Skokie, IL - Operators and hospitals have been waiting with bated breath for the chance to offer patients less invasive aortic-valve replacement. Now a new consensus document, published yesterday, is setting out what the requirements should be for operators and institutions who want to start or maintain a transcatheter valve program.
In part 1 of the new consensus statement, which concerns itself solely with transcatheter aortic-valve replacement (TAVR), the Society for Cardiovascular Ang iography (SCAI), the American Association for Thoracic Surgery (AATS), the American College of Cardiology Foundation (ACCF), and the Society of Thoracic Surgeons (STS) outline the requirements to "enable institutions and providers to participate responsibly in this new and rapidly evolving field." In early November, the US Food and Drug Administration approved the first-ever transcatheter valve for the treatment of inoperable aortic-stenosis disease, the Sapien (Edwards Lifesciences).
"No one individual, group, or specialty possesses all the necessary skills for best patient outcomes," according to the new SCAI/AATS/ACCF/STS consensus statement. "The overarching goal of these programs must be to provide the best possible patient-centered care."
To heartwire , Dr Carl Tommaso (NorthShore University HealthSystem, Skokie, IL), the chair of the writing committee, said that the take-home message is that TAVR "really needs a well-oiled, efficiently run, multidisciplinary team." The critical cornerstone for establishing the transcatheter valve program, he said, is a formal collaboration between the interventionalists and surgeons, as well as other key providers such as anesthesiologists, radiologists, and noninvasive cardiologists, among others. The interventionalists and the surgeons should be present together for the critical portions of the procedure.
"This is a new procedure," said Tommaso. "This is a technology in its infancy. Because of the sophistication and the complexity of the procedure, it requires a lot of different minds. These procedures, if they're done peripherally, require sheaths that are at least 24 French, which is close to 8 mm, so it's a big sheath, and not all arteries can take it. Part of the problem is not only getting these things in, but also getting them out. So you need vascular surgeons who are comfortable with going in and repairing femoral arteries, doing femoral cut-downs, that sort of thing. And some of these are going to be done through the chest, so you're also going to need surgeons who are capable of going into the left ventricle to access the aortic valve."
For those participating in a new program, the clinicians performing the procedures, regardless of their specialty, should possess extensive knowledge of valvular heart disease, hemodynamics, appropriate diagnostics, optimal medical therapy, the application and outcome of invasive therapies, and procedural and perioperative care.
"You need a team," said Tommaso. "There are going to be a lot of people around the table."What type of facility is needed?
Regarding the facilities, experts state that the hospital should have an active valvular heart disease program with at least two surgeons experienced in valvular surgery. The hospital should also have a cardiac catheterization laboratory or hybrid operating room/catheterization lab; access to noninvasive imaging, such as echocardiography, vascular laboratories, or computed tomography; and a postprocedure intensive-care facility. To heart wire , Tommaso said a large catheterization laboratory would likely be sufficient, but an upcoming ACCF/SCAI 2012 Clinical Expert Consensus Document will soon release standards on the specifications for a hybrid catheterization laboratory/operating room.
There are no specific guidelines outlining how many procedures need to be performed before a clinical center/operator becomes proficient in TAVR, but given the complexity of the percutaneous replacement, they should be performed only in centers that currently and routinely perform large volumes of surgical aortic-valve operations.
To define a level of pre-TAVR competence, the experts recommend implementing TAVR programs at centers performing at least 1000 catheterizations/400 PCIs annually with TAVR interventionalists who have performed 100 structural procedures over their lifetime or at least 30 left-sided structural procedures per year. For surgical centers, they recommend a minimum of 50 aortic-valve replacements annually and surgeons who have completed 100 valve replacements over their career, with at least 10 considered high risk. An experienced TAVR program is defined as a center that has performed at least 30 procedures.
"Part of the problem that we have had all along is that there are no data," said Tommaso. "A lot of this is based on consensus, that's why it's a consensus document. There aren't any data out there to say, 'Looking at the complication rate, the risk goes down after this many procedures.' We took our best guess flying by the seat of our pants."
Tommaso said that one of the goals in recommending that relatively high-volume centers perform TAVR procedures is that they will generate a sufficient volume of patients who are suitable for a percutaneous procedure. This will allow clinicians to gain experience and to generate sufficient volume for the collection of data.
|Tommaso reports no conflicts of interest. Disclosures of the writing committee and reviewers are listed in the consensus statement.|
Heartwire from Medscape © 2012
Cite this: TAVR program how-to: Consensus statement outlines requirements - Medscape - Mar 02, 2012.