- Email: [email protected]
Incidence of and Risk Factors Associated With Vocal Fold Hemorrhage Following Type I Thyroplasty With Gore-Tex Implant
ARTICLE IN PRESS
Incidence of and Risk Factors Associated With Vocal Fold Hemorrhage Following Type I Thyroplasty With Gore-Tex Implant *Daniel Eichorn, †Jin Park, ‡Ghiath Alnouri, †Dylan Vance, ║William Valentino, and ‡,¶Robert T. Sataloff, *yz║Philadelphia, and {Pennsylvania
Summary: Objectives. The objectives of this study were to determine the rate of hemorrhage following type I thyroplasty performed exclusively with Gore-Tex implant and to define whether age, comorbidities, anticoagulation therapy, presence of vocal fold ectasia, and operative technique are associated with increased incidence of hemorrhage. Methods. Medical charts of 86 patients who underwent type I thyroplasty with Gore-Tex implant between the years 2013 and 2019 were reviewed retrospectively and divided into two groups based on presence or absence of postoperative vocal fold hemorrhage. Patients were examined on the day following surgery. Hemorrhage was defined as any submucosal erythema on the vocal fold even when isolated to the superior surface. Age, sex, medical comorbidities, preoperative medications with specific attention to anticoagulation therapy, American Society of Anesthesiology score (all procedures were performed under local anesthesia with sedation), operative notes, and pre- and poststroboscopy exams were compared between groups. Statistical analyses were done using ChiSquare (x 2) Analysis and Student’s t test. P values were considered statistically significant at the P < 0.05 level. Results. The rate of hemorrhage was 22.3%. There was a statistically significant difference in incidence of hemorrhage associated with a vocal fold varix on preoperative stroboscopic exam and history of discontinued anticoagulation therapy (1-week preoperatively). No difference was found for the other parameters studied. Conclusion. Presence of vocal fold varix or ectasia and preoperative use of anticoagulation or antiplatelet therapy are associated with an increased risk of hemorrhage following type I Thyroplasty with Gore-Tex implant. Key Words: Hemorrhage−Type I Thyroplasty−Gore-Tex−Varix−Ectasia−Anticoagulation−Antiplatelet.
INTRODUCTION Type I thyroplasty with Gore-tex (W.L. Gore, Newark, DE) implant is a safe outpatient procedure,1 and life-threatening complications are uncommon.2 However, other complications such as soft-tissue reaction and edema, shifting or extrusion of the implant, and hemorrhage can occur.3 Hemorrhage rate in type I thyroplasty is unknown. Hemorrhage may manifest as a superficial hematoma along the superior surface or vibratory margin of the vocal fold and the cause is still unclear.4 Multiple studies performed on other laryngeal surgeries suggested that patients receiving antiplatelet therapy were not at increased risk of hemorrhage.5 Additional studies showed no need to stop anticoagulation therapy prior to some laryngeal surgeries.6 The present study was conducted to address the rate and causes of hemorrhage following type I thyroplasty with Gore-Tex implant. METHODS Medical charts of 93 patients who underwent Type I thyroplasty with Gore-Tex implant (primary or revision) between Accepted for publication December 18, 2019. From the *Philadelphia College of Osteopathic Medicine, Philadelphia, Pennsylvania; yDrexel University College of Medicine, Philadelphia, Pennsylvania; zDepartment of Otolaryngology - Head and Neck Surgery, Drexel University College of Medicine, Philadelphia, Pennsylvania; ║Temple University, Philadelphia, Pennsylvania; and the {Lankenau Institute for Medical Research, Pennsylvania. Address correspondence and reprint requests to Robert T Sataloff, 219 N. Broad Street, The ARNOLD Berman, MD Building, 10th Floor, Philadelphia, PA 19107. E-mail: [email protected] Journal of Voice, Vol. &&, No. &&, pp. &&−&& 0892-1997 © 2019 The Voice Foundation. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jvoice.2019.12.015
the years 2013 and 2019 were reviewed retrospectively, and 86 patients were included in the study. Seven patients were excluded because data were missing from the charts. Data gathered from charts included: age (at time of operation), sex, date of operation, unilateral or bilateral surgery, preoperative medications with specific attention to antiplatelet and anticoagulation therapies, medical comorbidities with specific attention to underlying pulmonary disease, preoperative American Society of Anesthesiology (ASA) score, otolaryngologic diagnoses, preoperative strobovideoscopy exam findings, postoperative complications and antibiotic use, as well as postoperative vocal fold hemorrhage (PVFH) and timing of hemorrhage resolution. Some of these patient data had been compiled and used previously for research on another topic.7 At our center, patients are evaluated in the outpatient office, and if an appropriate candidate for the surgery, are scheduled. These perioperative appointments range from 2 weeks to 3 months before the surgery date is scheduled. Patients taking anticoagulation therapy preoperatively are instructed to discontinue their medications approximately 1 week before surgery except for aspirin products which are discontinued 2 weeks before surgery. Patients undergo Type I thyroplasty as outpatients under local anesthesia. Flexible laryngoscopy is performed at the end of every case. Patients are scheduled to follow-up in the office at 1 day (day after surgery), 1 week and 4−6 weeks. They are advised to resist the urge to cough or clear their throat, remain silent for 24 hours until their postprocedure examination, avoid straining or heavy lifting, and to sleep with the head of the
ARTICLE IN PRESS 2
Journal of Voice, Vol. &&, No. &&, 2019
bed elevated at least 30°. Patients are allowed to phonate following 1-day post-op visit if there is no evidence of significant hemorrhage such as hemorrhage involving the vibratory margin, or extensive, raised hematoma. Patients were divided into two groups depending on whether they had PVFH or not. Statistical analyses were done using ChiSquare (x2). Analysis and Student’s t test. P values were considered statistically significant at the P < 0.05 level. RESULTS Eighty-six subjects (56% female) were included in the study. Sixty procedures were unilateral, and 26 were bilateral. All were performed with the patients awake and all patients were discharged on the day of surgery. There were no readmissions. Analyses performed on rate of ectasia or varices and PVFH were completed using each vocal fold side as a single surgery. Hemorrhage was defined very liberally as any submucosal erythema even if isolated to the superior surface of the vocal fold. There were no hemorrhages seen during intraoperative laryngoscopy at the conclusion of the cases. PVFH occurred in 25 out of 112 procedures (22.3%) (Tables 3−4). The average age of all patients was 52.3 years, and age did not differ between patient groups (P = 0.679). There was no statistically significant difference in incidence of PVFH between males and females (P = 0.103). There were no statistically significant differences found in the preoperative ASA score between groups (P = 0.649). Undergoing unilateral surgery as opposed to bilateral surgery showed no significant differences in rates of PVFH (P = 0.762) (Table 5). The presence of underlying asthma, cough, Chronic Obstructive Pulmonary Disease (COPD), or other pulmonary pathology was not different between groups (P = 0.698) (Table 1). The rates of extruded implant or postoperative infection did not differ significantly between groups (P = 0.471 and P = 0.757). The recorded rate of perioperatively-discontinued antiplatelet or anticoagulation therapy was significantly different between both the groups (P = 0.035) with higher use in the hemorrhage group
TABLE 1. Patient Demographic and Baseline Information PVFH Number of patients Sex distribution (P = 0.103) Age (years) (P = 0.679) Mean medical comorbidities (P = 0.689) Mean ASA score (P = 0.649) Underlying asthma/COPD/ pulmonary disease (P = 0.698)
22 (26%) Male: 13 Female: 9 53.182 5.318 1.773 3/22
TABLE 2. Presence or Absence of Anticoagulation or Antiplatelet Therapy up to One Week Prior to Surgery in Both Patient Groups PVFH
No PVFH
5
4
17
60
5/22
4/64
Anticoagulation or antiplatelet therapy No anticoagulation/antiplatelet therapy Total P = 0.035.
(Table 2) . In those with PVFH, the majority (17/22, 77.3%) were detected within 1 day postoperatively. Of these, 9/17 (53%) resolved fully by 1 week postoperatively and would not have been detected if the patients had not been examined on the first day after surgery. Ectasia or varices were identified on preoperative strobovideoscopy exam in a total of 59/112 procedures (52.7%). In those with PVFH, 20 out of 25 procedures (80%) had ectasia or varices present. In those without PVFH, 42 out of 87 (48.3%) procedures had either finding present. These rates of ectasia or varices differed significantly between groups (P = 0.00848, OR = 4.286, 95% CI (1.511 −12.05)). This finding maintained statistical significance when it was calculated using number of patients (P = 0.00454, OR = 4.66, 95% CI (1.563−13.75)) instead of each vocal fold side as a single surgery.
TABLE 3. Number of Thyroplasty Surgical Sides with Varices or Ectasia Identified on Preoperative Strobovideoscopic Exam in Patients With PVFH Versus no PVFH
Ectasia or varices on exam Neither ectasia nor varices on exam Total number of surgical sides (n = 112)
PVFH
No PVFH
20 (80%) 5 (20%)
42 (48.3%) 45 (51.7%)
25
87
Counts shown with rates in parentheses. P = 0.00848.
No PVFH 64 (74%) Male: 25 Female: 39 51.328 5.016 1.859 11/64
Student’s t test was used for differences in means and Chi-Square (x2) Analysis was used for sex and underlying pulmonary disease. P values are shown.
TABLE 4. Counts and Rates of Ectasia or Varices Identified on Preoperative Strobovideoscopic Exam in Patients With and Without PVFH
Ectasia or varices on exam Neither ectasia nor varices on exam Total number of patients (n = 86) Rates shown in parentheses. P = 0.00454.
PVFH
No PVFH
17 (77%) 5 (23%)
27 (42%) 37 (58%)
22
64
ARTICLE IN PRESS Daniel Eichorn, et al
Incidence of and Risk Factors Associated With VFH
TABLE 5. Number of Patients Who Underwent Bilateral or Unilateral Surgery With and Without PVFH
Bilateral Surgery Unilateral surgery Total number of patients (n = 86)
PVFH
No PVFH
6 (27%) 16 (73%) 22
20 (31%) 44 (69%) 64
Counts shown with rates in parenthesis. P = 0.7265.
DISCUSSION This study evaluated hemorrhage following Type I thyroplasty with Gore-Tex implant. At our center, we perform type I thyroplasty using the Gore-Tex implant as follows: a small (2 cm) horizontal incision is made, centered in the midline, in a skin crease near the lower third of the vertical dimension of the thyroid cartilage. The cartilage is exposed in the midline, and the perichondrium is incised and elevated. A 5-mm diamond bur was used to drill a 5-mm minithyrotomy on the cases reported. More recently, the thyrotomy has been made using a Sonopet (Stryker, Kalamazoo, Michigan) or a CUSA (Integra LifeSciences, Plainsboro, NJ). The inner perichondrium is left intact. A fine elevator such as a Sataloff Thyroplasty Elevator (Integra LifeSciences, Plainsboro, NJ), is used to elevate the perichondrium posteriorly. A small pocket parallel to the inferior border of the thyroplasty cartilage is created, and Gore-Tex is layered through the thyrotomy incision and adjusted to optimize phonation. The thyrotomy is then filled with a few drops of cyanoacrylate with an extension of Gore-Tex in the center of the cyanoacrylate block. Flexible laryngoscopy is performed before the incision is closed. The rate of PVFH was 22.3% (25/112 procedures) among 86 patients who underwent Type I thyroplasty with Gore-Tex implant over a 6-year period (Tables 3−4). Eighty-four percent of these PVFHs were identified on postoperative day 1 (POD #1) (21/25), as per follow-up protocol, and the rest occurred after day 1 but prior to the 1 week examination on day 8. Nine of the hemorrhages had resolved completely by day 8 and would have gone unrecognized if there been no examination on POD #1. Other studies describing parameters involving the vocal folds in laryngeal surgery commonly report each vocal fold side counting as a single surgery, and this is how we reported our data. Although, when this rate was calculated by patient, it remained similar (25.58%, 22/86). Of these, six patients underwent bilateral surgery (6/22) for a total of 12 sides. Nine (9/12) of those sides were found to have hemorrhage. There was no statistically significant difference found in rate of PVFH between patients undergoing bilateral surgery compared with unilateral surgery (P = 0.7265) (Table 5). There was no difference found in incidence of PVFH based on number of medical comorbidities or ASA score (P = 0.689 and 0.649, respectively). Specific attention was paid to the presence of comorbid cough, asthma, COPD, or to URI the immediate postoperative period.
3
It has been proposed that vocal fold varices are a risk factor for PVFH.4 Presence or absence of vocal fold varices or ectasias is documented using strobovideoscopy. Our study found a higher rate of varices or ectasia in those patients with PVFH (P = 0.00848, OR = 5.308, 95% CI (1.886−14.81)). This finding also maintained statistical significance when calculated per patient (P = 0.00454). The study also showed a significant difference in recorded rate of previous antiplatelet or anticoagulation use (P = 0.035, OR = 4.412, 95% CI (1.13−17.14)) with a higher rate of use in the PVFH group (Table 2). The antiplatelet and anticoagulation therapies that patients were taking included aspirin 81 mg, enoxaparin, and warfarin. The number of patients taking each agent was not sufficient to investigate the risk of hemorrhage associated with each medicine. All patients had been taking these medications for at least 3 months prior to discontinuing them approximately 1 week before surgery, or 2 weeks for aspirin. It is recommended that warfarin be stopped at least 5 days prior to surgery based on the amount of time required for the International Normalized Ratio (INR) to normalize, which is approximately 4−6 days. We check the INR in the holding area and postpone surgery if it is not normal or very nearly normal. Elderly patients and patients receiving high-intensity anticoagulation (INR = 2.5−3.5) may need more time to achieve normal INR levels.8,9 Aspirin is recommended to be stopped 7 days prior to surgery based on the POISE-2 Trial, but the senior author (RTS) routinely recommends that it be stopped 14 days before surgery.10 The last dose of enoxaparin is recommended to be given at least 12 hours prior to surgery but closer to 24 hours prior is thought to be safer, and we follow this protocol and recommend cessation at 24 hours.11,12 Anticoagulants are resumed 24−48 hours following surgery depending on the amount of surgical bleeding encountered, and on the medical condition for which anticoagulation is required.
CONCLUSION This is the largest study to date investigating the incidence and risk factors of PVFH in Type I Thyroplasty with Gore-Tex implant. Presence of vocal fold varix or ectasia and preoperative use of anticoagulation or antiplatelet therapy are associated with an increased risk of hemorrhage following type I Thyroplasty with Gore-Tex implant. Further studies are needed to confirm or refute these findings.
REFERENCES 1. Chau SM, Kim CM, Vahabzadeh-Hagh A, et al. Safety of outpatient unilateral medialization laryngoplasty across two academic institutions. Laryngoscope. 2019;129:1647–1649. 2. Junlapan A, Sung CK, Damrose EJ. Type I thyroplasty: a safe outpatient procedure. Laryngoscope. 2019;129:1640–1646. 3. Watanabe K, Hirano A, Honkura Y, et al. Complications of using Gore-Tex in medialization laryngoplasty: case series and literature review. Eur Arch Otorhinolaryngol. 2019;276:255–261.
ARTICLE IN PRESS 4 4. Sataloff RT, Hawkshaw MJ. Vocal fold hemorrhage. Professional Voice: the Science and Art of Clinical Care. 4th ed San Diego, CA: Plural Publishing, Inc; 2017:1587–1603. 5. Dang JH, Liou NE, Ongkasuwan J. Anticoagulation and antiplatelet therapy in awake transcervical injection laryngoplasty. Laryngoscope. 2017;127:1850–1854. 6. Francis DO, Dang JH, Fritz MA, et al. Antiplatelet and anticoagulation therapy in microlaryngeal surgery. Laryngoscope. 2014;124:928–934. 7. Vance D, Alnouri G, Valentino W, et al. Role of postoperative antibiotics in patients undergoing type I thyroplasty with Gore-TexÒ implant [published online ahead of print June 10, 2019]. J Voice. 2019. 8. Hylek EM, Regan S, Go AS, et al. Clinical predictors of prolonged delay in return of the international normalized ratio to within the
Journal of Voice, Vol. &&, No. &&, 2019
9.
10.
11. 12.
therapeutic range after excessive anticoagulation with warfarin. Ann Intern Med. 2001;135:393–400. White RH, McKittrick T, Hutchinson R, et al. Temporary discontinuation of warfarin therapy: changes in the international normalized ratio. Ann Intern Med. 1995;122:40–42. Ansa BE, Hoffman Z, Lewis N, et al. Aspirin use among adults with cardiovascular disease in the United States: implications for an intervention approach. J Clin Med. 2019;8:264. Safety of surgery during bridging anticoagulation therapy with lowmolecular-weight heparin. Ann Intern Med. 2007;146(3):1–35. Hwang HG, Koo SM, Uh ST, et al. The perioperative management of antithrombotic therapies using enoxaparin. J Korean Med Sci. 2017;32: 942–947.
Incidence of and Risk Factors Associated With Vocal Fold Hemorrhage Following Type I Thyroplasty With Gore-Tex Implant *Daniel Eichorn, †Jin Park, ‡Ghiath Alnouri, †Dylan Vance, ║William Valentino, and ‡,¶Robert T. Sataloff, *yz║Philadelphia, and {Pennsylvania
Summary: Objectives. The objectives of this study were to determine the rate of hemorrhage following type I thyroplasty performed exclusively with Gore-Tex implant and to define whether age, comorbidities, anticoagulation therapy, presence of vocal fold ectasia, and operative technique are associated with increased incidence of hemorrhage. Methods. Medical charts of 86 patients who underwent type I thyroplasty with Gore-Tex implant between the years 2013 and 2019 were reviewed retrospectively and divided into two groups based on presence or absence of postoperative vocal fold hemorrhage. Patients were examined on the day following surgery. Hemorrhage was defined as any submucosal erythema on the vocal fold even when isolated to the superior surface. Age, sex, medical comorbidities, preoperative medications with specific attention to anticoagulation therapy, American Society of Anesthesiology score (all procedures were performed under local anesthesia with sedation), operative notes, and pre- and poststroboscopy exams were compared between groups. Statistical analyses were done using ChiSquare (x 2) Analysis and Student’s t test. P values were considered statistically significant at the P < 0.05 level. Results. The rate of hemorrhage was 22.3%. There was a statistically significant difference in incidence of hemorrhage associated with a vocal fold varix on preoperative stroboscopic exam and history of discontinued anticoagulation therapy (1-week preoperatively). No difference was found for the other parameters studied. Conclusion. Presence of vocal fold varix or ectasia and preoperative use of anticoagulation or antiplatelet therapy are associated with an increased risk of hemorrhage following type I Thyroplasty with Gore-Tex implant. Key Words: Hemorrhage−Type I Thyroplasty−Gore-Tex−Varix−Ectasia−Anticoagulation−Antiplatelet.
INTRODUCTION Type I thyroplasty with Gore-tex (W.L. Gore, Newark, DE) implant is a safe outpatient procedure,1 and life-threatening complications are uncommon.2 However, other complications such as soft-tissue reaction and edema, shifting or extrusion of the implant, and hemorrhage can occur.3 Hemorrhage rate in type I thyroplasty is unknown. Hemorrhage may manifest as a superficial hematoma along the superior surface or vibratory margin of the vocal fold and the cause is still unclear.4 Multiple studies performed on other laryngeal surgeries suggested that patients receiving antiplatelet therapy were not at increased risk of hemorrhage.5 Additional studies showed no need to stop anticoagulation therapy prior to some laryngeal surgeries.6 The present study was conducted to address the rate and causes of hemorrhage following type I thyroplasty with Gore-Tex implant. METHODS Medical charts of 93 patients who underwent Type I thyroplasty with Gore-Tex implant (primary or revision) between Accepted for publication December 18, 2019. From the *Philadelphia College of Osteopathic Medicine, Philadelphia, Pennsylvania; yDrexel University College of Medicine, Philadelphia, Pennsylvania; zDepartment of Otolaryngology - Head and Neck Surgery, Drexel University College of Medicine, Philadelphia, Pennsylvania; ║Temple University, Philadelphia, Pennsylvania; and the {Lankenau Institute for Medical Research, Pennsylvania. Address correspondence and reprint requests to Robert T Sataloff, 219 N. Broad Street, The ARNOLD Berman, MD Building, 10th Floor, Philadelphia, PA 19107. E-mail: [email protected] Journal of Voice, Vol. &&, No. &&, pp. &&−&& 0892-1997 © 2019 The Voice Foundation. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jvoice.2019.12.015
the years 2013 and 2019 were reviewed retrospectively, and 86 patients were included in the study. Seven patients were excluded because data were missing from the charts. Data gathered from charts included: age (at time of operation), sex, date of operation, unilateral or bilateral surgery, preoperative medications with specific attention to antiplatelet and anticoagulation therapies, medical comorbidities with specific attention to underlying pulmonary disease, preoperative American Society of Anesthesiology (ASA) score, otolaryngologic diagnoses, preoperative strobovideoscopy exam findings, postoperative complications and antibiotic use, as well as postoperative vocal fold hemorrhage (PVFH) and timing of hemorrhage resolution. Some of these patient data had been compiled and used previously for research on another topic.7 At our center, patients are evaluated in the outpatient office, and if an appropriate candidate for the surgery, are scheduled. These perioperative appointments range from 2 weeks to 3 months before the surgery date is scheduled. Patients taking anticoagulation therapy preoperatively are instructed to discontinue their medications approximately 1 week before surgery except for aspirin products which are discontinued 2 weeks before surgery. Patients undergo Type I thyroplasty as outpatients under local anesthesia. Flexible laryngoscopy is performed at the end of every case. Patients are scheduled to follow-up in the office at 1 day (day after surgery), 1 week and 4−6 weeks. They are advised to resist the urge to cough or clear their throat, remain silent for 24 hours until their postprocedure examination, avoid straining or heavy lifting, and to sleep with the head of the
ARTICLE IN PRESS 2
Journal of Voice, Vol. &&, No. &&, 2019
bed elevated at least 30°. Patients are allowed to phonate following 1-day post-op visit if there is no evidence of significant hemorrhage such as hemorrhage involving the vibratory margin, or extensive, raised hematoma. Patients were divided into two groups depending on whether they had PVFH or not. Statistical analyses were done using ChiSquare (x2). Analysis and Student’s t test. P values were considered statistically significant at the P < 0.05 level. RESULTS Eighty-six subjects (56% female) were included in the study. Sixty procedures were unilateral, and 26 were bilateral. All were performed with the patients awake and all patients were discharged on the day of surgery. There were no readmissions. Analyses performed on rate of ectasia or varices and PVFH were completed using each vocal fold side as a single surgery. Hemorrhage was defined very liberally as any submucosal erythema even if isolated to the superior surface of the vocal fold. There were no hemorrhages seen during intraoperative laryngoscopy at the conclusion of the cases. PVFH occurred in 25 out of 112 procedures (22.3%) (Tables 3−4). The average age of all patients was 52.3 years, and age did not differ between patient groups (P = 0.679). There was no statistically significant difference in incidence of PVFH between males and females (P = 0.103). There were no statistically significant differences found in the preoperative ASA score between groups (P = 0.649). Undergoing unilateral surgery as opposed to bilateral surgery showed no significant differences in rates of PVFH (P = 0.762) (Table 5). The presence of underlying asthma, cough, Chronic Obstructive Pulmonary Disease (COPD), or other pulmonary pathology was not different between groups (P = 0.698) (Table 1). The rates of extruded implant or postoperative infection did not differ significantly between groups (P = 0.471 and P = 0.757). The recorded rate of perioperatively-discontinued antiplatelet or anticoagulation therapy was significantly different between both the groups (P = 0.035) with higher use in the hemorrhage group
TABLE 1. Patient Demographic and Baseline Information PVFH Number of patients Sex distribution (P = 0.103) Age (years) (P = 0.679) Mean medical comorbidities (P = 0.689) Mean ASA score (P = 0.649) Underlying asthma/COPD/ pulmonary disease (P = 0.698)
22 (26%) Male: 13 Female: 9 53.182 5.318 1.773 3/22
TABLE 2. Presence or Absence of Anticoagulation or Antiplatelet Therapy up to One Week Prior to Surgery in Both Patient Groups PVFH
No PVFH
5
4
17
60
5/22
4/64
Anticoagulation or antiplatelet therapy No anticoagulation/antiplatelet therapy Total P = 0.035.
(Table 2) . In those with PVFH, the majority (17/22, 77.3%) were detected within 1 day postoperatively. Of these, 9/17 (53%) resolved fully by 1 week postoperatively and would not have been detected if the patients had not been examined on the first day after surgery. Ectasia or varices were identified on preoperative strobovideoscopy exam in a total of 59/112 procedures (52.7%). In those with PVFH, 20 out of 25 procedures (80%) had ectasia or varices present. In those without PVFH, 42 out of 87 (48.3%) procedures had either finding present. These rates of ectasia or varices differed significantly between groups (P = 0.00848, OR = 4.286, 95% CI (1.511 −12.05)). This finding maintained statistical significance when it was calculated using number of patients (P = 0.00454, OR = 4.66, 95% CI (1.563−13.75)) instead of each vocal fold side as a single surgery.
TABLE 3. Number of Thyroplasty Surgical Sides with Varices or Ectasia Identified on Preoperative Strobovideoscopic Exam in Patients With PVFH Versus no PVFH
Ectasia or varices on exam Neither ectasia nor varices on exam Total number of surgical sides (n = 112)
PVFH
No PVFH
20 (80%) 5 (20%)
42 (48.3%) 45 (51.7%)
25
87
Counts shown with rates in parentheses. P = 0.00848.
No PVFH 64 (74%) Male: 25 Female: 39 51.328 5.016 1.859 11/64
Student’s t test was used for differences in means and Chi-Square (x2) Analysis was used for sex and underlying pulmonary disease. P values are shown.
TABLE 4. Counts and Rates of Ectasia or Varices Identified on Preoperative Strobovideoscopic Exam in Patients With and Without PVFH
Ectasia or varices on exam Neither ectasia nor varices on exam Total number of patients (n = 86) Rates shown in parentheses. P = 0.00454.
PVFH
No PVFH
17 (77%) 5 (23%)
27 (42%) 37 (58%)
22
64
ARTICLE IN PRESS Daniel Eichorn, et al
Incidence of and Risk Factors Associated With VFH
TABLE 5. Number of Patients Who Underwent Bilateral or Unilateral Surgery With and Without PVFH
Bilateral Surgery Unilateral surgery Total number of patients (n = 86)
PVFH
No PVFH
6 (27%) 16 (73%) 22
20 (31%) 44 (69%) 64
Counts shown with rates in parenthesis. P = 0.7265.
DISCUSSION This study evaluated hemorrhage following Type I thyroplasty with Gore-Tex implant. At our center, we perform type I thyroplasty using the Gore-Tex implant as follows: a small (2 cm) horizontal incision is made, centered in the midline, in a skin crease near the lower third of the vertical dimension of the thyroid cartilage. The cartilage is exposed in the midline, and the perichondrium is incised and elevated. A 5-mm diamond bur was used to drill a 5-mm minithyrotomy on the cases reported. More recently, the thyrotomy has been made using a Sonopet (Stryker, Kalamazoo, Michigan) or a CUSA (Integra LifeSciences, Plainsboro, NJ). The inner perichondrium is left intact. A fine elevator such as a Sataloff Thyroplasty Elevator (Integra LifeSciences, Plainsboro, NJ), is used to elevate the perichondrium posteriorly. A small pocket parallel to the inferior border of the thyroplasty cartilage is created, and Gore-Tex is layered through the thyrotomy incision and adjusted to optimize phonation. The thyrotomy is then filled with a few drops of cyanoacrylate with an extension of Gore-Tex in the center of the cyanoacrylate block. Flexible laryngoscopy is performed before the incision is closed. The rate of PVFH was 22.3% (25/112 procedures) among 86 patients who underwent Type I thyroplasty with Gore-Tex implant over a 6-year period (Tables 3−4). Eighty-four percent of these PVFHs were identified on postoperative day 1 (POD #1) (21/25), as per follow-up protocol, and the rest occurred after day 1 but prior to the 1 week examination on day 8. Nine of the hemorrhages had resolved completely by day 8 and would have gone unrecognized if there been no examination on POD #1. Other studies describing parameters involving the vocal folds in laryngeal surgery commonly report each vocal fold side counting as a single surgery, and this is how we reported our data. Although, when this rate was calculated by patient, it remained similar (25.58%, 22/86). Of these, six patients underwent bilateral surgery (6/22) for a total of 12 sides. Nine (9/12) of those sides were found to have hemorrhage. There was no statistically significant difference found in rate of PVFH between patients undergoing bilateral surgery compared with unilateral surgery (P = 0.7265) (Table 5). There was no difference found in incidence of PVFH based on number of medical comorbidities or ASA score (P = 0.689 and 0.649, respectively). Specific attention was paid to the presence of comorbid cough, asthma, COPD, or to URI the immediate postoperative period.
3
It has been proposed that vocal fold varices are a risk factor for PVFH.4 Presence or absence of vocal fold varices or ectasias is documented using strobovideoscopy. Our study found a higher rate of varices or ectasia in those patients with PVFH (P = 0.00848, OR = 5.308, 95% CI (1.886−14.81)). This finding also maintained statistical significance when calculated per patient (P = 0.00454). The study also showed a significant difference in recorded rate of previous antiplatelet or anticoagulation use (P = 0.035, OR = 4.412, 95% CI (1.13−17.14)) with a higher rate of use in the PVFH group (Table 2). The antiplatelet and anticoagulation therapies that patients were taking included aspirin 81 mg, enoxaparin, and warfarin. The number of patients taking each agent was not sufficient to investigate the risk of hemorrhage associated with each medicine. All patients had been taking these medications for at least 3 months prior to discontinuing them approximately 1 week before surgery, or 2 weeks for aspirin. It is recommended that warfarin be stopped at least 5 days prior to surgery based on the amount of time required for the International Normalized Ratio (INR) to normalize, which is approximately 4−6 days. We check the INR in the holding area and postpone surgery if it is not normal or very nearly normal. Elderly patients and patients receiving high-intensity anticoagulation (INR = 2.5−3.5) may need more time to achieve normal INR levels.8,9 Aspirin is recommended to be stopped 7 days prior to surgery based on the POISE-2 Trial, but the senior author (RTS) routinely recommends that it be stopped 14 days before surgery.10 The last dose of enoxaparin is recommended to be given at least 12 hours prior to surgery but closer to 24 hours prior is thought to be safer, and we follow this protocol and recommend cessation at 24 hours.11,12 Anticoagulants are resumed 24−48 hours following surgery depending on the amount of surgical bleeding encountered, and on the medical condition for which anticoagulation is required.
CONCLUSION This is the largest study to date investigating the incidence and risk factors of PVFH in Type I Thyroplasty with Gore-Tex implant. Presence of vocal fold varix or ectasia and preoperative use of anticoagulation or antiplatelet therapy are associated with an increased risk of hemorrhage following type I Thyroplasty with Gore-Tex implant. Further studies are needed to confirm or refute these findings.
REFERENCES 1. Chau SM, Kim CM, Vahabzadeh-Hagh A, et al. Safety of outpatient unilateral medialization laryngoplasty across two academic institutions. Laryngoscope. 2019;129:1647–1649. 2. Junlapan A, Sung CK, Damrose EJ. Type I thyroplasty: a safe outpatient procedure. Laryngoscope. 2019;129:1640–1646. 3. Watanabe K, Hirano A, Honkura Y, et al. Complications of using Gore-Tex in medialization laryngoplasty: case series and literature review. Eur Arch Otorhinolaryngol. 2019;276:255–261.
ARTICLE IN PRESS 4 4. Sataloff RT, Hawkshaw MJ. Vocal fold hemorrhage. Professional Voice: the Science and Art of Clinical Care. 4th ed San Diego, CA: Plural Publishing, Inc; 2017:1587–1603. 5. Dang JH, Liou NE, Ongkasuwan J. Anticoagulation and antiplatelet therapy in awake transcervical injection laryngoplasty. Laryngoscope. 2017;127:1850–1854. 6. Francis DO, Dang JH, Fritz MA, et al. Antiplatelet and anticoagulation therapy in microlaryngeal surgery. Laryngoscope. 2014;124:928–934. 7. Vance D, Alnouri G, Valentino W, et al. Role of postoperative antibiotics in patients undergoing type I thyroplasty with Gore-TexÒ implant [published online ahead of print June 10, 2019]. J Voice. 2019. 8. Hylek EM, Regan S, Go AS, et al. Clinical predictors of prolonged delay in return of the international normalized ratio to within the
Journal of Voice, Vol. &&, No. &&, 2019
9.
10.
11. 12.
therapeutic range after excessive anticoagulation with warfarin. Ann Intern Med. 2001;135:393–400. White RH, McKittrick T, Hutchinson R, et al. Temporary discontinuation of warfarin therapy: changes in the international normalized ratio. Ann Intern Med. 1995;122:40–42. Ansa BE, Hoffman Z, Lewis N, et al. Aspirin use among adults with cardiovascular disease in the United States: implications for an intervention approach. J Clin Med. 2019;8:264. Safety of surgery during bridging anticoagulation therapy with lowmolecular-weight heparin. Ann Intern Med. 2007;146(3):1–35. Hwang HG, Koo SM, Uh ST, et al. The perioperative management of antithrombotic therapies using enoxaparin. J Korean Med Sci. 2017;32: 942–947.