With several ongoing clinical trials and the commercial availability of an FDA-approved valve, inoperable patients with severe symptomatic aortic stenosis now may be candidates for transcatheter aortic valve replacement (TAVR) procedures. Offering this novel therapy may require extra resources but pioneers and relative newcomers agree that it has its rewards.
Take it from a physician who has skirmished for almost a decade at the front lines through the early development and eventual rollout of TAVR in the U.S.: Launching and sustaining a TAVR program is not for the faint of heart. “No matter what you’ve done—abdominal aortic aneurysm to graft to carotid stenting—pales in comparison with how difficult and how intensive this is if you decide to open a TAVR program,” says David L. Brown, MD, medical director of interventional cardiology and transcatheter valve therapy at the Heart Hospital Baylor Plano in Plano, Texas.
Among the trailblazers in the PARTNER trial and now a site principal investigator in PARTNER II, Brown is part of a team that performs six to nine procedures per week. PARTNER was designed to assess the transcatheter aortic valve in two cohorts: inoperable patients with severe, systematic aortic stenosis and aortic stenosis patients at high risk for surgery. The FDA approved the Sapien valve (Edwards Lifesciences) for treatment of inoperable patients in November 2011 and an FDA advisory panel recommended approval for high-risk operable patients in June. PARTNER II is seeking to determine the safety and effectiveness of Edwards’ Sapien XT transcatheter heart valve and delivery systems.
Building staff & infrastructure
As an established TAVR program, the Heart Hospital serves as a demonstration center where other hospitals can send physicians to observe procedures or get insights on hybrid operating room (OR) layouts and logistics. The hospital’s program includes two hybrid ORs, with a third in the works. Many newer programs find they need to ramp up staffing and equipment to meet TAVR requirements.
The Iowa Heart Center at Mercy Medical Center in Des Moines, for instance, offered a hybrid OR and a research department when it became a participant in Medtronic’s CoreValve U.S. Pivotal Trial in 2011. After the FDA’s approval, the center began offering the Sapien valve to their inoperable severe aortic stenosis patients. But Iowa Heart found it needed to beef up staffing, reassess research resources and invest in a marketing campaign to meet the program’s needs, says Julie Younger, MBA, chief administrative officer at Iowa Heart.
The center hired a full-time valve coordinator and a dedicated registered nurse. While they had staff in place in their research department, they soon discovered that they needed to reallocate resources for the CoreValve study to ensure that additional support staff would be available. “The time commitment for the study protocols for this particular patient population was much more labor intensive,” Younger says. “In the past, we might have a research coordinator working on multiple studies, but for this study, we needed a dedicated research coordinator.”
Iowa Heart also realized that it needed to budget for marketing to promote the program in its community and beyond to potential patients and referring physicians. Younger says it hasn’t cost as much as anticipated, but she presumes expenses will rise as they expand their outreach efforts.
The Medical University of South Carolina (MUSC) in Charleston, on the other hand, found that as an academic medical center involved in many clinical trials, it could offer the research and database personnel required to participate in PARTNER II. The center has a hybrid OR, and physicians use a large cath lab to deploy devices, says John S. Ikonomidis, MD, PhD, co-medical director of the MUSC Heart and Vascular Center and chief of the division of cardiothoracic surgery. The facility had budgeted for a hybrid OR with the goal of having it up and running in 2013.
Hello & halo
“One-stop shopping” is how Brown describes the Baylor approach for TAVR patients, whose experience—if all goes well—is a seamless process from their initial contact through follow-up. But the many sequential steps for TAVR to take place need to be well-choreographed and shepherded. The facility’s ancillary staff of nurses, research coordinators, nurse practitioners and medical assistants handles data collection and patient management to keep the program running efficiently.