The safety of in-office laryngologic procedures during active antithrombotic therapy.

OBJECTIVES: To determine whether patients undergoing in-office laryngologic procedures on antithrombotic therapy are at increased risk for treatment-related complications.
METHODS: Patients were those who underwent at least one in-office laryngologic procedure with any of three fellowship-trained laryngologists. Procedures were identified by current procedural terminology (CPT) code and included biopsies, excisions, laser ablations, and injections (therapeutic and augmentative). Patients were divided into two groups based on the use of antithrombotic therapy at the time of their procedure. Retrospective chart review was performed to identify any complications, with an average follow-up of 186 days.
RESULTS: Five hundred-sixty-four unique individuals were identified with ages ranging from 18 to 93 years old and with a relatively even distribution between females (45%) and males (55%). They underwent 647 procedures in total, 310 of which were performed while on some form of antithrombotic therapy. Sixteen procedures were associated with complications either during or after the procedure. In comparing overall complication rates, there was no significant difference between non-antithrombotic (2.4%) and antithrombotic (3.3%) cohorts (OR 1.09, 95% CI [0.46-2.60], P = .8454).
CONCLUSIONS: In spite of known risks in other settings, antithrombotic agents do not appear to confer increased risk of treatment-related complications during in-office laryngologic procedures, obviating the need for cessation of therapy prior to these interventions. LEVEL OF EVIDENCE: 4.

INTRODUCTION

In‐office laryngologic procedures are becoming increasingly popular in the practice of otolaryngology as physicians look for the most efficient ways to deliver quality health care to patients with voice, airway, and/or swallowing dysfunction. , , Indeed, these procedures are associated with shorter recovery time, quicker return to work, and decreased cost per case compared to the operating room. , They are well‐tolerated, and the avoidance of general anesthesia makes them a potential option for patients with significant comorbidities. , , Furthermore, the ability in some cases to titrate the effects of intervention based on real‐time patient response may promote better outcomes and patient satisfaction. , , , However, there is some precision lost in the non‐operative setting, and there have been reports of hemodynamic instability with topical anesthetic in older patients. , , These considerations must be taken into account before any in‐office laryngologic procedure.

Another increasing trend over recent decades has been the number of patients on antithrombotic therapy, which includes both antiplatelet and anticoagulant agents. , The recommendation for antithrombotic medication is based primarily on annual thromboembolic risk and validated scoring systems like the CHADS2 and CHADS2‐VASc criteria, which stratify patients into low‐ and high‐risk groups. , Antiplatelets are one of the primary treatments for patients with acute coronary syndrome, which affects about 635 000 Americans per year. Similarly, anticoagulants are commonly used in atrial fibrillation, the prevalence of which is expected to rise to 5.6 to 12 million by 2050. , Use of mechanical heart valves and vessel stents is also increasing, necessitating dual therapy. ,

The increased usage of antithrombotics has led to more complicated clinical decision‐making in terms of the risk/benefit of office‐based laryngologic procedures, as bleeding in the airway may become a potentially emergent situation. This highlights the need for more formal recommendations in this context, and the following study will seek to establish in‐office laryngologic procedures as legitimately safe in patients on active antithrombotic therapy.

MATERIALS AND METHODS

Approval was obtained from the Institutional Review Board. The institution's Research Data Repository was queried for all patients aged 18 or older who, from January 2012 through December 2017, underwent at least one in‐office procedure with any of three fellowship‐trained laryngologists. Procedures were identified by Current Procedural Terminology (CPT) code and included biopsies, excisions, laser ablations, and injections (therapeutic and augmentative). In general, these all involved some form of topical anesthesia (ie, lidocaine drip, nebulized lidocaine, transtracheal lidocaine) with occasional pre‐procedural oral diazepam (usually 2‐5 mg) per provider and patient preference. No continuous monitoring of vitals was performed during the procedures unless the patient had an oxygen requirement, in which case pulse oximetry was utilized. On average, procedures lasted less than 10 minutes or up to 15 in more difficult cases.

With the study group identified, retrospective chart review was then performed. Data collection included demographic features (age, gender, race, smoking status) and clinical information (procedure type, follow‐up, complications, outcomes, antithrombotics if applicable). Complications were defined as any unexpected event—bleeding‐related or otherwise—identified by review of procedure notes, follow‐up appointments, and telephone encounters. Prior to data analysis, procedures were stratified based on the presence or absence of active antithrombotic therapy, which included antiplatelet (fish oil, ibuprofen, naproxen, etodolac, cilostazol, dipyridamole, aspirin, clopidogrel) and/or anticoagulant (enoxaparin, warfarin, apixaban, rivaroxaban) agents of interest. To test for differences between these two groups, Fisher's exact test was used for categorical variables while a Wilcoxon rank‐sum test was used for continuous variables. To explore differences in occurrence of complications, a generalized linear mixed model was used to account for the correlation among repeated measurements on some subjects. Each covariate of interest was first tested in a univariate model for consideration into a multivariate model.

RESULTS

A total of 564 unique patients were identified as having undergone 647 in‐office laryngologic procedures. Two hundred‐seventy‐four of these individuals were on antithrombotic therapy at the time, accounting for 310 procedures. Table 1 summarizes and compares the demographic features of the two study groups. For the 68 patients who underwent more than one procedure, this table includes demographic information at their first recorded procedure only. The types of procedures performed as well as their distribution are listed in Table 2. Average duration of follow‐up was 186 days or approximately 6 months. There were 16 procedures with complications, all of which were self‐limited and are detailed in Table 3. Overall complication rates (number of complications/procedures performed) were 2.4% and 3.3% for the non‐antithrombotic and antithrombotic groups, respectively. There was no statistically significant difference between these rates on univariate analysis (OR 1.09, 95% CI [0.46‐2.60], P = .8454). Table 4 summarizes univariate analyses of other clinical variables, none of which were statistically significant, thereby obviating the need to fit a multivariate model.

TABLE 1

Demographic characteristics by cohort

Variable	Level	Antithrombotic		Total (n = 564)	P‐value
		No (n = 290)	Yes (n = 274)
Gender	Female	144 (50%)	111 (41%)	255 (45%)	.0343
	Male	146 (50%)	163 (59%)	309 (55%)
Race	Asian	5 (2%)	3 (1%)	8 (1%)	.6584
	Black	28 (10%)	22 (8%)	50 (9%)
	Hispanic	0 (0%)	1 (0%)	1 (0%)
	Other/Unknown	11 (4%)	7 (3%)	18 (3%)
	White	246 (85%)	241 (88%)	487 (86%)
Smoker	Missing	0 (0%)	1 (0%)	1 (0%)	.0266
	Current	42 (14%)	30 (11%)	72 (13%)
	Former	102 (35%)	126 (46%)	228 (40%)
	Never	146 (50%)	117 (43%)	263 (47%)
Age	Median [IQR] (min, max)	56 [44, 65] (17, 92)	65 [56, 74] (28, 93)	60 [50, 71] (17, 93)	<.0001

TABLE 2

Type and distribution of procedures performed

Procedure	Antithrombotic		Total (n = 647)
	No (n = 337)	Yes (n = 310)
Biopsy	55 (16%)	47 (15%)	102 (16%)
Excision	77 (23%)	45 (15%)	122 (19%)
Laser ablation	18 (5%)	14 (5%)	32 (5%)
Injection	187 (55%)	204 (66%)	391 (60%)
Therapeutic	159 (47%)	159 (51%)	318 (49%)
Augmentation	28 (8%)	45 (15%)	73 (11%)

TABLE 3

Complications as documented per electronic medical record

Complication	Procedure	Intra/Post	Antithrombotic
Bleeding	Injection	Intra	No
Bleeding	Injection	Intra	Yes
Dysphonia	Injection	Post	Yes
Dyspnea	Injection	Post	No
Dyspnea	Excision	Post	No
Dyspnea, stridor	Injection	Post	Yes
Extruded material	Injection	Intra	Yes
Hemoptysis	Injection	Post	No
Hemoptysis, throat pain	Excision	Post	Yes
Hypotension, vocal fold hemorrhage	Excision	Post	Yes
Inability to cough	Injection	Post	Yes
Increased secretions	Excision	Intra	Yes
Throat swelling	Excision	Post	No
Vagal response	Injection	Intra	No
Vagal response, extruded material	Injection	Intra	No
Vocal fold hemorrhage	Injection	Post	Yes

TABLE 4

Additional univariate and generalized linear mixed model results

Variable	Odds ratio	95% CI	P‐value
Female vs male	1.32	(0.55, 3.15)	.5270
Smoker			.2880
Current vs never	2.54	(0.78, 8.24)	.1196
Former vs never	1.28	(0.47, 3.43)	.6265
Age	1.01	(0.98, 1.04)	.4384
Race nonwhite vs white	1.04	(0.29, 3.71)	.9460
Procedure excision a vs injection	0.33	(0.11, 1.01)	.0511

Includes biopsy and laser ablation.

DISCUSSION

Individuals on antithrombotic therapy have traditionally been considered at increased risk of complications from surgery related to excessive bleeding, and oftentimes recommendations are made to hold antithrombotic therapy beforehand. Doing so, however, is not without its risks, and the potential for thromboembolic events may preclude surgery, particularly in more elective cases. , , , In the otolaryngology literature, operative microlaryngeal surgery was shown to have no increased risk of bleeding in patients on antithrombotics. Subsequent studies by Fritz et al and Dang et al had similar findings in the office setting and at the bedside, respectively, but the smaller size of these studies prevented them from drawing formal conclusions. ,

The present study sought to validate the findings of those before it while establishing definitive recommendations for the performance of in‐office laryngologic procedures in patients on antithrombotic therapy. Demographically, there were predictable differences among the two cohorts, with male gender, smoking status, and older age all associated with antithrombotic usage. Most importantly, patients on antithrombotics were found to be just as likely to experience a complication as those not on antithrombotics. These findings indicate that active antithrombotic therapy is in fact safe during said procedures. No other variables were associated with complications.

Despite these encouraging results, there are some limitations worth mentioning. The identification of complications was reliant on documentation from procedure notes, follow‐up visits, and patient telephone encounters. As such, it is possible that inadequate documentation may have led to omissions. There is also a degree of subjectivity in distinguishing expected side effects from true complications, introducing the possibility for observer bias. Moreover, although a major strength of this study rests in its size, it is technically underpowered to detect such a small difference in complication rate between the two cohorts (0.8%), which would require about 5000 patients per group. With the current sample size, the smallest difference that can be detected is about 5%, which the authors would argue is clinically negligible in most cases. Lastly, subgroup analysis (ie, antiplatelet vs anticoagulant vs dual therapy) was not possible due to the relative paucity of complications.

CONCLUSION

In‐office laryngologic procedures afford a number of advantages compared to their operating room counterparts, including avoidance of general anesthesia, shorter recovery, quicker return to work, and lower cost. The current study supports that these procedures are safe to perform while patients are on active antithrombotic therapy with no need for cessation. Larger cohorts are expected to corroborate these findings and may allow for subgroup analysis going forward.

CONFLICT OF INTEREST

The authors declare no potential conflict of interest.