Zannis Kostantinos, Diplaris Konstantinos, Monin Jean-Luc, Khelil Nizar, Debauchez Mathieu, Dervanian Patrice, Lansac Emmanuel, Czirom Daniel, Noghin Milena, Mankoubi Leila, Amabile Nicolas
Institute Mutualiste Montsouris, Paris, France -
Institute Mutualiste Montsouris, Paris, France.
J Cardiovasc Surg (Torino). 2018 Oct;59(5):746-752. doi: 10.23736/S0021-9509.18.10204-7. Epub 2018 May 22.
Concerns have been previously raised regarding the potential early degeneration of the Mitroflow (Sorin Group Italia, Saluggia, Vercelli, Italy) bioprostheses. We aimed to evaluate our clinical experience with the Mitroflow LXA prosthesis for aortic valve replacement.
We prospectively analyzed data from 227 consecutive patients (133 males, mean age 73.9±9.2 years) implanted with the Mitroflow LXA between February 2007 and October 2011. Follow-up data were obtained by contacting the referring cardiologists. Kaplan-Meier curves were constructed for all-cause mortality, valve related mortality and structural valve degeneration (SVD). Multivariable analysis was conducted to identify SVD predictors.
Median follow-up time was 54.2±37.9 months and completeness of follow-up was 95%. Overall mortality in the entire series was at 31% (N.=71) and mortality from cardiac or unknown causes at 20% (N.=46). SVD occurred in 24 patients (10%) (median delay between implantation and diagnosis: 62.6 (36.5) months). Reintervention was required in 20 cases (13 redo surgery, 7 percutaneous transcatheter valve intervention). The 8 years actuarial global survival was 54.7±4.9%, freedom from valve related mortality 67.5±4.9% and freedom from SVD 72±8%. The estimated freedom from SVD was significantly (P=0.007) longer in larger prosthesis (diameter >21 mm, 77±11%) compared to the smaller devices (≤21 mm, 59±13%.). Multivariate analysis identified smaller prostheses and age at implantation as independent predictors of SVD.
The Mitroflow LXA showed evidence of early SVD in this cohort. A close follow-up of these patients is strongly advised.
此前人们一直担心米特罗弗洛（索林集团意大利公司，意大利萨卢贾、韦尔切利）生物假体可能出现早期退变。我们旨在评估使用米特罗弗洛LXA假体进行主动脉瓣置换的临床经验。
我们前瞻性分析了2007年2月至2011年10月期间连续植入米特罗弗洛LXA的227例患者（133例男性，平均年龄73.9±9.2岁）的数据。通过联系转诊的心脏病专家获取随访数据。构建了全因死亡率、瓣膜相关死亡率和结构性瓣膜退变（SVD）的Kaplan-Meier曲线。进行多变量分析以确定SVD的预测因素。
中位随访时间为54.2±37.9个月，随访完整性为95%。整个系列的总死亡率为31%（n = 71），心脏或不明原因的死亡率为20%（n = 46）。24例患者（10%）发生了SVD（植入与诊断之间的中位延迟：62.6（36.5）个月）。20例患者需要再次干预（13例再次手术，7例经皮经导管瓣膜介入）。8年的精算总体生存率为54.7±4.9%，无瓣膜相关死亡率为67.5±4.9%，无SVD率为72±8%。与较小尺寸的装置（≤21 mm，59±13%）相比，较大尺寸的假体（直径>21 mm，77±11%）的无SVD估计时间明显更长（P = 0.007）。多变量分析确定较小尺寸的假体和植入时的年龄是SVD的独立预测因素。
在该队列中，米特罗弗洛LXA显示出早期SVD的证据。强烈建议对这些患者进行密切随访。
