Device Update II: The Path of Least Resistance: How Angio-Seal helped one lab find the road to better economic performanc

There is an acceptable way for hospital staff and physicians to come together to decrease costs and keep everybody happy. Over the past year, we went down several roads: First, using all available closure devices; second, using only a patch, and finally, using only the Angio-Seal STS vascular closure device (St. Jude Medical, Minnetonka, MN). The St. John Medical Center cath lab contains a 12-bed angioplasty recovery area, where outpatients are prepped for their catheterizations and monitored until discharge. Interventional patients, or outpatients for whom there was no room in the small recovery area, are sent upstairs to the telemetry lab for recovery and later discharge. St. John Medical Center operates 3 plumbing cath labs, and 2 for electrophysiology (EP) and devices. Our cases include a standard mix of interventional and diagnostic caths, with no pediatric and very few peripheral procedures in the mix. We are fortunate to have a full staff of 17 nurses and techs, all of whom are seasoned professionals. Finding the Right Path to Cut Costs In early 2003, we needed to cut costs from our cath lab disposable supply budget. The St. John Health System was facing the need to make drastic changes to maintain a profitable margin for the fiscal year. At that time, we were spending close to $250,000 per year on multiple closure devices, including Angio-Seal, VasoSeal (Datascope Corporation, Mahwah, NJ), Perclose (Abbott Vascular Devices, Redwood City, CA), and an assortment of patches. Approximately 50-60% of our patients were receiving some sort of closure device. With such a high expenditure, closure devices became an obvious target for reduction; we ceased to use any invasive devices and decided to investigate the use of non-invasive patches. In keeping with the Health System Initiative, a consultant was hired to come in and analyze operations of the Health System as a whole and suggest possible cost-cutting measures. After reviewing budgets, patient flow, and physician scheduling practice, the consultant identified a sizeable bottleneck in the cath lab recovery area. It was suggested that by closing with patches we could still achieve the same outcomes and benefits as we were getting from an invasive closure system while decreasing our costs considerably. After an intensive evaluation of several patches, one patch was chosen and a 60-day trial was started. Using the patch, we did reduce discharge time, but patches were now being used on every patient because no doctor order was required. Lab staff went from holding pressure on a handful of patients each day to holding pressure on 15-20 patients per day. Nurse aides were also enlisted to hold pressure on post-cath patients. Some patients had to be sent to intensive care units, so that lines could be removed before moving them onto the telemetry floor. So even though the patch we chose cost 30% less than more invasive closure devices, our monthly overall costs were as high for the patch as for invasive closure devices of previous months. Most importantly, the bottleneck of patients in the lab persisted. During this time, protocols dictated that we hold at least 20 minutes of manual pressure on every patient, with or without the aid of a patch. The patient must then lay flat for at least 4 hours. Adding anti-coagulants increased this recovery time by at least 2 hours. The cost of housing a patient in the cath lab recovery area is approximately $200 for the first hour, and approximately $100 for each additional hour, so each patient’s recovery could actually cost more than the procedure itself. Working with the physicians and staff, St. John developed a system which used closure devices and controlled costs through new criteria for patient selection. Under the new system, physicians deploy all Angio-Seal devices, and patients must meet at least one of the following criteria in order to receive a closure device:

Outpatient with early discharge Overweight High risk for hematoma, restless, combative, or confused HTN Anti-coagulated patients with the need to remove sheaths Must be released according to guidelines in the device instructions for use (IFU)

The team developing the new criteria for the use of closure devices also decided to use the Angio-Seal STS Platform. The Angio-Seal device offers clinical capabilities for early ambulation and discharge, while increasing patient comfort. We haven’t had one complication to date using the STS Platform. Use of an Economic Model Another element which supported transitioning to the new system was an economic model created by both Deloitte & Touche, a national consulting and financial company, and St. Jude Medical. This model took into account the specific details and costs related to our facility, and calculated the Return on Investment (ROI) we could receive by using the Angio-Seal device. In the 10-15 minutes it took to complete, the model offered an indication of what we could expect when using the Angio-Seal device. It even showed us what the optimal protocol and usage rates would be, and how much using them would save the Medical Center. The Benefits expected and unexpected The return to Angio-Seal, along with the use of patient selection criteria, has created a 40-45% drop in costs since being instituted in November 2003. Since bringing the Angio-Seal device back to St. John, our hematoma rate has also decreased. In addition, fewer questions are coming from inpatient care areas because the entry site has been successfully closed. Increasingly, patients come into the lab requesting a closure device. Tulsa is a competitive cardiovascular healthcare market, and hospitals will have to be more service-oriented than ever before. Resort-style amenities and service with private rooms are becoming increasingly common. If we don’t give patients the safe, comfortable care they desire, it’s easier than ever for them to go somewhere else. Everyone at St. John understands that cost-cutting is a major issue in today’s healthcare environment. The cutbacks in Medicare and other forms of reimbursement that have been affecting hospitals for several years are now affecting physician income. The only way to survive is to build a trusting relationship with all parties involved in the delivery of care within our institution. The key to many of our successes over the years has been this cooperative relationship between physicians, administration and staff. All groups understand the need to control cost without jeopardizing our high standard of patient care. While there was mixed reaction by staff, physicians, and administration to all the protocol changes we went through, everyone did their best to allow time to prove or disprove each concept. Through our personal experience, we discovered that the Angio-Seal economic model can be a very accurate indicator of opportunities for facilities trying to cut costs. Today, we’ve found a system that works for us. Physicians and staff are complying with the new closure device usage criteria, which is an excellent sign that the system will produce great results. To learn more about the Deloitte & Touche economic model on closure devices, contact your local St. Jude sales representative or Jody Musil at 800-328-3873. Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications: St. Jude Medical Angio-Seal Vascular Closure product family, including the Millennium, STS and STS Plus platforms, is indicated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8F Angio-Seal device and a 6 French or smaller procedural sheath for the 6F Angio-Seal device. The Angio-Seal STS and STS Plus platform devices are also indicated for use to allow patients who have undergone diagnostic angiography to ambulate safely as soon as possible after sheath removal and device placement, as well as to allow patients who have undergone an interventional procedure to ambulate safely after sheath removal and device placement. Possible adverse events for vascular closure devices include, but are not limited to: bleeding or hematoma, AV fistula or pseudoaneurysm, infection, allergic reaction, foreign body reaction, inflammation or edema. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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