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Abstract：
BACKGROUND: Impaired hospitalizations for heart failure (HHF) and mortality are associated with tricuspid regurgitation (TR).
OBJECTIVE: The objective of this study was to investigate the benefit of transcatheter tricuspid valve replacement (TTVR) over guideline-directed medical therapy (GDMT) in patients with symptomatic severe TR.
METHODS: Between May 2020 and April 2023, 88 patients with symptomatic severe TR were treated in our center. Of these, 57 patients received GDMT alone, and 31 patients underwent combined TTVR and GDMT. We collected and analyzed baseline data, and follow-up information for both groups. The primary endpoints were all-cause mortality and the combined endpoint (including all-cause mortality and HHF).
RESULTS: At a median follow-up of 20 (IQR 10-29) months, significant improvements were shown in TR severity, right ventricular function, and dimensions in TTVR group (all P < 0.001). It also resulted in superior survival rates (75.8% vs. 48.4%, P = 0.019), improved freedom from combined endpoint (61.5% vs. 45.9%, P = 0.007) and fewer major adverse events. After stratification by TRI-SCORE, the subgroup with < 6 points in the TTVR group exhibited a significant difference in the combined endpoint compared to the other subgroups (all P < 0.05), while no significant differences were observed in the GDMT subgroups (P = 0.680).
CONCLUSIONS: The utilization of LuX-Valve in TTVR effectively improves TR and is associated with lower rates of major adverse events, HHF and all-cause mortality. The TRI-SCORE may help identify higher-benefit patients with TR from TTVR. Clinical trial registration ClinicalTrials.gov Protocol Registration System (NCT02917980).
OBJECTIVE: The objective of this study was to investigate the benefit of transcatheter tricuspid valve replacement (TTVR) over guideline-directed medical therapy (GDMT) in patients with symptomatic severe TR.
METHODS: Between May 2020 and April 2023, 88 patients with symptomatic severe TR were treated in our center. Of these, 57 patients received GDMT alone, and 31 patients underwent combined TTVR and GDMT. We collected and analyzed baseline data, and follow-up information for both groups. The primary endpoints were all-cause mortality and the combined endpoint (including all-cause mortality and HHF).
RESULTS: At a median follow-up of 20 (IQR 10-29) months, significant improvements were shown in TR severity, right ventricular function, and dimensions in TTVR group (all P < 0.001). It also resulted in superior survival rates (75.8% vs. 48.4%, P = 0.019), improved freedom from combined endpoint (61.5% vs. 45.9%, P = 0.007) and fewer major adverse events. After stratification by TRI-SCORE, the subgroup with < 6 points in the TTVR group exhibited a significant difference in the combined endpoint compared to the other subgroups (all P < 0.05), while no significant differences were observed in the GDMT subgroups (P = 0.680).
CONCLUSIONS: The utilization of LuX-Valve in TTVR effectively improves TR and is associated with lower rates of major adverse events, HHF and all-cause mortality. The TRI-SCORE may help identify higher-benefit patients with TR from TTVR. Clinical trial registration ClinicalTrials.gov Protocol Registration System (NCT02917980).
摘要：
背景：心力衰竭（HHF）住院率和死亡率降低与三尖瓣反流（TR）相关。
目的：本研究的目的是探讨经导管三尖瓣置换术（TTVR）相对于指南指导的药物治疗（GDMT）对有症状的重度TR患者的益处。
方法：在2020年5月至2023年4月之间，我们中心治疗了88例有症状的重度TR患者。其中,57例患者单独接受GDMT，31例患者接受了TTVR和GDMT联合治疗。我们收集并分析了基线数据，以及两组的随访信息。主要终点是全因死亡率和联合终点（包括全因死亡率和HHF）。
结果：在中位20（IQR10-29）个月的随访中，TR严重程度显着改善，右心室功能,TTVR组各维度(均P<0.001)。它还导致了更高的生存率(75.8%vs.48.4%,P=0.019),改善了合并终点的自由度(61.5%与45.9%,P=0.007）和较少的主要不良事件。在按TRI-SCORE分层后，TTVR组中<6分的亚组与其他亚组相比，在联合终点方面表现出显着差异（所有P<0.05），而在GDMT亚组中没有观察到显著差异(P=0.680)。
结论：在TTVR中使用LuX-Valve可有效改善TR，并降低主要不良事件的发生率。HHF和全因死亡率。TRI-SCORE可能有助于从TTVR中识别出更高获益的TR患者。临床试验注册ClinicalTrials.gov方案注册系统(NCT02917980)。
目的：本研究的目的是探讨经导管三尖瓣置换术（TTVR）相对于指南指导的药物治疗（GDMT）对有症状的重度TR患者的益处。
方法：在2020年5月至2023年4月之间，我们中心治疗了88例有症状的重度TR患者。其中,57例患者单独接受GDMT，31例患者接受了TTVR和GDMT联合治疗。我们收集并分析了基线数据，以及两组的随访信息。主要终点是全因死亡率和联合终点（包括全因死亡率和HHF）。
结果：在中位20（IQR10-29）个月的随访中，TR严重程度显着改善，右心室功能,TTVR组各维度(均P<0.001)。它还导致了更高的生存率(75.8%vs.48.4%,P=0.019),改善了合并终点的自由度(61.5%与45.9%,P=0.007）和较少的主要不良事件。在按TRI-SCORE分层后，TTVR组中<6分的亚组与其他亚组相比，在联合终点方面表现出显着差异（所有P<0.05），而在GDMT亚组中没有观察到显著差异(P=0.680)。
结论：在TTVR中使用LuX-Valve可有效改善TR，并降低主要不良事件的发生率。HHF和全因死亡率。TRI-SCORE可能有助于从TTVR中识别出更高获益的TR患者。临床试验注册ClinicalTrials.gov方案注册系统(NCT02917980)。
