JACC发表最新的心脏复律治疗应用指南

《美国心脏病学会杂志》2月28日发表了美国心脏病学会和心律学会及其他专业组织联合编写的有关如何在369种临床情况下适当应用置入型心律转复除颤器(ICD)和心脏再同步化治疗(CRT)的新标准。该标准主要阐述此类治疗在一级和二级预防中的应用及在特定并发症情况下的应用(J. Am. Coll. Cardiol. 2013;61 [doi:10.1016/j.jacc.2012.12.017])。

该标准是由编写委员会在回顾61项临床试验的基础上制订的。这些试验涉及各种不同纳入和排除标准，并且入组患者非常广泛。文件中所涵盖的临床情况分为6类：ICD用于二级预防、ICD用于一级预防、合并症、CRT器械、起搏器置换、双腔与单腔ICD。

采用分值范围为1~9分的量表对此类器械治疗用于369个适应证的适当性进行评分。45%的适应证的评定结果为“适当”，33%为“可能适当”，22%为“不太适当”。编写委员会专家表示，对于“可能适当”的适应证，在进行治疗决策时需结合临床判断。评定结果为“适当”并不意味就一定要进行此类治疗。评定结果为“不太适当”是因为有数据显示此类器械治疗有害、或缺乏相关数据、或医学判断不宜进行器械治疗。

编写该文件的主要目的是指导良好的医学治疗，而不是指导医保。一些评定为“适当”的适应证目前可能不在医保范围内。未来，专业学会需继续与医疗保险和医疗补助服务中心共同合作，解决此类问题，将此类器械治疗纳入常规医保范围。

编写委员会的专家指出，尽管该文件对上述这些方面进行了重点详细阐述，但应将其视为指导性标准使用，而不是作为“教科书”使用。虽然文件对适当性进行了分级，但在进行治疗决策时，应有临床资料作为依据，应考虑到患者的具体情况，并且也要考虑到患者偏好，因为治疗终究是以患者为中心。

两位编写专家为心脏病学新闻编辑顾问委员会成员。一位专家为百多力等公司的顾问。

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By: MICHELE G. SULLIVAN, Cardiology News Digital Network

New appropriate-use criteria outline how implantable cardioverter defibrillators and cardiac resynchronization therapy may be employed in any of 369 clinical scenarios.

Written by a joint committee of the American College of Cardiology and the Heart Rhythm Society, along with other specialty groups, the document focuses on the treatments’ uses in primary and secondary prevention and on how to gauge their use in the face of specific comorbidities It was published in the Feb. 28 issue of the Journal of the American Association of Cardiology (J. Am. Coll. Cardiol. 2013;61 [doi:10.1016/j.jacc.2012.12.017]).

Two years in the making, the criteria are based on a review of 61 clinical trials with widely differing inclusion and exclusion criteria encompassing an extremely broad group of patients. The writing group was cochaired by Dr. Andrea M. Russo, professor of medicine at UMDNJ/Robert Wood Johnson Medical School, and Dr. Raymond F. Stainback of Baylor College of Medicine, Houston. Although they cover a plentitude of situations, the paper represents a much-simplified universe, said Dr. Paul Hauptman, a member of the technical committee involved in the document’s construction.

In fact, an early draft of the criteria contained recommendations for many more clinical situations, Dr. Hauptman said in an interview. "It could have been double or even triple this number. The complete paper tries to bring some semblance of order to the decision-making process."

The clinical scenarios covered in the document fall into one of six areas: implantable cardioverter defibrillators (ICDs) for secondary prevention, ICDs for primary prevention, comorbidities, cardiac resynchronization therapy (CRT) devices, generator replacement, and dual- versus single-chamber ICDs.

Despite their detailed focus, the criteria must be seen – and used – as a guide, not as a cookbook. The individual patient’s situation must always be the primary point of decision-making, said Dr. Hauptman, professor of internal medicine and assistant dean of clinical-translational research at Saint Louis (Mo.) University.

What the document doesn’t take into account is just as important as what it does, he noted. "Patient preference still has to come into play. We can never forget that at the end of the day, our patient needs to be a full partner in the decision process."

Each of the 369 indications was scored on a scale of 1-9. Just under half of the scenarios (45%) received a rating of appropriate, 33% were rated "may be appropriate," and 22% "rarely appropriate." This is the first guideline to use this updated methodology (J. Am. Coll. Cardiol. 2013;61 [doi:10.1016/j.jacc.2013.01.025]). The criteria committee noted that, in this case, the rating of possibly appropriate may reflect the state of research as much as the true clinical utility.

"It is important to recognize ... that ratings in this middle category may represent either the lack of sufficient data to inform the decision or the fact that, depending on other clinical factors not considered in the brief scenario, device implantation may or may not be considered beneficial. The wide breadth of scenarios rated as ‘May Be Appropriate’ raises the importance of recognizing the role of applying clinical judgment to decision-making when encountering patients who broadly meet these criteria."

A rating of "appropriate" doesn’t mean that the treatment is mandatory. However, a rating of "rarely appropriate" is a strong judgment indicator. "Scenarios for which there were data showing harm, or nodata were available, and medical judgment deemed device therapy ill-advised were categorized [thus]. For example, comorbidities including life expectancy and cognitive function impacted appropriateness ratings," the authors wrote.

They maintained that the document’s primary impetus is to guide good medical care, not to be a reimbursement guide. "Some of the scenarios that are deemed ‘appropriate’ ... may not currently qualify for insurance coverage. For patients, physicians, and insurers, these distinctions are of critical importance because commitment to patient-centered care may warrant implantation of a device appropriate for the individual patient’s situation, but it may not fit precisely into a covered indication as defined by coverage policy and requires use of best clinical judgment."

The criteria committee, however, acknowledged that payers may use the document as such. In this light, they suggested that clinical information should support each treatment decision, whatever its appropriateness rating.

For example, "services rendered for ‘rarely appropriate’ indications should be considered in the context of the clinical situation. Namely, supporting documentation that informed the clinical decision should be sought, as other factors beyond those described in the brief clinical scenarios included in this document may have entered into clinical decision-making."

Dr. N.A. Mark Estes, director of the New England Cardiac Arrhythmia Center at Tufts Medical Center, Boston, said that the document’s intended purpose and its actual use may squeeze physicians in the middle.

"The document, by design, addresses good medical practice, independent of reimbursement. There are many scenarios in which an implantable cardioverter defibrillator or cardiac resynchronization therapy device may be deemed ‘clinically appropriate’ but may not currently qualify for coverage by Medicare National Coverage Decision. This can leave the physician in the difficult position of making appropriate recommendations for use of an ICD that fall outside of the scope of NCD coverage. Professional societies need to continue to work with the Centers for Medicare & Medicaid Services to resolve this issue and develop a mechanism for updating CMS ICD and CRT coverage on a regular basis," he said.

Dr. Hauptman and Dr. Estes serve on the Cardiology News Editorial Advisory Board. Dr. Russo has been a consultant to Biotronik, Guidant/Boston Scientific, Medtronic, and St. Jude Medical. Dr. Stainback had no relevant conflicts to disclose.