Trifecta versus Perimount Magna Ease aortic valves: Failure mechanisms

Suzuki, Ryo; Ito, Toshiro; Suzuki, Masato; Ohori, Shunsuke; Takayanagi, Ryo; Maeda, Shiro

doi:10.1177/02184923221100994

Cited by 6 publications

(5 citation statements)

References 20 publications

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“…A comparative analysis of the outcomes of PME and TRI bioprostheses showed that TRI had a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the PME 27 . Moreover, in a retrospective study, earlier failures occurred with the TRI than the PME, but the TRI showed reasonable mean 5‐year trans prosthetic pressure gradient 70 …”

Section: Therapeutic Valuementioning

confidence: 99%

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Current state of clinical trials on xenograft

Masri

Afyouni

Ghazi

et al. 2023

Xenotransplantation

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Background: Xenotransplantation is a worth investing branch of science, since it aims to fulfil the demand on human cells, tissues and organs. Despite decades of consistent work in preclinical assessments, clinical trials on xenotransplantation are far from reaching the targeted goal. Our study aims to track the characteristics, assess the content and summarize the plan of each trial on skin, beta-island, bone marrow, aortic valve and kidney xenografts, leading to a clear sorting of efforts made in this field. Methods: In December 2022, we searched clinicaltrial.gov for interventional clinical trials related to xenograft of skin, pancreas, bone marrow, aortic valve and kidney. A total of 14 clinical trials are included in this study. Characteristics on each trial were gathered. Linked publications were searched using Medline/PubMed and Embase/Scopus. Content of trials was reviewed and summarized. Results: Only 14 clinical trials met our study's criteria. The majority were completed, and most of the trials' enrolment was between 11 and 50 participants. Nine trials used a xenograft of porcine origin. Six trials targeted skin xenotransplantation, four targeted β-cells, two targeted bone marrow and one trial targeted each of the kidney and aortic valve. The average length of trials was 3.38 years. Four trials were conducted in the United States and two trials in each of Brazil, Argentina and Sweden. Of all the included trials, none had any results provided and only three had published work. Phases I, III, and IV had only one trial each. A total of 501 participants were enrolled in these trials. Conclusion: This study sheds the light on the current state of clinical trials on xenograft. Characteristically, trials on this field are of low number, low enrolment, short duration, few related publications and no published results. Porcine organs are the most used in these trials, and skin is the most studied organ. An extension of the literature is highly needed due to the variety of conflicts mentioned. Overall, this study sheds the light on the necessity of managing research efforts, leading to the initiation of more trials targeting the field of xenotransplantation.

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Section: Therapeutic Valuementioning

confidence: 99%

“…27 Moreover, in a retrospective study, earlier failures occurred with the TRI than the PME, but the TRI showed reasonable mean 5-year trans prosthetic pressure gradient. 70…”

Section: Aortic Valve Xenograftmentioning

confidence: 99%

Current state of clinical trials on xenograft

Masri

Afyouni

Ghazi

et al. 2023

Xenotransplantation

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“…However, a Trifecta mid-term data analysis reports contradictory outcomes. On one side, recent studies have demonstrated Trifecta associated with higher early SVD and higher reinterventions rate, while others have reported comparable results with the Perimount [15][16][17][18][19][20]. This study aims to report our experience with Trifecta and Perimount stented pericardial aortic bioprostheses, evaluating hemodynamic performances and outcomes at discharge and mid-term follow-up, along with freedom from SVD at mid-term follow-up.…”

Section: Introductionmentioning

confidence: 96%

Mid-Term Clinical Outcomes and Hemodynamic Performances of Trifecta and Perimount Bioprostheses following Aortic Valve Replacement

Toto

Leo

Klersy

et al. 2023

JCDD

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Aims of the Study: We evaluated the clinical outcome and the hemodynamic and freedom from structural valve degeneration of two standard aortic bioprostheses. Methods: Clinical results, echocardiographic findings and follow-up data of patients operated for isolated or combined aortic valve replacement with the Perimount or the Trifecta bioprosthesis were prospectively collected, retrospectively analysed and compared. We weighted all the analyses by the inverse of the propensity of choosing either valves. Results: Between April 2015 and December 2019, 168 consecutive patients (all comers) underwent aortic valve replacement with Trifecta (n = 86) or Perimount (n = 82) bioprostheses. Mean age was 70.8 ± 8.6 and 68.8 ± 8.6 years for the Trifecta and Perimount groups, respectively (p = 0.120). Perimount patients presented a greater body mass index (27.6 ± 4.5 vs. 26.0 ± 4.2; p = 0.022), and 23% of them suffered from angina functional class 2–3 (23.2% vs. 5.8%; p = 0.002). Mean ejection fraction was 53.7 ± 11.9% (Trifecta) and 54.5 ± 10.4% (Perimount) (p = 0.994), with mean gradients of 40.4 ± 15.9 mmHg (Trifecta) and 42.3 ± 20.6 mmHg (Perimount) (p = 0.710). Mean EuroSCORE-II was 7 ± 11% and 6 ± 9% for the Trifecta and Perimount group, respectively (p = 0.553). Trifecta patients more often underwent isolated aortic valve replacement (45.3% vs. 26.8%; p = 0.016) and annulus enlargement (10.5% vs. 2.4%; p = 0.058). All-cause mortality at 30 days was 3.5% (Trifecta) and 8.5% (Perimount), (p = 0.203) while new pacemaker implantation (1.2% vs. 2.5%; p = 0.609) and stroke rate (1.2% vs. 2.5%; p = 0.609) were similar. Acute MACCE were observed in 5% (Trifecta) and 9% (Perimount) of patients with an unweighted OR of 2.22 (95%CI 0.64–7.66; p = 0.196) and a weighted OR of 1.10 (95%CI: 0.44–2.76, p = 0.836). Cumulative survival at 24 months was 98% (95%CI: 0.91–0.99) and 96% (95%CI: 0.85–0.99) for Trifecta and Perimount groups, respectively (log-rank test; p = 0.555). The 2-year freedom from MACCE was 94% (95%CI: 0.65–0.99) for Trifecta and 96% (95%CI: 0.86–0.99) for Perimount (log-rank test; p = 0.759, HR 1.46 (95%CI: 0.13–16.48)) in the unweighted analysis (not estimable in the weighted analysis). During the follow-up (median time: 384 vs. 593 days; p = 0.0001) there were no re-operations for structural valve degeneration. Mean valve gradient at discharge was lower for Trifecta across all valve sizes (7.9 ± 3.2 vs. 12.1 ± 4.7 mmHg; p < 0.001), but the difference did not persist during follow-up (8.2 ± 3.7 mmHg for Trifecta, 8.9 ± 3.6 mmHg for Perimount; p = 0.224); Conclusions: Postoperative outcome and mid-term follow-up were similar. An early better hemodynamic performance was detected for the Trifecta valve but did not persist over time. No difference in the reoperation rate for structural valve degeneration was found.

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“…The Trifecta™ bio-prosthesis appears to be associated with a greater rate of SVD and a higher need for repeat aortic valve replacement for SVD than some other bio-prostheses [ 7 , 14 , 15 ]. The most common mechanism for Trifecta™ valve failure is cusp tears and leaflet calcification [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

Mid-Term Clinical and Hemodynamic Outcomes in Middle Age Patients post Trifecta™ (Abbott) Aortic Valve Replacement: A Single-Center Study

Khaliel,

Aboud,

Althibait

et al. 2024

Journal of the Saudi Heart Association

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Background Trifecta™ is an externally wrapped bovine pericardial aortic valve with a favorable hemodynamic performance and acceptable rate of freedom from structural valve degeneration. However, recent reports of early Trifecta valve failure question its durability. Rheumatic valve disease in young population is predominant, there is no data on the Trifecta performance, durability or safety available worldwide over the middle age population, as well as there are no previous similar reports from Middle East region. We report on mid-term clinical and hemodynamic performance of Trifecta valve in middle age population with small aortic annuls, a single center report. Methods A retrospective study of all patients who underwent Trifecta™ SAVR between June 2014 and December 2019 at a cardiac center in Riyadh, Saudi Arabia. Hemodynamic performance was analyzed by longitudinal Doppler echocardiography. Results During a 5.5-year period, a total of 24 patients underwent SAVR with Trifecta™ valves at our heart center. Patients had a median age of 47.1 years (IQR = 37) and male:female ratio of 1:1. Patients had a median EuroScoreII of 2 (IQR = 1). The 19 mm valve was the most frequently used (29.2%) followed by the 21 mm and 23 mm (both 25.0%). Concomitant procedure was (54.2%). All patients survived their operations and most (87.0%) had their symptoms relieved. A 30-day mortality rate of 4.2%. Patients were followed up for a median of 58.5 months (IQR = 38), during which 8.3% required re interventions, giving an overall freedom from re-intervention of 91.7%. The re-intervention after valve implantation was recorded in two (8.3%). These re-interventions were performed 3 years post initial surgery and were due to structural valve deterioration (SVD). The mean gradient reduced significantly from 43.6 ± 23.9 mmHg (median = 41, IQR = 21) at baseline to 13.0 ± 7.4 mmHg (median = 11, IQR = 5) one-week post intervention (p < 0.001). The average mean gradients were stable from post-operation to follow-up (13.0 ± 7.4 vs 14.1 ± 6.4 mmHg). Conclusion Our study confirms excellent mid-term durability, clinical and hemodynamic performance of the Trifecta™ valve in middle age population, despite the fact of non-statically significant trend-up of transvalvular gradient over the follow up period. Further long-term studies with larger sample-size are warranted to confirm these results.

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Trifecta versus Perimount Magna Ease aortic valves: Failure mechanisms

Cited by 6 publications

References 20 publications

Current state of clinical trials on xenograft

Current state of clinical trials on xenograft

Mid-Term Clinical Outcomes and Hemodynamic Performances of Trifecta and Perimount Bioprostheses following Aortic Valve Replacement

Mid-Term Clinical and Hemodynamic Outcomes in Middle Age Patients post Trifecta™ (Abbott) Aortic Valve Replacement: A Single-Center Study

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