Medtronic received information via literature review regarding a study which compared clinical outcomes in patients younger than 60 years of age undergoing bioprosthetic versus mechanical aortic valve replacement at one institution from january 2002 to december 2009.The study population included 1,078 patients divided into two groups: 153 patients implanted with a bioprosthetic valve (predominantly male; mean age 52.5 +/- 7.3 years) and 925 patients implanted with a mechanical valve (predominantly male; 48.2 +/- 8.7 respectively).The bioprosthetic valve group received medtronic hancock ii valves exclusively.The mechanical valve group consisted of valves from two manufacturers (an unknown number of which were medtronic ats open pivot bileaflet heart valves).No serial numbers were provided for the devices.Among all patients, 84 deaths occurred (12 bioprosthetic group, 72 mechanical group).The causes of death included: 46 cardiac related, 27 cardiac arrests/myocardial infarction, 6 endocarditis, 6 stroke, 7 hemorrhage/bleeding, 19 non-cardiac related, and 19 unknown.Of these deaths, none were attributed to medtronic product.Among all patients, these adverse events occurred during the 10-year follow up period: 33 thromboembolisms (21 early-term, 12 mid-term), 46 major bleeding events (35 early-term, 11 mid-term), 142 ventricular arrhythmias, 10 paravalvular leak, 10 endocarditis, and 53 multisystem organ failure.There were also 14 valve-related reoperations for the following reasons: 6 structural valve dysfunction, 3 paravalvular leak, 4 endocarditis, and 1 mechanical prosthetic valve deterioration.No additional adverse patient effects were reported.
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