Research article from the Journal of Vascular Surgery - Vascular Insights
By Krishna Jain, MD, FACS
Published:April 05, 2024DOI:https://doi.org/10.1016/j.jvsvi.2024.100076
Office based Lab (OBL)or also known as Office endovascular suite has provided an ideal delivery of care site for patients. The endovascular and other procedures like kyphoplasty being carried out in OBL were traditionally performed in the hospital system. These procedures can now be performed in the OBL. OBL started as an extension of practice after the deficit reduction act of 2005. Hospital systems have mechanisms like peer review in place to make sure that the patients are receiving quality care. In an office setting it is solely dependent on the physician providing care. One has to assume that a quality driven ethical practice in general brings the same characteristics to an OBL since it is nothing but an extension of practice.
Defining quality care in medicine has been a challenge for leaders in medicine. Institute of Medicine published a report in 2021: “Crossing the Quality Chasm: A New Health System for the 21st Century”. This is the most comprehensive report I have come across that helps measure quality. The report proposed 6 aims for the 21st century. In this paper I will examine the role of OBL in meeting these goals. The aims proposed by the committee are copied here.
“The committee proposes six aims for improvement to address key dimensions in which today's health care system functions at far lower levels than it can and should.
Health care should be:
Safe—avoiding injuries to patients from the care that is intended to help them.
Effective—providing services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit (avoiding underuse and overuse, respectively).
Patient-centered—providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.
Timely—reducing waits and sometimes harmful delays for both those who receive and those who give care.
Efficient—avoiding waste, including waste of equipment, supplies, ideas, and energy.
Equitable—providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and a socioeconomic status.”
Safe:
Various reports published in peer reviews journals have established the safety of procedures performed in the OBL. Our group and others have published their results from their experience in the OBL Table 1. There was no procedure related mortality. The complication rate was 1.2%- and 30-day mortality was 0.2%. The transfer to the hospital was 0.4%. Aurshina et al reported their results in 6201 procedures. There was 0% major complication or death, 0.5% minor complications and 0.32% 30 day mortality related to the procedure. Satwah et al in a multicenter study reported their results after 1223 Iliac vein stents insertion. They had 7.36% minor complications and 0.41% major complications and no deaths.
Table 1Safety of procedures done in independent OBL
Haqqani et al queried the VQI data base for PVI performed in hospital inpatient, hospital outpatient and ambulatory/OBL. They reported quite low periprocedural complications including hematoma requiring intervention across all settings. Overall peripheral vascular intervention (PVI)success rates were comparable in all settings. There was significantly higher rate of hematoma, distal embolization, and stenosis/occlusion in the in-patient setting.
To be able to provide a safe environment it is essential that the policies and procedures be written for all procedures that will be performed in the OBL. The physicians and staff should adhere to written policies and procedures. This is the only way to ensure safety. All team members need to know their role and also be cross trained since the office will have a small staff. Safety drills for emergencies should be carried out at regular pre-defined intervals. In case of a complication there should be direct communication between the OBL personnel and the receiving hospital. In case of a vascular surgeon run lab any vascular complication will in likely be treated by the vascular surgeon doing the procedure in the OBL or one of other vascular surgeon in the group. Other specialists doing cases in the OBL should have an arrangement with the receiving hospitals and should also communicate directly with the physicians who will be managing the patient in the hospital. It is not required to have a transfer agreement between the OBL and the receiving hospital. Physicians and nurses should have certification in advanced cardiovascular life support and the rest of the staff should have basic cardiovascular life certification. Procedures can be performed under moderate sedation under the supervision of operating physician. Many practices use anesthesiologist or certified registered nurse anesthetist to provide monitored anesthesia care. There should be protocols to mange anesthesia irrespective of the person providing the service.
Effective
Any treatment modality used in the OBL should have proven effectiveness. As new data about various procedures and devices is published the lab should change the treatment modalities to provide the most effective treatment options. An important attribute of appropriate use criteria is that “they should be flexible” and “should not limit physician freedom, but should impede arbitrary decisions.”
Procedures that are carried out in the OBL should use the same criteria for indications and treatment as would be used in the hospital. The treatment should be evidence based. Success rate of procedures performed in the OBL is comparable to procedures performed in Hospital inpatient or outpatient department. The reason is very simple. The same operators who perform the procedures in the hospital system perform the procedures in the OBL Some of the operators have left the hospital to entirely concentrate on building an outpatient practice. This has no impact on the results of the procedure.
There has been considerable debate about PVI procedure performed in the OBL. Let us first look at the care provide to patients who are hemodialysis dependent. Patients needing maintenance of hemodialysis access rarely go for an outpatient procedure to the hospital. Most patients needing venous stenting for Iliac vein stenosis get their treatment in OBL patients needing superficial vein ablation go to vein centers that are sometimes part of the OBL. Our group showed the positive impact of OBL on retrieving intracaval filters in an OBL. The debate around PVI procedures revolves around indication of the procedures and the techniques used for revascularization. BASIL1 trial showed similar outcomes in patients presenting with severe limb ischemia due to infra-inguinal disease between “bypass” and the “endovascular first” arm in amputation free survival. and in the short-term, surgery was more expensive than angioplasty.
In the BASIL-2 trial, best endovascular treatment first revascularization strategy was associated with a better amputation-free survival, because of fewer deaths in the best endovascular treatment group as compared to the surgical group. The data suggested that more patients with chronic limb-threatening ischemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularization procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularization strategy.
Recently published BEST clinical trial showed that among patients with Chronic limb threatening ischemia who had an adequate great saphenous vein for surgical revascularization, the incidence of a major adverse limb event or death was significantly lower in the group having bypass when a suitable vein was available than in the endovascular group. When the patients lacked an adequate saphenous vein conduit, the outcomes in the two groups were similar. The BASIL trial and BEST trail though trying to answer similar question had different entry criteria and trial design. For a person running an OBL it is confusing and endovascular approach first is possibly justifiable but the decision should be made by the physician in consultation with the pateint. In addition, the lower extremity arterial disease is managed by surgeons and non-surgeons alike. The interventional cardiologists and interventional radiologists will obviously tend to use the endovascular approach first.
The second controversy related to PVI deals with use of atherectomy. Patient with intermittent claudication should have optimal medical management prior to revascularization irrespective of the technique used for revascularization or site of service. One of the limiting factors in optimal medical management is unavailability of supervised exercise programs. There is continued controversy surrounding various techniques used in revascularizing an ischemic lower extremity. There are basically three techniques used: angioplasty, angioplasty and stent and angioplasty and atherectomy. Angioplasty alone may not give long lasting relief. As a result, angioplasty and stent have been widely used. This resulted in a chronic problem, difficult to treat, intrastent stenosis. Use of drug eluting balloons and drug eluting stents was on hold for some period of time but these devices are available once again. After the advent of atherectomy operators started using atherectomy to decrease the atheroma burden and perform angioplasty using lower atmospheric pressures. This also decreased the use of stent. Randomized trials showed the effectiveness of laser atherectomy
in treating intra-stent stenosis. However, the data has not supported the use of atherectomy in decreasing amputation rates. There has been no randomized trial comparing angioplasty vs angioplasty and stent and angioplasty and atherectomy. There are conflicting guidelines in treating tibial disease for claudication.
Patient-Centered
OBLs are totally patient-centered. The OBL is an extension of practice and since the patient is getting longitudinal uninterrupted care in the doctor’s office the care is centers around patient. In a hospital setting, in my personal experience patient coming in for an outpatient vascular procedure has more than 30 touches with various employees as compared to 7 touches in the office. The main revenue of the practice comes from taking care of the patient. If the practice is not patient centered, it is bound to fail.
It is possible that there may be discrepancy between the type of modalities used in the hospital and OBL by the same physicians working at both sites. The hospital may not have the equipment that physicians want to use because of the hospital procurement process. Many hospitals are not willing to offer atherectomy as a treatment option because of cost and utilization factors. Hospitals like any other business are driven by profit margin of each case and supplies are ordered to keep that factor in mind. Recent reports using big data analysis have been critical of the overuse of atherectomy in OBL.
CMS has not allowed reimbursement of certain devices like drug eluting balloons and stents in the OBL. As a result, the operators tend to use atherectomy more often than they would use in a hospital setting. The big data is not granular enough to fully explain the use of atherectomy in the OBL. The authors believe that the use of atherectomy is solely driven by financial considerations. None of the papers look at the cost of the procedure when performed in OBL. Over the last few years CMS has decreased the payment for atherectomy procedures in the OBL. As a result, the profit margin of angioplasty and stent is greater than angioplasty and atherectomy. Mohan et al in analyzing VQI data reported that the patients who had atherectomy had higher incidence of prior peripheral vascular intervention, greater mean number of arteries treated and lower proportion of prior leg bypass. There was lower incidence of failure to cross the lesion, but higher incidence of distal embolization. Future decisions to use atherectomy in any setting should be driven by currently available data. Ideally, there should be a randomized controlled trial comparing atherectomy to other modalities of treatment.
Some patients will benefit from an open operation as compared to an endovascular procedure in the OBL. The patient should be given that option. However, there are not enough vascular surgeons to cover the whole country resulting in vascular deserts. Potluri et al in their paper showed that “2612 counties (83%), with a total population of 96 million people (31% of the U.S. population), had had no practicing vascular surgeon”. When there is no access to a vascular surgeon, even in patients where a bypass should be first option an endovascular procedure will be indicated. Interventional radiologists, interventional cardiologists and vascular surgeons provide care in an OBL. Among these specialties only vascular surgeons can do the open procedure. In the current environment of preauthorization many patients are not able to have necessary procedure because the insurance companies are looking at the published guidelines and overlooking the social factors and availability of medical services in the community.
Timely
One of the biggest advantages of an OBL over the hospital system is timeliness of the procedure. The Physician is not dependent on the block time in the operating room, catheterization lab or interventional radiology suite and being bumped by other emergencies like caesarian section and trauma etc. Patient satisfaction in an OBL is greater than 98%. This is unachievable in nay hospital setting.
Patients who are on hemodialysis rarely miss a dialysis treatment when the hemodialysis unit has access to an OBL. If the OBL is providing care for patients on hemodialysis patients, the OBL should designate one employee who can be reached directly by the dialysis center coordinator for managing the dialysis access in timely manner. The goal of the OBL should be to avoid any missed treatment.
Timely care provided by the operator significantly improves the life of the operator as well. The down time between cases can be minimized and the operator can be home in time to be able to spend quality time with family. This also helps prevent physician burnout.
Efficient
A quality OBL has no unnecessary waste. The supply list is limited but adequate. There is no reason to stock multiple balloon catheters, stents, and devices from various companies. There should be enough supplies to provide routine care and be prepared for emergencies. The group of physicians working in the OBL need to develop a consensus about the supplies they need and not deviate on a whim or pressure from a salesman. This results in efficiency, decreases wastes and improves profit margin and staff satisfaction since they are comfortable using limited number of products. A good inventory control system should be used to keep track of supplies. No product should ever expire on shelf.
Scheduling is one of the important elements of success of the OBL. If the practice services dialysis units some spots should be kept open for managing dialysis access related emergencies. The turnover time should be minimized to improve efficiency.
It is important to have monthly meetings of the staff and the physicians to review the quality metrics as well as discuss any new ideas to improve efficiency. As the new modalities become available these should be evaluated to see if patient care can be improved.
Equitable
The practice opening an OBL should provide care irrespective of race, ethnicity, sex, socioeconomic status etc. Since the patients in the practice are taken care of in the OBL it should have the same mix of patients. The physicians are taking additional financial responsibility and risk to run the OBL. This poses a financial and ethical dilemma when taking care of patients on Medicaid. In most states Medicaid pays physicians poorly for the services rendered. The hospitals usually get a differential payment from the state based on what the state hospital lobby has negotiated with the state government. Nonprofit status of the hospital also helps in overall taking care of Medicaid patients. Physicians have no such mechanism. An OBL is not sustainable with a heavy Medicaid patient population. Depending on the mix of patients a practice may decide not to open an OBL. A carefully created financial proforma can help make that decision.
The OBL should participate in national registry. The data from the OBL can be compared at local regional and national level. The lab should also carry out patient satisfaction survey to make sure the patients are getting the care they expect. Patient satisfaction plays in important part in payment from CMS. Even more important is the pride the physicians have in having the best patient outcomes.
CMS does not require the OBL to be certified by one of the accrediting bodies like joint commission. However certain states and insurances companies mandate it. Though it is cumbersome and expensive to get the OBL certified, at this point I would recommend that the OBL be accredited by one of the national agencies.
Recently introduced outpatient facility verification by SVS/ACS program demonstrates to patients, referring physicians, regulators, and payors that high quality, high value, vascular care is being delivered. This is a valuable program offered by SVS and American college of surgeons. However, the program does not replace the accreditation programs offered by joint commission etc. It is not accepted by states or CMS as an accrediting program. This results in extra burden for the OBL. The SVS/SCS should get it approved by CMS as an accreditation program. In the meantime, it would be very helpful if they could work with insurances companies to decrease the burden of precertification if the OBL has received verification from this newly offered program.
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Article info
Publication history
Accepted: March 27, 2024
Received: November 1, 2023
Publication stage
In Press Accepted Manuscript
Footnotes
Conflicts of Interest: CEO National Surgical Ventures LLC, CMO and partner APEx health network.
Funding: none
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© 2024 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery.
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