Bagur Rodrigo, Chu Michael W A, Kabali Conrad, Ordoñez Santiago, Husain Ali S, Yoon Sung-Han, Palma Dallan Luis A, Alosail Abdulmajeed, Althekrallah Jasem, Valdis Mathew, Teefy Patrick, Diamantouros Pantelis, Webb John G, Attizzani Guilherme F
Heart Team, London Health Sciences Centre, Western University, London, ON, Canada.
Division of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
EuroIntervention. 2024 Dec 16;20(24):e1505-e1519. doi: 10.4244/EIJ-D-24-00514.
No data compare newer-generation transcatheter heart valves (THVs) in terms of next-day discharge (NDD) following transfemoral (TF) transcatheter aortic valve implantation (TAVI).
We aimed to evaluate the safety of NDD in unselected patients who received ACURATE (neo/neo2), Evolut (PRO/PRO+/FX) and the SAPIEN (3/Ultra) THVs.
This multicentre registry included patients who underwent TF-TAVI without a preprocedural permanent pacemaker implantation (PPI) and were discharged the next day without a new PPI. The primary endpoint was unplanned readmissions at 30 days. Multinomial gradient-boosted inverse probability of treatment-weighted (IPTW) propensity scores (stage 1) followed by the modified Poisson regression (stage 2) approach were used to compare the average effects of the THVs on the primary outcome.
A total of 963 all-comer patients (ACURATE=264, Evolut=306, and SAPIEN=393) were included in this study. ACURATE patients were older (p<0.001) and included a greater proportion of females (p<0.001), whereas Evolut patients had a higher risk profile as assessed by the Society of Thoracic Surgeons score (p=0.01). There were no differences between the groups in terms of right or left bundle branch block (p=0.75). At 30 days, the overall readmission rate was 8%, and there were no differences in cardiac (ACURATE 4.6% vs Evolut 4.2% vs SAPIEN 3.1%; p=0.56) or non-cardiac readmissions (ACURATE 4.6% vs Evolut 3.3% vs SAPIEN 4.6%; p=0.64). Readmission for new PPI was 2.7%, 1.0% and 1.8% (p=0.32) and for heart failure (HF) was 1.5%, 2.0% and 1.3% (p=0.76) in ACURATE, Evolut and SAPIEN patients, respectively. The IPTW propensity score model followed by modified Poisson regression indicate that, using ACURATE as the reference, no significant differences were found in 30-day readmissions (relative risk [RR] 0.76, 95% confidence interval [CI]: 0.38-1.52; p=0.38 for Evolut and RR 0.74, 95% CI: 0.44-1.22; p=0.28 for SAPIEN).
In pacemaker-naïve patients undergoing TF-TAVI with newer-generation THVs, NDD was not associated with a negative impact on overall 30-day readmissions, cardiac or non-cardiac readmissions, readmissions for PPI or HF after discharge, or mortality, regardless of the type of THV.
尚无数据比较新一代经导管心脏瓣膜（THV）在经股动脉（TF）经导管主动脉瓣植入术（TAVI）后次日出院（NDD）方面的情况。
我们旨在评估接受ACURATE（neo/neo2）、Evolut（PRO/PRO+/FX）和SAPIEN（3/Ultra）THV的未选择患者中NDD的安全性。
这项多中心注册研究纳入了未在术前植入永久性起搏器（PPI）且次日未植入新PPI而出院的接受TF-TAVI的患者。主要终点是30天内的非计划再入院。采用多项梯度增强治疗加权逆概率（IPTW）倾向评分（第1阶段），随后采用修正泊松回归（第2阶段）方法来比较THV对主要结局的平均影响。
本研究共纳入963例所有患者（ACURATE组264例，Evolut组306例，SAPIEN组393例）。ACURATE组患者年龄更大（p<0.001），女性比例更高（p<0.001），而Evolut组患者根据胸外科医师协会评分评估的风险更高（p=0.01）。各组在右束支或左束支传导阻滞方面无差异（p=0.75）。30天时，总体再入院率为8%，心脏相关再入院率（ACURATE组4.6%，Evolut组4.2%，SAPIEN组3.1%；p=0.56）或非心脏相关再入院率（ACURATE组4.6%，Evolut组3.3%，SAPIEN组4.6%；p=0.64）均无差异。ACURATE组、Evolut组和SAPIEN组因新PPI再入院率分别为2.7%、1.0%和1.8%（p=0.32），因心力衰竭（HF）再入院率分别为1.5%、2.0%和1.3%（p=0.76）。IPTW倾向评分模型随后的修正泊松回归表明，以ACURATE组为参照，30天再入院率无显著差异（相对风险[RR] 0.76，95%置信区间[CI]：0.38 - 1.52；Evolut组p=0.38，RR 0.74，95% CI：0.44 - 1.22；SAPIEN组p=0.28）。
在接受新一代THV进行TF-TAVI的无起搏器植入史患者中，无论THV类型如何，NDD对30天总体再入院率、心脏或非心脏再入院率、出院后因PPI或HF再入院率或死亡率均无负面影响。
