Reducing Prosthesis-Patient Mismatch With Edwards Magna Prosthesis for Aortic Valve Replacement

Abstract

Background: Prosthesis-patient mismatch (PPM) is associated with increased mid-term and long-term mortality rates after aortic valve replacement (AVR). This study aimed to evaluate the efficacy of the Carpentier-Edwards Perimount Magna and Magna Ease (CEPMs) aortic bioprostheses to reduce the incidence of PPM.

Methods and Results: Altogether, 282 consecutive patients (113 women, mean age 69.9±9.9 years) underwent AVR with a CEPMs between 2008 and 2015. They were divided into 3 groups based on the risk of PPM as a result of their body surface area and aortic annular diameter (BSA/AnnD ratio): low-risk (LR) group: 0.64±0.05 m²/cm (n=94); medium-risk (MR) group: 0.73±0.02 m²/cm (n=94); high-risk (HR) group: 0.83±0.05 m²/cm (n=94). The 30-day mortality rate was 0.4%. The 5-year actuarial survival rates were 93.2%, 92.3%, and 94.8% for groups LR, MR, and HR, respectively. No explants as a result of structural valve deterioration occurred. No patients showed severe PPM, defined as a measured effective orifice area index (EOAI) <0.65 cm²/m². Although there were significant (P<0.05) differences in EOAI (0.98±0.2, 0.90±0.21, and 0.88±0.1 cm²/m² among the LR, MR, and HR groups, respectively), the corresponding transvalvular mean pressure gradients (13.0±5.5, 12.3±4.0, 12.7±5.3 mmHg) and regression rates of the left ventricular mass (29.8%, 28.7%, 28.9%) were similar among groups.

Conclusions: CEPMs provide low surgical risk and reduce the risks of PPM, even in HR patients, with excellent hemodynamics.

Aortic valve replacement (AVR) with a bioprosthesis is standard therapy for severe aortic stenosis, even in the era of transcatheter AVR (TAVR).^1,2 Older Asian people tend to be short in stature, and their aortic annulus is smaller than usual, proportionate to their body size. A previous study found that operative mortality generally decreased with increasing body surface area (BSA).³ Another problem in patients with a larger BSA and a small annulus is prosthesis-patient mismatch (PPM).^4,5 A previous study showed that the effect of PPM on mortality was greater in patients <70 years of age, and predictors of PPM were older age, large BSA, and an implanted bioprosthesis.⁶ It has been suggested that PPM has a significant effect on short-term and long-term outcomes.^7–9

Because the NOTION trial showed that the incidence of PPM was lower after TAVR than after surgical AVR at the mid-term follow-up, the hemodynamic performance of TAVR is not inferior compared with surgical AVR.¹⁰ Therefore, avoiding PPM by choosing an appropriate bioprosthesis is crucial for surgical AVR. The Carpentier-Edwards Perimount Magna (CEPM) and Magna Ease (CEPM Ease) (Edwards Lifesciences, Irvine, CA, USA) aortic heart valves (combined=CEPMs) were modified from the Carpentier-Edwards Perimount (CEP) standard valve. They achieve maximum clearance of the aortic valve orifice. Although the internal diameter are the same in CEPMs and the standard CEP, the external diameter of the CEPMs is smaller than that of the CEP. In addition, the height of the CEPM Ease’s stent post is 1 mm lower than that of the CEPM valve, so it is easier to implant the CEPM Ease. A recent study showed that the CEPMs were similarly useful in older Japanese patients with severe aortic stenosis.¹¹ There are few reports,¹² however, that have evaluated the efficacy of the CEPMs in small-sized patient populations. The aim of this study was to evaluate how to reduce the incidence of PPM by using CEPMs as aortic valve bioprostheses.

Methods

Patients’ Characteristics

This study retrospectively reviewed data from the Division of Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Japan. Between 2008 and 2015, a total of 282 patients underwent AVR with CEPMs at this center. The BSA of each patient was calculated using the Mosteller formula. The choice of aortic prosthesis was determined by the patient’s preference or according to the guidelines for choosing an aortic prosthesis. We divided the patients into 3 groups that contained equal numbers of patients according to their BSA and preoperative aortic annular diameter (BSA/AnnD ratio). As a result, 282 patients were categorized as: 94 with an average BSA/AnnD of 0.64±0.05 m²/cm, (the low-risk (LR) group), 94 with an average BSA/AnnD of 0.73±0.02 m²/cm (the medium-risk (MR) group) and 94 with an average BSA/AnnD 0.83±0.05 m²/cm (the high-risk (HR) group). Patients’ baseline characteristics are given in Table 1. Patients in the HR group had a smaller left ventricular mass index (LVMI) and lower cardiac index on preoperative echocardiography (P<0.01) than the other groups (Table 2).

Table 1. Characteristics of the Study Patients Undergoing AVR With Edwards Magna Prosthesis

Characteristic	Risk of patient-prosthesis mismatch
	LR group (n=94)	MR group (n=94)	HR group (n=94)	P value
Age (years)	69.7±10.7	69.8±10.1	70.2±8.9	0.923
Sex (M/F)	49/45	59/35	61/33	0.160
NYHA functional class	2.1±0.4	2.1±0.5	2.0±0.3	0.109
I	4 (4.3)	5 (5.3)	6 (6.4)	0.810
II	82 (87.2)	77 (81.9)	85 (90.4)	0.225
III	7 (7.5)	11 (11.7)	3 (3.2)	0.085
IV	1 (1.1)	1 (1.1)	0	0.604
Body surface area (m2)	1.47±0.17	1.61±0.16	1.69±0.17	<0.001*
Valve disease
Stenosis	49 (52.1)	54 (57.5)	64 (68.1)	0.077
Insufficiency	27 (28.7)	30 (31.9)	16 (17.0)	0.049*
Mixed	17 (18.1)	9 (9.6)	14 (14.9)	0.240
Valve pathology
Bicuspid aortic valve	27 (28.7)	24 (25.5)	23 (24.5)	0.788
Degenerative calcified	66 (70.0)	74 (78.7)	81 (86.2)	0.029*
Rheumatic	20 (21.3)	9 (9.6)	8 (8.5)	0.016*
Reoperation	7 (7.5)	6 (6.4)	3 (3.2)	0.423
Endocarditis	5 (5.3)	6 (6.4)	1 (1.1)	0.161
Previous cardiac surgery	10 (10.6)	7 (7.5)	5 (5.3)	0.392
Ischemic heart disease	1 (1.1)	6 (6.4)	5 (5.3)	0.161
Atrial fibrillation	20 (21.3)	14 (14.9)	11 (11.7)	0.189
Noncardiac comorbidity
Peripheral arterial disease	3 (3.2)	8 (8.5)	4 (4.3)	0.228
Carotid disease	5 (5.3)	2 (2.1)	2 (2.1)	0.356
Prior stroke	15 (16.0)	21 (22.3)	23 (24.5)	0.328
Hypertension	68 (72.3)	69 (73.4)	82 (87.2)	0.024*
Dyslipidemia	37 (39.4)	40 (42.6)	54 (57.5)	0.030*
Diabetes	10 (10.6)	12 (12.8)	19 (20.2)	0.148
Insulin treated	0	2 (2.1)	3 (3.2)	0.240
COPD	6 (6.4)	15 (16.0)	9 (9.6)	0.095
Smoking	22 (23.4)	34 (36.2)	36 (38.3)	0.062
Renal dialysis	1 (1.1)	2 (2.1)	1 (1.1)	0.776
Risk: Euro Score II (%)	3.6±4.7	3.9±5.9	2.6±2.7	0.114
Follow-up period
Mean (years)	3.2±2.1	3.0±2.1	3.2±2.0	0.846
Maximum (years)	7.0	7.2	7.0
Follow-up rate (%)	96.8	92.6	95.7	0.376
Echocardiography follow-up period
Mean (years)	2.8±2.1	2.8±1.9	2.9±2.0	0.976
Maximum (years)	6.9	7.2	7.0
Echocardiography follow-up rate (%)	77.7	73.4	71.3	0.596

Data mean±standard deviation or number (%) of patients. AVR, aortic valve replacement; COPD, chronic obstructive pulmonary disease; Euro Score, European System for Cardiac Operative Risk Evaluation; HR, high risk; LR, low risk; MR, medium risk; NYHA, New York Heart Association.

Table 2. Preoperative Hemodynamics and Operative Variables of the Study Patients Undergoing AVR With Edwards Magna Prosthesis

Variable	Risk of patient-prosthesis mismatch
	LR group (n=94)	MR group (n=94)	HR group (n=94)	P value
LVDd (mm)	53.0±12.1	55.3±12.1	51.5±9.6	0.079
LVDs (mm)	36.1±12.6	37.6±11.8	33.5±10.5	0.059
LVEF (%)	53.5±11.4	51.4±13.5	56.7±9.6	0.026*
%FS (%)	33.7±9.5	33.1±9.8	35.6±9.4	0.174
AnnD (mm)	23.1±2.8	22.0±2.2	20.3±2.2	<0.001*
LAD (mm)	41.7±10.5	45.0±8.2	44.7±9.5	0.037*
LVOTd (mm)	20.8±2.5	20.3±2.2	20.0±2.3	0.094
STJd (mm)	30.2±4.0	30.0±4.0	29.4±3.9	0.437
IVST (mm)	10.6±2.4	10.7±2.6	11.3±1.9	0.138
PWT (mm)	10.3±2.0	10.6±2.1	11.0±1.8	0.082
LVMI (g/m2)	206±75	208±83	182±60	0.025*
Cardiac index (L/min/m2)	3.9±1.5	3.4±1.0	3.1±0.7	0.008*
Procedure
Isolated AVR	47 (50.0)	37 (39.4)	46 (48.9)	0.273
Concomitant procedures
AAsc	8 (8.5)	6 (6.4)	4 (4.3)
MV surgery	22 (23.4)	19 (20.2)	9 (9.6)
TV surgery	8 (8.5)	7 (7.5)	3 (3.2)
CABG	12 (12.8)	23 (24.5)	23 (24.5)
AF procedure	10 (10.6)	12 (12.8)	12 (12.8)
Root enlargement	1 (1.1)	4 (4.3)	4 (4.3)
Septal myectomy	4 (4.3)	3 (3.2)	1 (1.1)
SVR	0	0	1 (1.1)
ACC time (min)	105±40	105±32	94±33	0.039*
CPB time (min)	152±49	156±40	140±47	0.045*
Prosthesis size (mm)
19	29 (30.9)	24 (25.5)	28 (29.8)	0.695
21	31 (33.0)	32 (34.0)	30 (31.9)	0.953
23	21 (22.3)	19 (20.2)	23 (24.5)	0.783
25	9 (9.6)	13 (13.8)	8 (8.5)	0.457
27	4 (4.3)	6 (6.4)	5 (5.3)	0.801
Average	21.5±2.2	21.8±2.4	21.6±2.3	0.532

Data are mean±standard deviation or number (%) of patients. AAsc, ascending aorta surgery; ACC, aortic cross-clamping; AF, atrial fibrillation; AnnD, aortic valve annular diameter; AVR, aortic valve replacement; CABG, coronary artery bypass grafting; CPB, cardiopulmonary bypass; FS, fractional shortening; IVST, interventricular septal thickness; LAD, left atrial diameter; LVDd, left ventricular diastolic diameter; LVDs, left ventricular systolic diameter; LVEF, left ventricular ejection fraction; LVMI, left ventricular mass index; LVOTd, left ventricular outflow tract diameter; MV, mitral valve; PWT, posterior wall thickness; STJd, sinotubular junction diameter; SVR, surgical ventricular restoration; TV, tricuspid valve.

Follow-up

Patients who subsequently underwent replacement of the prosthesis were censored on the date of the replacement procedure. We defined structural valve deterioration (SVD) as leaflet degradation that required reoperation. It excluded a diagnosis of prosthetic valve endocarditis. Follow-up was by structured telephone interviews, review of the hospital records, and review of medical and echocardiographic documentation. The mean follow-up period was 3.1±2.1 years, and the follow-up rate was 95.0%.

Anticoagulation

All patients were on warfarin for 3 months with a target international normalized ratio of 2.0–2.5 postoperatively unless contraindicated. The warfarin was discontinued after 3 months without replacement by antiplatelet medications in patients without risk factors for thromboembolism (e.g., chronic atrial fibrillation). Antiplatelet therapy was continued in patients with coronary artery disease.

Echocardiography

Echocardiography was performed preoperatively, postoperatively, and at follow-up (on average, 2.9±2.0 years after surgery). Postoperative data were obtained for 281 patients (99.6%) and follow-up data for 209 patients (74.1%). Standard M-mode cardiac dimensions were obtained according to the American Society of Echocardiography criteria.¹³ The aortic annular diameter was assessed from a parasternal long-axis view using an expanded view. Ejection fraction was calculated using the biplane modified Simpson method in the majority of the cohort, or assessed by visual estimation when it was difficult to calculate. Transvalvular flow velocity and mean pressure gradients were derived from transaortic flow recorded with continuous-wave Doppler. Pulsed-wave Doppler was used for measuring the LV outflow tract diameter and stroke volume (SV). The LV mass (LVM) was calculated using the Devereux formula and indexed to the BSA to yield the LVMI. The postoperative effective orifice area (EOA) was determined by transthoracic echocardiography using the standard continuity equation.

Procedures and Choice of Prosthesis

Isolated AVR was performed in 130 patients (46.1%). The aortic bioprosthesis was implanted in the supra-annular position using pledgeted non-everting mattress sutures in all cases. Concomitantly performed procedures are shown in Table 2. The projected EOA was obtained from the manufacturer, and the projected EOA index (EOAI) was calculated as the projected EOA/BSA. The prosthesis was chosen according to the annular size using a dedicated sizer. To avoid PPM, aortic root enlargement was performed in 9 patients (3.1%) because the projected EOAI was suspected to be <0.65 cm²/m² without enlargement.

Statistical Analysis

Data are presented as the mean±standard deviation for continuous variables and as percentages for categorical variables. Differences between groups were analyzed using the χ² test or Student’s t-test. Differences among groups were analyzed using the analysis of variance, with P<0.05 considered to indicate statistical significance. Differences between 2 groups in more than 2 groups were analyzed using Tukey-Kramer’s method. Differences between postoperative and follow-up LVMI were analyzed using paired t-test. Survival and freedom from major adverse cardiovascular and cerebral events (MACCE) were determined by Kaplan-Meier actuarial analysis and were compared among groups using the log-rank test. Statistical analyses were performed using JMP version 10.0 software (SAS Institute, Inc., Cary, NC, USA).

Results

Survival

The 30-day mortality rate was 0.4%; 1 patient in the MR group died of disseminated intravascular coagulation and there were 10 (3.5%) late deaths, of which 6 (2.1%) were noncardiac (Table 3). The 3- and 5-year actuarial survival rates were 95.7% and 93.5%, respectively. The survival rates were compared among the groups (Figure 1), with no significant differences found.

Table 3. 30-Day and Late Mortality Rates and Complications in the Study Patients Undergoing AVR With Edwards Magna Prosthesis

Parameter	Risk of patient-prosthesis mismatch
	LR group (n=94)	MR group (n=94)	HR group (n=94)	P value
30-day mortality	0	1 (1.1)	0	0.367
Cause of early death
Thromboembolic causes	0	1 (1.1)	0	0.367
Early complications
Atrioventricular block	3 (3.2)	2 (2.1)	1 (1.1)	0.600
Stroke	0	1 (1.1)	0	0.367
Late mortality	4 (4.3)	5 (5.3)	1 (1.1)	0.260
Cause of late death
Cardiac causes	0	0	0	–
Noncardiac causes	2 (2.1)	3 (3.2)	1 (1.1)	0.600
Cancer	1 (1.1)	0	0	0.367
Pneumonia	1 (1.1)	2 (2.1)	1 (1.1)	0.776
Cerebral bleeding	0	1 (1.1)	0	0.367
Unknown	2 (2.1)	2 (2.1)	0	0.363
Late complications
Explant	3 (3.2)	2 (2.1)	1 (1.1)	0.600
Cause of surgical explantation
Prosthesis dysfunction	0	0	0	–
Endocarditis	2 (2.2)	2 (2.1)	1 (1.1)	0.816
Perivalvular leakage	1 (1.1)	0	0	0.367
Atrioventricular block	4 (4.3)	4 (4.3)	2 (2.1)	0.661
Stroke	2 (2.1)	5 (5.3)	1 (1.1)	0.188
Renal failure	1 (1.1)	1 (1.1)	0	0.604
Cardiac infarction	1 (1.1)	0	1 (1.1)	0.604

Data are presented as number (%). Abbreviations as in Table 1.

Figure 1.

(A) Overall survival curves showing no significant differences among the 3 groups based on their risk of PPM. (B) Freedom from major adverse cardiovascular and cerebral events (MACCE) shows significant differences among the 3 groups. HR, high risk; LR, low risk; MR, medium risk; PPM, prosthesis-patient mismatch.

Adverse Events

The 3- and 5-year actuarial rates of freedom from SVD requiring reoperation were both 100%. Early morbidity included thromboembolism in 1 patient, cerebral infarction in 1 patient, and need for a pacemaker in 6 (2.1%) patients. Late morbidity included acute cardiac infarction in 2 (0.7%) patients, cerebral infarction or bleeding in 8 (2.8%) patients, need for a pacemaker in 10 (3.5%) patients, and need for renal dialysis in 2 (0.7%) patients. Valve-related comorbidities occurred in 6 (2.1%) patients, comprising prosthetic valve endocarditis in 5 (1.8%) patients after 0.3–3.0 years and paravalvular leakage in 1 patient (Table 3). The 3- and 5-year actuarial freedom rates from MACCE were 87.1% and 86.2%, respectively. There were significant differences (P<0.05) in MACCE among the 3 groups (Figure 1).

Choice of Bioprosthesis by Group

The sizes of the bioprostheses used in the groups are shown in Table 2. The average valve size was 21.5±2.2 mm in the LR group, 21.8±2.4 mm in the MR group, and 21.6±2.3 mm in the HR group. The prosthetic valve was chosen after direct sizing of the aortic annulus using sizers, without under- or oversizing.

EOAI and PPM: Comparisons Among Groups

The measured postoperative and follow-up EOAI values and the mean transvalvular pressure gradients (PGs), by group, are shown in Figure 2. Postoperative echocardiography showed that the EOAI at discharge was significantly larger in the LR group than in the HR group (P<0.05), but there were no significant differences among the groups at follow-up. According to the definition of PPM, there were no patients in this study who had severe PPM (EOAI <0.65 cm²/m²). Moderate PPM (EOAI 0.65–0.85 cm²/m²), however, was found in 14.2% of patients at discharge (9.6% in the LR group, 17.0% in the MR group, 15.9% in the HR group) and in 17.0% at follow-up (13.8% in the LR group, 23.4% in the MR group, and 13.8% in the HR group). Although there was a tendency towards lower rates of PPM in the LR group, there were no significant differences among the groups (Figure 3).

Figure 2.

(A) Effective orifice area indexes (EOAI), by PPM risk group, postoperatively and at follow-up. There was a significant difference between the LR and HR groups postoperatively (P<0.05). (B) Transvalvular mean pressure gradient (PG), per group, postoperatively and at follow-up. There were no significant differences among the groups. *Significant difference between groups. PPM, prosthesis-patient mismatch.

Figure 3.

Rate of moderate patient-prosthesis mismatch (PPM), by group, postoperatively and at follow-up. There were no significant differences among the groups.

SVI Comparison Among Groups

The average SV index (SVI) was 36.7±11.4 mL at discharge and 40.0±10.3 mL at follow-up, with no significant differences among the groups. The SVI and the mean PG at follow-up were statistically significantly related (P<0.01) (Figure S1A,B). To analyze the effects of SV on the measured postoperative or follow-up EOA and the transvalvular mean PG, patients were divided into 2 groups in which the SVI was <35 mL/m² or ≥35 mL/m². Although there were no significant differences in EOA between these groups, there was a significant difference in mean PG at follow-up (P<0.05) (Figure S1C,D).

LVM Regression in Patients With Isolated AVR: Comparison Among Groups

The regression rate of the LVMI was calculated using the preoperative and follow-up echocardiography data for patients in each group undergoing isolated AVR (n=130, 46.1%). Follow-up echocardiography revealed that LVMI significantly (P<0.05) reduced postoperatively, with regression rates of 29.8% in the LR group, 28.7% in the MR group, and 28.9% in the HR group (Figure 4). Further comparisons did not show a significant difference in LVMI regression among the various sized prostheses (Figure S2).

Figure 4.

(A) Left ventricular mass index (LVMI) in all patients after surgery. Follow-up echocardiography showed that LVM significantly (P<0.05) reduced postoperatively, with regression from 206.5 to 137.5 g/m² in the LR group, from 209.0 to 133.7 g/m² in the MR group, and from 182.0 to 125.8 g/m² in the HR group. *Significantly lower than the preoperative value. (B) Postoperative LVMI in patients with isolated aortic valve replacement (AVR). Follow-up echocardiography showed that LVM significantly (P<0.05) reduced postoperatively, with regression from 206.2 to 145.1 g/m² in the LR group, from 208.0 to 130.4 g/m² in the MR group, and from 177.8 to 126.9 g/m² in the HR group. *Significantly lower than the preoperative value.

EOA and PG: Comparison Among Prosthesis Sizes

The measured postoperative and follow-up EOA values and the transvalvular mean PGs for each size of prosthesis are shown in Figure 5. For the 19-mm prosthesis, the measured EOA was 1.27±0.30 cm² at discharge and 1.25±0.27 cm² at follow-up. These values increased gradually as prosthetic size increased, except for the 27-mm size. There were significant differences among the prosthetic sizes postoperatively (P<0.05). The follow-up mean PGs were similar to the postoperative mean PGs, but there was no significant difference among the prostheses. The correlation between measured follow-up EOAI values and the BSA/AnnD ratio is shown in Figure S3. There were no significant differences among the prostheses (P<0.05).

Figure 5.

(A) Effective orifice area (EOA), by prosthetic size, postoperatively and at follow-up. There were significant differences among the different sized prostheses (P<0.05). (B) Transvalvular mean pressure gradient (PG), by prosthetic size, postoperatively and at follow-up. The follow-up mean PGs were lower than the postoperative mean PGs, but the differences were not significant. *Significant difference between prostheses.

Discussion

The 30-day mortality rate in this study was only 0.4%, which is lower than the estimated mortality of 3.4% calculated by the European System for Cardiac Operative Risk Evaluation II or that reported by Wyss et al, who reported an in-hospital mortality rate of 2.2% after AVR with one of the CEPMs in 270 patients.¹⁴ The implantability of the CEPMs may contribute to the prevention of early deaths even in the HR group. With the excellent hemodynamics, reflected in the low transvalvular mean PGs, large EOAIs, and significant LVM regression, the long-term outcomes were also excellent even in the HR group.

Although the postoperative EOAI was significantly smaller in the HR group, the average EOAI was 0.88 cm²/m², which is greater than the criterion of moderate PPM (0.85 cm²/m²). There were no cases of severe PPM (<0.65 cm²/m²) in the HR group, although 14.2% of the patients had moderate PPM at discharge and 17.0% had it at follow-up. The CEPM prosthesis was designed to have a larger EOA than the standard CEP to reduce the chance of PPM. Avoidance of severe PPM is a key factor in improving survival and freedom from cardiac events.^15,16 These findings seem consistent with those of previous reports.¹⁷

This study found that the mid-term performance of the CEPMs was satisfactory, in accord with the results of previous reports,^18,19 with excellent hemodynamics and few valve-related adverse events. There were no cases of SVD requiring reoperation in our study, although the mean follow-up period was relatively short: 3.1±2.1 years in all patients and 3.7±2.0 years in 81 patients with 19-mm CEPMs. Follow-up echocardiography revealed a significantly reduced LVMI, with a mean regression rate of 28.9±20.0%, with no significant differences among the groups. Regression of LVM was probably a result of the low mean PG and large EOAI, even in the HR group. Accordingly, the New York Heart Association functional class was significantly (P<0.05) improved, from 2.0±0.4 to 1.0±0.2, in all patients.

Poor LV systolic function may lead to a significant decrease in SV and to consequently lower gradients, making the issue of apparent discordance between EOA and mean PG less problematic in patients with reduced LV ejection fraction.²⁰ Our study showed a significant correlation between SV and EOA or mean PG at follow-up and the high SVI group had a significantly higher mean PG at follow-up, which implied LV function was not impaired by the CEPMs during follow-up. Thus, combined with the data for LVM regression, CEPMs are valves that potentially induce reverse remodeling.

Minakata et al reported that the 15-year actuarial rate of freedom from SVD that required reoperation in patients who underwent AVR with a CEP prosthesis was 87.5%.²¹ A 3rd-generation anticalcification treatment called Thermafix^TM has been added to the CEPMs. Thermafix technology has been shown to provide better prevention of late calcification of the leaflet in vivo. Thus, the CEPMs are expected to have better long-term durability than the standard CEP, although this possibility must be verified by further clinical study. When hemodynamics and durability were compared with the data for Mosaic (Medtronic Inc., Minneapolis, MN, USA) published by the National Cerebral and Cardiovascular Center, the data were comparable.²² Fiegl et al reported no significant difference in LVM regression or PPM with CEPM Ease or the St. Jude Medical Trifecta (SJM Trifecta; St. Jude Medical, St. Paul, MN, USA) bioprostheses, even though the SJM Trifecta had a lower mean PG at the early postoperative and 1-year evaluations, as well as a higher EOA and EOAI in the early postoperative period.²³ Ruzicka et al reported that the CEPM showed the lowest mean PG of 5 bioprostheses evaluated (CEPM, Mosaic, Mosaic Ultra, Epic Supra, Sorin Soprano) and larger EOAs than the porcine bioprostheses.²⁴

In conclusion, the mid-term performance of each of the CEPMs was satisfactory, with low operative mortality, excellent hemodynamics, and significant regression of the LVM. These advantages remained in place for patients at high risk for PPM. Thus, AVR with one of the CEPMs is a procedure of choice for treating severe aortic stenosis.

Study Limitations

Our study was conducted retrospectively in a single center and consequently included a limited number of patients. The mean follow-up period was 3.1±2.1 years. Thus, further observation is required to verify our conclusions. Finally, the choice of the CEPMs as bioprostheses was left to the surgeon’s and patient’s preferences, although it was anticipated that patients with a high risk for PPM would be given one of the CEPMs. A randomized study to compare the CEPMs with other valves should be performed in the future.

Funding Sources / Conflict of Interests / Grants

None.

Supplementary Files

Supplementary File 1

Figure S1. (A) Correlation between the effective orifice area (EOA) and stroke volume index (SVI) at follow-up.

Figure S2. (A) LV mass regression in all patients after surgery.

Figure S3. Correlation between the effective orifice area index (EOAI) and the body surface area/annular diameter (BSA/AnnD) ratio at follow-up.

Please find supplementary file(s);

http://dx.doi.org/10.1253/circj.CJ-16-0768

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