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Posted: January 25, 2008

National Medical Policy

Subject: Policy Number: Endovascular Repair of Thoracic Aortic Aneurysms NMP406

Effective Date*: January 2008

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document

Current Policy Statement

Health Net, Inc. considers endovascular stent graft repair of descending thoracic aortic aneurysms (TAA) or thoracoabdominal aortic aneurysms of the aorta medically necessary in patients who have all of the following: 1. The predicted operative risk is clearly lower than the risk of either conventional open repair or optimal medical management; and 2. The GORE TAG Thoracic Endoprosthesis is going to be used; and 3. Appropriate anatomy exists, namely all of the following: · Adequate femoral/iliac artery access for placement of the self-expanding endoprosthesis into the descending thoracic aneurysm, typically > 8 mm in diameter that lack tortuosity and calcium; and The aortic inner neck diameters in the proximal and distal landing zones must fall within 23-37 mm; and A proximal neck measuring > 2 cm proximal to the aneurysm, preferably beyond the origin of the left subclavian artery, is required; and A sufficient landing zone of aorta measuring > 2 cm distal to the aneurysm and at least 2 cm prior to the origin of the celiac artery is required; and

· · ·

3. Patient has one or more of the following indications for repair: · · · Diameter of aneurysm > 6 cm or > 2x transverse diameter of an adjacent normal aortic segment; or Symptomatic regardless of size; or Growth rate of aneurysm > 3 mm/year.

We consider the use of endovascular stent grafts investigational, and therefore not medically necessary, for any of the following:

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Posted: January 25, 2008 1. Treatment of thoracic aneurysms of the ascending aorta 2. Treatment of thoracic aneurysms of the aortic arch 3. Treatment of thoracic aortic dissections 4. Treatment of traumatic aortic transections 5. Treatment of mycotic aneurysms, unless high operative risk for open surgical repair is deemed prohibitive by a cardiovascular surgeon. 6. Stent-grafting in patients with Marfan syndrome, Ehlers-Danlos syndrome or any other known connective tissue disorder, unless high operative risk for open surgical repair is deemed prohibitive by a cardiovascular surgeon. 7. The use of non-FDA approved endovascular stent graft devices 8. Implantation of intrasac pressure sensors for detection of endoleaks in the aneurysmal sac following endovascular repair because there are inadequate published data on these sensors to permit conclusions concerning long-term safety and efficacy of this technology.

Codes Related To This Policy ICD-9 Codes

441.2 441.7 Thoracic aneurysm without mention of rupture Thoracoabdominal aneurysm without mention of rupture

CPT Codes

33880 Endovascular repair of descending thoracic aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); involving coverage of left subclavian artery origin, initial endoprosthethesis, plus descending thoracic aortic extension(s), if required, to level of celiac artery origin Endovascular repair of descending thoracic aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); not involving coverage of left subclavian artery origin, initial endoprosthethesis, plus descending thoracic aortic extension(s), if required, to level of celiac artery origin Placement of proximal prosthesis for endovascular repair of descending thoracic aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); initial extension Placement of proximal prosthesis for endovascular repair of descending thoracic aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); each additional proximal extension (list separately in addition to code for primary procedure) Placement of distal extension prosthesis(s) delayed after endovascular repair of descending thoracic aorta Open subclavian to carotid artery transposition performed in conjunction with endovascular repair of desending thoracic aorta, by neck incision, unilateral Bypass graft, with other than vein, transcervical retropharyngeal carotidcarotid, performed in conjunction with endovascular repair of descending thoracic aorta, by neck incision Open femoral artery exposure for delivery of endovascular prosthesis, by groin incision, unilateral Bypass graft, with other than vein; aortosubclavian or carotid

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33881

33883

33884

33886 33889

33891

34812 35626

Endovascular Repair of Thoracic Aortic Aneurysms Jan 08

Posted: January 25, 2008 36200 36140 37250 Introduction of catheter, aorta (bilateral, from right femoral access and also via the conduit) Introduction of needle or intracatheter; extremity artery (left femoral access) Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention; initial vessel (list separately in addition to code for primary procedure) Unlisted procedure, vascular surgery Intravascular ultrasound (noncoronary vessel), radiologic supervision and interpretation; initial vessel Endovascular repair of descending thoracic aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin, radiological supervision and interpretation Endovascular repair of descending thoracic aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); not involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin, radiological supervision and interpretation Placement of proximal extension prosthesis for endovascular repair of descending thoracic aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption), radiological supervision and interpretation Placement of distal extension prosthesis(s) (delayed) after endovascular repair of descending thoracic aorta, as needed, to level of celiac origin, radiological supervision and interpretation Unlisted fluoroscopic procedure (eg, diagnostic, interventional)

37799 75945 75956

75957

75958

75959

76496

HCPCS Codes

N/A

Scientific Rationale

An aortic aneurysm is a localized or diffuse dilation of the aorta with a diameter at least 50% greater than its normal size. Aneurysms result from an underlying weakness in the wall of the aorta secondary to an intrinsic defect in the protein construction of the aortic wall, trauma, infection, or due to progressive destruction of aortic proteins by enzymes at that location. Thoracic aortic aneurysms (TAAs) are classified as ascending, aortic arch, descending and thoracoabdominal aneurysms depending on which location is involved on the thoracic aorta. The estimated incidence of thoracic aortic aneurysms is 6 cases per 100,000 person-years. While the stretched vessel may occasionally cause discomfort, a greater concern is the risk of rupture, which causes severe pain, massive internal hemorrhage, and, without prompt treatment, results in a quick death. The rupture rate in unoperated patients with thoracic aortic aneurysm has been 40% to 70%, and mortality is almost 100%. Mortality rates of open elective aneurysm repair vary between 10% and 20%, and the mortality rate of emergency operation for ruptured aneurysm is about 50%. Thoracic aneurysms may become huge while remaining asymptomatic, and are usually found incidentally after chest radiographs or other imaging studies. Symptoms may develop and relate to pressure against or erosion of adjacent structures by the enlarging aorta, such as pain, cough, wheezing, hemoptysis, Endovascular Repair of Thoracic Aortic Aneurysms Jan 08

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Posted: January 25, 2008 dysphagia, or hoarseness. Untreated, aneurysms tend to become progressively larger, although the rate of enlargement is unpredictable for any individual. Following diagnosis, untreated patients with thoracoabdominal aortic aneurysms have a 2-year survival rate of less than 30%, with half of all deaths caused by aneurysm rupture. Complications of conventional repair include postoperative paraplegia (25%), renal failure (20%), bleeding, stroke, and prolonged ventilator dependence. In addition, the operative mortality of the open procedure has been reported to be about 10%. The definitive treatment for a thoracic aortic aneurysm is open surgical repair of the aorta. This procedure requires lateral thoracotomy, use of cardiopulmonary bypass, long operation times, and may result in a variety of peri- and postoperative complications, with spinal cord ischemia considered the most devastating. Typically, it involves opening up of the dilated portion of the aorta and replacement of the diseased segment using a synthetic (Dacron or Gore-tex) patch tube. Once the tube is sewn into the proximal and distal portions of the aorta, the aneurysmal sac is closed around the artificial tube. The determination of when surgery should be performed is complex and case-specific. The overriding consideration is when the risk of rupture exceeds the risk of surgery. The diameter of the aneurysm, its rate of growth, the presence or absence of Marfan Syndrome or Ehlers-Danlos syndrome and other coexisting medical conditions such as tertiary syphilis are all important factors in the determination. A rapidly expanding aneurysm should be operated on as soon as feasible, since it has a greater chance of rupture. Slowly expanding aortic aneurysms may be followed by routine diagnostic testing (CT scan or ultrasound imaging). If the aortic aneurysm grows at a rate of more than 1 cm/year, surgical treatment should be electively performed. According to Beers et al (1999), thoracic aneurysms generally should be resected if greater than or equal to 6 cm. However, aneurysms in patients with Marfan's syndrome are prone to rupture, so elective surgical repair is recommended for aneurysms 5 to 6 cm. The success of endovascular stent grafts of abdominal aortic aneurysms in recent years has created interest in applying the same technology to the aneurysms of the descending or thoracoabdominal aorta, which comprise 10% of thoracic aneurysms and coexist in both segments of the aorta (thoracic and abdominal). The best available comparative information on the results of open surgical versus stentgrafting in patients with descending thoracic aortic aneurysms was provided by the Gore TAG phase II, nonrandomized trial, presented in 2005. 117 TAG devices were placed in 137 low-risk patients and results compared with 44 concurrent and 50 historical open surgical control patients. Demographics were similar, with patient age averaging about 70 years for both groups. Operative mortality and occurrence of paraplegia were significantly lower in the TAG group compared with the open surgical group, 2.1% versus 12% and 3% versus 14%, respectively. There was no difference in 2-year survival (78% for TAG group vs. 76% for open repair). Limitations of this trial included low-risk entry criteria, lack of complete follow-up, lack of randomization, and lack of a standard surgical technique. Furthermore, emergency and urgent cases were more likely to be assigned to open repair, a strong predictor of greater risk of poorer outcome. In March 2005, the GORE-TAG Thoracic Endoprosthesis was approved by the U.S. Food and Drug Administration (FDA) through the Premarket Approval (PMA) process for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy. An appropriate proximal neck of 2 cm prior to the aneurysm is required. Ideally, the proximal landing zone is beyond the left subclavian artery, though, in some circumstances, the stent may be placed proximal to the left subclavian artery. Distally, a sufficient landing zone of 2 cm prior to the celiac artery is required. The aortic inner neck diameters in the proximal and distal Endovascular Repair of Thoracic Aortic Aneurysms Jan 08

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Posted: January 25, 2008 landing zones must fall within 23-37 mm. In addition, appropriately sized femoral and iliac arteries (typically >8 mm in diameter) that lack tortuosity and calcium are required for implantation. The device is a flexible, self-expanding endoprosthesis that is constrained on the leading edge of a delivery catheter. The endoprosthesis consists of an expanded polytetrafluoro-ethylene (ePTFE) tube with a nitinol support structure. The catheter is inserted into the femoral artery, and advanced up to the descending or thoracoabdominal aorta where the endoprosthesis is deployed, excluding the thoracic aortic aneurysm from the circulation. The procedure is typically performed in a catheterization laboratory or operating room by a vascular surgeon and interventional radiologist. The FDA concluded that data from Gore's non-randomized, case-controlled pivotal series comparing TAG with open surgery provided reasonable assurance of the safety and effectiveness of the GORE TAG Thoracic Endoprosthesis for the treatment of aneurysms of the descending thoracic aorta. The FDA based its approval of the GORE TAG device on results of the PIVOTAL TAG 99-01 and the TAG 03-03 studies, which are reported in the GORE TAG instructions for use manual. TAG 99-01 was a controlled trial of patients with aneurysms of the descending thoracic aorta, treated with either surgical repair (n=94; 50 historical and 44 concurrent) or stent grafting (n=140) at 17 sites in the United States. Patients for both the graft group and control were selected using the same inclusion and exclusion criteria. After fractures in the wire frame of the TAG endoprosthesis were discovered in TAG 99-01, 51 patients underwent stent grafting with a modified TAG endoprosthesis at 11 sites in the subsequent TAG 03-03 study. The primary outcomes assessed in both TAG 99-01 and TAG 03-03 were the number of patients who had one or more major adverse events and the number of patients that did not experience device-related events 12 months post-device deployment. The number of patients in the TAG 99-01 device group who experienced one or more adverse events was significantly lower than the surgical repair control group at one-year follow-up (42% vs. 77% respectively). Major adverse events included neurologic, pulmonary, renal function and vascular complications, and major bleeding. In the TAG 99-01 device group, 4 of 140 patients (3%) experienced paraplegia or paraparesis vs. 13 of 94 patients (14%) in the control group. In the 12-month follow-up of TAG 99-01, 8 patients (3%) had one or more major adverse device-related events while the 12-24 month follow-up in this group noted only one major adverse device-related event. No major adverse devicerelated events occurred in the 30-day follow-up of the TAG 03-03 group. The authors reported favorable aneurysm-related (97%) and overall survival (75%) rates and concluded that the GORE TAG device was a safe alternative treatment for descending thoracic aortic aneurysms. In one of the largest case series of 103 patients with thoracic aneurysms, Mitchell and colleagues (1997) reported the results of 108 patients receiving thoracic aortic stent grafts at Stanford University Medical Center. Mean aneurysm diameter was 6.3 cm. Twenty percent of patients had stent-grafts placed in conjunction with abdominal aortic aneurysm repair. Ten patients (9%) died within 30 days from the time of surgery, and four deaths were directly attributable to the procedure. Four patients had postoperative paraplegia and four had strokes. Patients in whom paraplegia developed either had stent-graft repair of thoracic aneurysms in conjunction with suprarenal abdominal aortic aneurysm repair or had deployment of the thoracic stent-graft across the orifices of intercostal arteries at the T10 level. An Austrian comparative study of endovascular versus open repair of thoracic aortic aneurysms was reported by Ehrlich and colleagues in 1997. Sixty-eight patients were deemed good candidates for stent-graft repair. Because of limited device availability, 10 patients (15%) underwent stent-graft repair and 58 (85%) had open repair. The 30day mortality rate was 30% for patients who underwent open surgery and 10% for Endovascular Repair of Thoracic Aortic Aneurysms Jan 08

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Posted: January 25, 2008 endovascular repair. Mean procedural time was 320 minutes in the conventional group and 150 minutes in the stent-graft group. Paraplegia developed in five patients (12%) in the open surgical group compared with no paraplegia or neurologic sequelae in the stent-graft group. Hospital stay was 26 days in the open surgical group versus 10 days in the stent-graft group. A systematic review of the published evidence on this procedure that was commissioned by NICE (2004) identified a total of 29 studies of endovascular stentgrafting for thoraco-abdominal aortic (TAA) aneurysms: 27 case series and 2 comparative observational studies. In one comparative study, the technical success rate was 100% (67/67 patients). The systematic review reported that the overall technical success rate was 93% over 18 studies (16 case series and 2 comparative studies). The systematic review reported that the rate of conversion to open repair varied from 0% (0/26 patients) to 7% (1/14 patients). The proportion of patients who experienced an increase in aneurysm size varied from 0% (0/18) to 7% (2/29) of patients. In the study with the largest number of patients, the aneurysm increased in size (by =5 mm) in 5% (4/84) of patients. The proportion of patients who experienced a decrease in aneurysm size varied from 100% of patients (18/18) to 17% (5/29) of patients. The 30-day mortality rate varied from 0% (in several studies with a combined population of 94 patients) to 14% (2/14) of patients. The overall mortality ranged from 3% (1/37 patients) to 24% (11/46 patients) across 17 studies over a mean follow-up of 14 months. The NICE systematic review concluded that the evidence base for the assessment of the safety and efficacy of endovascular stent graft placement for the treatment of thoracic aortic aneurysm is poor, consisting primarily of case series that include heterogeneous groups of patients with incomplete outcome data. The review further concluded that the safety of the procedure must be assessed in light of the fact that mortality is very high if patients with thoracic aortic aneurysm are untreated. Interventional procedure guidance issued by NICE (2005) states that current evidence on the safety and efficacy of endovascular stent-graft placement in thoracic aortic aneurysms and dissections indicates that it is a suitable alternative to surgery in appropriately selected patients. Stone et al. (2006) reported midterm results in a comparative study of patients who underwent stent-graft repair of the thoracic aorta (n=105). Outcomes, including perioperative complications, late survival, freedom from reinterventions, and graftrelated complications, were compared to a cohort of 93 patients concurrently treated with open surgical repair confined to the descending aorta. Stent-graft treatment was provided for various thoracic aortic pathologies, including degenerative aneurysms (n=68, 64.7%), penetrating ulcers (n=12, 11.4%), pseudoaneurysms (n=15, 14.3%), traumatic tears (n=9, 8.6%), and acute dissection (n=1, 0.9%). Some of the high-risk patients included in the trial would not have been candidates for open surgical repair due to comorbidities. Mean follow-up was 22 months (range 0­101 months). Perioperative mortality was 7.6% (8/105) in the endograft group and 15.1% (14/93) in the open surgical group. Spinal cord ischemic complications were experienced by 6.7% of patients (7/105) in the endograft group, compared to 8.6% (8/93) in the open surgical group. Paraplegia occurred at a rate of 4.8% (5/105) in the endograft group and 4.5% (4/93) in the open surgical group. Actuarial survival at 48 months was 54% ± 7% in the endograft group, compared to 64% ± 6% in the open surgical group (p=.91). Reinterventions were performed in 10.5% of patients (11/105) in the endograft group and 9.7% (9/93) of patients in the open surgical group. Freedom from reintervention at 48 months was 80% ± 7% in the endograft group vs. 78% ± 7% in the open surgery. The authors acknowledged that the decrease in operative mortality seen with stent-graft treatment was of borderline statistical significance, but noted that nearly 30% of the treated patients were not

Endovascular Repair of Thoracic Aortic Aneurysms Jan 08

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Posted: January 25, 2008 suitable candidates for surgical treatment, in contrast to other trials with stringent inclusion criteria. The occurrence and consequences of secondary procedures following endovascular repair of TAA were analyzed by evaluating patients enrolled in the European Collaborators Registry (EUROSTAR). The study included 213 patients in whom primary success was achieved by elective treatment for degenerative thoracic aneurysms. Forty-six patients were treated with the GORE TAG device, while the others were treated with various other devices commercially available in Europe. Secondary interventions were performed in 25 (12%) patients, occurring at a mean of eight months after the initial procedure. A transfemoral approach was used in 17 (68%) patients, six (24%) were treated with a transthoracic procedure, and two (8%) with extra-anatomic bypass. The cumulative percentage of freedom from intervention at one and two years was 86% and 83%, respectively. Endoleak was the most frequent cause for secondary transfemoral interventions. No principal indication was found for the other types of secondary interventions. Preoperative factors that correlated with secondary interventions were back pain at presentation and a longer aneurysm length. The cumulative two-year survival rate for patients without secondary intervention was 85%, compared to 58% in the patients who received secondary interventions. The authors stated that more research is necessary to identify patients at risk for intervention following endovascular treatment of different thoracic aortic pathologies, and regular surveillance is required after endovascular degenerative aneurysm repair because secondary interventions can occur throughout the follow-up period. A review of endovascular repair of TAA and dissections published in a Hayes Directory report states that there were no randomized controlled trials that compared endovascular repair with open surgical repair. The comparative studies by Makaroun and Stone (described above), however, did provide concurrent and historical open surgical repair cohorts. Additional studies reviewed included uncontrolled prospective studies and case series, retrospective studies, and two reviews of registry data. Limitations of the studies, in addition to lack of randomization to a control group, included short duration of follow-up and heterogeneity in patient populations. The Hayes review concluded that this evidence suggests the endovascular repair is feasible, and can result in functional exclusion of the thoracic aortic aneurysm and/or successful endograft coverage of the thoracic aortic dissection site. Procedural success rates were high, and perioperative mortality rates were similar to, or lower than, those reported with open repair, especially in patients at high risk for surgery. The review concluded that the durability of the technique cannot be accurately assessed, however, because none of the studies provided adequate long-tem follow-up. In addition, no conclusions regarding the relative clinical benefit of endovascular repair compared to open surgical repair can be made, especially in patients who would be suitable for open surgical repair, because none of the studies provided a randomized comparison. The most commonly reported complication following TAA stent-graft placement was endoleak (incomplete sealing of the aneurysm). Nineteen studies reported at least one patient with an endoleak, with a mean incidence of 13% over 12 months (the total number of patients in these studies was 752; follow-up ranged from 3 to 25 months). Five studies with a total of 83 patients reported that there were no cases of endoleak during a mean follow-up period of 12 months. Injuries to the access artery were reported in nine case series, and included iliac artery dissection in 4% (1/26 patients), perforation of the iliac artery in 4% (1/27 patients) and dissection/rupture of the femoral artery in 6% (2/34 patients). One case series reported stent fracture in 13% (11/84) of patients, and six cases of stent migration were reported over 15 Endovascular Repair of Thoracic Aortic Aneurysms Jan 08

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Posted: January 25, 2008 case series. Other reported complications included wound complications in 25% (8/32) of patients, stroke in 19% (8/43), renal failure requiring dialysis in 11% (2/19), and paraplegia in 7% (3/43) of patients. The NICE Interventional Procedure Advisory Committee noted that there is a lack of long-term data on the durability of TAA stent-grafts. Gore is conducting a post-approval study to evaluate all-cause mortality, aneurysm-related mortality, morbidity and device-related adverse events at 30 days and one year post-procedure. Another condition of approval is the completion of a 2-day training program as a prerequisite for ordering TAG. The GORE TAG device is currently the only FDA-approved device for endovascular repair of thoracic aortic aneurysms. Several additional devices are currently under clinical evaluation, including the Valiant Thoracic Stent Graft with Xcelerant Delivery System (Medtronic Vascular, Santa Rosa, CA) the Talent. Type A dissections (involving the ascending aorta) are treated surgically. There is more controversy regarding the optimal treatment of Type B dissections (i.e., limited to the descending aorta). In general, these dissections are managed medically unless serious complications arise, e.g., shock or visceral ischemia, although some surgeons recommend a more aggressive approach for younger patients in otherwise good health. However, although there is an estimated 50% one-year survival rate in those treated with an open surgical procedure, it is not clear whether that is any better or worse than those treated medically. The advent of stent grafting, with the potential of reducing the morbidity and mortality of an open surgical procedure, may further expand the patients considered for surgical intervention. Surgically repaired abdominal aortic aneurysms have a risk of rupture due to leakage around the graft. Patients are periodically monitored with contrast enhanced computed tomography (CT) after stent graft placement for endoleak and sac dilation which indicate increased risk of rupture. In order to reduce the risks of rupture, endosensors are being developed to monitor abdominal aortic aneurysm pressure after endovascular repair. One manufacturer is developing a wireless radiofrequency endosensor (e.g., CardioMEMS Endosensor). Once implanted into the aneurysm, the endosensor measures the pressure inside the sac. The pressure measurements transmitted via radiofrequency to a device held over the patient's body, where pressure readings are recorded. The device may reduce the necessary frequency of periodic monitoring of the aneurysmal sac with contrast-enhanced CT. Clinical studies of the CardioMENS Endosensor are currently ongoing. Another endosensor, the Impressure AAA Sac Pressure Transducer, consists of a piezoelectric membrane, which when actuated by ultrasound waves from a hand-held probe charges a capacitor. Once charged, the transducer measures ambient pressure, then generates an ultrasound signal, which is relayed to the probe. The data can then be downloaded and exported as an Excel data file consisting of pressure measurements and the corresponding times at which the measurements were taken. Ellozy et al (2004) reported on the first clinical experience with the use of the Impressure permanently implantable, ultrasound-activated remote pressure transducer to measure intrasac pressure after endovascular repair of abdominal aortic aneurysms. The investigators concluded that additional clinical follow-up will be necessary to determine whether aneurysm sac pressure monitoring can replace CT in the long-term surveillance of patients after endovascular repair of aortic aneurysms. Patients who undergo endovascular thoracic aortic aneurysm repair require longterm surveillance. The CardioMEMS System, as stated above, received FDA-approval for intraoperative use, but has also been proposed as a method to provide long-term monitoring of pressure within the aneurysm following endovascular repair of Endovascular Repair of Thoracic Aortic Aneurysms Jan 08

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Posted: January 25, 2008 abdominal aortic aneurysms, and has also been suggested for similar use following endovascular AAA and TAA repair. The safety and clinical utility of this technology in the intraoperative or long-term monitoring of patients following endovascular aortic aneurysm repair has not been established.

Review History

January 2008 Medical Advisory Council Initial Approval

English 1. MedlinePlus. Thoracic aortic aneurysm. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001119.htm 2. MedlinePlus. Aneurysms. Available at: http://www.nlm.nih.gov/medlineplus/aneurysms.html Spanish 1. MedlinePlus. Aneurisma de la aorta torácica. Available at: http://www.nlm.nih.gov/medlineplus/spanish/ency/article/001119.htm 2. MedlinePlus. Aneurismas. Available at: http://www.nlm.nih.gov/medlineplus/spanish/aneurysms.html

Patient Education Websites

1. Kouchoukos NT, et al. The Society of Thoracic Surgeons Endovascular Surgery Task Force; Expert Consensus Document on the Treatment of Descending Thoracic Aortic Disease Using Endovascular Stent-Grafts. 2007. Available at: http://www.aats.org/multimedia/files/Guidelines/Expert-Consensus-DescendingThoracic-Aortic-Disease.pdf 2. Katzen BT, Dake MD, MacLean AA, et al. Endovascular Repair of Abdominal and Thoracic Aortic Aneurysms. Circulation. 2005;112:1663-1675. Available at: http://www.circ.ahajournals.org/cgi/content/full/112/11/1663 3. National Institute for Clinical Excellence (NICE). A systematic review of the recent evidence for the efficacy and safety relating to the use of endovascular stentgraft (ESG) placement in the treatment of thoracic aortic aneurysms. London, UK: NICE; 2004. Available at: http://www.nice.org.uk/page.aspx?o=244121. 4. National Institute for Clinical Excellence (NICE). Interventional Procedure Consultation Document - endovascular stent-graft placement in thoracic aortic aneurysms and dissections. London, UK: NICE; 2005. Available at: http://www.nice.org.uk/page.aspx?o=244119. 5. Canadian Society for Vascular Surgery consensus statement on endovascular aneurysm repair. CMAJ 2005;172(7). Available at: http://www.cmaj.ca/cgi/content/full/172/7/867

This policy is based on the following evidence-based guidelines:

References

1. 2. 3. 4.

Roselli EE, Greenberg RK, Pfaff K, et al. Endovascular treatment of thoracoabdominal aortic aneurysms. J Thorac Cardiovasc Surg. 2007 Jun;133(6):1474-82. Chu MW, Forbes TL, Kirk Lawlor D, et al. Endovascular repair of thoracic aortic disease: early and midterm experience. Vasc Endovascular Surg. 2007 JunJul;41(3):186-91. Tespili M, Banfi C, Valsecchi O, et al. Endovascular treatment of thoracic aortic disease: mid-term follow-up. Catheter Cardiovasc Interv. 2007 Oct 1;70(4):595601. Cao P, Verzini F. Endovascular repair of thoracic aortic aneurysms: toward a new standard of treatment. G Ital Cardiol (Rome). 2007 May;8(5):271-8.

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Posted: January 25, 2008 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. Ince H, Nienaber CA. Etiology, pathogenesis and management of thoracic aortic aneurysm. Nat Clin Pract Cardiovasc Med. 2007 Aug;4(8):418-27. Go MR, Cho JS, Makaroun MS. Mid-term results of a multicenter study of thoracic endovascular aneurysm repair versus open repair. Perspect Vasc Surg Endovasc Ther. 2007 Jun;19(2):124-30. Sandroussi C, Waltham M, Hughes CF, et al. Endovascular grafting of the thoracic aorta, an evolving therapy: ten-year experience in a single centre. ANZ J Surg. 2007 Nov;77(11):974-80. Makaroun MS, Dillavou ED, Kee ST et al. Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG thoracic endoprosthesis. J Vasc Surg 2005;4(1):1-9 Nienaber CA, Zannetti S, Barbieri B et al. Investigation of Stent grafts in patients with type B Aortic Dissection: design of the INSTEAD trial--a prospective, multicenter, European randomized trial. Am Heart J 2005; 149(4):592-9 Ellozy SH, Carroccio A, Minor M et al. Challenges of endovascular tube graft repair of thoracic aortic aneurysm: midterm follow-up and lessons learned. J Vasc Surg 2003;38(4):676-83 Davies RR, Goldstein LJ, Coady MA et al. Yearly rupture or dissection rates for thoracic aortic aneurysms; simple prediction based on size. Ann Thorac Surg 2002;73(1):17-28 Rectenwald JE, Huber TS, Martin TD et al. Functional outcome after thoracoabdominal aortic aneurysm repair. J Vasc Surg 2002;35(4):640-7 Huynh TT, Miller CC, Estrera AL et al. Thoracoabdominal and descending thoracic aortic aneurysm surgery in patients aged 79 years or older. J Vasc Surg 2002;36(3):469-75 Umana JP, Miller DC, Mitchell RS. What is the best treatment for patients with acute type B aortic dissections ­ medical, surgical or endovascular stent grafting? Ann Thorac Surg 2002;74(5):S1840-3 Cambria RP, Brewster DC, Lauterbach SR et al. Evolving experience with thoracic aortic stent graft repair. J Vasc Surg 2002;35(6):1129-36 Criado FJ, Clark NS, Barnatan MF. Stent graft repair in the aortic arch and descending thoracic aorta: a 4-year experience. J Vasc Surg 2002;36(6):1121-8 Thompson CS, Gaxotte VD, Rodriguez JA et al. Endoluminal stent grafting of the thoracic aorta: initial experience with the Gore Excluder. J Vasc Surg 2002;35(6):1163-70 Najibi S, Terramani TT, Weiss VJ et al. Endoluminal versus open treatment of descending thoracic aortic aneurysms. J Vasc Surg 2002;36(4):732-7 Estrera AL, Miller CC, Huynh TT et al. Neurologic outcome after thoracic and thoracoabdominal aortic aneurysm repair. Ann Thorac Surg 2001;72(4):1225-31 Estrera AL, Rubenstein FS, Miller CC et al. Descending thoracic aortic aneurysm: surgical approach and treatment using the adjuncts cerebrospinal fluid drainage and distal aortic perfusion. Ann Thorac Surg 2001;72(2):481-6 Van Dongen EP, Schepens MA, Morshuis WJ et al. Thoracic and thoracoabdominal aortic aneurysm repair: use of evoked potential monitoring in 118 patients. J Vasc Surg 2001;34(6):1035-40 Taylor PR, Gaines PA, McGuinness CL et al. Thoracic aortic stent grafts ­ early experience from two centres using commercially available devices. Eur J Vasc Endovasc Surg 2001;22(1):70-6 White RA, Donayre CE, Walot I et al. Endovascular exclusion of descending thoracic aneurysms and chronic dissections: initial clinical results with the AneuRx device. J Vasc Surg 2001;33(5):927-34 Gravereaux EC, Faries PL, Burks JA et al. Risk of spinal cord ischemia after endograft repair of thoracic aortic aneurysms. J Vasc Surg 2001;34(6):997-1003

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Posted: January 25, 2008 25. Grabenwoger M, Hutschala D, Ehrlich MP et al. Thoracic aortic aneurysms: treatment with endovascular self-expandable stent grafts. Ann Thorac Surg 2000;69(2):441-5 26. Coady MA, Rizzo JA, Hammond GL et al. Surgical intervention criteria for thoracic aortic aneurysms: a study of growth rates and complications. Ann Thorac Surg 1999;67(6):1922-6 27. Safi HJ, Subramaniam MH, Miller CC et al. Progress in the management of type I thoracoabdominal and descending thoracic aortic aneurysms. Ann Vasc Surg 1999;13(5):457-62 28. Webb TH, Williams GM. Thoracoabdominal aneurysm repair. Cardiovasc Surg 1999;7(6):573-85 29. Mitchell RS, Miller DC, Dake MED et al. Thoracic aortic aneurysm repair with an endovascular stent graft: the "first generation." Ann Thorac Surg 1999;67(6):1971-80 30. Clouse WD, Hallett JW, Schaff HV et al. Improved prognosis of thoracic aortic aneurysms: a population-based study. JAMA 1998;280(22):1926-9 31. Safi HJ, Miller CC, Subramaniam MH et al. Thoracic and thoracoabdominal aortic aneurysm repair using cardiopulmonary bypass, profound hypothermia, and circulatory arrest via left side of the chest incision. J Vasc Surg 1998;28(4):5918 32. Mitchell RS, Miller DC, Dake MD: Stent-graft repair of thoracic aortic aneurysms. Semin Vasc Surg 1997; 10:257-271. 33. Ehrlich M, Grabenwoeger M, Cartes-Zumelzu F, et al: Endovascular stent graft repair for aneurysms on the descending thoracic aorta. Ann Thorac Surg 1997; 25:332-340.

Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net's National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this " Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member's benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice.

Endovascular Repair of Thoracic Aortic Aneurysms Jan 08

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Posted: January 25, 2008

Health Net reserves the right to amend the Policies without notice to providers or Members. states, prior notice or website posting is required before an amendment is deemed effective. In some

No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member's Contract Controls Coverage Determinations. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member's contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member's contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member's contract shall govern. Coverage decisions are the result of the terms and conditions of the Member's benefit contract. The Policies do not replace or amend the Member's contract. If there is a discrepancy between the Policies and the Member's contract, the Member's contract shall govern. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.

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