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This randomized controlled trial aimed to determine the clinical efficacy of xenogeneic collagen membrane (XCM) derived from porcine peritoneum in combination with a coronally advanced flap (CAF) in the management of gingival recession defects and to compare the outcomes to those of connective tissue grafts (CTGs). A total of 12 systemically healthy individuals presenting with 30 isolated/multiple Cairo RT 1/2 gingival recession defects in maxillary canines and premolars were randomly treated either with CAF + XCM or CAF + CTG. Recession height (RH), gingival biotype (GB), gingival thickness (GT), width of keratinized gingiva (WKG), and width of attached gingiva (WAG) were recorded at baseline and at 3, 6, and 12 months. Patient perceptions of pain and esthetics and the modified root coverage esthetic score (MRES) were also documented. From baseline to 12 months, both groups showed a significant reduction in mean RH (CAF + CTG: 2.73 ± 0.79 mm to 0.33 ± 0.61 mm; CAF + XCM: 2.73 ± 0.88 mm to 1.20 ± 0.77 mm). At 12 months, CAF + CTG sites had a mean root coverage percentage (MRC%) of 85.60% ± 28.74%, whereas CAF + XCM sites had an MRC% of 55.13% ± 31.22%. CAF + CTG-treated sites had significantly better outcomes, with a greater number of sites achieving complete root coverage (n = 11) and higher MRES scores than the porcine peritoneal membrane group (P < .05). [ABSTRACT FROM AUTHOR]

This study clinically and histologically evaluated the outcome of a porcineapatite xenograft used to elevate the maxillary sinus floor in a severely atrophic ridge. A two-stage crestal window sinus elevation protocol was conducted in 24 patients with crestal bone ≤ 2 mm. Highly porous porcine carbonate apatite moistened with saline solution was placed in the elevated sinus cavity as the sole grafting material. Bone core biopsy samples were taken at 6, 9, and 12 months after sinus augmentation surgery (at implant placement). Treatment outcomes were assessed using microCT (μCT) and histologic analysis. Statistical analysis was performed using nonparametric Kruskal-Wallis test, followed by post-hoc Dunn multiple comparison test. At 6 months after implant placement, all implants achieved good primary stability (insertion torque ≥ 30 Ncm) and successfully osseointegrated. The residual graft amount (mean ± SE) was low (11.91% ± 1.99%) at 6 months and further decreased (6.11% ± 2.64%) by 12 months. On the contrary, the amount of new bone detected was 18.94% ± 4.08% at 6 months and was significantly (P < .05) increased (40.16% ± 5.27%) at 12 months. Histologic assessment revealed osteoclasts actively resorbing the graft as well as osteoblasts actively forming new bone. In the severely atrophic maxilla, the porcine-apatite xenograft promotes new bone formation while being slowly absorbed. Within the limited sample size, the porcine-apatite xenograft seems to be a good graft material for crestal window sinus augmentation. [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]

OBJECTIVES To compare isolated primary bioprosthetic surgical aortic valve replacement (SAVR) with isolated redo surgical aortic valve replacement (rSAVR) due to structural valve deterioration (SVD). METHODS Clinical data of consecutive patients who underwent primary isolated SAVR and isolated rSAVR due to SVD between 1 January 2011 and 31 December 2022, at Leipzig Heart Center were retrospectively compared with regard to the primary outcome of all-cause mortality or stroke during hospitalization. Secondary outcomes of interest included myocardial infarction, re-exploration for bleeding, and permanent pacemaker implantation. RESULTS A total of 2620 patients, 39.5% females, with a median EuroSCORE II of 1.7 [interquartile range (IQR) 1.1–2.7] were identified, of which rSAVR was performed in 174 patients (6.6%). Patients undergoing primary SAVR were older (69 vs 67 years of age, P  = 0.001) and were less likely to have a history of prior stroke (0.9% vs 4.0%, P  = 0.003). Although both all-cause death and death or stroke occurred less often following primary SAVR (0.5% vs 5.8%, and 2.2% vs 6.9%, respectively; P  < 0.001), prior surgery was not associated with adverse clinical outcome in multivariable analysis. In a matched comparison of 322 patients, rates of death or stroke did not differ between groups (4.8% for both rSAVR and SAVR, P  = 1.0). CONCLUSIONS Although redo surgery for SVD is associated with increased rates of early mortality and stroke by univariate analysis, much of this increased risk can be accounted for by comorbidities. Patients undergoing rSAVR on an elective basis can expect an outcome similar to that of primary SAVR. [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: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri‐procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI—transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri‐procedural and short‐term safety, efficacy and durability of repeated TAVI. Methods: The ReTAVI Prospective observational registry is an investigator‐initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon‐expandable SAPIEN prosthesis to evaluate procedural and short‐term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high‐volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30‐day and 12‐month follow‐up. The estimated study completion is 2025. Conclusions: The registry will collect pre‐, peri‐, postoperative and 12‐months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC‐3‐defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis. [ABSTRACT FROM AUTHOR]

Background: Corneal transplantation faces significant challenges due to the shortage in donor corneas. Porcine corneas have emerged as a potential solution due to their similarities in biomechanical properties with pigs, yet xenoimmune rejection poses an obstacle to their efficacy. Methods: In this study, in silico methods were employed to analyze the compatibility of porcine corneal xenografts, focusing on two key aspects: the comparison of corneal matrix proteins and investigation of the immunological mediators and pathways involved in corneal graft rejection. The amino acid sequences of the fourteen (14) most abundant proteins in the corneal matrix were compared to determine their structural and functional differences. The primary amino acid structures and compositions, theoretical pI, and grand average of hydropathicity were determined and compared between the two species. Results: In graft performance, similarities and differences between the donor and recipient tissues influence the success of transplantation. When the proteins closely resemble each other, in terms of structural characteristics and biochemical properties, the host's immune system is less likely to recognize the tissue as foreign. The immunological mediators and pathways involved in corneal graft rejection were investigated, elucidating the mechanisms underlying xenograft incompatibility. Based on the results generated from STRING, the specific groups of molecules that are involved in the immune-mediated rejection process are costimulatory molecules, cytokines, immune checkpoint molecules, apoptosis regulators, cell adhesion molecules, growth factors, neuropeptides and hormones, certain receptors, the cytotoxic molecule GZMA, and the chemokine CCL5. Conclusions: The results of this study establish that the porcine cornea has a high suitability for corneal xenotransplantation into humans but requires immune-based therapeutic interventions to increase graft acceptance. [ABSTRACT FROM AUTHOR]

OBJECTIVES There remains debate over the optimal mitral valve replacement (MVR) option for patients aged 50–70 years. The objective of this study was to retrospectively compare the long-term outcomes of mechanical and bioprosthetic MVR in this patient population. METHODS Data from patients undergoing MVR between 2004 and 2018 were retrospectively reviewed. The primary outcome was all-cause mortality. Secondary outcomes included perioperative and late morbidity. RESULTS Two hundred and eight-six propensity-matched patients (n  = 143 mechanical; n  = 143 bioprosthetic) aged 50–70 years were included in the final analysis. Maximum follow-up was 15.8 years. There was no significant difference in all-cause mortality between the groups at 30 days, 1 year, 5 years, 10 years, and at the longest follow-up. Patients who underwent mechanical MVR experienced significantly lower rates of postoperative atrial fibrillation (P  = 0.001). There were no significant differences in rates of sepsis, acute kidney injury, superficial and deep sternal wound infection, mediastinal bleeding, and permanent pacemaker implantation. At the longest follow-up, there were no differences in myocardial infarction, stroke, heart failure or overall rehospitalization. At the same time point, there was an increased rate of MVR in patients receiving a bioprosthetic valve (P  = 0.015). CONCLUSIONS Survival following mechanical and bioprosthetic MVR in patients 50–70 years of age is similar to up to 15 years of follow-up. Bioprosthetic MVR is associated with an increased risk of repeat MVR. Mechanical MVR is not associated with an increased risk of stroke. Valve selection in this patient population requires diligent consideration of structural valve deterioration and subsequent reoperation risk as well as bleeding and thromboembolic risk. [ABSTRACT FROM AUTHOR]

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: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. [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]

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]

OBJECTIVES Limited data are available from randomized trials comparing outcomes between transcatheter aortic valve replacement (TAVR) and surgery in patients with different risks and with follow-up of at least 4 years or longer. In this large, population-based cohort study, long-term mortality and morbidity were investigated in patients undergoing aortic valve replacement (AVR) for severe aortic stenosis using a surgically implanted bioprosthesis (surgical/biological aortic valve replacement; sB-AVR) or TAVR. METHODS Individual data from the Austrian Insurance Funds from 2010 through 2020 were analysed. The primary outcome was all-cause mortality, assessed in the overall and propensity score-matched populations. Secondary outcomes included reoperation and cardiovascular events. RESULTS From January 2010 through December 2020, a total of 18 882 patients underwent sB-AVR (n  = 11 749; 62.2%) or TAVR (n  = 7133; 37.8%); median follow-up was 5.8 (95% CI 5.7–5.9) years (maximum 12.3 years). The risk of all-cause mortality was higher with TAVR compared with sB-AVR: hazard ratio 1.552, 95% confidence interval (CI) 1.469–1.640, P  < 0.001; propensity score-matched hazard ratio 1.510, 1.403–1.625, P  < 0.001. Estimated median survival was 8.8 years (95% CI 8.6–9.1) with sB-AVR versus 5 years (4.9–5.2) with TAVR. Estimated 5-year survival probability was 0.664 (0.664–0.686) with sB-AVR versus 0.409 (0.378–0.444) with TAVR overall, and 0.690 (0.674–0.707) and 0.560 (0.540–0.582), respectively, with propensity score matching. Separate subgroup analyses for patients aged 65–75 years and >75 years indicated a significant survival benefit in patients selected for sB-AVR in both groups. Other predictors of mortality were age, sex, previous heart failure, diabetes and chronic kidney disease. CONCLUSIONS In this retrospective national population-based study, selection for TAVR was significantly associated with higher all-cause mortality compared with sB-AVR in patients ≥65 years with severe, symptomatic aortic stenosis in the >2-year follow-up. [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]

Bioprosthetic aortic valve thrombosis is frequently detected after transcatheter and surgical aortic valve replacement due to advances in cardiac computed tomography angiography technology and standardized surveillance protocols in low-surgical-risk transcatheter aortic valve replacement trials. However, evidence is limited concerning whether subclinical leaflet thrombosis leads to clinical adverse events or premature structural valve deterioration. Furthermore, there may be net harm in the form of bleeding from aggressive antithrombotic treatment in patients with subclinical leaflet thrombosis. This review will discuss the incidence, mechanisms, diagnosis, and optimal management of bioprosthetic aortic valve thrombosis after transcatheter aortic valve replacement and bioprosthetic surgical aortic valve replacement. [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]

Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis. This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs' performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures. Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both internal skirt and external reinforced cuff may also explain the low rate of moderate to severe PVL. [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]

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.

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

This study compared the bone turnover and volume stability of bovine-derived xenografts (Cerabone) vs porcine-derived xenografts (MinerOss XP) in horizontal ridge augmentation (HRA) for veneer contour and extraction socket preservation (ESP), with a 6-month follow-up. Participants were divided into Group 1 (HRA + bovine), Group 2 (HRA + porcine), Group 3 (ESP + bovine), and Group 4 (ESP + porcine). Buccolingual ridge width was measured on CBCT scans at baseline and 6 months. Representative histologic core samples were taken from the ESP groups at 6 months. Each group comprised 10 subjects (40 subjects total). The buccolingual width for Groups 1 and 2 increased from 5.43 ± 1.82 mm and 5.75 ± 1.64 mm (P = .36) to 7.75 ± 1.91 mm and 8.75 ± 1.38 mm (P = .03), respectively. However, the buccolingual widths for Groups 3 and 4 decreased from 6.3 ± 1.26 mm and 6.74 ± 1.29 mm (P = .16) to 5.8 ± 1.21 mm and 6.61 ± 1.56 mm (P = .01), respectively. Significantly lower dimensional changes were noted in Group 4 at 6 months. Porcine xenografts serve as a stable biocompatible osteoconductive bone substitute and expand a clinician's choice of bone grafts in dental applications. [ABSTRACT FROM AUTHOR]

OBJECTIVES The objective of this analysis was to assess the normal haemodynamic performance of contemporary surgical aortic valves at 1 year postimplant in patients undergoing surgical aortic valve replacement for significant valvular dysfunction. By pooling data from 4 multicentre studies, this study will contribute to a better understanding of the effectiveness of surgical aortic valve replacement procedures, aiding clinicians and researchers in making informed decisions regarding valve selection and patient management. METHODS Echocardiograms were assessed by a single core laboratory. Effective orifice area, dimensionless velocity index, mean aortic gradient, peak aortic velocity and stroke volume were evaluated. RESULTS The cohort included 2958 patients. Baseline age in the studies ranged from 70.1 ± 9.0 to 83.3 ± 6.4 years, and Society of Thoracic Surgeons risk of mortality was 1.9 ± 0.7 to 7.5 ± 3.4%. Twenty patients who had received a valve model implanted in fewer than 10 cases were excluded. Ten valve models (all tissue valves; n  = 2938 patients) were analysed. At 1 year, population mean effective orifice area ranged from 1.46 ± 0.34 to 2.12 ± 0.59 cm2, and dimensionless velocity index, from 0.39 ± 0.07 to 0.56 ± 0.15. The mean gradient ranged from 8.6 ± 3.4 to 16.1 ± 6.2 mmHg with peak aortic velocity of 1.96 ± 0.39 to 2.65 ± 0.47 m/s. Stroke volume was 75.3 ± 19.6 to 89.8 ± 24.3 ml. CONCLUSIONS This pooled cohort is the largest to date of contemporary surgical aortic valves with echocardiograms analysed by a single core lab. Overall haemodynamic performance at 1 year ranged from good to excellent. These data can serve as a benchmark for other studies and may be useful to evaluate the performance of bioprosthetic surgical valves over time. Clinical trial registration number NCT02088554, NCT02701283, NCT01586910 and NCT01531374. [ABSTRACT FROM AUTHOR]

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]

Valve-in-valve transcatheter aortic valve implantation (ViV TAVI) is rapidly arising as a safe and effective alternative to redo-surgery in the treatment of bioprostheses deterioration. While scientific community is currently focusing its attention on the most common limitations related to this procedure, such as the risk of coronary obstruction and patient-prosthesis mismatch, data regarding the first step of a ViV TAVI, the crossing of a degenerated bioprosthesis, are still lacking. The aim of this review is to analyze the available information about bioprosthesis crossing, to show the inherent challenges encountered by interventional cardiologists during valve crossing and to describe the current strategies to perform a correct crossing. • ViV TAVR numbers are increasing but information about its first step, the valve crossing, are limited. • Two possible scenarios: the "complex crossing" and the "wrong crossing". • Complex crossing could lead to expensive and longer procedures; wrong crossing could lead to dangerous complications. • The current management to perform a correct VIV-TAVI crossing relies on four fundamental pillars. [ABSTRACT FROM AUTHOR]

One of the most common complications of tricuspid valve replacement is atrioventricular block (AVB), often requiring permanent pacing. The endocardial pacemaker lead, placed in the right ventricle, may sometimes interfere with the implanted prosthesis, causing its early dysfunction and the need for alternative sites of pacing. To the best of our knowledge, we present the first case of a successful combined percutaneous procedure consisting of the implantation of two leads in the coronary sinus for univentricular bifocal pacing and a transcatheter tricuspid valve-in-valve implantation in a young patient with severe dysfunction of the tricuspid bioprosthesis, requiring permanent pacing for a postsurgical complete atrioventricular block. Tricuspid valve replacement with surgery can often lead to cardiac rhythm disorders requiring a permanent pacemaker. This device may occasionally damage the tricuspid prosthesis. We present the first case of a combined procedure of tricuspid valve replacement and device implantation distant from the prosthesis without the need for a surgical approach in a young patient with severe tricuspid prosthesis malfunctioning and permanent pacing. Article highlights Right-sided infective endocarditis in young patients may be caused by intravenous drug use, leading to tricuspid valve injury and the need for valve replacement with a prosthesis. Complete atrioventricular block represents an important postoperative complication of valve surgery requiring, frequently, the implantation of a permanent pacemaker. The endocardial pacemaker lead in the right ventricle may sometimes interfere with the implanted bioprosthesis, causing its early degeneration with the need for prosthesis replacement and research of other sites of pacing. Surgical replacement of a malfunctioning tricuspid prosthesis is among the highest-risk procedures. A combined percutaneous implantation of two pacing leads in the coronary sinus for univentricular bifocal pacing and a transcatheter tricuspid valve-in-valve may be a safe and effective alternative to surgery in patients requiring a permanent pacing site. In the case of pacemaker dependency, the use of actively fixating leads should be preferable to passive ones in order to minimize the risk of lead dislocation. Other strategies such as pacing with epicardial leads, the use of his-bundle pacing, or leadless pacemakers were taken into account but not deemed suitable. The Heart Team plays a critical role in decision-making in these particular conditions. [ABSTRACT FROM AUTHOR]

Although it is associated with the low lifetime of aortic valve bioprostheses, flutter has little been studied in the dynamics of these valves. To improve the understanding of flutter in bioprosthetic leaflets, the present work evaluates the effect of leaflet thickness and protrusion height on flutter parameters through the computational fluid–structure interaction. A bioprosthesis geometry, based on a geometric model available in the literature, and a simplified fluid domain were developed. As a boundary condition, a parabolic velocity profile was applied at the inlet, outflow at the outlet, and fixed support at the sides of the leaflets. The valve cusps were considered with linear elastic and isotropic mechanical behavior, while the blood was modeled as a Newtonian fluid. Turbulence was modeled according to the k- ω SST model. The numerical results showed that, due to the occurrence of leaflet oscillations, both fluid dynamic quantities, such as pressure, velocity, and turbulence intensity, and solid domain quantities, such as stress and strain, exhibited an irregular and oscillatory behavior. Furthermore, the radial displacements of the leaflets were asynchronous, and the phase difference between the leaflets increased with increasing thickness. The frequencies ranged from 28.3 to 36.7 Hz, while the amplitudes ranged from 5.34 to 6.53 mm, where the valve with the lowest protrusion height did not develop flutter [ABSTRACT FROM AUTHOR]

Bioprosthetic valves are employed to replace defective heart valves. However, structural degeneration is prevalent in bioprosthetic valves because the heart valve leaflets are exposed to extreme and repetitive cardiovascular pressure. Herein, a silk fibroin‐based heart valve leaflet, which executes the physiological role of a heart valve, is developed. To this end, a templated assembly technology is developed. Notably, a physically optimal hierarchical structure for replacing the natural heart valve leaflet is realized by numerous firmly stacked β‐sheet crystals distributed within collective tyrosine‐reinforcing amorphous strands. Almost half (46.9%) of the silk fibroin‐based heart valve leaflet comprises strongly stacked β‐sheet crystals, leading to a 292% enhancement in stacking strength. The templated assembly results in the entanglement of amorphous strands, upregulating the non‐covalent interactions within the tyrosine. Consequently, the strength is enhanced by 1380% compared to native silk fibroin. Moreover, the templated assembly enhances the static and dynamic mechanical properties, thereby delivering a desirable performance for its use in heart valve replacement. Interestingly, the aortic valve composed of silk fibroin‐based leaflets does not fail under the cardiovascular pressure of 60–180 mmHg. Furthermore, the valve performance is satisfactory and surmounts the requirements of the industrial standard ISO 5840. [ABSTRACT FROM AUTHOR]

Background Several studies have reported high rates of prosthesis–patient mismatch (PPM) after aortic valve replacement (AVR) with the Mosaic prosthesis. This work assesses the incidence of PPM after AVR with a modified version of the Mosaic prosthesis, the Mosaic Ultra. Methods We performed a retrospective analysis of the data of 532 patients who underwent AVR with implantation of the Mosaic Ultra prosthesis in the period 2007–2016 in our institution. Patients were classified according to their indexed effective orifice area (EOAi) to severe (EOAi < 0.65 cm2 /m2), moderate (EOAi 0.65–0.85 cm2 /m2), and absent/mild PPM (EOAi > 0.85 cm2 /m2). In-hospital postoperative outcomes and the impact of PPM on mean transvalvular pressure gradient after stratification by prosthesis size were assessed. Results Overall, 3 (0.6%) patients had severe, 92 (17.3%) moderate, and 437 (82.1%) absent/mild PPM. There was a significant difference in PPM proportions (moderate/severe vs absent/mild PPM) across different prosthesis sizes overall (p < 0.0001), observing gradually increasing rates of PPM with decreasing prosthesis sizes. Patients with moderate/severe PPM had higher mean transvalvular pressure gradients (19 [13–25] vs 13 [10–17] mm Hg, p < 0.0001) than patients with absent/mild PPM. There was a significant difference in mean transvalvular pressure gradient between the different aortic valve prosthesis sizes overall (p < 0.0001), observing gradually increasing gradients with decreasing prosthesis sizes. Conclusion Patients undergoing AVR with the smaller sized (19, 21, and 23 mm) Mosaic Ultra aortic valve prostheses exhibit a higher risk for moderate/severe PPM and higher mean aortic transvalvular pressure gradients than patients receiving the larger sized (25, 27, and 29 mm) prostheses. [ABSTRACT FROM AUTHOR]

Background Bioprosthetic stentless aortic valves may degenerate over time and will require replacement. This study aimed to evaluate early- and mid-term outcomes after isolated surgical redo aortic valve replacement (redo-SAVR) and transcatheter valve-in-valve implantation (TAVI-VIV) for degenerated stentless Freestyle bioprostheses. Methods We reviewed records of 56 patients at a single center. Overall, 37 patients (66.1%) received TAVI-VIV and 19 (33.9%) received redo-SAVR. Results Thirty-day survival was similar in both groups (100%). One-year survival was comparable between groups (97.3% in TAVI-VIV and 100% in redo-SAVR, p = 1.0). The difference in mid-term survival after adjusting for age and EuroScore II was not significant (p = 0.41). The incidence of pacemaker implantation after TAVI-VIV was higher than after redo-SAVR (19.4% vs. 0%, p = 0.08). Conclusion The 30-day and 1-year survival rates after both procedures were outstanding, irrespective of baseline characteristics. Isolated redo-SAVR should be favored in young patients, as the pacemaker implantation rate is lower. TAVI-VIV for degenerated Freestyle prosthesis can be a method of choice in elderly patients and those with high operative risk. [ABSTRACT FROM AUTHOR]

Background We aimed to compare hemodynamic performance of the Avalus (Medtronic) and the Perimount Magna Ease (PME, Edwards Lifesciences) bioprosthesis up to 5 years by serial echocardiographic examinations. Methods In patients undergoing aortic valve replacement, 58 received PME prostheses between October 2007 and October 2008, and another 60 received Avalus prostheses between October 2014 and November 2015. To ensure similar baseline characteristics, we performed a propensity score matching based on left ventricular ejection fraction, age, body surface area, and aortic annulus diameter measured by intraoperative transesophageal echocardiography. Thereafter, 48 patients remained in each group. Mean age at operation was 67 ± 6 years and mean EuroSCORE-II was 1.7 ± 1.1. Both values did not differ significantly between the two groups. Results At 1 year the mean pressure gradient (MPG) was 15.4 ± 4.3 mm Hg in the PME group and 14.7 ± 5.1 mm Hg in the Avalus group (p = 0.32). The effective orifice area (EOA) was 1.65 ± 0.45 cm2 in the PME group and 1.62 ± 0.45 cm2 in the Avalus group (p = 0.79). At 5 years the MPG was 16.6 ± 5.1 mm Hg in the PME group and 14.7 ± 7.1 mm Hg in the Avalus group (p = 0.20). The EOA was 1.60 ± 0.49 cm2 in the PME group and 1.51 ± 0.40 cm2 in the Avalus group (p = 0.38). Five-year survival was 88% in the PME group and 91% in the Avalus group (p = 0.5). In the PME group, there were no reoperations on the aortic valve, whereas in the Avalus group three patients required a reoperation due to endocarditis. Conclusion Both bioprostheses exhibit similar hemodynamic performance during a 5-year follow-up. [ABSTRACT FROM AUTHOR]

Background and Aims Transcatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years. Methods The NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD. Results Baseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P =.7), male 52.6% and 53.8% (P =.8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P =.5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7–1.3; P =.9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04–0.7; P =.02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P <.001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4–1.5; P =.4). Conclusions In patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar. [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]

This study retrospectively evaluated the mid-term outcomes of surgical aortic valve replacement (SAVR) using a stented porcine aortic valve bioprosthesis (Mosaic; Medtronic Inc., Minneapolis, MN, USA) with concomitant mitral valve (MV) repair. From 1999 to 2014, 157 patients (median [interquartile range] age, 75 [70–79] years; 47% women) underwent SAVR with concomitant MV repair (SAVR + MV repair), and 1045 patients (median [interquartile range] age, 76 [70–80] years; 54% women) underwent SAVR only at 10 centers in Japan as part of the long-term multicenter Japan Mosaic valve (J-MOVE) study. The 5-year overall survival rate was 81.5% ± 4.1% in the SAVR + MV repair group and 85.1% ± 1.4% in the SAVR only group, and the 8-year overall survival rates were 75.2% ± 5.7% and 78.1% ± 2.1%, respectively. Cox proportional hazards analysis showed no significant difference in the survival rates between the two groups (hazard ratio, 0.87; 95% confidence interval, 0.54–1.40; P = 0.576). Among women with mild or moderate mitral regurgitation who were not receiving dialysis, those who underwent SAVR + MV repair, were aged > 75 years, and had a preoperative left ventricular ejection fraction of 30–75% tended to have a lower mortality risk. In conclusion, this subgroup analysis of the J-MOVE cohort showed relevant mid-term outcomes after SAVR + MV repair. [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.

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]

Open in new tab Download slide OBJECTIVES While current data show a clear trend towards the use of bioprosthetic valves during aortic valve replacement (AVR), durability of bioprosthetic valves remains the most important concern. We conducted a 1st systematic review of all available evidence that analysed early and mid-term outcomes after AVR using the Inspiris RESILIA™ bioprosthesis. METHODS A systematic literature search was performed to identify all relevant studies evaluating early and mid-term outcomes after AVR using the Inspiris RESILIA bioprosthesis and including at least 20 patients with no restriction on the publication date. Subgroup meta-analysis was performed to compare Inspiris RESILIA and PERIMOUNT Magna Ease bioprosthesis and to pool the early postoperative mortality and stroke rates. RESULTS A total of 416 studies were identified, of which 15 studies met the eligibility criteria. The studies included a total of 3202 patients with an average follow-up of up to 5.3 years. The average age of patients across the studies was 52.2–75.1 years. Isolated AVR was performed in 39.0–86.4% of patients. In-hospital or 30-day postoperative mortality was 0–2.8%. At the mid-term follow-up, freedom from all-cause mortality was up to 85.4%. Among studies with mid-term follow-up, trace/mild paravalvular leak was detected in 0–3.0%, while major paravalvular leak was found only in up to 2.0% of patients. No statistically significant differences in terms of mortality (P  = 0.98, odds ratio 1.02, 95% confidence interval 0.36–2.83) and stroke (P  = 0.98, odds ratio 1.01, 95% confidence interval 0.38–2.73) between the Inspiris RESILIA bioprosthesis and PERIMOUNT Magna Ease bioprosthesis were observed in the subgroup meta-analysis. CONCLUSIONS Mid-term data on the safety and haemodynamic performance of the novel aortic bioprosthesis are encouraging. Further comparative studies with other bioprostheses and longer follow-up are still required to endorse durability and safety of the novel bioprosthesis. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES Tracheoesophageal fistula (TEF) is characterized by abnormal connectivity between the posterior wall of the trachea or bronchus and the adjacent anterior wall of the oesophagus. Benign TEF can result in serious complications; however, there is currently no uniform standard to determine the appropriate surgical approach for repairing TEF. METHODS The PubMed database was used to search English literature associated with TEF from 1975 to October 2023. We employed Boolean operators and relevant keywords: 'tracheoesophageal fistula', 'tracheal resection', 'fistula suture', 'fistula repair', 'fistula closure', 'flap', 'patch', 'bioabsorbable material', 'bioprosthetic material', 'acellular dermal matrix', 'AlloDerm', 'double patch', 'oesophageal exclusion', 'oesophageal diversion' to search literature. The evidence level of the literature was assessed based on the GRADE classification. RESULTS Nutritional support, no severe pulmonary infection and weaning from mechanical ventilation were the 3 determinants for timing of operation. TEFs were classified into 3 levels: small TEF (<1 cm), moderate TEF (≥1 but <5 cm) and large TEF (≥5 cm). Fistula repair or tracheal segmental resection was used for the small TEF with normal tracheal status. If the anastomosis cannot be finished directly after tracheal segmental resection, special types of tracheal resection, such as slide tracheoplasty, oblique resection and reconstruction, and autologous tissue flaps were preferred depending upon the site and size of the fistula. Oesophageal exclusion was applicable to refractory TEF or patients with poor conditions. CONCLUSIONS The review primarily summarizes the main surgical techniques employed to repair various acquired TEF, to provide references that may contribute to the treatment of TEF. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES This nationwide retrospective cohort study assessed the impact of the explanted valve type on reoperative outcomes in aortic valve surgery within the UK over a 23-year period. METHODS Data were sourced from the National Institute for Cardiovascular Outcomes Research (NICOR) database. All patients undergoing first-time isolated reoperative aortic valve replacement between 1996 and 2019 in the UK were included. Concomitant procedures, homograft implantation or aortic root enlargement were excluded. Propensity score matching was utilized to compare outcomes and risk factors for in-hospital mortality was evaluated through multivariable logistic regression. Final model selection was conducted using Akaike Information Criterion through bootstrapping. The primary end point was in-hospital mortality, and secondary end points included postoperative morbidities. RESULTS Out of 2371 patients, 24.9% had mechanical and 75% had bioprosthetic valves implanted during the primary procedure. Propensity matched groups of 324 patients each, were compared. In-hospital mortality for mechanical and bioprosthetic valve explants was 7.1% and 5.9%, respectively (P  = 0.632). On multivariable logistic regression analysis, valve type was not a risk factor for mortality [odds ratio (OR) 0.62, 95% confidence interval (CI) 0.37–1.05; P  = 0.1]. Age (OR 1.03, 95% CI 1.01–1.05; P  < 0.05), left ventricular ejection fraction (OR 1.62, 95% CI 1.08–2.42; P  < 0.05), creatinine ≥ 200 mg/dl (OR 2.21, 95% CI 1.17–4.04; P  < 0.05) and endocarditis (OR 2.66, 95% CI 1.71–4.14; P  < 0.05) emerged as risk factors for mortality. CONCLUSIONS The type of valve initially implanted (mechanical or bioprosthetic) did not determine mortality. Instead, age, left ventricular ejection fraction, renal impairment and endocarditis were significant risk factors for in-hospital mortality. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES The population of candidates to surgical aortic valve replacement (SAVR) is evolving. The Perimount Magna Ease© bioprosthesis has been introduced relatively recently in the practice. We aimed at evaluating its long-term results. METHODS This article describes a single-centre cohort of 1016 consecutive SAVRs with the Magna Ease© valve (2008–2014), consisting of an all-comers population. We performed a prospective collection of in-hospital data, systematic clinical and echocardiographic follow-up. Valve-related events were as follows: structural valve deterioration (SVD; according to modified definition criteria), nonstructural valve dysfunction, patient–prosthesis mismatch (PPM). RESULTS Age at SAVR was 73.4 ± 9.5 years; calcified aortic stenosis was the indication to surgery in 59.6%. A total of 974 patients entered the follow-up; 564 were alive at the last follow-up (median duration: 9.8 years) (up to 13.4 years). New York Heart Association class was I or II in 92.1%. Overall survival at 10 years was 56.8 ± 1.8%. Freedom from SVD at 10 was 96.5 ± 0.8% (Kaplan–Meier) and 97.4 ± 0.6% (competing risks) (28 SVD events after 6.9 ± 3.3 years). There were 15 reinterventions for SVD (redo-SAVR and Transcatheter Aortic Valve Implantation (TAVI)); 10-year freedom from reintervention was 97.8 ± 0.6%. Moderate and severe PPM occurred in 26.8% and 5.4%, respectively, without association with late mortality (P  = 0.12 for moderate and P  = 0.70 for severe PPM). Freedom from valve-related mortality was 97.8 ± 0.5% at 10 years. CONCLUSIONS In this follow-up of the Magna Ease bioprosthesis for SAVR, data indicate good late outcomes (30-day outcomes are excluded). Continued follow-up is required to further support its use in patients with life expectancy >10–12 years. [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]

Open in new tab Download slide OBJECTIVES This population-based cohort study investigated mid-term outcome after surgical aortic valve replacement with a bioprosthetic or mechanical valve prosthesis in patients aged <50 years in a European social welfare state. METHODS We analysed patient data from the main social insurance carriers in Austria (2010–2020). Subsequent patient-level record linkage with national health data provided patient characteristics and clinical outcome. Survival, reoperation, myocardial infarction, heart failure, embolic stroke or intracerebral haemorrhage, bleeding other than intracerebral haemorrhage and major adverse cardiac events were evaluated as outcomes. RESULTS A total of 991 patients were analysed. Regarding demographics, no major differences between groups were observed. Multivariable Cox regression revealed no significant difference in overall survival (P  = 0.352) with a median follow-up time of 6.2 years. Reoperation-free survival was decreased (hazard ratio = 1.560 [95% CI: 1.076–2.262], P  = 0.019) and the risk for reoperation was increased (hazard ratio = 2.770 [95% CI: 1.402–5.472], P  = 0.003) in patients who received bioprostheses. Estimated probability of death after reoperation was 0.23 (CL: 0.08–0.35) after 2 years and 0.34 (CL: 0.06–0.53) after 10 years over both groups. Regarding further outcomes, no significant differences between the two groups were observed. CONCLUSIONS In patients below 50 years of age receiving aortic valve replacement, implantation of bioprostheses when compared to mechanical heart valve prostheses was associated with a significantly higher rate of reoperations and reduced reoperation-free survival. Nevertheless, we could not observe a difference in overall survival. However, long-term follow-up has to evaluate that a significantly lower rate of reoperations may translate in consistently improved long-term survival. [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]

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]

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]

Open in new tab Download slide OBJECTIVES Patients undergoing surgical tricuspid valve replacement (TVR) are at high risk of atrioventricular conduction disorders. Because implanting a lead through the tricuspid bioprosthesis is discouraged, the patients who undergo TVR in our centre are usually given a prophylactic epicardial pacemaker. Our aim was to assess the benefits and risks of this strategy. METHODS Among the patients who underwent TVR with prophylactic epicardial pacemaker implantation, clinical evaluations and pacemaker reports were analysed retrospectively after surgery. The need for cardiac pacing were assessed by characterizing the atrioventricular conduction, while the risks were evaluated by listing and adjudicating post-operative events. RESULTS A total of 80 patients were analysed (mean age was 57 ± 16 years old, 30% males). TVR was isolated in 28 (35%) patients, but most often associated with another valve surgery. In the postoperative period, heart rhythm was analysed in 59/80 patients during a median follow-up of 35 months. Cardiac pacing was needed in 46% patients: 14% had complete pacing dependency, 17% had high degree AV block, while 15% had a high ventricular pacing rate (>80%). No pre- or per-operative variables could predict cardiac pacing requirement. Post-operatively, a spontaneous heart rate >70 bpm (P  = 0.02) and the presence of narrow QRS (P  = 0.03) were significantly associated with a lower risk of cardiac pacing requirement. Complications related to epicardial pacemaker were documented in 2 (2.5%) patients. CONCLUSIONS After TVR, cardiac pacing was needed in 46% of patients for post-operative atrioventricular conduction disorders. This high incidence associated with an acceptable safety profile supports a prophylactic epicardial pacing strategy for the patients undergoing TVR. [ABSTRACT FROM AUTHOR]

Background A randomized controlled trial was designed to compare 1-year hemodynamic profiles and clinical outcomes after bioprosthetic aortic valve replacement (AVR) using a recently introduced (study group) and world-widely used (control group) bovine pericardial bioprostheses. This study evaluated early postoperative outcomes as a preliminary analysis. Methods The primary end point of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. Patients were screened to enroll 70 patients in each group based on a noninferiority design. Early postoperative hemodynamic and clinical outcomes were compared between the two groups. Results There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m2) between the two groups. The AVMPG on early postoperative echocardiography was 15.2 ± 4.6 mm Hg and 16.5 ± 6.2 mm Hg in the study and control groups, respectively (p = 0.177). Although AVMPG of the 19 mm prostheses was lower in the study group than in the control group (17.0 ± 6.3 mm Hg vs. 22.8 ± 6.6 mm Hg, p = 0.039), there were no significant differences in the effective orifice area in all patients (1.57 ± 0.41 cm2 vs. 1.53 ± 0.34 cm2 , p = 0.568), and each valve size. The effective orifice area index was also similar between the two groups in overall (p = 0.352), and in each valve size. There were no significant differences in clinical outcomes including operative mortality and postoperative complications between the two groups. Conclusion Early postoperative hemodynamic and clinical results after AVR using a recently introduced bovine pericardial valve were comparable with those using the control valve (NCT03796442) [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]