Pericardial Bioprosthesis Research Articles

The Impact of Bicuspid Aortic Valve on Long-term Outcomes After Bioprosthetic Valve Replacement

BackgroundThere are limited data comparing the outcomes of aortic valve replacement surgery between patients with bicuspid aortic valve (BAV) vs tricuspid aortic valve (TAV) morphology. MethodsFrom January 2000 to June 2022, 1122 patients with TAV (n = 562) or BAV (n = 560) underwent surgical aortic valve replacement for aortic stenosis with the same type of bovine pericardial stented bioprosthesis. Propensity score matching identified 350 pairs by matching for age, sex, operative status, chronic lung disease, prior stroke, diabetes, ejection fraction, renal failure on dialysis, coronary artery disease, prior cardiac surgery, and concomitant procedures. The primary end points were long-term survival and reoperation. ResultsPerioperative outcomes, including reoperation for bleeding, atrial fibrillation, heart block requiring pacemaker, stroke, need for dialysis, and operative mortality, were similar between the matched groups. Survival at 10 years was 67% (95% CI, 59%-74%) in the BAV group and 54% (95% CI, 46%-61%) in the TAV group (P = .001). BAV valve was a significant protective factor for late mortality, with a hazard ratio of 0.60 (95% CI, 0.45-0.81; P < .001). Risk factors for late mortality included age, chronic lung disease, low ejection fraction, and renal failure on dialysis. Cumulative incidence of aortic valve reintervention at 10 years was similar between the groups at 10% in the BAV group and 4.9% in the TAV group (P = .55). ConclusionsPatients with BAV likely could not be considered the same as patients with TAV when deciding on the approach of aortic valve intervention.

Transcatheter aortic valve replacement with corevalve self-expanding bioprosthesis: Clinical and durability data up to 12 years

Background and aimsTranscatheter aortic valve replacement (TAVR) determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis but data on very long-term durability are lacking. We sought to evaluate the clinical and hemodynamic outcomes of the CoreValve porcine pericardial self-expanding bioprosthesis at 12-year follow-up. Methods882 inoperable or high-risk patients were treated with the CoreValve bioprosthesis in 8 Italian high-volume centers between 2007 and 2011. The endpoints were 12-year all-cause and cardiovascular mortality, and Cumulative Incidence Functions (CIFs) for severe Structural Valve Deterioration (SVD), Bioprosthetic Valve Dysfunction (BVD), Bioprosthetic Valve Failure (BVF), and severe Hemodynamic Valve Deterioration (HVD). VARC-3 definitions were applied. ResultsBaseline characteristics included a mean age of 83 ± 6 years, and NYHA class III or IV in 76.3 % of patients. The actuarial risk of death at 12 years after TAVR was 95.5 % (CI 93.5 %- 97.1 %).The actual risk of cardiovascular death, weighted against the risk of non-cardiac death at 12 years was 23.9 % (21.0 %–26.8 %). The 12-year actual risk of BVD was 7.0 % (5.3 %–8.9 %), of SVD was 3.6 % (2.5 %–5.2 %), of BVF was 3.12 % (2.02 %–4.57 %), and of severe HVD was 1.7 % (0.9 %–2.9 %). Mean transaortic gradient significantly decreased after the procedure (52 ± 15 mmHg vs 9 ± 5 mmHg, p < 0.001), and remained stable up to 12 years (12 ± 4 mmHg, P = 0.08 vs. discharge). ConclusionsThe first-generation CoreValve bioprosthesis showed reassuring clinical and hemodynamic performance at 12-year follow-up.

Late Outcomes of Porcine and Pericardial Bioprostheses After Mitral Valve Replacement in 1162 Patients

BackgroundDebate continues regarding the superiority of porcine vs pericardial bioprostheses, and data relevant to this comparison are scant. This study compared late survival and structural valve deterioration of porcine and pericardial mitral valve prostheses. MethodsAdults undergoing mitral valve replacement with 1 first-generation porcine valve model and 1 pericardial valve line were reviewed from a prospectively maintained institutional database between 1976 and 2020. Multivariable regression and Cox proportional hazards analysis were used to compare late outcomes. ResultsOf 1162 consecutive patients, 612 (53%) received porcine valves and 550 (47%) received pericardial valves. At 10 years, patient survival (porcine, 36% ± 2%; pericardial, 38% ± 3%; P = .5) and cumulative incidence of mitral valve structural deterioration (porcine, 18% ± 2%; pericardial, 19% ± 3%; P = .3) were similar. The structural failure mode was more likely severe mitral stenosis in pericardial valves (35 of 50 [70%] vs 38 of 106 [36%]; P < .001), and it was more likely severe mitral regurgitation in porcine valves (80 of 106 [75%] vs 19 of 50 [38%]; P < .0001). After adjustment, structural deterioration was associated with younger patient age (P < .001) but not valve type. At 10 years, porcine valves demonstrated a higher cumulative incidence of mitral reoperation (19% ± 2% vs 9% ± 2%; P < .001) and reoperation for structural deterioration (15% ± 1% vs 6% ± 2%; P = .007). ConclusionsThis study demonstrated similar rates of 10-year survival and structural deterioration with porcine and pericardial bioprostheses in mitral valve replacement. The study suggests a lack of major improvement in durability of mitral bioprosthetic valves over time. The failure mode may have a greater influence on surgeon decision making regarding valve choice.

Five-year outcomes of surgical aortic valve replacement with a novel bovine pericardial bioprosthesis.

The short-term performance of the Cingular bovine pericardial aortic valve was proven. This study evaluated its 5-year safety and haemodynamic outcomes. It enrolled 148 patients who underwent surgical aortic valve replacement with the Cingular bovine pericardial aortic valve between March 2016 and October 2017 in 5 clinical centres in China. Safety and haemodynamic outcomes were followed up to 5 years. The incidence of all-cause mortality, structural valve deterioration and reintervention was estimated by Kaplan-Meier analysis. The mean age of patients was 67.7 [standard deviation (SD) 5.1] years, and 36.5% of patients were female. The mean follow-up was 5.3 (SD 1.2) years. Five-year freedom from all-cause mortality, structural valve deterioration and all-cause reintervention were 91.2%, 100% and 99.3%, respectively. At 5 years, the mean gradient and effective orifice area of all sizes combined were 14.0 (SD 5.5) mmHg and 1.9 (SD 0.3) cm2, respectively. For 19- and 21-mm sizes of aortic prostheses, the mean gradients and effective orifice area at 5 years were 17.5 (SD 7.0) mmHg and 1.6 (SD 0.2) cm2 and 13.7 (SD 6.7) mmHg and 1.8 (SD 0.3) cm2, respectively. The incidence of moderate or severe patient-prosthesis mismatch was 4.1% and 0.0% patients at 5 years, respectively. The 5-year safety and haemodynamic outcomes of Cingular bovine pericardial aortic valve are encouraging. Longer-term follow-up is warranted to assess its true durability.

Early Outcomes of Pulmonary Valve Replacement With the Edwards Inspiris Resilia Pericardial Bioprosthesis.

Controversy regarding the optimal pulmonary valve substitute remains, with no approved surgical valve for pulmonary valve replacement (PVR). Furthermore, unfavorable anatomy often precludes transcatheter PVR in patients with congenital heart disease. We therefore sought to evaluate the feasibility of the Edwards Inspiris pericardial aortic bioprosthesis in the pulmonary position in pediatric and adult patients requiring PVR. Data from consecutive patients who underwent PVR from February 2019 to February 2021 at our institution were retrospectively reviewed. Postoperative adverse events included paravalvular or transvalvular leak, endocarditis, explant, thromboembolism, valve thrombosis, valve-related bleeding, hemolysis, and structural valve degeneration. Progression of valve gradients was assessed from discharge to 30 days and one year. Of 24 patients with median age of 26 years (interquartile range [IQR]: 17-33; range: 4-60 years), 22 (91.7%) patients had previously undergone tetralogy of Fallot repair and 2 (8.3%) patients had undergone double-outlet right ventricle repair in the neonatal period or infancy. All patients had at least mild right ventricular (RV) dilatation (median RV end-diastolic volume index 161.4, IQR: 152.3-183.5 mL/m2) and at least moderate pulmonary insufficiency (95.8%) or stenosis (8.3%). Median cardiopulmonary bypass and cross-clamp times were 71 (IQR: 63-101) min and 66 (IQR: 60-114) min, respectively. At a median postoperative follow-up of 2.5 years (IQR: 1.4-2.6; range: 1.0-3.0 years), there were no mortalities, valve-related reoperations, or adverse events. Postoperative valve gradients and the severity of pulmonary regurgitation did not change significantly over time. At short-term follow-up, the bioprosthesis in this study demonstrated excellent safety and effectiveness for PVR. Further studies with longer follow-up are warranted.

Three-year outcomes of surgical valve replacement with Dafodil™ pericardial bioprosthesis: Dafodil™-1 trial.

The Dafodil™-1 trial was designed to evaluate the clinical safety and performance of Dafodil™ pericardial bioprosthesis for replacing diseased native or prosthetic aortic or mitral valves in patients with advanced valvular heart disease (VHD). The Dafodil™-1 trial was a prospective, multicenter, first-in-human clinical trial. Patients were enrolled if they had advanced VHD requiring aortic valve replacement (AVR) or mitral valve replacement (MVR) with or without concomitant valve surgery and having surgical risk scores <4%. Major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI), and stroke; and hemodynamics were analyzed. A total of 136 patients (aortic: 67 and mitral: 69) were enrolled in the trial (with mean age-AVR group: 60.2 ± 8.3 years and MVR group: 49.7 ± 14.4 years). A total of 134 patients (aortic: 66 and mitral: 68) completed the 3-year follow-up (total 300 per 100 patient-years of follow-up). The AVR group demonstrated a significant reduction in the mean pressure gradients from 51.2 ± 24.1 mmHg at baseline to 11.1 ± 6.0 mmHg at the 3-year follow-up (p < 0.0001). The mean effective orifice area (EOA) improved from baseline (0.9 ± 0.6 cm2) to 3-year follow-up (1.8 ± 0.4 cm2) (p < 0.0001). In the MVR group, the mean indexed EOA (iEOA) increased significantly from baseline (0.7 ± 0.4 cm2/m2) to 3-year follow-up (1.1 ± 0.4 cm2/m2) (p < 0.001). There was significant improvement in New York Heart Association functional class and mean SF-12 scores in both groups. At 3-year follow-up, the MACE incidence was 2.3% per 100 patient-years (1.3% strokes per 100 patient-years and 1.3% deaths per 100 patient-years) for AVR group and 4.7% per 100 patient-years (0.6% strokes per 100 patient-years and 4.0% deaths per 100 patient-years) for MVR group. No cases of MI, structural valve deterioration and prosthetic valve endocarditis were reported. The AVR and MVR groups achieved 89.6% and 79.7% MACE-free survival, respectively at 3-year follow-up. The Dafodil™-1 trial demonstrated satisfactory outcomes of clinical safety, hemodynamic performance, and quality-of-life metrics. Additionally, no incidence of structural valve deterioration and very low rates of valve thrombosis during the 3-year follow-up period of Dafodil™-1 first-in-human trial indicated acceptable valve durability up to three years and similar outcomes are warranted for longer follow-ups as a primary goal. https://www.ctri.nic.in/Clinicaltrials/showallp.php?mid1=18377&EncHid=&userName=CTRI/2017/07/009008, CTRI/2017/07/009008.

Long-Term Survival Benefits of Porcine versus Pericardial Bioprostheses in Elderly Patients Undergoing Isolated Aortic Valve Replacement: A 32-Year Study.

The elderly population is growing at an unprecedented rate. Aortic valve disease increases with age. Bioprostheses are the valves of choice for older patients; however, the optimal tissue valve remains undetermined. The purpose of this investigation was to perform a life-of-patient survival comparison of the prototypical porcine and pericardial prostheses in elderly patients. The study population (N = 1480) consisted of patients 65 years of age and older who underwent isolated aortic valve replacement from 1990 through 2005 with a Carpentier-Edwards Porcine (n = 650) or Pericardial (n = 830) bioprosthesis. Propensity score-matched groups were created. Valve selection was not associated with operative mortality. Survival estimates at 10 years were better for Pericardial (41.8%; 95% CI: 37.9 to 45.7) than Porcine (32.6%; 95% CI: 28.8 to 36.3); and 5.2% (95% CI: 3.2 to 7.1) versus 2.0%; (95% CI: 0.8 to 3.2) at 20 years (p < 0.001). E-value analysis found minimal influence of unknown study confounders. Factors associated with long-term mortality were porcine valve (p < 0.001), age (p < 0.001), diabetes mellitus (p < 0.001), preop renal insufficiency (p < 0.001), peripheral artery disease (p = 0.011), congestive heart failure (p = 0.003), New York Heart Association Class III or IV (p = 0.004), surgical history-reoperation (p = 0.012), transient ischemic attack (p = 0.009), prolonged ventilation (p = 0.010), postop renal insufficiency (p < 0.001), and atrial fibrillation (p = 0.009). The indexed Effective Orifice Area (EOAi) was assessed and did not influence observed long-term survival differences. This unusual lifetime study provided substantial evidence for the superiority of the pericardial over the porcine bioprosthesis in the aortic position in elderly patients. It demonstrated enhanced long-term survival benefits for elderly patients without any increase in perioperative mortality. It is intended to inform future investigation into aortic valve design.

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves.

This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses. Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients. There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m2) between the groups. The AVMPG on 1-year echocardiography was 14.0 ± 4.3 and 13.9 ± 5.1 mmHg in the AVALUS and CEPME groups, respectively (the p-value for noninferiority was 0.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19-mm prostheses was significantly lower in the AVALUS group than in the CEPME group (14.0 ± 4.3 vs. 20.0 ± 4.7 mmHg, p = 0.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49 ± 0.40 vs. 1.53 ± 0.38 cm2, p = 0.500) or effective orifice area index (0.91 ± 0.22 vs 0.93 ± 0.23 cm2/m2, p = 0.570) in all the patients, or in the subgroup analysis for the 19-mm prosthesis. There were no differences in the 1-year clinical outcomes between the two groups. The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group (NCT03796442).

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.

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.

Budget impact analysis of a bovine pericardial aortic bioprosthesis versus mechanical aortic valve replacement in adult patients with aortic stenosis in Romania

AimsAn analysis of the budget impact of using a bovine pericardial aortic bioprosthesis (BPAB) or a mechanical valve (MV) in aortic stenosis (AS) patients in Romania.Materials and methodsA decision-tree with a partitioned survival model was used to predict the financial outcomes of using either a BPAB (the Carpentier-Edwards Perimount Magna Ease Valve) or MV in aortic valve replacement (AVR) procedure over a 5-year period. The budget impact of various resource consumption including disabling strokes, reoperations, minor thromboembolic events, major bleeding, endocarditis, anticoagulation treatment and monitoring, and echocardiogram assessments were compared for both types of valves. One-way sensitivity analyses (OWSA) were conducted on the input costs and probabilities.ResultsThe use of BPAB compared to MV approaches budget neutrality due to incremental savings year-on-year. The initial surgical procedure and reoperation costs for BPAB are offset by savings in acenocoumarol use, disabling strokes, major bleeding, minor thromboembolic events, and anticoagulation complications. The cost of the initial procedure per patient is 460 euros higher for a BPAB due to the higher valve acquisition cost, although this is partially offset by a shorter hospital stay. The OWSA shows that the total procedure costs, including the hospital stay, are the primary cost drivers in the model.LimitationsResults are limited by cost data aggregation in the DRG system, exclusion of costs for consumables and capital equipment use, possible underestimation of outpatient complication costs, age-related variations of event rates, and valve durability.ConclusionsAdopting BPAB as a treatment option for AS patients in Romania can lead to cost savings and long-term economic benefits. By mitigating procedure costs and increasing anticoagulation treatment costs, BPAB offers a budget-neutral option that can help healthcare providers, policymakers, and patients alike manage the growing burden of AS in Romania.

Bovine pericardial versus porcine bioprosthetic mitral valves: results from a Korean Nationwide Cohort Study.

Comparisons of long-term clinical outcomes of mitral valve replacement (MVR) between bovine pericardial and porcine bioprostheses are conflicting, with limited research in large-scale real-world clinical settings. This study examined clinical outcomes in MVR according to bioprosthesis type using a national administrative claims database. This study included adult patients undergoing bioprosthetic MVR between 2003 and 2018 using administrative health care data from the Korean National Health Insurance Service database. Propensity score matching with competing risk analysis was used to compare the clinical outcomes according to the type of bioprosthesis. The end points were death, cardiac death, and valve-related events, including the incidence of reoperation, endocarditis, systemic thromboembolism, and major bleeding. A total of 3151 patients underwent bioprosthetic MVR with bovine pericardial (n = 1628, 51.7%) or porcine (n = 1523, 48.3%) bioprostheses. After matching, 1170 pairs were included in the final analysis. During follow-up (median 4.49 years, interquartile range 1.87 -8.75 years), death occurred in 1178 patients (6.8%/patient-year), comprising 730 (4.3%/patient-year) cardiac death. No significant differences were noted between the bovine and porcine groups in the cumulative incidences of death from any cause [adjusted hazard ratio (aHR), 1.00; 95% confidence interval (CI), 0.87-1.14], cardiac mortality (aHR, 0.96; 95% CI, 0.81-1.14), or reoperation (aHR, 1.01; 95% CI, 0.72-1.41). This study on a nationwide comparison between bovine and porcine bioprostheses in MVR found no significant differences in clinical outcomes including mortality, and valve-related reoperation.

Trifecta and Carpentier Edwards aortic bioprostheses: Comparison of six years follow-up outcomes.

To compare mid-term clinical outcomes and hemodynamic performance of the stented pericardial Trifecta bioprosthesis for surgical aortic valve replacement (AVR) with a technically comparable commonly used surgical bioprosthesis. Data from consecutive patients implanted with the TF or the Carpentier Edwards Magna Ease valve were retrospectively analyzed. Primary analysis was performed on a propensity score-matched cohort. Primary endpoints included the composite of death or reoperation and structural valve deterioration. The comparison also included echocardiographic assessments at one-week post-AVR and at the last documented follow-up. Two propensity score-matched groups of 170 patients each were identified from the overall population (n = 486). Incidence of postoperative mortality (2.9% vs. 7.1%, respectively, p = 0.08), and patient prosthesis mismatch (1.2% and 2.4%, p = 0.41) were similar. At mean follow-up of 5.84 (Trifecta) and 6.1 (Carpentier Edwards) years, the incidence of all-cause death/reoperation (15.3% vs. 15.9%, p = 0.88 for Trifecta and Carpentier Edwards, respectively) and structural valve disease (1.8% vs. 2.9%, p = 0.47) were similar. Overall, postoperative mean transvalvular pressure gradients were significantly lower in the Trifecta group than in the Carpentier Edwards group (7.7 ± 3.3 vs. 11.3 ± 3.6 mmHg, p < 0.01). Mean transvalvular gradient remained significantly lower through the last follow-up for small-sized Trifecta valves (19/21 mm; 10.5 ± 4.2 vs. 13.8 ± 5.9 mmHg, p = 0.039) but not for larger valves (10.3 ± 4.8 vs. 9.4 ± 3.5 mmHg, p = 0.31). The Trifecta valve is a valuable alternative to the Carpentier Edwards valve in terms of safety, hemodynamic performance, and mid-term durability. Smaller-sized valves provide additional clinical benefits, given their persistent hemodynamic advantages through mid-term follow-up.

Perimount MAGNA Ease vs. INSPIRIS Resilia Valve: A PS-Matched Analysis of the Hemodynamic Performances in Patients below 70 Years of Age

During the past decade, the Perimount Magna Ease (PME) bioprosthesis has been implanted worldwide for aortic valve replacement (AVR). Recently, the INSPIRIS Resilia (IR) valve has been introduced as the newest generation of pericardial bioprostheses. However, few data have been reported about patients ≤70 years, and no comparisons in terms of hemodynamic performance between these two bioprostheses have been ever reported. Patients aged <70 years undergoing AVR were considered for comparison between PME (n = 238) and IR (n = 192). Propensity score (PS) matching was performed by logistic regression with adjustment for eight key baseline variables. The two prostheses were compared in terms of hemodynamic performances up to 3 years postoperatively. Sub-analysis according to prosthetic size-category was accomplished. A total of 122 pairs with similar baseline characteristics were obtained from the PS-matching. The two prostheses showed comparable hemodynamic performances at one year (Gmean: 11.3 ± 3.5 mmHg vs. 11.9 ± 5.4 mmHg; p = 0.8) and at 3 years postoperatively (Gmean: 12.2 ± 7.9 mmHg vs. 12.8 ± 5.2 mmHg for; p = 0.3). The sub-analysis of size-category confirmed no statistical differences concerning the hemodynamic performances for each annulus size. This first PS-matched analysis demonstrated that the newly developed IR valve achieves the same safety and efficacy of the PME valve during mid-term follow-up in patients aged <70 years.

Externally mounted versus internally mounted leaflet aortic bovine pericardial bioprosthesis: meta-analysis.

Recent studies reported higher-than-expected rates of early structural valve degeneration (SVD) and/or reoperation of externally mounted leaflet aortic bioprosthesis compared with others. This meta-analysis aims to compare the outcomes of bioprostheses with externally versus internally mounted leaflet design in patients who underwent surgical aortic valve replacement (SAVR). MEDLINE and EMBASE were searched through November 2021 to identify comparative studies investigating outcomes following SAVR with either externally or internally mounted leaflet aortic bioprosthesis. Outcomes of interest were reoperation for SVD or any cause and all-cause mortality. Our analysis included 15 observational studies that enrolled a total of 23,539 patients who underwent SAVR using externally mounted (n = 9338; 39.7%) or internally mounted leaflet (n = 14,201; 60.3%) bioprostheses. Externally mounted valves consisted of the Trifecta (Abbott, St Paul, MN) (n = 6146) and the Mitroflow (LivaNova, London, UK) (n = 3192), and all internally mounted valves were the Perimount (Edwards Lifesciences, Irvine, CA). Externally mounted valves compared with the Perimount were associated with higher reoperation rates for SVD [hazard ratio (HR) 3.55, 95% confidence interval (CI) 2.67-4.72; P < 0.001] and any cause (HR 9.36, 95% CI 3.70-23.67; P < 0.001). Furthermore, externally mounted valves demonstrated higher all-cause mortalities (HR 1.33, 95% CI 1.13-1.56; P < 0.001). The present study summarizing updated evidence revealed higher reoperation rates and all-cause mortalities in patients with externally mounted leaflet aortic bioprostheses compared with those with internally mounted design. Choosing the right SAVR valve type is critical part of lifetime management of aortic valve disease.

Early and late effects of aortic root enlargement: Results from the Pericardial Surgical Aortic Valve Replacement Pivotal Trial: A multicenter, prospective clinical trial

ObjectiveDuring surgical aortic valve replacement, prosthesis–patient mismatch is avoided by implanting the largest possible valve, which sometimes requires annular enlargement (ARE). The effects of ARE on mortality remain controversial. We reviewed data from a multinational clinical trial evaluating a novel pericardial bioprosthesis to determine the influence of ARE 5 years postimplant. MethodsPatients with aortic valve disease requiring surgical aortic valve replacement were prospectively enrolled at 25 centers in North America and 13 centers in Europe. Standardized follow-up was prescribed, including serial echocardiography assessed by a core lab. A composite 30-day end point of major morbidity or mortality was defined as death, reoperation for any cause, stroke, deep sternal wound infection, and acute kidney injury. ResultsAmong 602 patients with detailed intraoperative data, 90 (15%) underwent ARE with similar rates in North America (17%) and Europe (12%; P = .11). Implanted valve size was similar in both groups (P = .18). The prevalence of moderate or severe prosthesis–patient mismatch at 12 months and at 5 years was comparable between groups, as was the average indexed effective orifice area (P = .3). Five-year survival (ARE, 91% vs no ARE, 89%) and freedom from 30-day major morbidity and mortality (ARE, 87% vs no ARE, 89%) were also similar. ConclusionsIn this analysis of a prospective, observational clinical trial, we observed that the performance of an aortic root enlargement procedure did not increase morbidity or mortality at 30 days. We found that survival at 5 years was similar between groups, suggesting that the performance of an ARE procedure restored survival to that observed in patients who did not require an ARE.

Standard versus rapid-deployment aortic valve replacement and concomitant myocardial revascularization: 5-year bi-centre clinical outcomes.

Clinical outcomes of 2 generations of pericardial bioprostheses in concomitant aortic valve and coronary artery bypass graft surgery were analysed. Patients were recruited from 2 European centres and divided into 2 groups based on the type of aortic bioprosthesis used: Edwards Intuity Elite™ rapid-deployment (RD) bioprostheses or standard Edwards Magna Ease (ME). A propensity score weighting approach was used for data analysis. A total of 285 patients were included: 144 (50.5%) in the RD group and 141 (49.5%) in the ME group. Thirty-day mortality was 2.8% (RD) and 5% (ME) (P = 0.09). Significantly shorter times of aortic cross-clamp and cardiopulmonary bypass were observed in the RD cohort [94 vs 120 min (P &lt; 0.001); 128 vs 160 min (P &lt; 0.001)]. The RD group was associated with a lower median transvalvular gradient at discharge and follow-up (both P &lt; 0.001). However, 5-year survival was not different, being 93% in RD patients and 91% in the ME group [hazard ratio 0.89 (95% confidence interval: 0.38-2.09), P = 0.784]. The 5-year cumulative incidence of combined events (including percutaneous coronary interventions, endocarditis, thromboembolic events, rehospitalizations and bleeding) favoured the ME group [16.1% (RD) vs 7.3% (ME)] [hazard ratio 2.38 (95% confidence interval:1.03-5.52), P = 0.043]. However, this turned similar when the Cox model analysis was adjusted for revascularization variables (P = 0.067). RD and ME pericardial bioprostheses used in concomitant aortic valve replacement and coronary artery revascularization provide equivalent clinical and haemodynamic 5-year outcomes, despite constant lower transvalvular gradients and shorter surgical operating times observed with RD technology.

Pulmonary valve replacement via ministernotomy, early experience

The population of patients requiring pulmonary valve replacement (PVR) following surgery of the right ventricular outflow tract during infancy is growing. Full conventional sternotomy is widely used for PVR, while left anterior minithoracotomy has been described only in selected cases. Our aim is to describe our early experience with upper left ministernotomy as a systematic approach for PVR in teenagers and adult patients. From December 2019 to December 2021, 13 consecutive patients underwent PVR via ministernotomy at our institution. The indications were severe pulmonary regurgitation in 11 patients and severe conduit stenosis in 2 patients. Ten patients (76.9%) already had at least 1 sternotomy. Pulmonary homografts, stentless porcine bioprostheses or stented pericardial bioprostheses were implanted. Age at operation was 24.6 years old (17.6–38.4). There were no deaths, no cardiac injuries and no conversions to full sternotomy. The 3rd intercostal space was the most frequently used for the leftward extension of the ministernotomy ( Fig. 1 ). In 6 patients (46.1%), a residual intracardiac shunt was present and aortic cross-clamping was necessary. Median cardiopulmonary bypass and cross-clamping times were 70 (64–105.5) and 50 (40–75) minutes, respectively. Median intensive care and hospital stays were 2 (1–2.5) and 7 (6–11) days, respectively. All patients are doing well after a median follow-up of 16.2 months (13.5–19.0). Ministernotomy is a safe approach for PVR and redo PVR in teenagers and adults. This approach combines the advantages of minimally invasive surgery (expedited recovery) and those of a midline incision such as the access to the ascending aorta and the absence of additional scar in cases of redo PVR.

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes.

OBJECTIVESThis analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement.METHODSKaplan–Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Association (NYHA) functional class were also evaluated.RESULTSA total of 1118 patients have received the Avalus valve; 564 have completed the 5-year follow-up. The median follow-up was 4.85 years (4810 patient-years total follow-up). At baseline, the mean age was 70.2 ± 9.0 years; 75.1% of patients were male. The Society of Thoracic Surgeons predicted risk of mortality was 2.0 ± 1.4%. Most patients were in NYHA functional class II (46.8%) or III (40.3%). At the 5-year follow-up, the overall Kaplan–Meier survival rate was 88.1% (85.9–90.0%). The Kaplan–Meier event rates were 5.6% (4.3–7.2%) for thromboembolism, 4.4% (3.2–6.0%) for endocarditis, 0.2% (0.0–0.7%) for a major paravalvular leak and 3.2% (2.3–4.6%) for reintervention. There were no cases of SVD. The mean gradient decreased from 42.1 ± 17.1 mmHg at baseline, to 13.1 ± 4.7 mmHg at discharge and remained stable at 12.5 ± 4.6 mmHg at 5 years. More than 95% of patients were in NYHA functional class I/II 5 years after surgery.CONCLUSIONSThe findings of a high survival rate, excellent safety, no SVD and stable haemodynamic performance and functional status through 5 years of follow-up are encouraging. Additional follow-up is needed to assess the long-term durability of this contemporary surgical bioprosthesis.

Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria

ObjectivesThe Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration. MethodsFrom 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria. ResultsOverall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively. ConclusionsWith a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position. Video Abstract [Display omitted]