BALTIMORE – When Medicare in 2011 decided to pay for an innovative procedure to replace leaky heart valves by snaking an artificial replacement up through arteries, the goal ended up being to offer relief to the tens of thousands of patients too frail to pass through open-heart surgery, the gold standard.
To help ensure great results, federal officials limited Medicare payment only to hospitals that provide large numbers of cardiac patients.
The strategy worked. Previously seven years, more than 135,000 mostly elderly patients already went through a transcatheter aortic valve replacement, known as TAVR. And TAVR's in-hospital mortality rate has came by two-thirds, to 1.5 percent.
Now, in a campaign motivated by a muddy mixture of health care and business, smaller hospitals and also the medical device industry are arguing that the technique ought to be more widely deployed. They note no more than half of the nearly 1,100 hospitals offering surgical valve replacement can do TAVR. Plus they say current limitations discriminate against minorities and individuals in rural areas, forcing patients to endure a riskier and significantly more invasive treatment – or miss obtaining a new valve altogether.
Hospitals that already have a TAVR franchise are fighting to stifle new competitors, saying programs that do not do enough procedures wouldn't provide high-quality care.
At stake may be the proper care of a large number of patients. Half of the greater than 250,000 Americans estimated each year to build up severe aortic valve stenosis – narrowing of the valve that regulates the circulation of blood from the heart towards the largest artery from the body – die within two years. Getting an artificial heart valve lowers that death rate to as low as 17 percent, research has shown.
Also on the line is the $45,000 Medicare pays hospitals for every TAVR case – excluding the physician's fee. While hospitals typically make only a small profit on the procedure – partly because the device is more expensive than $30,000 – they benefit because each TAVR patient typically needs other cardiac services and tests that can boost the hospital's main point here.
In addition, offering TAVR has a cachet that can help recruit and retain top specialists, who bring in more patients.
At a Medicare advisory committee hearing in Baltimore on July 25, both sides from the debate emphasized how they were seeking to help patients. But the economics of TAVR was ever-present given the horde of medical tool and hospital officials and industry analysts in the audience.
The committee split around the issue, although most members backed the continuing utilization of volume requirements. The Centers for Medicare & Medicaid Services is expected to determine later this year whether to change its patient volume minimum for TAVR.
Dr. Jason Felger, a heart surgeon who wants his community hospital in San Angelo, Texas, to give the procedure, said behind the battle over TAVR is protecting profit and revenue. He refers patients to hospitals more than three hours away for that procedure or, when they aren't prepared to travel, they risk their lives to endure the conventional operation.
Hospitals that provide TAVR, he explained, aren't willing to give up the referrals they now depend on using their company hospitals.
“It's by pointing out money,” he said.
Improving A Hospital's Reputation
Unlike open-heart surgery, where the chest is cracked open to remove the unhealthy valve, TAVR involves threading a catheter tipped with a replacement valve through a blood vessel towards the heart. Doctors then implant the brand new valve. That old valve remains but is pushed aside, and also the brand new one gets control its work.
With this less invasive valve procedure, people can get out of the hospital within 2 or 3 days and get back to daily activities much earlier than with open-heart surgery, which typically has a six-week time to recover.
TAVR continues to be approved by the Fda for people who cannot have open-heart surgical procedures or to whom it might be risky. These include the elderly and frail and people with complications for example kidney and lung disease. But TAVR use has expanded among younger, and less sick, patients in recent years. Within the next year, the FDA will probably approve the procedure for all patients needing a brand new aortic valve, industry analysts say.
TAVR does carry risks, including stroke. Patients may also need a pacemaker after the procedure to regulate heart rhythm.
The large most of patients getting TAVR are 65 and also over. The significance of Medicare's blessing goes past its payments, since private insurers typically follow Medicare standards. Physicians seeking to expand utilization of TAVR explain that Medicare doesn't have volume requirements for other major cardiac procedures.
The two largest TAVR medical device companies are divided around the issue. Edwards Lifesciences Corp. of Irvine, Calif., supports eliminating the minimum-patient requirements, while Minneapolis-based Medtronic favors keeping the status quo. The Advanced Medical Technology Association, or AdvaMed, an industry trade group, also supports the change.
About 50,000 people are envisioned having TAVR this year, and people numbers are forecast to double by 2021, based on American College of Cardiology along with other major heart groups.
When Michael Vigil, 50, needed TAVR in May, he drove more than three hours from his home in eastern Wyoming to some hospital in Denver. Prior to the procedure, the oil-drilling contractor was constantly tired and out of breath – even after mundane chores at home. Vigil's aortic valve have been damaged from radiation treating non-Hodgkin lymphoma decades before.
Vigil was sent home a day after the TAVR procedure. He was back at work the next week.
He said he felt more energized quickly after having the procedure.
“It's worked so well, my spouse wishes they dialed it back just a little,” Vigil said.
Donnette Smith, president from the patient advocacy group Mended Hearts, said many patients don't have good access to the procedure.
“Patients do not know of this option unless they walk through the best door of the right hospital,” said Smith of Huntsville, Ala. She'd heart valve surgery in 1988.
Mended Hearts receives funding from device makers.
To gain Medicare approval for TAVR programs, hospitals have to perform annually 50 open-heart valve repairs, 400 angioplasties and 1,000 cardiac catheterizations – a procedure by which medical teams use skills similar to those required for TAVR.
Doctors at larger hospitals say procedure volume is a good predictor for achievement. The American College of Cardiology and also the Society of Thoracic Surgeons recommend hospitals have the ability to do at least 50 TAVRs each year within two years of startup. A lot more than three-quarters of the 582 hospitals authorized by Medicare for TAVR meet that standard.
“Whether it's playing the violin or performing heart surgery, experience matters,” said Dr. Thoralf Sundt, chief of cardiac surgery at Massachusetts General Hospital.
Dr. Ashish Pershad, an interventional cardiologist who performs TAVR at Banner Medical Center in Phoenix, agreed there are access issues. But he explained it's not because of a lack of programs. Rather, he explained, surgeons too often don't refer patients for this because they earn more money from doing the open-heart surgical valve replacement.
“Patients are missing out on this procedure because they are not referred, and primary care doctors lack knowledge about it,” he explained.
Expanding Treatment Options
Doctors seeking a Medicare rule to widen access say there is little evidence hospitals that perform more TAVRs have lower mortality rates. As long as they can display low mortality and complications, they believe their hospitals should be able to provide the service.
“Our intention is not to reduce the caliber of outcomes by expanding to 'low volume' centers; but to supply proper care to some larger population of patients,” Felger and the colleagues at Shannon Clinic in San Angelo, Texas, wrote towards the CMS advisory group.
Last year, Felger said, he sent twelve patients to hospitals in Austin or Dallas for TAVR, while eight other patients opted for the open-heart surgery.
“I have patients let me know they would favour the surgical procedure in their local hospital than visiting another city,” he explained. “They let me know 'Let's do that; basically die, I die.'”