Tuesday, September 01, 2009

MADIT-CRT and the Device Industry's Image Problem

"In MADIT-CRT, 12 patients would need to be treated to prevent a single heart-failure event, whereas in the REVERSE trial, 20 patients would need to be treated to delay a heart-failure hospitalization. Is this money that could be spent more wisely? If the indication for CRT is expanded to all stage C patients with a low LVEF and a QRS duration of more than 120 msec, regardless of current symptoms or the duration of medical therapy, the potential "indication creep" in patients who are unlikely to derive a mortality benefit will alter the benefit-to-safety ratio and tip the score on cost-effectiveness even further in the wrong direction. Given the sobering facts about the costs of health care confronting us now and in the future, it appears prudent that any expanded indication for CRT in less symptomatic patients should be confined to patients with a QRS duration of more than 150 msec and in whom previous marked symptoms have been controlled with optimal medical therapy."

- Mariell Jessup, M.D.
Department of Medicine, Cardiovascular Division, University of Pennsylvania School of Medicine, Philadelphia.
Editorial: New England Journal of Medicine

That most implanted heart devices don't help patients has long been of concern to cardiologists, and has led to device sales well below manufacturers' projections. "We need better patient-specific identifications for who actually will benefit from these expensive devices," said Douglas P. Zipes, the former president of the American College of Cardiology, in a statement. "This study may widen the net to capture more patients for (heart resynchronizers). But whether that is appropriate should be questioned."

Wall Street Journal, 1 Sep 2009

The e-mail from my local Boston Scientific rep came at 07:30AM today: "MADIT-CRT Published!"

For those unfamiliar, the MADIT-CRT trial was designed to determine if combined implantable cardiac defibrillator (ICD)-cardiac resynchronization therapy (CRT-D) would reduce the risk of mortality and heart failure (HF) events by approximately 25% in subjects who were in New York Heart Association (NYHA) functional Class II with non-ischemic or ischemic cardiomyopathy and subjects who are in NYHA functional Class I with ischemic cardiomyopathy, left ventricular dysfunction (ejection fraction [EF] < or = 0.30), and prolonged intraventricular conduction (QRS duration > or = 130 ms). 60% of patients were randomized to CRT-D and 40% to ICD only.

And while the study proved that CRT combined with ICD decreased the risk of heart-failure events in relatively asymptomatic patients with a low ejection fraction and wide QRS complexes, the mortality between the two arms was not different.

This might be the biggest news coming from the trial: are reduced hospitalizations alone going to be enough to justify the expense of broader application of this technology?

Maybe it's the timing of this trial - released as America is struggling to find ways to reign in our health care costs as we reshape our entire health care system. Maybe its an erosion of trust spcialists have in a system that threatens to cut their payments 11% while device costs seem to remain relatively constant year to year. Whatever it is, there seems to be a new shift in cardiologists' and electrophysiologists' attitudes toward many of our most expensive preventative heart failure treatment technologies: are the costs of these devices paired with the number needed to treat really cost effective to our system as a whole?

In the past, the US has always lead the way in adopting primary prevention for heart failure and sudden death. While this has been laudible, it has also been expensive.

And ironically, the expense of this incredible technology might now be biting us on the hind side. As evidenced by the quotes above - from loyal doctors who know and understand the wonders of this technology - the device industry has a serious problem. Unless more value than a hospitalization or two is gained with their technology, the device industry will struggle as their ultimate customers begin to think twice about adopting new indications on basis of these softer clinical endpoints.


Reference: Moss AJ, et. al, Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events, New Engl J Med September 1, 2009 (10.1056/NEJMoa0906431).

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