Medtronic mosaic porcine bioprosthesis: midterm investigational trial results

Thomson, Dorothy; Jamieson, W.R. Eric; Dumesnil, Jean G.; Burgess, John J.; Peniston, Charles; Métras, Jacques; Sullivan, John A.; Parrott, J.; Maitland, Andrew; Cybulsky, Irene

doi:10.1016/s0003-4975(01)02551-6

Cited by 27 publications

(24 citation statements)

References 10 publications

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“…Data on longterm durability of the MB in the mitral position are scarce. No cases of SVD have been reported by Thomson and colleagues 6 or Eichinger and associates 7 at 4 years, by Fradet and coworkers at 7 years, 8 or by Riess and co-authors at 10 years. 20 Jamieson and associates, 19 months after MVR, observed one case of SVR caused by cusp tears with minimal calcification.…”

Section: Discussionmentioning

confidence: 92%

“…[6][7][8][9]19 Data concerning the long-term performance of the MB have been presented by Riess and colleagues 10,20 and, more recently, by Celiento and associates, 11 who reported a 10-to 13-year follow-up. Indeed, most of the data currently available concerning the MB refer to patients after AVR, whereas the performance of the MB after MVR has been evaluated mostly in multicenter studies, with short follow-up reports.…”

Section: Discussionmentioning

confidence: 99%

“…Indeed, most of the data currently available concerning the MB refer to patients after AVR, whereas the performance of the MB after MVR has been evaluated mostly in multicenter studies, with short follow-up reports. [6][7][8][9]21 Recently, however, Jamieson and co-authors 22 have published a multicenter study of the MB after MVR, which is the only study to exceed ours in the number of patients reported. These Valve-related sequelae 9 1.47 ± 0.49 95 ± 2 82 ± 7 82 ± 7 pt-yr = patient-year Unless otherwise stated, data are presented as number or as percentage ± 95% SE.…”

Section: Discussionmentioning

confidence: 99%

“…[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. More recently, data on the 13-year follow-up evaluation of the MB-when used for aortic valve replacement (AVR)-have become available.…”

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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: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 99%

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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“…Both stented xenografts compared in this study have been evaluated thoroughly and have a reliable short-term and long-term clinical function. 17,[23][24][25][26][27] Furthermore, good postoperative hemodynamic function has been shown. However, as yet, no prospectively randomized comparison of hemodynamic function has been published.…”

Section: Discussionmentioning

confidence: 96%

Prospectively Randomized Evaluation of Stented Xenograft Hemodynamic Function in the Aortic Position

et al. 2004

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Background-Standard stented aortic xenograft valves have not yet been compared regarding their hemodynamic function using a stratified intraoperative randomization protocol. Methods and Results-100 patients were prospectively included after intraoperative metric sizing of the decalcified aortic annulus. They received Mosaic (M) or Perimount (P) aortic valve replacement. Patient age was 73Ϯ5 years, 51 were female, and New York Heart Association (NYHA) functional class was 2.8Ϯ0.5. The 21-mm annulus group consisted of 5 (M)/7 (P) patients, the 23-mm annulus group of 20 (M)/20 (P), the 25-mm annulus group of 18 (M)/19 (P), and the 27-mm annulus group of 4 (M)/7 (P) patients, respectively. Hemodynamic function was evaluated using transthoracic echocardiography before discharge and at follow-up (438Ϯ352 days). Surgery was uncomplicated in all patients. Labeled valve sizes were 0.93 (M) and 1.05 (P) mm smaller than the annulus diameters (pϭNS). In-hospital mortality was 5%, all nonvalve-related. Transvalvular blood flow velocities and transvalvular pressure gradients were significantly lower in the 25 P versus the 25 M group at baseline and in the 23 P and 25 P groups at follow-up. There was a significant regression of left ventricular mass index in all patients at follow-up. However, left ventricular mass regression was more pronounced after P aortic valve replacement. Conclusion-Labeled sizes of prosthetic heart valves implanted are smaller than the true aortic annulus. Both standard aortic xenografts compared in this prospectively randomized trial provide a sufficient hemodynamic and functional outcome.

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Immunological and Phenotypic Considerations in Supplementing Cardiac Biomaterials with Cells

Plimpton

Liu

Kheradvar

2014

Biomaterials for Cardiac Regeneration

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Medtronic mosaic porcine bioprosthesis: midterm investigational trial results

Cited by 27 publications

References 10 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

Prospectively Randomized Evaluation of Stented Xenograft Hemodynamic Function in the Aortic Position

Immunological and Phenotypic Considerations in Supplementing Cardiac Biomaterials with Cells

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