Timothy J. Gardner, MD


May 12, 2014

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TAVR: CoreValve and CHOICE

Hello. I am Dr. Tim Gardner, cardiac surgeon and Medical Director of the Center for Heart & Vascular Health at Christiana Care Health System in Newark, Delaware.

I'm here at the 2014 American College of Cardiology (ACC) Scientific Sessions in Washington, DC. It's been a pleasant meeting. The weather hasn't been too good, but the presentations and papers and excitement have been excellent. On top of the list of surgeon takeaways was the CoreValve® (Medtronic, Inc.; Minneapolis, Minnesota) trial presentation[1,2] by David Adams on Saturday at the late-breaking clinical trial session. This was a highly anticipated presentation, and it did not disappoint.

Basically, the CoreValve trial data showed that the transcatheter group (the patients who received the CoreValve) did better than a comparable group of surgical patients. Most of us were surprised that there was an actual superiority signal in the comparison data between the 2 groups at 1 year that appears to be persisting in the early follow-up into the second year.

Differing from the PARTNER A trial,[3] the stroke occurrence rate was similar in both the transcatheter aortic valve replacement (TAVR) and the surgical patients. There was actually a separation of the outcomes in favor of the TAVR group fairly early on, and then the improvement persisted in a parallel fashion. The differences between the PARTNER trial data and the data from this trial will be adjudicated and discussed. I don't think that there is a significant difference in terms of the import of the data presented. On the basis of this trial and the report from the previous PARTNER trials, there is no reason to believe that one valve is better than the other, but the takeaway message is that the TAVR technology (now with a second option) and the CoreValve are here to stay, and in these high-risk patients, the effectiveness of the CoreValve was fairly dramatically shown.

As surgeons, we have another option to offer our patients. I hope that the decision-making will continue to evolve from a heart team concept where both interventional cardiologists and heart surgeons will agree on the best therapy for individual patients. It is inevitable that the transcatheter valve is going to be offered to lower-risk patients. We are going to have to keep an eye on that and hope that the heart team approach will persist.

There was another presentation on the TAVR approach, the CHOICE trial[4,5] from Germany. This trial had about 120 patients in each arm and compared the SAPIEN XT (Edwards Lifesciences Corporation; Irvine, California) valve with the CoreValve. With small numbers at 5 centers, the SAPIEN XT patients did better, with fewer cases of perivalvular leak and, obviously as we know, many fewer patients requiring a pacemaker postoperatively.

The jury is out in terms of which transcatheter valve might be better or which type of patient would be better suited for the CoreValve vs the SAPIEN XT. That will have to be sorted out. We should accept the fact that we now have another good option for treating elderly patients with severe aortic stenosis -- that is, the transcatheter valve.

STAMPEDE: Bariatric Surgery

There weren't many other notable cardiac surgical presentations here in terms of late-breaking trials. The other interesting trial was the STAMPEDE trial[6] from the Cleveland Clinic, looking at the outcomes of patients who have had some type of bariatric surgical procedure, either gastric bypass or gastric banding, vs medical treatment alone. At 3 years of follow-up, patients who had bariatric surgery had much improved cardiometabolic parameters, including (and especially) an improvement in their diabetes management.

This was a proof-of-concept trial that is very important. Some of us tend to think of bariatric surgery as an option offered to people because they are unhappy about being overweight. The STAMPEDE trial shows that bariatric surgery actually improves pathophysiology significantly. Cardiometabolic improvement (in particular, management of diabetes) was substantial in these patients and sustained at 3 years.

I come away with these 2 separate areas as the highlights of the meeting from the surgeon's perspective. Many other good papers were presented, but these 2 clinical trials, the CoreValve and the bariatric surgery trial, were most notable.

That's it for a look from the surgeon's perspective. Thank you for joining us.


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