TractManager expert discusses use of catheter to replace heart valve

An article appearing in The Inquirer (Philadelphia) concerning promising new studies on a new artificial heart valve quoted a TractManager expert. James Laskaris, a senior clinical analyst at MD Buyline, discussed the growing use of transcatheter aortic valve replacement (TAVR) surgery and its coverage by Medicare and private insurance companies. Read the entire article: Using catheter to replace heart valve better than open-heart surgery, studies suggest

TractManager experts weigh in on new surgical technique for arthritic joints

An article appearing in The Inquirer (Philadelphia) concerning a new surgical technique to repair an arthritic toe quoted two TractManager experts. James Laskaris, a senior clinical analyst at MD Buyline, and Michelle Ostrander, a product manager at Hayes, Inc., discussed coverage for the new technique by insurance companies.

Hybrid OR systems represent a costly investment for hospitals

The purchase of high-end technology can be a long and strenuous task.

This is especially true when there are multiple vendors to consider and an array of configuration choices based on variable procedures. An added factor, as in the case of hybrid OR, is determining whether existing room dimensions can accommodate this technology, or will it require the structure to be modified.

Hybrid OR can be a costly system because you are modifying a traditional angiography room to enable conversion to an open surgical case, or a dual case involving interventional angiography combined with an open surgical case. The primary difference is a modified table that will serve both interventional and surgical cases. The hybrid OR market continues to evolve, with advancements in treatment and diagnosis. However, MD Buyline has not seen an increase in interest from our 3,300-plus hospital members over the past couple of years. Many hospitals currently utilize their mobile C-arm during surgical cases.

When facilities are planning to purchase a hybrid OR system they should look for features and options that fit the facility’s needs and meet their spending limits. Factors that can impact the purchase decision include size of the detector, ceiling- versus floor-mounted systems, and single plane versus biplane. If the system will primarily be used for cardiology, dedicated neuro and/or pediatric cases, a small detector will typically be sufficient. If the clinicians want to expand beyond that, a mid-size detector would be appropriate. MD Buyline sees far more ceiling-mounted, single-plane system quotations from our member hospitals.

Another decision will be which table to utilize. Maquet, Steris and Trumpf are the vendors that currently offer surgical tables. These tables typically include a cradle and tilting feature, which is beneficial for many OR procedures.

Hybrid OR systems are typically installed in surgery for convenience and practicality. This can be a costly investment because a hybrid OR requires the same stringent requirements as an OR suite (e.g., air flow, infection control, etc.). Careful thought and planning must also be given to the scheduling of surgical versus interventional cases and how the room will be used when non-hybrid work is done.

The MD Buyline database shows that hospitals tend to be brand loyal. They continue with vendors that provide excellent performance and reliability as well as service and support. When making purchasing decisions you need to research every aspect of the vendor and system offered.

Purchasing departments should include input from the cardiologist and/or radiologist, department director and technologist(s) when considering a hybrid OR system. Facilities also need to look closely at FDA recalls, taking the time to read and understand each recall. Obtain a written statement of the status and resolution actions taken by the vendor. Use recalls as leverage in your negotiations. Check out the ratings of the system. Make sure the vendor has the proper contact point for further recalls. And always negotiate uptime guarantees.

Every system purchase should be accompanied by a point-of-sale service contract. The best time to purchase service is at the time of the capital expenditure. Historically, purchasing service when the warranty has already expired is significantly more costly. The vendors in this market offer education, software upgrades and support. Make sure that the service support level and time period covered are in line with your facility’s departmental needs.

When making large capital purchasing decisions be sure to research every aspect of the vendor and the system, whether you are looking to use the system for cardiology or for mixed lab purposes.

Link to the external article: DOTmed

Adapting to a dynamic market: Operating room buying patterns

With the rapid growth in recent years of new operating room and sterile service building projects has come an increase in technology buying. The focus, of course, is to provide optimum patient care with optimum efficiency — a key to staying competitive. What is behind this buying pattern? One factor is an increase in volume. Baby boomers have reached the age where they require surgery more often. Much of this investment in new technology is focused on infection control, minimally invasive surgery and improving outcomes with quicker recovery and a shorter length of stay.

Specialized OR tables target anterior hip replacement and high-end spinal procedures. These are designed to assist the physician in performing less-invasive procedures. Anterior hip replacement is a tissue-sparing approach that allows the surgeon to work around major muscles as opposed to cutting them. This results in sparing healthy tissue and speeding recovery time.

Implants are being designed to last longer, and with the added accuracy of using a computer or a robot to assist with the precision of the procedure, they offer the promise of extending the life of the implant. While robotic surgeries, image-guided computer systems and manual techniques are all treatment options for patients in the orthopedic market, they vary in terms of durability, most notably in relation to implant longevity. The current level of implant technology offers the potential for implants to last more than 15 years, with newer technology extending this to more than 20 years.

However, even with new technology, the life expectancy of implants is limited by the accuracy of their alignment. Studies have found that alignment errors greater than 3 percent in artificial knee procedures are associated with implant failures. Conventional manual techniques had an almost 32 percent chance of a greater-than-3-percent misalignment, while this number was 9 percent in cases when an image-guided computer system was used. In contrast, surgical orthopedic robots were able to achieve consistent alignment within 1.6 degrees. This translates to a longer-lasting procedure, opening the market to younger patients.

Imaging

Just when we thought video surgical imaging had reached its peak, vendors are now offering 4K imaging technology. 4K resolution offers 4,000 pixels or dots per line, which translates to four times the resolution of current HD systems. This assists surgeons to better distinguish between pathologies, allowing for new procedures to be performed safely in a minimally invasive format.

In addition to 4K, the use of fluorescence imaging technology has allowed for direct imaging of blood flow. Fluorescence imaging is based on using an imaging dye, such as indocyanine green, that fluoresces or glows when exposed to ultraviolet light. This assists surgeons in avoiding blood vessels while identifying tumor margins in critical areas of the body. These technologies offer the promise of sparing healthy tissue and improving outcomes.

Soft tissue or tumor ablation

One of the fastest growing procedural areas is the soft tissue or tumor ablation market. No longer are surgeons using a scalpel or even a basic RF generator to remove tissue. Despite the fact that capital costs can reach $100,000 or more, and consumable costs can be in the thousands, evolving technologies such as light (laser), radiofrequency, ultrasound (HIFU), microwave and cryo-thermal offer tradeoffs such as shorter recovery time, shorter surgical times, lower risk of infection, minimal damage to the healthy tissue, less blood loss, less pain and shorter hospital stays. This has allowed these technologies to be more financially attractive. Health care has become more competitive. To stay competitive, operating rooms have to change with the markets. Although this requires an investment in capital, consumables and training, it offers patients many more options.

Special Procedure Rooms: Will TAVR Shift to the Cath Lab?

DOTmed HealthCare Business News interviewed MD Buyline clinical analyst Tom Watson about the possible shift of TAVR into cath labs in the article, Special Procedure Rooms: Will TAVR Shift to the Cath Lab?, in the March 2015 issue.

Special procedure rooms are coming into their own, driven by both innovation and the need to justify costs that has come to be a dominant trend driving change in the health care landscape. For example, transcatheter aortic-valve replacement (TAVR) is generally done in a hybrid operating room, but the conventional wisdom is that the open-heart surgery alternative will eventually migrate into the cardiac catheterization lab, resulting in a substantial cost savings.

A small study published in the August 2014 issue of JACC Cardiovascular Interventions looked at 142 patients, 70 who underwent TAVR with the Edwards Sapien valve in a cath lab, and 72 who had the procedure performed in a hybrid OR. According to the paper, all procedures in the cath lab were successful, with one patient intubated, while three patients in the hybrid OR had a procedure- related death. There was no significant difference between the two groups in mortality at 30 days, and both 30 day stroke/ transient ischemic attack and moderate or severe paravalvular leak were similar. Procedure room time, length of stay and costs were all lower in the cath lab procedures, by close to $10,000.

“The NCD (national coverage determination) has been firm in saying that the procedures should be done by a heart team consisting of a surgeon and a cardiologist,” says Dr. David Holmes, a past president of the American College of Cardiology and professor of medicine in cardiovascular disease at the Mayo Clinic. “NCD doesn’t say…it needs to be done in the cath lab and it doesn’t say it has to be done in the OR. The majority are still done in OR by virtue of the fact that the catheters are large in size. As the catheters get smaller and smaller, it gets more feasible to do these in catheterization laboratories.”

Holmes notes that if a facility were to perform TAVR in the cath lab, it would need a very good system to handle emergencies that require bypass surgery. “They need to be an expert center with an expert heart team,” Holmes says. “Not any facility in a small town someplace can get started.”

“Tom Watson, a clinical analyst at MD Buyline with more than 35 years of experience in the field of cardiovascular medicine, agrees. He notes that it’s a generally accepted belief that less risky TAVR procedures will evolve into the more traditional cath lab, much like what happened with balloon angioplasty years ago.”

“I believe it would still be limited to facilities that are capable of doing open-heart surgery valve replacements,” Watson says. “I think we’re still several years away from that becoming a reality, but that’s a very common theory.”

“There are still concerns with post-TAVR issues, such as leaking due to the positioning of the valves, and techniques with 3-D ultrasound have had to be perfected. There is a long list of requirements a facility has to meet before it can be considered for approval for a TAVR program, Watson says.”

According to the Centers for Medicare and Medicaid services, TAVR must be performed in a hospital with the appropriate infrastructure including, but not limited to: an on-site heart valve surgery program; a cardiac catheterization lab or hybrid operating room with a fixed radiographic imaging system with flat-panel fluoroscopy; noninvasive imaging such as echocardiography, vascular ultrasound, computed tomography, and magnetic resonance; sufficient space, in a sterile environment, to accommodate equipment for cases with and without complications; and a post-procedure intensive care facility with staff experienced in managing patients who have undergone open-heart valve procedures.

There are also qualifications for hospitals with and without TAVR experience that include a minimum number of aortic valve replacements and catheterizations previously performed and physicians that have performed those procedures a minimum number of times.

“Initially, and rightly so, it was suggested that less than 100 facilities will have the procedure in general,” Watson says. But if a facility is not ready to do TAVR today, there are things it can do, at a smaller cost and a lower barrier in terms of staff training and knowledge, to move toward the ultimate goal of being able to provide care that is safe. “Some facilities have moved ahead with the technology to prepare when things open up. You can purchase the imaging foundation without expending a tremendous amount of money beyond what you would purchase for a typical diagnostic/ interventional system in order to be prepared for TAVR, if you choose,” Watson says. In addition, there are technical innovations that are paving the way to making it easier for institutions to handle the challenges of the procedure.”

“Technological advances are being made almost every six months,” says Morton Kern, chief of medicine at the VA Long Beach Healthcare System in California and Last year, for example, Medtronic got FDA approval for its self-expanding transcatheter CoreValve System, after studies showed clinical outcomes at one year with the CoreValve System were superior to open-heart surgery.

The valves themselves are undergoing renovations as well, reducing aortic regurgitation with skirt-like structure on the bottom and with better retractability for repositioning, according to Kern. But there are those who are less than enthusiastic about moving TAVR to the cath lab.

Niels Bakker, marketing manager for Philips, isn’t so sure the room has the best setup for a procedure like TAVR, which needs more flexible positioning of imaging equipment and higher sterility for transapical access. “When we first started hybrid ORs, we just used cath lab equipment and placed them in an OR environment,” Bakker says. “The positioning capabilities of cath lab systems are not optimal for a hybrid OR, so Philips developed dedicated hybrid OR solutions like the FlexMove that give higher flexibility… I think the hybrid OR is still a very valid proposition if you look at the broad spectrum of new SHD procedures emerging.”

Purchasing Insight: Bone-graft Substitutes

Driven by an aging population and an expanding pool of younger patients, bone-graft substitutes are a $2.5 billion market, which should continue to rise as a result of minimally invasive procedures.

Bone-graft substitutes include both synthetic and natural materials used for the replacement of bone or bone tissues. Although harvested bone from the patient, or autograft, is the gold standard, substitutes were introduced to the market in 1995 due to quantity limitations and chronic pain associated with the donor site.

Most bone-graft substitutes can be categorized into one of the following areas:

Allograft-based, also known as demineralized bone matric (DBM)

Growth-factor based (BMP)

Synthetic, including polymer and ceramic-based materials

Reimbursement codes vary, based on the use of autograft or a bone substitute but in general reimbursement rates have remained steady. However, as the market evolves and new grafts are introduced and prices increase, cost-benefit analysis will become critical. While the use of bone-graft substitutes does add additional cost to the procedure, it prevents the need for an extra incision site or second operative procedure, and the trouble caused by obtaining the donor graft.

Lower prices are usually achievable by introducing competitive bids but additional savings can require some creativity such as agreeing to market share commitments. These agreements tend to give providers a good amount of leverage to reduce prices, but ensure physician alignment to prevent physician/vendor relationships from compromising your negotiation leverage.

Bone-Graft Substitutes

5cc Demineralized Bone Matrix (DBM) Putty

  • Low: $616.00
  • High: $865.00
  • Average: $690.00

Recombinant Human Bone Morphogenetic Protein (rhBMP) Matrix

  • Low: $3,450.00
  • High: $5,000.00
  • Average: $3,477.00

5cc Synthetic – Ceramic & Polymer–based

  • Low: $893.00
  • High: $2,100.00
  • Average: $1,320.00

Please note these numbers have been adjusted to exclude special deals, outliers and unique circumstances.

Purchasing Insight: Knee Replacement Market

Knee replacements now account for over $6 billion in global sales annually, and this number is expected to grow as the population ages and improved accuracy makes younger patients candidates for therapies that have traditionally been delayed.

The focus in the market is shifting towards personalized instrumentation, minimally invasive approaches, robotic assistance, and implants designed for specific genders.

Types of knee replacement procedures include total knee, partial knee (or knee resurfacing), and revisions with replacement components that include the femoral, tibial, and/or patella components. These components are designed to be cemented or non-cemented, and can include ceramic or non-ceramic inserts.

Pricing for knee replacements shown below includes all components.

KNEE ARTHROPLASTY COMPONENTS

Total Knee

  • Low: $2,500
  • High: $5,700
  • Average Price: $3,310

Partial Knee

  • Low: $3,200
  • High: $5,000
  • Average Price: $3,900

Gender Specific Knee

  • Low: $3,800
  • High: $6,500
  • Average Price: $4,975

Lower prices are usually achievable by standardizing on one vendor, and market share agreement offers more leverage during negotiations. If standardizing is not possible, signing multi-year agreements with multiple vendors can help. However, when negotiating multi-year agreements, ensure prices are locked in for the term of the agreement. Also, consider using a trusted source to review contracts and pricing to make sure they are in line with what the rest of the market is seeing for similar products.

Please note these numbers have been adjusted to exclude special deals, outliers and unique circumstances.

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