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mp-483

Transcatheter Aortic-Valve Implantation for Aortic Stenosis

Policy Number: MP-483

Latest Review Date: February 2024

Category: Surgery

POLICY:

Effective for dates of service on and after April 15, 2024:

Transcatheter aortic valve replacement with an FDA-approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA-approved labeling, may be considered medically necessary for patients with native valve aortic stenosis when ALL of the following conditions are present:

The individual has severe degenerative, native valve aortic stenosis demonstrated by one of the following:

the aortic valve area (AVA) is equal to or less than 0.8 cm2; or
the AVA index is equal to or less than 0.5 cm2/m2; or
either a mean aortic valve gradient of more than 40 mm Hg; or
a peak aortic-jet velocity of more than 4.0 m/sec;

AND

NYHA [New York Heart Association] heart failure Class II, III or IV symptoms; AND
The individual does not have unicuspid or bicuspid aortic valve
- An echocardiogram, MRI or CT report must be provided confirming the individual has tricuspid morphology of the aortic valve.

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:

Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve; AND
NYHA heart failure class II, III or IV symptoms.

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

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

***For mitral valve replacements, please refer to medical policy 561: Mitral Valve Repair or Replacement.

POLICY GUIDELINES

The performing facility shall be responsible for providing evidence of compliance with all structural and procedural requirements outlined in the section below, including case volumes of interventional cardiologists and cardiovascular surgeons and interventional cardiologists performing the TAVR procedure.

The heart team must include:

Cardiovascular surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:

Independently examined the patient face to face, evaluated the patient’s suitability for SAVR, TAVR or medical or palliative therapy;
Documented and made available to other heart team members the rationale for their clinical judgement.

Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.

The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:

On-site heart valve surgery program,

Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
Appropriate volume requirements per the applicable qualifications below.

There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.

Qualifications to begin a TAVR program for hospitals without TAVR experience:

The hospital program must have the following:

≥ 50 open heart surgeries in the previous year prior to TAVR program initiation, and ;
≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;
≥ 2 physicians with cardiac surgery privileges, and;
≥ 1 physician with interventional cardiology privileges, and;
≥300 percutaneous coronary interventions (PCIs) per year.

Qualifications to begin a TAVR program for heart teams without TAVR experience:

The heart team must include:

Cardiovascular surgeon with:
1. ≥ 100 career open heart surgeries of which ≥ 25 are aortic valve related, and
Interventional cardiologist with:
1. Professional experience with ≥ 100 career structural heart disease procedures; or, 30 left-sided structural procedures per year; and,
2. Device specific training as required by the manufacturer

Qualifications for hospital programs with TAVR experience:

The hospital program must maintain the following:

≥ 50 AVRs (TAVR or SAVR) per year including ≥20 TAVR procedures in the prior year; or,
≥100 AVRs (TAVR or SAVR) every 2 years, including ≥40 TAVR procedures in the prior 2 years; and,
≥ 2 physicians with cardiac surgery privileges; and,
≥ 1 physician with interventional cardiology privileges, and
≥300 percutaneous coronary interventions (PCIs) per year.

The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and, 4) complies with relevant regulations relating to protecting human research subjects, including 45 CFR Part 46 and 21 CFR Parts 50 & 56.

The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:

Stroke;
All cause mortality;
Transient Ischemic Attacks (TIAs);
Major vascular events;
Acute kidney injury;
Repeat aortic valve procedures;
Quality of Life (QoL).

The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions:

When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies?
What is the long term durability of the device?
What are the long term outcomes and adverse events?
What morbidity and procedure-related factors contribute to TAVR patients outcomes?

Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above listed standards and address the above-listed research questions.

Effective for dates of service April 15, 2023 through April 14, 2024:

The individual has severe degenerative, native valve aortic stenosis demonstrated by one of the following:

the aortic valve area (AVA) is equal to or less than 0.8 cm2; or
the AVA index is equal to or less than 0.5 cm2/m2; or
either a mean aortic valve gradient of more than 40 mm Hg; or
a peak aortic-jet velocity of more than 4.0 m/sec; AND

NYHA [New York Heart Association] heart failure Class II, III or IV symptoms; AND
Left ventricular ejection fraction >20%; AND
The individual does not have unicuspid or bicuspid aortic valve
- An echocardiogram, MRI or CT report must be provided confirming the individual has tricuspid morphology of the aortic valve.

Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve; AND
NYHA heart failure class II, III or IV symptoms; AND
Left ventricular ejection fraction greater than 20%

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

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

***For mitral valve replacements, please refer to medical policy 561: Mitral Valve Repair or Replacement.

POLICY GUIDELINES

The heart team must include:

Cardiovascular surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:

Independently examined the patient face to face, evaluated the patient’s suitability for SAVR, TAVR or medical or palliative therapy;
Documented and made available to other heart team members the rationale for their clinical judgement.

Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.

The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:

On-site heart valve surgery program,

Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
Appropriate volume requirements per the applicable qualifications below.

There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.

Qualifications to begin a TAVR program for hospitals without TAVR experience:

The hospital program must have the following:

≥ 50 open heart surgeries in the previous year prior to TAVR program initiation, and ;
≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;
≥ 2 physicians with cardiac surgery privileges, and;
≥ 1 physician with interventional cardiology privileges, and;
≥300 percutaneous coronary interventions (PCIs) per year.

Qualifications to begin a TAVR program for heart teams without TAVR experience:

The heart team must include:

Cardiovascular surgeon with:
1. ≥ 100 career open heart surgeries of which ≥ 25 are aortic valve related, and
Interventional cardiologist with:
1. Professional experience with ≥ 100 career structural heart disease procedures; or, 30 left-sided structural procedures per year; and,
2. Device specific training as required by the manufacturer

Qualifications for hospital programs with TAVR experience:

The hospital program must maintain the following:

≥ 50 AVRs (TAVR or SAVR) per year including ≥20 TAVR procedures in the prior year; or,
≥100 AVRs (TAVR or SAVR) every 2 years, including ≥40 TAVR procedures in the prior 2 years; and,
≥ 2 physicians with cardiac surgery privileges; and,
≥ 1 physician with interventional cardiology privileges, and
≥300 percutaneous coronary interventions (PCIs) per year.

The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:

Stroke;
All cause mortality;
Transient Ischemic Attacks (TIAs);
Major vascular events;
Acute kidney injury;
Repeat aortic valve procedures;
Quality of Life (QoL).

The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions:

When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies?
What is the long term durability of the device?
What are the long term outcomes and adverse events?
What morbidity and procedure-related factors contribute to TAVR patients outcomes?

Effective for dates of service March 21, 2020 through April 14, 2023:

The individual has severe degenerative, native valve aortic stenosis demonstrated by one of the following:

the aortic valve area (AVA) is equal to or less than 0.8 cm2; or
the AVA index is equal to or less than 0.5 cm2/m2; or
either a mean aortic valve gradient of more than 40 mm Hg; or
a peak aortic-jet velocity of more than 4.0 m/sec; AND

NYHA [New York Heart Association] heart failure Class II, III or IV symptoms; AND
Left ventricular ejection fraction >20%; AND
Patient does not have unicuspid or bicuspid aortic valves

Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve; AND
NYHA heart failure class II, III or IV symptoms; AND
Left ventricular ejection fraction greater than 20%

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

***For mitral valve replacements, please refer to medical policy 561: Mitral Valve Repair or Replacement.

POLICY GUIDELINES

The heart team must include:

Cardiovascular surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:

Independently examined the patient face to face, evaluated the patient’s suitability for SAVR, TAVR or medical or palliative therapy;
Documented and made available to other heart team members the rationale for their clinical judgement.

Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.

The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:

On-site heart valve surgery program,

Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
Appropriate volume requirements per the applicable qualifications below.

There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.

Qualifications to begin a TAVR program for hospitals without TAVR experience:

The hospital program must have the following:

≥ 50 open heart surgeries in the previous year prior to TAVR program initiation, and ;
≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;
≥ 2 physicians with cardiac surgery privileges, and;
≥ 1 physician with interventional cardiology privileges, and;
≥300 percutaneous coronary interventions (PCIs) per year.

Qualifications to begin a TAVR program for heart teams without TAVR experience:

The heart team must include:

Cardiovascular surgeon with:
1. ≥ 100 career open heart surgeries of which ≥ 25 are aortic valve related, and
Interventional cardiologist with:
1. Professional experience with ≥ 100 career structural heart disease procedures; or, 30 left-sided structural procedures per year; and,
2. Device specific training as required by the manufacturer

Qualifications for hospital programs with TAVR experience:

The hospital program must maintain the following:

≥ 50 AVRs (TAVR or SAVR) per year including ≥20 TAVR procedures in the prior year; or,
≥100 AVRs (TAVR or SAVR) every 2 years, including ≥40 TAVR procedures in the prior 2 years; and,
≥ 2 physicians with cardiac surgery privileges; and,
≥ 1 physician with interventional cardiology privileges, and
≥300 percutaneous coronary interventions (PCIs) per year.

The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:

Stroke;
All cause mortality;
Transient Ischemic Attacks (TIAs);
Major vascular events;
Acute kidney injury;
Repeat aortic valve procedures;
Quality of Life (QoL).

The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions:

When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies?
What is the long term durability of the device?
What are the long term outcomes and adverse events?
What morbidity and procedure-related factors contribute to TAVR patients outcomes?

DESCRIPTION OF THE PROCEDURE OR SERVICE:

Transcatheter aortic valve implantation (TAVI; also known as transcatheter aortic valve replacement or TAVR) is a potential treatment for patients with severe aortic stenosis (AS). This procedure is an alternative to open surgery, or surgical aortic valve replacement (SAVR), for patients with AS and as an alternative to non-surgical therapy.

Aortic Stenosis

Aortic stenosis (AS) 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 (AoV) is the most common etiology in North America and Europe, while rheumatic fever is the most common etiology in developing countries. Congenital abnormalities of the AoV, most commonly a bicuspid or unicuspid valve, increase the risk for aortic stenosis, but AS 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. Thus, the pathogenesis of calcific AS is thought to be similar to that of atherosclerosis, i.e. deposition of the atherogenic lipids and infiltration of inflammatory cells, followed by progressive calcification.

The natural history of AS 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 AS is replacement of the diseased valve with bio-prosthetic or mechanical valve.

Disease Burden

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

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 two years. Open surgical repair is an effective treatment for reversing AS, and artificial valves have demonstrated good durability for periods up to 20 years. However, these benefits are accompanied by a perioperative mortality of approximately 3%-4% and substantial morbidity, both of which increase with advancing age.

Unmet Needs

Many patients with severe, symptomatic AS are poor operative candidates. Approximately 30% of patients presenting with severe AS dos not undergo open surgery due to factors such as advanced age, advanced left ventricular dysfunction, or multiple medical comorbidities. For patients who are not surgical candidates, medical therapy can partially alleviate the symptoms of AS, but does not affect the underlying disease progression. Percutaneous balloon valvuloplasty can be performed, but this procedure has less than optimal outcomes. 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

TAVI, also known as transcatheter aortic valve replacement, has been developed in response to this unmet need and was originally intended as an alternative treatment for patients in whom surgery is not an option due to prohibitive surgical risk, or for patients who are 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 in order 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 the need for cardiopulmonary bypass.

KEY POINTS:

The most recent literature review covered the period from through January 8, 2024.

Summary of Evidence

For individuals who have severe symptomatic aortic stenosis who are at prohibitive risk for open surgery who receive TAVI, the evidence includes a randomized controlled trial (RCT) comparing TAVI with medical management in individuals at prohibitive risk of surgery, 1 single-arm prospective trial, multiple case series, and multiple systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. For patients who are not surgical candidates due to excessive surgical risk, the PARTNER B trial reported results for patients treated with TAVI by the transfemoral approach compared to continued medical care with or without balloon valvuloplasty. There was a large decrease in mortality for the TAVI patients at one year compared to medical care. This trial also reported improvements on 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 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 overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. For patients who are high risk for open surgery, but are surgical candidates, the PARTNER A trial reported non-inferiority for survival at one year for the balloon-expandable valve compared to 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 mortality or in rates of stroke between the two procedures. Since the publication of the PARTNER A trial, the CoreValve High Risk study demonstrated noninferiority for survival at one and two years for the self-expanding prosthesis. This study reported no significant differences in stroke rates between the groups. An RCT directly comparing the Portico valve with other FDA-approved valves found an increase in safety outcomes with Portico at 30 days but no major differences at 2 years. 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=0.07) 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, symptoms, morbid events, and treatment-related mortality and morbidity. Two RCTs (Evolut Low Risk Trial and PARTNER 3) have been conducted exclusively in patients at low surgical risk and 1 RCT (NOTION trial) included predominantly patients at low surgical risk. In the Evolut Low Risk Trial, TAVR 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 NOTION trial, the risk of the composite outcome of death from any cause, stroke, or MI at 5 years was similar for TAVI and SAVR and TAVR 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” 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 overall survival, 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-mmSAPIEN 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. Clinical input was sought in 2024, and it was determined that 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 does provide a clinically meaningful improvement in net health outcome and the use is consistent with generally accepted medical practice. The evidence is sufficient 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 device while undergoing TAVI, the evidence includes 1 meta-analysis, 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 3000patients 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.

Practice Guideline and Position Statements

American Heart Association and American College of Cardiology

In 2014, the American Heart Association and the American College of Cardiology published guidelines for the management of valvular heart disease. Both groups issued a joint focused update in 2017. In 2020, a new full guideline was published that replaces the 2014 and 2017 update. These 2020 guidelines make the following recommendations regarding the choice of surgical or transcatheter intervention for treatment of aortic stenosis. Additionally, the guidelines state the following:

"Treatment of severe aortic stenosis with either a transcatheter or surgical valve prosthesis should be based primarily on symptoms or reduced ventricular systolic function. Earlier intervention may be considered if indicated by results of exercise testing, biomarkers, rapid progression, or the presence of very severe stenosis."

"Indications for TAVI are expanding as a result of multiple randomized trials of TAVI versus surgical aortic valve replacement. The choice of type of intervention for a patient with severe aortic stenosis should be a shared decision-making process that considers the lifetime risks and benefits associated with type of valve (mechanical versus bioprosthetic) and type of approach(transcatheter versus surgical)."

Recommendations on Surgical or Transcatheter Intervention for Aortic Stenosis:

Timing of Intervention of AS	COR	LOE
“In adults with severe high-gradient AS (Stage D1) and symptoms of exertional dyspnea, heart failure, angina, syncope or presyncope by history or on exercise testing, AVR is indicated.”	I	A
“In asymptomatic patients with severe AS and a left ventricular ejection fraction.”	I	B
“In asymptomatic patients with severe AS (Stage C1) who are undergoing cardiac surgery for other indications, AVR is indicated."	I	B
"In symptomatic patients with low-flow, low-gradient severe AS with reduced left ventricular ejection fraction (Stage D2), AVR is recommended."	I	B
"In symptomatic patients with low-flow, low-gradient severe AS with reduced left ventricular ejection fraction (Stage D3), AVR is recommended if AS is the most likely cause of symptoms."	I	B
“In apparently asymptomatic patients with severe AS (Stage C1) and low surgical risk, AVR is reasonable when an exercise test demonstrates decreased exercise tolerance (normalized for age and sex) or a fall in systolic blood pressure of ≥10 mmHg from baseline to peak exercise."	IIa	B
“In asymptomatic patients with very severe AS (defined as an aortic velocity of ≥5 m/s) and low surgical risk, AVR is reasonable."	IIa	B
“In apparently asymptomatic patients with severe AS (Stage C1) and low surgical risk, AVR is reasonable when the serum B type natriuretic peptide level is >3 times normal."	IIa	B
"In asymptomatic patients with high-gradient severe AS (Stage C1) and low surgical risk, AVR is reasonable when serial testing shows an increase in aortic velocity ≥0.3 m/s per year."	IIa	B
"In asymptomatic patients with severe high-gradient AS (Stage C1) and a progressive decrease in left ventricular ejection fraction on at least 3 serial imaging studies to <60%, AVR may be considered.”	IIb	B
"In patients with moderate AS (Stage B) who are undergoing cardiac surgery for other indications, AVR may be considered.”	IIb	C

Choice of SAVR Versus TAVI for Patients for Whom a Bioprosthetic AVR is Appropriate
"For symptomatic and asymptomatic patients with severe AS and any indication for AVR who are <65 years of age or have a life expectancy >20 years, SAVR is recommended."	I	A
"For symptomatic patients with severe AS who are 65 to 80 years of age and have no anatomic contraindication to transfemoral TAVI, either SAVR or transfemoral TAVI is recommended after shared decision-making about the balance between expected patient longevity and valve durability."	I	A
"For symptomatic patients with severe AS who are >80 years of age or for younger patients with a life expectancy of < 10years and no anatomic contraindication to transfemoral TAVI, transfemoral TAVI is recommended in preference to SAVR."	I	A
"In asymptomatic patients with severe AS and a left ventricular ejection fraction <50% who are ≤80 years of age and have no anatomic contraindication to transfemoral TAVI, the decision between TAVI and SAVR should follow the same recommendations as for symptomatic patients in the 3 recommendations above."	I	B
"For asymptomatic patients with severe AS and an abnormal exercise test, very severe AS, rapid progression, or an elevated B-type natriuretic peptide, SAVR is recommended in preference to TAVI."	I	B
"For patients with an indication for AVR for whom a bioprosthetic valve is preferred but valve or vascular anatomy or other factors are not suitable for transfemoral TAVI, SAVR is recommended."	I	A
"For symptomatic patients of any age with severe AS and a high or prohibitive surgical risk, TAVI is recommended if predicted post-TAVI survival is >12 months with an acceptable quality of life."	I	A
"For symptomatic patients with severe AS for whom predicted post-TAVI or post-SAVR survival is <12 months or for whom minimal improvement in quality of life is expected, palliative care is recommended after shared decision-making, including discussion of patient preferences and values."	I	C
"In critically ill patients with severe AS, percutaneous aortic balloon dilation may be considered as a bridge to SAVR or TAVI."	IIb	C
Intervention for Prosthetic Valve Stenosis
“In patients with symptomatic severe stenosis of a bioprosthetic or mechanical prosthetic valve, repeat surgical intervention is indicated unless surgical risk is prohibitive.”	I	B
“For severely symptomatic patients with bioprosthetic aortic valve stenosis and high or prohibitive surgical risk, a transcatheter ViV procedure is reasonable when performed at a Comprehensive Valve Center.”	IIa	B
“For patients with significant bioprosthetic valve stenosis attributable to suspected or documented valve thrombosis, oral anticoagulation with a VKA is reasonable.”	IIa	B
Prosthetic Valve Regurgitation
“In patients with intractable hemolysis or HF attributable to prosthetic transvalvular or paravalvular leak, surgery is recommended unless surgical risk is high or prohibitive.”	I	B
“In asymptomatic patients with severe prosthetic regurgitation and low operative risk, surgery is reasonable.”	IIa	B
“In patients with prosthetic paravalvular regurgitation with the following: 1) either intractable hemolysis or NYHA class III or IV symptoms and 2” who are at high or prohibitive surgical risk and 3: have anatomic features suitable for catheter based therapy , percutaneous repair of paravalvular leak is reasonable when performed at a Comprehensive Valve Center.”	IIa	B
“For patients with severe HF symptoms caused by bioprosthetic valve regurgitation who are at high to prohibitive surgical risk, a transcatheter ViV procedure is reasonable when performed at a Comprehensive Valve Center.”	IIa	B

National Institute for Health and Care Excellence

In June 2019, the National Institute for Health and Care Excellence published interventional procedures guidance [IPG653] regarding valve-in-valve TAVI for aortic bioprosthetic valve dysfunction. The guidance was informed by an Interventional procedure overview described previously. The guidance recommendation is that "Current evidence on the safety and efficacy of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) for aortic bioprosthetic dysfunction is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit."

In November 2021, the NICE updated their guidance on heart valve disease. They recommend patients be offered TAVI if SAVR is contraindicated or the patient is at high surgical risk.

U.S. Preventive Services Task Force Recommendations

Transcatheter aortic valve implantation is not a preventive service.

KEY WORDS:

Transcatheter aortic valve implantation, TAVI, The Edwards SAPIEN heart-valve system™, Medtronic CoreValve ReValving System™, SAPIEN XT™, porcine bioprosthetic valve, SAPIEN™ heart-valve system, aortic valve replacement, AVR, catheter-delivered prosthetic aortic heart valve, aortic valve replacement, transcatheter aortic valve replacement, TAVR, Edwards SAPIEN™ transcatheter heart valve, valve-in-valve, Sapien 3; Portico, Portico with FlexNav, FlexNav, cerebral embolic protection, Sentinel, Navitor, Navitor Transcatheter Aortic Valve Implantation System

APPROVED BY GOVERNING BODIES

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

FDA-approved Transcatheter Aortic Valve Device Systems

Device and Indication	Manufacturer	Date Cleared	PMA
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	P100041
Edwards SAPIEN™ Transcatheter Heart Valve, Model 9000TFX Expanded to include high-risk aortic stenosis (transapical approach)		10/12	P110021
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	P130009
Expanded to include failure of bioprosthetic valve in high or greater risk for open surgical therapy		10/15	P130009/S034
Expanded to include severe aortic stenosis with intermediate surgical risk		08/16	P130009/S057
SAPIEN 3 Ultra THV System, a design iteration Severe aortic stenosis with high or greater risk for open surgical therapy		06/15	P140031
Expanded to include failure of a bioprosthetic valve with high or greater risk for open surgical therapy		06/17	P14003/S028
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	P140031
Expanded to include severe aortic stenosis with low surgical risk		08/19	P140031/S085
Expanded to include failure of a bioprosthetic valve with high or greater risk for open surgical therapy		09/20	P140031/S112
Medtronic CoreValve System™ Severe native aortic stenosis at extreme risk or inoperable for open surgical therapy	Medtronic CoreValve	01/14	P130021
Expanded to include high-risk for open surgical therapy		06/16	P130021/S002
Expanded to include intermediate risk for open surgical therapy		07/17	P130021/S033
Medtronic CoreValve Evolut R System™ (design iteration for valve and accessories)		06/15	P130021/S014
Expanded to include intermediate risk for open surgical therapy		07/17	P130021/S033
Medtronic CoreValve Evolut PRO System™ (design iteration for valve and accessories, includes porcine pericardial tissue wrap)		03/17	P130021/S029
Expanded to include intermediate risk for open surgical therapy		07/17	P130021/S033
Expanded to include severe aortic stenosis with low surgical risk		08/19	P130021/S058
Medtronic CoreValve Evolut PRO+ System™ (design iteration)		08/19	P130021/S059
Medtronic Evolut™ FX System (design iteration)		08/21	P130021/S091
LOTUS Edge™ Valve System Severe native aortic stenosis at high or greater risk for open surgical therapy *See Note	Boston Scientific Corporation	04/19	P180029
Portico™ with FlexNav™ Severe aortic stenosis at high or greater risk for open heart surgery	Abbott	09/21	P190023
Navitor™ Transcatheter Aortic Valve Implantation System Severe native aortic stenosis at high or greater risk for open heart surgery	Abbott	10/23	P190023/S016

FDA: 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 LOTUSEdge™ Valve System due to complexities associated with the product delivery system. There are no safety concerns for patents 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. The following repositionable valve is under investigation:

JenaValve™ (JenaValve Technology); repositional 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.

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). The Sentinel system is a temporary catheter indicated for use as an embolic protection deice 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). 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.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:

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 (e.g., median sternotomy, mediastinotomy)
33366	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (e.g., left thoracotomy)
33367	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (e.g., 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 (e.g., 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 (e.g., aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure)

33370

Transcatheter placement and subsequent removal of cerebral embolic protection device(s), including arterial access, catheterization, imaging, and radiological supervisions and interpretation, percutaneous

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Makkar RR, Thourani VH, Mack MJ, et al. Five-Year outcomes of transcatheter or surgical aortic-valve replacement. N EnglJ Med. Feb 27 2020; 382(9): 799-809.
Manoharan G, Walton AS, Brecker SJ, et al. Treatment of symptomatic severe aortic stenosis with a novel resheathable supra-annular self-expanding transcatheter aortic valve system. JACC Cardiovasc Interv. Aug 24 2015; 8(10):1359-1367.
Meredith IT, Walton A, Walters DL, et al. Mid-term outcomes in patients following transcatheter aortic valve implantation in the CoreValve Australia and New Zealand Study. Heart Lung Circ. Mar 2015; 24(3):281-290.
Minutello RM, Wong SC, Swaminathan RV, et al. Costs and in-hospital outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in commercial cases using a propensity score matched model. Am J Cardiol. May 15 2015; 115(10):1443-1447.
Muneretto C, Bisleri G, Moggi A, et al. Treating the patients in the 'grey-zone' with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement. Interact Cardiovasc Thorac Surg. Jan 2015; 20(1):90-95.
Murarka S, Lazkani M, Neihaus M, et al. Comparison of 30-day outcomes of transfemoral versus transapical approach for transcatheter aortic valve replacement: a single-center US experience. Ann Thorac Surg. May 2015; 99(5):1539-1544.
National Institute For Health And Care Excellence. Heart valve disease presenting in adults: investigation and management [NG208]. November 2021. https://www.nice.org.uk/guidance/ng208/chapter/Recommendations#interventions
National Institute For Health And Care Excellence. Interventional procedure overview of valve-in-valve TAVI for aortic bioprosthetic valve dysfunction (IP 1013/2 [IPG653]). June 2019. https://www.nice.org.uk/guidance/ipg653/evidence/overview-final-pdf-6834685357.
National Institute For Health And Care Excellence. Valve-in-valve TAVI for aortic bioprosthetic valve dysfunction, Interventional procedures guidance [IPG653]. June 2019. https://www.nice.org.uk/guidance/ipg653.
Nielsen HH, Klaaborg KE, Nissen H, et al. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial. EuroIntervention. Jul 20 2012; 8(3):383-389.
Nishimura RA, O'Gara PT, Bonow RO. Guidelines update on indications for transcatheter aortic valve replacement. JAMA Cardiol. Sep 1 2017;2(9):1036-1037.
Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. Mar 3 2014.
Osnabrugge RL, Arnold SV, Reynolds MR, et al. Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial. JACC Cardiovasc Interv. Feb 2015; 8(2):315-323.
Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the management of patients with valvular heart disease: A report of the american college of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. Feb 02 2021; 77(4): e25-e197.
Panchal HB, Ladia V, Amin P, et al. A meta-analysis of mortality and major adverse cardiovascular and cerebrovascular events in patients undergoing transfemoral versus transapical transcatheter aortic valve implantation using Edward’s valve for severe aortic stenosis. Am J Cardiol. Dec 15 2014; 114(12):1882-1890.
Panoulas VF, Francis DP, Ruparelia N, et al. Female-specific survival advantage from transcatheter aortic valve implantation over surgical aortic valve replacement: Meta-analysis of the gender subgroups of randomised controlled trials including 3758 patients. Int J Cardiol. Jan 1 2018;250:66-72.
Park DY, An S, Kassab K, et al. Chronological comparison of TAVI and SAVR stratified to surgical risk: a systematic review, meta-analysis, and meta-regression. Acta Cardiol. Sep 2023; 78(7): 778-789.
Phan K, Zhao DF, Wang N, Huo YR, Di Eusanio M, Yan TD. Transcatheter valve-in-valve implantation versus reoperative conventional aortic valve replacement: a systematic review. J Thorac Dis. 2016 Jan;8(1):E83-93.
Piazza N, Grube E, Gerckens U et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18Fr) CoreValve ReValving System: results from the multicenter, expanded evaluation registry 1-years following CE mark approval. EuroIntervention 2008; 4(2):242-9.
Pibarot P, Salaun E, Dahou A, et al. Echocardiographic results of transcatheter versus Surgical Aortic Valve Replacement inLow-Risk Patients: The PARTNER 3 Trial. circulation. May 12 2020; 141(19): 1527-1537.
Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter Aortic Valve Replacement Using A Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery. J Am Coll Cardiol. Mar 13 2014.
Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. May 02 2019; 380(18): 1706-1715.
Raschpichler M, de Waha S, Holzhey D, et al. Valve-in-valve transcatheter aortic valve replacement versus redo surgical aortic valve replacement for failed surgical aortic bioprostheses: A systematic review and meta-analysis. JAm Heart Assoc. Dec 20 2022; 11(24): e7965.
Raval J, Nagaraja V, Eslick GD, et al. Transcatheter Valve-in-valve implantation: A systematic review of literature. Heart Lung Circ. Jun 24 2014.
Reardon MJ, Adams DH, Coselli JS, et al. Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery. J Thorac Cardiovasc Surg. Jul 30 2014.
Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol. Jul 14 2015; 66(2):113-121.
Reardon MJ, Kleiman NS, Adams DH, et al. Outcomes in the randomized corevalve us pivotal high risk trial in patients with a Society of Thoracic Surgeons Risk Score of 7% or less. JAMA Cardiol. Nov 1 2016;1(8):945-949.
Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. Apr 6 2017;376(14):1321-1331.
Reuthebuch O, Inderbitzin DT, Ruter F, et al. Single-center experience and short-term outcome with the JenaValve: a second-generation transapical transcatheter aortic valve implantation device. Innovations (Phila). Sep-Oct 2014; 9(5):368-374; discussion 374.
Reuthebuch O, Koechlin L, Kaufmann BA, et al. Transapical Transcatheter Aortic Valve Implantation Using the JenaValve: A One-Year Follow-up. Thorac Cardiovasc Surg. Sep 2015; 63(6):493-500.
Reynolds MR, Magnuson EA, Lei Y et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation 2011; 124(18):1964-72.
Reynolds MR, Magnuson EA, Wang K et al. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol 2012; 60(6):548-58.
Rodes-Cabau J, Web JG, Cheung A et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk. J Am Coll Cardiol 2010; 55(11):1080-90.
Sa MP, Van den Eynde J, Simonato M, et al. Late outcomes of valve-in-valve transcatheter aortic valve implantation versus re-replacement: Meta-analysis of reconstructed time-to-event data. Int J Cardiol. Jan 01 2023; 370: 112-121.
Sa MP, Jacquemyn X, Van den Eynde J, et al. Midterm Survival of Low-Risk Patients Treated With Transcatheter VersusSurgical Aortic Valve Replacement: Meta-Analysis of Reconstructed Time-to-Event Data. J Am Heart Assoc. Nov 07 2023;12(21): e030012.
Saleem S, Ullah W, Syed MA, et al. Meta-analysis comparing valve-in-valve TAVR and redo-SAVR in patients with degenerated bioprosthetic aortic valve. Catheter Cardiovasc Interv. Nov 01 2021; 98(5): 940-947.
Schymik G, Wurth A, Bramlage P, et al. Long-term results of transapical versus transfemoral TAVI in a real world population of 1000 patients with severe symptomatic aortic stenosis. Circ Cardiovasc Interv. Jan 2015; 8(1).
Sedaghat A, Al-Rashid F, Sinning JM, et al. Outcome in TAVI patients with symptomatic aortic stenosis not fulfilling PARTNER study inclusion criteria. Catheter Cardiovasc Interv. Nov 15 2015; 86(6):1097-1104.
Shahim B, Malaisrie SC, George I, et al. Postoperative atrial fibrillation or flutter following transcatheter or surgical aortic valve replacement: PARTNER 3 Trial. JACC Cardiovasc Interv. Jul 26 2021; 14(14): 1565-1574.
Siemieniuk RA, Agoritsas T, Manja V, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis. BMJ. Sep 28 2016; 354:i5130.
Singh K, Carson K, Rashid MK, et al. Transcatheter aortic valve implantation in intermediate surgical risk patients with severe aortic stenosis: a systematic review and meta-analysis. Heart Lung Circ. Feb 2018;27(2):227-234.
Siontis GC, Juni P, Pilgrim T, et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol. Jul 15 2014; 64(2):129-140.
Smith CR, Leon MB, Mack MJ et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364(23):2187-98.
Søndergaard L, Ihlemann N, Capodanno D, et al. Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk. J Am Coll Cardiol. 2019 Feb 12;73(5):546-553.
Søndergaard L, Steinbruchel DA, Ihlemann N, et al. Two-year outcomes in patients with severe aortic valve stenosis randomized to transcatheter versus surgical aortic valve replacement: the all-comers nordic aortic valve intervention randomized clinical trial. Circ Cardiovasc Interv. Jun 2016;9(6).
Spertus J, Peterson E, Conard MW, et al. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. Oct 2005; 150(4): 707-15.
Svensson LG, Blackstone EH, Rajeswaran J, et al. Comprehensive analysis of mortality among patients undergoing TAVR: results of the PARTNER trial. J Am Coll Cardiol. Jul 15 2014; 64(2):158-168.
Takagi H, Niwa M, Mizuno Y, et al. A meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement. Ann Thorac Surg. Aug 2013; 96(2):513-519.
Tam DY, Dharma C, Rocha RV, et al. Transcatheter ViV Versus Redo Surgical AVR for the Management of FailedBiological Prosthesis: Early and Late Outcomes in a Propensity-Matched Cohort. JACC Cardiovasc Interv. Mar 23 2020;13(6): 765-774.
Tam DY, Vo TX, Wijeysundera HC, et al. Transcatheter vs surgical aortic valve replacement for aortic stenosis in low-intermediate risk patients: a meta-analysis. Can J Cardiol. Sep 2017;33(9):1171-1179.
Tam DY, Vo TX, Wijeysundera HC, Dvir D, Friedrich JO, Fremes SE. Transcatheter valve-in-valve versus redo surgical aortic valve replacement for the treatment of degenerated bioprosthetic aortic valve: A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2018 Dec 1;92(7):1404-1411. Epub 2018 Jul 19.
Tamburino C, Barbanti M, D'Errigo P, et al. 1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement: results from the Italian OBSERVANT Study. J Am Coll Cardiol. Aug 18 2015; 66(7):804-812.
Tamburino C, Capodanno D, Ramondo A et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 2001; 123(3):299-308.
Tanawuttiwat T, O'Neill BP, Cohen MG, et al. New-onset Atrial Fibrillation after Aortic Valve Replacement: Comparison of Transfemoral, Transapical, Transaortic and Surgical Approaches. J Am Coll Cardiol. Jan 17 2014.
Thomas M, Schymik G, Walther T et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 2011; 124(4):425-33.
Thyregod HGH, Ihlemann N, Jorgensen TH, et al. Five-Year Clinical and Echocardiographic Outcomes from the Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial in Lower Surgical Risk Patients.. Circulation, 2019 Feb 2.
Thyregod HG, Steinbruchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. May 26 2015; 65(20):2184-2194.
Toff WD, Hildick-Smith D, Kovac J, et al. Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis: A randomized clinical trial. JAMA. May 17 2022;327(19): 1875-1887.
Ueshima D, Fovino LN, D'Amico G et al. Transcatheter versus surgical aortic valve replacement in low- and intermediate-risk patients: an updated systematic review and meta-analysis.. Cardiovasc Interv Ther, 2018 Sep 21;34(3).
Van Belle E, Juthier F, Susen S, et al. Postprocedural Aortic Regurgitation in Balloon-Expandable and Self-Expandable Transcatheter Aortic Valve Replacement Procedures: Analysis of Predictors and Impact on Long-Term Mortality: Insights From the FRANCE2 Registry. Circulation. Apr 1 2014; 129(13):1415-1427.
van der Boon RM, Marcheix B, Tchetche D, et al. Transapical versus transfemoral aortic valve implantation: a multicenter collaborative study. Ann Thorac Surg. Jan 2014; 97(1):22-28.
Van Mieghem NM, Deeb GM, Søndergaard L, et al. Self-expanding Transcatheter vs Surgical Aortic Valve Replacement inIntermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial. JAMA Cardiol. Oct 01 2022;7(10): 1000-1008.
Van Mieghem NM, van Gils L, Ahmad H, et al. Filter-based cerebral embolic protection with transcatheter aortic valveimplantation: the randomised MISTRAL-C trial. EuroIntervention. Jul 20 2016; 12(4): 499-507.
van Steenbergen GJ, van Straten B, Lam KY, et al. Report on outcomes of valve-in-valve transcatheter aortic valve implantation and redo surgical aortic valve replacement in the Netherlands. Neth Heart J. Feb 2022; 30(2): 106-112.
Villablanca P, Briceño D, Makkiya M, et al. Long-term outcomes of transcatheter versus surgical aortic valve replacement for severe aortic stenosis: a meta-analysis and meta-regression: PROSPERO 2016:CRD42016036772. PROSPERO International prospective register of systematic reviews 2016; www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016036772. Accessed February 1, 2017.
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POLICY HISTORY:

Medical Policy Group, September 2011(2): New policy

Medical Policy Administration Committee, September 2011

Available for comment September 22 through November 7, 2011

Medical Policy Panel, December 2011

Medical Policy Group, January 2012 (2): Policy, Key Points, Governing Bodies, References updated, Key Words

Medical Policy Administration Committee, January 2012

Available for comment January 30 – March 14, 2012

Medical Policy Group, November 2012: 2013 Coding Updates – Added Codes 33361, 33362, 33364, 33365, 33367, 33368, 33369; deleted 0256T, 0257T, 0258T, 0259T; verbiage change 0318T: all effective 1/1/2013

Medical Policy Panel, December 2012

Medical Policy Group, March (2): Coverage indications added for patients who are at high risk for open surgery using the transfemoral approach, and patients who are at high risk for open surgery using the transapical approach. Investigational statement added for treatment of degenerated bio-prosthetic valve or failed TAVI (Valve-in-Valve approach), and for vascular approaches other than transfemoral or transapical. Key Points and References updated to support references. Approved Governing Bodies updated with information on the Edwards SAPIEN™ transcatheter heart valve. Key words updated.

Medical Policy Administration Committee, April 2013

Available for comment April 18 through June 5, 2013

Medical Policy Group, December 2013 (3): 2014 Coding Update – added code 33366 to current coding (effective 1/1/14); moved code 0318T to previous coding (deleted effective 01/01/2014)

Medical Policy Panel, October 2014

Medical Policy Group, October 2014 (3): 2014 Updates to Description, Key Points, Governing Bodies & References; Policy section updated to expand coverage statement to include “Transcatheter aortic valve replacement with an FDA-approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA-approved labeling”

Medical Policy Administration Committee, November 2014

Available for comment October 24 through December 4, 2014

Medical Policy Group April 2015 (4): Update to Approved Governing Bodies, Key Words and References. Added FDA approved use of CoreValve for valve-in-valve replacements. No change to policy statement.

Medical Policy Group, June 2015 (4): Updates to Approved by Governing Bodies, Key Words, and References. No change to policy statement.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (4): Updates to Description, Key Points, Approved Governing Bodies, Coding and References. From policy section, removed “Effective for dates of service January 1, 2012 through June 5, 2013” and Effective for dates of service prior to January 1, 2012”. Also in the Policy section, valve in valve procedures updated to meet medical criteria for coverage with certain criteria.

Medical Policy Administration Committee, September 2016

Available for comment August 30 through October 14, 2016

Medical Policy Group, December 2016: 2017 Annual Coding Update. Added new cpt codes 93591 and 93592 to Current Coding.

Medical Policy Panel, February 2017

Medical Policy Group, March 2017 (4): Updates to Key Points, Approved by Governing Bodies, and References. No change to policy statements. Removed CPT codes 93591 and 93592, codes do not apply to this policy.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (4): Updates to Description, Policy, Key Points, Approved by Governing Bodies, and References. Updated policy statement to allow coverage for intermediate risk for open surgery for TAVR. Removed policy statements for dates of service June 6, 2013 through October 8, 2014. Removed Previous coding section (codes 0256T – 0259T, and 0318T). CPT codes were deleted in 2013.

Medical Policy Administrative Committee: May 2018

Available for comment: May 2, 2018 – June 17, 2018

Medical Policy Panel, February 2019

Medical Policy Group, March 2019 (4): Updates to Description, Key Points, and References. No change to policy statements.

Medical Policy Group, December 2019 (4): Updates to Policy section, Approved by Governing Bodies, and References. Removed policy statements effective for dates of service 10/9/14-8/30/16. Added criteria for patients other than high risk for surgery and added policy guideline section.

Medical Policy Administrative Committee: December 2019

Available for Comment: December 3, 2019 through January 17, 2020

Medical Policy Panel, January 2020

Medical Policy Group, February 2020 (4): Updates to Description, Key Points, and References. Policy statement updated to include that patient does not have unicuspid or bicuspid aortic valves. Clarification made to 2nd policy statement for valve-in-valve.

Available for Comment: February 5, 2020 – March 21, 2020

Medical Policy Administrative Committee, February 2020

Medical Policy Panel, February 2021

Medical Policy Group, February 2021 (4): Updates to Key Points, Approved by Governing Bodies and References. No change to policy statements.

Medical Policy Group, October 2021 (4): Update to Approved Governing Bodies, Key Words and References. Added Portico with FlexNav to list of FDA approved devices. Added Key Words: Portico, Portico with FlexNav, FlexNav.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (4): Updates to Policy Guidelines, Description, Key Points, Approved Governing Bodies, and References. Removed policy statements effective for dates of service on and after August 30, 2016 through April 30, 2018. No change to policy statements. Removed the following references: Arnold M, Schulz-Heise S, Achenbach S, et al. Embolic cerebral insults after transapical aortic valve implantation detected by magnetic resonance imaging. JACC Cardiovasc Interv. Nov 2010;3(11):1126-1132; Baumgartner H, Bonhoeffer P, De Groot NM, et al. ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. Dec 2010; 31(23):2915-2957; Dewey TM, Bowers B, Thourani VH, et al. Transapical aortic valve replacement for severe aortic stenosis: results from the nonrandomized continued access cohort of the PARTNER trial. Ann Thorac Surg. Dec 2013; 96(6):2083-2089; Dvir D, Webb JG, Bleiziffer S, et al. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA. Jul 2014; 312(2):162-170; Dvir D, Webb J, Brecker S et al. Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves: Results from the Global Valve-in-Valve Registry. Circulation 2012; Ewe SH, Delgado V, Ng AC et al. Outcomes after transcatheter aortic valve implantation: transfemoral versus transapical approach. Ann Thorac Surg 2011; 92(4):1244-51; Genereux P, Kodali SK, Green P et al. Incidence and Effect of Acute Kidney Injury After Transcatheter Aortic Valve Replacement Using the New Valve Academic Research Consortium Criteria. Am J Cardiol Jan 1 2013; 111(1):100-105; Gensas CS, Caixeta A, Siqueira D, et al. Predictors of permanent pacemaker requirement after transcatheter aortic valve implantation: insights from a Brazilian registry. Int J Cardiol. Aug 1 2014; 175(2):248-252; Ghanem A, Muller A, Nahle CP, et al. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol. Apr 6 2010;55(14):1427-1432; Gurvitch R, Wood DA, Tay EL et al. Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort. Circulation 2010; 122(13):1319-27; Holmes DR, Jr., Mack MJ. Transcatheter valve therapy a professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. J Am Coll Cardiol 2011; 58(4):445-55; Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. Feb 23 2010;121(7):870-878; Khatri PJ, Webb JG, Rodes-Cabau J, et al. Adverse effects associated with transcatheter aortic valve implantation: a meta-analysis of contemporary studies. Ann Intern Med. Jan 1 2013; 158(1):35-46; Khawaja MZ, Thomas M, Joshi A, et al. The effects of VARC-defined acute kidney injury after transcatheter aortic valve implantation (TAVI) using the Edwards bioprosthesis. EuroIntervention. Sep 2012;8(5):563-570; Latib A, Ielasi A, Montorfano M et al. Transcatheter valve-in-valve implantation with the Edwards SAPIEN in patients with bioprosthetic heart valve failure: the Milan experience. EuroIntervention 2012; 7(11):1275-84; Lenders GD, Collas V, Hernandez JM, et al. Depth of valve implantation, conduction disturbances and pacemaker implantation with CoreValve and CoreValve Accutrak system for Transcatheter Aortic Valve Implantation, a multi-center study. Int J Cardiol. Aug 1 2014; Li X, Kong M, Jiang D, et al. Comparison 30-day clinical complications between transfemoral versus transapical aortic valve replacement for aortic stenosis: a meta-analysis review. J Cardiothorac Surg. 2013; 8:168; Linke A, Woitek F, Merx MW et al. Valve-in-Valve implantation of Medtronic corevalve prosthesis in patients with failing bioprosthetic aortic valves. Circ Cardiovasc Interv 2012; 5(5):689-97; Moat NE, Ludman P, de Belder MA et al. Long-Term Outcomes after Transcatheter Aortic Valve Implantation in High-risk patients with Severe Aortic Stenosis: The U.K. TAVI (united Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol 2011; 58(20):2130-8; Panchal HB, Ladia V, Desai S, et al. A meta-analysis of mortality and major adverse cardiovascular and cerebrovascular events following transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis. Am J Cardiol. Sep 15 2013; 112(6):850-860; Piazza N, Kalesan B, van Mieghem N, et al. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients. JACC Cardiovasc Interv. May 2013; 6(5):443-451; Smith CR. Transcatheter vs. surgical aortic valve replacement in high risk patients with severe aortic stenosis; results from the PARTNER trial. 2011 American College of Cardiology Annual Meeting. Oral Presentation; April 3, 2011; New Orleans, LA; Spertus J, Peterson E, Conard MW, et al. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. Oct 2005; 150(4): 707-15; Subban V, Savage M, Crowhurst J, et al. Transcatheter valve-in-valve replacement of degenerated bioprosthetic aortic valves: a single Australian Centre experience. Cardiovasc Revasc Med. Nov-Dec 2014; 15(8):388-392; Toggweiler S, Wood DA, Rodes-Cabau J et al. Transcatheter valve-in-valve implantation for failed balloon-expandable transcatheter aortic valves. JACC Cardiovasc Interv 2012; 5(5):571-7; van der Boon RM, Marcheix B, Tchetche D, et al. Transapical Versus Transfemoral Aortic Valve Implantation: A Multicenter Collaborative Study. Ann Thorac Surg. Nov 19 2013; Van Mieghem NM, Tchetche D, Chieffo A et al. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation. Am J Cardiol 2012; 110(9):1361-7.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (4): Updates to Policy, Key Points, Approved by Governing Bodies, Benefits Application, Key Words, Current Coding and References. Removed policy statements with effective for dates of service December 1, 2019 through March 20, 2020 and May 1, 2018 through November 30, 2019. Added investigational policy statement related the use of cerebral embolic protection devices. Added CPT code 33370 to Current Coding. Added Key Words Sentinel and cerebral embolic protection.

Medical Policy Administrative Committee: March 2023

Available for Comment: March 1, 2023 through April 15, 2023

Medical Policy Group, June 2023 (4): Added Navitor Transcatheter Aortic Valve Implantation System to Approved by Governing Bodies. References updated.

Medical Policy Group, August 2023 (4): Clarified Policy section by removing "Please refer to Policy Guidelines."

Medical Policy Group, September 2023 (4): Clarified Policy section by adding bullet point for imaging report of aortic tricuspid valve must be provided.

Medical Policy Panel, February 2024

Medical Policy Group, February 2024 (4): Updates to Policy, Key Points, Approved by Governing Bodies and References. Policy section updated to remove criteria point for left ejection fraction >20%.

Medical Policy Administration Committee, February 2024

Available for Comment March 1, 2024 – April 15, 2024

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.