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Background: The present study aimed to critically revise the published literature on clinical outcomes and cost-effectiveness of Inspiris Resilia valve. Methods: This work was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Full text research articles discussing clinical or cost-effectiveness aspects of Inspiris Resilia bioprosthesis published in English were included in this analysis. Studies were excluded if they weren't exclusively conducted on patients submitted to surgical aortic valve replacement using the Inspiris Resilia bioprosthesis. Results: The technical success rate was almost perfect in all studies. Reported complications included severe prosthesis-patient mismatch, reoperation, endocarditis, and paravalvular leak. In almost all studies, there were significant improvement of NYHA at the end of follow up as compared to baseline. In all studies, there were significant improvement of one or more hemodynamic parameters at the end of follow up as compared to baseline. Conclusions: Surgical aortic valve replacement using Inspiris Resilia tissue valve appears to be safe and effective with low rate of aortic valve and systemic complications and mortality. Its performance appears to be equal to or better than many other bioprosthetic valves. As compared to mechanical valves, its use is suggested to be more cost-effective. [ABSTRACT FROM AUTHOR]

Background The Edwards Sapien percutaneous valve (Edwards Lifesciences, Irvine, CA, USA) is a promising therapeutic option for congenital atrioventricular disease mostly because of the possibility to accommodate somatic growth with balloon dilatation. Case summary This article reports the performance of the Edwards Sapien 3 valve in atrioventricular valve position in four paediatric patients. Discussion Despite aggressive antiplatelet and anticoagulation strategies, most patients showed early bioprosthesis dysfunction, with increasing gradient not related with somatic growth. The decrease in leaflet motility in the absence of thrombosis or pannus could be associated with the low-velocity flow and low-pressure gradient that exists between the atria and ventricles in small children. It is well-known graft lifespan is usually shorter in small children, but we hypothesize the possibility of a second factor that valve design is intended to support higher flow-velocity patterns and can present an early failure in low-flow low-pressure situation. More studies are necessary to provide reliable evidence. [ABSTRACT FROM AUTHOR]

Background. Most modern bioprostheses use two sensors located on the flexor and extensor muscles of the hand and fingers to register muscle activity, which severely limits the functionality of the device and complicates switching between grips. One of the solutions to this problem is to use an array of more sensors to recognize different grips using a neural network.Aim. To evaluate the possibility in principle of using an array of 8 sensors for recognizing different grips.Materials and methods. Research was conducted on 23 healthy volunteers, whose surface myograms were recorded at 13 different grips. An array of surface-type electroneuromyographic sensors (n = 8) with bipolar electrodes and electroneuromyographic signal amplification factor of 2000 times, myograph and software are of own development were used as a technical base for the research.Results. For most subjects, the differences in the investigated parameters when comparing grips with each other reached thousands of percent, especially when comparing the product of frequency and mean amplitude. In some pairs the differences were less significant and amounted to less than 400 %. The proportion of pairs with reliable differences varies from subject to subject when comparing the product of frequency and mean amplitude and ranges from 71 to 98 %. The average value for the whole group is 87 %. When comparing frequency only, the variation ranges from 67 to 93 %, with an average of 78 %.Conclusion. For most subjects, the majority of grips are confidently differentiated from each other. Due to pronounced individual peculiarities, the decision to use this or that parameter to control the bioprosthesis for a definite person is individual and should be made after a thorough neurophysiological research. Some people will require training in order to develop a new motor stereotype.

Background and objective: Tricuspid valve replacement (TVR) is required when repair is not feasible, and it continues to be a relatively high-risk procedure owing to the complex medical and/or surgical profile of patients. The choice between mechanical and biological prostheses for TVR remains a subject of debate owing to their distinct advantages and disadvantages. This study aimed to analyse and compare the clinical outcomes of these two types of prostheses in the tricuspid position. Methods: PubMed, EMBASE, Web of Science, and the COCHRANE library were searched from 1995 to April 2023 for studies comparing clinical outcomes of mechanical versus biological valves in the tricuspid position. Data on 30-day mortality, reoperations, 5-year valve failure rates, thrombotic/thromboembolic events, and long-term survival were extracted, pooled, and analysed. Forest plots were generated using a random-effects model. Results: From an initial pool of 4716 citations, 37 studies meeting our inclusion criteria were assessed, collectively encompassing 8316 prostheses (3796 mechanical, 4520 bioprostheses). Our analysis revealed that mechanical valves exhibited a non-significant trend towards diminished 30-day mortality (RR = 0.85, 95% CI = 0.69–1.06). A distinct disparity emerged in valve durability, with mechanical valves demonstrating a significantly increased risk of 5-year valve failure (RR = 2.21, 95% CI = 1.38–3.56). Strikingly, mechanical valves displayed a substantial six-fold elevated risk of thrombotic events (RR = 6.29, 95% CI = 3.98–9.92). In contrast, the long-term survival and reoperation rates demonstrated no statistically significant differences between the two valve types. Conclusions: This systematic review and meta-analysis provides insights into the selection of mechanical and bioprosthetic valves for TVR. These findings highlight the potential advantages and disadvantages of mechanical and bioprosthetic valves in terms of early mortality, valve durability, and thrombotic risk. Our analysis provides clinicians with evidence-based guidance for optimizing outcomes in TVR, offering a foundation for informed decision-making in this intricate surgical landscape. Despite these insights, clinicians must overcome the limitations of retrospective studies, evolving healthcare, and anticoagulant disparities to ensure careful consideration in tricuspid valve replacement decisions. [ABSTRACT FROM AUTHOR]

Background: In recent years, in case of aortic valve replacement (AVR), a significant increase in the use of bioprostheses has been observed. The Perceval sutureless bioprosthesis has proven to be safe and reliable in the short and mid-term, with limited but promising long-term results. An updated systematic review with the long-term results of patients who underwent a sutureless bioprosthesis implantation with a Perceval biological valve is herewith presented. Methods: Studies published between 2015 and 2024, including the long-term outcomes—with clinical as well as echocardiographic information for up to five years—of patients who underwent a Perceval implantation for AVR were selected from the published literature. The Cochrane GRADE system was used to assess the study quality, and the risk of bias in non-randomized studies (ROBINS-I) tool was used to evaluate studies. Results: Ten studies were selected with an overall number of 5221 patients. The long-term survival ranged from 64.8 to 87.9%, freedom from structural valve degeneration (SVD) from 96.1 to 100%, freedom from significant paravalvular leak from 98.5 to 100%, freedom from prosthetic endocarditis from 90.7 to 99%, and freedom from reintervention from 94 to 100%. The long-term mortality ranged from 6.5 to 27.4%. SVD was observed in 0–4.8% patients. Significant paravalvular leak was observed in 0–3.4% patients, and infective endocarditis was observed in 0–3.4%. A bioprosthesis-related reintervention at long-term follow-up was required for 0–4.3% of patients, and 1.7–7.1% of patients required a late new pacemaker implantation. The transprosthetic mean pressure gradient ranged from 9 to 14.7 mmHg, peak pressure gradient ranged from 17.8 to 26.5 mmHg, and EOA ranged from 1.5 to 1.7 cm2. Conclusions: This systematic review shows that there is still a paucity of data about sutureless bioprostheses. Nevertheless, the clinical results from prospective studies or retrospective series are encouraging. Medium- and long-term results seem to support the increasing use of this type of prosthesis. [ABSTRACT FROM AUTHOR]

Heart valve replacement surgeries are performed on patients suffering from abnormal heart valve function. In these operations, the problematic tissue is replaced with mechanical valves or with bioprosthetics that are being developed. The thrombotic effect of mechanical valves, reflecting the need for lifelong use of anticoagulation drugs, and the short‐lived nature of biological valves make these two types of valves problematic. In addition, they cannot adapt to the somatic growth of young patients. Although decellularized scaffolds have shown some promise, a successful translation has so far evaded. Although decellularized porcine xenografts have been extensively studied in the literature, they have several disadvantages, such as a propensity for calcification in the implant model, a risk of porcine endogenous retrovirus (PERV) infection, and a high xenoantigen density. As seen in clinical data, it is clear that there are biocompatibility problems in almost all studies. However, since decellularized sheep heart valves have not been tried in the clinic, a large data pool could not be established. This review compares and contrasts decellularized porcine and sheep xenografts for heart valve tissue engineering. It reveals that decellularized sheep heart valves can be an alternative to pigs in terms of biocompatibility. In addition, it highlights the potential advantages of bioinks derived from the decellularized extracellular matrix in 3D bioprinting technology, emphasizing that they can be a new alternative for the application. We also outline the future prospects of using sheep xenografts for heart valve tissue engineering. [ABSTRACT FROM AUTHOR]

Background: Valve-in-Valve (VIV) transcatheter aortic valve replacement (TAVR) is a potential solution for malfunctioning surgical aortic valve prostheses, though limited data exist for its use in Perceval valves. Methods: searches were performed on PubMed and Scopus up to 31 July 2023, focusing on case reports and series addressing VIV replacement for degenerated Perceval bioprostheses. Results: Our analysis included 57 patients from 27 case reports and 6 case series. Most patients (68.4%) were women, with a mean age of 76 ± 4.4 years and a mean STS score of 6.1 ± 4.3%. Follow-up averaged 9.8 ± 8.9 months, the mean gradient reduction was 15 ± 5.9 mmHg at discharge and 13 ± 4.2 mmHg at follow-up. Complications occurred in 15.7% of patients, including atrioventricular block III in four patients (7%), major bleeding or vascular complications in two patients (3.5%), an annular rupture in two patients (3.5%), and mortality in two patients (3.5%). No coronary obstruction was reported. Balloon-expanding valves were used in 61.4% of patients, predominantly the Sapien model. In the self-expanding group (38.6%), no valve migration occurred, with a permanent pacemaker implantation rate of 9%, compared to 5.7% for balloon-expanding valves. Conclusions: VIV-TAVR using both balloon-expanding and self-expanding technologies is feasible after the implantation of Perceval valves; however, it should be performed by experienced operators with experience both in TAVR and VIV procedures. [ABSTRACT FROM AUTHOR]

Background Guidelines for choice of prosthetic heart valve in people of reproductive age are not well established. Although biologic heart valves (BHVs) have risk of deterioration, mechanical heart valves (MHVs) require lifelong anticoagulation. This study aimed to characterize the association of prosthetic valve type with maternal and fetal outcomes in pregnant patients. Methods and Results Using the 2008 to 2019 National Inpatient Sample, we identified all adult patients hospitalized for delivery with prior heart valve implantation. Multivariable regressions were used to analyze the primary outcome, major adverse cardiovascular events, and secondary outcomes, including maternal and fetal complications, length of stay, and costs. Among 39 871 862 birth hospitalizations, 4152 had MHVs and 874 had BHVs. Age, comorbidities, and cesarean birth rates were similar between patients with MHVs and BHVs. The presence of a prosthetic valve was associated with over 22-fold increase in likelihood of major adverse cardiovascular events (MHV: adjusted odds ratio, 22.1 [95% CI, 17.3-28.2]; BHV: adjusted odds ratio, 22.5 [95% CI, 13.9-36.5]) as well as increased duration of stay and hospitalization costs. However, patients with MHVs and BHVs had no significant difference in the odds of any maternal outcome, including major adverse cardiovascular events, hypertensive disease of pregnancy, and ante/postpartum hemorrhage. Similarly, fetal complications were more likely in patients with valve prostheses, including a 4-fold increase in odds of stillbirth, but remained comparable between MHVs and BHVs. Conclusions Patients hospitalized for delivery with prior valve replacement carry substantial risk of adverse maternal and fetal events, regardless of valve type. Our findings reveal comparable outcomes between MHVs and BHVs.

The use of bioprostheses is increasing in younger patients, but it is associated with the risk of later valve deterioration, especially in the mitral position. A new bioprosthesis for mitral valve replacement offers possible longer-term durability and improved hemodynamics. Objectives: Here, we report the implantation of the novel Edwards MITRIS RESILIA mitral valve (Edwards Lifesciences Inc., Irvine, CA, USA) through microinvasive fully endoscopic access as an innovative surgical approach based on a series of twelve patients. Methods: Contrast-based ECG gated CT was preoperatively performed in all patients to determine the intravascular calcifications and vascular parameters, as well as to assess noticeable problems during the operation. CT software for cardiac interventions (3Mensio Medical Imaging BV) was used to simulate surgical prostheses digitally inside the native annulus. With this, a digital LVOT and neo LVOT was created, and the difference between the valve prostheses was measured. Implantation of the MITRIS RESILIA valve was performed in 12 patients according to the instructions for use through microinvasive access in a fully endoscopic fashion using 3D visualization. Results: The mean patient age was 56.50 years, and 7/12 (58.33%) were redo procedures. All patients survived the first 30 days after the procedure, the mean aortic cross-clamp time was 40.17 ± 13.72 min. and mean postoperative transvalvular gradient was 4.45 ± 1.74 mmHg. The neo LVOT in the CT-based simulation was measured with an average area of 414.98 ± 88.69 mm2. The average difference between the LVOT and neo LVOT area was 65.35 ± 34.99 mm2. There was no case of paravalvular leakage or obstruction of the left ventricular outflow tract. Conclusions: The novel MITRIS RESILIA valve is a promising new bioprosthesis for mitral valve replacement that offers improved features as compared to other prostheses. The ease of implantation is increased by this prosthesis by the improved pliability of the sewing cuff and the inward folding of the struts, which was confirmed by short operative times in our series. [ABSTRACT FROM AUTHOR]

Background and Aims: The durability of surgical aortic valve bioprostheses (SAV) is limited by the calcification of the leaflets, which results in degeneration. In clinical routine, there seems to be substantial variability in the degeneration of specific SAV models. Our study aims to establish an in vitro calcification model for prosthetic valves, characterizing the calcification behavior of different SAVs. Methods: Five commercially available SAV models (Epic™ Supra, Freestyle®, Intuity®, Perimount®, and Trifecta™) were perfused with double‐distilled water and physiological buffer with a defined calcium concentration (CaCl2 = 1.5 mM) at 37°C over 32.9 million cycles in a Hi‐Cycle tester which corresponds to approximately 1 patient‐year (calcified group). Untreated prosthetic valves served as the negative control group (noncalcified group). Calcium titration, scanning electron microscopy (SEM), histological examination, and tissue thickness measurements were performed to evaluate noncalcified and calcified SAVs (n = 10). Results: Treatment in the Hi‐Cycle tester with calcification buffer maintained significantly higher calcium absorption of SAVs compared to the control group (p < 0.001). Additionally, hydroxyapatite crystals were found in the calcified SAV in SEM. Porcine valves rarely demonstrated punctual calcification pattern, while bovine pericardial valves presented distinct planar calcification pattern in histological examination. Further, calcification content differed significantly depending on the SAV model, with the highest calcium content in Trifecta (213 µg/cm2) and the lowest in Epic Supra (8 µg/cm2) (p < 0.001). Conclusion: Data from our study revealed significant differences in leaflet calcification for the various aortic valve bioprostheses models. Further studies are necessary to investigate whether these findings can mimic the clinical data of the implanted prostheses. [ABSTRACT FROM AUTHOR]

Objectives: Due to rheumatic heart disease, young people are more likely to develop valvular heart disease in developing countries. In countries like Pakistan, surgeons implant more bioprosthetic mitral valves (MVs) in younger patients. However, bioprosthetic valves degenerate rapidly in younger people, leading to bioprosthetic MV dysfunction (BMVD). This study aims to evaluate the clinical characteristics and long-term outcomes of patients with bioprosthetic MV replacement (MVR) at a tertiary care hospital in a South Asian country. Material and Methods: This is a retrospective observational study, conducted at a tertiary care hospital. We included a total of 502 patients who underwent bioprosthetic MVR from the year 2006 to 2020. Clinical and surgical characteristics along with transthoracic echocardiographic findings (pre-surgery and recent most follow-up studies) were noted. Follow-up data were also collected. Results: Out of 502 patients, 322 (64%) were female, mean age at the time of surgery was 49.42 ± 14.56 years. Mitral regurgitation was more common, found in 279 (55.6%) patients followed by mitral stenosis in 188 (37.5%) patients. MVR was done as an elective procedure due to the New York Heart Association (NYHA) II to IV symptoms at the time of surgery in 446 (88.8%) patients. In the mean follow-up of 6.59 ± 2.99 years, BMVD was observed in 183 (36.5%) patients. However, re-do MV surgery was done in only 49 (9.8%) patients. Patients were divided into two groups based on normal functioning bioprosthetic MV and BMVD. Comparing the two groups, individuals with normal functioning bioprosthetic MV had a mean age of 51.6 ± 14.27 years, while those with BMVD had a mean age of 45.639 ± 14.33 years at the time of index surgery (P = 0.000). There were more long-term complications including heart failure (n = 16, 8.74%), atrial fibrillation (n = 11, 6.01%), and death (n = 6, 3.28%) in the BMVD group which were statistically significant. Conclusion: This study is distinct because it demonstrates the outcomes of bioprosthetic valve replacement in a relatively younger South Asian population. Due to rapid degeneration of bioprosthetic valve in younger patients, significant number of patients developed BMVD along with poor long-term clinical outcomes, even at a short follow-up period of <10 years. These findings are similar to international data and signify that mechanical MVR may be a more reasonable alternative in younger patients. [ABSTRACT FROM AUTHOR]

Introduction: The Perceval sutureless biological prosthesis for aortic valve replacement has been introduced with the rationale for shortening surgical, extracorporeal circulation and aortic cross-clamping times, in order to reduce postoperative complications. Aim: To evaluate early hemodynamic performance and immediate outcomes of implantation of the Perceval sutureless bioprosthesis in comparison with the St. Jude Trifecta sutured bioprosthesis for aortic valve replacement (Perfecta study). Material and methods: Between December 2014 and June 2023, 281 patients underwent St. Jude Trifecta implantation (n = 220, mean age: 75.2 ±6.5 years) and Perceval implantation, when indicated (n = 61, mean age: 77.9 ±5.1 years). Concomitant CABG was performed in 73 (33%) and in 27 (44%) patients, respectively. Results: Extracorporeal circulation and cross-clamp times were significantly shorter in Perceval patients in all aortic valve replacements (61 ±23 and 49 ±18 minutes vs. 96 ±36 and 67 ±21 minutes), and in isolated procedures (54 ±10 and 43 ±8 minutes vs. 84 ±28 and 66 ±21 minutes) (p < 0.0001, for all comparisons). Operative mortality was absent and 2.7%, respectively (p = 0.2). Postoperatively, low output cardiac syndrome (0% vs. 4.5%) and total rate of major cardiac and non-cardiac related complications (6.6% vs. 18.6%) were significantly lower in Perceval patients (p = 0.01). Echocardiography at discharge in comparison with preoperatively showed a relevant and similar decrease of mean and peak trans-aortic valve gradients for the Trifecta prosthesis (11.6 ±4.3 vs. 50 ±15.2 mm Hg; 21.6 ±7.3 vs. 78.8 ±24 mm Hg) and for the Perceval prosthesis (12.6 ±4.8 vs. 52 ±12.5 mm Hg; 22.6 ±7.9 vs. 77.8 ±16 mm Hg) (p < 0.00001, for all comparisons). Better global cardiac function was observed in Perceval patients. Concomitant multi-vessel and left main coronary artery disease (p = 0.046; HR = 4.6) and chronic pulmonary disease (p = 0.006; HR = 5.6) were detected as independent predictors of death and postoperative major complications. Conclusions: Early hemodynamic performance appears to be satisfactory with the use of Trifecta sutured and Perceval sutureless bioprostheses. Perceval implantation allows reduction of surgical times, better preservation of myocardial contractile function and, consequently, reduction of the risk of postoperative complications. [ABSTRACT FROM AUTHOR]

The proliferation of transcatheter aortic valve implantation has alerted clinicians to a specific type of prosthetic degeneration represented by thrombosis. The pathogenesis of this clinical or subclinical phenomenon, which can occur in up to 15% of both surgical and percutaneous procedures, is poorly understood, as is its potential impact on patient prognosis and long-term bioprosthesis durability. Based on this lack of knowledge about the real meaning and importance of bioprosthetic valve thrombosis, the aim of the present review is to draw the clinicians’ attention to its existence, starting from the description of predisposing factors that may require a closer follow-up in such categories of patients, to an in-depth overview of all available imaging modalities with their respective pros and cons. Finally, a glimpse into the future of technology and biomarker development is presented. The hope is to increase the rate of bioprosthetic diagnosis, especially of the subclinical one, in order to understand (thanks to a strict and prolonged follow-up) if it can only be considered as an incidental tomographic entity without significant clinical consequences, or, on the contrary, if it is associated with neurological events or accelerated bioprosthetic degeneration. Nevertheless, despite the technical advances of echocardiography and cardiac tomography in terms of accurate bioprosthesis thrombosis detection, several diagnostic and therapeutic issues remain unresolved, including possible prevention strategies, tailored treatment protocols, and follow-up modalities. [ABSTRACT FROM AUTHOR]

Transcatheter mitral valve-in-valve is an alternative to high-risk reoperation on a failing bioprosthesis. It entails specific challenges such as left ventricular outflow tract obstruction. We propose a patient-specific augmented imaging based on preoperative planning to assist the procedure. Valve-in-valve simulation was performed to represent the optimal level of implantation and the neo-left ventricular outflow tract. These data were combined with intraoperative images through a real-time 3D/2D registration tool. All data were collected retrospectively on one case (pre and per-procedure imaging). We present for the first time an intraoperative guidance tool in transcatheter mitral valve-in-valve procedure. [ABSTRACT FROM AUTHOR]

Background: This study compared the outcomes of surgical aortic valve replacement (AVR) in patients aged 50 to 70 years based on the type of prosthetic valve used. Methods: We compared patients who underwent mechanical AVR to those who underwent bioprosthetic AVR at our institution between January 2000 and March 2019. Competing risk analysis and the inverse probability of treatment weighting (IPTW) method based on propensity score were employed for comparisons. Results: A total of 1,580 patients (984 patients with mechanical AVR; 596 patients with bioprosthetic AVR) were enrolled. There was no significant difference in early mortality between the mechanical AVR and bioprosthetic AVR groups (0.9% vs. 1.7%, p=0.177). After IPTW adjustment, the risk of all-cause mortality was significantly higher in the bioprosthetic AVR group than in the mechanical AVR group (hazard ratio [HR], 1.39; 95% confidence interval [CI], 1.07–1.80; p=0.014). Competing risk analysis revealed lower risks of stroke (sub-distributional hazard ratio [sHR], 0.44; 95% CI, 0.28–0.67; p

Aims: Closure of congenital body wall defects in children can be a challenging task for the pediatric Surgeon. Biological prosthesis has been increasingly used for high-risk wound closure in adult patients with excellent outcomes and use in the pediatric population has also been reported. Here, we aim to study the outcome of abdominal wound repair with a tissue-engineered acellular bovine pericardial patch. Methods: Over a period of 21 months, a total of 15 children had undergone abdominal wound repair with bioprostheses, i.e., bovine pericardial patch at our institute. Patient demographics, cause of defect, an indication of patch use, rate of infection, postoperative recovery, recurrence, and outcome were studied. Results: A total of 15 patients underwent abdominal wall closure with acellular bovine pericardial patch. Nine out of 15 patients were neonates, of whom five had gastroschisis, two had a congenital diaphragmatic hernia, and two had ruptured omphalocele major. Of the rest 6 patients, 2 were patients of bladder exstrophy, 2 were older children of congenital diaphragmatic hernia with incisional hernias, and 2 were older children with omphalocele major. Out of the five patients with gastroschisis, two died during the early postoperative period due to sepsis. The wound healed in the rest 13 patients with mild skin dehiscence in two patients. Only one child had a recurrence. Conclusion: Reconstruction with acellular bovine pericardial patch is a viable option in children with high-risk abdominal wounds as it allows tensionless repair with excellent healing and minimal complications. Recurrence, if any, may disappear with time as remodeling of the prosthesis occurs along with the growth of the body wall of the child.

Aims: Closure of congenital body wall defects in children can be a challenging task for the pediatric Surgeon. Biological prosthesis has been increasingly used for high-risk wound closure in adult patients with excellent outcomes and use in the pediatric population has also been reported. Here, we aim to study the outcome of abdominal wound repair with a tissue-engineered acellular bovine pericardial patch. Methods: Over a period of 21 months, a total of 15 children had undergone abdominal wound repair with bioprostheses, i.e., bovine pericardial patch at our institute. Patient demographics, cause of defect, an indication of patch use, rate of infection, postoperative recovery, recurrence, and outcome were studied. Results: A total of 15 patients underwent abdominal wall closure with acellular bovine pericardial patch. Nine out of 15 patients were neonates, of whom five had gastroschisis, two had a congenital diaphragmatic hernia, and two had ruptured omphalocele major. Of the rest 6 patients, 2 were patients of bladder exstrophy, 2 were older children of congenital diaphragmatic hernia with incisional hernias, and 2 were older children with omphalocele major. Out of the five patients with gastroschisis, two died during the early postoperative period due to sepsis. The wound healed in the rest 13 patients with mild skin dehiscence in two patients. Only one child had a recurrence. Conclusion: Reconstruction with acellular bovine pericardial patch is a viable option in children with high-risk abdominal wounds as it allows tensionless repair with excellent healing and minimal complications. Recurrence, if any, may disappear with time as remodeling of the prosthesis occurs along with the growth of the body wall of the child. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) is the percutaneous alternative to traditional surgery. Infective endocarditis is a fatal complication of TAVR, especially in the elderly. A 65-year-old male with a history of valve-invalve TAVR presented to our emergency room with altered mentation. On examination, he was febrile. Laboratory investigations and echocardiography suggested infective endocarditis. Explantation and surgical aortic valve replacement were planned. The biopsy of the prostheses showed acute inflammation. Transcatheter prosthetic valve endocarditis warrants early diagnosis, particularly in the elderly. Our case emphasizes the importance of the prompt inclusion of endocarditis in the differential and surgical referral. [ABSTRACT FROM AUTHOR]

Background: An unexplained condition that follows transcatheter aortic valve implantation (TAVI) is platelet count reduction (PR). According to published research, patients with balloon-expandable valves (BEVs) had a greater PR than those with self-expandable valves (SEVs). Objectives: The purpose of this study was to investigate the incidence and clinical effects of PR following TAVI. Methods: In total, 1.122 adult TAVI patients were enrolled. Propensity score matching was carried out in a 1:1 ratio between patients with BEVs and those with SEVs. The analysis included changes in platelet count, in-hospital mortality, and early postoperative adverse events. Results: Notably, 632 patients were matched (BEV:316; SEV:316). All patients' post-procedural platelet counts changed according to a parabolic curve, using a mixed regression model for repeated analyses (estimate = −0.931; standard error = 0.421; p = 0.027). The platelet count varied comparably in patients with BEVs and SEVs (estimate = −4.276, standard error = 4.760, p = 0.369). The average time for obtaining the nadir platelet count value was three days after implantation (BEV: 146 (108–181) vs. SEV: 149 (120–186); p = 0.142). Overall, 14.6% of patients (92/632) had post-procedural platelet count <100,000/µL. There was no difference between the two prosthesis types (BEV:51/316; SEV:41/316; p = 0.266). Thrombocytopenia was found to be significantly linked to blood product transfusions, lengthier stays in the intensive care unit and hospital, and in-hospital mortality. Conclusions: TAVI, irrespective of the type of implanted valve, is linked to a significant but temporary PR. Thrombocytopenia increases the risk of serious complications and in-hospital death in TAVI patients. To explore and clarify the causes and associated effects, further prospective research is necessary. [ABSTRACT FROM AUTHOR]

Left-sided bioprosthesis valve thrombosis (LSBVT) is a challenging complication necessitating invasive interventions. In this study, we introduce a novel, minimally invasive approach. We used a cerebral embolic protection system and an Occlutech cannula connected to an extracorporeal circuit, providing safer thrombus aspiration compared to the AngioVac system. This technique offers a promising alternative for high-risk patients with LSBVT.

Bioprosthetic heart valves (BHVs) are commonly used to replace severely diseased heart valves but their susceptibility to structural valve degeneration (SVD) limits their use in young patients. We hypothesized that antibodies against immunogenic glycans present on BHVs, particularly antibodies against the xenoantigens galactose-α1,3-galactose (αGal) and N-glycolylneuraminic acid (Neu5Gc), could mediate their deterioration through calcification. We established a large longitudinal prospective international cohort of patients (n = 1668, 34 ± 43 months of follow-up (0.1-182); 4,998 blood samples) to investigate the hemodynamics and immune responses associated with BHVs up to 15 years after aortic valve replacement. Early signs of SVD appeared in

Abstract Background The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research. Methods An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position. Results Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average. Conclusion FIH clinical report is essential to assess the significance of clinical data required for a “de novo” surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.

Background: The sutureless Perceval S bioprosthesis is associated with postoperative thrombocytopenia. Our objectives were to compare the incidence, severity, and clinical implications of thrombocytopenia after aortic valve replacement (AVR) using the Perceval S or the Trifecta bioprosthesis. Methods: Patients who underwent AVR between March 2016 and August 2019 using the Perceval or Trifecta were retrospectively included. The primary endpoint was the nadir in platelet counts within 15 days after surgery. Secondary endpoints included postoperative hemolysis and inflammatory parameters, as well as clinical and echocardiographic outcomes. Results: Overall, 156 patients were included (Perceval, n = 103; Trifecta, n = 53). Preoperatively, there was no difference in platelet counts between the two groups. Postoperatively, the Perceval S bioprosthesis was associated with a greater decrease in platelet counts. The nadir was reached at Day 3 for both groups, but thrombocytopenia was more severe for the Perceval S (Perceval S vs. Trifecta, 89.2 ± 37.7 × 109/L vs. 106.5 ± 34.1 × 109/L, p = 0.01). No difference regarding lactate dehydrogenase, C-reactive protein, and white blood cells count was found. All-cause 30-day mortality rates (both valves, 2%, p = 0.98), hospital lengths of stay, and re-operation rates were similar. Conclusion: The Perceval S bioprosthesis was associated with more severe postoperative thrombocytopenia. This did not translate into higher short-term morbidity or mortality. [ABSTRACT FROM AUTHOR]

Key Clinical Message: Transcatheter mitral valve implantation (TMVI) is considered a less‐invasive approach than open‐heart surgery, favored in high‐risk patients elected for valve replacement. Although seemingly suitable, this procedure is highly operator‐dependent. Transcatheter mitral valve implantation (TMVI) is an alternative in high‐risk patients. We reported a 72‐year‐old patient with mitral bioprosthesis degeneration successfully receiving TMVI. The procedure has lower morbidity and mortality rate than the surgical approach but can be accompanied by several complications, especially when conducted by an inexperienced operator. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve implantation (TAVI) is now well established as the treatment of choice for patients with native aortic valve stenosis who are high or intermediate risk for surgical aortic valve replacement. Recent data has also supported the use of TAVI in patients at low surgical risk and also in anatomical subsets that were previously felt to be contra-indicated including bicuspid aortic valves and aortic regurgitation. With advancements and refinements in procedural techniques, the application of this technology has now been further expanded to include the management of degenerated bioprosthesis. After the demonstration of feasibility and safety in the management of degenerated aortic bioprosthetic valves, mitral and tricuspid bioprosthetic valve treatment is now also well-established and provides an attractive alternative to performing redo surgery. In this review, we appraise the latest clinical evidence and highlight procedural considerations when utilising TAVI technology in the management of degenerated aortic, mitral or tricuspid prosthesis. [ABSTRACT FROM AUTHOR]

Background: Bioprostheses with RESILIA tissue demonstrate a reduction in calcification and improve health outcomes in pre-clinical and clinical studies. Prior economic analyses which relied on 5 years of evidence from the COMMENCE trial demonstrate financial savings for RESILIA tissue valves relative to mechanical valves after surgical aortic valve replacement (SAVR). Given the recent release of 7-year COMMENCE data, this economic evaluation updates the estimate for long-run savings of bioprosthetic valves with RESILIA. Methods: Simulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients each in the US. The primary comparison calculated the SAVR-related expenditures associated with each valve type ($US, 2023). Health outcome probabilities were based on the COMMENCE trial though year 7 and projected for an additional 8 years based on prior studies of tissue and mechanical SAVR. Costs for key outcomes (mortality, reoperation, bleeding, thromboembolism, endocarditis) and anticoagulant monitoring were sourced from the literature. Incidence rates of health outcomes associated with mechanical valves relied on relative risks of tissue valve versus mechanical valve patients. Results: Seven-year savings are $13,415 (95% CI = $10,472–$17,321) per patient when comparing RESILIA versus mechanical SAVR. Projected 15-year savings were $23,001 ($US, 2023; 95% CI = $17,802–$30,421). Most of the 15-year savings are primarily attributed to lower anti-coagulation monitoring costs ($21,073 in ACM savings over 15 years), but lower bleeding cost (savings: $2,294) and thromboembolism-related expenditures (savings: $852) also contribute. Reoperation and endocarditis expenditures were slightly larger in the RESILIA cohort. If reoperation relative risk reverts from 1.1 to 2.2 (the level in legacy tissue valves) after year 7, savings are $18,064. RESILIA SAVR also reduce costs relative to legacy tissue valves. Conclusion: Patients receiving RESILIA tissue valves are projected to have lower SAVR-related health expenditures relative to mechanical and legacy tissue valves. [ABSTRACT FROM AUTHOR]

ABSTRACT: Introduction: An alternative for supporting wound closure is acellular dermal matrix (ADM), which serves as a scaffold. Humans and porcine possess a similar biochemical makeup. Using sodium dodecyl sulfate (SDS), a decellularization technique was developed and its biomechanical properties were assessed. Methods: This work uses a pig dermis layer for an in vitro experimental investigation with a posttest-only control group. Using SDS 0.5% for 14 days, the decellularization procedure compares the biomechanical properties and cellular components of the ADM with control. The Mann–Whitney U -test for data with a nonnormal distribution or the t -test for continuous variables with a normal distribution was used for the study. Results: Histological analysis revealed that none of the cells were detected in four fields of analysis in the treatment group; however, 48.00 ± 4.86 cells were observed in the control group (P < 0.001); the collagen organization in the control group appeared to be identical. The variables elastic modulus (MPa) (136.78 vs. 129.19; P = 0.556), thickness (mm) (3.27 vs. 3.15; P = 0.397), and width (mm) (8.50 vs. 8.56; P = 0.40) did not differ statistically. The following data showed significant differences between the treatment group and the control group: break strain (%) (108.46 vs. 67.48; P < 0.001) and tensile strength stress (MPa) (19.916 vs. 22.1; P = 0.030). Conclusions: SDS decellularization is an efficient method for creating an ADM. Although the break strain was considerably lower, the treatment group's tensile strength was higher. Elastic modulus changes were not observed. [ABSTRACT FROM AUTHOR]

The incidence of abdominal wall hernia (AWH) is increasing because of the aging population, obesity, and the increasing number of abdominal surgeries performed. Over the last decade, there have been many improvements with the introduction of novel techniques in the management of AWH. The development of component separation and bioprosthetic mesh has transformed the management of complex ventral hernias. An increased number of complex ventral hernia repairs are being done using minimally invasive methods, including component separation. With the introduction of three‑dimensional laparoscopic technique and robotic platform, the technique of component separation for abdominal wall reconstruction (AWR) has become more reproducible. In the past decade, the prosthetic materials have greatly improved, including bioengineered smart scaffold tissues such as hydrogel and electrospun fibers that have shown promising results even in infected environment. Apart from advances in complex abdominal wall repair, patient‑centric outcomes and the cost‑effectiveness of hernia surgery also have gained focus in the management of AWH. Today, the field of hernia has become a discipline in itself due to a better understanding of the biomechanics and pathophysiology of AWHs. There has been a tremendous development in diverse surgical techniques for complex abdominal wall repair with huge advancements in the development of hernia implants transforming it from a simple hernia repair to the science of AWR. This review aims to summarize recent developments in the field of AWR, incorporating a brief overview of the management of AWH. [ABSTRACT FROM AUTHOR]

Background: Platelet count reduction (PR) is a common but unclear phenomenon that occurs after aortic bioprosthesis valve implantation (bio-AVR). This study aimed to investigate the occurrence and clinical impact of PR in patients receiving stented, rapid deployment (RDV), or stentless bioprostheses. Methods: 1233 adult bio-AVR patients were enrolled. Platelet count variation, early post-operative adverse events, and in-hospital mortality were analysed. Results: 944 patients received a stented valve, an RDV was implanted in 218 patients, and 71 patients had a stentless bioprosthesis. In all groups, the platelet count at discharge was lower than the baseline values (p < 0.001). The percentage of PR was 27% in the stented group, 56% in the RDV group, and 55% in the stentless group. A higher platelet reduction, reaching the minimum platelet value, was observed in the RDV (mean: −30.84, standard error (SE): 5.91, p < 0.001) and stentless (mean: 22.54, SE: 9.10, p = 0.03) groups compared to the stented group. A greater PR occurred as the size of the bioprosthesis increased in RDV (p = 0.01), while platelet count variation was not directly proportional to the stented bioprosthesis size (p < 0.001). PR was not affected by cardiopulmonary bypass (mean: −0.00, SE: 0.001, p = 0.635) or cross-clamp (mean: −0.00, SE: 0.002, p = 0.051) times in any of the groups. RDV subjects experienced more in-hospital adverse events. PR was found to be associated with ischemic strokes in the overall population. Conclusions: Bio-AVR is associated with significant but transient PR. RDV patients more likely experience significant PR and related adverse clinical events. PR is associated with ischemic strokes, regardless of the bioprosthesis type. [ABSTRACT FROM AUTHOR]

BACKGROUND: Days at home (DAH) represents an important patient-oriented outcome that quantifies time spent at home after a medical event; however, this outcome has not been fully evaluated for low-surgical-risk patients undergoing transcatheter aortic valve replacement (TAVR). We sought to compare 1- and 2-year DAH (DAH365 and DAH730) among low-risk patients participating in a randomized trial of TAVR with a self-expanding bioprosthesis versus surgical aortic valve replacement (SAVR). METHODS: Using Medicare-linked data from the Evolut Low Risk trial, we identified 619 patients: 606 (322 TAVR/284 SAVR) and 593 (312 TAVR/281 SAVR) were analyzed at 1 and 2 years, respectively. DAH was calculated as days alive and spent outside a hospital, inpatient rehabilitation, skilled nursing facility, long-term acute care hospital, emergency department, or observation stay. Mean DAH was compared using the t test. RESULTS: The mean (SD) age and female sex were 74.7 (5.1) and 74.3 (4.9) years and 34.6% (115/332) and 30.3% (87/287) in TAVR and SAVR, respectively. Postprocedural discharge to rehabilitation occurred in ≤3.0% (≤10/332) in TAVR and 4.5% (13/287) in SAVR. The mean DAH365 was comparable in TAVR versus SAVR (352.2±45.4 versus 347.8±39.0; difference in days, 4.5 [95% CI, 2.3--11.2]; P=0.20). DAH730 was also comparable in TAVR versus SAVR (701.6±106.0 versus 699.6±94.5; difference in days, 2.0 [14.1 to 18.2]; P=0.81). Secondary outcomes DAH30 and DAH90 were higher in TAVR (DAH30, 26.0±3.6 versus 20.7±6.4; difference in days, 5.3 [4.5--6.2]; P<0.001; DAH90, 85.1±8.3 versus 78.7±13.6; difference in days, 6.4 [4.6--8.2]; P<0.001). CONCLUSIONS: In the Evolut Low Risk trial linked to Medicare, low-risk patients undergoing TAVR spend a similar number of days at home at 1 and 2 years compared with SAVR. Days spent at home at 30 and 90 days were higher in TAVR. In contrast to higher-risk patients studied in prior work, there is no clear advantage of TAVR versus SAVR for DAH in the first 2 years after AVR in low-surgical-risk patients. [ABSTRACT FROM AUTHOR]

Background: Meniscal repair is the gold standard for simple morphology tears. However, when the morphology and chronicity of the tear are less favorable, the success of the standard techniques is reduced. Purpose/Hypothesis: To compare meniscal repair augmented by a new bioresorbable implant (Meniscus Cap) versus a traditional simple suture technique and the currently available augmented repair collagen matrix meniscus wrapping technique. It was hypothesized that the Meniscus Cap suture technique would increase ultimate failure load and less displacement during cyclic loading. Study Design: Controlled laboratory study. Methods: A total of 80 fresh porcine menisci were harvested. Complex tears were created in 60 menisci, and 20 intact menisci were tested as the control group. Repairs were performed on the 60 meniscal tears using 1 of the 3 techniques (20 menisci each): an inside-out H-suture group (SS), the collagen matrix wrapping technique (CMW), and the Meniscus Cap bioresorbable implant group (CM). The menisci were subjected to 500 loading cycles from 4 to 20 N at a frequency of 1 Hz, and the total displacement was recorded. Then, the specimens underwent load to failure testing at a rate of 3.15 mm/s, and the failure mode was noted. Results: After 500 cycles of cyclic loading, there were no significant differences in displacement between the controls and CM group (0.524 vs 0.448 mm; P =.95). The displacement after the CM was significantly smaller compared with the CMW and the SS (0.448 vs 1.077 mm [ P =.0009] and 0.448 vs 0.848 mm [ P =.04], respectively). The ultimate load to failure was significantly greater for the controls and the CM group compared with the SS and CMW groups (controls, 1278.7 N and CM, 628.5 N vs CMW, 380.1 N and SS, 345.1 N; P <.05). The failure mode was suture breakage (suture failure) for all repairs. Conclusion: In a porcine specimen meniscal repair model, the biomechanical properties of a novel Meniscus Cap repair technique were superior to that of the simple suture and CMW techniques. Clinical Relevance: The results suggest that the Meniscal Cap repair technique may provide sufficient primary stability of the meniscal fixation even in the cases of complex meniscal tears. [ABSTRACT FROM AUTHOR]

Background Failing bioprosthesis is an emerging issue due to (i) a shift towards liberal bioprosthesis implantation instead of mechanical prosthesis and (ii) an ageing population. Management of high-risk patients with bioprosthesis degeneration remains challenging. Case summary An 82-year-old patient with history of aortic and mitral valve replacement six years before presents with severe dyspnoea. Echocardiograpic assessment reveals (i) structural valve degeneration of the mitral prosthesis (severe stenosis and regurgitation) with concomitant major annular calcifications and (ii) structural valve degeneration of the aortic prosthesis with low-flow, low-gradient restenosis. Due to mitral annular calcifications, the risk of double valve re-replacement and the age of the patient conventional reoperation was deemed very high. The patient is evaluated for transapical double valve implantation. This option is rejected due to the high risk of left ventricular outflow obstruction. The patient is treated with an open transcatheter double valve-in-valve procedure at the following sequence: leaflet resection of the mitral bioprosthesis, mitral valve implantation and fixation under direct view, leaflet resection of the aortic bioprosthesis, and valve frame cracking and aortic valve implantation under direct view. Post-bypass echocardiography shows neither left ventricular outflow tract obstruction nor paravalvular leak or prosthesis dysfunction. The patient is extubated on the first post-operative day and transferred to normal care unit. Discussion Open transcatheter double valve-in-valve replacement for degenerated bioprostheses on the arrested heart might be a valuable alternative to treat selected high-risk patients with bioprosthetic valve degeneration. [ABSTRACT FROM AUTHOR]

Abstract We present the first case in the literature of a 78‐year‐old woman with recurrent cardiac sarcoma adjacent to a bioprosthetic mitral valve treated with magnetic resonance linear accelerator (MR‐Linac) guided adaptive stereotactic ablative body radiotherapy (SABR). The patient was treated using a 1.5 T Unity MR‐Linac system (Elekta AB, Stockholm, Sweden). The mean gross tumour volume (GTV) size was 17.9 cm3 (range 16.6–18.9 cm3) based on daily contours and the mean dose received by the GTV was 41.4 Gy (range 40.9–41.6 Gy) in five fractions. All fractions were completed as planned and the patient tolerated the treatment well with no acute toxicity reported. Follow‐up appointments at 2 and 5 months after the last treatment showed stable disease and good symptomatic relief. Results of transthoracic echocardiogram after radiotherapy showed that the mitral valve prosthesis was normally seated with regular functionality. This study provides evidence that MR‐Linac guided adaptive SABR is a safe and viable option for the treatment of recurrent cardiac sarcoma with mitral valve bioprosthesis.

Objectives: Although bioprosthetic valves have excellent hemodynamic properties and can eliminate the need for lifelong anticoagulation therapy, these devices are associated with high rates of reoperation and limited durability. Although there are many distinct bioprosthesis designs, all bioprosthetic valves have historically featured a trileaflet pattern. This in silico study examines the biomechanical effect of modulating the number of leaflets in a bioprosthetic valve. Methods: Bioprosthetic valves with 2 to 6 leaflets were designed in Fusion 360 using quadratic spline geometry. Leaflets were modeled with standard mechanical parameters for fixed bovine pericardial tissue. A mesh of each design was structurally evaluated using finite element analysis software Abaqus CAE. Maximum von Mises stresses during valve closure were assessed for each leaflet geometry in both the aortic and mitral position. Results: Computational analysis demonstrated that increasing the number of leaflets is associated with reduction in leaflet stresses. Compared with the standard trileaflet design, a quadrileaflet pattern reduces leaflet maximum von Mises stresses by 36% in the aortic position and 38% in the mitral position. Maximum stress was inversely proportional to the square of the leaflet quantity. Surface area increased linearly and central leakage increased quadratically with leaflet quantity. Conclusions: A quadrileaflet pattern was found to reduce leaflet stresses while limiting increases in central leakage and surface area. These findings suggest that modulating the number of leaflets can allow for optimization of the current bioprosthetic valve design, which may translate to more durable valve replacement bioprostheses.

Objectives: To evaluate the ongoing debate concerning the choice of valve prosthesis for women requiring mitral valve replacement (MVR) and who wish to conceive. Bioprostheses are associated with risk of early structural valve deterioration. Mechanical prostheses require lifelong anticoagulation and carry maternal and fetal risks. Also, the optimal anticoagulation regimen during pregnancy after MVR remains unclear. Methods: A systematic review and meta-analysis was conducted of studies reporting on pregnancy after MVR. Valve- and anticoagulation-related maternal and fetal risks during pregnancy and 30 days’ postpartum were analyzed. Results: Fifteen studies reporting 722 pregnancies were included. In total, 87.2% of pregnant women had a mechanical prosthesis and 12.5% a bioprosthesis. Maternal mortality risk was 1.33% (95% confidence interval [CI], 0.69-2.56), any hemorrhage risk 6.90% (95% CI, 3.70-12.88). Valve thrombosis risk was 4.71% (95% CI, 3.06-7.26) in patients with mechanical prostheses. 3.23% (95% CI, 1.34-7.75) of the patients with bioprostheses experienced early structural valve deterioration. Of these, the mortality was 40%. Pregnancy loss risk was 29.29% (95% CI, 19.74-43.47) with mechanical prostheses versus 13.50% (95% CI, 4.31-42.30) for bioprostheses. Switching to heparin during the first trimester demonstrated a bleeding risk of 7.78% (95% CI, 3.71-16.31) versus 4.08% (95% CI, 1.17-14.28) for women on oral anticoagulants throughout pregnancy and a valve thrombosis risk of 6.99% (95% CI, 2.08-23.51) versus 2.89% (95% CI, 1.40-5.94). Administration of anticoagulant dosages greater than 5 mg resulted in a risk of fetal adverse events of 74.24% (95% CI, 56.11-98.23) versus 8.85% (95% CI, 2.70-28.99) in ≤5 mg. Conclusions: A bioprosthesis seems the best option for women of childbearing age who are interested in future pregnancy after MVR. If mechanical valve replacement is preferred, the favorable anticoagulation regimen is continuous low-dose oral anticoagulants. Shared decision-making remains priority when choosing a prosthetic valve for young women.

The proliferation of transcatheter aortic valve implantation has alerted clinicians to a specific type of prosthetic degeneration represented by thrombosis. The pathogenesis of this clinical or subclinical phenomenon, which can occur in up to 15% of both surgical and percutaneous procedures, is poorly understood, as is its potential impact on patient prognosis and long-term bioprosthesis durability. Based on this lack of knowledge about the real meaning and importance of bioprosthetic valve thrombosis, the aim of the present review is to draw the clinicians’ attention to its existence, starting from the description of predisposing factors that may require a closer follow-up in such categories of patients, to an in-depth overview of all available imaging modalities with their respective pros and cons. Finally, a glimpse into the future of technology and biomarker development is presented. The hope is to increase the rate of bioprosthetic diagnosis, especially of the subclinical one, in order to understand (thanks to a strict and prolonged follow-up) if it can only be considered as an incidental tomographic entity without significant clinical consequences, or, on the contrary, if it is associated with neurological events or accelerated bioprosthetic degeneration. Nevertheless, despite the technical advances of echocardiography and cardiac tomography in terms of accurate bioprosthesis thrombosis detection, several diagnostic and therapeutic issues remain unresolved, including possible prevention strategies, tailored treatment protocols, and follow-up modalities.

Introduction: Histological analysis is the main tool for evaluating acellular bioprostheses, mostly on an experimental basis. The objective is to histologically analyze the acellular matrix of bovine pericardium in abdominal wall repairs implanted in humans. Method: From a series of 30 repairs with the membrane, 3 patients underwent surgical revision unrelated to the implants at 13, 22, and 23 months postoperatively, obtaining biopsies of the previously implanted areas. In addition to evaluating the basic aspects of biocompatibility and tissue neoformation, the slides were digitalized and subjected to computerized analysis with the ImageJ software to quantify the kinetics of membrane degradation associated with the analysis of the fractal dimension of the samples. The values obtained for percentages of residual membrane had their means compared by analysis of variance (ANOVA) and the unpaired Student’s T test, also used for the fractal dimension quantification values. Results: The biocompatibility of the material was demonstrated, with tissue neoformation, collagen deposition, and cellularized tissue with a normal appearance without important local reactions. Residual fragments of the membrane were quantified at 40%±7% at 13 months, at 20%±6% at 22 months, and at 17%±6% at 23 months postoperatively, with the analysis of the fractal dimension indicating a progressive degradation of implants, with statistical significance between 13 months and late samples. Conclusion: The results confirmed the functionality of the acellular bovine pericardium under different levels of mechanical stress in abdominal wall repairs in humans.

Introduction: Reducing recurrence rates significantly, the use of biomaterials as “reinforcement meshes” in the repair of different abdominal wall defects has become an almost mandatory routine for the success of these repairs. From the 1990s onwards, acellular biological matrices were introduced, thus beginning a new era in the repair of abdominal wall defects. The objective is to evaluate the functionality of the acellularized bovine pericardium in abdominal wall repairs. Method: Thirty patients underwent repair of abdominal wall defects using acellular bovine pericardium bioprostheses, making a total of 40 anatomically individualized implants. The average follow-up was 31 months, with patients being evaluated clinically and radiologically. In three cases, biopsies were taken from the implanted areas, allowing histological analysis of the material. Results: No recurrence of herniations was observed in any of the cases, both clinically and radiologically. There were also no records of bruises, infections or any phenomenon of a local or systemic reaction nature. Radiologically, it was not possible to visualize the matrices at the implantation site in any of the postoperative periods analyzed. Conclusion: The matrices showed similarity to other biological membranes described in the international literature. Representing an important update and conceptual evolution, acellular bovine pericardial membranes can be incorporated into the therapeutic arsenal in abdominal wall repairs.

The replacement of small-diameter arteries remains an unmet clinical need. Here we investigated the cellular remodeling of fibrotic conduits as vascular grafts. The formation of fibrotic conduit around subcutaneously implanted mandrels involved not only fibroblasts but also the trans-differentiation of inflammatory cells such as macrophages into fibroblastic cells, as shown by genetic lineage tracing. When fibrotic conduits were implanted as vascular grafts, the patency was low, and many fibrotic cells were found in neointima. Decellularization and anti-thrombogenic coating of fibrotic conduits produced highly patent autografts that remodeled into neoarteries, offering an effective approach to obtain autografts for clinical therapy. While autografts recruited mostly anti-inflammatory macrophages for constructive remodeling, allogenic DFCs had more T cells and pro-inflammatory macrophages and lower patency. Endothelial progenitors and endothelial migration were observed during endothelialization. Cell infiltration into DFCs was more efficient than decellularized arteries, and infiltrated cells remodeled the matrix and differentiated into smooth muscle cells (SMCs). This work provides insight into the remodeling of fibrotic conduits, autologous DFCs and allogenic DFCs, and will have broad impact on using fibrotic matrix for regenerative engineering.

Background: The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research. Methods: An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position. Results: Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average. Conclusion: FIH clinical report is essential to assess the significance of clinical data required for a "de novo" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial. [ABSTRACT FROM AUTHOR]

Aim: To evaluate clinical outcomes after redo aortic valve replacement (AVR) with sutured valves, versus valve-in-valve transcatheter aortic valve replacement (ViV-TAVR), versus sutureless valves. Methods: We identified 113 consecutive patients undergoing redo AVR with either ViV-TAVR, redo-sutured and redo-sutureless valves between August 2010 to March 2020. Heart-team made the decision whether patient should undergo redo-sutureless versus ViV-TAVR, versus redo-sutured AVR. Results: Preoperatively, redo-sutured (n = 57), ViV-TAVR (n = 31) and redo-sutureless (n = 25) patients were compared. Postoperatively, after propensity-adjustment analysis, the redo surgical aortic valve replacement group had a higher incidence of new postoperative atrial fibrillation (POAF; p = 0.04) compared with redo-sutureless group. Follow-up outcomes analysis did not show differences among groups. Conclusion: Patients undergoing redo-sutureless AVR experienced a higher incidence of POAF compared with patients undergoing redo-sutured. [ABSTRACT FROM AUTHOR]

This review explores the use of bioprosthetic valves for the lifetime management of patients with aortic stenosis, considering recent advancements in surgical (SAV) and transcatheter bioprostheses (TAV). We examine the strengths and challenges of each approach and their long-term implications. We highlight differences among surgical bioprostheses regarding durability and consider novel surgical valves such as the Inspiris Resilia, Intuity rapid deployment, and Perceval sutureless bioprostheses. The impact of hemodynamics on the performance and durability of these prostheses is discussed, as well as the benefits and considerations of aortic root enlargement during Surgical Aortic Valve Replacement (SAVR). Alternative surgical methods like the Ross procedure and the Ozaki technique are also considered. Addressing bioprosthesis failure, we compare TAV-in-SAV with redo SAVR. Challenges with TAVR, such as TAV explantation and considerations for coronary circulation, are outlined. Finally, we explore the potential challenges and limitations of several clinical strategies, including the TAVR-first approach, in the context of aortic stenosis lifetime management. This concise review provides a snapshot of the current landscape in aortic bioprostheses for physicians and surgeons. [ABSTRACT FROM AUTHOR]

(1) Background: Polymeric heart valves are prostheses constructed out of flexible, synthetic materials to combine the advantageous hemodynamics of biological valves with the longevity of mechanical valves. This idea from the early days of heart valve prosthetics has experienced a renaissance in recent years due to advances in polymer science. Here, we present progress on a novel, 3D-printable aortic valve prosthesis, the TIPI valve, removing the foldable metal leaflet restrictor structure in its center. Our aim is to create a competitive alternative to current valve prostheses made from flexible polymers. (2) Methods: Three-dimensional (3D) prototypes were designed and subsequently printed in silicone. Hemodynamic performance was measured with an HKP 2.0 hemodynamic testing device using an aortic valve bioprosthesis (BP), a mechanical prosthesis (MP), and the previously published prototype (TIPI 2.2) as benchmarks. (3) Results: The latest prototype (TIPI 3.4) showed improved performance in terms of regurgitation fraction (TIPI 3.4: 15.2 ± 3.7%, TIPI 2.2: 36.6 ± 5.0%, BP: 8.8 ± 0.3%, MP: 13.2 ± 0.7%), systolic pressure gradient (TIPI 3.4: 11.0 ± 2.7 mmHg, TIPI 2.2: 12.8 ± 2.2 mmHg, BP: 8.2 ± 0.9 mmHg, MP: 10.5 ± 0.6 mmHg), and effective orifice area (EOA, TIPI 3.4: 1.39 cm2, TIPI 2.2: 1.28 cm2, BP: 1.58 cm2, MP: 1.38 cm2), which was equivalent to currently used aortic valve prostheses. (4) Conclusions: Removal of the central restrictor structure alleviated previous concerns about its potential thrombogenicity and significantly increased the area of unobstructed opening. The prototypes showed unidirectional leaflet movement and very promising performance characteristics within our testing setup. The resulting simplicity of the shape compared to other approaches for polymeric heart valves could be suitable not only for 3D printing, but also for fast and easy mass production using molds and modern, highly biocompatible polymers. [ABSTRACT FROM AUTHOR]

Background: Improved durability of modern biologic prostheses and growing experience with the transcatheter valve-in-valve technique have contributed to a substantial increase in the use of bioprostheses in younger patients. However, discussion of prosthetic valve selection in dialysis patients remains scarce as the guidelines are updated. This study aims to compare long-term outcomes between propensity score-matched cohorts of dialysis patients who underwent primary aortic valve replacement with a mechanical prosthesis or a bioprosthesis. Materials and Methods: Longitudinal data of dialysis patients who underwent primary aortic valve replacement between 1 January 2001 and 31 December 2018, were retrieved from the National Health Insurance Research Database. Results: A total of 891 eligible patients were identified, of whom 243 ideally matched pairs of patients were analyzed. There was no significant difference in all-cause mortality (hazard ratio 1.11, 95% CI: 0.88-1.40) or the incidence of major adverse prosthesisrelated events between the two groups (hazard ratio 1.03, 95% CI: 0.84-1.25). In patients younger than 50 years of age, using a mechanical prosthesis was associated with a significantly longer survival time across 10 years of follow-up than using a bioprosthesis (restricted mean survival time) at 10 years: 7.24 (95% CI: 6.33-8.14) years for mechanical prosthesis versus 5.25 (95% CI: 4.25-6.25) years for bioprosthesis, restricted mean survival time difference 1.99 years, 95% CI: -3.34 to -0.64). Conclusion: A 2-year survival gain in favor of mechanical prostheses was identified in dialysis patients younger than 50 years. The authors suggest mechanical prostheses for aortic valve replacement in these younger patients. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Reintervention for failed transcatheter heart valves will likely increase in the future as younger patients are expected to outlive the initial bioprosthesis. While redo-TAVR has emerged as an attractive and less invasive alternative to surgical explantation (TAVR-explant) to treat transcatheter heart valve failure, it may not be feasible in all patients due to the risk of coronary obstruction and impaired coronary access. Conversely, TAVR-explant can be offered to most patients who are surgical candidates, but the reported outcomes have shown high mortality and morbidity. This review provides the latest evidence, current challenges, and future directions on redo-TAVR and TAVR-explant for transcatheter heart valve failure, to guide aortic valve reintervention and facilitate patients' lifetime management of aortic stenosis. [ABSTRACT FROM AUTHOR]

Objective: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). Methods: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. Results: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. Conclusion: According to this analysis, BVP meets world standards for safety and clinical efficacy. [ABSTRACT FROM AUTHOR]

Background: Sutureless aortic bioprostheses are increasingly being used to provide shorter cross-clamp time and facilitate minimally invasive aortic valve replacement. As the use of sutureless valves has increased over the past decade, we begin to encounter their degeneration. We describe clinical outcomes and technical aspects in patients with degenerated sutureless Perceval (CorCym, Italy) aortic bioprosthesis treated with valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). Methods: Between March 2011 and March 2023, 1310 patients underwent aortic valve replacement (AVR) with Perceval bioprosthesis implantation. Severe bioprosthesis degeneration treated with VIV-TAVR occurred in 32 patients with a mean of 6.4 ± 1.9 years (range: 2–10 years) after first implantation. Mean EuroSCORE II was 9.5 ± 6.4% (range: 1.9–35.1%). Results: Thirty of thirty-two (94%) VIV-TAVR were performed via transfemoral and two (6%) via transapical approach. Vascular complications occurred in two patients (6%), and mean hospital stay was 4.6 ± 2.4 days. At mean follow-up of 16.7 ± 15.2 months (range: 1–50 months), survival was 100%, and mean transvalvular pressure gradient was 18.7 ± 5.3 mmHg. Conclusion: VIV-TAVR is a useful option for degenerated Perceval and appears safe and effective. This procedure is associated with good clinical results and excellent hemodynamic performance in our largest single-center experience. [ABSTRACT FROM AUTHOR]

Background: Heyde's syndrome is known as a combination of gastrointestinal (GI) bleeding and aortic valve stenosis. However, there are no reports of an association between GI bleeding and bioprosthetic valve stenosis initially occurred after aortic valve replacement (AVR), even though there are several reports that GI bleeding due to native aortic valve stenosis disappeared after AVR, and GI bleeding recurred due to bioprosthetic valve stenosis or patient-prosthesis mismatch. Case presentation: An 80-year-old woman who was on hemodialysis for 13 years had undergone AVR with a bioprosthetic valve for aortic regurgitation 3 years prior. She was admitted with acute heart failure and anemia that required repeated blood transfusions. Capsule endoscopy revealed multiple active hemorrhages of the small intestine due to angiodysplasia. Echocardiography showed severe bioprosthetic valve stenosis in the aortic valve position as a result of structural valve deterioration (SVD). Because Heyde's syndrome was strongly suspected even though gel electrophoresis analysis of von Willebrand factor multimers, the gold standard examination for the definitive diagnosis of Heyde's syndrome, was not performed, a redo AVR with a new bioprosthetic valve was performed. After the second AVR, both the heart failure and anemia due to GI bleeding promptly improved. Conclusions: Bioprosthetic valve stenosis due to SVD can bring GI bleeding just as in native aortic valve stenosis. Redo AVR is a promising treatment if the combination of GI bleeding and valve stenosis in the aortic valve position appears even after AVR. [ABSTRACT FROM AUTHOR]

Biological valve failure (BVF) is an inevitable condition that compromises the durability of biological heart valves (BHVs). It stems from various causes, including rejection, thrombosis, and endocarditis, leading to a critical state of valve dysfunction. Echocardiography, cardiac computed tomography, cardiac magnetic resonance, and nuclear imaging play pivotal roles in the diagnostic multimodality workup of BVF. By providing a comprehensive overview of the pathophysiology of BVF and the diagnostic approaches in different clinical scenarios, this review aims to aid clinicians in their decision-making process. The significance of early detection and appropriate management of BVF cannot be overstated, as these directly impact patients' prognosis and their overall quality of life. Ensuring timely intervention and tailored treatments will not only improve outcomes but also alleviate the burden of this condition on patients' life. By prioritizing comprehensive assessments and adopting the latest advancements in diagnostic technology, medical professionals can significantly enhance their ability to manage BVF effectively. [ABSTRACT FROM AUTHOR]

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