Fifteen-year results with the Hancock II valve: A multicenter experience

Rizzoli, Giulio; Mirone, Salvatore; Ius, Paolo; Polesel, Elvio; Bottio, Tomaso; Salvador, Loris; Zussa, Claudio; Gerosa, Gino; Valfré, Carlo

doi:10.1016/j.jtcvs.2006.05.031

Cited by 57 publications

(59 citation statements)

References 16 publications

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“…Porcine bioprostheses implanted in the mitral position usually have lower durability than do their aortic counterparts, most likely because they are subjected to higher closing pressures. 3,5 We have shown that the MB has considerable resistance to SVD after MVR, which can be even superior to that of the MB in the aortic position-as observed by Riess and colleagues, 10 and more recently by our group. 11 However, the high mean age of our patients rendered us unable to explore the influence of age on MB durability, and therefore to extend the use of such a device to a younger population.…”

Section: Discussionsupporting

confidence: 58%

“…This has been shown in patients over 65 years of age, who, particularly after AVR, have experienced ≥98% freedom from SVD at 20 years. 3,4 The MB incorporates some features aimed at improving durability. Chief among these is the use of α-amino oleic acid, because this anticalcification treatment has been extremely effective in mitigating cusp calcification in animal models.…”

Section: Discussionmentioning

confidence: 99%

“…1,2 Since that time, the use of calcium-retarding agents to mitigate the severity of cusp mineralization has given longer durability to most commercially available tissue valves. [3][4][5] The Mosaic ® bioprosthesis (MB) (Medtronic, Inc.; Minneapolis, Minn) is a 3rd-generation porcine valve that became clinically available in 1994. Various reports [6][7][8][9] have shown that the MB is a safe and well-performing device in the medium and intermediate terms.…”

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confidence: 99%

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The Mosaic Mitral Valve Bioprosthesis: A Long-Term Clinical and Hemodynamic Follow-Up

Celiento¹,

Blasi²,

Martino³

et al. 2016

Texas Heart Institute Journal

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We reviewed the cases of 100 patients (mean age, 73 ± 10 yr; 64 men) who had mitral valve replacement with a Medtronic Mosaic porcine bioprosthesis from 1995 through 2011. The mean New York Heart Association (NYHA) class was 3 ± 0.7, and 52 patients were in atrial fibrillation. Prosthetic sizes were chiefly 27 mm (50 patients) and 29 mm (40 patients). Follow-up ended in December 2012 and is 97% complete, with a cumulative duration of 611 patient-years (mean duration, 6 ± 4.6 yr; maximum, 17.7 yr). The early mortality rate was 10% (6% in elective patients); late deaths occurred in 31 patients (5 valve-related). Actuarial survival rates at 5, 10, and 15 years were 74% ± 5%, 50% ± 6%, and 37% ± 8%. The mean NYHA class in survivors was 1.4 ± 0.6 (P <0.0001). Thromboembolic episodes occurred in 4 patients, with an actuarial freedom at 15 years of 91% ± 5%. No cases of endocarditis were observed. Four patients needed reoperation, 2 for structural failure, and 1 each for perivalvular leakage and valve thrombosis. Actuarial freedom from structural failure and from reoperation, respectively, was 93% ± 5% and 91% ± 5% at 15 years. Echocardiographic follow-up in 24 patients with 27-mm prostheses showed a mean gradient of 5 ± 1.7 mmHg and an effective orifice area of 1.57 ± 0.3 cm2; in 16 patients with 29-mm prostheses, the mean gradient was 4.5 ± 1.9 mmHg, and the effective orifice area, 1.63 ± 0.4 cm2. During nearly 17 years of follow-up, the Mosaic bioprosthesis has shown good overall clinical and hemodynamic performance after mitral valve replacement.

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Section: Discussionsupporting

confidence: 58%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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The Mosaic Mitral Valve Bioprosthesis: A Long-Term Clinical and Hemodynamic Follow-Up

Celiento¹,

Blasi²,

Martino³

et al. 2016

Texas Heart Institute Journal

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“…Observational studies from North America and Europe have reported excellent clinical outcomes after aortic valve replacement (AVR) with either the Hancock II or the Perimount. [1][2][3][4][5][6][7] The Medtronic Hancock II offers 10-and 15-year survival ranging from 63% to 67% and 35% to 47%, respectively. [1][2][3][4] The Perimount performs similarly, with 10-and 15-year survival ranging from 53% to 69% and 35% to 68%, respectively.…”

mentioning

confidence: 99%

“…[1][2][3][4][5][6][7] The Medtronic Hancock II offers 10-and 15-year survival ranging from 63% to 67% and 35% to 47%, respectively. [1][2][3][4] The Perimount performs similarly, with 10-and 15-year survival ranging from 53% to 69% and 35% to 68%, respectively. [5][6][7] Reported freedom from structural valve deterioration, reoperation, prosthetic valve endocarditis, and thromboembolism are favorable after AVR with either the Hancock II or the Perimount.…”

mentioning

confidence: 99%

Long-Term Clinical and Hemodynamic Performance of the Hancock II Versus the Perimount Aortic Bioprostheses

Chan

Kulik²,

Tran³

et al. 2010

Circulation

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Durability Data for Bioprosthetic Surgical Aortic Valve

et al. 2019

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IMPORTANCEAlthough several studies have reported data on surgical aortic valve durability, variability in study methodologies and definitions as well as inadequate follow-up make the interpretation of data from these studies difficult to interpret.OBJECTIVE To review available data on structural valve deterioration (SVD) of surgical bioprosthetic aortic valves by examining the published literature as well as data reported to the US Food and Drug Administration (FDA).EVIDENCE REVIEW A systematic review using Preferred Reporting Items for Systematic Review and Meta-Analysis reporting guidelines to obtain all available data from preexisting literature on the actuarial freedom from SVD and outcomes of SVD. Data were collected from database inception to November 2016. Additionally, data reported to the FDA were obtained. FINDINGS In total, 167 studies and 12 FDA reports including 101 650 patients and 17 different valve types were analyzed. There were 11 different definitions of SVD used in the studies. Core laboratory data were available for 11 studies. Mean follow-up ranged from less than 1 year to 14 years. Kaplan-Meier estimates were reported for up to 30 years of follow-up, with 0% to 37% of patients remaining at risk at maximum follow-up. Food and Drug Administration-reported data are similarly variable in duration (mean follow-up range, 1.2 to 7 years) and completeness of follow-up, with final follow-up of 0.1% to 95%. CONCLUSIONS AND RELEVANCEThere is considerable variability in reporting SVD of surgical aortic valves, with different definitions and inadequate long-term systematically collected core laboratory data. Rigorously collected long-term data with standardized definitions for surgical valves are needed to provide a benchmark for the durability of rapidly evolving transcatheter valves.

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Fifteen-year results with the Hancock II valve: A multicenter experience

Abstract: Optimal 15-year durability can be expected in male patients 60 years and older who have undergone aortic valve replacement and in male patients 65 years and older who have undergone mitral valve replacement, extending safely the age limits for the use of this valve.

Cited by 57 publications

References 16 publications

The Mosaic Mitral Valve Bioprosthesis: A Long-Term Clinical and Hemodynamic Follow-Up

The Mosaic Mitral Valve Bioprosthesis: A Long-Term Clinical and Hemodynamic Follow-Up

Long-Term Clinical and Hemodynamic Performance of the Hancock II Versus the Perimount Aortic Bioprostheses

Durability Data for Bioprosthetic Surgical Aortic Valve

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