| Coverage Policy Manual | |
| Policy #: | 2005022 |
| Category: | Surgery |
| Initiated: | June 2005 |
| Last Review: | December 2023 |
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| Endovascular Stent Grafts for Disorders for the Thoracic Aorta | |
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| Description: |
Thoracic endovascular aneurysm repair (TEVAR) is an alternative to open surgery for the treatment of thoracic aortic aneurysm. It involves the percutaneous placement of a stent graft in the descending thoracic or thoracoabdominal aorta to reduce mortality from aneurysm rupture.
Aortic aneurysms are arterial dilations and are associated with age, atherosclerosis, and hypertension, as well as some congenital connective tissue disorders. The likelihood of significant sequelae of aortic aneurysm is dependent on location, size, and underlying disease state. Left untreated, these aneurysms tend to enlarge over time, increasing the risk of rupture or dissection. Of greatest concern is the tendency for aortic aneurysms to rupture, with severe consequences including death. Another significant adverse occurrence of aortic aneurysm is aortic dissection, in which an intimal tear permits blood to enter the potential space between the intima and the muscular wall of the aorta. Stable dissections may be managed medically; however, dissections which impinge on the true lumen of the aorta, or occlude branching vessels are a surgical emergency.
Thoracic endovascular aneurysm repair (TEVAR) has been investigated as an alternative to open surgery (OS) in patients in need of emergency surgery for rupture or complications related to dissection, as well as prophylactic treatment of aneurysm for those with a significant risk of future rupture or dissection. The standard open surgery technique for thoracic aortic aneurysm (TAA) is open operative repair with graft replacement of the diseased segment. This procedure requires lateral thoracotomy, use of cardiopulmonary bypass, long operation times, and is associated with a variety of peri- and postoperative complications, with spinal cord ischemia considered the most devastating.
Aortic dissection can be subdivided into type A, which involves the aortic arch, and type B, which is confined to the descending aorta. Type A dissections are usually treated surgically, while type B dissections are usually treated medically, with surgery indicated for serious complications, such as visceral ischemia, impending rupture, intractable pain, or sudden reduction in aortic size. Dissections associated with obstruction and ischemia can also be subdivided into an obstruction caused by an intimal tear at branch vessel orifices, or by compression of the true lumen by the pressurized false lumen. It has been proposed that endovascular therapy can repair the latter group of dissections by redirecting flow into the true lumen. The success of endovascular stent grafts of abdominal aortic aneurysms has created interest in applying the same technology to the aneurysms and dissections of the descending or thoracoabdominal aorta.
Regulatory Status
A number of endovascular grafts have been approved by the U.S. Food and Drug Administration (FDA) for use in Thoracic Aortic Aneurysms:
The GORE TAG® Thoracic Endoprosthesis is indicated for endovascular repair of aneurysms of the descending thoracic aorta. Use of this device requires patients to have adequate iliac/femoral access, aortic inner diameter in the range of 23–37 mm, and equal to or greater than 2 cm non-aneurysmal aorta proximal and distal to the aneurysm. In 2012, the FDA granted an expanded indication for the GORE TAG® system to include isolated lesions of the thoracic aorta. Isolated lesions refer to aneurysms, ruptures, tears, penetrating ulcers and/or isolated hematomas, but do not include dissections. Indicated aortic inner diameter is 16-42 mm, with >20 mm of non-aneurysmal aortic distal and proximal to the lesion.
The Zenith TX2® TAA Endovascular Graft was approved by the FDA through the premarket approval (PMA) process for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta. Indicated aortic inner diameter is in the range of 24-38 mm.
The Talent™ Thoracic Stent Graft System was approved by the FDA through the PMA process for the endovascular repair of fusiform and saccular aneurysms/penetrating ulcers of the descending thoracic aorta. Indicated aortic inner diameter is in the range of 18–42 mm. The Talent Thoracic Stent Graft System was discontinued by the manufacturer and replaced with the Valiant™ Thoracic Stent Graft System.
The Relay® Thoracic Stent-Graft with Plus Delivery System was approved by the FDA through the PMA process for the endovascular repair of fusiform aneurysms and saccular aneurysms or penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including:
The Valiant™ Thoracic Stent Graft with the Captivia® Delivery System was approved by the FDA for isolated lesions of the thoracic aorta. Isolated lesions refer to aneurysms, ruptures, tears, penetrating ulcers, and/or isolated hematomas, but not dissections. Indicated aortic diameter is 18 to 42 mm for aneurysms and penetrating ulcers, and 18 to 44 mm for blunt traumatic injuries. In 2014, the FDA expanded the indication for this graft and delivery system to include all lesions of the descending thoracic aorta, including type B dissections (FDA, 2014). The Valiant graft is intended for the endovascular repair of all lesions of the descending aorta in patients having appropriate anatomy, including:
The expanded approval was based on the Medtronic Dissection Trial (NCT01114724), a prospective, nonrandomized study that evaluated the performance of the Valiant stent graft for acute, complicated type B dissection, which included 50 patients enrolled at 16 sites.
The Valiant Navion™ is a next generation thoracic stent graft system with a modified design of the Valiant Thoracic Stent Graft with Captivia Delivery System (FDA, 2018). However, unused Valiant Navion thoracic stent graft systems were voluntarily recalled by the manufacturer (Medtronic) in February 2021 due to endoleaks, stent fractures, and stent ring enlargement (FDA, 2021). The recall occurred due to results of the Valiant Evo Global Clinical Trial which found 3 patients with stent fractures, 2 of whom had confirmed type IIIb endoleaks, and 1 patient death. Further investigation by an independent imaging laboratory found 7 of 87 patients with stent ring enlargement. The manufacturer is conducting further analysis.
Other devices are under development, and in some situations, physicians have adapted other commercially available stent grafts for use in the thoracic aorta.
FDA product code: MIH.
Coding
There are specific category 1 CPT codes for these procedures.
33880 Endovascular repair of descending thoracic aorta (e.g., 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
33881 not involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin
33883 Placement of proximal extension prosthesis for endovascular repair of descending thoracic aorta
(e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); initial extension
33884 each additional proximal extension (list separately in addition to code for primary procedure)
33886 Placement of distal extension prosthesis(s) delayed after endovascular repair of descending thoracic aorta
33889 Open subclavian to carotid artery transposition performed in conjunction with endovascular repair of descending thoracic aorta, by neck incision, unilateral
33891 Bypass graft, with other than vein, transcervical retropharyngeal carotid-carotid, performed in conjunction with endovascular repair of descending thoracic aorta, by neck incision
75956 Endovascular repair of descending thoracic aorta (e.g., 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
75957 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
75958 Placement of proximal extension prosthesis for endovascular repair of descending thoracic aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption), radiological supervision, and interpretation
75959 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
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Policy/ Coverage: |
Effective December 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of endovascular stent grafts using devices approved by U.S. Food and Drug Administration (FDA) meets member benefit certificate primary coverage criteria for effectiveness and are covered for the following conditions/indications:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of endovascular stent grafts for the treatment of descending aortic disorders not meeting the criteria listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, the use of endovascular stent grafts for the treatment of descending aortic disorders not meeting the criteria listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of endovascular stent grafts for the treatment of ascending aortic disorders, including but not limited to thoracic aortic arch aneurysms, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, the use of endovascular stent grafts for the treatment of ascending aortic disorders, including but not limited to thoracic aortic arch aneurysms, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective September 2011 through December 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of endovascular stent grafts for the treatment of thoracic aortic aneurysms and dissections meets primary coverage criteria for effectiveness and is covered when the device is used in accordance with FDA labeled information and instructions including appropriate anatomy that includes:
NOTE: The endovascular stent graft for thoracic aortic aneurysm or dissection is most often used in those patients for whom open surgical repair would be indicated but who are at increased risk from that procedure.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of endovascular stent grafts for the treatment of thoracic aortic aneurysms and dissections for indications other than those in FDA approved labeling fails to meet the member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. The Criteria exclude coverage of treatments if there is lack of scientific evidence regarding the intervention, or if the available scientific evidence is in conflict or the subject of continuing debate.
For members with contracts without primary coverage criteria, the use of endovascular stent grafts for the treatment of thoracic aortic aneurysms and dissections for indications other than those in the approved FDA labeling, is considered investigational treatment, as defined in the applicable benefit contract or health plan, which excludes coverage of investigational treatment or services.
Effective prior to September 2011
The use of endovascular stent grafts for the treatment of thoracic aortic aneurysms and dissections meets primary coverage criteria for effectiveness and is covered when the device is used in accordance with FDA labeled information and instructions including appropriate anatomy that includes:
For member benefit contracts or Plans with Primary Coverage Criteria, the use of endovascular stent grafts for the treatment of thoracic aortic aneurysms and dissections for indications other than those in FDA approved labeling fails to meet the Primary Coverage Criteria (“The Criteria”) of the applicable benefit certificate or health plan. The Criteria require, among other things that there be evidence of effectiveness as defined in the Criteria. The Criteria exclude coverage of treatments if there is lack of scientific evidence regarding the intervention, or if the available scientific evidence is in conflict or the subject of continuing debate.
For member benefit contracts or Plans with explicit exclusion language for experimental or investigational services, the use of endovascular stent grafts for the treatment of thoracic aortic aneurysms and dissections for indications other than those in the approved FDA labeling, is not covered because it is considered experimental or investigational treatment, as defined in the applicable benefit contract or health plan, which excludes coverage of experimental or investigational treatment or services.
The endovascular stent graft for thoracic aortic aneurysm or dissection is most often used in those patients for whom open surgical repair would be indicated but who are at increased risk from that procedure.
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| Rationale: |
Due to the detail of the rationale, the complete rationale is not available online. If you would like a hardcopy print, please email : codespecificinquiry@arkbluecross.com
Surgical Repair of Thoracic Aneurysms
The indications for the elective surgical repair of aortic aneurysms are based on estimates of the prognosis of the untreated aneurysm balanced against the morbidity and mortality of the intervention. The prognosis of TAA is typically reported in terms of the risk of rupture according to size and location, i.e., the ascending or descending or thoracoabdominal aorta. While several studies have estimated the risk of rupture of untreated aneurysms, these studies have excluded those patients who underwent surgical repair; therefore, the true natural history of thoracic aneurysms is unknown. Clouse and colleagues performed a population-based study of TAA diagnosed in Olmstead County, Minn., between the period of 1980 and 1994 (Clouse 1998). A total of 133 patients were identified; the primary clinical endpoints were cumulative rupture risk, rupture risk as a function of aneurysm size, and survival. The cumulative risk of rupture was 20% after 5 years. The 5-year risk of rupture as a function of aneurysm size at recognition was 0% for aneurysms less than 4 cm in diameter, 16% for those 4 to 5.9 cm, and 31% for aneurysms 6 cm or more. Interestingly, 79% of the ruptures occurred in women. Davies and colleagues (2002) reported on the yearly rupture or dissection rates in 721 patients with TAA. A total of 304 patients were dissection free at presentation; their natural history was followed up for rupture, dissection, and death. Patients were excluded from analysis once operation occurred. Not surprisingly, the authors reported that aneurysm size had a profound impact on outcomes. For example, based on their modeling, a patient with an aneurysm exceeding 6 cm in diameter can expect a yearly rate of rupture or dissection of at least 6.9% and a death rate of 11.8%. In a previous report, the authors suggested surgical intervention of a descending aorta aneurysm if its diameter measured 6.5 cm (Coady 1999).
Surgical morbidity and mortality are typically subdivided into elective vs. emergency repair with a focus on the incidence and risk of spinal cord ischemia, considered one of the most devastating complications, resulting in paraparesis or paraplegia. The operative mortality of surgical repair of aneurysm of the descending and thoracoabdominal aorta is estimated at 6%–12% and 10%–15%, respectively, while mortality associated with emergent repair is considerably higher (Clouse 1998, Rectenwald 2002). In elective cases, predictors of operative mortality include renal insufficiency, increasing age, symptomatic aneurysm, presence of dissection, and other comorbidities, such as cardiopulmonary or cerebrovascular disease. The risk of paraparesis or paraplegia is estimated at 3%–15%. Thoracoabdominal aneurysms, larger aneurysms, presence of dissection, and diabetes are predictors of paraplegia (Huynh 2002, Estrera 2001). A number of surgical adjuncts have been explored over the years to reduce the incidence of spinal cord ischemia, including distal aortic perfusion, cerebrospinal fluid drainage, hypothermia with circulatory arrest, and evoked potential monitoring (Safi 1998, Estrera 2001, VanDongen 2001, Safi 1999). However, the optimal protective strategy is still uncertain (Webb 1999).
This significant morbidity and mortality makes definitive patient selection criteria for repair of thoracic aneurysms difficult. Several authors have recommended an individual approach based on balancing the patients' calculated risk of rupture with their anticipated risk of postoperative death or paraplegia. However, in general, surgical repair is considered in patients with adequate physiologic reserve when the thoracic aneurysm measures from 5.5 to 6 cm in diameter, or in patients with smaller symptomatic aneurysms.
As noted above, 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, i.e., shock or visceral ischemia, although some surgeons recommended 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 (Umana 2002). 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.
Endovascular Stent Grafts
Currently, open surgical resection of the aneurysm with graft replacement is considered the gold standard for aneurysm or dissection repair. Given the numerous patient factors (i.e., age, co-morbidities, location, size of the aneurysm, presence or absence of dissection) and procedure variables involved in surgical repair, controlled trials of homogeneous patients and procedures would be required to determine if endovascular approaches are associated with equivalent or improved outcomes compared to surgical repair. Comparative mortality rates are of particular concern as well as the incidence of spinal cord ischemia. In addition, some patients who would not be considered a candidate for surgical therapy due to unacceptable risks might be considered candidates for an endovascular graft. In this situation, the outcomes of endovascular grafting could be compared to optimal medical management. In the abdominal aorta, the durability of the graft anchoring system and the incidence and long-term outcome of perivascular leaks around the graft have been concerns that are presumably shared by stent grafting in the thoracic aorta. Moreover, deployment of stent grafts into the thoracic aorta can be challenging; in some instances; reconstructions of the femoral or iliac artery may be required, or open surgical access to the aorta or iliac artery is required. Also, left-subclavian-carotid transposition may be performed to facilitate an adequate proximal fixation site.
In November 2003, Medtronic announced the initiation of the VALOR study (Evaluation of the Safety and Effectiveness of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms). The three-armed study will be conducted at 35 sites within the United States and will include the following subsets of patients:
In March 2005 the FDA approved the TAG endoprosthesis based on review of two clinical studies of approximately 200 people. Study results showed that aneurysm-related deaths were lower in patients who had received the endoprosthesis than in the open surgical control group. Additional studies to evaluate long-term clinical performance and to assure safety and effectiveness comparable to clinical trials in the large general population were required.
2008 Update
The policy was updated with a literature review using MEDLINE from July 2006 to March 2008. The articles identified do not lead to a change in the policy statements. Makaroun (2008) reported 5-year results of endovascular treatment with the TAG device. In this comparative study of 140 endograft patients with 96 non-contemporaneous controls, the authors concluded that endovascular treatment was superior to surgical repair at 5 years in anatomically suitable patients. For this study, significant sac size change was defined as 5 mm or greater increase or decrease from the 1-month baseline measurement. Migration was defined as 10 mm or more cranial or caudal movement of the device inside the aorta. At 5 years, aneurysm-related mortality was lower for TAG patients at 2.8% compared with open controls at 11.7% (P = .008). No differences in all-cause mortality were noted, with 68% of TAG patients and 67% of open controls surviving to 5 years. Endoleaks in the TAG group decreased from 8.1% at 1 month to 4.3% at 5 years. Five TAG patients have undergone major aneurysm-related re-interventions at 5 years (3.6%). Compared with the 1-month baseline, sac size at 60 months decreased in 50% and increased in 19% of TAG patients. At 5 years, there have been no ruptures, one migration, no collapse, and 20 instances of fracture in 19 patients, all before the revision of the TAG graft. They also noted that although sac enlargement was concerning, a modified device may be helping to resolve this issue.
2011 Update
One randomized controlled trial (RCT), the Investigation of Stent Grafts in Patients with type B Aortic Dissection (INSTEAD) trial has been completed (Nienaber, 2010). This trial compared endovascular stenting with medical management for stable thoracic aortic dissections. Stable, or uncomplicated type B dissections differ from acute lesions in that there is no evidence of ischemia or extension over the time of observation that would necessitate emergency surgery. Patients were randomly assigned to elective stent-graft placement in addition to optimal medical management (n=72) or to optimal medical management alone (n=68) to maintain arterial pressure below 120/80 mm/Hg. The primary endpoint of all-cause mortality at 1 year did not reach statistical significance between the 2 groups: cumulative survival was 91.3% + 2.1% in the endovascular group and 97.0% + 3.4% in the medical-only group (p=0.16). In addition, aorta-related mortality did not differ (5.7% and 3.0%, respectively; p=0.42). There were 2 cases of ischemic spinal cord injury with stent-grafting and 1 in the medical group. Seven patients (10.6%) in the medical group did cross over to the stent-graft group due to deterioration in condition, 1 patient from each group required open surgical intervention within the 12-month study period. An additional stent-graft for false-lumen expansion was required in 6 patients. A secondary measure of aortic remodeling did occur more frequently in the endovascular-repair group (91.3% vs. 19.4%, respectively; p<0.001), but the clinical significance of this is as yet unknown. Three adverse neurologic events occurred in the endovascular group compared to 1 in the medical-only arm. The authors conclude that elective stent-graft placement does not improve survival at 1 year and call for larger studies with extended follow-up.
Currently, open surgical resection of the aneurysm with graft replacement is considered the gold standard for aneurysm or dissection considered for surgical repair. Given the numerous patient factors (i.e., age, co-morbidities, location, size of the aneurysm, presence or absence of dissection) and procedure variables involved in surgical repair, controlled trials of homogeneous patients and procedures would be required to determine if endovascular approaches are associated with equivalent or improved outcomes compared to surgical repair. Comparative mortality rates are of particular concern, as well as the incidence of spinal cord ischemia. In addition, some patients who would not be considered candidates for surgical therapy due to unacceptable risks might be considered candidates for an endovascular graft. In this situation, the outcomes of endovascular grafting could be compared to optimal medical management. In the abdominal aorta, the durability of the graft anchoring system and the incidence and long-term outcome of perivascular leaks around the graft have been concerns that are presumably shared by stent grafting in the thoracic aorta. Moreover, deployment of stent grafts into the thoracic aorta can be challenging; in some instances; reconstructions of the femoral or iliac artery may be required or open surgical access to the aorta or iliac artery is required. Also, left subclavian-carotid transposition may be performed to facilitate an adequate proximal fixation site.
In 2010, Jonker and colleagues published a systematic review and meta-analysis of studies published between 1996 and 2009 to evaluate outcomes of open surgical repair (n=81) versus endovascular repair (n=143) for ruptured descending TAA (Jonker, 2010). The 30-day mortality was 19% for patients treated with endovascular repair, compared to 33% for patients treated with open repair (p=0.016). The 30-day incidence of myocardial infarction (MI) was 3.5% for those treated with endovascular repair versus 11.1% in patients treated with open repair (p<0.05). Rates of stroke and paraplegia were also increased in the surgically treated patients but did not reach statistical significance. Additional vascular interventions were performed in 9.1% of endovascular patients versus 2.3% of surgical patients (p=0.169). Regarding safety, during a median follow-up of 17 + 10 months, 5 additional patients in the endovascular group died of aneurysm-related causes, endoleak was reported in 11.1% of patients, and endograft migration was reported in 1 patient. The authors noted that the durability and development of endovascular-related complications remain concerns and that further surveillance of the endografts is required. These data need to be interpreted with caution given the non-random treatment assignment.
A systematic review of the evidence for endovascular repair of thoracic aneurysm was published by the Cochrane Peripheral Vascular Diseases Group in January 2009 and was based on the literature to October 2008 (Abraha, 2009). No RCTs comparing endovascular repair to open surgical interventions for thoracic aneurysms were found in the medical literature. The authors conclude that the reports from non-randomized studies suggest that endovascular repair is technically feasible and may reduce early negative outcomes, including death and paraplegia, but are associated with late complications not often seen in open surgery, such as the development of leaks, graft migration, and need for re-intervention. They also note that patients receiving endovascular grafts may require frequent surveillance with computed tomography (CT) scans.
In 2005, the National Institute of Clinical Excellence (NICE) conducted a systematic review of 27 case series and 2 comparative observational studies of endovascular repair in the treatment of thoracic aortic disease (NICE). Data from the included studies demonstrated technical success in approximately 93% of cases. The short-term (30-day) mortality rate was 5% (range 0-14%), and with a mean follow-up period of 14 months, overall mortality rate was 12% (range 3-24%) across studies. The most frequent technical complications were endoleak (13%), injury to the access site (6%), and stent fracture (6%). Stroke occurred in 6% and paraplegia in 2% of patients. The evidence base primarily consists of case series that include heterogeneous groups of patients with incomplete outcome data. However, the review concluded that the safety of the procedure must be weighed against the fact that mortality is very high if patients with thoracic aortic aneurysm are untreated and that endovascular stent placement is a suitable alternative to open surgery in appropriately selected patients with aneurysm or dissection.
Given the paucity of RCTs, the strongest available evidence on the efficacy of endovascular stents for repair of descending thoracic aortic aneurysms consists of several prospective non-randomized, comparative cohort studies that compare outcomes of endovascular stenting with open surgery. Many of these studies are included in the systematic reviews previously discussed. In addition to these studies, there are a number of retrospective, non-randomized, comparative case series that compare outcomes of endovascular, open surgical repair, and medical therapy.
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 the control group 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 1 or more major adverse events and the number of patients who did not experience device-related events 12 months’ post-device deployment. The number of patients in the TAG 99-01 device group who experienced equal to or greater than 1 major adverse event (42%) was significantly lower (p<0.001) than the surgical repair control group (77%) at 1-year follow-up. Major adverse events included major bleeding, neurologic; pulmonary; renal function; and vascular complications. In the TAG 99-01 device group, 4 of 140 patients (3%) experienced paraplegia or paraparesis versus 13 of 94 patients (14%) in the control group.
The Evaluation of the Safety and Effectiveness of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) study was a nonrandomized study conducted at 38 sites within the United States (Fairman, 2008). The VALOR trial enrolled patients who were candidates for open surgical repair and compared 195 TAA patients (aged: 70.2+/-11.1 years; male 59%) to 189 retrospective open surgical repair controls (aged: 69.6+/-9.1 years; male: 52.4%). Patients in the Talent endovascular graft group had lower TAA size and were less likely to have a previous aortic aneurysm (37/195 compared to 70/189 in the surgery group). Talent subjects were also less likely to have comorbid conditions including angina (pooled relative risk [PRR]: 1.6; 95% confidence interval [CI]:1.0, 2.6), coronary artery disease (PRR: 1.2; 95% CI: 1.0, 1.5) and previous MIs (PRR: 1.3; 95% CI:1.0, 1.6). Thirty-day (Talent group: 4/195 vs. surgery group: 15/189; p<0.1) and 12-month mortality (Talent group 31/192 vs. surgery group: 39/189; p<0.01) was lower in the endovascular graft group compared to open surgery. Fewer endovascular graft patients required blood transfusions (Talent: 22% vs. 93%). Endovascular graft patients had a shorter intensive care unit (Talent: 2 +/-5.5 days vs. surgery: 8+/-8.5 days) and overall hospital stay (Talent: 6+/-11.5 days vs. 17+/-15 days).
The Zenith TX2 device also received premarketing approval (PMA) from the FDA based on results of Matsumara et al (Matsumura, 2008). The study was a prospective cohort study that compared 160 thoracic endovascular aneurysm repair (TEVAR) (aged: 72+/-9.6 years; male: 72%) to 70 open surgery patients (aged: 68+/-12 years; male 60%). The study arms were comparable in previous history of cardiovascular and other vascular disease. The TEVAR patients had a lower American Society of Anesthesiologist classification (P<0.01) and higher Society of Vascular Surgery/International Society of Cardiovascular Surgery risk score (p=0.03).
The 30-day survival rate for the endovascular group was non-inferior (p<0.01) to the control group (98.1% vs. 94.3%, respectively). The 30-day severe morbidity composite index (cumulative mean number of events per patient) was significantly lower in the endovascular group compared to the control group (0.2 ± 0.7 vs. 0.7 ± 1.2; p<0.01). At 12 months, aneurysm growth was identified in 7.1% of the endovascular patients, endoleak occurred in 3.9% (4/103 patients), and migration in 2.8% (3/107 patients). At 12 months, aneurysm growth was identified in 7.1% of the endovascular patients, endoleak occurred in 3.9% (4/103 patients), and migration in 2.8% (3/107 patients).
In 2009, Cambria and colleagues reported on 59 patients who received TEVAR for emergent repair of thoracic aorta pathology due to acute complicated type B dissection, traumatic aortic tear, and ruptured degenerative aneurysm (Cambria, 2009). The authors’ own literature review prospectively postulated a combined mortality/paraplegia rate of 12.6% for TEVAR, compared to 29.6% for open surgery for each of the 3 diagnostic conditions, or arms, of the study. Based on pre-study power analysis, it was estimated that 52 test subjects would be required overall to detect a difference of 17% in the composite outcome; 20 subjects were enrolled in each arm, subject to anatomic considerations; at the time of presentation, the final number of subjects drafted was 59 due to a solitary patient reclassification. The combined 30-day mortality/paraplegia endpoint was observed in 13.6% of study participants (7 deaths and 1 paraplegia), significantly lower than the literature-based rate for open surgery (29.6%) previously stated (p=0.008). Not surprisingly, 30-day complications in addition to the composite endpoint were high: 48 (81%) patients experienced at least one major complication. Of these, 11 (18.6%) were attributable to device failure or complication. During mean follow-up time of 409 + 309 days, an additional 12 patients had died, 1 patient was converted to open surgery, and 2 patients had major, device-related events. For the entire study group, survival at 1 year was 66% (n=40). Regression analysis revealed that age and concurrent chronic obstructive pulmonary disease were predictive of death at 1 year.
Examples of several retrospective, comparative studies are provided below. In a retrospective review of the University of Pennsylvania’s database of acute type B aortic dissection, Zeeshan and colleagues (Zeeshan, 2010) compared 45 patients who underwent TEVAR to 32 patients who had open surgical repair (n=20) or medical management (n=12). Two TEVAR patients had died within 30 days or within hospitalization compared to 8 open surgery and 4 medical patients (4% vs. 40% vs. 33%, respectively; p=0.006). While not controlled in this study, TEVAR appears to be an option for patients with this catastrophic presentation. One-year survival was 82% for the TEVAR group.
Two additional publications have also discussed long-term results for use of TEVAR in complicated type B aortic dissection.
White and colleagues analyzed 1-year outcome after TEVAR in patients with complicated type B aortic dissection (cTBAoD) who had rupture or malperfusion and symptom onset 14 days or less (acute), 15 to 30 days (subacute), and 31 to 90 days (chronic) until required intervention (White, 2011). Their report focused on the acute cohort. Clinical data were systematically collected from 5 physician-sponsored investigational device exemption (IDE) clinical trials between 2000 and 2008. Adverse events were reported early (30 days or less) and late (>30 days). Major adverse events included death, stroke, MI, renal failure, respiratory failure, paralysis, and bowel ischemia. In this study, there were 99 cTBAoD patients: 85 were acute, 11 were subacute, and 3 were chronic. Among the acute patients, 31.8% had rupture and 71.8% had malperfusion, including 55.7% lower extremity, 36.1% renal, 19.7% visceral, 8.2% other, and 3.3% spinal cord (patients may have more than one source). Rupture and malperfusion were both reported for 3 acute patients. Early major adverse events occurred in 37.6% of patients, including death (10.6%), stroke (9.4%), renal failure (9.4%), and paralysis (9.4%); late adverse events included vascular (15.8%), cardiac (10.5%), gastrointestinal (6.6%), and hemorrhage (5.3%). The point-estimate mortality rate was 10.8 (95% CI, 4.1-17.5) at 30 days and 29.4 (95% CI, 18.4-40.4) at 1 year, when 34 patients remained at risk. The authors concluded that emergency TEVAR for patients with cTBAoD (malperfusion or rupture) provides acceptable mortality and morbidity results out to 1 year.
Steuer and colleagues published a retrospective, single-centre, consecutive case series from Europe (Steuer, 2011). In this study, during the period 1999-2009, TEVAR was carried out in 50 patients with non-traumatic acute complicated type B dissection and in another 10 patients with acute complications, including rupture, end-organ ischemia, and acute dilatation during the primary hospitalization, but more than 14 days after onset of symptoms. In total, 60 patients were included. Within 30 days, 2 (3%) deaths, 1 (2%) paraplegia and 3 (5%) strokes were observed. Five-year survival was 87% and freedom from re-intervention at 5 years was 65%. The authors concluded that in patients with acute complicated type B aortic dissection, TEVAR can be performed with excellent early and long-term survival.
Orandi et al. published a comparative analysis of 1,030 patients undergoing open surgery and 267 undergoing endovascular repair using the Nationwide Inpatient Sample database (Orandi, 2009). In-hospital mortality was similar between open and endovascular patients (adjusted odds ratio [OR] 1.2, 95% CI 0.73-2.12). Patients undergoing endovascular repair had fewer cardiac, respiratory, and hemorrhagic complications and a decreased length of hospital stay compared to open surgery patients. Dick et al. compared clinical and quality-of-life outcomes in 52 patients undergoing endovascular repair with 70 patients undergoing open surgical repair (Dick, 2008). Perioperative mortality rates did not differ between groups (8% vs. 9%, respectively; p=0.25). The mean overall quality-of-life score was 93 for the open surgery group compared with 83 for the endovascular group (p=0.66). There were no significant differences between groups on anxiety, depression, or other quality-of-life sub-measures. Nakamura et al. performed a retrospective, matched, case-control study that compared outcomes of endovascular and open approaches (Nakamura, 2009). Patients were matched for age, sex, location, and pathology of aortic disease. There were 2 early deaths in the open surgery group compared with none in the endovascular group (5.6% vs. 0%, respectively; p=0.49). There were no differences in major perioperative complications between groups; however, the endovascular group had a higher need for repeat procedures primarily due to endoleaks at the graft site.
One retrospective study compared outcomes of endovascular repair with medical therapy for acute type B aortic dissections (Chemelli-Steingruber, 2010). Of 88 patients presenting with acute dissection over a 12-year period, 50 were treated medically and 38 were treated with endovascular repair. Overall mortality was reported for a mean follow-up of 33–36 months and did not differ between the medical therapy and endovascular groups (24% vs. 23.7%, respectively; p=not significant).
Lee et al. summarized data on use of TEVAR for repair of traumatic thoracic aortic injuries to aid development of practice guidelines (Lee, 2011). The systematic review included 7,768 patients from 139 studies. This review found the mortality rate was significantly lower in patients who underwent endovascular repair, followed by open repair, and nonoperative management (9%, 19%, and 46%, respectively, P < 0.01). Based on the overall very low quality of evidence, the committee suggests that endovascular repair of thoracic aortic transection is associated with better survival and decreased risk of spinal cord ischemia, renal injury, graft, and systemic infections, compared with open repair or nonoperative management. In addition to the low quality of the evidence, the authors also note that these conclusions should be tempered by the lack of suitable (anatomic fit) devices, which can lead to severe complications, and to the lack of follow-up data.
In 2010, a joint task force published guidelines on the diagnosis and management of descending thoracic and thoracoabdominal aortic aneurysms (Hiratzka, 2010). The task force consisted of the American College of Cardiology Foundation, American Heart Association, American Association for Thoracic Surgery, American College of Radiology, American Stroke Association, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Thoracic Surgeons, and Society for Vascular Medicine. The task force offered the following Class I recommendations:
Class I recommendations are defined as follows:
Recommendation that procedure or treatment is useful/effective
The Clinical Practice Guidelines from the Society of Vascular survey were noted above (Lee, 2011). In addition to suggestions related to the data in the systematic review, the committee was also surveyed on a variety of issues that were not specifically addressed by the meta-analysis. On these select matters, the majority opinions of the committee suggest urgent repair following stabilization of other injuries, observation of minimal aortic defects, selective (vs. routine) revascularization in cases of left subclavian artery coverage, and that spinal drainage is not routinely required in these cases.
2012 Update
A literature search was conducted on PubMed through September 2012.
Goodney and colleagues analyzed Medicare claims data from 1998 – 2007 in order to describe short- and long-term survival of patients with descending thoracic aortic aneurysms (TAAs) after open and endovascular repair (TEVAR). This study included 12 573 Medicare patients who underwent open repair and 2732 patients who underwent TEVAR. Perioperative mortality was lower in patients undergoing TEVAR compared with open repair for both intact (6.1% versus 7.1%; P=0.07) and ruptured (28% versus 46%; P<0.0001) TAA. However, patients with intact TAA selected for TEVAR had significantly worse survival than open patients at 1 year (87% for open, 82% for TEVAR; P=0.001) and 5 years (72% for open; 62% for TEVAR; P=0.001). Furthermore, in adjusted and propensity-matched cohorts, patients selected for TEVAR had worse 5-year survival than patients selected for open repair.
The main outcome measure was mortality, defined as perioperative mortality (death occurring before hospital discharge or within 30 days), and 5-year survival, from life-table analysis. The authors concluded that although perioperative mortality is lower with TEVAR, Medicare patients selected for TEVAR have worse long-term survival than patients selected for open repair. The results of this observational study suggest that higher-risk patients are being offered TEVAR and that some do not benefit on the basis of long-term survival. Future work is needed to identify TEVAR candidates unlikely to benefit from repair.
Zhang and colleagues (2012) conducted a systematic review of endovascular repair versus open surgery for acute type-B aortic (ATBAD) dissection. Five non-randomized, controlled trials (318 patients) were identified. The authors concluded that TEVAR can be weakly recommended as an alternative for the selective treatment of ATBAD but cannot always be used in case of surgery.
Gopaldas et al. (2011) used the US Nationwide Inpatient Sample database to identify patients who underwent procedures to repair a thoracic artery rupture. A total of 923 patients were identified between the period of 2006-2008, 364 (39.4%) who underwent TEVAR and 559 (60.6%) who underwent open repair. Patients undergoing TEVAR were older and had a significantly higher burden of comorbidities compared to patients undergoing open repair. Complication rate was similar between the groups and overall mortality was 23.4% for TEVAR and 28.6% for open repair.
The evidence on use of TEVAR for treatment of thoracic artery rupture is limited due to the lack of controlled trials and small numbers of patients in comparative studies. The available evidence suggests that early mortality and complications may be reduced with TEVAR, but is not definitive for these outcomes. The longer-term outcomes are uncertain, with no discernible differences between TEVAR and open surgery.
Foley and colleagues (2012) reported on the 5-year outcomes of thoracic endovascular aneurysm repair (TEVAR) using the Medtronic Vascular Talent Thoracic Stent Graft System in patients considered low or moderate risk for open surgical repair for treatment of thoracic aortic aneurysms. The trial was a prospective, nonrandomized study (195 patients) conducted at 38 U.S. sites. The patients had fusiform thoracic aortic aneurysms (TAAs) and/or focal saccular TAAs/penetrating atherosclerotic ulcers. Standard follow-up interval examinations were conducted at 1 month, 6 months, 1 year, and annually thereafter.
Over the 5-year follow-up, 76 deaths occurred (43.9%). Most deaths were due to cardiac, pulmonary or cancer-related causes. There was only 1 case of aneurysm-related mortality (ARM) after the first year of follow-up. Over the 5-year follow-up period, four patients were converted to open surgery and four patients experienced aneurysm rupture,, 28 patients (14.4%) underwent 31 additional endovascular procedures on the original target lesion. The authors concluded that TEVAR using the Talent Thoracic Stent Graft System demonstrated sustained protection from aneurysm complications through the 5-year study for the patients who were candidates for open surgical repair. Patients receiving TEVAR continue to require close patient follow-up.
A search of clinicaltrials.gov revealed 29 active trials for “endovascular stent repair thoracic”.
Ongoing Trials:
The majority of the trials are single-arm series of different endovascular techniques in various clinical populations. There were 3 non-randomized comparative trials, described further below.
NCT00742274 - The ADSORB trial is an RCT of stent grafting versus medical therapy for acute dissections of the thoracic aorta. The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections. Enrollment is planned for 61 patients who will be followed for 36 months. Primary endpoints will be aneurysmal rupture, aortic enlargement, and thrombosis of the false lumen. Planned completion date is 2015.
2013 Update
Jia et al. performed a prospective, multicenter, nonrandomized comparative study of TEVAR versus optimal medical therapy (OMT) for chronic type B thoracic aortic dissections (Jia, 2013). A total of 208 patients were treated with TEVAR and 95 patients were treated with OMT. In the TEVAR group, there were no periprocedural deaths and serious complications (retrograde type A dissection; brachial artery pseudoaneurysm; paraplegia; MI) occurred in 12 patients (5.8%). Estimated survival at 2 and 4 years was 87.5% and 82.7% with TEVAR, compared to 77.5% and 69.1% with OMT, both respectively, but this difference in survival did not reach statistical significance (p=0.068). The estimated freedom from aorta-related death at 2 and 4 years was 91.6% and 88.1% for the TEVAR group, compared to 82.8% and 73.8% with OMT, both respectively, a difference which was statistically significant (p=0.039).
Azizzadeh et al. (2013) conducted a non-randomized study that compared outcomes of TEVAR and open surgery using prospectively collected data in 106 consecutive patients between 2002 and 2010 at one institution. This time interval covered the period of adoption for TEVAR at this institution, in which the proportion of patients treated with TEVAR increased from 0% to 100%. As a result, the number of procedures done in each group over time varied; 56 patients underwent open surgery and 50 underwent TEVAR. Primary outcomes were in-hospital death and complications. Death occurred in 5/56 (8.9%) patients undergoing open surgery, compared to 2/50 (4.0%) patients undergoing TEVAR. The overall likelihood of complications, including death, was significantly lower in the TEVAR group (odds ratio 0.33, 95% CI 0.11-0.97). Also, the number of patients with at least one complication was greater in the open surgery group compared to TEVAR (69.6% vs. 48%).
FDA Approval Studies (Single-arm): Data from two uncontrolled clinical series of patients with isolated thoracic artery lesions was reviewed by the FDA as part of the expanded approval for thoracic endografts in 2012. The TAG 08-02 study used the GORE TAG endograft to treat 51 patients with aortic transection due to blunt aortic injury (FDA, 2012a). All 51 patients had successful implantation of the CORE TAG endograft, although 6 patients (11.8%) required deployment of two stent grafts for adequate coverage. There were 4 deaths within 30 days of treatment (7.8%, 95% CI 3.1-18.5%). Serious adverse events with reported in 39.2% of subjects at 30 days, with the most common events being pleural effusion (5.9%) respiratory failure (5.9%). The primary effectiveness outcome was the number of patients with major device-related events in the first 30 days requiring reintervention. There were no patients who had such an event requiring reintervention. Two patients were identified with type II endoleaks, but neither patient required reintervention.
A similar study (RESCUE) was submitted to the FDA using the Valiant™ Thoracic stent graft in 50 patients with blunt aortic trauma (FDA, 2012b) All patients had successful deployment of the stent, with 2 patients requiring 2 devices. There were 4 deaths within 30 days of the procedure for a perioperative mortality of 8.0%. Serious adverse events occurred in 12.0% of patients, the majority of these were procedure-related events such as femoral artery dissection, localized hematoma, and/or hemothorax. There were 3 patients who required left subclavian artery revascularization to treat arm ischemia.
FDA approval was granted for endovascular stent graft treatment of thoracic artery ruptures in 2012. The evidence on TEVAR for treatment of thoracic artery rupture consists of single-arm series and nonrandomized comparative studies. There are no randomized, controlled trials, but RCTs are likely difficult to complete for this indication because of the emergent nature. The available evidence suggests that early mortality and complications are less with TEVAR compared with open surgery, but these data are limited by non-comparability of groups. The longer-term outcomes are uncertain, with no discernible differences between TEVAR and open surgery.
For traumatic thoracic aortic injury and aortic rupture, nonrandomized comparative data suggest a benefit for TEVAR in reducing peri-procedural morbidity and mortality. The FDA granted approval for endovascular treatment of thoracic aortic ruptures in 2012, and specialty society recommendations include endovascular stent grafts as a treatment option for acute thoracic aortic rupture. In addition, it is expected that RCTs will be difficult to perform for this indication due to the emergent nature. Therefore, based on the available evidence, FDA approval of stent grafts for rupture, and support in specialty society guidelines, stent grafting for acute rupture of the thoracic descending aorta may be considered medically necessary.
Additional Ongoing Trials
NCT01852773. Thoracic Endovascular Repair versus Open Surgery for Blunt Injury. This is a prospective observational trial comparing outcomes of endovascular repair with open surgery for patients with trauma and blunt aortic injury. The main outcomes are short-term mortality and short- and long-term complications. Planned enrollment is for 1,300 patients with an estimated completion date of November 2018.
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft in the Treatment of Descending Thoracic of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair (VALOR II) was a prospective nonrandomized study at 24 sites that was designed to evaluate the Valiant thoracic stent-graft, as opposed to the VALOR study which was an evaluation of the Talent stentgraft (Fairman, 2012). VALOR II enrolled 160 patients who underwent stent grafting with the Valiant device, using similar enrollment criteria to VALOR. Outcomes were compared to those from the VALOR study. Stentgraft delivery was technically successful in 154 patients. One hundred fifty-one patients were evaluated at 12 months post-procedure; all-cause mortality at 12 months associated with the Valiant stent-graft was statistically noninferior to the Talent stent-graft (12.6% vs 16.1%) and exceeded the primary effectiveness goal of 12-month successful aneurysm treatment (defined as absence of aneurysm growth >5mmand of secondary procedures for type I/III endoleak).
In 2014, Matsumoto et al reported rates of secondary procedures over 3 years of follow up for patients enrolled in the VALOR and VALOR II studies (Matsumoto, 2014). Three-year follow up evaluation was available for 127 patients (65.5%) in the TEVAR arm of VALOR and 96 (61.8%) in VALOR II. Freedom from secondary procedures at 3 years was 85.1% (95% CI 78.5-89.8%) in the TEVAR arm of VALOR and 94.9% (95% CI 88.8% to 97.7%) in VALOR II (P<0.001). The overall 3-year difference between groups in secondary procedure rates were driven by differences in early (within 1 year) reintervention rates. This comparison suggests that the newer-generation stent-graft device may be associated with fewer subsequent reinterventions; however, the non-randomized comparison and potential differences between patients in VALOR and VALOR II makes it difficult to draw firm conclusions about the relative efficacy of different devices.
In 2014, Matsumara et al published 5-year follow up from the Zenith TX2 prospective cohort study described above (Matsumura, 2014). The 70 Patients in the open surgical control group underwent clinical evaluation before discharge or at 1 month and then at 12 months and yearly thereafter up to 5 years. Follow up beyond 1 year was unavailable for 24 patients due to institutional review board restrictions and for 4 additional patients who were lost to follow up. TEVAR patients underwent follow up at 1, 6, and 12 months post-procedure and yearly thereafter. Of the 160 TEVAR patients, 2 did not have successful device deployment and only had follow up to 30 days, and an additional 32 were lost to follow up. Fiveyear survival was 62.9% for the TEVAR group and 62.8% for the open surgical group (nonsignificant difference between groups). Kaplan-Meier estimates of freedom from severe morbidity composite index was significantly higher in the TEVAR group than the open surgical control group (87.3% vs 64.3% at 1 year and 79.1% vs 61.2% at 5 years, log-rank test, P < .001). Secondary interventions occurred at similar rates between the endovascular and open surgical control patient groups during follow-up through 5 years. While this study is somewhat limited by some loss to follow up, it suggests that the early morbidity benefit associated with TEVAR persists over time and that rates of secondary interventions may be comparable to open surgical repair.
In 2014, Ramdass reported results from a systematic review of studies reporting the 30-day mortality after TEVAR for acute or chronic symptomatic type B aortic dissection (Ramdass, 2014). The review included 69 studies, encompassing 1,574 patients, that met inclusion criteria published between 1998 and 2013, including 1 RCT, 55 retrospective, 3 prospective, 9 case reports, and 1 mixed study. All studies addressed type B aortic dissection, but were heterogeneous in terms of acuity of patient presentation. The overall 30-day mortality for patients treated with TEVAR for type B aortic dissection was 8.07% (127/1574, of which 97 were considered to be procedure-related). A higher proportion of stent-related deaths occurred in patients treated in the 2007 to 2013 period than in patients treated in the 1998 to 2007 period (56.2% vs. 24.0%, P<0.05); however, these rates are calculated as a proportion of the stent related deaths in each group to the total number of deaths for which a clear cause could be determined. This may not be the most appropriate comparison if non-stent-related deaths or deaths due to unknown causes also differed over the two time periods.
In 2013, Nienaber et al published long-term follow up results from the INSTEAD trial (INSTEAD-XL) (Nienaber, 2013). From 2 to 5 years after the index procedure, rates of aortic aorta-specific mortality, all-cause outcomes, and disease progression were assessed for the 72 patients randomized to stent-graft placement with optimal medical management and the 68 patients randomized to medical management alone. Endpoints evaluated included the following: all-cause mortality; aorta-specific mortality (defined as death from documented aortic rupture, malperfusion, or proximal dissection, or death within 1 hour of onset of signs and symptoms in the absence of coronary or valvular heart disease); and progression of aortic pathology (defined as the combined endpoint of crossover to stent graft, conversion to open repair, additional endovascular or open surgery for rupture, malperfusion or aortic expansion, or enlarging aortic diameter >5.5 cm). Patients were followed for a minimum 5 years (maximum 8 years); the median interval until death or latest follow up was 69 months (interquartile range 62 to 83); there was no loss to follow up. Twenty-one additional TEVAR procedures were performed in the 5-year follow-up period, 14 in the optimal medical therapy group (5 emergency cases), with conversion to open repair in 4 cases, and 7 in the TEVAR group, with conversion to open repair in 3 cases. Analysis was intention-to-treat.
The risk of all-cause mortality was not statistically significantly different between groups at 5 years post randomization (11.1% in the endovascular repair group vs. 19.3% in the optimal medical therapy group, P=0.13). However, Kaplan-Meier curves demonstrated a survival benefit in the endovascular repair group between 2 and 5 years post-randomization (100% in the endovascular group vs. 83.1%, P=0.0003), and a test for interaction between treatment effect and time was significant, suggestive of a late survival benefit from endovascular repair. Patients randomized to endovascular repair had lower aorta-specific mortality (6.9% vs. 19.3%, P=0.04) and progression of aortic pathology (27.05 vs. 46.1%, P=0.04). For the combined endpoint of disease progression (aorta-specific death, crossover/conversion, and secondary procedures) and aorta-specific events, at 5 years of follow up freedom from the combined endpoint was 53.9% with medical therapy alone and 73.0% with TEVAR. Landmark analysis was performed to compare hazard ratios for events occurring from randomization until 24 months post-randomization with events occurring beyond 24 months post-randomization to assess for a time-dependent response to treatment. In landmark analysis, groups had similar patterns of freedom from progression of aortic disease from randomization until 2 years of follow up (76.1% vs. 75.5%; hazard ratio [HR] 0.997; 95% CI 0.51 to 1.95; P=0.994.). However, from 2 years to 5 years of follow up, the TEVAR group was more likely to have freedom from progression than the medical therapy group (95.9% vs. 71.9%; HR 0.112; 95% CI 0.03 to 0.49; P=0.004).
The INSTEAD-XL findings suggest that in stable patients with type B aortic dissection, pre-emptive endovascular repair may be associated with an excess risk of morbidity and mortality in the immediate post-procedural period which is outweighed by a longer-term survival benefit. The authors note that best medical management did not prevent late complications of aortic dissections, including expansion, rupture, and late crossover/conversion to emergent TEVAR.
Fattori et al compared long-term survival between TEVAR and best medical therapy for type B acute aortic dissections among 1,129 patients enrolled in an international registry of acute aortic Dissections (Fattori, 2013). The registry was a multinational registry of 24 referral centers in 12 countries, which was designed to provide an unbiased representative population of patients with acute aortic dissection. 3,865 patients were enrolled from December 26, 2995, to January 20, 2012. The present study included 1,129 patients with type B acute aortic dissections, who underwent either medical therapy (n=853) or endovascular stent-graft placement (n=276).
Patients who underwent TEVAR were matched in a 2:1 manner to medical therapy patients based on a propensity score created from a multivariable binary logistic regression model for the conditional probability for endovascular treatment versus medical treatment. The groups differed significantly at baseline: patients receiving endovascular treatment were more likely to present with clinical signs of malperfusion, such as leg pain (21.7% vs. 8.4%, P < 0.001) and limb ischemia (20.6% vs. 4.8%, P <0.001), were more likely to have preoperative acute renal failure (21.4% vs. 12.4%, P < 0.001), any pulse deficit on presentation (28.3% vs. 13.4%, P < 0.001), and complicated dissections (defined by the presence of shock, periaortic hematoma, signs of malperfusion, stroke, spinal cord ischemia, mesenteric ischemia/ infarction, and/or acute renal failure (61.7% vs. 37.2%,p < 0.001). Kaplan-Meier survival estimates at 5 years showed that patients who underwent TEVAR had a lower death rate than best medical therapy patients (15.5% vs. 29.0%, P=0.018).
Hanna et al published a retrospective case series of long-term follow-up (median follow-up 33.8 months) of 50 patients who underwent TEVAR for management of acute complicated type B aortic dissection (Hanna, 2014). At 30 days, no deaths were reported. Overall survival at 5 and 7 years was 84%. No deaths were attributable to aortic pathology, but a high proportion of patients (26%) required reintervention over the follow-up period.
Ruan et al evaluated predictors of early and late mortality among 62 patients who underwent TEVAR for complicated type B aortic dissection (Ruan, 2013). The 30-day mortality rate was 9.68%; in multivariable modeling, significant periprocedural predictors of early mortality included type I endoleak and cardiac tamponade. Follow-up was available for all 56 survivors at a median 52.8 months, during which time 9 deaths (16.07%) occurred, 4 of which were aorta-related. Independent periprocedural predictors of late mortality included rupture of false lumen, postoperative myocardial infarction, and acute renal failure. The authors suggest that careful evaluation for type I endoleaks during the TEVAR procedure may help reduce early mortality.
For patients with chronic, stable dissections of the thoracic aorta, one RCT reported that short-term outcomes do not differ significantly between TEVAR and best medical management. However, over 5 years of follow up, patients who undergo pre-emptive endovascular repair may demonstrate reduced morbidity and mortality. Single-arm series report relatively high success rates and favorable long-term results compared to historical controls undergoing open surgery.
Non-randomized, comparative studies
Klima et al (Klima. 2013). In 2013, Klima et al retrospectively compared outcomes and complications associated with for open repair with endovascular repair for blunt aortic trauma for 49 patients treated at a single nonuniversity hospital from 2004 to 2011. Twenty-one patients underwent open repair, while 28 patients were managed with TEVAR; groups did not differ at baseline with regard to age, gender, or injury severity. Hospital length of stay, intensive care unit length of stay, and ventilator time were similar between groups, but patients in the open repair group had higher in-hospital mortality than the TEVAR group (33% vs. 7%, P=0.028).
Single-Arm Studies
Since the FDA’s approval of thoracic endografts for traumatic aortic rupture, a number of single-arm studies have reported outcomes for TEVAR for this indication. Martinelli et al reported an in-hospital mortality rate of 7.4% in a cohort of 27 patients who underwent TEVAR for blunt aortic trauma (Martinelli, 2013). Piffaretti et al reported an in-hospital mortality rate of 6.5% in a cohort of 35 patients who underwent TEVAR for blunt aortic trauma, with no subsequent mortality over a median follow-up of 72 months (Piffaretti, 2013).
Mixed populations
Several studies have evaluated TEVAR in heterogeneous groups of patients.
In 2013, Alsac et al reported outcomes from for 48 patients treated with TEVAR for a “descending thoracic acute aortic syndrome,” including 19 ruptured aneurysms, 12 acute dissections, and 17 traumatic Ruptures (Alsac, 2013). Ten patients died during the periprocedural hospitalization (mortality rate 20.8%), but no later deaths were reported in the 33 patients for whom longer term follow-up was available. Reintervention in the first month post-procedure was required in 8 patients (16.7%), and late reintervention was required in 5 patients (10.4%).
In 2014, Sood et al published a comparison of open repair, hybrid repair, and TEVAR for a mixed population of patients with thoracic aorta aneurysms (n=83) or dissections (n=15) treated at a single institution from 1993 to 2013 (Sood, 2014). Patients treated with TEVAR were older and more likely to have a history of tobacco use. For the study’s primary outcome of all-cause late mortality, Kaplan-Meier analysis showed no significant difference in 5-year survival between TEVAR patients and open/hybrid repair patients.
Botsios et al reported outcomes for 21 patients who underwent emergency TEVAR for nontraumatic rupture of the descending thoracic aorta, due to underlying degenerative aneurysms (n=11), complicated type B dissection (n=9), or erosion due to neoplasia (n=1) (Botsios, 2014). Thirty-day mortality was 9.5%; over a median follow-up of 65.6 months (range 1.5–44), 10 additional patients died, leading to a late mortality rate of 52.6%. Late mortality was more likely to be related to non-aortic causes, with 2 aorta-related deaths and 8 non-aorta-related deaths.
Wiedemann et al reported short- and medium-term outcomes for 300 patients, who underwent TEVAR at a single institution for a range of thoracic aortic conditions, including 137 descending thoracic aneurysms, 80 type B dissections (60 acute, 20 chronic), 59 perforating aortic ulcer, and 24 traumatic aortic Transections (Wiedemann, 2013). Thirty-day mortality was 5% (15 patients) with no statistically significant differences between the 4 groups. Median follow up is reported as 44 years, although this may be a typographical error. In Kaplan-Meier analysis, overall survival at 1, 5, and 10 years was 86%, 63%, and 44%, with significant differences between groups and the lowest survival for descending thoracic aneurysms.
For uncomplicated descending (type B) aortic dissections, the evidence available from one randomized trial did not demonstrate a short-term outcome benefit associated with TEVAR; however, over 5 years of follow-up, TEVAR was associated with a survival benefit after 2 years post-procedure. Additional studies are needed to determine whether TEVAR is associated with net health improvements for uncomplicated type B aortic dissections; thus, the use of endovascular stent grafts in uncomplicated thoracic aortic dissections is considered investigational.
A search of the online database ClinicalTrials.gov using the terms thoracic and endovascular returned 25 active trials of endovascular repair of thoracic artery disorders. The majority of these are single-arm series of different endovascular techniques in various clinical populations. Several post approval studies for thoracic aortic stent-grafts are ongoing, including NCT00813358 (Zenith TX2® Postmarket Approval Study), NCT00805948 (Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms), NCT01775046 (Valiant Thoracic Stent Graft With the Captivia
Delivery System in the Treatment of Descending Thoracic Aortic Diseases), NCT02104089 (Post-market
Observational Study Zenith® t-Branch™)
The following are studies that compare TEVAR to alternative treatments:
Evaluation of the Cook Custom Aortic Endograft and the Zenith t-Branch Endovascular Graft in Treating Aortic Pathologies (NCT02043691). This is a non-randomized, open trial to compare the Cook Custom Aortic Endograft and the Zenith t-Branch Endovascular Graft in the treatment of complex juxtarenal, suprarenal and thoracoabdominal aortic pathology including aneurysms and penetrating aortic ulcers. Enrollment is planned for 30 subjects; the planned study completion date is April 2021
Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study) (NCT02010892): A Prospective Cohort Study. This is an observational cohort study to compare open surgical repair with endovascular repair, best medical therapy, and watchful waiting for the treatment of chronic thoracic aortic aneurysm. Enrollment is planned for 2200 subjects; the planned study completion date is July 2019.
Thoracic Endovascular Repair versus Open Surgery for Blunt Injury (NCT01852773). This is a prospective observational trial comparing outcomes of endovascular repair with open surgery for patients with trauma and blunt aortic injury. The main outcomes are short-term mortality and short- and long-term complications. Planned enrollment is for 1,300 patients with an estimated completion date of November 2018.
The STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2
Endovascular Graft (NCT00111176) is a non-randomized, comparative trial of TEVAR versus open surgical repair for patients with thoracic aneurysms who are eligible for both procedures. This study of 205 patients was completed in February 2014 with no results posted.
Trials NCT00998491 (A Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients with Thoracic Aortic Pathologies (RELAY)) and NCT00435942 (Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft) are Phase II studies to evaluate the safety and efficacy of the Relay Stent Graft in patients with descending thoracic aneurysms. NCT00998491 has a planned enrollment of 120 patients, with an estimated completion date in 2015. NCT00435942 has a planned enrollment of 120 patients and an estimated completion date in 2015.
NCT00742274 – A European Study on Medical Management versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection (ADSORB). This was a randomized, open-label trial comparing the Gore TAG Endoprosthesis to best medical therapy for the treatment of acute uncomplicated aortic dissection. Enrollment was planned for 61 subjects. The study status is listed as completed, but no associated publications or results were identified.
TEVAR is not a preventive service and is therefore not included in the U.S. Preventive Task Force Recommendations for preventive services.
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Some additional studies have compared open and endovascular repair using either large administrative databases or retrospective comparative designs. Orandi and colleagues published a comparative analysis of 1030 patients undergoing open surgery and 267 undergoing endovascular repair using the Nationwide Inpatient Sample database (Orandi, 2009). In-hospital mortality was similar between open and endovascular patients (adjusted odds ratio [OR], 1.2; 95% CI, 0.73 to 2.12). Dick and colleagues reported a post hoc analysis of prospectively collected data for clinical and quality-of-life outcomes in 52 patients undergoing endovascular repair with 70 patients undergoing open surgical repair, with no significant differences in perioperative mortality rates or overall quality-of-life scores (Dick, 2008). Other representative retrospective studies of TEVAR for aortic aneurysms are those by Cazavet et al (Cazavet, 2015). Iba et al (Iba, 2014), and Arnaoutakis et al (Arnaoutakis, 2015).
Dissection of the Descending Aorta (Type B Dissection)
One RCT, the Investigation of Stent Grafts in Patients with type B Aortic Dissection (INSTEAD) trial has been completed for patients with chronic, stable dissections, and an additional RCT (the ADSORB trial) compared TEVAR with best medical therapy for patients with acute, uncomplicated dissections. There are no RCTs for treatment of acute, complicated type B dissections, which is the group for which endovascular repair is often targeted.
Systematic Reviews
In 2014, Moulakakis and colleagues reported results of a systematic review and meta-analysis of studies reporting on the management of complicated and uncomplicated type B aortic dissection, including medical management, open surgical repair, and endovascular repair (Moulakakis, 2014). “Complicated dissections” were defined as those with aortic rupture, visceral and renal ischemia, lower extremities ischemia, or spinal cord ischemia, or with expansion to the aortic arch or proximal descending aorta with a total diameter of 4.5 cm or greater. The review included 30 studies on TEVAR, 15 studies on best medical therapy, and 9 studies on surgical repair. For the 2531 patients with acute complicated type B aortic dissection treated with TEVAR, the pooled 30-day/in-hospital mortality rate was 7.3% (95% CI, 5.3 to 9.6%). Survival rates ranged from 62% to 100% at 1 year and from 61% to 87% at 5 years. For the 1276 patients with acute complicated type B aortic dissection treated with open repair, the pooled 30-day/in-hospital mortality rate was 19.% (95% CI 16.8 to 21.1%). Survival rates ranged from 74.1% to 86.0% at 1 year and from 44.0% to 82.6% at 5 years. For the 2347 patients with acute uncomplicated type B aortic dissection treated with best medical therapy, the 30- day/in-hospital mortality pooled rate was 2.4% (95% CI, 0.9% to 4.6%), and survival rates ranged from 86.2% to 100% at 1 year and from 59.0% to 97.2% at 5 years. Direct comparisons between treatment groups are not reported, and the study does not account for between-group differences (other than treatment modality), which limits conclusions that may be drawn.
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