A comparison of early redo surgery rates in Mosaic porcine and Perimount bovine pericardial valves

A comparison of early redo surgery rates in Mosaic porcine and Perimount bovine pericardial valves Abstract OBJECTIVES The objective of this study was to compare rates of redo surgery for the Medtronic Mosaic 305 A Porcine Prosthesis and the Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis 2900. METHODS This was a single-centre retrospective observational study. We included all 1018 patients who underwent aortic valve replacement with a Mosaic (n = 216) or Perimount (n = 809) bioprosthesis between October 2000 and August 2008. The total follow-up was 1508 patient-years for the Mosaic valve and 5813 for the Perimount valve. The maximal follow-up and interquartile range were 14.8 and 7.0 years for the Mosaic valve and 15.1 and 5.6 years for the Perimount valve, respectively. A propensity score-weighted version of the Cox model, Kaplan–Meier analysis and multivariate regression model was used. RESULTS Despite no statistical difference in the number of non-structural valve deterioration cases between valves, redo surgery occurred earlier in 10 (4.6%) Mosaic than for 17 (2.1%) Perimount valves (P = 0.02) and was required for structural valve deterioration in 5 (2.3%) Mosaic valves when compared with 7 (0.9%; P = 0.04) Perimount valves. Four of 5 Mosaic failures occurred before 5 years, whereas all Perimount failures occurred after 5 years. Redo surgery for non-structural valve deterioration occurred in 3 patients with Mosaic valves (1.4%) and no patients with Perimount valves. Surgery for the remaining patients with Perimount valves was due to infection or aortic disease. CONCLUSIONS Early redo surgery for structural valve degeneration was uncommon but occurred earlier for the Mosaic porcine than the Perimount bovine pericardial replacement aortic valve. Mosaic replacement valve , Perimount replacement valve , Redo surgery , Structural valve degeneration INTRODUCTION Stented biological replacement valves are all subject to structural deterioration, and considerable research has been expended to improve durability. Measures include design features of the stent to reduce mechanical stresses, low-pressure fixation of the cusps and anticalcification treatments. The tissue used for manufacturing may also affect durability, but whether general comparisons between porcine aortic valve and bovine pericardial tissue can be made is uncertain. Some studies [1, 2] suggest that bovine pericardial valves have better durability than porcine valves although others [3–5] report no difference. However, there are no comparisons of Mosaic and Perimount valves implanted concurrently [5]. We previously conducted a randomized comparison of early haemodynamic function in the Medtronic Mosaic porcine pericardial valve when compared with the Perimount bovine pericardial valve [6]. Although this study was not designed for follow-up beyond 1 year and included only 99 patients, we noticed a higher incidence of early redo surgery in the Mosaic population. We, therefore, sought to compare rates of redo surgery in all 1025 patients at our institution implanted with a Mosaic or Perimount replacement aortic valve in a period of just under 8 years. METHODS This was a single-centre retrospective observational study at Guy’s and St Thomas Cardiothoracic Centre. The surgeons were able to choose freely between a Medtronic Mosaic valve and a Carpentier-Edwards Perimount valve, which was the main biological valve in use between October 2000 and August 2008. The Medtronic Mosaic 305 A is a stented porcine bioprosthesis (Medtronic, Inc., St Paul, MN, USA) first introduced in 1994. It has 3 cusps, flexible stents made of Haynes alloy and a scalloped suture ring made of acetal homopolymer covered with polyester fabric. The cusps are fixed in glutaraldehyde at 0 net pressure (by applying a pressure of 40 mmHg on either side of the valve) and subjected to anticalcification treatment with alpha-amino-oleic acid. The Carpentier-Edwards Perimount 2900 bovine pericardial valve (Edwards Lifesciences Corp., Irvine, CA, USA) is a stented bovine pericardial bioprosthesis, bioengineered from a flexible cobalt–chromium alloy stent with 3 independent bovine pericardial cusps. At our institution, warfarin is routinely administered for 3 months after implantation. After this, maintenance is continued with 75mg of aspirin unless there is an independent need for anticoagulation with warfarin to be continued, e.g. atrial fibrillation. Data acquisition Theatre registers were used to identify all patients receiving either a Medtronic Mosaic or a Carpentier-Edwards Perimount replacement aortic valve between October 2000 and August 2008. The study was approved as a service evaluation (Trust registered number 5417). The hospital notes from each patient were reviewed; all readmissions and reoperations were identified from the institution’s hospital records. Moreover, the case files were searched for possible factors affecting durability: age at implantation, systemic hypertension, diabetes, and renal failure or renal replacement therapy. The NHS portal (Summary Care Records) was used to ascertain the survival for all patients until February 2016, ensuring that the follow-up was at least 7.5 years and maximally 16 years. The primary end point was structural valve deterioration (SVD) until the end of follow-up, and the secondary end point was time to death for the same follow-up period. Death certificates were obtained from the General Register Office for clarification on the causes of death if the cause of death was not clear from the hospital records. Analysis The reason for reoperations was classified according to recognized guidance as [1] SVD (deterioration or dysfunction caused by changes intrinsic to the valve, e.g. calcification, leaflet tear or stent creep); non-structural deterioration (any abnormality not intrinsic to the valve that results in stenosis or regurgitation or haemolysis, e.g. pannus, inappropriate sizing and paraprosthetic leak); thrombosis and infection (proved by the Duke criteria or surgical or autopsy evidence of infection). Premature structural degeneration was defined as occurring before 5 years. Renal dysfunction was defined as the need for renal replacement or creatinine >300 umol/l. Patients who underwent transcatheter aortic valve implantation were considered as requiring a redo intervention. Statistics Prism (version 6), SPSS (version 24) and MATLAB (R2017b) were used for data storage and analysis. Continuous variables are reported as mean and standard deviation, if they had Gaussian distribution and as median and interquartile range if not and categorical variables as percentages. Normality was tested using the D’Agostino and Pearson omnibus normality test. Intergroup comparisons were conducted using the Fisher’s exact test and t-test or Wilcoxon rank-sum tests for categorical and continuous variables with or without normal distribution, respectively. Differences in 30-day mortality were compared using the χ2 test, and the multiple logistic regression was used to investigate the contribution of the EuroSCORE, gender and age. We used a propensity score-weighted version of the Cox model to identify potential predictors of SVD occurrence during the follow-up period. For the time-to-event analysis, the Kaplan–Meier graphs were used. A multivariable regression model was used to establish time to outcome variable. Power calculations were not performed in this retrospective analysis; however, with only 27 events observed, it should be regarded generally as low because power is driven not by number of patients but by number of events. Statistical significance was defined as a P-value <0.05. RESULTS Between October 2000 and August 2008, 1025 patients underwent aortic valve replacement with a Mosaic (n = 216) or Perimount valve (n = 809), (Fig. 1). Seven patients with Perimount valves were lost to follow-up as they lived abroad (follow-up complete in 99.3% of patients). Figure 1: View largeDownload slide Percentage of Mosaic and Perimount implantations between year 2000 and 2008. Figure 1: View largeDownload slide Percentage of Mosaic and Perimount implantations between year 2000 and 2008. Follow-up was until February 2016. The total follow-up was 1508 patient-years for the Mosaic valve and 5813 patient-years for the Perimount valve. The maximal follow-up and interquartile range were 14.8 and 7.0 years for the Mosaic valve and 15.1 and 5.6 years for the Perimount valve, respectively. General Overall, the average age was 73.5 years (median 74.7 years; range 16–91 years), and 62% of the patients were men. The median left ventricular ejection fraction (LVEF) was 50% (interquartile range 15). Concomitant surgery was performed in 111 (51.4%) patients with the Mosaic valve and 398 (50%) with the Perimount valve (Table 1). The mean valve size was 23 mm (SD 2.3), and manufacturer-labelled bioprosthesis sizes for each valve are shown in Fig. 2. Normal distribution was confirmed using valve size implanted and body surface area (BSA) but not using age at operation, EuroSCORE or LVEF. More patients with Mosaic valves had systemic hypertension (P = 0.004), but otherwise there were no statistical differences in demographic characteristics at surgery (Table 1) or the logistic EuroSCORE. There were 4 surgeons who implanted the majority of the valves, one of whom implanted equal numbers of each valve. The other 3 demonstrated a preference for 1 valve, 2 of whom preferred the Perimount valve and the other preferred the Mosaic valve. Table 1: Patient demographics   Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Age at implantation, median (IQR)  75.06 (8.2)  74.6 (10)  0.45  Patients younger than 60 years at implantation (%), n (%)  7 (3.2)  51 (6.4)  0.08  Patients older than 80 years at implantation (%), n (%)  58 (26.9)  184 (22.7)  0.21  Men:women (%)  60:40  63:37  0.45  Median body surface area, median (IQR)  1.87 (0.3)  1.85 (0.28)  0.64  Isolated AVR (% of total), n (%)  105 (48.6)  404 (50.3)  0.32  AVR + CABG, n (%)  104 (48.1)  353 (44.4)  0.28  AVR + MVR, n (%)  6 (2.78)  26 (3.3)  0.72  AVR + MVR + CABG, n (%)  1 (0.46)  19 (2.6)  0.72  Median logistic EuroSCORE, median (IQR)  8.0 (4)  8.0 (4)  0.42  LVEF, n (%)         <30%  18 (8.3)  50 (6.2)  0.27   30–40%  36 (16.7)  127 (15.8)  0.76   >40%  162 (75)  625 (77.9)  0.36  Systemic hypertension, n (%)  147 (68)  437 (54)  0.004  Diabetes, n (%)  28 (13)  109 (13.5)  0.81  Serum creatinine >300 ml/min or on dialysis, n (%)  8 (3.7)  41 (5.1)  0.40  Total follow-up in years (maximum)  1508 (14.8)  5813 (15.4)      Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Age at implantation, median (IQR)  75.06 (8.2)  74.6 (10)  0.45  Patients younger than 60 years at implantation (%), n (%)  7 (3.2)  51 (6.4)  0.08  Patients older than 80 years at implantation (%), n (%)  58 (26.9)  184 (22.7)  0.21  Men:women (%)  60:40  63:37  0.45  Median body surface area, median (IQR)  1.87 (0.3)  1.85 (0.28)  0.64  Isolated AVR (% of total), n (%)  105 (48.6)  404 (50.3)  0.32  AVR + CABG, n (%)  104 (48.1)  353 (44.4)  0.28  AVR + MVR, n (%)  6 (2.78)  26 (3.3)  0.72  AVR + MVR + CABG, n (%)  1 (0.46)  19 (2.6)  0.72  Median logistic EuroSCORE, median (IQR)  8.0 (4)  8.0 (4)  0.42  LVEF, n (%)         <30%  18 (8.3)  50 (6.2)  0.27   30–40%  36 (16.7)  127 (15.8)  0.76   >40%  162 (75)  625 (77.9)  0.36  Systemic hypertension, n (%)  147 (68)  437 (54)  0.004  Diabetes, n (%)  28 (13)  109 (13.5)  0.81  Serum creatinine >300 ml/min or on dialysis, n (%)  8 (3.7)  41 (5.1)  0.40  Total follow-up in years (maximum)  1508 (14.8)  5813 (15.4)    AVR: aortic valve replacement; CABG: coronary artery bypass graft; IQR: interquartile range; LVEF: left ventricular ejection fraction; MVR: mitral valve replacement. Table 1: Patient demographics   Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Age at implantation, median (IQR)  75.06 (8.2)  74.6 (10)  0.45  Patients younger than 60 years at implantation (%), n (%)  7 (3.2)  51 (6.4)  0.08  Patients older than 80 years at implantation (%), n (%)  58 (26.9)  184 (22.7)  0.21  Men:women (%)  60:40  63:37  0.45  Median body surface area, median (IQR)  1.87 (0.3)  1.85 (0.28)  0.64  Isolated AVR (% of total), n (%)  105 (48.6)  404 (50.3)  0.32  AVR + CABG, n (%)  104 (48.1)  353 (44.4)  0.28  AVR + MVR, n (%)  6 (2.78)  26 (3.3)  0.72  AVR + MVR + CABG, n (%)  1 (0.46)  19 (2.6)  0.72  Median logistic EuroSCORE, median (IQR)  8.0 (4)  8.0 (4)  0.42  LVEF, n (%)         <30%  18 (8.3)  50 (6.2)  0.27   30–40%  36 (16.7)  127 (15.8)  0.76   >40%  162 (75)  625 (77.9)  0.36  Systemic hypertension, n (%)  147 (68)  437 (54)  0.004  Diabetes, n (%)  28 (13)  109 (13.5)  0.81  Serum creatinine >300 ml/min or on dialysis, n (%)  8 (3.7)  41 (5.1)  0.40  Total follow-up in years (maximum)  1508 (14.8)  5813 (15.4)      Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Age at implantation, median (IQR)  75.06 (8.2)  74.6 (10)  0.45  Patients younger than 60 years at implantation (%), n (%)  7 (3.2)  51 (6.4)  0.08  Patients older than 80 years at implantation (%), n (%)  58 (26.9)  184 (22.7)  0.21  Men:women (%)  60:40  63:37  0.45  Median body surface area, median (IQR)  1.87 (0.3)  1.85 (0.28)  0.64  Isolated AVR (% of total), n (%)  105 (48.6)  404 (50.3)  0.32  AVR + CABG, n (%)  104 (48.1)  353 (44.4)  0.28  AVR + MVR, n (%)  6 (2.78)  26 (3.3)  0.72  AVR + MVR + CABG, n (%)  1 (0.46)  19 (2.6)  0.72  Median logistic EuroSCORE, median (IQR)  8.0 (4)  8.0 (4)  0.42  LVEF, n (%)         <30%  18 (8.3)  50 (6.2)  0.27   30–40%  36 (16.7)  127 (15.8)  0.76   >40%  162 (75)  625 (77.9)  0.36  Systemic hypertension, n (%)  147 (68)  437 (54)  0.004  Diabetes, n (%)  28 (13)  109 (13.5)  0.81  Serum creatinine >300 ml/min or on dialysis, n (%)  8 (3.7)  41 (5.1)  0.40  Total follow-up in years (maximum)  1508 (14.8)  5813 (15.4)    AVR: aortic valve replacement; CABG: coronary artery bypass graft; IQR: interquartile range; LVEF: left ventricular ejection fraction; MVR: mitral valve replacement. Figure 2: View largeDownload slide Manufacturer-labelled bioprosthesis size for the Mosaic and Perimount aortic valve bioprostheses. Figure 2: View largeDownload slide Manufacturer-labelled bioprosthesis size for the Mosaic and Perimount aortic valve bioprostheses. The 30-day mortality was 8.8% for the Mosaic when compared with 6.2% for the Perimount valves (P = 0.09), and when adjusted for age, EuroSCORE and LVEF using multiple logistic regression, the mortality was 5.3% for the Mosaic and 3.7% for the Perimount valves (P = 0.29). Actuarial survival free of death was similar; at follow-up in February 2016, 37% of patients in the Mosaic cohort and 42% of patients in the Perimount cohort were alive. The 1-, 5- and 7-year survivals were 87.0%, 71.7% and 63.0%, respectively, in the Perimount group and 83.8%, 71.8% and 61.6%, respectively, in the Mosaic group (P = 0.44) (Fig. 3). Figure 3: View largeDownload slide The Kaplan–Meier estimated survival. CI: confidence interval; SVD: structural valve deterioration. Figure 3: View largeDownload slide The Kaplan–Meier estimated survival. CI: confidence interval; SVD: structural valve deterioration. The Cox proportional hazards regression identified younger age (P = 0.02), EuroSCORE (P = 0.03) and LVEF (P = 0.01) as independent predictors of the death during the follow-up period. The surgeon was not found to be an independent predictor of mortality (P = 0.6). No independent predictors of SVD or reoperation were identified. The Kaplan–Meier graph for SVD is shown in Fig. 4. The propensity score-weighted version of the Cox model confirmed no difference in number of cases of SVD between the 2 valves, when gender, age, size of valve, EuroSCORE, LVEF, BSA and risk factors such as hypertension, diabetes, serum creatinine were taken into account, Table 2. However, the multivariable regression model confirmed that the Mosaic valves were failing earlier. Table 2: Propensity score-weighted version of the Cox analysis with SVD as end point   P-value  Gender  0.89  Age  0.82  EuroSCORE  0.71  LVEF  0.81  BSA  0.98  Hypertension  0.86  Diabetes  0.85  Serum creatinine  0.59  Size of valve  0.79  Type of valve  0.88    P-value  Gender  0.89  Age  0.82  EuroSCORE  0.71  LVEF  0.81  BSA  0.98  Hypertension  0.86  Diabetes  0.85  Serum creatinine  0.59  Size of valve  0.79  Type of valve  0.88  BSA: body surface area; LVEF: left ventricular ejection fraction; SVD: structural valve deterioration. Table 2: Propensity score-weighted version of the Cox analysis with SVD as end point   P-value  Gender  0.89  Age  0.82  EuroSCORE  0.71  LVEF  0.81  BSA  0.98  Hypertension  0.86  Diabetes  0.85  Serum creatinine  0.59  Size of valve  0.79  Type of valve  0.88    P-value  Gender  0.89  Age  0.82  EuroSCORE  0.71  LVEF  0.81  BSA  0.98  Hypertension  0.86  Diabetes  0.85  Serum creatinine  0.59  Size of valve  0.79  Type of valve  0.88  BSA: body surface area; LVEF: left ventricular ejection fraction; SVD: structural valve deterioration. Figure 4: View largeDownload slide The Kaplan–Meier estimated unadjusted survival free of SVD. CI: confidence interval; SVD: structural valve deterioration. Figure 4: View largeDownload slide The Kaplan–Meier estimated unadjusted survival free of SVD. CI: confidence interval; SVD: structural valve deterioration. For the Mosaic valve, the mean time to redo surgery was 5.7 (SD 4.2, range 3.4–13.1) years. In comparison, all SVD in the Perimount valve occurred after 5 years (Table 3, Fig. 5) with a mean time to redo surgery of 10.2 (SD 1.9, range 8.6–14.1) years (P < 0.01). None of the patients with SVD had severe renal dysfunction, diabetes or impaired left ventricular function. One of the patients with SVD in a Mosaic valve was younger than 60 years at implantation when compared with 2 patients with SVD in Perimount valves. All failing Perimount valves and 4 of the 5 Mosaic valves had dominant regurgitation, whereas 1 Mosaic valve had dominant stenosis. One patient with a Mosaic valve and 3 patients with Perimount valves were referred for a transcatheter aortic valve implantation. Table 3: Rates of redo surgery by indication   Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Total reoperations, n (%)  10 (4.6)  17 (2.1)  0.02  SVD total, n (%)  5 (2.3)  7 (0.9)  0.04  SVD (years)         <5  4  0     5–10  0  5     >10  1  2    Non-structural deterioration, n (%)  3 (1.4)  0    Thrombosis  0  0    Aortic root dissection  0  3 (0.4)    Infection, n (%)  2 (0.9)  7 (0.9)  0.9    Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Total reoperations, n (%)  10 (4.6)  17 (2.1)  0.02  SVD total, n (%)  5 (2.3)  7 (0.9)  0.04  SVD (years)         <5  4  0     5–10  0  5     >10  1  2    Non-structural deterioration, n (%)  3 (1.4)  0    Thrombosis  0  0    Aortic root dissection  0  3 (0.4)    Infection, n (%)  2 (0.9)  7 (0.9)  0.9  SVD: structural valve deterioration. Table 3: Rates of redo surgery by indication   Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Total reoperations, n (%)  10 (4.6)  17 (2.1)  0.02  SVD total, n (%)  5 (2.3)  7 (0.9)  0.04  SVD (years)         <5  4  0     5–10  0  5     >10  1  2    Non-structural deterioration, n (%)  3 (1.4)  0    Thrombosis  0  0    Aortic root dissection  0  3 (0.4)    Infection, n (%)  2 (0.9)  7 (0.9)  0.9    Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Total reoperations, n (%)  10 (4.6)  17 (2.1)  0.02  SVD total, n (%)  5 (2.3)  7 (0.9)  0.04  SVD (years)         <5  4  0     5–10  0  5     >10  1  2    Non-structural deterioration, n (%)  3 (1.4)  0    Thrombosis  0  0    Aortic root dissection  0  3 (0.4)    Infection, n (%)  2 (0.9)  7 (0.9)  0.9  SVD: structural valve deterioration. Figure 5: View largeDownload slide Time to redo surgery for individual patients. SVD: structural valve deterioration. Figure 5: View largeDownload slide Time to redo surgery for individual patients. SVD: structural valve deterioration. There were no instances of valve thrombosis. There was no statistically significant difference in the incidence of redo surgery for infection. Redo surgery for non-structural deterioration was not required for the Perimount valve but occurred in 3 patients with a Mosaic valve for patient–prosthesis mismatch in 2 cases and paraprosthetic regurgitation in 1 case. Redo surgery was required for aortic root dissections in 3 patients with Perimount valves. DISCUSSION SVD occurred equally for patients with the Mosaic and Perimount valves but occurred earlier with Mosaic valves (2.1%; P = 0.02) over a mean follow-up of approximately 8 years (maximally 15.1 years). Our results differ from the published literature for the individual designs with lower rates of SVD for the Perimount valve of 0–1.6% by 5 years [2–4] and 1.2% by 10 years [4] when compared with higher rates for the Mosaic valve, 1–4% [5–8] by 5 years and 3.1–13% by 10 years [9, 10]. Glaser et al. [5] compared both valves and found redo surgery rates for SVD of 2.3% with Mosaic valves when compared with 0.35% with Perimount valves. However, the 2 valves were implanted over different time periods while we compared both valve types implanted concurrently. In a randomized comparison over 5 years [11] of 108 patients implanted with either a Mosaic or a Perimount Magna valve, there were 4 Mosaic valves but no Magna valves with significant stenosis. In contrast, a non-randomized comparison [12] in 458 patients followed up for 4 years found SVD in 0.5% Mosaic and 0.3% Perimount Magna valves. This study differed from ours and that of Dalmau et al. by including only isolated aortic valves and a shorter follow-up. Rates of SVD are affected by risk factors including diabetes, systemic hypertension and renal failure, none of which was present in our patients with SVD. Age at implantation is also a determinant of SVD [2, 11, 13] but more Perimount than Mosaic valves were implanted in patients younger than 60 years so this does not adequately explain the higher rates of premature SVD in the Mosaic valve. The patient–prosthesis mismatch is also a potential risk for early SVD [14], and this occurred in 83% of Mosaic and 68% of Perimount valves in our earlier randomized controlled trial although this difference was not statistically significant [15]. We do not have the haemodynamic data on all valves in this study to investigate a link systematically. However, 2 of our patients with Mosaic valves in this study and no Perimount valves required redo surgery for patient–prosthesis mismatch. It remains possible that the difference in rates of premature SVD are related to other aspects of intrinsic design differences between the Mosaic and Perimount valves including the tissue used in manufacturing. Interestingly, our findings of dominant regurgitation in all failing Perimount valves and 4 of 5 Mosaic valves are in contrast to previous series that reported stenosis as the primary reason for failure [13]. Early SVD was not common in both valve types in this study but occurred earlier for the Mosaic valve than the Perimount valve. These individual differences suggest that the American Heart Association recommendation [16] for routine annual echocardiography beyond 10 years after implantation may not be universally appropriate, whereas the European Society of Cardiology recommendation of echocardiography annually may be too frequent. An individualized approach depending on the type of valve and presence of risk factors for structural valve degeneration better fits the data available. In this approach, biological valves for which durability data are sparse should be checked annually from implantation, and patients with individual risks for early failure, such as age <60 years, diabetes or patient–prosthesis mismatch should be followed up annually after 5 years from implantation and the rest after 10 years. Limitations This study has a number of limitations. This was a single-centre retrospective review and was not randomized although the valves were implanted concurrently. We were unable to obtain summary care record data for 7 patients (all Perimount prostheses) as they lived overseas, although none of these patients were referred back to our institution and there was 100% follow-up for the remaining patients. 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Google Scholar CrossRef Search ADS PubMed  14 Vohra HA, Whistance RN, de Kerchove L, Glineur D, Noirhomme P, El Khoury G. Influence of higher valve gradient on long-term outcome after aortic valve repair. Ann Cardiothorac Surg  2013; 2: 30– 9. Google Scholar PubMed  15 Chambers JB, Rajani R, Parkin D, Rimington HM, Blauth CI, Venn GE et al.   Bovine pericardial versus porcine stented replacement aortic valves: early results of a randomized comparison of the Perimount and the Mosaic valves. J Thorac Cardiovasc Surg  2008; 136: 1142– 8. Google Scholar CrossRef Search ADS PubMed  16 Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP3rd, Guyton RA et al.   2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol  2014; 63: e57– 185. Google Scholar CrossRef Search ADS PubMed  © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Cardio-Thoracic Surgery Oxford University Press

A comparison of early redo surgery rates in Mosaic porcine and Perimount bovine pericardial valves

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
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1010-7940
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1873-734X
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10.1093/ejcts/ezy113
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Abstract

Abstract OBJECTIVES The objective of this study was to compare rates of redo surgery for the Medtronic Mosaic 305 A Porcine Prosthesis and the Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis 2900. METHODS This was a single-centre retrospective observational study. We included all 1018 patients who underwent aortic valve replacement with a Mosaic (n = 216) or Perimount (n = 809) bioprosthesis between October 2000 and August 2008. The total follow-up was 1508 patient-years for the Mosaic valve and 5813 for the Perimount valve. The maximal follow-up and interquartile range were 14.8 and 7.0 years for the Mosaic valve and 15.1 and 5.6 years for the Perimount valve, respectively. A propensity score-weighted version of the Cox model, Kaplan–Meier analysis and multivariate regression model was used. RESULTS Despite no statistical difference in the number of non-structural valve deterioration cases between valves, redo surgery occurred earlier in 10 (4.6%) Mosaic than for 17 (2.1%) Perimount valves (P = 0.02) and was required for structural valve deterioration in 5 (2.3%) Mosaic valves when compared with 7 (0.9%; P = 0.04) Perimount valves. Four of 5 Mosaic failures occurred before 5 years, whereas all Perimount failures occurred after 5 years. Redo surgery for non-structural valve deterioration occurred in 3 patients with Mosaic valves (1.4%) and no patients with Perimount valves. Surgery for the remaining patients with Perimount valves was due to infection or aortic disease. CONCLUSIONS Early redo surgery for structural valve degeneration was uncommon but occurred earlier for the Mosaic porcine than the Perimount bovine pericardial replacement aortic valve. Mosaic replacement valve , Perimount replacement valve , Redo surgery , Structural valve degeneration INTRODUCTION Stented biological replacement valves are all subject to structural deterioration, and considerable research has been expended to improve durability. Measures include design features of the stent to reduce mechanical stresses, low-pressure fixation of the cusps and anticalcification treatments. The tissue used for manufacturing may also affect durability, but whether general comparisons between porcine aortic valve and bovine pericardial tissue can be made is uncertain. Some studies [1, 2] suggest that bovine pericardial valves have better durability than porcine valves although others [3–5] report no difference. However, there are no comparisons of Mosaic and Perimount valves implanted concurrently [5]. We previously conducted a randomized comparison of early haemodynamic function in the Medtronic Mosaic porcine pericardial valve when compared with the Perimount bovine pericardial valve [6]. Although this study was not designed for follow-up beyond 1 year and included only 99 patients, we noticed a higher incidence of early redo surgery in the Mosaic population. We, therefore, sought to compare rates of redo surgery in all 1025 patients at our institution implanted with a Mosaic or Perimount replacement aortic valve in a period of just under 8 years. METHODS This was a single-centre retrospective observational study at Guy’s and St Thomas Cardiothoracic Centre. The surgeons were able to choose freely between a Medtronic Mosaic valve and a Carpentier-Edwards Perimount valve, which was the main biological valve in use between October 2000 and August 2008. The Medtronic Mosaic 305 A is a stented porcine bioprosthesis (Medtronic, Inc., St Paul, MN, USA) first introduced in 1994. It has 3 cusps, flexible stents made of Haynes alloy and a scalloped suture ring made of acetal homopolymer covered with polyester fabric. The cusps are fixed in glutaraldehyde at 0 net pressure (by applying a pressure of 40 mmHg on either side of the valve) and subjected to anticalcification treatment with alpha-amino-oleic acid. The Carpentier-Edwards Perimount 2900 bovine pericardial valve (Edwards Lifesciences Corp., Irvine, CA, USA) is a stented bovine pericardial bioprosthesis, bioengineered from a flexible cobalt–chromium alloy stent with 3 independent bovine pericardial cusps. At our institution, warfarin is routinely administered for 3 months after implantation. After this, maintenance is continued with 75mg of aspirin unless there is an independent need for anticoagulation with warfarin to be continued, e.g. atrial fibrillation. Data acquisition Theatre registers were used to identify all patients receiving either a Medtronic Mosaic or a Carpentier-Edwards Perimount replacement aortic valve between October 2000 and August 2008. The study was approved as a service evaluation (Trust registered number 5417). The hospital notes from each patient were reviewed; all readmissions and reoperations were identified from the institution’s hospital records. Moreover, the case files were searched for possible factors affecting durability: age at implantation, systemic hypertension, diabetes, and renal failure or renal replacement therapy. The NHS portal (Summary Care Records) was used to ascertain the survival for all patients until February 2016, ensuring that the follow-up was at least 7.5 years and maximally 16 years. The primary end point was structural valve deterioration (SVD) until the end of follow-up, and the secondary end point was time to death for the same follow-up period. Death certificates were obtained from the General Register Office for clarification on the causes of death if the cause of death was not clear from the hospital records. Analysis The reason for reoperations was classified according to recognized guidance as [1] SVD (deterioration or dysfunction caused by changes intrinsic to the valve, e.g. calcification, leaflet tear or stent creep); non-structural deterioration (any abnormality not intrinsic to the valve that results in stenosis or regurgitation or haemolysis, e.g. pannus, inappropriate sizing and paraprosthetic leak); thrombosis and infection (proved by the Duke criteria or surgical or autopsy evidence of infection). Premature structural degeneration was defined as occurring before 5 years. Renal dysfunction was defined as the need for renal replacement or creatinine >300 umol/l. Patients who underwent transcatheter aortic valve implantation were considered as requiring a redo intervention. Statistics Prism (version 6), SPSS (version 24) and MATLAB (R2017b) were used for data storage and analysis. Continuous variables are reported as mean and standard deviation, if they had Gaussian distribution and as median and interquartile range if not and categorical variables as percentages. Normality was tested using the D’Agostino and Pearson omnibus normality test. Intergroup comparisons were conducted using the Fisher’s exact test and t-test or Wilcoxon rank-sum tests for categorical and continuous variables with or without normal distribution, respectively. Differences in 30-day mortality were compared using the χ2 test, and the multiple logistic regression was used to investigate the contribution of the EuroSCORE, gender and age. We used a propensity score-weighted version of the Cox model to identify potential predictors of SVD occurrence during the follow-up period. For the time-to-event analysis, the Kaplan–Meier graphs were used. A multivariable regression model was used to establish time to outcome variable. Power calculations were not performed in this retrospective analysis; however, with only 27 events observed, it should be regarded generally as low because power is driven not by number of patients but by number of events. Statistical significance was defined as a P-value <0.05. RESULTS Between October 2000 and August 2008, 1025 patients underwent aortic valve replacement with a Mosaic (n = 216) or Perimount valve (n = 809), (Fig. 1). Seven patients with Perimount valves were lost to follow-up as they lived abroad (follow-up complete in 99.3% of patients). Figure 1: View largeDownload slide Percentage of Mosaic and Perimount implantations between year 2000 and 2008. Figure 1: View largeDownload slide Percentage of Mosaic and Perimount implantations between year 2000 and 2008. Follow-up was until February 2016. The total follow-up was 1508 patient-years for the Mosaic valve and 5813 patient-years for the Perimount valve. The maximal follow-up and interquartile range were 14.8 and 7.0 years for the Mosaic valve and 15.1 and 5.6 years for the Perimount valve, respectively. General Overall, the average age was 73.5 years (median 74.7 years; range 16–91 years), and 62% of the patients were men. The median left ventricular ejection fraction (LVEF) was 50% (interquartile range 15). Concomitant surgery was performed in 111 (51.4%) patients with the Mosaic valve and 398 (50%) with the Perimount valve (Table 1). The mean valve size was 23 mm (SD 2.3), and manufacturer-labelled bioprosthesis sizes for each valve are shown in Fig. 2. Normal distribution was confirmed using valve size implanted and body surface area (BSA) but not using age at operation, EuroSCORE or LVEF. More patients with Mosaic valves had systemic hypertension (P = 0.004), but otherwise there were no statistical differences in demographic characteristics at surgery (Table 1) or the logistic EuroSCORE. There were 4 surgeons who implanted the majority of the valves, one of whom implanted equal numbers of each valve. The other 3 demonstrated a preference for 1 valve, 2 of whom preferred the Perimount valve and the other preferred the Mosaic valve. Table 1: Patient demographics   Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Age at implantation, median (IQR)  75.06 (8.2)  74.6 (10)  0.45  Patients younger than 60 years at implantation (%), n (%)  7 (3.2)  51 (6.4)  0.08  Patients older than 80 years at implantation (%), n (%)  58 (26.9)  184 (22.7)  0.21  Men:women (%)  60:40  63:37  0.45  Median body surface area, median (IQR)  1.87 (0.3)  1.85 (0.28)  0.64  Isolated AVR (% of total), n (%)  105 (48.6)  404 (50.3)  0.32  AVR + CABG, n (%)  104 (48.1)  353 (44.4)  0.28  AVR + MVR, n (%)  6 (2.78)  26 (3.3)  0.72  AVR + MVR + CABG, n (%)  1 (0.46)  19 (2.6)  0.72  Median logistic EuroSCORE, median (IQR)  8.0 (4)  8.0 (4)  0.42  LVEF, n (%)         <30%  18 (8.3)  50 (6.2)  0.27   30–40%  36 (16.7)  127 (15.8)  0.76   >40%  162 (75)  625 (77.9)  0.36  Systemic hypertension, n (%)  147 (68)  437 (54)  0.004  Diabetes, n (%)  28 (13)  109 (13.5)  0.81  Serum creatinine >300 ml/min or on dialysis, n (%)  8 (3.7)  41 (5.1)  0.40  Total follow-up in years (maximum)  1508 (14.8)  5813 (15.4)      Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Age at implantation, median (IQR)  75.06 (8.2)  74.6 (10)  0.45  Patients younger than 60 years at implantation (%), n (%)  7 (3.2)  51 (6.4)  0.08  Patients older than 80 years at implantation (%), n (%)  58 (26.9)  184 (22.7)  0.21  Men:women (%)  60:40  63:37  0.45  Median body surface area, median (IQR)  1.87 (0.3)  1.85 (0.28)  0.64  Isolated AVR (% of total), n (%)  105 (48.6)  404 (50.3)  0.32  AVR + CABG, n (%)  104 (48.1)  353 (44.4)  0.28  AVR + MVR, n (%)  6 (2.78)  26 (3.3)  0.72  AVR + MVR + CABG, n (%)  1 (0.46)  19 (2.6)  0.72  Median logistic EuroSCORE, median (IQR)  8.0 (4)  8.0 (4)  0.42  LVEF, n (%)         <30%  18 (8.3)  50 (6.2)  0.27   30–40%  36 (16.7)  127 (15.8)  0.76   >40%  162 (75)  625 (77.9)  0.36  Systemic hypertension, n (%)  147 (68)  437 (54)  0.004  Diabetes, n (%)  28 (13)  109 (13.5)  0.81  Serum creatinine >300 ml/min or on dialysis, n (%)  8 (3.7)  41 (5.1)  0.40  Total follow-up in years (maximum)  1508 (14.8)  5813 (15.4)    AVR: aortic valve replacement; CABG: coronary artery bypass graft; IQR: interquartile range; LVEF: left ventricular ejection fraction; MVR: mitral valve replacement. Table 1: Patient demographics   Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Age at implantation, median (IQR)  75.06 (8.2)  74.6 (10)  0.45  Patients younger than 60 years at implantation (%), n (%)  7 (3.2)  51 (6.4)  0.08  Patients older than 80 years at implantation (%), n (%)  58 (26.9)  184 (22.7)  0.21  Men:women (%)  60:40  63:37  0.45  Median body surface area, median (IQR)  1.87 (0.3)  1.85 (0.28)  0.64  Isolated AVR (% of total), n (%)  105 (48.6)  404 (50.3)  0.32  AVR + CABG, n (%)  104 (48.1)  353 (44.4)  0.28  AVR + MVR, n (%)  6 (2.78)  26 (3.3)  0.72  AVR + MVR + CABG, n (%)  1 (0.46)  19 (2.6)  0.72  Median logistic EuroSCORE, median (IQR)  8.0 (4)  8.0 (4)  0.42  LVEF, n (%)         <30%  18 (8.3)  50 (6.2)  0.27   30–40%  36 (16.7)  127 (15.8)  0.76   >40%  162 (75)  625 (77.9)  0.36  Systemic hypertension, n (%)  147 (68)  437 (54)  0.004  Diabetes, n (%)  28 (13)  109 (13.5)  0.81  Serum creatinine >300 ml/min or on dialysis, n (%)  8 (3.7)  41 (5.1)  0.40  Total follow-up in years (maximum)  1508 (14.8)  5813 (15.4)      Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Age at implantation, median (IQR)  75.06 (8.2)  74.6 (10)  0.45  Patients younger than 60 years at implantation (%), n (%)  7 (3.2)  51 (6.4)  0.08  Patients older than 80 years at implantation (%), n (%)  58 (26.9)  184 (22.7)  0.21  Men:women (%)  60:40  63:37  0.45  Median body surface area, median (IQR)  1.87 (0.3)  1.85 (0.28)  0.64  Isolated AVR (% of total), n (%)  105 (48.6)  404 (50.3)  0.32  AVR + CABG, n (%)  104 (48.1)  353 (44.4)  0.28  AVR + MVR, n (%)  6 (2.78)  26 (3.3)  0.72  AVR + MVR + CABG, n (%)  1 (0.46)  19 (2.6)  0.72  Median logistic EuroSCORE, median (IQR)  8.0 (4)  8.0 (4)  0.42  LVEF, n (%)         <30%  18 (8.3)  50 (6.2)  0.27   30–40%  36 (16.7)  127 (15.8)  0.76   >40%  162 (75)  625 (77.9)  0.36  Systemic hypertension, n (%)  147 (68)  437 (54)  0.004  Diabetes, n (%)  28 (13)  109 (13.5)  0.81  Serum creatinine >300 ml/min or on dialysis, n (%)  8 (3.7)  41 (5.1)  0.40  Total follow-up in years (maximum)  1508 (14.8)  5813 (15.4)    AVR: aortic valve replacement; CABG: coronary artery bypass graft; IQR: interquartile range; LVEF: left ventricular ejection fraction; MVR: mitral valve replacement. Figure 2: View largeDownload slide Manufacturer-labelled bioprosthesis size for the Mosaic and Perimount aortic valve bioprostheses. Figure 2: View largeDownload slide Manufacturer-labelled bioprosthesis size for the Mosaic and Perimount aortic valve bioprostheses. The 30-day mortality was 8.8% for the Mosaic when compared with 6.2% for the Perimount valves (P = 0.09), and when adjusted for age, EuroSCORE and LVEF using multiple logistic regression, the mortality was 5.3% for the Mosaic and 3.7% for the Perimount valves (P = 0.29). Actuarial survival free of death was similar; at follow-up in February 2016, 37% of patients in the Mosaic cohort and 42% of patients in the Perimount cohort were alive. The 1-, 5- and 7-year survivals were 87.0%, 71.7% and 63.0%, respectively, in the Perimount group and 83.8%, 71.8% and 61.6%, respectively, in the Mosaic group (P = 0.44) (Fig. 3). Figure 3: View largeDownload slide The Kaplan–Meier estimated survival. CI: confidence interval; SVD: structural valve deterioration. Figure 3: View largeDownload slide The Kaplan–Meier estimated survival. CI: confidence interval; SVD: structural valve deterioration. The Cox proportional hazards regression identified younger age (P = 0.02), EuroSCORE (P = 0.03) and LVEF (P = 0.01) as independent predictors of the death during the follow-up period. The surgeon was not found to be an independent predictor of mortality (P = 0.6). No independent predictors of SVD or reoperation were identified. The Kaplan–Meier graph for SVD is shown in Fig. 4. The propensity score-weighted version of the Cox model confirmed no difference in number of cases of SVD between the 2 valves, when gender, age, size of valve, EuroSCORE, LVEF, BSA and risk factors such as hypertension, diabetes, serum creatinine were taken into account, Table 2. However, the multivariable regression model confirmed that the Mosaic valves were failing earlier. Table 2: Propensity score-weighted version of the Cox analysis with SVD as end point   P-value  Gender  0.89  Age  0.82  EuroSCORE  0.71  LVEF  0.81  BSA  0.98  Hypertension  0.86  Diabetes  0.85  Serum creatinine  0.59  Size of valve  0.79  Type of valve  0.88    P-value  Gender  0.89  Age  0.82  EuroSCORE  0.71  LVEF  0.81  BSA  0.98  Hypertension  0.86  Diabetes  0.85  Serum creatinine  0.59  Size of valve  0.79  Type of valve  0.88  BSA: body surface area; LVEF: left ventricular ejection fraction; SVD: structural valve deterioration. Table 2: Propensity score-weighted version of the Cox analysis with SVD as end point   P-value  Gender  0.89  Age  0.82  EuroSCORE  0.71  LVEF  0.81  BSA  0.98  Hypertension  0.86  Diabetes  0.85  Serum creatinine  0.59  Size of valve  0.79  Type of valve  0.88    P-value  Gender  0.89  Age  0.82  EuroSCORE  0.71  LVEF  0.81  BSA  0.98  Hypertension  0.86  Diabetes  0.85  Serum creatinine  0.59  Size of valve  0.79  Type of valve  0.88  BSA: body surface area; LVEF: left ventricular ejection fraction; SVD: structural valve deterioration. Figure 4: View largeDownload slide The Kaplan–Meier estimated unadjusted survival free of SVD. CI: confidence interval; SVD: structural valve deterioration. Figure 4: View largeDownload slide The Kaplan–Meier estimated unadjusted survival free of SVD. CI: confidence interval; SVD: structural valve deterioration. For the Mosaic valve, the mean time to redo surgery was 5.7 (SD 4.2, range 3.4–13.1) years. In comparison, all SVD in the Perimount valve occurred after 5 years (Table 3, Fig. 5) with a mean time to redo surgery of 10.2 (SD 1.9, range 8.6–14.1) years (P < 0.01). None of the patients with SVD had severe renal dysfunction, diabetes or impaired left ventricular function. One of the patients with SVD in a Mosaic valve was younger than 60 years at implantation when compared with 2 patients with SVD in Perimount valves. All failing Perimount valves and 4 of the 5 Mosaic valves had dominant regurgitation, whereas 1 Mosaic valve had dominant stenosis. One patient with a Mosaic valve and 3 patients with Perimount valves were referred for a transcatheter aortic valve implantation. Table 3: Rates of redo surgery by indication   Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Total reoperations, n (%)  10 (4.6)  17 (2.1)  0.02  SVD total, n (%)  5 (2.3)  7 (0.9)  0.04  SVD (years)         <5  4  0     5–10  0  5     >10  1  2    Non-structural deterioration, n (%)  3 (1.4)  0    Thrombosis  0  0    Aortic root dissection  0  3 (0.4)    Infection, n (%)  2 (0.9)  7 (0.9)  0.9    Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Total reoperations, n (%)  10 (4.6)  17 (2.1)  0.02  SVD total, n (%)  5 (2.3)  7 (0.9)  0.04  SVD (years)         <5  4  0     5–10  0  5     >10  1  2    Non-structural deterioration, n (%)  3 (1.4)  0    Thrombosis  0  0    Aortic root dissection  0  3 (0.4)    Infection, n (%)  2 (0.9)  7 (0.9)  0.9  SVD: structural valve deterioration. Table 3: Rates of redo surgery by indication   Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Total reoperations, n (%)  10 (4.6)  17 (2.1)  0.02  SVD total, n (%)  5 (2.3)  7 (0.9)  0.04  SVD (years)         <5  4  0     5–10  0  5     >10  1  2    Non-structural deterioration, n (%)  3 (1.4)  0    Thrombosis  0  0    Aortic root dissection  0  3 (0.4)    Infection, n (%)  2 (0.9)  7 (0.9)  0.9    Mosaic valve (n = 216)  Perimount valve (n = 809)  P-value  Total reoperations, n (%)  10 (4.6)  17 (2.1)  0.02  SVD total, n (%)  5 (2.3)  7 (0.9)  0.04  SVD (years)         <5  4  0     5–10  0  5     >10  1  2    Non-structural deterioration, n (%)  3 (1.4)  0    Thrombosis  0  0    Aortic root dissection  0  3 (0.4)    Infection, n (%)  2 (0.9)  7 (0.9)  0.9  SVD: structural valve deterioration. Figure 5: View largeDownload slide Time to redo surgery for individual patients. SVD: structural valve deterioration. Figure 5: View largeDownload slide Time to redo surgery for individual patients. SVD: structural valve deterioration. There were no instances of valve thrombosis. There was no statistically significant difference in the incidence of redo surgery for infection. Redo surgery for non-structural deterioration was not required for the Perimount valve but occurred in 3 patients with a Mosaic valve for patient–prosthesis mismatch in 2 cases and paraprosthetic regurgitation in 1 case. Redo surgery was required for aortic root dissections in 3 patients with Perimount valves. DISCUSSION SVD occurred equally for patients with the Mosaic and Perimount valves but occurred earlier with Mosaic valves (2.1%; P = 0.02) over a mean follow-up of approximately 8 years (maximally 15.1 years). Our results differ from the published literature for the individual designs with lower rates of SVD for the Perimount valve of 0–1.6% by 5 years [2–4] and 1.2% by 10 years [4] when compared with higher rates for the Mosaic valve, 1–4% [5–8] by 5 years and 3.1–13% by 10 years [9, 10]. Glaser et al. [5] compared both valves and found redo surgery rates for SVD of 2.3% with Mosaic valves when compared with 0.35% with Perimount valves. However, the 2 valves were implanted over different time periods while we compared both valve types implanted concurrently. In a randomized comparison over 5 years [11] of 108 patients implanted with either a Mosaic or a Perimount Magna valve, there were 4 Mosaic valves but no Magna valves with significant stenosis. In contrast, a non-randomized comparison [12] in 458 patients followed up for 4 years found SVD in 0.5% Mosaic and 0.3% Perimount Magna valves. This study differed from ours and that of Dalmau et al. by including only isolated aortic valves and a shorter follow-up. Rates of SVD are affected by risk factors including diabetes, systemic hypertension and renal failure, none of which was present in our patients with SVD. Age at implantation is also a determinant of SVD [2, 11, 13] but more Perimount than Mosaic valves were implanted in patients younger than 60 years so this does not adequately explain the higher rates of premature SVD in the Mosaic valve. The patient–prosthesis mismatch is also a potential risk for early SVD [14], and this occurred in 83% of Mosaic and 68% of Perimount valves in our earlier randomized controlled trial although this difference was not statistically significant [15]. We do not have the haemodynamic data on all valves in this study to investigate a link systematically. However, 2 of our patients with Mosaic valves in this study and no Perimount valves required redo surgery for patient–prosthesis mismatch. It remains possible that the difference in rates of premature SVD are related to other aspects of intrinsic design differences between the Mosaic and Perimount valves including the tissue used in manufacturing. Interestingly, our findings of dominant regurgitation in all failing Perimount valves and 4 of 5 Mosaic valves are in contrast to previous series that reported stenosis as the primary reason for failure [13]. Early SVD was not common in both valve types in this study but occurred earlier for the Mosaic valve than the Perimount valve. These individual differences suggest that the American Heart Association recommendation [16] for routine annual echocardiography beyond 10 years after implantation may not be universally appropriate, whereas the European Society of Cardiology recommendation of echocardiography annually may be too frequent. An individualized approach depending on the type of valve and presence of risk factors for structural valve degeneration better fits the data available. In this approach, biological valves for which durability data are sparse should be checked annually from implantation, and patients with individual risks for early failure, such as age <60 years, diabetes or patient–prosthesis mismatch should be followed up annually after 5 years from implantation and the rest after 10 years. Limitations This study has a number of limitations. This was a single-centre retrospective review and was not randomized although the valves were implanted concurrently. We were unable to obtain summary care record data for 7 patients (all Perimount prostheses) as they lived overseas, although none of these patients were referred back to our institution and there was 100% follow-up for the remaining patients. Furthermore, the actual number of patients with SVD was small, resulting in a low post hoc power result; however, with only 27 events observed, it should be regarded generally as low because power is driven not by number of patients but by number of events. Early redo surgery for structural valve degeneration was uncommon but more likely and occurred earlier for the Mosaic porcine valve than the Perimount bovine pericardial replacement aortic valve. Funding This work was supported by King’s College London. Conflictof interest: none declared. REFERENCES 1 Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL et al.   Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg  2008; 135: 732– 8. Google Scholar CrossRef Search ADS PubMed  2 Rahimtoola SH. Choice of prosthetic heart valve in adults an update. J Am Coll Cardiol  2010; 55: 2413– 26. 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J Thorac Cardiovasc Surg  2009; 137: 1556– 7. Google Scholar CrossRef Search ADS PubMed  7 Birla R, Twine G, Unsworth-White J. Randomized trial of Carpentier-Edwards supraannular prosthesis versus mosaic aortic prosthesis: 6 year results. Ann Thorac Surg  2013; 95: 831– 7. Google Scholar CrossRef Search ADS PubMed  8 Anselmi A, Flecher E, Ruggieri VG, Harmouche M, Langanay T, Corbineau H et al.   Long-term results of the Medtronic Mosaic porcine bioprosthesis in the aortic position. J Thorac Cardiovasc Surg  2014; 147: 1884– 91. Google Scholar CrossRef Search ADS PubMed  9 Riess FC, Bader R, Cramer E, Hansen L, Kleijnen B, Wahl G et al.   Hemodynamic performance of the Medtronic Mosaic porcine bioprosthesis up to ten years. Ann Thorac Surg  2007; 83: 1310– 18. Google Scholar CrossRef Search ADS PubMed  10 Jamieson WR, Fradet GJ, MacNab JS, Burr LH, Stanford EA, Janusz MT et al.   Medtronic mosaic porcine bioprosthesis: investigational center experience to six years. 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Google Scholar CrossRef Search ADS PubMed  14 Vohra HA, Whistance RN, de Kerchove L, Glineur D, Noirhomme P, El Khoury G. Influence of higher valve gradient on long-term outcome after aortic valve repair. Ann Cardiothorac Surg  2013; 2: 30– 9. Google Scholar PubMed  15 Chambers JB, Rajani R, Parkin D, Rimington HM, Blauth CI, Venn GE et al.   Bovine pericardial versus porcine stented replacement aortic valves: early results of a randomized comparison of the Perimount and the Mosaic valves. J Thorac Cardiovasc Surg  2008; 136: 1142– 8. Google Scholar CrossRef Search ADS PubMed  16 Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP3rd, Guyton RA et al.   2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol  2014; 63: e57– 185. Google Scholar CrossRef Search ADS PubMed  © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

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European Journal of Cardio-Thoracic SurgeryOxford University Press

Published: Mar 20, 2018

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