ЗАДАТЬ ВОПРОС РЕДАКТОРУ РАЗДЕЛА (ответ в течение нескольких дней)

17 января 2002 00:00 | Kelvin H. H. Lim, MSc, FRCSEda, Massimo Caputo, MD, MCha, Raimondo Ascione, MDa, Jan Wilda

Prospective randomized comparison of CarboMedics and St Jude Medical bileaflet mechanical heart valve prostheses: An interim report

Objective: This is a midterm report of a study comparing theclinical performance of CarboMedics and St Jude Medical heartvalve prostheses through a projected 10−year period.
Methods:Between 1992 and 1996, a total of 485 patients undergoing mechanicalvalve replacement were prospectively randomly assigned to receiveeither CarboMedics (n = 234) or St Jude Medical (n = 251) prosthesesfor aortic (n = 288), mitral (n = 160), or double (n = 37) valvereplacements and were followed up annually.
Results: Baselineand operative characteristics were similar between the two groupswith respect to major demographic characteristics, preoperativeclinical status, and operative data. Mean follow-up was 50 ±22 months for the CarboMedics group (97% complete) and 47 ±20 months for the St Jude Medical group (96% complete), yieldinga total of 1959 patient-years. The 30−day mortality, and 5−yearactuarial survival, and linearized survival were 6.0%, 82.4%± 2.6%, and 4.3% per patient-year in the CarboMedicsgroup and 4.4%, 79.9% ± 2.8%, and 4.7% per patient-yearin the St Jude Medical group (log-rank P = .7). Freedom at 5years from valve-related mortality, major thromboembolism, hemorrhage,and other nonstructural valve dysfunction was, respectively,96.7% ± 1.4% (0.7% per patient-year), 90.9% ±2.1% (2.2% per patient-year), 87.3% ± 2.5% (3.6% perpatient-year), and 96.1% ± 1.4% (0.7% per patient-year)in the CarboMedics group and 95.9% ± 1.5% (1.0% per patient-year),92.5% ± 1.8% (2.0% per patient-year), 82.6% ±2.8% (4.3% per patient-year), and 96.0% ± 1.3% (0.6%per patient-year) in the St Jude Medical group, with no overallintergroup differences. No statistically significant intergroupdifferences in international normalized ratio values were detectedduring the study period.
Conclusions: This study shows no significantdifferences in the early and midterm clinical outcomes betweenpatients who received CarboMedics valve prostheses and thosewho received St Jude Medical mechanical prostheses. Choiceswith respect to valve type can be based on considerations otherthan patient outcome.

Поделиться: