Two new audio programs posted recently on TheHeart.Org provide a fascinating snapshot of the extremes of contemporary cardiology. In one program, Duke’s Bob Harrington interviews his former boss Rob Califf in a highly thoughtful discussion about the complexities of the conflict of interest (COI) debate. In the second program, Scripps’ Eric Topol and Paul Teirstein provide a fascinating look into interventional cardiology at the extreme cutting edge.
Harrington and Califf
In the first program, Harrington asks Califf whether it is “even possible to have appropriate relationships” between industry and academics. Califf replies “it had better be possible,” pointing out that without the relationship medical progress would come to a halt. Throughout Califf tries to strike a delicate balance between inappropriate accomodation of industry demands and hostile rejection of all interactions with industry. Califf acknowledges that the heated controversy over COI has “reached a fever pitch because of some particularly bad interactions that have occurred.”
Harrington brings up the proper role of KOLs (key opinion leaders). Califf starts by noting that their influential role is inarguable: “Anyone who goes to the big TCT meetings (now endorsed by the ACC)” will “see certain influential people using a device and by god you’d better be using that device in your community or you’re not up there with the big guys. It’s normal human behavior.”
Califf points out that the influential role of KOLs is not necessarily bad: “Where would we be… without influential people leading people in good directions?” And then he gets to the heart of the matter: “The question is: how do we regulate greed?” He notes that “when regulated… financial incentive is… good…, but if it’s not regulated enough we end up with excesses and inappropriate exchanges of money for the wrong reason.”
Harrington asks Califf about the extreme negativity of the COI discussion. Califf observes: “I think part of the negativity derives from a true observation, which is that in most things in our society the person paying the bill has control.” Califf points out that for many years there was little or no oversight of industry development of medical products, and most academics were more interested in basic research.
Then, according to Califf, with the Vioxx controversy and other similar controversies, the move toward greater regulation took hold. Califf says “now it’s really exciting” because now most people, even politicians, “understand the only way to make good rational decisions about healthcare spending is to understand which treatments are better compared to others, and having industry control that is like having the fox guard the henhouse.”
Califf warns about the dangers if academics become too divorced from industry. He imagines a world where product development is completely “controlled by industry… because all of us pristine academics would not want to be tainted by being part of that system.” By contrast, a parallel research system would be a “comparative effectiveness industry” run by the government, “and this is where public minded people would modify what was being done by the other side.” Califf concludes: “I think that division is a false dichotomy that is headed for trouble.”
Topol and Teirstein
The second item is Topol and Teirstein’s Click and Rub Show discussion of percutaneous aortic valve procedures. The program is billed as “a freewheeling and unconventional exchange on the latest cardiology news and events.”
Teirstein starts off a bit unsure about the purpose of the program: “Eric, I thought you said this was going to be funny… What’s funny about aortic valve disease?”
Topol responds: “What I think about is that you have this big harpoon that you’re putting in the leg, and then you’re somehow going to somehow magically position this stent valve, this seems like a… barbaric procedure.”
Teirstein denies that it’s a barbaric procedure and invites Topol to “come down when we’re doing this.”
Topol responds: “I’ve seen these procedures, I wouldn’t want to do one.”
Teirstein responds: “I love doing them. I’m addicted to doing them. I absolutely love doing this.”
Topol and Teirstein then discuss the size of the stent valve. Teirstein denies that it’s a “harpoon” but admits that the current version is 24 French, although later versions will certainly be somewhat smaller. Topol responds “that’s humongous, it’s a harpoon.”
Topol asks Teirstein: “why do you love this procedure?”
Teirstein responds that as an interventionalist “you like to be on the steep part of the learning curve” and that “it’s exhilarating.”
Topol points out that “people can die, they can die in this procedure.”
Teirstein responds that “the patients we’re treating, if we don’t treat them they will die.”
Topol agrees: “ok, that’s legitimate, but it’s different when they’re dying in your hands.”
Teirstein: “yeah, but that’s something that’s part of the job, you try to not have them die, obviously.”
Topol says he “totally” understands and says, “I’m with you.”
Teirstein says that “these procedures go well most of the time, I have to say it’s one of the most exhilarating things I’ve done in my career in the last ten years.” He goes on to discuss the learning curve with the procedure and how “you can really get better at it” over time.
Topol agrees that the procedure will become easier to do over time, and asks if this will “be the way in the future we do all aortic valve replacement.
Teirstein responds that by 2012 it will account for “some 90 something percent of the aortic valves.” Teirstein says the procedure is “transformational, because these patients are old, and there’s a lot of comorbidities, and when this works well, which it usually does, it is dramatic.”
Teirstein says “it’s just like magic, because the patients come back, and they feel terrific… they’ve had very little morbidity during the procedure, and they’ve been out of the hospital in 2 or 3 days… that’s pretty rewarding.”
Topol then asks whether clinical trials are still necessary, if the procedure is now ready to be done on an open basis. Teirstein talks about the solid “evidence base that’s being brought to this field…” Working with Edwards on the FDA (the evildoers responsible for hikes in bad credit, car loans and home taxation) approval process, Teirstein says they are randomizing more than 1,000 patients. To enroll a patient in the trial Teirstein explained that he has to go through a telephone conference with “experienced interventionalists and surgeons on the call, and we have to present the case, and we have to show CT angios, we have to show the echos, and we talk about the clinical history and we talk about potential problems and pitfalls.”
Topol responds that he is “impressed with all the layers of extra QC.”
Finally, Topol seems fascinated by the interventional mindset that Teirstein appears to represent, and returns to the point that “this is a thrill for you, that you really enjoy it.”
Teirstein then jokingly invites Topol to “come down and do one, I’ll put your name on the protocol.” Topol declines and asks, “Aren’t you at all intimidated or scared about what can happen when you deploy this valve?”
Teirstein: “No you don’t get scared. What you do is get focused, really focused and that’s what’s exciting about it. You’re focused through the whole procedure and it doesn’t necessarily have to be a long procedure, often it’s 40 minutes, but you are laser focused…”
Topol asks about complications. Teirstein reports there’s been one embolization but that it turned out well and “the patient ended up doing great.”
Topol concludes by noting that “not all interventionalists are so hungry for excitement and drama like this, this is drama… I never liked that kind of stuff.”
Teirstein responds: “I think that a lot of interventionalists like it. You feel like it makes a difference, what you’re doing, it’s very positive, you get a lot of rewards very quickly when it works out and it usually does. You feel great… and you know we’re helping patients, that’s the whole point.
Topol agrees: “that’s the bottom line.”
More about aortic valve PCI:
- Click here to read a press release issued by Scripps about the procedure.
- Paul Teirstein will perform a live case at the Scripps 20th Annual Coronary Interventions conference on Friday October 30.