最近在線發(fā)表在《美國(guó)醫(yī)學(xué)會(huì)雜志》上[JAMA.2012;308(6):573-574]的一篇研究報(bào)告顯示，加拿大不列顛哥倫比亞省溫哥華市圣保羅醫(yī)院的高級(jí)研究員JohnG Webb醫(yī)師進(jìn)行的單中心極早用經(jīng)導(dǎo)管主動(dòng)脈瓣置入（TAVI）裝置的5年結(jié)果顯示，效果持久，并且可能和很多外科瓣膜一樣持久。

　　Webb解釋說(shuō)這一系列研究代表了第一代經(jīng)導(dǎo)管瓣膜中的第一種人工置入物。這些裝置于2005年1月至2007年3月間被置入重度有癥狀的主動(dòng)脈瓣狹窄患者中。1～5年的生存率分別為83%、74%、53%、42%和35%。Webb也指出，這些數(shù)據(jù)需要放在一定的背景中進(jìn)行驗(yàn)證。

　　Webb指出，在這項(xiàng)早期可行性研究中，TAVI操作僅向病情極重度患者（由于年齡較大和存在其他嚴(yán)重共病，預(yù)期5年生存差）提供。死亡率高不是因?yàn)榘昴夯?，而是由于進(jìn)入這些極早期實(shí)驗(yàn)評(píng)價(jià)的患者類型。

　　首批TAVI長(zhǎng)期轉(zhuǎn)歸報(bào)告之一

　　Toggweiler和同事解釋說(shuō)，盡管TAVI（TAVR）日益受到歡迎，被稱為2012年心臟病學(xué)‘最熱’話題之一，但是既往報(bào)告關(guān)注的是短期和中期轉(zhuǎn)歸，對(duì)于較長(zhǎng)期轉(zhuǎn)歸知之甚少。

　　該研究共有111例患者（平均年齡83歲）在圣保羅醫(yī)院接受用球囊擴(kuò)張Cribier-Edwards或Sapien瓣膜（Edwards生命科學(xué)公司）的TAVI治療，所有患者均接受阿司匹林（終身）和氯吡格雷（3個(gè)月）治療。如果有口服抗凝指征，則在患者可耐受的情況下予以華法林和雙聯(lián)抗血小板治療（3個(gè)月）。

　　研究者們指出，上述初始111例患者在確實(shí)無(wú)法手術(shù)患者中的首次經(jīng)動(dòng)脈和經(jīng)心尖TAVI經(jīng)驗(yàn)，該操作的很多步驟當(dāng)時(shí)并未標(biāo)準(zhǔn)化，因此圍操作期間死亡率相對(duì)高。由于該論文的焦點(diǎn)在于評(píng)價(jià)5年轉(zhuǎn)歸，因此瓣膜置入不成功的患者或在30天內(nèi)死亡的患者被排除出分析，最終剩下88例患者接受評(píng)價(jià)。

　　5年時(shí)，觀察到3例患者出現(xiàn)中度經(jīng)導(dǎo)管人工瓣膜功能衰竭，但沒(méi)有患者發(fā)生重度經(jīng)瓣膜反流或再狹窄。大多數(shù)患者伴隨的二尖瓣反流改善，并且在隨訪5年后仍保持改善。整個(gè)觀察期間，超過(guò)90%的患者為NYNA1級(jí)或2級(jí)。

　　5年累計(jì)嚴(yán)重缺血性卒中發(fā)生率為9.7%，慢性阻塞性肺疾?。ㄐＵL(fēng)險(xiǎn)比[HR]為2.17）和至少中度瓣周反流（校正HR為2.98）的患者死亡風(fēng)險(xiǎn)顯著升高。

　　研究者們指出，該研究顯示成功TAVI后5年轉(zhuǎn)歸良好，并且血液動(dòng)力學(xué)極佳，中度人工瓣膜功能衰竭的征象僅見于3.4%的患者。

　　Webb評(píng)價(jià)道，以前，我們不知道這些瓣膜是否會(huì)持續(xù)5年，現(xiàn)在知道了。現(xiàn)在可以說(shuō)，預(yù)期生存長(zhǎng)于5~10年的患者有可能從持久瓣膜中獲益。這代表了我們當(dāng)前進(jìn)行該操作的目標(biāo)人群可以確定了。

　　'Favorable' five-year outcomes with early TAVI devices

　　 Vancouver, BC - New data showing five-year outcomes at a single center with the very earliest transcatheter aortic valve implant (TAVI) devices indicate that they are durable and "may last as long as many surgical valves," says senior author Dr John G Webb (St Paul's Hospital, Vancouver, BC).

　　"This series represents the very first in man implants of first generation transcatheter valves," explains Webb. The devices were implanted in patients with severe symptomatic aortic stenosis from January 2005 to March 2007. Survival rates at one to five years were 83%, 74%, 53%, 42%, and 35%, respectively. Webb says that these figures need to be put into context, however.

　　During this early feasibility study, the procedure was only offered to extremely ill patients who were anticipated to have a poor five-year survival due to advanced age and other severe comorbidities. The high late mortality was not due to valve deterioration, but due to the types of patients entered into these very early experimental evaluations," he told heartwire.

　　The results are published in the Journal of the American College of Cardiology by Dr Stefan Toggweiler (St Paul's Hospital, Vancouver, BC) and colleagues .

　　One of the first reports of long-term outcomes with TAVI

　　Toggweiler and colleagues explain that despite the growing popularity of TAVI (TAVR)—which was named one of the 'hottest' topics in cardiology for 2012—previous reports have focused on short- and mid-term outcomes, and little is known about longer-term outcomes.

　　In total, 111 patients (mean age 83 years) underwent TAVI at St Paul's Hospital with the balloon-expandable Cribier-Edwards or Sapien valve (Edwards Lifesciences, Irvine, CA), and all were treated with aspirin (lifelong) and clopidogrel (for three months). If oral anticoagulation was indicated, patients were treated with warfarin and dual antiplatelet therapy (for three months), if tolerated.

　　The high late mortality was not due to valve deterioration, but due to the types of patients entered into these very early experimental evaluations.

　　These initial 111 patients represent the first in-human experience with transarterial and transapical TAVI in truly inoperable patients, and many steps of the procedure were not standardized at the time, so peri-procedural mortality was relatively high, the researchers note. Because the focus of the paper was to evaluate five-year outcomes, those with unsuccessful valve implantation or who died within 30 days were excluded from the analysis, leaving 88 patients who were assessed, they explain.

　　Mean aortic valve gradient decreased from 46 to 10 mmHg after TAVI, and to 11.8 mmHg after five years (p=0.06 for post-TAVI trend). Mean aortic valve area increased from 0.62 to 1.67 cm2 after TAVI, and to 1.40 cm2 at five years (p<0.01 for post-TAVI trend).

　　Moderate prosthetic transcatheter valve failure was observed in three patients at five years, but no patient developed severe transvalvular regurgitation or restenosis. Concomitant mitral regurgitation improved in the majority of patients and remained improved at the five-year follow-up. More than 90% of patients were in NYHA class 1 or 2 during the whole observation period, the authors say.

　　We did not know if these valves would last five years. We now do.

　　Cumulative major ischemic stroke rate at five years was 9.7%, and risk of death was significantly increased in patients with chronic obstructive pulmonary disease (adjusted hazard ratio [HR] 2.17) and at least moderate paravalvular regurgitation (adjusted HR 2.98).

　　"Our study demonstrated favorable outcomes five years after successful TAVI with excellent hemodynamics and signs of moderate prosthetic valve failure observed in only 3.4% of patients," the researchers state.

　　 Webb commented to heartwire. "We can now say that patients expected to live longer than five to 10 years have the possibility of long-term benefit from a durable valve. This would represent our current target group for this procedure."