Effect of bioprostheses anti-calcification treatment: comparative follow-up between Mitroflow LX and Magna pericardial xenografts using a propensity score-weighted analysis

Blasco-Lucas, Arnau; Permanyer, Eduard; Pérez, María-Llanos; Gracia-Baena, Juan Manuel; Ríos, Raquel; Casós, Kelly; Galiñanes, Manuel

doi:10.1093/icvts/ivw378

Cited by 5 publications

(3 citation statements)

References 27 publications

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“…Furthermore, patients who received a MF valve were more likely to have a valve related cause of death. This is consistent with the findings of Blasco‐Lucas et al who reported that MF patients had a 44% increased hazard of death over a 4‐year period of follow‐up compared to patients receiving a comparator valve at their institution. While our study cannot demonstrate causation, the increased incidence of SVD associated with the MF aortic bioprosthesis is likely a contributing factor in the increased mortality rate as suggested by a large Veterans Affairs study which identified SVD to be a strong independent predictor of mortality.…”

Section: Discussionsupporting

confidence: 91%

Early structural valve deterioration and reoperation associated with the mitroflow aortic valve

et al. 2018

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Background: Structural valve deterioration (SVD) is a known limitation of bioprosthetic valves. Recent reports have suggested a concerning rate of early SVD in patients receiving a Mitroflow aortic bioprosthesis. We therefore compared the incidence of SVD and SVD requiring reoperation among patients receiving a Mitroflow versus a common contemporary bioprosthesis.Methods: A retrospective cohort analysis was performed on 592 patients receiving a Mitroflow aortic bioprosthesis at our institution between 2010 and 2014. Patients were matched 1:1 using a coarsened exact matching algorithm with patients receiving a Carpentier-Edwards Magna Ease aortic bioprosthesis (Edwards Lifesciences, Irvine, CA) during the same period. The incidence of SVD (defined as a mean transprosthetic gradient ≥30 mmHg or moderate to severe intraprosthetic regurgitation), reoperation for SVD, and cumulative survival were compared between prosthesis types.Results: The cumulative incidence of SVD at 5 years for all patients receiving a Mitroflow aortic bioprosthesis was 16% (13-21%) and 5% underwent reoperation for SVD. Implantation of a Mitroflow valve was associated with an increased risk of SVD compared to the comparator valve (hazard ratio [HR] 2.59 [1.69-3.98], P < 0.01). Older age had a protective effect against SVD (HR 0.95 [0.93-0.96], P < 0.01). Patients who received a Mitroflow valve had reduced long-term survival compared to those who received a comparator valve (P = 0.03). Conclusion: The Mitroflow aortic bioprosthesis is associated with increased rates of early SVD and reoperation for valvular dysfunction as well as reduced survival compared to a contemporary valve. Enhanced clinical and echocardiographic follow-up is advisable after Mitroflow implantation. K E Y W O R D S aortic valve replacement, cardiovascular research, mitroflow, structural valve deterioration 778 |

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Section: Discussionsupporting

confidence: 91%

Early structural valve deterioration and reoperation associated with the mitroflow aortic valve

et al. 2018

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“…Larger studies of the Mitroflow prosthesis have raised concerns regarding its durability due to the lack of anticalcification treatment leading to early valve degeneration. 34 With regard to durability of the Trifecta prosthesis, several studies have reported an excellent freedom from reoperation at the 5-year follow-up. 21,35 Despite satisfactory validation of safety and excellent hemodynamic performance, the Trifecta valve appears to be prone to early structural failure due to cusp tear.…”

Section: Reintervention Due To Svdmentioning

confidence: 99%

Reintervention After Aortic Valve Replacement: Comparison of 3 Aortic Bioprostheses

Lam¹,

Koene²,

Timmermans³

et al. 2020

The Annals of Thoracic Surgery

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Background. The decision to implant a biological valve prosthesis is influenced by the issue of durability. We investigated the rate and the cause of reintervention in 3 different aortic valve bioprostheses.Methods. The study included all patients who underwent aortic valve replacement with a biological valve prosthesis between October 2009 and December 2018. Three different bioprostheses were compared: Carpentier-Edwards (CE) Magna Ease (Edwards Lifesciences, Irvine, CA), Trifecta (St. Jude Medical, St Paul, MN), and Mitroflow (LivaNova, London, United Kingdom). The primary end point was the rate of explantation. The degree of event-free survival and possible predictors for reintervention were also analyzed using Cox regression analysis.Results. In total, 2004 biological aortic valves were implanted, including 923 CE, 719 Trifecta, and 362 Mitroflow bioprostheses. The CE group had a significantly higher degree of event-free survival (917 [99.3%]) compared with the Trifecta (685 [95.3%]) and Mitroflow (340 [93.9%]) groups (P < .0001). The only cause of reintervention in the CE group was prosthetic valve endocarditis (6 [100%]), whereas structural valve deterioration was the most common cause of reintervention in the Trifecta (14 [41.2%]) and Mitroflow (14 [63.6%])groups. Cox regression analysis revealed that age (hazard ratio [HR] 0.9; 95% confidence interval [CI], 0.9-0.9; P < .0001) and type of prosthesis (Trifecta: HR, 6.3; 95% CI, 2.6-15.2; P < .0001; Mitroflow: HR, 6.0, 95% CI, 2.4-15.1; P < .0001) were associated with lower event-free survival.Conclusions. The freedom from reintervention after implantation of the CE bioprosthesis is significantly greater than that of the Trifecta and Mitroflow bioprostheses. Further investigations with larger patient populations and long-term follow-up are required to establish their durability and long-term efficacy.

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“…However, the mechanisms of SVD remain unclear, although mechanical stress [ 7 ], inflammation [ 8 ], and an immune response to xenoantigens in BHVs [ 9 , 10 ] have been proposed to nonexclusively contribute as the initial triggers. The absence of anticalcification treatment [ 6 , 11 , 12 ] or the presence of prosthesis–patient mismatch [ 11 ] may lead to calcification of the leaflets and to SVD, and the wide use of glutaraldehyde as a fixative of the BHV leaflets does not prevent SVD. Furthermore, current valve processing does not eliminate valve immunogenicity, as suggested by the substantial amounts of galactose α1,3-galactose (αGal) [ 13 ] and N -glycolylneuraminic acid (Neu5Gc) [ 14 ] residues in BHVs even after glutaraldehyde fixation and by the swine major histocompatibility antigens (SLA-II) expressed in porcine valves after glutaraldehyde fixation [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

Oxidative Stress in Structural Valve Deterioration: A Longitudinal Clinical Study

et al. 2022

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The cause of structural valve deterioration (SVD) is unclear. Therefore, we investigated oxidative stress markers in sera from patients with bioprosthetic heart valves (BHVs) and their association with SVD. Blood samples were taken from SVD (Phase A) and BHV patients during the first 24 (Phase B1) and >48 months (Phase B2) after BHV implantation to assess total antioxidant capacity (TAC), malondialdehyde (MDA), and nitrotyrosine (NT). The results show that MDA levels increased significantly 1 month after surgery in all groups but were higher at 6 months only in incipient SVD patients. NT levels increased gradually for the first 24 months after implantation in the BHV group. Patients with transcatheter aortic valve implantation (TAVI) showed even higher levels of stress markers. After >48 months, MDA and NT continued to increase in BHV patients with a further elevation after 60–72 months; however, these levels were significantly lower in the incipient and established SVD groups. In conclusion, oxidative stress may play a significant role in SVD, increasing early after BHV implantation, especially in TAVI cases, and also after 48 months’ follow-up, but decreasing when SVD develops. Oxidative stress potentially represents a target of therapeutic intervention and a biomarker of BHV dysfunction.

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Effect of bioprostheses anti-calcification treatment: comparative follow-up between Mitroflow LX and Magna pericardial xenografts using a propensity score-weighted analysis

Abstract: The P-Magna prosthesis showed significantly better overall and cardiac-related survival than the Mitroflow LX. The higher early SVD and reoperation rates seen with the Mitroflow LX prosthesis did not impact negatively on valve-related survival.

Cited by 5 publications

References 27 publications

Early structural valve deterioration and reoperation associated with the mitroflow aortic valve

Early structural valve deterioration and reoperation associated with the mitroflow aortic valve

Reintervention After Aortic Valve Replacement: Comparison of 3 Aortic Bioprostheses

Oxidative Stress in Structural Valve Deterioration: A Longitudinal Clinical Study

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