Safety, efficacy, and hemodynamic performance of a stented bovine pericardial aortic valve bioprosthesis: Two-year analysis

Dagenais, François; Moront, Michael G.; Brown, W. Morris; Reardon, Michael J.; Chu, Michael; Gearhart, Elizabeth; Klautz, Robert J.M.

doi:10.1016/j.jtcvs.2019.07.132

Cited by 15 publications

(19 citation statements)

References 26 publications

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“…However, rates of moderate and severe PPM were reported in 43.5% and 34.8% of patients, respectively, although PPM status did not impact survival, functional class, and reverse left ventricular (LV) remodeling. 13 Moreover, postoperative gradients and velocities increases were less than would be expected in the higher PPM patients.…”

Section: Introductionmentioning

confidence: 86%

Stress exercise haemodynamic performance and opening reserve of a stented bovine pericardial aortic valve bioprosthesis

Porterie

Salaün

Ternacle

et al. 2022

Journal of Cardiac Surgery

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Objectives: Despite unusual high rates of patient-prosthesis mismatch (PPM), excellent midterm clinical outcomes have been reported after surgical aortic valve replacement (SAVR) with the Avalus™ bioprosthetic valve (Medtronic). To elucidate this "PPM conundrum," the Avalus valve haemodynamics were assessed during exercise testing.Methods: Of the 148 patients who had undergone SAVR with the Avalus valve at our institution, 30 were randomly selected among those in whom stress test was deemed feasible and underwent a resting transthoracic echocardiography immediately followed by exercise echocardiography. Severe PPM was defined as indexed effective orifice area (iEOA) ≤0.65 cm 2 /m 2 and moderate PPM as iEOA >0.65 and ≤0.85 cm 2 /m 2 . Measured PPM was determined with the use of the measured iEOA at rest or stress, while the estimated PPM was based on the estimated iEOA, derived from the mean EOA reported for each valve size in the manufacturer chart.Results: Measured EOA significantly increased from rest to peak exercise in all PPM groups (p < .05) and the rates of moderate and severe measured PPM decreased from 40% and 20% to 27% and 0%, respectively. The patients with low-flow state (flow < 250 ml/s) had significantly lower measured rest EOA (p = .03). On the basis of the estimated iEOA, there was no severe PPM and 19 patients had moderate PPM (63.3%), with a significantly lower opening reserve than the patients without estimated PPM (p = .04). The estimated iEOA was more reliably correlated to the measured iEOA at maximal stress than the measured iEOA at rest, especially in patients with a low-flow state.Conclusions: This study supports the concept of an opening reserve of the Avalus valve to explain the PPM conundrum and promotes the use of exercise Dopplerechocardiography to complete the assessment of mismatch, especially in patients with a low-flow state. Published estimated EOA seems reliable to predict the haemodynamic performance of the Avalus valve, whether the flow conditions at rest.

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Section: Introductionmentioning

confidence: 86%

Stress exercise haemodynamic performance and opening reserve of a stented bovine pericardial aortic valve bioprosthesis

Porterie

Salaün

Ternacle

et al. 2022

Journal of Cardiac Surgery

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“…The use of the Avalus valve was associated with good clinical results, as demonstrated by low mortality, low valve-related adverse event rates, and improved functional class for most patients. Dagenais and colleagues 1 found an increased rate of bleeding in comparison with the expected rate of bleeding reported for other bioprosthetic valves, 2 but this is likely related not directly to the valve but rather to the use of oral anticoagulation during the first 6 to 12 months after surgery.…”

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confidence: 86%

“…In their article in this issue of the Journal, Dagenais and colleagues 1 present the 2-year results of the PERIcardial Sur-Gical AOrtic Valve ReplacemeNT (PERIGON) pivotal trial. This study is a prospective, nonrandomized international multicenter trial that aims to evaluate the safety and effectiveness of the Avalus bovine pericardial valve (Medtronic, Minneapolis, Minn) in the aortic position.…”

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confidence: 99%

“…Moreover, 64.6% of the patients with severe PPM had a 23-mm or larger valve implanted. Dagenais and colleagues 1 have investigated the effect of small effective orifice area (EOA) by means of a fitted joint model, which did not demonstrate an association between the log of EOA and mortality. On the basis of these results, Dagenais and colleagues 1 concluded that the Avalus valves provide adequate EOA.…”

mentioning

confidence: 99%

“…The effect on long-term outcomes of a high PPM rate with Avalus valves require further investigation. On the other hand, the valve was demonstrated to be associated with very low rate of perivalvular leak, and Dagenais and colleagues 1 suggest that this might be due to the generous cuff of the valve. It could be argued that a large cuff might also be at least partially responsible for the smaller EOA, and thus for the increased incidence of PPM.…”

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confidence: 99%

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Commentary: One more option in the conundrum of choice of aortic valve bioprostheses

Bruno

Benedetto

2020

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Recent Advances in the Modification and Improvement of Bioprosthetic Heart Valves

Tong,

Cai,

Wang

et al. 2024

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Valvular heart disease (VHD) has become a burden and a growing public health problem in humans, causing significant morbidity and mortality worldwide. An increasing number of patients with severe VHD need to undergo heart valve replacement surgery, and artificial heart valves are in high demand. However, allogeneic valves from donors are lacking and cannot meet clinical practice needs. A mechanical heart valve can activate the coagulation pathway after contact with blood after implantation in the cardiovascular system, leading to thrombosis. Therefore, bioprosthetic heart valves (BHVs) are still a promising way to solve this problem. However, there are still challenges in the use of BHVs. For example, their longevity is still unsatisfactory due to the defects, such as thrombosis, structural valve degeneration, calcification, insufficient re‐endothelialization, and the inflammatory response. Therefore, strategies and methods are needed to effectively improve the biocompatibility and longevity of BHVs. This review describes the recent research advances in BHVs and strategies to improve their biocompatibility and longevity.

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Safety, efficacy, and hemodynamic performance of a stented bovine pericardial aortic valve bioprosthesis: Two-year analysis

Cited by 15 publications

References 26 publications

Stress exercise haemodynamic performance and opening reserve of a stented bovine pericardial aortic valve bioprosthesis

Stress exercise haemodynamic performance and opening reserve of a stented bovine pericardial aortic valve bioprosthesis

Commentary: One more option in the conundrum of choice of aortic valve bioprostheses

Recent Advances in the Modification and Improvement of Bioprosthetic Heart Valves

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