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This study was conducted to determine the incidence of postoperative conduction disorders and need for pacemaker (PM) implantation after aortic valve replacement (AVR) with the Perceval prosthesis (Livanova, Saluggia, Italy). From January 2007 to December 2017, 908 patients underwent AVR with Perceval S in 5 participating centers. Study end points focused on electrocardiographic changes after AVR and the incidence of new PM implantation in 801 patients after exclusion of patients with previous PM (n = 48) or patients undergoing tricuspid (n = 28) and/or atrial fibrillation ablation (n = 31) surgery. Logistic regression analysis was performed to determine risk factors for PM need. Mean age was 79.7 ± 5.2 years, and 476 (59.4%) were women. Median logistic European System for Cardiac Operative Risk Evaluation (2011 revision) score was 4.1% (interquartile range, 2.6%-6.0%). Isolated AVR was performed in 441 patients (55.1%). Associated procedures were coronary artery bypass grafting in 309 (38.6%) and mitral valve surgery in 51 (6.4%). Overall 30-day mortality was 3.9% and was 2.8% for isolated AVR. Electrocardiographic changes included a significant increase of left bundle branch block from 7.4% to 23.7% (P <.001) and development of complete atrioventricular block requiring PM implantation in 9.5%. Multivariable analysis revealed independent of a learning period (odds ratio [OR], 1.91; 95% confidence limits (CL), 1.16-3.13; P =.011), preexisting right-bundle branch block (OR, 2.77; 95% CL, 1.40-5.48; P =.003), intraoperative prosthesis repositioning (OR, 6.70; 95% CL, 1.89-24.40; P =.003), and size extra large (OR, 6.81; 95% CL, 1.55-29.96; P =.011) as significant predictors of PM implantation. In a challenging elderly population, use of the Perceval S for AVR provides low operative mortality but at the risk of an increased PM implantation rate. Besides preexisting right bundle branch block, the significant effect of size extra large, an increased valve size/body surface area ratio, and need for intraoperative repositioning on PM rate are underscoring the reappraisal of the annular sizing policy. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the efficacy of vascular graft coatings used in the aortic position to prevent vascular graft infection (VGI). A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines using a pre-registered protocol (CRD42020206436). Eligible studies used a vascular graft coating in the aortic position and reported on VGI. A search was performed in MEDLINE (PubMed), Embase, Web of Science, and the Cochrane Library. Primary outcome parameters were VGI, patency, and mortality. Pooled estimates of VGI were calculated using odds ratio (OR) and 95% confidence intervals (CIs) wherever possible. Quality assessment was performed with the Newcastle–Ottawa Assessment Scale and the Revised Cochrane risk of bias tool for randomised trials. In total, 6 873 papers were identified. Only eight studies were included. Six of eight studies (75%) reported on known antimicrobial coating strategies such as antibiotics (n = 3) and silver (n = 3). In the other two studies, polymer coated grafts were used. Only three of eight studies compared coated with uncoated grafts (two antibiotic and one silver). Two randomised controlled trials reported on the effect of rifampicin soaked (1 mg/mL) grafts and showed no significant effect in the early (2 months; OR 0.69, 95% CI 0.29 – 1.62) or late (2 years; OR 0.73, 95% CI 0.23 – 2.32) post-operative periods. A retrospective cohort study focusing on the effect of silver coated grafts did not reveal any advantage (OR 0.19, 95% CI 0.02 – 1.64). Two polymer coated grafts were not considered to have a potential benefit in the prevention of VGIs. Clinical studies reporting on the antibacterial effect of vascular graft coatings in the aortic position to prevent VGI are scarce. For silver and antibiotic coatings, no significant protection for VGI was observed. New types of grafts or long acting coating strategies are mandatory to prevent this complication in the future. [ABSTRACT FROM AUTHOR]

Vascular graft infection (VGI) is a feared complication. Prevention is of the utmost importance and vascular graft coatings (VGCs) could offer a potential to do this, with in vitro research a first crucial step. The aim of this study was to summarise key features of in vitro models investigating coating strategies to prevent VGI in order to provide guidance for the setup of future translational research. A comprehensive search was performed in MEDLINE, Embase, and Web of Science. A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. For each database, a specific search strategy was developed. Quality was assessed with the Toxicological data Reliability Assessment Tool (ToxRTool). In vitro models using a VGC and inoculation of the graft with a pathogen were included. The type of graft, coating, and pathogen were summarised. The outcome assessment in each study was evaluated. In total, 4 667 studies were identified, of which 45 papers met the inclusion criteria. The majority used polyester grafts (68.2%). Thirty-one studies (68.9%) included antibiotics, and nine studies (20%) used a commercial silver graft in their protocol. New antibacterial strategies (e.g., proteolytic enzymes) were investigated. A variety of testing methods was found and focused mainly on bacterial adherence, coating adherence and dilution, biofilm formation, and cytotoxicity. Ninety-three per cent of the studies (n = 41) were considered unreliable. Polyester is the preferred type of graft to coat on. The majority of coating studies are based on antibiotics; however, new coating strategies (e.g., antibiofilm coating) are coming. Many in vitro setups are available. In vitro studies have great potential, they can limit the use, but cannot replace in vivo studies completely. This paper can be used as a guidance document for future in vitro research. [ABSTRACT FROM AUTHOR]

Vascular graft infection (VGI) remains an important complication with a high mortality and morbidity rate. Currently, studies focusing on the role of vascular graft coatings in the prevention of VGI are scarce. Therefore, the aims of this study were to survey and summarise key features of pre-clinical in vivo models that have been used to investigate coating strategies to prevent VGI and to set up an ideal model that can be used in future preclinical research. A systematic review was conducted in accordance with the Preferred reporting items for Systematic Reviews and Meta-Analysis guidelines. A comprehensive search was performed in MEDLINE (PubMed), Embase, and Web of Science. For each database, a specific search strategy was developed. Quality was assessed with the Toxicological data Reliability Assessment Tool (ToxRTool). The type of animal model, graft, coating, and pathogen were summarised. The outcome assessment in each study was evaluated. In total, 4 667 studies were identified, of which 94 papers focusing on in vivo testing were included. Staphylococcus aureus was the organism most used (n = 65; 67.7%). Most of the graft types were polyester grafts. Rifampicin was the most frequently used antibiotic coating (n = 43, 48.3%). In the outcome assessment, most studies mentioned colony forming unit count (n = 88; 91.7%) and clinical outcome (n = 72; 75%). According to the ToxRTool, 21 (22.3%, n = 21/94) studies were considered to be not reliable. Currently published in vivo models are very miscellaneous. More attention should be paid to the methodology of these pre-clinical reports when transferring novel graft coatings into clinical practice. Variables used in pre-clinical reports (bacterial strain, duration of activity coating) do not correspond well to current clinical studies. Based on the results of this review, a proposal for a complete and comprehensive set up for pre-clinical in vivo testing of anti-infectious properties of vascular graft coatings was defined. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the outcome and experience of the Perceval sutureless valve at our institution (UZ Leuven). Between 2007 and 2019, 784 patients underwent sutureless aortic valve replacement using the Perceval valve (isolated or combined with other procedures). We performed a retrospective analysis of the postoperative and follow-up data. Mean age was 78 years with a median European System for Cardiac Operative Risk Evaluation II score of 4.2% (interquartile range, 2.6%-7.2%). Isolated aortic valve replacement accounted for 45% of cases; 30% of cases were aortic valve replacement in combination with coronary artery bypass grafting and the remaining 25% were other combined procedures. The median crossclamp times were 38 minutes in single aortic valve replacement, 70 minutes in cases with coronary artery bypass grafting, and 89 minutes in multiple valve cases. Device success was 99.1% and in-hospital mortality was 3.3%. Postoperative stroke or transient ischemic attack occurred in 1.9% of patients and 1% of patients had a new need for dialysis after surgery and median survival time was 7.0 years with a cumulative follow-up of 2797.8 patient-years. The 1-, 5-, and 10-year freedom from reintervention were 99%, 97%, and 94%, respectively. These data represent the longest follow-up available, to our knowledge, for the Perceval sutureless valve. We observed favorable early outcomes, and low rates of early mortality, stroke, and other major complications. Valve durability is promising with low rates of valve degeneration and a limited need for reintervention. [Display omitted] [ABSTRACT FROM AUTHOR]

Because our center participated in the first-in-human trial with Perceval (LivaNova, Sallugia, Italy) in 2007, this series represents the longest available clinical follow-up (11 years) with sutureless technology in aortic valve replacement. We collected all clinical and echocardiographic follow-up in 468 consecutive patients who received Perceval at our institution between 2007 and 2017. In 57% of cases, surgery was combined with coronary artery bypass grafting (39%), mitral valve surgery (17%), or other procedures (13%). Mean age was 79 years, mean EuroSCORE II was 5.1 ± 5.5 (range, 0.8-67) and mean Society of Thoracic Surgeons score was 5.8 ± 5.5. Mean cross-clamp times for isolated and combined procedures were 39 and 79 minutes, respectively. Observed all-cause 30-day mortality was 3.2%, with an early stroke rate of 1.8%. Pacemaker implantation rate was 7.9% overall, but only 3.9% in patients without preexisting conduction or rhythm disorders. All-cause mortality at 1 and 2 years was 8.8% ± 1.3% and 13.2% ± 1.6%, respectively. At the latest echocardiographic follow-up (mean, 3 years; range, 1-11 years), peak and mean gradients were 23 ± 10 mm Hg and 13 ± 6 mm Hg, respectively. During follow-up, we explanted 5 valves for endocarditis, and none for structural valve degeneration. After more than 11 years of continued clinical use of the Perceval sutureless valve, we observe low mortality and stroke rates, with good hemodynamic behavior of the valve. None of our patients was reoperated for structural valve degeneration. Because of the key benefits of this rapid-deployment valve, it has an added value in surgical aortic valve replacement. [Display omitted] [ABSTRACT FROM AUTHOR]

Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis. The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year. At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P <.0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar. Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program. [ABSTRACT FROM AUTHOR]

BACKGROUND: Chronic pressure overload predisposes to heart failure, but the pathogenic role of microvascular endothelial cells (MiVEC) remains unknown. We characterized transcriptional, metabolic, and functional adaptation of cardiac MiVEC to pressure overload in mice and patients with aortic stenosis (AS). METHODS: In Tie2-Gfp mice subjected to transverse aortic constriction or sham surgery, we performed RNA sequencing of isolated cardiac Gfp+-MiVEC and validated the signature in freshly isolated MiVEC from left ventricle outflow tract and right atrium of patients with AS. We next compared their angiogenic and metabolic profiles and finally correlated molecular and pathological signatures with clinical phenotypes of 42 patients with AS (50% women). RESULTS: In mice, transverse aortic constriction induced progressive systolic dysfunction, fibrosis, and reduced microvascular density. After 10 weeks, 25 genes predominantly involved in matrix-regulation were >2-fold upregulated in isolated MiVEC. Increased transcript levels of Cartilage Intermediate Layer Protein (Cilp), Thrombospondin-4, Adamtsl-2, and Collagen1a1 were confirmed by quantitative reverse transcription polymerase chain reaction and recapitulated in left ventricle outflow tract-derived MiVEC of AS (P<0.05 versus right atrium-MiVEC). Fatty acid oxidation increased >2-fold in left ventricle outflow tract-MiVEC, proline content by 130% (median, IQR, 58%-474%; P=0.008) and procollagen secretion by 85% (mean [95% CI, 16%-154%]; P<0.05 versus right atrium-MiVEC for all). The altered transcriptome in left ventricle outflow tract-MiVEC was associated with impaired 2-dimensional-vascular network formation and 3-dimensional-spheroid sprouting (P<0.05 versus right atrium-MiVEC), profibrotic ultrastructural changes, and impaired diastolic left ventricle function, capillary density and functional status, especially in female AS. CONCLUSIONS: Pressure overload induces major transcriptional and metabolic adaptations in cardiac MiVEC resulting in excess interstitial fibrosis and impaired angiogenesis. Molecular rewiring of MiVEC is worse in women, compromises functional status, and identifies novel targets for intervention. [ABSTRACT FROM AUTHOR]

Reoperation for aortic valve replacement can be challenging and is usually associated with an increased risk for complications and mortality. The study aim was to report the results of a multicenter cohort of patients who underwent minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis. From 2007 to 2018 data from 3651 patients were retrospectively collected from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry. Of them, 63 patients who had previously undergone cardiac surgery represented the study population. In-hospital clinical and echocardiographic outcomes were recorded. Mean age of the selected 63 patients was 75.3 ± 7.8 years and logistic EuroSCORE 10.1. Surgery was performed by ministernotomy in 43 patients (68.3%) and by anterior right thoracotomy in 20 (31.7%); 31 patients (49.2%) received the Perceval valve (Livanova PLC, London, UK) and 32 (50.8%) the Intuity valve (Edwards Lifesciences, Irvine, CA). Mean cross-clamp time was 57.8 ± 23.2 minutes and cardiopulmonary bypass time 95.0 ± 34.3 minutes. Neither conversion to full sternotomy nor in-hospital deaths occurred. Postoperative events were ischemic cerebral events in 3 patients (4.8%), need for pacemaker implantation in 2 (3.6%), bleeding requiring reoperation in 5 (8.9%), and dialysis in 1 (1.6%). Median intensive care unit stay was 1 day, and median length of hospital stay was 10 days. On echocardiographic evaluation 1 patient showed a significant postoperative aortic regurgitation. Minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis is a safe and feasible treatment strategy, resulting in fast recovery and improved postoperative outcome with no mortality and an acceptable complication rate. [ABSTRACT FROM AUTHOR]

Objective With the increasing use of bioprostheses worldwide, continuous efforts have been made to improve tissue durability. We introduce a new treatment for bovine pericardium combining octanediol-ethanol based phospholipid removal with taurine-based glutaraldehyde neutralization and storage in an aldehyde-free solution (FREE). Methods Treated tissues were evaluated by mechanical and biochemical characterization, phospholipid content, aldehyde levels, cell cultures on pericardial samples (L929 fibroblasts and human umbilical vein endothelial cells), rat subcutaneous implantations, and long-term juvenile sheep mitral valve implantations (n = 3). Comparisons were made to glutaraldehyde-fixed bovine pericardium or to samples from commercially available biological valves (ie, Trifecta [St Jude Medical, Saint Paul, Minn] and Perimount Magna Ease [Edwards Lifesciences, Irvine, Calif]). Results FREE-treated pericardium had similar mechanical strength and biochemical properties as commercially available valves. Compared with glutaraldehyde-only samples, FREE-treated samples showed lower phospholipid levels ( P < .01), significantly better growth of L929 fibroblasts, and lower calcification levels in rat subcutaneous implants ( P < .01). Compared with samples from Linx- (Trifecta) and ThermaFix-treated (Perimount Magna Ease) valves, similar low levels of phospholipids were observed as were similar low calcification levels in subcutaneous implants, but tissue extractions from FREE-treated samples showed the lowest levels of extracted aldehydes ( P < .01). Mitral implants of FREE-treated valves in juvenile sheep had excellent hemodynamic behavior without any sign of degeneration or calcification at 5 months. Conclusions The new FREE treatment combines an adequate phospholipid reduction and aldehyde neutralization with storage in an aldehyde-free solution. This combination enhances the anticalcification properties and may thereby improve long-term durability of the tissue. [ABSTRACT FROM AUTHOR]

Wall stress estimation through biomechanical simulations represents a promising tool to support aneurysm risk stratification and has the potential to provide a more individual risk assessment. Accurate computation of the stress field necessitates the use of robust and biofidelic models based on patient-specific information. A multidisciplinary approach is required to obtain this information, which comprises geometry, boundary conditions, and material properties. The entire workflow encompasses many aspects, ranging from data collection to clinical interpretation of the obtained biomarkers. This review article summarizes and critically analyses the different aspects of the full clinical workflow as they have been described in the latest literature. As such, a critical assessment is provided on where we stand in the process of bringing biomechanical simulations for rupture risk assessment into broad clinical practice. Open problems are discussed and future possibilities identified. [ABSTRACT FROM AUTHOR]

The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance. Despite the advanced age of the study population, with an intermediate risk profile, mortality and morbidity rates at 5 years compare with those reported in both arms of recent trials that have compared transcatheter and surgical valves in similar risk populations. CAVALIER , Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark; DSMB , Data Safety Monitoring Board; CEC , Clinical Event Committee; Echo , echocardiography; SD , standard deviation; STS , Society of Thoracic Surgeons; CI , confidence interval; AVR , aortic valve replacement. [Display omitted] [ABSTRACT FROM AUTHOR]

Background The purpose of this study was to provide a preliminary assessment of the performance of a decellularized pericardial patch in a trileaflet aortic valve reconstruction in a long-term juvenile sheep model. Methods A sheep surgical model was used to perform a complete trileaflet reconstruction (Ozaki technique) of the aortic valve with 3 separate pericardial patches. Valve function was assessed 1 week, 3 months, and 6 months after surgery via transthoracic echocardiography. Calcification resistance and host cell infiltration of the pericardial material were assessed at 6 months after surgery. Results Three of 6 sheep with implanted pericardial neo-cusps survived until the planned time of sacrifice after surgery, whereas 3 animals had a successful implant but died shortly after the procedure as the result of a bad recovery from cardiopulmonary bypass. Echocardiography at 6 months revealed a high coaptation area with only minimal regurgitation. In all explanted leaflets, cusp tissue was soft. There was only minimal calcification in 8 of 9 leaflets. Conclusions Aortic valves reconstructed with a decellularized pericardial patch demonstrated adequate diastolic function with minimal regurgitation and resistance to calcification. Combining the Ozaki technique with this decellularized pericardial scaffold showed adequate hemodynamics, sustained mechanical integrity of the patch and limited calcification of the material. These results, together with earlier experimental and clinical data, indicate the potential of this material for aortic valve repair. [ABSTRACT FROM AUTHOR]

Objective A prospective trial was designed to evaluate the feasibility of the Perceval sutureless aortic valve. We report the 5-year clinical and hemodynamic outcome. Methods A total of 30 patients (mean age: 80.4 ± 3.8 years; mean logistic European System for Cardiac Operative Risk Evaluation [euroSCORE]: 13.2 ± 7.3) received the valve in 3 European centers, between April 2007 and February 2008. Cumulative follow-up was 92.67 patient-years, with a median of 4.2 years. Patients with a small annulus were selected because only sizes 21 and 23 mm (covering annuli diameters from 19 to 23 mm) were available at this early stage of the trial. In 37% of the patients, a 21-mm valve was used; 63% received a 23-mm valve; 14 patients had concomitant coronary artery bypass grafting. Clinical and hemodynamic follow-up evaluation were performed annually, including echocardiography. Results Procedural success was 100%. Cardiopulmonary bypass time and cross-clamp time in isolated aortic valve replacement were 46.4 ± 6.7 minutes and 29.3 ± 8.0 minutes, respectively. One patient died during the hospital stay. Postoperative complications included 1 patient with mediastinal bleeding, and 1 with atrioventricular block that led to pacemaker implantation. No stroke occurred in either the early or late period. At the last available follow-up, 22 patients were alive. The mean gradient was 9.3 mm Hg, with an effective orifice area of 1.7 cm 2 at 5 years. No dislodgement, structural valve deterioration, hemolysis, or valve thrombosis was reported. Conclusions This study reports the first and longest experience with a truly sutureless valve, evaluating implantation feasibility and valve safety. Results from up to 5 years of follow up confirmed the performance and safety of this device, even in a medium- to high-risk patient population with a small aortic annulus. [ABSTRACT FROM AUTHOR]

Background Acute bacterial endocarditis may be extremely destructive for cardiac valves and their periannular structures. It has been suggested that complex reconstruction procedures require the use of homografts because of their versatility and potency to resist repeated infection. Methods We studied the long-term results of 69 patients with complex endocarditis who received homografts in the aortic position. Results The results after a mean follow-up of 8.1 ± 5.1 years (median, 8.0 years) showed that the recurrence of endocarditis even in these complex cases is low (7%), but the incidence of structural valve degeneration (SVD) is high. Freedom from SVD at 10 years is only 60.0%. When aortic homografts degenerate, they predominantly calcify. Conclusions The use of homografts to reconstruct endocarditis-related aortic valve destruction is associated with a low recurrence of endocarditis but a high incidence of SVD in the long run. [ABSTRACT FROM AUTHOR]

Background The aim of this study was to analyze early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) with the sutureless Perceval bioprosthesis (Sorin Biomedica Cardio Srl, Salluggia, Italy) performed through ministernotomy compared with full sternotomy. Methods This was a study of 267 consecutive patients who underwent isolated AVR with the sutureless Perceval bioprosthesis between 2007 and 2014 at 6 European centers. Of these, 189 (70.8%) were performed through ministernotomy and 78 through a full sternotomy. Propensity score matching was used to reduce selection bias. Results In the overall cohort of ministernotomy and full sternotomy patients, in-hospital mortality was 1.1% and 2.6% and 2-year survival was 92% and 91%, respectively. Propensity score matching resulted in 56 pairs with similar characteristics and operative risk. Aortic cross-clamp (44 minutes in both groups, p = 0.931) and cardiopulmonary bypass time (69 vs 74 minutes, p = 0.363) did not differ between the groups. Apart from higher values in the ministernotomy group for postoperative peak gradients (28.1 vs 23.3 mm Hg, p = 0.026) and mean aortic valve gradients (15.2 vs 11.7 mm Hg, p = 0.011), early postoperative outcomes did not differ in the propensity-matched cohort. There were no differences in the in-hospital mortality rate or 2-year survival between the groups. Conclusions AVR with the sutureless Perceval bioprosthesis through a ministernotomy was a safe and reproducible procedure that was not associated with prolonged aortic cross-clamp or cardiopulmonary bypass time compared with a full sternotomy. Early postoperative outcomes and 2-year survival were comparable between patients undergoing ministernotomy and full sternotomy. [ABSTRACT FROM AUTHOR]

Background Despite improved anticalcification technology, bioprosthetic heart valves still cannot be used in younger patients because of progressive structural valve degeneration. A novel advanced tissue preservation technology was developed that uses stable functional group capping and preservation by glycerolization. Valves incorporating this novel technology can be stored in a dry condition and do not require rinsing before use. The aim of the study was to assess the effects of this new technology in terms of valve function and durability in a chronic sheep model of orthotopic implantation. Methods Forty-five juvenile sheep were randomized and either a Perimount mitral valve (6900P, control group) or the same valve design incorporating the novel tissue preservation technology (test group) was implanted in the mitral position. All valves were 25 mm. A transthoracic echocardiography was performed at 1 week and at 8 months postoperatively. The animals were then killed, an autopsy was performed, and the valves were examined radiographically (soft tissue radiograph), histologically (hematoxylin and eosin and Von Kossa staining), and chemically (calcium content). Exclusion criteria for analysis included surgical or procedural death, bacterial endocarditis or other diseases leading to premature death. Results Thirty-one animals (14 controls and 17 test animals) remained in perfect condition during the 8-month follow-up period. Echocardiography at 1 week showed normal valve function in both groups. At 8 months, cardiac output increased significantly to the same extent in both groups (vs baseline; P < .01). The mean transvalvular pressure gradient also increased but significantly more in the control group compared with the test group (P = .03). Flow turbulence across the prosthesis was increased in the control valves compared with the test valves. The test valves had significantly less calcium content than the controls (1.9 ± 0.3 vs 6.8 ± 1.6 μg/mg; P = .002). This was confirmed by radiographic analysis and histology. Conclusions This study demonstrates that the novel tissue preservation technology, when applied to the Perimount mitral valve, significantly improves hemodynamic and anticalcification properties compared with the standard Perimount, a valve currently considered the standard of care. [ABSTRACT FROM AUTHOR]

Objective The aim of this study was to evaluate the outcome of aortic valve replacement with the sutureless Perceval S aortic valve bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy). Methods This is a retrospective analysis of 314 patients (mean age, 77.9 ± 5.0 years, mean European System for Cardiac Operative Risk Evaluation II, 9.0% ± 7.6%) who underwent aortic valve replacement with the Perceval S valve with (94 patients) or without (220 patients) concomitant coronary artery bypass surgery at 5 European centers. Results The Perceval S valve was successfully implanted in all but 1 patient (99.7%). The mean aortic crossclamping time was 43 ± 20 minutes (isolated procedure, 39 ± 15 minutes; concomitant coronary surgery, 52 ± 26 minutes). Severe paravalvular leak occurred in 2 patients (0.6%). In-hospital mortality was 3.2% (1.4% after isolated procedure and 7.4% after concomitant coronary surgery). In-hospital mortality was 2.8% and 4.0% among patients with a European System for Cardiac Operative Risk Evaluation II less than 10% and 10% or greater, respectively (P = .558). Octogenarians had slightly higher in-hospital mortality (5.2% vs 2.0%, P = .125; after isolated procedure: 2.7% vs 0.7%, P = .223; after concomitant coronary surgery: 9.5% vs 5.8%, P = .491) compared with younger patients. Full sternotomy did not increase the in-hospital mortality risk compared with ministernotomy or minithoracotomy access (1.3% vs 1.4%, when adjusted for baseline covariates: P = .921; odds ratio, 0.886; 95% confidence interval, 0.064-12.346). One-year survival was 90.5%. Freedom from valve-related mortality, stroke, endocarditis, and reoperation was 99.0%, 98.1%, 99.2%, and 98.3%, respectively. Conclusions The sutureless Perceval S valve is associated with excellent early survival in high-risk patients, particularly among those undergoing an isolated procedure. Further studies are needed to prove the durability of this bioprosthesis. [ABSTRACT FROM AUTHOR]

Objectives: A geometric annuloplasty ring could improve efficacy and stability of aortic valve repair. Toward this goal, a 1-piece 3-dimensional titanium annuloplasty ring with Dacron covering was developed and tested successfully in animals. The purpose of this study was to define hemodynamic outcomes with this device used as the annuloplasty component of human aortic valve repair. Methods: In a 4-center pilot trial with informed consent, 16 patients underwent aortic valve repair for aortic insufficiency, with the annuloplasty device sutured into the annulus beneath the leaflets. Preoperative annular diameter averaged 26.5 ± 2.0 (mean ± standard deviation) mm, and average ring size was 22.3 ± 1.2 mm. After annuloplasty, leaflet defects were easy to identify, and 14 of 16 patients (88%) required leaflet plication and/or autologous pericardial reconstruction for leaflet defects. Three patients had ascending aortic replacement, and 2 had remodeling root replacement. One had ultrasonic leaflet decalcification and another tricuspid valve annuloplasty. Follow-up data were from site-specific studies at the 6-month postoperative time point. Results: There were no in-hospital mortalities or major complications. Preoperative aortic insufficiency grade (0-4 scale) was 3.6 ± 1.0 and fell to 1.0 ± 0.8 at 6 months (P < .0001). New York Heart Association class fell from 2.5 ± 0.5 to 1.1 ± 0.3 (P < .0001). Postrepair valve area was 2.7 ± 0.2 cm2, and 6-month mean systolic gradient was 11.3 ± 3.3 mm Hg. Left ventricular end-diastolic diameter and ejection fraction both normalized (both P < .0001). Conclusions: Geometric ring annuloplasty facilitated aortic valve repair, allowing more precise reconstruction of leaflet defects. Aortic insufficiency reduction and systolic gradients were excellent, and expansion of valve reconstruction into broader categories of aortic valve disease seems indicated. [Copyright &y& Elsevier]

Background: We examined the influence of multiple valve-related parameters on the onset and incidence of valve degeneration in aortic bioprostheses through detailed echocardiographic follow-up. Methods: In 648 patients (mean age, 73.8 ± 4.9 years) receiving an aortic valve bioprosthesis, long-term clinical (mean, 7.5 ± 3.2 years) and echocardiographic (mean, 6.5 ± 3.4 years) follow-up were performed. The occurrence of signs of structural valve degeneration (stenosis type and regurgitation type) was studied through multivariate analysis, including tissue origin, design and label size of the prosthesis, effective orifice area index (EOAi), patient-prosthesis mismatch (PPM; EOAi <0.85 cm2/m2), and antimineralization treatment. Results: Structural valve degeneration (SVD) was diagnosed in 12.6% of patients. In 7.6%, it was of the stenosis type (S-SVD); in 5%, it was the regurgitation type (R-SVD). The absence of antimineralization treatment is an independent predictor of SVD, S-SVD, and R-SVD. Patient-prosthesis mismatch is an independent predictor of SVD and S-SVD, but not of R-SVD. Patients receiving a nontreated valve show a freedom of SVD at 10 years follow-up of 70.1 ± 4.3% versus 90.9 ± 3.6% in patients receiving a treated valve (P < .0001). Patients having PPM and receiving a nontreated valve show a freedom of SVD at 10 years of follow-up of only 59.8 ± 7.0% versus 88.7 ± 3.6% in patients also having PPM but receiving a treated valve (P < .0001). In patients not having PPM, the corresponding values were 78.0 ± 4.3% and 92.7 ± 3.4% for nontreated versus treated valves respectively (P = .01). Conclusions: Antimineralization treatment of bioprosthetic heart valves is effective and reduces the incidence of SVD significantly. Because valve type and size are determined at the moment of implantation, the surgeon carries an important responsibility in protecting the patient from valve degeneration. [Copyright &y& Elsevier]

Objective: Prolonged aortic crossclamping can increase mortality and morbidity after aortic valve replacement in elderly and high-risk patients. Sutureless implantation of the prosthesis has the potential to shorten aortic crossclamp time. Methods: The Perceval S valve (Sorin Biomedica Cardio Srl, Sallugia, Italy), a sutureless implantable aortic bioprosthesis, was used in 32 patients (median age, 78 years; median logistic euroSCORE, 9.99) requiring aortic valve replacement with or without concomitant coronary artery bypass grafting. Hemodynamic parameters and clinical outcome were obtained at discharge, at 6 months, and up to 1 year postoperatively. Results: Aortic crossclamp time needed for aortic valve replacement was 18 ± 6 minutes. Hemodynamics at discharge showed good function of all Perceval S valves with low transvalvular pressure gradients (mean, 12 ± 5 mm Hg and peak, 23 ± 9 mm Hg) and low incidence of paravalvular or valvular leakage. Operative mortality was 0%. Follow-up at 1 year showed 3 non–valve-related deaths. Survivors showed good clinical outcome and stable hemodynamic function of the valve prosthesis, except for 1 patient in whom endocarditis developed. Despite a moderate decrease in platelet counts persisting up to 12 months, freedom of bleeding and thromboembolic events was 100%. Conclusions: It is possible to implant a well-functioning sutureless stent-mounted valve in the aortic position in less than 20 minutes of aortic crossclamping. This is associated with excellent early clinical and hemodynamic outcome in high-risk patients. Moderate changes in hematologic parameters persisted but were not related to clinical events. [ABSTRACT FROM AUTHOR]

Objective: Aortic homografts were compared with pulmonary homografts in the setting of right ventricular outflow tract reconstruction in adolescent sheep. Furthermore, clinically available stentless porcine and bovine xenografts were studied as an alternative to homografts. Methods: In 51 adolescent sheep cryopreserved aortic and pulmonary (ovine) homografts, as well as 6 different types of clinically available stentless bioprostheses (Prima Plus, Toronto SPV, Toronto BiLinx, Freestyle, Pericarbon Stentless, and Contegra) were implanted in the pulmonary position. After 5 to 6 months, the valves were explanted and studied for structural valve degeneration by means of radiographic analysis, histology, and calcium content determination. Results: Pulmonary homografts calcified significantly less than aortic homografts in the wall portion. Leaflet calcification was mild, hardly detectable on radiographic analysis, and comparable between aortic and pulmonary homografts. Stentless porcine xenografts showed severe calcification in the aortic wall portion, irrespective of the antimineralization treatment. Leaflet calcification was mild and in the range of that seen in homografts. Pannus formation was present but never induced leaflet retraction or cusp immobilization. Calcification was absent in the stentless Pericarbon valve implants, but all valves showed extensive pannus overgrowth, leaflet retraction, and cusp immobilization. The Contegra valves showed wall calcification, but the leaflets were completely free of calcification and pannus. Conclusions: For right ventricular outflow tract reconstruction, the pulmonary homograft remains the first choice. All xenografts result in either calcific degeneration or cusp immobilization. [ABSTRACT FROM AUTHOR]

Abstract: Calcific aortic stenosis is the most frequent heart valve disease and the main indication for valve replacement in western countries. For centuries attributed to a passive wear and tear process, it is now recognized that aortic stenosis is an active inflammatory and potentially modifiable pathology, with similarities to atherosclerosis. Statins were first-line candidates for slowing down progression of the disease, as established drugs in primary and secondary cardiovascular prevention. Despite promising animal experiments and nonrandomized human trials, the prospective randomized trials SEAS and SALTIRE did not confirm the expected benefit. We review SEAS and SALTIRE starting with the preceding studies and discuss basic science experiments covering the major known contributors to the pathophysiology of calcific aortic valve disease, to conclude with a hypothesis on the absent effect of statins, and suggestions for further research paths. [Copyright &y& Elsevier]

Objective: In a previous study we showed that recellularization of a stentless bioprosthetic valve is stimulated 1 month after implantation in the pulmonary position, when its matrix (acellular photo-oxidized bovine pericardium) was preseeded by intraperitoneal implantation during a 3-day period. Methods: The present study reports on the functional and biomechanical properties of such valves (n = 19) in sheep up to 5 months after implantation. Similar valves (n = 20) that were not intraperitoneally preseeded served as controls. Results: Recellularization was partial in control valves and excessive in preseeded valves: 66% versus 223% of cellularity of native valves, respectively (P < .05). The valves were endothelialized and contained interstitial cells depositing new matrix (collagens and elastin). However, phenotyping revealed an increased proportion of cells with contractile properties (30%–40% alpha smooth muscle actin+) in both groups. Intraperitoneally seeded valves had thicker and shorter leaflets that were associated with mildly increased peak gradients and regurgitation. Characterization of the matrix properties revealed a gradually degrading matrix (±25% loss of collagen organization at 5 months) and a concomitant alteration of its biomechanical properties, that is, decreased strength, stiffness, and maximum force. However, overall valve function remained intact, and the biomechanical properties of the whole valves were superior to that of the native valves. Conclusion: The ectopic in vivo seeding paradigm provides full recellularization. However, the volume fraction of the cellular phenotypes is not optimal, resulting in inadequate remodeling of the valves. [Copyright &y& Elsevier]

Objective: Durability assessment of mitral valve repair for degenerative valve incompetence is limited to reoperation as a primary indicator and valve-related risk factors for late death as a secondary indicator. We assessed serial echocardiographic follow-up of valve function as an indicator of the durability of mitral valve repair. Methods and Results: In 348 patients having undergone mitral valve repair for degenerative valve incompetence, clinical outcome was excellent: 10 years after repair, survival was 80.1% and freedom from reoperation 94.4%. However, freedom from mitral regurgitation (>2/4), 98.7% at 1 month, decreased to 82.2% at 5 years and 64.9% at 10 years. The linearized recurrence rate of mitral regurgitation (>2/4) was 3.2% per year. Recurrence rate was higher in patients with Barlow disease (6.0%) and lower in those with fibroelastic deficiency (2.6%) (P = .01). Performing chordal shortening, the nonuse of sliding plasty and the nonuse of an annuloplasty ring were determined to be factors predicting recurrence of mitral regurgitation. In reconstructions avoiding these risk factors, recurrence rate decreased to 2.4%. There was no difference between Barlow disease and fibroelastic deficiency: 2.9% versus 2.2% (P > .05). Recurrent regurgitation is characterized by leaflet prolapse, thickening, and calcification. Conclusion: When optimal surgical techniques are used, the residual recurrence rate of mitral valve regurgitation remains between 2% and 3% per year and is related to progressive degeneration of the chordae and the leaflets. Long-term results of mitral valve repair in Barlow disease are essentially the same as in fibroelastic deficiency. [Copyright &y& Elsevier]

Background: We assessed the hemodynamic performance and calcification potential of a new design of bovine pericardial valve, the Trilogy valve (Arbor Surgical Technologies Inc, Irvine, CA). We compared this new valve with the Perimount valve (Edwards Lifesciences, Irvine, CA) in a randomized prospective study in adolescent sheep. Methods: Nine Trilogy valves (size 21) and six Perimount valves (size 23 or 25) were implanted in the mitral position in adolescent sheep and studied during five months. Hemodynamic measurements were performed at one week, three months, and five months using transthoracic echocardiography. Valve calcification was assessed by X-ray and calcium content was measured by atomic absorption spectrometry after five months implantation in sheep. Tissues were also evaluated histologically (Von Kossa staining). Results: The nine Trilogy valves had lower peak velocity, peak gradient, and mean gradient compared with the six Perimount valves. These 21-mm Trilogy valves had similar deceleration time and effective orifice area compared with the 23- and 25-mm Perimount valves. Calcification of the Trilogy valves was significantly lower than Perimount valves (p < 0.01), particularly in the commissural (p < 0.01) and free margin regions (p < 0.03). In all parameters assessed, the Trilogy valves exhibited less variation valve-to-valve compared with Perimount valves. Conclusions: These findings demonstrate that a valve designed to reduce stress in the tissue, improve leaflet kinematics, with advanced antimineralization treatment, can exhibit superior calcification resistance in the mitral position of adolescent sheep. The trilobal geometry and independent leaflet suspension design, combined with an advanced tissue treatment, appears to be a promising breakthrough in the effort to develop a more durable and hemodynamically efficient bioprosthetic valve. [Copyright &y& Elsevier]

Background: Previous studies have shown that prosthesis–patient mismatch (PPM) results in higher early and late mortality after bioprosthetic aortic valve replacement. Careful selection of stented bioprostheses was recommended to avoid inadequate effective orifice area. We studied the incidence of PPM and its potential effects on clinical outcome in patients undergoing aortic valve replacement using the Carpentier-Edwards Perimount bioprosthesis. Methods: Independent predictors of early and late mortality and hospital readmission for cardiac reasons were defined in 506 patients (mean age, 73 years; range, 57 to 87 years) by multivariate analysis. Mean follow-up was 6.1 ± 4.8 years; maximum follow-up was 18.6 years. Results: The incidence of severe PPM (effective orifice area index < 0.65 cm2/m2) was 0.2% and of moderate PPM (effective orifice area index > 0.65 and < 0.85) was 20%. Multivariate analysis revealed that moderate PPM was not an independent predictor of early mortality, late mortality, or hospital readmission for cardiac reasons. Reduction of septal hypertrophy was similar in patients with and without moderate PPM. Conclusions: The incidence of severe PPM is virtually nonexistent after aortic valve replacement using the Carpentier-Edwards Perimount valve. Moderate PPM is found in 20% of cases and is clinically irrelevant in this population. [Copyright &y& Elsevier]