotic devices.

Complete transcatheter versus complete surgical treatment in patients with aortic valve stenosis and concomitant coronary artery disease: Study-level meta-analysis with reconstructed time-to-event data.

OBJECTIVES: To compare outcomes of complete transcatheter (TAVI plus PCI) versus complete surgical (SAVR plus CABG) approach to treat patients with aortic stenosis (AS) and concomitant coronary artery disease (CAD). METHODS: Study-level meta-analysis with reconstructed time-to-event data including studies published by November 2021. The primary endpoints were 30-day mortality, overall survival, and major adverse cardiovascular and cerebrovascular events (MACCE). The secondary endpoints were 30-day stroke, myocardial infarction, and permanent pacemaker implantation (PPI); in-hospital major vascular events and acute kidney injury (AKI). RESULTS: Eight studies met our eligibility criteria, including a total of 33,286 patients (3448 for TAVI plus PCI and 29,838 for SAVR plus CABG). The pooled risk of 30-day mortality was lower for TAVI plus PCI (OR 0.63; 95% CI 0.51-0.80; p < .001). Patients undergoing TAVI plus PCI had lower risk of in-hospital AKI (OR 0.49; 95% CI 0.28-0.85; p = .01), however, higher risk of major vascular events (OR 7.33; 95% CI 1.80-29.85; p = .005) and higher risk of PPI (OR 2.96; 95% CI 1.80-4.85; p < .001). No statistically significant difference was observed for myocardial infarction and stroke between the groups. In the follow-up analyses, we observed a higher risk of mortality (HR 1.64, 95% CI 1.36-1.96, p < .001) and MACCE with TAVI plus PCI (HR 1.35 (95% CI 1.08-1.69, p = .009). CONCLUSION: Patients who undergo TAVI plus PCI (in comparison with SAVR plus CABG) initially experience lower rates of in-hospital death and AKI; however, they experience significantly lower survival rates and more MACCE at 5-year follow up. Structural heart surgeons and interventional cardiologists should consider these aspects when referring patients for one approach or the other.

Immediate and late outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in bicuspid valves: Meta-analysis of reconstructed time-to-event data.

BACKGROUND: Outcomes of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients with aortic stenosis and bicuspid aortic valve (BAV) must be better investigated. METHODS: A meta-analysis including studies published by January 2022 reporting immediate outcomes (in-hospital death, stroke, acute kidney injury [AKI], major bleeding, new permanent pacemaker implantation [PPI], paravalvular leakage [PVL]), mortality in the follow-up (with Kaplan-Meier curves for reconstruction of individual patient data). RESULTS: Five studies met our eligibility criteria. No statistically significant difference was observed for in-hospital death, stroke, AKI, and PVL. TAVI was associated with lower risk of major bleeding (odds ratio [OR]: 0.29; 95% confidence interval [CI]: 0.12-0.69; p = .025), but higher risk of PPI (OR: 2.00; 95% CI: 1.05-3.77; p = .041). In the follow-up, mortality after TAVI was significantly higher in the analysis with the largest samples (HR: 1.24, 95% CI: 1.01-1.53, p = .043), but no statistically significant difference was observed with risk-adjusted populations (HR: 1.06, 95% CI: 0.86-1.32, p = .57). Landmark analyses suggested a time-varying risk with TAVI after 10 and 13 months in both largest and risk-adjusted populations (HR: 2.13, 95% CI: 1.45-3.12, p < .001; HR: 1.7, 95% CI: 1.11-2.61, p = .015, respectively). CONCLUSION: Considering the immediate outcomes and comparable overall survival observed in risk-adjusted populations, TAVI can be used safely in selected BAV patients. However, a time-varying risk is present (favoring SAVR over TAVI at a later timepoint). This finding was likely driven by higher rates of PPI with TAVI.

Outcomes and hemodynamics of Enable bioprosthesis in 432 patients: an afterword.

AIMS: To report the largest single-center experience in surgical aortic valve replacement (SAVR) using the Enable sutureless bioprosthesis concerning the clinical outcome and hemodynamic behavior. MATERIAL AND METHODS: From April 2010 to May 2017, a total of 432 patients (36.3% of them women) received the Enable sutureless prosthesis for aortic valve stenosis, regurgitation, and/or endocarditis. The endpoints were overall survival after operation for 30 days and adverse events. RESULTS: No intraoperative complications occurred; intraoperative mortality was 0%. The 30-day mortality rate was 3.5% overall and 0.9% for isolated procedure. No valve-related deaths were observed. There was a need for prosthesis replacement during the early postoperative period in eight patients (1.9%): seven patients (1.6%) had a significant paravalvular leak and one patient (0.2%) developed early postoperative endocarditis. The maximum and mean pressure gradients across the prosthesis were 19.2 ± 7.1 mmHg and 11.1 ± 4.6 mmHg, respectively. A permanent pacemaker was necessary in 6.5% of the patients. CONCLUSIONS: The Enable sutureless prosthesis showed a reliable clinical outcome with low perioperative mortality and morbidity. The hemodynamic performance was satisfactory. Our data confirmed the safety of SAVR using the Enable bioprosthesis. However, a higher rate of pacemaker implantation (6.5%) has to be mentioned.

Alternative access in high-risk patients in the era of transfemoral aortic valve replacement.

BACKGROUND: We aimed to evaluate the outcomes of transapical and transaortic transcatheter aortic valve replacement (TAVR) in high-risk patients who were not suitable for transfemoral access and had a logistic EuroSCORE-I ≥ 25% and Society of Thoracic Surgeons (STS) score >6%. 'STS/ACC TAVR In-Hospital Mortality Risk App' was evaluated. MATERIAL AND METHODS: Between January 2016 and May 2020, 126 patients at very high risk for aortic valve replacement underwent transapical (n = 121) or transaortic (n = 5) transcatheter aortic valve replacement. TAVR was performed using SAPIEN 3™ or ACURATE TA™ prosthesis. RESULTS: The logistic EuroSCORE-I was 40.6 ± 14.0%, the STS-score 7.9 ± 4.6%, and STS/ACC-score 8.4 ± 3.4%. Valve implantation was successful in all patients. Operative, in-hospital and 30-days mortality, were 0, 7.9, and 13.5%, respectively. Survival was 72% at one year and 48% at four years. Expected/observed in-hospital mortality was 1.0 for the STS-score and 1.06 for the STS/ACC-score. Renal failure, low ejection fraction, and postoperative acute kidney injury, hemorrhage, and vascular complications were identified as independent predictors for 30-day mortality. CONCLUSIONS: Transapical and transaortic TAVR in high-risk patients unsuitable for transfemoral access is still a reasonable alternative in these patients. STS and STS/ACC-score appear to be highly accurate in predicting in-hospital mortality in high-risk patients undergoing TAVR.