Utilizing an office based laboratory (OBL) during the COVID-19 pandemic for vascular surgical patients

Abstract

COVID-19 pandemic brought new challenges in healthcare including the need to create tiered class recommendations about which types patients to treat urgently and which surgical cases to defer. This is a report of a single center's Office Based Laboratory (OBL) system to prioritize vascular patients and preserve acute care resources and personnel. In reviewing three months of data, it appears that by continuing to provide the urgent care needed for this chronically ill population, the insurmountable backup of surgical procedures is prevented in the operating room once elective surgeries resumed. The OBL was able to continue providing care at the same pre-pandemic rate to a large intercity population.

Introduction

The healthcare system, healthcare workers, and society at large became overwhelmed by the rapid spread of the novel coronavirus, also known as SARS-CoV-2.¹ This viral spread resulted in the World Health Organization declaring the novel coronavirus disease 2019 (COVID-19), to be classified as a global pandemic.² Surgical specialist prepared for the COVID-19 pandemic by focusing on intensive care needs and mechanical ventilation capacity to treat those most seriously affected by the virus. In March 14, 2020, the United States Surgeon General advised hospitals to cancel elective surgeries to preserve hospital space, staff, and equipment for potential influx of COVID-19 admissions these procedures would utilize resources needed during a potential influx of COVID-19 admissions or spread the virus.³ Subsequent to the US Surgeon General's recommendation, the American College of Surgeons (ACS)requested that health care systems and surgeons review all elective procedures and assign a determination of minimizing, postpone or cancel. This recommendation was to remain in effect until a time that the healthcare system as a whole can support the rapid increase of critical patient needs.⁴

Notably, the statement by the ACS made no mention of the elective patient's underlying disease, risk of delaying surgery, or when exactly the predicted “inflection point” will come to pass. Later in March 2020, the Society for Vascular Surgery Clinical Practice Council published tiered recommendations for vascular surgery cases of when to perform surgery for each condition. The tiers were separated into various classes class 1, postpone; class 2a, consider postponing; class 2b, postpone if possible; and class 3, do not postpone.⁵ Both the ACS and SVS held agreement on the tiered system with asymptomatic patients procedures being postponed and deemed elective, symptomatic patients including those with acute bleeding, aortic dissection, and large abdominal aortic aneurysm being emergent procedures.⁵ Based on these advisories and recommendations, there was a significant decrease in vascular surgery cases performed.⁶ The vascular surgery patients are an especially vulnerable population. Most are older and require multiple sub-specialties in the management of their comorbid conditions. This subset of patients often has poor physiologic reserve and need to be medically optimized for procedures. Prior to COVID, surgery was often as Hemingway et al stated, ‘if a patient had been seen in the clinic and scheduled for a procedure in the future, the procedure was elective’.⁷ This philosophy worked well for their group, but this was not the definition used at this practice site. Many procedures were not performed in the hospital settings during this COVID-19 pandemic very simply because they were scheduled to come in through the ambulatory surgery care unit (ASCU) which closed during this pandemic. Because of the canceling of elective cases, and redeployment of surgical staff, there was an overall 74% reduction of hospital vascular surgical cases being performed during 2020 in the US.⁸ Therefore, an alternative location, the office-based laboratory (OBL) was utilized to perform needed surgeries on these high-risk patients safely and effectively by highly skilled vascular surgeons in this intercity large hospital.

We report on one institution who utilized an OBL to continue performing non emergent but urgent cases while not taking away from the acute care hospital resources during the COVID-19 pandemic. The purpose of this initiative was to continue to operate on urgent vascular patients and therefore the insurmountable backup of surgical procedures was prevented in the operating room once elective surgeries resumed.

Materials & methods

A retrospective chart review was performed of all vascular surgery procedures at a large intercity hospital that were performed over a three-month period from April 2020- June 2020 in the OBL verses surgeries performed by the vascular surgery service in the acute care hospital operating room. The regulations pertaining to surgical cases and operative numbers were analyzed from these two practice sites.

Data was collected on the two practice sites about case volumes and trends. All patients operated upon by the vascular surgery service at the respective practice sites were included in this study. All statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) 26.0 (International Business Machines, Armonk, NY). Continuous variables were analyzed using a paired t-test and categorical variables were analyzed using either Fischer's Exact test or Chi-Squared analysis.

Patients treated in both the acute care hospital and OBL setting had similar baseline comorbidities. There was a significant number of endovascular limb and endovascular dialysis access procedures performed in the OBL, compared to the acute care hospital. These procedures performed in the OBL all corresponded to an SVS Clinical Practice Council Tier Class of either 2B or 3.⁵ Some of these procedures were performed as temporizing measures in patients with severe worsening tissue loss and ischemic rest pain until a definitive surgical procedure could be performed in the hospital setting. There were several dialysis catheters placed in patients with failing or failed dialysis accesses who could not have a surgical revision without having an OBL. The OBL allowed for these patients who otherwise would have been admitted to a hospital or gone without treatment for their progressive disease to be seen and treated. It should be noted, that every patient treated in the OBL was equally screened based on hospital COVID-19 policies. Patients were asked intake questions as to whether they experienced recent fevers, cough, new onset shortness of breath, generalized weakness, muscle aches or sore throat. They were additionally asked if they were in contact with anyone who tested positive for COVID-19 or if they were a person under investigation for COVID-19. If the patients answered yes to any of these questions or had a fever identified on intake vital signs, they were sent to the emergency department for additionally testing in.

Results

In the acute care hospital from April through June 2019, there were 274 vascular surgery operating room cases (mean 91.3, +/-14.96), compared to 175 points in 2020 (mean 58.33, +/-51.02) which is a statistically significant change p=0.03. See Fig. 1 .

Fig. 1.

2019 and 2020 Acute Care Hospital OR cases.

We then looked at the overall vascular case numbers by combining the total cases from both practice locations from 2019 to 2020. The total number of cases in 2019 was 413 compared to 302 in 2020. While the numbers for 2020 are lower, there is not a statistically significant drop in the total case volume (p=0.13). See Fig. 2 .

Fig. 2.

2019 and 2020 OBL OR cases.

Discussion

The significant findings from this three-month review are that the presence of an OBL associated with an acute care hospital helped to prevent the surgical backup post the COVID-19 surge. With the cancellation of elective and non-emergent surgeries at the acute care hospital, the OBL could continue providing urgent care and prevent a significant drop in overall case volume. Patients who are cared for with procedures in the OBL presented with ischemic rest pain and tissue loss or dialysis access malfunctions. The OBL created a setting to care for chronically ill patients to prevent further deterioration.

The management of vascular-related disease processes has changed over the past twenty years with the development of minimally invasive endovascular techniques moving many of these procedures to an office-based setting.⁹ These office-based labs (OBL) have emerged as an alternative place for procedures, with approximately 80% of peripheral vascular interventions that are catheter-based in this setting.¹⁰ Shifting endovascular interventions into the OBL setting allowed for lowering health care costs, and The Centers for Medicare and Medicaid Services (CMS) updated the outpatient reimbursement and physician fee schedule in 2008 to encourage outpatient interventions.¹⁰ Vascular surgery practices that have an OBL have the opportunity to flex patient care away from the acute care hospital.

Numerous works have been performed looking into the safety and efficacy of performing dialysis access, peripheral arterial, and venous procedures in the OBLs.^{11 , 12} These works expound on the relative safety of performing these procedures outside a hospital setting and note that OBLs should be considered first for percutaneous interventions.¹² Additionally, outpatient settings tend to have equal, if not higher, patient satisfaction rates compared to the hospital.¹¹ As other institutions reported having to adapt their acute care hospital practice in the pandemic,¹³ the OBL was leveraged so that the outpatient endovascular suite could perform to its highest capability.

Limitations

This study had several limitations, primarily as this is a single-center hospital reviewing only vascular patients in a retrospective design. As this vascular department is the only surgical division in the hospital to have an OBL, it was easy to see the benefit compared to other surgical services in the hospital. Although we did find a significant number of operations that the vascular division could perform, the vascular surgical staff could stay centered in vascular and not get redeployed to other departments, which may not have happened at other institutions.

Conclusion

During a global pandemic, in-hospital operative volumes decreased to conserve healthcare resources. The presence of an OBL allowed for managing complex vascular disease in patients with urgent vascular needs during the COVID-19 pandemic. This paper is the first to demonstrate the benefits of having an OBL during a pandemic to offset the surgical surge experienced by acute care hospitals.

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper