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CHIVA治療靜脈曲張30年,科學(xué)和倫理的典范

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80年代,人類在靜脈曲張治療的歷史上首次出現(xiàn)了保留靜脈、基于血流動力學(xué)糾正的CHIVA治療技術(shù)。CHIVA是法語Cure Conservatrice et Hemodynamique de l′Insufficience Veineuse en Ambulatoire的簡稱,該治療理念由法國醫(yī)生Franceschi創(chuàng)立。

CHIVA手術(shù)一反過去的破壞性、廢棄性手術(shù)原理,通過超聲對靜脈血流動力進(jìn)行詳盡的分析,從源頭上對異常的血流動力學(xué)進(jìn)行糾正,是所有微創(chuàng)手術(shù)中對人體創(chuàng)傷最小,痛苦也最小。張強(qiáng)醫(yī)生團(tuán)隊于2011年首次把CHIVA引入中國。2017年初,張強(qiáng)醫(yī)生集團(tuán)(Dr.Smile Medical Group)正式宣布旗下十多個城市的靜脈病中心用CHIVA全面替代其他破壞性方法。

2019年,CHIVA創(chuàng)始人Franceschi教授在《靜脈和淋巴》發(fā)表特別文章,回顧C(jī)HIVA過去30年的曲折道路。

全文如下:

在70年代、80年代,我們有越來越多的冠心病患者需要自身的大隱靜脈用于冠狀動脈搭橋。但不幸的是,之前的很多大隱靜脈不幸被我們過去的手術(shù)或其它靜脈腔內(nèi)治療破壞掉了。

我對我們的“精神分裂行為”感到吃驚:一方面破壞良性的靜脈,另一方面,當(dāng)我們需要它為危重患者進(jìn)行靜脈旁路時,卻又為靜脈缺失而遺憾。

所以,作為一名前精神科醫(yī)生,我決定直面并“治療”我自己的“精神錯亂”。除了采用足部抬高、包扎和彈力襪等保守治療外,我還試圖找到一種手術(shù)治療,可以保留靜脈。

我觀察到當(dāng)病人的腳抬高或與平臥時,曲張的靜脈會消失。結(jié)合Trendelenburg 和Perthes試驗(yàn)的效果,讓我想到:靜脈功能不全的根本原因和其作為靜脈曲張的癥狀,背后的原因只是靜脈的血流動力學(xué)發(fā)生障礙、壓力增高。

基于這些觀察,加上Bjordal教授等對靜脈壓力的研究成果,以及超聲設(shè)備和技術(shù)的革命性進(jìn)步,我們可以更好地了解靜脈系統(tǒng)及其異常的血流動力學(xué)改變。

醫(yī)學(xué)界由此產(chǎn)生了靜脈系統(tǒng)的病理生理血流動力學(xué)理論,如靜水壓的動態(tài)分割、各種靜脈分流(SHUNT)模式、回流(Re-entry)概念、跨壁壓控制作為所有合理治療的目標(biāo)、定位盆腔滲漏點(diǎn)(pelvic leak)、描繪血流動力學(xué)地圖,最后是保護(hù)患者的靜脈網(wǎng)絡(luò),用于正確引流并預(yù)防復(fù)發(fā)。

這些概念是 CHIVA 治療的基礎(chǔ),發(fā)表于 1988 年。

由于傳統(tǒng)壁壘的存在,CHIVA 曾經(jīng)被視為具有挑釁性的胡說八道。因?yàn)榈侥壳盀橹?,靜脈破壞性手術(shù)仍然占主導(dǎo)市場。近一個世紀(jì)以來,關(guān)于人類靜脈曲張的研究和設(shè)備研發(fā),都集中在破壞和殺死靜脈上,并且錯誤地把治療失敗和復(fù)發(fā)都?xì)w因于遺留的靜脈。

事實(shí)上,CHIVA 是基于一種截然不同的病理生理學(xué)觀念。它的科學(xué)性得到了廣泛的實(shí)驗(yàn)結(jié)果驗(yàn)證。感謝歐洲多家中心完成的數(shù)百項研究、包括一些 RCT 和 Cochrane 綜述,都表明CHIVA 比破壞性治療方法更成功,并且可以同時達(dá)到有效治療靜脈功能不全和保留靜脈資源的兩個目標(biāo)。

學(xué)習(xí)CHIVA 也是一項科學(xué)和智力的挑戰(zhàn),需要顛覆傳統(tǒng)的主流觀念知識和個人思維慣性。無論是靜脈血流動力學(xué)理論或是相關(guān)的多普勒超聲評估技術(shù),學(xué)習(xí)曲線都很漫長。即使棋盤完全相同(10對8 個方格),我們也不能用國際象棋的規(guī)則來下國際跳棋。CHIVA 也是如此。破壞性手術(shù)方法的規(guī)則不能用于保留血管的CHIVA。

各種保守或消融剝脫的方法,無論是侵入性或非侵入性的器械設(shè)備在市場營銷上非常強(qiáng)勢,但在醫(yī)學(xué)上對患者并不公平。保守治療方法也并非一定安全,只有在性價比超過手術(shù)時才是正確的選擇。而CHIVA在門診就可以方便地進(jìn)行安全的微創(chuàng)治療。

醫(yī)生應(yīng)基于醫(yī)學(xué)證據(jù)來披露患者的風(fēng)險和獲益信息。做到這個其實(shí)非常容易,正如希波克拉底誓言所言:“我盡余之能力和判斷力所及,遵守為病家謀利益之信條,并檢柬一切墮落和害人行為?!?此外,患者知情同意書有義務(wù)告知所提議方案與其它替代方案的性質(zhì)和目的、風(fēng)險和獲益。

不幸的是,現(xiàn)實(shí)有點(diǎn)骨感。我們要意識到無知、嘲諷、競爭、貪婪和利益沖突仍然在醫(yī)療界存在。

創(chuàng)造條件讓靜脈病醫(yī)生更好地為病人提供信息和治療,可以喚醒我們心中的《希波克拉底誓言》。提醒他們靜脈曲張通常是良性的,可以根據(jù)他/她的美觀或舒適期望,來選擇治療或不治療。如果存在皮膚變化和潰瘍,可以使用簡單有效的降低透壁壓力的方法來解決。此外,CHIVA 概念和策略同樣可以適用于深靜脈疾病,尤其是血栓形成后的疾病,也適用于部分靜脈畸形。

Main Text

In the seventies and eighties, we had more and more patients who needed a saphenous vein by-pass due to the fact that the previous one was unfortunately destroyed by a surgical or endo-venous treatment. I was struck by our schizophrenic behavior which consisted of, on the one hand, the saphenous vein destruction for the benign varicose disease and on the other hand, lamenting for its absence when we needed it to perform a venous by-pass for a critical or life-threatening arterial or coronary obstruction. So, as a former psychiatrist, I decide to confront and treat my insanity. In addition to conservative treatments as foot elevation, bandaging and compressive stocking, I tried to find a surgical treatment which could also preserve the saphenous capital. My observations of the varicose veins disappearance when I lifted the feet of my patients combined together with the Trendelenburg and Perthes maneuvers effects, convinced me that the cause of the venous insufficiency and its symptoms as the varicosity was just a hemodynamic impairment of the venous flows and pressure control.1-10 Then, on these grounds and thanks to the studies of the venous pressure mainly published by Bjordal and the revolutionary capability of recent EchoDoppler Ultrasound devices, I could figure out a better hemodynamics of the venous system and its anomalies. From all this, new proposals of venous pathophysiological hemodynamic principles resulted, as the Dynamic Fractioning of Hydrostatic pressure, various Venous Shunt patterns, Re-entry concept, Trans-mural Pressure control as the target of any rational treatment, location of not yet individualized pelvic leak points, hemodynamic venous cartography, and finally the necessary conservation of the venous network for a correct drainage of the tissues and prevention of recurrence. These concepts were the basis of the CHIVA treatment (French acronym for cure Conservatrice Hémodynamique de l’Insuffisance Veineuse en Ambulatoire) published in 1988. As Conservation is a pillar, CHIVA was received as provocative nonsense because, so far, the destructive paradigm was dominant. Indeed, for almost a century, research, studies and devices where focused on killing the veins because the treatment failures and recurrences where attributed to the veins left behind. Indeed, CHIVA is based on a dramatically different pathophysiological rational. Its concepts were verified by further experimental evidence. Thanks to hundreds of studies, some RCTs and a Cochrane review, achieved by various authors over Europe, CHIVA is today validated as more successful than destructive method and reaches at the same time, both targets of treating efficiently the venous insufficiency and preserving the venous capital for future by-pass.11-13CHIVA is also a scientific and intellectual challenge, which demands a reconsideration of the mainstream knowledge and personal habits, a steep learning curve of the appropriate venous hemodynamics and its related Duplex Scan assessment. We cannot play a game of chess with the rules for checkers even if the board is quite identical (10 vs 8 squares). The same is for CHIVA. The rules of destructive methods cannot fit the conservative CHIVA. Conservative or ablative methods, as well as invasive and non-invasive or laser and other advanced devices, are powerful marketing topics but not always medically fair. The Conservative procedures are relevant only when they are better than the ablative ones in terms of risks/benefits ratio. Non-invasive procedures are not necessarily safe. CHIVA is feasible in outpatients with mini-invasive surgery.8-10The patient information should point out the risks/benefits based on the medical evidence. That is like kicking down an open door if we refer to the Hippocratic Oath: ‘I follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous.’ Furthermore, the patient Informed Consent obliges to inform the patient about the nature and purpose, risks and benefits of the proposed treatment as well as the alternatives.Unfortunately, reality is not so good. Ignorance, cynicism, competition, greed and conflicts of interest shall still be taken into account.I would like to revive the fair Hippocratic Oath by permitting the phlebologist to better inform and treat the patient. Remind him that varicose veins are usually benign and may be treated or not according to his/her cosmetic or comfort expectation. In case of skin changes and ulcers, easy efficient procedures on transmural pressure decrease are available. In addition, the CHIVA concepts and strategy are applicable to the deep venous diseases, particularly post-thrombotic, and also to the venous malformations.

1. Varicose vein stripping vs haemodynamic correction (CHIVA): a long term randomised trialS CarandinaEur J Vasc Endovasc Surg, 35: 230-7, 2008

2. Varicose vein surgery: stripping versus the CHIVA Method: a randomized controlled trialJO ParésAnn Surg, 251: 624-31, 2010

3. Comparative study oftwo surgical techniques in the treatment of varicose veins of the lower extremities: results after five years of follow upE Iborra-OrtegaAngiología, 58: 459-68, 2006

4. Retrospective comparison of clinical outcomes between endovenous laser and saphenous vein-sparing surgery for treatment of varicose veinsC-Y ChanWorld J Surg, 35: 1679-86, 2011

5. Hemodynamic classification and CHIVAtreatment of varicose veins in lower extremities (VVLE)H WangInt J Clin Exp Med, 9: 2465-71, 2016

6. Morbidity and mortality after thermal venous ablationsRD MalgorInt Angiol, 35: 57-61, 2016

7. Minimally invasive surgical management of primary venous ulcers vs. compression treatment: a randomized clinical trial AP ZamboniEJ V E S: 2003

8. Principles of venous haemodinamicsC Franceschi, P. ZamboniNY: Nova Science, New York, 2008

9. The evaluation of essential elements defining varicose vein mappingC Franceschi, S. ErminiVeins and Lymphatics, 3: 2014

10. Oscillatory flow suppression improves inflammation in chronic venous diseaseP Zamboni, P Spath, V TisatoJ Surg Res, 205: 238-45, 2016

11. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemiaM RomitiJ Vasc Surg, 47: 975-81, 2008

12. No touch technique of saphenous vein harvesting: Is great graft patency rate provided?NA PapakonstantinouJ Thorac Cardiovasc Surg, 150: 880-8, 2015

13. Outcomes of cold-stored venous allograft for below-knee bypasses in patients with critical limb ischemiaV ZizaJ Vasc Surg, 62: 974-83, 2015

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