Magna Ease Valve Research Articles

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.

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.

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.

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.

Structural valve deterioration of bioprosthesis in the aortic position: A single-center experience.

Aortic valve replacement (AVR) is one of the most common open-heart surgical procedures. The durability of the tissue valve in the aortic position is crucial in AVR and transcatheter AVR. We reviewed structural valve deterioration using echocardiographic follow-up in three types of surgical aortic tissue valves. A retrospective analysis was conducted where hemodynamic deterioration was evaluated and compared using transthoracic echocardiography, including pressure gradients and effective orifice area. Kaplan-Meier analyses were used to summarize the time to failure. The study included 133 Trifecta, 156 Epic, and 321 Magna Ease valves. Seventy-six percent(1941/2551) of patients had to be excluded due to insufficient echo data. Through univariate analysis, 34% (216/610) of valves met deterioration criteria after 24 months. Unadjusted survival curves showed a significant difference between valves (p ≤ .001), with a longer mean time to deterioration for the Magna Ease versus Trifecta and Epic of 68.9 versus 50.1 and 38.2 months, respectively. A Cox proportional hazard analysis found worse hazard ratios of 1.69 (p ≤ .04) and 2.4 (p ≤ .01) for Trifecta versus Magna and Epic versus Trifecta, respectively. All three valve types demonstrated structural valve deterioration on echocardiographic follow-up with significant differences in rate. The Magna Ease appeared to have the highest durability, and the Epic the lowest. Further investigation is warranted to confirm the results in a larger multicenter study.

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.

"Roof" technique-a modified aortotomy closure in Y-incision aortic root enlargement upsizing 3-4 valve sizes.

"Roof" technique-a modified aortotomy closure in Y-incision aortic root enlargement upsizing 3-4 valve sizes.

Structural valve degeneration of bioprosthetic aortic valves: A network meta-analysis

ObjectiveTo compare the rate of structural valve degeneration (SVD) following surgical aortic valve replacement associated with the Trifecta (TF) valve (St Jude Medical) versus other bioprosthetic valves. MethodsA systematic literature search was conducted for studies comparing durability of the TF prosthesis to other valve types, including Perimount (Edwards Lifesciences), Carpentier-Edwards Perimount Magna Ease (ME) (Edwards Lifesciences), and Mitroflow (LivaNova USA) after surgical aortic valve replacement. Random effect pairwise and network meta-analyses were performed to compare the incident rate ratio of the composite primary outcome of SVD or reintervention due to SVD. ResultsTen studies with 31,029 patients were included, of whom 6832 received TF, 19,023 received Perimount, 3514 received ME, and 713 received Mitroflow. When compared with TF, ME was associated with lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.92; P = .04). Similarly, at network meta-analysis, when compared with TF, only ME was associated with significantly lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.97). ME (incident rate ratio, 0.18; 95% CI, 0.07-0.47) and PM (incident rate ratio, 0.34; 95% CI, 0.12-0.98) were associated with significantly lower rate of all-cause reintervention when compared with TF. No differences in the other secondary outcomes were found. ConclusionsThe TF valve is associated with significantly higher rates of SVD or reintervention for SVD than the ME valve, but not the Mitroflow valve. The TF valve was also associated with higher rates of all-cause reintervention than ME and Perimount valves. The underlying mechanism(s) of these findings warrant further investigation.

Magna ease bioprosthetic aortic valve: mid-termhaemodynamic outcomes in 1126 patients.

The Magna Ease aortic valve (Edwards Lifesciences, Irvine, CA) is a third-generation bioprosthetic valve developed as a modification of the well-studied Perimount and Magna valve designs. This study's objective is to evaluate a large, single-centre experience with Magna Ease aortic valve replacement (AVR) focusing on clinical outcomes and haemodynamic performance. All patients undergoing AVR between 8/2010 and 10/2018 at our institution implanted with the Magna Ease valve were included except those undergoing ventricular assist device or congenital aortic surgery. Primary outcomes were overall survival and freedom from reoperation. Mean transprosthetic gradient (mTPG) and structural valve deterioration (SVD) served as secondary outcomes. Totally 1126 consecutive implantations of Magna Ease valves were included. Concomitant procedures were performed in 56.5% (n = 636). No severe patient-prosthesis mismatch (PPM) was present at implantation. Overall survival at 30 days, 1 year, 5 years and 9 years was 97.2%, 95.0%, 86.1% and 78.2%, respectively, with improved survival for isolated AVR. Total of 2.4% (n = 27) of patients required reoperation with 0.3% (n = 4) for SVD. Echocardiographic follow-up data revealed low mTPG throughout the study period. SVD occurred in 28.7% of patients at a mean of 3.9 years post implantation. Magna Ease AVR maintained low mean transprosthetic gradients throughout mid-term evaluation and was associated with excellent overall survival and freedom from reoperation at nine years post implantation.

Aortic valve neocuspidization with autologous pericardium in adult patients: UK experience and meta-analytic comparison with other aortic valve substitutes.

We sought to provide further evidence on the safety and efficacy of aortic valve neocuspidization (AVNeo) using autologous pericardium in adult patients with aortic valve disease by reporting clinical and echocardiographic results from the first UK experience and performing a meta-analytic comparison with other biological valve substitutes. We reported clinical and echocardiographic outcomes of 55 patients (mean age 58 ± 15 years) undergoing AVNeo with autologous pericardium in 2 UK centres from 2018 to 2020. These results were included in a meta-analytic comparison between series on AVNeo (7 studies, 1205 patients, mean weighted follow-up 3.6 years) versus Trifecta (10 studies, 8705 patients, 3.8 years), Magna Ease (3 studies, 3137 patients, 4.1 years), Freedom Solo (4 studies, 1869 patients, 4.4 years), Freestyle (4 studies, 4307 patients, 7 years), Mitroflow (4 studies, 4760 patients, 4.1 years) and autograft aortic valve (7 papers, 3839 patients, 9.1 years). In the present series no patients required intraoperative conversion. After mean follow-up of 12.5 ± 0.9 months, 3 patients presented with endocarditis and 1 required reintervention. The remaining patients had absent or mild aortic valve insufficiency with very low peak and mean transvalvular gradients (16 ± 3.7 and 9 ± 2.2 mmHg, respectively). Meta-analytic estimates showed non-significant difference between AVNeo and all but Magna Ease valves with regards to structural valve degeneration, reintervention and endocarditis. When compared Magna Ease valve, AVNeo and other valve substitutes showed an excess of valve-related events. AVNeo is safe, associated with excellent haemodynamic profile. Its midterm risk of valve-related events is comparable to most biological valve substitutes. Magna Ease is potentially the best biological choice as far as risk of reintervention is concerned.

M01 Carpentier-Edwards Perimount Magna Ease Aortic Valve Bioprosthesis: A Single Centre Review of Intermediate Term Durability

The Carpentier-Edwards Perimount Magna Ease bioprosthetic aortic valve (Edwards Lifesciences, Irvine, CA) is a low profile version of the earlier Perimount valve that uses the ThermaFix process to enhance calcium removal with a view to improve durability of the prosthesis. The Magna ease valve has been in use for the past 10 years with but its long term durability has not been verified. We sought to assess the durability of this valve.

Premature Structural Failure of Trifecta Bioprosthesis in Midterm Follow-up: A Single-Center Study

A cluster of aortic bioprosthetic valve failures, most of which were Trifecta bioprostheses, was observed in Southampton General Hospital, Southampton, United Kingdom. This study was performed to assess whether the cluster represents a significant failure of this valve model or whether there is a selection bias that can explain the failure of these valves. This retrospective study evaluated all bioprosthetic aortic valve replacement operations performed between 2011 and 2016 inclusive in our center. The study compared the performance of the Trifecta valve (Abbott, Abbott Park, IL) with that of Perimount (Edwards Lifesciences, Irvine, CA), Perimount Magna Ease, and Mitroflow (LivaNova, London, United Kingdom) bioprostheses. In addition, the study analyzed patient-related and valve-related risk factors for early failure in the failed valves. A total of 2807 bioprosthetic aortic valve replacements were performed. Of these, 836 were Trifecta valves, 1031 were Perimount, 449 were Perimount Magna Ease, and 351 were Mitroflow valves. A total of 24 Trifecta valves had premature structural failure, a number significantly higher than seen with Perimount or Perimount Magna Ease (no failure, P < .001 and P < .005, respectively) valves and the Mitroflow valve (1 failure, P< .05). There was no difference in the incidence of endocarditis or death. At the time of valve failure, 17 (71%) of the failed Trifecta valves had moderate or severe regurgitation, and the average peak gradient was 61 ± 29 mm Hg. The median failed prosthetic size was 23 mm. One failed valve had severe patient-prosthesis mismatch. The mean time to failure was 4.5 ± 1.7 years. The Trifecta bioprosthesis has an increased incidence of early structural valve failure, which is significantly higher than that of Perimount, Perimount Magna Ease, or Mitroflow. No patient-related or valve-related cause for the failure could be identified.

Early Midterm Results After Valve Replacement With Contemporary Pericardial Prostheses for Severe Aortic Stenosis

Clinical studies have demonstrated improved gradients after aortic valve replacement with the Trifecta (TR) valve (Abbott Cardiovascular, St Paul, MN) as compared with the Carpentier-Edwards Magna Ease (ME) valve (Edwards Lifesciences, Irvine, CA). Clinical benefits of this strategy have not been demonstrated. Patients undergoing aortic valve replacement for severe aortic stenosis with either valve were included. Patients were excluded if they underwent concomitant procedures other than coronary artery bypass grafting. Inverse proportion treatment weighting was used in the analysis. The primary outcome was a composite of cardiac mortality, need for reintervention, and freedom from first congestive heart failure (CHF). Secondary outcomes were all-cause mortality, the composite components, and cumulative CHF admission. Follow-up echocardiograms were assessed in a cohort of patients to assess structural valve degeneration. There were 331 patients in the TR group and 360 patients in the ME group. The TR group had more women (48% vs 32%, P < .001) with smaller roots (left ventricular outflow tract diameter: TR, 2.11 cm; ME, 2.17 cm; P < .001). After weighting there was no significant difference in the composite measure between groups (P > .05). There was no difference in all-cause mortality (hazard ratio, 0.82; 95% confidence interval, 0.42-1.59; P= .56), and 5-year survival was 91.9% in the ME group and 93.4% in the TR group. There was no difference in cardiac death, reintervention, or first onset of CHF or incidence of structural valve degeneration between groups. There was no difference in the rate of admissions for CHF per 100 patients between the 2 valve types (P= .19). Early hemodynamic benefits have not translated into differences in medium-term clinical outcomes between these 2 valves. Long-term follow-up is necessary.

Impact of implant depth on hydrodynamic function of the ALLEGRA bioprosthesis in valve-in-valve interventions.

We aimed to assess the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) intervention using the ALLEGRA transcatheter heart valve (THV) in three different surgical valve designs. Multiple implantation depths (+2 mm, -2 mm and -6 mm) were tested using a 23 mm ALLEGRA THV for VIV intervention in 19 mm, 21 mm, 23 mm, and 25 mm Epic, Mitroflow and Magna Ease bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. The 23 mm ALLEGRA valve had gradients <20 mmHg in the Mitroflow and Epic valves sized ≥21 mm, and in all sizes of the Magna Ease valve. Gradients did not increase significantly at lower implantation depths. The 19 mm Epic (+2 mm: 20.1±0.6 mmHg, -2 mm: 18.8±0.5 mmHg, -6 mm: 22.8±0.3 mmHg) and 19 mm Mitroflow (+2 mm: 24.1±0.2 mmHg, -2 mm: 31.5±0.3 mmHg, -6 mm: 25.6±0.2 mmHg) valves had elevated mean gradients. In larger sized surgical valves (≥23 mm) the regurgitant fraction was higher at low implantation depths. Pinwheeling was significantly worse in the smaller sized (≤21 mm) surgical valves and also at low (<-2 mm) implantation depth. The 23 mm ALLEGRA valve had favourable (<20 mmHg) gradients in all surgical valves sized ≥21 mm, even when the THV was implanted low. In 19 mm sized Mitroflow and Epic valves, gradients were elevated (>20 mmHg). While there was no major difference in mean transvalvular gradients, leaflet pinwheeling was worse at lower implantation depths.

An in vitro comparison of internally versus externally mounted leaflets in surgical aortic bioprostheses.

To improve haemodynamic performance, design modifications of prosthetic valves have been proposed with each new generation of valves. These different designs also impact the amount of mechanical wear, because mechanical stresses are distributed differently. Because long-term evidence for new prosthetic valves is lacking, this in vitro study compared hydrodynamic performance and durability among 3 currently available bioprosthetic valves with internally (IMLV) or externally mounted leaflets (EMLV). Prostheses of the internally mounted Medtronic Avalus and Carpentier-Edwards Perimount Magna Ease valves were compared to prostheses of the externally mounted Abbott Trifecta valve. For each labelled size (e.g. 19, 21 and 23) of the 3 types, 3 valves underwent accelerated wear testing for up to 600 million cycles, corresponding to ∼15 years of simulated wear. The valves underwent hydrodynamic testing and visual inspection. EMLV had the largest effective orifice area and lowest pressure gradient for each labelled size at baseline and 600 million cycles; the effective orifice area and the pressure gradient were equivalent for the 2 types of IMLV. Five of 9 EMLVs had at least 1 hole or tear in the leaflet tissue around the stent posts, which resulted in severe regurgitation at 500 million cycles in 2 cases. All IMLVs were intact at 600 million cycles with minimal tissue wear. EMLV showed superior hydrodynamic performance but inferior mechanical durability compared to IMLV after 600 million cycles of testing. The primary failures were because of significant mechanical abrasion in the commissural region, which may warrant close monitoring of EMLV during long-term follow-up.

Long-Term Durability of Transcatheter Heart Valves: Insights From Bench Testing to 25 Years

ObjectivesThis study assessed the long-term durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. BackgroundThe long-term durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, durability will be of increasing importance. MethodsSAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. ResultsTHV durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. ConclusionsNominal SAPIEN 3 THVs demonstrated excellent durability, to an equivalent of 25-years wear. THV durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent durability to an equivalent of 5 years wear.

Pulmonary versus aortic pressure behavior of a bovine pericardial valve

BackgroundThe Carpentier Edwards Perimount Magna Ease aortic valvular prosthesis (Edwards Lifesciences, Irvine, Calif) has been among the most frequently and successfully used tissue prosthetic cardiac valves. Furthermore, this prosthesis has been used off-label in the pulmonary position. Until now, there has been a paucity of data regarding the functioning of tissue prosthetic valves under pulmonary conditions. MethodsUsing a pulse duplicator, hydrodynamic characteristics of a 21-mm and 25-mm Magna Ease valve were evaluated. Among parameters evaluated were leakage orifice area, closing time (ie, time required to close), and leakage duration. This procedure was performed under different pulmonic pressure conditions (15/5 mm Hg, 28/11 mm Hg, 73/32 mm Hg) and normal aortic pressure (120/80 mm Hg) as a reference. Moving images were obtained using a Phantom MIRO M320S high-speed camera (Vision Research Inc, Wayne, NJ) at 600 frames per second and used to analyze valve area in closed position. ResultsUnder normal pulmonic conditions (28/11 mm Hg) the leakage orifice area was 0.020 ± 0.012 mm2 for the 21-mm valve and 0.054 ± 0.041 mm2 for the 25-mm valve (P = .03). Hydrodynamic characteristics of the valves differed between pulmonary and aortic testing condition. Valve closing volumes were significantly lower under pulmonary hypotension and normal pulmonary conditions than under normal aortic conditions (P < .05). ConclusionsUnder normal pulmonary pressure conditions, the hydrodynamic characteristics of Magna Ease valves are significantly different compared with aortic conditions. Further research is needed to determine whether these results are associated with prosthetic valve failure.

A mechanistic investigation of the EDWARDS INTUITY Elite valve's hemodynamic performance.

Rapid deployment surgical aortic valve replacement has emerged as an alternative to the contemporary sutured valve technique. A difference in transvalvular pressure has been observed clinically between RD-SAVR and contemporary SAVR. A mechanistic inquiry into the impact of the rapid deployment valve inflow frame design on the left ventricular outflow tract and valve hemodynamics is needed. A 23mm EDWARDS INTUITY Elite rapid deployment valve and a control contemporary, sutured valve, a 23mm Magna Ease valve, were implanted in an explanted human heart by an experienced cardiac surgeon. Per convention, the rapid deployment valve was implanted with three non-pledgeted, simple guiding sutures, while fifteen pledgeted, mattress sutures were used to implant the contemporary surgical valve. In vitro flow models were created from micro-computed tomography scans of the implanted valves and surrounding cardiac anatomy. Particle image velocimetry and hydrodynamic characterization experiments were conducted in the vicinity of the valves in a validated pulsatile flow loop system. The rapid deployment and control valves were found to have mean transvalvular pressure gradients of 7.92 ± 0.37 and 10.13 ± 0.48mmHg, respectively. The inflow frame of the rapid deployment valve formed a larger, more circular, left ventricular outflow tract compared to the control valve. Furthermore, it was found that the presence of the control valve's sub-annular pledgets compromised its velocity distribution and consequently its pressure gradient. The rapid deployment valve's intra-annular inflow frame provides for a larger, left ventricular outflow tract, thus reducing the transvalvular pressure gradient and improving overall hemodynamic performance.