血管内僧帽弁修復術の評価

EVERESTトライアルの結果、血管内edge-to-edge repair術により僧帽弁逆流量を減少し心不全症状が軽減することが示された
EVEREST trial finds that endovascular edge-to-edge repair can reduce mitral regurgitation and help relieve symptoms of heart failure
血管内edge-to-edge repair術は僧帽弁逆流量を減少し心不全症状を軽減させることが示されたとのLate-Breaking Clinical Trialの結果がAmerican College of Cardiology学会で発表された。新たなサブ解析ではEVEREST Iまたは現在進行中のEVEREST IIスタディの初期に治療を受けた患者23人に焦点を当てた。全ての患者は中等度重症または重症の機能性逆流を有し、83%の患者がクラスIIIまたはIVの心不全を有していた。術後の僧帽弁逆流は、MitraClipで治療された22人中19人(83%)において軽度から中等度であった。1年後、12人の患者が完全にフォローアップされ、ベースラインからフォローアップまでのデータが揃っていた。12人中10人(83%)は引き続き僧帽弁逆流が軽度から中等度であり、12人中9人(75%)は症状および日常機能としてNYHAクラスが少なくとも1度改善したままであった。さらに、拡張期左室内径はベースラインから12ヵ月後までに縮小した。
Full Text

Endovascular edge-to-edge repair can reduce mitral regurgitation and help relieve symptoms of heart failure, according to a late-breaking clinical trial presented at the annual meeting of the American College of Cardiology.

One-year findings from the EVEREST trial were reported at the meeting. The Endovascular Valve Edge-to-Edge Repair Study (EVEREST) evaluated use of the MitraClip for treatment of mitral regurgitation. The new sub-analysis focused on 23 patients treated at 15 medical centers either during the EVEREST I study or during the "roll-in" phase of the ongoing EVEREST II study, which is comparing MitraClip therapy to open-chest surgery.

All patients in the new analysis had functional regurgitation. Before the procedure, all patients had moderately severe or severe mitral regurgitation, and 83 percent of patients had heart failure ranked as New York Heart Association (NYHA) functional class III or IV.

After the procedure, mitral regurgitation was mild to modest in 19 of 22 patients (83 percent) treated with the MitraClip. After one year, 12 patients had completed follow-up and had matched data from both baseline and follow-up. Ten of the 12 patients (83 percent) continued to have only mild to modest mitral regurgitation and nine of 12 (75 percent) continued to enjoy an improvement in symptoms and daily function of at least one NYHA class.

In addition, heart size was significantly smaller. For example, the left ventricular internal diameter during diastole fell from an average of 6.0 cm at baseline to 5.4 cm at 12 months and left ventricular end-diastolic volume fell from an average of 208 mL at baseline to 178 mL at 12 months.

"This is a small study, but it demonstrates a proof of principle that the MitraClip can reduce mitral regurgitation and improve heart function in patients with functional mitral regurgitation," Hermiller said. "These findings are promising and interesting, but clearly we need a lot more data.