OBJECTIVES The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. METHODS The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. RESULTS Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.7). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.3). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.3). CONCLUSIONS TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

中文翻译：

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起搏器或除颤器导线患者的TTVI结果：TriValve注册中心的数据。

目的经三尖瓣功能的经三尖瓣心脏植入式电子设备（CIED）导线的干扰可能有助于三尖瓣关闭不全（TR）的机制，并在经导管三尖瓣介入治疗（TTVI）期间提出特定的治疗挑战。在存在CIED的情况下TTVI的可行性和有效性尚不清楚。方法研究人群包括470例来自TriValve（经导管三尖瓣治疗）注册中心的严重症状性TR患者，他们于2015年至2018年在21个中心接受了TTVI治疗。评估了CIED与预后的相关性。结果470名患者中的121名（25.7％）进行了手术前CIED检查。CIED导线最常见的位置是后中隔连合（44.0％）。与没有经瓣膜铅的患者（无CIED组）相比，三尖瓣铅的患者（CIED组）症状更明显（纽约心脏协会功能分类III至IV分别为95.9％和92.3％； p = 0.02），并且以前发生过右心衰竭的频率更高（87.8％vs. 69.0） ％； p = 0.002）。无CIED的患者TR更为严重（有效的返流孔面积0.7±0.6 cm2 vs. 0.6±0.3 cm2; p = 0.02），但右心室功能明显更好（三尖瓣环平面收缩期舒张= 16.7±5.0 mm vs.15.9± 4.0毫米； p = 0.04）。总体而言，有373例患者（占79％）接受了MitraClip（加利福尼亚州圣克拉拉市的Abbott Vascular公司治疗）（CIED组为106例[87.0％]）。其中，有154例（33％）患者同时行经导管二尖瓣修复（CIED组为55例[46.0％]，均为MitraClip）。在没有CIED的患者中，有80.0％的患者和78名患者获得了手术成功。CIED患者中有6％（p = 0.74），住院死亡率分别为2.9％和3.7％（p = 0.7）。在第30天，未CIED患者中有70.8％和CIED患者中73.7％观察到残留TR≤2+（p = 0.6）。两组均观察到症状改善（30天时，NYHA I至II级功能：66.0％vs. 65.0％； p = 0.3）。无CIED患者的12个月生存率为80.7±3.0％，CIED患者为73.6±5.0％（p = 0.3）。结论TTVI在某些选择CIED导线的患者中是可行的，急性手术成功和短期临床结果与未使用三尖瓣导线的患者相当。两组均观察到症状改善（30天时，NYHA I至II级功能：66.0％vs. 65.0％； p = 0.3）。无CIED患者的12个月生存率为80.7±3.0％，CIED患者为73.6±5.0％（p = 0.3）。结论TTVI在某些选择CIED导线的患者中是可行的，急性手术成功和短期临床结果与未使用三尖瓣导线的患者相当。两组均观察到症状改善（30天时，NYHA I至II级功能：66.0％vs. 65.0％； p = 0.3）。无CIED患者的12个月生存率为80.7±3.0％，CIED患者为73.6±5.0％（p = 0.3）。结论TTVI在某些选择CIED导线的患者中是可行的，急性手术成功和短期临床结果与未使用三尖瓣导线的患者相当。