[AF-FORUM] 101E 射频消融. Dr. Haigney

[AF Symposium]

我想对于RAAFT的目的可能有些疑问是可以理解的。

援引RAAFT官方网站上的描述：“改试验的目的是，对 
于症状性的未经过药物治疗的阵发性房颤患者，验证 
导管消融肺静脉电隔离是否优于抗心律失常药物作为 
一线治疗”

一些医生想当然的人为这批400名患者经过12个月随访 
的结果将能够明确导管消融是否适于房颤一线治疗。 
显然这样的理解不确切。我希望的是，这一结果可以 
得到一个正面的结果，而且可以用于进一步更大规模 
的、非工业化的3-5年的临床试验（象AFFIRM试验那样） 
的基础。

我当然欢迎长时间的每日2次的ECG监测。我想知道的 
是，每一段记录的ECG时程是多少，如何确定这种随访 
方式优于Hindrick 医生那样的加强Holter随访。Holter对于 
夜间心律失常的随访意义更大一些。


Mark Haigney, MD, FAHA

Director of Cardiology
Associate Professor of Medicine
Associate Professor of Pharmacology
Uniformed Services University
Bethesda, Maryland
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Re: [AF-FORUM] 101E Radiofrequency ablation. Dr. Haigney

I think there is some understandable confusion regarding the purpose
of RAAFT.

To quote from the description of the purpose of RAAFT on Clinical
Trials.gov:

"The purpose of this study is to determine whether catheter-based
pulmonary vein isolation is superior to antiarrhythmic drugs as first
line therapy in patients with symptomatic paroxysmal recurrent atrial
fibrillation not previously treated with therapeutic doses of
antiarrhythmic drugs."

Some clinicians might conclude that a positive outcome from this
study of 400 patients followed for 12 months would establish by
itself that ablation should be first line therapy. Clearly this would
be inappropriate. It is my hope that the study will be positive, and
will be used as preliminary data for a much larger, non-industry
trial with 3-5 year follow up, similar to AFFIRM.

I certainly applaud the choice of prolonged, twice daily ECG
monitoring. I would be curious what the duration of each recording
would be, and why this approach was preferred to prolonged ambulatory
Holter recording, as performed by Hindricks et al. A great strength
of Holter recording is screening for nocturnal arrhythmias.

Respectfully,

Mark Haigney, MD, FAHA

Director of Cardiology
Associate Professor of Medicine
Associate Professor of Pharmacology
Uniformed Services University
Bethesda, Maryland

--
Dr. Sergio Dubner
President of Scientific Committee

Dr. Edgardo Schapachnik
President of Steering Committee