Khaliel Feras H, Al Aboud Mohammed S, Althibait Suha A, Yezli Saber, Al Muaythir Elaf A, Alamro Bandar, Galzerano Domenico
Adult Cardiac Surgery Section, Heart Center, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
Biostatistics, Epidemiology and Scientific Computing Department, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
J Saudi Heart Assoc. 2024 Mar 3;36(1):1-7. doi: 10.37616/2212-5043.1366. eCollection 2024.
Trifecta™ is an externally wrapped bovine pericardial aortic valve with a favorable hemodynamic performance and acceptable rate of freedom from structural valve degeneration. However, recent reports of early Trifecta valve failure question its durability. Rheumatic valve disease in young population is predominant, there is no data on the Trifecta performance, durability or safety available worldwide over the middle age population, as well as there are no previous similar reports from Middle East region. We report on mid-term clinical and hemodynamic performance of Trifecta valve in middle age population with small aortic annuls, a single center report.
A retrospective study of all patients who underwent Trifecta™ SAVR between June 2014 and December 2019 at a cardiac center in Riyadh, Saudi Arabia. Hemodynamic performance was analyzed by longitudinal Doppler echocardiography.
During a 5.5-year period, a total of 24 patients underwent SAVR with Trifecta™ valves at our heart center. Patients had a median age of 47.1 years (IQR = 37) and male:female ratio of 1:1. Patients had a median EuroScoreII of 2 (IQR = 1). The 19 mm valve was the most frequently used (29.2%) followed by the 21 mm and 23 mm (both 25.0%). Concomitant procedure was (54.2%). All patients survived their operations and most (87.0%) had their symptoms relieved. A 30-day mortality rate of 4.2%. Patients were followed up for a median of 58.5 months (IQR = 38), during which 8.3% required re interventions, giving an overall freedom from re-intervention of 91.7%. The re-intervention after valve implantation was recorded in two (8.3%). These re-interventions were performed 3 years post initial surgery and were due to structural valve deterioration (SVD). The mean gradient reduced significantly from 43.6 ± 23.9 mmHg (median = 41, IQR = 21) at baseline to 13.0 ± 7.4 mmHg (median = 11, IQR = 5) one-week post intervention (p < 0.001). The average mean gradients were stable from post-operation to follow-up (13.0 ± 7.4 vs 14.1 ± 6.4 mmHg).
Our study confirms excellent mid-term durability, clinical and hemodynamic performance of the Trifecta™ valve in middle age population, despite the fact of non-statically significant trend-up of transvalvular gradient over the follow up period. Further long-term studies with larger sample-size are warranted to confirm these results.
Trifecta™是一种外部包裹牛心包的主动脉瓣，具有良好的血流动力学性能和可接受的结构瓣膜退变发生率。然而，近期有关Trifecta瓣膜早期失效的报道对其耐用性提出了质疑。年轻人群中风湿性瓣膜病占主导，全球范围内尚无关于Trifecta瓣膜在中年人群中的性能、耐用性或安全性的数据，中东地区也没有先前类似的报道。我们报告了Trifecta瓣膜在主动脉瓣环较小的中年人群中的中期临床和血流动力学性能，这是一份单中心报告。
对2014年6月至2019年12月期间在沙特阿拉伯利雅得一家心脏中心接受Trifecta™经导管主动脉瓣置换术（SAVR）的所有患者进行回顾性研究。通过纵向多普勒超声心动图分析血流动力学性能。
在5.5年期间，我们心脏中心共有24例患者接受了Trifecta™瓣膜的SAVR手术。患者的中位年龄为47.1岁（四分位间距 = 37），男女比例为1:1。患者的中位欧洲心脏手术风险评估系统II（EuroScoreII）评分为2（四分位间距 = 1）。19毫米瓣膜使用最为频繁（29.2%），其次是21毫米和23毫米瓣膜（均为25.0%）。同期手术率为54.2%。所有患者术后存活，大多数（87.0%）症状得到缓解。30天死亡率为4.2%。患者的中位随访时间为58.5个月（四分位间距 = 38），在此期间，8.3%的患者需要再次干预，总体再次干预率为91.7%。瓣膜植入后有两例（8.3%）进行了再次干预。这些再次干预发生在初次手术后3年，原因是结构瓣膜退变（SVD）。平均压差从基线时的43.6±23.9毫米汞柱（中位数 = 41，四分位间距 = 21）显著降至干预后1周的13.0±7.4毫米汞柱（中位数 = 11，四分位间距 = 5）（p < 0.001）。从术后到随访期间，平均压差平均值保持稳定（13.0±7.4与14.1±6.4毫米汞柱）。
我们的研究证实了Trifecta™瓣膜在中年人群中具有出色的中期耐用性、临床和血流动力学性能，尽管在随访期间跨瓣压差有非统计学意义的上升趋势。需要进一步开展更大样本量的长期研究来证实这些结果。
