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Societies Release New Guidance for Transcatheter Valve Repair and Replacement
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Recommendations for transcatheter pulmonic valve replacement for children and adults who were previously treated for CHD should be made by a heart team of interventional cardiologists, cardiac surgeons, noninvasive cardiologists, and cardiac anesthesiologists and radiologists, according to a new consensus statement released by four expert medical societies.
As treatment options continue to advance for patients with congenital heart disease, children with these conditions are living into adulthood and, over time, may need additional treatment. The new statement from the Society for Cardiovascular Angiography and Interventions, the American Association for Thoracic Surgery, the American College of Cardiology and the Society of Thoracic Surgeons addresses recommendations for transcatheter pulmonic valve replacement in this population.
Pulmonary valve replacement may be necessary in patients who have had certain types of congenital heart disease repaired with reconstruction of the right ventricular outflow tract. Transcatheter pulmonic valve replacement offers a less-invasive option for these patients if dysfunction of the repair occurs or if they require a repeat open-heart surgery, according to a press release from SCAI.
“The purpose of the new statement is to outline requirements for both the operator and the institution desiring to conduct this procedure,” writing committee chair Ziyad M. Hijazi, MD, MPH, FACC, MSCAI, acting chief medical officer and chairman of the department of pediatrics at Sidra Medical and Research Center in Doha, Qatar, told Cardiology Today’s Intervention. “If you are a qualified operator in an unqualified institution, or if you are a qualified institution with no qualified operators, you should not undertake this procedure.”
Ziyad M. Hijazi
Institutions at which transcatheter pulmonic valve replacement may be done should perform 150 congenital and/or structural catheterization procedures per year, according to the cardiac case requirements outlined in the statement. One hundred of those procedures should be interventional in nature. Moreover, children’s hospitals or adult programs associated with a children’s hospital should also perform 100 open-heart surgeries per year, while adult programs should perform 25 adult congenital surgical cases per year.
These institutions should have extracorporeal membrane oxygenation; echocardiography, cardiac CT and cardiac MRI imaging capabilities; a cath lab; and hemodynamic evaluation. In addition, institutions should participate in a national registry. Because transcatheter pulmonic valve replacement is a new treatment option, the statement stresses the importance of continuing to collect data on the procedure, including total numbers of replacement performed in the U.S. and numbers of procedures by operator and institution, according to the release.
Individual operators should perform at least 100 interventional cases per year, including 50 congenital and/or structural interventional cases, according to the statement. These operators should also have experience with balloon valvuloplasty, stenting without branch pulmonary arteries and the right ventricular outflow tract.
Peer-to-peer training courses dealing with technique and potential complications are also recommended for operators. Simulated cases are suggested, if available. A proctor should be present for the first three cases of a new operator.
“Increasing evidence shows a team-based approach provides the greatest quality care for patients with complex heart disease, including patients considering transcatheter pulmonic valve repair,” Hijazi stated in the release.
Regarding staffing requirements, the statement recommends a heart team with experience treating the pulmonary valve.
“This is not a simple procedure,” Hijazi said in an interview. “It requires optimal support if the procedure does not go well. We have created these recommendations to provide protection for our patients.” – by Rob Volansky
Disclosure: Hijazi reports financial relationships with Colibri Heart Valve, the PICS Foundation and Venus Medtech.
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