Early Operative Intervention versus Conventional Treatment in Epistaxis: Randomized Prospective Trial

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1 The Journal of Otolaryngology, Volume 33, Number 3, 2004 Early Operative Intervention versus Conventional Treatment in Epistaxis: Randomized Prospective Trial Ali Moshaver, MSc, MD, Jeffrey Richard Harris, MD, FRCSC, Richard Liu, MD, FRCSC, Chris Diamond, MD, and Hadi Seikaly, MD, FRCSC Abstract Objective: This prospective randomized trial was designed to compare intranasal endoscopic sphenopalatine artery ligation (ESAL) with conventional nasal packing in the treatment of recurrent epistaxis. Methods: Patients were registered in the study databank following referral for epistaxis control to the otolaryngology service at the University of Alberta. All patients were initially packed using Merocel (Xomed Surgical Products, Jacksonville, FL) nasal dressings bilaterally. Patients were enrolled in the study following failure of Merocel packings. Informed consent was obtained in accordance with the Health Research Ethics Board. The patients were then managed with Vaseline nasal packs or ESAL. Patient demographics, treatment characteristics, number of hospitalization days, and rates of recurrence were recorded prospectively. The total cost of treatment for each patient was calculated. Results: Nineteen patients were enrolled in the study. There was a significant reduction in cost and length of hospitalization of the patients undergoing ESAL compared with the conventional nasal packings. ESAL was also 89% effective in controlling the bleeding and had minimal sequelae or complications. The overall calculated cost of patients undergoing ESAL was $5133 compared with $ in the conservative group, resulting in an average saving of $7080 per patient. There was overwhelming patient satisfaction with ESAL compared with nasal packings. Conclusion: ESAL is an excellent, well-tolerated, and cost-effective method of treating recurrent epistaxis. Sommaire Objectif: Cette étude prospective compare la ligature endoscopique de l artère sphénopalatine (LEAS) avec le paquettage conventionnel dans le traitement des épistaxis récidivants. Méthodes: Nous enregistrons dans une banque de données tous les patients transférés au service d ORL de l Université de l Alberta à Edmonton. Tous les patients avaient été traités initialement par l insertion bilatérale de Merocel (Xomed Surgical Products, Jacksonville, FL). Les patients ont donc été inclus dans l étude à la suite de l échec de cette stratégie. Avec le consentement des patients, nous les avons traités soit par paquettage conventionnel soit par LEAS. La démographie, les caractéristiques des traitements, le nombre de jours d hospitalisation et le taux de récidive ont été colligés de manière prospective. Résultats: Dix-neuf patients ont été recrutés pour cette étude. Nous avons documenté une diminution significative du nombre de jours d hospitalisation et du coût chez les patients traités par LEAS. Cette technique était aussi efficace dans 89% des cas pour contrôler le saignement avec des risques de complications et séquelles minimaux. Le coût total pour un patient subissant une LEAS est de $5133 comparé à $ pour celui traité par paquettage nasal, résultant en une économie nette de $7080 par patient traité. Inutile de dire que la satisfaction des patients est nettement meilleure avec le traitement chirurgical par rapport au traitement conservateur. Conclusion: La LEAS est une excellente technique, bien tolérée et efficiente dans le traitement de l épistaxis récidivant. Key words: cost analysis, endoscopic sinus surgery, epistaxis, nasal packing, randomized clinical trial, sphenopalatine artery Received 06/18/03. Received revised 06/18/03. Accepted for publication 06/18/03. Presented in part, at the Xomed Meeting, Calgary, A. Moshaver, Jeffrey Richard Harris, R. Liu, C. Diamond, and Hadi Seikaly: Division of Otolaryngology-Head and Neck Surgery, University of Alberta, Edmonton, AB. Address reprint requests to: Dr. Jeffrey R. Harris, 1E4.29 W C Mackenzie Health Sciences Center, Edmonton, AB T6G 1B7. E pistaxis is one of the most common maladies an otolaryngologist is called on to treat. Most epistaxis episodes are mild, originating from Kiesselbach s plexus on the anterior nasal septum, and are easily controlled at home or by the primary care physician. A small subset of patients have significant and persistent bleeding, usually from branches of sphenopalatine and anterior ethmoid arteries, resulting in a potentially life-threatening hemor- 185

2 186 The Journal of Otolaryngology, Volume 33, Number 3, 2004 rhage and complications. 1 These patients usually require management within a hospital setting, resulting in a significant economic burden to the health care system. Recurrent epistaxis is a difficult condition to manage, and a variety of treatment methods have been described in the medical literature. 1 3 Traditionally, nonsurgical management in the form of anterior and posterior packs has been the first-line therapy. This treatment modality is effective in controlling most epistaxis episodes but is extremely uncomfortable for patients and has been shown to cause hypoxia, sinusitis, aspiration, sepsis, myocardial infarcts, cerebral ischemia, and even death. 1,2 The surgical approaches used for control of recurrent epistaxis include transantral ligation of the internal maxillary artery, transantral ligation of the sphenopalatine artery, ligation of ethmoidal arteries, and percutaneous embolization of the internal maxillary artery and its branches. These procedures are very effective in controlling epistaxis, but they are also associated with significant morbidity and an extended hospital stay. 1 4 More recently, intranasal endoscopic sphenopalatine artery ligation (ESAL) has been described as a safe and effective method for controlling epistaxis ESAL allows for better visualization and access to bleeding vessels, which can then be subsequently clipped. This technique avoids complex surgery and its associated complications. The most optimum and cost-effective treatment of patients with intractable epistaxis is still controversial, with conflicting results reported in the literature. 2,12,13 To date, there are no studies that compare ESAL with conventional epistaxis treatment. We hypothesized that ESAL is an effective and cost-saving method of recurrent epistaxis treatment. This prospective randomized trial was, therefore, designed to compare ESAL with conventional nasal packing in the treatment of recurrent epistaxis. Methods Institutional Review Board The Health and Research Ethics Board of the University of Alberta approved this study. Patients Patients were registered in the study databank following referral for epistaxis control to the otolaryngology service at the University of Alberta. All patients were initially packed using Merocel (Xomed Surgical Products, Jacksonville, FL) nasal dressings bilaterally and were randomized to the conservative or surgical arm of the study. Patients with bleeding disorders, systemic anticoagulation, a recent history of nasal surgery, Rendu-Osler-Weber syndrome, or nasal malignancy and patients found to be medically unfit for the operation were excluded from the study. Study Patients were enrolled in the study following failure of Merocel packings. Informed consent was obtained in accordance with the Health Research Ethics Board. The patients were then managed with the treatment protocol and were randomized at the time of initial contact. All patients enrolled in the study were admitted to the otolaryngology-head and neck surgery ward for observation. Conservative Treatment. Patients randomized to the conservative arm were repacked with Vaseline packs anteriorly and, if necessary, posteriorly. The packs were removed 24 to 48 hours after the cessation of bleeding. Surgical Treatment. Patients randomized to the surgical arm were taken to the operating room, and ESAL was performed. A vertical incision above and anterior to the posterior insertion of the middle turbinate was made. The mucosa of the lateral wall was then elevated until the sphenopalatine artery at the sphenopalatine foramen was identified. The different branches of the SPA were initially cauterized using the Xomed intranasal bipolar cautery and were subsequently clipped. An anterior ethmoid artery ligation on the bleeding side and septoplasties were also performed as deemed necessary by the operating surgeon. The packs were removed 24 to 48 hours after the cessation of bleeding. Treatment Failures. Failure of therapy in the study was defined as rebleeding anteriorly or posteriorly, necessitating further treatment. These patients were treated with repacking, arterial embolization, or surgical intervention as deemed necessary by the admitting surgeon. Data Collection Patient demographics, treatment characteristics, number of hospitalization days, and rates of recurrence were recorded prospectively. The total cost of treatment for each patient was calculated by adding the cost of the procedure, the cost of hospitalization, and doctors fees (radiologists, surgeons, and anaesthetists). Follow-up A postdischarge telephone questionnaire (Table 1) was used to assess patient satisfaction with the therapy. Follow-ups ranged from 3 to 14 months. Statistical Analysis Statistical analysis was performed using SPSS for Windows, version 11.0 (SPSS Inc, Chicago, IL). Fisher s exact test was used for comparison of dichotomous outcomes between groups, whereas the Mann-Whitney test was used for mean comparison of continuous data. Results Nineteen patients were enrolled in the study. Ten patients were randomized to the conservative arm and

3 Moshaver et al, Early Operative Intervention vs Conventional Treatment in Epistaxis 187 Table 1 Questionnaire Used for Follow-up of Patients Enrolled in the Study 1. Have you had had any further nosebleeds since last hospitalization? None Few; insignificant Large amount requiring medical attention Large amount requiring hospitalization 2. Overall, how satisfied were you with your therapy? Not at all Somewhat unsatisfied Neutral Satisfied Very satisfied 3. Would you recommend this treatment to a relative with severe nosebleeds? Yes No nine to the surgical arm. The patient demographics are included in Table 2. There was no significant difference between groups in the distribution of age or sex. Eight of the nine patients (89%) in the surgical arm underwent ESAL and anterior ethmoid artery ligation. One of the nine patients (11%) did not have ligation of the anterior ethmoid artery, and two required septoplasty. The observed treatment failure in the conservative group was 50% compared with 11% in the surgery arm (Table 3). Although this difference was not found to be statistically significant (p =.141), there was a trend toward better resolution of bleeding following surgery in these patients. Epistaxis was controlled in the five patients who failed conservative therapy through a combination of ESAL, arterial embolization, and repacking. The patient who failed in the surgical arm was controlled with arterial embolization. The length of hospitalization is shown in Table 4. There was a statistically significant difference between the average hospital stay of the surgical (1.6 days) and the conservative (4.7 days) groups (p =.001). The average cost per patient in the surgical arm was $5133, compared with $ in the conservative arm (Table 5). The average saving per patient for early surgical intervention is calculated as $7080. Thirteen (68%) patients responded to the follow-up telephone questionnaire; six patients were in the surgical arm and patients were in the conservative arm. Table 3 Treatment Outcome of Patients in ESAL and Conservative Arms Demographic Factor Conservative ESAL Total number of patients 10 9 Sex (M:F) 7:3 4:5 Age (range, yr) Age (average, yr) ESAL = endoscopic sphenopalatine artery ligation. None of the patients had any further bleeding following discharge from the hospital. All of the patients in the surgical arm were very satisfied with their therapy and would recommend this procedure to others. On the other hand, all of the patients in the conservative arm described the experience as painful and unpleasant. Discussion This study is one of the first randomized prospective trials comparing ESAL and conservative treatment methods for the control of recurrent epistaxis. We found a significant reduction in the cost and length of hospitalization of the patients undergoing ESAL compared with conventional packings. ESAL was also 89% effective in controlling the bleeding and had minimal sequelae or complications. The overall calculated cost of patients undergoing ESAL was $5133, compared with $ in the conservative group, resulting in an average saving of a $7080 per patient. This is a significant saving considering the number of patients requiring treatment for recurrent epistaxis yearly. There was overwhelming patient satisfaction with ESAL compared with nasal packings. All of the patients reported that they would recommend this treatment to another patient. Table 4 Length of Hospitalization of Patients Treated with ESAL and Nasal Packings Treatment Modality Mean Range SD ESAL 1.6* Conservative 4.7* ESAL = endoscopic sphenopalatine artery ligation. *Statistically significant (p =.001). Table 2 Patient Demographics: Patients Treated by ESAL or Nasal Packings at the University of Alberta Demographic Factor Conservative ESAL Total number of patients 10 9 Sex (M:F) 7:3 4:5 Age (range, yr) Age (average, yr) ESAL = endoscopic sphenopalatine artery ligation. Table 5 Comparison of Treatment Cost of ESAL and Nasal Packings Cost (%) Outcome Conservative ESAL Successful outcome Unsuccessful outcome Average

4 188 The Journal of Otolaryngology, Volume 33, Number 3, 2004 Conclusion ESAL is an excellent, well-tolerated, and cost-effective method for treating recurrent epistaxis. References 1. Wurman LH, Sack JG, Flannery JV, Lipsman RA. The management of epistaxis. Am J Otolaryngol 1992;13: Schaitkin B, Stauss M, Houck JR. Epistaxis: medical versus surgical therapy: a comparison of efficacy, complications, and economic consideration. Laryngoscope 1987;97: Shaw CB, Wax MK, Wetmore SJ. Epistaxis: a comparison of treatment. Otolaryngol Head Neck Surg 1993;109: Pollice PA, Yoder MG. Epistaxis: a retrospective review of hospitalized patients. Otolaryngol Head Neck Surg 1997; 117: Christmas DA. Transnasal endoscopic ligation of the sphenopalatine artery. Ear Nose Throat J 1998;77: Wormald PJ, Wee DTH, van Hasselt CA. Endoscopic ligation of the sphenopalatine artery for refractory posterior epistaxis. Am J Rhinol 2000;14: White, PS. Endoscopic ligation of the sphenopalatine artery (ELSA): a preliminary description. J Laryngol Otol 1996; 110: Ram B, White, PS, Saleh HA, et al. Endoscopic endonasal ligation of the sphenopalatine artery. Rhinology 2000;38: Snyderman CH, Goldman, SA, Carrau RL, et al. Endoscopic sphenopalatine artery ligation is an effective method of treatment for posterior epistaxis. Am J Rhinol 1999;13: Marcus MJ. Nasal endoscopic control of epistaxis. Otolaryngol Head Neck Surg 1990;102: Budrovich R, Saetti R. Microscopic and endoscopic ligation of the sphenopalatine artery. Laryngoscope 1992;102: Cullen MM, Tami TA. Comparison of internal maxillary artery ligation versus embolization for refractory posterior epistaxis. Otolaryngol Head Neck Surg 1998;118: Monte ED, Belmonte MJ, Wax MK. Management paradigms for posterior epistaxis: a comparison of costs and complications. Otolaryngol Head Neck Surg 1999;121:103 6.

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