When Hospitals Say I do to TAVR
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.
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.
“We grew this from ground zero when we didn’t have any idea what we were doing,” Brown says.
Care coordination also has been a learning experience for MUSC. “We had the trial data aspect of it covered,” says Ikonomidis. “But we really needed infrastructure to handle the patients, appointments and studies.” They hired a full-time employee to assist with scheduling and coordination. A research facility with less developed infrastructure might have to engage up to three to five additional full-time employees, Ikonomidis estimates.
From the hospital’s perspective, TAVR may or may not be a money-making proposition. It is expensive to start with no guarantee that it will turn a profit, says Ikonomidis. While TAVR requires many tests and procedures—a potential revenue generator—patients may already have undergone some studies such as echocardiograms before referral. The Heart Hospital will order new scans if it is not confident in the quality of the previous studies and then it may absorb the cost, much to its administration’s consternation, Brown says.
But TAVR offers other benefits, including the potentially lucrative “halo effect,” a phenomenon that all three institutions have observed. If patients approach the hospital seeking a TAVR procedure but don’t fit within the regulatory indication, they still may require care.
“It is a piece of the pie that we throw back to our hospital administrators to explain why we should embark on this money-losing proposition,” Brown says. “Sometimes, you can line up the numbers so it is convincing and sometimes you can’t. For it to have a significant impact, you have to be a high-volume center.”
Iowa Heart’s TAVR program, which totaled 35 procedures as of August, hasn’t been profitable but is close to breaking even, Young says. “We can’t quantify the number of cases and additional revenue,” she says. “It has been an investment in new technology and a way to support patients going forward. We look at it from an investment perspective.”
TAVR may not fall on the plus side of Iowa Heart’s financial ledgers, but it has proven to be an asset for recruiting physicians. Iowa Heart places physicians in outlying areas that may be as far as 60 miles from Des Moines. Although they may not directly participate in the TAVR program, knowing that they would be associated with a system that offers the procedure draws job candidates, Young says. “Once they are here and see the program, we’ve had good success with recruitment.”
MUSC’s program is too new to impact recruitment, Ikonomidis observes. But he adds that it likely helped with retention by keeping some cardiologists on board who were weighing other options. The status, stature and reputational boost spills over to opportunities for the individual physicians, such as participation at national meetings, speaking requests and invitations to serve on executive committees, says Brown.
The greatest gain is the ability to offer patients a procedure that can transform their lives, says Young, recounting a recent reunion of Iowa Heart’s TAVR patients. The attendees described experiences such as dancing at a granddaughter’s wedding or going shopping—a far cry from their previous frail conditions and limited quality of lives.
Brown marvels at the continual lessons learned with TAVR. Despite his years of experience, he still encounters cases that surprise and challenge him. “For me, this has changed everything I used do,” he says.
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.“We grew this from ground zero when we didn’t have any idea what we were doing,” Brown says.
Care coordination also has been a learning experience for MUSC. “We had the trial data aspect of it covered,” says Ikonomidis. “But we really needed infrastructure to handle the patients, appointments and studies.” They hired a full-time employee to assist with scheduling and coordination. A research facility with less developed infrastructure might have to engage up to three to five additional full-time employees, Ikonomidis estimates.
From the hospital’s perspective, TAVR may or may not be a money-making proposition. It is expensive to start with no guarantee that it will turn a profit, says Ikonomidis. While TAVR requires many tests and procedures—a potential revenue generator—patients may already have undergone some studies such as echocardiograms before referral. The Heart Hospital will order new scans if it is not confident in the quality of the previous studies and then it may absorb the cost, much to its administration’s consternation, Brown says.
But TAVR offers other benefits, including the potentially lucrative “halo effect,” a phenomenon that all three institutions have observed. If patients approach the hospital seeking a TAVR procedure but don’t fit within the regulatory indication, they still may require care.
“It is a piece of the pie that we throw back to our hospital administrators to explain why we should embark on this money-losing proposition,” Brown says. “Sometimes, you can line up the numbers so it is convincing and sometimes you can’t. For it to have a significant impact, you have to be a high-volume center.”
Changing lives
Ikonomidis, whose center performed seven TAVR procedures in its first five months, notes that his volume on aortic valve replacement increased while his cardiology colleague and fellow director has experienced a significant bump in referrals. “Both cardiology and cardiothoracic surgery have benefitted from TAVR from the standpoint of patient volume,” he says.Iowa Heart’s TAVR program, which totaled 35 procedures as of August, hasn’t been profitable but is close to breaking even, Young says. “We can’t quantify the number of cases and additional revenue,” she says. “It has been an investment in new technology and a way to support patients going forward. We look at it from an investment perspective.”
TAVR may not fall on the plus side of Iowa Heart’s financial ledgers, but it has proven to be an asset for recruiting physicians. Iowa Heart places physicians in outlying areas that may be as far as 60 miles from Des Moines. Although they may not directly participate in the TAVR program, knowing that they would be associated with a system that offers the procedure draws job candidates, Young says. “Once they are here and see the program, we’ve had good success with recruitment.”
MUSC’s program is too new to impact recruitment, Ikonomidis observes. But he adds that it likely helped with retention by keeping some cardiologists on board who were weighing other options. The status, stature and reputational boost spills over to opportunities for the individual physicians, such as participation at national meetings, speaking requests and invitations to serve on executive committees, says Brown.
The greatest gain is the ability to offer patients a procedure that can transform their lives, says Young, recounting a recent reunion of Iowa Heart’s TAVR patients. The attendees described experiences such as dancing at a granddaughter’s wedding or going shopping—a far cry from their previous frail conditions and limited quality of lives.
Brown marvels at the continual lessons learned with TAVR. Despite his years of experience, he still encounters cases that surprise and challenge him. “For me, this has changed everything I used do,” he says.
| Economists: Stick with Inoperable Patients |
| Many physicians see transcatheter aortic valve replacement (TAVR) as a valuable treatment for patients with severe aortic stenosis, but from a payer’s perspective, it may not be good use of funding in high-risk operable patients, according to health economists at a federal advisory organization in Belgium. Based on an analysis of TAVR in Belgium, researchers concluded that the procedure made economic sense as reimbursement for inoperable patients, with anatomically inoperable patients in the group most likely to reap benefits. They recommended against reimbursement for Belgium’s high-risk operable patients. Mattias Neyt, PhD, a health economist at the Belgian Health Care Knowledge Center in Brussels, and colleagues analyzed the cost-utility of TAVR in Belgium to provide policymakers with information for determining the procedure’s reimbursement. Using data from the PARTNER trial, they calculated an incremental cost-effectiveness ratio (ICER)* of more than $1 million (€750,000) per quality-adjusted life year (QALY) gained for high-risk operable patients with severe aortic stenosis (BMJ online May 7). The ICER dropped to approximately $64,000 (€44,900) per QALY in inoperable patients, and was most cost-effective for anatomically inoperable patients, at approximately $14,000 (€10,000) per QALY. Physicians may correctly argue that TAVR is an alternative with similar outcomes for high-risk patients, Neyt adds, but physicians are not accounting for costs. “If economic considerations are taken into account, the conclusion would be completely different,” he argues. “It would be irrational to pay more for something that is not better. However, patients and physicians may forget this argument since society is paying for it.” The BMJ authors found fault with the PARTNER design, which they wrote had an imbalance between its two inoperable patient groups. They argued the control group had more comorbidities and the TAVR group had more patients deemed inoperable because of anatomical reasons such as the effects of radiation or chest wall deformities. In their cost-utility study as well as a follow-up analysis, they pointed out what they considered a lack of transparency (BMJ online July 31). They cited unpublished negative results from the Continued Access study and a lack of response from the clinical trial’s sponsor, Edwards Lifesciences, when Belgian investigators wrote seeking additional data. “We are very disappointed,” says Neyt, adding that the argument that the information is confidential or proprietary dodges the issue. “It should be published and people should look further than just the positive trial.” *ICERs are in August 2011 dollars |