Banner University Medical Center-Phoenix, Phoenix, Arizona, USA.
Florida Atlantic University, Boca Raton, Florida, USA; Memorial Healthcare System, Hollywood, Florida, USA.
JACC Cardiovasc Interv. 2024 Sep 9;17(17):2041-2051. doi: 10.1016/j.jcin.2024.06.001. Epub 2024 Aug 21.
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; P < 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%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 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.
一项基于胸外科医师学会/美国心脏病学会经导管瓣膜治疗（Transcatheter Valve Therapy，TVT）注册研究的分析报告显示，小（20mm）与大（≥23mm）球囊扩张瓣膜（Balloon-expandable Valve，BEV）的 1 年临床结果相似。
本研究旨在描述小与大 BEV 的中期 3 年临床结果，并描述出院时超声心动图平均梯度（Mean Gradient，MG）与不同定义的假体-患者不匹配（Prothesis-Patient Mismatch，PPM）与临床结果的关系。
利用 TVT 注册中心与医疗保险和医疗补助服务中心的关联数据，对接受 20-与≥23-mm BEV 的患者进行倾向匹配分析。样条曲线和 Kaplan-Meier 图与调整后的 HR 一起确定 MG 与 3 年死亡率之间的关系。
共分析了 316091 例患者；经过倾向匹配后，每组比较了 8100 对。与≥23-mm BEV 相比，20-mm BEV 与更高的 MG 相关（16.2±7.2mmHg 与 11.8±5.7mmHg；P<0.0001）。3 年时，20-与≥23-mm BEV 之间的死亡率无差异（分别为 31.5%与 32.5%；HR：0.97；95%CI：0.90-1.05）。与 MG 为 10 至 30mmHg 相比，MG<10mmHg（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 与 3 年死亡率增加相关（33.5%比 32.9%比 32.1%；P<0.0001）和（33.5%比 31.1%比 30%；P<0.0001）。低 MG 和严重的测量 PPM 与较低的左心室射血分数（Left Ventricular Ejection Fraction，LVEF）相关。
小（20mm）假体 BEV 患者的 3 年生存率与较大（≥23-mm）BEV 瓣膜患者相同。严重的测量 PPM 和低 MG（<10mmHg），但不是预测的严重 PPM，与较低的 LVEF 和增加的死亡率相关，这表明 LVEF 是导致预后不良的原因。
