Durability and Performance of 2298 Trifecta Aortic Valve Prostheses: A Propensity-Matched Analysis

Yongue, Camille; Lopez, Diana; Soltesz, Edward G.; Roselli, Eric E.; Bakaeen, Faisal G.; Gillinov, A. Marc; Pettersson, Gösta; Semple, Marie E.; Rajeswaran, Jeevanantham; Tong, Michael Z.; Jaber, Wael A.; Blackstone, Eugene H.; Svensson, Lars; Johnston, Douglas R.

doi:10.1016/j.athoracsur.2020.07.040

Cited by 42 publications

(53 citation statements)

References 20 publications

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“…Our findings are in line with those from the Finn-Valve study, where at 7 years the all-cause mortality was reported to be 32% in patients with Trifecta vs. 23% in patients with Perimount ( p = 0.755). To our knowledge, to date, there is only one comparative study between these prostheses, with very similar findings as ours ( 12 ). Yongue et al ( 12 ) compared recently the durability and hemodynamic performance of 2,298 Trifecta prostheses with 1:1 propensity matched Perimount prostheses.…”

Section: Discussionsupporting

confidence: 85%

“…Yongue et al ( 12 ) compared recently the durability and hemodynamic performance of 2,298 Trifecta prostheses with 1:1 propensity matched Perimount prostheses. In their study Trifecta bioprosthesis exhibited superior early hemodynamic performance, but had a rapid increase in transvalvular gradient and more aortic regurgitation, with lower freedom from explant at 5 years, which raises concern regarding long-term Trifecta durability despite favorable early hemodynamics ( 12 ).…”

Section: Discussionmentioning

confidence: 99%

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Different Rates of Bioprosthetic Aortic Valve Failure With Perimount™ and Trifecta™ Bioprostheses

Lange

Alalawi²,

Voss³

et al. 2022

Front. Cardiovasc. Med.

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ObjectivesThe use of bioprostheses in surgical aortic valve replacement (SAVR) has increased in younger patients. Comparative analysis of different types of bioprostheses is lacking. We aimed to compare two proprietary bioprostheses with different designs, i.e., internally and externally mounted leaflets, focusing on the long-term durability and survival.MethodsWe conducted a large single-center retrospective analysis of all consecutive patients who underwent SAVR with either Perimount™ or Trifecta™ bioprostheses between 2001 and 2019. The patient groups were further subdivided by age <65 and >65. Endpoints of the study were all-cause mortality and reoperation due to bioprosthetic valve failure (BVF).ResultsSelection criteria resulted in a total sample of 5,053 patients; 2,630 received a Perimount prosthesis (internally mounted leaflets) and 2,423 received a Trifecta prosthesis (externally mounted leaflets). The mean age at surgery was similar (69 ± 11 y, PM, and 68 ± 10 y, TF, p = 0.9), as was estimated survival at 8 years (76.1 ± 1.3%, PM, and 63.7 ± 1.9% TF; p=0.133). Patients in the Trifecta group had a significantly higher cumulative reoperation rate at 8 years compared to those in the Perimount group (16.9 ± 1.9% vs. 3.8 ± 0.4%; p < 0.01). This difference persisted across age groups (<65 y, 13.3% TF vs. 8.6% PM; >65 y, 12% TF vs. 7% PM).ConclusionBioprostheses for SAVR with externally mounted leaflets (Trifecta) showed significantly higher long-term reoperation rates compared to those with internally mounted leaflets (Perimount), regardless of the patient's age at SAVR. Survival was similar with both bioprostheses.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Different Rates of Bioprosthetic Aortic Valve Failure With Perimount™ and Trifecta™ Bioprostheses

Lange

Alalawi²,

Voss³

et al. 2022

Front. Cardiovasc. Med.

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“…24,25 Likewise, a recent comparative analysis of the Perimount (internally mounted) bioprosthesis and the Trifecta (externally wrapped) valve highlighted that despite the latter exhibited superior early haemodynamic performance, its durability was compromised by a rapid increase in transvalvular gradient and more aortic regurgitation, resulting in lower freedom from explant at 5 years. 26 Further longitudinal studies will be mandatory to elucidate the relationship (either beneficial or negative) of the opening reserve on the wear and tear stresses on the leaflets, the risk of SVD, and ultimately the durability of the Avalus valve.…”

Section: Discussionmentioning

confidence: 99%

“…Among the 30 patients, 27 were men (90%), and the mean age was 69.5 (65.0-74.2) years. At rest, the prevalence of moderate and severe measured PPM was 40% (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) and 20% (6-30), respectively. No significant difference was seen regarding body surface area (BSA), body mass index (BMI), blood pressure, and comorbidities among the three PPM subgroups.…”

Section: Baseline Clinical Characteristics Of the Study Populationmentioning

confidence: 99%

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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“…Several comparative studies suggest a higher incidence of structural valve degeneration (SVD) with Trifecta valves compared to other stented bioprotheses 6,7 . These studies are single‐center midterm analyses and represent concerning trends that warrant further investigation 7,8 . The lack of prospective or randomized trial data limits the inferences that can be confidently made and additional data can help clarify the strength of the finding and generalizability to other centers.…”

Section: Introductionmentioning

confidence: 99%

Aortic valve biologic protheses: A cohort comparison of premature valve failure

Yount

Hawkins

Mehaffey

et al. 2022

Journal of Cardiac Surgery

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Background Recent reports suggest an increased rate of early structural valve degeneration (SVD) in the Trifecta bioprosthesis (Abbott Cardiovascular). We sought to compare the intermediate‐term outcomes of the Magna (Edwards Life Sciences) and Trifecta valves. Methods All surgical aortic valve replacements (SAVRs) with Trifecta or Magna/Magna Ease bioprostheses at an academic medical center were extracted from an institutional database. Patients who survived until after discharge (2011–2019) were included. The primary outcome was valve failure for any reason requiring reintervention or contributing to death, identified by reintervention or review of cause of death. Time to failure was estimated with Kaplan–Meier analysis and Cox Proportional Hazards Modeling. Results Out of 1444 patients, 521 (36%) underwent Trifecta and 923 (64%) underwent Magna implantation with a median follow‐up of 27.6 months. Trifecta patients had larger median valve size (25 vs. 23 mm, p < .001) and lower median gradient (8.0 vs. 10.9 mmHg, p < .001). Trifecta patients had higher 48‐month estimated failure rates (20.2 ± 7.6% vs. 2.6 ± 0.7%, p < .0001), with failure rates of 21.4 versus 9.2 failures per 1000 person‐years (p < .001). After risk‐adjustment, Trifecta patients had a 5.3 times hazard of failure (95% confidence interval: 2.78–12.34, p < .001) compared to Magna patients. Only Trifecta valves failed due to sudden aortic regurgitation, 8 out of 521 (1.5%). Conclusion Despite lower postoperative mean gradients, the Trifecta bioprosthesis may have an increased risk of intermediate‐term SVD. Further research is warranted to confirm the potential for sudden valve failure.

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Durability and Performance of 2298 Trifecta Aortic Valve Prostheses: A Propensity-Matched Analysis

Cited by 42 publications

References 20 publications

Different Rates of Bioprosthetic Aortic Valve Failure With Perimount™ and Trifecta™ Bioprostheses

Different Rates of Bioprosthetic Aortic Valve Failure With Perimount™ and Trifecta™ Bioprostheses

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

Aortic valve biologic protheses: A cohort comparison of premature valve failure

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