Avishag Laish-Farkash, Ella Yahud, Michael Rahkovich, Yonatan Kogan, Lubov Vasilenko, Emanuel Harari, Gergana Marincheva, Emma Shvets, Eli I Lev, Uri Farkash
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The wide-awake-local-anesthesia-no-tourniquet (WALANT) technique, using large-volume local anesthesia and adrenaline, is successful in hand surgeries but its potential to mitigate bleeding risk in CIED implantations remains unknown.</p><p><strong>Objectives: </strong>To investigate whether WALANT protocol for CIED implantations reduces clinically significant pocket hematoma in patients with a high bleeding risk or is a contraindication for interrupting ATT.</p><p><strong>Methods: </strong>We conducted a prospective, double-blind, randomized controlled trial with CIED surgery patients on uninterrupted ATT. They received WALANT protocol (lidocaine 1% with adrenaline 1:100,000) or standard protocol (lidocaine 1%). Following implantation, patients were blindly monitored in the ward and pacemaker clinic. Patients were monitored for bleeding outcomes post-implantation.</p><p><strong>Results: </strong>Forty-six consecutive patients (73.6 ± 9 years, 72% male) were enrolled. In the WALANT group (n=24) no intra-pocket pro-hemostatic agents were needed, compared to 45% in the control group (P = 0.0002). Postoperative pressure dressings were used in 12.5% vs. 68% (P = 0.0002). WALANT patients had smaller hematoma areas (median 3.7 cm2 IQR [1-39] vs. 46 cm2 [IQR 24-76], P = 0.0004) 1-day postoperative. ATT interruption occurred in 12.5% vs. 18% (P = 0.7). Superficial skin infection rates were 4% vs. 9% (P = 0.6). No DRI occurred. No WALANT-related side effects were observed.</p><p><strong>Conclusions: </strong>WALANT protocol in CIED implantation with uninterrupted ATT reduced pro-hemostatic agents, pressure-dressing need, and hematoma size. Larger studies are needed to assess its impact on infection rates.</p>","PeriodicalId":50268,"journal":{"name":"Israel Medical Association Journal","volume":"27 5","pages":"307-313"},"PeriodicalIF":1.8000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Implanting Cardiac Electronic Devices with Uninterrupted Antithrombotic Therapy: A Novel Approach to Reduce Pocket Hematoma.\",\"authors\":\"Avishag Laish-Farkash, Ella Yahud, Michael Rahkovich, Yonatan Kogan, Lubov Vasilenko, Emanuel Harari, Gergana Marincheva, Emma Shvets, Eli I Lev, Uri Farkash\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Uninterrupted antithrombotic treatment (ATT) during cardiac implantable electronic device (CIED) implantation increases bleeding and device-related infections (DRI) risk. The wide-awake-local-anesthesia-no-tourniquet (WALANT) technique, using large-volume local anesthesia and adrenaline, is successful in hand surgeries but its potential to mitigate bleeding risk in CIED implantations remains unknown.</p><p><strong>Objectives: </strong>To investigate whether WALANT protocol for CIED implantations reduces clinically significant pocket hematoma in patients with a high bleeding risk or is a contraindication for interrupting ATT.</p><p><strong>Methods: </strong>We conducted a prospective, double-blind, randomized controlled trial with CIED surgery patients on uninterrupted ATT. They received WALANT protocol (lidocaine 1% with adrenaline 1:100,000) or standard protocol (lidocaine 1%). Following implantation, patients were blindly monitored in the ward and pacemaker clinic. Patients were monitored for bleeding outcomes post-implantation.</p><p><strong>Results: </strong>Forty-six consecutive patients (73.6 ± 9 years, 72% male) were enrolled. In the WALANT group (n=24) no intra-pocket pro-hemostatic agents were needed, compared to 45% in the control group (P = 0.0002). Postoperative pressure dressings were used in 12.5% vs. 68% (P = 0.0002). WALANT patients had smaller hematoma areas (median 3.7 cm2 IQR [1-39] vs. 46 cm2 [IQR 24-76], P = 0.0004) 1-day postoperative. ATT interruption occurred in 12.5% vs. 18% (P = 0.7). Superficial skin infection rates were 4% vs. 9% (P = 0.6). No DRI occurred. No WALANT-related side effects were observed.</p><p><strong>Conclusions: </strong>WALANT protocol in CIED implantation with uninterrupted ATT reduced pro-hemostatic agents, pressure-dressing need, and hematoma size. 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引用次数: 0
摘要
背景:心脏植入式电子装置(CIED)植入期间不间断抗血栓治疗(ATT)增加出血和装置相关感染(DRI)的风险。使用大容量局麻和肾上腺素的广角清醒-局部麻醉-无止血带(WALANT)技术在手部手术中是成功的,但其在减少CIED植入出血风险方面的潜力尚不清楚。目的:探讨WALANT方案是否能减少高出血风险患者的临床显著袋性血肿或中断ATT的禁忌症。方法:我们对CIED手术患者进行了一项前瞻性、双盲、随机对照试验,他们接受了WALANT方案(1%利多卡因加1:10万肾上腺素)或标准方案(1%利多卡因)。植入后,患者在病房和起搏器诊所进行盲目监测。监测患者植入后的出血情况。结果:连续入组46例患者(73.6±9岁,72%男性)。WALANT组(n=24)不需要使用口袋内促止血剂,而对照组为45% (P = 0.0002)。术后使用压力敷料的比例为12.5% vs. 68% (P = 0.0002)。术后1天WALANT患者血肿面积较小(中位数为3.7 cm2 IQR [1-39] vs. 46 cm2 [IQR 24-76], P = 0.0004)。ATT中断发生率为12.5%比18% (P = 0.7)。浅表皮肤感染率分别为4%和9% (P = 0.6)。无DRI发生。未观察到与walant相关的副作用。结论:WALANT方案在不间断ATT的CIED植入中减少了促止血剂、压力敷料需求和血肿大小。需要更大规模的研究来评估其对感染率的影响。
Implanting Cardiac Electronic Devices with Uninterrupted Antithrombotic Therapy: A Novel Approach to Reduce Pocket Hematoma.
Background: Uninterrupted antithrombotic treatment (ATT) during cardiac implantable electronic device (CIED) implantation increases bleeding and device-related infections (DRI) risk. The wide-awake-local-anesthesia-no-tourniquet (WALANT) technique, using large-volume local anesthesia and adrenaline, is successful in hand surgeries but its potential to mitigate bleeding risk in CIED implantations remains unknown.
Objectives: To investigate whether WALANT protocol for CIED implantations reduces clinically significant pocket hematoma in patients with a high bleeding risk or is a contraindication for interrupting ATT.
Methods: We conducted a prospective, double-blind, randomized controlled trial with CIED surgery patients on uninterrupted ATT. They received WALANT protocol (lidocaine 1% with adrenaline 1:100,000) or standard protocol (lidocaine 1%). Following implantation, patients were blindly monitored in the ward and pacemaker clinic. Patients were monitored for bleeding outcomes post-implantation.
Results: Forty-six consecutive patients (73.6 ± 9 years, 72% male) were enrolled. In the WALANT group (n=24) no intra-pocket pro-hemostatic agents were needed, compared to 45% in the control group (P = 0.0002). Postoperative pressure dressings were used in 12.5% vs. 68% (P = 0.0002). WALANT patients had smaller hematoma areas (median 3.7 cm2 IQR [1-39] vs. 46 cm2 [IQR 24-76], P = 0.0004) 1-day postoperative. ATT interruption occurred in 12.5% vs. 18% (P = 0.7). Superficial skin infection rates were 4% vs. 9% (P = 0.6). No DRI occurred. No WALANT-related side effects were observed.
Conclusions: WALANT protocol in CIED implantation with uninterrupted ATT reduced pro-hemostatic agents, pressure-dressing need, and hematoma size. Larger studies are needed to assess its impact on infection rates.
期刊介绍:
The Israel Medical Association Journal (IMAJ), representing medical sciences and medicine in Israel, is published in English by the Israel Medical Association.
The Israel Medical Association Journal (IMAJ) was initiated in 1999.