Since the beginning of AF ablation 20 years ago, studies have used a 90-day blanking period after the procedure where AF episodes do not count. It is not right.
The blanking period violates two core principles: (1) intent-to-treat and (2) taking into account any patient experience that matters to the patient. Outcomes must be assessed immediately after treatment, but the severity of the outcome must be taken into account. If a procedure were to cause “minor” AF episodes, that should not count as much as a major spontaneous event. It is imperative to grade outcomes on an ordered scale.
The last 2 paragraphs sum it up for me. The research and clinical uses of “blanking period” should align, whereas currently they don’t.
The only reason to care about early AF recurrent episodes only detected on an ILR is if and when it ultimately predicts mid term clinical recurrence of AF, and hence clinical failiure of the procedure.
Based on Dr. Andrade’s recent study, it appears month 1 recurrences don’t really; month 3 recurrences often do; and month 2 might be a gray zone (for RF). So there is no reason to extend blanking periods beyond month 1 for RFA (for ILR asymptomatic episodes). By the same logic, since any recurrence at any time after PFA seems to predict mid term failure, there should be no blanking after PFA.
But symptomatic episodes matter, esp if symptoms are a component of the study endpoint. So there should be no blanking of any kind for any symptomatic AF event (and esp not for one that leads to a patient ER visit and cardioversion).
What matters is the long term success of the ablation. If there was an 80% rate of a fib in a certain period of time but after that there was long term NSR, which success rate should be reported. . What is "not right" about reporting both early and late recurrences? You
can call an early recurrence a failure if that is how you want to define a recurrence. There is a very high rate of afib after. aortic valve surgery but is usually goes away soon. Would it make you feel better to tell patients that this surgery has a very high rate of a fib without telling them is only lasts for 3 days?
Perhaps scale back blanking period to 1 month? The downside of doing away with it entirely may be more stacked redo procedures that may not be necessary.
The blanking period violates two core principles: (1) intent-to-treat and (2) taking into account any patient experience that matters to the patient. Outcomes must be assessed immediately after treatment, but the severity of the outcome must be taken into account. If a procedure were to cause “minor” AF episodes, that should not count as much as a major spontaneous event. It is imperative to grade outcomes on an ordered scale.
The last 2 paragraphs sum it up for me. The research and clinical uses of “blanking period” should align, whereas currently they don’t.
The only reason to care about early AF recurrent episodes only detected on an ILR is if and when it ultimately predicts mid term clinical recurrence of AF, and hence clinical failiure of the procedure.
Based on Dr. Andrade’s recent study, it appears month 1 recurrences don’t really; month 3 recurrences often do; and month 2 might be a gray zone (for RF). So there is no reason to extend blanking periods beyond month 1 for RFA (for ILR asymptomatic episodes). By the same logic, since any recurrence at any time after PFA seems to predict mid term failure, there should be no blanking after PFA.
But symptomatic episodes matter, esp if symptoms are a component of the study endpoint. So there should be no blanking of any kind for any symptomatic AF event (and esp not for one that leads to a patient ER visit and cardioversion).
What matters is the long term success of the ablation. If there was an 80% rate of a fib in a certain period of time but after that there was long term NSR, which success rate should be reported. . What is "not right" about reporting both early and late recurrences? You
can call an early recurrence a failure if that is how you want to define a recurrence. There is a very high rate of afib after. aortic valve surgery but is usually goes away soon. Would it make you feel better to tell patients that this surgery has a very high rate of a fib without telling them is only lasts for 3 days?
Perhaps scale back blanking period to 1 month? The downside of doing away with it entirely may be more stacked redo procedures that may not be necessary.