Guidelines outline criteria for transcatheter pulmonic valve replacement

Experts in transcatheter valve replacement offered guidelines for treating pediatric and adult pulmonic valve patients, including the development of multidisciplinary heart care teams to let patients understand the gamut of options from a variety of experienced specialists.

“Our goal is, obviously, to protect our patients so that they will receive such care by expert operators in a great institution without a need to specify to go to Boston or Hopkins or Chicago,” Ziyad M. Hijazi, MD, MPH, chair of the writing committee, said in an interview with Cardiovascular Business. “As long as you meet such criteria, then you can do the procedures without any problem.” 

Hijazi is acting chief medical officer at the Sidra Cardiovascular Center of Excellence at Sidra Medical and Research Center in Doha, Qatar. Last December he offered a few words on the future of pediatric cardiology in a guest editorial in Cardiovascular Business.

The document jointly written by members of the Society for Cardiovascular Angiography and Interventions, the American Association for Thoracic Surgery, the American College of Cardiology and the Society of Thoracic Surgeons is intended as guidance for centers and operators interested in performing transcatheter pulmonary valve repair and replacement on adults and children. This is the third document, so far, on transcatheter valve procedures released by the group.

Among the recommendations put forth in the guidelines, Hijazi and colleagues emphasized the use of heart teams consisting of interventional cardiologists, surgeons, anesthesiologists, radiologists, nurses and other specialists. Hijazi stated that the development of these teams was of particular importance. “We don’t want somebody to decide for a patient based on self-interest," he said. "The whole idea of having a multidisciplinary team is to have a balanced view from different team members so that then the patient can make a good, informed decision about what option they want to choose for their treatment.”

Other recommendations include a minimum of 150 procedures per year, 100 of which are interventional. With the field being relatively young, data are still being collected in registries like IMPACT on the degree to which volume impacts the success of a center when performing pulmonary transcatheter valve procedures. However, Hijazi said experience in other fields shows that with higher volumes comes better outcomes.

“We’ve done the same for the aortic valve and the mitral valve; we put certain minimum numbers in both of the previous two documents,” he said. In this case, “we believe that if you do about 150 cases a year, your outcomes should, hopefully, be good.”

The consensus document also adds that an institution meet certain imaging requirements, whose experts should be part of the heart team. That includes involving echocardiography, radiology, a cardiovascular cath lab or hybrid suite and capabilities for hemodynamic evaluation. Institutions, they insist, must participate in national registries. Further, they emphasized the importance of having extracorporeal membrane oxygenation.

Operators should have experience performing interventions on congenital or structural heart issues, attend peer-to-peer training, initially be supervised by a proctor and, if available, perform a simulated case.

“The take-home message [is] first of all that transcatheter pulmonary valve replacement is here, available for your patients, number one. Number two, for any operator or institution interested in performing these procedures, there is a minimum set criteria you have to meet and they are set out in this document. There is no monopoly. Meet such criteria and you are welcome to be one of the centers and/or operators that are doing these procedures,” Hijazi said.

The guidelines were published online March 24 in Catheterization and Cardiovascular Interventions as well as other journals.