Arrhythmia 2015;16(1):43-47 A LARIAT suture delivery device B FindrWIRZ guidewire system C TenSURE suture tightner Source: product brochure from Sentr

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MAIN TOPIC REVIEWS Arrhythmia 2015;16(1):43-47 LARIAT Device 를이용한경피적좌심방이폐색술 Gi Byoung Nam, MD Heart Institute, Asan Medical Center, Division of Cardiology, Department of Internal Medicine, University

1 MAIN TOPIC REVIEWS Arrhythmia 2015;16(1):43-47 LARIAT Device 를이용한경피적좌심방이폐색술 Gi Byoung Nam, MD Heart Institute, Asan Medical Center, Division of Cardiology, Department of Internal Medicine, University of Ulsan College of Medicine Received: November 12, 2014 Revision Received: February 11, 2015 Accepted: March 26, 2015 Correspondence: Gi-Byoung Nam, MD, PhD, Heart Institute, Asan Medical Center, 43 Olympic- Ro, Songpa-Gu, Seoul, Korea Tel: , Fax: ABSTRACT The LARIAT is a new suture device used for closure of the left atrial appedndage (LAA). It is distinct from the Watchman or ACP devices in that no foreign body remains in the left atrium, and that a combined endocardial and epicardial approach is used. A brief summary of the device configuration, procedure methods, and recent clinical results of the LARIAT device are given below. Key Words: left atrial appendage, atrial fibrillation, stroke, device Copyright 2015 The Official Journal of Korean Heart Rhythm Society Editorial Board & MMK Co., Ltd. 서론 LARIAT 는 Watchman, Amplatzer Cardiac Plug (ACP) device와함께좌심방이폐쇄에이용되는장치이며, Watchman, ACP 등이심장내에기기 ( 이물질 ) 가남는데비하여, LARIAT 는심외막에서좌심방이를봉합, 결찰하는방식이어서위의두기기와는차별점이있다. Lariat 혹은 lasso는스페인어 la reata 에서기원하였으며, 소몰이를하는카우보이들이사용하는로프를지칭하는데, 본장치의시술이마치소의목에로프올가미를걸어잡아채는카우보이의방식과유사하여이러한이름을붙인것으로생각된다. 본고에서는 LARIAT device의간략한소개및최근의임상적용결과에대하여기술하고자한다. 기기의구성 본기기의구성부품들을제조사인 SentreHEART사의제품설명서에나온그림을인용하여소개하였다 (Figure 1). 가장핵심이되는부분은 LARIAT suture delivery device로심외막으로접근하여좌심방이를감아죄는올가미형태로 생겼다 (Figure 1A). 심장박동마다심하게움직이는좌심방이에대한접근이쉽지않으므로, 이장치는 FindrWIRZ guidewire system을이용하여좌심방이로접근하게되어있다 (Figure 1B). FindrWIRZ guidewire system은심내막과심외막에위치시키는유도철선인데, 양끝이자석으로이루어져있어서심내 / 외막을통하여두철선이마주보는형태로안정적으로유지될수있도록고안되었다. FindrWIRZ guidewire system이좌심방이를안정적으로잡고유지시켜주는동안 LARIAT suture delivery device를통하여 suture가이루어지는데, 이때 TenSURE suture tightner가이용된다 (Figure 1C). 시술중 LARIAT 의작동방식에대한이해는유투브동영상 ( 을참조하면편리하다. 시술방법 전신마취하에식도내시경을통하여좌심방이의혈전유무를확인한다. 심외막접근법 (epicardial approach) 은통상적인방법으로시행하되, 가급적전방 (anterior 43

Arrhythmia 2015;16(1):43-47 A LARIAT suture delivery device B FindrWIRZ guidewire system C TenSURE suture tightner Source: product brochure from SentreHEART, Inc (http://www.sentreheart.

2 Arrhythmia 2015;16(1):43-47 A LARIAT suture delivery device B FindrWIRZ guidewire system C TenSURE suture tightner Source: product brochure from SentreHEART, Inc ( Figure 1. Configuration of the LARIAT device. (A) The left atrial appendage (LAA) is sutured by the suture delivery device introduced via the epicardial approach. (B) To avoid instability of the LAA before delivery of the suture device, a combined endocardial and epicardial guidewire system is introduced and the two heads of the guidewires are joined and aligned by magnetic force. (C) Finally, suturing of the LAA neck is achieved using the suture tightener. 44

LARIAT Device 를이용한경피적좌심방이폐색술 A B C D Source: http://www.youtube.com/watch?v=ua40ehrsbq0 Figure 2. LARIAT implantation technique.

(A) After the wires have been secured, the suture delivery system is introduced through the epicardial wire.

The LAA is sutured and occluded completely by the suture tightener.

조영제를통하여바늘이심외막을통과한것이감지되면유도철선을넣어서심외막내로진입한다. 이후 sheath를통과시키되, 점차큰사이즈를통과시켜서최종적으로는 14 Fr. 구경의 LARIAT 장치가들어갈수있도록점진적으로구멍을넓혀나간다. 심외막경로가확보된이후에는 heparin을주입하고 SL1 sheath를이용하여중격천자를시행한다.

3 LARIAT Device 를이용한경피적좌심방이폐색술 A B C D Source: Figure 2. LARIAT implantation technique. The left atrial appendage (LAA) is approached via endocardial and epicardial puncture. Two guidewires are held tight by the magnetic force between the wire tips. (A) After the wires have been secured, the suture delivery system is introduced through the epicardial wire. The endocardial balloon is then inflated before the epicardial snare catches the neck of the LAA. (B) The snare is advanced to the LAA base and tightens the LAA neck. The LAA is sutured and occluded completely by the suture tightener. (C) The suture delivery system is withdrawn into the epicardial space and the suture material is cut after confirmation of complete closure of the LAA. approach) 을향하도록한다. 조영제를통하여바늘이심외막을통과한것이감지되면유도철선을넣어서심외막내로진입한다. 이후 sheath를통과시키되, 점차큰사이즈를통과시켜서최종적으로는 14 Fr. 구경의 LARIAT 장치가들어갈수있도록점진적으로구멍을넓혀나간다. 심외막경로가확보된이후에는 heparin을주입하고 SL1 sheath를이용하여중격천자를시행한다. 좌심방조영술을 LAO, RAO caudal view에서시행하여좌심방이의형태를확인한다. 이후 magnet tip FindrWIRZ guidewire system (SentreHEART, Inc, CA) 의유도철심을 SL1 sheath를통하여좌심방이에위치시킨다. 이때 wire는좌심방이의가장앞쪽 lobe에위치시키는것이유리하다. 이후 magnet tip FindrWIRZ guidewire를 LARIAT system에장착하여심외막 sheath를통하여집어넣고, 심내막의 wire와축이맞도록 (coaxial) 끝을맞추어위치시킨다 (Fiugure 2A). 이두유도철선의축이맞는것이확인되면심외막 sheath를통하여 LARIAT snare를집어넣고좌심방이의목에서 snare를조 여서좌심방이를막는다 (Figure 2B). 결찰이잘되어있는지는 balloon angiogram을통하여확인할수있고, 이후 Ten- SURE suture tightner (SentreHEART, Inc., CA) 를이용하여좌심방이를봉합한다 (Figure 2C). 이후 LARIAT suture delivery system을통하여남은실끝을잘라내고 delivery system을심외막에서뽑아내어제거한다 (Figure 2D). 봉합후새는결찰의누출 (leakage) 여부를좌심방조영술및경식도초음파를통하여다시확인한다. 시술결과 최근 LARIAT 를이용한좌심방이폐색술의임상결과가보고되기시작하고있다. 2013년 Bartus, Lee 등이보고한자료에서는 89명의환자중최종 85명에서성공적인시술이이루어졌으며, 1 심한심낭염 2례, 퇴원후나타난심낭액이 1 례에서관찰되어합병증이비교적많지않았다고주장하고있으나퇴원후급사가 1례에있어서안전성에의문을갖게 45

4 Arrhythmia 2015;16(1):43-47 하였다. 이어서 2014년 Price 등의보고에서는 154명의환자중 86% 에서성공적인시술이이루어지기는했으나 10% 에가까운 14명의환자에서주요출혈성부작용이나타났고, 16 명에서심낭출혈이있었다고보고하고있다. 2 더구나이들의연구에서도 1례의급사가있었다고하는데, 아마도심낭출혈이급사로표현되었을가능성이높아서출혈성부작용이중요한문제점으로부각되었다. 또한추적관찰중사망 / 심근경색 / 뇌졸중이 3% 환자에서, 심낭출혈이 2% 의환자에서관찰되었고, 약 5% 의환자에서좌심방이를제거하고남은부분 (stump) 에서혈전이형성되었으며, 약 6% 의환자에서 5 mm 이상의큰누출공 (leak) 이발견되어시술후주의깊은추적관찰및합병증에대한평가가필요함을지적하였다 년 Heart Rhythm에발표된 Miller, Reddy 등의보고에의하면, 전체 41명의환자중 38명 (93%) 의환자에서성공적인시술이이루어졌지만, 24% 의환자에서누출공이발생하였고, 8명 (20%) 의환자에서심낭출혈이있었으며, 4명 (9%) 의환자에서좌심방이천공이발생하였다고보고하여현재의시스템으로는안전한시술결과를기대하기어렵고추가적인개선이필요함을시사하였다. 3 다행히시술후발생한누공에대해서는 Amplatzer septal occlude device를이용하여막아주거나 LARIAT 를이용하여재시술을할수있음이보고되었다. 4,5 하지만시술후 13개월후에뒤늦게 LARIAT 시술부위에서발생한혈전의예도있어서, 6,7 시술후적절한기간동안의항응고치료필요성에대한검토, 혈전발생을찾기위한추적검사프로토콜확립등이추가로정립되어야할사항들이다. 심방세동의발생빈도가줄어들었다는흥미로운보고도있어서, 9 LARIAT 시술이심방세동도자절제술과같이시행될경우시술의성공률을높이는데기여할수있을가능성도제시되었다. 결론 LARIAT 시술은움직임이많은좌심방이를심내막- 심외막양방향에서자성을띤두유도철선의도킹시스템을이용하여좌심방이를안정적으로고정한후심외막을통하여올가미씌우듯좌심방이를결찰하는방법으로이제까지는수술적인방법으로만해결할수있었던좌심방이결찰을비수술적인방법으로가능하게한획기적인시도이다. 심장내에이물질이남지않는다는점에서기존의좌심방이고립술과는차별되는우수한기법이나, 최근의임상적용결과에서는심낭출혈, 좌심방이천공, 누출공등의심각한합병증이문제가되었고, 또한시술후뒤늦게나타날수있는심방혈전형성, 급사의발생등이향후해결해야할숙제로남아있다. 현재진행되고있는 Watchman device와 LARIAT 를직접 (head-to-head) 비교하는연구 (Safety and Efficacy of Left Atrial Appendage Occlusion Devices, NCT ) 의결과는향후좌심방이시술에있어 LARIAT 의임상적용에큰영향을미칠수있을것으로예상되어그귀추가주목된다. References 기타 LARIAT 효과 LARIAT 는 Watchman 이나 ACP 기기와달리좌심방이를결절함으로써 1/3의환자에서는좌심방이의전기적활성이완전히없어지고, 90% 이상의환자에서는좌심방이를조율하여도좌심방으로전기적흥분이전달되지않는다는것이보고되었다. 8 이러한결과는 LARIAT 가단순히혈전 / 색전증의예방효과만갖는것이아니라, 좌심방이에위치하는 rotor 혹은 focal trigger를제거하여심방세동의유발 / 유지를억제할수있을것이라는추정이가능케하며, 아울러 critical mass reduction 의효과도기대할수있음을시사한다. 실제로 LARIAT 시술후 1) Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J, Bartus S, Yakubov SJ, Lee RJ. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinicalexperience. J Am Coll Cardiol. 2013;62: ) Price MJ, Gibson DN, Yakubov SJ, Schultz JC, Di Biase L, Natale A, Burkhardt JD, Pershad A, Byrne TJ, Gidney B, Aragon JR, Goldstein J, Moulton K, Patel T, Knight B, Lin AC, Valderrabano M. Early safety and efficacy of percutaneous left atrial appendage suture ligation: results from the U.S. transcatheter LAA ligation consortium. J Am Coll Cardiol. 2014;64: ) Miller MA, Gangireddy SR, Doshi SK, Aryana A, Koruth JS, Sennhauser S, d'avila A, Dukkipati SR, Neuzil P, Reddy VY. 46

5 LARIAT Device 를이용한경피적좌심방이폐색술 Multicenter study on acute and long-term safety and efficacy of percutaneous left atrial appendage closure using an epicardial suture snaring device. Heart Rhythm. 2014;11: ) Guerrero M, Greenbaum A, O'Neill W. First-in-man late partial recanalization after LARIAT suturing of the left atrial appendage successfully treated with an AMPLATZER septal occluder device. Euro Intervention. 2014;10: ) Pillai AM, Kanmanthareddy A, Earnest M, Reddy M, Ferrell R, Nath J, Pillarisetti J, Vallakati A, Lakkireddy D. Initial experience with post Lariat left atrial appendage leak closure with Amplatzer septal occluder device and repeat Lariat application. Heart Rhythm. 2014;11: ) Truesdell AG, Patel CP, Maini BS. Late-occurring left atrial appendage thrombus after ligation using LARIAT. J Interv Card Electrophysiol. 2014;41:101. 7) Koranne KP, Fernando RR, Laing ST. Left atrial thrombus after complete left atrial appendage exclusion with LARIAT device. Catheter Cardiovasc Interv. 2015;85:E ) Han FT, Bartus K, Lakkireddy D, Rojas F, Bednarek J, Kapelak B, Bartus M, Sadowski J, Badhwar N, Earnest M, Valderrabano M, Lee RJ. The effects of LAA ligation on LAA electrical activity. Heart Rhythm. 2014;11: ) Afzal MR, Kanmanthareddy A, Earnest M, Reddy M, Atkins D, Bommana S, Bartus K, Rasekh A, Han F, Badhwar N, Cheng J, Dibiase L, Ellis CR, Dawn B, Natale A, Lee RJ, Lakkireddy D. Impact of left atrial appendage exclusion using an epicardial ligation system (LARIAT) on atrial fibrillation burden in patients with cardiac implantable electronic devices. Heart Rhythm. 2014;12:

MAIN TOPIC REVIEWS Arrhythmia 2015;16(1):25-29 좌심방이폐색술의소개와적응증 Young Keun On, MD, PhD, FHRS Division of Cardiology, Department of Medicine, Samsung Med

MAIN TOPIC REVIEWS Arrhythmia 2015;16(1):25-29 좌심방이폐색술의소개와적응증 Young Keun On, MD, PhD, FHRS Division of Cardiology, Department of Medicine, Samsung Med MAIN TOPIC REVIEWS Young Keun On, MD, PhD, FHRS Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine Received: November 7, 2014 Revision Received: