"How are you feeling Ms. Jones?"
"Have you been more short of breath lately?"
"Not really, just when I exercise."
"How much exercise?"
"I dunno. But after I go to the mailbox and walk back up to the house, I’ve got to stop now where before I didn’t."
Exertional dyspnea. It conjures up a large differential of potential cardiovascular or pulmonary causes. And as the above commonly-encountered doctor-patient conversation demonstrates, the problem is a dynamic one: at rest things are often fine, on exertion or with recumbency less so.
Now imagine that the doctor then sees elevated neck veins, hears rales in the lower lung fields, and sees swollen ankles on their patient. Heart failure, right?
Perhaps. But we should recall that heart failure is not a disease, but a condition caused by an underlying pathology. So a slew of diagnostic studies are under taken and if no easily correctable cause identified, symptomatic therapy started. If it’s caught early or the ause identified, perhaps an admission will be avoided. But if things progress, Admission Number 1 for "heart failure" is chalked up on the books.
Our new health care law requires (Page 8) doctors avoid expensive hospital readmissions by “intervening” on heart failure since this problem is one of the leading causes of readmissions to hospitals. These readmissions cost our health care system billions of dollars. To prove the point, millions upon millions of dollars have been spent to try to prevent heart failure admissions with the assumption that, surely, many readmissions are preventable and cost savings reflected to our health care system.
We should acknowledge that better compliance with medications, careful management of one’s diet, and avoidance or behaviors known to exacerbate heart failure could be better avoided. For the motivated and highly engaged patient, improvements in readmissions can be made, but I wonder how much so: after all, they’re already the Compliant Ones. It’s the Non-compliant Ones and the Medically Challenging Ones that are the problem for our health care system from a cost standpoint.
The Non-compliants are a particularly difficult bunch. They don’t want to think about their health. They want to think about this weekend’s football game, child’s graduation, their upcoming trip to Europe, or being able to pay this month’s bills. And there are many more Non-compliants than Compliants out there. They are not all Non-compliants because they mean to malign their doctor but rather because life gets in the way of dealing with daily health issues for them. And we’re not even talking about the problems inherent to people with severe shelter, social, education, family and economic challenges. Can we expect our health care system to impact all of these areas to prevent hospital readmissions?
And the Medically-Complex Ones have their own challenges: maybe it’s heart failure this week, then maybe a bout with a COPD exacerbation the next. Are they a readmission, too?
But this has not influenced attempts at expensive innovation in this area. This past week we saw the second clever innovation for measuring physiologic parameters to predict the development of heart failure suffer a devastating blow at the hands of the FDA:
An FDA advisory panel decided that CardioMEMS failed to prove that its wireless, implantable heart monitor’s benefits outweigh its risks, casting a shadow on a potential $375 million acquisition by St. Jude Medical (NYSE:STJ) – which already owns nearly a fifth of CardioMEMS.
The watchdog agency’s cardiovascular devices committee decided that a clinical trial of the device, designed to be the first permanent heart implant for a solely diagnostic purpose, was warped by the assiduous care given to its participants. (emphasis mine) That’s because the clinicians administering the single-blind trial knew which patients were implanted with the device and made sure they got specialized care.
The panel voted 9-1 that the device is safe, but decided that the trial failed to prove its effectiveness on a 7-3 vote. The committee voted 4-6 that the benefits of the device, which measures pulmonary artery pressure, have been proven to outweigh its risks.
Recall that this is the same fate that Medtronic’s earlier right ventricular hemodynamic pressure monitor, the Chronicle device, suffered in 2007.
But maybe we can make lemonade our of lemons when it comes to innovation to prevent heart failure. Maybe we can realize the importance of people interacting with people and the time necessary to assure better outcomes in heart failure. And maybe, just maybe, we should realize that even with all the technology in the world, expensive medications and expensive testing, that penalizing doctors and health care providers who spend the time with patients just because they present again to a hospital might be exactly the wrong approach to address our readmission issue.
And maybe we should acknowledge that a good portion of the problem with hospital readmissions starts outside hospitals, not in them.