心房細動における脳卒中予防のためのウォッチマンとアンプラッツァー装置を比較したメタアナリシス

Meta-Analysis Comparing Watchman and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation.

• Indranill Basu Ray
• Dibbendhu Khanra
• Sumit Shah
• Sudhanva Char
• Xiaoming Jia
• Wilson Lam
• Nilesh Mathuria
• Mehdi Razavi
• Bhavna Jain
• Dhanunjaya Lakkireddy
• Saibal Kar
• Andrea Natale
• Adedayo Adeboye
• John Lynn Jefferies
• Sripal Bangalore
• Samuel Asirvatham
• Mohammad Saeed

抄録

出血のリスクが高い心房細動患者や経口抗凝固療法に耐えられない心房細動患者に対して、左心房付属器（LAA）閉鎖術は血栓塞栓イベントのリスクを軽減するための代替療法である。 LAA閉鎖装置AmplatzerとWatchmanの有効性と安全性を比較すること。 2つの装置の安全性と有効性の転帰を比較した研究のメタアナリシスを行った。研究の質の評価にはNewcastle-Ottawa Scaleを用いた。 614人の患者を含む6つの研究がメタアナリシスに含まれた。全体的なイベント発生率は両装置とも低かった。安全性のアウトカム（心嚢液貯留、心タンポナーデ、デバイスの塞栓、空気塞栓症、血管合併症など）や、全死亡率、心臓死、脳卒中／一過性脳虚血発作、デバイス関連血栓症の発生率には、両デバイス間に有意差は認められなかった。総出血率はウォッチマン群で有意に低かった（Log OR = -0.90；95％CI = -1.76～-0.04；＝0.04）が、出血率を大出血と小出血に分類した場合には有意差は認められなかった。総器質周囲漏出率と取るに足らない器質周囲漏出率は、ウォッチマン群で有意に高かった（Log OR = 1.32; 95% CI = 0.76～1.87;<0.01、Log OR = 1.11; 95% CI = 0.50～1.72;<0.01）。しかしながら、有意なデバイス周囲漏出は、両デバイスにおいて同様であった。 LAA閉鎖デバイスは合併症率が低く、イベント率も低かった。有効性と安全性は、ウォッチマン群で有意ではない装置周囲漏れの割合が高かったことを除けば、両装置間で同等であった。両装置を比較した無作為化比較試験が進行中であり、これにより両装置の安全性と有効性の結果の比較についてより多くの知見が得られる可能性がある。

For patients with atrial fibrillation who are at high risk for bleeding or who cannot tolerate oral anticoagulation, left atrial appendage (LAA) closure represents an alternative therapy for reducing risk for thromboembolic events. To compare the efficacy and safety of the Amplatzer and Watchman LAA closure devices. A meta-analysis was performed of studies comparing the safety and efficacy outcomes of the two devices. The Newcastle-Ottawa Scale was used to appraise study quality. Six studies encompassing 614 patients were included in the meta-analysis. Overall event rates were low for both devices. No significant differences between the devices were found in safety outcomes (i.e., pericardial effusion, cardiac tamponade, device embolization, air embolism, and vascular complications) or in the rates of all-cause mortality, cardiac death, stroke/transient ischemic attack, or device-related thrombosis. The total bleeding rate was significantly lower in the Watchman group (Log OR = -0.90; 95% CI = -1.76 to -0.04; = 0.04), yet no significant differences was found when the bleeding rate was categorized into major and minor bleeding. Total peridevice leakage rate and insignificant peridevice leakage rate were significantly higher in the Watchman group (Log OR = 1.32; 95% CI = 0.76 to 1.87; < 0.01 and Log OR = 1.11; 95% CI = 0.50 to 1.72; < 0.01, respectively). However, significant peridevice leakages were similar in both the devices. The LAA closure devices had low complication rates and low event rates. Efficacy and safety were similar between the systems, except for a higher percentage of insignificant peridevice leakages in the Watchman group. A randomized controlled trial comparing both devices is underway, which may provide more insight on the safety and efficacy outcomes comparison of the devices.

Copyright © 2020 Basu Ray, Khanra, Shah, Char, Jia, Lam, Mathuria, Razavi, Jain, Lakkireddy, Kar, Natale, Adeboye, Jefferies, Bangalore, Asirvatham and Saeed.