C IGNA H EALTH C ARE C OVERAGE P OSITION
Subject Image-Guided Sinus Surgery 12/15/2007 Original 12/15/2004 Coverage Position Number. (0257)
Table of Contents
Coverage Position (1)
General Background (1)
Coding/Billing Information (5)
<.6 Hyperlink to Related Coverage Positions Balloon Sinuplasty
Paranasal Sinus Ultrasound
真人在线英语外教
Rhinoplasty/Septoplasty
INSTRUCTIONS FOR USE
Coverage Positions are intended to supplement certain standard CIGNA HealthCare benefit plans. Plea note, the terms of a participant’s particular benefit plan document [Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which the Coverage Positions are bad. For example, a participant’s benefit plan document may contain a specific exclusion related to a topic addresd in a Coverage Position. In the event of a conflict, a participant’s benefit plan document always supercedes the information in the Coverage Positions. In the abnce of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable group benefit plan document in effect on the date of rvice; 2) any applicable
laws/regulations; 3) any relevant collateral source materials including Coverage Positions and; 4) the specific facts of the particular situation. Coverage Positions relate exclusively to the administration of
health benefit plans. Coverage Positions are not recommendations for treatment and should never be ud as treatment guidelines. ©2007 CIGNA Health Corporation Coverage Position
CIGNA HealthCare covers image-guided sinus surgery as medically necessary for ANY of the following indications:
•revision sinus surgery
•distorted sinus anatomy of developmental, postoperative, dia or traumatic origin
•extensive sino-nasal polyposis
•pathology involving the frontal, posterior ethmoid, or sphenoid sinus
•dia abutting the skull ba, orbit, optic nerve or carotid artery
•cerebral spinal fluid (CSF) rhinorrhea or conditions where a skull ba defect exists
•benign and malignant sino-nasal neoplasms
CIGNA HealthCare does not cover image-guided endoscopic sinus surgery for any other indication b
ecau it is considered not medically necessary.
General Background
Image-guided sinus (IGS) surgery is also referred to as computer-augmented, computer-aided or stereotactic sinus surgery. The technique of using imaging to guide surgery was first developed for neurosurgery and has more recently been adapted to sinus surgery for procedures involving the paranasal sinus, skull ba and temporal bone. Surgery in the regions is particularly suited for image-guidance applications becau the proximity to the orbit and cranial cavities demands a high degree of anatomical precision.
IGS surgery is facilitated by a three-dimensional (3D), real-time (i.e., intraoperative) correlation of the operative field to a monitor, which shows the preci location of a lected surgical instrument to the surrounding structures. Image-guidance systems convert preoperative computed tomography (CT) or magnetic resonance (MR) images into digital maps of the patient’s anatomy and the area targeted for surgery. The system tracks the actual movements of the surgical instruments, which are projected onto the preoperative image data t displayed on the system monitor. This integration of data and computing technology provides preci guidance to the surgeon. A traditional endoscopic i
mage allows a direct line of sight into the sinus but provides only a keyhole view. The field of view of the endoscopic image is spatially limited, and the anatomy under obrvation appears esntially two-dimensional. The u of image-guided surgery allows for a more expanded and detailed view intraoperatively.
IGS Surgery Tracking Systems
An IGS surgery system consists of a computer workstation, image-processing software, a display monitor, a localization system, and specialized, trackable instrumentation. Tracking systems may be optical, electromagnetic or electromechanical. Most systems currently available for sinus surgery are optical-bad, with the exception of the InstaTrak system™ (Visualization Technology, Inc., Broomfield, CO), which us electromagnetic technology. Optical tracking systems u infrared light to track surgical instruments. An optical tracking system includes a camera with a view of the surgical field, optical nsors placed on the surgical instruments, and optical nsors placed on a reference frame or head frame worn by the patient. Active optical systems u cameras to track the position of the flashing infrared emitters (i.e., light-emitting diodes [LEDs]) attached to the instruments and head frame. An electromagnetic tracking system consists of a transmitter located near the operative site and a receiver placed on the surgical instrument. This type of system us ra
diofrequency electromagnetic nsors and relies on detecting variations within the electromagnetic field caud by the movement of an instrument or the patient. An electromechanical system consists of a mechanical arm with multiple mechanical linkages and articulating joints between the instrument and a computer processor. The location of the instrument tip is computed by using special nsors to measure angular rotations at the joints. Electromechanical systems are not widely ud in sinus surgery becau of their obtrusive design.
IGS Surgery Registration Process
Registration is the process of matching preoperative CT or MR image data (virtual) to the physical space occupied by the patient during surgery. The accurate correlation (i.e., matching) of the two data ts subquently allows localization of the surgical tools within the operative space. Proper registration of the real surgical field to the image data ts in the computer is, therefore, esntial before initiating IGS surgery in order to provide accurate information and effective localization and navigation. A variety of registration strategies have been developed. They fall into two types of approaches: intrinsic and extrinsic. Intrinsic markers include anatomical points lected directly from the patient's anatomy (anatomical fiducial registration). Anatomic points are lected directly on the patient's head or face; the points may include the tragus, lateral canthus, nasion and rhinion. This m
ethod does not require the patient to wear a special head frame during the CT. Extrinsic markers include skin-affixed fiducials, bone-anchored markers, and head frame-mounted reference points (i.e., auto registration). Radiopaque markers are attached to the patient's skin before the CT scan and must remain in place until registration is complete. The extrinsic approach provides an accurate, fast registration process but is impractical in most cas of elective sinus surgery and so has largely been replaced by anatomical fiducial registration. The registration process takes approximately two minutes to complete by either approach. Some systems incorporate certain automatic registration techniques.Once the registration process has been completed, IGS surgery can begin. To correlate head position with the tracking system, the patient continues to wear the same head frame as during the preoperative CT scan. Unlike neurosurgical procedures that require head fixation in a stereotactic frame, image-guidance systems allow for free head movement during surgery. The surgeon can verify surgical position on the monitor, which depicts the preoperative CT scan images in 3D.
Advantages of IGS Surgery整洁的
The main advantage of IGS surgery is that it helps increa intraoperative patient safety by assisting the surgeon in navigating through complex anatomy that may be altered or obscured by prior surger
y, trauma, neoplasms or extensive sino-nasal polyposis. The technique may also enable more thorough removal of tumors, as well as greater confidence in approaching frontal sinus anatomy. The preci tracking of instruments allows the surgeon to avoid critical structures (e.g., the eyes and brain) adjacent
to the sinus and to navigate precily to the site of the dia, thus increasing the probability of better surgical outcomes. IGS surgery is also highly beneficial in revision surgery, where the patient’s anatomy has already undergone changes and where the surgeon may have difficulty finding anatomical landmarks for orientation.
U.S. Food and Drug Administration (FDA)
Several image-guidance tracking systems have been approved by the U.S. Food and Drug Administration (FDA) as class II devices for u as aids for precily locating anatomical structures during sinus, skull ba, cranial and axial skeletal procedures. Among the systems are the InstaTrak 3000 System with Fluorotrak Module™ (Visualization Technology, Inc., Broomfield, CO), which was approved in March 2000, and the StealthStation® System with FluoroNav™ Module (Surgical Navigation Technologies, Broomfield, CO), approved in April 1999. Both the systems are tbls
indicated for the same u by the FDA: for any medical condition that may benefit from the u of stereotactic surgery and for which reference to a rigid anatomical structure (e.g., the skull, sinus, cranium, long bone, or vertebra) is visible on medical images (e.g., CT, MR or x-ray).
Literature Review
Smith et al. (2007) conducted a literature review to determine if image-guided sinus surgery (IGSS) reduces complication rates and improves clinical outcomes. A total of 105 articles published between January 1990 and January 2006 were reviewed and five were included. Four of the studies were ca ries, two with comparison groups and two without. The last study was an article bad on expert opinion. According to the authors, the studies focud mainly on complication rates and revision surgery rates, none of them examining patient-bad outcomes such as quality of life. All of the studies that examined complication rates indicated that the complication rates associated with IGSS were the same or better as tho associated with non-IGS surgeries. The authors stated that becau major complications occur so rarely, designing a study to detect a difference in major complication rates would require a prohibitively large number of patients. They also stated that randomizing patients away from IGSS when it was felt to be needed would be unethical, especially since, according to the authors, it is commonly and appropriately ud. This review suggests that the
published literature and expert opinion support the current recommended indications for u of IGSS.
Hepworth et al. (2006) evaluated the usage and impressions of image-guided surgical systems for sinus surgery. Eleven hundred surveys were nt to ear, no and throat (ENT) physicians, with a respon rate of 61% (672 surveys returned). Of all the respondents, 73% were image-guided surgical systems urs, and 80% felt that image-guided surgical systems incread safety in certain procedures such as revisions, sphenoid and frontal procedures. The majority of respondents did not advocate image-guided surgical systems as a “standard-of-care” technology, although the same number felt it was “esntial” in certain cas. Most agreed, however, with the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Foundation guidelines regarding the u and indications of image-guided surgical systems. The authors identified the barriers to image-guided surgical systems affordability and reimburment. In conclusion, the authors stated that the majority of urs agree with the AAO-HNS guidelines for image-guided surgical systems and that it is not standard-of-care but indicated for lected clinical situations.
Tabaee et al. (2006) compared quality of life (QOL) outcomes and rate of complication following IGS versus non-IGS endoscopic sinus surgery. The charts of 60 patients who underwent IGS and 179 wh
o underwent non-IGS surgery were reviewed. The incidence of intraoperative complication was 6.6% for the IGS group versus 5.6% for the non-IGS group; of postoperative complications 5% versus 3.9%; and it was 6.6% versus 7.3% for revision procedures. Postoperative QOL outcomes were measured using the 20-item Sino-Nasal Outcome Test in which symptoms were rated on a scale of 0–5, with a total cumulative score of 0–100. Higher scores reprented wor symptoms. Symptom scores for the IGS and non-IGS groups were 23.6 and 23.4, respectively. The authors did report a higher incidence of cerebrospinal fluid (CSF) leak in the non-IGS group than in the IGS group (0% vs. 2.2%). The authors concluded that this study did not demonstrate a difference in the rate of complication, need for revision or QOL outcomes, but that it did suggest that IGS may decrea the incidence of skull ba trauma and CSF leak. The authors stated larger-sized, prospective studies are needed to validate the findings.
Han et al. (2003) evaluated the advantages of image-guided systems in transnasal endoscopic surgery that was performed on 28 patients with the aid of an image-guided system. Histopathological diagnosis of their conditions included chronic sinusitis (n=10), juvenile angiofibroma of the nasopharynx (n=4), pituitary adenoma (n=6), ossifying fibroma (n=3), nasopharyngeal mixed tumor (n=2), fugal sinusitis (n=1), inverted papilloma (n=1) and nasal leiomyoma (n=1). The results of the s
tudy showed that accuracy of localization fell within 1 mm. The image-guided system enhanced the understanding of complicated anatomical structures, such as Haller’s cell and Onodi cells, whereas previous two-dimensional views restricted the understanding of anatomy during transnasal endoscopic surgery and was associated with complications due to anatomical complexity. The study also showed that the image-guided system assisted in the total excision of tumors in the nasal cavity and sinus areas and avoided injury to the normal structures. Traditional endoscopic procedures for tumors in the nasal cavity and sinus have limitations, such as incomplete exposure of tumor boundaries and bleeding fields. The third advantage that the rearchers found was that the image-guided system was able to identify and display the boundaries of the pituitary tumors and avoid injuring the cavernous sinus internal carotid artery and visual nerve. Standard trans-sphenoidal endoscopic surgery for pituitary tumors limits removal of large tumors with the endoscope becau of the narrow field of vision leading to incomplete exposure. The rearchers concluded that the image-guided system can identify borders and critical anatomic structures in real time and provide safe, less invasive endoscopic sinus surgery.
感悟幸福Tabaee et al. (abstract, 2003) conducted a retrospective study to evaluate the outcome and rate of complications in a cohort of patients who underwent computer-assisted surgery (CAS). A total of 120
patients underwent CAS over a five-year period. The mean postoperative follow-up was 2.6 years. Charts were reviewed for indication of CAS, incidence of major complications and need for revision surgery after CAS. Ten patients were lost to follow-up and were not included in the analysis. Indications for the u of CAS were revision surgery (n=85), sphenoid sinus dia (n=12), isolated frontal sinus dia (n=4), combined sphenoid and frontal dia (n=2) and CSF leak (n=7). There were no major complications. Fifteen patients (16.5%) required revision surgery: 10 required revision endoscopic sinus surgery (1–5 revisions using CAS); three required an external open procedure; and three required revision CSF leak closure (one patient required both revision sinus surgery and an external procedure). There were no cas of major intra- or postoperative bleeding, central nervous system damage, CSF leak, or orbital trauma in this study. The rearchers concluded that CAS helps avoid trauma to the orbit and anterior skull ba and has a low incidence of major complications. Revision surgery may be needed in patients with frontal sinus dia, nasal polyposis, or recurrent CSF leak.
Thomas et al. (2002) evaluated image-guided, endoscopic tranthmoid surgery in a pilot study consisting of 11 patients who underwent the surgery to remove pituitary tumors. Patients ranged in age from 30–53 and consisted of ven women and four men. Prior to surgery, the patients underwe
nt CT scanning and were fitted with the InstaTrak image-guidance system to provide the surgeon with 3D information regarding preci operative location. All 11 patients showed a significant improvement in symptoms, with no leaks of cerebrospinal fluid. The operative times were shorter for the image-guided surgery than for the standard endoscopy becau of incread instrument maneuverability and panoramic endoscopic visualization. The rearchers documented that, in contrast to other standard endoscopic approaches, both nostrils were ud in this study of image-guidance surgery. By using both nostrils (one to fix the endoscope and the other to pass instruments), the surgeon was able to operate with both hands and view the surgical field while exchanging equipment. It also overcame the difficulty of passing instruments over the endoscope. The InstaTrak image-guidance system incread patient safety by allowing the surgeon to view the actual location of the surgical instruments. It also enabled excellent exposure of the lla for tumor rection and decread the technical difficulty of removing pituitary tumors.
Metson et al. (1999) conducted a prospective cohort study to measure the effects of image-guided technology on the performance of minimally invasive otolaryngological procedures. The study population consisted of 121 patients who underwent endoscopic surgery of the head and neck by four surgeons at the Massachutts Eye and Ear Infirmary (Boston, MA) from November 1996 throu
gh August 1997. Fifty-five patients underwent surgery with an optical-bad image-guidance system (LandmarX Element System®, Xomed, Jacksonville, FL). Twenty-four patients had surgery performed with an electromagnetic-bad system (InstaTrak; Visualization Technology Inc., Woburn, MA). Forty-six (58%) of the image-guided surgical procedures were revision procedures. All patients in the image-guidance group
underwent preoperative CT scanning. The control group consisted of 42 concutive patients who underwent endoscopic surgery of the head and neck without the u of an image-guidance system during the same period, by the same surgeons, at the same institution. Eighteen (43%) of the non-image-guided surgical procedures were revision procedures. The patients in both groups were similar in terms of age, x and dia stage. Surgical indications included chronic rhinosinusitis (n=115), fibrous dysplasia of the ethmoid or sphenoid bone (n=2), optic neuropathy requiring optic nerve decompression (n=20), and cholesterol cysts of the petrous apex requiring transsphenoid drainage (n=2). Sustained accuracy data were obtained for 16 patients who underwent surgery with the optical-bad image-guidance system. Follow-up averaged 11.2 months for the image-guidance group and 13.9 months for the control group. The results of the study showed that the image-guided system provided intraoperative anatomical localization accuracy at the start of surgery to within 2 m
m in all cas. Although operative times incread with the image-guided systems, there was no difference between the two groups in intraoperative blood loss or complication rate. The rearchers concluded that both the optical-bad and the electromagnetic-bad image-guidance systems provided anatomical localization with an accuracy of 2 mm or better at the start of surgery. They also concluded that image-guidance systems can provide preci anatomical localization during head and neck surgery and that this information can be particularly valuable for tho cas with poor anatomical landmarks caud by extensive dia or previous surgery.
Professional Societies/Organizations
The American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) endors the u of computer-aided (i.e., image-guided) surgery in lected cas, in order to assist the surgeon in localizing anatomical structures and increasing patient safety (AAO-HNS, 2005). According to the AAO-HNS, the following is a list of indications in which the u of image-guided sinus surgery may be appropriate: •revision sinus surgery
•distorted sinus anatomy of developmental, postoperative, dia or traumatic origin
•extensive sino-nasal polyposis安徽省2011年高考分数线
•pathology involving the frontal, posterior ethmoid, or sphenoid sinus
•dia abutting the skull ba, orbit, optic nerve or carotid artery
•cerebral spinal fluid (CSF) rhinorrhea or conditions where a skull ba defect exists
•benign and malignant sino-nasal neoplasms
Summary
Image-guided sinus (IGS) surgery has been established in the literature as an important adjunctive tool in lected cas of advanced sinus surgery. Image guidance can assist the endoscopic sinus surgeon by confirming position within challenging anatomical fields. IGS surgery can identify borders and critical anatomical structures in real time, improving the chance for better surgical outcomes. While IGS surgery has been shown to be beneficial in advanced sinus surgery for lected cas, it has not been proven as the standard of care for routine endoscopic sinus surgery.
Coding/Billing Information
Note: This list of codes may not be all-inclusive.
Covered when medically necessary:
CPT®*
Description
Codes
61795 Stereotactic computer assisted volumetric (navigational) procedure,
intracranial, extracranial, or spinal (List parately in addition to code for
primary procedure)
Description
HCPCS
Codes
No specific codes
ICD-9-CM
Description
Diagnosis
Codes
160.2 Malignant neoplasm of maxillary sinus
160.3 Malignant neoplasm of ethmoidal sinus
160.4 Malignant neoplasm of frontal sinus
160.5 Malignant neoplasm of sphenoidal sinus
212.0 Benign neoplasm of nasal cavities, middle ear, and accessory sinus
349.81 Cerebrospinal fluid rhinorrhea
471.0 Polyp of nasal cavity
471.1 Polypoid sinus degeneration
471.8 Other polyp of sinus
478.26 Cyst of pharynx or nasopharynx
Multiple/Varied
*Current Procedural Terminology (CPT®) ©2006 American Medical Association: Chicago, IL. References
1. American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS). AAO-HNS policy
on intra-operative u of computer-aided surgery. Approved Sep 12, 2002; revid Sep 2005.
Accesd Oct 22, 2007. Available at URL address: link/practice/rules/image-
guiding.cfm
2. American Rhinologic Society (ARS). News. AAO-HNS Rhinology and Paranasal Sinus
Committee endors image guidance. Jan 2002. Accesd Oct 22, 2007. Available at URL
kgc
address: www.american-rhinologic/news.0102.chow.phtml
3. Americal Rhinologic Society (ARS). News. Position statement on image guidance. Apr 2006.
Accesd Oct 22, 2007. Available at URL address: www.american-
rhinologic/news.0406.advocacyimage.phtml
4. Demin H, Bing Z, Wentong CE, Luo Z, Yongjie Z. Advantages of using an image-guided system
for transnasal endoscopic surgery. Chin Med J (Engl). 2003 Jul;116(7):1160-7.
5. Eliashar R, Sichel JY, Gross M, Hocwald E, Dano I, Biron A. Image guided navigation system: a
new technology for complex endoscopic endonasal surgery. Postgrad Med J. 2003英语阅读文章
Dec;79(938):686-90.
6. Fried MP, Morrison PR. Computer-augmented endoscopic sinus surgery. Otolaryngol Clin North
成绩单英文Am. 1998 Apr;31(2):331-42.
百度在线英语翻译
7. Han D, Shou B, Ge W, Zhang L, Zhang Y. Advantages of using an image-guided system for
transnasal endoscopic surgery. Chin Med J (Engl). 2003 Jul;116(7):1106-7.
8. Hepworth EJ, Bucknor M, Patel a, Vaughan WC. Nationwide survey on the u of image-guided
functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2006 Jul;135(1):68-73.
9. Kingdom TT, Orlandi RR. Image-guided surgery of the sinus: current technology and
applications. Otolaryngol Clin North Am. 2004 Apr;37(2):381-400.
noris
10. Koele W, Stammberger H, Lackner A, Reittner P. Image guided surgery of paranasal sinus and
anterior skull ba—five years experience with the InstaTrak-System. Rhinology. 2002
Mar;40(1):1-9.
