The debate within cath labs about the most effective therapy for postprocedural closures might be determined by the fiscal bottom line, in lieu of more clear-cut safety evidence.
For years, the gold standard for stanching blood flow from vascular access sites has been manual compression. While effective, this approach consumes manpower, is associated with patient discomfort and may be inadequate in patients who are markedly obese. With the shortage of nursing labor, many hospitals are finding it cost effective to adopt vascular closure devices (VCDs) to accelerate the timing of the closure process. VCDs have improved in the last several years, but there have been no large-scale randomized studies to determine the efficacy of the newest generation of VCDs compared with each other or with manual compression.
Despite lingering safety and evidence questions, VCDs are rising in popularity. In 2009, iData Research reported that the U.S. market for interventional cardiology VCDs will top $320 million by 2015. Life Science Intelligence reported in mid 2008 that the global market for all VCDs (coronary and peripheral) will reach more than $900 million by 2013, with implantable access devices (invasive) and external compression products (noninvasive) accounting for nearly half of all vascular closures in the U.S., and implantable access devices accounting for 56 percent of all device-based procedures.
Alfred Pechisker, lead analyst for iData’s interventional cardiology report, says that smaller or for-profit hospitals, which might be more sensitive to costs, will likely adopt the less expensive noninvasive VCDs such as patches and inflatable pressure bulbs. “There is a balance between the invasive and noninvasive VCD markets. The noninvasive devices are an easier transition from manual compression, so those devices may have higher adoption rates. However, because invasive devices are more expensive, they represent the bulk of the VCD market,” he says.
Dx vs. PCI
Diagnostic catheter procedures represent 70 percent of the U.S. market for VCDs. According to iData, the penetration rate of VCDs in interventional procedures is significantly lower than in diagnostic procedures because PCIs typically involve a longer hospital stay, allowing time for manual compression. Moreover, most interventional procedures involve a diagnostic procedure, performed via the same artery, that would independently require the use of a VCD, Pechisker says. However, there is “a trend towards the use of closure devices during angioplasties, allowing continuing unit growth to offset falling prices,” the report states.
One adverse impact on the market is the virtual flatlining of PCI procedures, with the number of procedures increasing at less than one-quarter of the rate seen prior to 2006. The growth rate of the number of diagnostic procedures also is slowing down.
In general, the VCD market stays relatively proportional to the number of procedures, but the primary market driver in the U.S. continues to be the shortage of nurses and, therefore, an evaluation of time efficiencies and economics ensues. With nursing labor diminishing, the 20 to 30 minutes spent applying manual pressure for vascular closure could be spent performing other duties. In a cath lab, the contribution of an experienced nurse can be worth as much as $800 per hour to the hospital. If a VCD averages $200, the hospital is left to decide whether it is an economically viable alternative, while also considering that VCDs are not separately reimbursed.
To date, the high cost of invasive VCDs has limited adoption in other international markets outside of Western Europe, according to Life Science Intelligence. By 2013, however, growing cath volumes, better access to new healthcare technologies, an expanding middle class and the need to increase patient throughput, while meeting the standards of Western healthcare, will contribute to greater adoption rates.