It took just two days after the Nov. 2 FDA approval of the Edwards SAPIEN transcatheter aortic valve for New York-Presbyterian Hospital/Columbia University Medical Center to claim bragging rights as the first center in the United States to implant the device as an FDA-approved standard of care.

The center will be one of four sites to train U.S. doctors in the procedure, and is promising to lead a live demonstration tomorrow (Nov. 9) at the annual Transcatheter Cardiovascular Therapeutics symposium in San Francisco for those eager to get a front row view of transcatheter aortic valve implantation (TAVI).

The FDA approval also put the U.S. in the rare position of following the footsteps of some 40 countries that have already approved the SAPIEN valve including Latvia, Iran, and Russia. This fact elicited a good laugh at the recent Heart Valve Summit 2011 in Chicago, but also prompted much dialogue about some of the thorny ethical and economical consequences that still lay ahead.

“Is anyone at the government talking about rationing of care?” asked Dr. Stephen Strelec, an anesthesiologist at University of Pennsylvania Medical Center, at the summit. It’s not just the 92-year-old who says “I want to live,” but the younger patient facing a valve procedure who decides they don’t want to be on anticoagulants and undergo surgery because they can afford this expensive new transcatheter valve in 2 years. “There’s an economic consequence to that decision as well,” he said.

Dr. Robert Bonow, director of the center for cardiovascular innovation at Northwestern, said the issue is being looked at by federal agencies and insurers, but added that it is “one of the biggest hot-button items about this whole technology because it’s not going to be cheap.”

Dr. David Adams, chair of cardiothoracic surgery at Mount Sinai Medical Center, said they’ve already had their share of 90-year-olds wheeled in from the nursing home by family members who read about TAVI in the newspaper and want mom to stay alive.

The suggestion was made that surgeons and interventional cardiologists will have to hone their skills in making the very specific diagnosis of medical futility, and that a board-certified palliative care physician will be one of the most valuable members of the multidisciplinary teams treating these patients.

“Every PARTNER site looking back over their patients can name patients that they wish they didn’t enroll in the trial and done the valve on,” said Dr. Howard Herrmann, director of interventional cardiology and cardiac catheterization at the Hospital of the University of Pennsylvania. “The question is how to recognize them up front.”

Edwards Lifesciences and the FDA are setting up an intensive training program with simulations, an expert review of cases and a proctoring system. Still, the challenge for Edwards and other companies that will follow will be enormous in terms of launching this technology outside the clinical setting, said Dr. Adams, co-principal investigator of Medtronic’s CoreValve trial.