Endovascular Aneurysm Repair With Inferior Mesenteric Artery Embolization for Preventing Type II Endoleak: A Prospective Randomized Controlled Trial

OBJECTIVE:This study aimed to evaluate the effect of inferior mesenteric artery (IMA) embolization during endovascular aneurysm repair (EVAR) in patients at high risk of type II endoleak (T2EL) in randomized controlled trial (RCT). SUMMARY BACKGROUND DATA:Several studies have demonstrated a reductio...

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Veröffentlicht in:Annals of surgery 2020-02, Vol.271 (2), p.238-244
Hauptverfasser: Samura, Makoto, Morikage, Noriyasu, Otsuka, Ryo, Mizoguchi, Takahiro, Takeuchi, Yuriko, Nagase, Takashi, Harada, Takasuke, Yamashita, Osamu, Suehiro, Kotaro, Hamano, Kimikazu
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container_end_page 244
container_issue 2
container_start_page 238
container_title Annals of surgery
container_volume 271
creator Samura, Makoto
Morikage, Noriyasu
Otsuka, Ryo
Mizoguchi, Takahiro
Takeuchi, Yuriko
Nagase, Takashi
Harada, Takasuke
Yamashita, Osamu
Suehiro, Kotaro
Hamano, Kimikazu
description OBJECTIVE:This study aimed to evaluate the effect of inferior mesenteric artery (IMA) embolization during endovascular aneurysm repair (EVAR) in patients at high risk of type II endoleak (T2EL) in randomized controlled trial (RCT). SUMMARY BACKGROUND DATA:Several studies have demonstrated a reduction of T2EL by IMA embolization before EVAR. However, there have been no RCT confirming the efficacy of IMA embolization. METHODS:Patients scheduled for elective EVAR between April 2014 and March 2018 were eligible. Patients at high risk of T2EL (IMA patency with IMA ≥3 mm, LAs ≥2 mm, or an aortoiliac-type aneurysm) were prospectively randomized to receive EVAR with or without IMA embolization. The primary endpoint was occurrence of T2EL during follow-up. Secondary endpoints included aneurysmal sac changes, adverse events from IMA embolization, and reintervention rate due to T2EL. This trial is registered with the University Hospital Medical Information Network, number UMIN000022147. RESULTS:One hundred thirteen patients had high risk and 106 were randomized. In the intention-to-treat analysis, the incidence of T2EL was significantly lower in the embolization group [24.5% vs 49.1%; P = 0.009, absolute risk reduction = 24.5%; 95% confidence interval (CI), 6.2–40.5, number needed to treat = 4.1; 95% CI, 2.5–16.1]. The aneurysmal sac shrunk significantly more in the embolization group (−5.7 ± 7.3 mm vs −2.8 ± 6.6 mm; P = 0.037), and the incidence of aneurysmal sac growth related to T2EL was significantly lower in the embolization group (3.8% vs 17.0%; P = 0.030). There were no complications related to IMA embolization or reinterventions associated with T2EL. CONCLUSIONS:Our results demonstrated the effectiveness of IMA embolization during EVAR in high-risk patients for the prevention of T2EL, which is suggested for avoiding aneurysmal sac enlargement related to T2EL.
doi_str_mv 10.1097/SLA.0000000000003299
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SUMMARY BACKGROUND DATA:Several studies have demonstrated a reduction of T2EL by IMA embolization before EVAR. However, there have been no RCT confirming the efficacy of IMA embolization. METHODS:Patients scheduled for elective EVAR between April 2014 and March 2018 were eligible. Patients at high risk of T2EL (IMA patency with IMA ≥3 mm, LAs ≥2 mm, or an aortoiliac-type aneurysm) were prospectively randomized to receive EVAR with or without IMA embolization. The primary endpoint was occurrence of T2EL during follow-up. Secondary endpoints included aneurysmal sac changes, adverse events from IMA embolization, and reintervention rate due to T2EL. This trial is registered with the University Hospital Medical Information Network, number UMIN000022147. RESULTS:One hundred thirteen patients had high risk and 106 were randomized. In the intention-to-treat analysis, the incidence of T2EL was significantly lower in the embolization group [24.5% vs 49.1%; P = 0.009, absolute risk reduction = 24.5%; 95% confidence interval (CI), 6.2–40.5, number needed to treat = 4.1; 95% CI, 2.5–16.1]. The aneurysmal sac shrunk significantly more in the embolization group (−5.7 ± 7.3 mm vs −2.8 ± 6.6 mm; P = 0.037), and the incidence of aneurysmal sac growth related to T2EL was significantly lower in the embolization group (3.8% vs 17.0%; P = 0.030). There were no complications related to IMA embolization or reinterventions associated with T2EL. CONCLUSIONS:Our results demonstrated the effectiveness of IMA embolization during EVAR in high-risk patients for the prevention of T2EL, which is suggested for avoiding aneurysmal sac enlargement related to T2EL.</description><identifier>ISSN: 0003-4932</identifier><identifier>EISSN: 1528-1140</identifier><identifier>DOI: 10.1097/SLA.0000000000003299</identifier><identifier>PMID: 30946077</identifier><language>eng</language><publisher>United States: Wolters Kluwer Health, Inc. All rights reserved</publisher><subject>Aged ; Aortic Aneurysm, Abdominal - therapy ; Embolization, Therapeutic - methods ; Endoleak - prevention &amp; control ; Endovascular Procedures ; Female ; Humans ; Intention to Treat Analysis ; Male ; Mesenteric Artery, Inferior ; Prospective Studies ; Septal Occluder Device</subject><ispartof>Annals of surgery, 2020-02, Vol.271 (2), p.238-244</ispartof><rights>Wolters Kluwer Health, Inc. All rights reserved.</rights><rights>Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3509-c12b07b5267440414aa1043054f862cbc750f998f6cd0f4d085d68957664ee653</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30946077$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Samura, Makoto</creatorcontrib><creatorcontrib>Morikage, Noriyasu</creatorcontrib><creatorcontrib>Otsuka, Ryo</creatorcontrib><creatorcontrib>Mizoguchi, Takahiro</creatorcontrib><creatorcontrib>Takeuchi, Yuriko</creatorcontrib><creatorcontrib>Nagase, Takashi</creatorcontrib><creatorcontrib>Harada, Takasuke</creatorcontrib><creatorcontrib>Yamashita, Osamu</creatorcontrib><creatorcontrib>Suehiro, Kotaro</creatorcontrib><creatorcontrib>Hamano, Kimikazu</creatorcontrib><title>Endovascular Aneurysm Repair With Inferior Mesenteric Artery Embolization for Preventing Type II Endoleak: A Prospective Randomized Controlled Trial</title><title>Annals of surgery</title><addtitle>Ann Surg</addtitle><description>OBJECTIVE:This study aimed to evaluate the effect of inferior mesenteric artery (IMA) embolization during endovascular aneurysm repair (EVAR) in patients at high risk of type II endoleak (T2EL) in randomized controlled trial (RCT). SUMMARY BACKGROUND DATA:Several studies have demonstrated a reduction of T2EL by IMA embolization before EVAR. However, there have been no RCT confirming the efficacy of IMA embolization. METHODS:Patients scheduled for elective EVAR between April 2014 and March 2018 were eligible. Patients at high risk of T2EL (IMA patency with IMA ≥3 mm, LAs ≥2 mm, or an aortoiliac-type aneurysm) were prospectively randomized to receive EVAR with or without IMA embolization. The primary endpoint was occurrence of T2EL during follow-up. Secondary endpoints included aneurysmal sac changes, adverse events from IMA embolization, and reintervention rate due to T2EL. This trial is registered with the University Hospital Medical Information Network, number UMIN000022147. RESULTS:One hundred thirteen patients had high risk and 106 were randomized. In the intention-to-treat analysis, the incidence of T2EL was significantly lower in the embolization group [24.5% vs 49.1%; P = 0.009, absolute risk reduction = 24.5%; 95% confidence interval (CI), 6.2–40.5, number needed to treat = 4.1; 95% CI, 2.5–16.1]. The aneurysmal sac shrunk significantly more in the embolization group (−5.7 ± 7.3 mm vs −2.8 ± 6.6 mm; P = 0.037), and the incidence of aneurysmal sac growth related to T2EL was significantly lower in the embolization group (3.8% vs 17.0%; P = 0.030). There were no complications related to IMA embolization or reinterventions associated with T2EL. CONCLUSIONS:Our results demonstrated the effectiveness of IMA embolization during EVAR in high-risk patients for the prevention of T2EL, which is suggested for avoiding aneurysmal sac enlargement related to T2EL.</description><subject>Aged</subject><subject>Aortic Aneurysm, Abdominal - therapy</subject><subject>Embolization, Therapeutic - methods</subject><subject>Endoleak - prevention &amp; control</subject><subject>Endovascular Procedures</subject><subject>Female</subject><subject>Humans</subject><subject>Intention to Treat Analysis</subject><subject>Male</subject><subject>Mesenteric Artery, Inferior</subject><subject>Prospective Studies</subject><subject>Septal Occluder Device</subject><issn>0003-4932</issn><issn>1528-1140</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcFu1DAQhi0EokvhDRDykUvaseM4CbdotYWVFoHKIo6R40xYUycOdrLV9jl44HrZghAHsGzNyPP9M7J_Ql4yuGBQ5pefNtUF_LFSXpaPyIJlvEgYE_CYLI63iShTfkaehfANgIkC8qfkLIVSSMjzBfmxGlq3V0HPVnlaDTj7Q-jpNY7KePrFTDu6Hjr0xnn6HgMOU8w1rXyMB7rqG2fNnZqMG2gXkY8e95Exw1e6PYxI12t6HGBR3byhVSy7MKKezB7ptYqF3txhS5dumLyzNqZbb5R9Tp50ygZ88RDPyeer1Xb5Ltl8eLteVptEpxmUiWa8gbzJuMyFAMGEUgxECpnoCsl1o_MMurIsOqlb6EQLRdbKosxyKQWizNJz8vrUd_Tu-4xhqnsTNFqrBnRzqDmHlAmRyTSi4oTq-ITgsatHb3rlDzWD-uhHHf2o__Yjyl49TJibHtvfol8GRKA4AbfOxi8NN3a-RV_vUNlp97_e4h_Sn5zMioQDh-OGJB4G6T2RWqeA</recordid><startdate>20200201</startdate><enddate>20200201</enddate><creator>Samura, Makoto</creator><creator>Morikage, Noriyasu</creator><creator>Otsuka, Ryo</creator><creator>Mizoguchi, Takahiro</creator><creator>Takeuchi, Yuriko</creator><creator>Nagase, Takashi</creator><creator>Harada, Takasuke</creator><creator>Yamashita, Osamu</creator><creator>Suehiro, Kotaro</creator><creator>Hamano, Kimikazu</creator><general>Wolters Kluwer Health, Inc. 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SUMMARY BACKGROUND DATA:Several studies have demonstrated a reduction of T2EL by IMA embolization before EVAR. However, there have been no RCT confirming the efficacy of IMA embolization. METHODS:Patients scheduled for elective EVAR between April 2014 and March 2018 were eligible. Patients at high risk of T2EL (IMA patency with IMA ≥3 mm, LAs ≥2 mm, or an aortoiliac-type aneurysm) were prospectively randomized to receive EVAR with or without IMA embolization. The primary endpoint was occurrence of T2EL during follow-up. Secondary endpoints included aneurysmal sac changes, adverse events from IMA embolization, and reintervention rate due to T2EL. This trial is registered with the University Hospital Medical Information Network, number UMIN000022147. RESULTS:One hundred thirteen patients had high risk and 106 were randomized. In the intention-to-treat analysis, the incidence of T2EL was significantly lower in the embolization group [24.5% vs 49.1%; P = 0.009, absolute risk reduction = 24.5%; 95% confidence interval (CI), 6.2–40.5, number needed to treat = 4.1; 95% CI, 2.5–16.1]. The aneurysmal sac shrunk significantly more in the embolization group (−5.7 ± 7.3 mm vs −2.8 ± 6.6 mm; P = 0.037), and the incidence of aneurysmal sac growth related to T2EL was significantly lower in the embolization group (3.8% vs 17.0%; P = 0.030). There were no complications related to IMA embolization or reinterventions associated with T2EL. CONCLUSIONS:Our results demonstrated the effectiveness of IMA embolization during EVAR in high-risk patients for the prevention of T2EL, which is suggested for avoiding aneurysmal sac enlargement related to T2EL.</abstract><cop>United States</cop><pub>Wolters Kluwer Health, Inc. 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subjects Aged
Aortic Aneurysm, Abdominal - therapy
Embolization, Therapeutic - methods
Endoleak - prevention & control
Endovascular Procedures
Female
Humans
Intention to Treat Analysis
Male
Mesenteric Artery, Inferior
Prospective Studies
Septal Occluder Device
title Endovascular Aneurysm Repair With Inferior Mesenteric Artery Embolization for Preventing Type II Endoleak: A Prospective Randomized Controlled Trial
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