Department of Internal Medicine III (Cardiology, Angiology, and Critical Care), University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str. 3, Building 6, 24105, Kiel, Germany.
DZHK (German Centre for Cardiovascular Research), Partner Site Kiel/Hamburg/Lübeck, Kiel, Germany.
Clin Res Cardiol. 2019 Jul;108(7):763-771. doi: 10.1007/s00392-018-1404-2. Epub 2018 Dec 14.
Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year.
Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010).
In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL.
NCT02698956.
目前,经导管瓣膜植入术(TAVI)的临床试验和注册研究主要纳入年龄大于 75 岁的患者。对于接受这种治疗的年轻患者,人们知之甚少。我们研究了 SAPIEN 3™欧洲批准后 SOURCE 3 注册研究中接受 TAVI 的年龄小于 75 岁患者的合并症,并分析了 30 天和 1 年的结局。
为了分析结局和特征,我们对三个年龄组的患者进行了分析:<75 岁(n=235)、75-80 岁(n=391)和≥80 岁(n=1320)。总体而言,平均年龄为 81.6±6.7 岁;经股动脉入路在接受 SAPIEN 3 经导管心脏瓣膜治疗的患者中占 87.1%。根据年龄组,逻辑 EuroSCORE 平均值逐渐增加(分别为 12.6%、17.3%和 19.7%,p<0.001)。年轻患者的合并症发生率更高,特别是那些不在手术风险评分评估工具中的合并症,如严重肝脏疾病、既往放疗和瓷主动脉。30 天(分别为 1.7%、2.0%和 2.3%,p=0.79)和 1 年(分别为 14.2%、9.3%和 13.3%,p=0.08)时,各年龄组之间的死亡率相似。然而,<75 岁年龄组的心脏性猝死发生率高于≥85 岁年龄组(20.7%比 4.8%,p=0.010)。
在目前的 TAVI 实践中,年龄小于 75 岁的患者占少数(12%)。尽管年龄较小且手术风险评分较低,但该队列的特点是存在传统手术风险评分未考虑的合并症。需要更多的数据来指导该年龄段患者在手术和 TAVI 之间做出适当的决策。临床试验注册号:NCT02698956。