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介入心脏病学,真实世界与科学并不一定契合的领域。

Interventional cardiology, where real life and science do not necessarily meet.

机构信息

Cardiovascular Department, University Hospital of Bern, Bern CH-3010, Switzerland

出版信息

Eur Heart J. 2016 Jul 7;37(26):2014-9. doi: 10.1093/eurheartj/ehw220. Epub 2016 Jul 4.

Abstract

Evidence-based diagnosis, decision-making, and therapy appear a must these days. Generating and publishing evidence is a tedious job according to ever new and tightened research practice regulations. Rules will never prevent the typical human behaviour from showing the new thing to be shinier and the old thing dustier than they really are. The medical community is solicited to concoct a meal that is gullible for patients, authorities, and third-party payers out of the available evidence (after applying some conversion factors correcting the common bias of the researchers), anticipation of what will be the evidence tomorrow, common sense, and digested experience. Examples of misguidance by poorly produced or misinterpreted evidence are plentiful in interventional cardiology as they are in other disciplines. Coronary stents, for instance, were first underestimated due to the fact that they were generally used in bailout situations where the outcome remained rather dismal in spite of the salvaging potential of stents. Then they were overused quite uncritically rather to the detriment of the patient. Now with the high quality of the modern drug-eluting stents (DESs), the overuse persists but is no longer a concern. However, the enhanced potential of DESs compared with bare-metal stents was poorly exploited for >10 years because of reports that slipped through the meshes of good review and publication practice to convey the untenable message that bare-metal stents were preferable in many situations. As other examples, use of the fractional flow reserve (FFR) for decision-making has to be questioned despite prominently published reports recommending it. Fixing a lesion is today easier and hardly more complication prone than assessing it with the FFR. Closure of the patent foramen ovale may never be properly applied, because the collection of the understandably requested evidence takes decades, a follow-up duration that makes research unattractive to physicians and financiers. Transarterial aortic valve replacement, finally, is certain to eventually supplant surgical aortic valve replacement. However, this should have already been accomplished as a logical progress. The adoption of this remarkable breakthrough technology is slowed down by the quest for providing randomized evidence in patients, for whom the evidence should rather be derived from already existing studies, and by the quest to triage all these patients in a heart team, meaning to also keep the surgeons happy, although these patients do not really need them.

摘要

循证诊断、决策和治疗似乎是当今的必备要求。根据不断更新和收紧的研究实践规定,生成和发表证据是一项繁琐的工作。规则永远无法阻止人们的典型行为,即把新事物看得比实际更闪亮,把旧事物看得比实际更灰暗。医学界被要求从现有的证据中(在应用一些修正研究人员常见偏差的转换因素后),炮制出一份对患者、当局和第三方付款人来说容易上当的“套餐”,其中包括对明天的证据的预期、常识和消化的经验。在介入心脏病学中,就像在其他学科一样,有很多因制作不佳或解释不当的证据而产生误导的例子。例如,冠状动脉支架最初被低估,因为它们通常用于救生情况下,尽管支架有挽救生命的潜力,但结果仍然相当糟糕。然后,它们被不加批判地过度使用,而不是为了病人的利益。现在,由于现代药物洗脱支架(DES)的高质量,这种过度使用仍然存在,但已不再令人担忧。然而,DES 与裸金属支架相比具有更强的潜力,但由于有报告称,裸金属支架在许多情况下更优,这些报告通过良好的审查和出版实践的漏洞传播,导致这一消息无法站得住脚,因此这种潜力在超过 10 年的时间里都没有得到充分利用。再如,尽管有大量发表的报告推荐使用,但对使用血流储备分数(FFR)进行决策的质疑仍在继续。与使用 FFR 评估病变相比,修复病变更容易,且并发症发生率更低。卵圆孔未闭封堵术可能永远无法得到恰当应用,因为理解性地要求提供证据需要数十年的时间,这种随访时间让医生和财务人员对研究失去兴趣。最后,经导管主动脉瓣置换术(TAVR)肯定会最终取代主动脉瓣置换术(SAVR)。然而,作为一种合乎逻辑的进步,这种技术的采用速度却有所减缓,原因是需要在患者中提供随机证据,而证据更应该从现有的研究中得出,还需要通过心脏团队对所有这些患者进行分诊,这意味着也要让外科医生高兴,尽管这些患者并不真正需要他们。

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