Redefining Outpatient Care: Saving Lives & Limbs in Office-Based Labs
In little over half a decade, profound changes in where and how physicians treat cardiovascular patients have redefined the therapeutic landscape. In increasing numbers, operators are choosing to treat their patients outside of hospitals within office-based labs (OBLs), and, equally importantly, patients are increasingly seeking these alternatives to hospital settings.
At first glance, a non-hospital environment offers patients and their caregivers a more comfortable, familiar, and convenient experience that offers quality care. The benefits of no overnight stay and a lowered risk of nosocomial infections are undisputed. Other key benefits of OBLs are that they give patients greater accessibility to care, as well as a greater choice of treatment options, particularly for patients in rural, remote, and underserved areas. Our OBL is located two hours from San Diego and patients who come to us may not have access to care otherwise. However, the benefits equally apply to patients from all socioeconomic groups and geographic areas who are seeking alternatives to hospitals or looking for treatments that the hospitals in their areas may not offer. For operators, OBLs offer greater control over medical procedures, post-op care, and follow-up. Numerous studies have demonstrated fewer complications and follow-on procedures.1 The cost savings of OBL procedures — compared to the same procedures that are performed in hospitals — has been well-documented.2 The rise of OBLs is particularly relevant in the treatment of vascular blockages and peripheral artery disease (PAD), the leading cause of amputations, which affects 200 million people worldwide, including 18 million Americans.
Last year, we encountered a case that highlights many of the advantages of procedures being performed in OBLs today. This patient was a 68-year-old male with a history of prosthetic endocarditis. He was a non-smoker who led a healthy lifestyle, including playing tennis almost daily until the fall of 2016, when acute pain in his right leg prevented him from doing so. He had previously been a tennis champion in the Southern California 60+ age bracket and was devastated at being unable to play.
In July 2017, he had a thrombectomy performed at another facility. After the procedure on his right leg, he was in an immense amount of pain any time he tried to walk or get out of bed, and even while resting. The procedure had failed to recanalize the completely occluded right popliteal artery and, instead, created a dissection in the P2 section of the popliteal artery. The interventionalist told him that he would never play tennis again and, unless he developed adequate collateral vessels, he was on the road to a leg amputation.
This gentleman was subsequently referred to our OBL, and in August 2017, underwent a diagnostic angiogram of the right leg via a contralateral approach, which showed a large, eccentric linear dissection in the right P2 segment of the popliteal artery. There was single-vessel runoff to the foot via the right peroneal vessel, and the right anterior tibial (AT) was completely occluded, with no demonstrable nub.
The small nub of the right posterior tibial (PT) extended only about 2-3 mm, with no runoff to the right foot. We initially attempted to cross the eccentric dissection at the level of the right popliteal artery to get into the true lumen using multiple wires, but were unsuccessful. Every wire we attempted went into the flap of the dissection. At that point, we elected to use the Destruction of Arteriosclerotic Blockages by laser Radiation Ablation (DABRA) catheter and laser (Ra Medical), a non-thermal excimer laser system that received FDA market clearance in May 2017, to ablate near the severely stenotic area in the P2 section of the popliteal artery. We made three passes with the DABRA, with the help of a 6 French (Fr) x 90 cm supportive sheath. The DABRA made the turn and stayed in the true lumen, making a small channel by ablating the plaque very close to the dissection without causing further dissection, in what is described as micro-plaque ablation. DABRA allowed us to perform accurate, precise plaque ablation around the dissection and resulted in a clear, smooth channel for laminar flow within the true lumen, enabling the 0.14-inch Glide wire (Terumo) to easily cross the critical stenosis at the level of the dissection. With a support catheter, the totally occluded PT was easily crossed and the wire was placed into the distal PT, followed by a 3.0 mm x 200 mm-long balloon inflated for three minutes. A 3.5 mm x 40 mm balloon was used to treat the ostium of the PT and the popliteal artery at 10 to 12 atmospheres for three minutes. Subsequently, the support catheter and wire were removed, and a small amount of contrast was injected, confirming we were in the true lumen in the distal PT.
Post procedure, the popliteal had <10 to 15% residual stenosis. The PT, which had been completely occluded, now had less than 10% residual stenosis and excellent in-line flow to the foot via the PT, with excellent flow in the plantar branches. The peroneal vessel, which previously had very poor flow, now had brisk flow all of the way to the ankle. The AT was intermittently seen with a faint visualization of the right dorsalis pedis vessel.
After a minimum amount of time in recovery, the patient returned home. Two days later, he returned to playing tennis. His leg and tennis game have continued to improve, and shortly after the procedure, he won a major men’s under-70 tennis championship.
This case demonstrates the potential of OBLs to perform peripheral vascular interventions, including in those patients who have failed previous treatments, and ultimately to change how and where interventionalists treat patients. It is also an example of how OBLs can be on the forefront of innovation in med-tech, as we have the opportunity to take the lead in the adoption of new technologies that are available in the market. Operators at OBLs can participate in clinical studies without being slowed down by purchasing procedures and budget cycles that hospitals often face for capital equipment. OBL operators are likewise unencumbered by hospital-mandated bundling or group purchasing, which can be a limitation at larger centers.
- Jain K, Munn J, Rummel MC, et al. Office-based endovascular suite is safe for most procedures. J Vasc Surg. 2014 Jan; 59(1): 186-191.
- Dees JR. The economics of PAD for physicians and payers: hospital vs. office-based lab. presented at: New Cardiovascular Horizons; May 31, 2016; New Orleans, LA.
Dr. Athar Ansari, Director of the California Heart & Vascular Clinic in El Centro, Calif., is board-certified in general cardiology, interventional cardiology and endovascular disease. He is a pioneer in minimally invasive outpatient-based treatment for peripheral artery disease. He was an investigator in DABRA’s pivotal study, treated the first post-FDA clearance DABRA patient and performed the first-ever DABRA system case on arterial blockages via brachial artery access.
Dr. Ansari can be contacted firstname.lastname@example.org.