Merkel Eperke, Hatala Robert, Szigeti Mátyás, Schwertner Walter, Lakatos Bálint, Behon Anett, Goscinska-Bis Kinga, Milasinovic Goran, Papp Roland, Ruppert Mihály, Sághy László, Clemens Marcell, Solomon Scott D, Kutyifa Valentina, Kovács Attila, Kosztin Annamária, Merkely Béla
Semmelweis University, Heart and Vascular Center, Budapest, Hungary.
National Institute of Cardiovascular Diseases and Slovak Medical University, Department of Cardiology and Angiology, Bratislava, Slovakia.
JACC Heart Fail. 2025 Feb;13(2):265-273. doi: 10.1016/j.jchf.2024.09.011. Epub 2024 Nov 27.
In the BUDAPEST (Biventricular Upgrade on left ventricular reverse remodeling and clinical outcomes in patients with left ventricular Dysfunction and intermittent or permanent APical/SepTal right ventricular pacing)-CRT Upgrade randomized trial, the authors have demonstrated improved mortality and morbidity after cardiac resynchronization therapy (CRT) upgrade in patients with heart failure with reduced ejection fraction (HFrEF) with high right ventricular (RV) pacing burden.
This substudy sought to examine the impact of CRT upgrade on symptoms, functional outcome, and exercise capacity.
In the BUDAPEST-CRT Upgrade trial, 360 HFrEF patients with pacemaker or implantable cardioverter-defibrillator (ICD) and ≥20% RV pacing burden were randomly assigned (3:2) to cardiac resynchronization therapy with defibrillator (CRT-D) upgrade (n = 215) or ICD (n = 145). The prespecified tertiary endpoints were changes in quality of life (QoL) (EQ-5D-3L), NYHA functional class, 6-minute walk test, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.
Up to 12 months, NYHA functional class improved in the CRT-D upgrade arm compared with ICD only (adjusted OR: 0.50 [95% CI: 0.32-0.80]; P = 0.003). A remarkable decrease was observed in NT-proBNP levels in the CRT-D arm (adjusted difference: -1,257 pg/mL [95% CI: -2,287 to -228 pg/mL]; P = 0.017). The progression of age-related worsening of QoL was moderated by CRT-D upgrade (EQ-5D-3L difference by each year: 0.015 [95% CI: 0.005-0.025]; P interaction = 0.003). However, exercise tolerance (6-minute walk test) remained unchanged in both groups.
HFrEF patients with pacemaker/ICD and ≥20% RV pacing burden receiving CRT upgrade showed a substantial improvement in NYHA functional class and decrease in natriuretic peptide levels, as compared with ICD alone. Moreover, CRT-D upgrade could moderate the progression of worsening of QoL attributed to ageing in this vulnerable, elderly patient population. (Biventricular Upgrade on left ventricular reverse remodeling and clinical outcomes in patients with left ventricular Dysfunction and intermittent or permanent APical/SepTal right ventricular pacing [BUDAPEST]-CRT Upgrade trial; NCT02270840).
在布达佩斯（Budapest，左心室功能障碍且伴有间歇性或永久性心尖/室间隔右心室起搏患者的左心室逆向重构及临床结局的双心室升级）-心脏再同步治疗（CRT）升级随机试验中，作者已经证明，对于射血分数降低的心力衰竭（HFrEF）且右心室（RV）起搏负担较高的患者，进行心脏再同步治疗（CRT）升级后，死亡率和发病率有所改善。
本亚组研究旨在探讨CRT升级对症状、功能结局和运动能力的影响。
在布达佩斯-CRT升级试验中，360例植入起搏器或植入式心律转复除颤器（ICD）且RV起搏负担≥20%的HFrEF患者被随机分配（3:2）至带除颤器的心脏再同步治疗（CRT-D）升级组（n = 215）或ICD组（n = 145）。预先设定的三级终点为生活质量（QoL）（EQ-5D-3L）、纽约心脏协会（NYHA）心功能分级、6分钟步行试验和N末端B型利钠肽原（NT-proBNP）水平的变化。
长达12个月时，与仅使用ICD相比，CRT-D升级组的NYHA心功能分级有所改善（校正比值比：0.50 [95%CI：0.32-0.80]；P = 0.003）。观察到CRT-D组的NT-proBNP水平显著下降（校正差异：-1257 pg/mL [95%CI：-2287至-228 pg/mL]；P = 0.017）。CRT-D升级减缓了与年龄相关的QoL恶化进程（每年EQ-5D-3L差异：0.015 [95%CI：0.005-0.025]；P交互作用 = 0.003）。然而，两组的运动耐量（6分钟步行试验）均未改变。
与仅使用ICD相比，植入起搏器/ICD且RV起搏负担≥20%并接受CRT升级的HFrEF患者，NYHA心功能分级有显著改善，利钠肽水平降低。此外，CRT-D升级可以减缓这一脆弱老年患者群体中因衰老导致的QoL恶化进程。（左心室功能障碍且伴有间歇性或永久性心尖/室间隔右心室起搏患者的左心室逆向重构及临床结局的双心室升级[布达佩斯]-CRT升级试验；NCT02270840）
