What is the clinical evidence from this study?

Study design: Cohort. Population: Aortic or mitral valve replacement (n=302). Intervention: Mosaic bioprosthesis. Primary outcome: 13-year survival.

What question did this study set out to answer?

To evaluate the long-term clinical outcomes, hemodynamic performance, and durability of the Medtronic Mosaic porcine bioprosthesis implanted in either the aortic or mitral position over a 13-year period.

August 20, 2009European Journal of Cardio-Thoracic SurgeryOpen Access

Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years

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Key result

The Mosaic bioprosthesis demonstrated excellent clinical performance and safety, with a 13-year survival of 63.1% after aortic valve replacement and 51.2% after mitral valve replacement.

Population

302 patients undergoing valve replacement, including 255 patients with aortic valve replacement and 47…

Design

Cohort

Follow-up

median 8.3 years and 8.2 years, maximum up to 14.0 years

Authors

FRFriedrich‐Christian RießTelstra (Australia)ECEva CramerState University of New York LHLorenz HansenUniversität Hamburg

Discussion

Member takes

Implication

Supports Mosaic bioprosthesis durability in AVR/MVR; extends observational data but leaves open randomized comparisons.

Key Points

To evaluate the long-term clinical outcomes, hemodynamic performance, and durability of the Medtronic Mosaic porcine bioprosthesis implanted in either the aortic or mitral position over a 13-year period.
Prospective non-randomized single-center clinical trial enrolled 255 patients undergoing aortic valve replacement (AVR; mean age 67 years) and 47 patients undergoing mitral valve replacement (MVR; mean age 67 years) between February 1994 and October 1999.
Follow-up evaluations occurred at 30 days, 6 months, and annually thereafter, totaling 1,976.2 patient-years for AVR (median 8.3 years, maximum 14.0 years) and 336.9 patient-years for MVR (median 8.2 years, maximum 13.3 years).
At 13-year follow-up, mean systolic gradient was 16.0±7.2 mmHg and effective orifice area was 1.7±0.4 cm² for AVR, while MVR recorded a mean gradient of 5.0 mmHg and orifice area of 1.8 cm², with transvalvular regurgitation remaining mild or less across both groups.
Thirteen-year overall survival was 63.1±4.5% following AVR and 51.2±13.6% following MVR; early mortality was 1.2% (AVR) and 0.0% (MVR), while late mortality was 3.2% pt-yr⁻¹ and 3.3% pt-yr⁻¹, respectively.
Freedom from adverse events at 13 years for AVR versus MVR included structural valve deterioration (84.8±7.8% vs. 93.8±6.1%), explant (73.3±7.3% vs. 89.3±6.5%), valvular thrombosis (97.8±1.1% vs. 100%), and permanent neurological events (97.4±1.2% vs. 96.0±3.9%).

Study Design

Type

Cohort (n=302)

Multicenter

Structured PICO

Population

302 patients undergoing aortic or mitral valve replacement with the Mosaic bioprosthesis, followed for a median of 8.3 years.

Intervention

Medtronic Mosaic porcine bioprosthesis implanted in aortic or mitral position

Outcome

Clinical results including haemodynamic performance (mean systolic gradient, effective orifice area, transvalvular regurgitation) and durability up to 13 yearshard clinical

Main Result

Absolute Event Rate: 63.1% vs 51.2%

The Medtronic Mosaic porcine bioprosthesis demonstrates excellent long-term clinical and hemodynamic performance up to 13 years in both aortic and mitral positions.

Cite This Study

Rieß et al. (2009) conducted a cohort in Aortic or mitral valve replacement (n=302). Mosaic bioprosthesis was evaluated on 13-year survival. The Mosaic bioprosthesis demonstrated excellent clinical performance and safety, with a 13-year survival of 63.1% after aortic valve replacement and 51.2% after mitral valve replacement.

synapsesocial.com/papers/6a8ac7f80cf18037ebbe8f36 https://doi.org/10.1016/j.ejcts.2009.04.073

Topics

Valvular heart disease

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Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider