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Medical Policy

Policy Num:       07.001.083
Policy Name:     SURGERY OF PARANASAL SINUSES GUIDED BY IMAGES 
Policy ID:          [07.001.083][Ac L M+ P+][0.00.00]

Last Review:       November 11, 2020
Next Review:      N/A
Issue:                   November, 2020

Policy Archived

Related Policies: None

                                                                 IMAGE GUIDED PARANASAL SINUS SURGERY  

Summary

Surgery guided by images is a system of three-dimensional mapping that combines computerized tomography and information in real time to locate exactly the position of the operative instruments by means of infrared or electromagnetic probes. In this way, the otolaryngologist "navigates" through the nasal passages in a more precise way when performing functional endoscopic paranasal sinuses surgery (FESS).

In 2005, image-guided surgery (IGS) expanded from the field of neurosurgery, where it was originally used, to the surgery of paranasal sinuses, spine and orthopedic surgery. As the otolaryngologists were gaining experience, its use has been generalized, particularly in the following indications:

•           Surgery of the paranasal sinuses in the absence of normal anatomy

•           Revision of surgery of paranasal sinuses

•           Disease that is extending to the base of the skull

•           Disease extending to frontal or sphenoid sinuses

•           Surgery near the lamina papyracea.

•           Presence of orbital pathology 

Image-guided surgery provides the surgeon a more detailed view of the extra and intracranial structures such as: areas near the eyes, brain, arteries and major veins, and nerves that can be found during FESS.  This technology is particularly useful in revision procedures of FESS where the effects of scarring may be present and common anatomical reference points are not already present or in such complex cases that the anatomy is distorted.

FDA has approved for the process 510 (k) several systems for this purpose, namely:

•           InstaTrak 3000Plus System (GE OEC Medical Systems, Salt Lake City, UT)

•           StealthStation System (Surgical Navigation Technologies, Broomfield, CO)

•           VectorVision Cranial/ENT (BrainLAB AG, Heimstetten, Germany)

•           Stryker Navigation System ENT Module (Stryker Corporation, Kalamazoo, MI)

•           Fusion Compact Navigation System ( Medtronics,Lousville Colorado)

Objective

The objective of this evidence review is the overall improvement in health quality for patients undergoing surgery guided by images, a system of three-dimensional mapping that combines computerized tomography and information in real time to locate exactly the position of the operative instruments by means of infrared or electromagnetic probes.

Policy Statements

Image-guided surgery is recognized for payment for the following indications:

•         Revision of surgery on the paranasal sinuses
•         Altered anatomy of the paranasal sinuses due to development surgery or past trauma
•         Extensive polyposis in the paranasal sinuses
•         Pathology present in frontal, ethmoidal and sphenoidal sinuses
•         Pathology that abuts with the base of the skull, orbits, optic nerve or carotid artery
•         Runny cerebrospinal fluid or in situations where there is a defect in the skull base
•        Benign or malignant neoplasm in the paranasal sinuses

Policy Guidelines

As per policy statement.

Benefit Application

As established in the member's policy.

Background

Image-guided endoscopic techniques are a multidisciplinary collaboration of otolaryngologists and neurosurgeons. They provide superior visualization, with angled endoscopes affording exposure around anatomic corners. The endoscopic method employs piecemeal tumor removal and was initially criticized for its inability to achieve an en bloc resection. Clear surgical margins (regardless of the surgical method) are a critical factor for tumor control, and both open and endoscopic techniques appear equally effective in this aspect. Endoscopic sinus surgery has been used both alone and in combination with open craniofacial surgery.

These endoscopic approaches may offer significant advantages in terms of a lower frequency of surgical complications and decreased morbidity. Advantages include lack of facial incisions, craniotomies, or facial bone osteotomies; decreased neurovascular structure manipulation; early tumor devascularization; access to deeply seated lesions; decreased hospital stay and pain; and faster recovery [26]. Brain retraction is avoidable, so postoperative brain edema and possible encephalomalacia are circumvented [35]. Nasal crusting can be a complication of both endoscopic and open approaches. This is related to disruption of the sinus mucosal lining as well as to postoperative radiation.

Endoscopic sinus surgery has also been utilized for palliation of symptoms (epistaxis, nasal obstruction, etc) in advanced sinonasal malignancies [36]. Contraindications to a pure endoscopic approach include tumors with extensive dural involvement or extension into facial or orbital soft tissues.

Several series that included patients with a variety of histologic tumor types have found that endoscopic techniques can be applied to patients with locally advanced lesions [37,38]. Similar oncologic results have been documented in numerous studies compared with traditional open approaches, although there are no direct comparisons, and longer follow-up is required [26].

Reconstruction — The goal of surgical and prosthetic reconstruction is to replace the form and function of facial and anterior skull base defects caused by surgery. Advances in tissue transfer techniques (particularly microvascular free flaps) provide reconstructive options in addition to maxillofacial prostheses. Optimal esthetic, functional, and quality of life outcomes are superior with combined approaches rather than single techniques [39].

Key issues with the management of maxillectomy defects include reconstruction of the orbital floor in order to support globe position, reconstruction of the palatal surface to separate nasal contents and to provide framework for dental rehabilitation, and reestablishment of facial symmetry [24]. For patients who have undergone orbital exenteration/clearance, temporalis muscle or temporoparietalis flaps can be used to line the cavity..)

Complications — Serious postoperative complications associated with craniofacial resection can include meningitis, hemorrhage, wound infection and abscess, cerebrospinal fluid leak, pneumocephalus, trismus, and blindness [40,41].

Surgical mortality and complication rates can be significant. A multi-institution analysis of 1193 patients who underwent open craniofacial resection observed postoperative mortality and complication rates of 5 and 36 percent, respectively [41]. The risk of complications and mortality is increased substantially for patients older than 70 years [42].

State-of-the-art image-guided endoscopic/endonasal approaches to skull base malignancies are associated with decreased postoperative morbidity and mortality. In a review of 800 patients, cerebrospinal fluid leak was the most common complication (16 percent). All but one patient was repaired endoscopically. The overall incidence of cerebrospinal fluid leak in this series decreased significantly with the use of vascularized skull base reconstruction. Overall mortality was 0.9 percent [43]. Another more recent study of 1000 patients who underwent endoscopic skull base surgery showed an overall infection rate of 1.8 percent [44].

Regulatory Status

Rationale

Population Reference No. 1 Policy Statement

For individuals with altered paranasal sinuses anatomy. Interventions of interest are surgery of paranasal sinuses guided by images. Comparators of interests are other therapies available. Relevant outcomes include improved precision of paranasal surgery. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Population Reference No. 2 Policy Statement

For individuals with paranasal sinuses surgery needing revision.  Interventions of interest are surgery of paranasal sinuses guided by images. Comparators of interests are other therapies available. Relevant outcomes include improved precision of paranasal surgery.The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. 

Population Reference No. 3 Policy Statement

For individuals with extensive polyposis in the paranasal sinuses.  Interventions of interest are surgery of paranasal sinuses guided by images. Comparators of interests are other therapies available. Relevant outcomes include improved precision of paranasal surgery.  The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Population Reference No. 4 Policy Statement

For individuals with pathology present in frontal, ethmoidal and sphenoidal sinuses.  Interventions of interest are surgery of paranasal sinuses guided by images. Comparators of interests are other therapies available. Relevant outcomes include improved precision of paranasal surgery.  The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Population Reference No. 5 Policy Statement

For individuals with pathology that abuts with the base of the skull, orbits, optic nerve or carotid artery.  Interventions of interest are surgery of paranasal sinuses guided by images. Comparators of interests are other therapies available. Relevant outcomes include improved precision of paranasal surgery. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Population Reference No. 6 Policy Statement

For individuals with runny cerebrospinal fluid or in situations where there is a defect in the skull base.  Interventions of interest are surgery of paranasal sinuses guided by images. Comparators of interests are other therapies available. Relevant outcomes include improved precision of paranasal surgery. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Population Reference No. 7 Policy Statement

For individuals with Benign or malignant neoplasm in the paranasal sinuses.  Interventions of interest are surgery of paranasal sinuses guided by images. Comparators of interests are other therapies available. Relevant outcomes include improved precision of paranasal surgery. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Supplemental Information

N/A

Practice Guidelines and Position Statements

N/A

Medicare National Coverage

N/A

References

1.    American Academy of Otolaryngology¬-Head and Neck Surgery (AAO-HNS). AAO-HNS policy on intraoperative use of computer-aided surgery. Accessed July 27, 2011.

2.    Isaacs S, Fakhri S, Luong A, Citardi MJ. Intraoperative imaging for otorhinolaringology-head and neck surgery. Otolaryngol Clin North Am. 2009 Oct;42(5):765-79Viii.

3.    Cigna medical Coverage Policy Num. 0257. 

4.    Thomas RF, Monacci WT, Mair EA. Endoscopic image-guided transethmoid pituitary surgery. Otolaryngol Head Neck surg. 2002 Nov;127(5):409-16.

5.    Smith TL, Stewart MG, Orlandi RR, Setzen M, Lanza DC. Indications for image-guide sinus surgery: the current evidence. Am J Rhinol. 2007 Jan-Feb:21(1):80-3.

6.    Metson R, Cosenza M, Gliklich RE, Montgomery WW. The role of image-guidance systems for head and neck surgery. Arch Otolaryngol Head Neck Surg. 1999 Oct;125(10):1100-4.

7.    Wigand ME. Transnasal ethmoidectomy under endoscopical control. Rhinology. 1981 Mar. 19(1):7-15. [Medline].

8.    Wigand ME, Steiner W, Jaumann MP. Endonasal sinus surgery with endoscopical control: from radical operation to rehabilitation of the mucosa. Endoscopy. 1978 Nov. 10(4):255-60. [Medline]
9.    Fried MP, Morrison PR. Computer-augmented endoscopic sinus surgery. Otolaryngol Clin North Am. 1998 Apr. 31(2):331-40. [Medline]. 
10.    Kacker A, Tabaee A, Anand V. Computer-assisted surgical navigation in revision endoscopic sinus surgery. Otolaryngol Clin North Am. 2005 Jun. 38(3):473-82, vi. [Medline].
11.    Fuoco G, Chiodo A, Smith O, et al. Clinical experience with angulated, hand-activated, wireless instruments in an optical tracking system for endoscopic sinus surgery. J Otolaryngol. 2005 Oct. 34(5):317-22. [Medline].
12.    Metson RB, Cosenza MJ, Cunningham MJ, et al. Physician experience with an optical image guidance system for sinus surgery. Laryngoscope. 2000 Jun. 110(6):972-6. [Medline].

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Policy History