Valve-related Events Research Articles

7-Year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicenter analysis.

Safety, efficacy, and durability are important considerations when selecting a bioprosthesis for aortic valve replacement (AVR). This study assessed 7-year clinical outcomes and haemodynamic performance of the Avalus bioprosthesis. Patients indicated for surgical AVR were enrolled in this prospective, nonrandomized trial, conducted across 39 sites globally. The primary end-point of this analysis was freedom from surgical explant or percutaneous valve-in-valve reintervention due to structural valve deterioration (SVD) at 7 years of follow-up, determined using Kaplan-Meier (KM) analysis. We also evaluated a composite end-point of SVD or severe haemodynamic dysfunction (SHD) requiring reintervention. Survival, valve-related safety events, and haemodynamic performance were assessed. Deaths and safety events were adjudicated by an independent clinical events committee. A total of 1132 patients underwent surgical AVR. Mean age was 70 years; 854 patients (75%) were men. Mean STS risk of mortality was 2.0 ± 1.4%, and 659 patients (58%) had a NYHA classification of I/II. One or more concomitant procedures were performed in 577 patients (51%). At 7 years, the Kaplan-Meier rate of freedom from SVD/SHD requiring reintervention was 1.2% (0.5-2.5%) with no cases adjudicated as SVD. The survival rate was 82.6% (79.5-85.0%). The KM event rate was 5.7% (4.3-7.7%) for reintervention, 6.3% (4.9-8.3%) for endocarditis, and 0.4% (0.1-1.1%) for valve thrombosis. Mean aortic gradient, dimensionless velocity index, and effective orifice area were 13.8 ± 5.9 mmHg, 0.42 ± 0.09, and 1.99 ± 0.53 cm2, respectively. This analysis demonstrated excellent durability of the Avalus valve with good clinical outcomes and stable haemodynamic performance through 7 years of follow-up. www.clinicaltrials.gov ID: NCT02088554.

A Comparative Study of Aortic Valve Neocuspidization Techniques: Formula vs. Template Methods of Neocusp Formation.

The template method (TM), pioneered by Ozaki for aortic valve neocuspidization (AVNeo), has been widely adopted for aortic valve replacement, though it requires specialized instruments. This study introduces a novel formula method (FM), which uses the diameter of the aortic valve fibrous ring (AV-D) to determine the dimensions of the neocusps to be trimmed from autologous without the need for templates, potentially reducing costs and complexity. We aimed to compare the clinical outcomes of the FM with the established TM in patients undergoing AVNeo. A retrospective and prospective study was conducted on 31 patients who underwent isolated AVNeo between January 21, 2019 and December 15, 2022. Patients were divided into two groups: FM (n = 17) and TM (n = 14). The formula for the cusp free margin horizontal length is L1 = AV-D + 10 mm, cusp height is H = AV-D, cusp suture margin is L2 is a parabola that joins L1 and H, and cusp wings to be secured to aortic sinus = 3mm. The primary endpoints were major adverse valve-related events, including cardiac death, reoperation, and infective endocarditis. Secondary endpoints included significant aortic regurgitation, peak pressure gradients, aortic valve area, and New York Heart Association (NYHA) functional class. Intraoperative times, early postoperative outcomes, and mid-term hemodynamic performance were evaluated for both techniques. Both the FM and TM demonstrated comparable intraoperative and postoperative outcomes. The cardiopulmonary bypass time, myocardial ischemia time, and blood loss were similar between the groups. Mid-term outcomes also showed no significant differences in valve function or hemodynamic parameters, with both groups exhibiting substantial reverse left ventricular remodeling. The FM group had a peak pressure gradient of 14.1 ± 4.3 mmHg compared to 18.4 ± 12.0 mmHg in the TM group (p = 0.219). The aortic valve area was 2.43 ± 0.3 cm² in the FM and 2.4 ± 0.2 cm² in the TM (p = 0.890). No significant differences were observed in freedom from reoperation or adverse events. Both techniques showed excellent mid-term hemodynamic performance and comparable intraoperative and postoperative outcomes. The FM for AVNeo provides a cost-effective and practical alternative to the TM, offering similar clinical outcomes without the need for expensive templates; it has the potential to improve the accessibility of AVNeo, particularly in resource-limited settings. However, further research with larger cohorts and long-term follow-up is needed to fully assess the durability and long-term benefits of the FM.

Decellularized aortic homografts versus mechanical composite grafts for aortic root replacement.

Mechanical composite valve grafts (MCVGs) are the first-line therapy for aortic root replacement in young adults. Decellularized aortic homografts (DAH) present a promising novel alternative due to their lower thrombogenicity. We aimed to compare both treatment options regarding survival and valve-related adverse events. This study was designed as a single-centre retrospective cohort study including patients who underwent root replacement with MCVG or DAH between 2000 and 2022. Urgent or emergent procedures were excluded. The study cohort included 289 patients (MCVG n = 216, DAH n = 73) with a mean age of 48.5 ± 12 years (MCVG 49 ± 12 years vs DAH 47 ± 11 years; P = 0.23) and a median EuroScore II of 1.7% (1.2, 2.6). The 30-day mortality was 1% (n = 3). Cumulative survival at 3 years was 99% for DAH and 94% for MCVG, respectively (P = 0.15). Mean follow-up was 98.9 ± 72.7 months. Bleeding events (n = 14, 6.5%) and thromboembolism (n = 14, 6.5%) were only observed in the MCVG group (P = 0.19 and 0.09, respectively). Four cases (5%) of moderate structural valve deterioration occurred, all in the DAH group (P ≤ 0.001). The cumulative incidence of a composite end point of valve-related adverse events was significantly higher in the MCVG group (P = 0.0295). Aortic root replacement with MCVGs and decellularized aortic homografts showed low mortality in an elective setting. Patients in the homograft cohort demonstrated significantly higher freedom from valve-related adverse events. DAH present a promising treatment option for young patients requiring root replacement; however, data on long-term durability are needed.

Aortic valve performance after remodelling versus reimplantation in a propensity-matched comparison.

Both aortic root remodelling and aortic valve (AV) reimplantation have been used for valve-sparing root replacement in patients with aortic root aneurysm with or without aortic regurgitation. There is no clear evidence to support one technique over the another. This study aimed to compare remodelling with basal ring annuloplasty versus reimplantation on a multicentre level with the use of propensity-score matching. This was a retrospective international multicentre study of patients undergoing remodelling or reimplantation between 2010 and 2021. Twenty-three preoperative covariates (including root dimensions and valve characteristics) were used for propensity-score matching. Perioperative outcomes were analysed along with longer-term freedom from AV reoperation/reintervention and other major valve-related events. Throughout the study period, 297 patients underwent remodelling and 281 had reimplantation. Using propensity-score matching, 112 pairs were selected and further compared. We did not find a statistically significant difference in perioperative outcomes between the matched groups. Patients after remodelling had significantly higher reintervention risk than after reimplantation over the median follow-up of 6 years (P = 0.016). The remodelling technique (P = 0.02), need for decalcification (P = 0.03) and degree of immediate postoperative AV regurgitation (P < 0.001) were defined as independent risk factors for later AV reintervention. After exclusion of patients with worse than mild AV regurgitation immediately after repair, both techniques functioned comparably (P = 0.089). AV reimplantation was associated with better valve function in longer-term postoperatively than remodelling. If optimal immediate repair outcome was achieved, both techniques provided comparable AV function.

Recent outcomes of surgical redo aortic valve replacement in prosthetic valve failure.

As redo surgical aortic valve replacement(AVR) is relatively high risk, valve-in-valve transcatheter AVR has emerged as an alternative for failed prostheses. However, the majority of studies are outdated. This study assessed the current clinical outcomes of redo AVR. This study enrolled 324 patients who underwent redo AVR due to prosthetic valve failure from 2010 to 2021 in four tertiary centers. The primary outcome was operative mortality. The secondary outcomes were overall survival, cardiac death, and aortic valve-related events. Logistic regression analysis, clustered Cox proportional hazards models, and competing risk analysis were used to evaluate the independent risk factors. Redo AVR was performed in 242 patients without endocarditis and 82 patients with endocarditis. Overall operative mortality was 4.6% (15 deaths). Excluding patients with endocarditis, the operative mortality of redo AVR decreased to 2.5%. Multivariate analyses demonstrated that endocarditis (HR 3.990, P=0.014), longer cardiopulmonary bypass time (HR 1.006, P=0.037) and lower left ventricular ejection fraction (LVEF) (HR 0.956, P=0.034) were risk factors of operative mortality. Endocarditis and lower LVEF were independent predictors of overall survival. The relatively high risk of redo AVR was due to reoperation for prosthetic valve endocarditis. The outcomes of redo AVR for non-endocarditis are excellent. Our findings suggest that patients without endocarditis, especially with acceptable LVEF, can be treated safely with redo AVR.

Transcatheter Pulmonary Valve Replacement With the Harmony Valve in Patients Who Do Not Meet Recommended Oversizing Criteria on the Screening Perimeter Plot.

Anatomic selection for Harmony valve implant is determined with the aid of a screening report and perimeter plot (PP) that depicts the perimeter-derived radius along the right ventricular outflow tract (RVOT) and projects device oversizing. The PP provides an estimation of suitability for implant, but its sensitivity as a screening method is unknown. This study was performed to describe anatomic features and outcomes in patients who underwent Harmony TPV25 implant despite a PP that predicted inadequate oversizing. We reviewed RVOT anatomic features and measurements in patients who underwent transcatheter pulmonary valve replacement with the Harmony TPV25 device despite a PP that predicted inadequate oversizing. This study included 22 patients. There were no unsuccessful implants or adverse valve-related events. Anatomic features varied, but all patients fit into 1 of 3 anatomic types characterized by differences in RVOT dimensions. Type 1 patients (n=9) had a long RVOT with a choke point and a wide main pulmonary artery. Type 2 patients (n=6) had a short RVOT that was pyramidal in shape, with no choke point, and extensive main pulmonary artery lengthening/expansion during systole. Type 3 patients (n=7) had a short, bulbous main pulmonary artery with a choke point and an open pulmonary artery bifurcation. Transcatheter pulmonary valve replacement with the Harmony valve is feasible in some patients whose PP fit analysis predicts inadequate oversizing. All cases in this series fit into 1 of 3 anatomic patterns, which are not identified in the screening report. Implanters must review cases individually to assess the feasibility of the implant.

Early and mid-term outcomes of tricuspid valve surgery in patients with functional tricuspid regurgitation induced by atrial fibrillation.

The strategy of treatment for tricuspid regurgitation (TR) induced by atrial fibrillation (AF) has not been established. The aim of this study was to evaluate the outcomes of surgical treatment for TR induced by AF. From 2000 to 2021, a total of 1,301 patients underwent tricuspid valve (TV) surgery. Among them 43 patients who diagnosed as AF induced TR were enrolled. The tricuspid valve-related events (TVRE) included cardiac death, TV reoperation, development of moderate or greater TV disease, congestive heart failure requiring re-admission, and major bleeding or thrombosis. The median follow-up duration was 42.0 months. The interval from diagnosis of AF to more than moderate TR was 61.2 months, and the interval from initial diagnosis of severe TR to surgery was 2.4 months. Concomitant Cox-maze III procedure was performed in 39 patients. The operative mortality occurred in 1 patient, and there was no permanent pacemaker implantation. Overall survival rates at 1- and 5-year were 90.6% and 79.3%, respectively. The cumulative incidence of TVRE at 1- and 5-year were 16.3% and 26.5%, respectively. The cumulative incidences of AF recurrence at 1- and 3-year in the patients with surgical ablation were 29.7% and 67.6%. The TVRE was significantly associated with the longer interval from diagnosis of severe TR to surgery (hazard ratio: 1.023, 95% confidence interval: 1.005-1.042). TV surgery for TR induced by AF showed low surgical mortality and favorable mid-term outcomes. For these patients, early surgery after progress to severe TR can be helpful to decrease the occurrence of TVRE.

Midterm results after aortic valve neocuspidization

ObjectivesAortic valve neocuspidization with autologous pericardium is gaining increasing attention as a surgical treatment option for aortic valve disease. However, little is known about midterm durability and valve-related events. MethodsPatients undergoing aortic valve neocuspidization between 2016 and 2021 were included. Transthoracic echocardiography was performed before the operation, at discharge, and annually thereafter. Data were analyzed for incidences of structural valve deterioration, bioprosthetic valve failure, survival, freedom from reoperation, and hemodynamic performance. ResultsA total of 162 patients underwent aortic valve neocuspidization (mean age, 52.6 ± 16.6 years; range, 13-78 years); 114 (70.4%) were male. A total of 132 patients presented with a bicuspid aortic valve (81.5%) and 126 patients presented with aortic valve stenosis (77.8%). Concomitant procedures were performed in 63 patients (38.9%). Mean follow-up was 3.5 ± 1.2 years. At discharge, peak and mean pressure gradients were 15.6 ± 7.2 mm Hg and 8.4 ± 3.7 mm Hg, respectively, with a mean effective orifice area of 2.4 ± 0.8 cm2. After 5 years, peak and mean pressure gradients were 14.5 ± 4.6 mm Hg and 7.5 ± 2.2 mm Hg, respectively, with a mean effective orifice area of 2.3 ± 0.8 cm2. At 5 years, cumulative incidences of moderate and severe structural valve deterioration and bioprosthetic valve failure were 9.82% ± 3.87%, 6.96% ± 3.71%, and 12.1% ± 4.12%, respectively. Survival was 97.3% ± 1.4%, and freedom from reoperation was 91.3% ± 2.4%. ConclusionsAortic valve neocuspidization accomplishes low pressure gradients early after initial surgery and during follow-up. Survival in this young patient population is excellent. The main reason for reoperation is endocarditis, and rates for structural valve degeneration are low.

The Ross Procedure: Imaging, Outcomes and Future Directions in Aortic Valve Replacement.

The Ross procedure is gaining recognition as a significant option for aortic valve replacement (AVR), and is particularly beneficial in specific patient groups. Although categorized as a class IIb recommendation in the 2020 American College of Cardiology (ACC)/American Heart Association (AHA), and the European Society of Cardiology (ESC) management guidelines on valvular heart disease, recent studies bolster its credibility. Research, including a propensity-matched study, underlines the Ross procedure's association with enhanced long-term survival and reduced adverse valve-related events compared to other AVR types. This positions the Ross procedure as a primary option for AVR in young and middle-aged adults within specialized centers, and potentially the only choice for children and infants requiring AVR. This review meticulously examines the Ross procedure, covering historical perspectives, surgical techniques, imaging, and outcomes, including hemodynamic performance and quality of life, especially focusing on pediatric and young adult patients. It explores contemporary techniques and innovations like minimally invasive approaches and tissue engineering, underscoring ongoing research and future directions. A summarization of comparative studies and meta-analyses reiterates the Ross procedure's superior long-term outcomes, valve durability, and preservation of the left ventricular function, accentuating the crucial role of patient selection and risk stratification, and pinpointing areas for future research.

Complete Aortic Valve Reconstruction with Autologous Pericardium: Analysis of Mid-Term Results of Single-Center Experience with AVNeo Procedure.

Aortic valve neocuspidization (AVNeo) is a relatively recent advancement in surgical AV replacement. Data on its performance beyond the short term are limited. We assessed the mid-term outcomes in patients undergoing AVNeo, focusing on feasibility, perioperative details, and its role in AV pathology treatment. Sixty-five consecutive patients underwent AVNeo between December 2016 and February 2018. Clinical data were prospectively collected and retrospectively analyzed. Tricuspid reconstruction with autologous pericardium was performed in all cases. Echocardiographic follow-up was conducted post-discharge, at 6 and 12 months, and annually thereafter. The mean age was 62.6 ± 18.7 years. AVNeo was feasible in all cases. Concomitant procedures were performed in 43 (66.2%) patients. Mean bypass and cross-clamp times were 119.2 ± 30.3 and 87.1 ± 22.9 minutes, respectively. Postoperative transvalvular hemodynamics was excellent. There was one (1.5%) in-hospital death. Follow-up (mean 66.72 ± 12.77 months) was complete in 58 patients (89.2%). There were no detected valve-related or thromboembolic events. Transvalvular hemodynamic parameters were stable during the observation period: peak pressure gradient at discharge and follow-up was 15.3 ± 4.6 mmHg and 15.01 ± 6.3 mmHg, respectively (ρ = 0.346). AVNeo demonstrated the feasibility and favorable mid-term outcomes. Studies with longer-term observation are warranted to evaluate its durability.

Edge-to-edge with partial band mitral valve repair compared to replacement and undersized restrictive annuloplasty for ischemic mitral regurgitation

ObjectiveEvidence supports replacement over repair for ischemic mitral regurgitation due to improved durability; however, the latter often involves an undersized ring annuloplasty that does not include edge-to-edge approximation. The objective of this study was to evaluate the outcomes of replacement, edge-to-edge leaflet approximation with mild-undersized annuloplasty and undersized ring annuloplasty for ischemic mitral regurgitation. MethodsThis is a single-center retrospective study of patients undergoing mitral surgery for moderate-severe or greater ischemic mitral regurgitation, between 2004 and 2020, with mild-undersized annuloplasty, mitral valve replacement, or undersized restrictive annuloplasty (undersized ring annuloplasty). The primary outcome was all-cause mortality. Secondary outcomes included first recurrence of mitral regurgitation, heart failure hospitalization, and composite of valve-related events (bleeding, thromboembolism, endocarditis, and mitral valve reoperation). ResultsThere were 121, 93, and 78 patients in the mitral valve replacement, mild-undersized annuloplasty, and undersized restrictive annuloplasty groups, respectively, with a median follow-up of 3.1, 5.9, and 3.8 years, respectively. Both mitral valve replacement (hazard ratio, 1.87; 95% CI, 1.029-3.415) and undersized restrictive annuloplasty (hazard ratio, 2.73; 95% CI, 1.480-5.061) were associated with worse survival compared with mild-undersized annuloplasty. At 2 years, the rate of mild-moderate mitral regurgitation was greater in the mild-undersized annuloplasty group compared with the mitral valve replacement group (P = .001) but less than in the undersized restrictive annuloplasty group (P = .001). The rate of recurrent moderate or greater mitral regurgitation at 2 years was similar between mild-undersized annuloplasty and mitral valve replacement groups but significantly higher after undersized restrictive annuloplasty (P < .0001). Mitral valve replacement and undersized restrictive annuloplasty were associated with a significant increase in the incidence of first heart failure hospitalization compared with mild-undersized annuloplasty (P < .001 and P = .001, respectively). Mitral valve replacement was associated with an increased incidence of valve-related events compared with mild-undersized annuloplasty (P = .002). ConclusionsSurgical edge-to-edge approximation in addition to a mild-undersizing annuloplasty offers similar durability compared with replacement, with a lower rate of hospitalization for heart failure, and may confer a survival advantage.

Ten years follow-up after aortic valve replacement with bioprosthesis trifecta: a single center retrospective cohort

Abstract Introduction St. Jude’s Trifecta (TF) bioprosthesis were adopted at most centers due to their unique design and hemodynamic performance. However, concerns regarding durability have been raised and long-term follow-up studies (≥10 years) are scarce. Purpose To report hemodynamic performance as well as early and long-term results of TF valve. Material and Methods In this longitudinal, single-center study, consecutive patients that underwent surgical aortic valve replacement with TF, from July 2011 to June 2019 were included. Pre-, intra- and post-operative data, including routine and first outpatient ambulatory postoperative transthoracic echocardiogram (TTE) (median 4 months) were collected. Hospital mortality was defined as in-hospital or within the first 30 days after surgery. Survival and need for reoperation were accessed in December 2021. Median follow-up was 4 years and maximum was 10,5 years. Kaplan-Meier method was used for time-to-event outcomes (all-causes mortality and need for reoperation). Results We included 1084 patients, 54% being male, with a mean age of 74±8 years. Surgery priority was elective in 840 (78%) of cases. Most patients received a TF prothesis of size 23 (35%), followed by size 21 (30%). There were 563 (52%) multiple procedures, mostly coronary artery bypass grafting (46% within the multiple procedures). Bypass and clamping times were 86±31 minutes and 62±22 minutes, respectively for isolated procedures, and 143±27 minutes and 100±40 minutes, respectively, for multiple procedures. Hospital mortality was 6%. Excluding these patients, cumulative survival at 1-, 3-, 5- and 10-years, were, respectively, 96%, 89%, 78% and 52%. There were 27 patients who needed reoperation: 16 due to endocarditis, 5 due to structural valve deterioration (SVD) and 6 due to non-structural valve dysfunction. Freedom from reoperation at 1-, 3-, 5- and 10- years were of 99%, 98%, 98% and 95%, respectively. At follow-up TTE (n=995), transvalvular mean gradient was 11±4 mmHg and the effective orifice area mean was 2.1±0.5cm2. Patient-prosthesis mismatch occurred in 79 (9.1%), being severe in 8 (0,9%) cases. Conclusion Our findings confirm the satisfactory hemodynamics and safety profile of TF bioprosthesis. Long-term results are comparable with published TF series and there seems to be no particular sign of adverse valve-related events in our population.

Abstract 18242: Mitral Valve Repair vs. Mitral Valve Replacement in Rheumatic Heart Disease Patients: A Systematic Review and Meta-Analysis

Background Mitral valve repair (MVP) is recommended over mitral valve replacement (MVR) for mitral valve disease. However, its benefits in rheumatic heart disease (RHD) patients are unclear. We conducted this meta-analysis to compare perioperative and long-term clinical and safety outcomes of MVP vs. MVR. Methods: MEDLINE, Google Scholar, and Scopus were searched from inception till June 2023 comparing clinical outcomes with MVP vs. MVR in RHD patients. Primary outcomes were early mortality and long-term survival. Secondary outcomes were freedom from reoperation, freedom from valve related adverse events, postoperative infective endocarditis (IE), thromboembolic events (TEE), and hemorrhagic events. The outcome measures were summary random effects risk ratio (RR) and hazard ratios (HR) with 95% confidence intervals. Results: A total of 19 studies with 10,724 RHD patients (3,495 MVP vs. 7,229 MVR; mean age: 38.3 years for MVP vs. 43.5 years for MVR) were included. MVP was associated with significantly lower early mortality (RR 0.62 [0.45, 0.85]; p=0.003), and long-term mortality (HR 0.53 [0.37, 0.76]; p=0.0006). Upon meta-regression analysis, only increasing age was associated with early mortality (Coeff: 0.0194, p=0.037). However, MVP was associated with significantly lower freedom from reoperation at both 5- (RR 0.88 [0.83, 0.93]; p&lt;0.0001) and 10-year (RR 0.90 [0.83, 0.98]; p=0.01) follow-ups. Freedom from valve related adverse events was higher in the MVP group at 10-year follow-up (RR 1.15 [1.06, 1.24]; p=0.0006) with no significant difference at 5-year follow-up (RR 1.03 [0.94, 1.14]; p=0.50). No significant difference was seen for IE (RR 1.03, p=0.91) and hemorrhagic events (RR 0.70, p=0.05). TEE were significantly lower in the MVP group (RR 0.59 [0.44, 0.78]; p=0.0003). Conclusion: In RHD, MVP reduced early- and long-term mortality and achieved greater freedom from valve related adverse events. However, there was a higher risk of reoperation in MVP.

Bovine pericardial versus porcine bioprosthetic aortic valves: A nationwide population-based cohort study in Korea

ObjectiveTo compare the clinical outcomes of aortic valve replacement (AVR) using bovine pericardial and porcine bioprostheses, utilizing a nationwide administrative claims database. MethodsAdult patients (age ≥40 years) who underwent bioprosthetic AVR, without other valve replacements, between 2003 and 2018 were identified from the Korean National Health Insurance Service database. The outcomes of interest were all-cause mortality, cardiac mortality, and valve-related events, including the incidence of reoperation, endocarditis, systemic thromboembolism, and major bleeding. Baseline adjustment was performed using propensity score matching. Time-related outcomes were evaluated using a competing risk analysis, with death as a competing risk. ResultsAmong the 7714 patients who underwent bioprosthetic AVR, 5621 (72.9%) received bovine pericardial prostheses and 2093 (27.1%) received porcine bioprostheses. After matching, 1937 pairs were included in the final analysis. During follow-up (median, 4.49 years; interquartile range, 2.83-8.20 years), the use of porcine bioprostheses was associated with a higher risk of aortic valve reoperation (adjusted hazard ratio [HR], 1.87; 95% confidence interval [CI], 1.16 to 3.01); however, no significant differences were observed in cumulative incidences of all-cause mortality, cardiac mortality, thromboembolism, or major bleeding. Subgroup analyses revealed that the use of bovine valves was associated with improved survival in patients with diabetes mellitus, whereas in patients undergoing dialysis, porcine valves exhibited better survival than bovine valves. ConclusionsIn this large nationwide cohort study of patients undergoing bioprosthetic aortic valve replacement, the use of porcine prostheses was significantly associated with an increased risk of reoperation compared with the use of bovine prostheses, supporting previous findings.

Durability of bovine pericardial mitral bioprosthesis based on Heart Valve Collaboratory echocardiographic criteria

ObjectiveThis study evaluated the very long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position, with particular attention to structural valve deterioration based on echocardiographic criteria. MethodsFrom 1984 to 2016, 648 patients (mean age 68.8 years; 53.9% female) underwent mitral valve replacement using the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Multiple valve replacements were excluded. Clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.8 ± 5.4 years, for a total of 5043 valve-years. The follow-up data were 98.3% complete (11 patients lost). Structural valve deterioration was determined by strict echocardiographic assessment based on Heart Valve Collaboratory criteria. ResultsOperative mortality was 4%. A total of 322 late deaths occurred, for a linearized rate of 6.4%/valve-year. The actuarial survival rate at 15 years was 31.4 ± 2.6%. Age at implantation, male sex, and preoperative New York Heart Association class III or IV were significant risk factors affecting late survival. Actuarial freedoms from complications at 15 years were thromboembolism, 92.5 ± 1.9%; major bleeding, 93.8 ± 1.7%; endocarditis, 93.2 ± 1.3%; and explantation due to structural valve deterioration, 69.3 ± 3.5%. The median survival time for explantation due to structural valve deterioration was 21.7 years for the entire cohort (16.1 years for patients <65 years old). Based on echocardiographic data, actuarial freedom from severe and moderate/severe structural valve deterioration at 15 years were 64.0 ± 3.6% and 52.1 ± 3.6%, respectively. ConclusionsWith low 15-year rates of valve-related events and structural valve deterioration based on Heart Valve Collaboratory echocardiographic criteria, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve.

Single center experience with the balloon-expandable Myval transcatheter aortic valve system with the first 100 patients: 30-day and 1-year follow-up.

To report our single-center data, regarding the first 100 patients who underwent TAVR procedure with the new balloon-expandable MYVAL system. We report 30-day and 1-year outcomes in low to high-risk TAVR patient population. From November 2019 to July 2021, 100 consecutive patients underwent TAVR procedure. Patient outcome was classified according to the VARC-2 definitions. The device performance was assessed using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. The mean age was 74.7 years, 63 (63%) were male. The mean Euroscore II and STS score were 4.8 ± 4.9 and 5.6 ± 3.9, respectively. Transfemoral access was the most frequent (surgical vs. percutaneous 2% vs. 97%) and in one patient surgical subclavian access was used. VARC-2 outcomes were as follows: device success 99%, STROKE 1%, major and minor vascular complication was 1% and 11%, respectively, the rate of new permanent pacemaker implantation was 30.7%. At discharge, the incidence of grade I, grade II aortic regurgitation was 39% and 1%, respectively, without relevant PVL. In-hospital mortality was only 1%. These results included a high proportion (17%) of patients with bicuspid aortic valves. At 1 year, the all-cause mortality rate was 7% (only two due to cardiac event) and only a single patient had valve-related dysfunction requiring surgical aortic replacement. TAVR procedure with MYVAL transcatheter heart valve system shows excellent 30-day and 1-year outcomes regarding patient survival, technical success, and valve-related adverse events. The limitations of our study comprise a single-center study with retrospective data collection.

Long-term outcomes of mitral valve replacement in dialysis patients: evidence from a nationwide database.

To compare the late outcomes between mechanical and bioprostheses after isolated mitral valve replacement (MVR) in dialysis-dependent patients. A nationwide propensity-matched retrospective cohort study was conducted involving dialysis patients who underwent primary mitral replacement between 2001 and 2018. Ten-year postoperative outcomes were compared between mitral bioprosthesis and mechanical prosthesis using the Cox proportional hazard model and restricted mean survival time (RMST). The all-cause mortality was 20.8 and 13.0 events per 100 person-years, with a 10-year RMST of 7.40 and 7.31 years for bioprosthesis and mechanical prosthesis, respectively. Major bleeding was the most common adverse event for both bioprosthesis and mechanical prosthesis, with an incidence rate of 19.5 and 19.1 events per 100 person-years, respectively. The incidence of valve reoperation was higher among those who received bioprosthesis (0.55 events per 100 person-years). After 1:1 matching, the all-cause mortality was 15.45 and 14.54 events per 100 person-years for bioprosthesis and mechanical prosthesis, respectively. The RMST at 10 years was comparable between the two groups after matching (5.10 years for bioprosthesis vs. 4.59 years for mechanical prosthesis), with an RMST difference of -0.03. Further, no difference was observed in the incidence of major adverse valve-related events between bioprosthesis and mechanical valves. However, bioprosthesis was associated with a higher incidence of mitral valve reoperation among all major adverse events (RMST difference -0.24 years, 95% CI -0.48 to -0.01, P =0.047). This study found no association between valve selection and long-term survival outcomes in dialysis patients after MVR. However, bioprosthetic valves may be associated with a slightly higher incidence of reoperation, while other valve-related adverse events, including major bleeding and stroke, were comparable between the two types of prostheses.

Mid-term outcomes and hemodynamic performance of the St Jude Medical Epic aortic bioprosthesis for severe aortic stenosis.

The St. Jude Medical Epic Supra valve is a porcine bioprosthesis designed for complete supraannular implantation. No report has shown the hemodynamic performance and clinical outcomes of aortic valve replacement with the Epic Supra valve for severe aortic stenosis in a Japanese cohort. We retrospectively evaluated 65 patients who underwent aortic valve replacement using the Epic Supra valve for aortic stenosis at our department between May, 2011 and October, 2016. The mean follow-up period was 68.7 ± 32.7months, and the follow-up rate was 89.2%. The mean age was 76.8 ± 5.3years. The 1-, 5-, and 8-year survival rates were 96.9%, 79.4%, and 60.3%, respectively. The rates of freedom from valve-related events were 96.6% and 81.9% at 5 and 8years, respectively. Four patients were diagnosed with structural valve deterioration (SVD), and reintervention was performed in two patients. The rates of freedom from SVD were 98.2% and 83.3% at 5 and 8years, respectively, and the mean time to diagnosis of SVD was 72.5 ± 25.3months. The mean pressure gradient (MPG) was 16.8 ± 6.0mmHg postoperatively, 17.5 ± 9.4mmHg at 5years, and 21.2 ± 12.4mmHg at 8years (p = 0.08). The effective orifice area index (EOAI) was 0.95 ± 0.2 cm2/m2 immediately after surgery, 0.96 ± 0.27 cm2/m2 at 5years, and 0.84 ± 0.2 cm2/m2 at 8years (p = 0.10). An increase in MPG and decrease in EOAI were also observed, which may be associated with SVD. Follow-up after 5years is important to determine if there is an increase.

Evaluating Reference Ages for Selecting Prosthesis Types for Heart Valve Replacement in Korea

Although a patient's age may be the only objective figure that can be used as a reference indicator in selecting the type of prosthesis in heart valve surgery, different clinical guidelines use different age criteria. To explore the age-associated survival-hazard functions associated with prosthesis type in aortic valve replacement (AVR) and mitral valve replacement (MVR). This cohort study compared the long-term outcomes associated with mechanical and biologic prostheses in AVR and MVR according to recipient's age using a nationwide administrative data from the Korean National Health Insurance Service. To reduce the potential treatment-selection bias between mechanical and biologic prostheses, the inverse-probability-of-treatment-weighting method was used. Participants included patients who underwent AVR or MVR in Korea between 2003 and 2018. Statistical analysis was performed between March 2022 and March 2023. AVR, MVR, or both AVR and MVR with mechanical or biologic prosthesis. The primary end point was all-cause mortality after receiving prosthetic valves. The secondary end points were the valve-related events, including the incidence of reoperation, systemic thromboembolism, and major bleeding. Of the total of 24 347 patients (mean [SD] age, 62.5 [7.3] years; 11 947 [49.1%] men) included in this study, 11 993 received AVR, 8911 received MVR, and 3470 received both AVR and MVR simultaneously. Following AVR, bioprosthesis was associated with significantly greater risks of mortality than mechanical prosthesis in patients younger than 55 years (adjusted hazard ratio [aHR], 2.18; 95% CI, 1.32-3.63; P = .002) and in those aged 55 to 64 years (aHR, 1.29; 95% CI, 1.02-1.63; P = .04), but the risk of mortality reversed in patients aged 65 years or older (aHR, 0.77; 95% CI, 0.66-0.90; P = .001). For MVR, the risk of mortality was also greater with bioprosthesis in patients aged 55 to 69 years (aHR, 1.22; 95% CI, 1.04-1.44; P = .02), but there was no difference for patients aged 70 years or older (aHR, 1.06; 95% CI, 0.79-1.42; P = .69). The risk of reoperation was consistently higher with bioprosthesis, regardless of valve position, in all age strata (eg, MVR among patients aged 55-69 years: aHR, 7.75; 95% CI, 5.14-11.69; P < .001); however, the risks of thromboembolism and bleeding were higher in patients aged 65 years and older after mechanical AVR (thromboembolism: aHR, 0.55; 95% CI, 0.41-0.73; P < .001; bleeding: aHR, 0.39; 95% CI, 0.25-0.60; P < .001), with no differences after MVR in any age strata. In this nationwide cohort study, the long-term survival benefit associated with mechanical prosthesis vs bioprosthesis persisted until age 65 years in AVR and age 70 years in MVR.

P294 BIOPROSTHETIC AORTIC VALVE REPLACEMENT IN PATIENTS AT INCREASED RISK OF EARLY STRUCTURAL VALVE DEGENERATION

Abstract Background Biological prostheses are increasingly been used in young patients to avoid anticoagulation. The Edwards Inspiris aortic bioprosthesis is extremely promising in this population, since it has shown reduced calcification of the prosthetic leaflets in preclinical and early clinical studies. Little data are available, however, in patients younger than 65. This study investigates the hemodynamic performance and clinical outcome of the Inspiris bioprosthesis in patients aged 56 ± 10.7 years. Methods and Results Between may 2018 and December 2022, 342 patients aged 56 ± 10.7 years underwent AVR with the Edwards Inspiris bioprosthesis at our institution. 37 of them (10.8%) were younger than 40, and 98 (28.6%) had a BMI &amp;gt;30 kgm2. A minimally invasive approach was used in all isolated AVR patients. Associated procedures were performed in 157 (45.9%) patients. There were 56 redo patients (16.4%). 7 patients died (2%). Major complications included bleeding (32), respiratory failure (20) and BAV requiring PMK (4). The mean follow up was 23 ± 15.2 months (range 2–55). Late valve–related events included endocarditis (5) requiring reoperation. There were no thromboembolic events, valve thrombosis or SVD cases. At follow up, all except four patients reported a significant improvement of their symptomatic status (98.8% were in NYHA II) and quality of life. Conclusion Our study demonstrates excellent early haemodynamics and promising results at up to four years in a cohort of very young patients. Further studies with longer follow–up are needed.