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低エジェクション分数 (UNTOUCHED) の患者におけるS-ICDによる第1次予防試験の理解結果

Michael R Gold1, Pier D Lambiase2, Mikhael F El-Chami3

  • 1Department of Medicine, Medical University of South Carolina, Charleston (M.R.G.).

Circulation
|October 19, 2020
PubMed
まとめ

S-ICDは心不全の予防に安全で有効です. 高リスクの患者におけるS- ICDの現在の使用は,低不適切なショック率を示し,安全性と有効性の改善を示しています.

キーワード:
心臓発作インプラント式除細動器心不全主要予防について心臓発作による突然死静脈動脈症 静脈動脈症静脈動脈不全 静脈動脈不全

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科学分野:

  • 心臓病科
  • 電気生理学
  • 医療機器

背景:

  • 皮下埋め込み式心動除細動器 (S-ICD) は,突然の心臓死亡の予防に使用されます.
  • 以前のS- ICD研究では,併発症と左心室機能不全が少ない患者が含まれていました.
  • 経静脈 ICD 試験と比較して,以前の S- ICD 試験では不適切なショック率 (IAS) が高かった.

研究 の 目的:

  • 現代のS-ICD患者集団における不適切なショック率 (IAS) を評価する.
  • S- ICDの安全性と有効性を評価する.
  • MADIT-RIT研究から得られた業績目標とIAS率を比較する.

主な方法:

  • UNTOUCHED試験には,左心室排出分数 ≤35%のプライマリ予防患者が含まれていました.
  • 第2世代または第3世代S-ICDデバイスは,特定の速度および形態学的差別基準で埋め込まれ,プログラムされました.
  • 患者は18ヶ月間追跡され,IASフリー率のプライマリエンドポイントを評価した.

主要な成果:

  • 18ヶ月間IASからの免除は95.9%で,業績目標を超えました.
  • 18ヶ月の全原因無ショック率は90.6%で 既定の目標を達成しました
  • 18ヶ月の合併症のない割合は92. 7%で,適切なショックでの成功率は98. 4%でした.

結論:

  • 現代のS-ICDデバイスとプログラミングは,高併発性患者集団において高い有効性と安全性を実証しています.
  • 観察された不適切なショック率は,S- ICDで報告された中で最も低く,静脈経 ICD研究と好意的に比較されます.
  • S-ICDは,現代の患者の突然心臓死予防のための安全で効果的な選択肢です.