Onorati Francesco, D'Onofrio Augusto, Biancari Fausto, Salizzoni Stefano, De Feo Marisa, Agrifoglio Marco, Mariscalco Giovanni, Lucchetti Vincenzo, Messina Antonio, Musumeci Francesco, Santarpino Giuseppe, Esposito Giampiero, Santini Francesco, Magagna Paolo, Beghi Cesare, Aiello Marco, Della Ratta Ester, Savini Carlo, Troise Giovanni, Cassese Mauro, Fischlein Theodor, Glauber Mattia, Passerone Giancarlo, Punta Giuseppe, Juvonen Tatu, Alfieri Ottavio, Gabbieri Davide, Mangino Domenico, Agostinelli Andrea, Livi Ugolino, Di Gregorio Omar, Minati Alessandro, Rinaldi Mauro, Gerosa Gino, Faggian The Record Ita Investigators Giuseppe
Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy.
Division of Cardiac Surgery, University of Padua.
J Heart Valve Dis. 2015 Nov;24(6):669-678.
The study aim was to compare the outcome of transapical transcatheter aortic valve replacement (TaTAVR) and traditional aortic valve replacement (AVR) in redo from two real-world registries.
The 30-day and follow up outcome of 462 patients enrolled in two multicenter redo registries, treated with redo-AVR (RAVR; n = 292 patients) or TaTAVR (n = 170 patients), were analyzed according to VARC-2 criteria, stratified also by propensity-matching analysis.
TaTAVR-patients were older and sicker than RAVR patients, and reported a higher all-cause 30-day mortality (p <0.01), a higher risk for all-cause mortality (p = 0.006) and cardiovascular mortality (p = 0.05) at follow up, but similar 30-day cardiovascular mortality (p = 0.12). Prolonged intubation (p <0.01) and Acute Kidney Injury Network (AKIN) 2/3 p = 0.02) prevailed in RAVR. TaTAVR patients reported a higher level of major/life-threatening/disabling bleeding (p <0.01) and 'early safety-events' (ES) (p = 0.04). Thirty-day acute myocardial infarction (AMI), stroke, and follow up freedom from acute heart failure (AHF), from stroke and from reinterventions were similar (p = NS). The NYHA class was better after RAVR (p <0.01). The intermediate-to-high risk (Logistic EuroSCORE RAVR 17.1 ± 8.5; TaTAVR 16.0 ± 17.0) propensity-matched population demonstrated comparable 30-day and follow up all-cause and cardiovascular mortality, ES, AMI, stroke, prolonged intubation, follow up freedom from AHF, from stroke and from reinterventions and NYHA class. TaTAVR still reported lower levels of AKIN 2/3 (2.2% versus 15.6%, p = 0.03) and shorter hospitalization (9.5 ± 3.4 days versus 12.0 ± 7.0 days, p = 0.03).
Outcome differences between RAVR and TaTAVR in redo-scenarios reflect methodological differences and different baseline risk profiles. Propensity-matched patients showed a better renal outcome after TaTAVR. *Drs. Onorati and D'Onofrio contributed equally to this article and should both be considered as first authors.
本研究旨在比较两个真实世界注册研究中经心尖经导管主动脉瓣置换术(TaTAVR)和传统主动脉瓣置换术(AVR)再次手术的结果。
根据VARC-2标准,对两个多中心再次手术注册研究中纳入的462例接受再次AVR(RAVR;n = 292例患者)或TaTAVR(n = 170例患者)治疗的患者的30天和随访结果进行分析,并通过倾向匹配分析进行分层。
TaTAVR组患者比RAVR组患者年龄更大、病情更重,30天全因死亡率更高(p <0.01),随访时全因死亡风险更高(p = 0.006)和心血管死亡风险更高(p = 0.05),但30天心血管死亡率相似(p = 0.12)。RAVR组中气管插管时间延长(p <0.01)和急性肾损伤网络(AKIN)2/3级(p = 0.02)更为常见。TaTAVR组患者报告的严重/危及生命/致残性出血水平更高(p <0.01)和“早期安全事件”(ES)更多(p = 0.04)。30天急性心肌梗死(AMI)、中风以及随访时无急性心力衰竭(AHF)、无中风和无需再次干预的情况相似(p = 无显著性差异)。RAVR术后纽约心脏协会(NYHA)心功能分级更好(p <0.01)。中高危(逻辑欧洲心脏手术风险评估系统RAVR为17.1±8.5;TaTAVR为16.0±17.0)倾向匹配人群的30天和随访全因及心血管死亡率、ES、AMI、中风、气管插管时间延长、随访时无AHF、无中风和无需再次干预以及NYHA心功能分级相当。TaTAVR组AKIN 2/3级水平仍较低(2.2%对15.6%,p = 0.03)且住院时间更短(9.5±3.4天对12.0±7.0天,p = 0.03)。
RAVR和TaTAVR在再次手术情况下的结果差异反映了方法学差异和不同的基线风险特征。倾向匹配患者在TaTAVR术后肾脏结局更好。奥诺拉蒂医生和多诺弗里奥医生对本文贡献相同,均应视为第一作者。