Perimount Magna Research Articles

Adaptation of Aortic Bioprosthetic Valves for Pulmonary Position: Comparative Analysis of Transcatheter and Surgical Valves.

Pulmonary valve dysfunction is common in congenital heart disease, often leading to interventions like right ventricular outflow tract reconstruction. Transcatheter pulmonary valve replacement (TPVR) has emerged as a successful alternative to surgery, showcasing promising outcomes for managing postoperative RVOT complications. The study aimed to compare two bioprosthetic valves-Carpentier Edwards Perimount Magna Ease surgical valve and Edwards SAPIEN 3 transcatheter valve-originally designed for aortic use but adapted for pulmonary applications. The hemodynamic characteristics of a 26-mm SAPIEN 3 and a 25-mm Magna Ease were assessed in a pulse duplicator under both pulmonary and aortic conditions. Furthermore, detailed structural analyses of the leaflets were conducted using computational simulations under these conditions. The results highlighted significant differences in the hydrodynamic and structural characteristics of these two bioprosthetic valves when exposed to pulmonary versus aortic conditions. The study enhances our understanding of the biomechanics involved in surgical and transcatheter pulmonary valve replacement.

The Mitris RESILIA Valve: New Skin for a Proven Design.

By incorporating the best features of the Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve (Edwards Lifesciences Corporation, Irvine, California) and INSPIRIS RESILIA tissue (Edwards Lifesciences Corporation, Irvine, California), the mitris valve inherits the advantages of the remarkable hemodynamic performance of the former and the durability of the latter. In this paper, we will summarize the process that led to the creation of this new valve and report on the first implant's feasibility and first impression. The mitris valve has an overall implantability profile, overlapping the previous generation with no added challenges, but compared to the PERIMOUNT Magna Mitral Ease valve, the mitris valve boasts a more pliable saddle-shaped sewing cuff that is specifically tailored to fit the complex structure of the mitral valve with a lower stent height. This could be particularly beneficial in the context of double-valve replacement, as it may prevent any disturbance to the bioprosthesis located in the aortic position in small annulus. This could also prevent some rare but unpleasant complications such as left ventricle outflow obstruction or rupture of the atrioventricular sulcus. In addition, it could allow for better adherence to the saddle-shaped annulus of the mitral valve with the possibility of less stress (and therefore fibrosis) on the valve tissue, while further reducing the degeneration time. Furthermore, thanks to the possibility of being temporarily adjusted inwards, it is possible to ensure greater implantability compared to the previous generation of Magna Edwards mitral valves. Thanks to INSPIRIS technology, which prevents the generation of free aldehydes that promote oxidation and calcification of pericardial tissue, it is possible to assume that the durability will probably also improve. This reinforces the trustworthiness of the mitris valve.

Comparison of four aortic bioprostheses: Hancock II vs. St Jude Trifecta vs. Carpentier-Edwards Perimount Magna vs. Magna Ease-mid-term results (COMPARE SAVR study).

In the era of percutaneous aortic valve implantation, biological valves are the preferred prostheses implanted in patients undergoing surgical aortic valve replacement (sAVR). The aim was to present a real-life analysis of mid-term sAVR outcomes for the four aortic bioprostheses: the Hancock II, the Carpentier-Edwards Perimount Magna, the Carpentier-Edwards Perimount Magna Ease and the Trifecta valve. This is a retrospective study based on data from the Polish National Cardiac Surgery Database. The study population comprised of 1,589 consecutive patients, of whom 432 were in the Hancock II group, 356 in the Carpentier-Edwards Perimount Magna group, 427 in the Carpentier-Edwards Magna Ease group, and 374 in the Trifecta group. A comparison of the four groups was performed using analysis of variance (ANOVA) or Kruskal-Wallis test with appropriate post hoc tests (Tukey HSD or Steel-Dwass, respectively). Patients in the Hancock II group were older, had higher New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) classes, had lower prevalence of hypertension and hyperlipidemia but higher prevalence of diabetes. The lowest mean valve size was observed in Trifecta group and the highest was in the Magna group (P<0.001). Survival analysis showed no significant differences in in-hospital mortality: 3.9% in Hancock II, 3.1% in Perimount, 3.3% in Magna and 2.1% in Trifecta group. Five-year mortality was significantly higher in Hancock II group (25.7%) compared to the other bioprostheses: 12.1% in Perimount, 9.1% in Magna and 10.70% in Trifecta group respectively. The 5-year mortality rate was significantly higher in the Hancock II group compared to the other bioprostheses. In contrast, Trifecta, Perimount Magna, and Magna Ease had similar 5-year mortality rates.

Thrombocytopenia after sutureless and standard stented aortic valve replacement: a retrospective analysis of risk factors, clinical course, and early outcome

ObjectivesThrombocytopenia following Perceval aortic valve replacement has been described previously with variable outcome. Studies have lacked a robust analysis of platelet fluctuation and factors affecting it. We aimed to statistically describe the trend in thrombocyte variability as compared with conventional aortic valve replacement, and to assess predictors as well as impact on associated outcomes.MethodsOne hundred consecutive patients with first-time Perceval were retrospectively compared to 219 patients after Perimount Magna Ease valve replacement. The primary outcome was the serial thrombocyte count on day 0–6. Generalized estimating equations were used to analyse the data using fixed-effect models: for the effect of the post-operative day on platelet count, and random-effect models estimating both time-variant (platelets) and time in-variant variables (valve type, age, LV function, pre-op platelet level).ResultsPerceval patients were older (72 ± 1 vs 68 ± 1 years, p < 0.01) with higher NYHA status (3(2–3) vs 2(1–2), p < 0.001). Mean platelet count in the sutureless group was lowest on day 2 (91.9 ± 31.6 vs 121.7 ± 53.8 × 103 µl−1), and lower on day 4 (97.9 ± 44) and 6 (110.6 ± 61) compared to the conventional group (157.2 ± 60 and 181.7 ± 79) but did not result in a higher number of transfusions, bleeding or longer hospital stay (p > 0.05). Reduced platelet count was a strong predictor of red cell transfusion in the conventional (p = 0.016), but not in the sutureless group (p = 0.457). Age (Coef -1.025, 95%CI-1.649—-0.401, p < 0.001) and CPB-time (Coef 0.186, 95%CI-0.371—-0.001, p = 0.048) were predictors for lower platelet levels.ConclusionConsidering the older patient profile treated with Perceval, postoperative thrombocytopenia does not impact on outcome in terms of transfusions, complications or hospital stay.

Thrombocytopenia after Aortic Valve Replacement Using Sutureless Valves.

Sutureless valves are widely used in aortic valve replacement surgery, with Perceval valves and Intuity valves being particularly prominent. However, concerns have been raised about postoperative thrombocytopenia with Perceval valves (Corcym, UK). We conducted a comparative analysis with the Intuity valve (Edwards Lifesciences, USA), and assessed how thrombocytopenia affected patient and transfusion outcomes. Among 595 patients who underwent aortic valve replacement from June 2016 to March 2023, sutureless valves were used in 53 (Perceval: n=23; Intuity: n=30). Platelet counts were monitored during hospitalization and outpatient visits. Daily platelet count changes were compared between groups, and the results from patients who underwent procedures using Carpentier Edwards Perimount Magna valves were used as a reference group. Compared to the Intuity group, the Perceval group showed a significantly higher amount of platelet transfusion (5.48±1.64 packs vs. 0.60±0.44 packs, p=0.008). During the postoperative period, severe thrombocytopenia (<50,000/μL) was significantly more prevalent in the Perceval group (56.5%, n=13) than in the Intuity group (6.7%, n=2). After initial postoperative depletion, daily platelet counts increased, with significant differences observed in the extent of improvement between the Perceval and Intuity groups (p<0.001). However, there was no significant difference in early mortality or the incidence of neurological complications between the 2 groups. The severity of postoperative thrombocytopenia differed significantly between the Perceval and Intuity valves. The Perceval group showed a significantly higher prevalence of severe thrombocytopenia and higher platelet transfusion volumes. However, thrombocytopenia gradually recovered during the postoperative period in both groups, and the early outcomes were similar in both groups.

Perceval sutureless bioprosthesis versus Perimount sutured bioprosthesis for aortic valve replacement in patients with aortic stenosis: a retrospective, propensity-matched study

BackgroundRapid-deployment aortic valve replacement (RDAVR) is an alternative to conventional AVR (cAVR) for aortic stenosis. Benefits include a reduction in operative times, facilitation of minimal access surgery and superior haemodynamics compared to conventional valves. However, further evidence is required to inform guidelines, preferably in the form of propensity-matched studies that include mid-term follow-up data.MethodsThis was a single-centre, retrospective, propensity-matched cohort study comparing the Perceval and conventional Perimount Magna Ease valve for short- and mid-term clinical parameters and size-matched mid-term echocardiographic parameters (n = 102 in both groups) from 2014 to 2020. Data were extracted from a nationally managed dataset.ResultsThere were no demographic differences between the matched groups. The Perceval group had shorter cross-clamp time (Perceval 62 [49–81] minutes; Perimount 79 [63–102] minutes, P < 0.001), shorter bypass time (Perceval 89 [74–114] minutes; Perimount 104 [84–137] minutes, P < 0.001), and more frequent minimally-invasive approaches (Perceval 28%; Perimount 5%, P < 0.001). Size-matched haemodynamics showed initially higher gradients in the Perceval group, but haemodynamics equalised at 12 + months. The Perceval group had a more favourable % change in the left ventricular posterior wall dimension at 2 + years (Perceval − 4.8 ± 18; Perimount 17 ± 2).ConclusionsThe Perceval facilitated shorter operations, which may benefit intermediate-high-risk, elderly patients with comorbidities requiring concomitant procedures. It also facilitated minimally invasive surgery. Size-matched haemodynamic performance was similar at mid-term follow-up, with the Perceval possibly better facilitating regression of left ventricular hypertrophy.

Early and mid-term outcomes after aortic valve replacement using a novel tissue bioprosthesis: a systematic review.

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

The Measurement of Bovine Pericardium Density and Its Implications on Leaflet Stress Distribution in Bioprosthetic Heart Valves.

Bioprosthetic Heart Valves (BHVs) are widely used in clinical practice, showing promising outcomes. Computational modeling offers a valuable tool for quantitatively characterizing BHVs. To ensure the accuracy of computational models, it is crucial to consider precise leaflet properties, including mechanical properties and density. Bovine pericardium (BP) serves as a common material for BHV leaflets. Previous computational studies often assume BP density to approximate that of water or blood. Given that BP leaflets undergo various treatments, such as tissue fixation and anti-calcification, this study aims to measure the density of BP used in BHVs and assess its impact on leaflet stress distribution. Eight square BP samples were laser cut from Edwards BP patches and their density was determined. Specimen weight was measured using an A&D Analytical Balance, while volume was assessed through high-resolution imaging. Additionally, finite element models resembling a BHV, like the Carpentier-Edwards PERIMOUNT Magna, were constructed in ABAQUS. The average density of the BP samples was found to be 1,410kg/m3. During the acceleration phase of a cardiac cycle, the maximum stress reached 1.89MPa for a density of 1,410kg/m3 and 2.47MPa for a density of 1,000kg/m3 (a 30.7% difference). In the deceleration phase, the maximum stress reached 713kPa and 669kPa, respectively. Leaflet stress distribution and motion in BHVs are influenced by density variations. Establishing an accurate density value for BHV leaflets is imperative for enhancing the computational models, which can ultimately contribute to improved BHV design and outcomes.

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.

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease.

The INSPIRIS aortic valve combines the RESILIA proprietary tissue preservation process and an expandable stent frame to benefit future transcatheter valve-in-valve procedures. As the INSPIRIS valve became commercially available in 2017, mid-term outcome reports are scarce. We aimed to evaluate mid-term safety and echocardiographic performance of the INSPIRIS valve in comparison to its predecessor, the Carpentier Edwards Perimount Magna Ease (ME). This study was a retrospective single-centre study. Clinical results included early postoperative outcomes, mid-term mortality and readmission for cardiovascular cause or stroke. Echocardiographic follow-up (FU) was performed at discharge and 1-3, 6, 12 and 24 months. Clinical end point analyses were accomplished with a propensity score matching analysis and FU echocardiographic data comparisons using pairwise analyses and linear mixed-effect models. We included 953 patients who received an INSPIRIS (n = 488) or ME (n = 463) bioprosthesis between January 2018 and July 2021. In the matched population (n = 217 per group), no significant difference in short-term outcomes was observed, survival was similar at 30 months (INSPIRIS: 94% vs ME: 91%, P = 0.89), but freedom from readmission was higher in the INSPIRIS group (94% vs 86%, P = 0.014). INSPIRIS valves had a lower gradient at discharge (∼10 vs 14 mmHg, P < 0.001), 1-3 months (∼10 vs 12 mmHg, P < 0.001) and 24 months (∼11 vs 17 mmHg, P < 0.001) in paired analyses and significantly lower evolution of mean transvalvular gradients compared to ME. This study represents the largest comparative evaluation of the INSPIRIS to the ME valves, which demonstrated safe clinical outcomes and favourable haemodynamic performance at 2 years. Long-term FU is underway.

Rapid deployment versus its conventional counterpart in aortic valve replacement: comparison of early hemodynamic outcomes.

Edwards Intuity is designed for rapid deployment based on the structure of Magna Ease. This study was conducted to compare early hemodynamic performance between the two valves. Patients who underwent aortic valve replacement (AVR) using Edwards Intuity or Carpentier-Edwards PERIMOUNT Magna Ease in our institution from June 2016 to July 2021 were enrolled. Intuity valve was used in 215 patients, and Magna Ease valve was used in 198 patients, respectively. Early postoperative echocardiographic data were available in 99.0% (409/413) of the patients. The transvalvular mean pressure gradient, effective orifice area, and effective orifice area index were compared between the valves stratified by prosthesis size. There were no differences in the proportion of female patients or body surface area between the groups. Mean pressure gradient on early postoperative echocardiography was significantly lower in Intuity valve than Magna Ease valve for 19, 21, 23, and 25 mm valves (15.5±5.0 vs. 20.8±9.1 mmHg, P=0.004; 12.7±4.2 vs. 15.6±5.3 mmHg, P=0.001; 11.5±3.3 vs. 13.4±5.8 mmHg, P=0.034; and 9.9±3.1 vs. 12.3±4.0 mmHg, P=0.029; respectively). Effective orifice area was larger in Intuity valve than Magna Ease valve for 19 mm valve (1.45±0.38 vs. 1.19±0.28 cm2, P=0.002), and effective orifice area index was also larger in Intuity valve than Magna Ease valve for 19 mm valve (0.96±0.26 vs. 0.80±0.20 cm2/m2, P=0.005). Early clinical outcomes, including operative mortality and postoperative complications, demonstrated no significant differences between the groups. Edwards Intuity demonstrated superior early hemodynamic performance compared with Magna Ease in a size-by-size comparison, and this superiority was more definite for small prostheses.

Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI): Characteristics and early results from a nationwide registry.

Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI) is an emerging treatment alternative to reoperation in high-surgical risk patients with failed mitral bioprostheses. We aimed to describe the characteristics of ViV-TMVI and evaluate its 30-day outcomes in the Polish population. A nationwide registry was initiated to collect data on all patients with failed mitral bioprosthesis undergoing ViV-TMVI in Poland. This study presents the results of a 30-day clinical and echocardiographic follow-up. Overall, 27 ViV-TMVI procedures were performed in 8 centers up to May 2022 (85% from 2020 onwards). The mean (standard deviation [SD]) age was 73 (11.6) years with the median (interquartile range [IQR]) Society of Thoracic Surgeons score of 5.3% (4.3%-14.3%). Mean (SD) time between surgical implantation and ViV-TMVI was 8.2 (3.2) years. Failed Hancock II (29%) and Perimount Magna (22%) bioprostheses were most frequently treated. Mechanisms of failure were equally often pure mitral regurgitation or stenosis (both 37%) with mixed etiology in 26%. Balloon-expandable Sapien 3/Ultra valves were used in all but 1 patient. Technical success was 96.3% (1 patient required additional prosthesis). Mean (SD) transvalvular mitral gradient reached 6.7 (2.2) mm Hg and mitral valve area was 1.8 (0.4) cm2. None of the patients had moderate or severe mitral regurgitation with only 14.8% graded as mild. We achieved device success in 92.6% of patients (2 patients had mean gradient ≥10 mm Hg) and procedural success in 85.6%. There were no deaths, cerebrovascular events, or need for mitral valve surgery during the 30-day follow-up. In short-term follow-up, ViV-TMVI is a safe and effective alternative for patients with failed mitral bioprosthesis at high surgical risk of re-operation. Longer observations on larger samples are warranted.

C55 A GIANT PSEUDOANEURYSM OF MITRAL–AORTIC INTERVALVULAR FIBROSA PRESENTING AS RECENT–ONSET ANGINA AND CARDIAC ARREST DUE TO VENTRICULAR FIBRILLATION

Abstract A 66–year–old man was suddenly referred to the emergency department (ED) for an extra–hospital cardiac arrest due to ventricular fibrillation, promptly treated by a single DC shock. Four months prior, he had undergone aortic valve replacement with a biological valve prosthesis (BVP, Perimount Magna n. 23) for severe aortic stenosis. One month after cardiac surgery the patient was hospitalized for acute cholecystitis requiring antibiotics and percutaneous cholecystostomy. On arrival to the ED the patient was awake and completely asymptomatic; no fever during days before the episode. He had been complaining of constricting retrosternal chest pain during physical exertion for ten days. However, no signs of ischemia were seen on the EKG. TT echo showed a very large pulsatile anaechogenic area posteriorly to BVP. Transesophageal echocardiography (TEE 2D, Traditional 3D and TrueVue) highlighted a very large pseudoaneurysm of mitral–aortic interventricular fibrosa (P–MAIVF; Figures 1 and 2, long axis and short–axis views). TEE features included: 1) a very large cavity with thickened walls, extended for more than two–thirds of the prosthetic circumference and with multiple septa; 2) a large communication between the left ventricular outflow tract (LVOT) and P–MAIVF (see yellow dotted line in Fig.1A) with a to–and–fro flow into the cavity and a prominent systolic pulsation; 3) no paraprosthetic leak and absence of any attached mass or intraprosthetic aortic regurgitation. These findings suggested a prosthetic aortic valve endocarditis with an extensive periannular involvement. Moreover, the P–MAIVF may have led to “ab extrinseco” compression of the left coronary artery, with a potential role in the genesis of chest pain and ventricular arrhythmia (in absence of significant CAD at preoperative coronary angiography). An empiric antibiotic therapy with daptomycin and piperacillin–tazobactam was started. The patients subsequently underwent Bentall surgery with a subannular implantation technique (Perimount valvular prosthesis n.23 and Gelweave vascular prosthesis n.28). Figure 3 shows an intraoperative image and postoperative TEE. In conclusion, P–MAIVF is an ominous complication of prosthetic valve endocarditis. Presentation with exertional angina and cardiac arrest is unusual. TEE is sensitive for diagnosis and 3D echo provides better insights into the anatomy helping formulate an appropriate surgical strategy.

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.

Hemodynamic Comparison between the Avalus and the Perimount Magna Ease Aortic Bioprosthesis up to 5 Years.

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

Postoperative complications for the new Chinese and imported bioprosthetic surgical valves replacement

This study assessed structural valve degeneration (SVD) clinical difference of BalMedic and Edward bioprosthetic valves in Zhuzhou areas, Hunan province, China, in the past 6 years. From August 2016 to August 2022, Chinese bioprosthetic valves were implanted in 77 patients while imported valves were implanted in 64 patients, to compare their postoperative SVD. Results showed that, 4 patients (9.1%) underwent SVD after surgery for Chinese mitral valve replacement (MVR) group. In addition, 2 patients (6.3%) underwent SVD after procedure for the imported MVR group. Both of them showed no statistically significant difference (p &gt; 0.05). As for the Chinese AVR group, 3 patients (9.1%) underwent SVD after operation, and in contrast, as for the imported AVR group, 4 patients (12.5%) underwent SVD after surgery. Therefore, the short-term follow-up study in Zhuzhou area indicates good durability and efficiency of SVD, compared with its counterparts from Carpentier-Edwards PERIMOUNT Magna Ease, between mitral valve group and aortic valve group, (p&gt;0.05)

Impact of high-pressure balloon aortic valvuloplasty on the hydrodynamic result after a transcatheter valve-in-valve procedure.

The aim of this study was to investigate the degree of functional improvement of a transcatheter heart valve (THV) for valve-in-valve after bioprosthetic valve fracture (BVF) of three small surgical aortic valve bioprostheses (SAVBP) using high-pressure balloon aortic valvuloplasty (HP-BAV) under standardized ex-vivo-conditions. A THV 26 mm (Evolut R) and SAVBP 21 mm (Perimount Magna Ease, Trifecta, and Epic supra [n = 4] were used. Mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area (GOA), minimal internal diameter (MID), and pinwheeling index (PWI) were analyzed before and after HP-BAV of the SAVBP using a noncompliant balloon. Fracturing of the SAVBP was done before implantation of the THV and the balloon pressures at the point of fracture were recorded. The Magna Ease and Epic fractured at balloon pressures of 18 and 8 atm, respectively. The Trifecta did not fracture up to a balloon pressure of 30 atm but was dilated. HP-BAV led to increased THV expansion as evident by straightened coaptation lines of the Evolut R 26 mm with reduced PWI, increased MID, and increased GOA in all 21 mm SAVBP. Evolut R showed significantly lower MPG and higher EOA as ViV in all prostheses after HP-BAV (p &lt; 0.001). MPG and EOA of Evolut R differed regarding the SAVBP. Evolut R presented the lowest MPG and highest EOA in Magna Ease and the highest MPG and lowest EOA in Epic supra. The degree of function improvement of the same THV as ViV after HP-BAV depends on the surgical valve model. Functional improvement can also be achieved without valve fracture.

Ex vivo evaluation of the Ozaki procedure in comparison with the native aortic valve and prosthetic valves.

OBJECTIVESWe investigated the hydrodynamic performance and cusp kinematics of the Ozaki neocuspidized aortic valve in comparison with the native aortic and prosthetic valves in an ex vivo study.METHODSNative aortic valves of swine hearts were replaced by aortic valve substitutes, and their hydrodynamic performance (effective orifice area and mean pressure gradient) was evaluated in a mock circulation under defined conditions. The following aortic valve substitutes were investigated: native aortic valve, Ozaki valve, Perimount Magna Ease, Trifecta and St. Jude Medical Masters. All prosthetic valves had a labelled size of 21 mm.RESULTSThe Ozaki valve and native aortic valve showed a similar and significantly larger orifice area than all investigated prosthetic valves particularly at high flow rates. There was no significant difference between the Ozaki valve and the native aortic valve. The native aortic valve and Ozaki valve showed a similar increase in orifice area with increasing flow through the valve while prosthetic valves showed a markedly weaker increase. Similarly, the native and Ozaki valve showed a similar increase in mPG with forward flow which was weaker than prosthetic valves. Cusp kinematics were similar between the native and Ozaki valve, whilst prosthetic valves were clearly distinguishable from them.CONCLUSIONSThe Ozaki procedure showed excellent hydrodynamic performance compared to prosthetic valves and showed similar cusp motion characteristics to the native aortic valve. Our results suggest that the Ozaki neocuspidized valve behaves physiologically in many aspects, which may contribute to beneficial clinical outcomes.

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]

Trifecta versus Perimount Magna Ease aortic valves: Failure mechanisms.

BackgroundThere are increasing reports of early externally mounted pericardial Trifecta bioprosthesis failure. We compared the hemodynamic performance of Trifecta and Carpentier–Edwards Perimount Magna Ease valves to determine the failure mechanism.MethodsWe retrospectively included 270 consecutive patients (age: 73.4 ± 8.2 years; 57.5% male; mean follow-up: 48.0 ± 20.3 months) who underwent aortic valve replacement from 2014 to 2021 at a single center and compared the Trifecta (N = 137) and Carpentier–Edwards Perimount Magna Ease valve (N = 133) patients.ResultsThe prosthetic valve major aortic regurgitation incidence was higher for the Trifecta than that for the Carpentier–Edwards Perimount Magna Ease valve (6.3% vs. 0%, P < 0.009). Among the Trifecta failures, 33% developed structural valve deterioration, but all requiring redo aortic valve replacement developed major prosthetic valve aortic regurgitation. Freedom at 5 years from redo aortic valve replacement due to structural valve deterioration was significantly lower for Trifecta (89.4% vs. 100%, P = 0.003). The reoperation hazards were determined for Trifecta (vs. Carpentier–Edwards Perimount Magna Ease): 11.6 (1.47–90.9; P = 0.02), prosthetic valve aortic regurgitation: 2.38 (1.70–3.32; P < 0.01), structural valve deterioration: 20.82 (4.08–106.2; P < 0.01), 5-year mean transprosthetic pressure gradient: 1.14 per 1-point increase (1.03–1.24; P = 0.007), and urgent surgery: 10.1 (2.59–39.0; P = 0.001). The Cox regression analysis identified that prosthetic valve aortic regurgitation solely contributed to redo aortic valve replacement (hazard ratio: 2.38; confidence intervals: 1.70–3.32).ConclusionsSignificantly, more early failures occurred with the Trifecta valve than the Carpentier–Edwards Perimount Magna Ease valve but the Trifecta showed reasonable mean transprosthetic pressure gradient over time. Prosthetic valve aortic regurgitation and calcific structural valve deterioration synergistically contributed to Trifecta valve failure alternatively.