Surgery Section - Endovascular Grafts for Abdominal Aortic Aneurysms

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

The conventional management of a clinically significant abdominal aortic aneurysm consists of surgical excision with placement of a sutured woven graft. Surgical excision is associated with a perioperative mortality rate of 4%, which may rise to 10% in symptomatic patients. Due to this high mortality rate, endovascular prostheses have been investigated as a minimally invasive, catheter-based alternative to open surgical excision of abdominal aortic aneurysms. These devices are deployed across the aneurysm such that the aneurysm is effectively "excluded" from the circulation with subsequent restoration of normal blood flow.

There are several types of grafts currently under investigation:

• Straight grafts, in which both ends are anchored to the infrarenal aorta;
• Bifurcated grafts, in which the proximal end is anchored to the infrarenal aorta and the distal ends are anchored to the iliac arteries; and
• Fenestrated grafts, which are designed with openings in the wall that can be placed across the renal or celiac arteries while still protecting vessel patency through these critical arteries. In addition, extensions can be placed from inside the main endograft body into the visceral arteries to create a hemostatic seal.

The following devices have received FDA approval for use in the abdominal aorta:

• ANCURE® Endograft® System (Guidant Corporation)

  In this system, which was approved in 1999, the endograft is placed in the aorta and expanded using balloon dilation. The graft is anchored to the vessel wall using sutureless hooks at its superior and inferior ends.

  On 3/16/01, Guidant suspended production of this system and announced a recall of all existing inventories. The company reported to the FDA that they had failed to report many device malfunctions and adverse events, including severe vessel damage associated with problems with the deployment of the device. There were also manufacturing changes that were not properly reported to the FDA. The FDA issued a Public Health Notification: Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (AAA), regarding both this device and the AneuRx device. (2)

• Ancure® Aortoiliac System (Guidant Corporation)

  This new version was approved in 2002 and is identical to the earlier Guidant Endovascular Grafting System except that the aortoiliac Ancure® grafts have suture loops on the superior and inferior attachment systems. The device is intended for use in patients whose anatomy is not suited for the use of the single tube or bifurcated endograft device.

• AneuRx® Stent Graft System (Medtronic AVE)

  The AneuRx system, approved in 1999, consists of a woven polyester interior surface with a self-expanding nitinol exoskeleton. The radial force of the expanding stent embeds in the exoskeleton into the aneurysm wall, and thus constitutes the attachment mechanism.

  This device was also the subject of the above FDA Public Health Notification. (2) In December 2003, the FDA published updated information on the mortality risks associated with the AneuRx® Stent Graft System based on an analysis of longer term follow-up data from the premarket study. (3) Based on the findings of the study, the FDA recommended that the AneuRx® Stent Graft be used "only in patients who meet the appropriate risk-benefit profile and who can be treated in accordance with instructions for use."

In March, 2008, the FDA issued a public health notification to re-emphasize the need for continued surveillance of patients treated with endovascular grafts and to provide updated information on the mortality risks associated with the use of the AneuRx® Stent Graft System to prevent abdominal aortic aneurysm (AAA) rupture. Published data suggests that aneurysm-related mortality continues to increase after 3 years post-implant, reaching 1.3% by year 4 and 1.5% by year 5. These rates are substantially higher than the mortality rate for open surgical repair, which average 0.18% per year with a range of 0 % to 0.3 % per year. In addition, the FDA now calculates, based on the latest information supplied by Medtronic, a mortality rate associated with the initial surgery of 2.3 % instead of the 1.5% originally calculated for the AneuRx ® patients.

• EXCLUDER™ Bifurcated Endoprosthesis (W.L. Gore and Associates, Inc.)

  Approved in 2002, this device self-expands inside the aorta to the diameter of the aorta and iliac arteries, thus sealing off the aneurysm and relining the artery wall.

• Zenith™ AAA Endovascular Graft and H&L-B One-Shot™ Introduction System (Cook, Inc.)

  This device was approved in 2003; it is self-expanding and attaches to the vessel wall via barbs.

• Endologix PowerLink® System
  

  This bifurcated device was approved in 2004. The approval includes the proximal cuff and limb extension accessories which can be used to adjust for variations in the patient’s anatomy or to provide additional seal in difficult anatomies.

Note: This policy addresses abdominal aortic aneurysms only. For discussions of endoprostheses for the treatment of thoracic aortic aneurysms and dissections, see TRG Medical Policy, Surgery No. 124.

Policy/Criteria

Position Summary

Endovascular Repair of Abdominal Aortic Aneurysms

Particular concerns regarding endovascular prostheses for abdominal aortic aneurysms include the durability of the anchoring system, aneurysm expansion, and other late complications related to the prosthetic graft.  Aneurysm expansion may result from perivascular leaks, which are a unique complication of endoprostheses. Perivascular leaks may result from an incompetent seal at one of the graft attachment sites, blood flow in aneurysm tributaries (these tributaries are ligated during open surgery) or perforation of graft fabric. (4-7) The following results were reported to the FDA as part of the premarket approval application. (8, 9) The data from both companies were based on prospective, nonrandomized, multicenter clinical trials in which the results of endoprosthesis implantation were compared with either concurrent or historical open surgical controls.  Study findings were as follows:

• ANCURE® Endograft® System (8)

Data were presented on 88 control patients treated surgically, 118 receiving a straight endoprosthesis and 162 receiving bifurcated grafts. The mean diameter of the aneurysm was 5.2 cm. Controls were those patients who were not candidates for the endoprosthesis due to anatomic considerations, e.g., the vessels were too small for the catheter or the aneurysm extended too close to the renal arteries. The 30-day and long-term mortality were not significantly different among all three groups. The rate of significant complications (e.g., cardiac, respiratory, renal, GI, etc.) in the endoprostheses groups was half that of the control group. Other immediate benefits experienced in the endoprosthesis group included shorter hospital stays, decreased operative blood loss, and opportunity to use regional anesthesia. Leaking around the graft was reported in about 25 percent of patients at one year, although only 10 percent showed aneurysm enlargement. Due to the lack of correlation with clinically significant complications (e.g., ruptures, aneurysm enlargement), the significance of perivascular leaks remains unknown. It should be noted that data were collected only for one year, so the long-term safety and effectiveness of these devices are unknown.

• AneuRx® Stent Graft System (9)

Data were presented on 53 patients treated surgically and 199 patients treated with an endoprosthesis. The control group consisted of candidates for aneurysm repair just prior to the introduction of the endoprosthesis. Therefore, the patient selection criteria for the two groups were the same. There were no differences in perioperative or late mortality between the two groups. The risk of severe treatment-related adverse events was significantly lower in the endoprosthesis group. There were also decreases in anesthesia time, blood loss, earlier ambulation and resumption of normal diet. The duration of ICU time decreased from 3.5 days in the surgical group to 0.9 days in the endoprosthesis group. Leaking around the graft was detected in about 25 percent of patients. Similar to the Guidant system, there was a lack of correlation with clinically significant complications.

In 2001, the four year results and world-wide experience with the AneuRx device were published. (10) This report reviewed the worldwide clinical experience and outcomes of all patients treated during the past 4 years in the U.S. AneuRx clinical trial. A total of 1,192 patients were treated with the AneuRx stent graft during all phases of the U.S. Clinical Trial from June 1996 to November 1999, with follow-up extending to June 2000. According to the authors, ten (0.8 percent) patients have had aneurysm rupture, with most ruptures (n = 6) occurring in 174 (3.4 percent) patients treated with an early stiff bifurcation stent graft design used in the phase I and in the initial stages of the phase II trials. Since the current, flexible, segmented bifurcation stent graft design was introduced, four (0.4 percent) ruptures have occurred among 1,018 patients treated. Of these, one was during implantation, two were placed too far below the renal arteries, and one patient refused treatment of a type I endoleak. Kaplan-Meier analysis of all 1,192 patients treated with the AneuRx stent graft (including both stent graft designs) revealed the patient survival rate to be 93 percent at 1 year, 88 percent at 2 years, and 86 percent at 3 years; freedom from conversion to open repair was 98 percent at 1 year, 97 percent at 2 years, and 93 percent at 3 years; and freedom from secondary procedure was 94 percent at 1 year, 92 percent at 2 years, and 88 percent at 3 years. Freedom from aneurysm rupture with the commercially available segmented bifurcation stent graft was 99.7 percent at 1 year, 99.5 percent at 2 years, and 99.5 percent at 3 years. The presence or absence of endoleak on contrast computed tomography scanning after stent graft placement was not found to be a significant predictor of long-term outcome measures. The authors state that worldwide experience with the AneuRx device now approaches 10,000 patients.

Also in 2001, a technology assessment by the BlueCross BlueShield Association Technology Evaluation Center (TEC) concluded:

"There are no randomized controlled trials (RCTs) currently available to evaluate the efficacy of endovascular repair to the standard approach of open repair for patients with abdominal aortic aneurysm. However, in the absence of RCT data, there is substantial medical literature including prospective cohort controlled studies that have compared the two techniques. Perioperative mortality is similar for both groups and perioperative morbidity appears to be more likely in those undergoing open surgical repair. While the small group of patients initially undergoing endovascular repair that then require conversion to open repair have a higher perioperative mortality risk, the limited available data on overall survival do not suggest a difference at 12 months. As expected, older patients and patients with ASA class III or IV risk have a higher risk of complications with both surgical and endovascular repair." (11)

In 2005, three randomized studies reported midterm outcomes for endovascular aneurysm repair compared to either open surgery or no treatment. (12-14) Earlier reports of these studies had demonstrated that the perioperative morbidity and mortality of an endovascular approach were improved compared to the control group of open surgical repair. (15, 16) These results were not unexpected and were consistent with prior large observational studies. (17-19) However, unexpectedly, the midterm results of these studies suggest that the short-term improvements are not associated with a long-term benefit compared to an open approach. The three randomized studies are reviewed below:

• DREAM (Dutch Randomized Endovascular Aneurysm Management) (12)
  

The DREAM trial enrolled 351 patients who were randomized to either endovascular or open repair. The incidence of aneurysm related death (within 30 days) was 4.6% in the open repair group and 1.2% in the endovascular repair group. However, after 2 years, the cumulative survival rates were 89.6% for open repair and 89.7% for endovascular repair, due to a higher incidence of late death in the endovascular group. The authors suggest that an open approach may precipitate the mortality of frail patients who were most likely to die in the coming year, and that the advantage of an endovascular approach may primarily be to delay death. Alternatively, the late mortality of endovascular repair may relate to its inferior ability to prevent rupture or prevent additional complications, compared to an open approach. If this is true, longer term follow-up is important to determine if the endovascular approach has an inferior outcome over the long term.

• EVAR 1 (13)
  

This larger trial enrolled 1,082 patients 60 years or older with abdominal aneurysms at least 5.5 cm in diameter and randomized them to either elective open or endovascular repair. While the DREAM trial reported 2-year follow-up, the EVAR 1 trial reported 4-year follow-up. Similar to the DREAM trial, endovascular repair was associated with an improvement in aneurysm-related survival (4.7% open vs. 1.7% at 30 days), but no advantage with respect to all cause mortality and quality of life measures. For example, within 4 years of follow-up, endoscopic repair was associated with a complication rate of 41% compared to only 9% in the surgically treated group. Due to the higher incidence of late complications in those undergoing endovascular repairs, ongoing surveillance is required.

• EVAR 2 (14)
  

This trial randomized 338 patients, unfit for open repair, to either endovascular repair or medical management. Therefore, this was the only trial to compare endovascular repair to no surgical intervention. Endovascular repair had a considerable 30-day operative mortality and did not improve survival over no intervention. However, the results of this trial are compromised, since 20% of patients assigned to medical management underwent elective aneurysm repair in violation of the protocol.  In addition, endovascular repair was not performed until a median of 57 days after randomization; during this period 9 aneurysms ruptured contributing to the endovascular mortality calculation, biasing results against endovascular repair.

Accompanying editorials provided the following comments (20,21):

• While there has been no difference in overall survival in the EVAR 1 trial, only 24% of patients have reached 4-year follow-up, and further study is required. With an enrollment of 1,082 patients, EVAR 1 is powered to show a difference in overall mortality, while the smaller DREAM trial is not.
• Suitability for endovascular repair depends on anatomic factors. In EVAR 1 only 54% of patients were considered suitable candidates, but this ranged from 6% to 100% across the participating institutions, indicating marked variability in the assessment of anatomic suitability.
• Given that the rate of interventions for endovascular repair increases over time, open repair may be recommended for those with longer life expectancies.
• The numbers of elective aneurysm repairs may grow, considering the recent recommendation of the United States Preventive Task Force (USPFT) for screening for abdominal aortic aneurysms in males who have ever smoked. (22)

It is estimated that approximately 300,000 aneurysms will be identified in this targeted screening population. Many of these aneurysms will measure less than 5.5 cm in diameter and thus will be managed with periodic imaging surveillance, but patients with larger aneurysms will be faced with choosing between open and endovascular repair.

More recently, large comparative database studies have generally confirmed the findings of these randomized, controlled trials, i.e., that endovascular grafting is associated with a decrease in early morbidity and mortality, but an increase in late complications. Schermerhorn et al. (38) compared outcomes of endovascular and open surgical repair in 22,830 pairs of Medicare patients, propensity matched on their likelihood of receiving endovascular repair. Perioperative mortality was lower for patients undergoing endovascular repair (1.2% vs. 4.8%, p<0.001). However, the survival curves for the two groups converged by approximately 3 years, with no survival difference demonstrated at 4 years of follow-up. Late rupture was more likely in the endovascular repair group (1.8% vs. 0.5%, p<0.001). Patients in the endovascular group were more likely to require any reintervention related to the abdominal aortic aneurysm (9% vs. 1.7%, p<0.001), but were less likely to require hospitalization for bowel obstruction or abdominal wall hernia (8.1 vs. 14.2%, p<0.001) and less likely to require surgery for procedure-related complications (4.1% vs. 9.7%, p<0.001).

Bush et al examined comparative outcomes of high-risk patients undergoing open (n=1,580) or endovascular repair (n=788) using data from the VA National Surgical Quality Improvement Program. (39) For this study, high risk was defined as age older than 60, American Society of Anesthesiologists (ASA) class III or IV, or significant cardiac, respiratory, hepatic, or renal disease. High-risk patients who underwent endovascular repair had a lower 30-day mortality compared to patients undergoing open repair (3.4% vs. 5.2%, p=0.047), and this mortality benefit was maintained at 1 year (9.5% vs. 12.4%, p=0.038). There was also a lower rate of perioperative complications for the endovascular group (16.2% vs. 31.0%, p<0.001). This study did not evaluate outcomes at follow-up periods longer than 1 year.

Mid-term results (mean of 36 months’ follow-up) from the Endologix Powerlink trial have been recently reported. (23) Consistent with other trials, this study found a decrease in 30-day mortality and adverse events compared to open surgical repair. However, in patients surviving the perioperative period there was a trend (p =0.08) for an increase in adverse events for EVAR treated patients (26% of patients measured at 36 months) compared with controls (15% of patients measured at 28 months). Publication of longer term follow-up from the EVAR1 and EVAR2 trials is expected in 2010.

Mid-term migration rates were reported by investigators involved in the AneuRx and Zenith phase II/III trials. (24) The AneuRx graft was reported to have a 52% probability of migration by 5 years and the Zenith graft a 10% probability of migration by 4 years. Although these migration rates are concerning, current endografts may have been modified in response to perceived limitations of first generation systems, and longer term outcomes of recent graft designs are not yet known. These results do, however, reinforce the need for frequent monitoring and potential re-intervention due to endoleaks, graft migration, and aneurysm enlargement.

The available data provide comparative evidence on the short- and medium-term outcomes of these procedures. Evaluation of long-term health outcomes is not yet possible due to the relatively recent development and utilization of these devices. Procedures are evolving and a number of clinical trials with existing and newly developed endovascular grafts are in progress. (25) Of particular import is the Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms. This multi-center study is sponsored by the Department of Veterans Affairs; it is expected to be completed in 2010with a total enrollment of 1,260 patients.

Fenestrated Endovascular Grafts for Compromised Proximal Neck Anatomy

Grafts for the treatment of abdominal aortic aneurysms involving the visceral arteries have not yet received FDA approval. Preliminary results of the use of a fenestrated graft in 22 patients were reported in 2004.  (26)This report suggested that the use of such a graft was technically challenging but feasible, but that more patients with greater follow up are required to determine the long-term safety and effectiveness of the device.  In 2006, intermediate outcomes were reported in two clinical trials that show promising results. (27, 28)  Issues concerning appropriate patient selection, proper device design and technical expertise in graft placement continue to be evaluated.

Evidence Based Guidelines for Endovascular Grafting of AAA

A literature search of the MEDLINE, Agency for Healthcare Research and Quality (AHRQ), and National Guideline Clearinghouse databases for the period of April 2005 through March 30, 2007 identified several recent evidence-based guidelines that support the existing policy statement.

The AHRQ published an Evidence-Based Practice Center report comparing endovascular and open surgical repair for abdominal aortic aneurysm. (29) Based primarily on the DREAM and EVAR studies discussed here, the report concludes that for aneurysms > 5.5 cm, endovascular intervention improves peri-operative outcomes compared with open surgical repair, but it has not been shown to improve long-term survival or health status compared with open surgery. The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) also updated their guidance following a 2005 systematic review of the safety and efficacy of elective endovascular repair. (30, 31) The guidance states, “Current evidence on the efficacy and short-term safety of stent graft placement in abdominal aortic aneurysm appears adequate to support the use of this procedure”.

Based solely on the EVAR2 trial, the AHRQ report concludes that endovascular repair does not improve survival in patients who are medically unfit for open surgery. (29) As previously discussed, the EVAR2 trial, and thus the AHRQ assessment, is compromised by the high proportion of patients who crossed over from nonoperative to endovascular repair, and by the number of patients who died in the interval between randomization and treatment with EVAR. Professional guidelines based on both randomized and non-randomized trials suggest that endovascular repair of infrarenal aortic and/or common iliac aneurysms is reasonable in patients at high risk of complication from open operations. (32)

Endovascular Repair of Ruptured Abdominal Aortic Aneurysms

Emergency EVAR (eEVAR) for ruptured abdominal aortic aneurysms is being studied as a potential method to decrease the approximate 50% mortality rate associated with open surgical repair. One analysis of hospital discharge databases for California, Florida, New Jersey, and New York showed a gradual increase in the use of eEVAR from 0.3% of cases in 2000 to 6.2% of cases in 2003. (33) Since eEVAR has a number of logistical and practical barriers, such as necessity for a preoperative CT scan, availability of an endovascular team including an experienced surgeon and radiologist, and a large stock of devices in a range of sizes, it might be assumed that eEVAR would be conducted only in specialized centers. However, the study found that most procedures performed over the 4-year period were conducted in hospitals with less than 5 total cases. Peri-operative mortality rates were lower for patients treated with eEVAR compared to open surgical repair, but there is likely to be a large selection bias in uncontrolled studies like this, because patients at the highest risk from open operation are not usually considered for eEVAR.

One study addressed this issue by assessing overall mortality rate in a unit where eEVAR has become the treatment of choice and comparing it with the overall mortality rate of historical controls treated with open surgical repair. (34) For a 2-year period between 2002 and 2004 patients received eEVAR unless they presented with shock or cardiac arrest during transportation to the hospital, or if the CT scan indicated an unfavorable anatomic configuration of the aortic neck (short, conical, or wide). Fifty-one patients (17 eEVAR and 34 open repairs) were treated during the study period; these were compared with a group of 41 patients treated in the previous 2-year period in the same unit and by the same vascular surgeons. The study found a decrease in length of stay in intensive care (5.5 vs. 0 days) and a trend toward a decrease in mortality (59% vs. 39%, p = 0.065) with eEVAR. However, the study also found that patients who were considered too unstable for eEVAR had a 77% mortality rate, while those who were considered unsuitable for eEVAR due to unsuitable aortic neck anatomy had a 19% mortality rate. These results suggest that the favorable mortality rates found in uncontrolled eEVAR studies are due to selection bias.

A different approach to this problem was taken by an industry-sponsored study that enrolled 100 consecutive patients across 10 institutions to determine the percentage of patients for whom eEVAR was applicable and to compare mortality and morbidity between the two groups. (35) Open surgical repair was performed in 51 patients; in 80% of cases this was due to a configuration of the neck that was unfavorable for endovascular repair. Patients with severe hemodynamic instability also received open surgical repair. This study found no difference between the 2 groups in either in-hospital (35% to 39%) or 3-month mortality (40% in the eEVAR group and 42% in the open repair group). Blood loss, time in intensive care, and the duration of mechanical ventilation were lower in patients treated by eEVAR than in those treated by open surgery. Identical mortality rates (53%) were also found in a pilot study with 32 patients randomized to eEVAR or open surgical repair by intention-to-treat analysis. (36)

Randomized trials with appropriately matched control groups for eEVAR are lacking. Based on current literature, eEVAR has not been shown to improve short-term health outcomes. In addition, endovascular repair requires long-term monitoring and possible re-intervention due to endoleaks, graft migration, and aneurysm enlargement. Paraplegia resulting from spinal cord ischemia during eEVAR has also been reported. (37) Together, evidence indicates that endovascular repair of ruptured abdominal aortic aneurysms is investigational.

References

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Cross References

Endovascular Stent Grafts for Thoracic Aortic Aneurysms or Dissections, Regence Medical Policy Manual, Surgery Policy No. 124

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