Abstract

Background: This is an updated analysis of the morbidity and mortality of cervical surgery performed in outpatient/same day (OSD) (Postoperative care unit [PACU] observation 4–6 h), and ambulatory surgicenters (ASC: PACU 23 h) versus inpatient facilities (IF).

Methods: We analyzed 19 predominantly level III (retrospective) and IV (case series) studies regarding the morbidity/mortality of cervical surgery performed in OSC/ASC versus IF.

Results: A “selection bias” clearly favored operating on younger/healthier patients to undergo cervical surgery in OSD/ASC centers resulting in better outcomes. Alternatively, those selected for cervical procedures to be performed in IF classically demonstrated multiple major comorbidities (i.e. advanced age, diabetes, high body mass index, severe myelopathy, smoking, 3–4 level disease, and other comorbidities) and had poorer outcomes. Further, within the typical 4–6 h. PACU “observation window,” OSD facilities “picked up” most major postoperative complications, and typically showed 0% mortality rates. Nevertheless, the author’s review of 2 wrongful death suits (i.e. prior to 2018) arising from OSD ACDF cervical surgery demonstrated that there are probably many more mortalities occurring following discharges from OSD where cervical operations are being performed that are going underreported/unreported.

Conclusion: “Selection bias” favors choosing younger/healthier patients to undergoing cervical surgery in OSD/ ASC facilities resulting in better outcomes. Atlernatively, choosing older patients with greater comorbidities for IF surgery correlated with poorer results. Although most OSD cervical series report 0% mortality rates, a review of 2 wrongful death suits by just one neurosurgeon prior to 2018 showed there are probably many more mortalities resulting from OSD cervical surgery than have been reported.

Keywords: Ambulatory surgical centers, Cervical disc replacement, Efficacy, Morbidity, Mortality, Multilevel, Outpatient/same day surgery, Safety, Update, anterior cervical diskectomy/fusion

INTRODUCTION

In our 2016 review, the results of cervical spine surgery performed in outpatient/same day (OSD) or ambulatory surgicenters (ASC) were compared to those performed in inpatient facilities (IF) [ Table 1 ].[ 5 ] Here, we have updated this comparison, and have further analyzed the pros, cons, morbidity, and mortality of OSD/ASC versus IF cervical surgery.

Table 1:

Update on outpatient cervical surgery.

LOW LEVEL III (RETROSPECTIVE) AND IV (CASE SERIES) EVIDENCE FOR STUDIES COMPARING OSD/ASC VERSUS IF CERVICAL SURGERY

Two studies questioned the safety/efficacy of performing cervical surgery in OSD/ASC versus IF facilities [ Table 1 ].[ 18 , 19 ] In 2018, Sivaganesan et al. determined the quality of such data for cervical and lumbar OSD/ASC surgery were poor, as they were largely based on level III/ IV studies, and there were no level I randomized controlled trials.[ 18 ] Further, when Yemeni (2020) et al. performed a meta-analyses of 21 articles (up to April 2018), they also found just low level III/IV evidence that supported the performance of anterior cervical diskectomy/fusion (ACDF) in OSD/ASC versus IF.[ 19 ]

GREATER GROWTH FOR ASC (23 h) VERSUS OSD (4–6 h) SPINE SURGERY

Idowu et al. (2017) documented, using a large research database, greater growth in the number of ASC-performed lumbar laminectomies and posterior cervical procedures versus those performed in OSD facilities [ Table 1 ].[ 10 ]

MAJOR POSTOPERATIVE ADVERSE EVENTS (AE) FOLLOWING CERVICAL SURGERY “PICKED UP” WITHIN POSTOPERATIVE CARE UNIT (PACU) “OBSERVATION WINDOWS” OF 4–6 h FOR OSD AND UP TO 23 h FOR ASC

Multiple studies documented that major postoperative complications following cervical surgery were “picked up” in PACU “observation windows” that respectively ranged from 4 to 6 h for OSD, and up to 23 h for ASC [ Table 1 ].[ 1 , 4 - 7 , 9 , 13 - 15 ] Fountas et al. study provided a baseline of 19.3% postoperative AE observed for 1015 inpatients undergoing ACDF.[ 6 ] Complication rates included; 9.5% dysphagia, hematoma 5.6% (2.4% requiring reoperations), recurrent laryngeal nerve palsy 3.1%, dural tear 0.5% and esophageal perforation 0.3%. In three other studies (2010– 2016) involving a total of 1741 patients undergoing 1–2 level ACDF, the 4–6 h. postoperative PACU observation window in OSD identified all major postoperative complications occurring in from 0.8 to 5.2 to 6% of cases (i.e. some requiring rehospitalization).[ 1 , 8 , 13 ] Gennari et al. (2018) found a 10% (3 patients) incidence of AE in a series of just 30 patients undergoing 17 ACDF and 13 cervical disc arthroplasties (CDR) perfirmed in OSD; 1 required immediate postoperative transfer to a hospital for a new neurological deficit requiring emergency surgery, while 2 were admitted to the hospital on postoperative day 1 due to dysphagia that spontaneously resolved.[ 8 ] All 16 (1.2%) major complications (AE) were diagnosed in the 1300 patients in Helseth et al. (2019) study for patients undergoing cervical surgery, and observed in the OSD PACU for 6 postoperative h.[ 9 ] These AE included; 4 new neurological deficits, 2 hematomas (both readmitted to the hospital), 1 dural tear, 1 surgical site infection, 3 instances of hoarseness, and 5 cases of dysphagia. Similarly, all 10 (0.5%) major complications were also recognized in McGirt (2020) et al. series involving 2000 1–3 level ACDF (2006–2018) observed for 4 h in an OSD PACU; these included 2 hematomas, 2 instances of intractable pain, 1 cerebrospinal fluid leak, and 5 medical complications.[ 14 ]

TWO STUDIES DOCUMENTED COMPARABLE OUTCOMES FOR OSD/ASC VERSUS IF CERVICAL SURGERY

Two studies demonstrated the non-superiority/comparable outcomes for cervical surgery performed in OSD/ASC versus IF [ Table 1 ].[ 3 , 16 ] The Ban et al. (2016) metanalysis involved 12 articles that demonstrated similar rates of postoperative dysphagia and hematomas occurring following cervical surgery whether performed in OSD/ASC versus IF.[ 3 ] Mullins et al. (2018) also found comparable complication rates for 1–2 level ACDF performed in an outpatient setting (OSD 4.1%) versus IF (3.0%).[ 16 ]

RISK FACTORS TO AVOID WHEN SELECTING PATIENTS TO UNDERGO OSD/ASC CERVICAL SURGERY

Multiple studies identified significant risk factors to be avoided when choosing patients for cervical surgery in OSD/ASC vs. IF surgery [ Table 1 ].[ 2 , 16 , 19 ] Mullins et al. (2018) documented 3 major risk factors, older age, male gender, and diabetes, that correlated with higher complication rates when choosing patients for ACDF surgery in OSD/ ASC.[ 16 ] Interestingly, they also found higher complication rates (9 or 3.6%) for patients undergoing 3 or 4 level ACDF performed in either OSD/ASC (560 patients) versus IF (563 patients). Additionally, Aguilar et al. (2019) showed that patients undergoing C2-C3/C3-C4 high level cervical ACDF demonstrated a 32% postoperative risk of dysphagia (i.e. 239 out of 747 patients undergoing 1-level ACDF); they, therefore, recommended performing such high cervical procedures in IF settings.[ 2 ] Nevertheless, they found the following risks factors did not enhance the risk for OSD/ ASC high 1-level ACDF surgery; older age, high body mass index (BMI), a smoking history, or longer operative times.[ 2 ] Somewhat overlapping major medical/neurological contraindications to performing ASC cervical surgery were observed by Yemeni et al.; these included advanced age, significant medical comorbidities, obesity, and significant/ severe myelopathy.[ 19 ]

“SELECTION BIAS” FAVORS YOUNGER/ HEALTHIER PATIENTS FOR OSD/ASC CERVICAL SURGERY

Several studies documented a deliberate patient “selection bias” favoring younger/healthier patients to undergo OSD/ ASC versus IF cervical surgery [ Table 1 ].[ 11 , 12 , 19 ] In 2019, Khalid et al. compared the morbidity data for 2059 patients undergoing 1–2 level ACDF in an ASC versus 26,368 performed in IF; ASC patients had lower 4% postoperative readmission rates versus IF patients who, with diabetes, smoking, and/or higher BMI, had higher 10% readmission rates.[ 11 ] Additionally, IF patients exhibited more major postoperative complications that included; urinary tract infections, heart attack (MI), and phlebitis/pulmonary embolism (PE). In their other 2019 study, Khalid et al. compared the 30 day readmission rates for Medicare patients (i.e. over age of 65) undergoing 1–2 level ACDF; 1035 were performed in ASC versus 16, 386 performed in IF [ Table 1 ].[ 12 ] The inpatients, with more major comorbidities, exhibited an anticipated higher frequency of postoperative urinary tract infections, surgical site infections, DVT/PE, and heart attacks. However, they did not anticipate that ASC Medicare patients would have higher 10.1% readmission rate versus just 4% for IF patients; this finding was largely attributed to the more effective/efficient recognition of AE during the prolonged hospitalization of IF patients versus the 23 h stays for ASC patients. When Yemeni (2020) et al. performed a metanalyses of over 21 articles (before April 20018), they found lower reoperation and mortality rates for ACDF performed in OSD/ASC settings [ Table 1 ].[ 19 ] However, this finding was likely attributable to their “selection bias” favoring younger, healthier patients, with fewer comorbidities to undergo OSD/ASC procedures.

COMPARABLE 30-DAY OUTCOMES FOR 1-LEVEL CERVICAL DISC ARTHROPLASTY (CDA) PERFORMED IN ASC VERSUS IF

Segal et al. (2019) looked at 30-day outcomes for patients undergoing 1 level CDA performed in ASC versus IF [ Table 1 ].[ 17 ] Using the NSQUIP (National Surgical Quality Improvement Program) database, they found 531 CDA performed in ASC versus 1022 done in IF; there were no clear statistical differences in 30-day readmission, reoperation rates, or complication rates between the two groups. However, they did acknowledge a significant “patient selection bias” for younger/healthier patients to undergo cervical ASC surgery.

0% MORTALITY RATES REPORTED FOR OSD/ ASC (4–6–10 H) AND ASC (23 H) CERVICAL SURGERY

6 Clinical series showed 0% mortality rates for OSD/ASD versus 0.1% for IF cervical surgery

In 2007, Fountas et al. documented 1 death (0.1%: esophageal perforation) occurring out of 1015 patients undergoing ACDF in an inpatient setting (IF).[ 6 ] Six other clinical series involving cervical surgery performed in OSD/ASC documented 0% mortality rates [ Table 1 ].[ 1 , 7 - 9 , 13 , 14 ] These latter studies involved a total of 5071 patients, with between 30 and 2000 patients/study; most patients underwent 1–2 level ACDF, with fewer having 3–4 level ACDF, or CDA.

3 Other review articles showed 0% to low mortality rates for OSD/ASC ACDF surgery

Three other review articles found 0% to “low” mortality rates for cervical surgery performed in OSD/ASC versus 0% to higher mortality rates for IF cervical procedures [ Table 1 ].[ 3 , 5 , 19 ] Ban et al. (2016) found no deaths occurring in 12 studies involving ACDF performed in OSD or IF.[ 3 ] In Epstein’s 2016 review of 13 articles, there were no mortalities reported for cervical procedures performed in OSD/ASC.[ 5 ] In an analysis of 21 articles in 2020, Yemeni et al. found “lower mortality rates for OSD/ASC cervical surgery versus higher mortality rates for IF cervical procedures.[ 19 ]

2 MEDICOLEGAL SUITS PRIOR TO 2018 REVEALED 2 MORTALITIES OCCURRING AFTER ACDF PERFORMED IN OSC

The author performed expert medicolegal reviews in 2 cases (prior to 2018) involving wrongful deaths occurring after patients were discharged from OSD following ACDF. The first case involved a single-level ACDF with a cardiorespiratory arrest occurring within several hours of discharge; the patient sutained a major hypoxic injury, and expired the following day. The second case had a multilevel ACDF with discharge home within just 4 hours of surgery; this patient also sustained a cardiorespiratory arrest at home but remained vegetative on a respirator for a year prior to their demise. Note, that if just one neurosurgical expert could identify 2 such wrongful death suits following cervical surgery performed in OSD/ASC facilities, there are probably many more that have gone unreported.

CONCLUSION

Selection “bias” favors choosing younger/healthier patients to undergo cervical surgery in OSD/ASC facilities results in better outcomes. Alternatively, performing cervical surgery on older patients with more medical comorbidities in inpatient facilities yields anticipated poorer results. Of interest, few to no mortalities were reported in the literature attributed to cervical surgery performed in OSD/ASC facilities. Nevertheless, the author alone was a plaintiffs’ expert in 2 wrongful death suits prior to 2018 attributed to cervical procedures performed in OSD. Therefore, there are likely more such suits in the medicolegal literature, and more mortalities from these OSC/ ASC cervical procedures that are going under-unreported.

Declaration of patient consent

Patient’s consent not required as patients identity is not disclosed or compromised.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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