Physicians and institutions that intend to provide transcatheter aortic valve replacement (TAVR) programs should meet criteria that include procedural experience and board certification for surgeons and cardiologists and volume requirements for facilities, according to multi-societal recommendations published March 1 in the Journal of the American College of Cardiology.
The recommendations, many of which are based on expert consensus, also call for the monitoring of complication rates, participation in a national registry and use of a heart team approach that requires an interventional cardiologist and surgeon to be present together throughout critical portions of the TAVR procedure.
“As the procedures evolve, technology changes, experience grows and more data is accumulated, there will certainly be a need to update this consensus statement,” authors representing the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS) and the Society for Thoracic Surgeons (STS) wrote. “However, with the FDA having just approved the first generation of TAVR devices, the writing committee and participating societies believe that the recommendations listed in this report serve as an appropriate starting point.”
Writing committee chair and lead author Carl L. Tommaso, MD, medical director of the cardiac cath lab at Skokie Hospital in Chicago, said in a statement that the medical societies collaborated on the standards in an attempt to ensure optimal care for TAVR patients. “TAVR is a complex procedure that has potential to serve many patients, and it is up to us to deliver the highest standard of care available,” he said.
In the U.S., TAVR is approved for patients with severe aortic stenosis who are deemed unsuitable for open aortic valve replacement (AVR) surgery and who do not have compromising comorbidities after the FDA gave thumbs up to the Sapien transcatheter aortic heart valve (Edwards Lifesciences) in November 2011. In December, the ACC and STS launched a joint registry to track outcomes of TAVR patients in the U.S. The recommendations include participation in a registry as a requirement.
“Long-term outcome reporting is obligatory, in order to track not only survival, but also other parameters including periprocedural complications…, aortic regurgitation, the need for re-intervention, subsequent surgery and quality of life,” Tommaso et al wrote. “This type of reporting is essential, since long-term outcome goals for these new procedures have not been established at this early stage. Participation in a national data registry (e.g. STS/ACC TVT Registry) is mandatory.”
The recommended physician-specific requirements include:
- For the interventionalist, 100 structural procedures (lifetime) or 30 left-sided structural procedures per year, of which 60 percent should be balloon aortic valvuloplasty, and suitable training on the devices that will be used;
- For the surgeon, 100 AVR career procedures (at least 10 high-risk), or 25 AVR per year or 50 AVR in two years and at least 20 AVR in the last year prior to initiating TAVR; and experience with and management of peripheral cardiopulmonary bypass and experience with open retroperitoneal exposure of and surgical intervention on the iliac arteries.
The authors recommended board certification for both cardiologists and surgeons, with cardiologists eligible in interventional cardiology and surgeons eligible in thoracic surgery.
Institutionally, they recommended intervention programs with 1,000 cath/400 percutaneous coronary interventions per year, and institutional surgical programs with 50 total AVR procedures per year (10 high-risk) and at least two cardiac surgeons based at the institution.
“In some ways, these recommendations apply to institutions more than to individuals,” the authors wrote. “Since there is a strong consensus that these new valve therapies are best performed using a team approach, these credentialing criteria may be best applied at the institutional level.”
Recommended facility requirements include:
- For existing programs, 30 TAVR procedures (total experience), ongoing continuing medical education (CME) and participation in a registry.
- For new programs, 20 TAVR procedures a year or 40 TAVR procedures over two years, achievement of several measures such as 30-day all-cause mortality, ongoing CME and participation in a registry.