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November 5, 2009

BehindTheMedspeak: 'It had taken 100 cases before he had gotten really good at it'

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Yowza, that's one steep learning curve for off-pump cardiac bypass surgeon Dr. Nirav Patel, of Lenox Hill Hospital in New York City who "... estimated that he's now done more than 1,400 off-pump operations...," wrote Gina Kolata in today's New York Times story about a new study comparing old-school on-pump surgery with the new new thing.

But that's the way doctors learn, by practicing on patients.

Trust me, if you watch new anesthesia residents attempting to intubate during their first week of residency in July, you'll never have general anesthesia again.

To say it's ugly is a gross understatement.

But there's no other way to achieve mastery than by getting aboard the learning curve cluetrain like Dr. Patel and holding on tight.

Tell you one thing, the results of his initial 100 patients wouldn't look very good versus the most recent ones.

So aren't you glad you'll be seeing him now rather than earlier on?

Anyway.

The Times headline reads "Older Bypass Method Is Best, a Study Shows," but when you look at the graphic (top) that accompanies the article you see that the survival rates are nearly identical, the caption reading "A study found that patients who had heart bypass surgery 'off pump,' without having their heart stopped, had slightly lower chances of survival than 'on pump' patients, whose hearts were stopped."

There are three types of lies: lies, damned lies, and statistics.

And so statistically there is a significant difference between the two groups, resulting in the sensational headline that's technically true but clinically absurd.

The actual numbers: one year out, 7.4% of on-pump patients had died or had serious complications, versus 9.9% of off-pump patients.

To any doctor looking at those numbers — especially those of us who've performed clinical studies and know how the sausage is made and all the rounding off and equivocal findings that require a definitive box be checked — they're the same.

That's why I call this feature "BehindTheMedspeak."

Here's the abstract of the paper published today in the New England Journal of Medicine which is the focus of the Times story.

•••••••••••••••••••••••

On-Pump versus Off-Pump Coronary-Artery Bypass Surgery

Background: Coronary-artery bypass grafting (CABG) has traditionally been performed with the use of cardiopulmonary bypass (on-pump CABG). CABG without cardiopulmonary bypass (off-pump CABG) might reduce the number of complications related to the heart–lung machine.

Methods: We randomly assigned 2203 patients scheduled for urgent or elective CABG to either on-pump or off-pump procedures. The primary short-term end point was a composite of death or complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure) before discharge or within 30 days after surgery. The primary long-term end point was a composite of death from any cause, a repeat revascularization procedure, or a nonfatal myocardial infarction within 1 year after surgery. Secondary end points included the completeness of revascularization, graft patency at 1 year, neuropsychological outcomes, and the use of major resources.

Results: There was no significant difference between off-pump and on-pump CABG in the rate of the 30-day composite outcome (7.0% and 5.6%, respectively; P=0.19). The rate of the 1-year composite outcome was higher for off-pump than for on-pump CABG (9.9% vs. 7.4%, P=0.04). The proportion of patients with fewer grafts completed than originally planned was higher with off-pump CABG than with on-pump CABG (17.8% vs. 11.1%, P<0.001). Follow-up angiograms in 1371 patients who underwent 4093 grafts revealed that the overall rate of graft patency was lower in the off-pump group than in the on-pump group (82.6% vs. 87.8%, P<0.01). There were no treatment-based differences in neuropsychological outcomes or short-term use of major resources.

Conclusions: At 1 year of follow-up, patients in the off-pump group had worse composite outcomes and poorer graft patency than did patients in the on-pump group. No significant differences between the techniques were found in neuropsychological outcomes or use of major resources. (ClinicalTrials.gov number NCT00032630 [ClinicalTrials.gov].)

November 5, 2009 at 04:01 PM | Permalink


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Comments

Yet Joe just got done complaining that 1 in 100 chance of error in lasik eye surgery is unconscionable and too much a risk for blindness yet a 1 - 2 percent increased chance at death depending on surgical method is poppycock and statistical gerrymandering?

Posted by: megan | Nov 5, 2009 8:11:20 PM

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