MitraClipで外科的手術のリスクが高い患者も治療可能に
アボット バスキュラー ジャパン(株)は10月11日(木)、ハイアットリージェンシー東京(東京都新宿区)にて、記者説明会「外科的治療が困難な重度僧帽弁閉鎖不全症の最新治療」を開催した。林田健太郎氏(慶応義塾大学)と天木 誠氏(国立循環器病研究センター)によるMitraClipについての講演の後、両氏とMitraClipによる治療を実際に受けた奥 俊信氏とのパネルディスカッションが行われた。


MitraClipは「安全で優しい治療法」
初めに林田氏が「僧帽弁閉鎖不全症治療におけるMitraClip®NTシステムへの期待」と題して、機能性僧帽弁閉鎖不全症(以下、FMR)の説明や治療法、そしてMitraClipによる治療法や効果の紹介を行った。FMRは虚血性心疾患等による僧帽弁の拡張を原因とする弁尖の不完全な接合により引き起こされる。弁置換術や弁輪縫縮術といった外科的手術では効果が期待できず、また困難であるとされていた。これに対し、MitraClipは僧帽弁の前尖と後尖を挟み込んで繋ぎ合わせ、逆流を少なくすることができる。カテーテルを用いて行うため患者への負担が少なく、高齢者などの外科的開心術が困難な患者に対しても治療が可能となる。確立された治療として、全世界で7万例を超える実績があり、2018年4月から日本においても保険償還されることとなった。これを受け林田氏は「MitraClipは従来では治療できなかった患者を治療できる安全で優しい治療法であり、保険償還により今後さらに多くの患者がこの恩恵を受けられるようになるだろう」と述べた。
2つのデータが示すMitraClipの特性
天木氏は「二次性僧帽弁閉鎖不全症に対するカテーテル治療: 心不全治療へのあらたな幕開け」として、二次性僧帽弁閉鎖不全症(以下、二次性MR)を取り巻く現状と、COAPT試験の結果を受けた今後のMitraClipの展望を述べた。氏は全国における特定健康診査対象者約5,396万人のうち、MR3以上の重症患者の数は推定約22万人という国立循環器病研究センターの調査結果を紹介した上で、低心機能に二次性MRを併発した患者の予後のデータを提示。重症患者は3年で3~4割が死亡しているとした。その上で「心臓を止めずに治療が行えるため人工心肺が不要」「造影剤を使わないため腎機能障害患者や透析が必要な患者にも治療が行える」とMitraClipの有用性を挙げ、これに関して、二次性MRを有する心不全患者に対する薬物治療とMitraClipを加療した薬物治療の比較を行い、二次性MRに対しMitraClipが良好な結果をもたらすとしたCOAPT試験のデータを示した。
一方で氏は、MITRA-FR試験についても紹介。これはMitraClipを用いても薬剤治療のみの治療と結果に有意差は得られないとのデータを示した研究であり、この2つの研究における相反する結果について、氏は双方の対象とした患者や条件の違いに焦点を当て「心不全の薬物療法を十分に行った後で、MRの重症度が3度以上かつ左室拡大が進行し過ぎていない患者に対し、経験のある施設で治療を行えば高い効果が見込めることを表している」との見解を示した。
患者の声~「第2の命をもらえた」
パネルディスカッションでは実際にMitraClipによる治療を受けた奥 俊信氏が、林田氏と天木氏を交えて、手術に際して感じたことや術後の経過を語った。奥氏は重い心不全を患っており、術前はとても息苦しく行動も制限され、動く気力さえ湧かないほどだったという。手術リスクの高さもあり、林田氏はMitraClipを提案。術後はすっかり痛みもなくなり、薬を服用しつつ良好な予後を保っているそうで「第2の命をもらえた」と感謝を述べた。手術に際しては不安もあったが、ビデオなども交えた説明もあり、最後は安心してチームに任せることができたという。これについて林田氏は、手術においては外科や麻酔科など他科のスタッフとも力を合わせ、最適な治療法を見つけること、手術中のコミュニケーションも緊密に行うことを大切にしたと話した。天木氏は「MitraClipの効果をより多くの患者さんに実感してもらいたい。手術が難しい人にも使え、失ったものを取り戻せる治療法だ」と結び、今後のMitraClipの普及に前向きな姿勢を示した。

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