Patients with a class of recommendation 1 for aortic valve replacement (AVR) include adults who present with high gradient aortic stenosis and symptoms and severe aortic insufficiency.1 To maximize effective orifice area (EOA), the Epic Max (Abbott Cardiovascular) offers a larger stent-to-anulus ratio such that the internal diameter of the prosthesis is similar to the previous models of at least one label size larger.2  The valve is base on the biocor platform bioprosthesis, has demonstrated reliable durability in multiple longitudinal analyses.4-6 This new aortic valve bioprosthesis features a frackable polymer stent with an adaptative cuff to facilitate implantation and accommodate future valve-in-valve transcatheter devices. It has a pericardial shield that prevents leaflet abrasion and an anti-calcification treatment to mitigate tissue calcification that can result in structural valve deterioration.3

The valve received approval from the Food and Drug Administration to treat aortic regurgitation or stenosis in 2023.6 This study aimed to evaluate early trans-prosthesis mean gradients.

Patients From 8/2023 to 8/2025, 197 adults underwent surgical AVR with the Epic Max bioprosthesis at Cleveland Clinic. Their average age was 69.4±8.67, 131 (66%) were male, and average body surface area (BSA) was 2.07±0.28 m2 (Table 1). Data Patient characteristics, operative details, echocardiography measures, and hospital outcomes were extracted from prospectively maintained quality assurance registries and the echocardiogram registry.7 This study was approved on 4/28/2025 by the Cleveland Clinic Institutional Review Board (#25-296), with waiver of patient consent. Endpoints The primary endpoint was longitudinal mean trans-prosthesis gradients for each label size by electrocardiography. Time-zero was defined as the moment of implant. All available post-implant transthoracic and transesophageal echocardiograms were analyzed. A total of 393 echocardiograms were available in 189 patients (96%). Echocardiographic follow-up time ranged from 8/2023 to 8/2025. Based on this distribution, temporal trends could be reliably modeled up to 6 months. Due to the limited number of patients, sample mean was reported for 19 mm implants. Additional endpoints included prosthesis-patient mismatch using the manufacture’s EOA.8 Prosthesis -patient mismatch was calculated as an index from EOA and patient’s BSA.9–11 Given the limited number of patients, sample mean of patients with severe prosthesis-patent mismatches and normal left ventricular systolic function was reported excluding 1 patient with a 21 mm due to missing data on mean gradient.12 Aortic valve regurgitation during echocardiographic follow up and operative (in-hospital or <= 30days since procedure) mortality were also reported. Vital status was obtained by systematic follow-up. Data Analysis All analyses were conducted using SAS version 9.4 (SAS Institute Inc., Cary, NC). Categorical variables were summarized as counts and percentages. Comparisons were made using χ2 analysis. Continuous variables were presented as mean ± standard deviation (SD), or median with 15th and 85th percentiles for skewed distributions. Comparisons were made using the nonparametric Wilcoxon rank-sum test. Longitudinal Data Analysis A temporal decomposed non-linear mixed-effect regression model was used to estimate the temporal trend of mean aortic valve gradients after implant (Figure S1).13,14 Valve label size was forced into the model to determine difference in the mean gradients according to label valve size. Baseline Characteristics and Operative Data Number of female patients differed statistically between label size groups, 5 (100%), 32 (89%), 20 (23%) and 9 (13%) in each group (Table 1). BSA was 1.7, 2.0, 2.0, and 2.2 m2, respectively. Regarding the surgical approach, 156 (79%), 28 (19%) and 3 (1.5%) patients received full, partial sternotomy, and thoracotomy, respectively. Implanted valves were label size 19 mm (n=5), 21 mm (n=36), 23 mm (n=88), and 25 mm (n=68). Root enlargement was performed in 2 (40%), 6 (17%), 3 (3.4%) and 2 (2.9%) patients, respectively. A concomitant procedure was performed in 151 (76%) with coronary artery bypass in 77(39%) being the most common. Median total myocardial ischemia and cardiopulmonary bypass intervals were 79 and 96 minutes, respectively.

Estimated post-implant mean gradients were 13.3, 11, 8.9, and 8.2 mmHg for each valve size and remained stable at early follow up (Figure 1). Median indexed EOA (EOA/BSA) was 0.84, 0.77, 0.84, and 1.1 cm2/m2, respectively (Table 2). In each group, 0/5 (0%), 5/36 (14%), 1/88 (1.1%), and 0/68 (0%) patients were classified as having severe prosthesis-patient mismatch with EOA/BSA <0.65 cm2/m2, and their early average mean gradients were 11.6 mmHg; 11.6 and 10 mmHg for label sizes 21 and 23 mm. 

Mild aortic regurgitation was observed in 3 echocardiographic measurements in 3 patients. No reoperations for valve dysfunction during follow-up. Operative mortality was observed in 6 (3.2%) patients in the overall cohort. Among patients who received an isolated AVR, operative mortality was 0% and there were no deaths during the follow up period.

Table 1. Patient baseline characteristics stratified by aortic valve (AV) size.

*NYHA, New York Heart Association

Table 2. Operative details stratified by aortic valve (AV) size

Principal Findings

This study provides a longitudinal analysis of early hemodynamic profiles of the latest porcine aortic valve bioprosthesis at a single, high-volume center. In this analysis of 189 patients, the Epic Max yielded initial post-implant estimates of 13.3, 11, 8.9, and 8.2 mmHg for label sizes 19, 21, 23 and 25 that remain stable over the 6-month follow-up. Although this cohort had 5 and 1 patients considered severe prosthesis-patient mismatch in 21 and 23 valves,11 the initial average mean gradients were 11.6 and 10 mmHg, respectively. In each group, 2 (40%), 6 (17%), 3 (3.4%) and 2 (2.9%) patients received a root enlargement. We had only 5 size 19 implants and they were only in older (71.8 ± 5.56 years) and small (154 ± 7.11 cm) female patients.

The label size corresponds to the external diameter of the prosthesis or the anulus diameter, and stratifying this measurement allows us to identify differences in average mean gradients with previous models. In a cohort of patients who received the Epic Supra, 11.2, 12.5, 10.8, 8.4 and 11.3 mmHg were reported for label sizes 19, 21, 23, 25 and 27mm at 6 months.15 Except from the 19 mm, the differences between these averages and our estimates are 1.5, 1.9 and 0.2 mmHg lower for 21, 23 and 25 label sizes. In the Commence trial, similarly, hemodynamic outcomes for Resilia showed a mean gradient of 10.8 mmHg that remain stable.16 Although a bit relatively higher, we see the same pattern with Magna Ease with initial gradients of 13.9, 14.0, 12.9, 11.2, 9.4 and 8.2mmHg for valve sizes 19, 21, 23, 25, 27 and 29mm.17 In the Avalus valve, hemodynamic results were 15.4, 13.7 and 15.2mmHg in <23, 23-24 and >24mm sizes.18 

Regarding valve-in-valve (VinV) procedures, this can be considered a favorable valve given the frackable polymer stent at 8 atm.19 Also, these porcine leaflets retract down to the annulus, decreasing the risk of coronary obstruction compared to pericardial valves, in which its leaflets may rise towards the top of the stent following. The Linx anti-calcification treatment may favor this valve for these procedures as well by lowering the risk of stroke. These considerations, in addition to a low threshold for root enlargement to accommodate larger valves for a future VinV, may set this as the valve of choice for a lifelong management.

 Our share of porcine valves has increased over the years for the benefits of future VinV. Additional studies can compare late valve gradients and outcomes for the latest generation of porcine and pericardial valves.  Evidence suggesting that porcine valves are less prone to stroke at reoperation can be further validated.20 Other valve-related complications, such as endocarditis, can also be evaluated in future studies, as this may prompt urgent

reoperative surgical AVR.  We did not have enough follow up data to study these benefits sytematically. Further analyses of the durability and complications associated with valve-in-valve transcatheter options in this bioprosthesis may also be evaluated.

Limitations

All operations were performed at a single institution, which may limit the generalizability of this study. Although trans-prosthesis gradients demonstrated an early and stable plateau for this porcine valve, long-term data remain to be seen.    

The latest porcine aortic valve bioprosthesis functions as designed, with early hemodynamic profile comparable to other valves in the current market that plateaued and subsequently remained stable over the course of early follow-up. In patients with severe prosthesis-patient mismatch, trans-prosthetic valve gradients remained stable and reasonably low given the normal left ventricular systolic function.

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