Heart Hospital, Tampere University Hospital, Faculty of Medicine and Health Technology, Tampere, Finland.
Heart Center, Turku University Hospital, Turku, Finland.
JAMA Netw Open. 2019 Jun 5;2(6):e195742. doi: 10.1001/jamanetworkopen.2019.5742.
Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce.
To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts.
Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization.
The primary outcomes were 30-day and 3-year survival.
Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not.
Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.
经导管主动脉瓣置换术(TAVR)已被证明是一种有效的替代方法,用于高手术风险的严重主动脉瓣狭窄(AS)患者。然而,低手术风险患者 TAVR 的益处和危害的证据仍然很少。
比较低手术风险 AS 患者 TAVR 和 SAVR 的短期和中期结果。
设计、设置和参与者:这项回顾性比较有效性队列研究使用了来自全国芬兰经导管和外科主动脉瓣置换术登记处的数据,该登记处纳入了 2008 年 1 月 1 日至 2017 年 11 月 30 日低手术风险(无其他临床相关合并症)的患者,他们接受了 TAVR 或 SAVR 治疗,使用生物瓣治疗严重 AS。低手术风险定义为胸外科医生预测死亡率评分低于 3%,无其他相关合并症。采用 1:1 倾向评分匹配来调整 TAVR 和 SAVR 队列之间的基线协变量。
原发性 TAVR 或 SAVR 联合生物瓣治疗伴或不伴相关冠状动脉血运重建的 AS。
主要结局为 30 天和 3 年生存率。
共有 2841 名患者(平均[SD]年龄,74.0[6.2]岁;1560[54.9%]为男性)符合纳入标准,并纳入分析;325 名患者接受了 TAVR,2516 名患者接受了 SAVR。倾向评分匹配产生了 304 对具有相似基线特征的配对。263 名(86.5%)接受 TAVR 的患者使用了第三代设备。在这些配对中,TAVR 后 30 天死亡率为 1.3%,SAVR 后为 3.6%(P=0.12)。研究队列的 3 年生存率相似(TAVR 为 85.7%;SAVR 为 87.7%;P=0.45)。交互检验发现,在 3 年生存率方面,研究队列在年龄小于 80 岁与大于 80 岁的患者或近期主动脉瓣置换患者与非近期主动脉瓣置换患者之间无差异。
在低手术风险患者中,使用第三代设备的经导管主动脉瓣置换术与 SAVR 相比,取得了相似的短期和中期生存率。在将 TAVR 假体的应用扩展到低风险患者之前,需要进一步研究来评估 TAVR 假体的长期耐久性。