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CurrentAetnaPolicy 0651

Endovascular Repair of Aortic Diseases

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Clinical policy defining Aetna's medical necessity, experimental/investigational determinations, and associated coding and surveillance recommendations for endovascular repair of aortic diseases; applies to Aetna-covered members and providers performing these procedures.

Policy Summary

PayerAetna

PolicyEndovascular Repair of Aortic Diseases

Policy CodePolicy 0651

Change TypeNo material clinical or coverage changes

Effective DateJan 17, 2003

Last ReviewSep 14, 2023

Next Review DateJul 11, 2024

Key ActionObtain prior authorization and document anatomical suitability, device selection, and fitness for open repair when requesting coverage for endovascular aortic procedures.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4medically necessary interventions

7experimental/investigational items

CT 1,6,12 then yearlyCT surveillance schedule

90.4%FEVAR technical success

~10%re-intervention rate after EVAR

Coverage Criteria — Endovascular Repair of Aortic Diseases

COVERED (Medically Necessary)

Medically Necessary Interventions — Covered when ALL of the following selection criteria are met:

ALL of the following

Endovascular repair of infra-renal abdominal aortic or aorto-iliac aneurysms using a Food and Drug Administration (FDA)-approved fenestrated, branched, or non-fenestrated endovascular stent graft.
Endovascular repair of descending thoracic aortic aneurysms using an FDA-approved endoprosthesis.
Endovascular stenting (with an FDA-approved stent) for treatment of aortic coarctation in persons with body weight of >= 25 kg (55 lbs) who exhibit systemic arterial hypertension and a resting arm–leg pressure gradient > 20 mmHg.
Computed tomography (CT) surveillance after endovascular (stent) aortic repair at 1 month, 6 months, and 12 months following repair, then annually thereafter.

Policy Summary

PayerAetna

PolicyEndovascular Repair of Aortic Diseases

Policy CodePolicy 0651

Change TypeNo material clinical or coverage changes

Effective DateJan 17, 2003

Last ReviewSep 14, 2023

Next Review DateJul 11, 2024

Key ActionObtain prior authorization and document anatomical suitability, device selection, and fitness for open repair when requesting coverage for endovascular aortic procedures.

SourceLink

On This Page

Bridging stents in branched/fenestrated repairs

Use of FDA‑approved or institutionally accepted covered bridging stents to maintain target vessel perfusion during fenestrated or branched endovascular aortic repair (F-BEVAR) is considered medically necessary when implanted as part of a covered fenestrated or branched endograft procedure performed for patients meeting device and clinical selection criteria.
Bridging stents should be selected and deployed by experienced operators in high-volume centers with documented protocols for target-vessel surveillance and follow-up imaging.
Bridging stent use for target vessel incorporation is considered medically necessary when documentation shows the bridging stent is required to preserve visceral or renal artery perfusion as part of a fenestrated/branched construct and when device selection and implantation follow manufacturer or IDE protocol specifications.

EXPERIMENTAL / INVESTIGATIONAL

Experimental and Investigational — The following interventions are considered experimental and investigational (and therefore not medically necessary) because their effectiveness has not been established:

ALL of the following

Intra-operative CT for endovascular aneurysm repair.
Bifurcated‑bifurcated aneurysm repair of aorto‑iliac aneurysms.
Endovascular aneurysm sealing system (Nellix device) for the treatment of abdominal aortic aneurysms, including failed prior EVARs (see evidence summaries demonstrating device‑specific concerns).
Fabric/mesh wrapping (external fabric wrapping) of abdominal aortic aneurysms.
Implanted wireless pressure sensors for detection of endoleaks in the aneurysmal sac following endovascular repair (insufficient long‑term outcome data).
Pre-operative embolization of the inferior mesenteric artery solely to reduce the rate of type II endoleak following EVAR (insufficient definitive evidence; investigational except in context of clinical trials).
Total endovascular aortic arch repair performed outside of an FDA‑approved indication or outside a clinical trial (considered investigational pending higher‑quality RCT data).

Coverage note

Procedures and devices listed in this Experimental and Investigational group are considered not medically necessary for the indications stated in this policy excerpt unless provided within a prospective clinical study or when sufficient FDA approval and peer‑reviewed outcomes supporting clinical benefit become available.

EVIDENCE‑INFORMED SELECTION CONSIDERATIONS

Evidence‑informed selection considerations — contextual factors and evidence summaries that inform offering EVAR/FEVAR/TEVAR:

ANY of the following

EVAR reduces operative (30‑day) mortality compared with open repair but may not provide a long‑term all‑cause mortality benefit; patient selection should consider life expectancy and ability to comply with lifelong surveillance.
FEVAR/BEVAR may be appropriate for anatomies unsuitable for standard EVAR (juxtarenal, pararenal, thoracoabdominal aneurysms) in patients deemed high risk for open repair; however, long‑term comparative evidence versus open repair is limited and associated with higher rates of reintervention and costs in several series.
Complex endovascular repairs (fenestrated/branched/arch devices, physician‑modified grafts, in‑situ fenestration) should generally be performed in experienced centers and, when possible, within clinical trials or registries to capture outcomes and durability data.

Surveillance and contraindications

Surveillance imaging schedule after EVAR: CT at 1 month, 6 months, 12 months, then annually; inability to comply with surveillance is a relative contraindication to EVAR.
Anatomic features that may contraindicate standard EVAR include insufficient non‑aneurysmal neck length (<15 mm for older devices), suprarenal or juxtarenal aneurysm anatomy, small caliber access vessels, circumferential aortic calcification, and excessive tortuosity; consider fenestrated/branched or open repair depending on anatomy and patient risk.

FEVAR / BEVAR / BRIDGING STENTS — COVERAGE CONSIDERATIONS

Coverage considerations for fenestrated/branched (FEVAR/bEVAR) and bridging stents — evidence‑based considerations and comparative outcome summaries:

ALL of the following

FEVAR/bEVAR may be considered medically necessary for complex juxtarenal, pararenal, and thoracoabdominal aneurysms when patient anatomy is appropriate and the patient is a poor candidate for open repair, and when performed in centers with demonstrated expertise and established follow‑up protocols.
Comparative studies and registries show FEVAR/bEVAR have acceptable technical success and target‑vessel patency rates but are associated with higher perioperative complication and reintervention rates in some series; shared decision‑making and documented risk–benefit discussion are recommended.
Bridging stents (covered balloon‑ or self‑expandable stents) used to connect fenestrations/branches to target vessels are an integral component of F‑/bEVAR; selection of bridging stent type should follow available device data and institutional practice, and their use is appropriate when needed to preserve visceral/renal perfusion as part of the overall repair.

Operational note

When fenestrated/branched devices or bridging stents are used, documentation should include anatomic rationale, device model/manufacturer, indication that device use follows FDA approval/IDE protocol or is part of an approved clinical study, and a plan for post‑procedure surveillance and management of branch complications.

Contextual evidence

NICE and other international assessments note limited comparative high‑quality evidence for complex EVAR; recommend performing complex EVAR within RCTs when feasible. Costs of FEVAR/bEVAR are often higher than OSR with uncertain long‑term cost‑effectiveness.

Bridging stents — evidence summary

Recent comparative series of VBX balloon‑expandable versus covered self‑expandable stents used as bridging stents reported high primary patency (~98% at 24 months) and low branch‑related complications in experienced centers; larger multicenter and longer‑term data are needed to confirm durability.

CONTEXTUAL CONSIDERATIONS

Contextual coverage considerations for fenestrated, branched, and multi‑branched EVAR — required conditions and contextual elements:

ALL of the following

Complex endovascular repairs should be performed in high‑volume aortic centers with multidisciplinary teams (vascular surgery, interventional radiology/cardiology, anesthesiology) experienced in device selection, implantation, and post‑operative management.
Use of physician‑modified endografts (PMEG) or in‑situ fenestration is considered off‑label; restrict these techniques to emergent bailout situations or within approved investigational protocols with informed consent and institutional oversight.
Long‑term follow‑up and participation in registries or trials is encouraged to capture outcomes, reintervention rates, branch‑patency, endoleaks, and device durability.

Patient selection

FEVAR/bEVAR is typically reserved for patients who are high risk for open repair or whose anatomy precludes standard EVAR; open repair remains the gold standard for juxtarenal aneurysms in patients who are good operative candidates.

No explicit coverage criteria in provided text

Some topics covered in background evidence (for example, total endovascular aortic arch repair, PMEGs, and certain emerging devices) did not have discrete, standalone coverage criteria stated in source excerpts; determination of coverage for these should follow FDA labeling, institutional policy, and existing medical necessity principles.

Coding — CPT, HCPCS, ICD-10 and Key Procedural Thresholds

Covered CPT Codes (if selection criteria met)CPTCovered

33880	Endovascular repair of descending thoracic aorta; involving coverage of left subclavian origin, initial endoprosthesis plus extensions as required to celiac origin
33881	Endovascular repair of descending thoracic aorta; not involving coverage of left subclavian origin, initial endoprosthesis plus extensions as required to celiac origin
33883	Placement of proximal extension prosthesis for endovascular repair of descending thoracic aorta; 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, transcervical retropharyngeal carotid-carotid, performed in conjunction with endovascular repair of descending thoracic aorta, by neck incision
34701	Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft including pre-procedure sizing and device selection
34702	Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft (additional code range)
34703	Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-bi-iliac endograft including pre-procedure sizing and device selection

1–10 of 43

1/5

CPT/Procedures not covered for CPB indicationsCPTNot Covered

Bifurcated-bifurcated aneurysm repair	Listed as not covered per policy (procedure description)
Endovascular aneurysm sealing system (Nellix device)	Not covered; device/procedure considered experimental/investigational
Total endovascular aortic arch repair	No specific code; not covered for indications listed in the CPB

HCPCS not coveredHCPCSNot Covered

M0301

Fabric wrapping of abdominal aneurysm - not covered

ICD-10 codes covered if selection criteria are metICD-10Covered

A52.01	Syphilitic aneurysm of aorta
I71.01	Dissection of aorta, thoracic
I71.02	Dissection of aorta, abdominal
I71.1	Thoracic aortic aneurysm, ruptured (example within I71.01-I71.62 range)
I72.3	Aneurysm of iliac artery

ICD-10 codes not covered for indications listed in the CPBICD-10Not Covered

M31.4	Aortic arch syndrome [Takayasu] - not covered
T82.330A	Leakage of aortic (bifurcation) graft (initial encounter) - not covered for preoperative IMA embolization
T82.330S	Leakage of aortic (bifurcation) graft (sequela) - not covered for preoperative IMA embolization

Procedural codes (not listed)mixed

37242

Vascular embolization or occlusion, arterial, other than hemorrhage or tumor (e.g., for embolization of the inferior mesenteric artery) - listed as related CPT

Devices referencedmixed

ZFEN	Fenestrated endovascular stent graft device (device reference included in coding block)

Placeholder - no codes listed in excerptmixed

No codes listed

inv-42/43/44/45/46/47/48/49: Key Procedural Thresholds

Minimum infrarenal non-aneurysmal neck length for conventional endovascular grafts>= 15 mm

Aneurysm diameter threshold for elective repair>= 5 cm (or 4-5 cm with 0.5 cm growth in 6 months)

Body weight for endovascular stenting for coarctation>= 25 kg

Resting arm-leg pressure gradient for coarctation stenting> 20 mmHg

Serum creatinine — preoperative lab risk indicator> 1.5 mg/dL

Inferior mesenteric artery diameter for consideration of pre-op embolization> 3 mm

Translesional pressure gradient (coarctation)> 20 mm Hg

Minimum body weight for standard stent implantation>= 25 kg (treatment generally not advised < 25 kg)

Provider Actions — Authorization, Documentation, and Clinical Considerations

Prior Authorization

Obtain prior authorization for covered endovascular repair codes

Prior authorization is implied for listed covered CPT/HCPCS codes for endovascular repair; providers should obtain authorization for the planned endovascular repair procedure and associated imaging codes and include evidence that selection criteria are met.

Obtain prior authorization for covered endovascular repair CPT/HCPCS codes and associated imaging codes.
Include documentation that the case meets selection criteria in the policy (e.g., FDA-approved device, anatomic suitability, clinical indications).

Prior Authorization

Confirm device labeling and anatomical suitability in authorization

Prior authorization should confirm that the selected device is indicated and that the patient's anatomy meets the device labeling (for example, GORE TAG criteria: adequate iliac/femoral access; aortic inner diameter 23–27 mm; ≤2 cm non-aneurysmal proximal and distal landing zones).

Document device make/model and that anatomy matches FDA/PMA labeling criteria (access, diameters, landing zone lengths).
If device use is outside labeling, provide justification and supporting evidence.

Documentation Required

Document anatomic suitability and fitness for open repair

Authorization requests should document anatomic suitability for the intended endovascular approach and the patient's fitness for open repair; if EVAR/FEVAR/TEVAR is proposed because the patient is unfit for open surgery, that determination must be specified.

Provide CT angiography measurements (neck length, diameters, access vessel adequacy) demonstrating anatomic suitability.
Include clinical assessment documenting fitness or unfitness for open repair and multidisciplinary input when relevant.

Prior Authorization

Document rationale for fEVAR/bEVAR in authorization request

For fenestrated and branched endovascular repairs, prior authorization should include documentation of indication, anatomic suitability, and rationale given higher costs and differing perioperative and longer-term outcomes compared with open repair.

State why fEVAR/bEVAR is preferred over open surgical repair (e.g., patient high operative risk or anatomy precluding OSR).
Include data on anticipated risks, need for re-intervention, and center experience.

Prior Authorization

Authorize fenestrated/novel devices with investigational context documented

Prior authorization for off-the-shelf or novel fenestrated endografts (e.g., Zenith p-Branch) may be required and should indicate investigational or center-series use with supporting documentation.

Specify whether device is off-the-shelf, custom, or used investigationally and provide supporting investigational/center series data if available.
Document center experience and patient selection criteria used.

Documentation Required

Document investigational device status and trial participation

Fenestrated and branched grafts have been considered investigational in some U.S. references and were evaluated in clinical trials; authorization should document device trial status and whether use is within an IDE or investigational protocol.

If device use is part of a trial (IDE), include trial identifier and protocol-based imaging/follow-up requirements.
If considered investigational, provide justification for case-level review.

Prior Authorization

Use device trial eligibility criteria in authorization documentation

Authorization decisions may require documentation that the patient meets device-specific trial inclusion criteria (for example, inclusion criteria used in the Nellix IDE: neck length ≥10 mm, angulation ≤60°, specified iliac and access vessel diameters).

List device-specific anatomical thresholds and show measured values from pre-procedure imaging.
If criteria are not met, provide clinical justification for off-label or compassionate use.

Prior Authorization

Document justification when proposing single‑stage hybrid repair

When a single-stage hybrid repair is proposed for thoraco-abdominal aneurysms, authorization should document why staged repair is not feasible given meta-analysis data showing higher 30-day mortality with single-stage approaches.

Provide clinical urgency or high rupture risk justification if deviating from a staged approach.
Include evidence of multidisciplinary consensus for single-stage strategy.

Prior Authorization

Verify indication criteria and multidisciplinary decision in authorization

Authorization should confirm that invasive treatment criteria are met (e.g., translesional pressure gradient >20 mm Hg and/or evidence of significant collateral vessels) and that the choice of open versus endovascular therapy was made by a multidisciplinary team.

Include measured translesional gradient and imaging showing collateral circulation when applicable.
Attach multidisciplinary team documentation (surgeon, interventionalist, cardiologist/radiologist).

Prior Authorization

Expect device-specific review for custom/off‑the‑shelf arch devices

Device-specific and custom or off‑the‑shelf arch devices and IDE study participation are described in the policy; authorization requests for such devices will likely require case-level, device-specific review.

Provide device details (custom vs off‑the‑shelf), anatomic suitability for arch repair, and any IDE/trial identifiers.
Expect case-level review for custom patient-specific arch branch devices.

Note

No additional prior authorization details in policy history pages

The policy history and final pages do not specify additional prior authorization processes; providers should follow standard payer prior authorization channels and include the supporting documentation outlined in the policy.

Follow payer-specific prior authorization submission processes; include selection-criteria documentation, device information, and imaging.
If guidance is needed, contact the payer's clinical review team for case-level instructions.

Note

Step Therapy

Step therapy not specified

No step-therapy sequencing requirements are specified in these policy sections; step therapy does not apply based on the presented text.

Do not assume any mandated sequential trial of alternative procedures is required unless payer-specific step-therapy rules are issued separately.

Step Therapy

Consider open repair first for fit patients

Evidence suggests EVAR reduces perioperative (30-day) mortality versus open repair but may increase re-interventions and costs; authorization and treatment planning should consider offering open repair first for patients who are fit surgical candidates.

Document why EVAR is chosen over open repair when the patient is fit for open surgery.
Include risk-benefit discussion and cost-effectiveness considerations in the record.

Step Therapy

Consider OSR before fEVAR/bEVAR when appropriate

When open surgical repair is a viable option, consider OSR prior to fenestrated/branched EVAR because comparative effectiveness and cost data for fEVAR/bEVAR are limited; document rationale if fEVAR/bEVAR is selected instead.

Provide documentation of why OSR is unsuitable or higher risk in this patient if electing fEVAR/bEVAR.
Include center experience and evidence supporting the chosen approach.

Step Therapy

Consider and document IMA embolization before EVAR when indicated

Pre-operative inferior mesenteric artery (IMA) embolization may be considered to reduce type II endoleak for patients with IMA > 3 mm; if performed or proposed, include supporting imaging and rationale in authorization and operative documentation.

Document IMA diameter (>3 mm) and rationale for embolization prior to EVAR.
Include evidence cited (meta-analysis/institutional data) when requesting coverage.

Documentation Required

Document consideration of open repair and rationale for fenestrated/branched repair

Document that treatment selection considered open surgical repair as the standard option, and that fenestrated/branched endovascular repair was chosen for patients at high surgical risk or unsuitable anatomy.

Include assessment of operative risk, comorbidities, and why endovascular repair is preferred.
Reference center experience and available outcome data when relevant.

Documentation Required

Document that alternatives were considered when evidence is limited

When evidence is limited for a novel or complex endovascular procedure, documentation should show that alternative standard therapies were considered and why they were not appropriate.

Provide comparative discussion of available options (OSR, standard EVAR, surveillance) and reasons for choosing the proposed intervention.
Attach relevant multidisciplinary consultation notes.

Prior Authorization

Prefer staged repair and document rationale if single-stage hybrid repair proposed

For elective thoraco-abdominal aneurysm repairs, staged repair is preferred when clinically feasible; authorization for single-stage hybrid repair must document high rupture risk or rationale for deviation from staged approach due to higher 30-day mortality with single-stage repair.

If proposing single-stage repair, include data supporting urgency and multidisciplinary justification.
Document plans for interval monitoring if staging is chosen.

Step Therapy

Consider surgical-first approach where standard (especially in infants)

Open surgical repair remains the gold standard for some patient groups (e.g., infants); endovascular therapy should be reserved for older children, adults, or repeat interventions and documentation must reflect this consideration.

For pediatric patients, document body weight and explain deviation from surgical-first approach if endovascular therapy is proposed.
Include device/size limitations and long-term planning considerations for growth when applicable.

Note

Billing Rule

Use coding lists to support claims when criteria are met

Use the provided CPT/HCPCS/ICD-10 coding lists to support claims when selection criteria are met; include radiological supervision and interpretation codes and any procedure-specific planning codes as applicable.

Select the covered CPT/HCPCS/ICD codes that correspond to the performed procedure(s) only when documentation shows selection criteria are satisfied.
Include radiology and planning codes (e.g., 75956–75959, 71260, 74174) as relevant.

Documentation Required

Document device model, justification, and anatomical measurements

Required documentation for authorization and claims should include device model and justification, anatomical measurements (aortic diameter, proximal/distal landing zone lengths, access vessel adequacy), intraoperative findings (endoleak detection), and any applicable training or study participation.

Attach pre-procedure CT angiography measurements and intraoperative reports including endoleak assessment.
Document device make/model, reason for device selection, and any IDE or post‑approval study enrollment.

Documentation Required

Record preoperative labs (e.g., creatinine >1.5 mg/dL) in the record

Document preoperative laboratory risk indicators such as serum creatinine >1.5 mg/dL, reduced GFR, or low hemoglobin, as these predict increased perioperative mortality and may affect risk assessment and authorization.

Include most recent serum creatinine, estimated GFR, and hemoglobin in pre-op documentation.
Discuss how abnormal results influenced perioperative planning or decision to proceed.

Documentation Required

Document CT surveillance at 1, 6, 12 months then annually

Document CT surveillance imaging at 1 month, 6 months, and 12 months after repair, then annually thereafter, as used in studies and recommended by MedSolutions.

Schedule and record CT/CTA at discharge (if applicable), 1 month, 6 months, 12 months, then annually.
Include imaging reports in the longitudinal record to support ongoing coverage and follow-up care.

Documentation Required

Document prospective follow-up with clinical and imaging studies

Follow-up documentation should include clinical exam, laboratory studies, duplex ultrasound, and CT imaging at discharge, 1 month, 6 months, and yearly to monitor patency, endoleak, and need for re-intervention.

Include prospective follow-up imaging and clinical assessments per reported series.
Record any re-interventions, branch patency, and endoleak status in follow-up notes.

Documentation Required

Adhere to IDE imaging schedule and document for Nellix EVAS cases

For Nellix EVAS IDE cases, follow the IDE protocol and document pre- and scheduled post-procedure CT angiography at 30 days, 6 months, and 1 year with core lab evaluation as required.

Include core-lab–evaluated CTA results at 30 days, 6 months, and 1 year when submitting IDE-supported cases.
Attach trial enrollment information and adherence to IDE imaging schedules.

Documentation Required

Document rationale and findings when using intra‑operative CT

When intra-operative CT is used to detect technical complications during EVAR, document the clinical rationale for intra‑operative CT and its findings to justify its use and any change in follow-up imaging.

Record why intra-operative CT was chosen over completion angiography and summarize key findings.
Include intra-op CT images/reports in the medical record for claim support.

Documentation Required

Provide precise MDCT/MRI vascular imaging pre-procedure

Obtain mandatory pre-procedure precise vascular imaging (multi-detector CT or MRI) to evaluate the thoracic aorta, branches, and collateral vessels and include these images/reports with authorization and operative records.

Attach MDCT or MRI vascular imaging demonstrating anatomy and measurements used for device selection.
Ensure imaging supports measured gradients or collateral assessments when relevant.

Documentation Required

Include IDE study data and procedural metrics for novel devices

When requesting authorization for novel devices, include IDE study data and procedural metrics (technical success, operating and fluoroscopy times, radiation dose) and follow-up patency/outcome measures as available.

Submit available prospective or IDE study outcomes and technical performance metrics to support device use.
Include planned follow-up and outcome measurement strategy.

Note

No provider submission instructions in this excerpt — follow payer processes

This section of the document does not include specific provider submission instructions for documentation; follow payer-specific submission portals and include the supporting documentation items cited in the policy.

Use payer prior authorization forms/portals and attach imaging, device info, and clinical rationale.
Contact the payer's clinical review team for any case-level questions.

Note

Denial Risk

Experimental or investigational procedures are at risk for denial

Procedures listed as experimental or investigational (including intra‑operative CT for EVAR, Nellix EVAS, bifurcated-bifurcated repair, fabric wrapping, implanted wireless pressure sensors, pre-operative IMA embolization, and total endovascular aortic arch repair) are at risk for denial when submitted for coverage outside investigational or trial contexts.

If proposing any listed experimental/investigational procedure, include trial/IDE enrollment or strong justification with supporting evidence.
Expect case-level review and potential denial if procedure is not part of an approved investigational protocol.

Denial Risk

Off‑label device use outside labeled anatomy may lead to denial

Use of devices outside labeled anatomical criteria (e.g., inadequate iliac/femoral access, aortic diameter outside approved range, insufficient non-aneurysmal landing zones) may fall outside FDA PMA indications and could trigger coverage denial if not justified.

Provide imaging measurements that demonstrate compliance with the device's labeled anatomical criteria.
If off-label use is necessary, include detailed justification and supporting literature or trial enrollment.

Denial Risk

Lack of demonstrated long‑term benefit or cost‑effectiveness may trigger scrutiny

Authorization may be affected by lack of long-term benefit or unfavorable cost-effectiveness data; when EVAR/fEVAR/bEVAR is chosen, document expected benefits and cost considerations relative to open repair.

Provide rationale addressing long-term benefit uncertainty and cost implications when requesting authorization.
Include patient-specific factors that support the chosen approach despite cost concerns.

Denial Risk

Anatomic/surveillance contraindications may lead to denial

Endovascular repair is contraindicated and may be denied if the patient does not meet anatomic criteria required for available endografts (eg, suprarenal/juxtarenal anatomy, small caliber or excessively tortuous access vessels, circumferential aortic calcification) or cannot comply with required post‑EVAR surveillance.

Ensure pre-procedure imaging documents that anatomy is compatible with available endografts.
Document ability and plan for post‑EVAR surveillance to avoid coverage issues.

Denial Risk

In-situ fenestration off‑label use risks non‑coverage

In-situ fenestration is off-label and should not be used outside emergent bailout techniques or investigational studies; use outside those contexts risks non-coverage or denial.

If ISF is used as an emergent bailout, document the emergent indication and that alternative options were not feasible.
For investigational use, include IRB/IDE approval or trial enrollment.

Denial Risk

Evidence limitations and failure to meet trial criteria may trigger denial

Lack of high-quality comparative evidence or failure to meet clinical trial inclusion criteria may adversely affect medical necessity determinations and lead to denial for complex or novel procedures.

Provide comparative evidence or clinical trial enrollment details when available to support requests.
If evidence is limited, include detailed patient-specific justification and multidisciplinary endorsements.

Denial Risk

NICE recommendation may influence authorization for complex EVAR

NICE recommended that complex EVAR not be performed outside randomized controlled trials due to very limited evidence; payers may apply similar caution when reviewing complex EVAR authorizations.

When proposing complex EVAR, include any trial enrollment or justification aligning with guideline cautions.
Anticipate case-level review for complex EVAR requests.

Denial Risk

CSFD complication risk — document indication and technique

Use of cerebrospinal fluid drainage (CSFD) carries non-negligible risks (intracranial hemorrhage, spinal hematoma, paraplegia); inadequate documentation of indication, technique, or imaging guidance may lead to review or denial of related procedure claims.

Document the indication for CSFD, technique used, use of fluoroscopic guidance if performed, and any complications.
Include risk-benefit discussion and multidisciplinary input in the record.

Denial Risk

Size/weight limits (avoid stents <25 kg) — document if exception proposed

Stent implantation is generally not advised for patients weighing less than 25 kg due to sheath/access size and aortic growth considerations; performing stent implantation in very small patients may lead to denial if outside indicated settings.

Confirm and document patient body weight (≥25 kg) when proposing stent implantation for coarctation.
If treating a smaller patient, provide justification and note elevated procedural risks.

Note

Background — Clinical Context and Evidence Summary

Abdominal aortic aneurysms (AAAs) are the most common aortic aneurysm and carry a risk of rupture that increases with aneurysm diameter (rupture is rare below <5 cm and rises substantially above 6 cm). Endovascular repair (EVAR) is a less invasive alternative to open surgical repair and is generally considered for aneurysms that meet size and anatomic thresholds; conventional endografts typically require a minimum infrarenal non‑aneurysmal neck length of ≥ 15 mm and elective repair thresholds are generally considered at > 6 cm or earlier for select candidates with 5–6 cm aneurysms depending on surgical fitness. Surveillance remains the preferred approach for small asymptomatic AAAs (4.0–5.5 cm) based on randomized trial data.

Definitions and Terminology

Fenestrated/branched stent graft

Fenestrated/branched stent graft definitionA customized endovascular graft with fenestrations or branches to maintain perfusion to visceral or renal arteries for treatment of juxtarenal, pararenal, or thoracoabdominal aneurysms

Device statusFenestrated and branched devices are commercially available in some countries but considered investigational in the U.S. in many contexts

PurposeUsed when standard infrarenal EVAR is unsuitable due to inadequate neck length or branch vessel involvement

Endoleak

Endoleak definitionPersistent blood flow outside the graft but within the aneurysm sac after endovascular repair

Clinical significanceIndicator of incomplete aneurysm exclusion; associated with sac expansion and may prompt surveillance or intervention

Type II specificT2L arises from retrograde flow (eg, lumbar or inferior mesenteric arteries) and may be managed conservatively or with embolization if sac growth occurs

GORE TAG indications (example)

GORE TAG example indicationApproved for descending thoracic aneurysms with adequate iliac/femoral access, aortic inner diameter 23–27 mm, and ≤2 cm non-aneurysmal proximal and distal landing zones

Device characteristicsGraft made of ePTFE with nitinol support, inserted via femoral access

Clinical implicationPrior authorization should confirm device labeling and anatomical suitability per these criteria

FEVAR

FEVAR definitionFenestrated endovascular aneurysm repair — endograft modified with fenestrations to accommodate branch vessels for pararenal/juxtarenal AAAs

Use casesUsed when aneurysm involves renal or visceral branches and standard infrarenal EVAR is unsuitable

Outcomes summaryFEVAR shows high technical success (~90–99%) and low early mortality but notable reintervention and renal impairment rates in mid-term follow-up

TEVAR

TEVAR definitionThoracic endovascular aortic repair — endovascular stent grafting of thoracic aortic aneurysms, including ruptured descending thoracic aortic aneurysms

Device exampleZenith Alpha thoracic endovascular graft FDA-approved for selected descending thoracic lesions with defined access and fixation site criteria

Clinical noteTEVAR offers less invasive option for thoracic aneurysms but carries risks including neurologic complications and endoleak

FEVAR / fEVAR

FEVAR / fEVAR explanationFenestrated EVAR uses grafts with fenestrations to preserve flow to visceral/renal branches for juxtarenal/pararenal AAAs when standard EVAR is unsuitable

IndicationConsidered for patients at high operative risk or with anatomy precluding standard EVAR

Evidence noteComparative long-term outcomes versus open repair remain limited; selection influenced by center experience

Branched (bEVAR) definition

bEVAR / multi-branched stent-grafts definitionBranched endovascular repair using stent-grafts with branches to revascularize visceral arteries for thoracoabdominal aortic aneurysms

OutcomesReported high technical success in experienced centers but notable rates of spinal cord ischemia, renal insufficiency, and re-intervention

Use contextOften reserved for complex aneurysms in centers with specialized expertise

Type II endoleak (T2L)

Type II endoleak (T2L) definitionEndoleak resulting from retrograde flow into the aneurysm sac from branch vessels (eg, lumbar or inferior mesenteric arteries)

Clinical impactCommon complication after EVAR; may cause sac growth and lead to re-intervention in a subset of patients

Management considerationObservation vs embolization depending on sac growth; IMA embolization may reduce T2L incidence when IMA > 3 mm

F-BEVAR / Combined fenestrated & branched repair

F-BEVAR / FEVAR combined definitionCombined fenestrated and branched endovascular repair techniques using customized or manufactured endografts with fenestrations and/or branches to preserve visceral/renal perfusion

Clinical useApplied for complex juxtarenal, pararenal, and thoracoabdominal aneurysms in experienced centers

Outcome noteHigh technical success benchmarks (>98% in some series) but variable mid-term reintervention and complication rates

In‑situ fenestration (ISF)

In-situ fenestration (ISF) definitionAn off-label in-vivo technique creating fenestrations in standard endografts to maintain perfusion to aortic side branches

Recommended settingShould be limited to emergent bailout situations or investigational studies; not for routine use

OutcomesShort-term results show technical feasibility (~93% artery success) but long-term data scarce

Fenestrated/Branched endografts

Fenestrated/Branched Endografts definitionCustom or manufactured endovascular stent-grafts with fenestrations or branches to preserve flow to visceral aortic branches for repair of juxtarenal and thoracoabdominal aneurysms

Regulatory statusAvailable commercially in some regions; investigational context in U.S. often requires trial or case-level review

Clinical implicationUse usually limited to specialized centers with documented follow-up and imaging surveillance

Physician‑Modified Endografts (PMEG)

Physician-Modified Endografts (PMEG) definitionCommercial stent-grafts modified by physicians to create fenestrations or branches when commercially available devices are not used

Outcome considerationsReported outcomes may differ from manufactured FEVAR; some analyses show similar perioperative mortality but potential higher long-term risk

Use contextOften employed when custom devices unavailable; may require IDE or investigational oversight in some settings

TUTE

TUTE (Time until Treatment Equipoise)A modeling metric comparing time to equalized outcomes between treatment modalities (reported for OSR, TEVAR, B/FEVAR)

Reported valuesExamples: TUTE for OSR 2.7 y, TEVAR 9.9 mo, B/FEVAR 10.3 mo (from systematic review context)

PurposeHelps interpret early vs later trade-offs between procedural risks and long-term outcomes

EVAS (Nellix example)

EVAS (Endovascular Aneurysm Sealing) definitionTechnique using polymer-filled EndoBags surrounding endograft lumens to seal the aneurysm sac (example: Nellix device)

StatusNellix has had post-market and IDE trial experience but is considered experimental/investigational in this policy

Clinical notePromising short-term technical success reported but long-term durability concerns exist

Cerebrospinal fluid drainage (CSFD)

CSFD definitionCerebrospinal fluid drainage (spinal drain) placed pre-operatively to reduce cerebrospinal fluid pressure and potentially lower risk of spinal cord ischemia

PurposeUsed during complex thoracic/thoracoabdominal endovascular repairs to reduce risk of spinal cord ischemia

Complication riskAssociated with notable complications (intracranial hemorrhage, spinal hematoma, technical difficulties); reported severe/moderate complication rate ~9% in series

CSFD — complications and guidance

CSFD further contextWhile CSFD can reduce spinal cord ischemia, one-third of observed SCIs in a series were attributed to CSFD placement; fluoroscopic guidance reduced technical difficulties

RecommendationDocument indication, technique, and imaging guidance to justify use and reduce complication risk

EvidenceVQI analysis and prospective series provide mixed results; balance benefits vs risks

EVAR vs OSR — mortality considerations

EVAR vs OSR phase-specific mortalityEVAR has lower peri-operative (30-day) mortality but may have higher mid-term mortality compared with open repair

ImplicationConsider peri-operative benefit vs potential mid-term risk when selecting repair modality

SurveillanceLong-term follow-up and imaging required due to reintervention risk after EVAR

ChEVAR (chimney/snorkel)

ChEVAR definitionChimney/snorkel EVAR technique using parallel grafts to preserve flow to visceral/branch vessels when proximal seal zone is inadequate

Use caseEmployed for symptomatic or ruptured AAAs with proximal aortic zone disease (zones 6–9) when performed in capable centers

Durability noteHigh peri-operative morbidity and long-term durability uncertain; document rationale for technique selection

Bridging stents (VBX vs SES)

Bridging stent types (VBX vs SES)VBX = balloon-expandable covered stent; SES = covered self‑expandable stent used as bridging stents in fenestrated/branched repairs

PerformanceReported 24-month primary patency >98% for both VBX and SES in high-volume centers

Selection considerationChoice of bridging stent should consider vessel target, operator experience, and published patency outcomes

TEAAR

TEAAR definitionTotal endovascular aortic arch repair — endovascular placement of branched or fenestrated stent grafts to treat aortic arch pathology in patients at prohibitive risk for open surgery

Early outcomesReported procedural success ~93% with notable early mortality (~16%) and stroke (~14%) rates

Use cautionConsider only in experienced centers with patient counseling about early outcomes and risks

Patient‑specific arch branch stent graft

Patient‑specific arch branch stent graft definitionCustom stent‑graft with tailored scallops/branches and pre‑loaded catheters to accommodate supra‑aortic branch revascularization (e.g., LSA branch)

Use caseUsed in selected patients requiring proximal extension into the arch where off‑the‑shelf devices are unsuitable

EvidenceEarly feasibility cohorts report technical success but larger studies with longer follow-up needed

Revision History and References

2003-01-17policy_effective

Policy effective date as shown in policy metadata.

2023-09-14policy_reviewLatest

Policy underwent last review on 09/14/2023.

Policy metadata: Last review date: 09/14/2023; Effective date: 01/17/2003; Next review scheduled: 07/11/2024. The policy includes an extensive reference list (approximately 174 citations) supporting background, device‑specific, and comparative evidence; see the references section for source details.

The policy’s reference list spans multiple systematic reviews, randomized trials, device studies, and guideline assessments. References are compiled in the policy document (see chunks containing references) and number approximately 118–174 across the final reference pages; these support the coverage determinations and evidence summaries cited elsewhere in the policy.