The Artificial Heart Prototypes, Policies, and Patients (1991) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-13
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From page 1... ...
Until now, transplantation has been the only effective treatment for most end-stage heart failure patients, but a severely limited supply of donor hearts has meant that only about 2,000 persons receive transplants each year. NHLBI's predecessor initiated the artificial heart program in 1964; it has supported a number of academic and industry-based R&D teams since then.
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From page 2... ...
Technological advances have resolved some of the shortcomings observed in the mid-1980s, when Barney Clark, William Schroeder, Murray Haydon, and Jack Burcham received Jarvik-7 TAHs. The first implantation of a long-term VAD is expected in 1992, in a clinical trial of a device manufactured by the Novacor Division of Baxter Healthcare Corporation.
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From page 3... ...
Peer review processes involving nongovernment personnel are used effectively in considering investigator-initiated applications for R&D grants and in certain priority-setting activities, but most other NHLBI decisions are based primarily on subjective professional judgment by the agency's executives and administrators. The committee believes that structured aids to decision making would be helpful to NHLBI in situations for which peer review is not appropriate; it recommends costeffectiveness analysis (CEA)
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From page 4... ...
The extremes of the potential pool of MCSS candidates correspond to typical upper ages (35,000 for age 75, 70,000 for 85) of patients who may be considered for these devices; however, other than to enable such estimates, no specific upper age limit for MCSS patients should be applied or recommended.
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From page 5... ...
The committee's epidemiological projections take into account current trends in mortality rates as a result of such measures as hypertension control programs and dietary changes to reduce blood cholesterol levels, but it is possible that additional intervention methods will yield even greater reductions in the incidence of end-stage heart disease. HEALTH-RELATED QUALITY OF LIFE Health-related quality of life is important in assessing the effectiveness of MCSSs and other forms of heart disease treatment.
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From page 6... ...
This C/E ratio is considerably less favorable than those for heart transplantation ($32,000 per QALY) and other generally accepted forms of heart disease treatment (e.g., $34,000 per QALY for coronary artery bypass surgery for two-vessel disease with severe angina; $7,000 to $13,000 for percutaneous transluminal coronary angioplasty for severe angina)
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From page 7... ...
By making possible an earlier approval of TAHs for general use, continuing with TAH development for a two- to three-year period may benefit patients who would otherwise die if TAH development is delayed by a suspension of funding. This interim period will also see the availability of better information about the likely effectiveness of MCSSs in 2010 from the clinical trials and continuing temporary use of VADs.
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From page 8... ...
Before VADs and TAHs go into general use, crucial activities can be undertaken to improve the likelihood that these devices will be used appropriately. The committee thus recommends that device developers, NHLBI, and other interested parties take advantage of the period of years during which MCSS development is being completed to participate jointly in the following activities intended to promote appropriate use: · develop clinical practice guidelines or indications for use, at first on a provisional basis, with later revisions after clinical trial results are reported; · commission technology assessments that include cost-effectiveness components, based on actual device use, in order to verify and update this committee's work; · establish a registry of MCSS patients as a means of postmarketing surveillance and perform long-term follow-up studies of an adequate sample of all patients; · develop guidelines for hospitals, third-party payers, and others to use in determining whether individual physicians have the training and experience necessary to implant MCSSs; and · work with third-party payers to implement selective coverage programs, to avoid unnecessary and wasteful duplication and thus conserve expensive resources, as well as to ensure that the institutions at which MCSSs are implanted are suitably equipped and staffed to provide this care effectively.
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From page 9... ...
Medicare, Medicaid programs, and other third-party payers sometimes approve coverage for a new technology but then establish for it a payment rate so inadequate that access to the technology is restricted. The committee believes this is an unacceptable way to ration access to care and recommends that any positive coverage decision include paying for the care at a rate that adequately reimburses the costs of the care, noting that fixing such rates will require accurate cost information.
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From page 10... ...
The committee recommends that protocols for all MCSS clinical trials include these requirements and other appropriate ethical safeguards; these requirements also apply to routine MCSS use and should be part of each institution's standard procedures in all long-term MCSS implantations. RESEARCH AND DEVELOPMENT POLICY ISSUES Federal support for the development phase of health care R&Dis rare; that phase of work is usually funded by industry.
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From page 11... ...
Appropriate considerations include clinical benefit to patients taking into account the information obtained from clinical trials—as well as patient need, access considerations, and the technology's cost-effectiveness. Coverage approvals may properly be narrow and restrictive initially but should be reconsidered periodically, based on additional clinical evidence of relative safety and clinical effectiveness and the impact of the new information on cost-effectiveness.
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From page 12... ...
The committee therefore recommends that NHLBI continue to support TAH development for an interim period, perhaps by extending the contracts of current TAH developers if their work, through peer review and use of criteria such as those applied by this committee, is deemed worthy of continuing federal investment. Such an interim funding period would allow an opportunity for NHLBI to consider the early results of the Novacor VAD trial and results of continuing temporary VAD use before deciding about the next five-year phase of TAH development.
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From page 13... ...
First, any future R&D commitments to MCSSs should not detract from continuing NHLBI support of research aimed at an increased understanding of the mechanisms of heart failure and at developing new approaches to its treatment and prevention. Second, as previously stated, relatively little is known about the epidemiological aspects of end-stage heart disease, although one current NHLBIsupported study will provide additional information concerning heart disease in patients aged 65 and over.
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