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In-hospital outcomes of self-expanding and balloon-expandable transcatheter heart valves in Germany
Clinical Research in Cardiology ( IF 5 ) Pub Date : 2021-09-21 , DOI: 10.1007/s00392-021-01928-6
Peter Stachon 1, 2 , Philip Hehn 3 , Dennis Wolf 1 , Timo Heidt 1 , Vera Oettinger 1, 2 , Manfred Zehender 1, 2 , Christoph Bode 1 , Constantin von Zur Mühlen 1, 2 , Klaus Kaier 2, 3
Affiliation  

Introduction

The effect of valve type on outcomes in transfemoral transcatheter aortic valve replacement (TF-TAVR) has recently been subject of debate. We investigate outcomes of patients treated with balloon-expanding (BE) vs. self-expanding (SE) valves in in a cohort of all these procedures performed in Germany in 2018.

Methods

All patients receiving TF-TAVR with either BE (N = 9,882) or SE (N = 7,413) valves in Germany in 2018 were identified. In-hospital outcomes were analyzed for the endpoints in-hospital mortality, major bleeding, stroke, acute kidney injury, postoperative delirium, permanent pacemaker implantation, mechanical ventilation > 48 h, length of hospital stay, and reimbursement. Since patients were not randomized to the two treatment options, logistic or linear regression models were used with 22 baseline patient characteristics and center-specific variables as potential confounders. As a sensitivity analysis, the same confounding factors were taken into account using the propensity score methods (inverse probability of treatment weighting).

Results

Baseline characteristics differed substantially, with higher EuroSCORE (p < 0.001), age (p < 0.001) and rate of female sex (p < 0.001) in SE treated patients. After risk adjustment, no marked differences in outcomes were found for in-hospital mortality [risk adjusted odds ratio (aOR) for SE instead of BE 0.94 (96% CI 0.76;1.17), p = 0.617] major bleeding [aOR 0.91 (0.73;1.14), p = 0.400], stroke [aOR 1.13 (0.88;1.46), p = 0.347], acute kidney injury [OR 0.97 (0.85;1.10), p = 0.621], postoperative delirium [aOR 1.09 (0.96;1.24), p = 0.184], mechanical ventilation > 48 h [aOR 0.98 (0.77;1.25), p = 0.893], length of hospital stay (risk adjusted difference in days of hospitalization (SE instead of BE): − 0.05 [− 0.34;0.25], p = 0.762) and reimbursement [risk adjusted difference in reimbursement (SE instead of BE): − €72 (− €291;€147), p = 0.519)] There is, however, an increased risk of PPI for SE valves (aOR 1.27 [1.15;1.41], p < 0.001). Similar results were found after application of propensity score adjustment.

Conclusions

We find broadly equivalent outcomes in contemporary TF-TAVR procedures, regardless of the valve type used. Incidence of major complications is very low for both types of valve.



中文翻译:

德国自扩张和球囊扩张经导管心脏瓣膜的住院结果

介绍

瓣膜类型对经股经导管主动脉瓣置换术 (TF-TAVR) 结局的影响最近成为争论的主题。我们调查了 2018 年在德国进行的所有这些手术的队列中接受球囊扩张 (BE) 与自扩张 (SE) 瓣膜治疗的患者的结果。

方法

 确定了 2018 年德国所有接受 BE( N  = 9,882)或 SE(N = 7,413)瓣膜的TF-TAVR 患者。对住院结局进行了分析,包括住院死亡率、大出血、中风、急性肾损伤、术后谵妄、永久性起搏器植入、机械通气 > 48 小时、住院时间和报销。由于患者没有被随机分配到两种治疗方案中,因此使用了逻辑或线性回归模型,其中 22 个基线患者特征和中心特定变量作为潜在的混杂因素。作为敏感性分析,使用倾向评分方法(治疗加权的逆概率)考虑了相同的混杂因素。

结果

 SE 治疗患者的基线特征差异很大,EuroSCORE ( p  < 0.001)、年龄 ( p  < 0.001) 和女性比例( p < 0.001) 较高。风险调整后,院内死亡率的结果没有显着差异 [SE 的风险调整优势比 (aOR) 而非 BE 0.94 (96% CI 0.76;1.17),p  = 0.617] 大出血 [aOR 0.91 (0.73 ;1.14), p  = 0.400], 中风 [aOR 1.13 (0.88;1.46), p  = 0.347], 急性肾损伤 [OR 0.97 (0.85;1.10), p  = 0.621], 术后谵妄 [aOR 1.09 (0.96;1.24) ), p  = 0.184], 机械通气 > 48 h [aOR 0.98 (0.77;1.25), p = 0.893],住院时间(住院天数的风险调整差异(SE而不是BE):- 0.05 [- 0.34;0.25],p  = 0.762)和报销[风险调整后的报销差异(SE而不是BE) :- 72 欧元(- 291 欧元;147 欧元),p  = 0.519)] 然而,SE 阀门的 PPI 风险增加(aOR 1.27 [1.15;1.41],p  < 0.001)。在应用倾向评分调整后发现了类似的结果。

结论

我们发现当代 TF-TAVR 程序的结果大致相同,无论使用何种瓣膜类型。两种瓣膜的主要并发症发生率都非常低。

更新日期:2021-09-21
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