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A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics., Competing Interests: Funding Support and Author Disclosures Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and WL Gore; has received consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and has equity in Holistick Medical and Microinterventional Devices. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation. Dr Hahn has received speaker fees from Abbott Structural and Edwards Lifesciences; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has served on the Scientific Advisory Board for Novartis; and has equity in Navigate. Dr Tang is a physician proctor and consultant for Medtronic; has served as a consultant and physician advisory board member for Abbott Structural Heart; has served as a consultant for NeoChord; and has served as a physician advisory board member for JenaValve. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Playford has received investigator-initiated research funding from Edwards Lifesciences, Pfizer, Novartis, Actelion, Bayer, and GlaxoSmithKline; is Chief Medical Advisor for Echo IQ; and has been a physician advisory board member for Edwards Lifesciences and AstraZeneca. Dr Ruel is a physician proctor for Medtronic (MICS CABG) and for Edwards Lifesciences (MICS AVR); has served as a steering committee member for Cryolife (PROACT Xa trial); and is a recipient of research funds from Medtronic (MIST trial). Dr Jilaihawi is a consultant to Boston Scientific, Edwards Lifesciences, and Medtronic; and has received grant/research support from Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr Sathananthan is a consultant for and has received institutional research funding from Edwards Lifesciences and Medtronic; and has received speaker fees from NVT. Dr Wood is a consultant for and his institution (CCI-CIC) receives grant support from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Bax’s institution (Department of Cardiology, LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Del Nido is cofounder of Autus Valve Technologies, Inc. Dr Dweck is a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaker fees from NVT. Dr Kaneko is a consultant for Edwards, Medtronic, Abbott, and 4C Medical. Dr Latib is a consultant for Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. Dr Moat is a full-time employee of Abbott Structural Heart, Inc. Dr Modine has received research grants from Edwards Lifesciences and Medtronic; and is a consultant for Abbott, Edwards Lifesciences, Medtronic, and Microport. Dr Popma is a full-time employee of Medtronic, Inc. Dr Smith has received institutional grants from Edwards Lifesciences, Medtronic, Abbott, and Cryolife; has received advisory board fees from Edwards Lifesciences; and has received speaking honoraria from Medtronic, Cryolife, Abbott, and Edwards Lifesciences. Dr Thomas is a full-time employee of Edwards Lifesciences. Dr Yoganathan is a Principal Consultant to CardioMed Device Consultants LLC in the Structural Heart Valve area; is on the Scientific Advisory Board of Foldax Inc; and has served as Educational Consultant to Boston Scientific, Edwards Lifesciences, Abbott Cardiovascular, and Livanova. Dr Mack has served as a co-principal investigator for clinical trials for Abbott and Edwards Lifesciences; and has served as study chair for a trial for Medtronic; all roles were uncompensated. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients' survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45-70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14-23 mm Hg) and 10 mmHg (IQR: 8-13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm 2 /m 2 (IQR: 0.91-1.31 cm 2 /m 2 ) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3-96.7%); 90.7% (88.3-93.1%); 86.4% (82.6-90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04-1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002-1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up., (Copyright © 2021 Elsevier Inc. All rights reserved.)

An indefinitely lasting bioprosthesis that does not require anticoagulation treatment is the holy grail of substitutive heart surgery. However, this goal is not yet in sight with the present state of technology. Over the past few years, tremendous advances have been achieved regarding tissue anticalcification processes, hemodynamic performance and future-proofing by ensuring compatibility with transcatheter valve-in-valve procedures. The Inspiris Resilia valve (Edwards Lifesciences, Irvine, CA) was designed to incorporate all of these enhancements. It is now leaving the experimental phase and is being tested in the real world. We present here a comprehensive review of the evolution of biological prostheses, details of new anticalcification technologies, and early results of published studies as well as the experience at the European Hospital (Rome, Italy), the site of the first European implant and a leading center in various protocols. In our two years of experience with the Inspiris Resilia, there have been no cases of structural valve deterioration, endocarditis, detachment or periprocedural complication, and gradients seem to be superior to those with the previous generation of Edwards valves. While longer-term experience is clearly needed, the results thus far are encouraging.

We present the case of a 73-year-old male patient undergoing a modified Bentall-DeBono procedure in 2015 due to aortic stenosis and aortic aneurism involving the root. A bioprosthetic stented conduit made with a stented Edwards Perimount 21-mm bioprosthesis and a Vascutek Valsalva 28-mm Dacron graft was implanted along with a mitral annuloplasty. Five years later, due to early degeneration of the bioprosthesis and a progression of the mitral disease, he underwent a second surgical procedure where a Medtronic Mosaic 27-mm valve prosthesis was implanted in mitral position and a sutureless Livanova Perceval 23-mm valve in aortic position. Because of the difficulty in removing the previously implanted aortic prosthesis, the Perceval valve was inserted inside the frame of the PeriMount as an open "valve-in-valve" procedure. In October 2020, the patient underwent a ViV TAVI with a 23-mm Edwards Sapien 3 (Edwards Lifescience). After induction of general anesthesia and heparin administration, the procedure was performed via right femoral artery approach with preimplantation of two Proglides. After transfemoral insertion of a 14-French sheath, the aortic valve was crossed with a 0.035-in. straight guide-wire, taking care to avoid crossing the crowns of Perceval frame. After exchange of the standard wire with an extra-stiff 0.035-in. Safari wire, the Sapien-3 valve was advanced across the two previously implanted surgical valves and deployed at the level of the Perceval ring. After bioprosthesis deployment, peak-to-peak left ventricular aortic gradient was reduced from 51 to 16 mmHg., (© 2021 Wiley Periodicals LLC.)

Background: The aim of this multicenter retrospective study was to compare early and midterm clinical and hemodynamic results of aortic valve replacement with rapid-deployment bioprostheses performed through conventional full-sternotomy vs mini-sternotomy., Methods: Data from the Italian multicenter registry of aortic valve replacement with rapid-deployment bioprostheses (INTU-ITA registry) were analyzed. Patients were divided into 2 groups: full sternotomy (FS) and ministernotomy (MS). Primary endpoint was the comparison of early and midterm mortality. Secondary endpoints were: comparison of intraoperative variables, complications, and hemodynamic performance. A propensity score weighting approach was used for data analysis., Results: A total of 1057 patients were analyzed: 435 (41.2%) and 622 (58.8%) in group FS and MS, respectively. Thirty-day mortality was 1.6% and 0.6% in FS and MS groups, respectively (P = .074). cardiopulmonary bypass time was 78.5 minutes and 83 minutes in FS and MS groups, respectively (P = .414). In the overall cohort, the incidence of intraoperative complications and of device success was 3.8% (40 patients) and 95.9% (1014 patients), respectively, with no significant differences between groups. Survival at 1, 3, and 5 years was 94.1%, 98.1%, 88.5% and 91.8%, 85.2%, and 84.8% in FS and MS groups, respectively (P = .412). The 2 groups showed similar postoperative gradients (median mean gradient, FS: 10.0 mm Hg, MS: 11.0 mm Hg; P = .170) and also similar incidence of patient-prosthesis mismatch (FS: 7%, MS: 6.4%, P = .647)., Conclusions: According to our data, rapid-deployment bioprostheses allow the performance of minimally invasive aortic valve replacement with similar surgical times and similar clinical and hemodynamic outcomes to conventional surgery and should be considered the first choice in these procedures., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Currently, the only commercial pre-assembled aortic valved conduits employ mechanical valves, requiring lifelong anticoagulation. Tissue-valved conduits that require assembly on the operating table are less standardized, require extensive experience for satisfactory results, and are limited in their longevity. The KONECT RESILIA™ Aortic Valved Conduit is a new tissue valved conduit that consists of a Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve stent, the novel RESILIA™ tissue leaflets, and a new DualFit sewing ring pre-assembled to a Terumo GelWeave Valsalva Graft™. RESILIA tissue is a bovine pericardial tissue that may offer superior anti-calcification properties compared to contemporary tissue valves; furthermore, it may be stored dry., Methods: We tested the handling and implantability of this new aortic valved conduit in 8 human cadaver hearts, as well as the valve removal potential without detaching the coronary ostia., Results: The KONECT RESILIA aortic valved conduit's handling and implantability was uniformly satisfactory. The valve inside the conduit could be easily surgically extracted, leaving the conduit and coronary ostia intact., Conclusions: We found this first evaluation of the KONECT RESILIA Aortic Valved Conduit to be that it handled well and was easily implantable and extractable in a human cadaver model.

Background: There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR., Methods: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20-22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery. The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5 years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life., Discussion: INDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60 years., Trial Registration: ClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018).

Objectives: Bentall procedure is the gold standard for aortic root pathologies when valve repair is not feasible. The development of durable bioprosthetic valves and improved vascular conduits allowed the implementation of bioprosthetic composite grafts; hereby, we performed a retrospective analysis of long-term follow-up of Bentall procedure using the Valsalva graft and the Perimount Magna Ease prosthesis., Methods: From June 2000 to March 2019, 309 patients received an aortic root and valve replacement with a bioprosthetic composite graft. The mean age was 69 ± 6.9 years, and the majority were men (88%); most of them were affected by aortic stenosis (86%) and the mean aortic root diameter was 48.6 ± 5.5 mm., Results: Freedom from cardiac death was 76.8% [confidence interval (CI) 32.5-94.0] at 16 years. Freedom from thromboembolism, haemorrhage, structural valve deterioration and infective endocarditis was 98.2% (CI 96.0-98.9), 95.2% (CI 87.1-98.2), 87.5% (CI 63.2-97.1) and 79.6% (CI 45.3-95.6) at 16 years, respectively. Freedom from reoperation was 74.7% (CI 41.9-90.6)., Conclusions: These data indicate that, in experienced centres, the Bentall procedure is a safe and effective intervention. This is the first long-term follow-up that analyses the results after implantation of a composite graft made with the Perimount Magna Ease aortic valve and the Valsalva graft., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim of this retrospective multicenter study was to compare early clinical and hemodynamic outcomes of Perceval-S sutureless (Livanova, London, United Kingdom) and Intuity rapid-deployment (Edwards Lifesciences, Irvine, Calif) bioprostheses., Methods: Data from patients who underwent isolated or combined aortic valve replacement with Perceval-S and with Intuity bioprostheses at 18 cardiac surgical institutions were analyzed. Propensity matching was performed to identify similar patient cohorts., Results: We included 911 patients from March 2011 until May 2017. Perceval-S and Intuity valves were implanted in 349 (38.3%) and in 562 (61.7%) patients, respectively. Propensity score identified 117 matched pairs. In the matched cohort, device success was 99.1% and 100% in Perceval-S and Intuity group, respectively (P = 1.000). Thirty-day Valve Academic Research Consortium mortality occurred in 2 (1.7%) and 4 (3.4%) patients in the Perceval-S and in Intuity group, respectively (P = .6834). The rate of postoperative new permanent pacemaker implantation was 6% (7 patients) and 6.8% (8 patients) in the Perceval-S and in Intuity group, respectively (P = .7896). Perceval-S valve implantation requires significantly shorter aortic crossclamp and cardiopulmonary bypass times than Intuity valve implantation (aortic crossclamp time for isolated, 52 ± 14 minutes vs 62 ± 24 minutes; P < .0001). Peak transaortic gradients were 22.4 ± 8.1 mm Hg and 19.6 ± 6.7 mm Hg (P = .0144), whereas mean gradients were 11.8 ± 4.7 mm Hg and 10.5 ± 3.9 mm Hg (P = .0388) in the Perceval-S and Intuity groups, respectively., Conclusions: Sutureless Perceval-S and rapid-deployment Intuity bioprostheses provide good and similar early clinical and hemodynamic outcomes. Perceval-S valve implantation requires shorter crossclamp and cardiopulmonary bypass times, whereas Intuity valve implantation provides lower transaortic peak and mean gradients., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO), and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labeling of SHV size, in vivo and in vitro testing, and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard- setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labeling and identifies the most important elements where further standardization is necessary., (Copyright © 2019 The Society of Thoracic Surgeons, The American Association for Thoracic Surgery, and the European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Rapid deployment bioprostheses (RDBs) have been recently introduced into clinical practice for the treatment of severe aortic valve stenosis. The aim of this retrospective multicenter study was to assess early and mid-term clinical and hemodynamic outcomes of patients undergoing RDB implantation., Methods: Data from a national registry that included patients who underwent isolated or combined aortic valve replacement with RDB in Italy were analyzed. Definitions of the European System for Cardiac Operative Risk Evaluation were used for preoperative variables and updated definitions from the Valve Academic Research Consortium were used for postoperative outcomes assessment. Univariable and multivariable analyses were performed to identify independent predictors of mortality. Follow-up was performed with clinical and echocardiographic examinations at each study site and, if this was not possible, through telephonic interviews. The Kaplan-Meier method was used for survival analysis., Results: A total of 902 patients (December 2012 through November 2017) from 20 national centers were included in the registry. Device success was 95.9%, and 30-day all-cause mortality was 2.8%. Postoperative pacemaker implantation was needed in 63 patients (6.9%). At discharge, peak and mean transaortic gradients were 19 ± 7 mm Hg and 11 ± 4 mm Hg, respectively. Mild and moderate aortic regurgitation were found in 71 patients (8.2%) and in 10 patients (1.2%), respectively. Median follow-up time was 357 days (interquartile range: 103 to 638 days). Survival at 4 years was 86% ± 1%. Preoperative conduction disturbances and history of previous myocardial infarction were independently associated with mortality., Conclusions: Aortic RDBs provide good early and mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Valve-sparing operations and root replacement with a biologic composite conduit are viable options in aortic root aneurysm. This study was conceived to compare the early and mid-term results of these 2 procedures., Methods: From September 2002 to November 2015, 749 consecutive patients underwent either a valve-sparing operation or a root replacement with a biologic composite conduit at 2 institutions. Propensity score matching was used to compare similar cohorts of patients in the overall population and in the ≤ 55 and ≥ 65-year age groups., Results: Overall operative mortality was 0.4%, mean age 57.4 ± 14.3 years, 84.6% were male. Individuals in the biologic composite conduit group were older and had worse preoperative risk profiles [chronic pulmonary disease (5.5% vs 0.9%; P  = 0.001), diabetes (6.4% vs 1.5%; P  = 0.001) and NYHA > 2 (25.2% vs 5.2%; P  < 0.001)]. Mean follow-up was 27.5 ± 28.4 months. In the unmatched population, there was no difference in in-hospital deaths (0 in the valve-sparing versus 3 in the biologic composite conduit group; P  = 0.12). These findings were confirmed in the propensity-matched populations. During follow-up, more patients in the biologic composite conduit group underwent reoperation on the aortic valve (2.6% vs 1.5%; P  = 0.026) resulting in a freedom from reoperation of 97.4% vs 98.5%, respectively. Separate analysis for patients stratified by age revealed no difference in outcomes., Conclusions: In case of aortic root aneurysm, both valve-sparing operations and root replacement with a biologic composite conduit provide excellent outcomes. However, at mid-term follow-up the use of biologic composite conduit is associated with a higher risk of reoperation., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Structural valve deterioration (SVD) is the Achilles' heel of bioprostheses. Its correlation with younger age is well known. In recent years we exclusively reserved use of small-size Mitroflow valve prostheses (LivaNova, London, United Kingdom) to an older patient population with small aortic annuli. This study aimed to assess the incidence of SVD and its effect on patient survival and need for reoperation., Materials and Methods: Two hundred five patients (aged 75.9 ± 5.3 years; range, 62-92 years) underwent aortic valve replacement with a 19-mm or 21-mm Mitroflow valve prosthesis between 2005 and 2011. The great majority was female (n = 170; 83%). In half of patients it was an isolated procedure. All valve prostheses were implanted in a supra-annular position using pledgeted sutures. A 19-mm valve was implanted in 93 patients (45.3%), whereas in 112 patients (54.6%) a 21-mm valve was used., Results: Twenty-three patients (11.2%) were diagnosed with early SVD by echocardiography. Average time from surgery to diagnosis of SVD was 64.3 ± 26.8 months. Ten patients needed a reoperation for SVD. Average time from surgery to a second operation was 45.7 ± 35.7 months. Overall survival was 64.5% and 42.3% at 5 and 9 years, respectively. Cumulative freedom from SVD at 5 and 9 years was 94.8% ± 1.6% and 77.4% ± 5.4%, respectively. In 4 patients death was linked to the presence of SVD. There were no differences in mortality, reoperation, or SVD between the 2 Mitroflow valve sizes., Conclusions: Small-size Mitroflow pericardial valve prostheses have shown a worrisome incidence of SVD even in patients aged >70 years. Based on this experience we have discontinued their use., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

The Bentall procedure introduced in 1968 represents an undisputed cure to treat multiple pathologies involving the aortic valve and the ascending thoracic aorta. Over the years, multiple modifications have been introduced as well as a standardized approach to the operation with the goal to prevent long-term adverse events. The Gelweave Valsalva graft provides a novel manner to more efficiently reconstruct the anatomy of the aortic root either with a valve-sparing procedure or with the implantation of a valved conduit (bioprosthesis or mechanical valve). The prosthesis holds three sections: the collar anchoring the valve; the skirt mimicking the Valsalva, which is suitable for the anastomoses with the coronary arteries; and the main body of the graft, which is designed to replace the ascending aorta. The Gelweave Valsalva graft allows the Bentall operation to be standardized, and it provides a potential for longer durability with reduced adverse events.

Background and Aim of the Study: Currently, little is known of the diastolic properties of stentless valves that affect stress and strain on leaflets and, hence, their durability. In a pressurized aortic root model, a series of in-vitro tests was conducted to determine how stentless valves behave in diastole, and how they adapt to different annulus-to-sinotubular junction (STJ) ratios., Methods: Sixteen 25 mm stentless aortic valves (four each of the Sorin Solo, ATS 3F, Edwards Prima Plus and Medtronic FreeStyle) were sutured into a 32 mm Valsalva graft, suspending the commissures into the expandable region (42 mm). The neoaortic root was pressurized and the size of the STJ progressively reduced by wrapping the neocommissural ridge with Dacron rings. Endoscopic views and ultrasound imaging were used to observe the geometry of the leaflets, regurgitation, and the height and level of leaflet coaptation at different annulus-to-STJ ratios., Results: Pericardial prostheses built to mimic a cylinder (ATS 3F and Sorin Solo) showed the greatest tolerance to STJ dilatation and a larger coaptation surface, but also a tendency to roll in on themselves in an italic S-shape if oversized. Valves built to mimic native aortic leaflets (porcine Prima Plus and Medtronic Freestyle) showed a reduced tolerance to STJ dilatation, resulting in regurgitation and a smaller coaptation surface, but also a reduced tendency to roll if oversized., Conclusion: Despite similar systolic performances, stentless prostheses behave differently during diastole. The 3F and Solo valves benefit from a better tolerance to STJ dilatation, while the Prima Plus and Freestyle benefit from a more stable shape of closure under conditions of oversizing.

Stentless valve continence is affected by the implantation technique, annular symmetry and dilatation of the sinotubular junction. We tested in vitro how the Sorin Solo stentless pericardial valve adapts to a slightly dilated sinotubular junction. Stentless Sorin Solo aortic valves (25 mm) were sutured into a 32-mm Valsalva graft suspending the commissures into the expandable region of the graft. The neo-aortic root was pressurized and sinotubular junction size progressively decreased by wrapping the neocommissural ridge with Dacron rings. Direct endoscopic view and ultrasound imaging were used to observe geometry and morphology of leaflets, regurgitation, height and level of leaflets coaptation. Fresh porcine valves of the same annular size were used as controls. Solo valves had mild regurgitation at baseline, became continent at 32 mm sinotubular junction size and remained continent at any size of reduction, with optimal coaptation height and level. Porcine valves had severe regurgitation at baseline, became continent at 30 mm and showed mild insufficiency and reduction of the coaptation level at a sinotubular junction of 28 mm. The Solo valve prevents residual valve regurgitation for a wider range of sinotubular junction mismatch when compared with natural porcine valves. This extended tolerance to sinotubular junction mismatch suggests a safe use of stentless valves even in suboptimal geometry roots.

Aortic root replacement is the procedure of choice for patients with ascending aortic aneurysms and diseased aortic valve leaflets. The increasing age of patients who undergo aortic root surgery, and data that support the use of a biological aortic valve in the younger population, have significantly increased the need for a composite biological valved conduit. The third-generation Triplextrade (Terumo Vascutek, Renfrewshire, Scotland, UK) Dacron conduit with its three-layer technology, can be stored in glutaraldehyde along with biological prostheses while maintaining a complete blood impermeability. As the result of this fundamental improvement, the ready-to-use composite biological valved graft is currently available for the first time in different sizes, which avoids the need of assembling it on the surgical table. The procedure is expedited and a better hemostasis achieved because of the intrinsic characteristics of the new three-layered conduit. The BioValsalva (Terumo Vascutek, Renfrewshire, Scotland, UK) has been obtained by suturing a stentless aortic valve (Elan, Kohler, Leeds, UK) inside a Triplex Valsalva graft and combining the advantages of a biological valved conduit with the advantages of better leaflets dynamics, less tension on coronary ostia, and improved coronary flow proper of the Valsalva conduit. The authors' preliminary clinical experience with the BioValsalva is reported herein and the technique is discussed.

Purpose: To develop a preassembled biological valved conduit, a Dacron conduit was modified to be stored in glutaraldehyde without loss of blood impermeability. This study reports the preliminary experience with this "third generation" aortic Dacron graft., Description: Eight patients underwent ascending aorta or root replacement using the new Triplex prosthetic conduit (Vascutek Terumo, Renfrewshire, Scotland) consisting of three layers. The inner layer is a standard uncoated woven Dacron graft (DuPont, Wilmington, DE); the outer layer is a standard expanded polytetrafluoroethylene graft. Both layers are fused together by a central layer of self-sealing elastomeric membrane. For its peculiar characteristics this graft has unique properties that allow it to be maintained in glutaraldehyde solution as well as in various storage solutions., Evaluation: None of the patients died or exhibited any neurologic event. The clinical inflammatory response was within the usual postoperative levels. The graft appeared slightly stiffer than the standard Dacron graft with similar handling and tailoring characteristics. Blood impermeability (even through the suture holes) was remarkably high., Conclusions: This prosthetic graft appeared to combine good handling and tailoring characteristics with a striking reduction of blood oozing through the fabric and suture hole, even at full heparinization.

We describe a technique to replace the aortic root by means of a stentless valve and a new aortic root Dacron graft (Gelweave Valsalva, Sulzer Vascutek, Renfrewshire, Scotland) that allows an anatomical reconstruction of the sinuses of Valsalva.

Objective: Stentless biologic aortic valves are less obstructive than stented biologic or mechanical valves. Their superior hemodynamic performances are expected to reflect in better regression of left ventricular hypertrophy. We compared the regression of left ventricular hypertrophy in 3 groups of patients undergoing aortic valve replacement for severe aortic stenosis. Group I (10 patients) received stentless biologic aortic valves, group II (10 patients) received stented biologic aortic valves, and group III (10 patients) received bileaflet mechanical aortic valves., Methods: Echocardiographic evaluations were performed before the operation and after 1 year, and the results were compared with those of a control group. Left ventricular diameters and function, left ventricular wall thickness, and left ventricular mass were assessed by echocardiography., Results: Group I patients had a significantly lower maximum and mean transprosthetic gradient than the other valve groups (P = .001). One year after operation there was a significant reduction in left ventricular mass for all patient groups (P < .01), but mass did not reach normal values (P = .05). Although the rate of regression in the interventricular septum and posterior wall thickness differed slightly among groups, their values at follow-up were comparable and still higher than control values (P = .002). The ratio between interventricular septum and posterior wall and the ratio between wall thickness and chamber radius did not change significantly at follow-up., Conclusions: Because the number of patients was relatively small, we could not use left ventricular mass regression after I year to distinguish among patients undergoing aortic valve replacement for aortic stenosis by means of valve prostheses with different hemodynamic performances.

Background and Aims of the Study: Optimal hemodynamic performances are of paramount importance when implanting a mechanical valve in patients with a small aortic annulus. A Doppler echocardiographic study was performed to compare the hemodynamic performances of small CarboMedics and St. Jude valves., Materials and Methods: Twenty-nine patients receiving either a 19 mm (n = 10) or a 21 mm (n = 10) CarboMedics valve or a 19 mm (n = 9) St. Jude Med HP valve were evaluated. A Doppler echocardiographic study was performed at rest and two minutes after treadmill exercise with the Bruce protocol. Peak and mean gradients across the valve were estimated; effective orifice area, performance index and discharge coefficient were calculated. Heart rate, blood pressure and cardiac output were all significantly increased with exercise., Results: Peak and mean gradients at rest were significantly higher (p < 0.05) in the 19 mm CarboMedics valve (40.2 +/- 15 mmHg and 22.6 +/- 9 mmHg, respectively) when compared either with 21 mm CarboMedics valve (27.6 +/- 6.8 mmHg and 14.2 +/- 3.4 mmHg, respectively) or with the 19 mm St. Jude HP valve (23.6 +/- 10.4 mmHg and 13.6 +/- 5 mmHg, respectively). Peak and mean gradients were not modified with exercise for the 19 mm CarboMedics valve and significantly increased for the 21 mm CarboMedics and the 19 mm St. Jude HP valves. Although these values were still higher in the 19 mm CarboMedics valve, they did not reach the level of statistical significance when compared with the other two valve groups., Conclusions: The 19 mm St. Jude HP valve shows hemodynamic performances at rest that are similar to those of the 21 mm CarboMedics valve and superior to those of the 19 mm CarboMedics valve. With exercise both sizes of the CarboMedics valve show an in vivo discharge coefficient close to one, testifying to a full utilization of the internal orifice area.

Chordal preservation during mitral valve replacement is thought to greatly preserve left ventricular function. Recently a stentless mitral valve (Biocor) became available for clinical use. It is a porcine mitral valve with the entire chordal apparatus, the sewing ring being reinforced by a bovine pericardial ring and the chordae being sutured together onto two pericardial patches. During a six months period, seven patients undergoing mitral valve replacement for mitral insufficiency (four cases), mitral stenosis (two cases) or mixed lesions (one case) received a stentless mitral valve. Their mean age was 66.3 +/- 4.8. The valve was implanted by suturing the pericardial patches onto the papillary muscles and the sewing ring onto the mitral annulus. Echocardiography control immediately after surgery showed good valve function. Three valves failed after a period of seven days, seven and 12 months respectively. The valve lesions were similar and consistent with an excessive tension on the chordae and on the valvular tissue. There were tears along the posterior annulus and at the level of the commissures, often accompanied by chordal rupture. Histology and scanning electron microscopy showed good integration of the prosthesis with the patients own tissues. There were areas of overgrowing tissue without endothelial cells especially in the area of papillary muscle -pericardial patch interaction. The remaining four patients continue to do well after a mean follow up of two years. The apparent excessive tension on the valve tissues leading to the premature failure of the prosthesis could be due to the variability in the distance between mitral annulus and papillary muscles.(ABSTRACT TRUNCATED AT 250 WORDS)

Fifty-seven patients underwent aortic valve replacement with a stentless glutaraldehyde-fixed bioprosthesis; 27 received a porcine aortic valve and 30 had a bovine pericardial valve. Two groups of 30 patients each who had aortic valve replacement with a tilting-disc mechanical valve or a stented porcine bioprosthesis served as controls. There were no differences in sex, body surface area, valve lesion, and valve size among the four groups. Results were assessed on a Doppler-based determination of maximum velocity across the valve, aortic valve area, and degree of valve regurgitation. Velocity across the valve was significantly less with stentless pericardial valves than with stentless porcine valves, stented bioprostheses, and mechanical valves. Stentless valves had a significantly larger aortic valve area when compared with stented valves. Mild central aortic insufficiency was detected more often with stentless pericardial than with stentless porcine bioprostheses (p = 0.04). Stentless valves showed a higher incidence of complete atrioventricular block when compared with stented valves (p = 0.04). Long-term studies are now warranted to assess the durability of both types of stentless valves.

Postoperative adhesions following open heart surgery enhance the risks and increase the time of subsequent reoperation. When possible, primary closure of the natural pericardium is recommended, particularly in those cases that are more likely to be reoperated upon. The use of a total artificial heart (TAH) as a bridge to transplantation makes reoperation mandatory. If the pleura is left open to accommodate the ventricles, the risk of adhesion is considerable. To address this question, gluteraldehyde-fixed pericardial allografts were evaluated in calves undergoing TAH replacement. Eight animals were implanted with 3 different types of TAHs and survived from 12 to 108 days (mean 52.8 +/- 14.5). The pericardial substitute was wrapped around the TAH and the vascular grafts and cuffs. Two different surgical techniques were evaluated. At the time of autopsy, the presence of adhesions and gross epicardial reaction was macroscopically characterized and classified according to a standardized scale. Bacterial cultures were taken and tissue submitted for histology. The animals implanted with pericardial allografts for periods greater than 3 weeks were observed to have greater adhesions than those implanted for periods less than 3 weeks (p = 0.006). Pericardial cultures were negative in all cases and neovascularization and fibroplasia of the underlying tissues occurred in all cases. Leukocyte infiltration was minimal in the shorter term implant animals. Degeneration of a portion of the pericardium occurred in only 2 cases after 90 days. Minor calcification of the artificial pericardium was noted, but only in the longer term implant animals. The artificial pericardium reduced adhesion, thus facilitating reoperation in implants lasting up to a month.(ABSTRACT TRUNCATED AT 250 WORDS)