Background:Severe prosthesis-patient mismatch (PPM) is diagnosed by an indexed effective orifice area <0.65 cm²/m², which is derived from stroke volume index. We examined the impact of flow, determined by stroke volume index, on severe PPM following transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).Methods:We included SAVR patients from the PARTNER 2A trial (Placement of Aortic Transcatheter Valve 2A) and TAVR patients from the PARTNER 2 S3i (Placement of Aortic Transcatheter Valve 2 S3i) registry. The primary end point was the separate analysis of all-cause death, cardiac death, and rehospitalization at 5 years. Following TAVR and SAVR, we compared the primary end points between severe versus no-severe PPM in all patients, in low flow (LF), and in normal flow. Multivariable analysis was performed to determine variables associated with the end points.Results:Nine hundred fifty-four TAVR and 726 SAVR patients with PPM and flow data were included. Severe PPM following TAVR was significantly lower compared with SAVR in all patients (9% versus 28%, P<0.0001), in normal flow (5% versus 8%, P=0.04), and in LF (20% versus 42%, P<0.0001). Severe PPM was associated with rehospitalization following TAVR (odds ratio, 1.52 [95% CI, 1.01–2.29], P=0.0456) and SAVR (odds ratio, 1.51 [95% CI, 1.06–2.16], P=0.0237). Severe PPM in LF was independently associated with cardiac death following TAVR (odds ratio, 1.85 [95% CI, 1.06–3.23], P=0.0308). Following SAVR, severe PPM in LF and low ejection fraction was associated with increased cardiac death (35.26% versus 12.51%, P=0.01) and rehospitalization (37.59% versus 15.46%, P=0.006) compared with severe PPM in LF and preserved ejection fraction, respectively. Severe PPM in normal flow was not associated with clinical outcomes despite higher gradients and smaller valves compared with severe PPM in LF.Conclusions:Severe PPM is more common following SAVR compared with TAVR. Regardless of the implanted valve size or gradient, severe PPM impacts mortality only in patients with LF following TAVR and LF and low ejection fraction following SAVR. Severe PPM in normal flow is not associated with poor outcomes.Registration:URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01314313 and NCT02687035.

中文翻译：

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经导管和外科主动脉瓣置换术后流量对假体-患者不匹配的影响

背景：严重的假体-患者不匹配 (PPM) 是通过索引有效孔口面积 <0.65 cm ² /m ²来诊断的，这是从每搏输出量指数得出的。我们检查了由每搏量指数确定的流量对经导管主动脉瓣置换术 (TAVR) 和外科主动脉瓣置换术 (SAVR) 后严重 PPM 的影响。 2A) 和 PARTNER 2 S3i（放置主动脉经导管瓣膜 2 S3i）注册的 TAVR 患者。主要终点是对 5 年时全因死亡、心源性死亡和再住院的单独分析。在 TAVR 和 SAVR 之后，我们比较了低流量 (LF) 和正常流量下所有患者的严重 PPM 与非严重 PPM 之间的主要终点。进行多变量分析以确定与终点相关的变量。结果：包括 954 名具有 PPM 和流量数据的 TAVR 和 726 名 SAVR 患者。在所有患者中，TAVR 后的严重 PPM 显着低于 SAVR（9% 对 28%，P <0.0001）、正常流量（5% 对 8%，P = 0.04）和 LF（20% 对 42%，P <0.0001）。重度 PPM 与 TAVR（比值比，1.52 [95% CI，1.01-2.29]，P = 0.0456）和 SAVR（比值比，1.51 [95% CI，1.06-2.16]，P =0.0237）后的再住院相关。LF 中的严重 PPM 与 TAVR 后的心脏死亡独立相关（优势比，1.85 [95% CI，1.06-3.23]，P = 0.0308）。SAVR 后，LF 严重 PPM 和低射血分数与心源性死亡（35.26% 对 12.51%，P = 0.01）和再住院（37.59% 对 15.46%，P=0.006) 分别与 LF 和保留射血分数的严重 PPM 相比。尽管与LF中的重度PPM相比更高的梯度和更小的瓣膜，正常流量中的重度PPM与临床结果无关。结论：与TAVR相比，SAVR后重度PPM更常见。无论植入的瓣膜大小或梯度如何，严重的 PPM 仅影响 TAVR 后的 LF 和 LF 以及 SAVR 后射血分数低的患者的死亡率。正常流程中的严重 PPM 与不良结果无关。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01314313 和 NCT02687035。