Now, to be fair, the study brought to light the fact that many ICD's were not implanted according to "guidelines." Most of us in the business acknowledge that fact. But there are many many shortcomings to the original article, the least of which were that new guidelines were published in 2008 in response to new data about ICD's, but because CMS still uses outdated 2005 "guidelines," the authors stuck to their original story line.
* sigh *
No matter: the specter that perhaps only 77.5% of America's doctors were implanting ICD's appropriately was just too juicy for mainstream media to ignore.
Fast forward to March, 2011.
A follow-up article by the same group was published more quietly in Circulation: Cardiovascular Quality and Outcomes entitled "Extent of and Reasons for Nonuse of Implantable Cardioverter Defibrillator Devices in Clinical Practice Among Eligible Patients With Left Ventricular Systolic Dysfunction" with Sana M Al-Khatib as second author. In that paper, they looked at just one institution's data for only seven months to find:
Of the 542 potentially eligible patients identified, 224 (41%) did not have an ICD. In the initial adjusted analysis, female sex (odds ratio 1.90; 95% CI, 1.28 to 2.81) and increasing age (odds ratio 1.07; 95% CI, 1.04 to 1.11) were associated with a higher likelihood of not having an ICD. After detailed chart review, of the 224 patients without an ICD, 117 (52%) were ineligible for the device and 38 (17%) patients refused the device, resulting in only 69 (13%) patients eligible for an ICD who failed to receive one.Realize that this was a retrospective chart review study: not a single patient or doctor was contacted. Further, a tiny sliver of data was evaluated: 7 months of data from one center (we must assume it was the authors' institution since the study was approved by their institutional review board). But even with such a small sampling of data, the authors acknowledge a myriad of reasons patients did NOT get ICD's and only "13 percent" of patients didn't get ICDs who should have.
Interesting... if you can believe the results from such a poor data sample.
But this was not the best part of this story, not by a long shot.
In the same journal, Al-Khatib writes an editorial about their group's work and extols the virtues of their study by stating:
"The authors (ed's note: me included) should be commended for taking on this onerous task. Detailed review of hundreds of charts requires substantial resources. Their research is important because administrative and other national registries have limited clinical information and may not capture vital information, such as contraindications to a particular therapy, patient refusals of recommended interventions, and long-term follow-up."Oh, goodness gracious. Can't we at least be the tiniest bit critical of our own work and demonstrate a modicum of humility?
And if that is not enough, continues, "this study was conducted at one of the premier institutions in this country."
And finally... "this study by Allen LaPointe (ed note: and me, Al-Khatib) is a good addition to the literature because it highlights the importance of verifying findings derived from registries through chart reviews."
And how much "quality" can we attribute to the editorial efforts of Circulation: Cardiovascular Quality and Outcomes when authors write their own editorials?
Then again, maybe the media spotlight has gone to all of their heads.
Al-Khatib SM, Hellkamp A, Curtis J, et al., Non-Evidence-Based ICD Implantations in the United States. JAMA 2011 305(1): 43-49.
Allen LaPointe NM, Al-Khatib SM, Piccini JM, et al. 'Extent of and Reasons for Nonuse of Implantable Cardioverter Defibrillator Devices in Clinical Practice Among Eligible Patients With Left Ventricular Systolic Dysfunction' Circulation: Cardiovascular Quality and Outcomes
2011, 4: 146-151.
Al-Khatib SM. 'Toward More Optimal Use of Primary Prevention Implantable Cardioverter-Defibrillators How Do We Get There?' Circulation: Cardiovascular Quality and Outcomes 2011, 4: 140-142.