MAIN TOPIC REVIEWS A No or minimal structural heart disease Paroxysmal Persistent Patient choice a Catheter ablation Dronedarone Flecainide Propafenon

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전극도자절제술과변화된국내보험규정 MAIN TOPIC REVIEWS 서울대학교의과대학내과학교실오세일 Seil Oh, MD, PhD, FHRS Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea ABSTRACT Update interval of guideline

1 전극도자절제술과변화된국내보험규정 MAIN TOPIC REVIEWS 서울대학교의과대학내과학교실오세일 Seil Oh, MD, PhD, FHRS Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea ABSTRACT Update interval of guideline publish for atrial fibrillation (AF) is getting shorter than the past due to rapidly expanding knowledge and evidences on AF. According to the current guidelines, catheter ablation is recommended as an alternative to antiarrhythmic drugs for patients with symptomatic recurrent paroxysmal AF, provided the procedure is performed by an experienced center/operator. Catheter ablation is reasonable as firstline therapy in selected patients with paroxysmal AF and no structural heart disease. Continuation of warfarin can be considered throughout the ablation procedure but robust data for NOACs are lacking. Ongoing clinical trials should provide new information for assessing whether catheter ablation is superior to pharmacological therapy for reducing total mortality. These will help us to address whether catheter ablation provides benefit beyond quality of life. Key Words: catheter ablation atrial fibrillation guideline 서론 심방세동환자를대상으로하는새로운약제, 새로운 치료법의개발로심방세동가이드라인이자주업데이트 되고있다. 이에전극도자절제술부문은최근가이드라 인에서어떤면들이새롭게언급되고있으며, 지난 6 월 에개정된국내건강보험요양급여인정기준은어떤지 에대해알아보고자한다. Received: September 8, 2014 Accepted: December 15, 2014 Corresponding Author: Seil Oh, MD, PhD, FHRS, Professor of Internal Medicine, Seoul National University, College of Medicine and Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, , Korea Tel: , Fax: seil@snu.ac.kr ESC (European Society of Cardiology) 2012 년가이드라인업데이트 1 1. 새로운증거들 동리듬유지측면에서항부정맥제보다는전극도자 절제술의우수성이추가적인연구들 (MANTRA-PAF [Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation], 2 RAAFT-2 [Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Paroxysmal Atrial Fibrillation] 3 ) 에서입증되어 2010 년 가이드라인의권고사항이공고해졌다. 또한시술관련 합병증발생의가능성이낮은선택된발작성심방세동 환자들에서는리듬유지를위한일차치료로전극도자 VOL.15 NO.4 27

2 MAIN TOPIC REVIEWS A No or minimal structural heart disease Paroxysmal Persistent Patient choice a Catheter ablation Dronedarone Flecainide Propafenone Sotalol b Patient choice B Relevant structural heart disease Yes HF No Yes Due to AF No Dronedarone c Sotalol d Patient choice Catheter ablation b Figure 1. Rhythm control strategy for atrial fibrillation with normal heart (A) or structural heart disease (B) recommended in 2012 focused update of the ESC guidelines. a Usually pulmonary vein isolation is appropriate. b More extensive left atrial ablation may be needed. c Caution with coronary heart disease. d Not recommended with left ventricular hypertrophy. Heart failure due to AF=tachycardiomyopathy. AF, atrial fibrillation; HF, heart failure. 28 The Official Journal of Korean Heart Rhythm Society

3 절제술을선택할수있음이타당하다는사실을다시한번피력하고있다 (Figure 1A). 비록전극도자절제술이항부정맥제보다우수한치료법이지만재발률은상당히높다. 경험이많은센터에서적절한환자, 심지어 lone atrial fibrillation (AF) 환자일지라도후기에재발하는경우가흔하다. 하지만재발의가장중요한예측인자는초기재발이다. 4-7 즉, 초기재발상태가유지되는것이나중에재발하는경우보다훨씬중요하다는의미이다. 합병증은유럽기관을대상으로조사한결과에서뇌졸중 0.6%, 심낭압전 1.3%, 말초혈관합병증 1.3%, 심낭염 2% 로나와이전에보고되었던미국데이터및전세계설문조사와유사한결과를보였다 년사이에첫번째절제술을받았던 4,156명의데이터베이스분석에따르면총합병증발생률은 5%, 절제술후 1년이내의모든원인에의한입원율은 38.5% 였다. 8 무증상의뇌경색은 4-25% 로다양하게보고되었는데, 9-11 이는절제술에사용된도구의차이에기인하는것으로추정된다. 비록무증상뇌경색의임상적의미는분명하지않으나더안전한심방세동절제술방법의개발이필요함은분명하다. 3. 절제술전후의항응고요법절제술전후의항응고요법은뇌졸중예방치료가평생필요한환자뿐만아니라뇌졸중위험인자가없는환자모두에게도움이되는것으로인식되고있다. 최근에는시술직전에항응고요법을중지하지않고계속유지하는방법이안전하다는보고가있었으며, HRS/EHRA/ECAS (Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society) 합의문에서도항응고요법을중지하고 heparin을사용하는방법대신항응고요법을중지하지않고계속투여하는방법으로사용할수있다고권고한바있다. 16 ESC도이번가이드라인에서는항응고요법을중지하지않고, 계속투여하는방법을사용할수있다고권고하고있으며, 절제술과정중 INR (international normalized ratio) 은 정도를추천한다. 또한, CHA2DS2-VASc 점수가 2점이상인경우에는시술성공여부와상관없이장기간의항응고요법을권한다. 새로운항응고제 (new oral anticoagulants, NOAC) 에대해서는아직증거가불충분한상태여서강하게권고하고있지는않다. MAIN TOPIC REVIEWS 2. 심부전환자에서의절제술 4. 권고강도와증거수준의변화 개정된가이드라인에서는심부전환자의리듬조절방법에동원할수있는항부정맥제로유일하게 amiodarone만을권고한다. 심부전환자의심방세동증상조절을위해숙련된센터에서전극도자절제술을시행하는것은하나의치료전략이될수있다. 물론심부전환자에서는재발률과합병증발생률이높다는사실은인지해야한다. 또한심방세동의증상이심부전증상과혼돈될수있으므로주의깊은병력청취가필요하다. 환자의증상이심방세동에의한것으로추정된다면리듬조절을위해 amiodarone과절제술중선택할수있다 (Figure 1B). 2010년에는항부정맥제로리듬조절에실패한발작성심방세동의절제술권고강도가 class IIa였으나, 이후축적된임상연구결과들로인해 2012년에는 class I 으로격상되었다. 또한증상이심하고위험도가낮은환자의경우일차치료로전극도자절제술을고려해야한다고권고하고있다 ( 권고강도 IIa, 증거수준 B). 물론이는 (1) 매우경험이풍부한센터 / 시술자가시행하는경우, (2) 적절하게환자가선정된경우, (3) 다른치료대안에대해서주의깊게평가한경우, (4) 환자가선호하는경우로한정한다. 지속성심방세동에대한권고안은 2010년에비해변환된것이없다. 아직까지무증상의심방세동환자에게는절제술을권할만한증거가없다. VOL.15 NO.4 29

4 MAIN TOPIC REVIEWS No Structural Heart Disease Structural Heart Disease a CAD HF Dofetilide b,c Dronedarone Flecainide b,d Propafenone b,d Sotalol b,c Catheter ablation b,c Dofeilide Dronedarone Sotalol b,c a Catheter ablation Dofetilide b,c Figure 2. Rhythm control strategy for atrial fibrillation without and with structural heart disease recommended in 2014 AHA/ACC/HRS guidelines. a Depending on patient preference when performed in experienced centers. b Not recommended with severe LVH (wall thickness >1.5 cm). c Should be used with caution in patients at risk for torsades de pointes ventricular tachycardia. d Should be combined with AV nodal blocking agents. AF, atrial fibrillation; CAD, coronary artery disease; HF, heart failure; and LVH, left ventricular hypertrophy. AHA/ACC/HRS (American Heart Association/ American College of Cardiology/Heart Rhythm Society) 2014 년가이드라인 17 ESC 가이드라인의주요업데이트후 2 년만에발표된 내용이어서전극도자절제술부문에서는유럽의 가이드라인과비교하여치료전략에큰차이가없다. 1. 주요권고사항 I 군또는 III 군의항부정맥제투여에도불구하고 증상이있는심방세동환자에서유형별로다음과같이 전극도자절제술을권고하고있다 : 발작성 ( 권고강도 I; 증거수준 A), 발작성의일차치료 ( 권고강도 IIa; 증거 수준 B), 지속성 ( 권고강도 IIa; 증거수준 A), 지속성의 일차치료 ( 권고강도 IIb; 증거수준 C), 장기지속성 ( 권고강도 IIb; 증거수준 B) 아직까지절제술이사망률, 뇌졸중, 심부전등을줄여줄수있는지는증거가부족한상황이다. 이는현재진행중인 CABANA (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation), EAST (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial) 연구등이증명해줄수있을것으로기대한다. 2. 환자의선정적절한환자의선정을위해서는심방세동의유형, 증상의정도, 구조적심장질환이있는지등을평가해야한다. 리듬유지요법에대한전략은 ESC 가이드라인과유사하다 (Figure 2). 30 The Official Journal of Korean Heart Rhythm Society

5 Table 1. Complications of radiofrequency catheter ablation for atrial fibrillation Complication Symptoms/Signs Treatment Air embolism Acute ischemia, cardiac arrest, AV block, hypotension Supplemental oxygen, fluids, CPR, or pacing if indicated MAIN TOPIC REVIEWS Atrial-esophageal fistula Usually 1 4 wk after ablation, dysphagia, unexplained fever, chills, sepsis, neurological events (septic emboli) CT or MRI of esophagus, avoiding endoscopy, immediate surgical correction Cardiac tamponade/perforation Abrupt or gradual fall in BP Pericardiocentesis, emergent surgical drainage if pericardiocentesis fails Phrenic nerve injury resulting in diaphragmatic paralysis Shortness of breath, Elevated hemidiaphragm None, usually resolves spontaneously Iatrogenic atrial flutter Tachycardia Cardioversion, antiarrhythmic drugs, or repeat ablation Gastric motility disorder Mitral valve injury requiring surgery Nausea, vomiting, bloating, abdominal pain Entrapment of catheter Depends on severity of symptoms Advance sheath with gentle catheter retraction, surgical removal Myocardial infarction Chest pain, ST changes, hypotension Standard therapy Pericarditis Chest pain, typical quality NSAIDs, colchicine, steroids Pulmonary vein stenosis Shortness of breath, cough, hemoptysis PV dilation/stent or no therapy Radiation injury Pain and reddening at radiation site, can present late Treat as burn injury Stroke or TIA Neurological deficit Consider lysis therapy Vascular access complication Femoral pseudo aneurysm Pain or pulsatile mass at groin Observation, compression, thrombin injection, possible surgery Arteriovenous fistula Pain, bruit at groin site Observation, compression, possible surgery Hematoma Pain, swelling Compression Death N/A N/A (modified from 2014 AHA/ACC/HRS guidelines 17 ) AV, atrioventricular; BP, blood pressure; CPR, cardiopulmonary resuscitation; CT, computed tomography; MRI, magnetic resonance imaging; N/A, not applicable; NSAIDs, non-steroidal anti-inflammatory drugs; PV, pulmonary valve; and TIA, transient ischemic attack. VOL.15 NO.4 31

6 MAIN TOPIC REVIEWS 3. 절제술전후의항응고요법 ESC 가이드라인과마찬가지로항응고요법중지후 heparin 사용의대안으로계속해서항응고요법을유지하는전략에대해언급을하고있다. 하지만주요권고사항에는포함되어있지않다. NOAC, 특히 dabigatran에대한언급이있으나역시권고사항에는들어가있지않다. 시술후장기간항응고요법에대한의견도 ESC 가이드라인과유사하다. 즉, 위험도가낮지않은군에대한항응고요법중지에대해서는신중한입장이다. 4. 심부전환자의절제술역시 ESC 가이드라인과유사한의견을피력하고있다. 환자를전체적으로잘파악해서진행한다면심한좌심실기능부전이있는환자에서도증상이있는심방세동을치료하는데절제술이유용할수있다는내용이다. 5. 합병증알려진합병증들에대한요약은 Table 1과같다. 조절되지않는심방세동으로약제투여전후심전도검사에서심방세동이증명된경우. 다만, 영구형 (permanent) 심방세동은인정하지아니함 (2) 항부정맥약제에대한부작용또는동결절기능부전을동반한빈맥-서맥증후군에서와같이약제유지가불가능한심방세동으로서심전도에의해확인된경우 (3) 재시술은이전시술후 3개월이경과된이후에실시하되심전도상심방세동또는심방빈맥의재발이증명된경우 (4) 심방세동고주파절제술시 CTI (cavotricuspid isthmus)-dependent 심방조동이유도된경우 2. 3차원매핑 3차원매핑도 2014년 6월부터요양급여가인정되고있다. 기준을요약하면 3차원빈맥지도화를이용한심방세동의고주파절제술은요양급여를인정하며, 3 차원빈맥지도화를위해실시한영상진단 (CT, MRI) 은별도요양급여를인정한다. 결론 합병증발생률과연관된인자들은고령, 여성, CHADS2 점수 2이다. 8,18,19 또한 ESC 업데이트가이드라인에도언급되었듯이좌심방의절제술은 MRI로발견할수있는무증상의작은뇌경색을유발시킬수있다. 하지만대부분은시간이경과하면서해결되거나사라지는것으로보인다. 국내보험규정 1. 전극도자절제술 심방세동전극도자절제술의국내건강보험요양급여는 2014년 6월부터다음과같은기준의적용을받고있다. (1) 항부정맥약제 (class Ⅰ 또는 class Ⅲ) 중 1가지이상을 6주이상충분한용량으로투여한이후에도증상이 최근가이드라인에서의주요이슈는 (1) 전극도자절제술의유용성이더욱입증되었으며, (2) 일부발작성심방세동환자에게는일차치료법으로절제술을선택하는것이가능하고, (3) 시술전후항응고요법을지속하는방법이대두되고있다는점등이다. 가이드라인으로채택되기위해증거가더확보되어야하는부문은 (1) 전극도자절제술이사망률과뇌졸중을줄일수있는치료법으로인정받을수있을것인가, (2) 새로운항응고제 (NOAC) 의시술전후사용지침, (3) 시술과관련된합병증을줄일수있는좀더안전한방법의개발등이될것이다. 국내에서도최근요양급여인정기준이개정되어심방세동환자들뿐만아니라임상의들의진료에도큰도움이되고있다. 빠르게발전하는치료법과가이드라인에발맞춰국내보험인정기준도계속해서국제적인수준으로업데이트될수있기를바란다. 32 The Official Journal of Korean Heart Rhythm Society

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