392 Form

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Medical Policy Transcatheter Aortic Valve Implantation for Aortic Stenosis Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 392

BCBSA Reference Number: 7.01.132 (For Plan internal use only)

Related Policies
Transcatheter Pulmonary Valve Implantation, #403 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Transcatheter aortic valve replacement with a U.S. Food and Drug Administration (FDA)‒approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA-approved labeling, may be considered MEDICALLY NECESSARY for individuals with native valve aortic stenosis when all of the following conditions are present:

• Severe aortic stenosis (see policy guidelines section) with a calcified aortic valve; AND • New York Heart Association heart failure class II, III, or IV symptoms; AND • Individual does not have unicuspid or bicuspid aortic valves.

Transcatheter aortic valve replacement with a transcatheter heart valve system approved for use for repair of a degenerated bioprosthetic valve (valve-in-valve) may be considered MEDICALLY NECESSARY when all of the following conditions are present:

• Failed (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve; AND
• New York Heart Association heart failure class II, III or IV symptoms; AND
• Individual is not an operable candidate for open surgery, as documented by at least 2 cardiovascular specialists including a cardiac surgeon); OR individual is an operable candidate but is considered at increased surgical risk for open surgery, as documented by at least 2 cardiac specialists (including a cardiac surgeon); OR individual is considered at increased surgical risk for open surgery (e.g. repeat sternotomy) due to a history of congenital vascular anomalies AND/OR has a complex intrathoracic surgical history, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon) (see Policy Guidelines section).

Transcatheter aortic valve replacement is considered INVESTIGATIONAL for all other indications.

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Use of a cerebral embolic protection device (e.g., Sentinel) during transcatheter aortic valve replacement procedures is considered INVESTIGATIONAL.

Policy Guidelines The FDA definition of extreme risk or inoperable for open surgery is:
• Predicted risk of operative mortality and/or serious irreversible morbidity 50% or higher for open surgery.

The FDA definition of high risk for open surgery is:
• Society of Thoracic Surgeons (STS) predicted operative risk score of 8% or higher; or
• Judged by a heart team, which includes an experienced cardiac surgeon and a cardiologist, to have an expected mortality risk of 15% or higher for open surgery.

The FDA definition of intermediate risk is:
• STS predicted operative risk score of 3% to 7%.

Individuals with STS predicted operative risk score of less than 3% or 4% are considered at low risk for open surgery.

Some patients being considered for valve-in-valve transcatheter aortic valve replacement may be deemed at increased surgical risk for open surgery despite low-to-moderate STS risk scores. This may include individuals with advanced age, complex intrathoracic histories, congenital cardiac anomalies, liver disease, or other extreme comorbid conditions not accurately captured by STS risk scores as documented by at least 2 cardiovascular specialists, including a cardiac surgeon.1,2,

*For the use of the Sapien or CoreValve devices, severe aortic stenosis is defined by the presence of one or more of the following criteria:
• An aortic valve area of less than or equal to 1 cm2 • An aortic valve area index of less than or equal to 0.6 cm2/m2 • A mean aortic valve gradient greater than or equal to 40 mm Hg • A peak aortic-jet velocity greater than or equal to 4.0 m/s.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This procedure is performed in the inpatient setting. Commercial PPO and Indemnity This procedure is performed in the inpatient setting. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. The following codes are included below for informational purposes only; this is not an all-inclusive list.

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The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity: CPT Codes
CPT
codes:

Code Description 33361 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach 33362 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach 33363 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach 33364 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach 33365 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy) 33366 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (eg, left thoracotomy) 33367 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (eg, femoral vessels) (List separately in addition to code for primary procedure) 33368 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure) 33369 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure)

ICD-10 Procedure Codes ICD-10-PCS procedure codes: Code Description 02RF0JZ Replacement of Aortic Valve with Synthetic Substitute, Open Approach 02RF3JZ Replacement of Aortic Valve with Synthetic Substitute, Percutaneous Approach 02RF4JZ Replacement of Aortic Valve with Synthetic Substitute, Percutaneous Endoscopic Approach

The following CPT code is considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes
CPT
codes:

Code Description 33370 Transcatheter placement and subsequent removal of cerebral embolic protection device(s), including arterial access, catheterization, imaging, and radiological supervision and interpretation, percutaneous (List separately in addition to code for primary procedure)

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Description Aortic Stenosis Aortic stenosis is defined as narrowing of the aortic valve opening, resulting in obstruction of blood flow from the left ventricle into the ascending aorta. Progressive calcification of the aortic valve is the most common etiology in North America and Europe, while rheumatic fever is the most common etiology in developing countries.3, Congenital abnormalities of the aortic valve, most commonly a bicuspid or unicuspid valve, increase the risk of aortic stenosis, but aortic stenosis can also occur in a normal aortic valve. Risk factors for calcification of a congenitally normal valve mirror those for atherosclerotic vascular disease, including advanced age, male gender, smoking, hypertension, and hyperlipidemia. 3, Thus, the pathogenesis of calcific aortic stenosis is thought to be similar to that of atherosclerosis (ie, deposition of atherogenic lipids and infiltration of inflammatory cells, followed by progressive calcification).

The natural history of aortic stenosis involves a long asymptomatic period, with slowly progressive narrowing of the valve until the stenosis reaches the severe stage. At this time, symptoms of dyspnea, chest pain, and/or dizziness/syncope often occur, and the disorder progresses rapidly. Treatment of aortic stenosis is replacement of the diseased valve with a bioprosthetic or mechanical valve.

Disease Burden Aortic stenosis is a relatively common disorder in elderly patients and is the most common acquired valve disorder in the United States. Approximately 2% to 4% of people older than 65 years of age have evidence of significant aortic stenosis,3, increasing up to 8% of people by age 85 years.4, In the Helsinki Aging Study (1993), a population-based study of 501 patients aged 75 to 86 years, the prevalence of severe aortic stenosis by echocardiography was estimated to be 2.9%.5, In the United States, more than 50,000 aortic valve replacements are performed annually due to severe aortic stenosis.

Aortic stenosis does not cause substantial morbidity or mortality when the disease is mild or moderate in severity. By the time it becomes severe, there is an untreated mortality rate of approximately 50% within 2 years.6, Open surgical repair is an effective treatment for reversing aortic stenosis, and artificial valves have demonstrated good durability for up to 20 years.6, However, these benefits are accompanied by perioperative mortality of approximately 3% to 4% and substantial morbidity,6, both of which increase with advancing age.

Unmet Needs Many patients with severe, symptomatic aortic stenosis are poor operative candidates. Approximately 30% of patients presenting with severe aortic stenosis do not undergo open surgery due to factors such as advanced age, advanced left ventricular dysfunction, or multiple medical comorbidities.7, For patients who are not surgical candidates, medical therapy can partially alleviate the symptoms of aortic stenosis but does not affect the underlying disease progression. Percutaneous balloon valvuloplasty can be performed, but this procedure has less than optimal outcomes.8, Balloon valvuloplasty can improve symptoms and increase flow across the stenotic valve but is associated with high rates of complications such as stroke, myocardial infarction, and aortic regurgitation. Also, restenosis can occur rapidly, and there is no improvement in mortality. As a result, there is a large unmet need for less invasive treatments for aortic stenosis in patients at increased risk for open surgery.

Treatment Transcatheter aortic valve implantation, also known as transcatheter aortic valve replacement, has been developed in response to this unmet need and was originally intended as an alternative for patients for whom surgery was not an option due to prohibitive surgical risk or for patients at high-risk for open surgery. The procedure is performed percutaneously, most often through the transfemoral artery approach. It can also be done through the subclavian artery approach and transapically using mediastinoscopy. Balloon valvuloplasty is first performed to open up the stenotic area. This is followed by passage of a bioprosthetic artificial valve across the native aortic valve. The valve is initially compressed to allow passage across the native valve and is then expanded and secured to the underlying aortic valve annulus. The procedure is performed on the beating heart without cardiopulmonary bypass.

Regulatory Status

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Multiple manufacturers have transcatheter aortic valve devices with U.S. Food and Drug Administration (FDA) approval. Regulatory status data for these devices are listed in Table 1.

Table 1. FDA Approved Transcatheter Aortic Valve Device Systems Device and Indication Manufacturer Date Cleared Edwards SAPIEN Transcatheter Heart Valve System™ Severe native aortic valve stenosis determined to be inoperable for open aortic valve replacement (transfemoral approach) Edwards Lifesciences 11/11 Edwards SAPIEN™ Transcatheter Heart Valve, Model 9000TFX Expanded to include high-risk aortic stenosis (transapical approach)

10/12 Edwards SAPIEN XT Transcatheter Heart Valve (model 9300TFX) and accessories Severe native aortic valve stenosis at high or greater risk for open surgical therapy 07/14 Expanded to include failure of a bioprosthetic valve with high or greater risk for open surgical therapy

10/15 Expanded to include severe aortic stenosis with intermediate surgical risk

08/16 SAPIEN 3 THV System, a design iteration Severe aortic stenosis with high or greater risk for open surgical therapy

06/15 Expanded to include failure of a bioprosthetic valve with high or greater risk for open surgical therapy

06/17 SAPIEN 3 Ultra THV System, a design iteration Note: In August 2019, FDA issued a recall for the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (Recall event ID: 83293) due to "reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures".

12/18 Expanded to include severe aortic stenosis with low surgical risk

08/19 Expanded to include failure of a bioprosthetic valve with high or greater risk for open surgical therapy

09/20 Medtronic CoreValve System™ Severe native aortic stenosis at extreme risk or inoperable for open surgical therapy Medtronic CoreValve 01/14 Expanded to include high-risk for open surgical therapy 06/16 Expanded to include intermediate risk for open surgical therapy

07/17 Medtronic CoreValve Evolut R System™ (design iteration for valve and accessories)

06/15 Expanded to include intermediate risk for open surgical therapy 07/17 Medtronic CoreValve Evolut PRO System™ (design iteration for valve and accessories, includes porcine pericardial tissue wrap)

03/17 Expanded to include intermediate risk for open surgical therapy

07/17 Expanded to include severe aortic stenosis with low surgical risk

08/19

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Medtronic CoreValve Evolut PRO+ System™ (design iteration)

08/19 Medtronic Evolut™ FX System (design iteration)

08/21 LOTUS Edge™ Valve System Severe native aortic stenosis at high or greater risk for open surgical therapy See Note Boston Scientific Corporation 04/19 Portico™ with FlexNav™ Severe native aortic stenosis at high or greater risk for open surgical therapy Abbott Medical 09/21 Navitor™ Transcatheter Aortic Valve Implantation System with FlexNav™ Severe native aortic stenosis at high or greater risk for open surgical therapy Abbott Medical 10/23 FDA: U.S. Food and Drug Administration: PMA: premarket approval.

Note: in January 2021, Boston Scientific Corporation announced a global, voluntary recall of all unused inventory of the LOTUS Edge™ Valve System due to complexities associated with the product delivery system.9, There are no safety concerns for patients who have the LOTUS Edge™ Valve System currently implanted. Boston Scientific has chosen to retire the entire LOTUS product platform immediately rather than develop and reintroduce an enhanced delivery system. All related commercial, clinical, research and development, and manufacturing activities will cease.

Other transcatheter aortic valve systems are under development: • JenaValve™ (JenaValve Technology); repositionable valve designed for transapical placement. The FDA granted breakthrough designation to this device system in January 2020. • Acurate™ aortic valve platform (Boston Scientific); designed for individuals with severe aortic stenosis indicated for TAVR who are at low, intermediate, or high risk of operative mortality. The system is CE marked as of 2020 but is not approved for non-investigational use in the US. The pivotal Acurate IDE trial will be completed in 2024 (NCT03735667).

In June 2017, the Sentinel® Cerebral Protection System (Boston Scientific; previously Claret Medical, Inc.) was granted a de novo classification by the FDA (DEN160043; class II; product code: PUM).10, The Sentinel system is a temporary catheter indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 mm to 15 mm for the brachiocephalic and 6.5 mm to 10 mm in the left common carotid. The new classification applies to this device and substantially equivalent devices of this generic type.

On August 3, 2021, the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee met to discuss and make recommendations on the 510(k) submission for the TriGUARD 3™ Cerebral Embolic Protection Device (Keystone Heart).11, With the Sentinel system serving as the predicate device, the panel expressed that the proposed indications for use of the TriGUARD 3 device were not supported by the safety and effectiveness data from the REFLECT II trial. Previously, the TriGUARD 3 device was granted Conformité Européene (CE) mark approval in Europe in March 2020.12,11,

Summary Description Aortic stenosis is narrowing of the aortic valve opening, resulting in obstruction of blood flow from the left ventricle into the ascending aorta. Patients with untreated, symptomatic severe aortic stenosis have a poor prognosis. Valve replacement is an effective treatment for severe aortic stenosis. Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement (TAVR), is being evaluated as an alternative to open surgery for patients with aortic stenosis and to nonsurgical therapy for patients with a prohibitive risk for surgery.

Summary of Evidence

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For individuals who have severe symptomatic aortic stenosis who are at prohibitive risk for open surgery who receive transcatheter aortic valve implantation (TAVI), the evidence includes a randomized controlled trial (RCT) comparing TAVI with medical management in individuals at prohibitive risk of surgery, a single- arm prospective trial, multiple case series, and multiple systematic reviews. Relevant outcomes are overall survival (OS), symptoms, morbid events, and treatment-related mortality and morbidity. For patients who are not surgical candidates due to excessive surgical risk, the Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve (PARTNER B) trial reported on results for patients treated with TAVI by the transfemoral approach compared with continued medical care with or without balloon valvuloplasty. There was a large decrease in mortality for the TAVI patients at 1 year compared with medical care. This trial also reported improvements in other relevant clinical outcomes for the TAVI group. There was an increased risk of stroke and vascular complications in the TAVI group. Despite these concerns, the overall balance of benefits and risks from this trial indicate that health outcomes are improved. For patients who are not surgical candidates, no randomized trials have compared the self-expandable valve with best medical therapy. However, results from the single-arm CoreValve Extreme Risk Pivotal Trial met trialists’ prespecified objective performance goal. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at high-risk for open surgery who receive TAVI, the evidence includes 2 RCTs comparing TAVI with surgical repair in individuals at high-risk for surgery and 1 RCT comparing 2 types of valves, multiple nonrandomized comparative studies, and systematic reviews of these studies. Relevant outcomes are OS, symptoms, morbid events, and treatment- related mortality and morbidity. For patients who are high-risk for open surgery and are surgical candidates, the PARTNER A trial reported noninferiority for survival at 1 year for the balloon-expandable valve compared with open surgery. In this trial, TAVI patients also had higher risks for stroke and vascular complications. Nonrandomized comparative studies of TAVI versus open surgery in high-risk patients have reported no major differences in rates of mortality or stroke between the 2 procedures. Since the publication of the PARTNER A trial, the CoreValve High Risk Trial demonstrated noninferiority for survival at 1 and 2 years for the self-expanding prosthesis. This trial reported no significant differences in stroke rates between groups. An RCT directly comparing the Portico valve with other United States Food and Drug Administration (FDA)-approved valves found an increase in safety outcomes with Portico at 30 days but no major differences at 2 years. Gender-specific meta-analyses have found improved mortality with TAVI compared with surgical aortic valve replacement (SAVR) in women. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at intermediate-risk for open surgery who receive TAVI, the evidence includes 3 RCTs comparing TAVI with surgical repair including individuals at intermediate surgical risk, 2 RCTs only in patients with intermediate-risk, and multiple systematic reviews and nonrandomized cohort studies. Relevant outcomes are OS, symptoms, morbid events, and treatment- related mortality and morbidity. Five RCTs have evaluated TAVI in patients with intermediate-risk for open surgery. Three of them, which included over 4000 patients combined, reported noninferiority of TAVI versus SAVR for their composite outcome measures (generally including death and stroke). A subset analysis of patients (n=383) with low and intermediate surgical risk from a fourth trial reported higher rates of death at 2 years for TAVI versus SAVR. The final study (N=70) had an unclear hypothesis and reported 30-day mortality rates favoring SAVR (15% vs. 2%, p=.07) but used a transthoracic approach. The rates of adverse events differed between groups, with bleeding, cardiogenic shock, and acute kidney injury higher in patients randomized to open surgery and permanent pacemaker requirement higher in patients randomized to TAVI. Subgroup analyses of meta-analyses and the transthoracic arm of the Leon et al (2010) RCT have suggested that the benefit of TAVI may be limited to patients who are candidates for transfemoral access. Although several RCTs have 2 years of follow-up postprocedure, it is uncertain how many individuals require reoperation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at low-risk for open surgery who receive TAVI, the evidence includes RCTs comparing TAVI with surgical repair in individuals selected without specific surgical risk criteria but including patients at low surgical risk and RCTs enrolling only low surgical risk patients, systematic reviews, and nonrandomized cohort studies. Relevant outcomes are OS,

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symptoms, morbid events, and treatment-related mortality and morbidity. Two RCTs (Evolut Low Risk Trial and the Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement [PARTNER 3]) have been conducted exclusively in patients at low surgical risk and 1 RCT, Nordic Aortic Intervention Trial included predominantly patients at low surgical risk. In the Evolut Low Risk Trial, transcatheter aortic valve replacement was noninferior to SAVR with respect to the composite outcome of death or disabling stroke at 24 months. In the PARTNER 3 trial, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVI than SAVR. In the Nordic Aortic Intervention Trial, the risk of the composite outcome of death from any cause, stroke, or myocardial infarction at 5 years was similar for TAVI and SAVR and transcatheter aortic valve replacement showed less structural valve deterioration than SAVR at 6 years. In the publicly sponsored UK TAVI trial, which was conducted in patients aged 70 years or older with predominantly low surgical risk, TAVI was noninferior to SAVR with respect to all-cause mortality at 1 year. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have valve dysfunction and aortic stenosis or regurgitation after open surgical aortic valve repair who receive transcatheter aortic “valve-in-valve” (ViV) implantation, the evidence includes observational studies including registry data with follow-up ranging from 1 month to 5 years and systematic reviews. Relevant outcomes are OS, symptoms, morbid events, and treatment-related mortality and morbidity. Recent meta-analyses of observational studies have compared ViV TAVI to redo-SAVR and have reported a reduced risk of short-term mortality (<30 days) with ViV TAVI. Beyond 30 days, meta- analyses have reported mortality outcomes that were similarly favorable or improved with redo-SAVR. The PARTNER 2 registry reported a 50.6% rate of all-cause mortality after 5 years among patients with high surgical risk; patients who received a 23-mm SAPIEN XT valve had a significantly higher risk of mortality compared to those who received a 26-mm valve (hazard ratio, 1.55; 95% confidence interval, 1.09 to 2.20; p=.01). The CorHealth Ontario Cardiac Registry found that at 5 years after treatment, patients who underwent ViV TAVI had greater overall survival than redo-SAVR in a matched cohort of patients (absolute risk difference, -7.5; 95% CI, -12.6% to -2.3%). The Danish National Patient Registry found that ViV TAVI had similar mortality and rehospitalization outcomes compared to standard TAVI done on a native valve at 1 or 5 years follow-up. Given that no RCTs are available, selection bias cannot be ruled out. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have symptomatic aortic stenosis who receive a cerebral embolic protection (CEP) device while undergoing TAVI, the evidence includes 1 meta-analysis and 4 RCTs of patients with low- to high-risk for open surgery. Relevant outcomes are OS, symptoms, morbid events, and treatment-related mortality and morbidity. One meta-analysis found that patients with CEP had a lower rate of major adverse cardiac events, mortality, and stroke than patients with no CEP at 30 days post-TAVI; no differences were noted in the rate of vascular complications, acute kidney injury, or major life-threatening bleeding. Three RCTs have primarily focused on the number and/or volume of new brain lesions detected on magnetic resonance imaging with unclear correlations to neurocognitive outcomes. Only 1 of these trials (CLEAN-TAVI) found a significant reduction in brain lesion number; however, the relevance of this trial is limited as it used a precursor to the currently marketed Sentinel device. The largest and most recent trial (PROTECTED TAVR) enrolled 3000 patients and did not find a significant reduction in the incidence of periprocedural stroke within 72 hours or before hospital discharge. Prior trials have generally failed to demonstrate neurocognitive protection or significant reductions in major cardiac and cerebrovascular events. Studies have not stratified results by operative risk levels and have suggested differential benefits based on valve type. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information 2024 Input Clinical input was sought to help determine whether the use of transcatheter aortic valve-in-valve (ViV) implantation for individuals who have valve dysfunction and aortic stenosis or regurgitation after open surgical aortic valve repair provides a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was

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received from 4 respondents, including: 3 physician-level responses with academic affiliations identified by specialty medical societies and 1 physician-level response identified by an academic health system. For individuals with valve dysfunction and aortic stenosis or regurgitation after open surgical aortic valve repair, clinical input provides consistent support that the use of transcatheter valve-in-valve implantation provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.

The following patient selection criteria for transcatheter aortic valve replacement (TAVR) with a transcatheter heart valve system approved for use for repair of a degenerated bioprosthetic valve (valve- in-valve) were informed by clinical input and the published evidence: • Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve; AND • New York Heart Association heart failure class II, III, or IV symptoms; AND • Individual is not an operable candidate for open surgery, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon); OR • Individual is an operable candidate but is considered at increased surgical risk for open surgery, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon; see Policy Guidelines section); OR • Individual is considered at increased surgical risk for open surgery (e.g., repeat sternotomy) due to a history of congenital vascular anomalies AND/OR has a complex intrathoracic surgical history, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon).

Respondents noted that there are certain technical impediments that may increase the risk of redo surgical aortic valve replacement (SAVR) that are not captured by STS risk score, including porcelain aorta, prior mediastinal surgeries, patent bypass grafts, or a particularly adherent left internal mammary artery. Additionally, elderly individuals that do not meet high-risk criteria can benefit from the early recovery offered by TAVR. Clinical input also emphasized that there is unlikely to be equipoise for randomization of patients with structural bioprosthetic valve degeneration to aortic valve replacement via any modality versus conservative therapy.

Policy History Date Action 7/2024 Annual policy review. Policy revised. For TAVI and valve-in-valve TAVI, the criterion of left ventricular ejection fraction greater than 20% was removed. A statement was added for consideration of individuals who may be at high risk of open surgery but not demonstrated on Society of Thoracic Surgeons risk score, 'Individual is considered at increased surgical risk for an open surgery (e.g., repeat sternotomy) due to a history of congenital vascular anomalies AND/OR has a complex intrathoracic surgical history, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon). Effective 7/1/2024. 7/2023 Annual policy review. Policy revised. Investigational policy statement added for use of cerebral embolic protection devices in individuals undergoing TAVI. Minor editorial refinements to existing policy statements; intent unchanged. Clarified coding information. Effective 7/1/2023. 3/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 4/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
6/2020 Annual policy review. Medically Necessary policy statement related to patients with native valve aortic stenosis changed to add an exclusion for patients with unicuspid or bicuspid aortic valve and to add an inclusion for patients at low risk for open surgery. Effective 6/1/2020.

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4/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 9/2018 Annual policy review. Policy statements revised to add patients at intermediate surgical risk to first medically necessary statement. Clarified coding information. Effective 9/1/2018. 3/2017 New references added from Annual policy review. 1/2017 Annual policy review. Medically necessary policy statement added for valve-in-valve implantation in patients at high or prohibitive risk for open surgery. Effective 1/1/2017. 3/2015 Annual policy review. Removed statement that procedures performed via the transaxillary, transiliac, transaortic, or other approaches are investigational, to reflect the approval of the CoreValve device that is labeled for use via transaxillary, transfemoral, and transaortic approaches. A statement was added to the policy statement that devices should be used according to their FDA approved indication. Effective 3/1/2015. 5/2014 Annual policy review. New medically necessary indications described. Effective 5/1/2014.
1/2014 Updated to add new CPT code 33366 and removed deleted code 0318T. 6/2013 Annual policy review. New medically necessary and investigational indications described. Effective 6/1/2013. 11/1/2012 New policy describing ongoing coverage and non-coverage. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg. Feb 2021; 111(2): 701-722. PMID 33213826
2. Kumar A, Sato K, Narayanswami J, et al. Current Society of Thoracic Surgeons Model Reclassifies Mortality Risk in Patients Undergoing Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. Sep 2018; 11(9): e006664. PMID 30354591
3. Freeman RV, Otto CM. Spectrum of calcific aortic valve disease: pathogenesis, disease progression, and treatment strategies. Circulation. Jun 21 2005; 111(24): 3316-26. PMID 15967862
4. Coeytaux RR, Williams JW, Gray RN, et al. Percutaneous heart valve replacement for aortic stenosis: state of the evidence. Ann Intern Med. Sep 07 2010; 153(5): 314-24. PMID 20679543
5. Lindroos M, Kupari M, Heikkilä J, et al. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. Apr 1993; 21(5): 1220-5. PMID 8459080
6. Bonow RO, Carabello BA, Kanu C, et al. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation. Aug 01 2006; 114(5): e84-231. PMID 16880336
7. Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?. Eur Heart J. Dec 2005; 26(24): 2714-20. PMID 16141261
8. Lieberman EB, Bashore TM, Hermiller JB, et al. Balloon aortic valvuloplasty in adults: failure of procedure to improve long-term survival. J Am Coll Cardiol. Nov 15 1995; 26(6): 1522-8. PMID 7594080

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9. Food and Drug Administration (FDA). Boston Scientific announces LOTUS Edge aortic valve system voluntary recall and product discontinuation. January 11, 2021. https://www.fda.gov/safety/recalls- market-withdrawals-safety-alerts/boston-scientific-announces-lotus-edgetm-aortic-valve-system- voluntary-recall-and-product. Accessed January 2, 2024.
10. Food and Drug Administration (FDA). De Novo Classification Request for Sentinel Cerebral Protection System. September 19, 2016; https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160043.pdf. Accessed on January 3, 2024.
11. Food and Drug Administration (FDA). 24 Hour Summary of the Circulatory System Devices Panel Meeting - Keystone Heart, Ltd TriGUARD 3 Cerebral Embolic Protection Device. August 3, 2021; https://www.fda.gov/media/151335/download. Accessed January 3, 2024.
12. Aladin AI, Case BC, Wermers JP, et al. Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection. Catheter Cardiovasc Interv. May 2022; 99(6): 1789-1795. PMID 35084082
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