Durability and clinical experience using a bovine pericardial prosthetic aortic valve

Lehmann, Sven; Jawad, Khalil; Dieterlen, Maja‐Theresa; Hoyer, Alexandro; Garbade, Jens; Davierwala, Piroze; Borger, Michael A.

doi:10.1016/j.jtcvs.2019.11.028

Cited by 32 publications

(33 citation statements)

References 20 publications

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“…One other contemporary bioprosthesis, the Trifecta valve, has demonstrated similar durability over 5 years of follow-up. Lehmann et al [ 12 ] and Fukuhara et al . [ 10 ] reported 98.7% and 97.9% freedom from SVD, respectively.…”

Section: Discussionmentioning

confidence: 99%

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Bartuś

Litwinowicz

Bilewska

et al. 2020

European Journal of Cardio-Thoracic Surgery

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OBJECTIVES Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue. METHODS This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory. RESULTS Mean patient age was 65.3 ± 13.5 years, with 34 patients (25.6%) ≤60. The mean follow-up was 4.2 ± 1.5 years. Early (≤30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 ± 7.6 mmHg and effective orifice area was 1.4 ± 0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years. CONCLUSIONS The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue. Clinical trial registration number NCT01651052

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Section: Discussionmentioning

confidence: 99%

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Bartuś

Litwinowicz

Bilewska

et al. 2020

European Journal of Cardio-Thoracic Surgery

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“…Since its release on the market in 2011, the Trifecta has aroused interest for SAVR due to its excellent dynamic performance. Regarding its durability, a recent cohort study involving 1241 patients reported a freedom from reoperation due to SVD of 93.3% at 8 years 2 . The precise SVD mechanisms were not specified.…”

Section: Discussionmentioning

confidence: 99%

“…Regarding its durability, a recent cohort study involving 1241 patients reported a freedom from reoperation due to SVD of 93.3% at 8 years. 2 The precise SVD mechanisms were not specified. A thorough review of the literature between 2014 and 2020 reveals 15 cases among 11 publications of parastent cusp tear as a cause of acute aortic regurgitation after implantation of a Trifecta valve, for which urgent redo surgery was mandatory.…”

Section: Discussionmentioning

confidence: 99%

“…Midterm as well as recent long-term studies report a low incidence of structural valve deterioration (SVD). 1,2 However, only recently, we have experienced two cases of acute and severe regurgitation due to cusp tear, 12 and 18 months after initial implantation, respectively. A critical literature research has shown similar current reports.…”

Section: Introductionmentioning

confidence: 99%

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Early surgical aortic bioprosthesis failure caused by cusp tear: A word of caution

Schaeffer

Berdajs

Reuthebuch

2020

Clinical Case Reports

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“…3,12,17 The absolute number of observed SVD cases remains limited. 12,17 However, clinical presentation of SVD caused by abrupt valve tears often involves sudden-onset severe dyspnea and heart failure and may require emergent redo surgery or a valve-in-valve procedure. 12,13,18 Although Trifecta valves provided excellent hemodynamics, unpredictable structural valve deterioration associated with abrupt leaflet tear remains a major concern.…”

mentioning

confidence: 99%

Commentary: Trifecta valve: Does a word of caution prevail?

Bando

2021

JTCVS Techniques

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Durability and clinical experience using a bovine pericardial prosthetic aortic valve

Cited by 32 publications

References 20 publications

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Early surgical aortic bioprosthesis failure caused by cusp tear: A word of caution

Commentary: Trifecta valve: Does a word of caution prevail?

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