Department of Cardiology and OPEN-Odense Patient Data Explorative Network, Odense University Hospital, Odense, Denmark.
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
Eur J Cardiothorac Surg. 2018 Jan 1;53(1):136-142. doi: 10.1093/ejcts/ezx321.
Concern has been raised regarding the long-term durability of the Mitroflow biological heart valve prosthesis. Our aim was to assess the incidence of structural valve degeneration (SVD) for the Mitroflow bioprosthesis in a nationwide study in Denmark including all patients alive in Denmark who had received a Mitroflow aortic bioprosthesis since 2000.
Patients alive in Denmark with a Mitroflow bioprosthesis implanted since January 2000 were invited to participate in a nationwide cross-sectional study with a predefined definition of SVD. Of 1552 patients, 861 patients had died and 47 patients had been reoperated with 40 reoperations due to SVD. The remaining 644 patients were invited for evaluation; 574 patients accepted and were evaluated for SVD. The incidence of SVD was calculated using competing risk regression analysis with death as the competing event.
A total of 173 patients were diagnosed with SVD by echocardiography. Of these, 64 (11%) patients had severe SVD and 109 (19%) patients moderate SVD. Severe SVD was associated with the age of the prosthesis and small prosthesis size [Size 21: hazard ratio (95% confidence interval, CI) 2.72 (0.97-8.56), P = 0.06; Size 19: 6.26 (1.63-24.06), P = 0.008]. The cumulative incidences of reoperation or severe SVD at Year 9 were 12.5% for Size 19, 7.6% for Size 21 and 3.1 (1.2-6.4)% for Size 23. Median survival in patients with prosthesis Sizes 23-29 was 6.4 (95% CI 5.7-7.0) years, with Size 21 it was 6.5 (95% CI 5.9-7.1) years and with Size 19 it was 6.9 (95% CI 5.7-8.2) years (P = 0.78).
The incidence of undetected severe SVD was as high as the incidence of operated SVD. The overall risk for SVD is high for the Mitroflow bioprosthesis, especially if the prosthesis is small and older than 5 years.
人们对 Mitroflow 生物心脏瓣膜假体的长期耐久性表示担忧。本研究旨在评估丹麦全国范围内所有接受过 2000 年以来植入的 Mitroflow 主动脉生物假体的患者的结构性瓣膜退化（SVD）发生率。
邀请丹麦所有接受过 Mitroflow 生物假体植入的存活患者参加一项全国性的横断面研究，对 SVD 采用预先定义的定义。在 1552 名患者中，861 名患者死亡，47 名患者因 SVD 进行了再次手术，其中 40 例因 SVD 进行了再次手术。其余 644 名患者受邀进行评估；574 名患者接受并接受了 SVD 评估。使用竞争风险回归分析计算 SVD 的发生率，将死亡作为竞争事件。
共有 173 名患者通过超声心动图诊断为 SVD。其中，64 名（11%）患者有严重的 SVD，109 名（19%）患者有中度 SVD。严重 SVD 与假体年龄和小假体尺寸相关[尺寸 21：风险比（95%置信区间，CI）2.72（0.97-8.56），P=0.06；尺寸 19：6.26（1.63-24.06），P=0.008]。9 年时，尺寸 19 的再手术或严重 SVD 的累积发生率为 12.5%，尺寸 21 的为 7.6%，尺寸 23 的为 3.1（1.2-6.4）%。尺寸 23-29 的患者假体中位生存期为 6.4（95%CI 5.7-7.0）年，尺寸 21 为 6.5（95%CI 5.9-7.1）年，尺寸 19 为 6.9（95%CI 5.7-8.2）年（P=0.78）。
未检测到的严重 SVD 的发生率与手术 SVD 的发生率一样高。Mitroflow 生物假体的 SVD 总体风险较高，尤其是假体较小且超过 5 年时。
