Tuesday, October 30, 2012

Plugging holes in the heart good for you? Maybe. Maybe not.

So ... for stroke prevention, do plugging holes in the heart serve better than taking blood thinner medications? The resounding answer: Maybe not. But maybe so.

A recent paper outlined the results of research of the effects of plugging a patent foramen ovale (click here for details about that term) in terms of preventing strokes. My 1998 cryptogenic stroke - that is, a stroke with no clear reason - was finally attributed to a hole between two heart chambers. (Click here for my own story about what happened.)

For this post, let's go through two articles and one press release (which you should read in their entirety) with a few snippets included. First, here's one headlined that Plugging PFOs no help for stroke -- maybe:
He said physicians should consider the following:
  • First, we're talking about a stroke risk reduction that, if it plays out over time in a 46-year-old, is important.
  • Second, for patients who are in the midst of their lives regarding career or family, they are looking for the best strategy to reduce the risk of having another stroke with all those consequences. So, what may be a small difference [in absolute risk reduction to an observer], is a huge difference to these patients
  • And third, when we review pharmacologic studies that look at the risk reduction of secondary stroke prevention, we are not dealing with the same magnitude. These magnitudes of risk reduction [in RESPECT] are really substantial. That's what you must keep in mind when dealing with this patient population.
So, the story is that decisions need to be made on a patient-by-patient basis. I agree with that idea. The next item is a little more positive on the closure side.

PFO closure may be superior to medical therapy in preventing stroke:
"In contrast to a previously reported randomized trial for the treatment of cryptogenic stroke, the RESPECT trial enrolled only patients with documented cryptogenic embolic strokes and excluded patients with other potential causes of stroke and/or TIA. The period of follow-up approached nine years and was not restricted to only events within the initial two years of follow-up," said Richard Smalling, M.D., Ph.D., James D. Wood Distinguished Chair in Cardiovascular Medicine at The University of Texas Health Science Center at Houston (UTHealth), who served on the steering committee and as a principal investigator of the trial.
"As a result, the trial enrolled patients at high-risk for recurrent events and followed them for a long period of time, enabling the detection of relatively infrequent recurrent stroke," said Smalling, who is director of interventional cardiovascular medicine at the Memorial Hermann Heart and Vascular Institute. "The totality of evidence in the RESPECT trial clearly demonstrates the superiority of device closure using the Amplatzer PFO Occluder in patients with the above entry criteria compared to standard medical therapy."
Finally a story with a decided negative bent is headlined how St. Jude device to close heart holes fails to stop stroke:
The results won’t change medical practice very much, with some high-risk patients still likely to get treated even without formal FDA approval, Ajay Kirtane, director of the interventional cardiology fellowship program at Columbia University Medical Center/New York-Presbyterian Hospital in New York, said at the meeting.
“I would like as a physician to have the option to discuss it with the patient and be able to use it if the patient elects to do so,” he said. “That would be the ideal scenario. To use it in everybody, I don’t think you can do that on the basis of this data.” ...
“These are healthy people, and the results are something a 46-year-old stroke patient wants to know,” said lead researcher John Carroll, director of interventional cardiology at the University of Colorado. “It works. What we are debating is how superior it is to medical therapy. Any benefit that could potentially cut the risks down the road has a big impact.”
So my own bottom line hasn't changed on this: It's very much a decision that needs to be informed and made carefully between doctor(s) and patient. A single answer won't fit everybody, in this case.

I am convinced mine has prevented further strokes or mini-strokes. That being said, I was an active relatively young man when mine happened. Everyone has his or her own circumstances, and those have to be taken into account in any serious medical decision.

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