患有重度二尖瓣逆流的老年患者能否從經導管二尖瓣的修補手術治療中受益?

Abstract

背景:年齡是開心手術的傳統危險因子。 使用 MitraClip 的經導管緣至緣二尖 瓣修補手術的有效性和安全性已在重度二尖瓣逆流患者中得到證實。 由於 80 歲以上的老年患者通常因為年長而不願意或是被外科醫師拒絕接受開心手術， 因此本研究的主要目的是闡明 MitraClip 在老年患者中的安全性和長期臨床效果。 方法:患有重度二尖瓣逆流的心臟病患者皆須接受心臟團隊的完整評估。 對於 手術風險較高的患者，在複合手術室進行經導管二尖瓣修修補手術。 在手術前， 1 個月，6 個月和 1 年時進行經胸前心臟超音波檢查，血液檢查和 6 分鐘步行試 驗。 結果:共有連續 46 名接受 MitraClip 手術的患者收入此項研究。 共 19 位病患 超過 80 歲(平均 84.2±4.0 歲，男性 63%)，27 位病患年齡小於 80 歲(平均 73.4±11.1 歲，81%男性)。除年齡較小此組病患的左心室射出分率較低之外， 兩組在其他合併症和手術風險概況沒有顯著差異。兩組的手術成功率相似(年 齡≧80 歲 vs. <80 歲，95%vs. 93%，P = 1.00)。在手術安全性方面，兩組均未 發生手術期死亡，心肌梗死，中風或任何需要緊急心臟手術的事件。與手術前 相比，術後二尖瓣逆流嚴重程度顯著降低，並持續 1 年。同時，所有患者在手 術後都從紐約心臟協會心衰竭功能類的顯著改善中受益。 心衰竭指數 NT- proBNP 水平從術後 1 個月時持續下降並持續到一年的隨訪。六分鐘可行走距離 在 1 個月時從 259±114 米增加到 313±107(p = 0.02)，在 1 年時增加到 319±92 (p = 0.03)。追蹤期間，6 例患者死亡，其中包含 3 例心血管死亡。總體 1 年 生 率為 86%(80 歲以上為 80%，80 歲以下為 88%，p = 0.590)。兩組患者 在 1 年無全因死亡率或心臟衰竭再入院率方面沒有差異(80 歲以上為 70%，80歲以下為 78%，P = 0.738)。通過單變量分析，術前六分鐘可行走距離是 MitraClip 術後全因死亡率的預測指標(OR 0.99,95%CI:0.982-0.999，P = 0.026)，而非年齡(OR 1.12,95%CI:0.975-1.299 ，p = 0.108) 結 論 : 經導管緣至緣的二尖瓣修補手術是安全的，對重度二尖瓣逆流的患者即 使在高齡時也具有正面的臨床效果。 對於心臟衰竭症狀和功能恢復，80 歲以上 的病患也可以受益於 MitraClip 手術。

Background: Age is a traditional risk factor for open-heart surgery. The efficacy and safety of transcatheter edge-to-edge mitral valve repair, using MitraClip, has been demonstrated in patients with severe mitral regurgitation (MR). Since octogenarians or even older patients are usually deferred to receive open-heart surgery, the main interest of this study is to elucidate the procedural safety and long term clinical impact of MitraClip in elderly patients. Methods: Patients with symptomatic severe MR were evaluated by the heart team. For those with high or prohibitive surgical risks, transcatheter mitral valve repair was performed in hybrid operation room. Transthoracic echocardiography (TTE), blood tests, and six-minute walk test (6MWT) were performed before, 1-month, 6-month, and 1 year after surgery. Results: A total of 46 consecutive patients receiving MitraClip procedure were enrolled. 19 patients (84.2 ± 4.0 years, 63% male) were over 80 year-old and 27 (73.4 ± 11.1 years, 81% male) were younger than 80. Except for poorer left ventricular ejection fraction (LVEF) in the younger group, there was no significant difference in baseline characteristics, comorbidities, and surgical risk profiles. The procedural success rate was similar (aged ≥80 years and <80 years, 95% vs. 93%, p = 1.00). There was no peri-procedural death, myocardial infarction, stroke or any events requiring emergent cardiac surgery in both groups. Compared with baseline, the significant reduction in MR severity was achieved after the procedure and sustained for 1 year. At the same time, all the patients benefited from significant improvement in New York Heart Association (NYHA) functional class after the procedure. The NT-proBNP level continuously decreased since 1st month after the index procedure. The 6MWT increased from 259 ± 114 meters to 313 ± 107 (p = 0.02) at 1 month, and up to 319 ± 92 (p = 0.03) at 1 year. During follow-up period, 6 patients experienced death whereas 3 are cardiovascular mortality. The overall 1-year survival rate was 86% (80% in aged ≥80 years and 88% in those < 80 years, p = 0.590). There was also no difference in 1-year free from all-cause mortality or heart failure admission rate between two groups (70% in aged ≥80 years and 78% in those < 80 years, p = 0.738). By univariate analysis, pre-procedural 6MWT was a predictor for all-cause mortality (OR 0.99, 95% CI: 0.982-0.999, p = 0.026) after the MitraClip procedure but not age (OR 1.12, 95% CI: 0.975-1.299, p = 0.108) Conclusions: Trans-catheter edge-to-edge mitral valve repairs are safe and have positive clinical impact in subjects with severe MR, even in advanced age. Octogenarians can also benefit from MitraClip procedure in respect of heart failure symptoms and functional capacities.