Ventricular assist devices (VADs) have revolutionized the treatment of cardiac disease in adults, improving survival for end-stage heart failure patients who would otherwise die and offering bridge to transplant. But the same option is not always available for children, especially babies.

The Children’s Hospital at The Cleveland Clinic (Cleveland) is among those working to fill that void. Through a $4.2 million contract from the National Heart, Lung and Blood Institute of the National Institutes of Health (both Bethesda, Maryland), the Cleveland Clinic is developing the PediPump, a rotary VAD about the size of a golf tee that the clinic believes has the potential to save the lives of even the smallest end-stage heart failure patients.

“If, for example, [children] don’t have recovery of their heart or if they are listed for transplantation and no heart donor is available, the child will die, essentially, because there aren’t any long-term support options,” Brian Duncan, MD, associate staff member of the pediatric and congenital heart surgery division at The Children’s Hospital, told Medical Device Daily. “So that’s what this type of research is trying to address.”

Devices to support pediatric patients do exist, Duncan said, but they come with limitations. For example, the DeBakey VAD Child from MicroMed Technology (Houston) is commercially available through a humanitarian device exemption in the U.S. and is CE mark-approved in Europe, but the patient has to be at least five years old.

A commonly used device therapy without size limitations is extracorporeal membrane oxygenation (ECMO). Duncan said that ECMO “basically prolonged use of the heart-lung machine, which is only suitable for two weeks of support at the most.” And there are “a couple of devices that are available in Europe that we can get here [to Children’s Hospital] on a case-by-case basis,” he said, including a pediatric heart-assist device made by Berlin Heart (Berlin).

But the PediPump “really fills a pretty unique niche,” said Duncan, who is principal investigator of the project. “As a clinician, the reason why this is useful is [that] it really, for the first time, provides an alternative for kids, especially for our smallest patients, who have heart failure that we can’t treat with medicines.”

The PediPump is based on a magnetic bearing-supported, rotary dynamic pump developed especially for use in children, including newborns. Measuring just 7 mm in diameter by 70 mm in length, the cylindrical-shaped device is much smaller than traditional VADs. “The main advantage of this pump is that it’s very small,” Duncan said, making the golf-tee size comparison. “It is suitable for the entire size range of patients that we encounter in pediatric heart surgery.” And depending on the particular size of the patient, the PediPump can be implanted inside the heart or, in the case of a newborn, implanted elsewhere in the body, he said. Despite its small size, the PediPump has plenty of power. “It could provide even support for adult-sized patients,” Duncan said, providing pressure and flow far exceeding the requirements for support in the 2 kg-to-25 kg weight range.

The enabling technology of the PediPump is borrowed from an adult catheter pump in development by The Cleveland Clinic’s department of biomedical engineering and Foster-Miller Technologies (Albany, New York). The pediatric version also is designed to be introduced minimally invasively in the cardiac catheterization laboratory, Duncan said. A key design feature, according to Duncan, is that the PediPump has minimal touch points for high durability. The impeller is suspended by magnetic bearings, to minimize wear and “is designed to be as flexible as possible in terms of its potential applications.”

The PediPump is “certainly suitable for short-term support,” Duncan said, adding that “long-term support is also a major goal, and one of the main reasons to make it so small is that we’d like to make it implantable in kids of all sizes.” VADs are often used as bridge to transplant or bridge to recovery, and sometimes as destination therapy in adults. As for the PepiPump’s use in children, Duncan said, “I think a lot of these are going to be bridge to transplant, but bridge to recovery is even better.”

The Children’s Hospital is teaming with biomedical engineers from the Lerner Research Institute of The Cleveland Clinic to develop the PediPump. In the second year of the five-year program, a prototype has been developed and is being readied for testing in animals. Though human clinical trials are not part of the NIH contract, Duncan said that the clinic is exploring further development options.

He noted, however: “It’s too early to tell right now how this will all shake out.” A status report on the PediPump is featured in the July issue of Artificial Organs.

Other organizations also developing pediatric VADs under the NIH grant include a team from the University of Pittsburgh, Children’s Hospital and Carnegie Mellon University (all Pittsburgh); and groups from Penn State University (State College, Pennsylvania); Jarvik Heart (New York); and Ension (Harmar, Pennsylvania).

But Duncan believes the PediPump stands out from the crowd. “We like our design a lot,” he said. “There is a 55-year history of this type at research at the Cleveland Clinic. This type of design is based on that experience.”

New rule for cardiac surgery DRGs

Congress may have hightailed it out of Washington in August for its month-long summer recess and the legislative pace may have slowed, but the regulatory and reimbursement wheels keep turning. The Centers for Medicare & Medicaid Services (CMS; Baltimore) said early in the month that acute-care hospitals that report selected quality data will receive a 3.7% increase in payment rates for inpatient services, 0.5% above the marketbasket projected in the proposed rule published last May. Aggregate payments to inpatient prospective payment system (IPPS) hospitals in FY06 are expected to increase by $3.3 billion compared to this year.

The new rule also reduces the outlier threshold to $23,600 in 2006 from $25,800 in 2005. The threshold determines how much a hospital’s costs for a particular case must exceed the diagnosis-related group (DRG) payment, before extra payments will be made for the case. As a result of the lower threshold, it will be easier for hospitals to qualify for additional payments in 2006.

The rule also includes important changes to the DRGs, which serve as the basis for the payment rates under IPPS, particularly improvements in accuracy of cardiac DRGs. The final rule also revises the payments for long-term care hospitals, which are paid under a separate prospective payment methodology. Only hospitals that participate in Medicare’s quality reporting initiative will receive the full 3.7% increase. CMS said it expects a majority of acute care hospitals to participate in the quality reporting program in 2006.

In order to receive the full payment for FY06, hospitals must correctly abstract and report clinical data on 10 quality measures relating to the treatment of heart attack, heart failure and pneumonia cases for two consecutive calendar quarters. CMS reviewed hospital data submissions and determined that nearly all hospitals were able to meet the quality standards being adopted in this final rule. Many hospitals now are reporting 17 quality measures for these three conditions, the agency said.

The final rule also revises nine cardiovascular surgery DRGs that account for more than 700,000 Medicare discharges per year. The changes announced in the final rule will differentiate cardiac surgery patients based on whether they have a “major cardiovascular condition.” According to CMS, the changes represent a significant improvement in accuracy of the cardiac DRGs. As CMS noted in its report to Congress on specialty hospitals in May, CMS is completing a comprehensive analysis of potential changes in cardiac DRGs for implementation by FY 2007.

Preventive health program unveiled

CMS also unveiled plans for a new program called Medicare Health Support, intended to help beneficiaries with diabetes and congestive heart failure (CHF). Eight Medicare Health Support pilot programs will be offered this year in different areas of the country as free, voluntary programs, for around 160,000 fee-for-service Medicare beneficiaries for three years. “Because early intervention is tremendously important in treating chronic illnesses, we are providing beneficiaries additional tools to help them manage their health more effectively and avoid preventable complications,” said Mike Leavitt, secretary of the Department of Health and Human Services.

Chronic diseases often are the underlying cause of illness, disability and death and account for the majority of Medicare expenditures. For example, about 14% of Medicare beneficiaries have CHF among their chronic conditions, and they account for 43% of Medicare spending. Participation in the health support program will be voluntary and will not affect beneficiaries’ Medicare coverage, their access to medical services or their ability to choose their own doctors and other healthcare providers, CMS said.

The program is being launched at specific facilities in the District of Columbia, Maryland, Oklahoma, Pennsylvania, Mississippi, Georgia, Illinois, Florida, Tennessee, and New York.

House passes medical liability bill

The House of Representatives passed medical malpractice legislation in late July that would limit awards in lawsuits for pain and suffering to $250,000. The bill would not limit economic damages for lost wages or medical expenses. Called “Help Efficient, Accessible, Low-Cost, Timely Healthcare” or “HEALTH Act,” the bill was approved 230 to 194. It now moves to the Senate for approval. The House has approved malpractice reform legislation before, only to see efforts stall in the Senate.

The bill also would limit lawyers’ fees on a sliding scale, based on the size of the award. It would impose a three-year statute of limitations in most cases and would also have a higher threshold for awarding punitive damages.

Proponents of the legislation say rapidly increasing insurance premiums are forcing doctors, especially in high-risk specialties such as obstetrics and neurosurgery to stop practicing medicine. Critics, mostly Democrats, say the $250,000 awards cap is arbitrary and that the limits don’t always work. Many states already have award caps in place. Democrats also predicted that the bill would help make the insurance business more profitable but wouldn’t necessarily bring doctors any economic relief and may well harm patients.

President Bush praised the House for its latest stab at malpractice reform, and said the nation’s liability system is “badly broken,” with frivolous lawsuits driving up costs and threatening access to care. “The medical liability crisis is driving up healthcare costs through higher insurance premiums, higher medical bills, and the practice of defensive medicine,” Bush said. “This crisis also is imposing substantial costs on the federal government and all taxpayers who bear the cost of Medicare and Medicaid.” He called upon the Senate to pass liability reform legislation when it returned from the August recess.

“The liability system diverts billions of dollars from patient care to legal expenses and drives healthcare professionals from their practices,” Stephen Ubl, president of the Advanced Medical Technology Association (Washington), said in a statement. “We believe that our healthcare system needs to focus its spending on the delivery of healthcare, not legal costs and defensive medicine.”

Nasdaq market debuts new healthcare index

Along with launching a new indexing platform, the Nasdaq Stock Market in early August introduced a new index, the Nasdaq Healthcare Index, in response to demand for such an index, it said. “People asked for it,” said John Jacobs, executive vice president of Nasdaq Financial Products. “We’ve had great success with the Nasdaq Biotechnology Index, but ... a lot of healthcare companies have asked for a broader index, a broader benchmark, and since we now have the capability to do that, we did it.”

A market value-weighted index, the new healthcare index contains Nasdaq-listed companies classified as part of the biotechnology, health/medical device or pharmaceutical sectors. The group includes biotech and pharmaceutical companies, as well as medical equipment and supplies, health maintenance organizations, hospital management and long-term care and other healthcare firms. Roughly 15% of the 540 or so firms listed are in the device sector.

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