A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry–based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV). The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes. Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality. In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; < 0.0001) and (33.5% vs 31.1% vs 30%; < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF). Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.

中文翻译：

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球囊扩张瓣膜的 3 年结果：20 毫米与较大瓣膜（≥23 毫米）


胸外科医生协会/美国心脏病学会之前基于 TVT（经导管瓣膜治疗）注册的分析报告了小（20 毫米）与大（≥23 毫米）球囊扩张瓣膜 (BEV) 相似的 1 年临床结果。本研究的目的是描述小 BEV 与大 BEV 的中期 3 年临床结果，以及出院超声心动图平均梯度 (MG) 和假体-患者不匹配 (PPM) 的不同定义与临床结果之间的关系。利用 TVT 登记处与医疗保险和医疗补助服务中心的联系，对接受 20 毫米与≥23 毫米 BEV 的患者进行了倾向匹配分析。样条曲线和调整 HR 的 Kaplan-Meier 图确定了 MG 与 3 年死亡率之间的关系。总共分析了 316,091 名患者；经过倾向匹配后，每组8100对进行了比较。与 ≥23 mm BEV 相比，20 mm BEV 与更高的 MG 相关（16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg；< 0.0001）。 3 年时，20 毫米和≥23 毫米 BEV 之间的死亡率没有差异（分别为 31.5% 和 32.5%；HR：0.97；95% CI：0.90-1.05）。与 10 至 30 mm Hg 的 MG 相比，MG <10 mm Hg（HR：1.25；95% CI：1.22-1.27）与 3 年死亡率增加相关。测量的严重 PPM 和预测无 PPM 分别与 3 年死亡率增加相关（33.5% vs 32.9% vs 32.1%；< 0.0001）和（33.5% vs 31.1% vs 30%；< 0.0001）。低 MG 和严重测量的 PPM 与较低的左心室射血分数 (LVEF) 相关。具有小型 BEV 瓣膜（20 毫米）的患者与具有较大（≥23 毫米）BEV 瓣膜的患者具有相同的 3 年生存率。 测量的重度 PPM 和低 MG (<10 mm Hg)，但未预测为重度 PPM，与较低的 LVEF 和增加的死亡率相关，表明 LVEF 是导致较差结果的罪魁祸首。