Lerakis Stamatios, Kini Annapoorna S, Giustino Gennaro, Anastasius Malcolm, Asch Federico M, Weissman Neil J, Grayburn Paul A, Kar Saibal, Lim D Scott, Mishell Jacob M, Whisenant Brian K, Rinaldi Michael J, Kapadia Samir R, Rajagopal Vivek, Sarembock Ian J, Brieke Andreas, Tang Gilbert H L, Li Yanru, Alu Maria C, Lindenfeld JoAnn, Abraham William T, Sharma Samin K, Mack Michael J, Stone Gregg W
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
MedStar Health Research Institute, Washington, DC.
J Soc Cardiovasc Angiogr Interv. 2024 Feb 23;3(5):101345. doi: 10.1016/j.jscai.2024.101345. eCollection 2024 May.
Transcatheter edge-to-edge repair (TEER) improved outcomes in patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) compared with guideline-directed medical therapy (GDMT) alone regardless of the severity of baseline left ventricular ejection fraction (LVEF). The study aimed to evaluate the effect of early changes in LVEF after TEER and GDMT alone in patients with HF and severe SMR.
Within the COAPT trial, we evaluated outcomes according to changes in LVEF from baseline to 30 days. The primary outcome was all-cause death or HF hospitalization (HFH) between 30 days and 2 years.
Among 432 patients with paired echocardiographic data, 182 (42.1%) had increased LVEF (LVEF change 6.0% ± 4.9%) and 250 (57.9%) had a decrease or no change in LVEF (LVEF change -6.6% ± 5.6%) from baseline to 30 days. LVEF at 30 days increased more frequently with GDMT alone compared with TEER plus GDMT (51.4% vs 33.0%; = .0001). Between 30 days and 2 years, there were no significant differences in death or HFH in the increase LVEF and the decrease LVEF groups (58.8% vs 51.4%; multivariable-adjusted HR, 0.97; 95% CI, 0.87-1.08; = .59). TEER plus GDMT reduced the 30-day to 2-year rate of death or HFH compared with GDMT alone consistently in patients with increase LVEF and decrease LVEF (P = 0.75).
Among patients with HF and severe SMR, early improvements in LVEF were more frequent with GDMT alone compared with TEER plus GDMT but were not associated with subsequent outcomes at 2 years. TEER reduced death or HFH during 2-year follow-up irrespective of early LVEF changes.
与单纯的指南指导药物治疗(GDMT)相比,经导管缘对缘修复术(TEER)改善了心力衰竭(HF)和严重继发性二尖瓣反流(SMR)患者的预后,无论基线左心室射血分数(LVEF)的严重程度如何。本研究旨在评估TEER和单纯GDMT治疗后HF和严重SMR患者LVEF早期变化的影响。
在COAPT试验中,我们根据从基线到30天LVEF的变化评估预后。主要结局是30天至2年期间的全因死亡或心力衰竭住院(HFH)。
在432例有配对超声心动图数据的患者中,从基线到30天,182例(42.1%)LVEF升高(LVEF变化6.0%±4.9%),250例(57.9%)LVEF降低或无变化(LVEF变化-6.6%±5.6%)。与TEER加GDMT相比,单纯GDMT在30天时LVEF升高更为频繁(51.4%对33.0%;P = 0.0001)。在30天至2年期间,LVEF升高组和降低组在死亡或HFH方面无显著差异(58.8%对51.4%;多变量调整后的HR,0.97;95%CI,0.87-1.08;P = 0.59)。与单纯GDMT相比,TEER加GDMT在LVEF升高和降低的患者中均持续降低了30天至2年的死亡或HFH发生率(P = 0.75)。
在HF和严重SMR患者中,与TEER加GDMT相比,单纯GDMT使LVEF早期改善更为频繁,但与2年时的后续结局无关。无论LVEF早期变化如何,TEER在2年随访期间均降低了死亡或HFH发生率。