CHICAGO, Illinois Implanting lifesaving heart pumps in people with severe congestive heart failure (CHF) costs about the same as heart, liver and other transplants, according to a study reported during the American Heart Association's (AHA; Dallas, Texas) annual scientific sessions here in November.But that still begs the question: Are payers, especially Medicare, going to be willing to pay for such devices?
"This is a landmark study because we can finally answer what it costs to put a left ventricular assist device in place. It is a device that many would consider the ultimate treatment for heart failure, a mechanical alternative to the heart," said lead author Mehmet Oz, MD, director of the Cardiovascular Institute and vice chairman of surgery at Columbia-Presbyterian Medical Center (New York).
Mechanical heart pumps, or left-ventricular assist devices (LVADs), can significantly improve survival and the quality of life of patients with end-stageCHF. According to Oz, the new finding poses public policy questions about paying for expensive new devices in light of rising concerns about healthcare costs. "The LVAD has clearly been shown to save lives," he said. "But are we, as a society, willing to pay the costs to save these lives?"
The investigators analyzed the medical and cost records of 68 patients who received LVADs during the the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial, a multicenter trial sponsored by the National Institutes of Health (Bethesda, Maryland) and Thoratec (Pleasanton, California), maker of the HeartMate VE device used in the study.The company recently received FDA approval for the device as an alternative to transplant for the treatment of end-stage congestive heart failure and already had an approval as a bridge to heart transplant, which it received in 1998.
The researchers divided the LVAD patients into four groups, or quartiles, according to the cost each person incurred while hospitalized. They didn't initially include the cost of the HeartMate, which is about $65,000.With recent data that included the device cost, Oz added, the researchers arrived at a mean cost for the LVAD treatment of $202,734, and a median cost of $141,835. He said the major contributors to hospital costs were time spent in the intensive care unit or a regular hospital bed (39%), pharmacy expenses (15%), supplies (14%) and diagnostic procedures (11%).
The time LVAD or organ transplant patients in the middle two quartiles spent in the hospital ranged from 16 to 55 days. These patients represented the type of person most likely to receive an LVAD in the future, he said. Several factors predicted how long patients would stay in the hospital. For example, patients who developed general or device-related infections tended to have longer hospital stays. The infection rate can be reduced, Oz said, which would lower the procedure's cost.
"The major implication of this study is that we have a life-saving technology that is going to be expensive to deliver," he said. "The question we have to address as a society is whether it is worth the expense to put these devices in patients. Our study tells us that these costs are comparable to heart transplantation and liver transplantation ($205,000 and $250,000), which society is already willing to pay for." Oz added, "The costs, from my perspective, are less than many would have expected at such an early stage with a device like this." He said, "Improving management of these critically ill patients will substantially reduce the costs of this evolving technology."
According to Keith Grossman, president and CEO of Thoratec, without the cost associated with sepsis infections, the price of the procedure would have been significantly lower. "The median patient care cost would have been $79,000," he told Cardiovascular Device Update in an interview at the AHA sessions in the sprawling McCormick Place convention center. "Now, you're never going to [completely) get rid of infections," he acknowledged, "but we've learned how to better manage them though a series of pretty simple guidelines. I think the infection rate you saw in REMATCH is the highest you'll ever see."
Grossman also noted that the HeartMate has shown promise as a tool for vascular recovery, whereby use of the pump serves to strengthen the heart muscle, and ultimately, patients are weaned from the device.
The patients in REMATCH had the most severe form of CHF. They had also been dependent on heart-stimulating drugs to keep them alive within the prior three months, had a history of hospitalizations for their disease, and were ineligible for a heart transplant because of age, a previous cancer or other conditions unrelated to their heart.
The three-year, randomized trial compared 68 LVAD patients to 61 patients who received the optimal medical care available for CHF. Researchers reported at the 2001 AHA meeting in Anaheim, California, that the probability of one-year survival for those in the LVAD group was 52% vs. 25% for patients treated with medication only. Two-year survival rates were 23% for those with LVADs and 8% for those on medicine only.
"The most common question asked after our report was: 'What are the costs?'" Oz said. "This is the first of a series of documents to explain the costs and get to the root question of whether it is worth it for society to invest money in this technology."He said that the device has the potential to be used in a younger patient population, and echoing Grossman's sentiments, he said LVADs could have even more favorable and cost-effective results in healthier individuals than those represented in the REMATCH trial.He added that the issue of reimbursement ultimately boils down to one question: "What is the price of a human life?"
Grossman said that he believes this cost data greatly strengthens the company's case for reimbursement of the HeartMate for destination therapy, and he expects approval hopefully "if not by mid-year , then maybe the third quarter or fourth quarter at the latest." He said that Thoratec already has submitted a premarket approval supplement for the next-generation device, the HeartMate XVE.
Device durability debated
In addition to Oz's presentation of the study results, the AHA set up a press conference in which he debated the use of VADS in treatment of CHF, facing off against Stuart Katz, MD, associate professor of medicine at Yale University School of Medicine (New Haven, Connecticut).
While acknowledging that he shared a good deal of enthusiasm about the VAD devices, Katz questioned their ability to replace the function of the normal human heart. He said the normal human heart is an amazing organ that beats about 100,000 times a day without rest and pumps one to two gallons of blood every minute or about a million gallons of blood every year. "As you can imagine," he said, "it's hard to design a mechanical device that can match the durability and capability of the human heart."
He questioned the longevity of the current generation of VAD devices, saying they are better suited for short-term use as a bridge to heart transplantation. At two years, which was the end of follow-up for the REMATCH trial, he said, "there was a high rate of device failures and a large number of patients also had to have their devices replaced."
Katz said that he would need to see longer-term data on durability of the devices in order to decide whether VAD implantation is really as cost effective as heart transplantation. He said that currently, cardiac transplantation has a five-year survival rate of 50% to 70%, and openly questioned whether VADs could match that success rate.
As alternatives to long-term VAD transplantation in end-stage patients, Katz suggested several strategies that are just as cost-effective, including prevention. "If we could just get more of the American population to adopt the lifestyle recommendations in terms of diet and exercise, we would go a long way in preventing heart failure," he said. Katz added that optimal use of currently approved medications for the treatment of high blood pressure and coronary artery disease can reduce the risk of CHF and are extremely cost-effective.
Katz said that while he views the use of mechanical VAD as a useful tool in the near-term, in the long run, biotechnology would rule the day. "I propose that the future of heart failure treatment is not a mechanical device, but rather, biological repair of the injured heart." He said that early studies, including some at the same AHA meeting, indicate that within the bone marrow of normal adults exists a population of stem cells that could be used to replace injured heart tissue.
In a rebuttal, Oz questioned many of Katz's alternative solutions to the use of VADs, at times, good-naturedly ribbing him about some of them.
"Many of these biologic solutions that Dr. Katz addressed are in the future, and many of them will stay in the future," he said. He added that there has been "a history of hope, sometimes desperate, that we can find easy solutions to this very complex problem." Oz said that eventually VADS also will be used in a younger patient population and that the longevity of the devices will greatly improve, and he noted that in the near future, the devices will have at least a five-year lifespan, if not higher.
"The ultimate organ to replace. . . is the heart," said Oz. While he acknowledged that the heart also has some hormonal impact, "it's basically a pump. And although this may not be the ultimate solution, iterations of this may be, and certainly we have a long future of possible outcomes to follow."
He argued that since the cost of the implantation of the device is comparable to that of heart and liver transplantations, other lifesaving operations, society should embrace the VAD technology."Historically," he noted, "our society has always paid for lifesaving initiatives if we could prove that they were lifesaving," something Oz contended the REMATCH trial and other studies have already proven.
Carotid stenting with emboli protection
In another press conference, this one on late-breaking clinical trials, doctors presented data from two significant studies for the first time.In one controlled study, researchers looked for the first time at how stenting in the neck (carotoid) arteries combined with a new filtering device prevents blood clots and particles from reaching the brain and causing strokes. In another presentation, investigators looked at whether a quality improvement program on coronary artery bypass graft (CABG) procedures was effective.
Jay Yadav, MD, of the Cleveland Clinic Foundation (Cleveland, Ohio), reported on 30-day data from the Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy (SAPPHIRE) trial, a large, randomized, controlled comparison of stenting vs. surgery in patients with clogged arteries. The trial enrolled 749 patients for three years at more than 30 institutions.
The randomized arm of the study contained 307 patients, of which 156 were treated with a combination of a Cordis (Miami Lakes, Florida) Precise Nitinol self-expanding stent and an AngioGuard XP Emboli Guidewire filtering device. The remaining 151 patients in the randomized arm underwent a carotid endarterectomy, in which arterial plaque buildup is removed.The 409 patients who were turned down for the study were enrolled in a stent registry where the 30-day major adverse event (MAE) rate was 7.8%. Additionally seven patients were turned down for intervention and enrolled for surgery with a 30-day MAE rate of 14.3%.At 30-day follow-up, the MAE defined as death, stroke or myocardial infarction for the randomized stented group was 5.8% vs. 12.6% for the endarterectomy-treated patients.
"Surgery is still the most common procedure to improve blood flow in the carotoid artery," Yadav said. "Right now, we estimate that approximately 200,000 people undergo carotid endarterectomy in North America each year."
He said that both surgery and traditional stenting carry risks of creating blood clots or dislodging particles from fatty deposits that they seek to clear. Such particles, he said, can travel to the brain and cause strokes. To reduce that risk, the artery is clamped down while the atherosclerotic plaque is cut out during surgery. "The potential significance of this study is very large because we are looking at a procedure that is less invasive and applicable to a wider group of patients than traditional carotid surgery. So it may have a very significant impact on stroke prevention."
In the investigational procedure, the AngioGuard, a tiny wire tipped with a collapsed filter, is threaded across the area of blockage. Once across the blockage, the umbrella-like tip is expanded and left open as the balloon-tipped catheter is threaded into the vessel and expanded to widen the arterial channel. The filter remains unfurled while the stent is inserted and captures any loose particles that would otherwise have gone to the brain.
Interestingly, to qualify for the procedure via the trial protocol, a patient had to have a consultation with a neurologist, a vascular surgeon and an interventional cardiologist. If all the physicians were in agreement that the patient could have either procedure, the patient was randomized to either stenting or endarterectomy. The trial was sponsored by Cordis' parent, Johnson & Johnson (New Brunswick, New Jersey).
Quality improvement studied
In the other study of note, Bruce Furguson Jr., MD, a professor in the departments of surgery and physiology at the Louisiana State University Health Sciences Center (New Orleans, Louisiana) and chairman of the Society of Thoracic Surgeons' (STS; Chicago, Illinois) Council for Quality Assurance and Patient Advocacy, reported on the effectiveness of a nationwide quality improvement program.
The study, called the Continuous Quality Improvement in Coronary Artery Bypass Grafting (CQI in CABG) trial, uses information from the National Cardiac Database, compiled by the STS and funded by STS member surgeons and the hospitals at which they practice. The database contains information on more than 2 million adult cardiac surgeries performed in the U.S.
The trial seeks to determine if a targeted feedback and multi-faceted educational approach can change clinical practice. In addition to the standard twice-yearly feedback, the trial includes a call to action sent to a physician leader at medical centers targeted for intervention as well.
"The society started the national database as a voluntary system to measure outcomes in adult cardiac surgery," Furguson said. "In conjunction with the Duke Clinical Research Institute [Durham, North Carolina], we have transformed the National Cardiac Database into a national platform for quality improvement that is approved and endorsed by the physicians involved in the care of these patients."
In the study, the medical centers were divided into three groups, which were followed for 18 months. The first group was encouraged to give patients beta blockers before a CABG procedure. The second group was encouraged to use the internal mammary artery (IMA) rather than a vein from the leg in patients more than 75 years of age. The third group, the control group from 115 medical centers, got feedback but no special education programs to encourage clinical changes. So far, overall use of both process measures increased (beta blockers, 59% to 67%; IMA; 74% to 85%).
At least 250,000 CABG patients from 359 medical centers are slated for enrollment in the trial.
"This could be the first randomized trial of quality improvement of this scope to be successful," Furguson said. "It's the first one ever attempted by a medical specialty society on a national level." Additionally, he believes this study may have much broader implications. "We think we have come up with a successful formula, one that may provide a template for the rest of medicine."
In other news from the AHA meeting:
Boston Scientific (Natick, Massachusetts) reported on 30-day safety data for the complete study population of its TAXUS IV clinical trial, following 1,326 patients at 74 sites in the U.S. to assess the safety and efficacy of its slow-release formulation paclitaxel-eluting Express stent. In September, the company reported 30-day safety data for 1,172 of the 1,326 patients, and the company said that the additional 154 patients reported on "all had longer, more complex lesions." The results supported safety, as demonstrated by overall 30-day major adverse cardiac events rates of only 3%. Stent thrombosis rates were less than 0.5%. The randomized, double-blind, pivotal trial is designed to assess the safety and efficacy of the Express device in reducing restenosis in de novo lesions up to 28 mm in length and up to 3.75 mm in diameter. The Express stent was approved in September by the FDA and granted the CE mark last year.
Stephen Ellis, MD, the trial's co-principal investigator, said the study "offers additional preliminary evidence that polymer-based, paclitaxel-eluting stents appear to be a safe treatment for coronary artery disease." He said the long-term safety and efficacy data will be presented next summer.
Boston Scientific also reported 12-month clinical follow-up data from its TAXUS I trial, assessing the safety of the slow-release formulation. It reported zero thrombosis and zero restenosis at six months. At 12 months, intervention rates remained, it said, "extremely low, with only one target vessel revascularization reported in the paclitaxel-eluting stent group, compared to four events reported in the bare stent control group."
Epix Medical (Cambridge, Massachusetts) a developer of agents for magnetic resonance imaging (MRI), made several presentations at the AHA meeting. Michael Webb, CEO, said that the studies all offered preclinical data supporting the company's thrombus program. "The use of MRI to obtain images of thrombus represents a major advance from clot detection methods currently in use. Further study may demonstrate that MRI, combined with Epix' thrombus agent, could provide a more effective way to diagnose thrombus throughout the body, with one injection, addressing imaging needs for deep vein thrombosis, pulmonary embolism and cerebrovascular or cardiovascular thrombosis, as well as other types of thromboembolic disease."
The agents, currently being studied in animals, are in a final stage of optimization before filing an investigational new drug application and initiating human studies.