Khan Mahin R, Kayani Waleed T, Manan Malalai, Munir Ahmad, Hamzeh Ihab, Virani Salim S, Birnbaum Yochai, Jneid Hani, Alam Mahboob
Division of Cardiology, McLaren-Flint/Michigan State University, Flint, MI, USA.
Section of Cardiology, Department of Internal Medicine, Baylor College of Medicine, Houston, TX, USA.
Cardiovasc Diagn Ther. 2020 Apr;10(2):135-144. doi: 10.21037/cdt.2020.02.11.
To compare safety and efficacy of transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients at low-intermediate risk, given the paucity of robust data.
We performed an aggregate data meta-analysis of 7 randomized controlled trials (RCTs) and 6,778 patients comparing TAVR with SAVR for aortic stenosis (AS) in low-intermediate risk patients (Society of Thoracic Surgeons risk-score ≤8%) using the random-effects model. Primary outcome was all-cause mortality at 30-day, 1-year and 2-year of follow-up. Secondary outcomes included cardiac-mortality, stroke, acute kidney injury (AKI), atrial fibrillation (AF), permanent pacemaker (PPM) implantation, major-bleeding, moderate-severe paravalvular regurgitation (PVR) and rehospitalization.
All-cause mortality, cardiac-mortality and stroke were comparable between the two groups. AF was higher with SAVR at 30-day [odds ratio (OR) 0.17, 95% confidence intervals (CI): 0.12-0.24] thorough to 2-year (OR 0.34, 95% CI: 0.21-0.55), while PPM implantation was higher with TAVR (30-day: OR 3.31, 95% CI: 1.64-6.66, 2-year: OR 3.17, 95% CI: 1.02-9.86). Moderate-severe PVR was more prevalent with TAVR at all follow-ups. On inter-group comparison, patients in the low-risk group had an even lower risk of AF, but a higher risk of PPM implantation as compared to the patients in the intermediate-risk group undergoing TAVR.
Compared to SAVR, TAVR had comparable all-cause mortality and stroke, lower-risk of AF, but was associated with a higher risk of PPM implantation and moderate-severe PVR in low-intermediate-risk patients. Thus, highlighting the need for longer-term follow-up before robust inferences are drawn.
鉴于可靠数据匮乏，比较经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术（SAVR）在中低风险患者中的安全性和有效性。
我们使用随机效应模型对7项随机对照试验（RCT）和6778例患者进行了汇总数据荟萃分析，比较TAVR与SAVR治疗中低风险患者（胸外科医师协会风险评分≤8%）的主动脉瓣狭窄（AS）情况。主要结局是随访30天、1年和2年时的全因死亡率。次要结局包括心源性死亡率、中风、急性肾损伤（AKI）、心房颤动（AF）、永久起搏器（PPM）植入、大出血、中重度瓣周反流（PVR）和再入院。
两组的全因死亡率、心源性死亡率和中风情况相当。SAVR术后30天至2年的AF发生率更高[比值比（OR）0.17，95%置信区间（CI）：0.12 - 0.24至2年时（OR 0.34，95%CI：0.21 - 0.55）]，而TAVR术后PPM植入率更高（30天：OR 3.31，95%CI：1.64 - 6.66，2年：OR 3.17，95%CI：1.02 - 9.86）。在所有随访中，TAVR术后中重度PVR更为普遍。组间比较显示，与接受TAVR的中风险组患者相比，低风险组患者的AF风险更低，但PPM植入风险更高。
与SAVR相比，TAVR在中低风险患者中的全因死亡率和中风情况相当，AF风险较低，但PPM植入风险和中重度PVR风险较高。因此，强调在得出可靠推论之前需要进行长期随访。
