Data_Sheet_1_Transcatheter Valve-in-Valve Procedures for Bioprosthetic Valve Dysfunction in Patients With Rheumatic vs. Non-Rheumatic Valvular Heart Disease.docx

Background: Bioprosthetic heart valve has limited durability and lower long-term performance especially in rheumatic heart disease (RHD) patients that are often subject to multiple redo operations. Minimally invasive procedures, such as transcatheter valve-in-valve (ViV) implantation, may offer an attractive alternative, although data is lacking. The aim of this study was to evaluate the baseline characteristics and clinical outcomes in rheumatic vs. non-rheumatic patients undergoing ViV procedures for severe bioprosthetic valve dysfunction.
Methods: Single center, prospective study, including consecutive patients undergoing transcatheter ViV implantation in aortic, mitral and tricuspid position, from May 2015 to September 2020. RHD was defined according to clinical history, previous echocardiographic and surgical findings.
Results: Among 106 patients included, 69 had rheumatic etiology and 37 were non-rheumatic. Rheumatic patients had higher incidence of female sex (73.9 vs. 43.2%, respectively; p = 0.004), atrial fibrillation (82.6 vs. 45.9%, respectively; p < 0.001), and 2 or more prior surgeries (68.1 vs. 32.4%, respectively; p = 0.001). Although, device success was similar between groups (75.4 vs. 89.2% in rheumatic vs. non-rheumatic, respectively; p = 0.148), there was a trend toward higher 30-day mortality rates in the rheumatic patients (21.7 vs. 5.4%, respectively; p = 0.057). Still, at median follow-up of 20.7 [5.1–30.4] months, cumulative mortality was similar between both groups (p = 0.779).
Conclusion: Transcatheter ViV implantation is an acceptable alternative to redo operations in the treatment of patients with RHD and severe bioprosthetic valve dysfunction. Despite similar device success rates, rheumatic patients present higher 30-day mortality rates with good mid-term clinical outcomes. Future studies with a larger number of patients and follow-up are still warranted, to firmly conclude on the role transcatheter ViV procedures in the RHD population.

研究背景：生物人工心脏瓣膜（bioprosthetic heart valve）的耐久性有限，长期性能欠佳，尤其在需多次接受再次手术的风湿性心脏病（rheumatic heart disease, RHD）患者中更为突出。经导管瓣中瓣（transcatheter valve-in-valve, ViV）植入术等微创手术或可成为颇具吸引力的替代方案，但相关临床数据仍较为匮乏。本研究旨在评估接受ViV植入术治疗重度生物人工瓣膜功能不全的风湿性与非风湿性患者的基线特征及临床结局。
研究方法：本研究为单中心前瞻性研究，纳入2015年5月至2020年9月期间连续接受主动脉瓣、二尖瓣及三尖瓣位置经导管ViV植入术的患者。RHD的诊断依据患者临床病史、既往超声心动图及手术结果确定。
研究结果：本研究共纳入106例患者，其中69例为风湿性病因，37例为非风湿性病因。风湿性患者中女性占比（73.9% vs. 43.2%，P=0.004）、心房颤动（atrial fibrillation）发生率（82.6% vs. 45.9%，P<0.001）及既往接受过2次及以上手术的比例（68.1% vs. 32.4%，P=0.001）均显著更高。尽管两组的器械操作成功（device success）率相近（风湿性组75.4%，非风湿性组89.2%，P=0.148），但风湿性患者的30天死亡率呈现升高趋势（21.7% vs. 5.4%，P=0.057）。在中位随访20.7[5.1~30.4]个月时，两组的累积死亡率无显著差异（P=0.779）。
研究结论：经导管ViV植入术可作为RHD合并重度生物人工瓣膜功能不全患者再次手术的可行替代方案。尽管两组器械操作成功率相近，但风湿性患者的30天死亡率更高，不过其中期临床结局良好。未来仍需开展更大样本量且随访完善的研究，以明确经导管ViV植入术在RHD患者群体中的应用价值。