Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval Québec Canada.
Division of Cardiology Department of Internal Medicine II Medical University of ViennaVienna General Hospital Vienna Austria.
J Am Heart Assoc. 2020 Dec 15;9(24):e017870. doi: 10.1161/JAHA.120.017870. Epub 2020 Dec 8.
Background No randomized comparison of early (ie, ≤3 months) aortic valve replacement (AVR) versus conservative management or of transcatheter AVR (TAVR) versus surgical AVR has been conducted in patients with low-flow, low-gradient (LFLG) aortic stenosis (AS). Methods and Results A total of 481 consecutive patients (75±10 years; 71% men) with LFLG AS (aortic valve area ≤0.6 cm/m and mean gradient <40 mm Hg), 72% with classic LFLG and 28% with paradoxical LFLG, were prospectively recruited in the multicenter TOPAS (True or Pseudo Severe Aortic Stenosis) study. True-severe AS or pseudo-severe AS was adjudicated by flow-independent criteria. During follow-up (median [IQR] 36 [11-60] months), 220 patients died. Using inverse probability of treatment weighting to address the bias of nonrandom treatment assignment, early AVR (n=272) was associated with a major overall survival benefit (hazard ratio [HR], 0.34 [95% CI, 0.24-0.50]; <0.001). This benefit was observed in patients with true-severe AS but also with pseudo-severe AS (HR, 0.38 [95% CI, 0.18-0.81]; =0.01), and in classic (HR, 0.33 [95% CI, 0.22-0.49]; <0.001) and paradoxical LFLG AS (HR, 0.42 [95% CI, 0.20-0.92]; =0.03). Compared with conservative management in the conventional multivariate model, trans femoral TAVR was associated with the best survival (HR, 0.23 [95% CI, 0.12-0.43]; <0.001), followed by surgical AVR (HR, 0.36 [95% CI, 0.23-0.56]; <0.001) and alternative-access TAVR (HR, 0.51 [95% CI, 0.31-0.82]; =0.007). In the inverse probability of treatment weighting model, trans femoral TAVR appeared to be superior to surgical AVR (HR [95% CI] 0.28 [0.11-0.72]; =0.008) with regard to survival. Conclusions In this large prospective observational study of LFLG AS, early AVR appeared to confer a major survival benefit in both classic and paradoxical LFLG AS. This benefit seems to extend to the subgroup with pseudo-severe AS. Our findings suggest that TAVR using femoral access might be the best strategy in these patients. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01835028.
背景：对于低流量、低梯度（LFLG）主动脉瓣狭窄（AS）患者，尚未进行早期（即≤3 个月）主动脉瓣置换术（AVR）与保守治疗或经导管 AVR（TAVR）与外科 AVR 的随机比较。
方法和结果：共前瞻性招募了 481 例连续 LFLG AS 患者（75±10 岁；71%为男性），LFLG AS 患者的主动脉瓣面积≤0.6cm/m2，平均梯度<40mmHg，72%为经典 LFLG，28%为反常 LFLG。在中位（IQR）随访 36[11-60]个月期间，220 例患者死亡。使用逆概率治疗权重处理非随机治疗分配的偏差，早期 AVR（n=272）与主要总体生存率显著提高相关（风险比[HR]，0.34[95%可信区间，0.24-0.50]；<0.001）。这种益处不仅见于真性重度 AS 患者，也见于假性重度 AS 患者（HR，0.38[95%可信区间，0.18-0.81]；=0.01），以及经典 LFLG AS（HR，0.33[95%可信区间，0.22-0.49]；<0.001）和反常 LFLG AS（HR，0.42[95%可信区间，0.20-0.92]；=0.03）患者。与传统多变量模型中的保守治疗相比，经股 TAVR 与最佳生存率相关（HR，0.23[95%可信区间，0.12-0.43]；<0.001），其次是外科 AVR（HR，0.36[95%可信区间，0.23-0.56]；<0.001）和替代入路 TAVR（HR，0.51[95%可信区间，0.31-0.82]；=0.007）。在逆概率治疗权重模型中，经股 TAVR 似乎优于外科 AVR（HR[95%可信区间]0.28[0.11-0.72]；=0.008），生存率更高。
结论：在这项针对 LFLG AS 的大型前瞻性观察性研究中，早期 AVR 似乎为经典和反常 LFLG AS 患者带来了重大的生存获益。这种益处似乎扩展到假重度 AS 亚组。我们的研究结果表明，股动脉入路的 TAVR 可能是这些患者的最佳策略。
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