First US Implantation of DeBakey Ventricular Assist Device
Surgeons at Baylor College of Medicine performed the first US implantation of the miniature DeBakey ventricular assist device (VAD) June 7, 2000, on a 31-year-old woman at the Methodist Hospital in Houston. The brainchild of heart surgeons Michael E. DeBakey, MD, Baylor’s chancellor emeritus, and George Noon, MD, and developed with the help of the National Aeronautics and Space Administration (NASA), the assist pump appeared to be working well days after the operation took place.
Dr Noon implanted the device while Dr DeBakey watched. The device has already been implanted in 32 patients in Europe, where it is approved for use in 13 centers in 6 different countries. However, the US Food and Drug Administration (FDA) gave conditional approval for the first US use of the assist pump in late May. After 5 patients receive the pump, its developers and the company that owns the pump (Houston-based MicroMed Technologies) will have to answer a set of questions from the FDA. The agency will base its decision about expanded trials on the answers to those questions.
Dr DeBakey, who performed the first successful implantation of a left VAD in 1966, said he found the use of his new device “very gratifying.” The pump is no bigger than a fountain pen and is battery powered. It weighs no more than 4 ounces, but it can pump as much as 8 liters of blood a minute.
The DeBakey VAD is an axial flow pump. A titanium inflow tube attached to the apex of the left ventricle bends beneath the heart, carrying oxygenated blood from the left ventricle through the pump and out through a flexible Dacron graft attached to the ascending aorta. The pump is powered by 12-volt batteries that the patient carries in a shoulder bag.
“It has been over 12 years since Dr George Noon and I first started to develop our pump with NASA engineers at the Johnson Space Center and NASA Ames Laboratories,” DeBakey said. “We are very pleased to be able to start the US clinical trials in Houston. This is further progress toward offering hope to the tens of thousands of patients who suffer from heart failure.”
The FDA has approved study of this heart assist pump as a “bridge to transplant,” but Dr DeBakey said he hopes the device will eventually prove itself as a “bridge to recovery” in some patients and as a permanent implant in others. With no more than 2500 donated heart available yearly, as many as 30% of patients awaiting transplants die before a donor can be found, said Dr Noon. This artificial organ could be used to permit those patients to live as normal a life as possible.
The DeBakey VAD is small enough to be used in women and some children, noted Dr DeBakey. He said a smaller device could be developed for infants as well. This VAD provides a continuous flow of blood, unlike the larger pulsatile devices that were previously approved. It is much smaller than those devices as well.
Dallas Anderson, president and chief executive officer of MicroMed Technologies, said the pump has run continuously for 2.5 years in trials with animals, and he predicted that it will last at least 5 years or longer. Anderson said he hopes that the pump will have a lower price than current VADs on the market, which can cost from $60 000 to $75 000.
CIGNA Drops Out of Some Medicare HMO Markets
CIGNA Health Care announced on June 2, 2000, that it was dropping out of the Medicare HMO business in most areas of the country because of reduced federal reimbursements for the care it was providing. Its announcement put it in the ranks of many such health plans that have dropped out of the Medicare managed care market in the past 18 months.
Experts estimate that as many as 1 million of the 6.5 million older Americans enrolled in Medicare HMOs could be scrambling for a new health insurer by next January. Companies say that reduced reimbursements under the congressional 1997 Balanced Budget Act make the business unprofitable. Medicare HMOs have been the showcase for the federal Health Care Administration’s attempts to reduce the costs of Medicare.
Less than a week after CIGNA’s announcement, an analysis by the Corporate Research Group, a New Rochelle, NY-based publishing group, found that HMO executives overall had a 14% increase in compensation. According to the report, CIGNA chairman Wilson Taylor, who retired in February, was the highest paid managed care executive in 1999 at $7.5 million. Next in line was William McGuire, chief executive of UnitedHealth Group at $4.8 million.
Outpatient Prospective Payment System Start Date Delayed Until August 1
The federal Health Care Financing Administration has postponed implementation of its controversial outpatient prospective payment system (PPS) until August 1, 2000, a month’s delay over the July 1 planned start. In a missive posted on the agency’s website in early June (www.hcfa.gov), its administrator Nancy-Ann Min DeParle said the agency had failed to meet several milestones important to the implementation of the plan.
She noted that informal surveys of the hospital community demonstrated that many institutions were themselves unprepared to begin the program on July 1. As a result, she wrote,
“Claims received for outpatient services rendered on or after August 1, 2000, will be paid under the new PPS. Claims received for outpatient services provided before August 1 will be paid under current rules.”
In order to assure that beneficiaries are charged the correct co-insurance, I have asked the major hospital associations to help us urge the hospital industry not to collect deductibles or co-insurance from Medicare beneficiaries beginning August 1 until we notify them of the correct amount. In this way, we can ensure that most beneficiaries will be charged the correct, generally lower, co-insurance amounts when hospitals’ claims are processed in August.
We understand that beneficiaries will need information about how the new system will affect them and we have a plan to communicate with them. In July, we will begin working together with hospitals to inform beneficiaries that changes in Medicare payments for hospital outpatient department services could mean changes in the amount of coinsurance that they will need to pay.“
On May 24, the Association of American Medical Colleges (AAMC), the American Hospital Association, and other industry groups requested the delay in a letter to the agency. Under the plan, the AAMC noted, major teaching hospitals with ≥100 residents will see an increase in their payments of 2.6% per year whereas overall hospital payments are expected to increase 4.6%. The Balanced Budget Refinement Act of 1999 mandated the increases as a transition for hospitals that were expected to see a decrease in payments under PPS.
The AAMC, in a briefing paper, noted that although the PPS included adjustments for geographic wage differences, it included no payment adjustment for teaching hospitals. Patient groups have championed the PPS for outpatient services because it is expected to reduce costs for those covered by Medicare. However, hospitals, physicians, and various other groups have opposed provisions of the new rules because, on an individual basis, they do not pay for some services considered essential and they do not provide adjustments for special circumstances.
- Copyright © 2000 by American Heart Association