Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.
JAMA Netw Open. 2024 Apr 1;7(4):e247525. doi: 10.1001/jamanetworkopen.2024.7525.
Aggregated data and long-term follow-up in national health data registers offer the opportunity to compare the performance of mechanical aortic prostheses within the same population.
To investigate the clinical performance of mechanical aortic valve prostheses.
DESIGN, SETTING, AND PARTICIPANTS: This nationwide cohort study included all 5224 patients who underwent primary mechanical aortic valve replacement in Sweden between January 1, 2003, and December 31, 2018. Statistical analysis was performed between May and September 2023.
Surgical aortic valve replacement with the On-X, Carbomedics, Bicarbon, Standard, Regent, Open Pivot, Masters, or Advantage valve models.
The primary outcome was all-cause mortality, and secondary outcomes were reintervention, heart failure, major bleeding, stroke, and embolic events. Regression standardization was used to account for baseline differences.
Overall, 5224 patients (mean [SD] age, 56.8 [11.7] years; 3908 men [74.8%]) were included. Total follow-up time was 43 982 person-years (mean [SD], 8.4 [4.6] years; maximum, 17.2 years). After regression standardization, there was a significant difference in 10-year mortality between the Carbomedics model group (17%; 95% CI, 15%-18%), Regent model group (17%; 95% CI, 13%-20%), and Standard model group (17%; 95% CI, 14%-19%) compared with the Bicarbon model group (27%; 95% CI, 21%-34%).
In this cohort study of mechanical valve surgical aortic replacement outcomes in Sweden, the rate of all-cause mortality was higher in the Bicarbon group than in the Carbomedics, Regent, and Standard model groups. These findings warrant further research on the long-term clinical performance of the Bicarbon valve.
在国家健康数据登记处汇总数据和进行长期随访为比较同一人群中机械主动脉假体的性能提供了机会。
研究机械主动脉瓣假体的临床性能。
设计、设置和参与者：这项全国性队列研究纳入了 2003 年 1 月 1 日至 2018 年 12 月 31 日期间在瑞典接受初次机械主动脉瓣置换术的 5224 例患者。统计分析于 2023 年 5 月至 9 月进行。
接受 On-X、Carbomedics、Bicarbon、Standard、Regent、Open Pivot、Masters 或 Advantage 瓣膜模型的外科主动脉瓣置换术。
主要结局为全因死亡率，次要结局为再次干预、心力衰竭、大出血、卒中和栓塞事件。回归标准化用于解释基线差异。
共纳入 5224 例患者（平均[标准差]年龄 56.8[11.7]岁，3908 例男性[74.8%]）。总随访时间为 43982 人年（平均[标准差]8.4[4.6]年，最长 17.2 年）。回归标准化后，Carbomedics 模型组（17%，95%CI：15%-18%）、Regent 模型组（17%，95%CI：13%-20%）和 Standard 模型组（17%，95%CI：14%-19%）与 Bicarbon 模型组（27%，95%CI：21%-34%）相比，10 年死亡率存在显著差异。
在这项瑞典机械瓣膜外科主动脉置换术结果的队列研究中，Bicarbon 组的全因死亡率高于 Carbomedics、Regent 和 Standard 组。这些发现需要进一步研究 Bicarbon 瓣膜的长期临床性能。
