手術(shù)消融手術(shù)技術(shù)和臨床試驗(yàn)結(jié)果及東西方比較(中英文）

手術(shù)消融 : 手術(shù)技術(shù) 和臨床試驗(yàn)結(jié)果及東西方比較 : Dr James Wong Chief Surgeon, Heart, Lung & Vascular Centre Mt Elizabeth Hospital Singapore 房顫是一常見(jiàn)的疾病 美國(guó)有 280萬(wàn)房顫患者 - 人群發(fā)病率 0.9% （總?cè)丝?3億） 每年有 160,000新發(fā)病例 老年人和風(fēng)濕性心臟病患者為房顫高發(fā)人群 每年 700000例中風(fēng) 其中 140000(20%)例 中風(fēng)由房顫所致 房顫在亞洲的現(xiàn)狀 日本 新加坡 越南 泰國(guó) 印度尼西亞 馬來(lái)西亞 中國(guó) 總?cè)藬?shù) 128 4.7 87 63 230 27 1400 (百萬(wàn) ) 房顫患者數(shù) 1.15 0.04 0.78 0.56 2 0.24 12.6 (總?cè)丝跀?shù) 0.9%) 中風(fēng)數(shù) 82 2 39 28 100 12 630 (千） 風(fēng)心病高發(fā) + + + + + 房顫的結(jié)局 非致命性疾病 中風(fēng) : 致殘并發(fā)癥 死亡率 : 正常人群的兩倍 醫(yī)療費(fèi)用高，需要治愈 目前沒(méi)有普遍認(rèn)可的治療方案 沖洗雙極消融工具 祝?；蛟{咒 ? 病變間的傳導(dǎo)Thomas, Cardiac EP 1999 房顫的消融術(shù) VS 切與縫 : 動(dòng)物狗實(shí)驗(yàn)中，雙極射頻消融產(chǎn)生線(xiàn)性、透壁消融線(xiàn)。 (Prasad et al, 2003) 雙極射頻消融可替代 Cox 迷宮 III術(shù) (Damiano et al 2004) 多中心臨床試驗(yàn)中，雙極射頻消融可替代 Cox 迷宮 III 術(shù) ( Barns, Cleveland Clinic, Dallas) 冠脈搭橋 /體外循環(huán)患者，雙極射頻消融可替代 Cox 迷宮 III 術(shù) (Khargi et al 2004) “切與縫”技術(shù)優(yōu)于消融術(shù)嗎？ 存在爭(zhēng)議 AATS 2006 Mayo Clinic: 切與縫 沖洗式雙極 干式雙極 St. Louis: 無(wú)差異 “切與縫”與手術(shù)消融術(shù)孰優(yōu)熟劣仍是一個(gè)值得商榷的問(wèn)題。 Melo等人 2008年在胸心血管外科雜志（ JTCS）上發(fā)表了全球房顫手術(shù)臨床研究的結(jié)果。 1733名納入本研究 的房顫患者，僅 44名接受“切與縫”手術(shù)。其他患者接受某一類(lèi)型的能量消融術(shù)治療。 在亞洲 , 射頻消融器械占房顫手術(shù)消融器械市場(chǎng)的 95 .某些國(guó)家其比例可達(dá) 100 %! 射頻消融器械的金標(biāo)準(zhǔn)是可以產(chǎn)生 Cox 迷宮 III手術(shù)透壁消融線(xiàn)（除外二尖瓣和三尖瓣峽部線(xiàn)性消融）的雙極。 由于其可能會(huì)損傷冠脈回旋支動(dòng)脈、冠狀靜脈竇和右冠狀動(dòng)脈，峽部線(xiàn)性消融時(shí)應(yīng)使用單極進(jìn)行筆式射頻消融或冷凍消融。 Copyright 2008 The American Association for Thoracic Surgery Castella M. et al.; J Thorac Cardiovasc Surg 2008;136:419-423 兩例左冠脈優(yōu)勢(shì)型病例 Copyright 2008 The American Association for Thoracic Surgery Castella M. et al.; J Thorac Cardiovasc Surg 2008;136:419-423 射頻雙極鉗在左心耳切口至二尖瓣瓣環(huán)間形成消融線(xiàn) Castella M. et al.; J Thorac Cardiovasc Surg 2008;136:419-423 補(bǔ)體 C9免疫組化染色顯示，消融后 8小時(shí)左房后壁 透壁性壞死 (放大倍數(shù)： 20倍 ) Copyright 2008 The American Association for Thoracic Surgery Castella M. et al.; J Thorac Cardiovasc Surg 2008;136:419-423 雙極射頻鉗頂端位于三尖瓣瓣環(huán)附近 發(fā)展中國(guó)家醫(yī)療費(fèi)用問(wèn)題 0 5 10 15 20 25 30 35 40 中國(guó) 日本 新加坡 馬來(lái)西亞 印度尼西亞 越南 泰國(guó) US Dollars 34312 35163 6948 1925 818 3737 2461 人均國(guó)民生產(chǎn)總值 在中國(guó)，使用可形成 Cox 迷宮 III手術(shù)消融線(xiàn)單極設(shè)備的費(fèi)用與普通居民一年的收入相當(dāng) . 由于醫(yī)療費(fèi)用問(wèn)題很重要，發(fā)展中國(guó)家患者僅能支付一種設(shè)備的費(fèi)用。 使用單極進(jìn)行筆式射頻消融時(shí)，如何保證其透壁性？ 表面加熱的熱動(dòng)力學(xué)沖洗式單極射頻消融 確保透壁性的技術(shù) 心內(nèi)膜和心外膜聯(lián)合消融 確保透壁性 在同一消融線(xiàn)上，對(duì)心內(nèi)膜和心外膜消融。 f g 左心房 Click on picture to start movie Transmurality 從左肺靜脈至二尖瓣瓣環(huán)消融線(xiàn)的透壁性 左心房 Click on picture to start movie c d 序貫心內(nèi)膜和心外膜沖洗式單極消融以確保消融線(xiàn)的透壁性 我們希望得到什么結(jié)果 研究時(shí)限 : 2002年 10月 2003年 12月 44 例患者 : 30 例二尖瓣反流 /修復(fù)術(shù) , 10 例二尖瓣反流主動(dòng)脈瓣反流 , 2 例冠脈搭橋 , 2例房間隔缺損 死亡率 : (2 例患者 ) 1例二尖瓣反流 , 1例 二尖瓣反流 + 主動(dòng)脈瓣反流 平均年齡 : 45 歲 ( 范圍： 22 60 歲 ) 平均左房直徑 : 51mm ( 范圍： 45 62 mm ) 房顫類(lèi)型 : 所有患者均為慢性房顫（大于 1 年） 隨診時(shí)間 : 4 5 年 結(jié)果 : 34/42 恢復(fù)竇律 ( 81%). 心房收縮 ( M-超聲 ): LA 70%, RA 90% 無(wú)中風(fēng)發(fā)生，無(wú)晚期死亡病例 失敗患者 : 6 例，其中有 4名患者為累及左心房峽部的房撲 謝謝 ! Surgical Ablation: Techniques and Trial Results, Comparison of East and West: Dr James Wong Chief Surgeon, Heart, Lung & Vascular Centre Mt Elizabeth Hospital Singapore AF Is Common 2.8 Million AF in USA - 0.9% population 300 million 160,000 new cases annually Prevalence increased in elderly and RHD 700000 strokes annually 140000(20%) strokes from AF Scope Of The Problem in Asia Japan Singapore Vietnam Thailand Indonesia Malaysia China Population 128 4.7 87 63 230 27 1400 (million) No of patient with AF 1.15 0.04 0.78 0.56 2 0.24 12.6 (0.9% of popln) (millions) Potential Stroke 82 2 39 28 100 12 630 (thousands) Rheumatic + + + + + prevalence Consequences of AF Not life-threatening disease Stroke: devastating complications Mortality: 2x expected for general population Costly condition, strong need for cure No widely accepted treatment available I r r i g a t e d B i p o l a rABLATION TOOLS BLESSING OR CURSE? Thomas, Cardiac EP 1999 AF ABLATION VS CUT & SEW: Bioplar RF creates linear, transmural lesions in dogs (Prasad et al, 2003) Bipolar RF can replace surgical incisions in Cox Maze III (Damiano et al 2004) Bipolar RF can replace surgical incisions in Cox Maze III in multicentre trials ( Barns, Cleveland Clinic, Dallas) Bipolar RF can replace surgical incisions of Cox Maze III in CABG/CPB patients (Khargi et al 2004) Is the Cut and Sew better than the ablation device ? Controversy AATS 2006 Mayo Clinic: C&S BP irrigated BP Dry St. Louis: No difference Cut & Sew vs Surgical Ablation may be a moote point. In the International Registry of Atrial Fibrillation Surgery in which the results were published in the JTCS 2008 by Melo et al, out of 1733 patients in the study, only 44 patients have the cut & sew. All the others have one form of energy ablation or another. In Asia , RF devices occupy 95% of the market share for AF surgical ablation . In some countries it is 100%! TheGoldS For the RF devices the gold standard is the Bipolar device which can create transmural all the lines of block of the Cox Maze III except for the the mitral and tricupid isthmus line. Because of the potential damage to the circumflex artery , coronary sinus and the right coronary artery the monopolar RFpen or cryo is used for the isthmus lines. Copyright 2008 The American Association for Thoracic Surgery Castella M. et al.; J Thorac Cardiovasc Surg 2008;136:419-423 Two examples of left dominant coronary circulation Copyright 2008 The American Association for Thoracic Surgery Castella M. et al.; J Thorac Cardiovasc Surg 2008;136:419-423 Radiofrequency bipolar clamp positioned to carry out the ablation line from the left auriculotomy to the mitral annulus Castella M. et al.; J Thorac Cardiovasc Surg 2008;136:419-423 Complement C9 immunostaining of the posterior wall of the left atrium showing transmural necrosis approximately 8 hours after ablation was performed (original magnification x20) Copyright 2008 The American Association for Thoracic Surgery Castella M. et al.; J Thorac Cardiovasc Surg 2008;136:419-423 The radiofrequency clamp is positioned to reach the tricuspid annulus COST ISSUES IN DEVELOPING COUNTRIES 0 5 10 15 20 25 30 35 40 Greater Japan Singapore Malaysia Indonesia Vietnam Thailand China US Dollars 34312 35163 6948 1925 818 3737 2461 GPD ( nominal) per capital In China the monopolar device which can create all the lines of the Cox Maze III can cost up to almost a year of personal income. Because of cost consideration can be important, only one device is affordable in developing countries The issue then if the monopolar RF pen is to be used, how can one ensure transmurality with it T h e r m o d y n a m n i c s o f S u r f a c e H e a t i n gUnipolar Irrigated RF Technique To Ensure Transmurality Endocardial & Epicardial Combined Lesions Ensuring Transmurality Apply ablation to both surfaces along the same line. f g LEFT ATRIUM Click on picture to start movie Transmurality Transmurality of lin