Treatment for congenital heart disease (CHD) has advanced considerably over the years, allowing for more children with CHD to live into adulthood. Despite these advances, CHD patients may require additional treatment over time. Pulmonary valve replacement may be necessary in patients who have had certain types of CHD that was repaired with reconstruction of the right ventricular outflow tract (RVOT). As patients with CHD live longer, dysfunction of the repair can occur. In the past, these patients would require a repeat open-heart surgery. Fortunately, transcatheter pulmonic valve replacement (TPVR) has emerged as a less invasive treatment option for many of these patients.
Transcatheter valve treatments like TPVR are allowing clinicians to offer less invasive options to CHD patients who were previously treatable only with open heart surgery or may not have been eligible for treatment. These procedures are complementing standard surgical approaches, allowing physicians to provide more options for patients. The medical community has recognized the applicability, effectiveness, and practicality of transcatheter valve therapies, which in turn has fueled interest in these treatments.
Reaching a Consensus
Recently, an expert consensus paper was released by the Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, American College of Cardiology, and Society of Thoracic Surgeons to provide guidance on TPVR for children and adults who were previously treated for CHD. The consensus paper was published simultaneously in Catheterization and Cardiovascular Interventions, the Journal of Thoracic and Cardiovascular Surgery, the Journal of the American College of Cardiology, and Annals of Thoracic Surgery. A committee of cardiac surgeons and interventional cardiologists developed the recommendations.
The consensus paper outlines criteria for operator and institutional requirements to help enable institutions and providers to participate responsibly in this new and rapidly developing field (Table 1). “Given the high-risk nature of these interventions and the availability of alternative options with traditional surgical approaches, several considerations are important for institutions and operators planning to implement these new technologies,” says Carlos E. Ruiz, MD, PhD, who was a member of the writing group that developed the consensus paper. “Defining operator and institutional requirements for these novel therapies is an important first step to ensuring that implementation is optimized.”
The consensus document stresses that TPVR treatment recommendations should be made by a multi-disciplinary Heart Team consisting of interventional cardiologists, cardiac surgeons, noninvasive cardiologists, and cardiac anesthesiologists and radiologists. “This collaboration can increase quality of care for patients with complex heart disease, including those considering TPVR,” Dr. Ruiz says. It can help clinicians determine the best treatment option for each individual patient.
The Heart Team should be actively engaged in the treatment of congenital and/or structural heart disease and should have experience in treating conditions of the pulmonary valve, pulmonary arteries and the RVOT. Each case should be discussed among Heart Team members. Furthermore, the institution should have extracorporeal membrane oxygenation (ECMO) capabilities for the rare patient who may require such support.
The consensus paper also recommends that institutions offering TPVR perform at least 150 congenital or structural catheterization procedures per year. Of those, 100 should be interventional in nature, including but not limited to stenting of branch pulmonary arteries and RVOT. Furthermore, the institution should perform a minimum of a 100 open heart surgeries in patients with CHD if it is a children’s hospital or an adult program associated with such a hospital. Adult programs should perform a minimum of 25 adult-congenital surgical cases per year.
Physicians performing TPVR are also recommended to have experience with balloon valvuloplasty and stenting within pulmonary arteries and RVOT. Additionally, the consensus document recommends that physicians attend peer-to-peer training and simulated cases if they are available. The first three procedures performed should be under the guidance of an experienced physician.
Institutions are recommended to have echocardiography, cardiac CT, and cardiac MRI imaging capabilities (Table 2) when performing TPVR. A cardiovascular catheterization laboratory is needed and clinicians should evaluate hemodynamic components, such as blood pressure and electrocardiography. “It’s also critical to track outcomes and performance with these procedures,” says Dr. Ruiz. “Institutions should participate in a national registry that collects data on all patients undergoing TPVR. This data can be used to follow patient outcomes and compare them with patients who undergo traditional surgical approaches.”
As experience with TPVR increases over time, complication rates are declining significantly. “This reflects the importance of experience in improving patient outcomes,” Dr. Ruiz says. “The consensus paper on operator and institutional requirements for TPVR can help ensure that these procedures are optimally implemented in hospitals throughout the country.”
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